7
The Institute of Medicine at Twenty Five

When Philip Handler declared the Institute of Medicine (IOM) open for business in 1970, he did not receive a communication from the President of the United States. Although the start of the IOM occasioned comment in journals such as Science and among those who followed the affairs of the National Academy of Sciences (NAS), it failed to elicit much reaction from the external policy community. Roger Bulger, the IOM's first executive officer, stated in 1974 that the IOM had not become a household word or, he might have added, a major player in health care policy. Some 21 years later, this situation had clearly changed. When the Institute of Medicine celebrated its first 25 years in December 1995, it heard from Health and Human Services (HHS) Secretary Donna Shalala, who thanked the Institute for "giving her so many health care leaders." She referred to the fact that nearly all of the agencies in the department concerned with health were headed by IOM members such as David Kessler at the Food and Drug Administration (FDA) and Bruce Vladeck at the Health Care Financing Administration (HCFA). Shalala also brought along a special message from President Bill Clinton. "Since 1970," the President wrote, ''the Institute of Medicine has contributed thoughtful and wise health policy covering an extraordinary range of issues."1

Kenneth Shine Arrives

It was Kenneth Shine who presided over the anniversary celebration. The dean of the University of California at Los Angeles (UCLA) Medical School, he interviewed for the IOM job during the 1991 annual meeting. The Council wanted someone to take over from Samuel Thier, who had announced his departure in May. As the search proceeded during the fall of 1991, Stuart Bondurant, dean of Medicine at the University of North Carolina at Chapel Hill, filled in



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To Improve Human Health: A History of the Institute of Medicine 7 The Institute of Medicine at Twenty Five When Philip Handler declared the Institute of Medicine (IOM) open for business in 1970, he did not receive a communication from the President of the United States. Although the start of the IOM occasioned comment in journals such as Science and among those who followed the affairs of the National Academy of Sciences (NAS), it failed to elicit much reaction from the external policy community. Roger Bulger, the IOM's first executive officer, stated in 1974 that the IOM had not become a household word or, he might have added, a major player in health care policy. Some 21 years later, this situation had clearly changed. When the Institute of Medicine celebrated its first 25 years in December 1995, it heard from Health and Human Services (HHS) Secretary Donna Shalala, who thanked the Institute for "giving her so many health care leaders." She referred to the fact that nearly all of the agencies in the department concerned with health were headed by IOM members such as David Kessler at the Food and Drug Administration (FDA) and Bruce Vladeck at the Health Care Financing Administration (HCFA). Shalala also brought along a special message from President Bill Clinton. "Since 1970," the President wrote, ''the Institute of Medicine has contributed thoughtful and wise health policy covering an extraordinary range of issues."1 Kenneth Shine Arrives It was Kenneth Shine who presided over the anniversary celebration. The dean of the University of California at Los Angeles (UCLA) Medical School, he interviewed for the IOM job during the 1991 annual meeting. The Council wanted someone to take over from Samuel Thier, who had announced his departure in May. As the search proceeded during the fall of 1991, Stuart Bondurant, dean of Medicine at the University of North Carolina at Chapel Hill, filled in

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To Improve Human Health: A History of the Institute of Medicine on an interim basis. At the end of the year, the Institute of Medicine announced the formal appointment of Shine, who assumed the job on a full-time basis on July 1, 1992. In selecting Shine, the Institute of Medicine preserved the tradition of having a leading academic health administrator as its president. Although Shine grew up in modest circumstances in Providence, Rhode Island, a special scholarship for talented students of the Providence public schools enabled him to go to Harvard College and then to Harvard Medical School. Like Samuel Thier, Kenneth Shine took his internship and residency at the Massachusetts General Hospital, another institution with a Harvard affiliation. At Massachusetts General, he developed an expertise in the muscles of the heart and sought an appropriate postdoc laboratory experience. He found it at UCLA and remained there as he worked his way up the academic and administrative ranks to become dean. Along the way, he developed expertise in the fields of cardiology, physiology, and academic administration, and as a result of his work with the Association of American Medical Colleges and the American Heart Association, he also became interested in public policy. Kenneth Shine inherited a large and complex organization from Samuel Thier. Each division produced numerous reports every year, and each division also played a part in the IOM's convening function by administering a special committee, forum, lecture series, or award. Enriqueta Bond, the IOM's executive officer, did a masterful job of keeping these activities on track during the year between Thier's departure and Shine's arrival on a full-time basis. When Shine took over the daily operations of the IOM in the summer of 1992, the country was in the middle of an election campaign that would bring the Democrats back into power. One of the key decisions that Shine faced was how to position the Institute of Medicine in an era of Democratic rule. The Inner Details of Health Care Policy As Shine contemplated how to approach his presidency, each division continued the work that led to reports on a wide variety of subjects. For example, a project on the implications of regional health care data bases for health policy fell into the bailiwick of the Division of Health Care Services, still headed by Karl Yordy, who had come to the IOM in the era of John Hogness and would remain until his retirement in October 1993. Roger Bulger, another old IOM hand

