PAGENO="0001"
NATiONAL HEART, BLOOD YESSEL LUNG, AND
BLOOD ACT OF 1972
7Z(oO: flCJ
HEARINGS
BEFORE THE
SUBCOMMITTEE ON
PUBLIC HEALTH AND ENVIRONMENT
OF THE
COMMITTEE ON
INTERSTATE AND FOREIGN COMMERCE
HOUSE OF REPRESENTATIVES
NINETY-SECOND CONGRESS
SECOND SESSION
ON
H.R.12571, H.R. 13715, H.R. 12460, H.R. 13500,
-" S. 3323 (and identical bills)
TO AMEND THE PUBLIC HEALTH SERVICE ACT SO AS TO
ADVANCE THE NATIONAL EFFORT AGAINST HEART, BLOOD
VESSEL, LUNG, AND BLOOD DISEASES AND AGAINST
NEUROLOGICAL DISEASES AND STROKE, AND FOR OTHER
PURPOSES
APRIL 25 AND 26, 1972
Serial No. 92-71
Printed for the use of the
Committee on Interstate and Foreign Commerce
RUTGERS LAW SCHOOL LIBRARY
~ CAMDEN, N. J. 08102
~OVERNMENT DOCUMENT
tLS. GOVERNMENT PRINTING OFFICE
WASHINGTON: 1~72
PAGENO="0002"
COMMITTEE ON INTERSTATE AND POREIGN COMMERCE
HARLEY 0. STAGGERS, West Virginia, C7&airman
TORBERT H. MACDONALD, Massachusetts
JOHN JARMAN, Oklahoma
JOHN B. MOSS, California
JOHN D. DINGELL, Michigan
PAULO. ROGERS, Florida
LIONEL VAN D]DERLIN, California
J. J. PICKLE, Texas
FRED B. ROONIIIY, Pennsylvaiila
JOHN N. MURPHY1 New York
DAVID B SATTERFIELD III, Virginia
BROCK ADAMS, Washington
RAY BLANTON, Tennessee
W. S. (BILL) STVCKEY, JR., Georgia
PETER N. KYROS, ilfaine
BOB ECKHARDT, Texas
ROBERTO. TIERNAN, Rhode Island
RICHARDSON PREYER, North Carolina
BERTRAM L PODELL, New York
HENRY HELSTOSKI, New Jersey
JAMES W. SYMINGTQN,. Missouri
CHARLES J. CARNBIZ, Ohio
RALPH H. METCALFE, IlIinois~
000DLOB E. BYROl~,MaryIand.
WILLIAM R. ROY, Kansas
JAMES N. MESWER, Jr.
WILLIAM J. DixoN
WILLIAM L. SPEINOER, Illinois
SAMUEL L DEVINE, Ohio
ANCHER NELSEN, Minnesota
HASTINGS KEITH, Massachusetts
JAMES T. BROYHILL, North Carolina
JAMES HARVEY, Michigan
TIM LEE CARTER, Kentucky
CLARZNC~ J. BROWN, Ohio
DAN KUYKENDALL, Tennessee
JOE SKUBIPZ,Kansas
FLETChER THOMPSON, Georgia
JAMES F. HASTINGS, New York
JOHN 0, SCHMITZ, ~aliforn4a
JAMES N. COLLINS, Texas
LOUIS FREY, JR., Florida
JOHN WARE, Pennsylvania
JOHN Y. McCOLLISTER, Nebraska
RICHARD 0. SHOUP, Montana
ROBERT F. OUTHRIE
KuRT BORCHARDT
SUBCOMMITTEE ON Puisuc UEALTH AND ENVIRONMENT
PAULO. ROGERS, Florida, Chairman
DAVID B. SATTERFIELD III, Virginia ANCHER NELSEN, Minnesota
PETER N. KYROS, Maine TIM LEE CARTER, Kentucky
RICHARDSON PREYER, North Carolina JAMES F. HASTINGS, New York
JAMES W. SYMINOTON, Missouri JOHN 0. SCHMITZ, California
WILLIAM R. ROY, Kansas
(II)
W. B. WILLIAMSON, Clerk
KENNETH J. PAINTER, ilesistant Clerk
Professional Siaff
CHARLES B. CURTIS
PAGENO="0003"
CONTENTS
Hearings held on- Page
April 25, 1972 1
April 26, 1972 195
Text of-
H.R. 12460 39
H.R.12571 2
H.R. 13500 59
H.R. 13715 21
H.R. 14493 63
H.R. 14682 63
H.R. 14686 63
S.3323 63
Report of-
Defense Department on H.R. 12460 and H.R. 12571 84
Health, Education, and Welfare Department on H.R. 12460, H.R.
12571, H.R. 13500, H.R. 13715, and S. 3323 84
Office of Management and Budget on H.R. 12460, H.R. 12571, H.R.
13500, H.R. 13715, and S. 3323 85
Statement of-
Baker, Dr. A. B., professor of neurology University of Minnesota
Medical School, on behalf of National áommittee for Research on
Neurological Disorders 291, 296
Barbero, Dr. Giulio J., chairman, General Medical and Scientific
Advisory Council, National Cystic Fibrosis Research Foundation. - 214
Bowsher, Prentice, staff member, Association of American Medical
Colleges 122
Cooper, Dr. John A. D., president, Association of American Medical
Colleges 122
Cooper, Dr. Theodore, Director, National Heart and Lung Institute,
National Institutes of Health, Department of Health, Education,
and Welfare 85, 145
DeBakey, Dr. Michael E., Baylor College of Medicine, Texas Medical
Center, in behalf of American Heart Association 197, 201
Duncan, Hon. John J., a Representative in Congress from the State
of Tennessee 195
DuVal, Dr. Merlin K., Assistant Secretary for Health and Scientific
Affairs, Department of Health, Education, and Welfare 85
Eilberg, Hon. Joshua, a Representative in Congress from the State
of Pennsylvania 282
Fox, Dr. Samuel M., III, president, American College of Cardiology. - 132
Goddard, Dr. Roy F., chairman, Pediatric Pulmonary Association - - 220
Hurst, Dr. Willis, president, American Heart Association 197
Kent, Dr. Donald C., medical director, National Tuberculosis and
Respiratory Disease Association 210
Marston, Dr. Robert Q., Director, National Institutes of Health,
Department of Health, Education, and Welfare 85
Olsen, Dr. Arthur M., past president, American College of Chest
Physicians 283
Oski, Dr. Frank, chief of hematology, Children's Hospital, Phila-
delphia, Pa 311
Plum, Dr. Fred, neurologist-in-chief, New York Hospital, and pro-
fessor and chairman, Department of Neurology, Cornell University
Medical College, New York City 291
Riccio, Leonard, founder of "Tommy Fund," Norristown, Pa 311
Soffer, Dr. Alfred, executive director, American College of Chest
Physicians 283, 288
Zapp, Dr. John S., Deputy Assistant Secretary for Legislation
(Health), Department of Health, Education, and Welfare 85, 145
(III)
PAGENO="0004"
Iv
Additional material submitted for the record by-
American Association of Neurological Surgeons, letter dated May 9,
1972, from William F. Meacham, M.D., president, to Chairman
Rogers, urging that stroke research not be moved to National Heart Page
and Lung Institute 315
American Dietetic Association, The, letter dated May 5, 1972, from
Katharine Manchester, R.D., president, to Chairman Rogers, in
support of H.R. 13715 316
American Medical Association, letter dated May 8, 1972, from Ernest
B. Howard, executive vice president, to Chairman Rogers, submit-
ting views on H.R. 13715 - 317
Association of State and Territorial Health Officers, letter dated May
15, 1972, from Ira L. Myers, M.D., president, to Chairman Rogers,
urging that project grants be located at Public Health Service Center
for Disease Control 318
Burke, Dr. Frederic Gerard, professor of pediatrics, Georgetown
University, statement - 313
Department of Health, Education, and Welfare:
Active specialized centers of research, National Heart and Lung
Institute 156
Approval system for grants and research contracts 152
Areas of emphasis on stroke research 168
Blood resources program - 118
Budget for cerebrovaseular disease and stroke-related diseases,
National Heart and Lung Institute 167
Comments on ~enate amendments to 5. 3323 193
Discontinuance of mobile X-ray units 116
Dissemination of applied research, Regional Medical Programs. - - 161
Estimates for first 3 years' funding of H.R. 13715 - 113
Excerpt from testimony of Dr. DuVal before Subcommittee on
Health, Senate Committee on Labor and Public Welfare, March
/24, 1972 88
Feasibility of screening and detection programs 151
Heart Disease Study Panel-list of members 86
Intramural research programs, people engaged, and their qual-
ifications 100
National Heart and Lung Institute programs 175
National Heart and Lung Institute programs of pediatric rele-
vance 110
Number of people in the United States having pernicious anemia~ 97
Operation of a medical center 174
Pediatric respiratory disease-Regional Medical Programs service_ 171
Plans for program of public and professional education in the
people-at-risk and sudden-death areas 153
Regional Medical Programs: Activities in heart and lung diseases 145
Role of Regional Medical Programs in screening and early diag-
nosis - 112
Scope of Government research on blood - 116
Updating knowledge of health professionals-Regional Medical
Programs 108
Albert Einstein College of Medicine of Yeshiva University, letter
dated May 3, 1972, from Robert Katzman, M.D., professor and
chairman of neurology, to Chairman Rogers, re the transfer of stroke
research to National Heart and Lung Institute 319
Executive Office of the President, Office of Science and Technology,
letter dated April 28, 1972, from Edward B. David, Jr., director, to
Chairman Rogers, offering cooperation and discussion of the work
of his office 315
Loma Linda University School of Medicine, letter dated April 25, 1972,
from Lawrence D. Longo, M.D., professor of physiology and ob-
stetrics and gynecology, to Chairman Rogers, deploring prolifera-
tion of new institutes within National Institutes of Health 320
Mayo Clinic, letter dated May 8, 1972, from Jack P. Whisnant, M.D.,
chairman, department of neurology, to Chairman Rogers, expressing
concern that stroke research stay within authority of National Insti-
tute of Neurologic Diseases and Stroke 322
National Committee for Research on Neurological Disorders, current
status of cerebrovascular (stroke) centers 306
PAGENO="0005"
V
Additional material submitted for the record by-Oontinued
National Hemophilia Foundation, Robert E. Long, executive corn- Page
mittee, statement 314
Pediatric Pulmonary Association:
Centers currently considered acceptable for consideration as
pediatric pulmonary centers 223
Exhibit A-Incidence and morbidity of chronic respiratory
diseases in children and young adults 226
Exhibit B-Model for a pediatric pulmonary center 231
Exhibit C-Placement and funding for regional pediatric
pulmonary centers 237
Exhibit D-Present status of pediatric pulmonary centers 240
Exhibit E-Pediatric pulmonary disease liaison groups-The key
to chronic pulmonary disease 265
Exhibit F-The early evaluation and diagnosis of allergy-
respiratory diseases in children 274
Providence Hospital, Columbia, S.C., letter dated May 30, 1972, from
Robert G. Kiger, M.D., director, department of cardiovascular
services, to Chairman Rogers, urging that the hospital participate
under section 415 of the bill 322
Temple University, letter dated May 4, 1972, from Sol Sherry, M.D.,
professor and chairman, department of medicine, to Chairman
Rogers, emphasizing importance of thrombosis aspects of program.. - 323
University of California School of Medicine, letter dated April 18, 1972,
from Augustus S. Rose, M.D., professor and chairman, department
of neurology, to Congressman John G. Schmitz, re transfer of stroke
research to National Heart and Lung Institute 323
Virginia Commonwealth University, Medical College of Virginia, letter
dated April 20, 1972, from William L. Rosenbium M.D., professor
and chairman, division of neuropathology, to W'. E. Williamson,
clerk, Committee on Interstate and Foreign Commerce, urging
need for increased funding for National Heart and Lung Institute.. - 324
ORGANIZATIONS REPRESENTED AT THE HEARINGS
American College of Cardiology, Dr. Samuel M. Fox III, president.
American College of Chest Physicians:
Olsen, Dr. Arthur M., past president.
Sofler, Dr. Alfred, executive director.
American Heart Association:
DeBakey, Dr. Michael B.
Hurst, Dr. Willis, president.
Association of American Medical Colleges:
Bowsher, Prentice, staff member.
Cooper, Dr. John A. D., president.
Department of Health, Education, and Welfare:
Cooper, Dr. Theodore, Director, National Heart and Lung Institute, National
Institutes of Health.
DuVal, Dr. Merlin K., Assistant Secretary for Health and Scientific Affairs.
Marston, Dr. Robert Q., Deputy Director, National Institutes of Health.
Zapp, Dr. John S., Deputy Assistant Secretary for Legislation (Health).
National Committee for Research on Neurological Disorders, Dr. A. B. Baker.
National Cystic Fibrosis Research Foundation, Dr. Giulio J. Barbero, chairman,
General Medical and Scientific Advisory Council.
National Tuberculosis and Respiratory Disease Association, Dr. Donald C.
Kent, medical director.
Pediatric Pulmonary Association, Dr Roy F Goddard, chairman
PAGENO="0006"
PAGENO="0007"
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD
ACT OF 1972
TUESDAY, APRIL 25, 1972
HOUSE OF REPRESENTATIVES,
SUBCOMMITTEE ON PUBLIC HEALTH AND ENVIRONMENT,
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,
Washington, D.C.
The subcommittee met at 10 a.m., pursuant to notice, in room 2322,
Rayburn House Office Building, Hon. Paul G. Rogers (chairman)
presiding.
Mr. ROGERS. The subcommittee will come to order, please.
The hearings today are on H.R. 12571, introduced by Chairman
Staggers, and H.R. 13715 which I introd~ced along with most of the
members of the Health Subcommittee, ajid S. 3323, bills designed to
more effectively carry out the national effort against diseases of the
heart, blood vessels, lungs, and blood.
Diseases of the heart, lungs, blood vessels, and blood are the major
killers in the United States today. Cardiovascular diseases account for
approximately 55 percent of all de,aths in the United States killing
more than 1 million people each year. Approximately 11/4 million
Americans suffer heart attacks annually. If this rate continues, more
than 12 million Americans will experience heart attacks within the
next 10 years.
Strokes kill more than 200,000 ~mericans annually. Asthma,
chronic bronchitis, and emphysema were responsible for over 30,000
deaths in 1970 and were acontributing factor to 60,000 other deaths,
and the incidence of these diseases is increasing, particularly in the
case of emphysema.
Asthma afflicts 5 million Americans; chronic bronchitis 4 million,
and emphysema, 1 million.
* Both cardiovascular and pulmonary diseases are a serious drain on
our national resources Arteriosclerotic and hypertensive diseases cost
their victims over $4 billion annually for medical care. It has been
estimated that the average American life expectancy could be increased
by 10.5 years if cardiovascular diseases were eliminated as a major cause
of disability and death. If this were to happen, the annual savings to the
economy in terms of medical care costs, lost wages, and productivity
and earnings eliminated by premature death could exceed $30 billion
per year.
The bills pending before the subcommittee today are designed to
strengthen the national attack upon these diseases by improving the
organization and structure of the National Heart and Lung Institute.
Last year the Congress enacted legislation strengthening the national
attack on cancer, and the time is now right for a similar approach on
cardiovascular disease and lung disorders.
At this point in the record there will be included the text of the
bills and the agency reports thereon.
(The text of H.R. 12571, H.R. 13715, H.R. 12460, H.R. 13500,
H.R. 14493, H.R. 14682, H.R. 14686, and S. 3323, together with de-
partmental reports thereon, follow:)
(1)
PAGENO="0008"
2~
92i CONGRESS
SEsSIoN . 1 2571
IN THE HOUSE OF REPRESENTATIVES
JANTJARY 24,1972
Mr. STAOOERS introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To amend the Public Health Service Act so as to strengthen
the National Heart and Lung Institute, the National In-
stitute of Neurological Diseases and Stroke, and the Na-
tional Institutes of Health in order more effectively to carry
out the national effort against heart, lung, and neurological
diseases and stroke.
1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SHORT TITLE
4 SECTION 1. This Act may be cited as the "Heart, Lung,
5 and Neurological Diseases and Stroke Amendments of
6 1972".
PAGENO="0009"
3
2
1 PROGRAMS OF THE NATIONAL HEART AND LUNG INSTITUTE
2 SEc. 2. (a) Part 13 of title IV of the Public Health
3 Service Act is amended by adding after section 414 the
4 following new sections:
5 "AUTHORITY OF DIRECTOR
6 `~SEc. 41~i. In carrying out the programs of the National
7 Heart and Lung Institute, the Director of the Institute,
8 after consultation with the National Advisory Heart and
9 Lung Council and without regard to any other provision of
10 this Act, may-
11 "(1) if authorized by the National Advisory Heart
12 and Lung Council, obtain (in accordance with section
13 3109 of title 5, United States Code, but without regard
14 to the limitation in such section on the number of days
15 or the period of such service) the services of not more
16 than fifty experts or consultants who have scientific or
17 professional qualifications;
18 "(2) acquire, construct, improve, repair, operate,
19 and maintain heart and lung centers, laboratories, re~
20 search, and other necessary facilities and equipment,
21 and related accommodations as may be necessary, and
22 such other real or personal property (including patents)
23 as the Director deems necessary; and acquire, without
24 regard to the Act of March 3, 1877 (40 U.S.C. 34),
25 by lease or otherwise through the Administrator of Gen-
PAGENO="0010"
4 r
3
1 eral Services, buildings or parts of buildings in the Dis-
2 trict of Columbia or commumties located adjacent to the
3 District of Columbia for the use of the Institute for a
4 period not to exceed ten years,
5 "(3) appoint one or more advisory committees
6 composed of such private citizens and officials of Fed-
7 eral, State, and local governments as he deems desirable
8 to advise him with respect to his functions,
9 "(4) utilize, with their consent, the services, equip-
10 ment, personnel, information, and facilities of other
11 Federal, State, or local public agencies, with or without
12 reimbursement therefor,
"(5) accept voluntary and uncompensated services,
14 "(6) accept unconditional gifts, or donations of
15 services, money, or property (real, personal, or mixed,
16 tangible or mtangible),
17 "(7) enter mto such contracts, leases, cooperative
18 agreements, or other transactions, without regard to
19 sections 3648 and 3709 of the Revised Statutes of
20 the United States (31 U SO 529, 41 U S C 5), as
21 may be necessary in the conduct of his functions, with
22 any public agency, or with any person, firm, association,
23 corporation, or educational institution, and
24 "(8) take necessary action to insure that all chan-
25 nels for the dissemination and exchange of scientific
PAGENO="0011"
5
4
i knowledge and information are maintained between the
2 Institute and the other scientific, medical, and biomedi-
3 cal disciplines and organizations, nationally and inter-
4 nationally.
5 "SCIENTIFIC REVIEW; REPORTS
"SEc. 416. (a) The Director of the National heart
7 and Lung Institute shall, by regu1at~on, provide for proper
8 scientific review of all research grants and programs over
9 which he has authority (1) by utilizing, to the maximum
10 extent possible, appropriate leer review groups established
11 within the National Institutes of Health and composed prm-
12 cipally of non-Federal scientists and other experts in the
13 scientific arid disease fields, and (2) when appropriate, by
14 establishing, with the approval of the National Advisory
15 Heart arid Lung Council and the Director of the National In-
16 stitutes of Health, other formal peer review groups ~1S may
17 be required.
18 " (b) The Director of the National Heart and Lung
19 Institute shall, as soon as practicable after the end of each
20 calendar year, prepare in consultation with the National
21 Advisory Heart and Lung Council and submit to the Presi-
22 dent for transmittal to the Congress a report on the activi-
23 ties, progress, and accomplishments of the Institute during
24 the preceding calendar yea.r arid a plan for the Institute dur-
25 ing the next five years.
PAGENO="0012"
6
5
1 "NATIONAL HEART AND LUNG DISEASES RESEARCH AND
2 DEMONSTRATION CENTERS
SEC. 417. (a) The Director of the National Heart and
4 Lung Institute is authorized to provide for the establishment
5 of centers for clinical research, training and demonstration of
6 advanced diagnostic and treatment methods relating to heart
7 and lung diseases. Such centers may be supported under sub-
8 section (b) or under any other applicable provision of law.
"(b) The Director of the National Heart and Lung
10 Institute, under policies established by the Director of the
~ National Institutes of Health and after consultation with the
12 National Advisory Heart and Lung Council, is authorized to
13 enter into cooperative agreements with public or private non-
14 profit agencies or institutions to pay all or part of the cost of
~ planning, establishing, or strengthening, and providing basic
16 operating support for existing or new centers (including, but
17 not limited to, centers established under subsection (a)) for
18 clinical research, training, and demonstration of advanced
19 diagnostic and treatment niethods relating to heart and lung
20 diseases. Federal payments under this subsection in support
21 of such cooperative agreements may be used for (1) construe-
22 tion (notwithstanding any limitation under section 405),
23 (2) staffing and other basic operating costs, including such
24 patient care costs as are required for research, (3) training
25 (including training for allied health professions personnel),
PAGENO="0013"
7
6
1 and (4) demonstration purposes; but support under this
2 subsection (other than support for construction) shall not
3 exceed $5,000,000 per year per center. Support of a center
4 under this section may be for a period of not to exceed three
5 years and may be extended by the Director of the National
6 Heart and Lung Institute for additional periods of not more
7 than three years each, after review of the operations of such
8 center by an appropriate scientific review group established
9 by the Director.
10 "(c) No center may be established or supported under
11 this section before the Director has consulted with the re-
12 gional medical program for the area in which the center is or
13 will be located.
14 "ni~u~T AND LUNG DISEASES CONTROL PROGRAMS
15 "Sno. 418. (a) rfhe Director of the National Heart and
16 Lung Institute shall establish programs as necessary for
17 cooperation with State and other health agencies in the diag-
18 nosis, prevention, and treatment of heart and lung diseases.
19 "(b) There are authorized to be appropriated to carry
20 out this section $20,000,000 for the fiscal year ending June
21 30, 1973, $30,000,000 for the fiscaJ year ending June 30,
22 1974, and $40,000,000 for the fiscal year ending June 30,
23 1975.
24 "BUDGET REQUESTS; AUTHORIZATION OF APPROPRIATIONS
25 "SEC. 419. (a) The Director of the National Heart
26 and Lung Institute shall prepare and submit, directly to the
PAGENO="0014"
8
7
1 President for review and traiismittal to Congress, an an-
2 nual budget estimate' for the programs of the Institute, after
3 reasonable opportunity for coinmeiit (but `without change),
4 by the Secretary, the Director of the National Institutes of
5 Health, and the National Advisory Heart and Lung Coun-
6 cii. The Director shall receive directly from' the President
7 and the Office of Management and Budget all funds appro-
8 priated by Congress for obligation and expenditure by the
9 National Heart and Lung Institute
10 "(b) For purposes of carrying out this part (other than
~ section 418), there are authorized to be appropriated $400,-
12 000,000 for the fiscal year ending June 30, 1973, $500,000,-
000 for the fiscal year ending June 30, 1974, and $600,000,..
14 000 for the fiscal year ending Jun~' 30, 1975."
15 (b) (1) Section 412 of. the Public Health Service Act
16 is amended by adding at the end thereof the following:.
17 , "(b) Under procedures approved by the. Director, of the
18 National Institutes of Health, the Director of the National
19 Heart and Lung Institute may approve grants under this
20 Act foi heart or lung diseases research or training-
21 "(1) in amounts not to exceed $35,000 after ap-
22 propriate review for scientific merit but without review
and recommendation by the National Advisory Heart
24 and Lung Council, and
25 "(2) in amounts exceeding $35,000 after appro-
PAGENO="0015"
9
8
1 priate review for scientific merit and review and recom-
2 mendation for approval by such Council."
3 (2) Section 412 of such Act is further amended-
4 (A) by inserting "(a)" immediately after "SEO.
5 412."; and
6 (B) by redesignating paragraphs (a), (b), (c),
7 (d), (e), (f), and (g) as paragraphs (1), (2), (3),
8 (4), (5), (Ei), and (7), respectively.
(3) Section 413 (a) of such Act is amended by striking
10 out "grants-in-aid" and inserting in lieu thereof "except as
11 provided in section 412 (b), grants-in-aid".
12 (c) The President *shall carry out a review of all ad-
13 ministrative processes applicable to programs of the National
14 Heart and Lung Institute, including the processes of advisory
15 council and peer group reviews, in order to assure the most
16 expeditious accomplishment of the objectives of such pro-
17 grams. Withiii one year of the date of enactment of this Act
18 the President shall submit a report to Congress of the find-
19 ings of such review and the actions taken to facilitate the con-
20 duct of such programs, together with recommendations for
21 any needed legislative changes.
22 (d) nIle President shall request of the Congress without
23 delay such additional appropriations (including increased
24 authorizations) a~ are required to pursue immediately any
25 development under a program of the National Heart and
PAGENO="0016"
10
9
1 Lung Institute requnmg proilipt and eXl)Cdit 10115 support and
2 for which regularly appropriated funds are not available.
3 (e) (1) Section 414 of the Public Health Service Act
4 is ameiided'by nddmg at the end thereof the followirig:
5 (Ii) rfIle Council shall meet at the call of the Three-
6 tor of the National Heart and Lung Institute or the Chair-
7 man of the Council, but not less often than four times a
8 year, and shall advise and assist the Director with respect
9 to the piogra.m~ of the Institute. The Council may hold such
10 hearings, take such testimony, and sit and act at such times
11 and places, as the Council deems advisable to investigate
12 programs arid activities of the Institute."
13 (2) Section 414 of such Act is further amended-
14 (A) by inserting "(a)" immediately after "Sr~c.
15 414.", and
16 (B) by redesignathig paragraphs (a) , (b) , (c)
1.7 (d) , (e) , and (f) as paragraphs (1), (2), (3), (4),
18 (5), arid (t3), respectively.
19 (f) (1) Section 217 of the Public health Service Act
20 is amended-
21 (A) by striking out "National Advisory Heart
22 Council" each place it occurs in subsection (a) and in-
23 serting in lieu thereof "National Advisory heart and
24 Lung Council",
PAGENO="0017"
11
10
1 (B) by striking out "heart diseases" in subsection
2 (a) and inserting in lieu thereof "heart and lung dis~
3 eases", and
4 (C) by inserting "lung," immediately after "heart,"
5 in subsection (b).
6 (2) Sections 301 (d), 301 (i), and 412 of such Act
7 are each amended by striking out "National Advisory Heart
8 Council" and inserting in lieu thereof "National Advisory
~ burt and Lung Council".
10 (3) Part B of such Act is further amended-
ii (A) by striking out "National Heart Institute" in
12 section 411 and inserting in lieu thereof "National Heart
13 and Lung Institute";
14 (B) by striking out "heart diseases" each place it
15 occurs in sections 412, 413 (b), and 414 (a) and in-
16 serting in lieu thereof "heart and lung diseases";
17 (C) by striking out "heart disease" in sections
18 413 (a) and 414 (a) (2) and inserting in lieu thereof
19 "heart and lung diseases";
20 (B) by striking out "fl1~Ai~T DISEASE" in the see-
21 tion heading of section 412 and inserting in lieu thereof
22 "hEART AND LUNG DISEASES"; and
23 (E) by striking out "NATIONAL llEA1~r INSrI-
24 TUTE" in the heading of such part and inserting in lieu
25 thereof "NATIONAL HEART AND LUNG INSTITUTE".
78-994 O-42-~--2
PAGENO="0018"
12
11
I PROGRAMS OF TIlE NATiONAL INSTITUTE OF NEUROLOGICAL
2 DTSEASES AND STROKE
3 Si~c. 3. (a) Part D of title IV of the Public I-Iealtli
4 Service Act is amended by adding after section 433 the fol-
5 lowing new sections:
t "DESIGNATION OF iNSTITUTE AN!) AI)VISORY COIJNCI IA;
7 AUTHORITY OF DIRECTOR
"SEc. 434. (a) The research institute on neurological
9 diseases established under section 431 is designated the `Na-
10 tional Institute of Neurological Diseases and Stroke', and
11 the advisory council established under section 432 to advise
12 the Secretary with respect to activities of the Institute is
13 designated the `National Neurological Diseases and Stroke
14 Advisory Council'. The Director of the Iiistitute shall be
15 appointed as provided in section 454.
16 " (b) In carrying out the programs of the Institute, the
1.7 Director, after consultation with the National Neurological
18 Diseases and Stroke Advisory Council and without regard
1.9 to any other provisioli of this A of, may-
20 " (1) if authorized by the Advisory Council, obtain
21 (in accordance with section 3109 of title 5, United
22 States Code, but without regard to the limitation in such
2:3 section on the number of days or the period of such
24 service) the services of not more than fifty experts or
PAGENO="0019"
13
12
~ 1 ~ : consnltaiits. whO have scieiitific or professional qualifica-
2 tioiis,
3 " (2) acquire, construct, improve, repair, operate,
4 and maintain neurological diseases and stroke centers,
5. laboratories, research, and other necessary facilities and
6 equipment, and related accommodations as may be neces-
7 c'uy, and such othei ieal or pei ~on ii pioperty (mcludmg
8 ` patents) as `the Director deems necessary; and acquire,
9 ` without regard to the Act of March 3, 1877 (40 U.S.C.
34), by lease or otherwise through the Administrator
11 of General Services, buldings or parts of buildings in the
12 `District of `Columbia or communities located `adjacent' to
13 the Di'stri~'t of Columbia fOr the use of' the Institute for
14 ` a"period not `to exceed ten years; `
15 "(3) appoint one 01 more advisory comnntkes
16 composcd of such private citizens and officials of Fed-
17 eral, Shte, `md local governments as he deems desirabic
18 to advise him with respect to `his `functions';
19 "(4) utilize, with their (onsent, the services, equip-
20 inent, personnel, information, and facilities of other
21 Federal, State, or local public agencies, with or without
22 reimbursement therefor,
23 "(5) accept voluntary and uncompensated services,
24 "(6) accept unconditional gifts, or donations of
25 services, money, or propei ty (real, personal, or mixed,
26 tangible or intangible),
PAGENO="0020"
14
13
1 "(7) enter into such contracts, leases, cooperative
2 agreements, or other transactions, without regard to
3 sections 3648 and 3709 of the Revised Statutes of the
4 United States (31 U.S.C. 529, 41 U.S.C. 5), as may
5 be necessary in the conduct of his functions, with any
6 public agency, or with any person, firm, association,
7 corporation, or educational institution; and
8 "(8) take necessary action to insure that all chan-
nels for the dissemination and exchange of scientific
10 knowledge and information are maintained between the
11 Institute and the other scientific, medical, and biomedical
12 disciplines and organizations nationally and interna-
13 tionally.
14 "(c) tinder procedures approved by the Director of the
15 National Institutes of Health, the Director of the National
16 Institute of Neurological Diseases and Stroke may approve
17 grants under this Act for research or training involving
18 neurological diseases or stroke-
19 "(1) in amounts not to exceed $35,000 after
20 appropriate review for scientific merit but without
21 review and recommendation by the National Neurologi-
22 cal Diseases and Stroke Advisory Council, and
23 "(2) in amounts exceeding $35,000 after appro-
24 priate review for scientific merit and review and recom-
25 mendation by the Advisory Council.
PAGENO="0021"
15
14
1 "(d) The Director of the National Institute of Neu-
2 rological Diseases and Stroke shall, by regulation, provide
3 for proper scientific review of all research grants and pro-
4 grams over which lie has authority (1) by utilizing, to the
5 maximum extent possible, appropriate peer review groups
6 established within the National Institutes of Health and corn-
7 posed principally of non-Pederal scientists and other experts
8 in the scientific and disease fields, and (2) when appro-
9 priate, by establishing, with the approval of the National
10 Neurological Diseases and Stroke Council and the Director
11 of the National Institutes of Health, other formal peer re-
12 view groups as may be required.
13 "(e) The Director of the National Institute of Neuro-
14 logical Diseases and Stroke shall, as soon as practicable
15 after the end of each calendar year, prepare in consultation
16 with the National Neurological Diseases and Stroke Council
17 and submit to the President for transmittal to the Congress
18 a report on the activities, progress, and accomplishments of
19 the Institute during the preceding calendar year and a plan
20 for the Institute during the next five years.
21 "NATIONAL RESEARCh AND DEMONSTRATION CENTERS FOR
22 NEUROLOOICAL DISEASES AND STROKE
23 "SEc. 435. (a) The Director of the National Institute
24 of Neurological Diseases and Stroke is authorized to provide
25 for the establishment of centers for clinical research, training,
PAGENO="0022"
15
1 and demonstration of advanced diagnostic imd treatment
2 methods relating to neurological diseases and stroke Such
3 centeis may be supported under subsection (b) or under any
4 other applicable provision &f law
5 "(b) The Director, under policies established by the
6 Duector of the National Institutes of Health and after con-
7 sultation with the National Neurological Diseases and Stroke
8 Advisory Council, is authorized to enter into cooperative
9 agreements with public or pi ivate nonprofit agencies or in
10 stitutions to pay all or part of the cost of planning, establish-
11 ing, or strengthening, and providing basic operating support
12 for existing or new centers (including, but not limited to,
1 centers established under subsection (a)) for clinical re-
14 search, training, and demonstration of advanced diagnostic
15 and treatment methods relating to neurological diseases and
16 stroke Fuleral payments under this subsection in support of
17 such cooperative agleements may be used for (1) construc-
18 tion (notwithstanding any limitation under section 405),
19 (2) stalling and other basic operating costs, including such
20 patient care costs as are required for research, (3) training
21 (including training for allied health professions personnel),
22 and (4) demonstration purposes, but support under this
23 subsection (other than support for construction) shall not
24 exceed $5,000,000 per year per center Support of a center
25 under this section may be for ft period of not to exceed three
PAGENO="0023"
1
1 years and may be extended by the Director for additional
2 periods of not more than three years each, after review of the
3 operations of such center by an appropriate scientific review
4 group established by the Director.
5 "(c) No center may he established or supported under
6 this section before the Director has consulted with the re-
7 gioiial medical program for time area in which the center is
8 or will be located.
"NEUROLOGICAL DISEASES AND STROKE CONTROL
10 PROGRAMS
"SEC. 436. (a) The Director of the National Institute
12 of Neurological Diseases aiid Stroke shall establish programs
as necessary for cooperation with State and other health
14 agencies in the diagnosis, prevention, and treatment of neuro-
Th logical diseases and stroke.
it) "(1)) There are authorized to be appropriated to carry
17 out this section $20,000,000 for the fiscal year ending
18 June 30, 1973, $30,000,000 for the fiscal year ending
19 June 30, 1974, aimd $40,000,000 for the fiscal year ending
June 30, 1975.
21 "NATIONAL NEUROLOGL~AL DESEASES AND STROKE
9')
ADVISORY COUNCIL
23 "SEC. 437. The National Neurological Diseases and
24 Stroke Advisory Council shall meet at the call of the Direc-
2 tor of the National Institute of Neurological Diseases and
PAGENO="0024"
18
17
1 Stroke or the Chairman of the Council, but not less often
2 than four times a year, and shall advise and assist the Direc-
3 tor with respect to the programs of the Institute. The Coun-
4 cii may hold such hearings, take such testimony, and sit and
5 act at such times and places as the Council deems advisable
6 to investigate programs and activities of the Institute.
7 "BUDGET REQUESTS; AUTHORIZATION OF APPROPRIATIONS
8 "SEC. 438. (a) The Director of the National Institute
9 of Neurological Diseases and Stroke shall prepare and sub-
10 mit, directly to the President for review and transmittal to
11 Congress, an annual budget estimate for the programs of
12 the Institute, after reasonable opportunity for comment (but
13 without change), by the Secretary, the Director of the Na-
14 tional In~titates of llealth, and the National Advisory Neu-
15 rological Diseases and Stroke Council. The Director shall
16 receive directly from the President and the Office of Man-
17 agement and Budget all funds appropriated by Congress for
18 obligation and expenditure by the National Institute of Neti-
19 rological Diseases and Stroke.
20 "(b) For purposes of carrying out the program of the
21 National Institute of Neurological Diseases and Stroke
22 (other than the program authorized by section 436), there
23 are authorized to be appropriated $300,000,000 for the fiscal
24 year ending June 30, 1973, $400,000,000 for the fiscal year
PAGENO="0025"
19
18
1 ending June 30, 1974, and $500,000,000 for the fiscal year
2 eiiding June 30, 1975."
3 (b) The President shall carry out a review of all ad-
4 ministrative processes applicable to programs of the National
5 Institute of Neurological Diseases and Stroke, including the
6 processes of advisory council and peer group reviews, in
7 order to assure the most expeditious accomplishment of the
8 objectives of such programs. Within one year of the date of
9 enactment of this Act the President shall submit a report
10 to Congress of the findings of such review and the actions
11 taken to facilitate the conduct of such programs, together
12 with recommendations for any needed legislative changes.
13 (c) Ph~ President shall request of the Congress without
14 delay such additional appropriations (including increased
15 authorizations) as are required to pursue immediately any
16 development under a program of the Institute requiring
17 prompt and expeditious support and for which regularly
18 appropriated funds are riot available.
19 APPOINTMENTS OF DIRECTORS OF THE INSTITUTES
20 SEe. 4. Section 454 of the Public Health Service Act is
21 amended-
22 (1) by striking out "Director of the National Can-
23 cer Institute" in the first sentence and inserting in lieu
24 thereof "Directors of the National Cancer Institute, the
PAGENO="0026"
20
19
National Heart and Lung Institute, and the National
2 Institute of Neurological Diseases and Stroke"; and
3 (2) by amending the second sentence to read as
4 follows: "Except as provided in sections 407 (b) (9),
5 419 (a), and 438 (a), the Directors of the National
6 Cancer Institute, the National Heart and Lung Institute,
7 and the National Institute of Neurological Diseases and
8 Stroke shall report directly to the Director of the Na-
9 tional Institutes of Health.".
10 EFFECTIVE DATE
11 SEc. 5. (a) This Act and the amendments made by
12 this Act shall take effect sixty days after the date of enact-
13 mont of this Act or on such prior date after the date of
14 enactment of this Act as the President shall prescribe and
15 publish in the Federal Register.
16 (b) The first sentence of section 454 of the Public
17 Health Service Act (as amended by section 4 of this Act)
18 shall apply only with respect to appointments of Directors
19 of the National Heart and Lung Institute and the National
20 Institute of Neurological Diseases and Stroke made after the
21 effective date of this Act (as prescribed by subsection (a)).
r
PAGENO="0027"
21
92n CONGRESS
II. R. 1 371 5
IN THE HOUSE OF REPRESENTATIVES
MARCH 9, 1972
Mr RoGERS (for himself, Mr SATTERPIELD, Mr K~nos, Mr PRETER of North
Carolina, Mr. SYMINCT0N, Mr. Roy, Mr. NELSEN, Mr. CARTER, and Mr.
HAsTnco'~) introduced the following bill, which ~ as referred to the Corn
mittee on Interstate and Foreign Commeice
A BILL
To amend the Public Health Service Act to enlarge the authority
of the National Heart and Lung Institute in order to advance
the national attack against diseases of the, heart and bkod
vessels, the lungs, and blood; and for other purposes.
1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SHORT TITLE
4 SECTION 1 This Act may be cited as the "National
5 Heart, Blood Vessel, Lung, and Blood Act of 1972"
6 FI~DINOS AND DECLARATION OF PURPOSE
7 SEC 2 (a) Congress finds and declares that-
8 (1) diseases of the heart and blood vessels collec-
9 tively cause more than half of all the deaths each year in
________________________
PAGENO="0028"
22
2
1 the United States and the combined effect of the disabil-
2 ities and deaths from such diseases is having a major
3 social and economiá impact on the Nation;
4 (2) elimination of such cardiovascular diseases as
5 significant causes of disability and death could increase
6 the average American's life expectancy by about eleven
7 years and could provide for annual savings to the econ-
8 omy in lost wages, productivity, and costs of medical
9 care of more than $30,000,000,000 per year;
10 (3) chronic lung diseases have been gaining steadily
11 in recent years as important causes of disability and
12 death, with emphysema alone being the fastest rising
13 cause of death in the United States;
14 (4) chronic respiratory diseases afiect an estimated
15 ten million Americans, emphysema an estimated ~ne mil-
16 lion, chronic bronchitis an estimated four million, and
17 asthma an estimated five million;
18 (5) thrombosis (the formation of blood clots in the
19 vessels) may cause, directly or in combination with
20 other problems, many deaths and disabilities from heart
21 disease and stroke which can now be prevented;
22 (6) blood and blood products are essential human
23 resources whose value in saving life and promoting
24 health cannot be assessed in terms of dollars; and
25 (7) the greatest potential for advancement against
PAGENO="0029"
23
3
1 diseases of the heart and blood vessels, the lungs, and
2 blood lies in the National Heart and Lung Institute of
3 the National Institutes of Health whose research in-
4 stitutes have brought into being the most productive sd-
5 entific community centered upon `health and disease that
6 the world has ever known.
7 (b) It is the purpose of this Act to enlarge the au-
8 thority of the National Heart and Lung Institute in order
9 to advance the national attack upon the, diseases of the
10 heart and blood vessels, the lungs, and blood.
HEART, BLOOD VESSEL, LUNG,. AND BLOOD DISEASE
12 PROGRAMS
13 SEc. 3. Part B of title IV of the Public Health Service
14 Act is amended (1) by redesignating section 413 as section
15 419A, (2) by redesignating section 414 as section 418,
16 and (3) by adding after section 412 the following new
17 sections:
18 "NATIONAJ~ HEART, BLOOD VESSEL, LUNG, AND BLOOD
19 `DISEASE PROGRAM
20 "SEc. 413. (a) The Director of the Institute, with the
21 advice of the Council, shall within one hundred and eighty
22 days after the effective date of this section, develop a plan
23 for a National Heart, Blood Vessel, Lung, and Blood Disease
24 Program (hereafter in this part referred to as the `Program')
25 to expand, intensify, and coordinate the activities of the In-
PAGENO="0030"
24
4
1 stitute respecting such diseases (including its activities under
2 section 412) The Program shall provide for-
3 " (1) investigation into the epidemiology, etiology,
4 and prevention of all forms and aspects of cardiovascular,
3 lung, and blood diseases, including investigations into
(3 the social, environmental, behavioral, nutritional, bio-
7 logical, and genetic determinants and influences in-
8 volved in the epidemiology, etiology, and prevention of
such diseases;
10 "(2) studies and research into the basic biological
11 processes and mechanisms involved in the underlying
12 normal and abnormal cardiovascular, pulmonary, and
13 blood phenomena;
14 "(3) research into the development, trial, and
15 evaluation of techniques, drugs, and devices used in,
16 and approaches to, the diagnosis, treatment, and pre-
17 vention of cardiovascular and pulmonary diseases and
18 the rehabilitation of patients suffering from such diseases;
19 "(4) establishment of programs and centers for
20 the conduct and direction of field studies, large-scale
21 testing and evaluation, and demonstration of preventive
diagnostic, therapeutic, and rehabilitative approaches
23 to cardiovascular and pulmonary diseases;
24 "(5) studies and research into blood diseases (such
25 as sickle cell anemia and hemophilia) and blood, its
PAGENO="0031"
25
5
1 uses for clinical purposes and all aspects of the man-
2 agement of its resources in this country, including the
3 collection, preservation, fractionalization, a.nd distribu-
4 tion of it and its products;
"(6) the education and training of scientists and
6 clinicians in fields a.nd specialties requisite to the conduct
7 of programs respecting cardiovascular, pulmonary, and
S blood diseases;
9 "(7) public and professional education relating
110 to all aspects of cardiovascular, pulmonary, and blood
diseases and the use of blood and blood products and
12 the management of blood resources; and
13 "(8) establishment of programs and centers for
14 study and research into cardiovascular, pulmonary, and
15 blood diseases of children (including cystic fibrosis, hya-
16 line membrane, and hemolytic and hemophilic diseases)
17 and for the development and demonstration of diagnos-
18 tic, treatment, and preventive approaches to these dis-
19 eases.
20 "(h) (1) The plan required by subsection (a) of this
21 section shall be traiismitted to the Congress and shall set out
22 the Institute's staff requirements to carry out the Program
23 and recommendations for appropriations for the Program.
24 "(2) The Director of the Institute shall, as. soon as
23 practicable after the end of each calendar year, prepare in
PAGENO="0032"
26
6
1 consultation with the Council and submit to the President for
2 transmittal to the Congress a report on the activities, prog-
3 ress, and accomplishments under the Program during the
4 preceding calendar year and a plan for the Program during
5 the next five years.
6 "(c) In carrying out the Program, the Director of the
7 Institute, after consultation with the Council and without
8 regard to any other provisions of this Act, may-
9 "(1) if authorized by the Council, obtain (in ac-
10 cordance with section 3109 of title 5, United States
11 Code, but without regard to the limitation in such sec-
12 tion on the number of days or the period of such service)
13 the services of not more `than fifty experts or consultants
14 who have scientific or professional qualifications;
15 "(2) acquire, construct, improve, repair, operate,
16 and maintain cardiovascular and pulmonary disease con-
17 ters, laboratories, research, and other necessary facilities
18 and equipment, and related accommodations' as may be
19 necessary, and such other real or personal property (in-
20 cluding patents) as the Director deems necessary; and
21 acquire, without regard to the Act of March 3, 1877 (40
22 U.S.C. 34), by lease or otherwise through the Adininis-
23 trator of General Services, buildings or parts of buildings
24 in the District of Columbia or communities located adja-
PAGENO="0033"
27
7
1 cent to the District of Columbia for the use of the Insti~
2 tute for a period not to exceed ten years; and
3 "(8) enter into such contracts, leases, cooperative
4 agreements, or other transactions, without regard to sec~
5 tions 3648 and 3709 of the Revised Statutes of the
6 United States (31 U.S.C. 529, 41 U.S.C. 5), as may be
7 necessary in the conduct of his functions, with any pub-
8 lie agency, or with any person, firm, association, corpo-
9 ration, or educational institution.
10 "HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE
11 CONTROL PROGRAMS
12 "SEC. 414. (a) The Director of the Institute, under
13 policies established by the Director of the National Institutes
14 of Health and after consultation with the Council, shall estab-
15 lish programs as necessary for cooperation with other Fed-
16 eral health agencies, State, local, and regional public health
17 agencies, and nonprofit private health agencies in the diag-
18 nosis, prevention, and treatment of heart, blood vessel, lung,
19 and blood diseases.
20 "(b) There are authorized to be appropriated to carry
21 out this section $20,000,000 for the fiscal year ending
22 June 30, 1973, $30,000,000 for the fiscal year ending
23 June 30, 1974, and $40,000,000 for the fiscal year ending
24 June 30, 1975.
78-994 O-72---~--3
PAGENO="0034"
2
1 "NATIONAL CLINICAL RESEARCH AND DEMONSTRATION
2 CENTERS FOR CARDIOVASCULAR AND PULMONARY
3 DISEASES
4 "SEC. 415. (a) The Director of the Institute may pro-
5 vide for the developrneiit of-
6 "(1) fifteen new centers for clinical research into,
7 training in, and demonstration of, advanced diagnostic
8 and treatment methods for cardiovascular diseases; and
9 "(2) flfteei~ new centers for clinical research into,
10 training in, and demonstration of, advanced diagnostic
11 and treatment methods for chronic pulmonary diseases
12 (including bronchitis, emphysema, asthma, and cystic
13 fibrosis and other pulmonary diseases of children).
14 Centers developed under this subsection may be supported
15 under subsection ~b) or under any other applicable pro-
16 vision of law.
17 "(b) The Director of the Institute, under policies estab-
18 lished by the Director of the National Institutes of Health
19 and after consultation with the Council, may enter into
20 cooperative agreements with public or nonprofit private
21 agencies or institutions to pay all or part of the cost of
22 planning, establishing, or strengthening, and providing basic
23 operating support for, existing or new centers (including
24 centers established under subsection (a)) for clinical re-
25 search into, training in, and demonstration of, advanced
PAGENO="0035"
29
9
1 diagnostic and treatment methods for cardiovascular and
2 chronic pulmonary diseases. Funds paid to centers under
3 cooperative agreements under this subsection may be used
4 for-
5 "(1) construction, notwithstanding section 405,
6 "(2) staffing and other basic operating costs, in-
7 eluding such patient care costs as are required for
8 research,
9 "(3) training, including training for allied health
10 professions personnel, and
11 "(4) demonstration purposes.
12 The aggregate of payments (other than payments for con-
13 struction) made to any center under such an agreement
14 may not exceed ~5,000,000 in any year. Support of a cen-
15 tei' under this subsection may be for a period of not to cx-
16 (eed five years and may be extended by the Director of the
17 Institute for additional 1)(~rio(ls of f~ot more than five years
18 each, after review of the operattons of such center by an
19 appropriate scientific FCYiCW group established by the Di-
20 rector.
21 "INP1~I~AQJ~NCY TECHNICAL COMMITTEE
22 "SEc. 416. (a) The Secretary shall establish aii Inter-
23 agency Technical Committee on Heart, Blood Vessel. Lung,
24 and Blood Diseases and Blood Resources which shall he
PAGENO="0036"
30
10
1. responsible for coordinating those aspects of all Federal
2 health progra~ris and activities relating to diseases of the
3 heart, blood vessels, the lung, and blood and to blood re-
4 sources to assure the adequacy and technical soundness of
5 such programs and activities and to provide for the full corn-
6 immication and exchange of information necessary to main-
7 tam adequate coordination of such programs and activities.
8 "(b) The Director of the Institute shall serve as Chair-
9 man of the Committee and the Committee shall include rep-
10 resentation from all Federal departments and agencies whose
11 programs involve health functions or responsibilities as de-
12 termined by the Secretary.
13 "NATIONAL HEART AND LUNG ADVISORY COUNCIL
14 "SEC. 417. (a) There is established in the Institute a
15 National Heart and Lung Advisory Council to be composed
16 of twenty-two members as follows:
17 "(1) The Secretary, the Director of the National
18 Institutes of Health, the chief medical officer of the Vet-
19 erans' Administration (or his designee), and a medical
20 officer designated by the Secretary of Defense shall be
21 cx officio members of the CounciL
22 "(2) Eighteen members appointed by the Secre-
23 tary.
24 Each of the appointed members of the Council shall be
25 a leader in a field of fundamental science, medical science,
PAGENO="0037"
31
11
1 or public affairs. Nine of the appointed members shall
2 be selected from among the leading medical or scientific au~
3 thorities who are skilled in the sciences relating to diseases
4 of the heart, blood ~resse1s, lungs, and blood; two of the ap-
5 pointed members shall be selected from full-time students
6 enrolled in health professions schools; and seven of the np-
7 pointed members shall be selected from the general public.
8 "(b) (1) Each appointed member of the Council shall
9 be. appointed for a term of four years, except that-
10 "(A) any member appointed to fill a vacancy óc-
11 curring prior to the expiration of the term for which his
12 predecessor was appointed shall be appointed for the
13 remainder of such term; and
14 "(B) of the members first appointed after the of-
15 fective date of this section, five shall be appointed for a
16 term of four years, five shall be appointed for a term
17 of three years, five shall be appointed for a term of two
18 years, and three shall be appointed for a term of one
19 year, as designated by the Secretary at the time of
20 appointment.
21 Appointed members may serve after the expiration of their
22 terms until their successors have taken office.
23 "(2) A vacancy in the Council shall not affect its
24 activities, and twelve members of the Council shall constitute
25 a quorum.
PAGENO="0038"
32
12
:t ~ ~ ~ "~(3) The Council shall supers~de the existing National
2 Advisory Heart ~ C ~ ouneil appointed ~ under ~ se~ti9n 217, and
3 the appointed members of the' National Advisory Heart
4 Oöunoil' serving on the effective date of this `section: shall
5' serve as additional members of the National Heart and Lung
6 Ad'~isory Council for the duration of their ttrms then exist-.
7' ing, or for such shorter time as the Secretary may prescribe.
8 "(4) Membcrs of the council who aie not officeis or
~ employees `Of the United States' shall receive for each day
10. they are engaged in the performance of the functions of the
11 Council compensation at rates not to, exceed the daily equiv-
12. alOnt of the annual rate `in effect for `grade' `GS-18 of the
13 C enei ii Schedule, including tr'rs eltime, and all membei s,
14 while so seivmg away from then homes oi regular pl'ices of
1'S business,, may be allowed. travel'exp'enses,'iiicluding per diem.
16 in lieu of subsistence," in `the' same manner as such expeilses
17 are authorized *by section 5703, title 5, United States
18 ` Code;: for persoi~ in the Government service employed
19 `intermittently.' ` ` ` ` " ` ` ` `
20 "(c) The Chairm'ui of the Oouncil shall be `ippoin~ed
21 b~ the Seuet'iiy fiom among the members of the Council and
22 `shall serve as Chairman for aterm of two years. `
23 `" (d) The Director of the Institute shall (`1) designate
24 t member of the staff of the Institute to `ict `is Executl\ c Sec
25 rotary of `the Council, and (2) make available `to the Council
PAGENO="0039"
33
13
1 such staff, information, and other assistance as it may require
2 to carry out its functions.
3 "~e) The Council shall meet at the call of the Director
4 of the Institute or of the Chaii.xnari, but not less often than
5 four times a year."
6 AUTHORIZATION OF APPROPRTATIONS FOR PART B OF TITLE
7 IV OF THE PUBLIC HEALTH SERVICE ACT
8 SEC. 4. Part B of title TV of the Public Health Service
9 Act is amended by adding at the end thereof the following
10 new section:
11 "AUTHORIZATION OF APPROPRIATIONS
12 "SEC. 419B. For the purpose of carrying out this part
1;~ (other than section 414), there are authorized to be a.ppro-
14 printed $350,000,000 for the fiscal year ending June 30,
15 1973, $400,000,000 for the fiscal year endinig Juiie 30,
16 1974, and $450,000,000 for the fiscal year ending June 30,
17 1975."
18 DIREcTOR'S AUTHORITY TO APPROVE GRANTS
19 SEc. 5. Sectioii 419A of the Public Health Service Act
20 (as so redesignated by section 3 of this Act) is amended-
21 (1) by striking out "grants-in-aid" in subsection
22 (a.) and inserting in lieu thereof "except as provided in
23 subsection (c), grants-in-aid"; and
24 (2) by adding after subsection (b) tile following
25 new subsection:
PAGENO="0040"
34
14
1. "(c) Under procedures approved by the Director of
2 the National Institutes of Health, the Director of the Na1.
3 tional Heart and Lung Institute may approve grants under
4 this Act for research and training in heart, blood vessel, lung,
5 and blood diseases-
6 "(1) in amounts not to exceed $35,000 after appro~
7 priate review for scientific merit but without review and
8 recommendation by the Council, and
9 "(2) in amounts exceeding $35,000 after appro~
10 priate review for scientific merit and recommendation for
11 approval by the Council."
12 CONFORMING AMENDMENTS TO PART B OF TITLE IV OF THE
13 PUBLIC HEALTH SER~I~E AOT
14 SEc. 6. (a) Section 411 of the Public Health Service
15 Act is amended by striking out "National Heart Institute"
16 and inserting in lieu thereof "National Heart a~~nd Lung
17 Institute".
18 (b) Section 412 of such Act is amended-
19 (1) by striking out "heart" each place it occurs
20 (except in `the heading) and inserting in lieu thereof
21 "heart, blood vessel, lung, and blood";
22 (.2) by striking out "Surgeon General" and insert-~
23 ing in lieu thereof "Secretary";
24 (3) by striking out "National Advisory Heart
PAGENO="0041"
35
15
1 Council" and inserting in lieu thereof "National Heart
2 and Lung Advisory Council";
3 (4) by redesignating paragraphs (a), (b), (c),
4 (d), (e), (f), and (g) as paragraphs (1), (2), (3),
5 (4), (5), (6), and (7), respectively; and
6 (5) by amending the section heading to read as
7 follows:
8 "RESEARCh AND TRAINING IN DISEASES OF TIlE HURT,
9 BLOOD VESSELS, LUNG, AND BLOOD".
(c) Section 418 of such Act (as so redesignated by sec~
~ tion 3 of this Act) is amended-
12 (1) by inserting "(a)" immediately after "SEC.
418." and by adding at the end thereof the following
14 new subsection:
15 "(b) (1) The Council shall advise and assist the Direc~
16 tor of the Institute with respect to the Program established
17 under section 413. The Council may hold such hearings,
18 take such testimony, and sit and act at such times and places,
19 as the Council deems advisable to investigate programs and
20 activities of the Program.
21 "(2) The Council shall submit a report to the President
22 for transmittal to the Congress not later than January 31
23 of each year on the progress of the Program toward the
24 accomplishment of its objectives."
PAGENO="0042"
36
16
1 (2) by striking out "Surgeon General" each p1a~e
2 it occurs (except paragraph (f) ) and inserting in lieu
3 thereof "Secretary";
4 (3) by striking out "heart" each place it occurs and
5 inserting in lieu thereof "heart, blood vessel, lung, and
6 blood";
7 (4) by striking out "Surgeon General" iii P~'-
8 graph (f) and inserting in lieu thereof "Secretary, the
9 Director of the National Institutes of Health, and the
10 Director of the National Heart and Lung Institute"; and
11 (5) by redesignating paragraphs (a), (b), (c),
12 (d), (e), and (f) as paragraphs (1), (2), (3), (4),
13 (5), and (6) , respectively.
11 (d) Section 41 9A of such Act (as so redesignated by
~5 section 3 of this Act) is ameiided-
16 (1) in subsection (a~ , by (A) striking out "Sur-
17 geon General" and inserting in lieu thereof "Secretary",
18 and (B) striking out "heart" and inserting in lieu there-
19 of "heart, blood vessel, lung, and blood"; and
20 (2) in subsection (b) , by (A) striking out "The
21 Surgeon General shall recommend to the Secretary
22 acceptance of conditional gifts, pursuant to section 501,"
23 and inserting in lieu thereof "The Secretary may, in
24 accordance with section 501, accept conditional gifts",
PAGENO="0043"
37
17
1 and (B) striking out "heart" and inserting in lieu thei e-
2 of "heart, blood vessel, lung, and blood"
(e) The heading for p'ut B of such Act is amended
4 to i ead as follows
5 "PART B-NAIIONAL HEART AND LUNG INSTITUTE"
( (ONFORMINO AMENDMENTS TO OTHER PROVISIONS OF THE
7 PUBLIC HEALTH SEE\~ICE ACT
8 SEC 7 (a) Section 217 of such Act is amended-
9 (1) by striking out "the National Advisory Heart
10 Council," each place it occurs in subsection (a)
11 (2) by striking out "heart diseases," in subsection
12 (a) and by striking out "heart," in subsection (b)
13 (b) Sections 301 (d) and 301 (i) of such Act are
14 each amended by striking out "National Advisory Heart
15 Council" and inserting in lieu thereof "National Heart and
16 Lung Advisory Council"
17 REPORT TO CONGRESS
18 SEC 8 The Secretary of Health, Education, and Wel-
19 fare shall carry out a review of all administrative processes
20 under which the National Heart, Blood Vessel, Lung, and
21 Blood Disease Program, established under part B of title IV
22 of the Public Health Service Act, will operate, rnoludmg the
23 processes of advisory council and peer group reviews, m
24 order to assure the most expeditious accomplishment of the
I
I
PAGENO="0044"
38
18
1 objectives of the Program. Within one year of the date of
2 enactment of this Act, the Secretary shall submit a report
3 to the Congress of the findings of such review and the actions
4 taken to facilitate the conduct of the Program, together with
5 recommendations for any needed legislative changes.
6 EFFEOTIVE DATE
7 Si~c. 9. This Act and the amendments made by this Act
8 shall take effect sixty days after the date of enactment of
9 this Act or on such prior date after the date of enactment
10 of this Act as the President shall prescribe and publish in
11 the Federal Register.
PAGENO="0045"
39
92D CONGRESS
2D SESSION . 1 2460
IN THE HOUSE OP REPRESENTATIVES
JANUARY 18,1972
Mr. PmPER introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To amend the Public Health Service Act to strengthen the
* National Heart and Lung Institute and the National Insti-
tutes of Health in order more effectively to carry out the
national effort against heart and lung diseases.
I Be it enacted by the Senate and House of Representa~
2 tives of the United States of America in Congress assembled,
3 SHORT TITLE
4 S~c~ioi~ 1. This Act may be cited as "The Nation~
5 Heart and Lung Diseases Act of 1972".
6 FINDINGS AND DECLARATION OF PURPOSE
7 Si~o. 2. (a) The Oongress finds and declares-
S (1) that the incidence of heart and lung diseases.
9 is increasing and they are a major health concern of
10 Americans today; * S * *
PAGENO="0046"
1 (2) that new scieiitific leads, if comprehensively
2 and energetically e~ploitcd, may significantly advance
3 the time when moi e adequate preventive and thera-
4 peutic capabilities ai e available to cope with those
5 diseases,
6 (3) that those dise'tses aie a leading cause of death
7 in the United States,
8 (4) that the present state of our understanding of
9 those diseases is `i consequence of broad advances across
10 the full scope of the biomedical sciences,
11 (5) that a great opportunity is offered as a result
12 of recent advances in the knowledge of those diseases
13 to conduct energetically a national program agamst
14 them;and
15 (6) that m order to provide for the most effective
16 attack on those diseases it is important to use all of the
17 biomedical resources of the National Institutes of Health
18 (b) It is the purpose of this Act to enlarge the author-
19 ities of the National ileart and Lung Institute and the
20 National Institutes of Health in order to advance the
21 national effort against heart and lung diseases
22 NATIONAL HEART AND LUNG DISEASES PROGRAM
23 SEc 3 (a) Part B of title IV of the Public Health
24 Service Act is amended by adding after section 414 the
25 following new sections
PAGENO="0047"
41
3
1 "NATIONAL HEART AND LUNG DISEASES PROGRAM
2 "SEc. 415. (a) The Director of the National Heart
:3 and Lung Institute shall coordinate all of the activities of the
4 National Institutes of Health relating to heart and lung
5 diseases with the National Heart and Lung Diseases Pro-
6 gram.
7 "(b) In carrying out the National Heart and Lung
8 Diseases Program, the Director of the National Heart and
9 Lung Institute shall:
10 "(1) With the advice of the National Heart and
11 Lung Advisory Board, plan and develop an expanded,
12 intensified, and coordinated heart and lung diseases
13 research program encompassing the programs of the
14 National Heart and Lung Institute, related programs
15 of the other research institutes, and other Federal and
16 non-Federal programs.
17 "(2) Expeditiously utilize existing research facili-
18 tics and personnel of the National Institutes of Health
19 for accelerated exploration of opportunities in areas of
20 special promise.
21 " (3) Encourage and coordinate heart and lang dis-
22 eases research by industrial coi~cerns where such con-
23 cerns evidence a particular capability for such research,
24 "(4) Collect, analyze, and disseminate all data
25 useful in the prevention, diagnosis, and treatment of
~lIL
PAGENO="0048"
42
4
1 heart and lung diseases, including the establishment of
.2 an international heart and lung diseases research data
3 bank to collect, catalog, store, and disseminate insofar
4 as feasible the results of heart and lung diseases research
5 undertaken in any country for the use of any person
6 involved in heart and lung diseases research in any coun-
7 try.
8 . . "(5) Establish or support the large-scale produc-
9 tion or distribution of specialized biological materials and
10 other therapeutic substances for research and set stand-
11 . ards of safety and care for persons using such materials.
12 "(6) Support research in the field of heart and
13 lung diseases outside the United States by highly quali-
14 fled foreign nationals which research can be expected to
15 inure to the benefit of the American people; support
16 collaborative research involving American and foreign
17 participants; and support the training of American
18 scientists abroad and foreign scientists in the United
19 States.
20 "(7) Support appropriate manpower programs of
21 training in fundamental sciences and clinical disciplines
22 to provide an expanded and continuing manpower base
from which to select investigators, physicians, and allied
24 health professions personnel, for participation in clini-
25 cal and basic research and treatment programs relating to
PAGENO="0049"
43
1 heart atid lung diseases, including where appropriate the
2 use of training stipends, fellowships, and career a~vards.
3 "(8) Call special meetings of the National Heart
4 and Lung Advisory Board at such times and in such
5 places as the Director* deems necessary. in order to
6 consult with, obtain advice from, or to secure the ap-
7 proval of projects~, programs, or other actions to be
8 undertaken without delay in order to gain maximum
9 benefit from a new scientific or technical finding.
10 "(9) (A) Prepare and submit, directly to the Pres-
11 ident for review and transmittal to Congress, an annual
12 budget estimate for the National Heart and Lung Dis-
13 eases Program, after reasonable opportunity for corn-
14 ment (but without change) by the Secretary, the
15 Director of the National Institutes of Health, and the
16 National Heart and Lung Advisory Board; and (B)
17 receive from the President and the Office of Manage-
18 ment and Budget directly all funds appropriated by
19 Congress for obhgation and expenditure by the National
20 Hetrt and Lung Institute.
21 "(c) (1) There is established the President's Heart
22 and Lung Panel (heremalter in this section referred to as
23 the `Panel') which shall be composed of three persons ap-
24 pointed by the President, who by virtue `of their training,
25 experience, and background are e~ee~tionally qualified to
78-994 O-72--4
PAGENO="0050"
I
t appraise the National Heart and Lung Diseases Program.
~ At least two of the members of the Pan~1 shall be distin-
3 guished scientists or physicians.
4 "(2) (A) Members of the Panel shall be appointed for
5 three-year terms, except that (i) in the case of two of the
6 members first appointed, one shall be appointed for a term
7 of one year and one shall be appointed for a term of two
8 years, as designated by the President at the time of appoint-
9 merit, and (ii) any member appointed to fill a vacancy
10 occurring prior to the expiration of the term for which his
11 predecessor was appointed shall be appointed only for the
12 remainder of such term.
13 "(B) The President shall designate one of the members
14 to serve as Chairman for a term of one year.
15 "(0) Members of the Panel shall each be entitled to
16 receive the daily equivalent of the annual rate of basic pay
17 in effect for grade 08-18 of the General Schedule for each
18 day (including traveltime) during which they are engaged
19 in the actual performance of duties vested in the Panel, and
20 shall be allowed travel expenses (including a per diem al-
21 lowance) under section 5703 (b) of title 5, United States
22 Oode.
23 " (3) The Panel shall meet at the call of the Ohairmaii,
24 but not less often than twelve times a year. A transcript shall
25 be kept of the proceedings of each meeting of the Panel, and.
PAGENO="0051"
45
7
1 the Chairnian shall make such transcript. available to the
2 1NIMiC.
3 " (4) The Panel shall inoiiitor the development and cx-
4 edution of the National heart, and Lung Diseases Program
5 under this section, and shall report directly to the President.
6 Any delays or blockages in rapid execution of the Program
7 shall iniinediately be brought to the attention of the Presi-
8 dent. The Panel shall submit to the President periodic
9 progress reports on the Program and annually an evaluation
10 of the efficacy of the Program and suggestions for improve-
11 inents, and shall submit such other reports as the President
12 shall direct. At the request of the President, it shall submit
13 for his consideration a list of iiames of persons for considera-
14 tion for appointment as Director of the National Heart
15 and Lung institute.
16 "NATIONAL 1'1EM'~T AND LUNG DISEASES RESEARCh ANI)
17 DEMONSTRATION CENTERS
18 "SEe. 408. (a') The Director of the National heart and
19 Lung Institute is authorized to provide for the establishment
20 of fifteen new centers for clinical research, training, and dem-
21 onstration of advanced diagnostic arid treatment methods re-
22 lating to heart and lung diseases. Such centers may be
23 supported under subsection (li) or 111111cr ally other a~pJ)hi-
24 cable provision of law.
25 " (b) The Director of tile National Heart and Lung
PAGENO="0052"
46
8
1 Institute, under policies established by the Director of the
2 National Institutes of Health and after consultation with the
3 National Heart and Lung Advisory Board, is authorized to
4 enter into cooperative agreements with public or private
5 nonprofit agencies or institutions to pay all or part of the
6 cost of planning, establishing, or strengthening, and pro-
7 viding basic operating support for existing or new centers
8 (including, but not limited to, centers established under sub-
* section (a)) for clinical research, training, and demonstra-
10 tion of advanced diagnostic and treatment methods relating
to heart and lung diseases. Federal payments under this
12 subsection in support of such cooperative agreements may
13 be used for (1) construction (notwithstanding any limita-
14 .tion under section 405), (2) staffing and other basic operat-
13 ing costs, including such patient care costs as are required
16 for research, (3) training (including training for allied
17 health professions personnel), and (4) demonstration pur-
18 poses; but support under this subsection (other than sup-
19 port for construction) shall not exceed $5,000,000 per year
20 per center. Support of a center under this section may be
21 for a period of not to exceed three years and may be extended
22 by the Director of the National Heart and Lung Institute
23 for additional periods of not more than three years each,
24 after review of the operations of such center by an appro-
PAGENO="0053"
47
9
1 priate scientific review group established by the Director
2 of the National Heart and Lung Institute.
3 "HEART AND LUNG DISEASES CONTROL PROGRAMS
4 "Si~c. 416. (a) The Director of the National Heart
5 and Lung Institute shall establish programs as necessary
6 for cooperation with State and other health agencies in the
7 diagnosis, prevention, and treatment of heart and lung
8 diseases.
9 "(b) There are authorized to be appropriated to carry
10 out this section $20,000,000 for the fiscal year ending
11 June 30, 1973, $30,000,000 for the fiscal year ending
12 June 30, 1974, and $40,000,000 for the fiscal year ending
13 June 30, 1975.
14 "AUTHORITY OF DIRECTOR
15 "SEC. 417. The Director of the National Heart and
16 Lung Institute (after consultation with the National Heart
17 and Lung Advisory Board), in carrying out his functions
18 in administering the National Heart and Lung Diseases Pro-
19 gram and without regard to any other provision of this
20 Act, is authorized-
21 "(1) if authorized by the National Heart arid Lung
22 Advisory Board, to obtain (in accordance with section
23 3109 of title 5, United States Code, but without regard
24 to the limitation in such section on the number of days
PAGENO="0054"
48
10
1 or the period of such service) the services of iiot more
2 than fifty experts or consultants who have scientific or
3 professional qualifications;
4 "(2) to acquire, construct, improve, repair, op-
5 erate, and maintain heart and lung centers, laboratories,
6 research, and other necessary facilities and equipment,
7 and related accommodations as may be necessary, and
8 such other real or personal property (including patents)
9 as the Director deems necessary; to acquire, without
10 regard to the Act of March 3, 1877 (40 U.S.C. 34),
11 by lease or otherwise through the Administrator of
12 General Services, buildings or parts of buildings in the
13 District of Columbia or communities located adjacent to
14 the District of Columbia for the use of the National
15 lEleart and Lung Institute for a period not to exceed
16 ten years;
17 "(3) to appoint one or more advisory committees
18 con~iposed of such private citizens and officials of Fed-
19 eral, State, and local governments as he deems desirable
20 to advise him with respect to his functions;
21 "(4) to utilize, with their consent, the services,
22 equipment, personn~1, information, and facilities of other
23 Federal, State, or local public agencies, with or without
24 reimbursement therefor;
PAGENO="0055"
49
11
1 "(5) to accept voluntary and uncompensated
2 services;
3 "(6) to accept unconditional gifts, or donations
4 of services, money, or property, real, personal, or
5 mixed, tangible or intangible;
6 "(7) to enter into such contracts, leases, coopera~
7 tive agreements, or other transactions, without regard
8 to sections 3648 and 3709 of the Revised Statutes of
9 the United States (31 U.S.C. 529, 41 U.S.C. 5), as
10 may be necessary in the conduct of his functions, with
11 any public agency, or with any pei~oi~, firm, associatiOn,
12 corporation, OF (diWatiOiIal institution and
13 " (8) to take necessary aet.ioii to insure that all
14 channels for the dissemination and exchange of scientific
15 knowledge and information are maintamed between the
16 National heart and Lung Institute and the other scien-
17 tific, medical, arid biomedical disciplines and organiza-
18 tions nationally and internationally.
19 "SCIENTIFIC REVIHW; REPORTS
20 "SEC. 418. (a) The Director of the National ilearl
21 and Lung Institute shall, by regulation, provide for proper
22 scientific review of all research giants and programs over
23 which he has authority (1) by utilizing, to the maximum
24 extent possil)le, appropriate pe~ review gro.up~ established
PAGENO="0056"
50
12
1 within the National Institutes of Health and composed prin-~
2 cipally of non-Federal scientists and other experts in tbe
3 scientific and disease fields, and (2) when appropriate, by
4 establishing, with the approval of the National Heart and
5 Lung Advisory Board and the Director of the National In~
6 stitutes of Health, other formal peer review groups as may
7 be required.
8 "(b) The Director of the National Heart and Lung
9 Institute shall, as soon as practicable after the end of each
10 calendar year, prepare in consultation with the National
11 Heart and Lung Advisory Board and si~bmit to the Presi-
12 dent for transmittal to the Congress a report on the activi-
13 ties, progi'ess, and accomplishments under the National
14 Heart and Lung Diseases Program during the preceding
15 calendar year and a plan for the Program during the noxt
16 five years.
17 "NATIONAL HEART AND LUNO ADVISORY BOARD
18 "Si~o. 419. (a) There is established in the National
19 Heart and Lang Institute a National Heart and Lung Ad-
20 visory Board (hereinafter in this section referred to as the
21 `Board') to be composed of twenty-three members as
22 follows:
23 "(1) The Secretary, the Director of the Office of
24 Science and Technology, the Director of the National
25 Institutes of Health, the chief medical officer of the
PAGENO="0057"
51
18
1 Veterans' Administration (or his designee), and a
2 medical officer designated by the Secretary of Defense
3 shall be ox officio members of the Board.
4 "(2) Eighteen members appointed by the Presi~
5 dent.
6 Not more than twelve of the appointed members of the
7 Board shall be scientists or physicians and not more than
S eight of the appointed members shall be representatives from
9 the general public. The scientists and physicians appointed
10 to the Board shall be appointed from persons who are among
11 the leading scientific or medical authorities outstanding in
12 the study, diagnosis, or treatment of heart and lung diseases
.13 or in fields related thereto. Each appointed member of the
14 l3oard shall be appointed from among persons who by virtue
15 of their training, experience, and background are especially
16 qualified to appraise the programs of the National Heart
17 and Lung Institute.
18 "(b) (1) Appointed members shall be appomted for
19 six~year terms, except that of the members first appointed
20 six shall be appointed for a term of two years, and six shall
21 be appointed for a term of four years, as designated by the
22 President at the time. of appointment.
23 "(2) Any member appointed to fill a vacancy occurring
24 prior to expiration of the term for which his predecessor
25 was appointed shall serve only for the remainder of such
PAGENO="0058"
52
14
1 term. Appointed members shall be eligible for reappointment
2 and may serve after the expiration of their terms until their
3 successors have taken office.
4 "(3) A vacancy in the Board shall not affect its ac-
5 tivities, and twelve members thereof shall constitute a
6 quorum.
7 "(4) The Board shall supersede the existing National
8 Advisory Heart Council, and the appointed members of the
9 Council serving on the effective date of this section shall
10 serve as additional members of the Board for the duration
11 of their terms theit existing, or for such shorter time as the
12 President may prescribe,.
13 "(c) The President shall designate one of the appointed
14 members to serve as Chairman for a term of two years.
15 "id) The Board shall meet at the call of the Director
16 of the National Heart and Lung Institute or the Chairman,
17 but not less often than four times a year and shall advise
18 and assist the Director of the National Heart and Lung
19 Institute with respect to the National Heart and Lung
20 Diseases Program.
21 "(e) The Director of the Nationa.l Heart and Lung
22 Institute shall designate a member of the staff of the Jnsti-
23 tute to act as Executive Secretary of the Board.
24 "(f) The Board may hold such hearings, take such
25 testimony, and sit and act at such times and places as the
PAGENO="0059"
53
15
1 Board deems advisable to investigate programs and activities
2 of the Program.
3 " (g) The Board shall submit a report to the President
4 for transmittal to the Congress not later than January 31
5 of each year on the progress of the Program toward the
6 accomplishment of its objectives.
7 "(h) Members of the Board who are not officers or
8 employees of the United States shall receive for each day
9 they are engaged in the performance of the duties of the
10 Board compensation at rates not to exceed the daily equiva-
11 lent of the annual rate in effect for GS-18 of the General
12 Schedule, including traveltime; and all members, while so
13 serving away from their homes or regular places of business,
14 may be allowed travel expenses, including per diem in lieu
15 of subsistence, in the same manner as such expenses a.re
16 authorized by section 5703, title 5, United States Code, for
17 persons in the Government service employed intermittently.
18 "(i) The Director of the National Heart and Lung
19 Institute shall make available to the Board such staff, infor-
20 matiomi, and other assistance as it may require to carry out
21 its activities.
22 "AUTJIOBIZAT1ON OF APFROPR]ATIONS
23 "SEc. 419A. For the purpose of carrying out this part
24 (other than section 416), there are authorized to be appro-
25 priated $400,000,000 for the fiscal year ending June 30,
PAGENO="0060"
54
16
`1 1973; $500,000,000 for the fiscal year eiiding June 30,
2 1974; and $600,000,000 for the fiscal year ending June 30,
3 1975."
4 (b) (1) Section 412 of the Public Health Service Act
5 is amended by adding at the end thereof the following:
6 "(b) Under procedures approved by the Director of the
7 National Institutes of Health, the Director of the National
8 Heart and Lung Institute may approve grants under this
9 Act for heart and lung diseases research or training.-.
10 "(1) in amounts not to exceed $35,000 after ap.-
11 propriate review for scientific merit but without the re-
12 view and recommendation by the National Heart and
13 Lung Advisory Board prescribed by section 413 (a), and
14 "(2) in amounts exceeding $35,000 after appro-
15 priate review for scientific merit and recommendation
16 for approval by such Board as prescribed by section
17 413(a)."
18 (2) Section 412 of such Act is further amended-
19 (A) by inserting "(a)" immediately after "SEC.
20 412."; and
21 (B) by redesignating paragraphs (a), (b), (c),
22 (d), (a), (f),and (g) as paragraphs (1), (2), (3),
23 (4), (5), (6), and (7), respectively.
24 (3) Section 413 (a) of such Act is amended by striking
PAGENO="0061"
55
17
1 out "grants4n-aid" and inserting in lieu thereof "except as
2 provided in section 412 (b), grants4n~aid".
3 BEPOET TO CONGRESS
4 Si~c. 4. (a) The President shall carry out a review of
5 all administrative processes under which the National Heart
6 and Lung Diseases Program, established under part B of title
7 IV of the Public Health Service Act, wifi operate, including
8 the processes of advisory council and peer group reviews, in
~ order to assure the most expeditious accomplishment of the
10 objectives of the program. Within one year of the date of
11 enactment of this Act the President shall submit a report
12 to Congress of the findings of such review and the actions
13 taken to facilitate the conduct of the Program, together with
14 recommendations for any needed legislative changes.
15 (b) The President shall request of the Congress without
16 delay such additional appropriations (including increased
17 authorizations) as are required to pursue immediately any
18 development in the National Heart and Lung Diseases Pro~~
19 grain requiring prompt and expeditious support and for
20 which regularly appropriated funds are not available.
21 PRESIDENTIAL APPOINTMENTS
22 SEc. 5. Section 454 of the Public Health Service Act
23 as amended-
2. (1) by striking out "Director of the National Can-
PAGENO="0062"
56
18
1 cer Institute" in the first sentence and inserting in lieu
2 thereof "Directors of tile National Cancer Institute and
3 the National heart and Lung Institute"; and
4 (2) by inserting mnnediately before the period at
5 the eiid of the second sentence "; a.nd except as pro-
6 vided in section 415 (b) (9), the Director of the Na-
7 tional Heart aiid Lung Institute shall report directly
8 to the Director of the National Institutes of Health".
9 CONFORMING AMENDMENTS
10 SEc. 6. (a) Section 217 of the Public Health Service
11 Act is amended (A) by striking out "National Advisory
12 }Ieart Council," each place it occurs in subsection (a),
13 (B) by striking out "heart diseases," in subsection (a)
14 of such section, and (C) by striking out "heart," in sub-
15 section (1)) of such section.
16 (b) Sections 301 (d) 301 (i), and 412 of such Act
17 are each amended by striking out "National Advisory Heart
18 Council" aiid inserting iii lieu thereof "National Heart and
19 Lung Advisory Board".
20 (c) Section 414 of such Act is amended-
21 (A) by striking out "Council" in the matter pre-
22 ceding paragraph (a) and inserting in lieu thereof
23 "National Heart and Lung Advisory Board", and
24 (B) by striking out "COUNCIL" in the section
25 heading and inserting in lieu thereof "BOARD".
PAGENO="0063"
57
19
1. (d) Part B of such Act is further amended-
2 (A) by striking out "National Heart Institute"
3 in section 411 arid inserting in lieu thereof "National
4 Heart ai~d Lung Institute";
5 (B) by striking out "heart diseases" each place
6 it occurs in s~ections 412, 413 (b), and 414 and inserting
7 in lieu thereof "heart and lung diseases";
8 (0) by striking out "heart disease" in sections
413 (a) and 414 (b) and inserting in lieu thereof `4heart
10 and lung diseases";
11 (D) by striking out `~HEART DISEASE" in the see-
12 tion heading of section 412 and inserting in lieu thereof
13 "HEART AND LUNG DISEASES"; and
14 (E) by striking out "NATIoN~ HEART INSTI-
15 TUTE" in the heading of such part and inserting in lieu
16 thereof "NATIONAl4 HEART AND TilING INSTITUTE".
17 EFFECTIVE DATE
18 SEC. 7. (a) This Act and the amendments made by
19 this Act shall take effect sixty days after the date of enact-
20 mont of this Act or on such prior date after the date of
21 enactment of this Act as the President shall prescribe and
22 publish in the Federal Register.
23 (b) The first sentence of section 454 of the Public
24 Health Service Act (as amended by section 5 of this Act)
~ shall apply only with respect to appointments of Directors
V
PAGENO="0064"
58
20
1 `of the National Heart and Lung Institute made after the
2 effective date of this Act (as prescribed by subsection (a)).
3 (o) Notwithstanding the provisions of subsection (a),
4 members of the National Heart and Lung Advisory Board
5 (authorized under section 419 of the Public :H~jth Service
.6 Act, as added by this Act) may be appointed, in the manner
7 provided for in such section, at any time after the date of
8 enactment of this' Act. Such~ officers shall `be compensated
9 from ~the date they first take office, at the rates provided
10 for in such section 419. . . :.
PAGENO="0065"
A BILL
To expand the scope of the National Heart and Lung Institute,
to provide for special emphasis on the prevention of arterio-
sclerosis and the creation of cardiovascula.r disease preventiOn
centers, and for other purposes.
1 Be ~t enacted by the Senate and house of Representa-
2 tives of the United States of America in Congress assembled,
3 SITOET TITLE
4 Si~c~io~ 1. This Act shall be known as the "Heart Dis-
5 ease Prevention Act of 1972".
6 STATEMENT OF PIJIIPOSE
7 Si~c. 2. It is the purpose of this Act to-
8 (1.) provide for the creation of centers concerned
9 with the siudy and research of arteriosclerosis;
59
92n CONGRESS
21) Si SSION I'!. R. 1 3500
IN THE hOUSE 01' REPRESENTATIVES
MArCH 1, 1972
Mi 1)L'ciN intiodiiced tiic following bill \%hlch w is iefried to the Corn
mittee on Interstate and Foreign Commerce
78-994 O-~2-5
PAGENO="0066"
60
2
1 (2) provide for the establishment of model cardio-
2 vascular disease prevention centers within the frame-
3 work of the existing programs; and
4 (3) provide for a clearinghouse for iiiformation
5 concerning arteriosclerosis and cardiovascular di sense
6 within the National heart and Lung Institute.
7 AMENDMENT TO PUBLIC HEALTII SERVICE ACT
8 SEC. 3. Part B of title IV of the Public health Service
9 Act is amended by adding at the end thereof the following
10 new sections:
ii "NATIONAL CENTEI~S FOR TIlE PREVENTION OF
12 ARTERIOSCLEROSIS
13 "SEc. 415. (a) The Director of the National Heart and
14 Lung Institute is authorized to provide for the establishment
15 of new multidisciplinary centers for the study of arteriosele-
16 rosis including its prevention, epidemiology, genesis, clinical
17 manifestations and treatment, and the screening of individuals
18 to determine those who are high risk in relation to arterioscie-
19 rosis. Such centers are to be located at major medical centers.
20 "(b) Payments under this section may be used for-
21 " (1) construction;
22 "(2) staffing and other basic operational costs, in-
23 eluding such patient care costs as are required for
24 research;
PAGENO="0067"
61
3
1 "(3) training, including training for allied health
2 professions personnel; and
3 "(4) demonstration purposes.
4 "(c) Support under this section shall not exceed $10,-
5 000,000 per year per center. Support of a center may be for
6 a period of not to exceed three years and may be extended
7 by the Director for additional periods of not more than three
8 years each, after the review of the operation of such center by
9 an appropriate scientific revi~\v group.
10 "OARDIOVASCTJLAR DiSEASE PREVENTION CLINICS
11 "Si~c. 416. (a) The Director of the heart and Lung
12 Institute is authorized to estabhsh teii model cardiovascular
13 disease prevention clinics throughout the United States within
14 the framework of existing programs. The purpose of such
15 clinics shall be-
16 "( 1) to develop improved methods of detecting
17 high risk individuals;
18 "(2) to develop improved methods of intervention
19 against high risk factors; and
20 "(3) to develop highly skilled manpower in eardlo-
21 vascular disease prevention.
22 "(h) Such clinics shall be served by a central coordinat-
23 ing unit that shall be responsible for the development of
24 standardized procedures for diagnosis, treatment, and data
25 collection in relation to cardiovascular disease.
PAGENO="0068"
62
4
1 "OFFICE OF HEART HEALTH EDUCATION
2 "SEC 417 Theie is heieby established within the Na-
3 tional lleait and Lung Institutc an Officc of lEducation which
4 shall provide a program of heart health education for public,
5 medical, and allied health professions. Special emphasis
6 shall be placed upon dissemination of infoimation regardmg
7 diet, hypertension, cigarette smoking, weight control, and
8 other factors in the prevention of arteriosclerosis and cardi-
9 ovascular disease.
10 "AUTHORIZATION OF APPROPRIATIONS
11 "SEC. 418. There are authorized to be appro~riated for
12 the purposes of sections 415, 416, and 417, $50,000,000 for
13 the fiscal year ending June 30, 1973; $75,000,000 for the
14 fiscal year ending June 30, 1974; $100,000,000 for the
15 fiscal year ending June 30, 1975; $100,000,000 for the
16 fiscal year ending June 30, 1976;' and $100,000,000 for
17 fiscal year ending June 30, 1977."
PAGENO="0069"
63
[H.R. 14493, 92d Cong., 2d sess., introduced by Mr. Patten on
April 19, 1972;
H.R. 14682, 92d Cong., ~d sess., introduced by Mr. Minish on
April 27, 1972;
H R 14686 92d Cong 2d sess introduced by Mr Rodino on
April 27, 1972; and
S 3323 92d Cong 2d sess passed the Senate April 7 1972 and
referred to the Committee on Interstate and Foreign Corn
merce on April 10, 1972,
are identical as follows]
A BILL
To amend the Public Health Service Act to enlarge the authority
of the National Heart and Lung Institute in order to advance
the national attack against diseases of the heart and blood
vessels, the lungs, and blood, and for other purposes.
