IN THIS ISSUE n 607 W 64: VOLUME 93 NO. 6 * NOVEtvlBER-DECEMBER lS7S. PtJBLlSWEb SINCE 978 Official Journal of the U.S. Public Health Service 591 Editorial. Evolution of a concept--Julius B. Richmond (cover 2) Public Health Reports' ftrst century-a chronicle--f. Stewart blunter 600 Prevention in health care: an agenda for the next 100 years- Joseph A. Califano, Jr. 602 607 Public health in the United States: the next 100 years-Milton Terris The Food and Drug Administration and the backward motion toward de source-Donald Kennedy 616 The changing priorities of the Center for Disease ControI- William H. Foege 622 Dealing with alcohol and drug abuse and mental illness- Gerald L. Klerman 627 Assuring the nation's health resources-Henry A. Foley 637 The Health Services Administration: improving the access to health care of the nation's underserved-George I. Lythcott 642 The National Institutes of Health yesterday, today, and tomorrow- Donald S. Fredrickson 648 Organizational milieus of local public health units: analysis of response to questionnaire-WiEZiam Shonick and W&et Price 666 Research needed on socioeconomic differentials in U.S. mortality- Edward G. Stockwell, Jerry W. Wicks, and Donald j. Adamchak 673 Bridging the gap between clinical medicine and public health: experi- mental course for medical students--Stephen N. Rosenberg, Mitchell Schorow, and Margaret L. Haynes Contents continued The National Institutes of Health Yesterday, Today, and Tomorrow DONALD S. FREDRICKSON, MD IT IS A PRIVILEGE TO CONTRIBUTE to Public Health Reports in its 100th year. Like PHR, the National Institutes of Health looks back on almost a century of history, having had its start some 91 years ago in a one-room laboratory in the Marine Hospital on Staten Island. There Dr. Joseph J. Kinyoun, founder and director of the Laboratory of Hygiene (it became the Hygienic Laboratory in 1891), introduced scien- tific research into the Marine Hospital Service. His work in bacteriology and isolation of the cholera or- ganism laid the groundwork for the present biomedi- cal research programs of NIH. Growth Before the Present Decade The National Institutes of Health is the principal medical research arm of the Public Health Service. It is today one of the largest medical research centers in the world. For its first 60 years, however, its func- tion was purely intramural as it served essentially as the laboratory for PHS operations. It began with activities in nutrition and microbiology, and early in this century it was made responsible for bioIogics standards in the country (subsequently transferred to the Food and Drug Administration in 1972). Over the years the responsibilities of NIH grew slowly. It had its first big spurt of activity immedi- ately after World War II. The Public Health Service Act of 1944 gave NIH the legislative basis for its post-war programs and began the major Federal com- mitment to the support of biomedical research- something unprecedented in the history of this country. Few people realize that before World War II the support of science was not regarded as a responsi- bility of the Federal Government. Those of us who Tearsheet requests to Dr. Donald S. Fredrickson, Director, Na- tional Insfitutes of Health, Bldg., I, Rm. 124, 9000 Rockville Pike, Bethesda, Md. 20014. Joseph J. Kinyoun, MD (18651919), who joined the Marine Hospital Service in 1886, was director of the Hygienic Laboratory from its establishment in August 1887 until ApM 3O,t899 remember the excitement that followed the successful splitting of the atom can recall vividly the national mood it inspired: that brains and money couId accom- plish miracles. In common with other science agencies of the Federal Government, NIH was a beneficiary of this national spirit. The advent of space flight in the mid-1950s gave a further boost to, science and technology. NIH entered a period of unprecedented growth. Each year from 1957 to 1963 the NIH budget increased by an average of 40 percent annually; appropriations grew from $98 million in 1956 to $930 million in 1963. There was a 1%fold expansion in grants to academic insti- 062 htbllo N08NJl N8p8rlr tutions as the result of a deliberate congressional policy to expand the U.S. capability for biomedical research by rapidly increasing o Funds to support research projects o Federal assistance for the construction of research facilities o Fellowships and training programs for research r manpower o Support for research abroad-to a limited extent. By 1963 the United States was preeminent in bio- medicai research. NIH made grants to foreign insti- tutions and had offices in Paris, Tokyo, and Rio de Janeiro, from which the seeds were sown for a renais- sance of biological research in the developed coun- tries of the world. But the geometric progression of 40 percent annual increases clearly could not be continued-in another 7 years it would have brought the NIH appropriation to $8 billion. The growth of NIH slowed markedly. In