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To Improve Human Health: A History of the Institute of Medicine whose arrival at the IOM had preceded Yordy's, chaired the steering committee that produced a report on Health Data in the Information Age in 1994. Similar in tone to an earlier report on the computer-based patient record, the study tried to establish some guidelines for the use of health data bases that respected a patient's right to privacy yet yielded appropriate and helpful data. The committee realized that the information contained in the data bases could serve two conflicting purposes. On the one hand, the information might violate an individual's privacy and produce adverse consequences; on the other hand, however, it had the potential to improve the quality of medical care for large groups of individuals. To minimize the harm and maximize the benefits, the steering committee recommended that employers "not be permitted to require receipt of an individual's data from a health database organization as a condition of employment or the receipt of benefits" but suggested that "health database organizations should release non-person-identifiable data upon request to other entities once those data are in analyzable form."2 Another project from the Division of Health Care Services came from a congressional mandate that the Institute of Medicine study whether there was a need for more nurses in hospitals and nursing homes in order to improve the quality of patient care and reduce work-related injuries and stress among nurses. Nursing professional associations and special interest groups, concerned about changes in health care settings made to promote efficiency and reduce costs, supplied the impetus for the study. Receiving a formal request from the Health Resources and Services Administration to undertake the study in 1994, the Institute of Medicine assembled a committee headed by Frank Sloan, an economist from Vanderbilt, and Carolyne Davis. The choice of Davis, an experienced nurse who had gone into the field of nursing education and ultimately became the head of HCFA, was particularly appropriate. Davis and Sloan, assisted by IOM staff member Gooloo Wunderlich, conducted an investigation that lasted two years and included literature reviews, public hearings, and site visits. In a report released in January 1996, the committee concluded that the number of registered nurses was adequate to meet national needs. It nonetheless made many specific recommendations for necessary changes in staffing patterns and for research projects needed to refine public policy decisions. In particular, the committee recommended that the National Institute of Nursing Research fund research on "the relationships between quality of care and nurse staffing levels." It suggested that Congress set as a goal for the year 2000 a requirement that there be 24-hour coverage by registered

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To Improve Human Health: A History of the Institute of Medicine nurses in nursing facilities (the current standard was 8 hours). The committee felt that geriatric nurse specialists should be more involved in the supervision of nursing care and in the direct provision of such care. Hospitals and nursing homes, for their part, should carefully screen applicants for patient care positions filled by nurse assistants to make sure they had no past history of patient abuse.3 Both of these studies exemplified the traditional IOM role of appointing an expert panel to help in the process of setting standards of medical practice and administration and to identify topics that required more research. They also helped validate the conjectures of health policy researchers, for example, in the finding of the nursing study that the quality of hospital care had not suffered after implementation of the prospective payment system under Medicare.4 In this capacity, the studies served the additional function of laying a controversy to rest by virtue of examining the available evidence in an impartial manner. Even in an IOM study, however, there were possibilities for what might be described as latent conflicts of interest. A panel led by Carolyne Davis passed judgment on a prospective payment system that she had helped to put in place as the administrator of the Health Care Financing Administration. Panel members issued calls for more research that they might end up doing themselves. Neither of the studies had a particularly compelling theme or message. Not to put too fine a point on it, they were not the sorts of publications one might read for pleasure. People were likely to read the reports only if they had a direct interest in the subject at hand. The Institute of Medicine did these sorts of studies either in direct response to a congressional inquiry or because of an interest on the part of a foundation or a component of the medical community. The existence of such studies furthered the IOM's reputation as an organization concerned with what might be described as the inner details of health care policymaking. The Institute as Public Health Crusader In the era of Kenneth Shine, the Institute of Medicine pursued these routine studies, yet it lost none of the crusading spirit in the field of public health that could be traced back to Walsh McDermott. The work of the Division of Biobehavioral Sciences and Mental Disorders (renamed the Division of Neuroscience and Behavioral Health in 1996) on Growing Up Tobacco Free, a 1994 report, showcased this spirit. Unlike the reports on nursing or regional data