1 Be it enacted by the Senate and House of Bepresenta-
2 lives of the Un?ted States of America in Congress assembled,
3 SHORT TITLE
4 SECTION 1. This Act may be cited as the "National
5 Heart, Blood Vessel, Lung, and Blood Act of 1972".
6 FINDINGS AND DECLARATION OF PURPOSE
7 SEc. 2. (a) Congress finds and declares that-
8 (1) diseases of the heart and blood vessels collec-
9 tively cause more than half of all the deaths each year in
PAGENO="0070"
64
2
1 the United States and the combined effect of the dis-
2 abilities and deaths froni such diseases is having a major
3 social atid ecoiiomic impact on tile Nation;
4 (2) elimination of such cardiovascular diseases as
5 significant causes of disability and death could increase
6 the average American's life expectancy by about eleven
7 years and could provide for annual savings to the econ-
8 omy in lost wages, productivity, and costs of medical
9 care of more than $30,000,000,000 per year;
10 (3) chronic lung diseases have been gaining
11 steadily in recent years as important causes of disability
12 and death, with emphysema alone being the fastest rising
13 cause of death in the United States;
14 (4) chronic respiratory diseases affect an estimated
15 ten million Americans, emphysema an estimated one
16 million, chronic bronchitis an estimated four million, and
17 asthma an estimated five million;
18 (5) thrombosis (the formation of blood clots in the
19 vessels) may cause, directly or in combination with
20 other problems, many deaths and disabilities from heart
21 disease and stroke which can now be prevented;
22 (6) blood and blood products are essential human
23 resources whose value in saving life and promoting
24 health cannot be assessed in terms of dollars;
25 (7) the provision of prompt and effective emer-
PAGENO="0071"
65
3
1 gency medical services utilizing to the fullest extent possi-
2 ble, advances in transportation and communications and
3 other electronic systems and specially trained profes-
4 sional and paraprofessional health care personnel can
5 reduce substantially the number of fataifties and severe
6 di~abilities due to critical illnesses in connection with
7 heart, blood vessel, lung, and blood diseases; and
8 (8) the greatest potential for advancement against
9 diseases of the heart and blood vessels, the lungs, and
10 blood lies in the National Heart and Lung Institute of
11 the National Institutes of Health whose research insti-
12 tutes have brought into being the most productive scien-
13 tific community centered upon health and disease that
14 the world has ever known.
15 (b) It is the purpose of this Act to enlarge the author-
16 ity of the National Heart and Lung Institute in order to ad-
17 vance the national attack upon the diseases of the heart and
18 blood vessels, the lungs, and blood.
19 hEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES
20 PROGRAMS
21 SEc. 3. Part B of title IV of the Public Health Service
22 Act is amended (1) by redesignating section 413 as section
23 419A, (2) by redesignating section 414 as section 418, and
24 (3) by adding after section 412 the following new sections:
PAGENO="0072"
66
4
1 "NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD
2 DISEASE PROGRAM
3 "Siic. 413. (a) The Director of the Institute, with the
4 advice of the Council, shall within one hundred and eighty
5 days after the effective date of this section, develop a plan for
6 a heart, blood vessel, lung, and blood disease program (here-
7 after in this part referred to as the `program') to expand,
S intensify, and coordinate the activities of the Institute re-
9 specting such diseases (including its activities under section
10 412) The program shall provide for-
11 "(1) investigation into the epidemiology, etiology,
12 and prevention of all forms and aspects of cardiovascular,
lung, and blood diseases, including investigations into the
14 social, environmental, behavioral, nutritional, biological,
15 and genetic determinants and influences involved in the
16 epidemiology, etiology, and prevention of such diseases;
17 (2) studies and research into the basic biological
18 processes and mechanisms involved in the underlying
19 normal and abnormal cardiovascular, pulmonary, and
20 blood phenomena;
21 "(3) research into the development, trial, and eval-
22 uation of techniques, drugs, and devices used in, and
23 approaches to, the diagnosis, prevention, and treatment
24 (including emergency medical service) of cardiovascular
PAGENO="0073"
67
5
1. and pulmonary diseases and the rehabilitation of patients
2 suffering from such diseases;
3 "(4) establishment of programs that will focus and
4 apply scientific and technological efforts involving bio-
5 logical, physical, and engineering sciences to all facets
of cardiovascular, pulmonary, and other related diseases
7 with emphasis on refinement, development, and evalua-
8 tion of technological devices that will assist, replace or
9 monitor vital organs and improve instrumentation for
10 detection, diagnosis, and treatment of these diseases;
ii "(5) establishment of programs and centers for the
12 conduct and direction of field studies, large-scale testing
13 and evaluation, and demonstration of preventive, diag-
14 nos;tic, therapeutic, and rehabilitative approaches (in-
15 chiding emergency medical services) to cardiovascular
16 and pulmonary diseases;
17 "(6) studies and research into blood diseases (such
18 as sickle cell anemia and hemophilia) and blood, its uses
19 for clinical purposes and all aspects of the management
20 of its resources in this country, including the collection,
21 preservation, fractionalization, and distribution of it and
22 its products;
23 "(7) the education and training of scientists, clini-
24 cians, and educators in fields and specialties requisite to
PAGENO="0074"
68
6
1 the conduct of programs respecting cardiovascular, pul-
2 monary, and blood diseases;
3 "(8) public and professional education relating to
4 all aspects of cardiovascular, pulmonary, and blood dis-
5 eases and the use of blood and blood products and the
6 management of blood resources;
7 "(9) establishment of programs and centers for
8 study and research into cardiovascular, pulmonary, and
9 blood diseases of children (including cystic fibrosis,
10 hyaline membrane, and hemolytic and hemophilic, dis-
11 eases) and for the development and demonstration of
12 diagnostic, treatment, and preventive approaches to these
13 diseases; and
14 "(10) establishment of programs for study, re-
15 search, development, demonstrations, and evaluation of
16 emergency medical services for people who sustain criti-
17 cal illnesses iii connection with heart, blood vessel, lung
18 or blood diseases which programs shall include the train-
19 ing of paraprofessionals in emergency treatment proce-
20 dures, and in the utilization and operation of emergency
21 medical equipment, the development and operation of
22 mobile critical care units (including helicopters and
23 other airborne units where appropriate), and radio and
24 telecommunications, other communications and elec-
25 tronic monitoring systems, the coordination with other
PAGENO="0075"
69
7
1 comniunity services and agencies in the joint use of all
2 forms of emergency vehicles, coinniunications systems,
3 and other appropriate services.
4 "(b) (1) The plan required by subsection (a) of this
5 section shall be transmitted to the Congress and shall set out
6 the Institute's staff requirements to carry out the program
7 and recommendations for appropriations for the program.
8 "(2) The Director of the Institute shall, as soon tis
9 practicable after the end of each calendar year, prepare in
10 consultation with the Council and submit to the President for
11 transmittal to the Congress a report on the activities, prog-
12 ress, and accomplishments under the program during the
13 preceding calendar year and a plan for the program during
14 the next five years.
15 "(c) In carrying out the program, the Director of the
16 Institute, after consultation with the Council and without
17 regard to any other provisions of this Act, may-
18 "( 1) ii authorized by the Council, obtain (in ac-
19 cordance with section 3109 of title 5, United States
20 Code, but without regard to the limitation in such section
21 on the number of days or the period of such service) the
22 services of not more than fifty experts or consultants who
23 have scientific or professional qualifications;
24 "(2) acquire, construct, improve, repair, operate,
25 and maintain cardiovascular ~nd pulmonary disease ceu~
PAGENO="0076"
70
1 ters, laboratories, research, training, and other necessary
2 facilities and equipment, and related accommodations as
3 may be necessary, and such other real or personal prop-
4 erty (including patents) as the Director deems neces-
S sary, and acquire, without regard to the Act of March 3,
6 1877 (40 U S C 34), by lease or otherwise through the
7 Administrator of General Services, buildings or parts of
8 buildings in the District of Columbia or communities lo-
9 cated adjacent to the District of Columbia for the use of
10 the Institute for a period not to exceed ten years, and
11 "(3) enter into such contracts, leases, cooperativc
12 agreements, or other transactions, without regard to sec-
11 tions 3648 and 3709 of the Revised Statutes of the
14 United States (31 U S C 529, 41 U S C 5), as may
15 be necessary in the conduct of his functions, with an~
16 public agency, or with any person, firm, association, cor-
17 poration, or educational institution.
18 "HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE
19 PREVENTION AND CONTROL PROGRAMS
20 "SEc 414 (a) The Director of the Institute, undei
21 policies established by the Director of the National Institutes
22 of Health and after consultation with the Council, shall estab-
23 lish programs as necessary for cooperation with other Federal
24 *health agencies, State, local, and regional public health agen-
25 cies, and nonprofit private health agencies in the diagnosis,
PAGENO="0077"
71
9
1 prevention, and tre'itment (including emergency medical
2 services) of heart, blood vessel, lung, and blood diseases,
3 appi opi iately emph't~izing the prevention, diagnosis, and
4 trv~tnicnt of heait, blood ~esse1, lung, and blood diseases of
5 children
6 "(b) (1) The Director of the Heait and Lung Institute
7 is authoiized to est'iblish ten model cardiovascular disease
8 prevention clinics throughout the United States within the
9 framework of e~istirig progr'ims The purpose of such clinics
10 shall be-
11 "(A) to develop improved methods of detecting
12 high risk individuals,
13 "(B) to develop impi oved methods of intervention
14 `ig'iinst high risk factors,
15 "(0) to develop highly skilled manpower in cardio-
16 vascular disease prevention, and
17 "(D) to develop improved methods of providing
18 emergency medical services"
19 "(2) Such clinics sh'ill be served by a central coordinat-
20 ing unit that shall be responsible for the development of
21 standai di7ed procedures foi diagnosis, treatment, and dat'i
22 collection in relation to cardiovascular disease
23 "(c) There are authorized to be appropriated to carry
24 out this section $30,000,000 for the fisc'il year ending
25 June 30, 1973, $40,000,000 for the fiscal year ending
PAGENO="0078"
72
10
1 June 30, 1974, and $50,000,000 for the fiscal year ending
2 June 30, 1975.
3 "NATIONAL BASIC AND CLINICAL RESEARCH AND DEMON-
4 STRATION CENTERS FOR CARDIOVASCULAR AND PUL-
5 MONARY DISEASES
6 "SEC. 415. (a) The Director of the Institute may pro-
7 vide for the development of-
8 "(1) fifteen new centers for basic and clinical re-
9 search into, training in, and demonstration of, advanced
10 diagnostic and treatment methods (including emergency
11 medical services) for cardiovascular diseases; and
12 "(2) fifteen new centers for basic and clinical re-
13 search into, training in, and demonstration of advanced
14 diagnostic and treatment methods (including emergency
15 medical services) for chronic pulmonary diseases of
16 adults and children (including but not limited to ~ron-
17 chitis, emphysema, asthma, and cystic fibrosis and other
18 pulmonary diseases of children).
19 Centers developed under this subsection may be supported
20 under subsection (b) or under any other applicable provision
21 of law.
22 "(b) The Director of the Institute, under policies es-
23 tablished by the Director of the National Institutes of Health
24 and after consultation with the Council, may enter into
25 cooperative agreements with public or nonprofit private
PAGENO="0079"
73
11
1 agencies or institutions to pay all or part of the cost of plan-
2 ning, establishing, or strengthening, and providing basic
3 operating support for, existing or new centers (including
4 centers established under subsection (a)) for clinical re-
5 search into, training in, and demonstration of advanced
6 diagnostic and treatment methods for cardiovascular and
7 chronic pulmonary diseases. Funds paid to centers under
8 cooperative agreements under this subsection may be used
9 for-
10 "( 1) construction, notwithstanding section 405,
11 "(2) staffIng and other basic operating costs, in-
12 cluding such patient care costs as are required for re-
13 - search,
14 "(3) training, including training for allied health
15 professions personnel, and
16 "(4) demonstration purposes.
17 The aggregate of payments (other than payments for con-
18 struction) made to any center under such an agreement may
19 not exceed $5,000,000 in any year. Support of a center
20 under this subsection may be for a period of not to exceed
21 five years and may be extended by the Director of the
22 Institute for additional periods of not more than five years
23 each, after review of the operations of such center by an
24 appropriate scientific review group established by the
25 Director.
PAGENO="0080"
74
I
12
1 "INTERAGENCY TECHNICAL COMMITILE AND 01 FlOE OF
2 HEART AND LUNG IILALTH EDUCAI1ON
3 "S~c 416 (a) The Secretary shall establish an Intei-
4 agency Technical Committee on Heait, Blood Vessel, Lung,
5 and Blood Diseases and Blood Resouices which shall be
6 responsible for coordinating those aspects of all Federal
7 health programs ~nd activities relating to diseases of the
8 heart, blood vessels, the lung, and blood `and to blood re-
9 sources to assure the adequacy and technical soundness of
10 such programs and activities and to provide for the full
11 communication and exchange of information necessary to
12 mamtam adequate coordination of such programs and
13 activities
14 "(b) The Direotoi of the Institute shall serve as Chair
15 man of the Committee and the Committee shall include rep-
16 resentation from all Federal departments and agencies whose
17 programs involve health functions or responsibilities as de-
18 termmed by the Secretary
19 "(o) There is hereby established within the Department
20 of Health, Education, and Welfare an Office of Heart and
21 Lung Health Education which shall provide a program of
22 heart and lung health education for public, medical, and
23 allied health professions. Special emphasis shall be placed
24 upon dissemination of information regarding diet, hyperten-
2) sion, cigarette smoking, weight control, and other factors in
PAGENO="0081"
75
13
1 the prevention of arteriosclerosis, cai diovascular disease, and
2 lung disease
3 "NATIONAL HEART AND LUNG ADVISORY COUNCIL
4 "SEC 417 (a) There is established in the Institute a
5 National Heart rnd Lung Advisoiy Council to be tomposed
6 of twenty-three members as follows
7 "(1) The Secretary, the Director of the National
8 Institutes of Health, the Director of the Office of Scuince
9 and Technology, the chief medical officer of the Vet-
10 erans' Administration (or his designee), and a medical
11 officer designated by the Secretary of Defense shall be
12 ex officio members of the Council
13 "(2) Eighteen members appointed by the Secre-
14 tary
15 Each of the appointed members of the Council shall be
16 leaders in the fields of fundamental sciences, medical sciences,
17 or public affairs Not more than twelve of the appointed
18 members of the Council shall be leading medical or scientific
19 authorities who are skilled in the sciences relating to disease
20 of the heart, blood vessels, lungs, and blood, and not more
21 than eight of the `ippointed members shall be representatives
22 of the general public
23 "(b) (1) Each appointed member of the Council shall
24 be appointed for a term of four years, except that-
25 "(A) any member appointed to fill a vacancy oc-
78-994 O-72----6
PAGENO="0082"
76
14
1 curring prior to the expiration of the term for which his
2 predecessor was appointed shall be appointed for the
3 remainder of such term; and
4 " (B) of the members first appointed after the effec-
5 tive date of this section, five shall he appomted for a term
6 of four years, five shall be appomtment for a term of
7 three years, five shall be appointed for a term of two
8 years, and three shall be appointed for a term of one
9 year, as designated by the Secretary at the time of
10 appointment.
11 Appointed members may serve after the expiratiorr of their
12 terms until their successors have taken office.
13 "(2) A vacancy ii1 the Council shall not affect its ac-
14 tivities, and twelve members of the Council shall constitute
15 a quorum.
16 "(3) The Council shall supersede the existing National
17 Advisory heart Council appointed under section 217, and
18 the appointed members of the National Advisory Heart
19 Council serving on the effective date of this section shall
20 serve as additional members of the National Heart and Lung
21 Advisory Council for the duration of their terms then exist-
22 ing, or for such shorter time as the Secretary may prescribe.
23 "(4) Members of the Council who are not officers or
24 employees of the United States shall receive for each day
25 they are engaged in the performance of the functions of the
PAGENO="0083"
77
15
1 Council compensation at rates not to exceed the daily equiva~
2 lent of the annual rate in effect for grade GS-18 of the Gen-
3 eral Schedule, including traveltirne; and all members, while
4 so serving away from their homes or regular places of busi-
5 ness, may be allowed travel expenses, including per diem in
6 lieu of subsistence, in the same manner as such expenses are
7 authorized by section 5703, title 5, United States Code, for
8 persons in the Government service employed intermittently.
9 "(c) The Chairman of the Council shall be appointed by
10 the Secretary from among the members of the Council and
11 shall serve as Chairman for a term of two years.
12 "(d) The Director of the Institute shall (1) designate a
13 member of the staff of the Institute to act as executive secre-
14 tary of the Council, and (2) make available to the Council
15 such staff, information, and other assistance as it may require
16 to carry out its functions.
17 "(e) The Council shall meet at the call of the Director
18 of the Institute or the Chairman, but not less often than four
19 times a year."
20 AUTHORIZATION OF APPROPRIATIONS FOR PART B OF
21 TITLE IV OF THE PUBLIC HEALTH SERVIGE ACT
22 SEc. 4. Fart B of title IV of the Public Health Service
23 Act is amended by adding at the end thereof the following
24 new sections:
PAGENO="0084"
1 "AUTHORIZATION OF APPROPRIATIONS
2 "Sno 419B For the purpose of carrying out this part
3 (other th~n section 414), theie `ire `iuthoriied to be appro-
4 priated $400,000,000 for the fiscal ~ e ii ending June 30,
5 1973, $450,000,000 foi the fiscal year ending June 30,
6 1974, and $500,000,000 foi the fiscal ye'ir ending June 30,
7 1975, of which not less than 20 per centum of the funds
8 appiopii'ited undei this section in e'tch such year shall be
9 reser~ ed for programs in connection with diseases of the lung
10 and not less than. 20 per centum of the funds appropriated
11 under this section in each fiscal ycar shall be reseived for
12 progr'ims in connection with diseases of blood
"Si~o 4190 Notwithstanding `my limitation on appro-
14 puations for any progiam 01 `ictivity under section 419B of
15 this Act or any Act authorizing appropriations for such pro-
16 gram or activity, not to exceed 10 per centum of the amount
17 appropriated or allocated for each fiscal year from any ap-
18 propriation for the purpose of allowing .the Secretary to carry
19 out any such progi'im or activity under section 419B of this
20 Act may be transferred and used by the `Secretary for the
21 purpose of carrying out any other such program or activity
22 under this part"
23 DIRECTOR'S AUTHORITY TO APPROVE GRANTS
24 SEc. 5. Section 419A of the Public Health Service Act
25 (as so redesignated by section 3 of this Act) is amended-
PAGENO="0085"
79
17
1 (1) by striking out "grants-rn-aid" in subsection
2 (a) and rnsertrng in lieu thereof "except as provided
3 in subsection (c), grants-in-aid", and
4 (2) by adding after subsection (b) the following
5 new subsection
6 "(c) Under procedures approved by the Director of
7 the National Institutes of Health, the Director of the Na-
8 tional Heart and Lung Institute may approve grants under
9 this Act for research and training in heart, blood vessel,
10 lung, and blood diseases-
11 "(1) in amounts not to exceed $35,000 after ap-
12 propriate review for scientific merit but without review
1~ and recommendation by the Council, and
14 "(2) in amounts exceeding $35,000 after appro-
15 priate review for scientific merit and recommendation
16 for approval by the Council"
17 CONFORMING AMENDMENTS TO PART B OF TITLE IV OF
18 THE PUBLIC HEALTH SERVICE ACT
19 SEC 6 (a) Section 411 of the Public Health Service
20 Act is amended by striking out "National Heart Institute"
21 and inserting in lieu thereof "National Heart and Lung
22 Institute".
23 (b) Section 412 of such Act is amended-
24 (1) by striking out "heart" each place it occurs
PAGENO="0086"
80
18
1 (except in the headings) and inserting in lieu thereof
2 "heart, blood vessel, lung, and blood";
3 (2) by striking out "Surgeon General" and insert-
4 ing in lieu thereof "Secretary";
5 (3) by striking out "National Advisory Heart
6 Council" and inserting in lieu thereof "National Heart
7 and Lung Advisory Council";
8 (4) by redesignating paragraphs (a), (b), (c),
9 (d), (e), (f), and (g) as paragraphs (1), (2), (3),
10 (4), (5), (6), and (7), respectively; and
11 (5) by amending the section heading to read as
12 follows:
13 "RESEARCH AND TRAINING IN DISEASES OF THE HEART,
14 BLOOD VESSELS, LUNG, AND BLOOD".
15 (c) Section 418 of such Act (as so redesignated by see-
16 tion 3 of this Act) is amended-
17 (1) by inserting "(a)" immediately after "SEC.
18 418." and by adding at the end thereof the following
19 new subsection:
20 "(b) (1) The Council shall advise and assist the Direc-
21 tor of the Institute with respect to the program estab1ish~d
22 under section 413. The Council may hold such hearings, take
23 such testimony, and sit and act at such times and places, as
24 the Council deems advisable to investigate programs and
25 activities of the program.
PAGENO="0087"
81
19
1 "(2) The Council shall submit a report to the President
2 for transmittal to the Congress not later than January 31 of
3 each year on the progress of the program toward the accom-
4 plishrhent of its objectives."
5 (2) by striking out "Surgeon General" each place
6 it occurs (except paragraph (f) ) and inserting in lieu
7 thereof "Secretary";
8 (3) by striking out "heart" each place it occurs and
9 inserting in lieu thereof "heart, blood vessel, lung, and
10 blood";
11 (4) by striking out "Surgeon General" in para-
12 graph (f) and inserting in lieu thereof "Secretary, the
13 Director of the National Institutes of Health, and the
14 Director of the National Heart and Lung Institute"; and
15 (5) by redesignating paragraphs (a), (b), (c),
16 (d), (e), and (f) as paragraphs (1), (2), (3)., (4),
17 (5), and (6), respectively.
18 (d) Section 419A of such Act (as so redesignated by
19 section 3 of this Act) is amended-
20 (1) in subsection (a), by (A) striking out "Sur-
21 geon General" and inserting in lieu thereof "Secretary",
22 and (B) striking out "heart" and inserting in lieu there-
23 of "heart, blood vessel, lung, and blood"; and
24 (2) in subsection (b), by (A) striking out "The
25 Surgeon General shall recommend to the Secretary ac-
PAGENO="0088"
82
20
1 ceptance of conditional gifts, pursuant to section 501,"
2 and mserting in lieu thereof "The Secretary may, in ac-
3 cordance with section 501, accept conditional gifts", and
4 (B) striking out "heart" and inserting in lieu thereof
5 "heart, blood `~ essel, lung, and blood"
6 (e) The heading for part B of such Act is amended
7 to read as follows
8 "PART B-NATIONAL HEART AND LUNG INSTITUTE"
9 CONFORMING AMENDMENTS TO OUHER PROVISIONS OF
10 THE PUBLIC HEALTH SERVICE ACT
11 SEC 7 (a) Section 217 of such Act is amended-
12 (1) by striking out "the National Advisory Heart
13 Council," each place it occurs in subsection (a),
14 (2) by striking out "heart diseases," in subsection
15 (a.) and by striking out "heart," in subsection (b).
16 (b) Sections 301 (d) and 301 (i) of such Act are each
17 amended by striking out "National Advisory Heart Council"
18 and inserting in lieu thereof "National Heart and Lung
19 Advisory Council"
20 REPORT TO CONGRESS
21 SEc. 8. The Secretary of Health, Education, and We!-
22 fare shall carry out a review of all administrative processes
23 under which the national heart, blood vessel, lung, and blood
24 disease program, established under part B of title IV of the
25 Public Health Service Act, will operate, including the proc-
PAGENO="0089"
83
21
1 esses of advisory council and peer group reviews, in order to
2 assure the most expeditious accomplishment of the objectives
3 of the program Within one year of the date of enactment of
4 this Act, the Secretary shall submit a report to the Congress
5 of the findings of such review and the actions taken to facili-
6 tate the conduct of the program, togeth& with recommenda-
7 tions for any needed legislative changes
8 EFFECTIVE DATE
9 Sii~ 9 This Act and the amendments made by this Act
10 shall take effect sixty days after the date of enactment of this
11 Act or on such prior date after the date of enactment of this
12 Act as the President shall prescribe and publish in the
13 Federal Register
PAGENO="0090"
84
DEPARTMENT OF DEFENSE,
DEPARTMENT or THE ARMY,
Washington, D.C., April 26~ 1972
Hon. HARLEY 0. STAGGERS,
Chairman, Committee on Interstate and Foreign Camm~erce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: Reference is made to your request to the Secretary of
Defense for the views of the Department of Defense on H.R. 12460, 92d Congress,
a bill "To amend the Public Health Service Act to strengthen the National
Heart and Lung Institute and the National Institues of Health In order more
effectively to carry out the national effort against heart and lung diseases ;"
and ILR. 12571, 92d Congress, a bill "To amend the Public Health Service Act
so as to strengthen the National Heart and Lung Institute of Neurological
Diseases and Stroke, and the National Institutes of Health in order more effec-
tively to carry out the national effort against heart, lung, and neurological
diseases and stroke." The Department of the Army has been assigned respon-
sibility for expressing the views of the Department of Defense on these bills;
The purpose of the bills is to enlarge the authorities of the National Heart
and Lung Institute, the National Institutes of Health, and other national
institutes in appropriate instances in order to advance the national effort against
heart and lung diseases and, in the case of H.R. 12571, neurological diseases
and strokes through research projects advisory committees, demonstration
centers, and control programs.
Inasmuch as enactment of the bills would not affect the operations of the
the Department of Defense, the Department of the Army on behalf of the
Department of Defense defers to the views of the Department of Health, Edu-
cation, and Welfare as the agency having primary interest in this matter.
The enactment of these bills will cause no apparent increase in budgetary
requirements of the Department of Defense.
This report has been coordinated within the Department of Defense in acord-
ance with procedures prescribed by the Secretary of Defense.
The Office of Management and Budget advises that, from the standpoint of
the Administration's program, there is no objection to the presentation of this
report for the consideration of the Committee.
Sincerely,
KENNETH E. BELIET.T,
Acting secretary of the Army.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., June 1, 1972.
Hon. HARLEY 0. STAGGERS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: This letter is in response to your requests of January
20, January 28, March 6, March 16, and April 14, for a report on H.R. 12460,
H.R. 12571, H.R. 13500, H.R. 13715, and S. 3323 as passed by the Senate, respec-
tively. All of these bills deal with expansion of the national effort in heart and
lung disease.
The Department's views on H.R. 13500, HR. 13715, 5. 3323, and similar legisia-
tion were presented to the Subcommittee on Public Health and Environment by
Dr. Merlin K. DuVal, Assistant Secretary of Health nd Scientific Affairs, on
April 25, 1972.
Dr. Duval's statement, enclosed, raises objection to certain provisions of these
bills, but indicates our preference for H.R. 13715, rather than 5. 3323, if the
suggestions outlined in regard to H.R. 13715 are incorporated. We would have
no objection to enactment of H.R. 13715, if so amended.
We are advised by the Office of Management and Budget that there is no
objection to the presentation of this report from the standpoint of the Adminia.
tration's program.
Sincerely,
ELLIOT L. RICHARDSON,
secretary.
PAGENO="0091"
85
EXECUTIVE OFFICE OF TEE PRESIDENT,
OFFICE OF MANAGEMENT AND BUDGET,
Washington, D.C., May 4, 1972.
Hon. HARLEY 0. STAGGERS,
Chairman, Committee on Interstate and Foreign Commerce, House of Repre-
sentatives, 2125 Rayburn House Of/Ice Building, Washington, D.C.
DEAR Mis. CHAIRMAN: This is in response to your requests of March 16, 1972
and April 13, 1972, respectively, for our views `on H.R. 13715 and 5. 3323 as passed
by the Senate, bills "To amend `the Public Health Service Act to enlarge the au-
thority of the National Heart and Lung Instititie in `order to advance the national
attack against diseases of the heart and blood vessels, `the lungs, and blood, and
for other purposes'."
The Department of Health, Education, and Welfare, in `testimony `before your
Committee on April 25, 1972, identified a significant number of objectionable pro-
visions in 5. 3323. The Department stated that it would prefer enactment of H.R.
13715 su'bje~t to certain revisions, rather than 5. 3323, as it passed `the Senate.
In addition, the Office of Science and Technology in its report on 5. 3323, indicates
its concerns from a scientific viewpoint about several provisions in the bill, and
has also recommended that `t'he Committee adopt the provisions of H.R. 1371'S
with the changes recommended by HEW, rather than 5. 3323.
We concur in the views expressed by the Department of Health, Education, and
Welfare and the Office of Science and Technology. Accordingly, we would prefer
the enactment of H.R. 13715 with the changes recommended by `t'he Department,
rather `than `the Senate-passed version of 5. 3323.
This will also serve as our report on H.R. 13500, H.R. 12571, and H.R. 12460,
related bills concerning research on heart and lung diseases on which your Com-
mittee has requested our views.
Sincerely,
WILFRED H. ROMMEL,
Assistant Director for Legislative Reference.
Mr. ROGERS. This morning our first witnesses will be from the De-
partment of Health, Education, and Welfare. We are pleased to wel-
come to the committee Dr. Merlin DuVal, the Assistant Secretary for
Health and Scientific Affairs; Dr. John Zapp, Deputy Assistant Secre-
tary for Legislation (Health); Dr. Robert Marston, Director of the
National Institutes of Health; and Dr. Theo'dore Cooper, Director of
the National Heart and Lung Institute. We welcome all of you gentle-
men here. We appreciate your presence to'day and we will be glad to
receive your testimony.
It is the Chair's understanding that Dr. DuVal has a slight case of
laryngitis, so he ha's a spokesman with him to give some of his view-
points. We certainly understand, and we `appreciwte your presence here.
STATEMENT OF DR. MERLIN K. DUVAL, ASSISTANT SECRETARY
FOR HEALTH AND SCIENTIFIC AFFAIRS, DEPARTMENT OP
HEALTH, EDUCATION, AND' WELFARE; ACCOMPANIED BY D~R.
~O'HN S. ZAPP, DEPUTY ASSISTANT SECRETARY FOR LEGISLA.
TIO'N (HEALTH), DIIEW; D'R. ROBERT Q. MARSTON, DIRECTOR,
NATIONAL INSTITUTES OF HEALTH, DHEW; AND' DR. THEODORE
COOPER, DIRECTOR, NATIONAL HEART AND LUNG INSTITUTE,
NATIONAL INSTITUTES OF HEALTH, DHEW
Dr. DnVAL. Mr. Chairman, thank you very much, I am sorry to be
indisposed at the present time. I have a keen interest in this legislation
and wish to be present. However, wth your permission, I will ask Dr.
Marston to read my statement.
Mr. ROGERS. We understand, and `appreciate your being here.
Dr. Marston?
V
PAGENO="0092"
86
Dr. MARSTO.N. Mr. Chairman and members of the subcommittee, I am
pleased to be speaking here today to present the views of the adminis
tration on several legislative proposals before your committee The
high incidence and prevalence of diseases of the heart, blood vessels,
lungs, and blood constitutes a major national health problem which
the President himself has characterized as deeply disturbing The con
tinned interest in this problem and in the health of the American peo
ple which has been demonstrated by this committee is to be corn
mended, and we appreciate the opportunity to share with you our plans
for dealing with this health problem
As you know, the President, in his state of the Union address of
this year said
* * * we will be giving increased attention to the fight against diseases of the
heart blood vessels and lungs which presently account for more than half of
all the deaths in this country It is deeply disturbing to realize that largely
because of heart disease the mortality rate for men under the age of 55 is about
twice as great in the United States as it is for example in some Scandinavian
countries
The President also 1stated his intention, which he reaffirmed in his
health message of March 2, to assign a panel of distinguished profes
sional experts to guide us in determining why heart disease is so
prevalent rind what we should be doing to combat it I am pleased to
report tojou that the President has named Dr John Millis, president
of the Niftional Fund for Medical Education as chairman of the panel
He has also appointed 18 distinguished physicians to serve on the panel
along with Dr Millis
Mr ROGERS May I interrupt to say that I think it would be helpful
if you could furnish the names of the panel for us and their qualifi
cations.
(The following information was received for the record )
HEART DISEASE STUDY PANEL
~ANNOUNCEMENT OF APPOINTMENT OF 18 MEMBERS OF THE PANEL
APRIL 4, 1972
The President today announced that he has asked a panel of experts to deter-
mine why heart disease is so prevalent and so menacing and what can be done
about it.
Previously, on March 24, 1972, the President announced that he had asked
Dr John S Mllhs president and director of the National Fund for Medical
Education to head the panel The 18 panel members are
Arthur C Beall Jr professor of surgery Baylor College of Medicine Houston
Tex Born in Atlanta Ga in 1929 he holds the B S and M D degrees from Emory
University A noted thoracic surgeon he is the author of more than 200 scientific
papers.
S. Gilbert Blount, Jr., professor of medicine and head, division of cardiology,
University of Colorado Medical Center Denver Cob Born in Providence R I in
1917 he received the B S degree from Rhode Island State College and the MD
degree from Cornell University Medical College He won the American Heart
Association Research Achievement Award in 1962 and the American College of
Cardiology Cummings Humanitarian Award in 1966. He and his wife, Jean, have
five daughters Randa Ann Donna Sarah and Lauren
Morton D Bogdonoff department of medicine Umversity of Illinois Medical
Center Chicago Ill specialist in internal medicine Born in 1925 he received
his M D from Cornell University Medical College in 1948 He completed his
residency at the New York Hospital, New York City, and Duke University Afilli-
ated Hospitals in Durham N C
Eugene Braunwald Hersey Professor of Medicine at the Harvard Medical
School in Boston Mass Dr Braunwald a native of Austria received his A B and
PAGENO="0093"
87
M D from New York University From 1949 to 1952 he was a Schepp Founda
tion Scholar.
C Joan Coggin, assistant prafessor of medicine Loma Linda University Loma
Linda Calif Dr Coggin was born in Washington D C in 1928 and educated
at Oolumbia Union College Maryland and Loma Linda University California
where she received her M P She served as cardiologist with the Loma Linda
Heart Surgery Mission to Pakistan and Southern Asia sponsored by the Depart
ment of State in 19G3 and was cardiologist and codireetor of the Loma Linda
University Heart Surgery Team in Athens Greece 1967-71 She has won awards
from the City of Karachi Pakistan and Evangelisinos Hospital Athens for
service to the people of those countries
Julius H Comroe Jr professor of physiology and director C~irdiovasci~lar
Research Institute University of California Medical Center San Francisco Calif
Born in York Pa in 1911 he received his M D from the University of Pennsyl
vania in 1934
Eliot Corday clinical professor of methcine at the University of California at
Los Angeles ~Jalif Dr Corday a native of British Columbia received his MD
from the University of Alberta in 1940
Joyce Wilson Craddick associate cardiologist at Children s Hospital Medical
Center Oakland C~ilif Born in Laconia N H in 1932 she received the B S
degree from Wheaton College Wheaton Ill and the M D from the University
of Pennsylvania School of Medicine She has also served as teaching coordinator
of pediatrics at the Highland Alameda County Hospital in Oakland and as Nor
man Leet Fellow and AHA Research Fellow in pediatric cardiology at Children s
Hospital Medical Center, `Oakland.
Salvadore J. DeVIto, chairman of the cardiovascular unit, Laughlin Hospital
and Ohnic and clinical professor of cardiology Kirksville College of Osteopathic
Medicine Kirksville Mo A diplomate of the American Osteopathic Board of In
ternal Medicine and a fellow of the American College of Osteopathic Surgeons
Dr. DeVito received his B.A. from the University of Buffalo and the D.O. degree
from Kirksvllle College of Osteopathy and Surgery. He held a fellowship in
cardiopulmonary disease at `the Detroit Osteopathic Hospital during 1970-71.
Mary Allen Engle director of pediatric cardiology and attending pediatrician
the New York Hospital, and professor of pediatrics, Cornell University Medical
College, New York, N.Y. She received her A.B. degree from Baylor University
and the M.D. from the Johns Hopkins University School of Medicine. She is a
diplomate of the American Board of Pediatrics and sub-Board of Pediatric Car-
diology In 1958 she won the Spence Chapin Award for Outstanding Contribution
to Pediatrics."
Nancy 0 Flowers professor of medicine Department of Medicine Medical
Oollege of Georgia, Augusta, Ga. Born in McComb, Miss., in 1928, she received
the B S degree from the Mississippi State College for Women and the M D from
the University of Tennessee College of Medicine Memphis She also attended
the Medical College of Virginia School of Physical Therapy.
Mario R Garcia Palmieri professor and head department of medicine and
chief section of cardiology University of Puerto Rico School of Medicine San
Juan, P.R. Born in 1927, Dr. Garcia-Palmieri received his B.S. from the Univer-
sity of Puerto Rico and his M P from the University of Maryland He is a former
Secretary of Health of Puerto Rico and president of the board of directors of the
Puerto Rico Medical Center He has published 63 scientific papers and a book
on electrocardiography and vectorcardiology in congenital heart disease
Ronald Martin Lauer professor of pediatrics and director section of pediatric
cardiology University Hospital University of Iowa Iowa City Born in Win
nipeg Manitoba in 1930 Dr Lauer received his B S and M D degrees at the
University of Manitoba He is a former associate professor of pediatrics at the
University of Kansas Medical Center and assistant professor of pediatrics at the
University of Pittsburgh He and his wife Eileen have a son Geoffrey 11 and
a daughter Judith 5
William H Muller Jr thoracic surgeon University of Virginia Hospital
Charlottesville Va and professor University of Virginia School of Medicine
Dr Muller was born in Dillon, S C in 1919 and received his M P from the Duke
University School of Medicine Durham N 0 He is a diplomate of the American
Board of Phoracic Surgery His internship and residency were served at the
Johns Hopkins Hospital in Baltimore
John C Norman thoracic surgeon, Harvard Medical School, member of staff
of Boston City Hospital Boston Mass Born in Charlestown W Va in 1930
Dr Norman received his B A from Harvard College and M D from Harvard
PAGENO="0094"
88
Medical School. He is the author of more than 200 scientifIc papers and in 1971
was named by the Charlestown Gazette-Mail as the "West Virginian of the Year."
Raymond Donald Pruitt, director of the Mayo Graduate School of Medicine,
University of Minnesota, dean of the Mayo Medical School, and director for edu-
cation of the Mayo Foundation, Rochester, Minn. He is former vice president for
medical affairs and chief executive officer of the Baylor University College of
Medicine. Born in Wheaton, Minn., in 1912, he won his B.S. at Baker University,
B.A. and M.A. at Oxford University while a Rhodes Scholar, and M.D. at Kansas
University. He has won distinguished service awards from the University of
Minnesota, the University of Kansas, and University of Kansas Medical School.
Joseph C. Ross, professor and chairman of the department of medicine at the
Medical University of South Carolina, Charleston, S.C. Dr. Ross, a native of Ken-
tucky, received his B.~. from the University of Kentucky and his M.D. from
Vanderbilt University. He resides in Charleston, S.C.
Roger J. Williams, director of the Clayton Foundation Biochemical Insitute at
the University of Texas in Austin, Tex. Born in Ootacumund, India, Dr. Williams
received his Ph. D. from the University of Chicago.
Dr. MAR~rON. Mr. `Chairman, I would propose to submit the entire
statement of Dr. DuVal for the record, but if it is all right with the
committee, I would like to move to the middle of page 6 and speak
directly to the administration's position on these bills.
Mr. ROGERS. Without objection, the statement will be made a part
of the record at the end of your testimony.
Dr. MARSTON. In summary, Mr. Chairman, this administration is
in agreement with many of the goals expressed by H.R. 13500, H.R.
13115, and S. 3323 as amended and passed by the Senate. The Presi-
dent has re~peatedly stressed his intention to foster an augmented at-
tack on the problems of heart, vascular, and lung diseases. In honoring
this commitment, he has made a budget request of more than $250
million for 1973, and he has appointed the panel I described earlier.
Any further fiscal requests should await the recommendations of the
President's panel as to the appropriate areas for scientific investiga-
tion.
In `our review of H.R. 13715 we have identified some changes that
would, we believe, result in improvement and eliminate some issues
that might be troublesome. Excerpts from our Senate testimony con-
cerning S. 3323, as introduced, a bill identical to H.R. 13715, are of-
fered for the record.
Mr. chairman, I would be pleased to make these available.
Mr. ROGERS. Without ~bjection, they will be made a part of the rec-
ord at this point.
(The following material was received for the record:)
EXCERPT-TESTIMONY OF DR. MERLIN K. DUVAL BEFORE THE SUBCOMMITTEE ON
HEALTH, SENATE COMMITTEE ON LABOR AND PUBLIC WELFARE, MARCH 24, 1972
Mr. Chairman, as reflected in the request for over $250 million for 1973, the
Administration agrees with the essential goals contained in a number of the
bills before the Committee. The President, in both his State of the Union Message
and Message to Congress on Health this year, has stressed his commitment. One
of the bills you have before you, S. 3323, captures the concerns we have and, as
we understand them, the concerns of the scientific community outside the Govern-
ment. This Committee has highlighted most of the important matters that need
resolution.
In our review of 5. 3323, we have identified a few changes that would, we be~
lieve, result in some improvement and eliminate some issues that might be trou-
blesome. I would like to list these for your consideration:
PAGENO="0095"
A
89
AUTHORIZATION LEVELS
The bill would establish specific authorization levels for the conduct of heart
and lung disease research for Fiscal Years 1973 through 1975. We have tradi-
tionally favored "such sums as may be necessary" in authorizing legislation.
BLOOD DISEASES
Research in blood diseases takes place in several places in the National Insti-
tutes of Health. These programs are operating effectively and are more related
to the other work of the Institutes in which they now are than to the programs
of the National Heart and Lung Institute. The National Heart and Lung Insti-
tute concentrates on blood resources, on thrombosis (blood clotting), and on
embolic phenomena (the blocking of blood vessels), and on uses of blood as a
therapeutic agent. The National Institute of Allergy and Metabolic Diseases per-
forms research on hematological diseases, and has long had an intramural pro-
gram and laboratory. The National Cancer Institute performs and supports
research on blood malignancies, and the National Institute of Allergy and Infec-
tious diseases research on infectious diseases of the blood. If it is understood
these programs will continue to be administered where they are, we have no
objections.
CYSTIC FIBROSIS
This is a more difficult problem. Research on cystic fibrosis is now being per-
formed and supported by the National Institute of Arthritis and Metabolis Dis-
eases because the disease is a metabolic disorder and the biochemical disturb-
ance which is responsible for the clinical manifestations are not confined to the
lungs.
Solutions and control of the disease will not be found in the lungs, but in fun-
damental and pervading areas involving aberrant metabolism throughout the
body. We therefore suggest that cystic fibrosis not be included here.
CONTROL PROGRAMS
S. 3323 would aptborize what we interpret as a program of services for heart
and related diseases. While we recognize an important aspect of health programs
is bridging the gap between the laboratory and the day-to-day use of knowledge
in the practice of medicine, we believe that the National Heart and Lung Insti-
tute should concentrate its efforts on research activities. Moreover, the Regional
Medical Programs of the Health Services and Mental Health Administration are
already authorized to conduct programs along the lines proposed in the bill, but in
a more comprehensive framework. The delivery of services should only be in-
cluded in a research institute where essential to the achievement of the research
and demonstration functions and this authority is already implicit in the conduct
of research.
CONCLUSION
In summary, Mr. Chairman, subject to the preceding comments, we have no
objection to the enactment of 5. 3323.
I appreciate the opportunity to be here and discuss with the Committee this
common concern. My associates and I will be pleased to answer questions.
Dr. MARSTON. S. 3323 as amended and passed by the Senate includes
a number of additional provisions which we consider objectionable.
The first area of concern is a matter of general policy. These bills
would establish specific authorization levels for fiscal years 1973
through 1975. We favor provision for "such sums as may be necessary"
in authorizing legislation for research programs. Specified amounts
tend to limit the flexibility desirable for exploiting new developments,
and earmarking tends to discourage discontinuance of programs that
have outlived their usefulness. Also to specify a fixed percentage of the
NHLI appropriation as proposed by S. 3323 for research on diseases
of the lungs and blood would further limit the flexibility and profes-
sional discretion to set the funding for research at levels commensurate
with the scientific opportunities in the field.
PAGENO="0096"
90
The second area of concern has to do with three of the categorical
research programs contained in the bill (1) blood diseases, (2) cystic
fibrosis, and (3) asthma. There is a sound basis for the distribution of
programs and they should be maintained in their current organiza
tional frameworks Leaving them undisturbed will in no way corn
promise the goals of the legislation For example
One, because the National Heart and Lung Institute must deal with
problems of shock and hemorrhage, it concentrates on resources for
blood replacement and transfusion and on thrombosis The National
Institute of Arthritis and Metabolic Diseases studies red blood cell
formation and metabolism The National Cancer Institute conducts
and supports research on white blood cells because an understanding
of these cells is necessary for studying malignancies of the blood like
leukemia The National Institute of Child Health and Human Devel-
opment conducts a program on hemolytic disease of the newborn; this
is a critical problem that cannot be studied out of the context of preg-
nancy and total human development. The inclusion of blood diseases
in the NHLI authority would be acceptable only if it is understood
that these other programs will remain in the Institutes where they are
presently located.
Two, cystic fibrosis is a disorder which involves many tissues besides
the lungs The basic biology of this condition is appropriately studied
in association with other biochemical and metabolic disorders Re
search on cystic fibrosis is now being performed and supported by the
National Institute of Arthritis and Metabolic Diseases. Pulmonary
facets of the problem are and will continue to be studied by the Na-
tional Heart and Lung Institute; however, control of the disease will
not be found in the lungs alone. Therefore, we recommend that the
cystic fibrosis program remain under the aegis of the National Insti-
tute of Arthritis and Metabolic Diseases.
Three, asthma is an allergy. Therefore, the key to solving this im-
portant problem is an understanding of the basic biology of allergy
The National Institute of Allergy and Infectious Diseases has an ex
tensive program in allergy and has established seven allergic disease
centers most of which are studying asthma. The response of the lung to
this process is also studied by the NHLI where the primary concerns
are the derangement in pulmonary function and metabolism The pres
ent wording of these bills could cause difficulty in program develop
ment between the National Institute of Allergy and Infectious Dis
eases and the National Heart and Lung Institute and could even
tually cause a major shift in emphasis which we would consider un
desirable and unprofitable from a research standpoint Deletion of all
reference to asthma in the bill will solve this problem
Unless provisions in the bills for programs dealing with blood dis
eases, cystic fibrosis, and asthma are altered in such a way as to allow
for continuation and growth of these programs as outlined within the
Institutes wthere their program content dictates the greatest research
relevance, a number of the Institutes of the National Institutes of
Health will experience disruptive blurring of research, unnecessary
multiplication of administrative procedures, and perhaps even a dilu
tion of support for essential basic research efforts
S 3323 would also mandate the creation of an Office of Heart and
Lung Health Education in the Department of Health, Education, and
PAGENO="0097"
91
Welfare. We strongly oppose this provision. It will serve as a dan-
gerous precedent for creating an office to discharge a similar public
iii~ormation function for each major category of d~ease on which the
National Institutes of Health conducts research. Moreover, the statu-
tory creation of such an office restricts rue flexibility of the Secretary
in organizing the Dep~a.rtment and would simply add another or-
ganizational layer on top of ongoing activities. Also, section 412(e) of
tho Public Service Act currently provides that the National Heart and
Lung Institute shall-
Establish an information center on research, prevention, diagnosis, and treat-
ment of heart diseases, and collect and make available . . . information as to,
and the practical application of, research and other activities carried on pursuant
to this part.
Since the NHLI currently has an ongoing heart and lting public
information program, we believe that the proposal to establish a stab-
tory office is unnecessary.
A further cause for concern arises from the inclusion in the Senate-
passed bill of an emergency medical services program for victims of
heart, blood vessel, lung, and blood diseases. ~A~s you know, the Presi-
dent has recently directed the Department of Health, Education, and
Welfare to "develop new ways of organizing emergency medical serv-
ices (EMS) ." Accordingly, we are now implementing an "EMS
Initiative" to meet this directive under existing legislative authorities
in the agency in the Department responsible for health service delivery
demonstrations, the Health Services and Mental Health Administra-
tion. Under this initiative, we will be supporting the planning, develop-
ment, initial operation, and evaluation of sev~eral areawide comprehen-
sive emergency medical service systems through which the resources
of communities will be coordinated for the provision of a full range
of emergency medical services regardless of the medical diagnosis.
Also under this initiative, we will be establishing and maintaining
effective communications and coordination among those Federal de-
partments and agencies, including NHLI, with responsibilities and
activities in EMS. The addition of separate and duplicating responsi~
bilities within the NHLI could, in our opinion, be disruptive to the
effort underway and would lead to unnecessary duplicating costs and
re~ponsibilities.
H.R. 13715, and S. 3323 as amended and passed by the Senate, would
authorize what we interpret as a program of services for heart and
related diseases. While we recognize an important aspect of health
programs is bridging the gap between the laboratory and day-to-day
use of knowledge in the practice of medicine, we bdlieve that the Na-
tional Heart and Lung Institute should concentrate its efforts
search activities Moreover, th~ regional medica1
Health Services and Mental Health Admrnistr~
thorized to conduct programs alonç
in a more comprehensive I
only be included in a research i~.
mont of the research and demonstration fi
is already implicit in the conduct of reset
In summaiv, we believe th'it because of t
we have outlined above, S 3323 as passed b
the dvelopment of a balanced and productive re~
TS-994-72--T
PAGENO="0098"
92
cordingly, we would prefer H.R. 13715 to S. 3323, as passed by the
Senate, subject to acceptance of our recommendations for changes
cited in the excerpts from our Senate testimony on S. 3323, as intro-
duced, which was identical to your bill, Mr. Chairman, }II.R. 13715.
My colleagues `and I would ~e pleased to answer any questions you
or other members of the subcommittee may have.
(Dr. DuVal's prepared statement follows:)
STATEMENT OF Dn. MERLIN K. DUVAL, ASSISTANT SECRETARY FOR HEALTH AND
SCIENTIFIC AFFAIRS, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Mr. Chairman and members of the subcommittee, it is a pleasure for me to be
here today to present the vieWs of the Administration on several legislative
proposals before your Committee. The high incidence and prevalence of diseases
of the heart, blood vessels, lungs, and blood constitutes a major national health
problem which the President himself has characterized as "deeply disturbing."
The continued interest in this problem and in the health of the American people
which has been demonstrated by this Committee is to be commended, and we
appreciate the opportunity to share with you our plans for dealing with this
health problem.
As you know, the President, in his State of the Union Address of this year
said:
we will be giving increased attention to the fight against diseases of
the heart, blood vessels and lungs, which presently account for more than
half of all the deaths in this country. It is deeply disturbing to realize that,
largely because of heart disease, the mortality rate for men under the age
of 55 is abotit twice as great in the United States as it is, for example, in
some Scandinavian countries.
The President also stated his intention, which he reaffirmed in his Health Mes-
sage of March 2, "to assign a panel of distinguished professional experts to guide
us in determining why heart disease is so prevalent and what we should be doing
to combat it." I am pleased to report to you that the President has named Dr.
John Millis, President of the National Fund for Medical Education as Chairman
of the Panel. He has also appointed 18 distinguished physicians to serve on the
panel along with Dr. Millis.
Now, Mr. Chairman, I should like to describe briefly for you the scope of the
problem of heart disease and some of our current programs to combat it.
CARDIOVASCULAR DISEASE
Statistics do not reflect the cost of disease in terms of human suffering, but
they do illustrate the extent and seriousness of the problem. Each year about
one and one quarter million Americans suffer heart attacks; of these. more than
half a million die of the attack. and of them one half die too suddenly to receive
medical attention. Cardiovascular diseases account for at least 40 per cent of ~al1
deaths among Americans in their most productive years, ages 35 to 64, and two-
thirds of all deaths among Americans over age 65. The death rate from heart at-
tacks is twice as high for American men as for men in Denmark, Norway, and
Sweden, and six times as high as for men in Japan. No age group or economic
class is exempt from heart disease, which takes many forms and which often
is well advanced before its presence is discovered.
Death from heart disease ranked fourth among causes of death in 1900, at
which time the death rate from heart diseases was about 150 per 100,000 popula-
tion. By 1968 heart disease had not only become the number one killer disease
in the countr~~ but the death rate had climbed to 373 per 100,000.
The most common form of heart and blood vessel disease is arteriosclerosis, a
hardening and thickening of the artery walls. This disease starts early in life
and progresses continuously for many years before the patient becomes aware of
it. It is probable that in the United States most men and women beyond 50
years of age have moderately advanced arteriosclerosis even though they have
not yet manifested any symptoms.
Not only is heart disease the number one killer disease in this country. it is
also a major cause of disability. The combined economic and social impact of
this morbidity and mortality is enormous. Direct costs of medical care for
patients with heart disease and related complications are estimated to cost
PAGENO="0099"
billions of dollars per year. Indirect costs as a result of lost work and lost
income add to the total.
LUNG DISEASES
Lung diseases also constitute an extremely serious health problem. Some
36,000 people die each year from chronic respiratory conditions', and more than
13,000 of these are under the age of 65 years. These figures do not include the
victims of cancer of the lung or of respiratory infections such as tuberculosis,
nor do they include the 20,000 infants who die each year with `respiratory disk
tress syndrome or hyaline membrane disease. Present therapeutic regimens
do not, in most cases, significantly alter the cotirse of these diseases. This means
that, with present treatment methods, many Americans will be obliged to stub-
mit to what has characteristically been a long and debilitating illness with heavy
financial burdens.
BLOOD AND BLOOD DISEASES
Blood diseases and the management of blood resources are health problems
worthy of national attention. This Committee has already held extensive hearings
on sickle cell disease. You are well aware that an estimated two million black
Americans carry sickle cell trait and 25,000 to 50,000 black Americans' `suffer a
painful, debilitating, and life-shortening form of the disease called sickle cell
anemia.
Another important blood disease problem involves the clotting of `blood. The
formation of blood clots within blood vessels-thrombosis-is thought to be im-
plicated in stroke, gangrene of the limb's, blindness of sudden onset, and heart
attacks. On the other hand, there are some 10 to 15 thousand severe hemo-
philiacs in this country who must exercise extraordinary caution because their
blood will not clot properly. Research to investigate the basic mechanisms of clot-
dissolution and blood coagulation and to evaluate drugs permitting manipulation
of these mechanisms for preventive or therapeutic purposes is important
The management of blood resources must be improved. Human blood is an
essential health resource. Currently, our society fails to realize all of the po-
tential health benefits from the use of blood because existing arrangements~ are
deficient in meeting blood demand. We need to improve the efficiency of procure-
ment, processing, distribution, and usage methods. The President, in r -
tion of the problem of blood resources, stated in his recent ~ -
Blood is a unique national resource. An adequate system
and delivering `blood at its time and place of need can say
we do not have a nationwide to meet
upon the skills of modern m
have therefore directed the I
to make an intensive study
plan for developing a safe,
and distribution system.
Of particular importance are
the presence of hepatitis in blood pri
of hepatitis induced by transfusion
has been made in the development of a t
completely effective test remains to be discove
CURRENT PROGRAMS
Public and private programs to combat diseases of the
lungs, and blood have been serving the American p
more widely publicized a "nplishments of `these i
of open-heart si cry, nakers, `ie use of C
tow~
ave
ease
risk
terol
been t..~e princ~1
t of methods to combat and control t
s have also been extremely important.
PAGENO="0100"
DF THE NATIONAl
Prt~sident's firm commitment to s.~, ~_..~ese cL~.~ses at
an increase of $22 million in fiscal year 1973.
SUMMARY OP TEE ADMINISTRATION'S POSITION
Mr. Chairman, this Administration is in agreement with many of the goals ex-
pressed by H.R. 13500, H.R. 13715, and S. 3323 as amended and passed by the
Senate. The President has repeatedly stressed his intention to foster an aug-
mented attack on the problems o~ heart, vascular, and lung diseases. In honoring
this commitment, he has made a budget request of more than $250 million for
1973, a~td be has appointed the panel I described earlier. Any further fiscal re-
quests should await the recommendations of the President's panel as to the ap-
pr~priate areas for scientific investigation.
In our review of H.R. 13715 we have identified some changes that would, we
,believe, result in improvement and eliminate some issues that might be trouble-
some. Excerpts from our Senate testimony concerning 5. 3323, as introduced, a
bill Identical to HR. 13715, are offered for the record. 5. 3323 as amended and
passed by the Senate includes a number of additional provisions which we con-
sider objectionable.
The first area of concern is a matter of general policy. These bills would estab-
lish specific authorization levels for fiscal years 1973 through 1975. We favor
provision for "such s as may be necessary" in authorizing legislation for re-
d amounts tend to limit the flexibility desirable for
c1~ t0 discourage discontinuance of
to specify a fixed percentage
:or research on diseases of the
~ and professional discretion to
is commensurate with the scientific oppor-
has to do with three of the categorical research
bill: (1) blood diseases, (2) cystic fibrosis, and (3)
asthma. There is a sound basis for the distribution of programs and they should
be maintaine4 in their current organizational frameworks. Leaving them un-
disturbed will in no way compromise the goals of the legislation. For example:
1. Because the National Heart and Lung Institute must deal with problems of
shock and hemorrhag0, it concentrates on resources for blood replacement and
transfusion and on thrombosis. The National Institute of Metabolic Diseases
`~ [es red blood cell formation and metabolism. The National Cancer Institute
white blood cells because an understanding
maligna-~'~s of the blood like leukemia.
~an Development conducts a
s a critical problem that can-
l human development. The
y would be acceptable only if
q remain in the Institutes where
ases in the ~
t these other pi
re presently located.
is a disorder which involves many tissues besides the lungs.
~s condition is appropriately studied in association with
abolic disorders. Research on cystic fibrosis is now
rted by the National Institute of Arthritis and Meta-
facets of the problem are and will continue to be
rt and Lung Institute, however, control of the dis-
s alone. Therefore, we recommend that the
"r the aegis of the National Institute of
es.
erefore, the key to solving this important problem
`~~c biology of allergy. The National Institute of
~ has an extensive program in allergy and has
-e centers most of which are studying asthma.
seven allerg
PAGENO="0101"
In summary, we believe that
outlined above, S. 3323 as p~
a balanced and productive research'
ILR. 13715 `to S. 3323, as passed by the
CONCLUSION
95
The response of the lung to this process is also studied by the NHLI where tile
primary concerns are the derangement in pulmonary function and metabolism.
The present wording of these bills could cause difficulty in program development
between the National Institute of Allergy and Infectious Diseases ~tnd the Na-
tional Heart and Lung Institute and could eventually cause a major shift in
emphasis which we would consider undesirable and unprofitable from a research'
standpoint. Deletion of all references to asthma in the bill will solve this prob-
lein
Unless provisions in the bills for programs dealing with blOod diseases, cystic
fibrosis and asthma are altered in such a way as to allow for continuation and
growth of these programs as outlined within the Institutes where their pi~ogram
content dictates the greatest research relevance, a number of the Institutes of
the National Institutes of Health will experience disruptive blurring of research,
unnecessary multiplication of administrative procedures, and perhaps even a
dilution of support for essential basic research efforts.
S. 3323 would also mandate the creation of an Office of Heart and Lung Health
Education in the Department of Health, Education, and Welfare. We strongly
opposed this provision. It will serve as a dangerous precedéTtit for creating an
office to discharge a similar public information function for each major category
of disease on which the Natio'nal Institutes of Health conducts research. More-
over, the statutory creation of such an office restricts the flexibility of the Sec-
retary in organizing the Department and would simply add atiotber organiza-
tional layer on top of ongoing activities. Also, Section 412(e) of the Public Health
`Service Act currently provides that the National Heart and Lung Institute shall:
* . . establish an information center on research, prevention, diagnosis, aitd
treatment of heart diseases, and collect and make available.. . information as to~
a~d the practical application of research and other activities carried on pursuant
to this part.
Since the NHLI'currently has an ongoing heart and lung public information
program, we believe that the proposal to establish a statutory office is unneces~
sary.
A further cause for concern arises from the inclusion in the Senate-passed bill
ot' an emergency medical services program for victims o'f heart, bloed vessel,
lung, and blood diseases. As you know, the President has recently directed the
Department of Health, Education, and Welfare to "develop new ways of organiz-
lug emergency medical services (EMS) ." Accordingly, we are now implementing
an "EMS Initiative" to meet this directive under existing legislative authorities
in the agency in the Department responsible for health service delivery demon-
strations, the Health Services and Mental Health Administration. Under this
initiative, we will' be supporting the planning, development, initial operation,
and evaluation of several area-wide comprehensive emergency medical service
systems through which the resources of communities will be coordinated for
the provision of a full-range of emergency medical services regardless o'f th~
medical diagnosis. Also under this initiative, we will be establishing and main~
taming `effective communications and coordination among f ~e Federal
departments and agencies, including NHLI, with rc~
activities in EMS. The addition of separate and e
the NULl could, in our opinion, be disruptive
lead to unnecessary duplicating costs and r
11.11. 13715 and S. 3323, as amended and
what we interpret as a program of Se:
we recognize an important aspect .~
tween the laboratory and day-to-day use o~.
we believe that the National Heart and
efforts on research activities. Moreover,. tI
i Services and ~
et prc'~'-'~
us and this
y is a
PAGENO="0102"
96
ommendations for changes cited in the excerpts from our Senate testimony on
S. 3323, as introduced, which was identical to your bill, Mr. Chairman, H.R. 13715.
My colleagues and I would be pleased to answer any questions you or other
members of the Subcommittee may have.
Mr. ROGERs. I might say I presume you~know most of the subcommit.
tee members have introduced separate legislation for emergency
health care. We will probably be taking this up this year to deal with
this problem rather than separating it into various pieces of legislation.
Mr. SATTERF1ELD. Thank you, Mr. Chairman. I think this statement
is a very lucid one. It certainly points up your views. I don't think
there is much question about what it is you are saying. I will study it
very carefully as we get into this bill. I appreciate your coming here
his morning and delivering it.
Mr. ROGERS. Dr. Carter?
Mr. CARTER. Thank you, Mr. Chairman. I think the statement has
been very good and I find many of the suggestions about the Senate
bill to be, in my opinion, correct. I think your position is correct in that,
except that that bill might be adding to overlaying the work of differ-
ent agencies, and I think it should be simplified as you suggest.
I was interested in some of the things you said about heart diseases,
same of the causes. What do you think i~ the most prevalent cause of
heart disease?
Dr. COOPER. Arteñoscierosis of the coronary arteries is the most corn-
jaon cause of heart disease in this country today.
Mr. CARTER. Why is the rato in Denmark so much less than the
United States?
Dr. Coopsn. I don't know the answer to that~ question. It is an impor-
tant one we must pursue to find what we can do in order to' further our
own interest. The important thing to keep in mhid, in addition, is that
Denmark and these other Scandinavian countries are beginning to
catch up with us. What we may be seeing is a lag as they readh the peak
of disease incidence.
Mr. CARTER. What is the cause of arteriosclerosis? Large amounts
of cholesterol would cause this, `arteriosclerosis, and so forth.
Dr. COOPER. What we have been able to idenitify so far are several
factors called risk factors which `seem to be associated with the devel-
opment of arteriosclerosis. But no single one can be said to be `the cause
of arteriosclerosis. The most serious of these risk factors are cholesterol,
high blood pressure, cigarette smoking, overweight, diabetes, in-
activity, and stress.
Mr. CARTER. So far `as cholesterol is concerned, I `think the diet of
the Danes should be as heavy as it is in `the United State's.
Dr. COOPER. That is correct.
Mr. CARTER~ To get the basic cause of this, don't you think that
stress has more to do with heart attacks than almost any other one
thing?
Dr. COOPER. Stress is an important cause that has been identified in
several studies thus far. It may be that stress expresses itself through
some common metabolic path perhaps related to the liquid hypothesis.
Mr. CARTER. We know that stress does express itself in different
actions within the `body, internal secretions and so on?
Dr. COOPER. Yes, indeed.
PAGENO="0103"
97
An estimated range of 13,000 to 20,000 people in the U.S. are found to have
pernicious anemia.
Mr: CARTER. Do you think it is as large a problem as sickle cell
anemia?
Dr. MARSTON. It certainly is a large problem at present. In terms
of control of the disease, I think we do a better job of controlling perni-
cious anemia than we do sickle cell anemia.
Mr. CARTER. There is no question about that, because we do have and
have had medicines which would permit a pernicious anemia patient
to live longer and more comfortably. I noticed you don't want this
particular part in the Heart and Lung Institute; is that correct?
Dr. MARSTON. I think I would point out, as far as the sickle cell
anemia program is concerned, while the Heart and Lung Institute
is carying the lead role there, it is a coordinating role not only with
the other institutes in NIH, but with the community-based programs
and family planning servicesof the Health Services and Mental Health
Administration. So I think we have made it very clear in the sickle
cell anemia cause that this is not a Heart and Institute pro
It is a joint program involving a number of ac
Mr. CARTER. You would include that in
the Heart and Lung Institute-the study 0:
pernicious anemia, leukemia, and so on?
Dr. MARSTON. There are different parts of it. Leukemia, of
is primarily the responsibility of the Cancer Institute, and th
other problems and blood-related things such as l'epatitis.
ers four institutes. I have set up a formal co
be sure that maximal use of the competence s
various institutes is used. I don't think you (
hematology and say it belongs to j one c
You have to go further down the]
out something like leukemia, or 1, or perni
Mr. CARTER. You would fragment it among differ
is that correct?
Dr. MARSTON. I think if::"
an organizational arrangem
I don't consider this a fragmenta
Mr. CARTER. I believe the concei
should be made. I
you should have~
Dr. MARSTON. )
the Arthritis and 1~ -
Mr. CARTER. I would suggest to you that certainly I believe it is
probably the most comon cause of deaths from heart conditions. Many
people think this is true.
Dr. COOPER. Yes.
Mr. CARTER. I notice in your paper you mention sickle cell anemia.
We did pass a bill on that in which 25,000 to 50,000 of our black people
suffer. Do you have any evidence of the number of people in the United
States that have pernicious anemia.
Dr. MARSTON. We would submit that for the record.
(The following information was received for the record:)
NUMBER Or PEOPLE Ix THE UNITED STATES HAVING PERNICIOUS ANEMIA
on on hematolo
PAGENO="0104"
focus. On the other hand, it is important for the Heart and Lung
institute to be concerned about blood resources.
Mr. CARTER. Thank you, Mr. Chairman.
Mr. RoGERs. Dr. Roy?
Mr. Roy. I have no questions at this time, Mr. Chairman. Thank
you.
Mr. ROGERS. Maybe you could tell us right new what your present
setup is in the National Heart Institute. How many people do you
have working for you, your budget, how many working on lung,
how many on heart, and so forth?
Dr. CooPER. Yes, sir. At the current time we are staffed at approxi-
mately 600 positions. We expect to complete the year at approximately
625 positions, and our plan for next year calls for an additional 38
positions.
Mr. RoGERs. How many of those are Ph. D.'s or M.D.'s, and so
forth?
Dr. COOPER. Approximately 75 full-time people in the intramural
program are full-time professionals out of a total cadre of 358. An
additional 150 are young sicentists and physicians who will be with us
for a short period of time.
In the nonintramural portion of the Institute, we have approxi-
mately another 50 professionals. The remaining staff of the Institute
is made up of technical support and clerical support. The majority
of our people are concerned with programs that are related to the
cardiovascular mission of the Institute.
In the pulmonary segment, we began our program in late 1969,
and at the present time we have nine people at the professional level
spending their time on the study of the lung. In addition, a good deal
of the clerical and program staff, obviously, perform functions for all
segments of the Institute's program. So we would have to fractionate
out the rest of the nonintramural staff for their role in the manage-
ment and administration of the pulmonary programs.
Mr. ROGERS. In other words, you have no specific separate section
handling the extramural programs for lung?
Dr. COOPER. That is right. We combine them to make it a more
efficient operation. The pulmonary section is as yet a small portion
`~he tetal Institute's expenditures; approximately 10 percent. There-
~,, we have not duplicated services by maintaining a separate pul-
xpertise do those handling the extramural pro-
g and pulmonary disease section?
way we have arranged this is that we have re-
r lung program ~ ho is an associate director
Dr. (21 ~ Lenfant, from the University of Wash-
has recruited during this past year two people in the ex-
rOgram to `begin the core of the pulmonary extramural
~ are supported by clerical staff. One is basically meta-
c oriented toward the metabolics of the lung and the second is
to the physiologic functions of lung.
borat ye division Dr. Lenfant has recruited two people
n's directing a contract program in that area.
initiated the centers program and utilizes him
amural staff to begin this program.
PAGENO="0105"
vonemph~sem~ `a
~ntercj
in pu
ci between arteri
sion. These are mi
schools which focw
gram where
sources to de~ a i
For exar ree ~
problems in children.'
There are others focusing r
chi'tis and so on.
We are also trying to develop a devices ~
assistance devices program, and one professional
vices program is devoting his attentio~ to this.
In the intramural program we have no ~ two
this. We have initiated a pulmon
be able to service the hospital as
have recruited a basic protein
studies on the basic properties `and funci
ent time Dr. Lenfant coordinates this
rest of the programs of the Institute.
Mr. ROGERS. So you have three people doing research i
tramural program?
Dr. COOPER. Yes, sir. This is a program which we r
during this next year. We have developed the
of the problem in recruiting the staff ~ the t
until this Spring. New modules have Ic: :~ freed
the closing of other older labon and*
tioning pulmonary program
at least 36 people, the average in
We also expect that many of~ ~ scieni
icad pharmacology, and genetic laboratories
of their time and convert their interest to the pul
expect to accomplish this next year.
Mr. ROGER. You expect to have 36 people abroad?
Dr. COOPER. I doubt whether we can r t 36
at one time, but the goal would be to r~
oratory program in the intramural r
institute to about 36 people. This wo
years to accomplish.
Mr. ROGERS. You started getting into this in 1969?
Dr. COOPER. Yes, sir.
Mr. ROGERS. How many people were hired in 1969?
Dr. COOPER. None in 1969.
Mr. ROGERS. How many in 1970?
Dr. COOPER. In 1970 we hired Dr. Lenfant and then we recr
extramural chief at that time. The remaining people were
during this past 1971.
Mr. ROGERS. So, basically, at this moment you
mural research program?
PAGENO="0106"
100
Dr. COOPER. That is right: Oniy the core pulmonary function lab-
oratory and the initial implementation of the chemical program.
Mr. ROGERS. Now in heart you say you have 75 in the intramural
program?
Dr. COOPER. Seventy-five at the professional level, plus the 150 young
scientists that are there for short periods of time.
Mr. ROGERS. What periods of time?
Dr. COOPER. They generally serve 2 years to 3 years in their tour
with the Institute.
Mr. ROGERS. Now, are all these 75 in intramural research actually
doing active research?
Dr. COOPER. Yes.
Mr. ROGERS. Could you set forth in the record for us all of the vari-
ous programs you are researching and how many people are devoted
to it and their qualifications?
Dr. COOPER. Yes.
(The following information was supplied for the record:)
INTRAMURAL RESEARCH PROGRAMS, WiTH PEOPLE ENGAGED AND
THEIR QUALIFICATIONS
The Institute's intramural clinical research programs include twenty-one
senior investigators in cardiovascular diseases, three in blood diseases, and five
in pulmonary diseases. In addition, there are thirty-six younger or tempoi~ary
scientists in the cardiovascular area, four in blood diseases, and two in the
pulmonary field.
Mr. Roo~is. What has been your budget beginning in 1969 for the
whole institute and then a breakdown of intramural and extramural.
Dr. COOPER. The budget in 1969 was approximately $161 million.
I can provide the specific figures. In 1970 we increased the budget by
$35 million.
Mr. ROGERS. So that would make it how much?
Dr. COOPER. We went to $1~6 million approximately. Then we went
on to another $37 million and that brought it to the current $232
million.
Mr. ROGERS. 1973?
Dr. COOPER. 1973 is planned for $254 million.
Mr. ROGERS. ~[f you would give us a breakdown of intramural and
extramural. What are the percentages?
Dr. COOPER. The percentage is approximately 10 percent.
Mr. ROGERS. Intramural?
Dr. COOPER. Intramural.
Mr. ROGERS. That is in the heart field?
Dr. COOPER. It has largely been in the heart field and the basic
laboratory undergirding the applied cardiac laboratories.
Mr. ROGERS. Should it be more?
Dr. COOPER. Shouid which be more?
Mr. ROGERS. The intramural programs.
Dr. 000PER. For us to accomplish our pulmonary mission we should
be doing more in the lung and in certain blood areas particularly ap-
plicable to our Institute's mission. We hould be doing more, and that
is in our forward plan.
Mr. ROGERS. You say nine people in lung have been recruited. Are
they actually on board?
Dr. 000PER. Yes.
PAGENO="0107"
V would
YOU are
~bout heart?
C
-~
the part of the ~
Heart failure, on I
tio~ of the heart
deficient blood s
other types r
sequent to rheumat
cannot Pump well. It resu
breath, accumulation of
ance, and so on.
Mr. CARTER. If the distingujsh~~ gentlem~~ w
Mr. ROGERS. Certainly
Mr. CARTER. I believe ~OU stated a heart a
terrup~on of the blood Supply to the I
know is true. However, what wou]
tf-1 ~dia?
DOPER A su
heart attack, anhiea~t
committee?
Dr. COOPER. What
rcIisru~
~s in s
erentiatethc
ier hand
~i can be
for ~
ich as r
acku1
~ legs, ai
CARL~R. Or stress.
PAGENO="0108"
~ene on the risk factors in order to'i
on the development or initiation of the disease;
tion of hypertension and particularly
that are known to be moderate or severe.
Secondly, would be the elimination of the lipid abnormality
exists, trying to keep the lipid abnormality down, and the elimination
of cigarette smoking.
Mr. ROGERS. What do you mean by "lipid"?
Dr. COOPER. The fatty substances in~ the blood that are associated
with the increased risk of arteriosclerosis, specifically cholesterol and
triglyceride.
* Mr. RoGERs. The third was what?
Dr. COOPER. Cigarette smoking.
Mr. ROGERS. What about diet other than the fat? Is there any prob-
lem there?
Dr. COOPER. Yes, in two ways. The most important way that you
can manage elevated cholesterol when elevation is not due principally
to the inheritance is by regulation of total caloric intake. That is an-
ether way of saying you should seek your lean weight. This will help
a great deal in minimizing the effects or propensity toward eleva-
tion of serum cholester~l.
Other types of cholesterol abnormalities are related to the ingestion
of other food substances, such as carbohydrates and sugars. It is a
problem of what you eat, not just how much, but both are important.
It is both the total calories and the composition.
So weight control, activity control, the control of stress, the elimi-
nation of stress, and personality factors, ought to influence the prog-
ress of the ~
r. Chairman, would you yield?
~s. Certainly.
~ER. I would like to ask you if decreased ingestion of choles-
paralleled by a decrease in blood cholesterol.
- ~~snot.
"~? Do you mean the less fat you eat doesn't al-
have less cholesterol and triglycerides in the
associated with eating `less cholesterol or less
fewer total calories, the answer would be yes.
ve been advised to stop eating cholesterol and
g a lct of other substances and their cholesterol
o to adjust the total caloric composition. Then
wiil lower their cholesterol.
~rue there is a genetic factor in this?
do you do in a case like that? Will ingestion of
the blood cholesterol if there is a genetic factor?
yoi
PAGENO="0109"
netic cause?
also, in the -
in red
oulci be r~
are we ~
ams? -~
rams, or are
this
we are ~
IS flOe
Mr.
Dr.
tion. I ~ in th
hypertc ~, a program in resear(
program in order to accumulate the sciei
To acquire this, we will indeed have
lish quality controlled laborai
large numbers of people in t~
lect out the high susceptibles I
detection's sake in the treatmentserv
Mr. ROGERS. Let me ask you this
early, does that help? Can you then L
Dr. Coop If there is followthrough on therapy, it w
sir.
Mr. ROGERS. I am saying do we know how to treat
tect it?
Dr. COOPER. In the moderate and severe
that.
Mr. ROGERS. Should that be done to pr(
Dr COOPER In the moderate to severe case ]
gram that should be done by somebody
Mr. ROGERS. I know the Department takes
want anything done like that in NIH. I understa:
Dr. COOPER. I want to qualify what I am sayi
lent studies of the Veterans' Administration by JIJ
onstrated in the mclerate and severe iv
treatment with is curr
~ stroke and
riskf
the
lnclergo proper tres
FIELD. Would the g~ntlem~~ yield?
DOERS. Certainly.
a progra
sense.
r' )~OU can detect
PAGENO="0110"
104
su In many cases I
erate ~J severe degree there are ..
of salt and water metabolism and salt-L~ee L
nificant improvement in the lives of those people.
Mr. ROGERS. Now, what about the elimination of the lipids? That
is a question of diet?
Dr. COOPER. Diet is a factor, in our opinion, in the management of
all abnormal lipids. We think that the diet alone will be ineffective in
many types of lipid abnormalities. We feel the important thing here
is weight control and that is based on diet and a balance between
activity and diet; weight control, selective identification of the genetic
and other abnormal lipid types. Then there are other pharmacologic
and research approaches that may be used in special cases to treat
these people. But weight control, activity control, will be an important
factor in almost every case to help reduce the risk based on the elevated
cholesterol.
Mr. CARTER. Mr. Chairman?
Mr. ROGERS. Yes.
Mr. CARTER. What really has been the basic reason for control in
hypertensive cases in the past few years?
Dr. COOPER. I think there are probably three categories of influences,
Dr. Carter. One is the recognition that all hypertension is not idio-
pathic. There are many cases that can now be diagnosed and treated
specifically, whether it be secondary to renal disease or other forms
of vascular disease. Second, is the availability of potent pharma-
cologic agents, such as guanethidine and reserpine.
Mr. CARTER. As I se~ it, other drugs you have mentioned are quite
effective, but thiazides have done more to control hypertension than
almost any other drug?
Dr. COOPER. Yes, I think they have a wider applicability with wider
margin of safety in influencing the background that salt and water
plays on the response of neural hormones and other factors.
Mr. ROGERS. Now, let me ask you, if diet is a factor-evidently it
is for weight, cholesterol, and nutrition, I presume-the foods that we
eat have a definite effect on all of this. What have you done to work
with Food and Drug and the National Academy of Sciences and their
diet committee, Food Standards, to get any action to change the Amer-
ican diet? Have you taken any action as a department?
Dr. COOPER. We in the Institute have worked with the Food and
Drug Administration in the efforts to improve food labeling. One of
the important things is, if I say it to a housewife, you should feed your
husband and family a 30- to 35-percent fat diet, that she be able to
seleôt foods to provide this. With the nutritional backgrqund of the
physicians in many cases, much less the public, they are unable to
easily translate into a workable and economically feasible program
of food planning or a diet in meal planning the requirements to lower
fat.
So we do think that a program of labeling of foods will not only
insure some information about what a calorie count means and how
PAGENO="0111"
to become facile in doing it, but in trying to determine the composi-
tion of what you take in. We have been active with the Food Com-
mittee of the Academy since 1966 in the discussions of what are
appropriate criteria, and have recently worked with the Food and
Drug Administration in their plans on fat labeling.
Mr. ROGERS. Now, what action has been taken? Has the Academy
recommended any changes? Have they come out with any change of
standard?
Dr. CooPER. I have not seen a recent position.
Mr. ROGERS. It is all study, study, study but no action.
Dr. DUVAL. Mr. Chairman, the FDA has been meeting with National
Academy of Sciences representatives of the consumer groups, to col-
late information from the consumer groups as to how best they would
like to have the information displayed. We are tremendously en-
couraged by this. It is not easy labeling foods, but progress is being
made.
Mr. ROGERS. Even in the classification of milk, do you work with
Agriculture on that? They have gotten the American people believing
it is better to have butterfat in the milk. It is a great appeal. Is t~his
good?
Dr. DUVAL. In some instances it is good and in some it isn't. Ob-
viously, that doesn't fall within our jurisdiction, so it is a little more
difficult to control.
Mr. ROGERS. Why not? If you can influence diet and labeling, why
shouldn't it be? If it is related to health, it is a health factor.
Dr. DUVAL. It is a dairy product and it falls under the Agriculture
Department. -
Mr. ROGERS. That is why we need a separate Department of Health.
Dr. DUVAL. The President's Department of Consumer Re~ources
would do the same thing.
Mr. ROGERS. I can't see why you can't take action now.
I don't understand. If milk products have fat in them, ~
have a different categorization? Have you had discussions
culture on that?
Dr. COOPER. Yes.
Mr. ROGER. What do they say?
Dr. COOPER. They indicated it
the food products that are curr~ --
seek from us the e
really do not have as
approach. They are wo~
could reduce the saturated i~ of be
unsaturated or leaner. So I think a disci
they regularly are appraised by us of what
lipid metabolism field are.
Mr. ROGERS. It is my understanding that this
how to do it, but until there is positive I
son the same way, they don't want to do a
Dr COOPER They want proof that lo r the 1
eliminating the other risk factors will in fact preve
or prevent the progress of the disease.
Mr. ROGERS. Doesn't the fat also put on weight? When you
doesn't it have a tendency to increase your weight ~
lye cvi
on the
PAGENO="0112"
Dr. CooPEr~. `Fat is a high caloric food. If a lot of it is in your total
diet you will gain weight, but the problem is not fat alone.
Mr. ROGERS. But I think that would be one of the factors we want
to eliminate.
Dr. CooPER. Yes, sir.
Mr. CARTEn. Mr. Chairman, we brought out just a few minutes ago
that in Denmark, where the production and consumption of milk
products is probably twice as high as it is in the United States, heart
attacks are half as numerous as they are here. You see, there are factors
other than the ingestion of fats involved. I think a lot of this is a matter
of exercise on the part of the people of this country. If they exercise
enough they will metabolize the ingested food.
Mr. RoGERs. I understand that, but I don't know how we can `get
the American people to exercise. I think we can change the diet, and
if you cut the fat out that ought to help. I know in Norway during
the war-and this can be documented-when they cut out milk and
dairy products-and I am not advising that; I am just saying get
some fat out of it-Ancher says take it easy-but when they cut it out
of the diet, heart disease and heart attacks dramatically fell. When it
was put back in the diet after the war, it went up again.
Now, I am not going to press that too far, Ancher, but I am sure,
as Dr. Carter says, if you get people to exercise properly, to bring
about a metabolism, it would use it up. I can understand that. But I
think it is going to be easier to change the diet than to get people to
exercise.
Mr. NELSEN. Mr. Chairman, Dr. Carter referred to Denmark. I
have recently been there. They ride bicycles in Denmark. I am going
to contribute to your bicycle if you will exercise a little more.
But don't be toQ tough on my dairy cows, because they claim you
can drop a dime to the bottom of a pail of Holstein milk and see it on
~ ~ So I think we move in the direction of less fat.
~. I think this is what we should do, but we are n~t doing
is one question I would like to ask the heart
is colostrum?
rum the early phase of lactation products that
re the mothers' milk.
1 com~osition?
`;composition, but I know it
as well as protein.
esterol and triglycerides
)OPER. Yes, sir.
My question is: What are we going to do to lessen this
- ~r youngsters-
nk the chairman wanted to imply that at all
1 1 be eliminated. Many fats in the diet are
is again here a proper prescription in
thand.
would advise mastectomies; is that correct?
remind Dr. Carter, as he well
`s at that stage of the game is
PAGENO="0113"
a or t.
o provi~
Df the prese
~ ROGERS. I think we should have
doing, what discussions there have 1":
haven't Seen ffiuch-what the chances are 1~
Dr. MARSTON. I think the very fact that we
as if there were one type of lipid problem,
types with different implications,
is concerned, indicates Terent
information that ~..
policy issues facing t
can provide it. (See ~
Dr. COOPER. thing? 1.
doing, understai - . or six d ~erent
malities, the Institute has now distributed a"
booklets which are designed for the physicia]
determine the abnormalities and then how to
for each One of these. These are in high demand ~
the country.
Mr. ROGERS. Aren't we
factors that we ought to ~
to do this in many areas.
Dr. DUVAL. That would be ~
good headway and it is very ~
quite there. The most we know
strokes, we have epidemiologic
blood pressure and high blood i
those three things occur together,
the incidence of stroke.
Beyond that finding, `which is relative
have much. The confusion has been
point. We don't know whether 1
it is high fats. We arei quite t
area where this may
wrong to move pre bously i
Mr. ROGERS. I don't know
you know those three factor~ c
one who has that combination ~
Dr. DUVAL. We are just r~.
Mr. ROGERS. You are slow starting. Ho~ long I
stitute been in ~
Dr. COOPER.
Mr. ROGERS.
witnesses, t
a
University of L.
78-994__72..~
ature. I thu
ctivé
~7, for
ortant,
firm a~
rit i
take Son(
PAGENO="0114"
legi'siatjon on heart, ii
be sep~
~b ~n sti. ~ima~ry
Disease and roke Institute sh I be con inued. ~v v
ongoing basis, and have had now for 4 years, a committee with repre-
sentation from both of these Institutes that meets on a regular basis
for these programs.
Mr. NELSEN. One other question. You referred to heart attacks
and severe pain. It seems to me there are many deaths by heart attack
that aI~e almost painless.
Dr. COOPER. There are prthably many different manifestations of
a heart attack, depending on which portion of the heart is injured and
which portion of the blood supply is injured. On a statistical basis,
about 80 percent of the heart attacks are associated with clear signals,
the most important of which is pain. Probably about 15 to 20 percent
occur either when you are sleeping or without any associated pain.
Very often what is called really instantaneous death can occur from
an arrhythmia of a serious nature, from ventricular fibrillation with
no serious pain at all.
Mr. ROGERS. Dr. Roy?
Mr. Roy. Do you support or not support the interagency technical
committee idea?
Dr. DUVAL, We have one in operation now with regard to the cer-
tain aspects of heart disease. In principle we do.
Mr. Roy. Do you think there is any labeling at the present time that
would be worth while, labeling of cholesterol contents in foods?
Dr. DUVAL. I am reluctant to answer that affirmatively. We do think
that labeling of foods, from the viewpoint of calories and general
nutritional value, is keenly desirable. We are a little reluctant to move
too far into the area of labeling in the area of cholesterol `because we
are not certain of its meaning.
Each time you take that step you `further, as it were, excite the
public. We are cautiously looking at that one. We are moving more
`y in the area of labeling of nutritional value.
If foods were labeled, those who chose not to eat a great
:erol would `have a choice; is that correct?
.r. T)UVAL. That is correct.
Mr. Roy. You say that RMP has the duty of bringing some informa-
tion you have to the practicing physician. Could you submit for the
record wh'at program RMP `has and in fact what is being done?
Pr. DUVAL. Yes.
(The following material was received for the record:)
UPDATING THE KNOWLEDGE OF HEALTH PROFESSIONALS-
REGIONAL MEDICAL PROGRAMS
~inuing e~"~tion activities must deal increasingly with health care system
~egardless of how well `continuing education is now provided or
e prov d in the future. the public benefits will depend upon the extent to
h contin ng education efforts give attention to the management and utiliza-'
of health services. The goal of continuing education is improving the per-
PAGENO="0115"
109
formance of the provider of the services so that the maximum benefits of science
are provided to the consumer through effective health care delivery.
