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