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To Improve Human Health: A History of the Institute of Medicine bases, this one received an enthusiastic launch from the Institute of Medicine. This meant issuing a separately bound summary and taking extra care with the report's design. A poster, drawn by Juan Morrell, a young student at PS 54 in Brooklyn, appeared on the cover. ''I have a dream," the poster read in an obvious reference to Martin Luther King, Jr., and the promises of the civil rights movement, of "a beautiful world without cigarettes." The poster's design featured a neighborhood, a clean and well-lighted place in which people walked the streets safe and secure and free of the menace of cigarette smoke. Although the poster reflected a child's fantasy view of the world, it also reinforced the theme of the report. The report took the harmful nature of cigarette smoking for granted. The problem for public health authorities fell into the domain of behavioral modification: how to stop people from smoking. The basic insight of the report was that antismoking campaigns should be targeted at young people. "In the long run, tobacco use can be most efficiently reduced through a youth-centered policy aimed at preventing children and adolescents from initiating tobacco use," the report stated. Here, then, was a compelling report with a clear message.5 The report contained hard-hitting recommendations on ways to restrict the use of tobacco products to adults. The committee, headed by Paul Torrens of UCLA's School of Public Health, proposed banning tobacco products from public vending machines as well as a ban on the free distribution of tobacco products at public events or through the mail. At the heart of the committee's strategy to prevent young people from starting to smoke was a mass media campaign that would include explicit antitobacco advertisements on commercial television stations. To help finance this campaign and further to discourage smoking, the committee suggested an increase in the excise tax on cigarettes. The report accompanied these recommendations with charts and graphs that eloquently summed up the case against smoking. One chart, for example, made the point that "cigarettes kill more Americans than AIDS, alcohol, car accidents, murders, suicides, drugs and fires combined."6 In a sense, Growing Up Tobacco Free, funded by the Robert Wood Johnson Foundation, constituted a free ride for the Institute of Medicine. No one in the public health community advocated the use of tobacco. To recommend an antismoking campaign reinforced feelings people already had; it was the public health equivalent of a bipartisan good government measure. Although the tobacco companies exerted substantial influence over Congress and state legislatures, they were less of a factor in the communities that supported the IOM and from which the IOM drew its members and audience. By way of contrast,