Regional Medical Programs are supporting sixty (60) projects which are de-
signed to update the knowledge and improve the skills of health professions in
the area of heart disease. These efforts constitute a significant thrust in Regional
Medical Programs throughout the country-the expenditure in this fiscal year
amounts to over four million dollars.
The New Jersey RMP, in an effort to improve manpower utilization, is suppoi~t-
ing a program to standardize coronary care unit training programs for licensed
practical nurses, so that they can function with the same protection ~nd legal
sanctions as registered nurses. Given a high turnover rate among coronary care
unit trained registered nurses, their use as supervisors and teachers of licensed
practical nurses may represent better utilization of professional nursing per
sonnel
Other manpower and training activities, although basically designed to provide
continuing education for professional and allied health personnel, have im-
portant spin-off benefits. A recently completed program to upgrade the quality
of continuing education at a community medical center ip Columbus, Georgia,
for example, has contributed to substantial grbwtb in the city's physician popula-
tion and the establishment of the medical center as an areawide continuing
education resource for smaller neighboring hospitals.
As the basis for the program, the medical center in Columbus established a
regular university-affiliated teaching program with the Emory University School
of Medicine Local physicians were sent to the University for a newly organii~ed
clinical training program, and then, on return to the medical center in Oolumbus,
set up similar clinical and didactic training for their associates. As part of its
upgrading, the medical center at Columbus was selected by the Georgia RMP as
one of five community hospitals across the State which would become areawide
continuing education facilities. In addition, approximately 28 new physicians
have been attracted to the town during two years of the project, while there had
been no increase in the previous eight years.
The Michigan RMP supported a pilot study in Grand Rapids-a major medical
referral center. This watershed includes 10 counties outside of Grand Rapids
with a total of 315,000 people with a per capita income 35% below the state
average, and served by less than 70 active primary physicians. In 1970 a sys-
tematized approach to education in coronary care was applied to the entire rural
area. In the first 11/2 years of full-scale operation, funded by MRMP, 400 hours of
consultant teaching were delivered to the staffs of 9 outlying hospitals within
110 miles of Grand Rapids.
To conserve time for patient care, physicians were taught on their home ground
on a regular basis by the same group of consulting cardiologists from Grand
Rapids. Teaching methods were adjusted for major impact on patient care. Prac-
ticality and self-sufficiency were emphasized.
By chart review and PAS analysis, the mortality rate from myocardial infarc-
tion dropped from 34% (pre-course) to 18% (post~course). Such a statistic v
significant change has been rare in other types of p~-~ `~"~ ~ `~r "r~
programs. At the end of the prc4"~' ~ 8 of the
sustaining funds for the education
Many of the current continuin
such as those highui~1~ted a'~ "--~ `~ -.
a new focus in the I
proposals from
that funds will b r a number ( thes
the present fiscal:
These community-based education programs s viewe
and "more scientific" approach for linking con ming c
nurses, and other health professions with the ~.
of health manpower in given areas. It also is e
will be able to more effectively use the increasin
monitoring mechanisms, targeting continuing e~~.ucation
where remedial action is indicated.
Mr. Roy. How much money are you spending and ~
do you have in the ar~as of research into cardiovascular
diseases in children?
Dr. CooPER. I cannot break that out all at one time.
?ducat
sing e:
PAGENO="0116"
Dr. MARSTON. I think probably, Dr..
summary.
Mr. Roy. Is there a total there to give us some idea
of the grants is being spent?
Dr. CooPER. I will have to break that out and we will r~
Could you define what should be included in programs ~1
Mr. Roy. You can do that better than I.
Dr. CoornE. There will be some overlapping. As I mentioned
previously, in the pulmonary program we have areas where we can
identify amounts spent on children. We can do that in the new arterio-
sclerosis centers as well. We will make an estimate of the amount of
effort in that area and submit it.
(The following material was received for the record:)
Extramural regular research grants $2, 882,383
Training grants and awards 1, 485, 162
Specialized Center of Research 533, 691
Lipid Research Clinics 750, 465
In addition, the following intramural and extramural cardiovascular prograths
have ~ediatric relevance or pediatric program components: Biochemical Genetics,
Endocrinology, Surgery and Technical Development; and the collaborative con-
tract program in Medical Devices. The amount of funding of the pediatric
portion of these programs is not available as a separate budget item.
B. Pulmonary Program. The principal programs of pediatric relevance in this
dizease category are three: acute respiratory distress syndrome in the newborn
or hyaline membrane disease; cystic fibrosis; and the pediatric aspects of
chronic pulmonary disease.
The Institute's total budget in FY 1971 for programs with major emphasis on
pediatric pulmonary disease was:
lhtramural regular research grants $194, 220
Training grants and awards 159, 043
Specialized Centers of Research (2) 949, 044
"~" ~ ~ural la"--~tory of Technical Development and the col-
~m i~' --~ Devices supported research of pediatric
pediatric portion of these programs
tom.
I programs of pediatric relevance in this
d Disc ~ses i Sickle Cells Disease and Hemophilia and
~1 budget in FY 1971 for programs with major emphasis
~sease and blood management was:
research grants $943, 913
following extramural programs have pediatric relevance or
--~-ponents: Sickle Cell Disease Program and the National
im which includes studies of Hemophilia. The amount
portion of these programs is not available as a
types of hyperlipemia in children can he diagnosed
`NATIONAL HEART AND LUNG INSTEruTE PROGRAMS OF PEDIATRIC RELEvANCE
The National Heart and Lung Institute has programs with major emph~isis
or impct on the pediatric population in each of three areas: cardiovascular, Ping,
and blood programs.
A. Cardiovascular Programs. The principal programs of pediatric relevance in
this disease category are three: congenital heart disease, rheumatic fever and
rheumatic heart diseasO, and pediatric aspects of arteriosclerosis.
The Institute's total budget in FY 1971 for these programs was:
some projects currently being carried on
technology as early as from the core blood
PAGENO="0117"
i the scre(
to be done with the
Mr. Roy. May I
with State health
but with regard to i
Dr. COOPER. We are not c involved with
Programs in any formal way with State departments
written information on requests. We have no formal
the Institute
Mr. Roy. Is there anythi:
something that might be ~
Dr. DUVAL I wou
the point of your
research projects. ~. t in time when ri
whi~h is useful, then it goes out, as it were, to the State I
ments either through RMP or through projects on the
We have treated these two differently.
Mr. Roy. I just wondered if there were so
this respect. I am aware of the variability
I am aware, also, `of the fact that they see
many States. I wondered, again, if there
be established with regard to dissemin~
Dr. DTJVAL. Yes, sir. We do better
we do better, under the children
through the State health departme~~5
Mr. Roy. I have no further questions.
Mr. ROGERS. How many centers are there ~ow t
main effort to heart that we are o
Dr. COOPER. The specialized centers of resea
the 13 devoted largely to arteriosclerosis and five
to hypertension.
Mr ROGERS The b~li provides Lonal ct
you felt they should not have a u
Dr. DnVAL. I think the point c
illustrate that the concept of a ~
on clinical experience in order to deterrr
that or the other step is useful. ~
the NIH. After having f
methodologic tool is r~-~--
a service organiza~j.~~
other device, rather thar
L. the service arm.
R. I orien~e,
thas]
~ow of `any, o you?
r to be gained in
[5 arep ~
bi~ youi
a very e
grams? j
PAGENO="0118"
Dr. DUVAL. I think, depending on
"control" -
Mr. RoGERs. I am talking about e
Dr. DUVAL. We do have opportui
being displayed by RMP. I do t~
treatment of conditions than are recognized, s
standing track record here.
Mr. RoGE1Is. I think it would be well to give us for the record what
RMP's have done to try to control heart disease in this Nation.
(The following material was received for the record:)
ROLE OF REGIONAL MEDICAL PROGRAMS IN SCREENING AND EARLY DIAGNOSIS
Regional Medical Programs seek to improve personal health care through the
regionalization of health resources and enhancement of the capabilities of
providers of care at the community level. As such, they are concerned with the
entire range of health care, including prevention and early intervention in the
disease process, as well as diagnosis, treatment, and rehabilitation.
The Regional Medical Programs are currently supporting some 53 projects
dealing with screening and/or early detection, funded at a level of $4.4 million.
Sixteen of these projects, funded at a level of approximately $1 million, are
directly related to heart disease. Many of the others involve multiphasic screen-
ing which includes heart disease.
The 56 individual Regional Medical Programs are involved with screening and
early diagnosis in a varThty of ways. One line of emphasis is the development of
new diagnostic and predictive techniques, and means of automating existing tests.
The Ohio Valley RMP, for example, is initiating an automated multiphasic
screening project which envisions extensive use of autotnated techniques and
paramedical manpower. The Memphis RMP is experimenting with a mobile
multiphasic health screening unit in Northeastern Mississippi. A mobile health
trailer will first serve the medical trade areas of two applicant hospitals, after
which it will serve a five-country area It is expected that up to 20,000 will be
screened annually.
Another are of emphasis is demonstration projects involving particular popula-
tion groups. Among the types of activities being carried on are:
~8creewing of Children for Heart Disease, Southeast Tennessee-Through coop-
erative efforts of Tennessee/Mid-South RMP and the Chattanooga Heart Asso-
ciation, school children in Appalachian counties are being screened by Cardio-scan
for heart disease. Follow-up is also provided for positive cases. Begun in 1970
for a three-year period, the project had screened 17,194 children in 14 counties
by the end of 1971. In 1972, two other counties and between 12,000 and 22,475
children will be screened.
North Carolina Adult ~S~ereening and Referral Program-Another screening
project was initiated im July, 1971, in Winston-Salem, North Carolina, under the
sponsorship of the local Heart Association, which has begun testing 100 adults
per day for hypertension, diabetes, anmesia, and elevated cholesterol. Local
vounteers work as technicians and aides. Initial testing covered an industrial
setting, a low-income area, and a rural area. The project is designed to develop
screening procedures which can be used on a State-wide basis in future years.
Areas selected for screening over the three-year period will include a minimum
total adult (age 21+) population of 500,000 covering a cross-section of urban.
rural, economic, and white/non-white factors.
School Heart Sounds Screening Program-This project has tested 38,402
school children in 12 Missouri communities for previously unsuspected heart
disease. Of these, 1,524 were referred for further examination to their physicians,
with a resultant 600 children found positive. The Missouri Heart Association
plans to continue this program on a State-wide basis when Missouri RMP fund-
ing terminates in late 1972.
In addition to the variety of screening programs currently being carried out
by the Regional Medical Programs, the authority was added in the 1970 legislative
extension and is now available in Section 910(a) (2) of the Public Health Service
Act for the "development, trial, or demonstration of methods for control of heart
disease, cancer, stroke, kidney disease, or other related diseases."
PAGENO="0119"
113
This authority may be used to fund such disease control programs either
through the 56 individual Regional 1\Jedical Programs, through two or more
RMPs for an interregional program, or through individual public or nonprofit
private agencies. Thus the authority provides a high degree of flexibility as to
the types of disease control programs which may be carried out, and a~ to the
types of institutions and agencies selected to run them. With the additional grant
funds projected as being available in fiscal year 1973, this authority for heart
and other disease control programs could be used to a greater extent, allowing
for initiation of an expanded variety of control activities.
Mr. CARTER. Mr. Chairman?
Mr. ROGERS. Yes.
Mr. CARTER. On that very thing we do have some programs that are
oriented mostly toward diagnosis and treatment. I know that Vander-
bilt and western Kentucky, which is associated with it, and western
Tennessee have a very good program in which physicians in rural com-
munities can get almost instant readings of electrocardiograms and
so on, which is very helpful. They also have relations with the pro-
fessors at Vanderbilt in which they come out to the rural communities
and teach or tell the physicians the newer methods. I think this is
good.
I regret that these programs are not being carried out in other parts
of our country. For instance, in eastern Kentucky, they have not been
implemented as well as they should be. This network should be used
by the university or with very knowledgeable specialists and the phy-
sicians that are giving primary aid.
Thank you for yielding.
Mr. ROGERS. Now, let me ask you this, Dr. Cooper: Does the National
Heart and Lung Institute have any input as to what kinds of programs
are being run by regional medical? Do you design it?
Dr. COOPER. We do not design their programs, nor do we specify
what the concept of their programs should be. We are available for
consultation and cooperation.
Mr. ROGERS. You are there if they want to ask you, `but you find all
of the research out and then somebody down there starts getting out
regional medical programs and, hopefully, as Dr. Carter says, maybe
they will be implemented and maybe they won't.
Mr. CARTER. I think we need more direction and leadership in t
to see that these programs are implemented I have watched it a
seen in many areas it has not been done.
Mr ROGERS What would we need to
as we now envision it in its current status ~
the record? Give us this as far ~
You may not be able to give us an ~ -~
(The following information was received
Es
It 1-
or the bi]
enactment of 1
plan required i~.
for the first three
merely represent S
r"~ ~ ed to i
tice.
estimates
record:)
IMATES von FIRsT THREE YEARS' FuNDING or HR. 13715
~ to ~-`~ - satisf'~ `~ to the quesi
elopment of
bject to ad.1
I, the I
Dn.It 5]
PAGENO="0120"
jin millions of dollars)
Program component Year 1 Year Ii Year iii
1. Development of program plan 1 (1) (1)
2. Control programs 30 40 50
3. Centers programs, including construction 100 117 148
4. interagency Technical Committee (1) (1) (1)
5. Natiobal Heart and Lung Advisory Council (1) (1) Q)
6~ Research grants and trsining 167 176 ltlO
1. Collaborative programs 70 80 82
8. intramural program, including constrCctios 20 22 24
9. Research and management services - 12 15 16
Total 400 - 450 500
Funding requirements would be small.
Mr. ROGERS. Are we having any important developments in arti-
ficial hearts or parts?
Dr. COOPER. As you may recall, in March we did announce somen
developments in engine technology and control systems technc
which demonstrate the feasibility of having an implantable ~
There have also been improvements in material design and in r
design.
Mr. ROGERS. Do any of these have to be approved by you or by
anyone else before they are used?
Dr. COOPER. For the ones that are currently being directly sup-
p~rted by our coordinated program we do make it a requirement to `be
approved for clinical use by us before allowing it even to be used
experimentally. In other words, we undertake a technical review and
make sure at the place proposed for implantation that the proposers
have subjected it to a local peer review in association with arrange-
ments e~ ~`y available for human research review.
I? ~1s just goes to `any project funded by you?
OPER. `1 ~ is true of any project funded by us, but in this
r~ program we undertake an additional technical review of
rcy of the scientific base before we concur in the decision for
- -. -. ~ it. We do not select out the patient nor enter into any
particular clinical decision at the bedside. We do make a special re-
view of `the adequacy of the `scientific base for its general use.
Mr. ROGERS. Did you approve the devices of heart implant, the
pacemakers?
Dr. COOPER. No, sir, we did not. These were not developed under
our supervision nor our contract programs. These were independently
developed by the community in association with medical centers and
industry. The decisions for applying these were made in the com-
munity itself.
Mr. ROGERS. I was wondering how you let it get out if that were
so without the protective shield to prevent the radiation that is stop-
ping it.
Dr. COOPER. In the radar shield.
Mr. ROGERS. Yes.
fli' C ~. We cannot review that material.
We hope to get to a medical devices bill this year.
Behinitz?
CHMITZ. I will have to apologize for having been unavoidably
~o attend a previous meeting during part of the witness' testi-
PAGENO="0121"
l15~
mony. I would like to ask or~e question here. Is the basic thrust of th~
bills before us to find a cure for these illnesses or to find some way of
getting people to act on the already known causes?
Dr. Coop~n. Both.
Mr. ROGERS. I think both.
Mr. SOHMITz. Don't we know, for example, with regard to heart
diseases, that if people exercised we could cut it down three-fourths?
Dr. COOPER. Not with exercise alone, but appropriate planning
would help in the management of the problem. But exercise alone will
not account for a three-fourths reduction.
Mr. SCIIMITZ. If everyone exercised the way their bodies were in-
tended to exercise, how much would this cut down on heart and lung
disease?
Dr. COOPER. This would be a very difficult estimate to make. But
as a single risk factor, I would put it in the perhaps 10 to 20 percent
category. That is just a guess.
`Mr. SCHMITz. I would guess a lot higher than that. I am not a
doctor, though.
Mr. CARTER. Mr. Chairman, on that very thing, not long ago there
was an interesting study by, I believe, Boston University in conneç-
tion with the University of Dublin.
Dr. COOPER. Was it Belfast?
Mr. CARTER. It could have been Belfast; I am not sure. I don't be-
lieve it was. This study showed that although those Irishmen ate twice
or three times as much as Americans in the Boston area, again the inci-
dence of heart disease was approximately one-half or even less.
Dr. COOPER. My memory doesn't serve me too well here, Dr. Carter,
but I have the impression that in Ireland, and in the British Isles as
well, the attack rate very closely approximates ours.
Mr. CARTER. I hate to tell you that what you say is directly in con-
flict with this study, and I would commend this study to you.
Mr. SCHMITz. Would the gentleman yield?
Mr. CARTER. Yes, sir.
Mr. Sorn~nTz. I am also aware of that study, along with other
studies, which support my comments. Although I am not ~ doctor,
most of the things I have read in this field are from doctors. Othei~
doctors make an excellent case for the proposition that our ~
problem with regard to all of these diseases before us here i~
the nature of our society, which is quite abnormal.
Mr. ROGERS. In the lung area, what have you done in
pollution is quite high?
Dr. COOPER. We 1~
ordinating our program ~
Health Sciences'. They a g `a y down ~1
Carolina which will offer a laboratory in which we can work w
on the `study of this problem. We, do feel `that substances in
vironment are injurious `to certain pulmonary functions an1
deal of work on this system needs to be done in this area.
Mr. ROGERS. In other words, you have not do'ne any v~
but you are planning it?
Dr. COOPER. Yes, sir.
Mr. ROGERS. You haven't had a
it? You have two people to
PAGENO="0122"
I understand ~ or somebody advised about not doing
X ray examinations for t i~ because of the potential harm c Lina
tion. Was that Food and Drug? Do you concur in that o
asked to give your opinion?
Dr. COOPER. I was not asked to give my opinion on
Mr. ROGERS. Let us know if anybody asked Heart
cur in that action. I think it would be helpful to
judge coordination.
(The following material was received for the record:)
DIsCoNTINUANCE OF MOBILE X-RAY UNITS
So far as can be `ascertained, this question refers to discontinuance of mobile
X-ray units for detection and early diagnosis of tuberculosis. No consultation on
the matter was made with the National Heart and Lung Institute In this instance,
since the decision was apparently made on the basis of the high cost for a low
yield program. While no mechanism of formal coordination between research
and service programs exists it is customary for consultation to take place on sub-
stantive issues.
Mr. ROGERS. What about your manpower situation for your work in
blood as such? What do you have there?
Dr. COOPER. We have a very small staff in blood, Mr. Chairman.
Mr. ROGERS. Whom do you have? How many?
Dr. COOPER. The chief of our national blood resource program is
Dr. Stengel, and he has four young associates with him. In the ex-
tramural program we have Dr. Fann Harding. We will have Dr.
Therriault coming on board in June. In the intramural program we
have a laboratory section under the supervision of Drs. French and
Anderson which will be proposed for branch level within the coming
year.
Mr. ROGERs. So you have three senior people?
Dr. COOPER. Three senior people at the present time.
Mr. ROGERS. And four students?
Dr. COOPER. There are more in the extramural program. There are
probably on the order of eight or nine students.
Mr. ROGERS. That is the Government's effort in research on blood.
Dr. COOPER. It is not the total Government effort. The National In-
stitute of Arthritis and Metabolic Diseases has a major laboratory.
Mr. ROGERS. What are they doing?
Dr. COOPER. I am not competent to speak on that.
Mr. ROGERS. Maybe Dr. Marston can speak quickly and supplement it
for the record.
Dr. MARSTON. We have a program in the Arthritis aruci Metabolic
Diseases Institute and another in the Allergy and Infectious Diseases
Institute, where we have a major program for hepatitis, and then in
the Division of Biologic Standards we have the control functions for
blood and blood products. I would be glad to expand each of these for
the retord.
(The following information was received for the record:)
SCOPE OF GOVERNMENT REsEARCh ON BLOOD
NATIONAL INSTITUTE OF ARTHRITI5 AND METABOLIC DISEASES
he co~m~iiittc
The area of Institute responsibility is defined by reference to (1) certain
disease areas and corresponding fields of inquiry, (2) certain training and
PAGENO="0123"
NATIONAL INSTITUTE OF
NATIONAL INSTITUTE OF NE
The Institute's area of respoflf~
entity under study is either the ne~
apparatus, hearing, equilibrium t
based symbo~j~ processes such as langua~
The cerebrovascular disease program F
th~ mechanism of damage to nervous i
vessels (e.g., the pathogene~j5 of cerebral
NATIONAL CANCER INSTITUTE
The area of Institute responsibility includes basic and Clinical
to cancer in man and animal species.
Within this responsibility programs relating to cai
Pulmonary, and hematopo~e~j~ system abnormalities ~
ment of tumors; development of collateral lymphatic and vasc~
lymphatjcvenous anastomoses
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELO~
The a'~a of Institute ~ponsibi
lating to 1 healt
~tain
:ory dL~.
ROGERS. 1~
~ or decre~
L) V ~IJ4.
~OGERS. ~
t it from transf
MARSTON. The
lepatitis as c
rears with t
~ and
scope of the 1
related to transfu~
1
-Ifectious~ he~ ~bis
ris. The a
~er or r~
t only a;
but also is allowi
to ha~vej
PAGENO="0124"
BLOOD RESOURCES PROGRAM
The question of infectious diseases transmitted by transfusion of blood is
one with which the National Blood Resources Program is properly concerTled.
This problem includes infections such as cytcmegalovirus, toxoplasmosis,
malaria, as well as the most important problem, hepatitis. The Blood Resources
Program is supporting projects on ways to prevent infections associated with
blood transfusion, especially the improvements in techniques to identify bloods
which contain the hepatitis agent, and to some extent to prevent the development
of hepatitis in blood recipients by specific immune globulin.
While the National Heart and Lung Institute is engaged in these activities,
the National Institute of Allergy and Infectious Diseases is conceriied with
viral l~epatitls as an infectious disease, the characterization of the agent (s),
the development of active immunization, and the usefulness of passive immu-
nization for prophylaxis against accidental parenteral exposure, etc. The Divi-
sion of Biologics Standards is also involved in its relationship to the regulation
of. blood and blood products. The National Institute of Arthritis and Metabolic
Diseases, because of its program in hematology, is also involved in hepatitis
diagnosis and prophylaxis, and in the treatment of hepatitis. The Clinical Center
blood bank is also engaged in hepatitis research. The multiplicity of Institutes
h on viral hepatitis led Dr. Marston to establish a Task
~1t1O t~. maintain communication among the interested In-
I to coordinate programs by assignmeslt of respon-
considerable trial and tribulation, the coordination
~n well.
1972 RESEARCH HEPATIT1S GRANTS AND CONTRACTS
PRIMARY HEPATITIS PROJECTS
Amount Title and number
II Institute of Allergy and Infectious
s: Riopelle, Arthur i. Tulane University_ 1 ~48, 565 Study of hepatitis in chimpanzees, NO1AI 12197.
University of Southern 62, 059 Measles virus or other virus infections (human, mice,
rabbits), R01A103874.
E., University of Colorado 26, 850 Transplantation and applied immunology, PO2AIO-
ur. 8898.
New York Blood Center_ 58, 939 Serum hepatitis virus related antigen (human,
primates), RO1A 09516.
iorstmann, Dorothy M., Yale University - - 78, 062 Etiology of viral hepatitis (human, rodents), ROlAl0~
9937.
M A University of Maryland 42 329 Viral hepatitis sequelae in Pakistani soldiers (human)
RO7A 110049.
David J., Columbia University Viral hepatitis-Role of Australia antigen and other
agents (human), RO1A 110165.
r F., University of Colorado 31, 142 Immunologic response to hepatitis-associated antigen
iter. (human, rodents, ungulates), R01A110176.
,.s W. University of Southern 37, 200 Epidemiology of HAA-positive viral hepatitis (human),
RO1A 110586.
Carver, Daed H., Johns Hopkins University_ 23, 191 Intrinsic interference assay for hepatitis viruses
(human, chimpanzees), ROIAI1O7I1.
Wright, Harry T., Jr., Children's Hospital (2) Etiolo8ic agents of viral hepatitis (human), ROll
(Los Angeles). 9041.
,~cont~
So I would say t. field i~
major, almost crash, program in World
problems at that time, to learn more about hei
the most part, failed, but in recent years we
significant progress.
Mr. ROGEES. I think if you could outline the details for the record
this would be helpful.
(The following information was supplied for the record:)
;titution
PAGENO="0125"
119
B. National Institute of Arthritis and Metabolic
Diseases:
Grants:
Leaf, Alexander, Mansachusetts General
Hospital.
Schoenfeld, Leslie, Mayo Foundation
Saravis, Calvin, Harvard ~
C. Division of Biologics Standards:
Contracts:
Goldfield, Martin:
NJ. State Dept. of Health
TRW Inc. (Hazelton Labs, Inc.)... -
D. National Cancer Institute:
Grants:
Blumberg, Baruch S., Institute for Cancer
Research
Do
Do
Vaughn, Clarence B., Michigan Cancer
Foundation.
E. Center for Disease Control:
Grants:
Carver, David H., Johns Hopkins University.
Vyas, Girish N., University of California
(San Francisco).
F. National Heart and Lung Institute:
Contracts:
Melnick,Joseph, Baylor College of Medicine
Mechanism of viral injury to liver (mice, human),
P02AM04501.
Digestive and hepato~biliary function. Hepatttis
(human mice), P02AM06908.
Diseases of liver and portal circulation. Serum
hepatitis associated antigens (human), PO1AMO-
8681.
Australia antigen-Transmission to primates, PO2CA-
06551.
Chemical composition of Australia antigens, P02C-
A06551.
Australian antigen, hepatitis virus and its relation
to leukemia, P01CA06927.
Clinical cancer research center immunological pro-
gram (human) P02CA07177.
Name and institution
i972 RESEAROH HEPATITIS GRANTS AND PQNTRACTS-C~ntrnued
PRIMARY HEPATITIS PRO~JECT~-Continued
AMount Title and number
$52, 900
52, 250
26, 000
226, 800 Epidemiological study of transfusion-associated
hepatitis, NOl BS02026.
76, 500 Susceptibility of subhuman primates to human
hepatitis, NOl BS22050.
32, 820
32, 280
55, 380
74, 280
45, 785 Viral studies of infectious hepatitis (human), RO1CC-
00499.
48, 157 Serologic specificity of the Australia antigen (human),
R01CC00578.
DevoJop tests to detect the HAA (human, mammals
nonhuman), N01HL02231.
Halbert, Seymour P., Cordis Corp Hepatitis associated antigen (human, sheep, horses),
N01HL02232.
Blumberg, Baruch S, Institute for Cancer Australian antigen (human), N01HL02234.
Research.
Prince, Alfred M., New York Blood Center Produce antibodies to the Australian antigen in
animals (human, monkeys) N 0111102236.
Pert, James H., N.Y. State Department of Health Antibodies to the Australia antigen (guinea pigs,
goats, sheep, rabbits), N01HL02240.
Grady, George:
Harvard University 42, 905 Hepatitis-associated antibody (human), N01HL120~4.
Aerojet-General Corp Develop test protoool to detect HAA (mammals
nonhuman), N01HL12350.
Gitnick, Gary 1., University of California 9, 856 Detection of hepatitis in blood (human), N01HL12351.
(Los Angeles).
Smith, James E., Syracuse University Detection of hepatitis in blood (human, mammals
nonhuman), M01HL12352.
Aach, Richard 0., Washington University Detection of hepatitis in blood (human, mammals
nonhuman), N01HL12353.
Melnick, Joseph L., Baylor College of Remove agent of hepatitis from blood (human,
Medicine, mammals nonhuman), N01HL12354,
Vyas, Girish N., University of California 15, 100 Detection of hepatitis in blood (mammals non-
(San Francisco). human), N01HL12355.
Hinman, John, Blood Research Institute...., 1, 991 Transmembrane washing of red blood cells (human),
N01HL12356.
Prince, Alfred M., New York Blood Center Bioassay for serum hepatitis virus (human),
N01HL12358.
Johnson, Allan, Jr., New York University Removal of infectious agent of hepatitis frOm blood
(human), N01HL12359.
Grants:
Kehns, William J., New York University Prevention of hepatitis after cardiovascular surgery,
R01HL12732.
Johnson, Allan, New York University Removal of hepatitis-associated antigen from plasma
(human), R01HL13984
Prince, Alfred M., New York Blood Center~ 155, 790 A research and resource program in blood virology
(human, rats,chimps), PO1HLO9O11.
G. Office of the Director: Contracts: National Acad- Establish a committee on viral hepatitis, N010D40044.
emy of Sciences.
PAGENO="0126"
120
Name and institution
Amount
Title and number
H.
Research Resources:
Grants:
Abbruzzese, Americo, Peter Bent Brigham
Hospital.
Senior, J., University of Pennsylvania
Jeifries, Graham H., Cornell University
Medical College.
Kohler, Peter F., University of Colorado
Medical Center.
$23, 547
17, 750
11, 450
16, 800
Detection of occult liver disease in bldod donors
(human), MO1RR00031.
Anicteric hepatitis after administration of frozen
washed red blood cells (human), MO1RR0004O.
P liver disorders, hepatitis viral (human)
MO1RR00047.
Antibody effect on HAA carrier(human), MO1RR00051.
Mann, G. A., Philadelphia General Hospital__
Hersh, Theodore, Baylor College of
Medicine.
17, 000
10,340
Post-transfusional hepatitis (human), MO1RROO1O7.
Malabsorption and hepatitis (human), MO1RROO134.
Gocke, David J., Columbia University
12, 625
Role of Australia antigen in pathogenesis of hepatitis,
MOl RR00645.
Do
12, 625
Treatment of fulminant viral hepatitis with hepatitis
immune globulin (human), M01RR00645.
SECONDARY HEPATITIS PROJECTS
A. National Institute of Allergy and Infectious
Diseases:
Grants:
Weller, Thomas H., Harvard University Pathogenic agents using in vitro technique (rats),
RO1A 101023.
Morgan, Councilman, Columbia University_ $49, 678 Electron microscopy of virus-host interactivity,
RO1A 106814.
Enders, John F., Children's Hospital (Bos- 74,447 Viral cytopathogenicity-Mechanisms and applica-
ton). tions (human, hamsters), RO1A101992.
Douglas, Steven D., Mount Sinai School of 37, 995 Cellular and subcellular studies in immunogenetics
Medicine. (human), RO1A 109338.
Bang, Frederick B., Johns Hopkins Univer- International center for research and training,
sity. RO7A 110048.
Buckley, Rebecca H., Duke University 44,061 Bone marrow transplantation in immunoIogi~ defi-
ciency (human), RO1A 110157.
Fields, Bernard N., Yeshiva University Genetic and biochemical studies of Reovirus RO-
1A 110326.
B. National Institute of Arthritis and Metabolic
Diseases:
Grants:
Popper, Hans, Mount Sinai School of 110, 409 Structure and function in liver injury (human, rats),
Medicine. R01AM03846.
Schur, Peter H., Robert B. Brigham Hos- Antigen-antibody complexes in human disease
pital. PO2AM05577.
Klatskin, Gerald, Yale University Hepatic injury (human, rats), RO1AM05966.
Iber, Frank 1., Tufts University 37, 923 Interhospital cooperative studies of cirrhosis (human)
R01AM09128.
Matelson, Samuel, Michael Reese Hospital 27, 153 Guanidino compounds in health and disease (human,
and Medical Center. swine), R01AM09958.
Sturgeon, Phillip, University of California 81, 142 Automation of hematological methods (human ani-
(Los Angeles). maIn), R01AM10722.
Combes, Burton, University of Texas South- 85, 888 Splanchnic hemodynamics and splanchnic metabolism
- west Medical School. (human, rats, guinea pigs), RO1AM137 -.
B. Division of Biologics Standards:
Contracts:
Dalgard, Dan W., Thompson Ramo Wool- 23, 100 Provide housing and special care of chimpanzees,
dridge. NO1BS12O4O.
Sharp, D. Gordon, University of North Caro- Zonal centrifugation in identifying biological samples,
lina. N01BS92197.
C. National Cancer Institute:
Grants:
Blumberg, Baruch S., Institute for Cancer Immunologic basis for susceptibility to cancer in man,
Research. PO2CAOtS5J.
Do Relation of inherited antigens to cancer susceptibility
in man, PO2CA06551.
Do Human and animal antisera to detect leukemia-related
antigens (rabbits), P02CA0655.
Do Factors in the development of malignant hepatoma.
P02CA06551.
D. National Institute of General Medical Sciences:
Grants:
Brqnner, Edward A., Northwestern Uni- Anesthesia research center (human, monkeys, mam-
versity. mals non-human), PO1GM1542O.
Van Oss, Carel J., State University of New 44, 882 Separation of blood proteins by ultrafiltratinn,
York (Buffalo). RO1GM16256.
E. National Heart and Lung lnstitute: Grants: 103, 943 Blood coagulation components-Structure and func-
Johnson, Alan J., New York University. tion (human, baboons, dogs), RO1HLO5003.
F. National Institute of Neurological Diseases and Fine structural alterations in CNS viral disease (hu-
Stroke: Grants: Herndon, Robert M., Johns Hop- man, mice, rats, cats), R01NS08997.
kins University.
G. Research Resources: Grants: Hendrix, Thomas R., Intestinal disaccharidases (human), MO1RR00035.
Johns Hopkins University.
1972 RESEARCH HEPATITIS GRANTS AND CONTRACTS-Continued
PRIMARY HEPATITIS PROJECTS-Continued
PAGENO="0127"
)gram ~ im~ at i
~tion and we have a
What has been your b -
for blood Since 19
Sick~.
at the present t~, $10
cell initiative
The remainder of the program has been rela,
the $12 mill ion level. This past year we ir
blood fractionatioflhepat,.ti areas by
Mr. ROG1~RS. Should stroke be transl
Do you feel it should not?
Dr. DtTVAL. Absolutely not.
Mr. Roa~Rs. Stroke then doesn't have anything to do with t
valves?
Dr. DUVAL Sure it does. The same thing as the fever has
to do with measles.
Mr. Chairman, the point is one made
neurologj~~~ diseases experts are goin
stroke. T ~ does not mean that
`~ermane and should r
who
There i~
Are th
Our next
of the Assoc
PAGENO="0128"
Dr. Cooper, we welcome you to the c
to receive yot~r testimony.
STATEMENT OP DR JOHN A D
OP AMERICAN MEDICAL ~
BOWSHER, STAFF MEMBER
Dr. CoOPER. Mr. Chairman, I have with me Mr. Prentice Bowsher,
who is a member of the association staff.
The association welcomes this opportunity to appear before the sub-
committee on this very important legislation which it is considering
to expand `and extend the National Heart and Lung Institute and the
national attack against cardiovascular and pulmonary diseases.
I do have a statement which has been written, and I hope can be
inserted in the record.
Mr. ROGERS. Without objection, it will be placed in the record.
Dr. CooPER. I would like to highlight some points we have made
in the written statement, and add a few additional comments.
Phe legislation which this subcommittee is dealing with at this
time, èoncerned with the diseases of the heart, lungs, blood, and blood
vessels, is very important to the Nation, because these diseases are
reaching epidemic proportions and we haven't devoted adequate at-
tention to them. They are the major causes of ~death in the United
States, killing more than a million people each year. Cardiovascular
disease alone accounts for 54 percent of all of the deaths in the United
States and it kills old and young alike. More tha~i 12 million Amen-
cars will suffer from some form of heart attack in the next 10 years.
In addition., lung diseases are also deadly killers and debilitators.
Approximately 20 million Americans are disabled with diseases of
the lung. Death from emphysema is rising at a rate which is unparal-
leled by any other disease.
In addition, an enormous number of people are being killed or
disabled by thrombosis. This is responsible for most of the suffering
and death caused by the 200,000 strokes occurring annually in the
United States.
We would like to point out, in response to your question to the
mt Secretary and his staff, it is important that all of the inform-
I on arteriosclerosis and other studies of the blood vessels
applied to the area of stroke, because stroke is related
s in the blood vessels and the central nervous system which
~r from those occurring in other parts of the body.
concerned that apparently only about $13 million
expended in the National Institute of Neurological
~ against this very important and deadly disease.
the information that has already been provided to you
ministration, clearly establishes that it would be in the
~t to mount a real attack on cardiovascular and lung
strike down people in their prime and most productive
Te have considered the various bills which have been introduced
into the House in relation to cardiovascular and pulmonary diseases,
and we think that the bill that you have introduced, Mr Rogers, is
certainly preferable to all of the other bills. It is the broadest and
PAGENO="0129"
the best appros Li these
problems. it is not restricted, as some of the other bills are, fo specific
and particular diseases.
We think that all diseases oLthe heart, lungs, and bloo4 offer real
opportunities for increased effort at this time, and thç~ bill that you
and your colleagues have introduced provides a basis for undertaking
this effort.
One of the things I would like to point out, however, as we did whei~
we testified last year on the cancer legislation, is the fact that the
present scientific understanding which has led to our ability to mount
an initiative in heart and lung diseases is the direct result of broad
advances over the full scope of the biomedical sciences.
I think the colloquy between Dr. Carter and Dr. Cooper ou the
control of hypertension pointed out that advances which have been
made in this important disease, have come from an understanding of
the basic physiology of salt and water metabolism.
Advances in basic biomedical sciences provide us with the under-
standing of these major killer diseases and the opportunities for tar-
geted research such as that which we are considering in this particular
bill.
With regard to the other bills introduced, I might speak about them
very briefly. The legislation which was introduced by Representative
Pepper and the bill by Mr. Staggers include a number of very desir-
able approaches to overcome cardiovascular and pulmonary diseases.
They include authority to establish control programs and demonstra-
tion centers and to simplify the approval of research and training
grants. The legislation, however, also includes a number of oI~ga4iza-
tional proposals which were developed in the 1971 debate on the legis-
lation for an expanded national attack on cancer.
While many of those proposals might have seemed appropriate in
* that debate, we don't think they are as pertinent in this effort. We
think we are confronting a different problem here, and we think this
ought to be recognized in whatever legislation is recommended by
this committee.
Mr. Duncan's bill encompasses many useful things, centered, how-
ever, almost entirely `around arteriosclerosis. The other diseases do
not seem to be covered by this legislation. We would like to point out
that we are really dealing here with a family of diseases. There is
little to be gained by singling out a single disease f Or legislative
action. We think Mr. Duncan's bill is too limited in terms of the nature
of the problem to be dealt with.
As I said, the bill you and your colleagues have introduced is
broader, and, we believe, a very effective framework to deal with the
problems of all of the cardiovascular and pulmonary d
blood which the Heart and Lung Institute has, under i*.c
The bill does authorize the Director of the National]
Advisory Council to develop a 18) days
of the legislation for a F 1 1 1
We think the development c this plan i
the maximum and most effective program i~
ordinating activities of the Institute concerning
would provide for action in eight broad areas.
78-994-72-9
PAGENO="0130"
124
i would confront
rocesses and
;car
diseases, and for the development and c~moi ~
treatment and preventive approaches to these ci iood d
It is impQrtant that this plan, when it is submitted to the ~
contain staff requirements to carry out the program, as well as rec-
ommendations for program appropriations. We prefer the determina-
tions of allocation of effort within the program by the Institute Direc-
tor and the Advisory Council through the development of this plan
rather than through a predetermined distribution, such as has been
added to the Senate bill.
We are also deeply concerned about the lack of an adequate staff
within the Institute, not only to mount the expanded program which is
envisioned under this legislation, but also to carry out properly the
present program. We think this is a matter of great importance if
we are to have an effective program incardiovascular and lung disease,
because it is an adequate staff within the Institute which will make
it possible to coordinate this program with other agencies and to de-
velop effective plans and approaches to these diseases. This Institute
does not now have, in our view, an adequate staff.
We think that this requirement for the report of a plan within 180
days really makes unnecessary the Commission which the President
has recently appointed. The plan will be developed by individuals
with competence in the areas represented by their membership on the
Council. They will then be a part not only of the development of the
plan but of seeing that the plan is implemented in the years ahead.
We hope that in the development of the plan by the Director and
Council that related lung and blood problems, such as cystic fibrosis
and malignant diseases of the blood, constitute part of the whole
effort.
We do think, however, that maybe some minor changes in the
language in section 413 of the bill might be necessary to assure full
coordination with the efforts of other institutes on these diseases.
We think the rolling plan which is envisioned in the bill will pre-
vent us from developing a fixed approach, and changes can be incorpo-
rated as new opportunities are presented in the future. The Council
and Director will present annually to the Congress their assessment
of the new opportunities as they unfold from previous work.
The other important part of the legislation which we heartily en-
dorse is the interagency technical committee. You have brought out in
your questioning of the administration witnesses the fact that there
has not been good coordination, not only within the Department itself,
but with other Federal agencies. We think that this technical com-
mittee, established by the Department, will permit a much more unified
and intensified attack upon cardiovascular and pulmonary diseases
by all of the Federal agencies that have some interest and concern. We
think this is a very important part of the legislation.
PAGENO="0131"
~i you sc
- budget i
relation
search and res
and researc
support programs, C
grants-these are the inve~
with indameni
procc
PAGENO="0132"
Mr. Chairman and members of the subcommittee: Ihe Associa
Medical Colleges welcomes this opportunity to appear before t~.
at its request during consideration of legislation to strengthen tL. ~~al
Heart and Lung Institute to advance the national attack against cardiovascular
and pulmonary diseases.
Formed in 1876 to work for reforms in medical colleges, the Association has
broadened it~ activities over~ the years, so that today it represents the whole
complex of persons and institutions charged with the undergraduate and gradu-
ate education of physicians. It serves as a national spokesman for all of the 108
opera~tional U.S. medical schools and their students, more than 400 of the major
teaching hospitals, and 52 learned academic societies whose members are en-
gaged in medical education and research.
Through its members, the concerns of the Association range far beyond medical
education itself. They include the total health and well-being of all of the Amen-
éan lDeople. The Association is concerned with the education and training of per-
Sons in other, related health professions and in allied health occupations. It is
concerned with the conduct of a substantial portion of the nation's medical and
health care research. It is concerned with the delivery of health care, directly
through the facilities of teaching hospitals, and indirectly through the develop-
nient of improved community health services. It is concerned with innovation and
experimentation in all of these fields. The Association and its membership thus
h-we a deep and direct involvement in the legislation the subcommittee is now
-~---~ng.
THE PROBLEM
~oinmittee asked the Association to comment on
~es of the heart, lungs, blood and blood vessels.
these diseases and the epidemic proportions
of death in the
Cardiovascular
~d States, killing
i12
PROPOSALS FOR ACTION
s studied the various legislative proposals before the sub-
~i diseases of the heart, lungs, 1' 1 blood vessels.
Heart and Lung Diseases Act was introduced
.`l enlarges the auth )f the National
- - rtoad-
lishes a
)ointed
~ Di-
PAGENO="0133"
sen
muitjc
of 10 ~
Of Hea~'~ ~
vide for
to be ~
ris
heajtj
Ooum
Sinipi ~
of less than
propria~~J
& A~soc~
PAGENO="0134"
128
. pulmonary diseases. Am~rng them are the authority to establish control pro-
grams and clinical research and demonstration Qenters and to simplify the
approval of routine research and training grants. The legislation a]~so appears
to include, however, a number of organizational proposals developed during the
1971 debate over legislation for an expanded national attack against cancer.
While most of those proposals seemed to be apprpriate in that debate, the As-
sociation does not consider them appropriate to this effort. A different problem
is to be confronted, and a different set of issues is involved. These differences
should be recognized, in the Association's view, in whatever legislation is recom-
mended by this subcommittee.
Representative Duncan's bill, the Heart Disease Prevention Act of 1972, en-
compasses many useful proposals centered, however, almost, exclusively around
arteriosclerosis. Other cardiovascular and pulmonary diseases do not appear to
be covered by the legislation. We would emphasize th'at we are dealing here with
a family of related diseases affecting the vital role of breath and blood in sus-
taining the life process. There is little to be gained in singling out a single disease
process for legislative action. Thus, we feel this bill is much too limited in terms
-of the problems to be dealt with.
Representative Rogers' bill, the National Heart, Blood Vessel, Lung and
]3lood Act of 1972, would provide considerably broader and. we believe, a
more effective framework to deal with the problems of cardiovascular and
plumonary diseases. This bill authorizes the Director of the National Heart
and Lung Advisory Council, to develop a plan 180 days after enactment of the
jegislation for a heart, blood vesel, lung and blood program. The program would
expand, intensify and coordinate the activities of the Institute concerning these
diseases and would provide for action in eight broad areas. Among other thinas,
these areas include research into the basic biological processes and mechanisms
involved in the underlying normal and abnormal cardiovascular, pulmonary and
blood phenomena; studies and research into blood diseases, such as sickle cell
anemia and hemophilia; studies and research into the use of blood banks; and
estahlishment of programs and centers for study and research into children's car-
diovascular, pulmonary and blood diseases, and for the development and demon-
stration of diagnostic, treatment, and preventive approaches to these childhood~
diseases.
This basic plan is to be submitted to Congress and would contain staff require-
ments to carry out the program as well as recommendations for program ap-
propriations. The Association believes this provision constitutes a rational
approach to the problem of organizing the national attack against cardiovascular
and pulmonary diseases. Such a plan would seem to provide a coherent plan for
action and method of evaluation. Indeed, it is the provision of this plan in HR
13715 which, in the Association's view, makes this legislation distinctive and
superior to the other bills considered.
The Association would hope, however, that the development of this plan would
recognize and make provision for the work of other NIH institutes related to lung
and blood problems which in the area of cystic fibrosis and the m~lignant and
infectious diseases of the blood constitute an important part of the whole effort
in these areas. Some minor change in the language of section 413 of the bill might
be desirable to assure full coordination with these efforts in the overall plan.
Other essential elements of Representative Rogers' bill to help achieve the
objectives of the program are provisions to establish control programs, clinical
research and demonstration centers, and an Interagency Technical Committee.
These provisions will enable the National Heart and Lung Institute to mount a
unified, intensive attack upon cardiovascular pulmonary diseases. They will help
establish effective and direct methods of disease prevention, diagnosis, and
treatment.
As a consequence of this review of the legislation now before the subcommittee,
the Association must conclude that Representative Rogers' bill provides a co-
herent. balanced program to deal with cardiovascular and pulmonary diseases.
While it increases and strengthens the attack against a specific group of
diseases, it simultaneously recognizes the necessity of full support for the broad
base of scientific research.
Before closing, the Association must return to an important, underlying con-
cern. It is fully supportive of the major new research efforts proposed here for
heart and lung diseases and enacted recently for cancer. But the Association must
agajn emphasize in the strongest possible way that useful progress in these
categorical areas is completely and utterly dependent upon advances at more
fundamental scientific levels. Unfortunately, support for this area of basic, funds-
PAGENO="0135"
129
mental research is not a separate program whose needs can be dealt with ip
primary and direct terms. Rather, such support is encompassed in what is called
the regular research grant program of the National Institutes of Health and
appears only as a secondary budget item within the overall appropriations esti-
mates of the several NIH institutes.
rrhus, despite Congressional establishment of appropriation authorizations and
action on appropriation requests, there is no direct way for the Congress to
insure that support for this area of basic research is sufficient to undergird the
various categorical efforts. An example illustrates this pOint. In the President's
budget request last year for fiscal 1972, a special additional sum of $100 million
was included for an expanded national attack against cancer. However, the
additional funds were provided through a real but hard-to-perceive reduction
in the regular research grant programs of the other institutes. Similarly this
year, despite the increases proposed in the President's budget for cancer and
heart in fiscal 1973, support for new and competing research grants and for
general research support have been cut back. In simpler terms, M~. Chairman,
this is tantamount to starving the goose that days the golden egg. Without a
vigorous and expanding body of fundamental scientific activity, there iS little
point in legislating new and massive categorical programs.
There is, in fact, much to suggest that the current NIH structure for support
of investigator-initiated academic science in the face of nationally organized
categorical research programs is becoming increasingly contradictory. It may
be time for the Congress to review this structure in the context of current
national objectives, the scope and nature of the scientific activity requisite to
these objectives, and the most framework for its support.
Mr. ROGERS. Thank you very much, Dr. Cooper. I know the com-
inittee shares your concern about reduction in the basic research sup-
port. In trying to design the bills the emphasis is also given to basic /
support.
Mr. Nelsen?
Mr. NELSEN. No questions. I thank the witness for this statement.
Mr. ROGERS. Mr. Kyros?
Mr. KYROS. Just one statement, Mr. Chairman. First of all, I wel-
come you here. I was enlightened by the testimony and I agree with
everything you have said.
Let me say this question, as a layman. You have talked about the
basic research in the chairman's bill. What about the fact that today
we do not know how to rehabilitate the man who has sustained a myo-
cardial infarction. We are all prone to it. How do rehabilitate him?
Dr. COOPER. If this relates to the difference between, let us say, inves-
tigator-initiated research and the more programr dirc
search, we would say we are fully in support of e
opportunities that are available to us now in a coi
many diseases. They are available, and we don't t
an optimal amount of our resources to underst
quer these diseases.
The point we are trying to make, however, is
to mount this attack comes from the informatk
from the basic biomedical investigator-initiate(
In regard to the rehabilitation of individi
instance, coronary occlusions or myocardial
great number of studies going on, for e:
occur in the metabolism of cardiac tissue as a
in the blood supply which comes from the -
come a real understanding about, for instanc
shim out of the muscle, and this further c
activity of that muscle, w hich is not only ~
PAGENO="0136"
.Lt)~J
but now has a complete disarrangement in its metabolic activities.
This leads to further necrosis atLd death of tissue.
Understanding these kinds of things will permit us to try to do
something to be more effective in preventing medical deaths from the
infarction, in rehabilitation and in resupplying the heart with blood.
There are many operations that are now `being tried. Whether they
are successful or not, I think, is open to speculation. Other techniquus
are certain to come out of the other directed programmatic research.
Mr. CARTER. Some of these transplants are successful, are they not?
Dr. COOPER. Yes, sir.
Mr. Kynos. Doctor, do I take it, then, that even in this field of re-
habilitation of the patient, postcoronary occlusion requires still fur-
ther basic research of all opportunities in other multidisciplinary
fields to let us know what is going on?
Dr. COOPER. Not only to prevent the death, but to understand what
we might do to this damaged organ, which is like a broken arm, but
you can't put a splint on it. We need more knowledge of how to bring
back the metabolism which it needs to produce the contractions
Mr. Kmos. Do you induce myocardial infarction in animals?
Dr. COOPER. Yes, sir. You tie off a vessel.
Mr. KyRos. And you do research in how to save them afterwards?
Dr. COOPER. Yes, sir.
Mr. KYROS. Thank you very much, doctor.
Mr. ROGERS. Dr. Carter?
Mr. CARTER. I was particularly interested in what you said on page
9, `that actually funds had been taken from other programs, as far as
the cancer appropriation is concerned; is that correct?
Dr4 COOPER. What we did here was just to compare-and I gave you
the data-on what has happened to appropriations for other programs
in other institutes. What we are concerned about is that these new
initiatives be add-on programs. We don't think that the level of re-
search support today for all of the institutes is excessive. We don't
believe that we are going to move ahead on the front of all diseases
if we rob Peter to pay Paul.
What h'as actually happened in fiscal 1972 is that although $100
s added in the cancer area, which we fully supported, there
~uate1y corresponding reductions in the support of other
~I programs. These support the basic investigator-initiated
words, the total increase which was given to the NIH did
the $100 million.
What was that total increase? There was an increase.
I was talking about the `administration request. The
Loll request was largely for an increase in the cancer budget
`in other institutes.
Let me go over that appropriation again. The $100 mil-
lion was appropriated for cancer; that is true, isn't it?
Dr. COOPER. Yes, sir.
Mr. CARTER. What about your other appropriations? Were they at
~et t for fiscal 1972,
- ~ fiscal 1971. In
~ed for the cancer
si support requ
PAGENO="0137"
131
program. That means there was a reduction in the other institutes of
some $21 million.
For example, there was a reduction of $491,000 in Divisidn of ~3io-
logics Standards.
Mr. CARTER. You are absolutely positive of what you ar~ stating,
that there was a reducation in what was appropriated for NIH outside
of cancer?
Dr. Coopp~. Yes, sir, what was requested.
Mr. CARTER. I want to be sure of that. And other programs have
been deprived to the extent of $21.4 million?
Dr. COOPER. Yes, sir. That was in the President's request. The Con-
gress appropriated more money. I am talking about the concerns we
have about the kind of allocation of resources and effort that the ad-
ministration has requested. $70 million came out of changes within
the other programs. Now, there were increases in some other insti-
tutes. For example, child health and human development went up al-
most $~~/2 million; the Eye Institute $1.3 million; Environmental
Health Sciences $4 million, and so on. There were some increases in
some of the other institutes besides cancer.
If one examines now the programs within the institutes and the par-
ticular areas in which funds were to be expended, one sees that the'
research and training programs were down; general resear~h sup-
port was down; new and competing research grants across all of the
institutes were down.
Mr. CARTER. Your approach then, to the Institutes of Health was
$20.6 million less, not counting the $100 million?
Dr. COOPER. That was the President's request.
Mr. CARTER. Now, let us see what you said here. "The additional
fund's were provided through the real but hard to perceive reduction
in the regular research grant programs of the, other institutes." That
doesn't `say one thing about the President's request.
Dr. COOPER. I think it comes in the first sentence: "In the President's
budget request last year."
Mr. CARTER. You say the "requests." That doesn't mean a thing,
It is actually the appropriation that counts, what gets to the people.
Let us get down to the appropriations and make it so that it is r
meaningful. Has there been any decrease in the appropriations t ~
National Institutes of Health outside the cancer program?
Dr. COOPER. No, sir.
Mr. CARTER. All right. That is good. Now you are
thing. There has been no decrease, but: Li have inf
is not good to come before the comm~ ~ in sayin~
didn't want to give `it but it was actually ~
Dr. COOPER. Dr. Carter, the reason ~
of our concern that the direction of the' i
stitutes of Health under the present oi~
for those institutes is determined by the s
is not able to direct `how the funds for those particular h
be expended.
The reason we brought this up is evidence c
administration is reducing programs critical to
of basic biomedical knowledge.
PAGENO="0138"
132
Mr. CARTER. I don't deny in some areas they may have diminished
the appropriations. But in others it more than accounts for that, ac-
cording to what you have said. But in certain areas they were
diminished.
Dr. COOPER. We think the Congress showed great wisdom in re-
storing some of these funds that had been cut in the administration's
request.
Mr. BOWSHER. If I might amplify this a minute, I think what you
two are discussing here is a case study of what Dr. Cooper mentioned
at the bottom of page 9 of his prepared statement. We are talking
about the possibility contradictory nature of categorical programs
versus basic investigator-initiated research. What is happening is that
the categorical program for cancer did in fact increase $100 million.
The way they got a good deal of the $100 million increase was to re-
duce support for basic, fundamental research across the entire range
of biomedical science. I think that you `are illustrating what we pointed
out.
Mr. CARTER. I have heard you say that. You and he have gone over
that. Yet you admit the appropriation to NIH outside of the $100
million cancer bill was increased.
Dr. CooPER. Yes, sir; by the Congress.
Mr. ROGERS. I think you are saying that was done by the Congress.
Mr. CARTER. The administration doesn't appropriate the money any-
way; the Congress has to do that.
Mr. Rooms. Are there any other questions?
Thank you so much for being here. We appreciate the testimony.
It is most helpful.
Our next witness is Dr. Samuel M. Fox, president of the American
College of Cardiology.
We are delighted to welcome you, Dr. Fox, and we will be pleased
to receive your statement.
STATEMENT OP DR. SAMUEL M. POX III, PRESIDENT, AMERICAN
COLLEGE OP CARDIOLOGY
Dr. Fox. Thank you, Mr. Chairman and other members of the sub-
committee. It is a privilege and pleasure to appear before you and
to join with you and your colleagues in seeking means to more effec-
tively prevent and control diseases of the heart and circulation, dis-
eases of the lungs, and disorders of the blood.
I have a fairly extensive statement which I will not take time to read
in its full detail.
Mr. ROGERS. We will put it in the record and you may highlight the
points you would like the committee to consider.
Dr. Fox~ I would appreciate that. If I may request your attention
to page 7, I have detailed some recommended areasof needed support
for of the funds for control of these diseases. One of these areas is a
new peripheral vascular disease program. This is not only important
because people are disabled and uncomfortable with disorders of the
circulation in their arms and legs, but because the peripheral circula-
tion also represents a very fertile area in which to study the changes
in the atherosclerotic process, to which other witnesses have testified.
Mr. Knios. May I ask a question about nocturnal leg cramps in the
PAGENO="0139"
133
Ii
respect, as do my
need and would cai
e wish to
trh
do
t mo(
iblood
calf of a leg. I know people my age experience them now. and then, and
perhaps they go away and you may never have them again. Has this to
do with circulatory problems?
Dr. Fox. Some of them are due to circulatory problems. As people
relax in sleep and have a reduction of the circulation with the lower
heart rate and stimulus to heart action, you may get a circulatory in-
sufficiency and get a cramp from that cause. However, I would like
to assure you in the case of many of us in the middle and very produc-
tive years that some of the cramps are not related to circulatory in-
adequacy and are not thereby suggestive of impending further difficul-
ties of a more serious nature. Indeed, there are drugs available, as Dr.
Carter and Dr. Roy, I am sure, have used in their practices, that help
to, or at least tend to, eliminate the occurrence of such crampy pains.
The next item on page 7 is stroke research. We believe we must come
out strongly for the return of the primary stroke preventive research
effort to the National Heart and Lung Institute. Some years ago it
was, indeed, largely in the National Heart Institute. Then at that time,
and without much congressional discussion, the research program on
blindness of that Institute was removed to become the new Eye In-
stitute, perhaps a very well justifies thing, about which I cannot speak
with expertise. At that time there was a movement to put stroke over
in the neurological area.
As you well realize, the prime factor in the background of most
strokes is either high blood pressure, which produces leakage or hemor-
ihage in the brain or brain stem areas or the occlusion of vessels. It i~
a vascular phenomenon. It lends itself to productive blood vessel re-
search and, I believe, cure, through modification of those processes
which produce vascular disease.
Therefore, we do make a strong plea that the prime focus for the
vacular element be in the area of the National Heart and Lung
Institute.
On page 8, stroke rehabilitation research is likewise included as
needing more support. As we have stated in the prepared statement,
there has been really very little research productivity in the 17 centers
under the National Institute of ~euroIogical Diseases and Stroke. The
support of these centers, as I understand it from inquiry, has declined.
There is only $1.3 million of other ~
~. We believe I
stroke r
odore
Cs 1
is a ~
Next there is acute heart attack t
for more of the which is already star
our patients when they shown signs si
attack area.
PAGENO="0140"
need a specific
gets at Dr. Carter's comments
v able to `et out off soi
JIIow~
PAGENO="0141"
B been
lese areas, we r
people b
bid, in
for -
Jtitute b
e recomu
I have
but we have many and var
money.
Mr. ROGERS. This is very h
broken this down in this way.
Dr. Fox. It took Some restraint because I
more into these areas.
Returning, if I may, t
13715 and the Senate J~
following
risome
~ieve t
more
save
~Secretai
~tratively .iii
~~1morec
COmmittee s~.
PAGENO="0142"
136
Sixth, we believe the, authorization should be moved up if, indeed,
it is to have any finite numbers, although I share with others the idea
tl~at appropriate a~ "necessary to do the job" would be more appro-
prikte.
Seventh, there is a rather detailed enumeration why this should be
the case. Time constraints do not permit a detailed review. I think the
percentage formulas should be relaxed or eliminated.
Finally, I wish to make a personal plea of a somewhat different
nature. I do this not as an officer of the American College of Cardi-
ology, but as a private citizen, if I may.
I believe you are as aware, Mr. Chairman, as am I of the many
dedicated men and women in our Government who are serving all our
citizens at considerable personal, family, and financial sacrifice. I am
concerned about how we will be able to maintain the interest of our
present Government employees and to attract the extra talent we need
to move forward with the programs I have just recommended.
Perhaps the most attractive increment that might be considered is
the provision of a meaningful college tuition benefit package for
Government workers. College tuition expenses are rising and, after the
payment of taxes, represent a sizable family budget item. The loss
of tuition benefits is one of those most frequently mentioned as being
a reason for persons not leaving academic life for Government service.
I hope some favorable consideration of this can be given by the ap-
propriate committees of the Congress.
I would be glad to answer any questions, und I very much appreciate
the opportunity to appear before you.
(Dr. Fox's prepared statement follows :~
STATEMENT OF DR. SAMUEL M. Fox, III, PRESIDENT, AMERICAN OOLLEOE OF
CARDIOLOGY
Mr. Chairman and Members of the Subcommittee: I am Samuel M. Fox, III,
President of the five thousand member American College of Cardiology.
It is a privilege and pleasure to appear before you and to join with you and
your colleagues in seeking means to more effectively prevent and control diseases
of the heart and circulation, diseases of the lungs and disorders of the blood.
It is well established that heart disease is the cause of over half the deaths
in the United States each year. It is also well established that many of these
deaths occur prematurely in those in the prime of life-on whom families and
society depend. Close to forty (40) percent of all deaths among persons under age
sixty-five (65) are attributed to diseases of the heart. Much of the same back-
ground of high blood pressure and/or slowly accumulating fatty "atherosclerotic"
material reducing the blood supply to the brain contributes to more than two
hundred thousand (200,000) deaths each year classified as cerebrovascular
disease-commonly called stroke. Heart disease and stroke are the first and third
most frequent causes of death in this country.
The House of Representatives has had a distinguished history of providing
generous support to the heart disease effort-for which we are most thankful.
We are here today to give testimony in support of an even larger and accelerated
effort appropriate to the expectations of our citizens and consonant with our
belief that it will quickly repay the sizeably increased investment proposed.
Although we appreciate the hazards of planning a health strategy by assem-
bling into a "patchwork whole" those individual efforts which command major
attention, we believe special recognition for the needs of heart disease prevention
and control is long overdue. Heart disease, cancer and stroke cause over seventy
(70) percent of deaths in the United States.
We believe the best location for the planning and programming of the national
heart disease prevention and control effort of the Federal Government is within
the National Heart Disease and Lung Institute.
PAGENO="0143"
137
This is not only because of the widely recognized competence of its present
Director, Dr. Theodore Cooper, but because the Institute has earned great respect
for the manner in which it has enlisted the participation of non-Federal persons-
both citizens and professional health workers-in its planning and review pro-
cedures. We therefore endorse the elevation of the National Heart and Lung Insti-
tute to status equivalent to that recently accorded the National Can~er Institute
and support its designation as the coordination point for all Federal heart-related
activities.
There are large numbers of conscientious and dedicated practioners and
planners who have tried to implement the intent of Congress in applying, at the
community level, what is known or thought promising through Regional Medical
Programs. Lack of full support for their efforts and inadequate recognition of the
importance of their work in the specific area of heart disease prevention and con-
trol has discouraged many and frustrated others. A focus of cardiovascular
strategic and tactical planning and programming appears to be the needed ingre-
dient for re-activating this valuable cadre of interested aild dedicated workers~
The Health Services and Medical Health Administration Social and Rehabilita-
tion need increased funding to move forward with their heart related programs,
but we believe the administration of national planning and coordination will be
done best by career professionals using the advice and review of non-Federal
experts-a function with which the Heart and Lung Institute has demonstrated
competence.
With the support of the House, past research has given us much understanding
of the basic nature of many forms of heart, blood vessel, lung and blood diseases.
The leads discovered make all the more important and persuasive the need to
push forward further and faster. Further basic research into the energetics o1~
the heart is necessary if we are to appropriately treat those with disease. The
most powerful approaches to disease prevention and treatment will only become
available with an understanding of the control mechanisms and how they become
deranged.
There are also many unrealized opportunities to develop both fundamental and
practical knowledge concerning the best forms of treatment. The collaborative
efforts of the few Myocardial Infarction Research Units are developing mean-
ingful data on the indications and contra-indications for specific heart attack
therapies. Similar efforts in other areas, as well as more adequate support of
these heart attack studies, would be productive.
A great need exists to evaluate scientifically both the long-term value of and
contraindications relating to the exciting new techniques of coronary by-pass
surgery. Optimistic reports abound and in my own practice I have seen impres-
sive improvement provided my patients by my surgical colleague Dr. Paul Adklns.
However, he, many others, and I are insecure as to when to apply this promising
therapy. With the enthusiasm for this dramatic approach so great It will be ~iffl-
cult to undertake the appropriate evaluations. This very enthusiasm, however,
makes it all the more imperative that such studies be done-done well and done
promptly.
As we advance with fundamental and clinical r ~ on
their management, we must also move forward in Ui
search that suggest effective means for disease preve
After n review of r `i reports the Inter-Sd
Disease Resources has I aerous Co
to contribute to the multi
most frequent diagn - -
Concerning none
effect relationship
munity. The necessary sti
and resources but some of
son for optimism that ai
control of elevated "~
for the reduction of ii
will give us some of tI
on a "Multifactor ~
for getting the a:ii~ - extensive e
more securely.
Six blood lipid centers undertaking some vital new studies hay
recently and perhaps six more will soon start, but even twelve suci
present circumstances of short funding will have great difficulty dev
e yet c
opriat
PAGENO="0144"
138
information required. We need two or three dozen such centers, e~
at a deliberate rate to becomeconiprehensive atherosclerosis research ~
centers of far broader scope. They should be specifically designed to support the
translation of research results into community services as well as continue the
ftirt1u~r research. Likewise, there is a small but struggling high blood pressure re-
search effort following up on the most encouraging work done in the Veteran's
4dministration. In the area of hypertension, we are trying to find answers to
a condition involving over twenty million (20,000,000) individttals in the United
~tates and threatening many more. We are trying to do this with grossly in-
adequate resources.
We must recognize that the work relating to both lipids and blood pressure is
almost exclusively in adults yet it is widely accepted that the start of these dis
orders occurs in the teens or before
A~noz~g other identified coronary risk factors, the contribution of diabetes,
obesity, physical inactivity and psycho-social tension are all amenable to study,
yet almost nothing is now being done to acquire the understanding w~ need of
these factors for developing our total strategy.
Drs. Jeaii Mayer and Frederick Stare of Boston, Dr. Eterman Flellerstein of
Cleveland, Dr. Robert Bruce of Seattle and my colleague, Dr. John Naughton
here at George Washington University have been leaders in exploring the role
of the physically more active life in coronary disease prevention and control.
Preliminary data demonstrate that those persons who have bad a heart attack
return more rapidly to a more satisfying and productive life-of possibly
longer duration-if provided with a carefully prescribed physical re-conditioning
program. This Is also applicable to many de-conditioned ~A~mericans without
myocardial infarets. Yet at this time there is no adequate study being mounted
to define the place of increased habitual physical activity as either preventive or
rehabilitative therapy. This is especially of concern because vigorous physical
activity programs are now being widely endorsed and often pursued by our
citizens without appropriate evaluation and advice and at intensities that can be
catastrophic. In a larger view, such programs command the attention of all of
us and require first-class scientific evaluation because of their great relevance to
our concern with preserving and enhancing general health and stimulating a
more creative, productive and happier society.
Diseases of the peripheral arteries-those to the hands and feet-cause severe
disability and much pain. The use of present measurement techniques, and the
a )lication of bio-pbyslcal and engineering talent to develop new non-invasive
us to evaluate the effects of diet, drugs and changes in
tic intact man without "invading" his
sometimes involve both dis-
is now being supported,
`~-is. There is also grossly
i of new measurement
-or strokes-is considered
th high blood pressure and
~i the brain damage
the desired pri-
therefore believe
?valuat
acciden
isease-wi
ated.
edge 1
Ll prevention a
in our communities that which holds promise we must evaluate
diffi roaches. their benefits and their costs. There is great need to
evaluate various models of Prevention Clinics, Community Cardiovascular Con-
trol Centers and other such attractive concepts to provide valid data for wide
implementation of the best activities.
PAGENO="0145"
139
There is great enthusiasm in many areas concerning early coronar~v care and
other emergency services outslde-before admission-to the hospital. Programs
in Seattle, San Francisco, Columbus, Miami and our neighboring MontgOme~y
County, Maryland demonstrate that an effective service can be provided-yet many
of these programs are faltering or being discontinued because funds to tra~n and
support the personnel are lacking. It has been ~alculated that at least thirty~-
five thousand (35,000) premature cardiac d~atb5 could be pi~vented each year
if we only applied what we presently know in the way of good emergency care.
The training of personnel at all levels requires eithanced aid. Particularly,
we need to train persons at all professional levels of expertise to operate the
Prevention Clinics and other community prdgrams. We also must have con-
sistency in program planning or we will lose those we train for research or
community service into other areas. Sporadic support of training will continue
to impose damaging delays in program effectiveness unless corrected, New
authority for the Heart and Lung Institute must also include enhanced training
opportunities to permit the adequate translation of knowledge into service.
Likewise, along with a rejuvenated Control Program effort must be a parallel
professional and public education and information program far above the
restricted effort now In effect.
There are many other examples we could give of attractive Or well pro~efl
programs and opportunities which need accelerated Implementation and suppqrt.
Part of this support must be in the area of facilities construction and mainte-
nance in addition to the support of personnel and supplies. Laboratory and
clinic space is often not available where men with bright ideas or a deep com-
mitment to the provision of needed services are ready and eager to work.
There will also be the necessity to give the strengthened Heart and Lung
Institute the ahility to attract top level talent to join the staff in the new planning
and programming efforts. Competition here is keen and appropriate inducements
must be available.
We applaud the recognition by this Subcommittee of these needs for Increased
heart disease prevention and control. We support the Subcommittee's efforts to
provide protection against and care for the disability ançl distress that plague
our patients, friends and families in the form of diseases of the heart, blood
vessels, lungs and blood.
Last week, on the 21st of April 1972, the College of Cardiology presented its
recommendations for FY 73 appropriation increments above the President's
Budget for the National Heart and Lung Institute. We made specific and, we
believe, highly justified proposals for programs above the level that would be
permitted by the FY 73 Administration Budget of 254 million dollars. Our pro-
grams would require approximately one hundred million dollars of additional
support just to initiate programs of the highest priority. Clearly a major in-
crease in the entire Heart and Lung Institute program and staff is in order,
We repeat the same list In our testimony today to demonstrate the specific
nature of the opportunities and to make certain that no one carries away the
impression that we are calling for authority and funding without a clear pro-
gram that justifies our citizens' investment in it.
The opportunities are presented in the order of cardiovascular prevention, care
and rehabilitation rather than in the order of their scientific importance or
urgency.
PERIPHERAL VASCULAR DISEASE
One of the areas of greatest neglect is the study of the peripheral arteries in
the arms and legs in which the atherosclerotic process can be evaluated by new
techniques. This year there is less than three quarters of a million dollars worth
of support available for this important research.
In the area of venous disease there is also a great need fOr stimulating
research above the almost invisible effort now being supported. We recommend
one half million dollars ($500,000) be made available specifically to develop in-
strumentation for the detection ~and more adequate management of thrombo-
phlebitis-the abnormal clotting of venous blood which occurs far more fre-
quently than is generally appreciated. The often lethal breaking loqse of frag-
ments from such clots requires major diagnostic a"l treatment p-~--~ -i develop-
ment. Encouraging reports of new instrumental ~ ---~----~- -`---. ~----
We therefore recommend a new peripheral ~
73 with four parts.
78-994-72-10 S
PAGENO="0146"
140
Miltiein~
1. Three to five Peripheral Vascular Research and Development Centers
with initial support of five hundred thousand dollars ($500,000) for
each center $2. 5
2. Support for Special Academic Awards to stimulate research personnel
and program design 0.3
3. Epidemiologic and research project activities 1. 0
4. Throrobophiebitis detection and therapy 0.5
Total 4. 3
STROKE RESEARCH
Closely related to peripheral vascular disease-and with exceedingly serious
manifesthtions-is the area of cerebral vascular disease. Either hemorrhage or
blockage of the vessels to the head and brain can prodace blindness or a stroke
with major resulting disability or death. Over two million victims of stroke are
alive in the United States and over two hundred thousand (200,000) persons
die of strokes each year.
Upon inquiry we find, however, that the National Institute of Neurological
Disease and Stroke supports only seventeen (17) stroke research centers with
only 3.7 million dollars and that the Institute has only 1.3 million dollars of other
research being supported by grants. Five million dollars ($5,000,000) of research
for a disease from which two million (2.000,000) Americans suffer! The causes
of almost all strokes are vascular-not neurologic-even though brain and nerve
damage are the dreaded results.
On March 24, 1972, we made a strong plea to the Senate Subcommittee on
Health of the Committee on Labor and Public Welfare that the major research
responsibilities relating to stroke prevention and control be returned to the
National Heart and Lung Institute from which they were moved without much
Congressional discussion some years ago. Today we repeat the request that the
responsibilities for stroke be returned to the National Heart and Lung Institute
and recommend an immediate increment of research support in the following
areas:
Millions
1. Clinical trials of platelet anti-aggregants $0.6
2. Diagnostic instrumental research and development 1.0
3. Stroke rehabilitation research 2.0
Total increment for stroke 3.6
CLINICAL TRIALS OF ATHEROSCLEROSIS PREVENTION
Of paramount importance is the need to pursue at a more rapid and adequate
level the many clinical trials having to do with the prevention of atherosclerosis-
the process of fatty deposition that reduces the blood carrying capacity of arteries
and predisposes to an acute occlusion, or total blockage, of the coronary or cere-
bral vessels producing a heart attack or stroke. In the search for the causes of
atherosrierosis and its manifestations there has been major progress in the last
twenty years-much of it made possible through Congressional support.
It is highly desirable that we evaluate the concept of risk reduction in relation
to the prevention of coronary and other atherosclerotic manifestations. In the
budget document we have reviewed, the fiscal increment requested by the adminis-
tration will not suffice to support adequately even the early start we are happy
to see being projected for community studies this year. It is most essential that
these large and very demending community trials be done correctly for an inade-
quate trial would leave false impressions more damaging than having not
attempted the research in the first place. We believe it is imperative to expand
the support of these trials to help assure that the information derived is not of
questionable statistical significance.
Three "Major Risk Factors" have been identified: High Blood Pressure, Ele-
vated Blood Fat Levels and the Smoking of Cigarettes. Controlled clinical trials
are mandatory because proof that risk factor reduction will prevent coronary
disease has not been established.
1. Hypertension detection and control in the comnwnity.-We recommend an
additional one and a half million dollars ($1,500,000) above the requested support
which will permit the addition of six more research clinics each to be funded at
PAGENO="0147"
141
two hundred and fifty thousand dollars per year. These will provide the more
rapid and secure accumulation of data than will be available with the hine clinics
currently under development.
2. Diet and drwq therapij of hitjh serum lipid levels-For the study of th~ type
disorders producing elevated blood fats and for the recruitment of study subjects
for specific dietary and drug trials, we recommend the addition of six more clinics
to be funded at six hundred thousand dollars ($600,000) each~-a total of 3.6
million dollars. This is in addition to twelve clinics already started or projected
and budgeted at nine million dollars ($9,000,000).
3. Multi-factor study.-We are particularly persuaded that it will be necessary
to create and support ten to fourteen additional clinics at a toUil cost of three
and a half million dollars ($3,500,000) in the first year (FY 73) to screen, evalu-
ate, select, and recruit the eleven thousand (11,000) participants in the multi-
factor trials ~rho will be randomly allocated into treatment and control groups.
We believe it unrealistic to think the presently projected six clinics with onl~r two
and a half million dollars ($2,500,000) can undertake this formidable tasl~ of
evaluating control of hypertension, elevated serum lipids and the cigarette habit.
Budget summary of additional support for clinical trials. Millions
Hypertension detection and control in the community $1.5
Lipid centers 3.6
Multifactor trials 3.5
Totnl -- 8.6
These three studies are those recommended by the NHLI Task Force on Athero-
sclerosis as being urgently needed and promising of results that relate to the
cause of eighty percent (80%) of all cardiovascular deaths under the age of sixty-
five years.
ACUTE HEART ATTACK TREATMENT RESEARCH
In the therapy of those with acute heart attacks we have seen most encouraging
results reported with the administration of thrombolytic agents-those that dis-
solve elements in blood clots. A three year trial of these agents is recommended
with five to six thousand (5,000-6,000) patients under a randomized treatment
and control allocation. A first year cost of three and a half million dollars
($3,500,000) is requested.
Two other acute care efforts command our support:
1. Pharmacologic and instrumental approaches to the support of the severely
damaged heart show encouraging results. The administration of glucose, insulin,
potassium and the enzyme hyaluronidase needs study as do the metabolic inter-
mediary substances fumarate, malate and glutamate.
2. New and improved devices for work sparing circulatory "counterpulsation,"
both within the body and applied externally, need evaluation as do the instru-
ments developed for observing and controlling their application.
A FY 73 inCrement of two million dollars ($2,000,000) is appropriate-and
indeed will only just start the necessary further development.
Up to sixty percent (60%) of acute coronary deaths occur outside hospitals
involving over one hundred and fifty thousand (150,000) United States' citizens
under age sixty-five each year. Many of these catastrophies are thought to be
the result of acute changes in the electrical stimulus to thO heart from that which
produces effective mechanical contraction to that which produces chaos. No
adequate trial has been undertaken of some of the presently available drugs that
appear to have application in these conditions-and new agents are being devel-
oped both here and abroad. Another one million dollar ($1,000,000) add-on is
recommended for anti-dysrhythmic trials to be started.
CORONARY CARE INSTRUMENTATION IMPROVEMENT
Coronary Care Units have resulted in the reduction of in-hospital coronary
mortality from around thirty percent to the mid-teens-almost half. Numerous
attempts to operate mobile coronary care services have been started with some
very encouraging results. The personnel involved in all these efforts r
instrumental and computer support that our space technology L
not yet fully applied to acute medical care. There is a particular
ably-priced systems of continuous surveillance and data analys~
cardiogram from the time the patient can first be seen to ~ t
demonstrated he is in a status of acceptably low risk
PAGENO="0148"
or t.
monL~
A great need exists to evaluate a tifleally I long-term value of and
contraindications relating to the exciting new techniques of coronary by-pass
surgery. Optimistic reports abound and in my own practice I have seen impressive
improvement provided my patients by my surgical colleague Dr. Paul Adkins.
However, he, many others, and I are insecure as to when to apply this promising
therapy. With the enthusiasm for this dramatic approach so great it will be
difficult to undertake the appropi~iate evaluations. This very enthusiasm, how-
ever, makes it all the more imperative that such studies be done-done well and
done promptly.
We recommend four million dollars ($4,000,000) for FY 73 to initiate a con-
trolled trial of coronary by-pass surgery.
In the new bills upgrading the National Heart and Lung Institute (S. 3323
supported by the administration, all citizen and organizational witnesses and
already passed, and those of similar intent in the House) provision is made
for" . . . fifteen new centers for basic and clinical research into, training in, and
demonstration ~f advanced diagnostic and treatment methods (including emer-
gency medical services) for cardiovascular diseases."
Each of these centers are projected at a level up. to five million dollars
($5,000,000) and thus some significant part of seventy-five million dollars ($75,-
000,000) is needed~-perhaps a first year (FY 73) fundipg level of thirty-six million
dollars ($36,000,000) would be appropriate.
one million dollars
including a new
dollars ($20,000,000) for
make possible the many
y described.
REHABILITATION OF CORONARY PATIENTS
Many encouraging reports of the benefits of physical and psychological re-
habilitation after a heart attack have been reported but no well-controlled studies
of sufficient size and duration have been started.
New Instruments of measurement would enhance the scientific validity of
such studies-instruments both physiologic and psycibologic in application. Such
studies should have major importance in our broad efforts to create a more
productive, creative and happier society as well as one in which patients can
recover their ability to work and live more actively with lesser hazard.
The American Odlege of Cardiology supports the urgency of such studies in
rehabilitation and requests that two million dollars ($2,000,000) be provided for
thh~ purpose in FY73.
Pbe Social and Rehabilitation Service and its system of Research and Training
Centers has made plans for such research but without adequate funding being
assured. We do not feel it is our place to specify the administrative base for such
studies hut we do welcome the opportunity to urge that they be done promptly
and with the best of sci~ntiflc talent and technique.
NEW CENTERS
Construction f -
- v well-i
CONSTRUCTION OF FACILITIES
1 if we are to move ahead with these programs.
or c'~ - service teams cannot expand their
-- space is provided to conduct clinical
eseareh."
~ramsp
MODEL PREVENTION CLINIC EVALUATIONS
Much research is needed to delineate the control mechanisms that are dis-
rupted as disease replaces health. While we learn how to help protect against the
PAGENO="0149"
143
developtuent of disease at the level of basic mechanisms ~ve must also learn how
to develop systems for disease prevention, detection, therapy arid rehabilitation
that will attract and hoh~ people's interest. The College recommends the establish-
inent of teu (10) mOdel ~li~ies in various parts of the country with eight million
dollars ($8,000,000) of FY 73 support. Careful evaluation of differing approacheS
tailored to local styles of life ave an essential part of this effort.
TRAINING OF PERSONNEL
In the area of training we wish to emphasize our continuing concern about
diminishing support for the creation of competent research and service personnel
during a time of increased appreciation of the needs of heart disease prevention
and control.
It is inconsistent with good sense to try to do an increased amount and more
technically demanding types of research and community service without in-
creasing training program support. We recommend two million dollars ($2,000,-
000) be provided in FY 73 to start new heart disease training programs involving
nutritionists, health educators, pliy~icai educators and others as well as
physicians.
PROFESSIONAL AND LAY EDUCATION
Finally, there is a tremendous need fo~ an expanded prog~ax~t for professional
and lay education concerning what is established fact or considered valuable in-
formation. There is no imw money in the President's budget request and the
present National Heart and Lung Institute expenditure in this area is only
three hundred thousand dollars ($300,000). To expand present functions and
support research into improved techniques for learning we recommend four
million dollars ($4,000,000).
Recommended ivudget additions above the admin/istralion's request of $354
million for fiscal year 1973 for the National Heart and Lung Institute
Millions
Peripheral vascular disease - $4. 3
Stroke 3. 6
Clinical trials of atherosclerosis prevention 8. 41
Acute heart attack treatment 5. 5
Anti-dysrhythmia trials 1. 0
Coronary care instrumentation 3. 0
Surgical research 4. 0
Coronary rehabilitation 2.-0
New centers 30. 0
Construction of facilities 20. 0
Model prevention clinics 8. 0
Personnel training 2. 0
Professional and lay education 2. 0
Total 100,0
Returning, if we may, to some specific aspects of your bill }J.R. 13715 and
the Senate Bill 5. 3323 I would like to make the following suggestions:
First, we are impressed with the statement of Dr. Huntley, Director of the
Division of Emergency Health Services of the Health Services and Mental
Health Administration at the Second Annual Meeting on Emergency Medical
Services, December 12, 1971, concerning the unmet needs in ambulance and
emergency care. He stated that thirty-five thousand (35,000) of the sinty thou-
sand (60,000) American lives that could potentially be saved by a truly modern
ambulance-emergency care system would be acute cardiac patients. We made a
specific point of this opportunity in our testimony before the Senate S~bcom-
inittee on Health and are gratified that under Sec. 2, Item 7, of the 5. 3323
there is a statement on "the provision of prompt and effective emergency medical
services utilizing to the fullest extent possible, advances in transpertation and
communications and other electronic systems and specially tralbed professional
and paraprofessional health care personnel " We believe this is worthy
of inclusion and recommend it for Congressional actiun, perhaps as in S, 3323
under Section 413 (a) sections 5 and 10, Section 414 (a), (b), (d) and Section
415 (a) (2).
PAGENO="0150"
144
Secoud, we strongly recommend that ten Model Carviovascu~ar Disease Pre-
vention Clinics be established as part of the expanded control program function
of the Heart and Lung Institute ( Section 414) and that increased appropriations
of thirty million dollars ($30,000,000) for the fiscal year ending June 30, 1973,
forty million dollars ($40,000,000) for the fiscal year ending June 30, 1974, and
fifty million dollars ($50,000,000) for the fiscal year ending June 30, 1975, be
authorized-and at the appropriate time and place be appropriated-for these
centers and other control program functions.
Third, we believe that it would be preferable to have the Interagency Tech-
nical Committee and Office ef Heart and Lung Health Education located within
the National Heart and Lung Institute rather than within the Office of the
Secretary as implied in Section 416 (a) of S. 3323. As presented in our written
statement I am so impressed with the competence, knowledge and dedication of
Di. Theodore Cooper and his staff to the larger national cause that I believe
we would find more effective performance of this important function if such a
coordination and stimulation role was geographically, physically and admin-
istratively within the Institute rather than within a loose and ever-expanding
group of such Technical Committees within the Office of the Secretary.
That some "neutral" ground has some points of appeal is recognized-but
in this specific case I believe other considerations are more persuasive. We are
particularly desirous of seeing the Office of Heart and Lung Education (Section
416 (c)) established within the Institute so that the superb talent of the inves-
tigative and administrative staff are most conveniently available to insure the
most valid presentation of educational communications.
Fourth, we believe that of the eighteen members to be appointed by the Seére-
tary to the National Heart and Lung Advisory Council (Section 417 (a) (2))
not more than twelve of the appointed members of the Council shall be leading
medical or scientific authorities who are skilled in the sciences relating to dis-
ease of the heart, blood vessels, lungs, and blood, and not more than eight of the
appointed members shall be representatives of the general public. We see no need
for students on this Council with its complex and demanding responsibilities.
Fifth, we believe that the Director of the National Heart and Lung Institute
should be designated the Ohairman of the Council (Section 417 (c)) rather
than a member of the Council. We understand the importance of having the
Council serve as an outside review group not only concerning the present and
anticipated responsibilities of the National Heart and Lung Institute but also
to consider future opportunities of all sorts. We believed, however that there
is so much of importance that the Council must consider that even four (4)
meetings a year, of perhaps three (3) days each, will require management
demands and scheduling of a type that may place too heavy a burden on an
outside Council member. We therefore propose that the Director be designated
Chairman, that a Council member be designated Co-Chairman and that this
same Council member be the Chairman of the National Heart and Lung Advisory
Council Planning Committee-a well-established committee function that has
worked well in Heart Institute functions of the past.
Sixth, we strongly recommend increasing the authorization of funds to four
hundred and fifty million dollars ($450,000,000) for the fiscal year ending June
30, 1973, five hundred million dollars ($500,000,000) for the fiscal year ending
June 30, 1974, and five hundred and fifty million dollars ($550000000) for the
fiscal year ending June 30, 1975 (Section 419 B).