fact, the latter half of the decade of the 1960s has been char- acterized as an era of no growth. The average increase in funding was a little less than 6 percent in .those years, construction funds ran dry, foreign grants were sharply curtailed, and the number of research grants began to fall. The Current Decade-Selective Growth The 1970s have had a different character, marked by narrowly mandated and selective growth. The decade began with a widely heralded campaign to mount a war on cancer. After enactment of the LNationaI Cancer Act of 1971, appropriations for the National Cancer Institute trebled in 4 years. This funding per- mitted needed growth in several basic disciplines then ripe for expansion: genetics, immunology, cell biol- ogy, and virology-all areas relevant not only to cancer but to all of the life sciences and medicine. This legislation was followed by the National Heart, Blood Vessel, Lung, and Blood Act of 1972, an act reflecting the new and expanded interest in diseases of the lung and of the vascular system. In that year also, new legislation emphasized further support for research and training in digestive diseases and added a new title-the National Institute of Arthritis, Metabolism, and Digestive Diseases-to an old institute. The Research on Aging Act of 1974 brought an 11th institute into the NIH complex. The new National Institute on Aging was authorized to support not only biological research, but also social and behavioral research related to the aging process and the special needs and problems of the aged, thus *adding a new dimension to the programs of NIH. This era continues to be one of intense public and CongressionaI interest in specific diseases. Laws have been enacted that call for increased research on Cooley's anemia, multiple sclerosis, sudden infant death, diabetes, arthritis, Huntington's chorea, and certain communicable diseases. Congress has thus be- come more closely involved in the setting of research priorities. Although this kind of interest is welcome, it can also be unsettling, Support for some areas that are not so visible or that do not command popular ap peal (for example, endocrinology and metabolism, kidney research, and hematology) tends to decrease. The National Institute of General Medical Sciences, set up to fund basic medical sciences, and also the National Institute of Allergy and Infectious Diseases, have lost about 10 percent of their purchasing power in recent years. Recent Innovative Action8 This brief historical glance at the evolution and di- rection of NIH offers very limited opportunity for useEu1 speculation about the Euture. Nonetheless, some recent developments at NIH istration, programs, and policy will its course in the years ahead. related to admin- certainly influence For example, NPH has been intensively reviewing its peer review system -at one time a unique experi- ment in self-discipline and quality control in the dis- tribution of public funds. For 35 years this system has served the scientific community and the public well. Neither excellence nor sound stewardship has been compromised, and the return on the pubIic in- vestment has been substantial. Nor has there been any real challenge to the system, only a certain dis- comfiture with it. As most readers of Public Health Reports are aware, the system originated at NIH in the late 1940s. It consists of a two-tier peer review system. The first review is conducted by specialty scientists, who assess the technical quality of research proposals. Then ad- visory councils, which include members of the pubIic as we11 as health professionals, judge the proposed project in terms of its potential contribution to the prevention and cure of disease. In recent years the system has come into question on such issues as possible conflicts of interest, the reappointment of distinguished people by an alleged "old boy" system, favoritism to investigators at dis- tinguished institutions so that the rich get richer, the secrecy of deliberations, and the finality of a system that provides for no intercession and no appeal. In 1976 NIH undertook its own internal review of the peer review system. Public hearings were held in Chicago, San Francisco, and Bethesda, Md., and writ- ten comments were obtained from present and former non-Federal members of review bodies as well as from applicants, grantee institutions, and the general public. The peer review study team submitted 69 recom- mendations. After consideration by a small working group of senior staff members and program heads, 33 of the recommendations redeived outright ap proval, and 9 others were approved with minor modi- fication. Action on 19 proposals was deferred pending additional examination and discussion, 3 recommen- dations were rejected, and 5 required no action. One set of recommendations that was adopted is designed to improve communication with applicants. It requires NIH advisory councils and boards to promptly provide a11 applicants with the