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To Improve Human Health: A History of the Institute of Medicine two projects of the Division of Health Promotion and Disease Prevention, one on Agent Orange and the other on unintended pregnancy, took the IOM farther into the realm of controversy. The Division of Health Promotion and Disease Prevention functioned as one of the IOM's busiest divisions during the presidency of Kenneth Shine. The division administered many of the IOM's convening functions such as the National Forum on the Future of Children and Families, the National Forum on Health Statistics, and the Roundtable for the Development of Drugs and Vaccines Against AIDS. It also assisted in the process of selecting the winner of the Gustav O. Lienhard Award, a prestigious prize that the IOM conferred on accomplished members of the health community for achievement in improving personal health care services. Often this award went to people who had played a prominent role in the development of the IOM itself. In 1993, for example, David E. Rogers, the Walsh McDermott University Professor of Medicine at Cornell University and previously the head of the Robert Wood Johnson Foundation, received the award. In other years, the award went to Robert Ball, the former Social Security commissioner and resident scholar at the Institute of Medicine, and Julius Richmond, President Carter's Surgeon General and "pro tem" head of the Institute of Medicine between Donald Fredrickson and David Hamburg. Like other Institute of Medicine components, the staff of the Division of Health Promotion and Disease Prevention spent most of its time not on convening or honorific functions but on the conduct of actual studies, such as the one begun in 1992 on Agent Orange. The study stemmed from a congressional request, contained in a law passed at the beginning of 1991, for the National Academy of Sciences to conduct a study of the health effects of Agent Orange and other herbicides used during the Vietnam War. The military used these herbicides as a way of clearing the underbrush that obscured the targets of aerial bombing or provided cover for enemy soldiers intent on killing American and South Vietnamese forces. Although most of the herbicides, including the widely used Agent Orange (named after the color of the barrel in which it came), were sprayed from airplanes, some were dispersed from tanks on the backs of soldiers. Use of the herbicides sparked considerable controversy, first from groups concerned about the use of chemical agents in warfare and then from veterans who complained about the health effects of these herbicides. In 1970, Congress directed the National Academy of Sciences to study the ecological and physiological effects of the use of herbicides in South Vietnam. In a 1974 report, an NAS committee did not find definitive evidence of an association between exposure to herbicides

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To Improve Human Health: A History of the Institute of Medicine and ill health, although the committee's primary focus was on the environmental, not the individual, effects of herbicides. Complaints from veterans kept the issue alive in the media and in Congress and led to many epidemiological investigations, some conducted with the oversight of the Institute of Medicine, that tried to determine the link between exposure to herbicides and various cancers. Complex political, epidemiological, and legal issues were involved. Congress hoped that the Institute of Medicine could provide an authoritative version of the scientific and medical "facts" pertinent to the issue. 7 Kenneth Shine realized the political sensitivity of the case and, for this reason, took extra precautions to ensure that the members of the study committee were not themselves participants in the medical or scientific aspects of the controversy. The very fact that the Institute of Medicine, rather than the National Research Council acting on behalf of the National Academy of Sciences, conducted the study indicated the IOM's rise in status since the original NAS study of herbicides in the early 1970s. To chair the study committee, the IOM chose Harold Fallon, the dean of the University of Alabama School of Medicine, and David Tollerud, the director of occupational and environmental medicine at the University of Pittsburgh. They and 14 others, with the active assistance of project director Michael Stoto, conducted an ambitious study in which they investigated the history of the conflict, read through the considerable volume of scientific studies and reached conclusions on their validity, and considered the need for further research.8 At the heart of the completed report was a table that presented the committee's conclusions about the level of correlation between particular diseases and exposure to herbicides. For example, the committee found a positive association between soft-tissue sarcoma and exposure to herbicides and no association between skin cancer and exposure to herbicides. This finding failed to settle the dispute, however, because most of the evidence the committee assembled came from studies of people exposed to dioxin or herbicides in occupational and environmental settings, rather than during the Vietnam War. In fact, the committee knew that most Vietnam veterans had lower levels of exposure to herbicides than did the subjects of the other studies, but the exact level of exposure of Vietnam veterans remained unknown. To get at this question of exposure levels, on which many previous investigators had floundered, the committee made recommendations to facilitate the necessary research, for example, that the Department of Defense and the Department of Veterans Affairs should better identify those who had served in South Vietnam in their personnel and medical records. The committee suggested that