Seventh, under Section 419 B and C of Senate Bill 3323 there is a potential
problem. If a maximum of only sixty percent (60%) of the Heart and Lung
Institute appropriation can be allocated to cardiovascular disease program with
a possible extra ten percent (10%) as authorized in Section 419 we might find
ourselves limited in the ability to initiate new cardiovascular progrsms. Under
these circumstances we would have but two hundred and forty million ($240,000,-
000) cardiovascular dollars (60% of $400,000,000) available for FY 73 under
5. 3323 (possibly with 10% or $40,000,000 more using the 10%) or $210,000,000
of $350,000,000 if the same 60% formula was applied to HR 13715 for FY
1973. In the written statement presented we have proposed one hundred million
dollars $100000,000) worth of new-highly justified-programs that we believe
~ ould bring prompt returns This hundred million added to a projected FY 73
President s Budget proposed program of one hundred and ninety four million
dollars for cardiovascular disease ($254000000 minus $30000000 each for mug
and Blood Programs) would give two hundred and ninety four million dollars
($294 000 000) of valuable cardiovasculai program for FY 1973 yet at most we
PAGENO="0151"
145
may be suthorized two hundred and eighty million dollars ($280,000,000) includ-
ing the ten percent (10%).
We suggest that the percentage formulas be relaxed or eliminated and that
the authorization figures be expanded above those of S. 3323. This would permit
the Institute to take advantage of the best of all opportunities.
I will be glad to try to answer any questions you have and wish to again express
my appreciation and that of the College of Cardiology for this opportunity to
speak concerning this important and beneficial legislation. Thank you.
Mr. ROGERS. We appreciate your patience with the committee today.
We had a lot of questions to go into with the administration. I think
your testimony in such detail will be helpful.
Dr. Fox. Would you like me to try to get back at 2:30 for questions?
Mr. ROGERS. I think it would be better to go over in detail the ques-
tions and tihen get back to you.
The committee stands adjourned until 2:30 this afternoon.
(Whereupon, at 12:30 p.m. the subcommittee recessed, to reconvene
at 2:30 the same day.)
AFTER RECESS
(The subcommittee reconvened at 2:30 p.m., Hon. Paul G. Rogers
presiding.)
Mr. ROGERS. The subcommittee will come to order.
I was anxious to know what the regional medical program really is
doing in the heart and lung field. Are they doing much in heart and
lung?
STATEMENTS OP DR. JOHN S. ZAPP, DEPUTY ASSISTANT SECRE-
TARY FOR LEGISLATION (HEALTH), DEPARTMENT OP HEALTg,
EDUCATION, AND WELFARE, AND DR. THEODORE COOPER, DI-
RECTOR, NATIONAL HEART AND LUI4'~G INSTITUTE, NATIONAL
INSTITUTES OP HEALTH, DHEW-Resunied
Dr. ZAPP. I would have to, as Dr. DuVal did this morning, submit
for the record a list of these.
Mr. ROGERS. I think we need to know that.
(The following material was received for the record:)
REGIoN~ MEDIcAL PROrn~AMS: AcTIvITIEs IN HEART AND LUNG P-~
Listed below are some 130 operational projects that relate direc
and lung disease currently supported with RMP grant funds. ~
$9 million, and account for roughly 22 percent of the RMP fund
granted for operational projects.
This listing does not reflect either (1) operational projects of a mul
or comprehensive character or (2) those activities carried out by
staffs of the 56 Regional Medical Programs. Many of t~"~' ~"
projects and activities are also relevant for heart ai
example, an operational project designed to result in imp]
services will benefit acute coronary attack victims as well as
automobile accidents Similarly a survey and fea ly con
program staff of a RMP which seeks to ii_ feve~
grams for that Region's Indian population ma: -
treatment of this ailment and yet never require
Therefore, the listing below very possibly under~
tivity and grant investment in "the heart and lung fiel
As a simple listing of projects it also fails to r
is actually being done.
A one-line entry, "Oklahoma-Coronary Care Mon
Transmission-$174,000," cannot begin to relate that
PAGENO="0152"
1'~w
monitoring services comparable to those available in large urban bos~~
being introduced into Oklahoma's small cor~ipiunity and rural hospitals ~, a
result of a state-wide coronary care program initiated by the Oklahoma regional
medical' program. As a result, 43 monitor equipped beds for heart attack victims,
or attack-threatened patients, in 29 small community hospitals have been linked
by special telephone lines to 10 central monitoring hospitals (CMU's).
This program has been described by the University of Oklahoma cardiologist
directing it as "a boon for small rural hospitals which cannot afford the services
of the highly trained personnel required to operate an independent coronary
care unit."
Specially trained nurses in the central monitoring units help monitor remote
patients, and when an abnormally is detected confer with local staffs by tele-
phone hotlines. The importance of immediate coronar~V cdi~e stems from the fact
that most heart attack victims who die, do so within the first few hours.
The general hospital mortality rate from acute coronaries (myocardial infarc-
tIon) is about 30 percent. With coronary care units, this is usually reduced 15 to
20 percent. An October 1970 survey of Oklahoma hospitals by the project staff
sI~owed that 46 percent of that State's hospitals with 50 beds or less had no
facilities for coronary care, and 33 percent of hospitals with 51 to 150 beds had
none. Besides training for nurses, the project also provides continuing education
and training for physicians and paramedical personnel, including preparation of
coronary care technicians.
Nor does this listing of present activities begin to convey the dimensions of the
still unmet needs, which are staggering, or the real contribution RMP could make
in this connection. Many of the individual projects listed below are reflections of
need, the need for the major control programs and activities such as the early
detection and management of hypertension, rheumatic fever sèreening and pre-
vention, and the diagnosis and treatment of chronic respiratory and pulmonary
diseases.
Major new control activities of this kind could be mounted both through
regular grants to the 56 liMPs and by using the existing authority under Section
910(a) (2) to make grants to a wide range of public and private nonprofit agencies
and institutions (e.g., health departments, hospitals) for the "development, trial,
and demonstration of methods for control of heart disease ~ * *~
Current Heart Disease Projects in Regional Medical Programs
Region and project
T. Hypertension:
Metropolitan Washington, D.C.: Establishment of selected hyper- Funding
tension clinics $36, 700
Intermountaii : Curable hypertension Identification 112, 100
Mississi - - pertension. control demonstration for aged,. dis-
11, 617
~l pressure control, early screening for stroke 160, 200
-~ for Improved control of hVpertension_ 113, 559
Center, demonstration hypertension___ 84, 300
total 518, 476
r and/or congential heart disease:
detection of heart disease 4 300
MIssouri: School heart screening by phonocardioscan 18, 000
North Carolina: Comprehensive rheumatic fever prevention pro-
gram `38, 827
Northeastern Ohio: Strep culture program 225, 941
Category total 287,068
III. Heart disease:
Alabama: Continuing nurses education, mobile coronary care
unit 15,900
Albany: Coronary care training program 8,879
Arizona: Cardiopulmonary resuscitation training program 29,273
Arkansas:
Coronary care training for nurses 32, 522
Cardiac rehabilitation 28,917
Bi-State: Coronary care training program for nurses 67, 116
PAGENO="0153"
147
Region and project
III. Heart disease-Continued
California: FundMtg
Coronary care $80,149
Pacemaker'registry 67, 841
Per~atal monitoring 89,450
Rapid hospital myocardial infarction 55, 895
Metropolitan Washington, D.C.:
Establish central peripheral vascular facility 4,900
Coronary care nurses training. Freedmen's Hospital 7, 300
Regional exercise stress testing services 61, 600
Florida:
Regional computerized EKG processing center 36, 900
Coronary care data collection 38,400
Cardiovascular screening in four rural Florida counties. 121, 600
Supervisory paramedical emergency teams 7,100
Coronary care nurses training in 7 hospitals 8,, 400
Georgia: Cardiovascular area facilities 100,000
Greater Delaware Valley:
Coronary care training, northeast Pennsylvania 50, 600
Coronary care training, east central Pennsylvania 48, 700
Coronary care training, Delaware 49, 100'
Coronary care training 25. 000
Do 25, 000
Hawaii: Physiological data monitoring system 54,246
Illinois: Multipbasic screen 208, 800
Indiana:
Network of conorary care units throughout Indiana 149, 471
Nursing incoronary care units 31, 896
Intermountain:
Physicians cardiovascular training project 101, 100
Nurses training in cardiac resuscitation 95, 200
Clinical cardiology training 64, 100
Community cardiovascular review 117, 000
Regional myocardial infarction data system 193, 700
Iowa:
Coronary care training for physicians 3, 6&)
Clinical associate training in pediatric cardiology 60, 272
Mobile coronary care unit 34, 595,
Cardiac ausculation cardio examination of children 15, 220
Kansas: Cardiac care ` 15,460
Lake area: Coronary care training for nurses 50, 800
Louisiana: Cardiopulmonary resuscitation progrttm 42, 154
Maine:
Coronary care 39, Q03
Coronary care 38, 408
Maryland:
Early detection of heart disease in newborns 12, 1QO
Coronary care program 95,300
Closed chest cardiopulmonary resuscitation - 37, 300
Memphis:
Intensive cardiopulmonary care training 93, 9~9
Strep center 38; 057
Electrocardiographic program 20, 195
Coronary care unit, St. Bernards Hospital 10, 838
North Mississippi cardiovascular clinics 29, 934
Michigan:
Cardiovascular center 21, 324
Western Michigan medical education 39, 340
Mississippi:
Cardiovascular clinics for indigents consultant continuing
education
Coordinated system in coronary care unit hospital training_
PAGENO="0154"
148
Region and project
III. Heart disease-Continued
Mi~souri: Funding
Training unit for intensive care of cardiac patients $25, 800
Intensive care unit pulmonary function laboratory 64,400
Cardiovascular education evaluation, Springfield 65, 000
Cardiac care in Missouri 50, 000
Intensive care rehabilitation project 20, 000
Mountain States: Intensive care unit training in Southwest Idaho 20, 800
Nebraska: Coronary care training 141, 800
New Jersey:
Statewide program for cardiopulmonary resuscitation in
Community Hospital 25, 700
Evaluation status of Beth Israel Hospital pacemakers 69,500
Decentralized RN-LPN cardiac care training 34, 300
New Mexico:
Model cardiac care unit 22, 461
Coronary care nurses training program 6, 384
Monitoring remote coronary care unit project 22, 518
North Carolina:
Coronary care training and development 42, 635
Close chest cardiopulmonary resuscitation 43, 954
Heart sounds screening program 16, 676
Comprehensive cardiac pacemaker education program 32, 819
Coronary care training course for nurses 8, 742
Northeastern Ohio: Coronary care unit training 150, 759
Northern New England: Progressive coronary care program 159, 339
Northlands:
Multidisciplinary myocardial infarction medical ca~e_ 158~ 600
Pediatric cardiology education~ 20, 300
Ohio:
Intensive cardiac care training 327, 623
Coronary care nurses training.. 78, 686
Sudden death mobile coronary care 138, 152
Oklahoma: Coronary care monitoring network ERG transmission 174, 900
Oregoii:
Coronary care training in Salem Memorial Hospital 54, 900
Coronary care training in Sacred Heart Nursing Academy~ 61, 400
Nurses education in rapid EKG consultation 27, 300
Coronary care teaching aids library, ERG tapes 900
Physicians in-residence course in techniques of cardiology_. 42, 400
Puerto Rico:
Pediatric cardiovascular diseases 146,600
Education and training program for physicians and nurses in
intensive care unit for cardiac patients ____ 88, 700
Rochester:
Cardiovascular nursing 42, 508
Telephone ERG consultation 5, 029
South Carolina:
Training coronary care nurses 61, 043
Comprehensive care of heart disease in children and infants~ 97, 009
Comprehensive coronary care unit 31,493
South Dakota: Coronary care training 132, 300
Susquehamia Valley:
Coronary care nurses training 19, 000
Nurses training coronary care unit program 14, 500
Tennessee mid-south: Cardiac screening of schoolchildren 22,478
Training program in eardlo pulmonary resuscitation 22, 639
Coronary care unit holding units 27, 124
Virginia:
Myocardial infraction training program 96, 100
Coronary care evaluation 39,200
Western Pennsylvania:
Regional education program for nurses 137, 100
Regional training program for hospital emergency teams
in cardio pulmonary resuscitation 33, 300
Category total 6, 083, 632
PAGENO="0155"
149
Region and project
IV. Pulmonary disease:
Arizona: Chronic pulmonary disease program for Arizona___ $116, 230
California:
Chronic respiratory disease 97, 744
Comprehensive respiratory disease 91, 635
Metropolitan Washington, D.C.: Comprehensive pulmonary
training for physicians, nurses, and technicians 14, 800
Greater Delaware Valley:
Chronic pediatric pulmonary disease 161, 600
Respiratory care centers 64, 700
Renal disease patient support 33, 700
Indiana: Chronic pulmonary disease 4, 693
Intermountain: Chronic respiratory disease 92, 200
Lakes Area: Chronic respiratory rehabilitation training 620, 900
Mississippi: Training in diagnosis and treatment of Chronic
pulmonary disease 137,988
Mountain States: Continuing education in inhalation therapy
in respiratory care - ~5, 800
North Carolina: North Carolina emphysema and lung disease
program 60,000
Oklahoma: Regional emphysema 65, 500
Puerto Rico: Pediatric pulmonary disease center 120, 000
South Carolina: Comprehensive respiratory disease training
statewide 17, 597
Texas: Inhalation therapy 29, 175
Western Pennsylvania: Emphysema and pulmonary disease~ 18, 000
Category total 1, 762, 262
Mr. ROGERS. I think we need to know what the regional program
that is developed in the line of heart research as well as services.
Dr. ZAPP. The regional medical program
Mr. ROGERS. Yes.
I)r. ZAEP. I might say, Mr. Chairman, I think our position is, maybe
not that it is effectively doing as we would like to see it, but what we
would like to see is that once the National Institutes of Health have
proven a particular method for application, the regional medical pro-
grams be used as a vehicle to transfer those methods into the field with
their relationship between the academic centers and the practicing
profession, and at that time that we use various existing or proposed
third-party payment mechanisms to pay for the services.
But there is at many times a blurred line I.
an institute has been working on a particular rcs~
that it has to that particular proven point and such 1
odology is defined enough so it can be transferred to the
profession.
Mr. ROGERS. How quickly do you think these centers
lished that we included in the legislation?
Dr. COOPER. We have centers program exporience~ Mr. ~-
They are not centers quite as large as the ones envis 1
tion, but I think the time period that is iequi
months in order to get out an announcement. to allow a snitabli
for competition and review
Mr. ROGERS. I presume you would also try to
geographically.
Dr. COOPER. We have 1 ... .1 ~. ~11 the r~
excellence as the primary
ondary, and then location f. gei~eral av&~ -
third.
PAGENO="0156"
to c
oe S~(
)ut 10 percent,
op~ ~~xis ~ ~~mural progran
ception of the management requiremer
on grant mechanisms.
Mr. RoGERs. How long does it take to approve a grant and how long
does it take to approve a contract as an average?
Dr. Coori~ii. The average time of submission depends, in part, upon
the time of the year, but, in general, it takes between 6 and 9 months
on a grant application in order to undergo submissions classifications,
study, revjew, and referral to council and award.
In the contract area this, in some cases, is just as long. In other cases,
depending on the nature of the request, it can be somewhat more rapid,
because the nature of the proposals is more limited, the competition is
more limited~ and the review process, although it involves two leve]s,
can be accomplished with greater rapidity.
Mr. ROGERS. Where does HEW have to approve in the process of
grants and contracts?
Dr. CooPER. In the grant area, as I am sure has been established
since the initial legislation, the primary responsibility for recommend-
ing grant ~tpproval is a statutory function of the Council. The re-
~ponsibility of the Department, therefore, is limited to determining
whether the awards are appropriate within the fiscal constraints that
are currently available within the funding plan. They do not make a
determination whether they are recommended for approval or not, but
they do influence the procedure in determining the amounts of funds
that are available for the total system.
In the contracting area, a similar surveillance is employed, and in
some large contracts I believe it is the function of the Department
from time to time to review particularly the large contracting activities
prior to award.
Mr. ROGERS. In those contracts what is the time element, the ones
~ have to have departmental approval?
COOPER. It does not exceed 9 months if it involves that procedure.
E~ERS. I understand that sometimes it is very difficult to get
ital a val on equipment or a new facility where it s
new s to can v on reseai cli pi ojects What about that ~
I that in your Institute, too?
~ have not had a large experience in the contracting
es construction, because we have largely limited our con-
~ operation to support of direct research operations and have
r operations sui~orted construction of facilities to any large
t type of problem.
uk we can set up proper screening programs
y.
possible to set up appropriate screening
~rain of followthrough to go beyond it.
~ a very accomplishable goal?
.Eic abnormalities.
those for the record?
rmation was supplied for the record:)
PAGENO="0157"
s for
tory p
~g are needed. ~
~ disease are now bei
~ heaLth screening or
Answer Screeni
Populations with t.
have interests In
Screeni progr~
organjz~ d to e~
enCour - parti
An
13. LUNG SORRi
The feasibility of
demc,nstraited in
tuberculosis and C
~ASIBIL~Y 01
nslderable ~
A. IJEAnT SCREENING
can c
be intended.
~e$ and whjoh synjptom,~, would lend then
creening proC
urement of blo
Logran~ would
- h may
c medicalev
be needed f~,,
S found
of any
PAGENO="0158"
152
d~en, a more specialized area, screening for cystic fibrosis has also been success-
ful. Screening for other lung diseases on a mass-scale may be done also, but in
this case its advisability is subject to special considerations such as relative
frequency of the conditions in a givefk population, reliability and cost of screen-
ing methods, etc.
At the present time, chronic obstructive pulmonary diseases provide the best
opportunity for lung screening programs because these are the moat common
pulmonary disorders and because they can. be easily identified by means of a
simple spirometric test and brief symptoms questionnaire. Before embarking
on a chronic obstructive pulmonary diseases screening program, however, con-
sideration should be given to the responsibility befalling the sponsoring agency
for the follow-up and handling of newly detected cases since OOPD is not par-
ticularly amenable to management even wh'en good medical resources are avail-
able. A review of the indications and pitfalls of mass screening for CO'PD (i.e.
chronic bronchitis and emphysema by the PHS-NTRDA "Task Force `on Chronic
Bronchitis and ~mphysema," Princton, N.J., October 1966) led to `the follow-
ing conclusions:
"The Task Force discussed in detail the indications for mass surveys for
chronic bronchitis and emphysema. It recognized tha't significai~t contributions
to knowledge can be made by surveys, but only if the programs are properly
planned and `carried `out. Before embarking on such a program a clear defini-
tion of the objectives of the study and a realistic appraisal of the community
resources are essential. The cooperation of community physicians is needed and
methods for the referral of cases to physicians should be systematized. Provision
for periodic re-evaluation of cases should be made, and all results of the study
should `be validated.
The Task Force did not recommend large-scale surveys solely for the pur-
pose of case finding. Unless the survey has broader objectives, or is part of a
carefully planned demonstration or epidemiologic s'tudy, it may not be the best
investment of manpower and resources.
Study of the respiratory system is an important aspect of all pre-employment
and periodic health examinations, and of muitiphasic screening health programs.
The inclusion of pulmonary function `tests, both in the initial evaluation and
in subsequent follow-up examinations, was strongly endorsed by `the Task Force."
On the basis of past experience, COPD screening could be Organized readily
i~i any community where TB detection programs by official and voluntary agen-
cies exist. Depending on the scope of the new program the time necessary for
gdtting it under way would be of `the order of a few months to one year. Re-
sources for follow-up discussed above would vary between communities. Ac-
ceptance of such programs by a given community, it should be kept in mind, can
not always be taken for granted.
Mr. ROGERS. Also, I think it would be well to set forth for the record
who has to give approval of those contract grants and specified by
specific offices.
Dr. COOPETL Yes.
(The following material was received for the record:)
APPROVAL SYSTEM FOR GRANTS AND RESEARCH CONTRACTS
In fiscal year 1972, `the Institute will fund `approximately 1,470 regular re-
search grants and 245 research contracts. Authority to approve grants and con-
tracts has been delegated to the InStitute and is exercised in accordance with
NIH policy and procedure. A dual review system of approval is utilized to insure
consideration of both `technical merit and `broader program relevance. Grant
proposals require approximately four to five months between application dead-
line and final Advisory Council approval. Approved grants with high priorities
are then awarded within thirty to sixty days of approval, depending on the
requested start date. Grantee institutions request a Start date in accordance With
the scheduled meeting time of the Advisory Council, or to coincide with their
academic year. Research contract proposals generally require between two to
three months for review, negQtiation and award. Additionsi ~`learance, after
Institute approval, is required from the Department of State for gran'ts to
foreign institutions. Research contracts over $300,000 are reviewed by the NIH
Office of Contracts and Graitis.
PAGENO="0159"
`153
Mr. ROGERS. What about people being treated, say, in the first 5
or 10 minutes in a heart situation? Is this a very critical time or not?
Dr. Coopi~n. This is a very critical time in the problem of heart
attacks. Of the over 600,000 people who die each year from heart
attacks, perhaps 300,000 or 350,000, by some estimates, die without the
benefit of attention. If one applies the best information that we have at
this point in time, a large number of those so-called sudden deaths
occur in the early minutes and hours right after myocardial infarction.
So this is a very vulnerable and very important period.
* Mr. ROGERS. Now, what is the best way to get at this problem?
Dr. COOPER. I think there are two or three facets to this that are im-
portant. One is to try to find out what the risk factors for sudden death
are as opposed to general arteriosclerosis to help you pick out those
people who are at risk of sudden death.
The second is to try to educate the persons at risks as to what the
warning signals are and to encourage them not to deny these signals
and not to be overly concerned about seeking medical attention as
promptly as possible.
The American Heart Association last year initiated a warning sig-
nals program which has proven in its initial attempts to be quite effec-
tive. This has been very helpful.
So I think this type of a program of education of the peoplt~ at risk
and the public at large is very important.
The third element is to have a system of responsiveness by the pro-
fession in the community in general that can deal with these emergency
situations on a vigorous basis.
Mr. ROGERS. Now, what about an education program? Do you do
anything on that from your Institution?
Mr. COOPER. We have an office of information in the Heart and Lung
Institute currently at the present time in which we do some develop-
ment of information and a limited distribution in certain areas. We do
not have a special program on sudden death education at the preser~t
time.
Mr. ROGERS. Shouldn't we have?
Dr. COOPER. This would be an area where something could be ac-
complished, yes.
Mr. ROGERS. Would you let us know what you plan to do?
Dr. COOPER. Yes, sir.
(The following information was received for the record:)
PLANS FOR P1~OGRAM OF PUBLIC AND PROFESSIONAL EDUCATION IN THE
PEOPLE-AT-RISH AND SUDDEN-DEATH AREAS
The National Heart and Lung Institute currently has underway plans for an
a~ugmented program of public and professional education, to be conducted by a
separate organizational unit within the Institute. The responsibilities of this
office would be numerous. It would stimulate greater use both of education and
commercial television and radio time for discussion of heart and lung diseases
and measures for their correction; it would also develop programs in cooperation
with professional `societies for continuing professional education in these areas.
Heart, lung, and blood diseases would be included in the programing. In the
area of sudden death, particular attention would be given to advising the public
concerning relationship between smoking and heart disease; the seeming rela-
tionship between certain eating and physical activity habits' and heart disease;
the need to treat and control hypertension; and the need for persons at high
risk of sudden death to know significant symptoms of impending heart attack
and to act appropriately if premonitory signs appear.
PAGENO="0160"
154
Mr. Roo~s. Suppose we do put in the language saying you shall
coordinate the heart information for the Government. Could you do it
if we were to put it in the law?
Dr. Coon~R. If the resources were forthcoming, besides the authori-
zation and people to do it with, this ought to be possible.
Mr. ROGERS. Dr. Zapp, wouldn't it be a good idea ?You said we didn't;
need this because they already bad the authority. Suppose we want
them to do it. Wouldn't it be possible for us to spell this out?
Dr. ZAPP. Where you are talking about governmentwide programs
with interagency agreements and arangements, I would think the clear
intent of Congress is always helpful.
Mr. ROGERS. So it would be good to spell out what the committee
desires in that effect?
Dr. ZAPP. I think if that is the clear intent to cross agency lines.
Mr. ROGERS. And even within the Department?
Dr. ZAPP. I think that within the Department, certainly we have
authority. I wouldn't by any means, say in all cases.
Mr. RoGERs. I understand. But it has not been used.
Dr. ZAPP. It has not been used. But, of course, as we discussed this
morrdng, I would assume this may be one of the things that the new
panel the President appointed on heart would be addressing.
Mr. ROGERS. We are going to address it ourselves. I am just saying it
has not been used in the Department, and we want something done on
it. I would agree with you that it is probably best for us to spell out
our desires in legislation. I would hope the President's panel would
address itself to that particular problem.
Dr. Carter?
Mr. CARTER. Thank you, Mr. Chairman. One of the bills provides for
15 research centers to be constructed and manned in our country, I
believe. Is that correct?
Dr. COOPER. Yes; 15 in cardiovascular disease and 15 in pulmonary
disease.
Mr. CARTER. Where do you plan to locate these?
Dr. COOPER. We have no plan at the present time of any specific loca-
tions for these centers.
Mr. CARTER. Where do you think would be a good place for them?
Dr. CoOPER. I think the best determination of that should be deter-
mined on three criteria: The specific area of particular excellence and
scientific merit that the team available to do the work has is one
criterion.
The second criterion is the special interest and special resources local
to the area to deal with the specialized problem. For example, in the
area of lung, there are certain regions of the country where it is most
appropriate to deal with the problem of pneumoconiosis-occupa-
tional lung disease.
The third is to determine a balance where this would provide the best
resource for other reference and service to the profession and public at
large.
I think those criteria would be the determining factors.
Mr. CARTER. What personnel would you use to man these centers?
Dr. COOPER. The personnel that should man these centers should be
the personnel local to the operation that was available in each locale,
I do not feature it to be a responsibility of the Institute to man them.
PAGENO="0161"
l~55
I would think it would be the responsibility of the applicant to
demonstrate that they could man such an operation.
Mr. CARTER. You think, then, in areas where we have widespread
pneumoconiosis, we would have the personnel to man such research
centers?
Dr. COOPER. If that were the plan, and they would have the core re-
sources, the clinical material, and the basic personnel to man it with
additional resources, I think they could recruit and train the additional
personnel they would need.
Mr. CARTER. You really didn't answer my question. Do you think
these areas have the manpower and training and talented men for re-
search centers?
Dr. COOPER. I think some areas do; not all of them.
Mr. CARTER. That is extremely doubtful. In areas where we have
widespread pneumoconiosis, you have some trained men but not many
of the caliber to do research in this area. Do you think these research
centers should be arms of medical schools or be associated with them?
Dr. COOPER. I think traditionally the manpower pool is greater if it
is in association with an academic center. It gives them some other re-
sources and scientific base to operate with. ~But I don't think it is a
sine qua non-that it is a necessary requirement.
Mr. CARTER. You are probably right on that. But certainly to con-
duct good research, you have to have people who are capable of doing
it.
Dr. Coopi~. Yes, sir.
Mr. CARTER. You can't just establish a center anywhere without the
talent there.
Dr. COOPER. I agree with you. That is why I said the merit was the
first criterion.
Mr. CARTER. As sadly as I hate to say it, areas which are high with
pneumoconiosis, as in my own particular district, just don't have suffi-
cient manpower for these centers. But with the assistance from the
University of Kentucky, we might provide that.
I believe you have five research centers at the present time, is that
correct?
Dr. COOPER. Thirty-four.
Mr. CARTER. Where are some of these?
Dr. COOPER. There are some in Florida, Texas, California, Missouri,
Philadelphia, Pa., Tennessee.
Mr. CARTER. Where in Tennessee?
Dr. COOPER. At Memphis, hypertension. At Vanderbilt, pulmonary.
Mr. CARTER. The one at the University of Texas is in Houston?
Dr. COOPER. At Baylor University in Houston, arteriosclerosis; the
University of Washington, Seattle, lung
I could provide for the record the detailed list
(The following material was supplied for the record:)
78-994 O-72----1i
PAGENO="0162"
156
KATtIISAL REAR? AND LUNG 1$ST!TUTE
ACTIVE ~PECIALZZED CENTERS OF RESEARCH
T~t)e
Inve*t*$etor
74~e~ber In titutI~n Req Sec A3~sJed
WLPI4 136 CENTIR FOR STUDY OF OI3STRUCTIVE LUN(~. OI.~CASE
ARIZONA U COLL OF MEDICINE TUCSON AR1Z 31
ARIZONA UNIVERSITy TUCSON ARIZ 30
8URROWS 8ENJAMIN MD 83~22~3398
01 671572 732208 287405 337965 71 All 306
HLR14 138 SPECIALIZED CENTER OP ~LSEARC ATHEROSCLEROSIS
LOS ANGELES CQ~%JSC M~O CE~NTER L&, AN(~ELES C.4L 54
SOUTHERN CALIFORNIA U LOS ANGELES CAL 50
SLANKENHORN DAVID H MD 314~2b-9835
0* 67157~ 897152 .70906 697149 71 £71 230
MLRI414L SCOR FOR ATHEROSCLEROSIS IN CHILUH000
MAM1 U SCHOOL OF MEDICINE MIAMI FLA 21*
MIAMI UNIVER~ITY CORAL CIASLLS FLA 110
I3LUMENTHAL SIDNEY MO 6~3O'-O321
01 67157~ 592904 410971 533691 71 *71 246
*4LR14 142 COAGULATION AND CELLS IN THROMBOSIS AND HEMQSTASI~e
WAYNE ,TAT U COLL OF MEDIC1NE~DETROIT MICH25I
WAYNE STATE UNIVERSITY (DETROIT MZCH2SO
SEE~~LR$ WALTER H PHD 382~2O~7867
01 671572 390076 24~J58 J~6.~O 71 All 258
HLRI4 147 SPECIALIZED CENTER OF RLSEAR~H IN THROM8OSIS
WASHiNGTON U ~T LOUL SCH MED ~T LOUiS MO 281
WASHINGTON U ~ LOUI ST LOUIS MC 280
WESSL2~R STANFORD MD
ul 671572 694~76 .39i~56? 4631~3 71 471 192
HLRI4 146 HYPERTLt~hSX0N CENTER
COLUMLIIA U COLL OF PHVS 6 ~URGNEW YORK "JY 361
COLOf~t2IA VN!V~R~lTY NEW YORK NY 360
LARAuH IUHN H MD ~7 ~
0* 67157~ 13,~896~ dO5~.87 ~9~86 II 471 180
HLRI41SQ SPECIALIZED CENTLQ (iF RESLARCH IN HYPERTENSION
HARVARD MED1EAL ~iCHOOL 80~TON MA~S~~41
HARVARD UNIVER~ITY CAMBRIOGL MA~.~4O
6ARGE~ A CLIFFORD MC 24~22~458b
ri 671572 43J0~2 333166 4l8~74 71 471
I
236
PAGENO="0163"
157
HLR14152 PULMONARY SPECIALIZED CENTER OP RESEARCH
WASHINGTON U SEATTLE MED SCH SEATTLE WASNS3
WASHINGTON U SEATTLE SEATTLE WASHS3O
BUTLER JOHN MD £03 ..32~2357
UI 671572 626076 314333 370157 71 *71
HLR*4 153 JOHNS HOPKINS LUNG CENTER
JOHNS HOPKINS U SCM HYG C, P H BALTIMORE MD 236
JOHNS HOPKINS UNIVERSITY BALTIMORE MD 230
PERMUTT SOLBERT MD 422~-16~797b
01 671572 473753 205168 238754 71 *71 243
HLRIAIS9 SPECIALIZED CENTER OF RESEARCH IN HYPERTENSION
INDIANA U PURDUE U SCM MED INDIANAPOLIS INO 161
IND1ANA UNIVERSITY BLOOMINGTON DID 160
HIGGINS JAMES T JR MD 238-46-0948
01 671572 463870 360074 47596* 71 All £22
HLR14164 ARTERIOSCLEROSIS RESEARCH CENTER
BOWMAN GRAY SCHOOL OP MEDIC INEWINSTON SALEM NC 371
BOWMAN GRAY SCHOOL OF MEDICINEWINSTON SALEM NC 371
CLARKSON THOMAS B DVM 411-583036
01 671572 617883 588667 604706 71 *71 193
HLR14169 PULMONARY DISEASE CENTER
CALIFORNIA U SAN DIEGO SCH MEDLA JOLLA CAL 51
CALIFORNIA U SAN DIEGO LA JOLLA CAL SO
MOSER KENNETH M MO 220-20-8585
01 671572 927237 449353 538757 71 A71 £53
HLRI4I?4 ATHEROSCLEROSIS--BEHAVIORAL C, EPIDEMIOLOGICAL STUDIES
STANFORD U sCM OF MEDICINE PALO ALTO CAL 51
STANFORD UNIVERSITY STANFORD CAL SO
FAROUHAR JOHN W MD 561-26-6351
01 671572 585444 352590 363514 71 471 230
HLRI4I77 CENTER FOR PREVENTION & TREATMENT OF ATHEROSCLEROSIS
A58ANY MEDICAL COLLEGE ALBANY NY 361
ALBANY MI~DICAL COLLEGE ALUANY NY 361
THOMAS WILBUR A MD 427-14-7017
01 671572 692311 000540 b41~Z4 71 *71 210
PAGENO="0164"
158
HIj~l4279 CENTER FOR THE STUDY OF LUNG DISEASE
YALE I) SCHOOL OF MEDICINE NEW HAVEN CONN It
YALE UNIVERSITY NEW HAVEN COHN 70
BOUHUYS ARENO MDPHD 256~72- 1416
01 671572 566439 347317 465468 11 471 243
HLRI4 182 SPECIAL CENTER OF RESEARCH IN THROMBOSIS
BETh ISRAEL HOSPITAL BOSTON BOSTON MA55244
BETH ISRAEL HOSPITAL BOSTON BOSTON MAS$244
DEYKIN DANIEL MO 1O~26~9936
.01 671572 215071 173065 168012 71 All 246
HLRI4 187 CENTER FOR LUNG RESEARCH
TEXAS U SOUTHWESTERN MED SCH DALLAS TEX 481
TEXAS U SOUTHWESTERN MED SCH DALLAS TEX 481
SAID SAM! I MD 65-~3O~l354
01 671572 659132 374969 479540 71 47$ 260
HLR14192 SPECIALIZED CENTER OF RESEARCH IN HYPERTENSION
VANDERBILT U SCM OF MED NASHVILLE TENN47I
VANDERBILT UNIVERSITY NASHVILLE TENN4IO
FOSTER JQP4N H MD 4S2-22~94O9
01 671572 423441 351864 413436 71 471 193
HLRI4 194 PAThOPHYSIOLOGY OF ATHEROSCLEROSIS
BAYLOR COLL OF MEDICINE HOUSTON TEX 481
BAYLOR COLL OF MEDICINE HOUI TON TEX 481
GOTTO ANTONIO M JR MDPHD 5O9-58~359O
01 671572 702369 250004 356961 71 All 285
HLRZ4 196 LIPIDS THROMBOSIS o GENETICS IN ATHEROSCLEROSIS
MAYO FOUNDATION ROCHESTER MINNZ65
MAYO FoUNDATiON ROCHESTER M&NN265
KQTTKE BRUCE A MDOSC 473-3lI~7591
01 671572 543870 3~72OO 483191 71 471 170
HLRI4 197 SPECIALIZED CENTER OF RESEARCH ON ARTERIOSCLEROSIS
CALIFORNIA U SAN DIEGO SCH MEDLA JOLLA CAL 51
CALIFORNIA U SAN DIEGO LA JOLLA CAL 50
STEINBERG DANIEL MDPHD 371~I2~5351
01 671572 635803 402523 480571 71 471 220
PAGENO="0165"
159
`$LR14~O1 PULMONARY DISEASE RESEARCH CENTER
CALIFORNiA U S F SCH OF MED SAN FRANCISCO CAL 51
CALIFORNIA U S F SCH OF MED SAN FRANCISCO CAL 51
COMROE JUJUS H JR MC 2I%-~24~6O34
101 671572 1300660 747472 873893 71 471 *26
~LR142O7 EARLY DETECTION AND PREVENTION OF ARTERIOSCLEROSIS
JOHNS HOPKINS U SCHOOL OF MED BALTIMORE MD 231
JOHNS HOPKINS UNIVERSITY BALTIMORE MD 230
KROVETZ L JEROME MDPHD I15~'20-7825
701 671572 334535 301081 221427 7* All 263
HLR14209 M I T ARTERIOSCLEROSIS CENTER
MASS INSTITUTE OF TECHNOLOGY CAMBRIDGE MASS24O
MASS INSTITUTE OF TECHNOLOGY CAMBRIDGE MASS24O
LEES ROBERT 5 MD 129~-28~7214
901 671572 476628 434258 561593 71 All 183
HLR 14212 CORRELATED STUD 1ES OF PULMONARY DISEASE
VERMONT U COLL OF MEDiCINE BURLINGTON VT 511
VERMONT UNIVERSITY BURLINGTON VT 510
GREEN GARETH M MD 16-'24~155O
201 871572 446921 205823 272303 71 All 268
HLRI4214 NEONATAL LUNG CENTER
VANDERBILT U SCH OF MED NASHVILLE TENN471
VANDERBILT UN! VERS I TV NASHV ILLE TENN47O
STAHLMAN MILDRED ThORNTONMD 358~.26~07l7
401 671572 449650 432251 5*2501 71 All *40
HLR14217 SPECIAL 1ZED CENTER OF RESEARCH~-THROMBO8lS
TEMPLE U SCHOOL OF MEDICINE PHILAUELPHIA PA 431
TEMPLE UNIVERSITY PHILADELPHIA PA 430
SHERRY SQL MD 89~26~46l8
701 671572 666959 494695 630498 71 471 *73
HLR142IO NEWBORN LUNc~ CENTER
COLUMBIA U COLL OF PHYS & SURGNEW YORK NY 361
JAMES L STANLEY MD 74~3O~45l3
501 671572 881856 358390 436543 71 All 226
PAGENO="0166"
160
IIL~14228 SP~C1ALIZ$D C!IIT*R OF RESZA*C11 1$ tl1ft(~I$0SIS
NORTH CAROLINA V SCH OF MED CHAPEL HILL NC 37*
NORTH CAROLINA UNIVERSITY CHAPEL HILL NC J7O
8RINKI4OU$ KENNETH H MD 478-30-6415
01 671572 365095 316384 370675 71 *71 215
HLR*4230 LiPIDS ATHEROSCLEROSIS AND THROMSOS1S
IOWA U COLL OF MEDICINE IOWA CITY IOWAI7Z
IOWA UNiVERSiTY IOWA CITY IOWAI7O
CONNER WILLiAM E MD 485-05-7873
4)1 671572 670795 559045 709749 71 163
P41J114236 CENTER FOR PREVENTION OF PREMATURE ARTERIOSCLEROSIS
ROCKEFELLER UNIVERSITY HOSP NEW YORK NY 364
ROCKEFELLER UNiVERSITY NEW YORK NY 360
AHRENS EL)WARO H JR MD 71-28-6045
01 671572 1307331 1196339 939~8O 71 A71
80*51 971572 300685 72
HLR14237 ARTERIOSCLEROSIS CENTEI4
CALIFORNIA U S F SCH OF MED SAN FRANCISCO CAL 51
CALIFORNIA U S F SCH OF MED SAN FRANCISCO CAL 51
KAVEL RiCHARD J MD 537-03-1670
Dl 671572 410686 410686 479649 71 A71 2*3
SPECIALIZED CENTER OF RESEARCH IN HYPERTENSION
TENNESSEE V COLL OF MEDICINE MEMPHIS 7ENN471
TENNESSEE U MEDICAL UNITS MEMPHIS TENN479
MU1RHEAD ERNEST ERIC MD 458-16-8764
01 671572. 842525 388308 449694 71
*71
240
HLR14242
A7I
262
HLRI 4251 PHYSIOLOGY MANAGEMENT OF RESPIRATORY INSUFFICIENCY
MEDICAL COLL OF VIRGINIA VCU RICHMOND VA 521
VIRGINIA COMMONWEALTH U RICHMOND VA 520
PATTERSON JOHN L JR MD 254-50-2732
.01 671672, 349305 111388 134625 71 ATI 306
PAGENO="0167"
161
Mr. CARTER. Are most of these 34 associated with teaching institu-
tions?
Dr. COOPER. At the present time, all of them are.
Mr. CARTER. Are they related to the regional medical program, inte-
gral parts of that?
Dr. CooPER. No.
Mr. CARTER. When I came in, Chairman Rogers was speaking to
you about regional medical programs. How are they working at the
present time?
Dr. ZAPP. I think, Dr. Carter, Mr. Rogers and I were discussing the
fact that I would have to supply for the record the information I
think both of you are most interested in. That is, currently, what the
state of the art is with the RMP programs in transferring proven
research into application in the professional community. I am sure
without having a record to provide you today we could say it is
uneven.
In some areas we would probably find this, particularly in the
center where you would have one of the 15 centers of each type as
the 34 Dr. Cooper was talking about. In a health scienOG center, we
have a strong relationship between the RMP and the science center.
In cases such as that, you would see the transference of that applied
research information into the profession. In other cases it may not
be good.
I think we, ourselves, need to take a good look at that, because we
are depending on them to be that transitional arm, so to speak, from
the applied research into the applied professional mechanisms. I think
we would be pleased to take a good look at that and provide it to the
committee.
(The following material was supplied for the record:)
DIsSEMINATION OF APPLIED REsEAaoH, REGIONAL MEDICAL PROGRAMS
Adaptation of a curriculum, a technology, or a procedure to a specific situation
usually involves some experimentation and evaluation of alternative modes of
performance. In this sense, most regional medical programs demonstrations, train-
ing and information projects, in their own localities have some characteristics of
applied research and development.
Generally, however, the Regional Medical Programs Service has classified as
research and development those projects and other activities whose novel fea-
tures are not in widespread standardized use, require technical (as distinguished
from situational) experimentation, and may yield patterns of application that
can be generalized for use in other situations.
To date, such activities have included projects ranging from development and
demonstration of the physician assistant concept, adaptation of automatic equip-
ment to patient care, organizational development and consumer-oriented research
particularly related to problem-oriented medical records and various data sys-
tems.
RMPS has also had a variety of contracts, particularly in relation to fulfilling
the requirements of Section 907 of the legislation dealing with maintaining in-
formation on the most advanced methods and techniques of diagnosis and treat-
ment for heart disease, cancer, and stroke.
Probably the best example of this is the contracts with the Inter-Society Com-
mission for Heart Disease Resources, an organization brought into being to im-
plement a con'tract between RMPS and the American Heart Association. The
purpose of the contract and the Commission is to establish guidelines for the
prevention, treatment and rehabilitation of patients with cardiovascular diseases.
These guidelines have been disseminated around the country and are being used
in varying degrees for planning, evaluation, and quality of care standard setting
and performance review mechanisms.
PAGENO="0168"
162
This is being followed up by a contract on evaluation of the heart guidelines,
to see how and if those sections which have been completed are being imple-
mented. This activity offers RMPS the opportunity to test the premise that the
regional medical programs offer a unique mechanism to encourage broad adoption
by individuals, institutions, and community groups of new methods for organiz-
ing and delivering comprehensive care.
The following illustrate the variety of operational projects involved with ap-
plied research:
Pacemaker Implant Evaluation~-The New Jersey RMP supported a project
designed to evaluate 500 patients with implanted pacemakers in an effort to
predict impeding failure. Eight satellite centers located in community hospitals
with teletype link-up are presently operating. It is anticipated that the new
method will reduce the number of deaths and emergency replacements. This new
method, if successful, will be documented and guidelines will be published ex-
plaining in detail the equipment, procedures, methodology, and results for use
by others throughout the Nation.
Communications Networks.-In Alabama, a Medical Information Service via
Telephone (MIST) has been started. Physicians practicing in small towns and
isolated rural areas of Alabama have instant access to specialists at the Uni-
versity of Alabama in Birmingham through the MIST. Calls can be placed free of
charge from any point in Alabama, at any time of the day or night, on the MIST
circuit. The systems switchboard operators are trained to locate specialists in
all fields on split-second notice. This project was developed through the coopera-
tive efforts of the Alabama Regional Medical Program, the University of Alabama
in Birmingham, and the American Medical Association's Education and Research
Fund. It has served as a prototype for similar programs in other regions.
Problem-Oriented Medical Information.-A contract with the Dartmouth Med-
ical School, New Hampshire, is designed to establish a university-based center
where health personnel can be trained in the philosophy and use of the problem-
oriented medical information system. This system provides for restructuring of
existing medical records according to a list or index of defined patient medical
problems to allow for computerization of data. The format allows computeriza-
tion of clinical data for: rapid audit of quality of care, analysis of personnel
utilization, communication between health personnel, and a tool for physician con-
tinuing education. Ultimately, a regional medical information system will be
developed based on this contract, linking medical centers at the University of
Vermont, Dartmouth Medical School, and Augusta, Maine with rural practicing
physicians in the three-state area. The training center will also provide for dis-
semination of the system to other states nationwide.
Computer-Assisted Instruction.-The Ohio State RMP has funded a Computer
Assisted Instruction project, designed to establish and evaluate a computer-based
information network having CAl capabilities aimed at both health professionals
and allied health personnel. In its early stages, terminals were set up in 10
hospitals, linking them to the Ohio State University Medical Center. Eighteen
new courses or course modules have been developed since August 1971.
Regional medical programs will be involving themselves to a greater extent
as implementing arms for the products of the National Center for Health Services
Research and Development, with its emphasis on advanced technology and sys-
tems innovations. Barriers to the transferability of new concepts of health de-
livery point to the need for clearly perceived mechanisms for testing and subse-
quent adoption by the private sector of valuable new ideas. The 56 regional
medical programs, with their coverage of the entire Nation, provide at least one
such mechanism.
In addition, there will be an increased emphasis on developing emergency
medical service systems which promote both the use of advanced technology and
the cooperative linkage of all involved elements for optimum effectiveness in
performance. This involves coordination of the advanced technological aids avail-
able in terms of communications systems, transportation equipment and systems,
and medical facilities and equipment.
Mr. CARTER. The way it was developed to begin with was for your
heart and lung and stroke centers to have arms radiating into the
communities throughout the country. Some of them have been devel-
oped that way and others have not. Why, I cannot understand.
Actually, in our research centers which we are discussing today,
PAGENO="0169"
163
do you think in many cases they should be separated from our uni-
versities, from our medical centers, or not?
Dr. ZAPP. I think for scientific judgment, Dr. Cooper would have
to answer that. We were discussing before-and I think it is a very
valid point-as to the strengths they would have to build on, they
wouldn't necessarily have to be, I think, in the same physical plant
but as an outreach they could build on what is existing in the health
science center. But I think a satellite might be helpful.
Mr. CARTER. If we can tie all of these things into a good plan, if
we could integrate our different institutions and get them on the same
sort of plane, we would be much better off.
After we pass legislation we find separate institutions all over the
country and we will realize we added another layer, a different agency,
and that they are not coordinated and correlated as they should be,
just as we in many cases have failed with our Hill-Burton legislation,
which has been extremely helpful. We all know the value of it. Yet
in some areas we have beds which are not utilized. In other areas we
have a scarcity of hospital beds. We should plan and not complicate
that plan too much.
Thank you, Mr. Chairman.
Dr. ZAPP. We couldn't agree more with you on that last point. We
are in total agreement on that.
Dr COOPER. In our present centers program we are making a spe-
cial feature of coordination and regulatory input from the Institute
itself. So these programs do not go off all by themselves. There is an
element of coordination and direction from the Institute so we can
minimize duplication and yet facilitate the use of the strengths of the
particular locales in a total national plan or strategy to attack all
four of these areas. We couldn't agree more with you about this
problem.
Mr. ROGERS. The Chair is very pleased to recognize the presence of
Mrs. Albert Lasker, who has done so much in the health field for
this Nation. I think you showed your endurance and real interest in
health when you sat through all of those cancer hearings that you did
so much for. We are pleased to recognize you today.
Mr. Symington?
Mr. SYMINGTON. I echo your sentiments, and I think Dr. Carter
does, too, concerning Mrs. Lasker's devotion to American health.
I think some of these figures here will surprise and interest Ameri-
cans, the fact that Scandinavian countries, as shown on page 2 of your
statement, have a death rate from heart attacks half the level of ours.
The Japanese is one-sixth. Has the Institute come to any conclusion
as to why that is?
Dr. COQPER. We have made no firm determination as to the actual
reason fo~ this. I do not know the answer for this difference. There
are several important things we are learning from this observation,
however. For example, when the Japanese leave their own environ-
ment and come to America or Hawaii they begin to take on the
American characteristics of the death rate. We have similar data from
the Scandinavian countries and United Kingdom. As they have come
to this country in specific occupational categories they have taken on
the characteristics of our death rate for this disease.
PAGENO="0170"
164
This would suggest there is something in the American life style
that is related to the current so called epidemic of heart attacks in
this country But there is one other observation that, I think, is quite
important That is, in the Western European countries that have this
lower death rate, as one follows their statistics that are available
since World War II, one does find they are on the increase, where
as we are currently seeming to level off, although we have not turned
the corner.
Mr SYMINOTON How long have you or the Institute been addressing
itself to this kind of question ~ In other words, it seems to me if there
is a different experience between civilized peoples, that this is a good
place to look for answers Have you been looking a long time ~
Dr COOPER Yes, sir
Mr SYMINUTON Then you must have studies considering the life
styles
Dr COOPER Yes, sii, we have studies that have been going on for
some time.
Mr SYMINGTON Is it bicycle riding in the United Kingdom and
Japan that ceases when people come here ~ Has the exercising some
thing to do with it?
Dr COOPER There are some indicators that are important One is
the level of physical activity Some is the nature, perhaps, of the
climate or other geographical factors As Dr Carter pointed out this
morning, I could not focus exclusively on the differences in diet, be
cause he has overwhelming data to indicate that the diet, obviously,
cannot be the only factor, particularly in the Scandinavian countries,
if you were to try to implicate diet as a factor
Mr. SYMINGTON. They are great butter and egg people.
Dr COOPER Obviously, there are some factors which we can try
to determine and others that are still obscure at the present time
Mr SYMINGTON Has there been some systematic approach to at
tempt to isolate factors and make comparisons that would lead to
conclusions ~ What lund of studies have you engaged in ~
Dr COOPER We have been trying to design clinical studies which
would allow us to isolate single factor analysis in a multifactorial
situation This is very difficult in a free living population which is
quite mobile, but we are trying to determine the effects of various ele
ments in the life style which would address themselves to this difference
Mr. S~INGToN. I would hope this legislation would give you some
fuel for that search.
I think one other point I would like to make, Mr Chairman, is con
cerning the statistics that half of the heart patients who die, die before
medical attention I take it of that one half, a great many, could be
saved if they had prompt medical attention
Dr COOPER Yes, we think so
Mr SYMINOTON Is there some estimate of how many of the one half ~
Dr. COOPER. If we were to extrapolate from the experience in the
coronary care unit where the management of electrical abnormalities
of the heart could be dealt with promptly, the saving there has been on
the order of 25 to 30 percent So I think, as a minimum figure, we could
anticipate that type of saving.
Mr SYMINGTON If 1 million die a year, 500,000 of them may die be
fore medical attention and 150,000 of them could be saved
PAGENO="0171"
165
Dr COOPER That is the rough estimate I have come to myself in
various speeches, Mr Symrngton
Mr SYMINOTON What studies have you made concerning one or
both of two things One, self administered injections provided by the
family or individual himself, or the establishment of paramedical units
so broadly and widely through a community that no man is more than
5 minutes away from the nearest unit ?
Dr COOPER We have approached the problem of self administration
of antiarrhythmic agents This is a difficult problem, because the drugs
that are available for self administration are quite potent drugs If
the patient or his family makes a misdiagnosis and applies the wrong
drug at the wrong time it is conceivable he could precipitate a cata
strophic event, as well as treat a catastrophic event
Our efforts in this regard have been to develop techniques in which,
by the use of modern communications media and availability of identi
floation of high-risk susceptibles, education of the susceptible and his
family in consultation with his physician, we think it is feasible to
provide supplies of agents to the family and to the patient That is
like the astronauts have in the capsule `at the present time.
Mr CARTER If the distinguished gentleman would yield
Mr. SYMINGTON. Yes.
Mr CARTER There is an old adage about that He who doctors him
self has an unbalanced man, putting it politely, or woman, as a
patient
Mr SYMINOTON The corollary of which is He who doesn't is dead
Dr COOPER So I think there is a middle ground
Mr CARTER He might certainly be dead when he doctors himself
Mr. SYMINOT0N. The old `adage of the lawyer who represents himself
has a fool for a client has great applicability, because certainly there
are other lawyers in the neighborhood to consult One doesn't generally
have to have legal counsel in 5 minutes, although I am sure some of
us need it that quickly
I think it is different with doctors I think if doctors are not there
in 5 minutes,~no matter how good they are, they are not much better,
in the judgment of the gentleman in pain If he has a device which has
been approved for the reliability not only of the contents of it but for
the likely usage of it, I would think it might prove to be a helpful ad-
junct to the overall effort to meet this problem.
Dr COOPER I think there is a ground here where, with advice from
the physician and a good emergency care system a useful technique
could be developed which would not depend on self treatment but on
administration of the drug with good advice on short notice.
The answer to your second question about what we are doing in de
velopment of paramedical personnel, this is not a responsibility at the
present time of the National Heart and Lung Institute. We do not
have specific programs in that area
Mr. SYMINOTON. But you would certainly endorse the dissemination
of the latest state of the art, equipment, and expertise, wouldn't you ~
Dr COOPER Yes, indeed
Mr SYMINOTON I would have in fact thought, although it is not
within the direct purview of your Institute, that there would be noth
ing to prevent you from making the suggestion
Dr. Coopi~. We do make the suggestion; yes, sir.
PAGENO="0172"
166
Mr. SYMINGTON. To whom would you make such a suggestion?
Dr. CooPER. We would make the suggestion to the voluntary agencies
and their plans and also to the Bureau of Health Manpower, which is
responsible for the development and training of these people. And I
think this would be a fertile ground for exploration.
Mr. SYMINGTON. I do, too, and I think you would want to make the
suggestion, if you believe in it, very forcefully to other agencies of
Government which have some jurisdiction, authority, and responsi-
bility for assisting-let us say the Law Enforcement Assistance
Agency, for example, with the police.
I am interested in getting help to these people quickly. I think we all
are. I would hope you would turn your attention to good ways to do it.
Dr. COOPER. We shall.
Mr. CARTER. On that, many patients are given nitroglycerin tablets
which they take if they have pain, such as anginal pain. Again, if they
are faced with physical exertion, they could also take nitroglycerin
prior to that.
Oxygen is routinely used by cardiac patients. Breathing apparatuses
are often available, particularly in cases of emphysema, at fire depart-
ments as a usual thing and should be and perhaps more so.
There are many, many things that are helpful and could be helpful,
and certainly we want to avail ourselves of that.
The use of the preventive medicines routinely would be extremely
dangerous by one who doesn't know his medicines quite well.
Dr. COOPER. I would agree'. I think the implementation of good
advice is what would be sought, not the decision of what to use and
when to use it.
Mr. SYMINGTON. I think, Mr. Chairman, when we passed the Health
Manpower bill there was provision in that bill for what we call para-
medical assistance. The term "para" perhaps is a much abused term. It
creates false hope. I would have thought in this connection it would
mean individuals capable of absorbing that degree of training that
would enable them to use devices geared to their capabilities and make
the right choice. I don't knQw. I would certainly defer to my distin-
guished colleague, Dr. Carter, and his judgment on these things.
Civilization is getting very complicated. We all have to be a little
brighter in the manner in which we handle our difficulties, because
help is not around the corner all of the time when we need it.
Mr. ROGERS. Should stroke be transferred from the Institute over to
Heart, Dr. Zapp?
Dr. ZAPP. Not in our judgment, Mr. Chairman.
Mr. ROGERS. Why not? The president of the College on Cardiology
just testified they felt strongly it should be because it results from a
breakdown either in the blood vessel or a clotting and so forth.
Dr. ZAPP. In our judgment, it should remain in the Stroke and
Neurological Disease Institute. I think Dr. Cooper could explain a
little better as to how the blood related components can be coordinated
with the National Heart and Lung Institute. We feel that it wouldn't
necessarily be an additive to the program to simply uproot it, because
as it has become a part of its present Institute it has built its own
interrelationships and strengths. Simply to move it over would prob-
ably be more disruptive to the research program.
Mr. ROGERS. What is the current budget on stroke?
Dr. ZAPP. I am not sure I have the figures.
PAGENO="0173"
167
Mr. ROGERS. Is it about $13 million?
Dr. ZAPP. We would have to supply that for the record. I believe
that is about accurate. The only figures I have are for the complete
institution.
Mr. ROGERs. But it is my understanding it is approximately $13
million. If you would let us know for the record whether that is correct
or not it would be helpful.
(The following information was supplied for the record:)
NATIONAL HEART AND LUNG INSTITUTE-BUDGET FOR CEREBROVASCULAR DISEASE AND STROKE-RELATED
DISEASES, MAY 5, 1972
(Dollars in thousands(
1973
1968 1969 1970 1971 1972 (estimated)
A. CerebrovascularCirCulatiOfl $1,602 $1,219 $976 $835 $464 $490
B. Thrombosis 2, 553 2, 702 2, 859 3, 720 4, 169 5,725
C. Hypertension studies 3, 031 3, 165 3, 307 4, 747 5, 179 5, 376
D. Arteriosclerosis 4, 652 3, 873 3, 558 5, 500 6, 391 7, 045
E. Epidemiology 382 402 423 445 469 395
Total 12,220 11,361 11,123 15,247 16,762 19,031
Total obligations 162, 134 161, 834 160, 433 194, 826 232, 000 255, 000
Percentoftotalobligations 7 7 6 7 7 7
Mr. ROGERS. Now, $200,000 out of that doesn't seem to be a very high
priority in that Institute. Is it?
Dr. ZAPP. I very honestly didn't come prepared well enough to dis-
cuss that.
Mr. RoGERS. You might let us have for the record what they have
done and what progress has been made, what research projects they
are funding and what the projection is for the coming year.
Dr. ZAPP. We would be pleased to give you a full status. (See p. 168.)
Mr. ROGERS. If we were to decide to put it in Heart could it be
developed there? In other words, is there enough relationship that it
would not be out of place in the Heart Institute? I don't want to put
you on the spot here.
Dr. COOPER. I am not on the spot here. I think the nature of the
disease explains the options which are available for choice in program-
ing. I think here we have a disease which results from a disruption
of the blood supply to the brain. The disease begins in the blood vessels
or in the blood itself or is related to blood pressure. Obviously, the
National Heart and Lung Institute activities and scope of research
activities are related to the problem of stroke and will be continued
to be related to it.
Mr. ROGERS. And you are doing something in this area now?
Dr. Coopi~u. Yes, sir.
Mr. ROGERS. About what is the budget allocated now?
Dr. CoorioR. It depends on how you want to define the problem. If
we are only talking about the cerebral circulation, it is somewhat less
than a million dollars. But if you want to talk about the problem of
hypertension as a primary factor in stroke, then we have a program
close to $19 million.
Now, the great advances that have been made in the control of
stroke over the past 20 years, a 20-percent reduction in the death rate,
PAGENO="0174"
168
although it is still 200,000, as you pointed out, is due largely to the
control of the hypertension that has occurred during the past 20
years I think that our programs, obviously, have an important impact
and interrelationship to the problem of stroke
As a clinical entity, a disease of the nervous system, as it expresses
itself, it also requires a great deal of attention from neurological ex
perts. I would say, in all candor, that the National Heart and Lung
Institute does not have neurologists on its staff or expertise in this
particular area.
We have tried to approach this joint problem, as we have in other
areas, by attempting to coordinate our decisions and choices with the
experts in the other areas We feel on an ideological basis the problem
of stroke will relate to our problems On the problem of diagnosis of
location of the lesion in the brain, the study of what its consequences
are on brain function and on rehabilitation, will require other types
of experts to participate in the total solution of the stroke problem
So you have a problem here of where the appropriate leadership
should be, where the appropriate emphasis should be at any time, and
I don't think it is an either/or, black and white situation It is a
matter of judgment as to what to emphasize at what time
Mr CARTER Mr Chairman, if you will yield on this
Mr ROGERS Certainly
Mr CARTER You would admit that most of the causes of most of the
cases originate in the cardiovascular system
Dr COOPER That is right
Mr CARTER If you want to treat the cause it should be in the Heart
and Lung Institute, is that correct ~
If you want to rehabilitate, or if you want to diagnose, it would be
long in the other, is that correct ~
Dr COOPER I think that is the spectrum of the problem
Mr CARTER In some few instances we do have a few cases of stroke
which are not necessarily related to the vascular system
Dr COOPER Yes, sir These are related to tumors or congenital mal
formations There are infectious processes that cause a similar process
which invades the bloodstream and causes a catastrophe but is not
related primarily to a disease that originates in the blood vessel
itself
Mr ROGERS I think it might be well for the Department to give us
some language which would be able to put the functions, as Dr Carter
and Dr Cooper have discussed them, in the various areas where em
phasis should be given Could you give us that, Dr Zapp ~
Dr ZAPP Yes, sir
(The following material was received for the record )
NATIONAL HEART AND LUNG INSTITUTE-CEREBRAL VASCULAR DISEASE AND STROKE
MAGNITUDE OP THE PROBLEM
Stroke is the most common form of disease affecting the central nervous sys
tern and the second leading cause of death among the cardiovascular disorders
During 1970 strokes claimed the lives of 207 800 Americans approximately
37000 of them under age 65 A brain disease brought on by blood vessel disease
stroke afflicts an estimated 17 million American adults and is a major cause of
disability in the elderly. There are no reliable data on the total number partially
or totally disabled by stroke but data from the Framangham Study suggests
that fully half of those who survive their first stroke may be left with some
degree of permanent disability
PAGENO="0175"
169
BISK FACTORS
A preventave approach 4o cerebrovascular disease seems imperative since the
damage done to the central nervous system `by stroke is within the current state
of medical knowledge irreversible Fortunately through epidemiological studies
on human populations at Frammgham and elsewhere scientists have identified a
number of factors in the -person or in his environment that increase his suscepti-
bility to cerebral vascular disease and his risk of stroke. The most serious factors
aside from advancing age are elevated blood pressure elevated blood levels of
certain fatty substances (in subjects under age 50) diabetes or other evidence
of impaired carbohydrate metabolism, various heart disorders or electrocardio-
graphic evidence of impaired heart function, cigarette smoking, and obesity.
Conibmations of these factors can sharply escalate risk
CURRENT APPROACHES TO pREvENTION
The close similarity between factors increasing susceptibility to stroke and
those increasing susceptibility to coronary heart disease make clear that stroke
is an integral part of the larger problem of cardiovascular disease A number of
these risk factors are stfbject to correction or amelioration with the help of a
physician It is reasonable to suppose that many strokes might be postponed or
averted by dietary measures or drugs to control hypertension blood lipid prob
lems diabetes and other modifiable risk factors particularly if the stroke prone
individual is identified early and preventive measures are initiated promptly
The value of blood pressure control in reducing stroke risk has been well docu
mented in a number of clinical studies and many scientists believe that the wide~
spread application of measures for the control of hypertension may be largely
responsible for the 20 percent reduction in mortality rate from stroke that has
been achieved since 1950 It is to be hoped that an aggressive approach to other
r%sk factors can result in further reductions in death and disability from stroke
particularly among subjects under age 65.
CURRENT ACTIVITIES AND FUTURE PLANS
Current NHLI activities potentially relevant to the problems of stroke include
research activities in thronthosas atherogenesis etc , epidemological studies
aimed at determining the underlying causes of stroke; primary prevention inter-
vention trials particularly on the risk factor of hypertension research con
cerned with treatment of hypertension These activities will be continued and
intensified in the future.
NATIONAL HEART AND LUNG INSTITUTE-CEREBROVASCULAR DISEASE AND STROKE-RELATED DISEASES
MAY 5 1972
LDollars in thousandsj
(Estimated)
1968 1969 1970 1971 1972 1973
A. Cerebrovascular circulation $1,602 $1,219 $976 $835 $464 $490
B Thrombosis 2 553 2 702 2 859 3720 4 169 5 725
C Hypertension studies 3 031 3 165 3 307 4 747 5 179 5 376
D Arteriosclerosis 4 652 3 873 3 558 5 500 6 391 7 045
E. Epidemiology 382 402 423 445 469 395
.* _.____ ---- *.*_ ---- __*._*. --- _.
Total 12 220 11 361 11123 15 247 16 672 19 031
Total obligations 162 134 161 834 160 433 194 826 232 000 255 000
-~
Percent of total obligations~ - - - 7 7 6 7 7 7
STROKE RESEARCH SUPPORTED BY THE NATIONAL INSTITUTE OF
NEUROLOGICAL DISEASES AND STROKE
The major emphasis programs in stroke in the NINDS began in 1961 with
the initation of the Cerobrovascular Research Center Programs funded by
research grants
At present there are 17 centers having a total funding In 1972 of $3 900 000
In addition NINDS supports a number of ordinary research projects relating
to stroke. Several cooperative studies of different methods of treating stroke a-re
currently In progresa
PAGENO="0176"
170
The following table indicates the total level of research support by the NINDS
since 1~O8, used specifically for stroke. Training support in various disciplines
and research in related fields such `as brain injury and basic neuroscience also
contributes directly to stroke although `they are not so identified.
1972 1973
1968 1969 1970 1971 estimate estimate
Total stroke research grants (in millionsof dollars)
Research grant total obligation (in millions of dollars)
4.7
52. 6
5.5
53. 6
4.9
50. 0
5.5
53. 8
8.0
64. 3
8.0
64. 3
Percent of stroke grants to total grants
8. 9
10. 3
9. 8
10. 2
12. 4
12. 4
In 1972 an increase of $2 million was approp$ated to establish several Stroke
Acute Care Research Centers. A task force has been appointed to plan this
program, and it is anticipated that applications will be ready for review by the
NANDS Council in November 1972. Since funding will be in FY 1973, we have
asked the Congress to permit us to spend the additional $2 million made avail-
able during FY 1972 for ordinary research project grants related to stroke.
With new funds that are available in FY 1972, the NINDS has initiated a
contract program in stroke epidemiology, development of non-invasive, diagnostic
methods, and other directed stroke research.
The Director of the NINDS has recently appointed a Commission on Stroke
under the chairmanship of Dr. Clark Millikan, a distinguished neurologist with
many years ~f experience in stroke. In addition to members in the required
scientific disciplines, liaison members from NHLI, VA, and RMPS have been
appointed. The first meeting will take place on May 10, 1972.
The Commission is charged with reviewing existing research programs in
stroke, in formulating strategies, and identifying new opportunities for future
research. In addition to this Commission, the NHLI/NIN.DS Joint Council
Subcommittee on Cerebrovascular Disease will continue to advise both Institutes
and to coordinate their activities in stroke.
During 1972 two conferences supported by the NINDS took place to discuss
in detail current research in progress on stroke. These were the Princeton Con-
ference on Cerebrovakular Disease and the Cerebrovaseular Research Center
Workshop.
NATIONAL INSTITUTE OF NEUROLOGICAL DISEASE AND STROKE-STROKE OBLIGATIONS
[In thousands of dollarsj
Estimate, Estimate,
1968 1969 1970 1971 1972 1973
1. Total stroke obligations 4, 987 5, 899 5, 109 5, 784 8, 628 8, 633
2. Total Institute obligations 121,979 126, 085 97, 164 103,445 116, 491 117, 298
3. Percent of stroke to total 4.1 4.8 5.3 5.6 7.4 7.4
Included in line 2 above:
Eveobligation 20,419 21,519 1,978
GRSG 7, 140 7, 430 5, 477 5, 027 5, 136 5, 439
NIH management fund 4,888 6, 358 5, 226 6, 500 5, 507 5, 588
Total 32,447 35,307 11,781 11,527 10,643 11,027
Total stroke obligation 4,987 5, 899 5, 109 5, 784 8, 628 8, 633
Total Institute obligation minus eye, GRSG, and
management fund 89,532 90,778 85,383 91,918 105,848 106,271
Percent of stroke to total 5. 6 6. 5 6. 0 6. 3 8. 1 8. 1
Stroke is a disease which causes severe damage to the brain. Its predominant
underlying causes are atherosclerosis, hypertension, thrombosis, and congenital
abnormalities of the blood vessels. Since these causative factors are the subject
of major research programs of the National Heart and Lung Institute, the
Committee expects that the Institute will give these programs high priority and
that the new Advisory Council will give special emphasis to the continued devel-
opment of these programs in the NHLI and to effective coordination with related
stroke programs in the National Institute of Neurological Diseases and Stroke.
Mr. Roo~ls. What is your feeling about including the pediatric pul-
monary centers in the bill.
PAGENO="0177"
171
Dr. COOPER. I feel that to study lung function you don't set an age
limit on it. It has been our approach to study the function of the lung
where the problems lie. I think we have directed some initial intention
to the study of the pediatric problem and would hope to be able to
continue to do so.
Mr. ROGERS. In other words, you would have no objection to pedi-
atric pulmonary programs being directed to this.
Mr. CARTER. If you would yield.
Mr. ROGERS. Certainly.
Mr. CARTER. You are referring to cystic fibrosis?
Mr. ROGERS. Part of it.
Dr. COOPER. I would agree with that. There is the problem of pre-
maturity, of hyaline membrane disease. The problem of prematurity
should be in the childrens' institute. The problem of pulmonary func-
tion in infants and children needs to be studied by lung specialists as
well.
Mr. ROGERS. I think you could use a coordinating committee tech-
nique here, couldn't you?
Dr. COOPER. Yes, sir. I think a coordinating committee technique is
a valuable one for this purpose.
Mr. ROGERS. I would like for the record tohave what RMP has done
in this pediatric pulmonary program, or any other such programs the
Department has in being, and what the plans are for the future, along
with proposed funding and what the funding has been, along with the
numbers of people involved and any progress that has been made.
(The following information was supplied for the record:)
REGIONAL MEDICAL PROGRAMS SERVICE-PEDIATRIC RESPIRATORY DISEASE
Grants 1971 1972
Colorado/Wyoming $38, 600 Terminated in 1971 after 3 years
support.
Georgia 143, 500 $73, 887
Greater Delaware Valley 16,600 263,489
Louisiana 445, 198 Approved but unfunded to date.
Metropolitan District of Columbia 133, 457 Do.
New Mexico 99, 100 95, 024
New York Metropolitan 172, 000 Support terminated after 3 years.
Puerto Rico 120,000 120,000
Washington/Alaska (6 months) 58,000
Total 1,189,055
CENTERS Now BEING FUNDED BY OUTSIDE SOURCES
California: $175,400; is now self-supporting.
Hawaii: $107,000; $15,000 granted to the Center by Wyeth Laboratories.
The approach of Regional Medical Programs has been one of Federal guidance
and funding on the one hand and local planning and decisionmaking on `the other.
One basic tenet has always been that the Regional Advisory Group can best
design the implementation and operation `of programs which meet the needs of
its region as defined by the community being served and its Comprehensive Health
Planning agency. The role of the RMP and its Federal counterpart has been to
assist in finding and demonstrating the best approach to meeting health needs.
Thus the pediatric pulmonary *disease proposals must compete at the local
level for program priority and funds, and it is basically the local Regional Ad-
visory Group which has the responsibility to make those `decisions.
As an example of the types of pediatric pulmonary activities `being carried
out by the Regional Medical Programs, the pediatric pulmonary disease program
78-994 O-72---12
PAGENO="0178"
172
sponsored by the Greater Delaware Valley RMP is working on the development
of an acute diagnostic center the development of satellite centers and attempting
to develop expertise among physicians and other health professionals in provid
ing early diagnosis and treatment With the leadership and assistance of the
Philadelphia Pediatric Center satellite centers have been developed to the point
where they are beginning to provide needed services in their respective
communities
Funding for this program next year is planned to be at a level not less than
that provided in 1972 which is consistent with the overall program budget re
quested for 1973 Further expansion is possible and dependent upon local program
priorities in the same manner as are all other activities funded by regional
medical programs
Great emphasis to date has been placed upon providing physicians and other
health professionals with the necessary specialized training and as a result
of these efforts significantly laiger numbers of people may be expected to benefit
because of earlier diagnosis and treatment.
Mr ROGERS How many people do you need for lung research ~
Dr COOPER In the Institute or in the country ~
Mr ROGERS Both, if you can give it to me I realize these would be
estimates
Dr COOPER When the assessment of whether there needed to be a
new focus program to the National Institute of Health for lung re
search, when these original studies were done, it became quite clear
there was a great shortage of pulmonary experts and pulmonary scien
tists throughout the country As Dr Carter pointed out earlier, even
in areas where there are special environmental problems, the experts
for certain types of activities were just not available Perhaps 48 or
50 percent of the major teaching institutions were deficient in having a
staff that was adequate for doing lung research
Now, to put an exact number of people on it is very difficult The
Institute is now conducting a survey in association with the specialty
board in pulmonary diseases and the professional societies of pul
monary disease in order to try to determine what the national needs
in these categories are
We hope to have this study, which is being funded by a contract
with the National Tuberculosis and Respiratory Disease Association,
completed within the next several months That, hopefully, will put
a figure to shoot at on our projections
But we, obviously, feel there is a great need This would apply to
the Institute as well.
Mr RooRns Would you keep us advised of that report ~
Dr. COOPER. Yes, sir.
(The following information was supplied for the record )
As of this date, there are no results available from the survey of personnel
needs in the pulmonary area We have a contractor making the survey and the
final report will be available around the end of July at which time further in
formation can be supplied
Mr ROGERS Obviously we are not producing enough young people
to go intc~ the area of lung, so this must be encouraged
Dr. CO~PER. Yes.
Mr RO~ERS What about heart ~
Dr COO~ER The heart problem, ii~ my opinion, is a selective one
Because of the long term support of the Institute's program for the
last 20 years, there has been significant development of cardiovascular
and cardiological experts, and we have trained in excess of 15,000
people in this category to this point.
PAGENO="0179"
1:73
This has demonstrated that in some areas we probably are produc
ing, in my opinion, enough experts for some categories In other areas,
even in the cardiological sphere we feel, now that we know what is
necessary, we will need to do more
In order to try to put some precise data on that, we are also conduct-
ing a survey in association with the American College of Cardiology,
the Specialty Board of Cardiovascular Diseases, the Medical Board
and with the American Heart Association in order to quantify that
number We should have that data available within the next 9 or 10
months as well.
I think this will be more selective I don't think it is a case of need
ing more for everything all of the time
Mr ROGERS What about researchers in the area of heart ~
Dr COOPER This will also be in selective areas In some specific dis
ciplines, of people who direct their attention to the specialty of the
cardiovascular system, we may have enough in some areas at this time
in other areas we probably do not have enough, like morphologists, in
my opinion I think we will need to identify where we need some of
these areas bolstered
We have finished the study of pediatric cardiological needs We have
an estimate of what we might need in this area over the next 10 years
Mr. ROGERS. What is that estimate?
Dr. COOPER. It is about ~25 experts in this field by 1980.
Mr. ROGERS. Is that within your Institutes?
Dr. COOPER. No, this would be a reflection of the national need for
the certified specialists in this area
Mr ROGERS I was not clear I think I might ask you to comment on
establishment of these centers and prevention control functions in the
centers How can we really get going on prevention control ~
Dr COOPER I think in chronic disease the key to prevention is an
awareness in the public and an awareness in the profession of what is
really available in order to advise people who are basically nonsympto~
matic to do something that will eliminate a disease which probably be
gins early in life and takes a large segment of time to develop There
fore, it is important that people have available for themselves the abil-
ity to get their blood pressure checked and, if abnormal, properly
treated, to get advice about their activity, about their rest, about then
diet and so on.
Now, unfortunately we cannot approach prevention in this disease
by, for example, a vaccination at the present time.
I think another area that needs to be investigated is the possibility
of drug preventives We probably need to explore what can be done on
this Obviously, the most potent agents that we have for the control of
hypertension right now are the application of pharmacologic agents
So I think the function of centers in this national problem is a focus
on awareness, education, the resource available to the professional com-
munity as well, that will help in the overall adaptation of the Ameri-
can mind to the need for greater awareness of the problems of preven
tion in these diseases.
Mr ROGERS But we could establish screening programs You feel
this is feasible, as I recall
Dr COOPER For the areas that should be identified, as you asked me
to provide for the record, I think we should encourage the identifica-
tion of these abnormalities.
PAGENO="0180"
174
Mr. ROGERS. I think it would be well if you could give us an example
in your testimony for the record of the operation of `a center, how you
envision the center operating, personnel, what census population it
could probably cover.
Dr. COOPER. All right.
(The following material was supplied for the record:)
OPERATION OF A CENTER
The centers to be established would be comprehensive in concept and in opera-
tion. They would be concerned with all the major aspects of disease prevention,
epidemiology, genesis, clinical manifestations, and treatment. They would be lo-
cated at or near major medical centers `but, to a large extent, would be free-
standing. These centers can best be viewed as national resources devoted to the
alleviation of cardiovascular and pulmonary diseases. In virtually all circum-
stances, this would `require new construction and the purchase and development
of new and additional facilities; the recruitment of senior level personnel as well
as technical and administrative staffs; and the development o'f suitable organiza-
tional frameworks.
The centers would, of course, have to be multidisciplinary in their approach and
equipped with personnel and modern instrumentation to deal with the study, de-
tection, prevention, arrest, and reversal of the particular diseases in question.
They would be actively engaged in the screening of populations; they would pro-
vide an environment wherein new therapies could be promptly evaluated; al-
though not primarily designed for training purposes, the environment would be
especially suitable for such activities.
Mr. ROGERS. Is there any profile of activity or diet that is associated
particularly with people who have a good set of lungs? Is there any
profile of this? Is there any particular criteria that has been set forth
to avoid lung diseases, other than smoking?
Dr. COOPER. Other than smoking and environmental pollution we are
much further kehind in the understanding of the risk factors in the
genesis of lung disease than we are in cardiovascular disease. Just re-
cently the suggestion has been made that there are also genetic factors
that make individuals more susceptible to emphysema and this could
be correlated with the specific enzyme in the blood. Whether this will
prove to be a useful tool we are not sure, and we have a program de-
signed to try to approach this evaluation.
We are fairly certain that infection plays a role in the long-term
genesis of obstructive lung disease. We think allergy is a factor. We
think environmental influences are.
One of the important deficiencies in our knowledge here is how to
assess pulmonary function or what technique should be used early on in
order to try to detect who is susceptible and what to do early enough.
This is one of the objectives of our new program in lung research in
order to try to develop methods to detect early compromise of the
major airway systems.
I think when we have those techniques, we will be able to better
answer your question. I am sorry I cannot be more specific scientif-
ically in this area, but this is a great void of information that needs
a great deal of research.
Mr. ROGERS. I think you might let us know what you are projecting
in the way of research in this area, the funding, and the way you have
been handling it.
Dr. COOPER. We will have a complete report available by the end of
June, it is expected, on the various facets of the factors influencing
pulmonary disease.
PAGENO="0181"
175
(The following information was supplied for the record:)
As of this date, there are no results available from the survey in the pulmonary
area. We have a contractor making the survey, and the final report will be avail-
able around the end of ~luly.
Mr. ROGERS. Also, I think the committee would like to see the various
diseases that you are doing work on in your Institute, the amount of
money, the pattern of that disease, say, over the last 20' years, whether
it is going up or down in its rate, what significant advances have been
made, and~if those advances have been funded by our people or out-
side so we can `have some concept of what h'as happened in this area.
(The testimony resumes at p. 192.)
(The following material was received for the record:)
NATIONAL HEART AND LUNG INSTITUTE PROGRAMS
The National Heart and Lung Institute is the focal center of the Federal
government responsible for research, development and education to ~ontrol heart,
blood, and lung diseases. This report briefly summarizes the Institute's programs
and their historical development since the formation of the Institute in 1948.
Tables I and II depict the funding and staffing history of the Institute.
Hundreds of threads are woven into the fabric of NHLI programs. This re-
port does not include every one of them. But the sampling included is broad
enough to give a comprehensive idea of the real issues faced by the NHLI and
how the Institute is tackling these problems.
The federal involvement in programs related to heart, blood, and lung diseases
is a public health issue commanding the attention of every American. As a tax-
payer contributing funds for the solution of these problems or an individual who
may directly benefit from new methods of prevention and therapy for these dis-
eases, the American "consumer" has a great stake in the successful development
of federal programs which will stem the tremedous economic and social drain
resulting from the unchecked ravages of these diseases among our people. It is
a costly problem running into billions of dollars a year, and it is exceedingly
wasteful of human resources, amounting to the loss of more than one million
lives per year and disabling many more of our citizens every year, year after
year.
The stated mission of the Institute is as follows: conducts, fosters and sup-
ports research, investigations, and demonstrations relating to the cause, pre-
vention, and methods of diagnosis and treatment of diseases of the heart, lungs,
and circulation through: (1) research performed in its own laboratories and
through contracts; (2) research grants to scientific institutions and to individ-
uals; (3) training and instructions in the research and clinical aspects of cardio-
vascular and respiratory diseases; (4) promoting the coordination of all such
research and activities and the useful application of their results, and (5) col-
lection and dissemination of information on these diseases.
Over the years the Institute has developed a number of approaches to tackle
these disease problems. These approaches include mechanisms for selection and
development of people and research ideas throughout the national and inter-
national research communities; expansion of knowledge and expertise within the
Institute itself; development of management tools and mechanisms to evaluate
performance and efficiency of programs and guide future plans and develop-
ments; a continuous, aggressive search for new opportunities and powerful
skills which could substantially contribute to solving or reducing the problems
of heart, blood and lung diseases; and programs to ensure professional educa-
tion in and public understanding and acceptance of these new public health
developments.
As a result of these efforts National Heart and Lung Institute researchers
have pioneered and developed many new ideas, techniques and skills which have
significantly increased the options for dealing with these diseases in the United
States population. It should be emphasized that many of these concepts and de-
velopments remain untapped as far as benefiting the American public as a whole.
It is a paradox that almost by virtue of this relative neglect of application of
available resources and solutions in cardiovascular and respiratory research, the
potential opportunities for improved management of these diseases are now so
much greater than would have been the case had applications kept pace with
PAGENO="0182"
176
new developments all along The Institute has made plans for programs that
will shorten the lead time for bringing these new developments to the people
and these plans are included in the five-year plan developed by the Institute It
is because of this substantial reservoir of knowledge and skills and the presence
of these plans that one can predict with a high degree of confidence that in
creased funding of the Institute s programs at this point in time offers definite
prospects of both immediate and long term returns on the investment in terms
of improving the quality of life for our people Quite frankly it is time to put
these research findings to work for the American people by demonstrating their
efficacy in actual field tests in community settings and the Institute is ready
and committed to proceed with this task.
I HEART AND BLOOD VESSEL DIsJi~sEs
ISSUES
Diseases of the heart and blood vessels account for more than 54 percent of
all deaths in the United States and the economic drain of heart disease alone
has been estimated at more than $30 billion' Among the major high priority dis
ease problems to be tackled by the Institute are arteriosclerosis hypertension
and kidney diseases and other cardiac and cardiovascular diseases
DESCRIPTION OF PROGRAMS
A Art erwscieros'&s
Arteriosclerosis commonly referred to as hardening of the arteries is the great
set killer among the cardiovascular diseases All ages are involved with an in
creasing frequency in each decade of life Over the years the Institute has
developed a number of approaches to the prevention treatment and rehabilitation
of patients suffering from this serious disease including support for research
grants research contracts training grants and fellowships A comprehensive re
view of the field including conclusions and recommendations for further research
and development may be found in the June 1971 report by the NHLI Task
Force on Arteriosclerosis
In 1949 the Framingham Heart Disease Epidemiology Study was transferred
to NHLI from the Bureau of State Services This study has provided important
data on factors such as high blood pressure smoking overweight and elevated
blood lipids that increase susceptibility to coronary heart disease and stroke
two clinical disorders related to arteriosclerosis This information is helping
physicians to identify the highly susceptible patient early and to imtiate measures
calculated to reduce his risk
In 1950, NIH launched the first undertaking in what was to become a long and
distinguished series of cooperative studies wherein investigators from numerous
institutions pooled their efforts in attacking a common research or clinical prob
lem The first of these efforts was in arteriosclerosis and explored the relationship
between blood hpoprotein patterns and atherosclerosis Subsequent cooperative
studies related to arteriosclerosis include The Joint U S United Kingdom Study
of Cardiopulmonary Disease initiated in 1959 to investigate factors in the person
and his environment responsible for the differing patterns of mortality from
coronary heart disease and chronic respiratory diseases existing in the U S
the Cooperative Study of Extracranial Arterial Occlusion initiated in 1959 to
identify patients with strokes resulting from atherosclerotic or other obstructions
to the brain s major feed lines in the chest and neck and with evaluation of the
results of surgical procedures to remove or bypass operable obstructions and
plans were begun in 1960 for the current Cooperative Study of Drugs and
Coronary Heart Disease The objectives of this large scale clinical trial in
volvmg 8341 men with previous myocardial infarctions are to evaluate the effec
tiveness of several lipid lowering drugs in the prevention of recurrences of
premature death from heart attacks The study involves 53 clinical groups plus
five supporting units.
In 1956 NHI participated for the first time in the U S U S S R Scientific Ex
change Missions Dr James Watt NHI Director was a member of the mission
to visit centers for the study and treatment of heart disease in the Soviet Union
i?his was followed in 1957 by a reciprocal visit by leading Russian cardiologists
to NHI and other U.S. heart research centers and by additional missions in sub-
sequent years.
1 1064 President s Commission on Heart Disease Cancer and Stroke
PAGENO="0183"
177
Planning was begun in 1960 for a National Diet Heart Feasibility Study to
determine whether a large long term population study to assess the effects of
cholesterol lowering diets on morbidity and mortality from coronary heart disease
should be undertaken by the NHI The clinical phase of the feasibility study was
begun in 1962 and completed in 19~5 The final report and recommendations were
completed in 1968
In 1966 NHI established the Artificial Heart Myocardial Infarction Program
for the purpose of combining bioengineering and biomedical approaches toward
the reduction of death and disability from acute heart attack The Myocardilal
Infarction Branch of the program was established in 1966 for the purpose of
setting up and administering a national program of research aimed at reducing
death and disability from acute heart attacks An important phase of this pro
gram is the establishment of a chain of Myocardial Infarction Research Umts at
major U S medical centers These units combine unexcelled medical care for
heart attack patients with intensive clinical and laboratory research on acute
heart attacks and their complications. The purposes of the MIRU's is to in-
crease medical knowledge of the acute heart attack itself to Identify physiologi
cal psychological and other factors that critically affect the outcome and to
seek new or improved methods of diagnosis patient monitoring and treatment
that will be widely applicable to the care of coronary patients Considerable prog
ress has been achieved along these lines progress of direct benefit to patients
with the disease.