compIete summary statements or critiques of their proposals, including priority scores, once final action is taken. Another set of proposals that was adopted is aimed at opening up the process for nominating and select- ing non-Federal advisors for service on councils and initial review groups. NIH is aIso committed to assur- ing that women and members of ethnic minorities who qualify as experts have maximum Opportunity to serve Tn advisory groups. Pending further study of a group of recommenda- tions to establish a formal grants peer review appeals system (to include an ombudsman), decision was with- held to enable further evaluation of the implications of such a system vis-a-vis legal, financial, and person- nel resources. Meanwhile, interested members of the scientific community, including readers of this ar- ticle, are free to offer further recommendations and suggestions. As to program developments, the public continues to make known its concerns about unsolved problems or areas in which scientific knowledge is scanty. One such area that has caught the public's attention is nutrition. Leaders in Congress have been especially vocal in their call for more concentrated efforts in nutrition research. Reflecting this national interest, NIH has mounted a number of specific programs in this area. The Na- tional Institute of Child Health and Human Devel- opment is launching a new program on clinical nutri- tion and early development. At the other end of the age spectrum, the NationaI Institute on Aging has begun its own program in clinical nutrition and at In a laboratory in the Natlonal Institute a? Child Health and Human Development, en etomic ebsorpfion ti8me spectro- photometer is being used to invesVggatt3 nutrtrionel abnormaiitles a s-day conference in June 1978 brought together some of the nation's outstanding clinical nutrition experts to discuss the nutritional needs of the aging adult. Also in June 1978, the NIH Nutrition Coordinat- ing Committee sponsored a conference on the "Bio- medical and Behavioral Basis of Clinical Nutrition: A Projection for the 1980s." Leaders in nutrition re- search in this country reviewed biomedical and be- havioral nutrition research, related this research to current clinical practice, and helped project the fu- ture frontiers of nutritional investigation. Partici- pants from other government agencies, academic authorities on nutrition, members of congressional staffs, and consumer advocates affirmed the need for new knowledge about nutrition and wide dissemina- tion of that knowledge. A "consensus development" conference on the surgical treatment of morbid obesity is scheduled for Iate in 1978; another such conference also is pIanned to draw up recbmmendations on tota parenteral nutrition and hyperalimentation-subjects of great interest and some controversy at present. Subsequent consensus conferences will provide a mechanism for seeking professional agreement upon the clinical significance of new medical procedures. The idea is to bring together a variety of points of view on new or controversial procedures and to have an open and extensive discussion of their advantages and drawbacks. In this way it is hoped to speed the transfer of technology from bench to bedside and thereby to assure that pertinent and valid informa- tion is put to work as promptly as possible in improv- ing patient care. In fact, NIH held its first consensus development conference last year. At that meeting, which focused on the use of mammography for breast cancer screen- ing, consensus was reached that routine use of mam- mography should be limited to women 50 years of age or older. The success of that conference has en- couraged NIH to make subsequent use of this device to speed health policy decisions. In some areas of science and research, particularly those with important social and ethical implications, the public must share in thi3 planning and develop- ment, right from the beginning. An example is the advent of DNA recombinant techniques in micro- biological research. And almost from the beginning, the public has been involved in helping NIH for- mulate guidelines for the conduct of such research. Concerns about the safety of recombinant DNA research were called to the attention of the scientific community and the public by scientists themselves- ReSe8rCherS 8t NW's P-4 COnt8inm8nt f8Ci/ity 8t Fort Detrick et Frederick, Md., use shoulder-length rubber gloves 10 move 8fId COntrOl8ll f?78fSri8lS. The f8Cility iS the fit& recombinsnt DNA research laboratory certified to meet NIH guidelines I know of no similar situation. Some of those who originally expressed misgivings about such research have now concluded that their fears were exaggerated and, in an about-face, have come to oppose govern- ment regulation of it. But it is to their credit that they freely shared and aired their doubts and in the process of doing so, made a historic contribution to the public governance of science. With the