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To Improve Human Health: A History of the Institute of Medicine the studies necessary to determine exposure levels be conducted in the most neutral way possible, which meant that much of the work should be done by "independent, nongovernmental scientific panels." In this spirit, the committee recommended that "a nongovernmental organization with appropriate experience in historical exposure reconstruction should be commissioned to develop and test models of herbicide exposure for use in studies of Vietnam veterans."9 In this way, the Institute of Medicine came to play a credible role in the Agent Orange controversy. Although it did not resolve this controversy, it did summarize and analyze the data in a way that was helpful to policymakers. Armed with this report, IOM leaders could testify before Congress and add a scientific voice to what inevitably was an emotional debate that involved not just Agent Orange but the larger issue of the meaning of the Vietnam War and the debt America owed its Vietnam veterans. Congress knew that the IOM was as impartial as any organization could be. At the same time, recommendations for further research, even those produced by a thorough and dispassionate review of the evidence, inevitably introduced subtle conflicts of interest. By suggesting a nongovernmental panel to examine a particular issue, as the IOM did in the Agent Orange study, it risked the charge that it was drumming up business for itself. Such conflicts were unavoidable, because the IOM was removed from the subject under study—the defense and chemical industries—but not from the business of medical research. If the Agent Orange study exemplified the work of the Division of Health Promotion and Disease Prevention in the public service mode, the unintended pregnancy study, another project of this division in the Shine era, illustrated its public education mode. In this project, as in the project on tobacco, the IOM showed its desire to alert the nation to a public health hazard and to suggest ways of alleviating the hazard. Published in 1995 and conducted during a period of widespread interest in health care reform, the study, chaired by Harvard psychiatrist and veteran IOM member Leon Eisenberg, made the simple point that all pregnancies should be intended at the time of conception. All pregnancies should be the result of a conscious desire on the part of men and women to have children. The committee marshaled evidence to show that most pregnancies in America were unintended. Using 1987 data, the committee demonstrated that less than half of the pregnancies in America were intended and resulted in live births; 8 percent were unwanted pregnancies that resulted in live births, and 29 percent were unwanted or mistimed pregnancies that ended in abortion. The high rate of unintended pregnancies held dire public health consequences. An unwanted pregnancy diminished the

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To Improve Human Health: A History of the Institute of Medicine chances that the mother would seek prenatal care early in the pregnancy and raised the chances that the baby would be born with a low birthweight. An unwanted pregnancy also increased the likelihood that births would occur to women who faced special medical risks or heavy socioeconomic burdens, such as adolescents, unmarried women, and women over 40. The committee stressed that the problem affected older as well as younger women.10 Although the problem was easy to identify, the solutions raised profound moral questions. For one thing, they involved the matters of birth control and abortion, subjects on which religious leaders held firm convictions; for another, they touched on the question of whether sexual activity on the part of young or unmarried people should be condoned. Some believed that the solution to unwanted pregnancies was abstaining from sexual intercourse. Such a view, according to the committee, reflected a denial of recent social trends—the age of first intercourse was dropping, for example—and a misreading of social statistics—most people at risk of unintended pregnancy were "beyond adolescence and many are married." The committee took the position that although sexual activity could not be controlled, its consequences could be regulated through the proper use of birth control. Hence, the committee recommended the initiation of a major education campaign to make the public aware of the social burdens caused by unwanted pregnancies. Among the goals of this campaign were improving "knowledge about contraception and reproductive knowledge" and increasing "access to contraception." The committee recommended that ''an independent, public-private consortium," formed at the national level, should lead the effort. They saw this crusade as part of a common sense public health effort, similar to efforts to reduce smoking, reduce drunken driving, or promote the use of seat belts.11 Contrary to contemporary trends in health care finance, the committee did not hesitate to advocate an increase in public and private spending to support the campaign. It recommended, for example, that more health insurance policies cover contraceptive services and supplies, with no copayments or other forms of cost sharing. For the medically indigent, it supported using Medicaid to cover contraceptive services for two years following childbirth, and it recommended the provision of federal, state, and local funding for "comprehensive contraceptive services, especially for those low-income women and adolescents who face major financial barriers in securing such care."12 The funding recommendations made it clear that the report was a call for birth control, a traditional item on the liberal political agenda, but with the new rationale of protecting the wellbeing of children and families by reducing unintended pregnancy, a