In 1968 the Institute undertook a complete review and analysis of the research
in arteriosclerosis. The scope of this study included a review of the grant pro-
gram of the Nh with a view to determining the types of research being sup
ported, a study of the apparent balance of the program in terms of kinds of re
search and their relation to each other and identification of research inactivity
and the causes thereof as well as identification of tethnical and scientific areas
where lack of appropriate interest appeared to be delaying the discovery or ap~
plication of knowledge about arteriosclerosis The study also extended beyond
the NHI to the entire USPHS and to other agencies such as the Veterans Ad
ministration the Amertean Heart Association the Life Insurance Medical Re
search Fund and the Canadian Heart Foundation
The NHI reorganization on August 12 1969 provided for the formation of a
branch for Arteriosclerotic Disease in the Extramural Program The subject
matter assigned to this branch includes research into the etiology and patho
genesis prevention diagnosis and treatment of arteriosclerosis coronary artery
disease peripheral vascular disease cerebrovascular disease aging and dis
orders of connective tissue of blood vessels The variety of research supported
through this branch continues to be very great It ranges from the most basic
studies in molecular structure and function to the evaluation of surgical pro
cedures and the epidemiological description of disease Recent progress includes
animal models mimicking the human disease of arteriosclerosis and the new
techniques in cardiovascular surgery including revascularization of the heart
In Fl 1971 the branch initiated a chain of thirteen Specialized Centers of Re
search in Arteriosclerosis throughout the United States It is anticipated that
these Centers will form a complimentary and supplementary network of sophisti
cated investigations that will appreciably shorten the timetable to attain common
goals in the study of arteriosclerotic disease
On June 12-13 1970 the National Heart and Lung Institute convened a panel on
Hyperlipidemia and Premature Atherosclerosis. Its missiOn was to evaluate the
opportunities and requirements for a program which would apply the most
sophisticated techniques available to the detection and management of premature
atherosclerosis associated with hyperlipidemia The panel concluded that further
federal assistance is necessary to effect the optimal application of new knowledge
acquired through many man years of research The panel recommended that
the Institute fund a number of coordinated lipid laboratories where quality eon
trol of both methods and interpretation will be monitored new diagnostic tests
dev~loped and evaluated physicians will provide consultation ion diagnosis and
therapy data on prevalence will be uniformly collected and forwarded fec central
collation and important research questions relative to hyperlipoprotelnemia will
be studied by the most sophisticated techniques available The prevention of
premature atherosclerosis through the treatment of hyperlipidemia is a primary
goal of the Institute. In order to capitalize on recent advances in the understand-
ing of hyperlipidemia, the Institute established a Lipid Metabolim Branch in Fl
1971 which will coordinate the work of the newly established Lipid Research
Clinics in different parts of the country.
PAGENO="0184"
178
During FY 1971 the Institute convened a Task Force on Arteriosclerosis to
develop plans designed to prevent and control the disease process and treat its
complications, in order to reduce the number of victims and minimize the loss of
health and of productive life. The report 1y the Task Force was submitted to the
Institute on June 30, 1971 and is currently being considered by the Institute in
future planning in arteriosclerosis.
B. Hypertension and kidney disease
Hypertension is one of the most commonly encountered forms of cardiovascular
disease, affecting an estimated 17-22 million adult Americans. Of these, 10.5
million suffer from heart disease as a consequence of hypertension. Hypertension
aggravates and accelerates the development of atherosclerosis, and is a major
cause of strokes, heart failure, and kidney failure.
The great majority of patients with hypertension (perhaps 80-90 percent)
must be labelled "essential" due to lack of identification of a specific cause. It
appears that many variables contribute to this condition. However, identifiable
causes of high blood pressure have been discovered in increasing numbers in
recent years. Almost any form of kidney disease may be associated with an
elevation of the blood pressure. Regrettably, curable causes of hypertension are
identified in only a small fraction of patients.
However, the results of research show that there is considerable hope for
these patients. Carefully controlled clinical trials have shown that `treatment of
hypertension is effective in decreasing the occurrence of some manifestations of
arteriosclerosis, i.e., stroke and congestive failure. Despite the impressive evi-
dence that treatment is effective, numerous studies indicate that the treatment
of hypertension in the population is inadequate. For instance, in a county of
Georgia, 70 percent of hypertensives were not receiving treatment at the time
of the study. Of those found to be hypertensive, 41 percent did not even know
that the condition was present. Only 47 percent of those receiving treatment had
normal blood pressure readings; thus 53 percent of these taking medication were
inadequately treated. It is apparent that improvements in the health delivery
system must and can be made in order to identify patients with hypertension and
provide them with effective treatment.
A Branch for Hypertension and Kidney Diseases was established within
the Extramural Program on August 12, 1969, and in FY 1971 five Specialized
Centers of Research in Hypertension were established in different parts of the
United States. It is expected that the presence of these centers will quicken the
pace of translating research results to bedside practice.
Recently, through its Clinical Applications Program, the NHLI initiated a
program in nine communities throughout the United States to develop and
evaluate methods of detecting and caring for hypertensive persons in the popu-
lation at large. Initially, a population of about 3,000 hypertensives will be iden-
tified in their communities. These individuals will then be referred to various
programs for medical care and periodic long-term follow-up. A major effort of the
program will be the study of those patients who neglect taking adequate treat-
ment. Procedures will be developed to improve participation both by helping to
motivate the patients and by removing other barriers to compliance. Subsequently,
the effects of treatment in terms of reduced death and disability will be studied
in these patients.
C. Cardiac and other cardiovascular diseases
The research which falls within this category is concerned both with cardio-
vascular diseases, other than the above, and with normal cardiovascular func-
tion. Thus, there is little homogeneity of characteristics either within the sub-
groups or within the category as a whole.
The principal categories are: cardiac arrhythmias, studies of heart muscle,
cardiovascular dynamics, congenital and rheumatic heart disease, heart failure
and shock.
Studies by the Institute in the field of congenital heart diseases have included
studies to identify potentially preventable causes of congenital heart defects,
studies on the natural history of congenital heart defects, development of im-
proved techniques for detecting and evaluating congenital heart defects, and
more effective surgical procedures for palliating or correcting such defects and
better life-support techniques (heart-lung machines, hyperbaric oxygenation,
etc.) for sustaining patients during prolonged open-heart operations.
PAGENO="0185"
179
Long-term research continues on rheumatic heart disease. Studies conducted
by the Institute over the years include: development and application of more
rapid and sensitive means for early detection of strep infections, wider applica-
tion of continuous antibiotic prophylaxis to protect susceptible individuals
against recurrent attacks, more effective support measures for managing rheu-
matic carditis (inflammation of the heart), preventing or coping with congestive
failure, a variety of artificial valves for replacing those hopelessly damaged by
rheumatic fever, and improved methods of preserving, and installing valve
homografts.
D. Mu~ticategork~aI programs
In lOfil, NHI embarked on a bold new program of research support with the
awarding of the first of the program project grants. These are large grants,
usually with long-term commitments, designed to stimulate broadly based, in-
depth, multidisciplinary approaches to cardiovascular problems. The goal has
been to encourage scientists skilled in such diversified fields as medicine, bio-
chemistry, physiology, and engineering to work together in teams, each individual
lending his particular expertise where needed in solving problems related to the
team's research projects.
During FY 1972 the Institute started the largest single clinical trial it has ever
undertaken to test the effects of multiple risk factors-smoking, high blood pres-
sure, and elevated lipids together-and their relationship to heart attacks,
strokes, and other events. This program is called the Multiple Risk Factor Trial
and is scheduled to last for ten years. It is a very important study since it is
expected to give a definite answer to the question whether it is possible to
interfere with the process of arteriosclerosis once it has started. This study will
be conducted in cooperation with a number of centers throughout the United
States and will involve long-term, careful study of more than 10,000 people.
HISTORY
The National Heart Institute was created on Tune 16, 1948, when President
Harry S. Truman signed the National Heart Act. The new Institute was charged
with conducting research into the causes, prevention, diagnosis, and treatment of
diseases of the heart and circulation; fostering, supporting, and coordinating
cardiovascular research and related activities by public and private agencies,
providing training in matters relating to heart diseases; developing more effective
methods of prevention, diagnosis and, treatment; and assisting States and other
agencies in the application of these methods.
On August 1, 1948 the Institute was formally established as one of the National
Institutes of Health with headquarters at Bethesda, Maryland, and Dr. C. J. Van
Slyke was appointed its first Director. During the fall of that first fiscal year
(F.Y. 1949), the Institute was organized and staff recruiting begun. The first
organization chart included the Office of the Director, the Cooperative Research-
Projects Section, the Statistical Analysis Branch, and the Heart Information
Center. Later that fiscal year, an Associate Director for Research was added, a
post initially occupied by Dr. James A. Shannon, later director of NIH. The Heart
Disease Epidemiology Study at Framingham, Massachusetts, was transferred
from the Bureau of State Services, PHS, to NHI on July 1, 1949. On July 6, 1953,
the first patient was admitted to the Clinical Center for heart disease research.
The Institute received its first appropriation in 1950. It provided $10,725,000
for the support of current cardiovascular programs which had been transferred
to NHI from elsewhere at NIH and $5,350,000 of contract authority, primarily
for committing a second year of support for training grants and research con-
struction. The Institute's intramural research budget that year was about $1.36
milton. Some $3.9 million was allocated for research grants and $1.7 million for
training grants to 45 medical schools and for clinical traineeships to 45 physicians.
The appropriations for heart and blood vessel research during the remainder of
the Institute's history are detailed in Table I.
By fiscal year 1950, the fundamental organization of the Institute was well
outlined. Organizational changes have occurred over the years in response to the
changing needs of cardiovascular research and training and the new opportunities
for progress that have developed from earlier programs. Table II depicts the
Institute's staffing history up to the present time In each of the major program
areas of cardiovascular research, and Table III shows the current organizational
components of the Institute.
PAGENO="0186"
180
Over the years groups of cardiovascular experts have met at periodic intervals
to appraise developments and to determine needs and opportunities for continued
and accelerated progress against heart and blood vessel diseases and to prepare
reports. Some of these gatherings and their reports are: The first National Con-
ference on Cardiovascular Diseases, sponsored by NHI and the American Heart
Association, January 18-20, 1950; `a report to the Nation on "A Deca'de of Prog-
ress Against Cardiovascular Disease," presented by the American Heart Asso-
ciation and NHI on February 19, 1959, at Department of Commerce Auditorium,
Washington, D.C.; the report to President John F. Kennedy on April 21, 1961, by
the President's Conference on Heart Disease and Cancer, to assist in charting the
Government's further role in a National attack on these diseases; the second
National Conference on Cardiovascular Diseases, sponsored by the American
Heart Association, NHI, and Heart Disease Control programs of PHS, November
22-2t, 1964; the report to President Lyndon B. Johnson on December 9, 1964, by
the President's Commission on Heart Disease, Cancer, and Stroke, to recommend
steps that can be taken to reduce the burden and incidence of these diseases; the
20th anniversary of NHI commemorated at the White House, with President
Lyndon B. Johnson on November 14, 1968, and prominent figures associated with
NHI, past and present, participating; a report was prepared for the occasion
reviewing research progress; and finally during the last couple of years a number
of consultant groups have carried out in-depth analysis of all the major program
areas of the Institute and submitted reports to the Institñte delineating recom-
mendations for future plans for research and developments; the most recent
group is the NHLI Task Force on Arteriosclerosis which submitted its report in
June, 1971.
OPPORTUNITIES AND OPTIONS
The future opportunities and the options generated by recent Institute re-
search in cardiovascular diseases are numerous and of great promise in terms
of improved health of the nation. The 1971 Task Force on Arteriosclerosis pre-
pared a two volume report containing detailed recommendations for programs
to be implemented in the near future as a result of new research findings.
Specific recommendations included a national, coordinated, comprehensive pro-
gram for the prevention and control of arteriosclerosis; the development of new
national resources such as centers for prevention, cardiovascular disease pre-
vention clinics, and an office of health education within the Institute; clinical
trials to test the "risk factor" hypothesis that modification of risk factors such
as smoking, hypertension, and food intake can help prevent arteriosclerosis;
expansion of lipid research clinics, a clinical trial to test the effect of interfering
on `several risk factors in one and the same person; studies to reduce death and
disability from the acute events of arteriosclerosis, such as heart attacks and
strokes; recommendations for research; manpower development and training;
and managerial aspects of `arteriosclerosis, such as the giving of incentives to
the food and tobacco industries `to make their products commensurate with optLl-
mal human health.
Research has given the physician of today a variety of drugs for treating
hypertension of all degrees of severity, including milder forms of the disease,
often left untreated before. The resulting decline in mortality has been striking
in patients with severe or malignant hypertension. But none of these drugs is
perfect, and some have unpleasant and sometimes serious side effects. Oppor-
tunities exist for new or improved therapeutic agents which will further increase
the options available for the patient with hypertensive disease, so as to prevent
the serious side effects of stroke and heat failure.
II. BLOOD PROGRAM
ISSUES
The Institute's programs in blood are intimately related to its responsibilities
in cardiovascular and pulmonary diseases, and are sometimes so closely related
that it becomes difficult to separate them from these areas of activity. Blood is
a very vital part of the circulatory system since it is the vehicle in which oxygen,
nutrients, and other body chemicals are carried through the blood vessels to
every part of the body, to be exchanged for carbon dioxide, waste products and
chemicals which in turn need to be transported away from the tissues to other
body organs either for excretion from the body, or for use in their life processes.
Principally, the three areas addressed by the Institute's blood program are:
Thrombosis, Hemorrhagic and other Blood Diseases, and Blood Management.
PAGENO="0187"
`Si
Thrombosis (clotting of the blood carried in the blood vessels) may be a
serious circulatory complication in cardiovascular and pulmonary disorders The
Institute 5 current militancy in blood management programs is primarily a re
spouse to new needs created by successful new ventures in other NHLI pro
grams, particularly in earthovascular surgery These new developments call for
unusually large quantities of blood (e g 20 units) for a single surgical pro
cedure and the strong public demand for these new cardiovascular operations
threaten to jeopardize the blood supply for other patients such as hemophilacs
patients with sickle cell crises accident victims etc who also have legitimate
claims to this limited vital resource
DESCRIPTION OF PROGRAMS
A BZood Management
The Institute 5 programs in blood management include studies to improve
the quality of transfused blood by developing new preservatives and by eliminat
ing contaminating disease agents such as hepatitis virus studies aimed at
multiplying the usefulness of a single unit of blood by fractionatmg it into Its
therapeutic component parts and giving each component to a different patient
as his need dictates and systematic studies of blood banking techniques and
blood therapy to develop systems for more intelligent and efficient utilization
of the limited national blood supply
Early in the development of the Program emphasis was on research in blood
preservation and fricationation Work on adenine as a blood preservative was
successfully completed during FY 1969.
In 1967 a major project was undertaken with the American National Red
Cross in the field of blood fractionation Much of this work has been completed
and the results disseminated to the blood banking community Further refine
ments are possible and work continues with current emphasis being on research
in methods of platelet (one of the formed elements in the blood) preservation
Beginning in fiscal year 1969 research was started to improve the effectiveness
and detection of hepatitis virus in blood and blood products and techniques for
removing it. This work was expanded in fiscal year 1970 and the Institute has
undertaken a number of projects related to the control of hepatitis in blood
primarily in three areas (1) refinement of testrng procedures to detect the
hepatitis associated antigen (BAA) (2) methods to produce the hepatitis as
sociated antibody (HAAB) in large animals and (3) distribution of the hepatitis
associated antibody to blood banks throughout the United States Research
during the past past several years has shown that blood that is serologically
positive for the BAA carries a very high risk of transmitting the hepatitis virus
If it were possible to remove all units of blood that contained the HAA then
the incidcnce of post transfusion hepatitis in recipients would undoubtedly be
significantly reduced If these tests could be further developed and refined then
many more units of potentially infectious blood could be identified and removed
prior to transfusion Significant progress has been achieved toward these goals
The Institute plans to continue support in this area to reduce the time necessary
to complete the new tests and to make them simple enough for routine blood
bank screening of blood. Both of these goals are feasible. Prior to February 1971
no HAAB was commercially available to blood banks in the United States to
test for the BAA. The Institute anticipated this need and undertook a program
together with the National Hemophilia Foundation and the Division of Biologics
Standards to prepare and distribute the HAAB to all State Health Departments
throughout the United States for use in their blood banks This program was
extremely successful Commercially produced HAAB has since become available
The Institute has initiated a number of studies aimed at improving the utih
zation of the national blood supply In fiscal year 1968 studies were begun for
the development of computerized automation of donor blood inventories and
doner recipient information The purpose of these studies was to permit more
complete utilization of available blood resources and to decrease the probability
of human errors in blood handling and hence reduce the risk to the patient re
ceiving the blood A systematic study of blood banking techniques and blood
therapy in this country was initiated in fiscal year 1971 This study will cover
both present and future resources and needs Questions relating to the procure
ment processing and distribution of blood from donor to recipient will be
examined This study is extremely important since little comprehensive informa
tion Is available on the various aspects of blood banking In the United States.
PAGENO="0188"
182
B. Thrombosis
The Institute's programs in thrombosis include investigations carried out in
its intramural laboratories and extramural research through grants and contracts.
To provide additional thrust and emphasis in this area, a new initiative
designated Specialized Centers of Research (SCOR) in Thrombosis was started
in fiscal year 1971. The goal of this program is to achieve a solution to the
problem of prevention, early diagnosis and improved treatment of thrombosis
and hemorrhage. Five specialized centers of research in thrombosis are currently
in operation. Projects underway include: investigations on the pathogenesis of
thrombosis; diagnosis of clinical thrombosis by isotopic, radiologic and Doppler
ultrasound techniques, and evaluation of measurements of certain blood factors
influencing coagulation; studies of the degradation products of blood clots;
and therapy, including the use of thrombolytic and antithrombolytic agents.
The National Blood Resources Program has conducted a series of clinical trials
of urokinase and streptokinase, two agents which hold great promise against
clotting complications so often responsible for the crippling or lethal manifesta-
tions of heart and blood vessel diseases. The first phas.e of these cooperative
trials was successfully completed in August 1970. It was found that urokinase
and subsequent beparin therapy sigificantly accelerated the resolution of clots
in the lungs (pulmonary embolism). Upon the successful completion of the
first trial, a second phase was entered in which the clot-dissolving capacity of
urokinase will be compared with streptokinase, the other most common throm-
bolytic (clot.dissolving) agent. The limited supply of and hence the exorbitant
cost of urokinase has prevented its extensive use in patients. Efforts by the
Institute to produce large (and practically unlimited) quantities of urokinase
from human èells grown in test tubes were recently successful and will make it
possible to initiate further studies to evaluate this agent for the treatment of
patients with heart attacks, certain strokes, and other thrombo-embolic (clots in
the blood vessels or travelling through the blood vessels) complications of cardio-
vascular disorders, and studies in patients suffering from heart attacks are
currently being initiated.
C. Bleeding dAsorders
Since 196fi when Dr. Judith Pool discovered a method (cryoprecipitate) to
concentrate the antthemophilic factor (AHF) from blood, this material has been
the main stay of treatment for hemophiliacs (an inherited bleeding disorder)
throughout the United States. Unfortunately, no good standardized method now
exists for production of this material. Consequently the therapeutic effects of
transfusion of bemophiliacs with cryoprecipitate are extremely variable. In PY
1971 the National Blood Resources Program undertook a project to study the
variables important in preparing AHF and to develop a standard process whereby
blood banks can be assured of maximum yields of this material from blood. An
important result of this work could be an AHF concentrate that could be pre-
pared in sufficiently large quantities at sufficiently low cost to permit its use as a
routine rather than an emergency procedure for preventing or controlling hemor-
rhage in hemophiliacs.
D. sickle cell disease
Sickle cell disease is an inherited disorder of the blood found almost exclusively
in blacks. It is due to a genetically determined change in the chemical substance
(hemoglobin) responsible for the oxygen-carrying capacity of the blood. The
presence of the changed hemoglobin (hemoglobin S) leads to distortions in the
shape of the normally biconcave red blood cells carrying the hemoglobin, Luaking
these cells less able to survive in the blood circulation and less able to move
freely through the smaller blood vessels. Thus, the presence of hemoglobin S in
the blood cells may have serious consequences such as anemia (a reduction
below normal of the number of blood cells) and also intermittent blockage of
blood vessels, usually termed sickle cell vaso-occlusive crisis. These crises are
characterized by severe pain, fever and anemia and require costly, recurrent
hospitalization throughout the patient's life.
In spite of the degree of refined molecular knowledge about sickle cell hemo-
globin, little is known about the pathophysiological mechanisms involved in
precipitating and sustaining the painful vase-occlusive crisis of sickle cell disease;
and no treatment of proven efficacy is yet available to deal with it. The National~
Blood Resources Program has initiated a co1laborati~e program to test the efficacy
of promising approaches to the therapy of sickle cell crisis.
PAGENO="0189"
183
The NHLI is coordinating the HEW Sickle Oell Disease Program initiated by
the President in 1971. The major objectives of this new program are: 1) To foster
research and development both at the fundamental and clinical level; 2) To
initiate and expand community education, screening and counseling programs;
3) To educate medical and allied health profes'ssions about the problems of
sickle cell disease; 4) To explore ways in which to broaden the monetary support
base through federal, state, local, and non-government agency participation; 5)
To strengthen and expand the base of black professional and technical personnel;
and 6) To improve clinical care for victims of sickle cell disease, including the
application of current technical knowledge. Current planning is proceeding along
two major avenues: research and development, and community services.
HISTORY
In 1950, NHI was designated to administer the research and development
phase of an intensified National Blood Program aimed at insuring an adequate
supply of blood and blood products for military and civilian needs. The experi-
ence gained with this program was to make NHI the choice as the focal point
of the National Blood Resource Program begun sixteen years later.
The National Blood Resource Program was initiated late in 1966 at the behest
of the Congress, which appropriated an additional $1,950,000 to the NHI for this
purpose. A National Blood Resources Branch was established within the Col-
laborative Research and Development Program of the Institute to provide a
mechanism for research contracts for highly targeted research in this area. Al-
though headquartered at NHI, the Program is a cooperative endeavor involving
a number of Institutes and Divisions of the National Institutes of Health and
other federal and non-federal agencies concerned with the acquisition, processing,
distribution, usage, or study of blood and blood products. Cooperation has been
maintained with the American National Red Cross, the National Hemophilia
Foundation, and the Council on Thrombosis of the American Heart Association.
In 1966 the Task Force on Thrombosis of the National Research Council pointed
out that thrombosis was not being properly appreciated as a public health prob-
lem, especially since the lesion probably represented the leading cause of serious
acute morbidity and mortality in this country today (e.g. from acute heart at-
tacks, strokes, and pulmonary infarction (damage to the lungs caused by clots
in the blood vessels). The Task Force stressed the need for the development of an
appropriate focus on thrombosis, and recommended that measures be instituted
which could accelerate significantly the prevention and solution of this most im~
portant clinical problem.
A number of important measures have been taken since the Task Force Report.
These events, which have laid the groundwork for a major attack on the
thrombosis problem in this country, include: an International Conference on
Thrombosis of the American Heart Association; the founding of the Interna-
tional Society of Thrombosis and Hemostasis; and most recentiy (FY 1971) the
institution of NHLI supported Special Centers of Research in Thrombosis
(SCORs).
On October 26, 1968, NHI received the National Hemophilia Foundation's
Research and Scientific Achievement Award for its "medical leadership
tremendous stimulation and support of research activities directiy related to
the study and treatment of hemophilia."
In 1968 and 1969 the Institute undertook a complete analysis of all its research
in thrombosis and hemorrhage through a contract with an expert in this field,
and recommendations for future research and development were prepared for
consideration by the Institute and its advisors.
In the NHI 1969 reorganization of the Institute's Extramural Programs a
branch for Thrombosis and Hemorrhagic Diseases was established along with
four other program branches along disease category lines.
In FY 1971 the NHLI's blood program underwent a large expansion in response
to the pressing need for programmed research in blood banking and blood
therapy. A systematic study of blood banking techniques and blood therapy in
the United States was initiated through a contract with a major management
consultant firm. Staff of the National Blood Resource Branch are working closely
with members of the consultant firm in this effort.
A program in stickle cell disease was initiated by the Institute during FY 1971
as well, and later, in February 1971 in his message to Congress, President Nixon
identified sickle cell anemia as a high-priority target and called for $5 million
PAGENO="0190"
184
increase in Federal expenditures for this disease during FY 1971. The National
Heart and Lung Institute was assigned responsibility for coordinating the joint
efforts of the DHEW Sickle Cell Disease Program and a Sickle Cell Disease
Branch was established within the Institute.
Tables I and II show the budget and staffing history of NHLI programs in
blood diseases.
OPPORTUNITIES AND OPTIONS
The Institute's programs in blood management have identified many new
opportunities for solving the critical problems relative to the limited national
supply of blood and blood components for transfusion, and have significantly
increased the options available in blood therapy. Specifically, the development of
blood fractionation techniques has resulted in an increasing identification of
blood components as separately useful in patient therapy. Thus, the usefulness
of a unit of blood from a single donor can be multiplied by giving each part to a
different recipient as his need dictates. However, there remains a serious tech-
nological lag which prevents the large-scale application of this knowledge. This
problem Is made acute by the rapidly increasing civilian and military needs for
blood components. Studies by the Institute have determined that these critical
demands can be met if component blood transfusion therapy rather than whole
blood was more extensively employed and if non-utilization of whole blood due
to outdating in storage could be diminished. Methods have been developed for
utilizing stored blood in a more intelligent and effective fashion, and systems are
being developed for computerized ~automation of donor blood inventory, donor-
recipient information, and other elements of blood banking techniques and blood
therapy. The Institute's programs have also led to considerable Improvement in
the safety of blood transmission in blood and blood products. All these develop-
ments are of direct benefit to the millions of Americans requiring blood trans-
fusions each year. The Institute has identified a number of new opportunities
for improvements in blood therapy, opportunities which will extend the options
still further for using blood and/or `related blood products such as bone marrow.
Future opportunities include platelet typing to further identify the type of blood
to be used; blood bank tissue typing of organs, bone marrow transplantation
to correct inherited blood cell disorders, further fractionation of blood into use-
ful components, and the preparation from blood of hepatitis-free diagnostic
agents such as radioisotope-tagged fibrinogen for diagnosis of blood clots within
blood vessels.
In `the area of throntbosis (or clotting of blood in blood vessels) new' oppor-
tunities exist for the development of improved diagnosis of clots through new
radiographic contrast media, radioisotope tagging with substances which absorb
onto or into the clot, ultrasonic techniques, and the identification of breakdown
products from the clot. There is considerable promise that clot-dissolving therapy
may be of value in heart attack~, and the possibility exists that the formation
of clots in thrombosis-prone patients may be prevented by small prophylactic
doses of a drug called heparin.
Additional progress can be expected in the control of hemorrhagic diseases
such `as hemophilia. It is likely that home therapy may become feasible and
economical in the near future. Self-administration of anti-hemophilic factor
(AHF) immediately upon the first sign of bleeding may help prevent the serious
side effects of immobilized joints that may occur as a consequence of uncontrolled,
massive bleeding into these sites, and there is the further possibility that AHF
may eventually be used prophylactically by the patient in his home to prevent
bleeding altogether. In the future it may become possible to transplant normal
blood forming tissue into these patients.
In the case of sickle cell disease, early diagnosis, treatment, and careful man-
agement, as well as the eventual possibility of transplantation of normal blood
forming tissue at or before birth offer significant improvements in the outlook
for the future of these patients. The possibility of identifying carriers of the
sickle cell trait, and prenatal diagnosis offer additional options to the individual
patient and his family.
III. LUNG PRoGRAMs
ISSUES
Lung disease afflicts the young and the old. In the newboPn the most com~non
cause of death is the dreaded respiratory distress syndrome (RDS) which
affects between 50,000 and 100,000 babies in the United States each year, about
PAGENO="0191"
185
half of whom die. RDS is Implicated in the development of adult respiratory
diseases as well.
Of the adult respiratory diseases emphysema and chronic bronchitis are the
major killers. Emphysema, chronic bronchitis and asthma were the underlying
cause of more than 30,000 deaths in 1970, and the contributing cause of twice
that number. These diseases represent a particularly pressing health problem
since the death rate and prevalence of these conditions has been increasing at an
alarming rate over the past fifteen years. The number of deaths from emphysema
and chronic bronchitis [chronic obstructive pulmonary diseases (COPI) I is c\ir-
rently doubling every five years. Emphysema alone is the fastest rising of any
cause of death in the United States today. As a disabling disease, it is second
only to heart disease.
The exact causes of emphysema are largely unknown, but a number of factors,
such as cigarette smoking, air pollution, allergy, and respiratory infections, are
strongly suspected of playing important roles In its development. While recogili-
tion of these factors has led to reasonable programs to prevent severe disability,
and while they may indicate promising research leads, it is apparent that we do
not understand either the causes of emphysema or its mode of development.
DESCRIPTION OF PROGRAMS
A joint United States-United Kingdom Study on Cardiopulmonary Disease was
initiated in 1959. This program is a comparison of British- and Norwegian-born
residents of the United States, with nonmigrant siblings, regarding morbidity
and mortality from chronic bronchitis and heart disease. These are studies in
relation to country of origin and length of residence in the United States. Parallel
data on lung cancer are being obtained from the same group of subjects under
support from NCI. The expected occurrence of these diseases in Britons and
Norwegians is appreciably modified by migration to the United States, the effect
being most marked for chronic bronchitis and least for cancer.
The Institute's Lung Program is carried out through a variety of mechanisms
including grants and contracts to investigators and groups of investigators. The
complexities posed by these diseases require a diversity of research approaches.
The Institute places special emphasis on those respiratory diseases that represent
national health problems. These include chronic obstructive pulmonary diseases,
acute respiratory distress syndromes, and interstitial diseases. While the public
health problems of COPD and RDS are well documented, it is less well recog-
nized that almost 200 different syndromes have been identified as interstitial
diseases of infectious, allergic, or occupational origin. These are diseases of
extreme morbidity; they are on the Increase; they are a major cause of respira-
tory problems in the young adult; and they may be implicated as a cause of
COPD.
In the past several years since becoming the National Heart and Lung Insti-
tute, the Institute has moved rapidly ahead to identify critical problems in
respiratory diseases. These efforts have included studies to obtain up-to-date
Information on incidence, prevalence, and morbidity from respiratory diseases;
a review and analysis of the Institute's total grant and contract programs in
terms of pulmonary disease categories and research approaches; a review of
epidemiology of chronic respiratory disease; and a critical review of literature
on epidemiology of chronic respiratory disease in children; and a series of
meetings with consultants who are experts in the field.
In June, 1970, the Institute sponsored a meeting of Pulmonary Directors to
discuss the research and training needs in `the pulmonary disease field. The topics
considered included: 1) training in pulmonary disease control; 2) research oppor-
tunities and needs in the pulmonary field; 3) intensive respiratory care; and
4) problems of clinical `management of patients with chronic lung disease. The
report and recommendations of this group of 150 scientists and physicians have
proved valuable in shaping the Institute's pulmonary disease program. One of
the key problems identified was the need for more physicians well trained to
treat pulmonary diseases. As mentioned below under Manpower Development a
Pulmonary Academic Award was established later In the year in response to
this need.
A Task Force on Research In Respiratory Diseases was initiated in October,
1971, which will report to the Institute in June, 1972. This Task Force is part of
a long range effort by the Institute to sharpen the focus of its research planning
so that it will be particularly responsive to national health requirements. The
desire is to make the emphasis of `the Lung Program directly related to the inag-
PAGENO="0192"
186
nitude of the morbidity, mortality, and economic, social and psychological conse-
quence of the various respiratory diseases. The Task Force has the following
specific objectives: 1) review of up-to-date health statistics for respiratory
diseases; 2) quantitative and qualitative assessments of the national research
effort addressed to these diseases; 3) professional judgments on which problems
and research approaches are likely to have the greatest payoff in terms of public
health; 4) critical appraisals of the state of the art in areas important to pul-
monary diseases; and 5) recommendations relative to problems and approaches
that are either presently neglected, currently overemphasized, or timely and
promising in view of the current state of the art.
During 1971 the Institute established eleven Pulmonary Specialized Centers of
Research throughout the United States. These centers will develop clinically
relevant programs designed to bridge the gap between basic research and clin-
ical care. The major efforts of the centers will be directed toward respiratory
distress syndrome in infants and chronic obstructive respiratory diseases. The
approaches used include epidemiology and population studies, pathogenesis,
disease mechanisms, pulmonary function and diagnosis, treatment, and pathology.
Currently, the Institute's Lung Program as a whole includes the following
program activities: A. Epidemiological studies; B. Treatment of lung diseases;
C. Importance of Pollutants in lung disease; D. Pediatric pulmonary disease;
E. Mechanisms of disease; F. Lung pathology; and G. Pulmonary training
program.
A. Epidemiological studies
These studies are aimed at determining prevalence, Incidence, etiological
factors and risk factors in respiratory diseases, particularly emphysema and
chronic bronchitis.
B. Treatment of lung diseases
Treatment of lung diseases, particularly chronic lung diseases, is notably
ineffective and a variety of approaches are being explored to tackle this problem.
These include inhalation therapy, intensive respiratory care, rehabilitative
therapy, and transplantation.
C. Importance of pollutants in lung diseases
The importance ~of environmental pollutants as causative or aggravating
agents in respiratory diseases cannot be overstated, and several studies are
being conducted in this area. The role of cigarette smoking in developing pul-
monary disease other than cancer is also being explored.
D. Pediatric pulmonary disease
Pediatric pulmonary disease is an important facet of the Institute's Lung
Program, not only because of the public health problems that these diseases
present in themselves but also because chronic pulmonary disease in the adult
may have its inception in childhood.
E. Mechanisms of disease
Insight into the mechanisms by which respiratory diseases develop and by
which therapeutic regimens delay or reverse the clinical course are essential
to an effective program of prevention and treatment. Fundamental genetic,
biochemical, immunological, physiologic and pharmacologic studies are under-
way to develop further information in this area.
F. Lung pathology
Lung pathology is an important area of study, particularly in the grant pro-
gram, but is currently receiving insufficient attention by investigators. For this
reason, the Lung Program arranged a workshop to alert investigators in the
Pulmonary Centers to the need and opportunities in this discipline and to
encourage the development of this facet of their programs.
HISTORY
The Institute has a longstanding history of support of research in eardio-
puliponary diseases both through its intramural and extramural programs.
During the Nh reorganization on August 12, 1969, a Pulmonary Disease
branch was established within the Extramural Programs.
PAGENO="0193"
187
In November 1969, the name of the National Heart Institute was changed
to the National Heart and Lung Institute to reflect the amplification of itS
mission to include the support of research, investigations, and demonstrations
relating to the lung as well as to the circulatory system. The Institute's Advisory
Council was expanded to provide expertise in pulmoziary diseases and on June
23, 1970, an Office of the Associate Director for Lung Programs was establisbe~I
to implement diagnosis, prevention and treatment of pulmonary disease and
for the training of professional manpower in this categorical disease area by
evaluating current resources in each area and identifying operational QbjeC-
tives for satisfying the program plan for meeting the identified objectives. It
established and maintains cooperative working r~lationsbips with organiza-
tional units within the federal structure, and with the National Advisory Heart
and Lung Council and other advisory committees.
In order to implement the Lung Program goals a Respiratory Diseases Branch
within the Institute's Collaborative Research and Development Program was
established in 1971. This branch is planning, developing, and administering a
directed program in the field of detection and prevention of chronic respiratory
disease, and the identification and improvement of methods of care for respira-
tory patients.
A Pulmonary Branch in Intramural Research was established in March, 1972,
for the purpose of developing a broad and comprehensive program of pulmonary
research including clinical respiratory, basic research in non-respiratory func-
tions of the lung, and investigations of the pulmonary response to various types
of injury such as pollutants and trauma.
OPPORTUNITIES AND OPTIOI~S
During the last 25 years, the research in pulmonary diseases has expanded
considerably. However, recent analysis by the Institute of this field of research
has revealed that certain lines of research have been grossly neglected while
others have advanced rapidly. The bulk of the effort has been devoted tO a
limited number of clinical diseases and been rather one-sided in their emphasis
of physiology and pathology. As a result a paradox has developed in that most
clinical disease entities can now be readily recognized through well developed
pulmonary function tests, whereas understanding of the mechanisms of develop-
ment of disease and of effective therapy have not kept pace. Also, there is a
market lack of adequate information on the incidence and prevalence of these
diseases in the United States. Finally, the lack of sensitive tests for detecting
early stages of disease has held back efforts to develop programs of early pre-
vention for patients afflicted with these diseases.
This numerous opportunities exist for advancing the knowledge in pulmonary
diseases and for improving the outlook for patients. The Institute is moving ahead
rapidly to identify areas of immediate and future need and to develop plans for
attacking these problems according to tbeFr apparent priorities.
There is considerable optimism with regard to the potential of advancing the
field of respiralogy. The tremendous advances made in many biom~diCal dis-
ciplines such as biochemistry, pharmacology, immune and allergic mechanisms,
and molecular biology in general have not yet been fully utilized i~n this field
of research. It can be expected that the influx Qf knowledge from these fields will
have considerable impact on respiratory disease control in the future, that many
new options will be created, and that new opportunities for understanding, treat-
ing, and preventing these diseases will result.
Obviously, limitation of resources will not permit simultaneous development
of all potential leads. Accordingly, a series of studies will be implemented as
determined by their relative priority. Considerations in reaching decisions on
priorities include: (1) the urgency of the need, (2) the readiness of cui~rent re-
search to provide solutions, and (3) the lack of current efforts in the field.
Among the current top priorities are studies of interstitial diseases of the lung,
populations living in environments associated with high incidence of respiratory
disease, occupations involving exposure to specific air pollutants, and genetic
factors which may predispose to lung disease under certain environmental con-
ditions. Other high priority areaS are improved therapy for chronic obstructive
pulmonary disease, extension of treatment technology through engineering ap-
proaches, studies of resources and manpower, and perhaps most importantly,
improved coordination of efforts.
73-994--72-----13
PAGENO="0194"
188
IV. Tzcrn~otooi~ DEVELOPMENT
ISSUES
Modern research iii detection, prevention, diagnosis, treatment, and tehabilita-
tion of patients with cardiovascular, respiratory, and blood diseases depends
heavily on the parallel development of a variety of new t~cbniques, new instru-
zuentatlon, mediéal devices, control systems, monitoring systems, automation of
clihical laboratories, `and computer facilities.
DESCRIPTION OF PROGRAMS
The Institute has supported a number of programs which are Intimately
related to advances in `technology, and which `would not be possible without these
aids. Some of the most prominent areas are: cardiovascular surgery, pacemaker
cleve~opnien~, and development of cardiovascular and respiratory life support
devices, new diagnostic procedures,
4. Cardiovascular surgery
Before surgery could be used to correct any but the simplest of heart defects,
i~iethod~ bad `to be developed to sustain patients duri'ng direct-vision `operations'
in widely opened hearts. Development of two such life-support `techniques, bypo-
`ther;rnia and extracorporeal circulation, has not only made such surgery possible,
but further development and refinement of `these techniques has also made possi-
ble all of the progress made during recent years in `the field of open-heart surgery~
and hypothermia, or `body cooling, slows metabolism `and reduces tissue-oxygen,
needs so that the heart and brain can withstand short periods of interrupted or
reduced bloodfiow.
To sustain the patients for longer periods, `techniques of extraeorporea'l cir-
culation have `been developed. In these techniques blood `bypasses the heart and
lungs completely. It is pumped and oxygenat~d by a so-called heart-lung machine
located outside the `body. Modern `heart-lung machines may also chill the blood
to produce hypothermia as well.
Modern life-support techniques provide the oppor'tunity for direct vision access
to the heart for periods long enough to correct many of the most complicated
congenital or acquired heart defects.
As a result of these developments, which have improved both the effectiveness
and safety of open-heart surgery, surgeons a're now performing remedial heart
operations for more newborn infants than ever before, instead of recommending
that a child try to live with a life-threatening defect for several years before
operative correction is attempted.
Spectacular strides have been made during recent years in the development
of better artificial heart valves. With the development of improved methods
of sustaining the patient during prolonged open-heart operations, surgeons can
repair or replace as many as three damaged heart valves during a single opera-
`tion with good prospects of success.
Improved artificial blood vessels and new techniques of blood vessel surgery
make it possible to open up obstructured blood-vessel segments and remove
the obstruction or severely diseased portions may be bypassed or replaced by
synthetic blood vessel grafts in the larger and medium-sized arteries. Many cases
of cerebral insufficiency or stroke result from obstruction to the brain's major
arterial feedlines located in the chest or neck. Approximately 7~ percent of such
obstructions are operable, and over half of these patients are likely to be helped
by blood reconstruction.
B. Pacemaker development
A variety of ingenious, totally implantable artificial pacemakers have been
developed to restore and maintain normal heartbeat in patients in whom the
electrical condi~ctlon system of the heart has been Interfered with or disrupted
by disease or injury.
Most pacemakers in current clinical use are compact, completely implantable
devices, powered by long~lived batteries requiring replacement only every 24-86
months. Most are fixed rate pacemakers, I.e., they are set to' pace the heart at a
fiNed rate. Once implanted, their rate cannot be changed.
More recent models make provision for changing the firing rate of the arti-
ficial pacemaker to make allowances for increased circulatory needs resulting
from exertion or other factors. An even more sophisticated pacemaker retains the
services of nerve and hormonal control mechanisms that ordinarily regulate heart
PAGENO="0195"
189
beat by their influences on the heart's natural pacemakei~. Thus, the impulse rate
of the pacemaker is not fixed, but varies with the bony's circulatory require-
ments. If unaccountably, the natural control mechanisms should fall, the pace-
maker contains a fixed-rate circuit that autopiatically assumes contrOl to the
l~eartbeat.
Modern pacemakers are highly reliable devices, but they sometimes do fail.
Battery tailure has been a common cause of pacemaker failure. And, although
the replacement of run-down batteries requires relatively simple surgery, usual-~
ly performed under local anesthesia, a pacemaker requiring no batteries at all
would be a significant improvement. Such a pacemaker is already well along
in its development. This device is powered by a plezoelectric crystal that converts
mechanical energy to electricity.
The Institute is also supporting research directed toward the development
of long-lived pacemakers powered by an isotopic heat source. This work has
been carried out with the cooperation and support of the Atomic Energy Com-
mission. The goal is a safe, implantable, nuclear-powered pacemaker that would
last for 10 years or more. The Institute has completed preliminary tests of such a
device.
C. Medical device applications program
The Medical Device Applications Program seeks to reduce death and dis-
ability from heart disease through the development of devices and techniques
for providing temporary or permanent assistance to a failing circulation and
a total replacement for hearts damaged beyond salvage. In 1970, the scope of
the program was enlarged to encompass the areas of biomaterials, lpstrumenta-
tion, and pulmonary assist and replacement devices. This program provides for
contract support of research attacking specific bloengineering, physiological,
biochemical, and related problems of artificial and respiratory device develop~
ment.
This program utilizes a modified systems development approach, enlisting
the collaboration and expertise of scientists, physicians, and engineers located
at universities and medical centers, chemical and engineering fir~us, electronic
corporations and other elements of private Industry.
Considerable technological progress has been achieved in recent years. Several
new materials and surfaces have been developed that will not cause blood to clot
when used in implanted devices. An improved capillary membrane oxygenator,
which has been under development by the Program since early 1969, represents
a significant advance over previously available systems. An electrically powered
assist device has been used in calves and has functioned satisfactorily for more
than 3 months and a radio-isotope powered model has undergone preliminary
testing in animals.
The Institute is currently engaged In a study of the need for pulmonary assjst
devices and plans are underway for a comprehensive technology assessment of
artifical organs.
Two comprehensive Test and Evaluation Centers have been establis~ied to
provide thorough objective evaluation of devices developed by the Program.
D. New diagnostic procedures
New diagnostic procedures have been developed which make it possible to
recognize the presence of arteriosclerotic lesions in the blood vessels during Ii~
by special x-ray examinations after injecting radio-opaque materials into the
blood stream, thereby allowing visualization of the arteries. This technique is
referred to as angiography or arteriography. This development has made It
possible tO arrive at accurate diagnosis prior to decision regarding sn~gleai
intervention or other therapy. However, as a means o~ following the nati~a1
evolution of the disease and the effect of therapeutic interventions, angiography'
is not feasible as a routine diagnostic procedure in asymptomatic 1ndividu~s
because of the need for hospitalization, occasional serious complications, anil
practical difficulties associated with repeated examinations.
Accordingly, noninvasive diagnostic techniques suitable for screening are
urgently needed to enable the earlier identification of the individual with
presymptomatic arteriosclerotic disease Several promising new techniques are
being developed, one of them being the use of ultrasound to o~1tline diseased
blood vessel segments.
Techniques are also being developed for localizing blood clots by means ot
radio-isotope tagged substances which absorb onto or into clots,
PAGENO="0196"
190
HISTORY
Research in technical development is a long-standing Institute activity.
The Laboratory of Technical Development was established within the Intra-
mural Program in November, 1948. Its initial objectives were the design and
development of instrumentation and apparatus for application in cardiovascular
patients. In December, 1969, the scope of the laboratory was enlarged to include
development, ~ontro1 and application of cardiovascular and pulmonary assistance
systems.
An Artificial Heart Program was established in 1964 within the Collabora-
tive Research Program. The name of this program was changed to Medical
Devices Applications Program in 1970 to reflect the broadened mandate `of the
program. Current responsibilities `of this contract research program include
development of devices needed to support patients with chronic lung disease.
OPPORTUNITIES AND OPTIONS
The opportunities created `by the past several years of technological develop-
ment are far-reaching, and have implications in terms of social, ethical, legal,
and economic consequences, including definitions of life and death, quality
`of life after technological replacement of vital functions of heart and lungs,
find acceptance `by society of these now modes of human life.
These technological advances have generated many new options both for
prevention, diagnosis and treatment of disease, and thus affects all stages of
disease. The prospects for further progress are almost unlimited from the
standpoint of technology and science but will need to be seasoned with cor~-
siderable wisdom in implementation.
V. MANPOWEn DEVELOPMENT
* ISSUES
Clinical and basic research in cardiovascular, pulmonary and blood diseases
and blood management systems requires highly qualified clinicians, scientists,
engineers, and technologists with specialized training both for the conduct of
the research itself as well as for the subsequent implementation and follow-up
of the results. The availability of highly skilled manpower is vital to the quality
and innovative aspects of research, whether it be investigator-initiated or
targeted cooperative ventures between investigator groups inside and outside
the Federal government.
In addition to the clinician in both the medical and surgical specialties, the
National Heart and Lung Institute must promote manpower development in
other areas where there presently are shortages. These include programs to
train epidemiologists, `biostatisticians, and scientists interested in the psycho-
logical and behavioral aspects of these diseases.
DESCRIPTION OF PROGRAMS
The Institute, through its training grants and awards programs, has as its
ultimate goal the provision of high quality medical care in sufficient quantity to
meet the needs of patients with cardiovascular, pulmonary, and blood diseases.
This goal is being approached by programs aimed at attracting a sufficient
number of promising young trainees, providing them with high quality training,
and encouraging the most capable among those inclined towards an academic
career to undertake advanced scientific training and supervised research ex-
perience. Specifically, the Institute's current training programs include under-
graduate training grants, graduate training grants, fellowships, career devel-
opment awards, and pulmonary academic awards.
A. Undergrad'uate training grants
One problem recognized at the beginning by the NHI staff and the National
Advisory Heart Council was the need for greater emphasis on cardiovascular
di~eases in the undergraduate teaching of the medical schools. The most direct
attempt to resolve this problem would be to make funds for this purpose avail-
able annually to each schooL Thus, the NHI initiated its program of "teaching
* grants", which soon came to be called "undergraduate training grants." It was
decided that there would be one and only one such grant awarded to a school
and that one would be awarded to each school, including any new medical school
PAGENO="0197"
191
as soon as the new school had appointed a chairman of the Department of ~edi-
clue. The Institute supported 96 such programs in medical schools, 6 in schools
of osteopathy, and 13 in schools of public health. It is now felt that although
this program was worthwhile in the past, it has now served its primary purpose
and a decision has been made to discontinue the program.
B. Cardiovascular training program
The cardiovascular training grant is designed to provide suppc~rt for ad-
vanced training programs for physicians and scientists intending to pursue an
academic career devoted to teaching, clinical service and/or research in the
general area of cardiovascular or renal disease. These grants are made on a
competitive basis to medical schools, universities, and other resear~h-educa-
tional organizations in order to assist the institution in providing high quality,
educational and training opportunities.
C. Pulmonary training program
The pulmonary training training grant is designed to provide support for
advanced training programs for physicians and scientists intending to pursue
an academic career in the general area of pulmonary disease. Grants are made
on the same basis as those awarded under the Cardiovascular Training Program.
With the new emphasis placed on the pulmonary disease area by the NHLJ, the
number of training grant applications in this area has been steadily increasing.
D. Pulmonary academic award program
The Pulmonary Academic Award Program was initiated in 1971. This Award
is designed to develop and/or strengthen the pulmonary program in schools of
medicine or osteopathy and, at the same time, to provide financial support, en-
couragement, and opportunities for academic career growth to youhg physicians
or scientists interested in pulmonary diseases. Each eligible institution may
nominate one candidate for a Pulmonary Academic Award. The Award is made
for a five year period and may be -renewable for a maximum of three sears.
With the limited funds available the Institute has only been able to issue four of
these awards so far.
E. Fellowships
The two primary objectives of the Fellowship Program are: (1) to increase
the number of trained cardiovascular and pulmonary investigators, and (2)
to assure the continuing flow of skilled and imaginative research workers into
the cardiovascular, pulmonary, and related fields. Promising scientists, ~elected
on a national competitive basis, receive these awards enabling them to obtain
advanced scientific training and supervised research experience. These awards
serve to encourage the research interests of young persons who show promise
of becoming competent research scientists; they serve to provide mature investi-
gators with additional or specialized research experience and thus further de-
velops their research skills; and they serve to provide stable support for the
advanced investigator in an attempt to insure retention of the most qualified
individuals within the field of cardiovascular research.
F. Career development awards
The Career Development Award Program is designed to provide stable career
opportunities for scientists with outstanding potential and competence in car-
diovascular, pulmonary, and renal research and teaching. This award carries an
implied commitment from the institute for long-term retention of the awardees.
It supports the younger investigator or scientist of demonstrated ability who
needs further experience to qualify for more senior positions.
The Institute is currently conducting a thorough review and analysis of its
total training needs, and the results of these studies will be available during the
summer of 1972.
HISTORY
The undergraduate training grants were initiated in 1948 and initially carried
a stipend of $14,000 and $8,000 for four-year schools and two-year schools respec-
tively. Since 1953 the undergraduate training grants have been $25,000 and
$15,000. Within broad policy and legal limitations, the funds were to be used
in whatever way the program director and the grantee institution would consider
best to achieve the purpose for which the grant was awarded, since it was believed
that the schools themselves could best make these decisions. As mentioned above,
these awards are now being terminated.
PAGENO="0198"
~92 /
The training programs were established in 1949. Over the total period FY
1946 through 1958~, the undergraduate exceeded the graduate training grants in
~both number of awards and money granted, hut `beginnjpg with FY 1956, grad-
t~ate training grants in both these respects began to increase at a faster rate
than the undergraduate program.
The primary purpose of the direct traineesliip program, established in fiscal
year 1949 and terminated at the end of fiscal year 1958, was to encourage yOung
physicians to take advanced training in the clinical aspects of cardiovascular
and related diseases, and to help stimulate the development of additional and
`improved training in this area.
iteart research fellowships were awarded for the first time in FY 1949, start-
ing with 67 fellowships. The number of fellowships graduaUy rose, particularly
tinring the late fifties and the early sixties, and numbered 165 in 1970.
The Pulmonary Academic Awards were initiated in 1971 to fill the need for
more physicians well trained to treat pulmonary diseases.
OPPORTnNITIE$ AND OPTIONs
By 1969 the total number of persons who had had Institute-supported training
was `10,02& An analysis of these persons was carried out in 1970, and revealed
that of these former trainees and fellows approximately 3,400 were in teaching,
860 in research, 3,500 in hospital service, 2,500 in private practice, 160 in admin-
Istration, 2,100 in some other activIty, 3,800 on medical school faculties, 500 on
university or college faculties, 4,000 on hospital staffs, 378 on staffs of other
organizatIons, 2,227 with professorial rank in medical schools and hospitals, and
998 with professorial rank equivalent in other organizations, Many additional
.stat~stics were gathered; however, the most important fact is that 7,762 out of
~t total 10,023 former trainees and fellows are in teaching, research and hospital
Service as their main professional~actiyities. To have this many of the former
trainees and fellows carry their Nfl training into these activities suggests the
Nfl training program as a whole must have had an important impact not only
on the trainees and felh)ws themselves but also on the medical institutions in
which they were located.
Thus past training programs have resulted in the development of a unique pool
~of `individtials trained in such areas as biochemistry, physiology, pathology, and
:phar~naeology, and their applications to clinical problems. It is important that
`the development of new opportunities and options for the prevention and treat-
ment of cardiovascular, pulmonary, and blood diseases, will depend on the con-
tinuous entr~t of these individuals into the field.
The basic sciences such as biochemistry, endocrinology, physiology, and phar-
niacology must be encouraged to produce more and better equipped physicians
and scientists to meet the escalating needs of modern medicine.
Mr. RoGERs. I know right now regulation of blood banks is not in
your purview. This committee is going into that question. But cer-
tainly you must be aware of some of the problems that exist in this
situation, particular with commercial outlets. Could you just com-
ment on that for us briefly?
Dr. CooPER. Yes. The national blood resource program has been
`very much concerned with the special problems of blood banking.
Although they are not responsible for regulation or the development
of the system, I think we have been concerned with some of the special
problems.' `These are hepatitis in blood transfusion, the inadvertent
human errors in cross-matching and typing the blood, unanticipated
contamination, the use of specific fractiolls in order to avoid protein
challenges that might be unnecessary; in other words, more specific
therapy; the prolongation of the shelf life of the blood in order to
reduce the blood loss on the shelf.
`These have been particular areas that we have been concerned with
in the national blood resource program.
Mr. RooEns. Do you have any authority to deal with any of these
problems presently?
PAGENO="0199"
193
Dr. CooP1~R. Not in any regulatory sense. Merely in th~e research
sense.
Mr. ROGERS. Does the Depa~rtment have authority in this a~rea?
Dr. ZAPP. No. I might add, Mr. Chairman, we identified this as a
problem and the President directed the Department, as part of the
health message this year--~and Dr. DuVal currently has the assigt~-
ment-to develop a position to recommend to the Secretary for us
on this whole blood banking and blood regulations, with the tradi-
tional patterns of people contributing for members of their own
community and so forth. We realize it is a much more complex thing
than it looks, but we hope to have a position by the time you are
ready to hold hearings.
Mr. ROGERS. I am also going to give you, so you can comment on
these you have not yet commented on, the amendments that `were added
in the Senate. I think you did some of it in your statement. I think
there were some, and I will give you this comparison and ask you to
nave official comment made for the record.
Dr. ZAPP. We would be pleased to incorporate that in our answer
to the record.
Mr. ROGERS. Any. other questions?
Thank you. I think if you will supply this information for the
record as rapidly as possible this would be helpful. We appreciate your
coming back this afternoon.
(The following waterial was received for the record,:)
COMMENTS ON SENATE AMENDMENTS TO S. 3323
EMERGENCY SERVICES PROVISIONS
A cause for concern arises from the inclusion in the Senate-passed bill of an
emergency medical services program for victims of heart, blood vessel, lupg,
and blood diseases. The President has recently directed the Department of
Health, Education, and Welfare to "develop new ways of organizing emergency
medical services (EMS)." Accordingly, we are now implementing an "EMS
Initiative" to meet this directive under existing legislative authorities in the
agency in the Department responsible for health service delivery demonstra-
tions, the Health Services and Mental Health Administration. Under this initia.
tive, we will `be supporting the planning, development, initia operation~ an(l
evaluation of several area-wide comprehensive emergency medical service sys-
tems through which the resources of communities will be coordinated for the
provision of a full-range of emergency medical services regardless of the medical
diagnosis. Also under this initiative, we will be establishing and maintaining
effective communications and coordination among those Federal departments
and agences, including NHLI, with responsibilities and activities in EMS. The
addition of separate and duplicating responsibilities within the NHLI could, in
our opinion, be disruptive to the effort underway and would lead to unnecessary
duplicating costs and responsibilities.
OFFICE OF HEART AND LUNG HEALTH EDUCATION
S. 3323 would also mandate the creation of an Office of Heart and Lung Health
Education in the Department of Health, Education, and Welfare. We strongly
oppose this provision. It will serve as a dapgerous precedent for creating an
office to discharge a similar public information function for each major cate-
gory of disease on which the National Institutes of Health conducts research.
Moreover, the statutory creation of such an office restricts the 1~1exibility of the
Secretary in organizing the Department and would simply add another organiza-
tional layer on top of ongoing activities. Also, Section 412(e) of the Publit~
Health Service Act currently provides that the National Heart and Lung Insti-
tute shall:
PAGENO="0200"
194
Establish an information center on research, prevention, diagnosis, and treat-
ment of heart diseases, and collect and make available . . . information as to~
and the practical application of research and other activities carried on pur-
suant to this part.
Since the NHLI currently has an ongoing heart and lung public information
program, we believe that the proposal to establish a statutory office is unnecessary.
FIXED PERCENTAGE OF NULl APPROPRIATIoNs
To specify a fixed percentage of the NHLI appropriation as proposed by S. 332S
for research on diseases of the lungs and blood would limit the flexibility and
professional discretion to set the funding for research at levels commensurate
with the scientific opportunities in the field. As well as limiting the flexibility
desirable for exploiting new departments in all areas of the NHLJ, earmarking
funds such as this would tend to discourage discontinuance of programs that
hate outlived their usefulness.
ESTABLISHMENT OF 10 MODEL CARDIOvA5CULAB DISEASE PRSVENTION CLINICS
The Department of HEW does not oppose the establishment of these disease-
prevention clinics. We recognize an important aspect of health programs is
bridging the gap between the laboratory and day-to-day use of knowledge in the
practice of medicine, but we believe that the NHLI[ should concentrate its efforts
on research activities, The delivery of services should only be included in a
research institute where essential to the achievement of the medical research,
and research and development of health services delivery are more appropriately
located in the Health Services and Mental Health Administration.
Mr. ROGERS. The committee will stand adjourned until 10 o'clock to-
morrow morning.
(Whereupon, the hearing adjourned, to reconvene at 10 a.m.,
Wednesday, April 26, 1972.)
PAGENO="0201"
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD
ACT OF 1972
WEDNESDAY, APRIL 26, 1972
HousE OF REPRESENTATIVES,
SUBCOMMITTEE ON PUBLIC HEALTH AND ENVIRONMENT,
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,
Washington, D.C.
The subcommittee met at 10 a.m., pursuant to notice, in room 2322,
Rayburn House Office Building, Hon. Paul G. Rogers (chairman)
presiding.
Mr. ROGERS. The subcommittee will come to order, please. We are
continuing our hearings on proposed legislation to expand the National
Heart and Lung Institute.
Our first witness this morning is a colleague, the Honorable John J.
Duncan, from the State of Tennessee, who has a statement he wishes
to present. Welcome to the hearing, sir, and proceed as you see fit.
STATEMENT OF HON. JOHN J. DUNCAN, A REPRESENTATIVE Iiq
CONGRESS FROM THE STATE OP TENNESSEE
Mr. DUNCAN. Thank you, Mr. Chairman. On March 1, 1972, I intro-
duced H.R. 13500 which is a bill to expand the scope of the National
Heart and Lung Institute to provide for special emphasis on the pre-
vention of arteriosclerosis and the creation of cardiovascular disease
prevention centers. This bill is known as the Heart Disease Prevention
Act of 1972.
Heart disease is the No. 1 killer in the Ijnited States; and in my
home State of Tennessee, 14,679 Tennesseans died of heart disease last
year alone. This is three times the number of Tennesseans killed bi
auto accidents during a similar period.
The National Institutes of Health Advisory Committee recently
indicated that 845,000 Americans are hospitalized each year for heart
disease and 104,000 for problems produced by arteriosclerosis or
"hardening of the arteries." Most alarming is the fact that 36 million
American adults are afflicted by cardiovascular diseases that produce
more than 1 million deaths each year. These figures give me a great
sense of urgency with regard to this bill.
The time has come to help our citizens fight back. Americans have
worked hard to build the most productive society in the history of the
world. Heart disease has also worked with extra effort to rob Ameri-
cans of the fruits borne by their labor. H.R. 13500 provides for the
establishment of nationwide heart disease prevention centers through
which our citizens can gain valuable information on how to combat this
indiscriminate killer.
(195)
PAGENO="0202"
19T6
Gentlemen, I urge your support of H.R. 13500. Th~ three major pro-
visions of this bill will cause the estabhshment of heart disease pre
vention centers throughout the Nation. These provisions include:
First, the creation of arteriosclerosis centers particularly aimed at
identifying those in the younger a~e groups afflicted with this disease.
Second, the establishment of cardiovascular centers to provide early
diagnosis and preventative care for high-risk individuals. And third,
the establishment of an Office of Health Educatioh within the National
Heart and Lung Institute to serve as a clearinghouse for information
on arteriosclerosis.
WI~ile research is important, Americans must have some day-to-day
assistance in fighting heart disease. The chairman of this committee
hhs articulated `the need for a practical application of our research
* efforts when he stated that "the taxpayer deserves some direct benefits
~from our costly research effort." H.R. 13500 establishes such a work-
ing relationship between our research and its practical application.
The prevention centers which this bill creates will permit our citizens
to have his or her life style professionally diagnosed in ordei~ to
identify those patterns which lead to heart disease and early death.
The National Heart `and Lung Institute is the best equipped Federal
agency to take on this task. Thanks to the research conducted by this
Institute, starting in 1948, we now know more than ever before about
the.causes, treatment, and prevention of heart disease. The National
Heart `andLung Institute clearly pos'sesses the organizational capac-
ity, the staff, and the past experience necessary to carry out the man-
date of this legislation. Your favorable consideration of this bill will
authorize the Director of the Heart and Lung Institute to establish
10 model cardiovascular disease prevention clinics throughout the
I5nited States within the framework of existing programs. The pur-
pose of such clinics shall be: (1) To develop improved methods of
detecting `high risk individuals, (2) to develop improved methods of
intervention against high risk factors, and (3) to develop highly
skilled manpower in cardiovascular disease prevention. Such clinics
shall be served by a.central coordinating unit that shall be responsible
for the development of standardized procedures for diagnosis, treat-
ment, and data collection in relation to cardiovascular disease.
Why should we now emphasize the establishment of these preven-
tion centers? The answer begs the question. All of the research in the
world is of little value unless it is transformed into useful informa-
tion which the average citizen can apply to his daily life. Dr. Jere-
miah Stamler, chairman of the Department of Community Health at
Northwestern university and a leading expert on preventative medi-
cine, expounded the need for such centers when he said, "There is a
lot `of misinformation on heart `disease and oniy limited sources of pre-
cise information. Even when a person knows he has a high risk of
coronary disease, he doesn't know how to reduce the risk." This, then,
is w'hat this bill is all about. It provides for the dissemination of this
life-or-death information.
* Before funding this bill, the question must be asked, "Do these
centers offer realistic hope for cutting th'e death rate due to heart
disease?" The result found by a recent `Government-sponsored task
force on heart disease would indicate a most emphatic yes. This 15-
member task force headed by Dr. Theodore Cooper, Director of the
PAGENO="0203"
197
National Heart and Lung Institute, concluded that a major preveiat~-
tive treatment program which encourages Americans to modify their
diets and stop smoking cigarettes would cut the death rate due to heart
disease by 90 percent. It is this type of hope that urges me to ask yO~i
for your careful consideration of the great opportunity this bill
affords us in our battle to conquer heart disease.
The time to act against heart disease is now. This sense of urgency
was made most clear to me when Dr. Ernest Wynder, president of the
American Health Foundation, testified before the House Ways and
Means Committee on which I serve. Doctor Wynder told us why time
is of the utmost importance in fighting heart disease when he noted~
that "this rarely observed disease of 1918 now accounts for more than
50 percent of the deaths of males over the age of 40 in the United
States and it appears to be affecting a progressively greater number of
young people. In truth, an epidemic has struck."
It is my hope that this bill will further our efi~orts to guarantee
America the full benefit of her greatest resource-her people. Our
people in turn will benefit from the Heart Disease Prevention Act o~
197~ by living longer to enjoy the fruits of a full productive life.
Thank you.
Mr. ROGERS. Thank you, Mr. Duncan, for your interesting contri-
bution to these hearings.
We are very pleased this morning to have as our next witnesses
representatives of the American Heart Association, its presideut, Dr.
Willis Hurst and the executive director, Dr. Campbell Moses, and, of
course, an old friend of this committee, too, Dr. Michael D~Bakey.
We would be pleased if you gentlemen would like to ~it at the table.
We are delighted that you can be `here.
Members of the committee, as you know, except one, have introduced
legislation to begin to accelerate our fight against heart disease, lung,
and blood problems. We do welcome you and we are very pleased to
have you here with us. We will be pleased to have you here with us.
We will be pleased to receive your testimony.
Dr. Moses, do you wish to sit with them at the table?
Dr. MosEs, No. We will leave it to the professionals.
STATEMENTS OP DR. WILLIS HURST, PRESIDE:NT, AEA, `AND ~
MICHAEL E. DeBAKEY, BAYLOR COLLEGE OP MEDICINE, TEXAS
MEDICAL CENTER, IN BEHALF OP AMERICAN HEART ASSO-
CIATION
Dr. HURST. Mr. Rogers, we appreciate this opportunity to come and
be before your group.
First, I would like to `congratulate you and your staff, and' all mem-
bers of this committee, because we feel that the bill demonstrates that
you have done considerable homework, that the facts are all there, the
background information is correct and that it is beautifully put `to-
gether so that we have nothing but praise for what you have done.
I should say praise for the American people, in eluding patients who
now exist, and people like you `and I, who will be patients with this
particular disease.
Now, I would like to cover a few things in general and then becorrie
a little bit more specific. There are a lot of things th'at we can do now,
PAGENO="0204"
198
we believe. Ithink a good bit can be done in preventive care. I could
only mention the ext~nsion of, say, the eradication Of rheumatic fever,
for which we have the methods at hand now. I could mention that
we know a great deal about the treatment of high blood pressure, yet
we are unable at the present time to effectively manage this in the
majority of people who have high blood pressure.
As a matter of fact, I will throw in one figure; I think it is about
20 million people `who have high blood pressure. We know a good deal
about the treatment of this now, but the staggering problem of getting
it done, I think, is obvious when you realize 20 million people have
hypertension. That, of course, feeds into the prevention of stroke. The
control of high blood pressure might reduce the incidence of stroke
considerably.
Then, we are terribly interested in the early treatment of heart at-
tacks. We think we have information now that will assist us in de-
creasing the mortality rate of the 350,000 people who do not make it
to the hospital each year because of heart attacks.
I could go on in the preventive area, but I think it is proper to
simply state we know enough now to do a lot of things. I will follow
that statement by saying, regrettably, we don't know enough and we
still don't know the exact cause of a heart attack. That accounts ,for
750,000 deaths annually. We know the risk factors and how to prevent
some of the attacks, we think, but basically we need more research
in the area of coronary and arteriosclerosis and atherosclerosis, gen-
erally. We think the time is ripe now for training centers.
I would like to make a plea now that if these centers are developed,
that we think it through properly, so that we can get them through
the planning phase and into `the reality phase. What has happened so
often is interest and enthusiasm and `then it collapses and crushes
the spirit of a number of people who have worked so hard to develop
the program, only to find that it cannot be carried out as they had
hoped it might.
We are terribly interested in education. This includes the education
of the pi~iblic. It includes professional education and all of its ramifica-
tions. We simply need more people, highly skilled people, to accomplish
the goals that we think we must.
Then, I make a plea for emergency services~ because as I have men-
tioned, 350,000 people with heart attacks do not make it to the hospital
for one reason or `another. We think `that can be changed. There are
many reasons why we think emergency services must be looked `at
carefully from `the vantage point of your bill.
Let me, if I may, go just to specifics without reading in detail, of
urse/, but just highlight some of the points I hav~ just made.
Let us take section 2, item 7. That simply emphasizes the portion in
the Senate bill that might be looked at in your bill that deals with
emergency services. We would like to be certain that that is in some
way incorporated in the House bill.
Then, section 413, item 4, addresses itself to the establishment of
programs that will focus on and apply scientific and `technological
efforts involving biological, physical and engineering sciences to all,
facet's of cardiology, pulmonary, and related diseases. We think this
is an extremely important item.
PAGENO="0205"
199
In years past, it seems to me at least, that we have left this kind
of development almost to chance, that if some area happens to be
moving along in certain technical areas, then medicine could eventually
get some of the spinoff. But here, it seems, to me, a concerted effort to
think through what we need in the biological, physical and engineer-
ing services that would enable you not to wait by chance for a spinoff
of something else that was not primarily devoted to the cause that you
are fighting.
No. 5, establishment of programs and centers for the conduct atid
direction of field studies. We think this is terribly important.
Then, No. 7, still under section 413. I will not go into detail again
except to underscore t1~ie absolute essentiality of education, and that is
in the training of scientists and clinicians and educators in the fields.
It does require a degree of competence to accomplish what we are
after, including the execution of what is known; we cannot leave it
to chance. This has to be developed, I think, to the finest point. So,
again we are underscoring training of all types of people.
Eight also again is education, this time'referring to public and pro-
fessional education. I personally believe that you can't have a good
health care system in any discipline unless there is a good health edu-
cation system. I think they are linked because the first step is the per-
son's understanding of certain aspects of the problem.
No. 10 is the establishment of programs for study, research, devel-
opment, demonstrations, and evaluations of emergency medical serv-
ices. So, in the Kennedy bill that I hope will be looked at with favor,
and your bill, would be items 4, 5, 7, 8, and 10 in section 413 with par-
ticular emphasis on education of all elements.
Then, in section 414, we would be pleased to have inserted there,
where it says, "The director of the Institute, under policies established
by the Director of the National Institutes of Health and after consul-
tation with the Council, shall establish programs as necessary for co-
operation with regional medical programs and other Federal agencies,"
we think maybe to list it by name would be appropriate since that is
the thrust presented here, some of the thrust of RMP and clearly some
of the thrust of the Heart and Cancer Commission that I was on, and
Dr. DeBakey chaired in the summer of 1965.
Now, look at item (b) under section 414 and I believe that your bill
should show the increase from the original Kennedy bill and that we
think that it is proper to elevate that the $30 million for the first year
and $40 million for the second year and $50 million for the third year.
Under section 415, in both items (1) and (2) under (a), you. note
that it says 15 new centers for basic and clinical research and cardio-
vascular and 15 new centers in basic and clinical research for
pulmonary.
I think it might be important to be certain that the authority here
does not prevent the support of well-known and good facilities in
research units that are in existence today. There might be a few that
are in trouble that are old and, therefore, should be supported as else
we lose the expertise that has developed over a long period of time.
I don't know that the word "new" there would have restricted that,
but I thought that the idea that the old should continue and the new
should start is probably wise.
PAGENO="0206"
2cO
Again, emp~asizing in part (b), section 415,~ jt~in (3), once ag~dn
~tra~ining, including training for allied health professionals, and I think
t1~is is important bet~ause we canflot do this mammoth job. The di-
seases that kill, say, 1.2 million a year will require the cooperative
efforts of many skilled people.
Now, section 416, item (c), where it says that "There is hei~eby
~stablished within the Department of Health, Education, and Wel-
fare an office of Heart and Lung Health Education," now we would
be very much in favor of the Department of Health, Education, and
Welfare in the area of heart and lung for the public and for the pro-
fessions~ ~We would think it wiser to place this in the Heart and Lung
In~titute rather than as implied in this item 416 simply because the
know-how is there, the assessment of programs such as `this would
have the expertise already spelled out. It would prevent development
of some new system and that is where the experts are that know what
should be transmitted to the public.
Finally, in section 419(b), we think it wise to eliminate the per-
~Ontages given there which say 20 percent for lung, 20 percent for
blood, and 10 percent that could be altered by the Secretary. We think
it is wiser planning allowing for flexibility for these percentages to be
eliminated. A danger could be there, I think we should point out.
If the appropriation is not in the range we are discussing, then
the amount for heart and blood vessel diseases could indeed be less
than is now appropriated. I think we cannot take that chance.
Now, an alternative would be to increase the figure that we are
discussing but somewhere, we have to be assured, I think, that ade-
quate money is allocated for the heart, blood vessel, lung, and blood
program. This way. it will not necessarily guarantee that an adequate
amount of money is for heart and blood vessel disease, for example.
We would be a bit against `the percentages and make one statement
that I believe strongly that where this first sounds like more money
than I have ever heard of, I am not at all sure that it is enough.
For example, if construction gets involved in the development
of the 30 centers, then that could be quite a lot of money. Yet, you
would need the construction to create `the facility to create the pro-
grams. There are several items there that I think might cost more
money than we have appropriated. We badly need the emergency sys-
tern. It is almost shameful we do not now have it. Yet, the development
of that will cost a lot of money and this, of course, we are recommend-
ing as being part of the bill.
So, if we u~e the percentages I have cousiderable worry whether
we will achieve `what we are after. The alternative is to look care-
fully `at it and increase the amount of money we are talking about.
In summary, we think you and your group have been representing
the citizens, which `are made up of patients, quite well. We admire it
and congratulate all of you.
I have made some suggestions that I hope will be useful.
Mr. RoGi~Rs.. Thank you very much, Dr. Hurst. We do appreciate
your suggestions and your statement here.
Dr. DeBakey ~
PAGENO="0207"
201
STATE1VI]~NT OP DR. 1VlICRA~L P~ DeBA1~EY
Dr. DEBAKEY. Thank you, Mr. Rogers. I am happy `to be here
today and appear before this committee again. I re~a1l so well my
appearance before this committee about this `same subjeèt matter 7'
years ago. Some of the members of the committee were here then
that are here now.
I feel that we are starting again in an area in which we started with
very bright `hopes 7 years ago, but I must say that those hopes were
dimmed by some of `the things that took place, particularly the inabil-
ity to move the programs.
You will recall that I appe'ared before you as `a witness to report
to you on the President's Commission Report on Heart Disease,
Cancer, and Stroke, and particularly to report some legislation that
we finally did pass and this committee was so helpful in `moving, the
national medical program, particularly. But there were many other
aspects of `the recommendations of the Commission that never got
any `attention, really, never got any money, and never got off the
ground.
Here we are 7 years later hoping to start them again. It pleases me
greatly to see this same committee make this effort `again.
I had to testify not long ago before one of the Senate committees
in which we were asked about certain reports of the Commission-~-
as to what happened to them. I was asked particularly about the ?resi~'
dent's Commission report. I, with great reluctance, h'ad to admit that
the great majority of the recommendations in that report were ne~/er
implemented. I was asked why. I simply had to state that I did not
know completely why, `of course, but I thought one of the basic reasons
was that many of these recommendations were never put in the hands
of anyone to implement.
That is, the responsibility to implement them was never given. Yet,
the Heart Institute really had the responsibility, but they never `got*
the money and they were never given the proper charge to achieve
some of the goals `that were set in that report 7 years ago which I
think would h'aye put us far ahead of where we stand today in the~
control of `heart disease.
There is no question that there are many things that we now know
and can `do that can reduce the mortality and morJ~idity in the heart
disease area, a `disease which, as you know, is our No. 1 disease.
I have had occasion `to go to Russia on several occasions and I had'
occasion to go there recently and meet with the Minister of Health,
who happens to be a surgeon, and therefore, I have known him for
many years now because I have had occasion to train some of his own
young people in the cardiovascular area.
It is very interesting that he has a copy of the President's Commis~
sion Report on Heart Disease, Cancer, and Stroke, that he regards as
an extremely important document and has discussed with `me many
of the recommendations'and the ways and means by which they cait be
implemented and has already taken great pain's to try to implement
many of the recommendations that we have made in that report. So,
it is a di'sease of great importance to them, too, `and indeed, to all the
countries of the world, particularly developed countries, industrial
countries.
PAGENO="0208"
202
Now, I think it is extremely importan1~ that this committee has rec-
ognized the need in a~ sense to legislate these charges. To be perfectly
frank ~bont it, the Heart Institute really provides all the authoriza-
tions that are really needed to move many of the programs.that have
not been moved but I think philosophically it is absolutely essential
that they be given the charge. I think that is why this legislation is so
extremely important.
I jU$t want to congratulate the committee on the leadership that
exists here in the `health field in an effort to `develop a piece of legis-
lation that I regard-as probably will ultimately be regarded-as his-
tbric legislation in the heart disease field. I think there is no question
about it. I would like to endorse cornp1etel~ the suggestions `by Dr.
Hurst for the changes that you might consider in the legislation. I
think it would enhance it and improve it in terms of its practical effect.
Now, in the legislation `here, there is reference made to the establish-
ment of centers. J would like to take a few moments of your time to
tell you something about what I think is the significance of centers. It
is a word that is so misused and so broadly used that I think sometimes
we don't get the real impact of what we mean by centers.
Now, in this area, what we really mean by center is, in a sense, an
organizational unit that has all the resources that are needed to pro-
vide both the best form of clinical application of diagnosis and treat-
ment in all the scientific disciplines, in the various scientific disci-
plines, including both the biologic and physical, that can attack and
focus our attention and interest upon our specific problems. Now, the
interchange of these disciplines creates in itself, a kind of ferment
that enh'ances and accelerates the research program.
We have, and have h'ad for nearly a decade now, a cardiovascular
research and training center that over the past 3 years has been housed
in a geographic area that has enhanced tremendously the effectiveness
of the center. It is for this reason, particularly, that I think it is quite
important to place `within this legislation authorization for construc-
tion because if you are really going to get the centers you want you
*are going to `have to provide some construction, yo'u are going to have
to provide space for it that just doesn't exist now.
If you try to do it i~i a piecemeal fashion, that will fragment it
`and in a sense, vitiate the very purpose of the program. If yoti have
one program even in the building next door, the people in that build-
ing next door will hardly speak to the people in the other building.
In our own medical center, for example, you were recently down
there and you saw the number of buildings. I have not been in the
M. D. Anderson Hospital in 6 months-yet, it is less than a block
away-because I am, busy with my own patients, I have no reason to
get over there.
Now, in our center, we h'ave `had the good fortune of being able to
obtain some private funds that helped us to get the matching money
to build this thing. It cost us $121/2 million just to build. It is six
floors. It houses all of the research laboratories, including all the basic
science disciplines, pathology, blood chemistry, myocardiology, biol-
ogy, and all the physical sciences.
We `have the support of Rice University `and also Texas A. & M.
~nd all the clinical disciplines, surgery, medicine, cardiology,
PAGENO="0209"
203
We have eight operating rooms in this center, all for cardiovascular
work~ Dr. Schwartz, in myocardiology, will sometimes step down
from his laboratory, and he is a basic scientist interested in the biology
of the cells of the heart, really, myocardium, he will frequently step
down in the operating room on a patient worth studying and will
take specimens back to his laboratory to study.
The same thing is true in a number of other areas. It is this inter-
action that becomes extremely important. Of course, the training of
young men, young scientists, young clinicians, in an atmosphere of
this kind enhances completely their ability to do their job in this
field, both research and training.
Finally, in the terms of quality of the medical services it provides~
it provides a superior quality of medical service. So, these centers, I
think, are extremely important.
As you know, there was appropriated by Congress on four occa-
sions, 4 years annually, moneys to plan centers. Yet, to this day, not
a single center of this kind has been established. Despite the fact
that we recommended this 7 years ago in the Commission on Heart
Disease, Cancer, and Stroke-I have repeatedly gone before the Ap-
propriations Committee and pointed this out-we have yet to start
one single center.
Now, we have a center in our place because we have put together
the funds from many different sources, including private moneys, to
get our center going, and we have it. But it is the only one like it in
the world. This country should have at least 25 or 30 of these centers.
Indeed, really, it should have approximately 50 of them across the
country.
If we put enough effort in the training of our scientists, we can
manage these centers. It will take time no~w to man the 25 ~or 30 cen-
ters but we have to start. I find it extremely important that in a sense
we mandate by this legislation the establishment of these centers.
In addition, of course, the centers will have tremendous impact in
the enhancement and extension of knowledge in the surrounding areas,
both through our training program and through our relations with
the practitioners that we have in our own community. They will un-
doubtedly have tremendous value so far as the regional medical pro-
gram is concerned, too.
There, again, there is a place where I think deficiency occurred in
the planning, construction, and development in the regional pro-
gram with the lack of development of any centers of any kind. I think
this becomes an extremely important aspect.
I would like, particularly, to endorse what Dr~ Hurst has pointed
out about the funding. I seriously doubt that the ceilings that are
present here will do the job that you want done, that you are trying to
get done over the period of time you are talking about. I can see the
ceiling in the first year, but if you can get this program going, then by
the second or third year, the authorization should be increased.
I think you need to recognize that it is going to cost money to
build these centers and get them going, to do `the other jobs which you
have indicated, the goals which you have indicated, which I think
are just as important. I doubt seriously that these funds will be ade-
quate. I would suggest that at least the authorization beyond the
78-994-72-14
PAGENO="0210"
2~4
first year be increased by $0 million to $100 million or `to, in some way,
ipdicate in the legislation a means by which th~ needs could be met if
they~could be bronght back to Congress to indicate what t~ie amount
should be.
Finally, I would also endQrse particularly the relative figures that
are given which would really produce, I thin1~, constraints in terms
of ~he flexibility in the use of the moneys that you have autho'ri~ed and
could easily vitiate what you are trying to do by this legislation if the
authorizatlQns were limited to what you have here and the authoriza-
t'ions or legislatio~i included the 20-percent limitation for lung and
blood diseases.
M~r. Chairman, may I say that it is really most delightful for me to
come before this committee and support this legislation. I have long
hoped and worked in many ways to try to stimulate efforts along these
lines and have been frustrated in doing so. I just think that this is one
of the brightest days I have had in a long time in this program, I want
to thank the committee most deeply.
Mr. ROGERS. We are very grateful for your being here, for your help
and for your leadership along with Dr. Hurst~ too, in the whole
area. As you say, I remember well when you appeared before the com-
mittee 7 years ago. The advice you gave us then is that we had better
write in exactly what we want done.
Dr. DEBAKEY. That is right.
Mr. ROGERS. Give clear direction. What are the major breakthroughs
that you see possible in the heart field? Are we making significant
prqgress? What are those areas that appear most likely to show
progress?
Dr. HURST. I mentioned this earlier. When we remember that ~0
million people have high blood pressure and that that is a prime risk
factor in `stroke and plays its role in heart attacks as well and when
we remember that we do have treatment, not perfect treatment, but
we do have treatment that can be applied, then you can see that this
would require a rather mammoth approach to get at this problem. So,
that, T think, is a breakthrough.
Mr. ROGERS. In other words, we can treat hypertension now.
Dr. Huns~. Yes.
Mr. ROGERS. In `a signifi~ant way to bring results and `bring about
prevention.
Dr. Hims~. Yes.
Mr. ROGERS. When does it have to be detected to really become effec-
tiye for treatment? Should it be early or at what age would screening
occur?
Dr. HURST. It probably should start certainly, I would think, by
high~ school. The reason I say that is that we have just learned in the
last few years that the levels `we have accepted as normal may actually
not be normal for the teenager, for example. So, I could see detection
beginning much earlier than we have in the past.
We must remember that when I said 20 million people, that is an
estimate. it is probably more. In some groups, it reaches 30 percent `of
the population, in certain defined groups. Detection `and then treat-
ment and then the `constant search for even better treatment.
Whereas, treatment is now good and better than it used to be, it
still is not perfect. When we start treating `this, you see we may have
PAGENO="0211"
205
20 or 30 years of treatment whereupon toxicity and so forth,. ~otild
accumulate over 20 years.
I would not want to leave you with the idea that the treatment is
perfect. We still need research for better drugs and better methods.
But I think this is a great public health hazard at the present time.
Mr. ROGERS. This is one area you feel we could make significant
gains if we got at it?
Dr. Htms~. No question about it.
Dr. DEBAXEY. As I see the future in terms of breakthroughs, I thiiik,
perhaps one of the most important would be a better understanding
and better control of the lesion in atherosclerosis. We are now begin-
fling to have a better understanding of this disease.
We have learned a great deal in our clinical research efforts in this
disease. For example, we now know that this is not a single disease.
lqVe talk about atherosclerosis, arteriosclerosis. We feel there are dif-'
ferent forms of this disease. There are forms where the lesions are
extremely well localized and the aorta above and below the lesion is
perfectly normal, and other forms in which the disease is much more
extensive.
For example, in the study of coronary heart disease, now we are
beginning to do arteriographic studies much more widely, we `are
beginning to realize these same patterns. We are beginning to learn
about the patterns of arteriosclerosis, and atherosclerosis, and these
patterns occur in different forms and can be categorized.
We know their natural history is different. I have some patients
I have followed for 20 years atherographically, that have had no re~-
currence, that seemed to have gone into a kind of remission state, and
then other patients who will develop rapid progress of th~ disease
and extension, leading to stroke or to a heart attack or to loss of a leg.
This is at the other end of the spectrum in terms of the pattern of
progress of the disease. I think with more intensive research and some
of the research that is going on today, we are going to learn to be able
to pinpoint these patterns and possibly to predict and even to pre~rent
them.
This, to me, would be the biggest breakthrough that can take place.'
rphis is the cause of a great majority of heart diseases we are talking
about.
Mr. ROGERS. Are you doing research on this in your institution?
Dr. DEBAKEY. We have an intensive program. We would like to
have a bigger program. If we had more money we would do more.
We have two `of the leading authorities in this field working with
us, a man by the name of Gotto who came from the National Insti-
tutes of Health, setting up `the lipid protein program, a man by the
name of Evans Horning, one of the great `blood chemists in the
country.
They have an extension `program. They are wbrking with our
tients. This comes from having a center. `They are working on patients,
not rabbits or dogs. So, they understand the `disease in patients as it
occurs in man which is extremely important.
Mr. ROGERS. Let me ask you a couple of questions very quickly, be.
cause we have quite a number of witnesses.
Is there any chance of an immunization `approach?
Dr. DEBAKEY. I think there is a chance of a number of different
kinds of approach, yes.
PAGENO="0212"
206
Mr. iRoGERs. Is this being investigated?
Dr. DEBAKEY. Ye~, we have a whole immunology sec~ion working
with us.
Mr. ROGERS. Is it encouraging?
Dr. DEBAKEY. I wouldn't say it is encouraging at this time because
we don't `hav~e enough facts `to be able to say that. It is being investi-
gated because it is a possibility.
Mr. ROGERS. What about diet? Should we try to do something on diet,
labeling, trying to shift food standards in the Nation?
Dr. DEBAKEY. I think at the moment, you will find differences of
opinion, wide differences on this, and the reason is that we don't have
enough facts to be able to legislate diet. I think we do need to control
the diet to some extent and also to advise people who need this. There
are certain people who do need proper advice about diets.
Dr. HtmsT. I think the study that should be done might at this point
be broader than just diet because I think most people feel there are mul-
tiple factors involved in the cause of atherosclerosis and a prospective
study trying to elimante all risk factors, not just using the proper diet,
might be the appropriate way to go. There :are many good ideas about
that.
May I add one point that I think is important. If we obtain all of this
and execute it beautifully, funded by the Federal Government, I would
like to point out that I feel that this will increase the responsibility on
a volunteer health agency such as the American Heart Association.
The reason I think that is that to begin to execute some of these pro-
grams will call for a lot of people beyond that which is funded here.