participation of many individuals and groups-scientists, lawyers, ethicists, environmental- ists, and consumer advocates--in June 1976, the NIH formulated guidelines governing the use of DNA recombinant techniques. These guidelines are at the present writing undergoing revision. It is hoped they may (a) exempt from regulation certain classes of DNA experiments, (b) strengthen institutional au- thorities in determining compliance with the guide- lines, and (c) for the first time make provision for private industry to register voluntarily its recom- binant DNA activities with NIH. It is still uncertain whether legislation will be enacted that will provide the regulations with the force of law to govern such experiments. Nevertheless, whatever happens, the con- duct of the scientific community in this matter has been responsible and in the best public interest. Planning Future Research There is no doubt that this nation is firmly com- mitted to basic biomedical research. Both President Carter and Secretary Califano have reaffirmed that commitment, as have leaders in the Congress. But policymakers and administrators alike are faced with the enormous dilemma of maintaining the momen- tum of research in an era of shrinking resources. Maintaining that momentum will take skill and patience and prudent planning on the part of all concerned. In a wide-ranging and very supportive speech earlier this year, Secretary Califano suggested the development of a multi-year plan for health re- search. By the time this article appears, we at NIH will have held the first of what may be a series of conferences-shared in by scientists, health profes- sionals, and the public alike-to define the principles on which such a multi-year effort should be based. We have already been giving thought to directions for the future, being well aware that we must con- stantly hone both the form and function of our programs. One of the problems is defining basic research. There is considerable confusion and disagreement, even within the scientific community, as to its char- acter and boundaries. In an effort to avoid this im- passe, and for ease in planning, we have classified our activities under four major headings: science base, clinical application, training, and transfer. We are using these concepts in both program planning and budget development. Science base. Under the science base umbrella, we include all those elements that contribute to the search for new knowledge about fundamental proc- esses--grant support for research projects (NIH has about $800 million in research grants) and program projects, some center-based activities, some intra- mural research efforts, some research contracts; and some special resources. CIinicaI application. CIinicaI application involves the further development and assessment of knowledge for immediate practical purposes. Clinical trials, the largest element in this category, are prospective re- search activities undertaken to assess the value and effect of agents, devices, and procedures on human subjects (NIH has some $200 million in this activity). In addition, research on the development of vaccines, other biologics, drugs, and devices also qualifies, be- cause the outcome of such research yields knowledge immediately applicable to human beings. Transfer. The transfer sector of the research con- tinuum includes five activities-demonstration, con- trol, education, consensus building, and dissemi- nation. Part of the responsibility of the research community is to transfer new knowledge promptly to the health professionals who can put it to work. Training. Without a consistent flow of new investi- gators, the future of biomedical research would surely founder. Promising young people must be found, mo- tivated, and trained for careers in biomedical science. At a meeting of the NIH Director's advisory coun- cil at NIH June 16 and 17, 1978, major issues emerged that the Department of Health, Education, and Welfare may wish to address in future long-range planning of health research and in arriving at prin- ciples suitable for guiding such a plan. The outcome of this activity- in which other Public Health Service agencies have also been engaged-will help set the planning agenda for health research in the future. Future Funding of Research Consideration of what the economics of biomedical science will be tomorrow evokes a beautiful illus- tration of what Voltaire was talking about in his Dictionnaire Phdosophique, when he stated, "It is said that the present is pregnant with the future." We can never be sure what era we are bringing to birth, but we want to assure that the capacity for exploration is kept strong and that the ultimate de- velopment will be in the public interest. Three questions about biomedical science may per- tinently be asked at this point: 1. Is it likely that we will return to a parochial period in which resources will be derived primarily from private sources? When completed, the new Ambulatory Cafe Reseerch Facility being constructed on the NIH campus at Bethesda, Md., will accommodafe an estimated 300,OVO outpatient visits each year The answer is assuredly negative. The Federal 60~ ernmeut has not become disenchanted with nor dis- interested in research. But research must compete with other desirable health programs and goals. And some of these other programs, because the problems related to them are perceived as being more imme- diate or more serious (the costs of and access to health care come to mind), may have a higher priority at the moment. 