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To Improve Human Health: A History of the Institute of Medicine rationale unrelated to population control and only tangentially related to improving the quality of life for women. The committee realized that the prevention of unintended pregnancies carried less political stigma than did such things as family planning or a woman's right to terminate a pregnancy. The report on unintended pregnancy showed how the Institute of Medicine maintained its independence from partisan politics yet remained engaged in contemporary issues. Although the report involved a close reading of social statistics and other forms of hard data, it also contained philosophical assumptions—for example, on the moral validity of birth control—that went largely unexamined. In this regard, the Institute of Medicine often operated from within a broad area of consensus that was defined by the accepted opinions of medical and public health experts. Certain shades of opinion, libertarian views, or the views of fundamentalist religious leaders, for example, did not enter this arena. Science and Politics All of the IOM divisions had to resolve the tensions between staying independent of partisan politics and remaining engaged in contemporary issues. Even the Division of Health Sciences Policy, the part of the IOM that came closest to a concern for a pure science, dealt with politically sensitive issues. For example, the division administered the Forum on Blood Safety and Availability, the Forum on Drug Development, and the Roundtable on the Role of Academic Health Centers in Clinical Research and Education. Each of these convening functions involved the discussion of matters with what might be described as a high science content; each also concerned the politics of health science policy. Perhaps the most important report from the Division of Health Sciences Policy that appeared in the Shine era concerned microbial threats to health in the United States. Published under the title of Emerging Infections in 1992, the report argued that the nation could not afford to become complacent about infectious disease. "The next major infectious agent to emerge as a threat to health in the United States may, like HIV, be a pathogen that has not been previously recognized," wrote study cochairmen Joshua Lederberg, a Nobel laureate, and Robert Shope, a Yale epidemiologist. The committee believed that the threat to the nation's health posed by disease-causing microbes "will continue and may even intensify in the coming years." Furthermore, in the matter of infectious diseases, there were

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To Improve Human Health: A History of the Institute of Medicine no national boundaries. On the contrary, ''there is nowhere in the world from which we are remote and no one from whom we are disconnected." Hence, the country needed to maintain surveillance against emerging infectious diseases, and such surveillance efforts should have both domestic and international components. The committee also recommended interventions in the traditional IOM style, such as "the expansion and coordination of National Institutes of Health-supported research on the agent, host, vector, and environmental factors that lead to emergence of infectious disease."13 As it turned out, the report proved quite prescient. In 1994, for example, public health authorities worried about the emergence of bubonic plague in India and the reemergence of drug-resistant forms of tuberculosis. For this reason, the IOM decided to follow up on the report and to support the efforts of the Centers for Disease Control and Prevention (CDC) to receive early alerts on significant microbial threats.14 Emerging Infections, therefore, showed how the best IOM projects combined science and public health policy. For Assessing Genetic Risks, a project of the Division of Health Sciences Policy that was completed in 1994, the IOM assembled the nation's leading experts, including University of Washington geneticist Arno Motulsky, to anticipate another problem on the boundary between science and social policy. This one concerned genetic testing. In every state, for example, newborns received genetic screening for a condition known as phenylketonuria. By performing this test, doctors could prevent a form of mental retardation. This test met the committee's conditions that screening be limited to situations in which there was a "clear indication of benefit to the newborn," a system was in place to confirm the diagnosis, and "treatment and follow-up are available for affected newborns." Many pregnant women at risk for bearing a Down's syndrome child received a test that, among other things, revealed the sex of a baby before birth. This test raised the possibility that a couple who desired a child of a particular sex might terminate a pregnancy if the fetus was of the other sex. Such a use of fetal diagnosis, according to the committee, represented ita misuse of genetic services that is inappropriate and should be discouraged by health professionals." In general, the committee tried to distinguish useful forms of diagnosis from "eugenic goals," although the distinction often proved elusive. Eliminating the population of Down's syndrome children was, after all, an eugenic goal. Advances in science raised even more difficult conundrums, as in the possibility that conditions with adult onset, such as Alzheimer's disease or certain types of cancer, might be identified in utero or in early childhood.15