If you think of prevention centers, how will you get the people
there? I `see this as enhancing the need for an even larger volunteer
health agency that would assist-
Mr. ROGERS. Try to get people to take :advantage of what will be
available?
Dr. HURST. Yes. It will clearly define the many, many people who
will be needed to execute this program.
Mr. ROGERS. Let me ask you this: Should w~e transfer stroke to this
Institute or let this Institute work on stroke as it `applies to the
cardiovascular system and let the Neurological Institute continue in
its work in stroke, on the effect?
Dr. HURST. I think the primary point is that we want the ravages
of atherosclerosis conquered. I `think there would be considerable
merit in placing stroke within this because the common denominator
by and large is atherosclerosis.
Dr. DEBAICEY. I agree with that. One has to recognize that all
strokes are not caused by vascular diseases but a great majority of
them are. There is a great deal that can be `done for them. Hypertension
is one of the biggest factors in the cause of strokes underlying the
disease of atherosclerosis. To a certain extent, I would say that type
of stroke that is vascular-related needs to be placed within this
program.
Mr. ROGERS. Then, should we have a coordinating committee be-
tween the two Institutes?
Dr. DEBAKEY. There is in the legislation here another agency co-
ordinating committee. That is needed in any case, definitely.
* Mr. ROGERS. But particularly, I presume, in stroke.
PAGENO="0213"
207
Dr. DEBAKEY. Yes.
Mr. ROGERS. Thank you very much.
Mr. Nelsen?
Mr. NELSEN. Thank you, Mr. Chairman.
Listening to the testimony yesterday and today, it seems that normal
blood pressure, diet, and exercise are factors that will help prevent
heart attacks. Doesn't this `seem to be, to some degree, an educational
undertaking so the public will understand this? Some of the preven-
tive remedies certainly are in the hands of the local doctor, but he
can be of little help if the early signs that come along are unheeded
and the doctor is called in when it is too late. Isn't this pretty much
the story?
Dr. DEBAKEY. A s a matter of fact, Mr. Nelsen, as you know, there
is in the bill reference to some public education. This really falls in
the public education area. The physicians know this. I think we could
enhance the program tremendously if we could get the public to under-
stand and take the initiative in getting this information to them.
Now, we had recommended in the President's Commission on Heart
Disease, `Cancer, and Stroke, the same thing-in fact, have recom-
mended some $7 million for this purpose, public education.
I think this is an extremely important aspect. We could do all we
can in terms of, say, hypertension, but nevertheless, when we get the
public to understand the need to find out and then to do something
about their having high blood pressure, we can't do anything more
than that. That is why it is essential, I think, to have education in the
matters you refer to.
Mr. NELSEN. Your research has certainly moved a long ways and
you now know many things that cause heart attack.
Would it not seem logical that information be brought to the atten-
tion of school youngsters so that they may understand as they go
along what the problem is, know how to guard against it, to know
what to watch for, and know what to do?
Dr. HURST. Mr. Nelsen, my own view is, and this is perhaps not
appropriate at this time to make this statement, but I think one of
the greatest omissions in this country is health education that starts
in the first grade, second grade, third grade, fourth grade, all the
way through, because I have seen many, many brilliant Ph. D.'s who
know virtually nothing about health.
So that the college graduate does not necessarily find himself very
knowledgeable or interested in the health area. I think it is a glaring
omission in our country. I ~vould hope that in the context of a health
education system that takes into account first grade all the way up,
that within that you could begin to teach some of the things we are
talking about today.
Mr. NELSEN. Another area that is certainly in the public eye at the
moment is the use of drugs. When you discuss drug use with groups
such as those attending college, or if you attempt to mold thinking at
that level, you get a little rebellion.
Dr. HURsT. It is too late.
Mr. NELSEN. If you advise youngsters in the elementary grades
about the dangers of drugs, it wou'd seem to me you could make a
better start and get an understanding about the dangers involved.
Dr. HURST. That is right.
PAGENO="0214"
208
Mr. NELSEN. Thank yoti very much.
Mr. ROGERS. Mr. Preyer?
l\~r. PREYER. It is certainly an honor to have two such distinguished
men at these hearings. We appreciate your taking the time to be
with us. I regret I was not here 7 years ago, I am in the phase 1 learn-
ing stage about this. Rather than taking the time to ask uninformed
questions, I would just like to thank you for your testimony and the
cotitribution you have made to it. Thank you very much.
Mr. ROGERS. Dr. Carter?
Mr. `CARTER. Thank you Mr. Chairman. Certainly it is a pleasure
~to have you distinguished gentlemen here today. For my part, I mean
tosupport increased funding for this bill. I think it is very necessary.
I would like to see these centers established throughout our land. We
have failed so many, many ways. Certainly, I want to support the
public education phase of it. I think that is extremely important.
It is vei~y nice to have you. I am glad to see you again.
Dr. DEBAKEY. Thank you.
Mr. ROGERS. Dr. Roy?
Mr. Ror. I will reiterate what the other gentlemen have said. It is
especially an honor for me to be in the presence of two such distin-
guished physicians. I think it is especially an honor for a garden
variety of ob-gyn man.
I have a couple of questions. Of course, with the Commission on
ITeart Disease, Cancer, and Stroke you recommended centers which
have not materialized. When we passed the National Cancer Act, we
directed moneys toward centers and we are speaking about it in this
act.
Should these centers be one and the same? How important is it that
if we have 15 new centers that they be as you originally recommened-
directed to all the so-called killer diseases rather than a cancer center
here and a heart, lung, and stroke center somewhere else?
Ibr. DEBAKEY. I don't think it is absolutely necessary `that one have
a. cancer and a heart center together, if that is what your question was
directed to.
Mr. Rdr. Would it be desirable?
Dr. DEBAKEY. In some places; yes. Buft in other places~ it is not
necessary. I think one has' to recognize the fact `that there are many
areas of overlap in terms of the scientific base of both programs. Of
course, the enhancement of one area of science usually enhances an-
other. In many places, this will occur. Especially where there are
medical institutions such as a medical school they will undoubtedly
have this type of program because of the interest and in the sense the
attraction of the scientists in the institution to develop these areas.
I do not regard these centers as absolutely essential in the medical
school. That is why I say it is not absolutely necessary. In fact, I think
in some areas they can be just as well done, so long as they have the
resouites, without actually being in a medical school.
Mr. Roy. This is true, of course, in Houston, if I am not mistaken,
that you arenow anticipating having a medical school.
Dr. DEBAKEY. We have a medical school in Houston.
For example, the M. D. Anderson Cancer Hospital, which I think
is one of the finest in the country, was developed without a medical
school, in the sense of being at least part of a medical school. They
PAGENO="0215"
209
related to u~ and our medical school worked with them but mostly in
the graduate program and some of our faculty worked w~th them,
having joint appointments. But it was developed really without the
necessary association of, say, a medical school.
Mr. Rot. Do you materially share basic scientists with M. D.
Anderson?
Dr. DEBAKEY. Yes; we have a number of basic scientists that have
joint appointments, and we share them,
Mr. Roy. The other question I have is with regard to education. The
American Heart Association has done a great job in education. Are
your education programs coordinated in any way with the National
Institute of Heart and Lung?
Dr. HURST. We work with Dr. Cooper and counsel there actively.
My own view there is neither the American Heart Association or the
Heart and Lung Institute has really been able to accomplish what I
think we need.
Mr. Roy. If you were working in closer coordination, do you thitik
you would have a better chance?
Dr. HURST. I think we could. I noted very carefully in the wording
of the bill it makes it possible for the Heart and Lung Institute tQ
arrange cooperative activity with private agencies which at that mo-
ment I saw in the role of the American Heart.
The point is that I don't think we have scratched the surface either
on public education or professional education. Now we have done a
lot of things. I won't burden you with my own ideas about what we
ought to do next, but I don't think what we are now doing is adequate
and I think we ought to do better.
Mr. Roy. I will ask a third question. I have had the impression that
some of the opposition or some of the reasons for not establishing the
centers recommended in your report, Dr. DeB:akey, have beei~ reasons
of politics within medicine.
Now, I don't claim to know about the politics in medicine but again,
as we establish these individual centers, are we going to be threatening
medical schools and others and are we going to see resistance in the
future?
Dr. DEBAKEY. I don't think that is the reason at all. It is possible
it may have played a role in some places. The basic reason is the fact
that there has not been any money.
Mr. Roy. You don't think it is the fear of the super medical schools
that helped shoot down the centers?
Dr. DEBAicEy. No. Organized medicine has strongly supporteçl the
general thrust of the development centers, both in the cancer area and
the. heart area. It has for a long time. On a number of occasions, when
I have testified before congressional appropriations committees for
moneys for this purpose, where they did establish planning grants but
never gave the money to the centers themselves, we got the support of
organized medicine completely.
Mr. Roy. That is reassuring. I was hoping my guess was wrong. ~
certainly hope it is wrong as far as any future problems.
Dr. DEBAKEY. In our area, our center has gone on for nearly a
dec:ade. We have had the strong support of the local medical
community.
Mr. Roy. Thank you very much, `Mr. Chairman.
PAGENO="0216"
2110
Mr. ROGERS. This committee has `also introduced separate legislation
on emergency health care. We may ~want to handle that in one package
rather than `breaking up emergency health care. `The committee will
have to decide that.
Dr. DEBAKEY. Yes, except for one thing. Let me point out that
I would hope that it `would not be separated, the emergency care th'at
is essential in the heart disease area should not `be separated from
the heart disease area. That is the only point I would make. I think
it is important, for example, in centers, in the coronary care area,
that they not be excluded, you see, from emergency medical care and
emergency medical investigation. That would be the only concern
I would have in separating it. I agree with you there is certainly a
strong need *across this country to upgrade the various emergency
medical services. There is no question about that.
Mr. ROGERS. Thank you so much. Your testimony has been most
helpful. I think you both fully qualify for the term "statesmen in
medicine."
Dr. DEBAKEY. Thank you.
Dr. HURST. Thank you so much.
Mr. ROGERS. Our next witness is Dr. Donald C. Kent, medical
director of the National Tuberculosis and Respiratory Disease
Association.
Dr. Kent, the committee welcomes you, and we will be pleased to
receive your testimony.
STATEMENT OP DR. DONALD' C. KENT, MEDICAL DIRECTOR, NA-
TIONAL TUBERCULOSIS AND RESPIRATORY DISEASE' ASSOCIA~
TION
Dr. KENT. It is my pleasure to be here today to represent the
National Tuberculosis and Respiratory Disease Association, `and have
the opportunity to present our testimony. If I may, I will read my
testimony.
Mr. ROGERS. Thank you very much.
Dr. KENT. The National Tuberculosis and Respiratory Disease
Association is strongly in favor of legislation to advance the campaign
against diseases of the heart, blood vessels, lung, and blood. Our
organization has been in the forefront of efforts to enlist support for
~ stepped-up national program to combat lung diseases such as emphy-
sema and chronic bronchitis. The NTRDA includes 600 affiliated
TB-RD associations and an active medical section, the American
Thoracic Society.
Until late 1969 when the National Heart Institute became the
National `Heart and Lung Institute, attention within the Federal
health establishment was not focused on the chronic pulmonary dis-
ease problem in such a way as to encourage development of a vital
program. Even now, the N'HLI is restricted in its ability to implement
a program commensurate with the problems as they exist.
Emphysema, chronic bronchitis, and asthma, as a group, have in-
creased rapidly in recent years to the point where they are now the
fifth cause of death from disease amOng white males. Emphysema is
the second cause for which workers `are retired prematurely under the
PAGENO="0217"
211
social security program. Benefits under that program for respiratory
disease disability amount to approximately $400 million annually.
This estimate is exclusive of payments for "black lung."
The country must enlarge its research efforts before we will have
the answer to the etiology of these conditions which are so terrifying
because they affect man's ability to breathe. In the meantime, there
continues to be a dearth of qualified specialists in pulmonary disease.
The attempts of the leadership of NHLI to correct this situation are
both recent and necessarily limited because of budgetary pressures,
although their efforts have been gratifying.
The Director of the Institute and his deputy in pulmonary diseases
have moved swiftly to plan a dynamic pulmonary disease program.
However, progress has not been as rapid as needed; the budget foi~
pulmonary disease is less than $25 million. In order to move ahead,
the NHLI needs the kind of enlarged authority and support which
this legislation provides.
PROPOSED BILLS
The NTRDA is opposed to weakening the Federal medical research
capability and identity of the National Institutes of Health. Therefore,
it favors the approach of H.R. 13715 which strengthens the authorities
of the NHLI but does not place responsibility for its budget or over-
all direction of its program outside NIH.
Before speaking to specific provisions of H.R. 13715, we would like
the committee to give thorough consideration to the possible need for.
specific authorization for each of the organ entities the bill encom-
passes, as is done in section 419(b) of S. 3323 as passed by the Senate.
Prior to enlargement of the National Heart and Lung' Institute's
pulmonary program, the greatest impediment to promoting a stronger
pulmonary effort was the fact that no satisfactory measurement of the
then existing pulmonary program of NIH was possible. There was
no uniform accounting of what resources went into the pulmonary
effort. Thus, there was no way of evaluating from year to year the
emphasis the various institutes were placing on pulmonary diseases
in terms of money spent.
Although NHLI today makes a more adequate accounting of the
sum devoted to pulmonary disease, there is still no way to insure that
the pulmonary program will receive the attention it requires. With
a specific authorization, however, as in S. 3323, as passed by the Senate
it can be ascertained if the pulmonary program is actually receiv~1ng
the amount of support which Congress believes it needs.
We believe that the provision in 419(c) of S. 3323 for transfer o~
10 percent of funds between programs protects against overuse of
funds for any one program although the language of this section does
not make clear to what base the 10 percent is applied. We would hope
that this would be clarified in the final bill.
At this time, I would like to support the stand of our friend from
the American Heart Association regarding the very, very important
part of education; both the education of the professional as well as
the education of the public, as one of our great needs in our steps
forward to eradicate the problems of respiratory disease in this
country. I will speak to this later.
I would like to comment about specific sections of H.R. 13715:
PAGENO="0218"
212
Section 4L9(ct) (6)
We believe the part of the program described in this subsection
should provide for training of educators as well as scientists and
clinicians, ~ts is done in S. 3323. One of the greatest barners to increas-
ing the number of pulmonary disease specialists is the inadequate
number of p'i~ilmonary disease faculty in medical schools who can
inspire students to enter the field. In a recent survey, close to 20 per-
cent of all `pulmonary disease faculty positions could not be filled
because of the lack of qualified~ teachers. This means 200 positions
are vacant.
Section 413(e) (2)
For the same reason, the authority of the Director under this sub-
section should be extended to include training facilities in addition to
the facilities included in this bill. This, you will note, was included in
the Senate bill.
Section 414(a)
We are v~r~i pleased that the bill includes provision for control pro-
gra~ms. The lack of these has been acutely felt in the pulmonary
disease area. Community control programs were beginning to be estab-
lished by the former chronic respiratory disease program when that
program was terminated by the Department of HEW in 1969. It is
our opinion that programs to demonstrate control of specific diseases
provide considerable impetus to expanding and improving diagnostic
and treatment facilities. In other words, upgrading our clinical care
capabilities. It is our observation that such control programs are also
~n excellent resource for training of personnel and for dissemination
of information to the public which is of great importance. Therefore,
we recommend that public education and training be included as a part
of these programs' authorities.
Section 415(a) (2)
We~ welcome the addition of 15 new centers for basic and clinical
research, training, and demonstration of advanced diagnostic and
treatment methods in chronic pulmonary diseases. The centers form a
* i~ery important and promising component of the revitalized pulmonary
disease program of NHLJ.
I would underline Dr. Hurst's statement that these new centers do
not mean forgetting the ones already in existence and which have
ongoing programs which one should expand upon. However, the word-
ing of section 415 (a) (2) implies th~t all pulmonary diseases of chil-
dren could be handled by these centers but not necessarily all adult
puli~onary diseases. We believe the wording should reflect the obvious
intent more accurately if this section were reworded to say: "Chronic
pulmonary diseases of adults and children, including, but not limited
to bronchitis, emphysema, asthma, and cystic fibrosis."
Section 417(a) (2)
We agree that membership of the National Heart and Lung Ad-
visory Council should be increased in view of the strengthened author-
ities ~nd enlarged work program proposed in the bill for the various
disease interests involved.
PAGENO="0219"
2l3~
However, `the Council presently has 12 scientific members. Under
section 417(a) (2) of H.R. 13715 there ~rould bea reduction of the
scientific membership to nine-a number which is not adequate, in
our opinion, for representation of the different disciplines or for the
technical and `large workload the program requires. We believe that
the act should insure that the number of scientific members exceed
the number currently on the Council. The change made in S. 3323'
is not satisfactory in that it does not guarantee that even 12 sdientific
members would be appointed.
Because the legislation is concerned with advancing the attack on
selected diseases, it should stipulate that these special disease in-
terests are to be represented on the Council in the persons of qualified
specialists. A number of members shotild be specified from each of
the three disciplines-heart, long, and blood diseases-and assurance
provided `that all will be represented in the first appointments made.
Neither H.R. 13715 nor S. 3323 provides for such categorical repre-
sentation.
&ct~on419(b)
As the program gathers momentum, demands for research and
training funds will rise. The funds required for just construction of
these facilities will demand large funds. If those demands ai~e frus-
trated because of insufficient authorizations, the whole purpose of the
program will have been lost. Therefore, we recommend that the j3u~-
thorizatjops for 1974 and 1975 be increased to what we believe will
be necessary to carry out this program, namely, to the sums of $450
million and $550 million respectively.
We note `that authorizations in the bill are for 3 years, whereas
the Director has the. responsibility under section 413(b) (2) for plan-
ning a program of 5-years' duration. A 5-year authorization seems
necessary to insure the sustained effort being proposed in this legis-
lation. If that is done, we recommend that $650 million and $700
million respectively be authorized for 1976 and 1977.
We approve the increase in S. 3323 of $10 million annually for con-
trol programs for each of the 3 years authorized. We recommend that
the authorization for these programs also be extended through 1977.
We appreciate this invitation to testify on an expanded pulmonary
disease program, which is long overdue. We commend `the committee
for their recognition of the threat these diseases pose and the need th
accelerate the attack on them.
Thank you.
Mr. Rooims. Thank you very much, Dr. Kent, for your statement,
It is most helpful. I think it gives the committee some very good sug-
gestions.
What is the association doing as far as scholarships for training
of personnel? Do you devote any of your funds to this effort?
Dr. Ki~NT. We, at this point in time, at a national level, provide
training scholarships for nurses in respiratory disease. We are launch-
ing a program in the near future for paraprofessionals and inhalation `~
therapists. We are providing about 40 fellowships for medical train-
ing in pulmonary disease as well as for training in some pf the soientific
disciplines. There are now four chairs for pulmonary disease that we
are supporting along with local tuberculosis associations and universi-
PAGENO="0220"
214
ties. These provide chairs in some of the schools that do not have'them.
At the present time, we have six medical schools in the United States
that do not have departments of pulmonary disease. In addition there
are 200 vacant positions in medical schools.
Our affiliated associations also provide a sizable amount of money
at the local level for these types of programs. In addition, they pro-
vide summer scholarships for medical students.
Mr. ROGERS. Thank you.
Dr. Carter?
Mr. CARTER. No questions.
Mr. ROGERS. Mr. Preyer?
Mr. PEEYER. Thank you for your very clear testimony. I have no
questions.
Mr. ROGERS. Dr, Roy?
Mr. Roy. No questions, either. Thank you.
Mr. ROGERS. Dr. Kent, thank you. I think your message came through
clearly. We appi~e~iate it.
Dr. KENT. Thank you, Mr. Chairman.
Mr. ROGERS. Our next witness is Dr. Giulio J. Barbero, chairman of
the General Medical and Scientific Advisory Council of the National
Cystic Fibrosis Re~earch Foundation.
We welcome you to the committee,
STATEMENT OF DR. GIULIO I. BARBERO, CHAIRMAN, GENERAL
MEDICAL AND SCIENTIFIC ADVISORY COUNCIL, NATIONAL
CYSTIC FIBROSIS RESEARCH FOUNDATION
Dr. BARBERO, I certainly thank you for the opportunity to represent
the National Cystic Fibrosis Research Foundation and its interest in
House bill 13715.
I would like to make some comments in addition to the testimony
that we have placed in your hands.
Mr. ROGERS. Would you like for us to put your prepared statement
in the record?
Without objectio~i, it will be done. Then you can make whatever
comments you desire.
Dr. BARBERO. Thank you.
First, as a foundation representing both the lay and scientific mem-
bership, we think it is a superb bill. It reminds me of what Abe Lincoln
said, "If we could know where we are and whither we are tending, we
could then better judge what to do and how to do it." Certainly, the
kind of thought that this bill incorporates is just the kind of sense
that Abe Lincoln seemed to connote.
Mr. CARTER. Mr. Chairman, let me congratulate our distinguished
witness on his erudition in his reference to a great American.
Dr. BARBERO. Thank you.
The second point I wanted to make was the reference to children.
`Dhe very notion that children are specifically described. You see
children so frequently do not have their own advocacy. You know,
adults are the big bulk of the outspoken voices. So, it does mean that
those of you and those of us somehow have to stand up for the chil-
dren in some way.
PAGENO="0221"
215
I think the children are the heritage and need this kind of advoeacy.
The bill that by specific statement describes the problems of heart
and lung and blood with respect to children, I think, is very unique
and good promotion that is intended, By this very fact, I think it
does recognize that specific aspects of the bill that indicate preven-
tion are the key in respect to children.
Children are almost like the arrow from the point of conception
to plateau in adulthood and ultimately to the end of life, but the
development of many of the processes that have been described in
our understanding of heart and lung and blood problems dQes rise from
the very onset, but almost insidiously, it is almost unevidencM in this
early point in time and it only emerges as a specific disease at a later
point in time.
Not only are there aspects of specific biochemical or other kinds
of research but our understanding of the patterns of life, the stresses
and strains, the types of nutrition, the practices that we set up, the
aspects of school and what its educational processes might be-these,
I think, are all parts of the circles that interface ultimately into some
of these diseases which are then a major deprivation, in both children
and adults. I think the broad concept that this bill tends to encompass
certainly espouses this need.
The second thing th'at I would like to refer to is the question of the
centers. Much as I mentioned in relation to Abe Lincoln I think this
is a timely point to bring together that there are already certain
levels of knowledge in a demonstration fashion to bring convergency
between education of a clinical nature and basic nature and finally
training which is so crucial, training at both levels, perhaps some
aspect in terms of school in the pediatric or child group area as well
as in the adult area.
The very fact of trying to find some innovative way of handling
the smoking problem, you know, is an interesting notion in and by
itself and we need to learn a great deal more about this. So, I think
this kind of notion of a center rather than simply one that is focused
in any one area but trying to converge and bring together is highly
enlightening and appropriate.
I would now like to speak to the question of the advisory member-
ship. The very fact you have included children also speaks that we
would like to strongly espouse that people who have familiarity with
children also be included in this advisory group and that at least a
minimum of two pediatricians be members so that they at least can
convey some of that frame of reference to this total group.
Last, I would like to speak regarding the educational area. Already,
I think we have enough information `that may be at least important
to both urban and rural areas at a public education level. The same
holds for the physician. Too frequently, we forget the general ph~si-
cian that exists in many other area's because there is such `glamour in
the centers. Somehow, this association must intensify and be continu-
ally enriched. It is our feeling that that kind of educational focus that
is within `this bill is most `sound aftd must include that kind of
orientation.
I want to thank you very much for the opportunity to be before the
committee.
(Dr. Barbero's prepared statement follows:)
PAGENO="0222"
216 /
SrArEMErT or GwLxo J. BAummo, M.D., OUAIEMAN, DE ~TM~NT or PEDIATRXQ$,
- HAUNEMAWN MEDICAL COLLEGu, PIIILADELrHIA, PA~
Mr. Chairma:n, distinguished members of the Health Committee, I am Dr.
Giullo J. Barbero, Chairman of the Department of Pediatrics, Hab*nemann Medi'
cal Colleges Ptiiladephla, Pennsylvania, and Chairman of the General Medical
and Scientific Advisory Council of the National Cystic Fibrosis Research Foun-
dation. The NCFRF is a foundation concerned not only with cystic fibrosis but
with the pedIatr~c 1Jaimona~y problems of five million limg-damaged children of
all races from birth to adulthood. It is a foundation that has 140 chapters geo-
graphically located throughout the country. It supports or participates in 55
clinics, and 45 teaching, care and rcsekrch centers. It is a foundation that has
about a Four Mililon Dollar annual program supported by funds it has raised4
and as you can readily see, we find great difficulty in being able to meet the
large number of pulmonary problems which these centers and clinics encounter.
/ It is unquestionably a major reason why we are so Interested in the nature
of tbi~ bill. It is urgent and immediate in its requirements because of its broad
implications, not only in the nature of training and research but also In trying
to c~emonstrate some of the implementation which is so crucial and is already
a~7ailable in the managen~ent of these patients with lung disease.
I wish to thank you for the opportunity to testify in support of H.R. 18715
National Heart, l3lood Vessel, Lung and Blood Act of 1972. I wish to compli-
ment Congressman Rogers ttnd the other sponsors for their leadership, interest
and support in this most important area of health, and I acknowledge the in-
di4~ated interest of the Administration in also promoting further support. This
legislation as proposed is vital to the health of this country, and we endorse
it, but our main area of concern here today is to comment upon those provisions
which specifically refer to the lungs. At the onset, we should like to make per-
fectly clear that we do not advocate transferring all of the cystic fibrosis pro-
grams in existence at NIH to the Heart and Lung Institute. We request only
that those programs concerned with the pulmonary aspects of cystic fibrosis
become a part of the rung programs of the Heart and Lung Institute. We believe
that this inclusion of the pediatric pulmonary program provisions to the Heart
and Lung Institute will be a progressive and positive step because it will result
in a closer interaction between the adult lung programs and the pediatric lung
programs. Children's lung diseases include such conditions as hyaline membrane
disease, bronchitis, bronchiectasis, allergies and asthma. Many contributing
`causes, genetic and non-genetic, known and unl~nown are involved. Cystic fi-
brosis is one of the most common serious lung diseases. Cystic fibrosis is not
the only one and much more research is needed for all to understand the con-
tinuum of disease development from childhood and to adulthood. We believe that
prevention of disease in the adult may lie in understanding the early develop-
ments of pulmonary disease in children. Research that will be conducted on
children and adults will have ultimately, Implication for both. The specialists
on pediatric pulmonary disease must become aware of the problems that will
face his patient as the patient becomes older and specialists on adult medicine
must likewise understand the problems facing the specialist for children's lung
disease. The provisions of the proposed act are essential to the overall needs of
a coordinated national program.
Another point I would like to indicate is that which pertains to children. I
think it is absolutely wonderful that the word "children" has been incorporated
into this Bill. The main bulk of population being adults, it is so often that
children are left out of many legislated acts. They require advocacy and the
inClusion of the word "children" to me represents an important spirit Incor-
porated in this Bill. Children are the roots in many ways also for some of the
diseases that ultimately emerge at the later point in life. Those of us who are
pediatricians see them as an arrow which is .started at the point of conception and
moves in ascendancy to the point of adulthood. So, it is in this sense that we
feel that this Bill is also most sound.
Our Foundation feels that the pediatric pulmonary programs authorized
under the Regional Medical Program leave much to be desired. Nearly all of them
have had to close their doors through lack of funding. We feel strongly that
centers for pediatric pulmonary disease have proven themselves as an essen-
tial and effective instrument of di~ease control. A network of such centers ade~
quately supported and on a long-term basis located throughout the United States
PAGENO="0223"
/ 217
is an essential component for any national program for lung disease. It would
be tragic if these were diminished. However, it is also clear that cystic fibrosis
as a specific disease is one of a specti~um of illnesses with which children are
involved and not infrequently the children will come with a question of cystic
fibrosis, and have also myriad of other pulmonary problems, and then end up
not having' the disease of cyutic fibrosis. Our centers are consulted fre~juentl~
with almost a ten-to-one ratio of this nature. Thus, it would be very unsound
to separate out cystic fibrosis because of the research that may exist in other
institutes. It is a lung disease. The children suffocate anj die prevailingly, apd
almost entirely from the overwhelming secretions which pile up in their lungs.
Measures have been built up over the past decade which have clearly shown that
early diagnosis, various approaches towards management, including antibiotics,
therapy, pulmonary drainage and various kinds of medicinal and other ap-
proaches are crucial in the preventive or minimization of the handicap present.
This, by its very nature, falls within the description of your Bill, apd it is for
this purpose that we would think it would be most unsound and inappropriate
to separate it off in any fashion.
There is another reason that this is also true. It is that cystic fibrosis Is the
most serious pulmonary disease of man; it acts as a key model in understanding
the research aspects for pulmonary disease, and therefore must exist in some
juxtaposition to at least a spectrum of understanding of the disturbances which
are involved in the nature of the pulmonary disease in man.
I would like to next turn to the question of the composition of the Advisory
Council which has been described in the Bill. Just as in research, as I mentionèul
the advocacy of children, it must be brought to your attentlofl that the current
Advisory Council does have any lung specialists in children. I think that this kind
of representation of the advocacy for children, in a key area, must be consideted,
especially when one recognizes that fifty percent of the health proble~is in cliii-
dren are of a respiratory nature.
Lastly, in looking at what is exciting about this Bill, it strikes us that first
the demonstration of the multidisciplinary requirements involved in any kind
of chronic pulmonary disease are clearly highlighted.
Second, it is supportive of a viewpoint that the child and adult is a continuum
in lung disease, and it is just this broad nature which must not be embarrassed
by any modification.
Third, it lays the groundwork for bringing back and also developing some of
the control, and hopefully preventive measures which would diminish our hetlth
load.
STATISTICS GLEANED FROM 1970-71 REPORTS FROM 29 CARE, TEACHING AND RESEARCH CENTERS
Other -
C/F pulmonary 0.1.
Total patients registered and seen atleastoncein past year 3,952 2,477 764'
Number of centers with:
O patients 4
1-40 patients 2 8 9
41-100 patients 10 9 4
101-200 patients 15 4 3
201-300 patients 1 2 0
Over 500 1(800) 1(670)
Patients registered and seen at least four times per year 2, 682 1, 121 290
Number of centers with:
0 patients 0 6 18
1-40 patients 5 16 - 8
41-100 patients 18 3 4
101-200 patients 6 2 0
Over 300 1(525) 1(350)
New patients seen for consultation 237 1, 668 753
New patients followed regularly 485 916 109
Average number of days hospitalized 47. 5 28. 7 (?)
Number of, patients hospitalized - - 928 662 180
Deaths 156 25 6'
Note: Average number of patients visits per year, 4.7.
PAGENO="0224"
218.
ESTIMATED RELATIVE INCIDENCE OF CYSTIC FIBROSIS AND SICKLE CELL ANEMIA
INCIpENCE OFTHE GENE CARRIERS/HETEROZYGOTES
,
Cystic fibrosis
Sickle cell
anemia
Relative gene
frequency
(a) In total population 5 percent= 10,000,000 1 percent=1900,000 CF 5 times more commo1~ than
SCA in total population.
(b) In blacks 2 percent=450,000 8.5 percent=1,900,000 SCA 4 times more common than
CF in blacks.
Cystic fibrosis Sickel cell anemia
Total population 1 in 2,000=1,750 per year 1 in 3250=1,077 per year.
Black population 1 in 12,000=44 per year 1 in 500=1,062 per year.
3. LIVING PATIENTS
Cystic fibrosis Sickle cell anemia
15 years life expectancy=26,250 20 years life expectancy=21,540.
20 years life expectancy=35,000 25 years life expectancy=26,925.
Sources: Scott, Robert B.: Health Care Priority and Sickle Cell Anemia. JAMA 214: 731-734, Oct. 26, 1970. di Sant'
Agnese, Paul A., and Talamo, Richard C.: Pathogenesis and Physiopathology of cystic fibrosis of the pancreas. New Eng. J.
Med. 277: 1295 December 1967. National Center for Health Statistics for 1968: Total births in U.S.=3,501,564;total black
births in U.S.=531,152. Bureau Of the Census: 1968 total population in the United States=201,152,000; 1968 total black
population in United States=22,344,000.
Mr. ROGERS. Thank you very much, Doctor, for most helpful
testimony.
Do you think it is wise for us to actually name, and I presume
you do, since you gave us wordage, the various diseases to be con-
sidered in the research programs and the administration in this par-
ticular institute such as cystic fibrosis?
Dr. BARBERO. Well, to consider any lung kind of area without cystic
fibrosis would be like cutting off a piece of one's body in which one
could not function. This is one of the most serious ones.
Mr. ROGERS. I noticed some of the testimony from Dr. Marston
suggested we not put any wordage in this institute but I think it
would be very closely related to research in this area.
Dr. BARBERO. I think it is appropriate and fits in and we strongly
support the wordage which has been indicated. W~ hope that at the
same time, the basic programs that are in the arthritis and metabolic
institutes will also continue and that the interagency kind of quality
that is espottsed within the bill be an important kind of way to handle
some of this.
Mr. ROGERS. In research has there been any optimistic findings on
cystic fibrosis yet?
Dr. BARBERO. Yes. I think we now have pretty well identified that
there are circulating components present in the blood and in many
other secretions which seem to modify the nature of the secretions
and ultimately end at the chest, the secretions plug up the bronchial
tubes. I think the identification of that circulating component or
something that is present in the secretions is going to be the charge
for this decade in that disease.
Mr. ROGERS. Thank you.
PAGENO="0225"
219
Mr. Nelsen?
Mr. NELSEN. No questions. Thank you.
Mr. ROGERS. Mr. Preyer?
Mr. PREYER. I have no questions, Dr. Barbero, thank you.
Mr. Room~s. Dr. Carter?
Mr. CARTER. I want to congratulate the distinguished gentleman
on his presentation. I have no questions.
Mr. ROGERS. Dr. Roy?
Mr. Roy. I have just one question. As I recall, I heard the figure
of $55,000 as being spent in the area of research grants in the Institute
of Heart and Lung at the present time on cystic fibrosis. Is this `an
accurate figure?
Dr. BARBERO. I am not conversant with the actual figure in the
heart and lung at the present time. It has been more striking that in
arthritis and metabolism the specific research has had a great deal
of involvement in this area.
On the other hand, the Heart and Lung Institute has had a great
interest in trying to identify and develop this program. I am quite
sure that the nature of this bill with its language is most harmonious
with their interest.
Mr. Roy. The question in my mind, of course, is whether it is appro-
priate to go ahead in this bill. If the thrust has been so light within
heart and lung, I wonder if again the major thrust should not remain
within the Institute of Arthritis and Metabolic Diseases.
Dr. BARBERO. One of the ways to look at it is that the main problem
in cystic fibrosis is from death. Fifty percent of the children who die
from age 12 or so are at the lung level. That has been an area that
requires a great deal of focus and a great deal of care as well.
It involves a kind of center orientation. The very nature of this bill
is much more conducive to that kind of development. I think it is
timely now that in `addition to the basic metabolic studies that have
occurred in arthritis and metabolism that we now hone down on the
preservation and understanding of the factors in the chest which
are crucial to survival.
Mr. Roy. So, the center factor of this bill is very attractive.
Dr. BARBERO. Essential.
The National Cystic Fibrosis Research `Foundation has 45 teaching,
care and research centers. It is also a matrix that a certain number
of them would be able to converge in relation to the development of
some of the elements within this bill. So, it represents an excellent
convergency to some degree between the private and the Federal
sector.
Mr. Roy. Thank you very much, Doctor Barbero.
Mr. ROGERS. Mr. Symington?
Mr. SyMINGTON. No questions.
Mr. ROGERS. We are very pleased to have the ranking minority
member of our full committee, Mr. Springer.
Do you have any questions?
Mr. SPRINGER. I have no questions, Mr. Chairman. Thank you.
Mr. ROGERS. Thank you very much, Doctor, we appreciate your
presence.
Dr. BARBERO. Thank you.
Mr. ROGERS. Our next witness is Dr. Roy Goddard, chairman, Pedi-
atric Pulmonary Association, Albuquerque, N. Mex.
78-994 0-72-15
PAGENO="0226"
220
Dr. Goddard, the committee welcomes you and will be pleased to
receive your testimony.
STATEMENT OP DR. ROY P. GODDARD, CHAIRMAN, PEDIATRIC
PULMONARY ASSOCIATION, ALBUQUERQUE, N. MEX.
Dr. GODDARD. Thank you, Mr. Chairman. We welcome the oppor-
tunity to appear before you and speak primarily for House bill 13715.
I should tell you *that perhaps our organization is the youngest
organization in the field of pediatric pulmonary disease programs.
We do not have 5,000 members. We have simply something like 250.
We are certainly interested in what Dr. Barbero has been telling you
about the needs of the children of this country, but particularly in try-
ing to establish early diagnosis, control, and practice preventive medi-
cine in infants, children, and young adults with chronic pulmonary
disease.
Now, I would tell you `that we work together with the Pediatric
Pulmonary Liaison Council, which includes representatives of the
American Academy of Pediatrics, American `College of Chest Physi-
cians, whom you will hear from, the American Thoracic Society,
American Academy and `College of Allergists, and you have already
heard from Dr. Barbero, of the `National Cystic Fibrosis Research
Foundation. We are also in contact with many other organizations
concerned wi'th chronic pulmonary disease of children and we are
authorized to speak for the Allergy Foundation of America and the
Association of Convalescent Homes and Hospitals for Asthmatic
Children.
You have already heard in testimony presented yesterday and today
of the importance of cardiorespiratory problems in the adult, and Dr.
Barbero has just touched on the problems of children. I would now
like to enlarge on this, and say we are speaking in behalf of 50 per-
cent of the population of this country, those under `the age of 24. Just
as we represent 50 percent of the population, we would like to speak
in behalf of those children with chronic pulmonary disease, which you
will see, on your first exhibit A (p. 226) represents 48 percent of all
the chronic conditions in children. Over 7 million children today are
afflicted with asthma, `allergies, sinusitis, bronchitis, bronchiectasis,
cystic fibrosis, and other chronic pulmonary diseases. This is roughly
10 percent of the population in this age group.
Over 33,000 children under the age of 20 die each year from respira-
tory diseases. A's to morbidity_-the days of illness, days of school
missed, reduction in efficiency-_some 55 percent of all school days lost
because of chronic conditions, result from chronic pulmonary disease.
Our Nation's schoolchildren lose well over 100 million days from
school, and preschool aged infants and children lose 120' million days
from their usual preschool activities because of 70 million episodes of
acute respiratory illness each year. This is roughly 10 days out of each
year that are missed from these illnesses.
I would comment on one ot'her area of the problem. Simply, to state
that neonatal respiratory disease, composed of respiratory distress
syndrome, asphyxia neonatorum, neonatal aspiration syndromes, and
other conditions, kill's and maims more of our children than all other
diseases of childhood. In 1968, some 29,000 under `the age of 1 year
PAGENO="0227"
221
died from respiratory conditions. Eighty percent of these deaths are
usually due to the respiratory distress syndrome. The average cost per
family of the child with asthma today is `as high as 15 percent of the
total family income, and in cystic fibrosis this may be 25 percent or
more of the family income. I do not believe I need to dwell any further
on the seriousness of the problem of chronic pulmonary diseases in our
young adult population.
The Association of Pediatric Pulmonary Centers and others for
whom we speak endorse House bill 13715 in its entirety and the com-
ments of our colleagues who have already testified before us, and will
testify subsequently. We should like to `comment specifically on several
areas of the bill.
National Clinical Research `and Demonstration Centers, section
415 (`a), page 8. 1 would like to refer first to section 415 w'hich men-
tions 15 new centers. We have submitted a proposal to Congressman
Rogers, in which we would propose 12 new centers f'or clinical research
into, training i'n, and demonstration of advanced diagnostic `and treat-
ment methods for chronic pulmonary diseases `of infants, children and
young adults, including treatment of respiratory diseases of infancy,
allergies and `asthma, bronchitis and bronchiectasis, cystic fibrosis, and
other pulmonary `diseases `of children. These centers would be for
children `and young adults, and would be set up on a developmental
or incremental pattern; 12 in the first year, `an additional 12 in the
second and third years, making a total of 36 such `centers at the end of
3 `years. We must insure continuity of these programs in each center,
and they must be funded for a minimum of 3 years. I believe exhibits
B and ~J (pp. 231 and 237) cover these in considerable detail.
Interagency `Technical Committee, section 416(a), p'age 9. Such a
multidisciplinary approach, we believe, can be effectively `administered
through the Heart and Lung Institute as outlined in section 416, which
specifies that the Secretary shall establish an interagency technical
committee-I repeat this is very essential and important-shall estab-
lish an interagency technical committee, which shall be responsible for
coordinating all Federal health programs and activities. We believe
that in section 416(b), page 10, representation `should include `particu-
larly the National Institutes of Allergy and Infectious Diseases;
Arthritis and Metabolic Diseases; Child Health and Human Develop-
ment; and Health Manpower Education; and the Maternal Child
Health Division of Health Services and Mental Health Administration.
All of these governmental agencies are concerned in `children's
programs.
National Heart and Lung Advisory Council, `section 417(a) (2),
page 10. Pertaining to section 417, we would recommend that of the
18 members to be appointed by the Secretary, 12 of these should be
selected from among the leading medical and scientific authorities,
two of whom should be pediatric oriented.
Appropriations, section 419B, page 13; and control programs, sec-
tion 414(b), page 7. Gentlemen, in section 419, wherever it specifies
the funds to be appropriated for each fiscal year, we would hope that
this would provide for $10,000,000 per year as a basic minimum for
the pediatric portio'ns of this program. From comments of today and
yesterday, it would seem justifiable to double this figure. Pertinent
to this, and as outlined in section 414(b), page 7, reference control
PAGENO="0228"
222
programs, we believe that an adequate network of pediatric pul-
monary centers can be built around exemplary locations already in
existence with the assistance of the appropriations so authorized.
Some of these designated in the bill as new should be old or con-
tinuing centers. We will be glad to supply the committee with a list
of centers we have already reviewed in this country which we think
would be able to participate in this program.
Four contract or control pediatric pulmonary center programs
established in 1968 through the Chronic Disease Division of the
TJSPHS were terminated in July 1971. I refer you to page 5, exhibit
D (p. 244), which shows all of the centers are out of existence as
of last summer.
As to the RMP programs, which have been mentioned as covering
some of these education and control areas, I think there is ample
evidence in Secretary Richardson's letter to Senator Hiram Fong,
page 19, exhibit D, Dr. Harold Margulies' letter to Congressman
Corman, page 23, exhibit D, and other communications and docu-
mentary material in exhibit D, to emphasize the point that many
such programs will no longer be covered by RMP funding. As of
April 20, 1972, only one of the nine original pediatric pulmonary
centers under the RMP program had been formally funded beyond
fiscal year 1972.
There has been considerable confusion concerning RMP objectives.
This has been on a national as well as a local basis, and reemphasizes
what Dr. DeBakey and others have said, "An inability to move
programs."
Gentlemen, money was appropriated for pediatric pulmonary
*centers for fiscal year 1972. The language of your congressional
Appropriations Committee, and the language of the Senate committee
last year, stated "that notwithstanding phasing out, these programs
would be continued to the same extent in fiscal year 1972 as in fiscal
year 1971; namely, $1,3 million in fiscal year 1972. As of this date,
only $169,000, not $1.3 million, has been obligated, and beyond fiscal
year 1973 only $74,000 has been obligated. Unless there are some
radical changes, pediatric pulmonary centers are essentially out of
existence as of August 31, this year.
You have heard doctors testify yesterday and today about the knowl-
edge that we have which will be lost with the phasing out of these RMP
programs. Dr. Fox has talked about control programs, that we have the
state of the art today which can be utilized if we put this into effect. In
essence, we have respiratory intensive care units in this country, not
just for adults but for children, and we are able to save many of these
babies, as pointed out by Dr. Barbero.
What we have learned in cystic fibrosis we have been able to apply
in other diseases, physical therapy, inhalation therapy, and proper
drainage of these secretions. Cystic fibrosis must be incorporated in
the same bill. You cannot take asthma, or cystic fibrosis out of this bill,
or any of these conditions which start in young adulthood or even in
infancy. I don't need to go into lipid and other diseases, such as, hyper~
tension that Dr. Hurst referred to this morning starting in the teens.
Also, whatever affects lungs affects the heart in many respects and we
cannot separate these.
PAGENO="0229"
223
The sociopsychological impact of chronic disease, I believe, has just
been barely touched upon. Rehabilitation, special education, manpower
education, and control and survey must be emphasized. I think we have
to work with the Heart and Lung Institute in the educational area, also.
I would like to touch on construction. I think perhaps pediatric
pulmonary centers are a little ahead in the construction area. I am not
saying, as Dr. DeBakey did, that we don't need funding but we do have
some centers in this country today that with very little modification
could go ahead with the comprehenEive programs that we have talked
about and outlined in exhibit B.
I1~is essential that we put money into the staffing, the basic operating
cost, and patient care costs as required for research. It is essential that
we include training, including training not just for physicians, but for
allied health professions' personnel and demonstration purposes. I will
tell you that our association is also involved in the joint committee
with the Thoracic Society and the College of Chest Physicians in a
manpower survey. You have heard Dr. Kent and others say we are
lacking in chest physicians. We are even more lacking in those trained
in pulmonary problems in children.
With reference to your question yesterday of how many people
should we train ~ I believe Dr. Cooper, from the Heart and Lung Insti-
tute, said they believe in 1980 they should have 225 trained pediatric
cardiologists.
Gentlemen, we held a symposium entirely devoted to pediatric pul-
monary training last October (p. 3, exhibit E, p. 268). We don't have
pediatric pulmonary trained people in this country and we need them.
We can supply, again, areas having medical schools and nonmedical
school institutions, that can help in this training.
Mr. ROGERS. I think it would be helpful to have those submitted for
the record.
(The information referred to follows:)
CENTERS CURRENTLY CONSIDERED ACCEPTABLE FOR CONSIDERATION AS
PEDIATRIC PULMONARY CENTERS
NUMBER, AREA, CENTER, AND LOCATION
1.-Northeast: Combined Boston Medical Schools and Boston Children's Hos-
pital, Boston, Mass.
2.-Northeast: Yale University, New Haven, Conn.
8.-Upper New York: Albany Medical Center, Albany, N.Y.
4.-~Upper New York: Rochester Medical School, Rochester, N.Y.
5.-Metropolitan New York and New Jersey: Combined New York Medical
Schools and Babies Hospital, New York, N.Y~
6.-Greater Delaware Valley and Pennsylvania: Combined Philadelphia Medi-
cal Schools and Hospitals, Philadelphia, Pa.
7.-Washington, D.C., Maryland and the Virginias: Combined Washington,
D.C., Medical Schools and Hospitals, Washington, D.C.
8.-Mid-Atlantic: Duke University Medical School, Durham, N.C.
9.-Southeast. Medical College of Georgia, Augusta, Ga.
10.-South: Tulane University Medical School, New Orleans, La.
11.-South: University of Mississippi Medical Center, Jackson, Misa
12.-Northern Ohio: Case Western Reserve Medical School, Cleveland, Ohio.
13. Southern Ohio: Ohio State Medical School, Columbus, Ohio.
14~-Michigan: Detroit Children's Hospital, Detroit, Mich.
15.-Indiana: University of Indiaiia Medical School, Indianapolis, md.
16.-Illinois: Northwestern University Medical School and Children's Memorial
Hospital, Chicago, Ill.
17.-Minnesota: University of Minnesota Medical School, Minneapolis, Minn.
PAGENO="0230"
224
18.-Wisconsin: University of Wisconsin Medical Center, Madison, Wise.
19.-Plains: University of Nebraska, Omaha, Nebr.
20.-Missouri: Combined St. Louis Medical Schools and Hospitals, St. Louis,
Mo.
21.-Kansas: University of Kansas Medical Center, Kansas City, Kans.
22.-Oklahoma: University of Oklahom.a Medical School, Oklahoma City, Okia.
23.-Texas: Baylor Medical School, Houston, Tex.
24.-Southwest: Lovelace-Ba'taan Medical Center and The University of New
Mexico Medical School. Albuquerque, N. Mex.
25.-flocky Mountain: University of Colorado Medical School, Denver, Cob.
26.-Intermountajn: University of Utah Medical School, Salt Lake City, Utah.
27.-Washington/Aiaska: University of Washington Medical School, Seattle,
Wash.
28.-Oregon: University of Oregon Medical School, Portland, Oreg.
29.-No. California/No. Nevada: Combined Medical Schools and Hospitals,
San Francisco and Oakland Bay Area, San Francisco, Calif.
30.-So. California/So. Nevada: Combined Los Angeles, Orange County Medi-
cal Schools and Hospitals, Los Angeles, Calif.
31.-Hawaii: University of Hawaii Medical School, Honolulu, Hawaii.
32.-Puerto Rico: University of Puerto Rico, San Juan, P.R.
Dr. GODDARD. We believe that diagnosis, together with the evaluation
of how severe that disease is in early age, is going to be our biggest
effort in the prevention of the pulmonary and cardiac cripple of the
future.
Now, we have learned that there is a critical threshold. You might
ask how often are those children in trouble? There are many contribut-
ing factors. Dr. Marston, I believe, said we should take asthma out of
the heart and lung bill. I don't think so. There are allergy factors,
there are respiratory factors, including infection, draining ears and
sinuses, there are metabolic deficiencies. There is environment, both
smoking and pollutants, all of these, and emotional factors.
Why one child may have asthma and the next one does not may
in part be determined by this critical threshold. I won't go into further
emphasis of that. I believe it is adequately depicted in another exhibit,
exhibit F (p. 274).
The training and demonstration, research and investigation, tie all
of these things together. I have mentioned that what we have already
determined in some areas leads us to better recognition in other fields,
not only pulmonary diseases, but in cardiac conditions, and so on.
We are also just finishing, for example, research studies into predict-
ing not only who has asthma but how severe his asthma is. There is
a demonstration in exhibit F on the diffusion of oxygen from the lungs
across to the circulatory system. This method allows us to study not
only how much oxygen is taken into the lungs, but how much goes
across the lung membranes and how much emphasis we should put
into managing this patient.
These techniques require further refinement. I believe the bill you
are proposing will help us make available to the American public these
techniques, after they are refined, and help the children whom we
want to prevent from becoming emphysematous adults.
I believe this can be done. If you will pass legislation which will
provide the practical methods of attacking this real major health
prdblem of today, we can substantially reduce the mortality and the
morbidity in these chronic pulmonary diseases in childhood and young
adulthood, and build toward a stronger, more healthy America of
the future.
PAGENO="0231"
225
One of the most important factors to be considered in this total
program is the aspect of preventive medicine. I believe Dr. Carter
asked how much could be prevented if we carried out some of these
programs. I believe 60 to 80 percent of our asthmatic children with
chronic pulmonary disease could be prevented from getting above
this threshold if we put into practice many of the things that we
have learned.
Thus, recognizing that today's distressed child becomes tomorrow's
citizen, productivity depends on his well being, and the economy of
the Nation is synonymous with humanitarian principles in health care.
I would like to endorse the testimony given by Dr. Barbero and Dr.
Kent, and reiterate what they have said. I would like the committee
to take cognizance of Dr. Frederick Burke's comments. I know he
has filed his comments with you. He was unable to stay yesterday.
I don't believe we need to dwell further on these. You have them iii
your minutes.
Thank you again for the opportunity to appear to represent our
Pediatric Pulmonary `Center Association and those 7' million children
in our country who suffer from chronic respiratory conditions.
I will be glad to answer any questions.
(The exhibits to Dr. Goddard's statement follow:)
PAGENO="0232"
226
ASSOCIATION OF PEDiATRIC PULMONARY CENTERS
~XI1IBIT ~
INCIDENCE AND NORBIDITY OF CHRONIC RESPIRATORY DISEASES
IN CHILDREN AND YOUNG ADULTS
[00%
~--
50%
Chronic Pulmonary Disease
Comprises 48% of All Chronic
Disease Under 17 Years of Age
50~
0%
Chronic Pulmonary Disease
Causes 55% of All School Days
Lost Because of Chronic Conditions
PAGENO="0233"
227
INCIDENCE AND MORBIDITY OF CHRONIC RESPIRATORY DISEASES
IN CHILDREN AND YOUNG ADULTS
Forty-eight percent of all chronic conditions in children under the
age of seventeen are due to allergy-respiratory conditions. Fifty-five percent
of all school days lost from chronic conditions are also due to allergy-respiratory
conditions. This is a significant part of pediatrics and young adult practice
and we believe warrants more emphasis in the early recognition, evaluation and
treatment of these problems.
aralysis and ortho-
pedic impairments
Incidence of Chronic Disease
Under 17 Years of Age
Other allergies
School Days Lost Because
Of Chronic Conditions
Based on U.S. National Health Survey Data, Childrens Bureau Pub. 405,
Washington, D.C., U.S. H.E.W. Department, 1963.
c~ç~s~ma 22.9%
PAGENO="0234"
228
DATA ON CHRONIC PULMONARY DISEASE IN CHILDREN
1967 - Prevalence of Selected Chronic Pulmonary Disease Among
Children Under 15 Years of Age
Hayfever Without Asthma 1,934,000
Asthma With Or Without Hayfever 2,040,000
Sinusitis i ,l30,000
Bronchitis 1 ,401 ,000
Other 723,000
7,228,000
Rate Per 100 Population
Hayfever Without Asthma 3.2 %
Asthma With Or Without Hayfever 3.4 %
Sinusitis 1.9 %
Bronchitis 2.3 %
Other i .2 %
Source: National Center for Health Statistics - HEW, Washington
Unpublished figures from interview survey of civilian
population, non-institutionalized.
PAGENO="0235"
229
PREVALENCE OF CHRONIC CONDITIONS AMONG CHILDREN
IN THE UNITED STATES OF AMERICA
(National Health Survey, 1968)
BOYS
GIRLS
BOTH
TOTAL POPULATION
51.90%
34,776,000
48.10%
32,230,000
67,006,000
ALL CHRONIC LISTED
c9~gIuQ~S
.Q4%
.1~2,~.?Q~QQQ.
1. Hayfever, Asthma &
Other Allergies*
10.67%
3,700,000
9.02%
2,907,000
6,618,000
2. Other Respiratory
Conditions*
5.99%
2,083,000
5.10%
1,644,000
3,727,000
3. Orthopedic &
Paralytic
2.48%
862,000
2.20%
709,000
1,571,000
4. Skin Diseases
1.43%
497,000
1.58%
509,000
1,006,000
5. Digestive
1.32%
459,000
0.85%
274,000
733,000
6. Speech Disorders
1.19%
414,000
0.50%
161,000
575,000
7. Hearing Problems
0.96%
334,000
0.63%
203,000
537,000
8. Visual Disorders
0.65%
226,000
0.56%
180,000
406,000
9. Mental and Nervous
Conditions
0.73%
254,000
0.60%
193,000
447,000
* ALL CHRONIC RESPIRATORY
16.66%
5,794,000
14.12%
4,551,000
10,345,000
(15.44%)
CHILDREN WHOSE ACTIVITIES ARE RESTRICTED
BY CHRONIC DISEASES
PER CENT OF ALL
NUMBER CHILDREN
ALL CHRONIC CONDITIONS
15,620,000
23.3%
100.0%
THOSE WITH ANY LIMITATIONS
1,427,000
2.1%
9.2%
THOSE WITH SOME LIMITATIONS IN
SCHOOL OR PLAY ACTIVITIES
825,000
1.2%
5.3%
HOSE WITH'LESSER' LIMITATIONS
602,000
0.9%
3.9%
PER CENT OF ALL
CHRONIC CONDITIONS
(Data from the National Health Survey, 1968)
PAGENO="0236"
230
THE IMPACT OF ACUTE AND CHRONIC ILLNESS
IN RESTRICTING CHILDRENS ACTIVITIES
(National Health Survey, 1968)
LIMITED IN
SCHOOL OR PLAY
FOR ILLNESSES
UNITED IN
SCHOOL (ALONE)
FOR 1LLNESSES
bA~(S SPENT IN
BED
FOR ILLNESSES
(Age 0 - 15)
(Age 0 - 15)
CHILDREN WITH CHRONIC
CONDITIONS (1966-1967)
PER CENT OF ALL CHILDREN
WITH CHRONIC CONDITIONS
TOTAL DAYS OF RESTRICTED
ACTIVITIES FOR ALL
CHILDREN (1968)
~
DAYS LOST FOR LISTED
ACUTE CONDITIONS (1968)
1,097,000
597,133,100
(almost 10
days lost by
evervchiliL
(Age 0 - 17)
.
605,629,000
(Age 6 - 16)
191 ,562,000
(Age 0 - 17)
266,973,000
1. Infections
2. Acute Respiratory
a. Acute URI's (Colds)
b. Influenza
c. Other Acute Resp.
3. Gastro-Intestinal
4. Injuries
5. All Other Acute
98,020,000
343,605,000
(175,067,000)
(148,409,000)
(20,128,000)
25,563,000
81,180,000
57,261,000
33,209,000
122,683,000
(59,005,000)
(60,719,000)
(2,959,000)
7,772,000
12,035,000
15,873,000
49,561,000
169,288,000
(73,211,000
(84,996,000
(11,080,000
10,459,000
15,388,000
22,277,000
DAYS LOST FOR LISTED
CHRONIC CONDITIONS (1968)
1. Asthma (22.9% rate set
in 1959-1961)
2. Other Allergies (4.5%)
3. Other Respiratory
Diseases (27.6%)
4. All Other Chronic
Conditions (45.0%)
62,912,000
27,667,000
6,338,000
1,245,000
7,636,000
12,450,000
11,067,000
.
DAYS LOST FOR ACUTE AND
CHRONIC CONDITT~N~
668,541,000
219,229,000
278,040,000
PAGENO="0237"
231
EXHIBIT B
MODEL FOR A PEDIATRIC PULMONARY CENTER
A. PURPOSE
To establish a comprehensive and coordinated diagnostic, treatment,
training, clinical and basic research program in pediatric pulmonary
disease.
B. INTRODUCTION
The prevalence, mortality and morbidity statistics emphasize the importance
of acute and chronic lung disease as a health problem in children. The
establishment of pediatric pulmonary disease centers is the most practical
and economical method of increasing the availability of professional per-
sonnel and improving the quality of care in this field.
C. OBJECTIVE
The primary objective of this program is to bring together in a teaching
center personnel with special skills for a coordinated approach to the
diagnosis and compreher~sive management of children with acute and chronic
respiratory diseases. This center will represent an optimal program unit
which is structured to:
(1) Serve as a training area for physicians of various disciplines, medical
students, nurses, paramedical, and health career personnel;
(2) Provide optimal diagnostic and treatment services for children having
acute and chronic respiratory diseases;
(3) Stimulate and conduct clinical and basic research in the pathophysiological
changes associated with chronic respiratory diseases thus improving the
clinical management of these afflictions;
PAGENO="0238"
232
(4) Develop and improve communications between the pediatric respiratory
unit and the medical and/or paramedical personnel in the outlying
communities. This will permit the prompt application of new
diagnostic and therapeutic measures in the treatment of neonatal,
pediatric and young adult pulmonary diseases; and,
(5) Provide an opportunity for the longitudinal study of children and
young adults with chronic respiratory diseases, thus obtaining informa-
tion concerning the natural course of pulmonary diseases, and the
effectiveness of preventive or prophylactic measures.
D. SERVICES
The pediatric respiratory center will coordinate the existing broad diagnostic
treatment and rehabilitation and research programs found at the university
medical center in order to provide comprehensive and exemplary care for
children with chronic and acute respiratory diseases. The center must
have the required personnel and facilities to provide the exact diagnosis
ai~d subsequent optimal care of the patient and the family afflicted with any
type of respiratory disease (allergic, congenital, immunologic defect,
infectious, etc.).
Inpatient services should include:
(1) Nursery
(2) Intensive Care Respiratory Unit
(3) Facilities and Personnel for Diagnosis and Treatment of Patients With
Infectious, Acute and Chronic Respiratory Diseases
(4) Rehabilitation.
PAGENO="0239"
233
Outpatient facilities and personnel should complement and extend the
inpatient services Home visitation programs should be an integral part
of the program
Services will be offered at a level and phase appropriate to the nature
and severity of the individual child~s basic pulmonary problem. An attempt
will be made to provide comprehensive outpatient evaluation therapy and
followup with hospitalization reserved for patients requiring special
diagnostic studies or intensive therapeutic measures Such care will
necessitate the interaction of the entire medical team of the respiratory
center. In addition, for optimal care a close liaison will be developed
among the center staff local physicians public health authorities and
community services.
All children seen at the center especially those handicapped by their
respiratory diseases will have a thorough. followup with the aid of the voca~
tional and social services in order to make certain that the child realizes
the full potential for rehabilitation Since the results of rehabil~tation
with pediatric problems is directly related to the enthusiasm and effective~
ness of the therapeutic program provided by the parents or other members of
the household special instructions will be given to the family members as
well as the local community in the medical and emotional management of the
child with chronic pulmonary disease Educational programs will be carried
out both at the center and in outlying communities
The longitudinal study of children with chronic respiratory disease provides
an opportunity to obtain data concerning the natural course of pulmonary
disease, especially the subsequent development of chronic obstructive
respiratory diseases in adulthood The effectiveness of various therapeutic
regimens will also be evaluated by developing a multiple parameter computer-
ized evaluation system.
PAGENO="0240"
234
E. TRAINING
An equally important objective of the center is to provide a training
ground for pediatric pulmonary disease specialists. Pediatricians, internists,
specialists, and trainees in the field of pulmonary disease, child psychiatry,
clinical psychology, nursing, physical therapy, inhalation thera~y~ ~adLology~
social work, and education will have an opportunity to train in this insti-
tute. The center is expected to play a key role in training a broad spectrum
of pediatric pulmonary disease professional personnel to serve in the pul-
monary clinic facilities across the area served by the medical center.
Community and continuing education training programs will be a part of the
overall training.
CLINICAL TRAINING:
(1) Fellowship training for periods of 1 - 2 years will be available to
board certified specialists.
(2) Selected training programs for periods of 1 - ~ weeks will be made
available f or physicians in practice.
(3) Elective programs will be available for medical students.
(Li) Specific programs will be made available for physician assistants,
inhalation therapists, public health nurses, nurses, and other health
career personnel.
F. RESEARCH
A clinical research unit should be available to perform appropriate investi-
gative studies concerning the etiology and pathophysiology of pulmonary
afflictions in children.
PAGENO="0241"
235
Normal values for pediatric patients must be secured especially in regard
to pulmonary function testing. An attempt should be made to obtain simpler
diagnostic tests especially in patients less than 6 years of age.
Specific therapeutic programs should be developed and evaluated.
Basic research must be integrated with the clinical aspects to assure the
utmost returns in research areas.
6. CONSULIATIVE SERVI~~
Other medical and paramedical services and facilities should be available
for integration into the care, research and teaching programs. These
include:
1. MEDICAI.~
a. Anesthesiology
b. Biostatistics
c. Cardiology
d. Radiology
e. Thoracic Surgery
f. ENT
g. Environmental Health
h. Infectious Diseases
i. Allergy
j. Immunology
k. Psychiatry and Psychology
2. PARAMEDICAL
a. Nursing (RN, LPN, Nurses' Aides and Assistants)
b. Inhalation Therapy
c. Physical Therapy
d. Pulmonary Physiology Technicians
e. Laboratory Technicians
f. Allergy Technicians
78-994 O-72----16
PAGENO="0242"
236
3. COMMUNITY
a. Community Medicine and Public Health
b School Teacher Vocational and Occupational Therapy
c. Social Workers
d Welfare Departments
e Allied Lay Health Agencies
f Health Planning Agencies Manpower Development Groups HMO s
PAGENO="0243"
237
EXHIBIT C
PLACEMENT AND FUNDING FOR REGIONAL PEDIATRIC PULMONARY CENTERS
`lo effectively carry out critical research into training in and
demonstration of advanced diagnostic and treatment methods for chronic
pulmonary diseases of infants children and young adults including the
respiratory diseases of infants allergy bronchitis bronchiectasis
cystic fibrosis and pulmonary diseases of children it is proposed that
regional pediatric pulmonary centers be established based on geographical
and population distribution
A proposed plan of 22 geographic regions is hereby submitted It is
suggested that 12 pediatric pulmonary centers be established in the
first year, an additional 12 in the~second ar~d third years. The additions
above and beyond the 22 regions depicted on the enclosed map would be
added in the more populous areas (An additional 14 over the 22 geograph-
ical regions.)
To insure continuity of programs each center should be funded for a
minimum of three years Each of these centers would not necessarily be
new centers, but might be continuing from the original 12 regional
pediatric pulmonary centers only 4 of which are now receiving any
Government support The closing of these centers has meant a loss of
important manpower and teams vital to the multidisciplinary programs
called for in the Bill
The proposed incremental funding of these centers is also appended We
are adviged that these figures should probably be increasea by as much
as fifty to one hundred per cent to meet the needs of the broad principles
written into House Bill No 13715 and Senate Bill 3323
PAGENO="0244"
A PROPOSED PLAN
FOR
REGIONAL PEDIATRIC PULMONARY CENTERS
1960-1965 POPULATION (MiflionsI
*estimated
PAGENO="0245"
239
PROPOSED INCREMENTAL FUNDING OF CENTERS
(Millions of Dollars)
Proposed No.
of Centers
Year
Year 1
ear 2 Year 3
Total
1
12* 3.6
3.46 3.0
10.06
2
24** 3.6
3.46 3.0
10.06
3
36 3.6
3.46 3.0
10.06
30.18***
*These budget
figures are on the basis
of an
appropriation per center per
year,
as follows:
Year 1
Year 2
Year 3
300,000
280,000
250,000
**Each year, 12 additional centers are added
exist within the network by the third year
to the program until a total
of the program.
of 36
10,060,000
7,060,000
3,000,000
30,180,000
***Total funding for the entireproposed budget is $30,180,000 for the three-year
programs for 36 centers: However the actual amount of funding per year would
be:
3,600,000
7,060,000
Year 1
Year 2
Year 3
Year L~
Year 5
PAGENO="0246"
240
EXHIBIT 0
THE PRESENT STATUS OF PEDIATRIC PULMONARY CENTERS
HISTORICAL BACKGROUND OF PEDIATRIC PULMONARY CENTERS
During the past two decades there has been growing recognition
of the importance of pediatric pulmonary diseases and the significance
of care, teaching and research in these areas. Accordingly, numerous
institutions, including private clinical and teaching organizations and
institutions throughout the country began to devote specific departments
and divisions toward this multidisciplinary approach. Considerable progres
was made in the 50's, and in the early 60's the National Cystic Fibrosis
Research Foundation began to organize centers throughout the country to
contribute to the early diagnosis and evaluation, treatment, educational
training and~monstration, and research, particularly in the area of cystic
fibrosis. Today there exist 97 Cystic Fibrosis Centers throughout the
country, to which the National Cystic Fibrosis Research Foundation contri-
butes $892,000 per year, towards the partial support of these centers.
Forty-two of these centers are organized with multidisciplinary approaches,
as care, teaching and research centers, to which $510,649 is contributed
for partial support and another $135,000 for clinical research done by
these centers. Fifty-five of the centers are designated as clinics, which
primarily are engaged in the evaluation and care of patients with cystic
fibrosis and other respiratory diseases. They are supported partially by
grants of $84,500 for the clinical aspects, and $11,761 for clinical re-
search. Another $3 million was budgeted last year by the National Cystic
Fibrosis Research Foundation for public education, costs of medication,
assistance in local programs, and basic research.
In 1967, the National Cystic Fibrosis Research Foundation, to-
gether with others interested in pediatric pulmonary disease programs,
appeared before Congress in support of the establishment of pediatric
pulmonary centers throughout the country. Congress appropriated $1,619,478
for the establishment of two types of programs. Four centers were estab-
lished as control programs, with contracts negotiated directly through the
chronic respiratory disease control program of the USP}JS and started in
the summer of 1968 (See Page 5). The second type of program was in associa-
tion with Regional Medical Programs and 9 centers were involved in these
PAGENO="0247"
241
programs starting in February 1968 (See Page 6) All of the contract or
control programs were terminated in the summer of 1971, with the exception
of one project which was extended to `3-24-72 without additional funds.
Thus currently all contract centers a~e out of existence Of the 9
Pediatric Pulmonary Centers funded under the Regional Medical Programs,
5 were terminated in 1971; one of these has been re-instated at a reduced
program and budget for half of 1972; 4 programs are receiving funding for
fiscal year 1972, three of these will be terminated by the end of the
summer of 1972, with only one program continuing into 1974. Two of these
will be considered f or extension, and one other project previously terminated
has been given verbal approval, although no formal notice has been received
from the National Regional Medical Program Administration To sum up two
programs out of 13 of the original pediatric pulmonary centers, authorized
by Congress in 1968 will remain in existence in fiscal year 1973 and beyond,
unless the Regional Medical Program changes its policies with respect to
pediatric pulmonary centers and continuing programs, or announces re-instate-
ment of other programs before the end of 1972
During the past year a serious problem has evolved in the dis-
birseinent and distribution of appropriations passed by the legislative
branch of the government and signed by the executive branch The president
called for a 1972 budget of $52 771,000 (see page 7) for regional medical
programs Dr Giulio Barbero appeared before the House Committee on
Appropriations, and Dr Jack Docter appeared before the Senate Committee
on Appropriations to present testimony to both committees that local
funding was not available for fiscal year 1972 to take over the programs
called for in the original planning The House added another 30 million to
the appropridtions and the Senate increased this 40 million The Senate-
House Conference Agreement reduced this figure by 20 thousand for a total
Regional Medical Program budget for fiscal year to $102,771 000 In the
House report it is stated that `The Committee will expect that the pediatric
pulmonary program be continued in 1972 at not less than the 1971 level
(See Page 8) In the Senate report the language is essentially the same
The committee concurs with the House expectation that the pediatric
pulmonary program be continued in 1972 at not less than the 1971 level
It also wants to make it clear that notwithstanding earlier notice of
impending termination all pediatric pulmonary program projects ongoing
PAGENO="0248"
242
in 1971 are to be funded in 1972." (See Page 9). This level of funding
for fiscal year 1971 was $1,017,200 (See Page 6). Public Law 92-80, 92nd
Congress HR 01161, was passed by both houses, and signed into law August
10, 1971 by the President. This appropriation of $102,771,000, together
with a carryover of over $30 million made a total of $145,104,000 for the
Regional Medical Program for fiscal year 1972. Although the appropriations
had been set aside and the law signed by the President, it was apparent
by mid-October that the funds were not being released from the Bureau of
the Budget to HEW and thence to RN?. In spite of the fact that the
language in both the Senate and House reports assured continuation of
pediatric pulmonary programs, and reinstatements of projects which had
received notice of termination, programs were continuing to be terminated.
Therefore, the Association of Pediatric Pulmonary Centers appointed a
special ad hoc legislative action committee to investigate the problems
concerned with the release of these monies and the termination of the
programs. This committee met with officials of the Health Services and
Mental Health Administration of the Department of Health, Education and
Welfare on October 27, 1971, to discuss possible solutions to the problems,
and were requested to submit a plan for comprehensive health care of
infants, children and young adults with chronic pulmonary disease to
H.S.M.H.A for its review. In the meantime, the Executive Committee of
the Association of Pediatric Pulmonary Centers, through contacts with the
pediatric pulmonary centers throughout the country, were informed of the
termination of the various programs without any funding, ±rrespective
of the language of the House and Senate reports. Various centers,
organizations, and individuals contacted the President and the Secretary
of Health, Education and Welfare, requesting that monies be released so
that the funding of these centers which were being terminated might be
continued (See Pages II and 12).
During the last six months, little, if any progress, has been
made in channeling these specified funds into pediatric pulmonary programs.
Following the request of H.S.M,H.A., an outline of comprehensive health
care planning for chronic pulmonary disease of children and young adults
was submitted by the Association of Pediatric Pulmonary Centers on
December 8, 1971 to H.S.M.H.A. The ad hoc legislative committee met with
Regional Medical Program representatives on February 14, 1972 to discuss
PAGENO="0249"
243
the plan, and at this time very little, if any, encouragement was given
for the future of pediatric pulmonary center programs under the regional
medical program. Following this poor reception the Association of
Pediatric Pulmonary Centers turned to Congressman Rogers, and submitted
a proposal at his request, for a plan for Pediatric Pulmonary Centers to
be incorporated into the National Heart, Blood Vessel, Lung, and Blood
Act of 1972, being prepared by congressional house and senate health
subcommittees (Currently now House Bill H1~ 13715, and Senate Bill S 3323).
The Association of Pediatric Pulmonary Centers has continued to work
closely with members of the Senate and House in attempting to give life
blood back to the pediatric pulmonary center programs (under regional
medical program) which have been currently terminated. However, from this
correspondence seen on pages 13 - 2~ very little has been accomplished
(and it is apparent that although Congress is being asked to appropriate
130.2 million for FY 1973 for Regional Medical programs, no funds are
earmarked for Pediatric Pulmonary Centers (See Page 25). There has been
considerable confusion in directives from the national Regional Medical
Program offices, and even more confusion at regional and local levels.
We therefore believe that it is imperative that legislation, which will
meet the ever present need of 7 million American children with chronic
pulmonary disease and the concept of a multidisciplinary approach, be
passed, which will place funding for these programs in national adminis-
trative institute, which can contract directly with Centers for such
programs.
PAGENO="0250"
244
REGIONAL MEDICAL PROGRAMS SERVICE
Pediatric Pulmonary Contracts (4)*
Contract Period Funds En umbe Termi nation
1 Georgetown Univ 7/30/68 7/29/71 216 891 00 7/29/71
2 Hahnemann Med Coll 6/20/68 6/23/71 209 164 00 6/23/71
3 Los Angeles Cty Hosp 6/20/68 6/30/71 217 500 00 6/30/71
4 Tulane Univ 7/25/68 7/24/71 216 916 00 7/24/71
Ext to 4/30/72
without additional
funds
3 Year Total 860 471 00
1 Year Total 286 823 00
* These four contracts or control programs were directly through the Chronic Disease
Division of the United States Public Health Service and were terminated in July
1971 (with proviso to continue Tulane Center through 4/30/72 with out additional
funding)
Georgetown turned down by National Regional Medical Program October 1971
Los Angeles re applied to Regional Medical Program through conibined inter area
project and disapproved locally some question proposal may be reviewed nationally
July 1972
Tulane s new proposal approved with high priority at local level turned down
nationally /
PAGENO="0251"
245
REGIONAL MEDICAL PROGRAMS SERVICE
FUNDED PROJECTS
Pediatric Pulmonary Disease
RMP Start FY FY FY FY FY Exp. Date
Date 1968 1969 1970 1971 1972 RMPS Support
104 4 1,326 1 1,558 0 1,017 2 168 9
* Renewal application received for June 1972 program review - _______________
** New Project Proposal currently under review
This table from letter to Congressman James Corman of California from Dr Margulies
Regional Medical Program Director, dated March 7, 1972.
As of present date (April 20, 1972) no formal additional awards have been made to any
of the above centers.
Colorado/Wyoming proposal approved locally, turned down nationally.
Greater Delaware Valley 1972 funding has been extended to 8/31/72. Local
Regional Medical Program supports additional 3 year period awaiting Natl action
Puerto Rico has submitted a proposal for one additional year (FY 1972
budget of 117 000 00)
Washington/Alaska has applied for 3 year program to start 7/1/72 (340 000)
Verbal approval locally without formal notice from national
California project not funded from 8/31/71 New limited neonatal program
approved and funded for 2 1/2 years, starting 2/1/72 (at 83.0, 137.4 and
110.0).
272.6 239.7 175.4 ** 8/31/71
I. California 7/68
2. Colorado-Wyoming 2/68
3 Georgia 7/68
4. Greater Delaware Val. 4/69
5. Hawaii 2/69
6. New Mexico 11/68
7. New York Metropolitan 2/69
8. Puerto Rico 5/70
9. Washington/Alaska 2/68
49.6
71.0
156.6
247.5
210.9
59.6
255.3
71.0
209.4
319.2
114.6
121.2
191.1
291.8
38.6
143.5
161.6
107.0
99.1
172 .1
120.0
73,9
95.0
** 12/31/71
9/7 1-8/74
** 3/31/72
9/30/71
8/31/72
12/31/71
* 5/30/ 72
** ,2/~i/n9
PAGENO="0252"
246
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
The 1972 Health and Welfare Appropriation Bill
(Includes extension legislation; excludes new legislation)
REGIONAL MEDICAL PROGRAMS
1971 1972
Comparable Budget House Department Senate Conference
Appropriation Estimate Allowance Appeal Allowance. Agreement
1. Grants 99,500,000 40,500,000 70,500,000 ** 110,500,000 90,000,000
(Obligations) (70,298,000) 75,000,000 (115,000,000) ** (155,000,000) (115,000,000)
2. Technical
Assistance and
Disease Control 8,811,000 8,883,000 8,883,000 8,883,000 8,883,000 8,883,000
3. Program
Management 3,297,000 3,388,000 3,388,000 3,388,000 3~388,OOO 3,388,000
TOTAL 111,608,000 52,771 ,000 82,171 ,000 122,771,000 102,171 ,000
**The Department has urged the Senate to amend the House bill to bring it as close to the Presiden't
budget request as possible. The Secretary of HEW in his appeal letter requested `. . .that the Comnittee
adopt the overall level of the President's budget as a cons~tr.aint on its action on the bill."
PAGENO="0253"
247
HOUSE OF REPRESENTATIVES
(COMMITTEE PRINT]
NOTICE.-This report is given out subject to release when con-
sideratIon of the bili which is accompanies has been completed by
the whole committee. Please check on such action before release In
order to be advised of any changes.
92o Cowwuus) ROUSE OF REPRESENTATIVES ( Rzrosrr
* IstSeseion j~ ~ No.-
* DEPARTMENTS OF LABOR, AND HEALTH, EDUCATION,
* AND WELFARE, AND RELATED AGENCIES APPROPRL4~-
TION BiLL, 1972
JOLT 22, 1971.-Committed to the Committee of the Whole Rouse on the Stats
of the Unlors.and ordered to be p rinted
Mr. FLOOD, from the Committee on Approp nations,
submitted the following
REPORT
[To accoinpanyR.R.10061]
16
The $30 million increase reeoi~ñiuended bc the Committee, plus the
carryover of funds from 1971, will make $1 lô,104,000 available for
obligation for Regional ~1edicnl Programs.
in addition to the basic Regional Medical Programs discussed
above, this appropriation funds the activities "Technical assistance
and disease control" tmd `Program management." Tue budget
included $8,883,000 and $3,388,000, respectively for them, substan-
tially the same program level as for 1971.
The~ornmittec :wilLexpeet that tfr ~1ia uQTh~ Prnpain
beconuimcdJ~~~tLk~1.
From Report of House of Representatives Appropriations Committee on
Department of Labor, Health, Education & Welfare Agencies Appropriation
Bill, 1972, dated July 22, 1971.
PAGENO="0254"
248
SENATE
Calendar No. 310
02m Co~iorn~cs 1 SENATE REPORT
1.~tSess~on j N~92-3l6
DEPARTMENTS OF LABOR, AND HEALTH, EDUCATION,
AND WELFARE, AND RELATED AGENCIES APPROPRIA-
TI&N BILL, 1972
JULY 29, 1971.-Ordered to be printed
Mr. MAGNUSON, from the Committee on Appropriations,
subnutted the following
REPORT
[To accompany }LR. 10061]
26
One f the most proniisuu~ f iotentin! improvenients ii; the delivery
of health care are lIMO's, health maintenance organizations or group
practice. and other adaj)t etions of pre-pzinl health caio that are con-
templated. The Committee feels t.hal. RMP is in perhaps the best
position to contribute effectively to proving out such programs. The
Committee was informed that. RMP stands ready to ~~-ork in tandem
with others, Federal agencies as `veil as public anti private organiza-
tio;i~i. to prove out such proj)osals and would approve the use of it
portion of the increase provided in such projects. The Cornnutt.ee will
itl~o expect a portion of the increase pro~~i~led to be utilized in the
expansion of pediatric pulmonary I ruining (enter programs. The Corn-
nuttee concurs with the House expectation that the Pediatric PitI-
monary Program be continued in 1972 at not less thin the 1971 level.
it aLto wants tc make it clear that notwithstanding earlier notices (if
impending termination, all Pediatric Pulmonary Pi ograin projects
ongoing in 1971 are to be funded in 1972.
PAGENO="0255"
249
PUBLIC LAW 92~8O BILL
~ 7/ Public Law 92~ 80
92nd Congress H B 10061
August 10 197!
3n ~ct
`1 kI a. ~ ~ ri tI a t * 3) Vt ~ art te ot f Lit) r a 111 atth 1 to ott ~
Ut %~ Ifs an) *ota~rd ~gtntip f r Oh floes) year entlli.g I rn ON) 21) 2
13)1*1 for ntb~r )alrpases.
Re I esta ted Ijy floe Set ale a oF haute of Repoesenlato es of file
I noted ,Slatee of America a ConQress aoaenil)1e41, That the following Departments of
StUns tire t~)j)3 ( pointed OtIt of *31) 3010083 tn the Tn t'Ur% iiot otliet'it ose Labor end
apj~r9n oted for the l)o partno uts of 1 thor and Healib 1' ducat*on ~ ith Iduca
ma Welt ore nat related ao.eln te'o for tIa fiscal year endinj. June 3)) t~ &itd 61 1~'
19o2 and for othtr puoposis namely f~3* & S Re
lat S A~eneisa
ApproprIation
At 1972
August 10 1971 5 Pub Law 92-80
~~85 S1~
ti)3RE1D\51%* HEILTU rLONXoia. %X13 SERVICES
To ~ol) oy out St ttion~ 610 314(a) throu,Jt 314(e) `327 and 329 of the
Public Health Service Act, and except as otheraise provided, sections 42 USC 242h,
101 and llloftht 0ot ~`. ~)) ))304)f) 1 ci F d Thatop4,, lQ)KK)ina~ be 246 24Th
transferred to this appropriation, as authorized by section »=01 (g) (1). 254b.
of the `toi*l ~tec)trit~ tit at amended I torn ony one or all of th trust ~35tat 691
fn~ds referred to tho icon and nct~ be o~pended for function'o d~ Ic 42 ~ 241
gated to the tdnuntsttatoi of th Health ~ mowvs and Mental lit tlth 243
tdnunistranon under tith \\ 111 of tIn ~otnd Secnnty ~ct 79 Stat 338
47 USC 401.
300TE9'.U Ott) flILD iILbt.flt 79 St t 291
42 USC 1396.
For &aro~ in,. out excej t as oth r ~ pro toted a `tttons 301 311
and title ~of the Public lit auth tt i tice ~ct toad title \ of the toctal 84 St t 1506
`tecurtty tet t33() l.1 000 1 tot u/ed Th~t nor allotment to a St ote 42 USC 300
pursuant to se~~tzon 103(2) or 304(~) of such Aot shall notbe included 81 Stat. 921,
in compntmg forthe purpoat a of subsections (a) and (b) of soction ~ 42 USC 701
of stub tU an amount expended at estinnthd to. be expended by the
`otate
SE000t 61. IOEDOC tL P1200136)15
To carry Out title 1\ stttflona 44P(,,) 401(a) (1) 483(a) and to
the extent not otheraise pros ukot 301 and 311 of the I ublac Ho ~lth
Sero oce ~et $102 sTl 000 42 USC 299
282 283
289
From Publlc Law 92-80 92nd Congress H R 10061 dated August 10 1971
PAGENO="0256"
250
TELEGRAM~ November 9, 1971
TO: President Richard M. Nixon
The White House
Washington, D. C.
FROM: Roy F. Goddard, M.D.
5200 Gibson Blvd. S. E.
Albuquerque, New Mexico 87108
Mr. President, there are 5 million children in this country suffering
from thronic lung disease, 20, 000 of whom live in New Mexico. Many
of these children are not receiving adequate care and some no care at
all. Through Pediatric Pulmonary Centers operating under the Regional
Medical Program grants, a beginning was made in the past three years
to furnish this much needed care and to educate medical and paramedical
personnel in the recognition, evaluation and management of these
children. Some of these programs have already been discontinued,
and others are trying to operate with inadequate funding. The health
of these chronically disabled children is in jeopardy. We implore you
to help these children by allowing Pediatric Pulmonary Centers to
continue in 1972 at rio less than the 1971 level, as requested in HR10061 and
signed by yourself as Public Law 92-80 on August 10, 1971. You can
effectively insure the future of many of tomorrow's young citizens by
releasing the entire $102, 771, 000 appropriated for Regional Medical
Programs to the Department of Health, Education and Welfare today.
PAGENO="0257"
251
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
\ PUBLIC HEALTH SERVICE
HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION
ROCKVILLE MARYLAND 2O~S2
December 6, 1971 REGIONAL MEDICAL
PROGRAMS SERVICE
Roy F. Goddard, M.D.
5200 Gibson ~ou1evard, S.E.
Albuquerque, New Mexico $7108
Dear Dr. Goddard:
The President has asked me to reply to your recent communication about
support of pediatric pulmonary centers. We are keenly aware that
permanent arrangements for care are needed by children suffering from
pulmonary disorders. Most of these children have been cared for in
centers that are not devoted exclusively to such diseases. Public
agencies that care for these children include State and local health
departments and crippled children's agencies. Most of these agencies
receive Federal assistance from the Maternal and Child Health Service
of the Health Services and Mental Health Administration, They operate
clinics that provide comprehensive care for underprivileged children,
including children with pulmonary diseases, The MCH grants are the
only form of continuing support the Federal Government provides for this
care.
Since 1968 Regional Medical Programs have granted money to demonstrate
exemplary pediatric pulmonary care through specialized centers. These
grants, like others which are for demonstration purposes, are of limited
duration with continuation dependent upon other sources of support.
As they prove their worth, pediatric pulmonary centers are most likely
to receive timely help for continuation through assistance organized
in their own communities. We sincerely hope the centers that have proven
successful will be able to find such local support. Regional Medical
Programs will strongly encourage the systematic improvement of medical
care services for these and other urgent ht~a1th problems.
Sincerely yours,
Harold Margulies,
Director
78-994 0-72-17
PAGENO="0258"
252
DEPARTMENT OF HEALTH EDUCATION. AND WELFARE
\~ I PUSLIC HEALTH SERVICE
HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION
ROCKVILLE, MARYLAND 2O~5S
REGIONAL MEDICAL
PROGRAMS SERVICE
Honorable Daniel IC. Inouye
United States Senate
Washington, D.C. 20510
Dear Senator Inouye:
Your letter of August 30 to the Legislative Liaison, Department of
Health, Education, and Welfare regarding the Pediatric Pulmonary
Center at Kauikeolani Children's Hospital has been referred to me
for reply.
Continued support for the Pediatric Pulmonary Center activity was
considered, along with 15 other regional activities, by our
National Advisory Council in August. The amount of $812,366 wi.lJ.
be awarded for support of the Hawaii Regional Medical Program and
its activities for its next program year which begins October 1, 1971.
The degree of funding awarded to individual activities rests with
the Hawaii RMP, as determined by its own priorities of specific needs.
The amount to be awarded for Hawaii's total program is less than the
$1,102 ,00 recommended b~e our Councill Although the President signed
the Appropriation Bill for FT 1972 which provides the Regional Medical
Programs Service with an authorization of $102,771,000, we do not
know at this time what our level of grant funds for FT 1972 will be.