2. Are we headed for another period of exuberant growth or unselective expansion? The answer is almost surely just as negative, partly because there is greater competition for Iimited Fed- eral funds. Also, a drop in school-age children will curtail university expansion. Moreover, there are also clear signs that the always smaI1 fraction of medical school graduates interested in research as a profession is, at least temporarily, diminished, in part because of deep concern abou t the stability of support for such a career. And we are groping for ways to attract bright young minds into ,scientific inquiry, At the same time, it is worth noting that at this writing, the NIH reservation is reverberating with new construction, which in itself is a foreshadowing of things to come. The new 1%story Ambulatory Care Facility will expand and strengthen the com- bined laboratory and patient care programs of the Clinical Center, our research hospital. When com- pleted in the early 198Os, the new addition will be able to handle an estimated 800,000 outpatient visits each year, nearly 3 times the current figure, At the other end of the NIH campus, the IO-story Lister Hill Center building will be a part of the National Library of Medicine. When it is completed in 1980, the building will house the communications technology and network programs of the new Na- tional Center for Biomedical Communications and the cIoseIy reIated functions of the National Medical Audiovisual Center, presently located in Atlanta, Ga. Finally, there is a third question that should be asked: be practical, useful results emerging: that is the essence behind the labels "technology transfer" Or "consensus development." Science must prove itself capable of self-governance in regard to laboratory safety and other issues in which the public has a vital stake. The controver%y that has swirled around the subject of recombinant DNA research has been a profound experience for scientists, for NIH as an institution, for the Congress, and for the public as a whole. If science fails to gov- ern itself, reguIations and Iaws will descend upon the laboratories, and science may find itself tragically fettered. At the same time, within scientific institutions there must be adaptation and accommodation, and there is a rather narrow limit to the rational management of science through the aIIocation of resources. Conclusion Society will continue to set mandates for biomedical research-as patron, that is its right. Those who ad- minister the research funds have to arbitrate and interpret. The rate of scientific progress is determined by the interplay of such factors. Problems that presently admit no speedy or tidy resolution will be addressed with all the energy and zeal we can command. In its first 90 years, NIH has added enormously to man's store of knowledge and has measurably enriched the nation's health. There is every reason to believe that when Public Health Reports celebrates its 200th anniversary, a future di- rector of the National Institutes of Health will look back with pride on another century of outstanding progress. The National Institute of Health was established in 1930 and became the National Institutes of Health in 1948. Following are the years in which the Institutes and the National Library of Medicine were established. National Cancer Institute 1938 National Heart, Lung, and Blood Institute 1948 National Institute of Dental Research 1948. National Institute of Arthritis, Metabolism and Digestive 3. If maintenance implies increasing selectivity, what are the future funding strategies? Diseases National Institute of Neurological and Communicative Disorders and Stroke 1950 1950 The answer is compound: one part concerns the po- National Institute of Allergy and Infectious Diseases 1955 Iitical imperatives: the other, the allocation of re- National Library of Medicine 1956 sources within institutions for the conduct of scien- National Institute of Child Health and Human Devd- tific inquiry. opmen t 1932 National Institute of General Medical Sciences 1962 First, biomedical science is preeminently humane National Eye Institute Is8 in its objectives, and it must consciously adjust to its National Institute of Environmental Health Sciences 1969 patrons' expectations and needs in every way that National Institute on Aging 1974 does not destroy the process of discovery. There must Norombo+Dooombor WI%, Vd. U, No. 8 UT