Until the apportionment for this fiscal year is made by the Office
of Management and Budget, we must continue to fund grants in accordance
with the President's budget message which is the same as the amount
of funds available for grants for F! 1971, or $70,000,000.
As soon as the Hawaii RMP has reevaluated its pri~orities in view of
its total budget and allocated its funds accordingly, we will let
you know to what degree the Pediatric Pulmonary Center activity
is to be supported.
Sincerely yours,
Harold Margulies, M.D.
Director
PAGENO="0259"
253
COPY
NEW YORK METROPOLITAN
REGIONAL MEDICAL PROGRAM
A Program for Heart Disease, Cancer, STroke and Related Diseases
2 East 103 Street, New York, N. Y. 10029 92129 427-4100
17 September 1971
Carolyn R. Denning, H. D.
Director, BAbies Hospital
Pediatric Pulmonary Center
630 West 167th Street
New York, New York 10032
Dear Carolyn:
This refers to your note of September 7 and the accompanying correspondence
concerning the HEW appropriations bill.
There are two questions involved here:
1. The increase in HMP funds in the budget bill, even though signed by
the President, does not assure that the moneys will actually be made
available. This *is a decision to be made by the administration through
its Office of Budget and Management. As you know, shortly after the
HEW bill was signed, the President's economics message was delivered
and he referred to a cut-back in Federal expenditures. My contacts in
Washington cannot tell me at this time what this means. Probably no
decision will be made until mid-November, which is certainly no help
to you right now.
2. The wording in reference to continuation or reinstatement of pediatric
pulmonary disease projects requires further interpretation, and Washington
is trying to get this for me as soon as possible.. Of course, the question
is academic unless the RMP funds are definitely increased. It would he
impossible for us to consider continuation of the Babies Hospital Project
within our present budget limitation ~or Fiscal `72.
Assuming more money may be made available, the question arises as to
whether the provisions actually call for pediatric pulmonary programs
to operate differently than other aspects of RMP, namely, continuation
with Federal support beyond the period for which an application was
originally approved. RHPS, as well as other Federal agencies, hac always
considered that projects should not be continued beyond such date; thus,
the provision for `reinstatement of those slated for termination," is
inconsistent with general policy. Of course, we shall be guided by any
directives from Washington.
An R~S visitor on September 15, left me a copy of a letter from the RNPS
Director to a person posing the same question as you did. A copy of this is
enclosed. The names were deleted before it was given to me.
Sincerely,
I. Jay Br ightman, H. 0.
Director
PAGENO="0260"
254
*1.1.0143.11.1.01*10G. LA.,GIAi*l4*N
JOHN I.. MCCI.BUAN.*RIC. MILTON B. YOUNG N. DAN.
JOHN C. $1114110. MIII. MAIIGAREICHASC$MITO. MAINE
~ NO lION N. `?Jtflz~e~I ,~,fti~1c~ JJ)Cncde
WIUJAM PNOXMIIIE, WIG. J.CALEB BONGO. DII.. COMMITTEE ON APPROPRIATIONS
K. INOIlY1~ HAWAII EDWARD W. IRDOICI. ~ WASHINGTON. D.c. 20510
THOMAGJ. $COI'I.IIII1$CLIIOC
WM.W.W000IWFI.cØUNUl. December 10, 1971
Dr. Roy F. Goddard, President
Association of Pediatric Pulmonary Centers
5200 Gibson Boulevard, Southeast
Albuquerque, New Mexico 87108
Dear Doctor Goddard:
Following up our conversation in October, 1 am writing
to let you know I have been advised the Office of Management and
Budget has notified HEW that $100 million will be available for
grants to Regional Medical Programs in the current 1972 fiscal
year, compared with $71 million in 1971.
I am advised, however, that this does not mean Pediatric
Pulmonary Centers will automatically be funded. It depends upon
whether the Regional Me~cal Program for each particular area has
requested funding for the PPC.
It may be necessary, as I understand it is in the case of
Hawaii, for the RMP to reapply to HEW for funds to cover the PPC.
I do hope this information is h~lpful to you.
With aloha and best wishes for the holiday season,
Sincerely yours,
~ /
HiramL. Fong
HLF:atk
PAGENO="0261"
255
ALL*NJ. EU.END*S, LA.,CIIAIRMAN
JOHN I~. MCCLELLAN, ARK. MII.TON S. YOUNR, N. DAN.
WARREN N. MASNU500. WASH. KARl. N. MOANS. S. DAN.
JOHN C. SIENNIS, MISS. MARSAREICHASE SMITH. MAINS
~ ~`~: `?JCniteb ,~f,a1ega ,S.~ena1c
SI MAN EI.DM50 CALEB 5011 El. COMMiTTEE ON APPROPRIATIONS
JOSEPH N. MOMENTA, N,MEIC. CHARLES II. PERCY. ILL.
DANIELK. INNATE, HAWAII EDWARDS. BROOKS, MASS, WASHINGTON. D.C. 50510
ERNEST P. HOUJNGS, S.C.
THOMAS A. SCOTT.CH1EI'CLENIC
WM.W.W000RUPI', COUNSEL
February 28, 1972
Dr. Roy F. Goddard, President
Association of Pediatric Pulmonary Centers
5200 Gibson Boulevard, S. E.
Albuquerque, New Meixco 97108
Dear Dr. Goddard:
Enclosed for your information is a copy of the February 25
reply received from HEW Secretary Elliot L. Richardson to u~y
January 25 letter on funding for Pediatric Pulmonary Centers.
The letter is selt..explanatory and indicates that the Depart~
meat of Health, Education, and Welfare is releasing additional funds
to Regional Medical Programs but that funding of PPC' a under the
EMP's will depend on the decision of the local RMP's assisted by
their Advisory Groups.
It seems clear that HEW is willing to fund the PPC's but will
not force any RMP to use its allocation of BMP monies for a PPC if
that RMP does not wish to apply funds to the Center.
With kind regards and aloha,
Sincerely yours,
~ frI
HLF:tc Hiram L. Fong ~
PAGENO="0262"
256
JHNLMC .M~N~YOUND. N. DAD.
~JCnffcb ~1aie~ ,~enc4c
WILUAM RAOXMIRE. WIN. I. CALEB BARDS. DEL. COMMITTEE ON APPROPRIATIONS
CANIELK. INODEE. HAWAII EDWARD W. BROWSE MASS. WASHiNGTON. D.C. 20510
January 25 1912
The Honorable Elliot L Richardson
Secretary
U S Department of Health, Education and Welfare
330 Independence Avenue S W
Washington, D. C. 20201
Dear Mr. Secretary:
1 am writing to express my deep concern that, despite the clear
mandate of the Senate Committee on Appropriations on which I serve
Pediatric Pulmonary Centers ongoing in 1971 are not all being funded
in fiscal year 1912 as our Committee report directed
You will recall that on page 26 of this report (S Rapt 92s.316),
the Senate Appropriations Committee stated
The Committee concurs with the House expectation that
the Pediatric Pulmonary Program be continued in 1972 at
not less than the 1971 level It also wants to make
clear that notwithstanding earlier notices of impending
termination all Pediatric Pulmonary Program projects
ongoing in 1971 are to be funded in 1972
Despite this clear language the PPC in Hawaii has to date not
received a penny from HEW for fiscal year 1972 1 was informed when I
was recently in Honolulu Since then I am advised the PPC in New
Mexico is still awaiting rerunding the Washington and Alaska PPCs re-
main unfunded although approved, and the New York program was terminated
in December 1971
In looking into the Hawaii situation, I discovered that the Regional
Medical Program in Hawaii did not fund the Honolulu PPC out of its orig-
inal allocation for 1972 received from HEW, although it was in the RMP's
approved program for 1972 and that it does not plan to fund thi8 PPC
out of any further allocation of 1972 funds until it receives a direc-
tive from HEW to do so.
On the other hand, the Health Services and ?~ieneal Health Adminis-
tration takes the position I am informed, that it is up to the Hawaii
RMP to amend its application to HEW and designate high enough priority
PAGENO="0263"
257
to the Honolulu PPC to permit funding the PPC out of remaining alloca-
tions from HEW.
In other words, the Hawaii RNP is waiting for HS~IHA to act, and
HSHMA is waiting for the Hawaii ENP to act. Under the circumstances,
an impasse has developed which I hope you will quickly resolve.
In light of the directive in S. Rept. 92-316 and in light of the
HEW announcement of December 27 that "all funds appropriated by the
Congress to the Department for Fiscal Year 1972 will be obligated dur-
ing their period of eligibility as specified in the Appropriations Act,"
would you please take the necessary steps to see that all Pediatric
Pulmonary Centers ongoing in 1971 continue to be funded in 1972 and
that all new PPC~ ready for funding receive the necessary amount.
4s nearly seven months of fiscal year 1972 have elapsed, your
prompt attention to this matter would be deeply appreciated.
With kind personal regards and warm aloha,
Sincerely yours,
Hiram L. Fong
PAGENO="0264"
258
~ ~
~ THE SECRETARY O~ HL~ALTH. EDUCATION, AND WEtFi~RE ~ ~
WASHIRGTON,O.C.20201 I
FE~15 ~)
Honorable Hiram L. Fong
United States Senate
Washington, D. C. 20510
Dear Senator Pong:
Thank you for your letter of January 25 about the pediatric pulmonary
projects supported by several Regional Medical Programs (RMP `s).
Following is the current status of the four you nentioned,
1971 1972
7w~ed ~q~st
Hawaii $107,028 $121,222 (fourth year)
New Mexico 99,134 95,024 (third year)
New York 172,060 (fifth year)
.Washington/Alaska 58,313 (first year) ~/
lL For a six month period 7/1/72 12/31/72.
Regional Medical Programs do not provide long'-teriu support for con-S
tinuing health care services. Since their inception, Regional Medical
Programs have provided a unique arrangement with Federal guidance and
funding on the one hand and local planning and decisionmaking on the
other. One basic tenet has always been that the Regional Advisory
Group can best ~design the implementation and operation of programs
which meet the needs of its region as defined by the community being
served and its Comprehensive Health Planning agency. The role of the
EM? and its Federal counterpart has been to assist in findi~g~,p,~
4~onscratingjbe best approach to meeting health needs. Federal
resources are used as "start-up funds" to initiate three-year,
demonstration projects. The grants are made with the prior under-
standing that local support will be found for any parts of the
activities that are to be continued after the awards expire.
PAGENO="0265"
259
It should also be pointed out that very cone the 56 RMP's will he
receiving increased amounts based on the Decerthe.r 27, 1911, deci~on
to obligate all appropriated funds. ESCe R~? will be free to Lund
any approved projects it wishes. This neuns, for example, that the
Hawaii RN? could Lund its pediatric pulmonary project for a fourth
year should they decide to do so.
Individual Proj~s
Hawaii
It is our understanding that the h~w~ii Regional Medical Program's
Regiosal Advisory Group line taken the position that it will not
support the project, even with increased funding, because they be-
lieve the needs in ocher health care areas are greater than those
in the pediatric pulmonary field.
New Mexico
The New Mexico RMP sought and received approval for funding this
project in 1972, and is currently funding it at the level indicated
above.
New York
The hew York Metropolitan Regional Advisory Group has decided that
these funds should now be utilized to extend and improve other types
of health care ~ervices. ~s a result, the New York Metropolitan
RN? did not seek funding spproval for 1972 nor has it, as yet,
indicated an interest in doing so.
~as~g~pn/A1aska
The Washington/Alaska dNP recently submitted a new project proposal
(out of cycle with its regular application) which received final
review and approval by the National Advisory Council when they met
February 8-9.
As we understand the above statub reports, to insure funding of two
of these pediatric pulmonary projects would require a Federal
directive contrary to tha need as perceived by those who live in
PAGENO="0266"
260
the region and have cart~fully studied their health care problems
Further we believe that sucn a directive would unnecessarily
endanger valuable relatioxmhips and would set a precedent which
could prove most harmful in the future
You may be assured that your continued interest in the pediatric
pulmonary projects is appreciated and tnat the 1971 fundi~ng level of
$1 million for this program will be available to the 56 RNP's in
1972 and 1973.
With best regards,
Sincerely,
Secretary
PAGENO="0267"
March 3, 1972
Roy F. Goddard, M.D.
Director, Pediatric Pulmonary Center
Lovelace Foundation and Clinic
5200 Gibson Blvd., S.E.
Albuquerque, New Medco 87108
Dear Roy:
Enclosed please find a letter from (Los Angeles) Congressman
James Corman to Dr. Harold Margulies and the Supplemental Infor-
mation which we prepared for Technical Review of our Southern
California Pediatric Pulmonary Center proposal to the Regional
Medical Program I believe that some of these data presented
as they are here, will be useful to you. They may also save you
considerable time in developing these statistics.
I have 3ust received verbal information that the RMP Technical
Review Committee REJECTED our proposal. This must be followed
with more formal specifics indicating why they rejected us.
An appeal is available but this news is very discouraging
At the same time we were informed of this disapproval I had
received a copy of a letter from Dr. Harold Margulies, (National)
Director of the Regional Medical Programs Services which clearly
indicates that the funds Earmarked by Congress lost their
earmark somewhere in the processes of approval signature and
disbursement of the budget This being the case it is lil'ely
that our proposal would have to compete with other proposals at
a Regional (statewide) level and given the current stated funding
st-itu3 of the California Region-il Medical Programs pluc their
large backlog of worthy propoc~ils our chances would be slim
to negligible
I look forward to seeing you in Kansas City and to further
communication with you.
Best wishes
Dan Wiseman, M.D.
Assistant Professor of Pediatrics
261
UNIVERSITY OF SOUTHERN CALIFORNIA
SCHOOL OF MEDICINE
2025 ZONAL AVENUE
LOSANGELES CALIFORNIA 90033
to REPLY RsFERTO:
Los ~ COUNTY-USC MEDICALCENTER
PEDIATRIC RESPIRATORY 0155,85 CENTER
GENERAL LABORATORIES 9UILOIN9, ROOM 20 12
200 TORTS STAYS STREET
Los ACCAISS. CALIFORNIA 90033
TOLEPRONE:
12131 229-3131
EXT. 7.3R72
7-2232
PAGENO="0268"
262
DEPARTMENT OF HEALTH, EDUCA11ON, AND WELFARE
PUBLIC HEALTH SERVICE
HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION
ROCKVILLES MARYLAND 2O~52
COPY March 7, 1972
Honorable James C. Corman
House of Representatives
Washington, D.C. 20515
Dear Mr. Corman:
This letter is in response to your communication about Dr. Dan
Wiseuzan's request for funds to support a pediatric pulmonary disease
program at the Los Angeles County University of Southern California
Medical Center.
In regard to your question about "What is being done to implement
the intent of Congress that, `... notwithstanding eaxlier notices of
impending termination, all Pediatric Pulmonary Program Projects
ongoing in 1971 are to be funded in 1972." We are aware of this
language in the Senate and House Report but it is our understanding
that it was not in the final appropriations bill that was signed by
the President. Let me assure you that we are concerned about the
health care available to all persons in this country, and we, in
Regional Medical Programs Service (R~lPS), are specifically concerned
with improving the health care delivery system. There are 56 local
Regional Medical Programs (RMP's) that are working to improve, all
health care throughout the country and this includes respiratory
disease patients.
We are pleased to report that all funds appropriated by the Congress
for DHEW health programs have been released and this includes monies
for the RI4PS operations. We contemplate no reduction in funding
patterns for any of the local RMP's; however, as a matter of policy,
program priorities are established and approved by each of the local
Regional Advisory Groups,
As you know, the emphasis' in RItE'S in the past has been on heart,
cancer, stroke, and related diseases, but more recently, our mission
has been expanded to include improving the total health care delivery
system. In this regard, we recognize that the need for pediatric
respiratory disease efforts has not diminished, but we now feel they
should be considered in the context of a health care delivery system
that is concerned about the total health care available to all persons
in the nation. While all funds appropriated have been released and
will be spent this does not guarantee indefinite Federal support for
an individual RMP project.
RItE'S resources are used as "start up funds" to initiate projects and
demonstrate their value for a specified period of time. Grants are
made with a definite understanding that local support would be found
for the activities that are to continue after the awards expire. Gen-
erally, grants are made for one to three years based upon the time
PAGENO="0269"
263
required for a program to become self-supporting. Funds that become
available front expiring projects are reprogrammed as "start up funds"
to initiate other new projects in other locations. In this way, RMPS
resources are used to stimulate a maximum number of programs throughout
the country.
A number of the pediatric pulmonary disease grants have expired or were
terminated because the local Regional Advisory Group felt the program
had completed its original objectives or had not been able to meet them.
The prescheduled expirations affect many kinds of programs that we sup-
port, but they are a part of the normal cycle of EMPS operations.
The scheduled expiration of these awards are the only events which might
be interpreted as reductions in support for pediatric pulmonary care.
There are many demands for the limited health funds that BMPS has to pro-
vide amd the local advisory groups have the responsibility to make maximum
use of all health care resources in the community~ In summary, we must rely
on local expertise and j~dgment to determine the health priorities in each
region.
Although all commitments are not contpleie.d by the 56 R$P s, we are assured
that at least 6 regions are funding pediatric pulmonary programs in ~Y `72.
We are enclosing for your information an analysis by region of the Regional
Medical Programs Service's supported Pediatric Pulmonary Disease Projects.
The attached chart fails to show FT `72 funds in some cases simply because
the fiscal years of the local RMP's may not ceincide with the Federal
accounting period and there could be a carry over of funds awarded during
FY `71. This occurred in California and $71,000 was available and used
in the Pediatric Pulmonary Program at Irvine, California, We also have
information that some portions of the program have been phased into a new
project and is to be funded for the next two years at $110,000 each year.
The proposal that Dr. Wiseman has an interest in is a joint project ex~titled
"Inter-Area Pediatric Chronic Respiratory Disease." This application repre-
sents the combined efforts of three Areas in the California Regional ~iedical
Program--Area IV, University of California at Los Angeles; Area V, University
of Southern California; and Area IX at Watts-WillowbrOOk. It is a joint
effort on the part of three sub-regions in southern California to collaborate
their pediatric pulmonary activities. The project is part of a total appli-
cation presently under review at the local level, and it will be evaluated
by the National reviewing bodies on July 1, 1972. Therefore, we cannot tell
you at this time what the results will be of their deliberations. However,
we are informed by Mr. Paul Ward, Executive Director, California Regional
Medical Program, that programs for pediatric pulmonary disease will be viewed
on a statewide (regional) basis, as indeed are all other categorical disease
activities.
A number of conferences have been held with the pediatric respizatorY center
group about the change in direction of RMPS and it is our plan to continue
this dialogue. We have introduced them to the Maternal and Child Health
Service, National Heart and Lung Institute and the Bureau of Health Manpower
Education as other sources for potential funding. If we can be of further
assistance, please do not hesitate to contact us.
Harold Margulies, M. D., Director
PAGENO="0270"
264
AIWIA. CLOAII.L.,CIIA3RMJOI
JO N 0 CLfl.I.AN *010. 0 TON 0000 AK
~ ~: ~: ~: ~Cn~icb ~~ia1e~ ,~cnc~ie
W N N W CA 000 COMMITTEE ON APPROPRIATIONS
JO CPA H H HA MOO CO LEO 0..
KANIOLK. 00000, HAWAII EDWARD W. 000000, MOOS. WASHINGTON. D.C. 20510
WOO RUPE COON 01. January 28 1972
Mr Victor K. B Young
President Hawaii Chapter
Cystic Fibrosis Foundation
245 North Kukui Street
Honolulu, Hawaii %817
Dear Victor
I thought you would be interested in the Regional
Medical Program budget request for fiscal year 1973
Congress is being asked to appropriate $130 2
million compared with appropriations of $99 million in
fiscal year 1972
In terms of total fund availability however the
1973 amount is a net decrease of $13 7 million from the
total amount available for RMP' S in 1972 The 1973
figure consists of increases of $7 0 million, offset by
decreases totalling $20 7 million for non-.recurring
construction and for transfer of planning projects to
health maintenance organization activities
No funds are earmarked for Pediatric Pulmonary
Centers, but I am advised that if RMP1s wish to fund these
Centers they will be permitted to do so
With kind regards and aloha,
Sincerely yours,
Hiram L Fong
HLF:tcc
PAGENO="0271"
265
ASSOCIATIoN OF ~PEDIATRIC :PULM0NARY CENTERS
EXHIBIT E
ASSOCIATION OF PEDIATR1C PULMONARY CENTERS
PEDIATRIC PULMONARY DISEASE LIAISON GROUPS
THE KEY TO CHRONIC PULMONARY DISEASE
PAGENO="0272"
266
GUIDELINES AND ORGANIZATION OF
ASSOCIATION OF PEDIATRIC PULMONARY CENTERS
October 16, 1971
1. The Association of Pediatric Pulmonary Centers is organized as a no
dues, no by-laws organization for members of the medical and para-
medical professions interested in pulmonary problems of infants,
children and young adults.
2. The major purposes and activities of this association shall be to~
a. Bring together those interested in pulmonary problems in in~anta,
children and young adults, for mutual presentation and dis-
cussion of the many problems involved in children with respira-
tory disease.
b. To establish and maintain active liaison with presently
existing national and international organizations and those
others vitally concerned with pulmonary diseases in children.
c. To work together with local, state, regional, and national
educational, lay, and governmental organizations and agencies
in the furthering and promotion of development of pediatric
pulmonary centers and/or programs for improved care of
children with respiratory diseases.
3. Membership shall be made up of:
a. Active voting members - representing a pediatric pulmonary
center; or an institution, or pediatric center with an organized
pulmonary disease section, clinic, or program.
b. Liaison organizational members (non-voting) - representing any
liaison organization - educational, health, governmental, lay,
etc.
c. Associate members (non-voting) - representing invited or
appointed physicians or paramedical professional personnel.
~ Officers shall be:
a. President
b. Vice-President (President-elect)
c. Secretary
PAGENO="0273"
267
4. Officers (continued)
The officers, together with two other active voting members shall
constitute the executive committee. (All members of the executive
committee must be active voting members; terms of office shall be
one year, but nay be succeeded up to a maximum of three years.)
Any other special committees may be appointed by the president, with
concurrence of the executive committee. The executive committee
shall meet twice annually, at the time of the scientific and business
meetings of the association, at other times when called by the
president, or by a telephone conference. The officers and executive
committee shall conduct the affairs of the association and represent
it wherever and whenever necessary.
5. The president or another designated member of the executive committee
shall represent the association at the meetings of the Pediatric
Pulmonary Council.
6. Meetings shall be held twice (once) a year in conjunction with and
at the time of selected major medical meetings, encompassing
pediatrics and chest diseases. The president of the association,
or a designated program chairman, shall be responsible for the (1)
call for papers, (2) selection of papers, and (3) meeting arrangements.
A business meeting shall be held twice annually at the same time as
the scientific sessions.
7. Finances:
There shall be no dues to belong to the association. The National
Cystic Fibrosis Research Foundation and other groups will assist.
financially in the support of the annual (bi.~annual) scientific
session(s). Other expenses incurred in the conduct of the association
and its business may be requested through grants from governmental,
educational, or pharmaceutical organizations.
Accepted, as revised, at e
~
Roy F. Goddard, . fl., President,
Association of Pediatric Pulmonary Centers*
)`C5200 Gibson Blvd., S. E.
Albuquerque, New Mexico 87108
Telephone No. 505 842-7104
78-994 0-72-18
PAGENO="0274"
268
SCIENTIFIC PROGRAM FOR
ASSOCiATION OF PEDIATRIC PULMONARY CENTERS*
Saturday, October 16, 1971
Room 6 Third Floor Palmer House
Chicago Illinois
THE TEACHING OF PEDIATRIC PULMONARY DISEASE
MODERATOR Roy F Goddard N 0
President Association of Pediatric Pulmonary Centers
Medical Director Pediatric Pulmonary Center of the New Mexico
Regional Medical Program
Department of Pediatrics University of New Mexico and Love1ace~-
Bataan Medical Center Albuquerque New Mexico
2 00 p N INTRODUCTION - Dr Roy F Goddard
2 05 p N MODEL FOR A DIVISION OF PEDIATRIC RESPIRATORY DISEASES
Alexander Spock N D Associate Professor of Pediatrics
Duke University Medical Center Durham North Carolina
2 15 p M STANDARDIZATION OF PEDIATRIC PULMONARY FELLOWSHIP PROGRAMS
Gunyon M Harrison, N 0 Associate Professor of Pediatrics
Baylor Medical School, Houston Texas
2 30 p N EVALUATION OF CURRENTLY LISTED PEDLATRIC PULMONARY FELLOWSHIP PROGRAMS
Daniel H Wiseman N D Medical Director
Pediatric Respiratory Disease Center
University of Southern California School of Medicine
Los Angeles, California
2:45 P. N. THE ROLE OF A LAY ORGANIZATION IN ORGANIZING TEACHING PROGRAMS
Bettina C Htlman N 0 Chairman Pediatric Chest Section
American Thoracic Society
Associate Professor of Pediatrics, Louisiana State University
Shreveport, Louisiana
3 00 P M PULMONARY DISEASE TEACHING IN A RURAL STATE
Frank P. Anderson, N. D., Medical Director
Pediatric Pulmonary Center of Georgia Regional Medical Program
Professor of Pediatrics, Medical College of Georgia
Augus1~ Georgia
3:15 P. N. COFFEE BREAK
3:30 P. N. WHY A PEDIATRIC PULMONARY COUNCIL?
William W Waring N 0 Chairman Pediatric Pulmonary Council
Chairman Section on Diseases of the Chest, American Academy of Pediatrics
Professor of Pediatrics Tulane University School of Medicine
New Orleans Louisiana
3 45 P M HOW SHOULD PEDIATRIC DEPARTMENTS OF MEDICAL SCHOOLS BE INVOLVED?
LeRoy Matthews N D Professor and Chairman
Department of Pediatrics
Case Western Reserve Cleveland Ohio
4 00 P N OISCUSSION**
*Held in association with 40th Annual Meeting of the American Academy of Pediatrics
**Dlscussjon by panel members and open discussion from the floor
I
PAGENO="0275"
269
* !\S ~ T~'~\~( ~N\1~Y cI~N'rt~Rs
/ /
SCIENTIFIC PROGRAM FOR
ASSOCIATION OF PEDIATRIC PULMONARY CENTERS*
Sunday, May 21, 1972
Towers 22
Muehibach Hotel
Kansas City, Missouri
PEDIATRIC ORIGINS OF ADULT RESPIRATORY DISEASE
MODERATOR: Denise Strieder, M. D.
Member, Executive Committee
Association of Pediatric Pulmonary Centers
Children's Hospital Medical Center
Boston, Massachusetts
8:00 A. N. INTRODUCTION Dr. Denise Strieder
A. Lh~i the Problem
8:05 A. N. Dan Wiseman, M. 0.
Assistant Professor of Pediatrics
University of Southern California School of Medicine
Los Angeles, California
B. The Inf1uenceofEnvironme~~e1c~jndImrnunoch~.ka1
Mechani sms
8:20 A. M Environmental Factors in the Development of Chronic Pulmonary
Disease'
Clayton Loosli, M. D., Dean Emeritus
Hastings Professor of Medicthe and Pathology
University of Southern California School of Medicine
Los Angeles, California
8:50 A. N. "Cystic Fibrosis'
Giulio Barbero, N. D.
Professor and Chairman, Department of Pediatrics
Hahnemann Medical College and Hospital
Philadelphia, Pennsylvania
9:10 A. N. "Serum Antitrypsine Deficiency and Chronic Lung Disease"
Barry W. Levine, N. D.
Massachusetts General Hospital
Boston, Massachusetts
*Held in association with the annual meeting of the American Thoracic Society,
supported in part by grants from the National Cystic Fibrosis Research Foundation and
the National Tuberculosis and Respiratory Disease Association.
PAGENO="0276"
270
9:40 A. N. `The Role of Immune Deficiencies in Resptratory Diseases"
Joseph A. Bellanti, M. D.
Professor of Pediatrics and Microbiology
Georgetown University School of Medicine
Washington, D. C.
10:00 A. M. COFFEE BREAK
C. Lung Growth and the Pathology ofObstructiveLungj~
10:20 A. M. James C. Hogg, H. 0.
Department of Pathology
McGill University
Montreal, Quebec, Canada
D. Adult-Adolescent-Childhood ~yndro
10:50 A. N. "Asthma and Allergies"
Frederic Speer, H. 0.
Assistant Clinical Professor of Pediatrics
Chief of Pediatric Allergy Clinic
University of Kansas School of Medicine
Kansas City, Kansas
11:10 A. N. "Bronchitis and Bronchiectasis"
William Waring, H. D.
Department of Pediatrics
Tulane University Medical Center
New Orleans, Louisiana
11:25 A. M. "Cystic Fibrosis in Adults"
Harry Shwachman, N, D.
Professor of Pediatrics
Harvard University Medical School
Boston, Massachusetts
E. From Infancy to Adulthood
11:40 A. M. Roy F. Goddard, N. 0.
Medical Director, Pediatric Pulmonary Center
Lovelace Foundation for Medical Education and Research
Albuquerque, New Mexico
11:50 A. H. F. Discussion**
~biscussion by pane1ii~ibers and open disucssion from the floor.
PAGENO="0277"
271
PEDIATRIC PULMONARY DISEASE LIAISON GROUPS
1. American Academy of Pediatrics
2. American College of Chest Physicians
3. American Thoracic Society
~ American Academy and College of Allergists
5. National Cystic Fibrosis Research Foundation
6. National, Regional and State Organizations
7. Governmental and Educational Organizations
8. Allergy Foundation o~ America's
9. Association of Convalescent Homes and Hospitals
for Asthmatic Children *
*Added in 1972.
PAGENO="0278"
Allergy Foundation of Amenca
801 Second Avenue/New York N Y 10017/ (212) 684 7875
Dear Senator:
It has been brought to our attention by Roy F.
Goddard, M, D., New Mexico, President of the Association
of Pediatric Pulmonary Centers, that legislation is
pending that would give much needed additional assistance
in the fight against the various forms of pediatric
pulmonary disease.
Our particular concern of course is for allergic
disease in children and more particularly for the
asthmatic child Although we have no specific detailed
information on the legislation at the time of writing
this letter, and though at the present we are not as
yet a member of the Association we would like to pledge
our general support of and express our interest In
aiding the passage of appropriations that would benefit
programs in pediatric pulmonary disease.
We would appreciate having copies of the proposed
legislation, and your suggestions for us to consider
as to how we might help.
Sincerely,
Walter B. Furbush
Executive Director
WBF:csr
cc: Paul F. deGara, M.D.
Roy F. Goddard, M.D.
272
COPY
Senator Edward M. Kennedy
United States Senate
Washington, D.C. 20510
March 20, 1972
~d~d)
I
PAGENO="0279"
273
EN8
TUFTS UNIVERSiTY SCHOOL OF MEDICINE - BOSTON CITY HOSPITAL
MAURICE S SEGALID :Ie~A:R%sQNAvENu~
February 10, 1971
Roy F. Goddard, M. D.
Lovelace Clinic
4800 Gibson Boulevard, S.E.
Albuquerque, New Mexico
Dear Roy:
After spending a lifetime in the management of obstructive
lung problems in adults I have become convinced that rehabilitation
of the~ ut~~ patient is the ke~y I think this may be the area
that I will work in after my emeritus status in a couple of years
I would like to spend a few days to a week visiting with you for
I have been impressed with the work you have been doing with children
If you would suggest the better time of year for a visit
with you I would go ahead and make plans I would prefer comfortable
hotel or lodge accommodations that would provide pool and tennis
facilities not too far from your hospital unit. If you feel that my
monosyllabic utterings on deaths in bronchial asthma or the manage-
ment of respiratory failure could be useful I would be pleased to
talk on these subjects while in Albuquerque
At any rate, I hope this brief note finds you well. It is some
time since our paths have crossed.
Sincerely,
Maurice S. Segal, M.D.
NSS:drb
enc,
PAGENO="0280"
274
ASSOCIATEON OF PEDIATRIC PULMONARY CENTERS
EXHIBIT F
THE EARLY EVALUATION AND DIAGNOSIS OF
ALLERGY-RESPIRATORY DISEASES IN CHILDREN
*From the Booklet entitled,"Respiratory Problems and Related Allergies
in Children," by Roy F. Goddard, M. D., Lovelace Foundation Manual No. 1,
Seventh Printing, April, 1972.
PAGENO="0281"
275
Page 1
Factors Contributing to
Allergy-Respiratory Problems
It is very rare that any single factor is a major cause of allergic or
respiratory problems. Usually a combination of factors from three main
categories contribute to allergy-respiratory problems:
Allergenic Factors
1. Ingestants * These include foods as well as medicines that are
ingested or eaten.
2. Inbalants - These include all of the various agents which are
breathed in and irritate either the upper or the lower respiratory system,
such as animal dander, (lust (including house), pollen from the trees,
grasses and weeds, fungus and molds.
Respiratory Factors
1. Infection - This includes infection in the upper respiratory system,
such as a cold, naso-pharyngitis, tonsillitis, laryngitis, or infection in the
lower respiratory system, such as bronchitis or pneumonia.
2. Organic - Included here are disorders of the structures associated
with the respiratory system, such as the sinuses and the ears.
3. Respiratory Stress - Many times activities such as riding a bicycle
or running and playing, will initiate wheezing and considerable respiratory
distress in children. Occasionally this is seen in older subjects following
hearty laughing.
Other Influencing Factors
I. Metabolic (a) The gamma globulin levels, which are a measure
of the ability of the body to manufacture antibodies for protection against
infection, may be lower than normal; (b) Excessive sweating frequently
occurs in sonic respiratory disorders, resulting in loss of electrolytes (salts).
while local irritants are those that conte in contact with the body such as
adhesive tape, rubber I)ants or gloves, etc.
3. Environmental- It is well known that changes in humidity and
temperature play an important role in the incidence of allergies and
respiratory conditions. Frequently a change of climate may be of some
value. Some of this may be due to a lowering of incidence of respiratory
infections in a warmer. drier climate.
4. Constitutional - \Vhile one does not inherit an allergy, one may
inherit a respiratory constitution or system which is more sensitive to the
factors which contribute to disorders of this system.
5. Emotional- It is well known that emotional upsets may influence
the breathing pattern and cause bronchial constriction.
PAGENO="0282"
276
Page 2
Critical Thresholds
This is the name given to a situation resulting from a combination
of several factors which produce the symptoms of an illness. The critical
threshold may be viewed as analagous to placing many blocks on top of
each other until the addition of one more block causes all of them to
topple. (Sec Fig. 10). Except for a rare instance in which a person is highly
sensitive to something he has eaten, such as shcll~sh, or to an insect bite,
a critical threshold usually results from the simultaneous occurrence of all.
or at least a majority of the factors mentioned above. Thus, a child with
several factors may feel no distress until one more factor is added to cause
him to wheeze, have shortness of breath, or develop other Symptoms of
respiratory illiiess.
r ~ ti~ ~
EMOTIONAL /
CONSTITUTIONAL
OTHER
INFLUENCING ENVIRONMENTAL
FACTORS
IRRITANTS
METABOLIC
f RESPIRATORY STRESS
RESPIRATORY
FACTORS ORGANiC
INFECTION
ALLERGENIC J INHALANTS
FACTORS ~ INGESTANTS - Z
Figure /0- Critical Threshold in Allergy-Respiratory Problems
Page 18 and Page 19 from the booklet entitled, `Resptratory Problems
and Related Allergies in Children,t By Roy F. Goddard, N. D., Lovelace
Manual No. 1, Seventh Printing, April, 1972.
PAGENO="0283"
277
Page 3
I
Cystic Fibrosis (C/F)
Cystic fibrosis is a congential defect, or an inherited condition. It is
not a contagious disease and cannot be transferred from one child to
another. Both parents must carry the genetic trait. (See Genetic Chart,
Figure 2S.) This is said to be a Mendelian recessive genetic trait present
in one in 20 individuals. The odds of two such persons marrying is one
in 400. One out of 4 of their children will inherit the cystic fibrosis gene
from both parents and be a cystic fibrosis patient. Two may inherit the
genes from only one parent and be carriers, and one child may be normal,
Both sexes arc affected equally. The age of the parents has no influence
on the incidence, nor does the birth order )f the child.
Cystic fibrosis is believed to be caused by the lack of, or insufficiency
of sonic vital chemical substance, possibly an enzyme or hormone, which
is essential to normal fund ioning of the sweat, mucous and other glands
of external secretion. This basic bio~chemical defect is produced by the
abnormal gene and remains unknown today. Normnallv the mucus secreted
by the lining membranes of the organs, is thin, clear and slippery. The
mucus produced in the cystic fibrosis patient is thick and sticky, may
obstruct the intestines, block the ducts of the pancreas and the liver, and
plug up the airsvavs in the lungs.
GENETICS OF CYSTIC FIBROSIS
Father Mother
~ -I
Fiyurc 28--Inheritance Patter?l of Cystic Fibrosis
PAGENO="0284"
278
Page 4
The Clinical Manifestations ol C/F
The clinical manifestations can be divided according to the various
systems affected:
1. Sweating and Heat Prostration - Among the non-mucus producing
glands f the endocrine system which are affectel are the sweat glands,
the tear glands, and the salivary glands. Jn the sweat glands, the absence
Pancreatic Insufficiency
Figure 29-The Main Clinical Features of Cystic Fibrosis
From the booklet entitled, tChronic Respiratory Problems in Children,"
by Roy F, Goddard, M. D., LOvelace Foundation Manual, No. 2, 3rd
printing, December, 1967.
Sweating and heat prostration
Chronic Lung disease
PAGENO="0285"
279
Page 5
DIFFUSING CAPACITY STUDIES
DIFFUSING CAPACITY (STEADY STATE) IN CHILDREN
I I I I I I I
mm
30 Age 6-I5yeors
n:IOO
25 -
20 -
15-
10 - r:.79
DLCO: .3106 Height -27.65
5 SEE.: ±4.2
I I I I I I I
0100 110 120 130 140 ISO 160 170 180 190
Height, cm
DIFFUSING CAPACITY ASTHMA VS. NORMAL CHILDREN
I ~I I 1 ,~
mm -~
~ D~~0:.3IO6 Height-27.65
30 - SE.E.:±4.2
:: *:average of asthma
:
- " Asthma Mean DLCO:17.3
Asthma Mean Height: 147
C- I I I I J.
moO 10 20 30 40 50 60 70 180 i~0
Height, cm
PAGENO="0286"
280
Page 6
MEAN DiFFUSION CAPACITY
OF CHILDREN AND YOUNG ADULTS
Mean
D Mean
Number LCO Height
Classification Studied (ml/rnin/mmHg) (cm.)
Normal 100 20.5 155
Asthma 45 17.3 147
Cystic Fibrosis 25 12.2 138
CORRELATION OF DIFFUSION CAPACITY (DL
WITH CLINICAL RATINGS CO
Diffusion Good- Fair- Poor-
Capacity Excellent Excellent Good Good Fair Fair Poor Total %
Above 100%
Asthma 1 10 3 1 15 37.5
C/F 1 1 3 1 624.0
Below 100%
Asthma - 1 9 8 4 3 25 67.5
C/F 2 1 4 2 7 3 1976L0
On Page 5 the diffusing capacity has been determined for normal children
from a research study on 100 children. The top chart indicates the normal
values and one standard deviation from the normal. The lower chart shows
the values obtained in studying 45 children with asthma in contrast to
the normal values. It is seen that the mean value is considerably lower
than for the normal child (see top table this page) and that 67.5 per cent
of these asthmatic children studted were below the 100 per cent value (see
lower table on this page). Of those below the normal value the majority
with poor diffusing capacity also had poor clinical ratings. Thus~ thts
new test determines the severity of the disease and correlates this with
the clinical condition and prognosis.
PAGENO="0287"
28i1
Mr ROGERS Thank you so much, Dr Goddard Your statement is
clear We appreciate your being with us to give us the benefit of your
thinking
Mr Nelsen ~
Mr NELSEN No questions
Mr ROG]3~RS Dr ~arter~
Mr CARTER I want to compliment the witness for his excellent
statement and say that if we want to do something about pulmonary
diseases we should start in early childhood You have made a very
sigmficant statement
Dr GODDARD There is a letter I am sure, Dr Carter, you would
like to read, from Dr Segal in exhibit E that says the key to pul
monary disease is prevention in childhood
Mr. ROGERS. Dr. Roy?
Mr Ro~ I have one or two questions You would foresee within
each of the 15 new centers a pediatric pulmonary center?
Dr GODDARD I would perceive, Dr Roy, that either pediatric corn
ponents should be incorporated into these centers or enough appro
priations written in the legislation so that these could be separate
It would depend again upon the institution and the locality I think
we should analyze carefully the needs and capabilities around the
country In exhibit C we have prepared for you a proposed geo
graphical plan and the list we will give you suggests facilities which
can be combined together, whether they are in a medical school 9r
nonmedical school setting
Mr Ror Shouldn't these centers be located in such a place that we
could be sure there would be comprehensive care of the child ~
Dr. GODDARD. Yes, sir.
Mr Ror Would the danger exist that we might not have such corn
prehensive care if we put them in a large center ~
Dr GODDARD I would be very happy to submit to the committee
and to send you programs that are now in existence in which we have
what are called outreach programs For example, let us take your State
of Kansas or my State of New Mexico, or Georgia We don't have a
pediatric pulmonary center in Kansas at the moment, but in Georgia
and New Mexico, we have programs in our centers, and then we take
teams out to the communities throughout our State
We put on programs and we education and stress recognition and
management training, not only for medical people, but paramedical
people, too. This total comprehen~ive health care should be a far.
reaching program to every corner of the State, not just pediatric
pulmonary centers
In what we have outlined in the model, in exhibit B, this would be
a part of a pediatric pulmonary center Education in outlying areas
and not just professional and paraprofessional, but to the lay public
also
Mr Ror Thank you I appreciate your testimony
Thank you, Mr Chairman
Mr ROGERS Thank you very much We appreciate your presence
here today
Dr GODDARD Thank you
Mr ROGERS I see we have our distingtiished colleague, Congress
man Eilberg, here Our committee will be pleased to recognize you
I am gorng to ask the gentlemen that you will mtroduoe to us if
PAGENO="0288"
282
they would mind giving their te~timony right after lunch at 2:30
but we would like for you to intrc~duce them to the committee and ask
that they come at 2:30 p.m.
The reason is that we have two gentlemen who have to catch a
2:30 plane. We are going to try to hear them first if they will permit.
STATEMENT OP HON. JOSHUA EILBERG, A REPRESENTATIVE IN
CONGRESS PROM THE STATE OP PE}INSYLVANIA
Mr. EIU3ERG. Thank you very much, Mr. Chairman.
Mr. Chairman, I want to thank you for the opportunity to appear
before you today and to indicate my support of the National Heart,
Blood Vessel, Lung and Blood Act of 1972, H.R. 13715.
As the bill itseif states, diseases of the heart and blood vessels
collectively cause more than half of all the deaths in our Nation
each year.
It is estimated that the elimination of cardiovascular diseases as
a significant cause of disability and death in the United States could
result in an 11-year increase in the average life expectancy of our
citizens and could save an estimated $30 billion annually in medical
costs.
Thus, the time for a coordinated attack on these problems is at
hand. H.R. 13715, which seeks to expand the present excellent mech-
anism of the National Heart and Lung Institute of the National Insti-
tutes of Health, would certainly go far to meet this need.
Once again, the Health Subcommittee of the House of Representa-
tives is to be commended for its excellent work. I ~recall this body's
sustained effort to enact Public Law 92-157, the health manpower
amendments of last year, its superb work during the passage of the
Cancer Attack Act earlier this year and in so many other vital
matters.
I think the subcommittee as a whole, and you individually, in a
very special way deserve the thanks of the House and the lasting
appreciation of the American people for outstanding service con-
sistently rendered in the cause of the Nation's health.
I was with you in the matters just referred to and can assure you,
Mr. Chairman, of my very strong support of your position on H.R.
13715.
Now, if I may, Mr. Chairman, I would like to introduce two gentle-
men from my home of Philadelphia. One is a noted doctor and medi-
cal scholar, the ether is a father who lost a 5-year-old son to blood
disease.
My friend Leonard Riccio is the founder ~f the "Tommy Fund"
which memorializes his young son who passed on approximately 11/2
years ago. Mr. Riccio has circulated petitions calling for precisely the
kind of ooordipated effort provided for in H.R. 13715. He will now
present these petitions containing 15,000 signatures to the committee.
I need not say more. His presence, his action are eloquent testimony
to his abiding and living love of a boy named Tommy and to his
concern for all children sharing the affliction which struck his son. We
can but share his commitment to take action to end the suffering of
children.
PAGENO="0289"
283
Dr. Franh Oski is associate professor of pediatrics `at the University
of Pennsylvania School of Medicine and director of hematology at
Philadelphia Children's Hospital.
The doctor has written more than 100 articles appearing in various
medical periodicals `and scholarly journal's. He is coauthor o~ Hema-
tol'ogic Problems in the New Born, which is presently ih its second
edition.
I understand that the doctor is nct unfamiliar with this body-it
seems that he recently testified before you on the sickle cell anemia
bill which has since passed both Houses of Congress and will, hope-
fully, become public law in the near future.
I commend the remarks of these gentlemen to your attention ai~d
thank you for your kindness in permitting our appearance.
Thank you, Mr. Chairman.
Mr. ROGERS. Thank you very much for being here and for your strong
support in all matters of health affecting the public that the Congress
has had an opportunity to act `on. I know this comthittee is `aware of
your strong support. We do appreciate it. We `are very pleased to wel-
come Dr. Oski and Mr. Rioeio. We will be pleased to receive `your testi-
mony this afternoon. Thank you for taking time to come to the
committee.
Mr. EILBERG. Thank you, Mr. Chairman.
Mr. ROGERS. Two of our witnesses h'ave to catch a 2:30 plane. So, I
am going to ask them if `they would like to come to the table. Dr.
Arthur Olsen, who is past president, ACCP, professor of medicine,
the Mayo Graduate School of Medicine, and Dr. Alfred Soffer, execu-
tive director, A'CCP, from Chicago, Ill.
Mycolleague may have some comment.
Mr. NELSEN. Only to welcome them here. Of course, the Mayo's have
been in the news so far as this committee is concerned for some time. We
are happy to know that this fall the first class will be enrolled in their
new medical school. We are proud of that an4 we are proud to have
you with us today.
Mr. ROGERS. I might say one of the main reasons that the bill was
written as it was, to make sure Mayo could help establish a school, is
because of the work of our colleague, Ancher Nelsen. I am sure they
are aware of it. We welcome you.
STATEMENTS OP DR. ARTHUR M. OLSEN, PAST PRESIDENT, ACCP,
PROFESSOR OF MEDICINE, MAYO GRADUAT1~ SCHOOL OP MZDI-
CINE, ROCHESTER, MINN., AND DR. ALFRED SOFFER, EXECVTIV~
DIRECTOR, ACCP, IN BEHALF OP AMERICAN COLLEGE `OF CHEST
PHYSICIANS
Dr. OLSEN. Thank you, Mr. Chairman.
Chairman Rogers and members of the committee, first of all, D~.
Soffer and I wish to express our appreciation to you for letting us
present our testimony before lunch. We do have rather tight schedules.
I would like to advise you that Dr. Sof1~er is not orUy executive
director of the American College of Chest Physicians, but he is also
the editor of our scientific journal, Chest. In the past, he has been
senior editor of the Journal of the American Medical Associntion~ In
78-994-72-19
PAGENO="0290"
284
addition, he is a specialist in internal medicine and cardiology and
for a number of years ~vas on the faculty of the University of Roch-
ester. So, I feel that Dr. Soffer is just as qualified as I am to appear
before you.
I think I can begin by saying that the American College of Chest
Physicians strongly endorses the bill that you have presented, and
rather than read the statement I would suggest, if you would, that it
be incorporated in the record.
Mr. ROGERS. Without objection, the statement will be printed in
full in the record.
Dr. OLSEN. I would like to merely summarize some of the more
important aspects of this. I might say that the `College of Chest
Physicians is ii~terested in both the cardiovascular and Pulmonary
aspects. We feel that the cardiac point of view was so thoroughly pre-
sented by Dr. Fox yesterday and by Dr. Hurst and Dr. DeBakey this
morning that I thought I would restrict my remarks largely to the
Pulmonary field.
Much of what I have incorporated in my statement and that I might
have to say has already been said by Dr. Kent and also by Dr. Goddard
and Dr. Barbero. So, if I do eliminate some things, it will be because
they have already been thoroughly emphasized.
Mr. ROGERS. Thank you.
Dr. OLSEN. I would like to point out that the field of Pulmonary
diseases is a young specialty. Thirty years ago, when I got into this
field, most lung specialists were TB specialists and many of them
were doctors who had had TB themselves. Today, the lung specialty
is just as Sophisticated a specialty as any of the other subspecialties in
internal medicine.
The chest specialist must be a physiologist, he must know his pathol-
ogy, his bio~themistry, his immunology, his genetics. He must be as
highly educated an individual as a cardiologist.
The shortage of chest specialists has already been emphasized by
Di. Kent.
Dr. Goddard called attention to the fact that the American Thoracic
Society, our sister organizatjo~, and the American College of Chest
Physicians have a joint committee under the chairmanship of Dr.
~John Murray, which is currently inve~tigating the needs in the pul-
monary field, the need not only for chest specialists available to hos-
pitals but also for teachers in the medical schools. The training pro-
grams and research opportunities in the Pulmonary field are being
scrutinized.
Their report is not as yet available. I am Sure it will become
av~ilable to you the moment that Dr. Murray and his group have
completed it.
However, there are certain things that I think we already do
know. As Dr. Kent pointed out, there are quite a few of our medi-
cal schools that do not have adequate faculties to teach Pulmonary
disease. S~i~e of the leaders in medical education do not appreciate
the importance of pulmonary disease as a subspecialty.
Dr. Kent has already called attention to the increasing incidence of
Pulmonary disease.
There are not enough trained chest specialists available for teaching
posts. We have quite a number of positions open in our medical Schools
PAGENO="0291"
285
and in other teaching institutions which are not filled because there
are not enough chest `physicians that are yet available.
We were tremendously grateful when the National Heart Institute
took the lung under its wing, so to speak, and made it the National
Heart and Lung Institute. We do want to be certain that the pul-
monary field gets its share of attention in the consideration of this bill
and the other bills that `have been presented on behalf of the National
Heart and Lung Institute.
I have already mentioned the fact that we have a shortage of train-
ing programs and a shortage of teachers in pulmonary disease. ~ike-
wise much research needs to be done with respect to the etiology and
pathogenesis of many pulmonary diseases.
We need a great deal more research in lung diseases. Some very
fundamental research is already going on under the auspices of the
National Heart and Lung Institute regarding the etiology of emphy-
sema. A deficiency in certain protein substances is associated with some
cases of emphysema. Breakthroughs like this are an indication of what
can be done.
So, the pulmonary diseases are particularly in need of your support
and we are very happy to see that you have made provisions for them.
The authorization of 15 new centers for research and training in
pulmonary diseases is a very great step in the right direction. The
general public and medical students must become aware of the oppor-
tunities in the field of pulmonary disease. The glamour associated
with heart surgery and certain other subspecialties has influenced
some of our medical students. However, there are tremendous oppor-
tunities in the pulmonary field for a young medical man.
I would like to make just a few comments regarding the composi-
tion of the Advisory Council. This has already been tou~lmed upon.
It was my privilege to serve as a member of the Advisory Council of
the National Heart and Lung Institute. In fact, Dr. Hurst and I
served together on that Council.
I can assure you that there is a tremendous amount of homework for
that Council to do. When they keep sending large stacks of research
applications to review, one really has to burn the midnight oil in order
to come prepared to adequately pass judgment on the grant
applications.
This requires considerable number of well-qualified scientific
members on the Council. I do not wish to belittle the contributions of
the public members. Yet, on the other hand, when it comes to the
grant aplications, they are' the first ones to admit that they are really
not well qualified to evaluate the merits of scientific protocols.
The ratio that we have had in the past; namely, of about three
scientists to one public member, has been a good one. I think it would
be a mistake to reduce the number of scientific advisors.
You have noted, of course, that two of the public members were
supposed to be students from the health professions schools. I think
that this ought to require a little clarification. As Dr. Kent pointed
out, su'ch students would be graduated by the time they finished their 4-
year terms `on the Council.
Medical students would probably have relatively little to contrib-
ute at that stage of development. I would urge that if we are going
to select student for the Council that we choose students that are in
PAGENO="0292"
286
the final stages of their training in heart and hrng disease. I really feel
that they might have a contribntion to make.
We ar~ delighted that your bill provides for an enlargement of tue
staff of the National Heart and Lung Institute. As all of you know,
much research is done on the campus in Bethesda.. They authorize,
and therefore subsidize research drnic 111 various inedlical ceuiters
throughout the coimtry. Most. important they deteuTnilie which j)artic-
ulai projects are cieseiving of grant support.. So, this takes a tremen-
clous sta if.
FinaIly~ one comment regarding the chai rnmnslii p of the Advisory
Council. During my period on this Couuiicil, the Council was ehaired~
either by the Director of the National Institutes of Health, Dr. Mars-
ton, or 111010 often by J)r. Theodore Cooper.
No member of the Courici I coul ci . have, done as well in supervising
the activities of the National Heart and Lung Institute.
Nothing would be gained by asking the Secretary to appoint a chair~
man from among the. appointed members of the Council. I would prefer
to see Dr. Marston and Dr. Cooper retain the chairmanship.
In anticipation of two possible questions that you might have, I
would like to state my view about the question of stroke and whether it
should be included in the Nation~u1 Heart and Lung Institute.
As has already been emphasized today, stroke is a vascular disorder
`and is related to arteriosclerosis, or hypertensions, both of which are~
being studied by the National Heart and Lung Institute.
I would think that at least we should share with the Institute of
Neurol~gic Diseases a real interest in the stroke problem. I don't see
how you can separate them. I think it is quite logical for us to be~
interested in stroke.
In connection with the question of cystic fibrosis, I would have to
admit that the research now being done by the National Institute for*
Arthritis and Metabolic Diseases is certainly laudable.
A great deal of the work has been done to prolong the lives of these
unfortunate people~ mostly children to be sure, wtih cystic fibrosis. It
has been done by people who are experts in pulmonary disease. The
techniques that are necessary in order to relieve the pulmonary maui-
festations at least are best done by pulmonary specialists. For that
reason, I don't see how we can continue to avoid having an interest
in cystic fibrosis.
(Dr. Olsen's prepared statement follows:)
STATEMENT OF ARTHUR 1VI. OLSEN, M.D., PAST PRRSIDENT, AMERICAN COLLEGE OF
CHEST PHYICIANS
Mr. Chairman, I am indeed grateful for the opportunity o.f speaking for the
American College of Chest Physicians today. With your permission I should
like to say a few words about this organization. The American College of Chest
Physicians has approximately 5,500 members in the United States. Thirty-five
percent are internists who devote at least 50 percent of their time to pulmonary
and cardiovascular diseases. Twenty-three percent are specialists in pulmonary
disease and 18 percent are cardiologists. Twenty percent are surgeons specializing
in thoracic' and cardiovascular surgery. The remaining 4 percent are in allied
speelalties such as allergy, radiology, pediatrics, anesthesiology, and the b~asi'c
sciences.
Our organization is devoted primarily to education in the cardio-pulmonary
field. With the cooperation of leading medical centers, we sponsor post-graduate
courses in cardiopulmonary medicine and surgery. During 1971, eighteen such
PAGENO="0293"
287
courses were orgaulzêd by the College throughout the United states and Canada.
Nearly 2,500 physicians and surgeons attended these courses, each of which
lasted from 3 to 5 days. Our programs provide continuing education for chest
specialh~ts and usually are devoted to indepth study of various pulmonary and
cardiac diseases including emphysema, high blood pressure, arteriosclerosis~
chest injuries~ etc. In addition, our annual scientific assembly attracts 2,700
physicians, surgeons and other scientists from all over the United States. Thte
annual meeting is primarily an educational experience for all those who attend.
The College publishes a scientific journal called CH1~ST, with a circulation of
15,000 which brings to the medical profession recent advances in the diagnosis
and treatment of cardiopulmonary disease.
The American College of Chest Physicians is very much in favor of legls~ation
such as that proposed in this bill. I am sorry I have not had tbe~ opportunity of
reading HR. 12571 and HR. 13500. Therefore, my critique is largely directed
toward Representative Rogers' bill H.R. 13715 because it is the one I bare had
the opportunity of studying.
I am going to confine my remarks largely to the pulmonary or thoracic field.
I have spent the major portion of my professional life in pulmonary disease.
Until recently it was my privilege to serve as Chairman of the Division of
Thoracic Disease at the Mayo Clinic.
The specialty of lung diseases is quite young as compared with cardiology.
Although I was fortunate in having thorough training in internal medicine,
many of my contemporaries in chest disease 30 years ago confined their activities
to the treatment of tuberculosis. In fact, many of the early lung doctors came
into the specialty because they themselves had tuberculosis.
Tbday, the pulmonary specialist has had jbst as sophisticated a t~aining' as
his colleagues in other disciplines. Although be is still interested In tuberculosis,
most of his time is spent with patients who have emphysema, bronchitis,
bronchiectasis, lung cancer and a variety of diffuse diseases of the lung. He baa
become an expert in the management of respiratory failure.
One of his great challenges is the rehabilitation of the pulmonary cripple.
Whether he be a surgeon or clinician, be must have a strong background in
physiology, pathology, biochemistry, immunology, genetics, et cetera, and be must
develop a considerable number of technical skills.
However, the specialty of pulmonary disease has a long way to go to catch up
with cardiology. With the tremendous increase in pulmonary disease, especially
emphysema and lung cancer, we do not have nearly enough chest specialists. The
American College of Chest Physicians and its sister organization, the American
Thoracic Society, have a joint committee headed by Dr. John Murray of San
Francisco which is studying the manpower problems in chest disease. This study
Is still in progress and they have released no information as. yet. However, there
are certain things that we do know.
A recent survey sho*ed that a very significant number of our nation's medical
schools have no faculty teaching pulmonary diseases. Many of these ~choo~s have
funds for pulmonary teachers but have been unable to find suitable candidates for
the posts. In other words, there is a critical shortage of teachers in pulmonary
disease.
By the same token, there are not nearly enough postgraduate training programs
in pulmonary disease and there are not enough students in the existing training
programs. In addition, there is a very large number of hospitals throughout the
country with inadequate facilities for the care of respiratory problems. Even if
these hospitals did have such facilities they could not get adequately trained
medical and paramedical personnel-(and I emphasize paramedical because they
are extremely important both in intensive respiratory and cardiac care units)-
to staff their respiratory care units or even operate their pulmonary function
laboratories. Finally, it Is well recognized that if the pulmonary specialty l~ to
keep pace with other medical subspecialties, much research is necessary. Most
major advances in medical knowledge are made in the laboratory.
However, such advances usually are made by research workers who are also
teachers and who are experienced in the care of the sick. If we are to make head~
way in our search for the causes of pulmonary disease and find answers for their
prevention or treatment, we must augment our research and teaching programs~
Only then will we be able to provide adequate care for the respiratory ills of the
people of our nation.
It would appear to me that a bill such as that which we have before us will do
much to strengthen the National Heart and Lung Institute in its fight against
PAGENO="0294"
288
~diseases of the heart, blood vessels, lungs and blood. Because of my strong feeling
that pulmonary diseases are particularly in need of support, I would hope that
provisions could be written into the bill which would make certain that research
and education in lung diseases would receive its fair share.
It would appear that the development of 15 new centers for research and train-
ing in pulmonary disease is a step in the right direction. Unquestionably, funds
for construction must be included. Likewise, it would be well to make provision
for the recruitment of both medical and paramedical pulmonary trainees. This
undoubtedly will require an educational effort directed at students of medicine
and the general public. Both the needs and the opportunities in the pulmonary
field must be given adequate publicity.
I should like to make some comment regarding the composition of the Advisory
Council of the National Heart and Lung Institute. You will recall that Repre-
sentative Rogers' bill provides for a membership of 22 members, 18 to be ap-
pointed by the Secretary of Health, Bducation and Welfare. Nine of these would
be scientists, seven would represent the public and two would be students from
schools in the health professions.
Although the Council receives a great deal of help from study groups, site
visit teams and other advisory' or review groups, the final lesponsilbility for allo-
cation of funds rests with the Council. Traditionally, the Advisory Council (and
I believe this is true of most institutes) has had three `scientists for each public
member, This ratio in `my estimation has worked out well. I would queStion the
desirability of `altering this ratio as suggested in `the proposed bill. I can speak
from personal experience `that a great deal `of homework `must be `done by the
members of the Advisory Council, and most of it requires scientific knowledge.
In other words, We need more rather than fewer scientific council members.
Furthermore, the selection of two students from the health professions schools
requires `some clarification. I applaud the principle `of encouraging students to
take an interest in governmental affairs and in the problems of research and
training in their chosen specialties. However, I doubt that their contribution to
the deliberations of the council would be very significant, certainly at a medical
school levels. If students are to be appointed, I think they should be `advanced
fellows in cardio-pulmonary training programs.
Speaking as a former member of the Advisory Council of the National Heart
and Lung Institute I have tremendous respect for the professional staff of the
Institute. They are competent, very dedicated people and `they have shown great
qualities of leadership. I am very pleased to note that the bill provides for en-
largement of the scientific, professional and administrative staff.
The Director of the National Institutes of Health or his deputy, the Director
of the National Heart and Lung Institute, has served as chairman of the Advisory
Council and run the meetings with great efficiency, invariably utilizing the spe-
cial knowledge of his department `heads. My confidence in `the present administra-
tion of the Institute is such that I can see nothing to be gained by asking the
Secretary to appoint a chairman from among the appointed members of the
Council.
With the reservations that I have just expressed, I wish to speak for the Ameri-
can College of Chest Physicians in strongly endorsing this bill.
ST~TEl\~ENT OP DR. ALPRED SOPPER, EXECUTIVE DIRECTOR, ACCP
Dr. SOFFER. Mr. Chairman and members of the committee, I appre-
ciate the opportunity to speak to Mr. Rogers on the p~hone recently. At
that time, I said that the entire medical profession `is becoming aware
of the leadership of this commitee in medicine. I `believe the Medical
World News issue this coming week will show, Mr. Rogers, an inter-
view with him, and the suggestion that he is "Mr. Medicine" of this
decade.
We know of your expertise not only in heart and lung but in all
matters of medicine. We are very cognizant that this committee has
become the authority to the medical profession in legislation.
Thank you for the honor of appearing before you.
I want to endorse strongly Professor Olsen-who is a very dis-
tinguished scientific teacher-in hi's endorsement of Dr. Theodore
PAGENO="0295"
289
Cooper. All of us wear many hats. As an administrator of the Ameri-
can College of Chest Physicians, I have learned to respect Dr. Cooper
as a skillful administrator. As a professor of `cardiology, I have
learned to respect Dr. Cooper's teaching ability and scientific research
in St. Louis and the many splendid articles he has written. Finally, as
editor of "Chest" we consider him a scientist whom we can follow,
The American College of Chest Physicians believes very firmly that
the chairman of the Council ought to be Dr. Cooper rather than some-
one appointed by the Secretary from the' members of the Council.
The emblem'which I showed Chairman Rogers and the members of
the committee suggests that the heart and 1un~ cannot be and must
not be separated. Recently, in Miiineapolis, a cTistinguished surgeon,
Dr. Richard Varco, pointed to a group of physicians and business
executives in the room and said, "Most of us here will die a pulmonary
death." By this, he meant we are at the point that we can prolong in-
definitely the heart and circulation but medicine has "forgotten to keep
up" in research on what we can do for the lung deaths. With our poi-
luted environment, with cigarette smoking by 50 million or more Amer-
icans, many will die, not from cessation of the heart, but essentially
because we don't know how to preserve lung function.
A major priority now should be the development of the artificial
lung for many conditions, including some cases of "shock" lung. What
is this new dramatic syndrome, the "shock" lung? It has been with us'
for three decades, but we have now labeled it. It means that the man,
woman, or child who dies of burns, of inhalation of poisonous gases,
of an accident, may die a lung death. We must know `more about how
to treat the shock lung.
I asked a group of surgeons, cardiologists, and pulmonary sp~cial-
ists, at the O'Hare Airport a few days ago, "Should every major hos-
pital in the country have an open heart surgical team?" Their answer
was, "Only, Dr. Soffer, if you have a good chest man in the hospital,
because the complications of heart surgery are pulmonary." There-
fore, we commend your wisdom in supporting a heart and lung bill,
because until now, we have separated them artificially to the detriment
of the patient.
I want to conclude with the scientific implications of critical care
medicine. Critical care medicine is the most exciting innovation of
this decade. It exists in the emergency room, in the mobile coronary
care unit, in the ambulance, in the out-patient clinic, on the ward, and
in the intensive care units of our hospitals.
Whether it be diabetic coma, emphysema, respiratory failure, or
coronary thrombosis, those patients need the cooperative efforts of a
team of heart and lung specialists, the anesthesiologist and paramedi-
cal or allied health professional. The team approach in critical care
demands emphasis on the lungs, which you have wisely written into
this bill.
Thank you, Mr. `Chairman.
Mr. ROGERS. Thank you, Dr. Soffer, and thank you, Dr. Olsen, for
very helpful statements to the committee. We are very honored that
you took the time to be with us.
Mr. Nelsen?
Mr. NELSEN. No questions, Mr. Chairman, except', of course, to say
thank you to both of the witnesses.
PAGENO="0296"
2~O
Mr. ROGERS. Mr. Kyros.
Mr. KTROS. No questions, Mr. Chairman.
Mr. ROGERS. Dr. Carter?
Mr. CARTER. Thank you, Mr. Chairman.
I am in agreement with you that stroke should be kept in heart and
lung, of course, and again, cystic fibrosis should remain where it is.
That is all. Thank you, Mr. Chairman.
Mr. ROGERS. Dr. Roy?
Mr. Roy. I have no questions, Mr. Chairman. Thank you.
Mrs. ROGERS. We appreciate so much your being here. I know your
testimony will be very helpful to the committee. Thank you.
Dr. OLSEN. Thank you very much for giving us the chance to
testify.
Mr. ROGERS. Mr. Nelsen?
Mr. NELSEN. Mr. Chairman, in view of the tight schedule I have, I
wanted to introduce Dr. Baker in the `event that something develops to
prevent me from being here this `afternoon.
Dr. Baker comes from the University of Minnesota. Last night, I
got on the telephoneS. I did a little checking to get a little more back-
ground on Dr. Baker. I called my dear old friend, Dr. Charlie Shep-
pard of St. Peters. He said he is tops.
So, Mr. Chairman, this afternoon, you are going to hear from a
very distinguished gentleman from the University ~of Minnesota. I
note by the report I have that he joined the university staff in 1934.
I was elected to the State senate in 1935 and the finance committee,
of which I was a member, usually heard from the Medical School of
the University of Minnesota, concerning their budget. So, you and 11
have been associated with the medical school in many ways in the
years past. So, Dr. Baker, we will hear you after we come back.
We are now having a quorum call. So, we will get over to the floor
and,be back at 2:30.
Mr. ROGERS. We will be back at 2:30 p.m.
Dr. Baker, we welcome you and we will look forward to hearing
your `testimony.
Dr. Plum, we will hear your testimony this afternoon.
The committee stands adjourned until 2:30 this afternoon.
(Whereupon, at 12:25 p.m., the subcommittee recessed, to reconvene
at 2:30 p.m. the same day.)
ArrER RECESS
(The subcommittee reconvened at 2:30 p.m., Hon. Paul 0. Rogers
presiding.)
`Mr. ROGERS. The subcommittee will come to order, please, continu-
ing hearings on heart and lung legislation.
Our next witness, who has been introduced to the committee, is Dr.
A. B. Baker, professor of neurology, University of Minnesota Medi-
cal School. He is appearing on behalf of the National Committee for
Research on Neurological Disorders.
Dr. Fred Plum, would you like to appear with him?
Dr. Plum is professor of neurology, New York Hospital, Cornell
University Medical College.
We welcome you gentlemen to the committee and we will be pleased
to hear your testimony.
PAGENO="0297"
291
STATEMENTS OP DR. A. B. BAKER, PROFESSOR OP NEUROLOGY,
UNIVERSITY OP MINNESOTA MEDICAL SCHOOL, ON BEHALF OP
NATIONAL COMMITTEE FOR RESEARCH ON NET.tROLOGIpAL XXS~
ORDERS, AND DR. FRED PLUM, NEUROLOGIST-IN-CHIEF, NEW
YORK HOSPITAL, AND PROFESSOR AND CHAIRMAN OF DSPART-
MENT OP NEUROLOGY, CORNELL UNIV'ERSITY MEDICAL COL-
LEGE, NEW YORK CITY
Dr. BAKER. Mr. Chairman, with your permission I would like to
have Dr. Plum start because I think he will have some preliminary
explanations which will help you to better understand my testimony.
Mr. ROGERS. Certainly. We can make your statements in full part
of our record.
Dr. PLUM. Mr. Chairman, with your permission we will shnRly
enter our written statements in the record and not bore you with
repetition.
Mr. ROGERS. Without objection, it is so ordered.
Dr. PLUM. Let me in my introduction first say that Dr. Baker is past
president of both the American Neurological Association and the
American Academy of Neurology, which are the two major profes-
sional organizations in the field. I think he speaks with a voice for both
of those organizations.
Mr. ROGERS. How many neurologists are there, do you estimate, in
the country?
Dr. PLUM. The membership of the academy at last standing I be~.
hove was in the neighborhood of 4,000. That includes both clinical neu-
rologists and of course the very important scientists interested in the
nervous system affiliated with the clinical physicians.
Mr. ROGERS. How many clinical physicians?
Dr. BAKER. In the area of 2,000. It may be more than that now.
Dr. PLUM. There are roughly 2,500 clinical physicians in neurology
and there are also 600 pedple in clinical training annually. In addition
to that, roughly 250 in research training. It happens to be a discipline
with a very large percentage of its members who go into full1-time re-
search `and teaching positions rather than directly into practice.
Mr. ROGERS. Thank you.
Dr. PLUM. I think the othe.r point that one might make is that the
two of us happen to have been lucky enough to be with stroke rese~rch
centers that were the two first ones established in `the country. Th~
center at the University of Minnesota and the center at Cornell were
both initiated in 1955. We have therefore been in the business of doing
research on stroke for what amounts to 17 years, and come to you with
these sympathies and interests.
As we looked over your bill, I must say we had an exceptional feel-
ing of admiration for your grasp of the problem and the synthesis of
what has been proposed for the Heart and Lung Institute, It is a
splendid bill. I think we were particularly full of admiration for the
concept of increasing the numbers of centers of excellence and the
teaching program which is, after all, crucial to the next generation
of scientists and physicians to attack the problem.
PAGENO="0298"
292
I think we did have a special view that it was not primarily desir-
able for the national health need to put stroJ~e primarily under the
aegis of the new Heart and Lung Institute. Our reasons for this were
several, and if I may I would like to dilate briefly on them.
First, of course, is the size of the problem. While it is true that
circulatory disorders make up about half the mortality in the country,
as you yourself know, stroke all by itself is about one-third of the
mortality. Above and beyond that, if one takes causes of long-term
hospitalizatiofl, it is the cause of about half more or less of the hos-
pital beds occupied in the country at any given time.
Now, the major reason for involving the sympathy of the Heart
and Lung Institute in stroke is the already superb job that they have
done in the field of atherosclerosis and, in identifying hypertension
as a cause of stroke and, therefore, something which by its control
could potentially prevent stroke.
However, what this concept leaves out of consideration is the fact
that atherosclerosis and hypertension are only one of the causes of
stroke. By stroke, what we mean is a local vascular injury which
produces death of part of the brain.
- The big difference between the brain and the heart is that if one
damages the heart, the muscle grows back, it grows its own blood
vessels and in many instances one has an organ that is stronger than
before the heart attack. In the brain, on the other hand, it can't grow
back. Brain tissue which at birth is differentiated in such a way
that it can grow and expand but it can't be replaced in the presence
of a serious injury. Once one has reached maturity this means that
either other parts of the brain must compensate for what is gone or
very special forms of treatment are necessary to compensate for the
individual's neurological loss.
As examples of this-J am sorry that Dr. Roy, for example, is not
here because a certain number of women post natum suffer stroke.
what is called puerperal thrombosjs~thi5 vascular iujury is one of
the major causes of mental retardation in perinatal brain injury and
vascular injury.
In addition to this there are abnormalities of the blood vessels
which are unique to the brain.
Mr. ROGERS. Are you saying that type of stroke then is not a part
of the cardiovascular system as such?
Dr. PLUM. What I am really saying is that there is no precedence
in general cardiology for recognizing or knowing these special
problems.
Mr. ROGERS. Because the small blood vessels in the brain are not
really studied by the cardiologist?
Dr. PLUM. There are two differences in the blood vessels of the
brain. In the first place, they are not as heavy, their wall is different.
In the second place, they are Physiologically very special. They have
a special kind of chemical wall which is called the blood brain barrier
which is different from any other tissue in the body. Your brain and
my brain are entirely different from our muscles. They are different
chemically. If one pounds them or injures them they respond to trauma
differently. This is imposed by a very special and chemically different
set of vessels which people have really given their lives to studyflig.
PAGENO="0299"
293
I think we can expect only limited solutions to the problems of blood
brain barrier, for example, from general physiologists or general cir-
culatory work. On the other hand, the major effort, of course, of the
NINDS has been to identify and encourage research on the cerebral
vessels in the past 15 years. It seems to us it would be a setback to
change that effort at this point or to try to bring in a new group of
individuals without the background to face the problem.
Mr. ROGERS. Have they done a significant amount of work?
Dr. PLUM. iDr. Baker plans to discuss this with you and describe
specifically the program at the stroke centers which have been under
the NINDS.
What I and my colleagues ~e, is that we, in fact, do need more funds
for stroke research. Stroke is a major health problem. It is a problem
which affects the newborn, it is a problem which affects the child, and
of course above all it is a problem which affects people in the older
age group.
Let me give you examples. At the present time if one closes off a
vessel to the brain, that part of the brain will irreversibly die within
about 4 minutes. What we are looking for at the present time are
chemical ways to see if we can hibernate the brain until the threat
passes. In other words, if one had a technique that could quickly
hibernate or chemically turn off the tissue wheii the oxygen supply
was stopped, then it is conceivable one might get by that critieal period
and allow the tissue later to be revivified.
One of the important associated problems that causes serious brain
injury but which is not a direct effect of the stroke is the swelling of
the brain that goes along with it. What happens is when stroke affects
part of the brain, the surrounding area swells up and squeezes other
parts. This swelling is treatable, but the central "stroke" is not. Yet
in the end, the swelling may damage the individual as much or more
as the first lesion did.
Finally, as neurologists, we must emphasize that within our lifetime,
no matter what is done about the prevention of atherosclerosis we are
not going to prevent strokes. Early treatment is going completely to
require specialized knowledge in diagnosis and specialized skill in the
treatment of the stroke itself, and this specialized knowledge is part
of the neurologist's training, but not part of the cardiologist's training.
In summary, we believe this bill `is superb and we think it is going
to make an important difference to the health of people with vascular
disease. We think it will help our cause immeasurably in the preventive /
aspects of stroke. We would hope that this committee would consider
equally important the problem of diagnosis and treatment of the
stroke, itself, and that in future years they would give the same sup~
port to the National Institute of Neurological Disease an4 Stroke for
such effort that presently is being considered this year for the Heart
and Lung Institute.
(Dr. Plum's prepared statement follows:)
STATEMENT OF DR. FRED PLUM, NEUROLOGIST-IN-CHIEF, Nnw YORK HOSPITAL AND
PRoFEssoR AND CHAIRMAN OF DEPARTMENT OF NEUROLOGY, CORNELL UNIV~RSITY
MEDICAL COLLEGE, NEW YORK CITY
May I introduce myself. I am Neurologist-in-Chief of the New York Hospital
and Professor and Chairman of the Department of Neurology of the Cornell
University Medical College, New York City. I also am Chief Editor of the Archives
PAGENO="0300"
PAGENO="0301"
2~5
grow new blood vessels, and the organ will return to Its earlier strength and may
even be healthier than before the attack. This is because the muscle is pretty much
the came everywhere. By contrast, and herein lies the problem, the brain is
locally vulnerable, is never repaired to its original state, and if stroke causes
a loss of language or a paralysis, there is a strong chance that recovery of
these functions will never occur. Since we will almost certainly not be able to
prevent afl strokes in the foreseeable future, solutions as to bow to protect the
brain against injury must be sought for without them, large numbers of patients
are going to remain permanently disabled. And these solutions require men with
the specialized training and experience in the particular scientific problems posed
by the brain. This complex organ differs from all others in its structure, its~ orga-
nization, its physiology, its chemistry and in the way it responds to injury.
Neurologists of various special talents are spending their professional lives work-
ing exclusively in these areas and the National Institute of NeurologicaI~DiseaseS
and Stroke, through its already existing contact with them, stands in far the
best position to Identify these men and to encourage them to direct their efforts
towards solving the problems of stroke.
Without in any way diminishing anyone's efforts, one should emphasize that
the realities of medicine are such that even the best and most humane physicians
are not all interested in the same things. In my experience, most cardiologists
are not very interested in patients with a bad stroke, nor do many of them bav~
the training or experience to correctly diagnose an impending stroke at the time
it first gives off its early warning signals. The reason that medicine today is
specialized is that accurate diagnosis and treatment of even a single system
of the body requires years to learn and the training and interests required
of a skilled cardiologist are very different from those required of a skilled
neurologist. Furthermore, damage to the brain often damages the meaning Of life
itself, and it requires a special awareness and knowledge in the physician for
him to apply promptly the measures that will minimize the risk to the brain.
This knowledge is part of the neurologist's training as is the knowledge of tbe
acute steps which must be taken to prevent recurrence or enlargement of the
stroke. In many instances, a stroke changes the individual, again imposing
special demands on the physician to determine the psychologh~al effects of the
brain injury and to plan the appropriate rehabilitation care. Special skill and
neurological experience are required in predicting a patient's outcome after
a stroke.
This is often not `a pleasant requirement but one which must be undertaken
responsibly and accurately for legal and social reasons. All of these special
neuro'logic problems in diagnosis, acute care and aftercare will best be met
by continuing and expanding the major effort of the Nation's stroke program
under the auspices of the Nation'al Institute of Neurological Disease and Stroke.
We well recognize that we cannot move ahead in solving the basic problems
of preventing stroke without the programs of the National Heart and Lung
Institute in atherosclerosis, hypertension and heart disease control. At the same
time, the full efforts of the National Institute of Nouro;Iogical Diseasel~ and
Stroke are required to focus on the special clinical and research problems im-
posed `by the brain's unique qualities and responses to injury. The joint inter-
Institute Council and programs already cited have proved an excellent n~o~lel
of government at its best for past cooperation `and serve as an instrument to
develop future strategic cooperative attacks on the stroke problem,
Finally, may I affirm the clear and present need for more funds with Wbi~h
to attack the stroke problem. Some of our stroke centers at this moment are
inhibited from their full clinical and research potential simply because monies
are not available to examine the problems we already know exist. Some of them
problems include: Can one chemically "turn off" the brain when a stroke starts,
protecting it against oxygen lack that otherwise would `be lethal? What
causes the swelling of the brain that sometimes occurs in stroke and can it-
self as `an independent process be fatal? How can one prevent or treat this swell-
ing? Are there inexpensive and effective treatments for transient, little ~strokOs
that can be used for treating individuals in underprivileged populations who
sometimes don't easily understand the complicated anticoagulant treatment pro-
grams available today? Since we know that one can produce hypertension by
small lesions in the brain, can one find in experimental animals equally small
areas whose inhibition or suppression might cure hypertension? And there are
others, but these few will give examples of directions in which we couki go
with the proper resources.
PAGENO="0302"
296
Accordingly, Chairman Rogers and members of the Committee, I believe it
imperative that the Nation move ahead vigorously and expand its already or-
ganized natiOnal pI~ogram in stroke. The legislation being considered today
under the auspices of the National Heart and Lung Institute will be a grati-
fyingly important step in this direction. May I also urge you to consider with
equal vigor and enthusiasm the need for increasing the resources and oppor-
tunities of the National Institute of Neurological Diseases and Stroke for
attacking this major health problem.
Thank you for your attention.
Mr. ROGERS. Thank you very much, Dr. Plum.
Mr. NELSEN, I have one question concerning the affliction some-
times called early senility, which I understand is caused by a harden-
ing of the small blood vessels that feed the brain. Has there been any
extensive research in this area and what are the prospects of any
findings on the subject ~
Dr. PLUM. There is a very strong effort in this, Mr. Nelsen, because
the curious thing is that this is an isolated organ problem in many
instances. As you know, senile brain disease does not similarly affect
the kidney or the lung or the heart in the same way that it affects
the brain. There are two major groups working on this, one at the
Albert Einstein, another at the Harvard Medical School, and there
are others with less intense total programs.
We think from our own research work, that the problem you men-
tion is related to abnormalities in the blood brain barrier problem that
I told you about earlier. It would be misleading to say that we see
the answer around the corner. However, I think we see some of the
immediate problems, and some of the immediate chemical changes.
Now what we must do is to get at the cause of these. We are not `there
yet but `there is vigorous research effort into the problem.
Mr. NELSEN. Thank you.
Mr. RooRus. Dr. Baker.
STATEMENT OP DR. A. B. BAKER
Dr. BAKER. I too would like to join Dr. Plum in complimenting the
committee on a very excellent bill. I think H.R 13715 is an excellent
bill. Certainly any move to expand the heart effort is a good one be-
cause heart is a real problem in this country. I think this bill has to
be supported.
Again, I have concern about the fact that there has been a sugges-
tion that stroke should be included in the bill because it is my feeling
that to work on stroke one must have a thorough knowledge of the
structure and the function of the brain and this knowledge is the
knowledge of the neurologist or those scientists working with the
Neurological Institute. It is where it has always been and where it
will be for a long time. Unless we have that knowledge we are not
going to make any progress in the field of stroke.
For example, about 3 years ago the regional medical programs were
asked to put out a small reference volume covering all aspects of
stroke. This was for the physician in general practice so that he
would have access to up-to-date knowledge on stroke.
The regional medical programs had to go to the American Neurolog-
ical Association to get the job done, not the American Heart Asso-
ciation. The American Heart Association did not have the manpower
PAGENO="0303"
or skills to
ical ~
wc~
rmal )nOflt e
In 1962 the Congress want~. done on str
logical Institute at that time was mandated to expand its effort on
stroke. It was given funds to do this. It has done really quite an amaz-
ing job, I know because I have been with them on this job right
along.
As Dr. Plum pointed out, we have had some centers going for a
long time, but through these additional funds the Neurological Insti-
tute set up 18 clinical research centers on stroke throughout this coun-
try and they are really superb centers and have grown as more man-
power has become available.
Dr. Plum has one such center. There is one center in Florida under
Dr. Sheinberg, professor of neurology at the University of Miami.
We at the University of Minnesota have a center. There are 18 cen-
ters total. It is interesting to note that this is the only effort being
made toward centers on strokes. No other institute in the National
Institutes of Health is supporting or working on such stroke centers
except the NINDS.
As a matter of fact, of these centers, 14 are headed by neurologists.
Two are headed by neurosurgeons and two by epidemiologists. Not a
single one by a cardiologist. It shows that the centers doing research
today on stroke are all headed by scientists working and trained in
neurological sciences. This again shows where the interest and where
the capabilities are in this field of stroke. As a matter of fact, the Neu-
rological Institute, in order to hasten the efforts and the progress in
these centers, has set up a yearly workshop of which I am secretary.
Once a year the scientists from these many centers are brought together
with consultants from all over the world. They have a 2- to 3-day meetS-
ing so that the consultants can meet with the scientists and see if they
can help solve some of their problems and difficulties and thus hasten
the job along so that we can get more progress on stroke.
As a matter of fact, the thrust on stroke has been so greatly identi-
fied in the Neurological Institute that Congress itself changed the
name from the National Institute of Neurological Disease and Blind-
ness to the National Institute of Neu~ological Disease and Stroke,
again `acknowledging the fact that the stroke problem was part of the
brain and part of the Neurological Institute even by name.
It also indicates that to work in the stroke field one must have a
thorough knowledge of all the intracacies~of brain function, its phys-
iology, pathology, its chemistry. This takes years and years of train-
ing. Therefore, to expand the stroke center it has been necessary to set
up training programs to train young scientists to be able to work in the
field of stroke.
These training centers have been developed over the past 10 years
but always under the supervision of the National Institute of Neuro-
logical Diseases and Stroke. All the training grants support, and all
the organization for manpower training is now in, the Neurological
Institute.
aer. The Arn~'~
PAGENO="0304"
and un-
PAGENO="0305"
~~nrological Institute ~n d~ the ~am~ j~ob wjØ~ the st~oke problem.
Both iii~*tutes could coopei~te in theirj~ e~ort~ They ~ir~ady
have such a cooperating committee, the .T~Tf!VCouncil' iSubcommit~ëe /
on Stroke. There is no reason why this comI~1ittee can't continue to
function by occasional meetings. But the main research thrust should
be allowed in separate institutes where they hitve the know-how ax~d
the skills which are unique to the t~o different kinds of instrtutes.~
(Dr. Baker's prepared stateniënt ~
STATEMENT or DR. A. B. BARER, PROFESSOR AND. HEAD OF DEFAXu~MENT OF
NEUROLOGY, UIW/ERSITY or MIN sor~p~c~i~ SCMOOL
I am Dr. A. B. Baker, Professor and Head of th~ Department of Neurology
at the University of Minnesota Medical School; mexfijer of the ExOcu~lve Coin~
mittee of the Council on Strokes of the American Hea~rt Association; Director o~
a clinical research center on cerebrov~scu1ar disease; and Secretary of the
National Workshop on Strokes sponsored by the National Institute of Nem~ologh
cal Diseases and Stroke. It is my privilege to appear b~orè you to testify regard-
ing Bill H.R, 1~715 to enlarge the authority of the National Heart and Lut~g
Institute. I should like to compliment your committee for producing~ an ~excellent
Bill. Any national effort which would hasten the solution of the problem Of
heart, lung, and blood diseases is extremely importa~it to the health of' t1~
natiqn and must be supported. I hope that your Bill will be passed by Con.
gress and signed into law in Its present form.
However, I am somewhat concerned and uneasy about the suggestion that the
stroke problem also should be included in this Bill and transferred to the author-
ity of the Heart and Lung Institute. As a neurologist and an investigalor in the
field of stroke for the past 30 years, I can find very little justification for such
a move. There is no question that stroke is a disease of the brain and not the
heart. It is important to keep in mind that the term "stroke" includes a variety
of disorders in which the brain's vascular structure is compromised and the
brain's function threatened and disrupted. In order to thoroughly understlu~d
this problem, one must have a thorough knowledge of the function and structure
of the brain, and this knowledge is found exclusively in the realm of the neurolo-
gist and those scientists affiliated with the NINDS. Most advances made in this
field have been made through the efforts of those specialized in the field of the
nervous system, both basic and clinical. I should like to point out that if one Is
to obtain detaile~ information concerning tthe subject of stroke, one must refer to
text books of neurology, not to text books of cardiology or not even text books
of medicine, where this subject is usually mentioned very superficially. When the
Regional Medical Programs were mandated to produce a coniprebensive, up-to-
date review of the total subject of stroke which could be made available to the
physicians in this country, they turned to the American Neurological Aasoc~a-
tion, not the American Heart Association. It was the ANA who was able tn
mobilize the neurological specialists throughout this country to put together thjs
important reference volume, which will appear shortly in finished form and will
contain the current status of the stroke problem in this country.
Congress has been cognizant of the important contributions of the National
Institute of Neurological Diseases and Stroke in the stroke field. When Congress
desired a greater effort in this field, they justifiably turned to the Neuroioglcbj
Institute and appropriated additional funds so that the Institute could expand
their programs in the field of stroke. The NINDS responded by establishing 18
superb research centers for stroke throughout the United States. 1 call your / /
attention to the fact that these are the only stroke research centers In the United
States supported by NIH. No other organization or institute hks supported
stroke centers. These centers are manned by some of the foremost talent in this
country in the field of stroke. This is a vigorous, dynamic effort to help solve the
problem of stroke which has been expanded as more personnel became available.
For example, there is a stroke research center at the University of Miami sup-
ported by NINDS. The Head of the center is Dr. Peritz Scheinberg, Chairman of
the Department of Neurology. We, at the University of Minnesota, also have a
stroke research center of which I am the Head. At the present time, we have 24
neurological scientists devoting their entire research effort toward a solution to / / /
the stroke problem. There are many other centers throughout the United States. /
78-994-72-20 /
PAGENO="0306"
300
As a ni~ttter of fact, ~f ~i~e 18 stroke research centers, 14 are beaded b~ nenrol-
okists, two by epidemiol~i~tS~ and two by neurosurgeons. It is apparent that
most of the leaders of thè~ centers are individuals related to the field of t1~e
nervous system rather then the heart. In order to coordinate this entire effort,
the National Institute of Neurological Diseases and stroke has established a
yearly workshop where tb~se many Investigators, as well as special consultants,
are gathered `to discuss their various problems and they augment and hasten
progress in their respective research aspects in this field. `The NINDS has also
recently completed plans and launched a pilot effort on the problem of the acute
stroke. With this type of hemorrhagic stroke, 8~ perhent'of the patients usually
die. This waste of humafl resources must be overcome. However, the presently
available medical or surgical' intensive care units have no effective means of
miiitoring the function of the brain. The monitoring methods effective in heart
studies are of no value when applied to the brain. I know from personal experi-
ence, since I have been engaged in such monitoring procedures for the past five
years in our acute stroke unit. It is hoped that this new ?4INDS effort will do for
the brain what has been done successfully for the heart; and that through the
leadership of the NINDS, proper monitoring equipment for brain function will
be developed.
- Because of the importance of stroke to nation and because o&the accepted
fact that the Neurological Institute has been the focus of effort in `this disease,
even the name of t~ie Institute has been changed to that of the Naional Institute
of Netirological Diseases and Stroke. This in itself indicates the important fact
that to properly study the problem of stroke, which Is a disease of the brain, one
must have thorough training in all aspects of brain function. This type of train-
ing takes years of postgraduate experience and exposure in specialized centers
established for this purpOse. It is important to point out that these centers, for
the training of specialists in brain function and for training the manpower to
study stroke, have always been under the direction and supervision of the NINDS.
Most research personnel working in the various stroke centers have been through
a very intensive traitiing program, and these NINDS training centers continue to
produce the manpower necessary to cover the various complex aspects of the
Stroke problem.
If ope were to transfer the stroke problem to the Heart Institute, it would
serlously threaten this entire ongoing program of manpower training and "stroke"
research. It would mean that scientific personnel, who do not understand the
brain and its function, would be asked to accept leadership of a research pro-
gram on a disease which is outside their present range of knowledge, and that a
superb organizational arrangement for national coordination and cooperation
would be disrupted and would have to be rebuilt. It would mean that, individuals
working in the heart field, which in itself is a very complex field, would also have
to become highly specialized in the field of the nervous system. To date, there is
no one in this country who is highly specialized in both of these fields. Each of
these fields is very complex. It requires years of constant study to keep abreast
and make' any contribution to either one of these fields, let alone both.
`One might question the reason for considering the transfer of the stroke prob~
lem to the Heart Institute. As I pointed out, I personally have been nnable to find
justification based upon my own experience as a clinician and a teacher. It has
been suggested that one of the reasons for this transfer is the fact that the Heart
rnstitute has concerned itself with diseases of the blood vessels and blood vessels
are involved in many cases of stroke. However, it is important to keep in mind
that the involvement of the blood vessels of the brain differs in many respects
from the involvement of the blood vessels in other parts of the body. `The struc-
ture of the blood vessels of `the brain are different from those of other parts of
the body. The mechanisms of the control of the brain blood flow are different
from the mechanisms of the heart or lung blood flow. The effects of impairment
of the circulation of the blood within the brain is different from the impairirient
of the circulation in other organs of the body. Considering the specificity of the
vascular supply to the brain, it is quite apparent that stroke or cerebrovascular
disease is quite different from heart disease or lung disease and involves an en-
tirely different approach, a different set of research techniques, and different re-
search personnel. It may be of Interest to point out that the nerve supply of the
body is accepted as being within the scope of the neurologist and the National
Institute of Neurological Diseases and Stroke. Since heart function as well as the
function of the llood vessels are regulated by a nervous control, does this mean
that heart disease and blood vessel disease should be in the realm of the neurolo-
PAGENO="0307"
301
gist and the NINDS? Obviously this is not so. Progress will be made in both of
these fields by those specially trained to study the specific organ disturbances an~
not the vascular or nerve supply to that organ.
It is apparent that we are dealing with two of the largest medical problems
in the world today, heart disease and stroke. The latter, being chiefly the
disease of an aging population~ is rapidly increasing in frequency. If we are to
properly solve these two huge medical problems, then it is my feeling that their
solution should be assigned to separate institutes; institutes which are best
equipped both by traditiOn and by past experience and effort, to solve these
problems. There is no question that the Heart Institute ha~ been estabIi~bed for
years and has done an excellent job in approaching the problem of heart disease,
and it should be encouraged and supported to increase this effor1~. I am coii-
vinced the same holds true for the problem of stroke. This is a disease of the
brain. It belongs under the supervision of the NINDS where it already has
been one of the chief concerns for over a decade. The Neurological Institute
should be encouraged and supported so that it can expand its effort in this
respect, launch the already planned new programs, and further mobilize that
segment of the medical profession who is best equipped to contribute to the
solution of this problem; namely those in the basic and clinical aspects of
the neurological sciences.
In conclusion, I urge the Committee to give its enthusiastic support to providing
the National Heart and Lung Institute with the new authority proposed in HR
13715 and to provide the NINDS with similar legislation so that it can expand
its efforts in stroke and other neurological diseases,
Mr. RoGERs. Thank you, Dr. Baker, for giving us the benefit of
your thinking in this matter, because the committee will have to make
some decisions here. It is most helpful.
Mr. Nelsen.
Mr. NELsEN. No questions, except to express thanks to the witnesses
who are here. Having heard of Dr. Baker for years, I am pleased to be
on this committee to hear him. I am sure his experience is something
that we can draw upon in doing a better job. Thank you very much.
Dr. BAKER. I might make one statement. There is an interesting
thing that I thought of in putting the testimony together. One of the
reasons that has been given for putting stroke into the Heart Institute
is the fact that heart deals with blood vessels and stroke does have
involvement of blood vessels, therefore, put stroke in the Heart In-
stitute.
Let me reverse that. The nerves to the body belong to the neurolog-
ical system. But nerves go to the heart and nerves go to the blood ves-
sels. If you jeopardize those nerves, the heart does not work, the blood
vessels do not work. Since nerves are causing this disturbance, let
us transfer all heart and blood vessels research to the Neurological
Institute and make them part of the Neurological Institute. Either
argument is as sound as the other. It is not the nerves or the blood
vessels, it is the organ that we are involved with. One is heart and one
is the brain. The effort should go to the organ, not the fact that one
has nerves and the other blood vessels.
Mr. NELSEN. May I comment that next Sunday I will be at the Uni-
versity of Minnesota, which is celebrating the 25th anniversary of the
School of Veterinary Medicine, which legislation I authored when I
served in the State legislature. I will be back there for their celebration
Sunday.
Dr. BAKER. That is wonderful.
Mr. RoGERs. Dr. Carter.
Mr. CARTER. I was very much interested in your analogy that nerves
come from the brain, go from the brain to all parts of the b?dy, the
PAGENO="0308"
3O2~
heart and so on, and the blood vessels, which we know is true; there-
fore, everything should be placed under neurology and stroke. But
we might use a little reverse psychology that way and say that the
heart pumps all the blood to all the blood vessels of the body, to the
brain, and therefore neurology should be plafled under Heart.
Dr. BAKER. This is the point. That is why I say you can look at the
coin on either side.
Mr. CARTER. That happens to be the other side of the coin. Certainly
it has been a pleasure to listen to you.
What percent of strokes are caused really by vascular damage, either
rupture or embolism?
Dr. PLUM. You are asking what percent of the strokes are directly
traceable to atherosclerosis and hypertension?
Mr. CARTER. Yes.
Dr. PLUM. Which is not the same question.
Mr. CARTER. I did not ask if it is not the same question. Answer the
question I asked.
Dr. PLUM. What I am saying is that there are specific vascular prob-
lems of organs which are different from atherosclerosis.
Mr. CARTER. Of course. You can have aneurism of the circulatory
system. Only 40 percent of the strokes are caused by vascular damage
or by rupture or by embolism. Is that true?
Dr. PLUM. No. if you add rupture and embolism I think it would be
70 percent.
Mr. CARTER. At least 70 percent. And what are the other causes of
stroke?
Dr. PLUM. Perinatal brain damage, which is a vascular lesion. Post
partum thrombosis-
Mr. CARTER. Wait. You are getting into the first part of the question.
Dr. PLUM. You mean in what percentage is the blood vessel injured
at all? It obviously would be 100 percent.
Mr. CARTER. I would not say that. Of course, if you have a tumor, it
impinges on the vascular supply in that sense. But from within the
blood vessel it is what percentage of involvement of that blood or yes-
`sel~ that cause stroke?
Dr. PLUM. By definition, since by definition stroke is a vascular in-
jury to the brain, a hundred percent.
i~{r. CARTER. I couldn't agree with that. I don't believe you got my
question. Ruptin~e or embolism, or a gradual occlusion of the brain by
athersclerosis results in the greater part of the strokes that we have.
Is that not true?
Dr. PLUM. That is true.
Mr. CARTER. From that the argument follows that this is part of the
cardiovascular system; that the vascular part should be relegated to the
Heart and Lung Institute. That is their argument, as I see it.
Dr. BAKER. If you take that argument, of course, it would mean
therefore that all the vascular problems of the kidney and all the vas-
cular problems of the gut and all the vascular problems of the skin and
all the vascular problems of the subcutaneous tissue should be in the
Heart arid Lung Institute. Are we going to take all organs of the
body that may have vascular problems and put them in the Heart
Institute?
PAGENO="0309"
Mr. CARTER. I ~
have so much athero~
you don't have to inc
eluded althou~ 1
because you n
Dr. BAKER. L
causing changes of the brairL. i. n~ important -~
cial kind because the causes of atherosclerosis of the heart are not the
same causes of athersclerosis of the brain. The dietary factor plays no~
role in the atherosclerosis of the braitL. In other words, there is an
entirely new set of causative factors that we in the Brain Institute are
working on. The Heart Institute is working on atherosclerosis of the
heart but not the factors that involve the brain.
Mr. CARTER. What is the difference?
Dr. BAKER. We don't know. I have `been working on atherosclerosis
of the brain for 10 years. I have been collecting atherosclerosis of the
brain around the whole world. We have collected now over 13,000 cir-
cles to look at atherosclerosis of the brain and we are checking all
causative factors. The diet and the factors that affect atherosclerosis
of the heart do not play a role on the brain. We have a whole new set' of
factors that we have to discover and find if we are going to prevent the
stroke. This will be a research project exclusive of the heart because
the heart problem is not the same as the brain problem. It may be a
blood vessel problem but it is different than the blood vessel problem of
any other organ.
Mr. CARTER. Who treats hypertension, for instance, which is a com-
mon cause of stroke? Do neurologists treat that or do cardiovascular
people, internists, arid so on?
Dr. BAKER. In my patients, I treat them. I don't refer my patients
to an internist to treat hypertension. /
Mr. CARTER. If your patients come to you with hypertension you
treat them?
Dr. BAKER. That is right.
Mr. CARTER. You are the first neurologist I have ever seen that really
takes that as part of his fee. Certainly there may be logic to what you
say. I think you are certainly capable of doing it but it is rather un-
usual for a neurosurgeon or neurologist to treat hypertension.
Dr. BAKER. Not in this day and age. I think now with what has hap-
pened in the field and with all this new interest in the field of strok~
and with all these research centers, the neurologist is treating all those
factors that have something to do with the cerebral changes.
Mr. CARTER. It might be a good plan for that to be done but most
hypertension is treated by an internist and general practitioner and so
on. I am sure of that.
Dr. BAKER. By volume percentagewise this would have to be true.
There are not that many neurologists in the country.
Mr. CARTER. No more than 1 percent, I guarantee you, is treated
by neurologists or neurosurgeons throughout the country.
Dr. BAKER. I think you would not have too much more than that in
cardiology because most of them are treated by practitioners and
internists.
Mr. CARTER. It is rather interesting what you have said. I thought
that we ought to look at both sides of it. I think that they ti~eat before
PAGENO="0310"
~.1
ftlt I thin
~KER. I t
sion is the n
casesthat (
U are a
~ we have to
am cause of
~R. We i
ial occlusion by a
tumors which cause it. ~v
gummatous lesion of the]
new ii ~ foulage VRDL
body. Both of v
was
~esting 1
ian.
ask this:
~B main cai
Are we making substant
~ reasons we understand v
stroke activity is because i
i done in the present Institu
enoug1 1 L lot -
Lile.
- ~ing. I have be
as as you have f~
t been very lucrative be
Ln't blame the Institute for not
inds. It is not really the Inst
;ative committees that work
1ce the . I think we c
"~ess.
ent almost 30 years v
~ someone new
~Iii~
ou can do this for the
~e? As we say, what are
or not?
udyin~
I hai
me to se~
do ~ -
ne fact ~ Uerl
as we are it is L~ ~ me to see how t.
ri we who are informec, who have spent all
PAGENO="0311"
305
~rev~ ionist -
the blood supply is to brain
stick needles in people and you c~ t to ~, he~
son. We don't want to do that. So, we have to 1 i how to 1
do the same kind of blood flow circulation technique without stickir
needles. Hopefully, we will make a breakthrough soon by using in-
halation. Give the patient a whiff of Xenon, take a scan of the brain
and you can see how well the brain is being circulated by blood. If we
could perfect this technique, and three or four institutions are work-
ing on it, then we will have a survey procedure, we will be able to give
a patient a whiff of Xenon and say, "This brain now has a certain sp9t
that is not getting enough circulation. What can we do to improve the
circulation?"
This is almost a breakthrough. It has taken years to get to this point
of almost getting a preventive technique so that we can follow through.
The delay in developing this technique, is the fact that the brain cir-
culation is complex. The brain is the most complex organ in the body
and it takes a lot of time to study it. I don't see how anybody is going
to gain anything by taking this complex problem and transferring it
to a group of people who are already busy and know nothing about
the problem.
Mr. ROGERS. What are the main risk factors in stroke?
Dr. BAKER. I think there are many risk factors. We have been study.~
ing that for a long time. Diabetes is one risk factor, hypertension is
another risk factor. One of the biggest risk factors is certain mecha-
nisms of blood coagulation. The other factor of course is what happens
to the brain tissue itself. The blood brain barrier is an extremely im-
portant process that creeps up no matter what you do. It always comes
to the fore. It is a peculiar structure of the brain that is different from
any other organ of the body, that plays a role no matter that type of
procedure you start setting up.
I think the important thing right now is for us to find a method to
predict who has decreased circulation when he is well and then do /
something about it. Can drugs help? What procedures can we set up
to do something about this impaired circulation? Many risk factors
are discovered too late. You take a young lady who takes antipreg-
nancy pills. By the time one realizes that there is a risk factor, she has
had a stroke. The big problem is what do you do now. I think we now
have a number of scientists already working on this problem.
We need more of them. We need more funds. But to disrupt this
program right in the middle of 10 years of work and transfer it else-
where, to me is the height of waste, particularly since the institute
with its research centers is doing a beautiful job. These 18 iiIstitutes
are excellent institutes. The one we have in Florida is a top-notch in-
stitute. Dr. Scheinberg is one of the best men in the country on blood
flow. Dr. Plum's institute is a top-notch institute. We have a lot of
those institutes that are really tops and doing the best they can do.
Mr. ROGERS. Could you let us have for the record a rundown of these
institutes, and their personnel, key personnel, and the main work that
is being done and the funding.
Dr. BAKER. We can do that. We can have that for the record.
(The following information was supplied for the record:)
PAGENO="0312"
CEREBROVASCULAR (STROKE) CENTERS-CURRENT STATUS, MAY 1, 1972
Title and institution Program director Professional and scientific staff Areas of emphasis -
A. B. Baker, M.D Baker, A. B., professor and head, neurology department; Resch,
Joseph A., professor of neurology; Berry, James, professor of
neurology (chemistry); Cohen, Harold, associate professor of
neurology (chemistry); Ayala, Giovanni, associate professor of
neurology (CBF); Loewenson, Ruth, assistant professor of
neurology (statistics); Sung, Joo Ho, professor of pathology;
Klasseri, Arthur, assistant professor of neurology; Mastri,
Angeline, assistant professor of pathology; Lee, Myoung,
assistant professor of neurology (chemistry); Johnston, Kay,
instructor; Zeeso, James, assistant professor of radiology; un,
Sping, associate professor of neurology; Alter, Milton, epi-
demiology; supporting staff: 15.
Clark Millikan, M.D Millikan, C. H., professor of neurology; Whisnant, J. P., professor
of neurology; Sundt, T. M., Jr., professor of neurosurgery;
Yanagihara, T., assistant professorof neurology; Matsumoto, N.,
research assistant; Didisheim, P., associate professor of Medi-
cine; supporting staff: 6.
James F. Toole, M.D Toole, J. F., professor of neurology; McKinney, W. M., professor of
neurology; Barnes, R. W., professor of neurology; Choi, Kwan,
assistant professor of medicine; Nornier, A. M., research fellow
U. Sonic; supporting staff: 8
Fletcher McDowell, M.D McDowell, Fletcher, professor of neurology; Plum, Fred, professor
of neurology; Posner, Jerome, assistant professor of neurology;
Louis, Sidney, assistant in neurology; Harpel, Peter, instructor
in medicine; Potts, Gordon, associate professor of radiology;
Stern, Peter, clinical assistant, professor of medicine; Mc-
Devitt, Ellen, associate professor of medicine; Duffy, Thomas,
assistant professor of neurology.
John Stirling Meyer, M.D Meyer, J~ S., professor of neurology; Ericsson, A. D., associate
director of neurology; Pilgeram, L. 0., associate director of
physiology; Faibish, G. M., assistant professor; Dodson, R. F.,
assistant professor; Gin, N. Y., assistant professor; Hoff, H. F.,
assistant professor of physiology; lsaacs, G., assistant professor;
Mathew, N. T., assistant professor; Rivera, V. M., assistant
professor; Weibel, J., assistant professor; Suzuki, Mmcm,
associate professor of pathology: Bell, Robert, assistant pro-
fessor of neurclogy; Beer, Paul, associate professor of neurology;
supporting staff: 12.
Program project to study the cerebrovascular Abraham Lilienfeld, M.D Lilienfelcl, k M., epidemiology; Kuller, L., associate professor of
diseases, Johns Hopkins University, Balti- epidemiology; Nefzger, MD., associate professor of epidemi-
more, Md. ology (medical statistics); Diamond, E., professor of epidemi-
ology; Miller, G., assistant professor of epidemiology; Stalley,
J.; supporting staff: 23.
Neurological Research Center in Cerebro-
vascular Disease, University of Minnesota
Medical School, Minneapolis. Minn.
Cerebrovascular Clinical Research Center,
Mayo Foundation, Rochester, Minn.
Cerebral Vascular Research Unit, Bowman
Gray School of Medicine, Winston-Salem,
N.C.
Research Center for Cerebrovascular Disease,
Cornell University Medical College, New
York, N.Y.
Baylor Center for Cerebmovascular Research,
Baylor College of Medicine, Houston, Tex.
Epidemiology (ethnic differences, risk factors); cerebral
atherosclerosis; blood coagu!ation and thrombosis;
clinical coagulation and thrombosis ; clinciaf diagnosis
and treatment; cerebral metabolism; stroke in-
tensive care; cerebral hypertension; controlled
clinical trails; and cerebral blood flow.
Epidemiology; blood coagulation and thrombosis;
cerebral hemorrhage; cerebral metabolism; surgical
therapy of stroke; medical therapy of stroke; transient
ischemic attack; and improve methods of clinical
diagnosis.
Angiographic diagnosis; clinical diagnosis and therapy;
speech therapy; intensive care; diagnostic in-
strumentation; vascular factors in stroke; and the
transient ischemic attack.
Cerebarl atherosclerosis; cerebral matebolism; cerebral
infarction; blood coagulation and thrombosis; cere-
bral hemorrhage; stroke rehabilitation; and stroke
prevention.
Blood coagulation and thrombosis; cerebral infarction;
clinical diagnosis and treatment; cerebral hyper-
tension; cerebral metabolism; controlled clinical
trials; early prevention; and cerebral blood flow.
The transient ischemic attack;(geographic differences,
racial differences); stroke risk factors; organization
of community health resources; and cerebral athero-
sclerosis and aging.
PAGENO="0313"
Scheinberg, Peritz, professor and chairman, department of neu-
- rology; Reinmuth, 0. M., professor of neurology; Namon, Rich-
ard, research associate (biophysist); Kogure, K., assistant pro-
fessor of neurology; Fujishima, M., research assistant; Nilsson,
Lorenz, visiting research scientist; Schwactzman, Robert, assist-
ant professor of neurdlogy; Dick, Arthur, assistant professor of
neurology; McCollough, Newton, associate professor of ortho-
pedics- supporting staff: 14.
Robert A. Fishman, M.D Fishinan, Robert A., professor of neurology; Yatsu, Frank M., asso-
date professor of neurology; Blaisdeil, F. W., professor, surgery;
Drake, William, assistant clinical professor of neurology; Barnes,
Barbara, assistant clinical professor of neurology; Sahud, Mer-
vyn assistant professor of medicine- supporting staff: 6.
Lawrence C. McHenry, Jr., M.D... McHenry, L. C., Jr., professor of neurology; Goldberg, HI., chief,
neuroradiology, professor of radiology; Cooper, E. S., attending
physician, medical service, professor of medicine; West, J. W.,
assistant attending physician, neurology service; Canales, K. 1.,
assistant attending physician, neurology service; Patel, A. N., as-
sistant attending physician, neurology service; Mann, 0. S. M.,
senior attending physician, neurology service; supporting staff:
12.
Albert 1-leyman, M.C l-leyman, Albert, professor of neurology; Schanberg, Saul, assistant Epidemiology of stroke, racial and regional differences;
professor of neurology; Kinsbourne, Marcel, associate professor risk factors; blood coagulation and thrombosis; cern-
of neurology and pediatrics; Appel, S., professor of neurology; bral metabolism; improved methods of clinical diag-
McKee, P., associate professor of medicine; Obrist, W., professor nosis, treatment; cerebral blood flow; and psycho-
of psychiatry; McMahon, S., professor of medicine; Day, E., as- logical factors in stroke.
sistañt professor of medicine; Rosenthal, M., assistant professor,
department of physiology and pharmacology; 0'Fallon, M., as-
sistant professor, medical statistics; Brody, I., associate pro-
fessor of biochemistry; Anderson, B., associate professor of
ophthalmology; supporting staff: 14.
Goodglass, Harold, professor of soeuropsychology; Howes, Davis, Clinical diagnosis; cerebral infarction; language dis-
associate professor of neuropsychology; Geschwind, Norman, orders and therapy; risk factors in stroke; and cern-
lecturer in neurology; Pandya, Deepsak, assistant professor of bral hypertension and atherosclerosis.
neurology; Domesick, Valerie, assistant professor of neurology;
Zurif, Edgar, assistant professor of neurology; Butters, Nelson,
associate professor of neuropsychology; 1(aplan, Edith, assist-
ant professor of neuropsychology; Green, Eugene, associate
professor of English; Samuels, lna, assistant professor of neuro-
psychology; Berman, Marlene, assistant professor of neuro-
psychology; Albert, Martin, assistant professor of neurology;
Boiler, Francois, assistant professor of neurology.
Research Center br Cerebrovascular Disease, Peritz Scheinberg, M.D
University of Miami, Miami, Fla.
Stroke Research Program, University of Cali-
fornia, San Francisco, Calif.
Stroke Research Center, Philadelphia Gen-
eral Hospital, Philadelphia, Pa.
Duke-V.A. Center for Cerebrovascular Re-
search, Duke University,Durham, N.C.
Boston University Aphasia Research Ceeter, Harold Gooclglass, Ph. D
Boston University, Boston, Mass.
Cerebral blood flow; cerebral metabolism; cerebral
atherosclerosis and infarction; improved methods of
diagnosis; clinical diagnosis and treatment; and
stroke differential diagnosis.
Cerebral hypoxia; cerebral metabolism; blood coagula-
tion and thrombosis; cerebral hypertension; diagno-.
sis and treatment; and cerebral angiography.
Cerebral metabolism; cerebral atherosclerosis and in-
farction; improved~ methods of clinical diagnosis,
treatment; cerebral blood flow; cerebral angiography;
and intensive care methodology.
PAGENO="0314"
CEREBROVASCULAR (STROKE) CENTERS-CURRENT STATUS, MAY 1, 1972-Continued
Title and insitutioin Program director Professional and scientific staff
University of Tennessee Cerebrovascular Re- Francis Murphy, ~ Murphy, Francis, professor of neurological surgery; Pitner,Samuel,
search Center, University of Tennessee, assistant professor of neurology; Robertson, James, associate
Memphis, Tenn. professor of neurosurgery; Utterback, Robert, professor of neu-
rology; Martinez, Julio, associate professor of neuropathology;
White, Richard, associate professor of neuropharmacology;
Friedman, Ben, professor of radiology; Harris, James, research
associate; Dugdale, M., associate professor of hematology;
Desaussure, R. L, clinical associate; Wood, R. W., clinical
assistant; Durst, Dana, technical assistant in hematology; Beach,
Gail, executive secretary of neurosurgery; Johnson, Marion W.,
research assistant.
Cerebral Vascular Disease Clinical Research Mark L. Dyken, M.D Dyken, MarkL, professor of neurology; Kolar, Oldrich, associate
Center, Indiana University, Bloomington, professor of neurology; May, James H., assistant director for
Ind. aimisiatration; Fitzougri, Kat-il sel, nsunpsych lugist; Crnall,
Karen, chief research; Easton, Joyce, assistant chief, research
nurse; Marie, Fred, research nurse; Shako, Patricia, research
nurse; Young, Barbara, research nurse; Qillin, Virginia, re-
search nurse; supporting staff: 5.
An interdisciplinary stroke program, Wash- William M. Landau, M.D Landau, William M., professor of neurology; O'Leary, James L.,
ington University, St. Louis, Mo professor of neurology; Schwartz, Henry G., professor of neuro-
surgery; Goldring, Sidney, professor of neurosurgery; DoJge,
Philip, R., professor of pediatric neurology; Potchen, E. James,
professor of nuclear medicine; Fletcher, Anthony, professor of
medicine; Alkjaersig, Norma, associate professor of medicine;
DeVivo, Darryl, assistant professor of pediatrics; Zarkowsky,
Harold, assistant professor of pediatrics; Hochmuth, Robert,
assistant professor of physhlogy; Brooks, John, assistant pro-
fessor of neurology; Eliasson, Sven, professor of neurology;
Klinkerfuss, George, associate professor of neurology; Chesanow,
Robert, assistant professor; Hardin, William, assistant professor
of neurology; Heilbrun, Peter, instructor of neurology; Ter-
Pogossian, M., ~orofessor of radiology; support,ng staff: 6.
Areas of emphasis
Cerebral hypertension; cerebral infarction and ath-
erosclerosis; blood coagulation and thrombosis;
clinical diagnosis and treatment; and surgical treat-
ment of stroke.
Cerebral hypertension; cerebral infarction; speech
~erapy; cerebral atherosclerosis; blood coagulation
tsronbosis; controlled clinical trials; and evolution
of cosim~nity prevention programs.
Blood coagulation and thrombosis; cerebral infarction
and atherosclerosis; clinical diageosis treatment;
cerebral hypertension; intensive care development;
controlled clinical trial; brain blood flow; cerebral
hypaxia; and stroke in children.
CAD
PAGENO="0315"
Cerebrovascular Clinical Research Center, Erland Nelson, M.D Nelson, Erland, professor of neurology; Merlis, Jerome, professor Clinical diagnosis, treatment; cerebral hypertension;
University of Maryland, Baltimore, Md. of neurology; Heck, Albert F., associate professor of neurology; epidemiology; cerebral infarction; cerebral athero-
Mayer, Richard, professor of neurology; Price, Thomas R., assist- sclerosis; stroke prevention; diagnotic instrument
ant professor of neurology; Sutton, Granger, assistant professor tion; and intensive care development.
of neurology; Mosser, Robert, assistant professor of neurology;
Toro, Rodrigo, assistant professor of neurology; Law, William,
professor of internal medicine; Kawamjra, Junichiro, research
associate; Robbins, Solomon, instructor; Rennels, Marshall,
associate professor; Kamijyo, Yoshinari, research associate;
Scherlis, Leonard, professor of cardiology; Borges, Francis J.,
director of medical services, Montebello State Hospital; Work-
man, Joseph, associate professor, radioisotopes division; En-
twisle, George, professor and head, department of preventive
medicine; Henderson, Maureen, professor and head, physical
medicine; Richardson, Paul, professor and head, department
of physical medicine; Garcia, Julio, professor neuropathology;
Wagner, John, professor of neuropathology; Mclaughlin, Joseph,
associate professor of surgery; Attar, Safuh, associate professor
of surgery; Richards, Richard D., professor of ophthalmology;
Murphy, Marion, professor and dean, school of nursing; Hears,
John, professor of radiology; supporting staff: 9.
Cohen, Maynard M., professor of neurology; Klawans, H. 1., Jr.,
Cerebrovascular Research Center, Rush- Maynard Cohen, M.D associate professor of neurology; Hartmann, J. F., director, Cerebral metabolism; cerebral hypoxia; cerebral hype-
Presbyterian-St. Luke's Medical Center, neurobiology; Harrison, W. H., associate professor; Patel, K., tension; control of cerebral circulation; diagnosis and
Chicago, Ill. electron microscopy; Whisler,W. W., neurosurgeon; Waxman,J., therapy; intensive care.
neurologist; Simon, R. G., neurochemist; Davis, F. A., assistant
professor.
Cerebrovascular Disease Research Center, James H. Halsey, M.D Halsey, James H., professor of neurology; Galbraith, J. G., professor Cerebral infarction; cerebral metabolism; diagnosis,
University of Alabama, Birmingham, Ala. of neurosurgery; Little, Samuel C., professor of neurology; treatment; cerebral hemorrhage; cerebral hyper-
Wilson, Edwin M., associate professor, school of engineering; tension; stroke monitoring techniques; and surgical
Bridgers, William F., professor of pediatrics; Ceballos, Ricardo, treatment of stroke.
associate professor of anatomical pathology; Nichols, Lane,
graduate student, department of engineering biophysics; Oh,
Shin Joong, assistant professor, division of neurology; Dmar,
Hassen Mohamed, research assistant, division of neurology;
Rao, Nagbhushan S., assistant professor, division of neurology;
Vitek, Jiri, assistant professor, department of diagnostic radiol-
ogy; West, Seymour, professor and chairman, department of
engineering and biophysics; Witten, David I., prosessor and
chairman, department of diagnostic radiology; supporting
staff: 5.
Epidemologic Research on Stroke, University Warren Winkeistein, Jr Winkelstein, Warren, Jr., professor of epidemiology; Syrne, Risk factors; hypertension; blood lipids; transient
of California, Berkeley, Calif. Leonard S., professor of epidemiology (statistics); Nichaman, ischemic attack; diet and stroke; social and psycholo-
Milton Z., assistant professor of neurology; Paffenbarger, Ralph gical factors in stroke; and genetic factors in stroke.
S., professor of epidemiology; Gay, Michael; Treiman, Beatrice;
supporting staff: 7.
PAGENO="0316"
NATIONAL COOPERATIVE STUDIES
lnsitutions Coordinating center Description
COOPERATIVE STROKE-HYPERTENSION STUDY
Dr. Karleen Neill, University of Mississippi School of Medicine,Jackson, Miss.; Dr. Edward S. Cooper, Philadelphia Dr. Sibley W. l4oobler, University of Michi- A study of the effect of lowering elevated
General Hospital, Philadelphia, Pa.; Dr. Walter J. Brown, Jr., Medical College of Georgja,Augusta, Ga.; Dr. Elbert gan Medical Center, Ann Arbor, Mich. blood pressure as a preventive against
Tuttle, Emory University School of Medicine, Atlanta, Ga.; Dr. William T. McLean, Department of Neurology, second strokes.
Bowman Gray School of Medicine, Winston-Salem, N.C., Dr. David W. Richardson, Virginia Commonwealth Uni-
versity, Richmond, Va.; Dr. Raymond B. Bauer, Wayne State University, Detroit, Mich.; Dr. Erland Nelson, Uni-
versity of Maryland, Baltimore, Md.; Dr. Samuel E. Pitner, University of Tennessee Coil ege of Medicine, Memphis,
Tenn.; Dr. MiltonG. Ettinger, Hennepin County General Hospital, Minneapolis, Minn.
ACUTE TREATMENT OF RUPTURED INTRACRAN1AL ANEURYSMS
Dr. Marshall B. Allen, Jr., Medical College of Georgia, Augusta, Ga.; Dr. Edwin B. Boldrey, University of California 5Dr. A. L. Sahs, University of Iowa, Iowa 1. A controlled clinical trial to validate the
- School of Medicine, San Francisco, Calif.; Dr. Guy L. Odom, Duke University Medical Center, Durham, N_c.; City, Iowa. best methods of treating cerebral hem-
Dr. Robert R. Smith, University of Mississippi Medical Center, Jackson, Miss.; Dr. Alexander T. Ross, Indiana orrhage.
University Medical Center, Indianapolis, Ind.; Dr. Kenneth Shulman, Albert Einstein College of Medicine, 2. Clinical trial of drugs to prevent further
Bronx, N.Y. bleeding during first 10 days following
- a hemorrage.
PAGENO="0317"
311
Dr. BAI~ER. Could one make the point that we are not trying to be
competitive. There is no, question that prevention of vascular disease,
prevention of hypertension, prevention of atherosclerosis, and ahno~t
certainly prevention of thrombosis is going to be the heavy col~cern
of your new institutes covered in this legislation. It is an u~nbe1ievth1y
important thing. I believe, however, that the Heart Institute does not
have the background training or even the interest to meet the stroke
problem. I think this is really the issue that I would like to present.
Mr. ROGERS. Thank you very much. Your testimony has been most
helpful. Thank you for being here.
T)r. BAKER. Thank you.
Mr. ROGERS. Our next witnesses are Dr. Frank Oski and Mr. Leonard
Riccio. We appreciate your appearance with the committee. We are
delighted to welcome you here. We will be pleased to receive your
testimony.
STATEMENT OP LEONARD RIOCIO, POUNDER OP "TOMMy PIJND,"
NORRISTOWN, PA.
Mr. Riccio. Mr. Chairman, members of the committee, I don't feel
as though I have too much to offer except to say that just a year and
a half ago we started a campaign to raise funds for the Children'S
Hospital in Philadelphia in blood research. We realized at the time
that to raise funds is a backbreaking job without too many results.
We have managed to raise $5,000 or $6,000 in this past year and the
results, because we have no restrictions on the way the research has
used the money outside of the fact that it should be done in blood re-
search, have been fantastically good. We feel that the best approach
is to come before the Government. When this bill came about we felt
it would be good for our needs. We have petitions amounting to 10,000
to 15,000 names that have been gathered these past few months. I pre-
sent these to the committee.
Mr. ROGERS. Thank you. They will be made part of our file.
Mr. Riccio. Thank you, sir.
Being just a layman, I don't have too much to offer the committee
in constructive criticism of any type. So I will refer the bill to the
doctor.
Mr. RoGERs. Let me say on behalf of the committee that we appre-
ciate your interest as a citizen who has been willing to get out and do
something. That is what will help us get results. We appreciate your
being here today and giving us the names of all of these people wh~
are behind you in the drive to do something.
Mr. Riccio. Thank you.
STATEMENT OP DR. PRANK OSKI, CHIEF OP HEMATOLOGY,
CHILDREN'S HOSPITAL, pHILADEL1~KIA, PA.
Dr. OsKI. Thank you, Mr. Chairman.
I would like to echo the sentiments of many of the other witnesses
and congratulate you on the formulation of this bill. I think it is going
to do a lot for a lot of people. My only concern is that although in the
initial statement the purpose of the bill, blood and blood diseases, seems
to rank equally with the heart and lung, I am concerned, in that I am
PAGENO="0318"
312
afraid that in the spelling out of the precise proposals of the bill, blood
has been spilled, or lost somewhere along the way, and I don't want
to see ll.R. 13715 become `anemIc as a consequence of it.
I specifically refer to sections 4~3 (c) (2) and 415 (a) where we talk
about establishment of centers. In neither of those sections is any
mention made of establishing similar centers for the study of blood
and blood diseases.
I would like to propose that a like number of centers be described
for the primary study of blood. I am sure that you are quite `aware
that there is some fragmentation in this area already. Centers are now
in the process of being established for the study of sickle-cell anemia,
which is a blood disturbance. Cancer centers will concern themselves
with `a blood disease-leukemia. Some thought must be given to how
this is going to overlap or integrate with the establishment of centers
for blood disease.
I would also like to suggest that in the establishment of the centers
some real charge be given to the scientific organizations responsibh~
for the establishment of these centers, that not all the funds be spent
on research alone, and that `a significant proportion of the funds are
used for patient Services as well as education.
Many times the funds are spent wisely for education of physicians
but the public education is left undone. Certainly in many, many of
these centers patient services have `a very low priority. I don't think
that we can justify that kind of funding and spending of Government
money in the future.
I think that also some concern should be given to the geographic
placement of these centers, and some suggestion made by your com-
mittee along those lines. Unfortunately, in these circumstances the
best places can continue to get them and concentrations are in the
northeastern part of the country and maybe on the west coast, and
three-quarters of the country is disenfranchised as a consequence of
this. We would Tike to see some attention paid to that.
I also would like to support Dr. Barbero's statement this morning
that pediatrics be included. They certainly have an interest not only
in the area of lung diseases and cardiac heart disease but certainly
blood disease. as well.
If we think in actuarial terms alone, we talk about extending the
average life as stated in this bill by 11 years by salvaging people with
heart disease and stroke. And I know that as we get older that may be a
more pressing concern to us, but if you think in terms of the things
that can be salvaged in terms of directing attention to children, you
have 65 years or more every time you salvage a child's life and there
are approximately 5,000 children a year who are dying from blood
and blood related disorders, not to say anything about the quaTity of
life in those children afflicted with chronic disorders such as hemo-
philia which we have the canacitv to treat and keep the child free of
all difficulty, given the funds and manpower to do it.
These are only small items. I do want to again compliment you on the
bill and I support i~, with the reservations that I have made.
Mr. ROGERS. Thank you so much, Doctor. We appreciate this testi-
mony. We are very grateful to both of you for taking time to come
and let the committee have the benefit of your thinking.
PAGENO="0319"
313
Dr. OsKI. Thank you.
Mr. ROGERS. I believe this concludes the witnesses for today, and for
this hearing. Therefore, the committee will stand adjourned.
(The following statements ~nd letters were received for the record:)
STATEMENT OF FREDERIC GERARD BURKE, M.D., PROFESSOR OF PEDIATRICS,
GEORGETOWN UNIvERsITY
Mr. Chairman and members of the subcommittee, my name is Dr. FrederiC
Gerard Burke. I api a professor of Pediatrics at Georgetown University, project
director of the Pediatric Pulmonary Center and was a member of the flr~t
National Advisory Council of the Institute of Child Health and Human Develop-
ment. I am particularly concerned with the matter of chronically handicapped
children and their families and as a pediatrician have spent the past 25 years
observing and treating childhood diseases and their consequences in later life.
I am honored to appear before this conunittee to submit further testimony to
support H.R. 13715 and in particular the provision that would expand and sup-
port the national attack on diseases of the lung.
The problem of chronic pulmonary diseases in children is of such a major pro-
portion that it can only be met by a concerted national effort and this thrust
should be led by an expanded authority for the National Heart & Lung Institute.
Severe lung disease begins in the newborn period as acute respiratory distress
syndromes and in the first few days of life accounts for more loss of life than
any other cause. The relatively high newborn mortality rate in this country com-
pared to other nations finds its major basis in pulmonary failure.
During the 1966-1967 school year, of the 171 million days lost from school by
children ages 6 thru 16, 57% were due to respiratory diseases. The figures on
death and illness show beyond question that the severity of this problem and the
costs-to the children, their `parents and the nation are incalculable.
There is good evidence to indicate that the high incidence of pulmonary dis-
eases in infancy and early childhood are all closely related and may well repre-
sent a time-biologic continuum. Acute Respiratory Distress Syndrome is a clini-
cal manifestation Widely recognized by the physician which appears in later in-
fancy and childhood as bronchiolitiS, croup, bronchitis, asthma, the chronic
asthma-emphysema complex and cystic fibrosis. While the etiologic factors and
cellular responses of these medical entities may vary, they all have several effects
in common and need elucidation and clinical research. Air hunger and difficulty in
breathing are common and frequently noted among respiratory patients. Oifr
medical students, physicians, nurses and technicians need to be taught the best
methods of treatment in the control of these crippling conditions. In addition,
programs of parent education are extremely important in teaching the family
how to deal with life threatening episodes of pulmonary distress as well as help-
ing in the rehabilitation of these children.
I must again point out that the effects of severe lung disease in the early part of
life leave scars and dirty fingerprints that steal from the individual his pulmo-
nary reserve. Chronic pulmonary disorders in early and middle adult life fre-
quently have their onset in childhood.
Chronic asthma, for instance, is a potentially preventable disease which fre-
quently extends into adult life. About 20% of all children manifest hayfever,
eczema or asthma, and a common mechanism of causation for these conditions
is indicated by the fact that one readily merges into the other. Recurrent respira-,
tory insults to fragile bronchial and aveolar tissues can and may result in the
atrophy and thinning of airway walls, thus permitting the eventual collapse of the
pulmonary tissues as is seen in pulmonary fibrosis and emphysema. Air pollu-
tants, chemical and infectious agents may cause destruction of the hair-like cilia
losing the ability to propel foreign matter from the respiratory tract. This would
permit the accumulation of toxic or irritative material from polluted air tb~ough-
out the tract causing additional damage to the impaired lungs. However, the in-
terrelationship of childhood respiratory diseases with potential loss of pulmo-
nary reserve in adult lung disease needs further elucidation. Interaction of adult
with pediatric pulmonary disease units must be encouraged in order to obtain this
information, particularly since it is emminently clear that the best way to treat
the crippling effects of adult lung disease is to prevent it.
The Georgetown University Pediatric Pulmonary Center was established in
1969 and in addition to undertaking several training programs, developed a com-
PAGENO="0320"
314
puterized registry for patients with chronic lung disease, a model respiratory
data bank. Utilizing a shared-time computer, four hospitals in the Washington,
D.C. area were tied together by teletypewriter~ to share vital information regard-
ing severely ill children who had chronic respiratory diseases.
Patient information shch as physical findings, case history, diagnosis and de-
tails of past treatments are recorded and stored in a computer for "on-line," rapid
retrieval by any physician at the time of the next visitation to the Emergency
Room or admission to any of the four hospitals. It was planned to carry on this
registry into adult life and thus provide a time-span study of patients from
childhood into adolescence and adult life. Aiiy number of hospitals could easily
be brought into this system not only in the Washington area but anywhere in
the country. The feasibility of a unified computerized was demonstrated not only
in these four hospitals but also from coast to coast.
TlUs system could easily be utilized by all pulmonary centers as they are
established.
~ 13715 proposes to establish fifteen new centers for clinical research, train-
ing and demonstration of advanced techniques in treatment of chronic pulmonary
diseases in children. There are some 7 million involved children and their families
that stand in great need for this commitment. In terms of national purpose and
need this is a medical challenge of the seventies which up to now has been virtually
Ignored. The passage of this Bill would enhance the possibility of great strides and
hopes for success to conquer the ravages of this challenge.
STATEMENT or ROBERT E. LONG, ON BEHALF OF THE NATIONAL HEMOPHILIA
FOUNDATION
Gentlemen, I am Robert E. ;Long of Buffalo, New York, and a member of the Ex-
ecutive Committee of the National Hemophilia FOundation. I am grateful for the
opportun~y to submit a statement on `behalf of the National Heart, Blood Vessel,
Lung and Blood Act of 1972 (H.R. 13715). I wish also `to commend the Chair-
man of the Subcommittee on Public Health and Environment, Representative Paul
0. Rogers, as well as the members of the Subcommittee for their leadership in
developing a program designed to save the lives of thousands of Americans each
year.
We are particularly concerned with advancing research into the cause and cñre
of hemophilia, which is one of the oldest diseases known to mankind-a disease
of genetic origin with a rapid rate of mutation. More than thirty percent of
bemophiliacs are "new" hemophiliacs with no prior family history of the disease.
Various medical authorities have estlihated that there are approximately 100,000
hemophilie patients in the United States today, of which some 15,000 to 20,000 are
severely enough involved `to require continuing and continuous medical care. Medi-
cal advances are providing the materials for replacement of the missing clotting
factor in the patient but this material is still extremely costly. Research is needed
to develop methods for producing the clotting factor more efficiently and cheaply,
or to develop a synthetic factor capable of absorption in the human system.
The children being born today need never become crippled or undergo the
severe pain and bleeding common to this disem~se if they can be treated on a
preventive or prophylactic basis. In the past ten years, there has been a marked
increase in blood product utilization by hemophiliacs and the Foundation has
been one of the leading advocates of the concept of "component therapy". Very
simply, this means that a unit of blood is fragmented and its parts distributed
according to specific medical needs: a hemophiliac requires only a portion of
the plasma, the leukemlc utilizes `the platelets and surgical patients might use
the whole red cells.
Our organization is particularly interested in the section of H.R. 13715, Sec.
418, under (8): "Establishment of programs and centers for study and research
Into cardiovascular, pulmonary and blood diseases of children, including cystic
fibrosis, hyaline membrane and hemolytie and hemophilic diseases and for the
development and demonstration of diagnostic az~d preventive approaches ~f these
diseases".
In many of the specialty clinics treating hemophiliacs, programs of a limited
nature have been initiated, fop "home therapy". At the onset of a bleeding epi-
sode, the patient may give himself an infusion of the necessary blood component
to control both pain alid bleeding. This can be done at home, at work or at
PAGENO="0321"
315
school. Preliminary eyidence shows that home treatment cuts down on absentee-
ism fror~ school and from work `and results in fewer days in hospital. PrQg-.
nosis for effective control of the disease is therefore quite favorable. But more
knowledge and information on a national basis is badly needed. Demonstra-
tion programs on a much broader basis will have to be carried out to produce the
necessary data on this method of treatment, as well as the cost factors involved,
Perhaps no area of public health can be investigated with such minimal funding
in order to produce such dramatic and effective results.
Again we commend the Chairman and the members of the Subcommittee for
their vision in drafting this important health legislation and we earnestly plead
that sufficient funds will be allocated for its immediate implementation.
EXECUTIVE OFFICE OF THE PRESIDENT,
OFFICE OF SCIENCE AND TECHNOLOGY,
Washington, D.C., April 28, 1972.
Hon. PAUL G. ROGERS,
Chairman, $ubcommittee on Public Health and Environment, Committee on
Interstate and Foreign COmmerce, House of Representatives, Washing-
ton, D.C.
DEAR MR. CHAIRMAN: I understand that during the hearings on H.R. 12308 you
expressed some interest in the health-related aspects of the work of the Office of
Science and Technology (OST). Dr. Leonard Laster, my Assistant Director for
Human Resources, has submitted our comments through Dr. John Zapp of I~EW,
but I would like to take the occasion to communicate with you personally. In ad-
dition to serving the President as his Science Adviser, I am concurrently Director
of the OST and Chairman of the President's Science Advisory Committee. My con-
cerns do indeed encompass the scientific and technical aspects of health and
medicine. My Assistant Director for Human Resources is a physician with a
background both in clinical medicine and biomedical research. His responsibilities
include research and development related to delivery of health services, bio-
medical research, environmental health, health effects of regulatory diseases, oc-
cupational health, and narcotics. rrhe staff of the OST Human Resources Group
has two additional physicians who work with the Assistant Director.
Also, the OST has a roster of medical experts who serve as health consultants
and who provide advice primarily by participating in panel studies of specific
areas. There are 48 such consultants working on such subjects as: Health Serv-
ices R&D, Biomedical Research, Research Manpower, and Chemicals and Health.
The membership of the President's Science Advisory Committee includes one
physician and two biomedical scientists. They participate in the work of the
entire committee and also work with the OST consultants on the panels noted
above.
As Dr. Laster indicated in his memorandum to Dr. Zapp, some months ago at
my request he explored the nature of the opportunities for productive biomedical
research in the field of aging and, together with HEW, prepared a paper in which
a series of potential research initiatives were laid out. Our' office undertakes
studies of this type in various areas related to health care and biomedical
research and if you would be interested in any further discussion of our work,
I would be delighted to meet with you for that purpose.
Sincerely,
EDWARD E. DAVID, Jr., Director.
NASHVILLE, TENN., May 9, 1972.
Hon. PAUL ROGERS,
house of Representatives,
Washington, D.C.
DEAR CONGRESSMAN RoGERs: As President of the American Association of
Neurological Surgeons, spokesman organization for neurological surgery in the
United States, I should like to solicit your consideration for the continuation of
the problem of cerebrovascular disease and stroke to be included in the National
Institutes of Neurological Diseases and Stroke rather than to be moved to the
Heart and Lung Institute.
There are several very cogent reasons that would make this an important
decision. First of all, stroke affects the human brain and central nervous system,
and in the field of neurology and neurological surgery, individuals knowledg&
able and interested in the physiology and function of the central nervous system
78-994--72-----21
PAGENO="0322"
316
are the appropriate individuals to investigate and to carry out research regarding
the effect of stroke and its prevention on the human brain. Obviously those with
special interests in this area are the ones most capable of carrying out such
pursuits.
Secondly, in the mind of the lay public as well as in the profession, patients
so afflicted with stroke have deficits in the central nervous system perfortuance
that immediately implicates the brain and central nervous system to a degree
that wpuld make it obvious that specialists `in heart and lung disorders would be
somewhat alien to this particular clinical disorder.
Third, research in the problem of stroke involves knowledgeable appreciation
Of neurophysiology, neuroanatomy, and the micro~circulation of the brain, all
of which is under scrutiny and investigation by those individuals related to the
/ neurological sciences such as neurophysiologjstfl, neurologists and neurosurgeons.
It would seem to me that this would be a very unfamiliar and alien field `to the
specialists in cardiology and pulmonary physiology. And finally, the management
of the clinical problems of those individuals victimized by stroke woujd best be
handled by those concerned in their daily practice with central nervous system
deficits. It would therefore seem to be inappropriate to consider removing the
problem of stroke from the National Institutes of Neurological Diseases and
stroke to any other agency, and I write this letter to indicate to you that in my
personal opinion, and very likely in those of all the members of our organization,
such a move would be ill-advised.
With my best wishes, I remain
Yours most sincerely,
WILLIAM F. MEAOIXAM, M.D.,
President, American Association of Neurological Surgeons.
THE AMERICAN DIETETIC ASSOCIATION,
Chicago, Ill., May 5, 1972.
Hon., PALrL 1. ROGERS,
Chairman, Subcommjjttee on Public Health and Environment, Committee on
Interstate and Foreign Commerce, U.S. House of Representatives,
Washington, D.C.
DEAR MR. CHAIRMAN: I am writing on behalf of The American Dietetic
Association in support of HR. 13715 that would strengthen and expand the
research and research training programs of the National Heart and Lung
Institute.
Although we recognize that there is a relationship between diet factors and
cardiovascular disease we also recognize the need for both basic research on
the relation `of diet factors to prevention of cardiovascular heart disease and
research related to the u'se of modified diets in treating patients with diagnosed
disease. Man.y investigations have been reported on the controversial `subject
of the relationship of dietary factors ~to the prevention and treatment of cardio-
vascular heart disease. Some researchers contend that the experimental evidence
available supports recommendations that major changes should be made in diet
patterns for the entire population of our country. Others believe that existing
evidence to support major dietary changes to curb heart disease is poor and
that no cause and effect relations'hip between specific dietary facto'rs and heart
disease has been definitely established. Both scientific objectivity and reliable,
valid research evidence is urgently needed in this important area which con-
cerns human welfare.
Phe dietitian should be funded to `do research on an individual basis and as
an integral member of the clinical health teams investigating problems related
to heart disease. Monies should be `made available to duly qualified nutritionists
for `basic research with `diet as the variable. `Monies should also be made avail-
able for research by dietitians on the bes't way to incorporate dietary modifica-
tions into the life patterns of `the American people. Likewise, dietitians `should be
involved in development and modification `of foods and recipes `to incorporate
recommended dietary alterations for use by patients, the food industry and the
rood service industry. Furthermore, `dietitians should be actively participating
in the process of communication `to the public, `through all appropriate media,
the knowledge and motivation required to `achieve optimum nutrition for preven-
tion and treatment of heart disease.
We recommend that `the funds available `for the training and `education of re-
search personnel include support for the graduate training of `dietitians to pro-
PAGENO="0323"
317
vide the professiona~I personnel necessary to perform research.
May I respectfully reQuest that this letter be made a part of the printed record
of hearings.
With best wishes, I am
Sincerely,
KATHARINE MANCHESTER, R.D.,
Presi (lent.
AMERICAN MEDICAL AsSocIATIoN,
Chicago, lU., May ~, 1972.
lion. PAUL G. Rooirns,
Chairman, Subcommittee on Public Health and EnvIronmcnt,
House of Representatives,
Washington, D.C.
DEAU~ REPRESENT4TIVE Rooms: We are pleased to submit our views on JIlL
13715, the National Heart, Blood Vessel, Lung, and Blood Act of 1972, presently
pending before your Subcommittee. The expressed intent of this bill is to en-
large the authority of the National Heart and Lung Institute to advance the
national ttttack upon the diseases of the heart and blood vessels, the lung and
blood. These diseases are in the forefront in terms of the devastating effect they
have upon the lives and well-being of our people. An intensified and augmented
national effort for research concerning these diseases ~s highly desirable so that
we may increase our ability to pi~ovide preventive, therapeutic and rehabilitative
measures for our patients. Thus, we support an expanded national research
program, such as proposed in H.R. 13715, and in doing so, we shall offer recoin-
mendations for modification to the bill.
Under HR. 13715, the expanded research program is based iu the National
Heart and Lung Institute, in NIH. The Director of the National Heart and Lung
Institute is directed to prepare a plan embracing a multi-faceted approach, but
a coordinated one, to foster research in the various diseases named. We are
pleased that while a coordinated and concentrated attack is centered in the Insti-
tute, the legislation, as we understand it, retains an overall coordination of all
basic research in the Institutes under the Director of the National Institutes of
Health. This will be particularly important since some aspects of research into
the named diseases do take place in other Institutes. In the interests of the most
effective accomplishment of our goals, we believe that this central coordination
should continue, under the general direction of the Director of NIH.
Under section 415 of the bill, in subsection (a), new research centers are au-
thorized, fifteen for heart disease research, and fifteen for lung disease. In
addition, under subsection (b), cooperative arrangements are also authorized for
the support of existing or new centers (including but apparently not limited to
the thirty above). In an expanded research program it may well be necessary
to create new centers, but we believe it is important that there be expressed an
overall limitation in the number of new centers. We recommend that you do SO.
Our nation's research efforts, from which can come major benefits, should not
be diverted by heavy construction expenditures or general treatment programs.
Within the next few years we believe that thirty new centers (fifteen for heart
disease and fifteen for lung disease, but including in such total. all new centers
authorized under subsection (a) or (b) of section 415 or otherwise under the
bill) should afford an adequately based research program, and we recommend
that. the bill be modified accordingly.
Opportunity for continuous review by the President and the Congress of the
program's progress, measured against the nation's future needs, is provided ifi
section 413(b) (2) directing the submission of such reports by the Director or the
Institute. This will afford a ready opportunity for further Congressional action
if additional support for centers is shown to be warranted. For the same reasons,
we recommend that the five-year periods of support for the cooperative arrapge-
ments be reduced to three years. As this Committee so clearly expressed its in-
tent of limited patient care in the centers provided for in the recently enacted
cancer legislation, we believe it is beneficial that you reiterate this intent with
equal specificity in any Report on HR. 13715, namely that demonstrations and
patient care should be provided only as required for research purposes. The
Institute functions should not include patient care, treatment or demonstrations
unless directly tied in and required for research. The major lasting benefits
PAGENO="0324"
318
from the proposed program will come from progress in researcth activities, Un-
diverted by general treatment programs,
We also call to your attention some overlap in this legislation with Regional
Medical Programs. While research is basic to NIH, general aspects of education,
training, and demonstrations for heart disease, etc., are properly within RMP.
Thus, while the development of new basic research information can be expected
within the NIH, the dissemination of information on new techniques to practicing
physicians, through various educational means~ including demonstrations, is the
undertaking of RMP. We believe a clear expression should be made for research
in NIH, limiting patient care and demonstration to research needs, and provid-
ing for education, training and demonstrations through RMP. I~ preservation
of the value and integrity of both programs, we urge the deletion of section
413(a) (4) and (7) of H.R. 13715 providing for programs and centers for studies,
large scale testing and evaluation and demonstrations, as well as for professional
training relating to all aspects of cardiovascular~ pulmonary and blood diseases.
For your consideration of other bills before the Committee, we also recommend
that provisions such as in 5. 3323, passed by the Senate, for the creation of
ten new model cardiovascular disease prevention clinics should not be adopted.
We believe that appropriate purposes of suph clinics can be carried out through
existing centers or the thirty new ones authorized under H.R. 13715, as well as
through Regional Medical Programs. In addition, we believe any program for
emergency medical care in (5. 3323) should not be adopted in NIH legislation, but
should be considered as a part of a separate legislative proposal for development
of comprehensive emergency medical care services.
With the modifications we have proposed, which we believe will strengthen
a concentrated research effort in NIH, we support HR. 13715. The proponents
of this legislation, members of this Subcommittee, are to be commended for their
contribution to this vital national research effort for the introduction of this
bill. Too, the Administration has demonstrated its support for an expanded pro-
gram through requests for increased research funding for these diseases.
Physicians welcome and support this renewed effort to seek relief from the
toll in suffering and in lives imposed by these diseases.
We appreciate this opportunity to submit our views on this important legis-
lation, and we respectfully request that these comments be made a part of the
hearings on H.R. 13715.
Sincerely,
FIRNEST B. HOWARD, M.D.,
Ewecutive Vice President.
THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICERS,
Washington, D.C., May 15,1972.
Hon. PAUL C. ROGERS,
Chairman, th~bcommittee on Public Health and Environment, Committee on
Interstate and Foreign Commerce, UJ~. Honse of Representatives, Washing-
ton, D.C.
DEAR Ma. CHAIRMAN: I am writing on behalf of the Association of State and
Territorial Health Officers with respect to H.R. 13715 that would strengthen and
expand the activities of the National Heart and Lung Institute.
I knOW that I do not have to remind you that the Public Health Service previ-
ously administered outstanding programs In the field of chronic disease control.
These programs were abolished by the Partnership for Health Program which has
never been funded at an adequate level. Perhaps the major loss of that legislation
was the abolition of Federal leadership in the fields of control programs for such
diseases as cancer and heart disease. ASTHO strongly urges that the proj~ct
grants for the control of heart and lung diseases be located at the Center for
Disease Control, the focal point in the Department fo~ disease control programs.
State Health Departments are the official agencies charged by law with the
responsibility for heart and lung disease control programs. State Health Depart-
ment programs in these areas are many and varied, ranging from throat culture
programs for the prevention of rheumatic fever through coronary prevention
clubs for primary prevention of coroilary heart disease, to smoking cessation
clinics for the reduction of chronic obstructive pulmonary disease. Health De-
partments are the primary national resource for delivery of disease control pro-
grams at the community level and are also the major source of technical and
professional talent and experience in this field. Because of this established
PAGENO="0325"
319
capability and recognized role in community health care delivery, Health Depart-
ments should be heavily involved hi any ~ederal grant program for heart and
lung disease control. Health Departments should be given an opportunity for
meaningful input into the legislation and regulations governing tl~is area. Fur-
thermore, Health Departments should be given the primary responsibility for
the coordination of Federally funded heart and lung disease control programs
at the State level to avoid excessive fragmentation of effort an'd duplication of
activities.
On behalf of the Association, I urge that you give careful consideratiott to
these recommendations and ask that this letter be included as a part of the
printed record of hearings.
Sincerely,
IRA L. M~rzns, M.D., President.
ALBERT EINSTEIN COLLEGE OF MEDICINE
OF YESHIVA UNIvEasIvY,
Brona,, N.Y., May 3, 1972.
Hon. PAUL G. ROGERS,
House of Representatives,
Washington, D.C.
DEAR Sin: I have been very upset to learn that there is discussion about trans-
ferring responsibility for research in cerebrovascular disease and strokes from
the National Institute of Neurological Diseases and Stroke to the National Heart
and Lung Institute. I feel that I can express an especially informed opinioli
about this, since I have been concerned with the care of patients with strokes
and with the teaching of medical students and residents about these diseases
for seventeen years. Also, I have served as a consultant to NINDS on stroke
projects for three years, but I am not personally a recipient of such a grant
and I am not biased by any potential loss of government support to myself or
my department. There is, of course, no doubt that if the Heart and Lung In-
stitute developed methods to prevent arteriosclerosis, hypertension, and clotting
diseases, ninety-five percent of strokes would disappear (the remainder being
due to congenital anomalies). However, this millenium is not at hand, and during
the next several decades, we must deal with the disease itself. The cerebrovascu-
lar system and the organ it supplies, the brain, differ markedly ~from vascular
systems and target organs elsewhere. The cerebral circulation is unique in that
it is primarily controlled by the needs of tile brain, leading to a form of auto-
regulation not seen in other tissues. The transport of materials betwe~n the
blood and the brain is unique in that the cells in the brain capillary wall form a
continuous sheet that precludes the usual transfer of materials across it, so that
except for simple diffusible molecules such as gases and water, other materials
are transported into the brain by specialized chemical processes, the nature of
which is just beginning to be understood. The brain, of course, is unique in its
sensitivity to deprivation of oxygen. It is unique in the readiness with which it
swells as the result of tissue injury. Even the nature of the arteriosclerotic and
hypertensive diseases in cerebral vessels is different than in other parts of the
body. For example, a common form of "small stroke", the transient isehemic.
attack, is often due to showers of platelet emboli thrown from an arteriosclerotic
plaque at the origin of the internal carotid artery. Subarachnoid hemorrhage is
due to a form of aneurysm that is different in nature from aneurysms seen else-
where in the body.
Information abc~ut all of these points that I have raised has markedly in-
creased during the past seventeen years, and almost all of the advances have
been due to careful observations by neurologists, neurophysiologists, and others
working with cerebral blood flow, cerebral metabolism, and cerebrovascular dis-
ease. Moreover, substantial advances in therapy have at last begun to occur.
When I first entered neurology, four-fifths of the patients who had subaracinnuld
hemorrhages due to aneurysms were certain to die from their initial bleed or
a rebleed within a year. With the addition of the operating room microscope,
the neurosurgical ~pproach to intracranial aneurysms has so improved just with~
in the past few years, that this figure has now been reversed. The neurosurgical
approach to intracranial thromboses is just beginning and should yield similar
advances. Meanwhile, our understanding of the events taking place fol~owing
PAGENO="0326"
320
strokes has moved to the point where we are b~ginniflg to find ways of salvaging
some patients and redm4ng the amount of tissue damage in others. The people
professionally devoted to this problem `are nettrologists, neurosurgeons, neilro-
pby5iQlogists, and neurochemists. It would, in my opinion, be a disaster at this
time to disrupt this work by the transfer of the monies supporting these re-
searches from the National Institute of Neurological Diseases and Stroke to an-
other institute.
Thank you for your consideration of these views.
* Sincerely yours,
ROBERT KATZMA1~, M.D.,
Professor and Chairman of Neu~'oZogy.
L0MA LINDA UNIvERsITY,
SCHOOL OF MEDICINE,
DEPARTMENT or PHYSIOLOGY, PHARMACOLOGY, AND BIOPHYSICS,
Loma Linda, Calif., April 25, 1972.
Congressman PAUL O~ ROGERS,
Chairman, subcommittee on Health, Interstate and ForeiOn Commerce Commit-
tee, House of Representatives, Washington, D.C.
DEAR CONGRESSMAN ROGERS: Last month while in Washington, I met with
your legislative assistant, Mr. Robert Johnson, to discuss proposed legislation
for the Heart and Lung Institute of the National Institutes of Health, the pro-
`posed Institute of Aging and needs for the National Institute of Child Health
and Human Development. I am a physiQlogist and researcher in fetal growth
and development and a "national correspondent" of the Public Af1~airs Com-
mittee of the Federation of American Societies for Bxperimental Biology.
First, I'd like to say that I, `and most of my fellow biomedical scientists, great-
ly appreciate the work that you are doing to help improve health care and re-
search through increased funding for the National Institutes of Health. Specifi-
cally, I appreciate your battle to retain the National Cancer Institute within
the NIH and your recent legislation to place increased emphasis on the Heart
and Lung Institute.
I also agree wholeheartedly with the increased emphasis that you wish to
place on aging. Certainly there should be more unUerstanding of the aging
process and the possibility of controlling it. However, as I mentioned to Mr.
Johson, I believe that creating another Institute, the National Institute of Aging,
is `not only unnecessary but may be deleterious. There is a great danger in
proliferation of new Institutes within the NIH. This is partly because, of the
enormous amount of administrative superstructure that will be necessary if a
new Institute is created. It is jny understanding that the administrative costs of
establishing and running a new institute is about one-half million dollars. These
funds could be used for additional research in aging if the same work were to
continue within, the NICHD. Since the aging process probably begins at birth,
research relating to it Should not be separated from research on developmental
biology, growth and development that is carried on within the NICHD.
I would like to point out one serious problem at the NICHD. As you are
probably aware, during the fiscal year of 1971 this Institute had the lowest
overall rate of funding of any of the Institutes of the NIH. The NICHD was
able to fund only 232 (21.3%) of the total of 1041 applications submitted.
This number (232) was only 38% of the 609 grant applications that were
"approved" by the study sections and council, I believe that this is a tragedy,
and is out of proportion to the importance of fetal development, maternal care,
population studies and aging, to human health and well being. Particularly the
level of funding for research in problems relating to fetal and newborn develop-
ment and health is receiving too little support in relation to its overall relevance~
As an example, research work in the prevention of congenital anomalies, birth
defects and mental retardation would have considerable impact in decreasing
the number of dependent children that require either total or partial custodi'al
care. As you can appreciate, this investment would result in millions of dollars
of savings to the Nation over a period of years, as well as alleviate an untold
amount of suffering `and personal tragedy.
The following are several areas in which research would probably have a great
payoff in preventing disease and in the reduction of custodial care:
PAGENO="0327"
321
A. Problems relatin9 to premat~tre birth
1. An understanding of factors contributing to Intrauterine Grov)th Reta~da~
tio'n (so called "small-for-dates" or "small-for-gestational-age" infants)
2. An understanding of factors causing Spontaneous Premature Labor in
pregnant women.
3. An understanding of problems relating to Adaptation of the Prematurei~ji
Born Newborn Infant to Its extrauterine e~çistence:
(a) Bespiratory Distress Syndrome (a disease affecting the newboru'~
lungs, which often results in death).
(b) Hyperbilirubinemia (an increase in bilirubin, a `product of blood
metabolism, In the newborn infant).
(c) Problems in Temperature Control of the newborn.
B. Problems relating to infancy and early childhood `
1. An understanding of the physiological and biochemical prohiems involved
in Erythroblqstosis Fetalis (a disease in which the red blood cells of the fetus-in-
utero and newborn are broken down).
2. The Sudden luf ant Death Syndrome (a mysterious malady, or a group of
diSeases, resulting in sudden death for infants who were apparently well a short
time before. It is believed to affect about 10,000 infants per year in the U.S.).
3. The effects of Maternal Nutritional Deficiency on fetal growth and develop-
ment as you are probably aware, recent work suggests that maternal under-
nutrition may not only affect the infant of a given pregnancy, but even that of
the second generation (the grandchildren).
4. Problems of Fetal and Pediatric Pharmacology (understanding the effects
of drugs ingested by the mother and the biologic effects of various drugs on the
fetus and newborn infant).
C. Genetic problems and congenital defects
1. Defects of Genes and Chromosomes. Many of these conditions can be diag-
nosed during the prenatal period through the use of amniocentesis (withdrawing
amniotic fluid from the uterus of the pregnant mother). This technique can be
used to detect both inborn errors of metabolism (various biochemical disorders)
and chromosomal disorders (Mongolism, etc.).
2. There is a large group of Congenital Defects of Unknown EtiolQ~qy, perhaps
caused by environmental factors such as atmospheric carbon monoxide, lead etc.
D. Problems relating to aging `
1. An understanding of developmental factor that predispose an individual
to age after growth ceases.
2. Assess fundamental causes of biçloglc deterioratioti, for example, bio-
chemical and environmental factors causing the death of brain cells and heart
muscle.
3. Determine to what extent suboptimal conditions during fetal development,
whose basic structures are being formed, lead to subtle deficiencies in later life.
B. The fifth area that I think should receive definite consideration for increased
funding is Basic Research in the Biology of Early Embryology and, Fetal
Development
There are a number of important questions for which the tools and techniques
are presently available to find answers, but adequate progress is not being made
because of insufficient funding. These include problems such as:
1. An understanding of the genetic determinants of differentiation of the
embryo and the control of fetal development.
2. An understanding of factors controlling the exchange o1~ various substances
from the mother to fetus across the placenta.
3. An understanding of mechanisms that control blood `flow to the pregnant
uterus and placenta, and that control fetal blood flow, both in health ~tnd
disease.
4. An understanding of the mechanisms that control oxygenation of the fetus-
in-utero.
While an understanding of the specific problems of this last group may not
have immediate "payoffs" clinically, it is only by understanding the basic
physiology and biochemistry of embryology and fetal development that we can
have any hope of `controlling and intelligently minimizing the various disorderS
that account for a large amount of fetal and infant Wastage.
PAGENO="0328"
322
If I may suggest, I believe that it would be worthwhile if yoi~ could meet with
Dr. Gerald LaVeck, Director of the NIORD, to discuss some of the problem
areas noted above. Certainly If the NIOUD had addltion~l funding it could
increase the research suppo~ for solving many of tl~ese problems and diseases.
As an example of the benefits of research, i think that you will agree that t~ie
discovery of polio vaccine has been an advance in medicine with a blessing to
untold multitudes. While I do not have any hard figures, any form of "cost-benefit"
analysis would prove its value. Numerous other problems relating to pregnancy,
fetal devel~pme~~ and infancy are awaiting their "Salko" and `~Slubins". How-
ever, the grant applications of these invOstig~tor~ must be `Punde~" rather than
just "~&pproved, but not FU~dêd". This can only occur if the NICUD receives
additional support.
Again, I certainly appreciate the work that you are doing in health care and
research. i wish to do anyt~iing I can to assist. with this. Thank you.
Sincerely,
LAWRENCE D. LONGO M.D.,
Prof essor of Phyl~l~gy and Obstetric,s and Gynecology.
MAYO CLINIC,
Rochester, Minn., May 8, 1972.
Ron. PAITh ~
House of Representatives,
Wash4ngto~, D.C.
DEA5 Ma. ROGERS: Those of u~ who are interested in diseases of the nervous
system have been greatly disturbed at the effarts on the part of some persons to
change the authority of the National Heart and Lung Institute so that the full
responsibility for research in regard to cerebrovascular disease (or stroke) lies
jj~ in that institute.
In recent years we have seen a close working relationship between the Heart
Institute and the National Institute of Neurologic Diseases and Stroke in regard
to investigation of stroke problems. This cooperation has been of benefit to both
institutes and to investigators who are interested in stroke problems.
It is imperative that the responsibility for investigation in stroke lies pri-
mai~ily in the National Institute for Neurologic Diseases and Stroke, but I would
be hopeful that there would be a continued cooperative approach between the two
institutes where that furthers the advancement of knowledge in this difficult
clinical problem.
Sincerely,
JACK P. WHISNANT, M.D.,
Chairman, Departrne~t of Neurology, Mayo Clinic and Mayo Medical School.
PROvIDENcE HOSPITAL,
Columbia, S.C., May 30, 1972.
Re H.R. 15081.
flon. PAVL G. ROGERS, M.C.,
Cbairmou, Subcommittee on Public Health and Enviroument, House of Repre-
sentatives, Washington, D.C.
DEAR CONGRESSMAN Roonas, I wish to thank you for your response and for
affording me with a copy of the "National Heart, Blood Vessel, Lung and Blood
Act of 1~72".
After review of this bill I would completely concur with the emphasis that
has properly been placed upon the magnitude of the problem and commend you
and your cohorts for the correct identification of the needs involved.
I would hope that as the development of this bill materializes into reality that
Providence TI~spitai will be able to participate in some manner under Section 415
as described on page 9 of the bill. Since South Carolina leads the States in the
incidence of heart attacks and strokes it would seem only appropriate that one
of the centers should be located in the state that carries the greatest risk in our
nation.
Sincerely yours,
ROBERT G. KIGER, M.D., F.A.C.P.,
Director, Department of Cardiovascular Services.
PAGENO="0329"
323
Pnrn~~~n U~sIVERSIT±,
ScHooL OF Maincr~u~,
Ph4ktdelphla, Pa', May 4, 1972.
I-Ion. PAUL G. ROGERS,
House of Representatives,
Washington, D.C.
DEAR Mn. ROGERS: Now that legislation is being introduced for an expanded
Heart, Lung and Blood Program, may I call your attention to the need for em-
phasizing the thrombosis aspects of this program in such legislation. As the
former Chairman of the N.I.H.'s Advisory Committees on Thrombosis and on
Thrombolytic Agents and the National Research Council's Task Force on Throm-
bosis, and as the current Chairman of the Council on Thrombosis of the American
Heart Association, and of the Councils of both the International Society on
Thrombosis and Haemostasis, and of the International Society of Cardiology, I
fear that the current legislation does not provide an appropriate emphasis on
this very important public health problem, particularly at a time when new
developments are likely to have a profound Influence on the way we prevent
and treat this disease.
Thrombosis, as you know, is the formation of a clot in the blood vessels (these
blqod clots cut off the circulation and produce serious consequences) and repre~
sents a major, if not the major, cause of acute myocardial infarction (heart
attacks) and strokes. Also it is the cause of thrombophiebitis and, even more
importantly, of its dread complication, pulmonary embolism. Moreover, throm-
bosis and its embolic complications are the cause of many cases of acute blindness
and of gangrene of the extremities. Collectively, such thrombi and emboli are the
leading cause of morbidity and of mortality in adult population of the United
States. In round numbers, these events probably account for 1,000,000 deatb~ a
year (500,000 from acute myocardial infarction, 250,000 from stroke, 50,000 from
pulmonary embolism, and the remainder from thrombotic occlusions of other
major vessels).
While it is true that arteriosclerosis and thrombosis are often found together
and the former predisposes to the latter, they are separate processes and may
occur independently of each other. Furthermore thrombosis in the veins and it~
serious hazard, pulmonary embolism has nothing to do with arteriosclerosis.
While I do not wish, in any way, to downgrade the importance or long term
gains to be achieved by the prevention of arteriosclerosis, I would point out that
equally great gains can be achieved readily by the prevention or better manage-
ment of the patient with an acute thrombotic event. Furthermore *hile the goal
of controlling arteriosclerosis is not near at hand, recent developments in throm-
bosis research are likely to be applied readily to the patient and could, in the
next few years, revolutionize our ability to prevent or better treat acute throm-
botic events, regardless of whether they are in the arteries or veins. Proper epl-
phasis on the thrombosis problem in the pending legislation will accelerate the
achievement of this goal, and in turn will reflect well on the wisdom of the
legislation.
Sincerely yours,
Son SHERRY, M.D.,
Professor and Chairman, Department of Medicine.
IJNIv]mR5ITY OF CALIFORNIA, Los ANGELES,
DEPARTMENT OF NEUROLOGY, ScHooL OF MnDTcnsa,
Los Angeles, Calif., April 18, 1072.
Hon. JOHN G. ScHMITz,
Honse of Representatives,
Washington, D.C.
DEAR CONGRESSMAN SCHMITZ: It is my understanding that your Subcom~
mittee on Public Health and Environment in considering the Bill (HR. 18715)
for the enlargement of the authority of the National Heart and Lung Institute,
has given thought to the possibility of proposing an amendment that would
transfer the responsibility for research on "Stroke" from the National InStitUte
of Neurological Diseases and Stroke to NHLI. I trust that this Is not so but if it is
correct, I hope that you in your wisdom will be willing to reconsider. In my
judgment to make this transfer would constitute a major national calamity,
PAGENO="0330"
324
As you are aware, the addition of the word Stroke to NINDS three years
ago, at the time the National Eye Institute was created and eye research was
withdrawn, was reasonably Considered by the proponents of the change as
being a good mechanism for increasing the much needed research in all areas
pertaining to `the massive problems of stroke. In `the interval, NINDS has done
a respectable job in mounting good research despite the unhappy but necessary
~urtai1ments in funds that occurred. At the present there `are 18 clinical centers
across `the country for stroke research supported by NINDS and there are well
formulated plans to expand the functions of these and of new centers, to include
appropriate training for medical students and physicians in the community.
NIN'DS is fostering the development of research `to improve the `techniques of
monitoring the central nervOus system `for patients with stroke admitted to
Intensive Care Units in hospitals. Approximately 16 million dollars have been
~pent by NINDS on stroke research since 1969,' and during this fiscal year it
is anticipated `that 8 million dollars will be granted to these vari'ous endeavors.
No other Institute within NIH now provides any support for organized research in
~troke,-~-the one on carotid artery disease `supported by NHI was completed
ias't year.
The `brain and the nervous system are complex in structure and physiology.
Disturbances in function from many causes can produce the clinical syndrome
of a `paralytic stroke. At the clinical level accurate diagnosis is required. The
study `of brain dysfunction~ from whatever cause and at every level requires
that the investi'ga~ors `be properly experienced in brain pathology and physiology.
It fS reasonably considered that the NINDS through its Study Sections and peer
review mechanisms is better prepared to evaluate proposals for research and
to administer federally supported grants than any other of the NIH Institutes.
Rumor has it `that the justification for the transfer of Stroke is based on `the
failure of NINDS to accomplish success in the field. If such a r~1mor is seriously
considered by reasonable people, it can only be said `that these people have
not ha'd access to appropriate facts. Funds for research are Profoundly important
and greatly needed but those funds should be directed toward `and granted to
individuals who are most competent to carry out worthy investigation.
Your earnest consideration is requested.
Sincerely,
AUGUSTUS S. Rosn, M.D.,
Prof essor and Chairman, Departm~n~ of Neurology.
VIRGINIA COMMONWEALTH UNIVERSITY,
MEDICAL COLLEGE OF VIRGINIA,
W. B. WILLIAMSON,
April 20, 1972.
Clerk of Committee on Interst ate and Foreign Commerce,
House of Representatives,
Washington, D.C.
DEAR Sin: Thank you for notification of the hearings on Bill H.R. 13715-
Expand National Heart `and Lung Institute. Unfortunately my duties prevent me
from leaving the Medical College of Virginia tiext week. However, the follow-
ing letter outlines the points I would have made in committee testimony. I
would appreciate it if this letter could be made available to the members of the
Subcommittee on Public Health and Environment. These comments represent a
more Concise expression of my feelings than does my original letter sent to
Senator Kennedy and Representative Rogers.
1. There is a great need for increased financing of the National Heart and
Lung Institute. However, unfortunately the situation concerning vascular disease
`is much as it was over decade ago, when Congress seemed to understand that
biomedical science unlike physicaj science lacked sufficient basic knowledge to
forge a major breakthrough at the clinical level. While I commend any attempt
to increase overall funding for research on vascular disease, it would be self-
defeating, although poltically attractive, to expand clinical research at the
expense of basic research in this area. The Bill H.R, 13715 is explicit in stating
what sums of money shall be appropriated for setting up centers for clinical
research, diagnosis, and treatment. Thirty centers are involved, and each center
may receive up to $5,000,00o per year. This is between 30 and 50% of the total
PAGENO="0331"
325
~UIl1R)1iZfltiOI1 requested for the eiitire progiarn. I ;un coiieeriied that iinIe~s a
~imi1ar specific allocation is 1fl8(le to basic research. w~e will arrive at a situation
in which the 1)rincipaI increase in fuiicls will go for clinical progr~rns, perhaps
even ~it the (~XI)(~11Se of basic research. iiOt only in the 1-leart Instit~ite but
in other iflStittttes as well. As an exaniplo of such a 1)lleflOIflenon I would cite
tht~ (~\~(~11tS which have followed the setting up of new 1!llfl(IiI!g inacliiiieiy for
(~I1IC(~r research.
At that time, all Coiicerned eml)llatidahiy denied that there would be a resultant
(h1'OI) in fuiid~ to (,tller Nil! institutes. In fact such a (1101) occurred, with niany
institutes either receiving no increases in fuiiding or increases too snuill to
kee1, 1)0cc with inflation. This condition was perhaps exacerbated by the well
kl]OWfl failure ut the Budget Bureau to release all funds authorize(I by Con-
gress. rJiIiii~ VOIlI good iiiteiitioiis may become rather irrelevaiit ; your legislation
iiia~~- have le(1 to a (limillution of funding outside the cancer area. My first con-
cern i~ that the wor(ling of the present legislatioii may Permit a sinlilar (lecrease
ill funding OUtside of the area of heart and lung disease, and more particularly
;~ (lecrease ill funding of basic iesearcli in the field of vascular (IiSe:Ise.
A second concern of mine lies in the area of `stroke" which after cancer and
disease of the heart per se is perhaps the major killer or disabler of Americans.
2. SI oke 01'. cerebral thi'oiiibosis, (`InboUsm 01' lieiuoi'rhage, present with
symptoms of iieurologic dysfunction, hence is often seen and treated by neurol-
ogists or neurosurgeons. ~flhi~s it was not unreasonable to place major support for
stroke research in the neurological institute, especially if neurologists and neuro
surgeons were to carry out the regional stroke programs of Johnsonian days.
However, the training of such individuals generally concerns the function of the
bra iii cells themselves and not the `plumbing," derangement of which, unfortu-
iiately, forms the basis of the stroke problem. Consequently, it would seem
advisable to deal with time massive problem of stroke by distributing increases in
funds for basic research on stroke through the Heart and Lung Institute
which already has the expertise, the l)anel of review-ers and the backlog of appli-
cants with expertise, in such pertinent areas as atherosclerosis, thrombosis,
behavior of vascular smooth muscle, vascular permeability and edema (leak-
age of vessels). Unless we find out why vessel walls deteriorate, why vessels go
into spasm, why blood clots forni, when and why vessels leak, and how to control
these basic processes, we are not going to make much more progress in t~
prevention or treatment of Stroke.
Any proposals of your own should recognize the basic fact that stroke proble.~..
are primarily vasc'ular problems, rather than problems arising in the nerve cells,
and your proposals should aim to achieve the greatest Possible efficiency in re-
cruiting the efforts of basic scientists working in time vascular field. In contrast
to this suggestion, I-JR. 13715 never specifically mentions stroke, and, unfortu-
nately, the layman does not generally connect stroke with diseases of blood or
blood vessels. The bill should make time connection for him.
3. It is my understanding that a major reason for your recent prOI)OSals has
been testimony indicating inefficiency in some of the procedures of NIH. I note
in time bill that grants of up to $35,000 might be given without review and recom-
mendation by Council. This certainly would slIced research funds into the hands
01: the investigators. iou should realize, however, that an even more frustrating
impedimemmt to tIficliiit utilization of gi'ant monies is the system which puts theni
under control of State personnel and Purchasing Systems, when awards are marie
to State Institutions. Thus, in my State of Virginia, in spite of the strong objec-
tions of representatives from all State Colleges and Universities, mill. ~ monies
have been taken over by time Slate, and must be dispensed as if they were the prod
IW!: of the State taxes. For brevities sake, I will cite only one example of time detri-
mental effect of such action. The investigator carefully selects a idece of equip-
~nenI: for his particular needs. FTc decides it is time best of its type, applies to NIH
for the money to purchase it. and receives that money. By now, a year may have
already have elapsed s.immce the time of application. Now, however, the State steps
in and insists on requesting bids for the item in question. Time bidding procedure
(`xteimds not only to the vendors of a given bi'mmd of equipment, but act-ualiy to the
brands themselves. If sonic company, not desired by the investigator, produces a
low 1)1(1 the ~t~te will mmmsm~t on purchasing this item even if tlm mnvestigitom in
sists that it is unsuitable or inferior. The investigator's only recourse is either to
refuse to make any purchase, or to prove to the State purchasing office that the
low lad equipmiment is, in fact, imiferior. Since the State purchasors are scientific
PAGENO="0332"
326
laymen, this is often frustrating and always time consuming. I have even had
them waste unconscionable amounts of time to verify my statement that there
was, in fact, only a single manufacturer of the type of e~hipment I desired.
Phe point is that all of the Stat&s procedures negate~'the investigator's original
efforts in planning and justifying his budget to NIH. State employment or hiring
practices niso impede efficient use of federal funds, where States refuse to allow
the investigator to spend all of the salary money allotted to him, but insist instead
upon his paying State salary levels even when these do not permit effective com-
petition with local industry. All of this could `be avoided if grants were given with
the express provision that the expenditure of funds was solely at the discretion
of the Investigator and the granting agency; that the State or Private Institution
acting `as recipients of the funds were only to act as conduits of the funds to the
investigator; that the institution was to provide him with accounting services,
purchasing services, etc., for which services overhead payments are made; but
th'at State or local purchasing procedures, hiring procedures are to be waived at
the discretion of the investigator, provided only that State and Federal law is a1~
ways observed.
Sincerely,
WILLIAM I. ROSENI3LUM, M.D.,
Professor and Chairman, Division of Neuropathoiogy.
(Whereupon, at 3:30 p.m., the committee adjourned.)
0