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To Improve Human Health: A History of the Institute of Medicine its "unique convening capacity" to create a framework for analyzing the proposal. At the 1993 annual meeting in the fall, Shine reiterated the point that the IOM stood "ready to help in any way it can to evaluate this extraordinary effort which is about to take place." 30 It was as if the Institute of Medicine would act in an oversight capacity, much as it often did for research plans of the National Institutes of Health, for example. On the one hand, the IOM kept its distance from the process through which the Health Security Act was created. On the other hand, it offered all the advice it could and even lent direct aid, for example, by sending the Robert Wood Johnson Foundation Fellows in Health Care Policy to work with the White House Task Force on Health Care Reform. In January 1993, Shine gave Hillary Clinton and Donna Shalala an IOM white paper on health care reform that consisted of a compendium of previous IOM proposals. The Division of Health Care Services directed much of its energy toward health care reform, releasing reports early in 1993 on access to health care in America and on the frayed relationship between employment and health benefits. The IOM also formed a special committee on assessing health care reform proposals, chaired by Walter McNerney, that issued a report in April 1993, setting down the broad goals for the health care reform effort.31 Hillary Clinton and her task force worked independently of the IOM, and the IOM played little role in the congressional debate that took place in 1993 and 1994. By the time the IOM met in the fall of 1994, the Clinton health care bill was dead. In retrospect, Shine's decision not to have an IOM health plan proved to be astute. Nonetheless, he looked on the collapse of heath care reform with real regret. He told IOM members that the nation would suffer "by virtue of an environment in which quality will come under pressure as the so-called market attempts to control costs." It seemed all the more important for the IOM to continue a three-year project it had launched on the quality of care. The project would involve what Shine described as a "whole range of activities"—from symposia and workshops to formal reports—all in an effort to understand how quality was measured in the health care system. If the Clinton health care plan had passed, the IOM would undoubtedly have played a major advisory role on the many quality of care issues the plan would have raised. Without the Clinton health care plan, the IOM's quality initiative still served as an important reminder, as the IOM Council stated in a July 1994 white paper, that "quality of care issues should be confronted with the same vigor and sophistication as will be

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To Improve Human Health: A History of the Institute of Medicine directed at issues of access and cost.''32 In this manner, quality of care became an important motif of Kenneth Shine's presidency. The special initiative on health care quality, as the project was formally known, began in the spring of 1994 and became a large and elaborate undertaking. It fulfilled the desire, articulated in the 1993 strategic planning exercise, for an Institute-wide project that would last for several years and consist of activities "designed to support and advance a significant policy issue." Health care reform, the Council decided, was simply too large a topic to handle. Not only was quality of care a more manageable theme, it also built on a long history of IOM work in this area. One report, in particular, on a strategy for quality assurance in Medicare, had yielded a useful definition. "Quality of care," the report noted, "is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."33 Using this definition, the IOM proceeded to investigate the ways in which quality of care could be evaluated and improved. The project produced a 1997 statement, issued under the signature of the presidents of the NAS's three central organizations, on "Focusing on Quality in a Changing Health Care System"; a series of special newsletters; and a number of IOM reports. As part of the initiative, the IOM also convened a National Roundtable on Health Care Quality.34 Unlike the subject of national health insurance, in which the Institute of Medicine was one voice among many, the IOM acquired a form of collective expertise on matters related to quality of care and spoke with considerable authority on the issue. The National Academy of Medicine? As the IOM headed toward its 25th anniversary, it maintained a full roster of activities. These ranged from annual meetings in which members learned about the IOM's latest activities and heard from the nation's leading policymakers and researchers, to forums in which interested parties debated particular subjects, to specialized projects in which carefully appointed committees contemplated particular issues. The members were among the nation's most distinguished physicians, scientists, social scientists, and health care researchers. At the end of 1993, for example, the IOM contained no fewer than 23 Nobel laureates. It seemed to Kenneth Shine and many members of the Council that the IOM resembled nothing so much as a National Academy of Medicine. With the passage of 25 years, it appeared appropriate for

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To Improve Human Health: A History of the Institute of Medicine the IOM to make a formal name change. There were a number of compelling reasons for the change. The present name invited confusion between the independent Institute of Medicine and the governmental National Institutes of Health. On an international level, the name baffled foreign authorities, who could not understand why the United States chose to call its academy an institute. The word "institute" implied an organization that undertook research, and although this described part of what the IOM did, it failed to comprehend the special nature of the IOM's activities. Finally, the name implied that the IOM was somehow a second-class member of the Academy complex, which contained an academy of science, an academy of engineering, but only an institute of medicine. In retrospect, the name reflected an accident of history. When the IOM was created, Philip Handler expected the NAS to contain a number of institutes. As matters worked themselves out, the Institute of Medicine stood alone. Shine hoped to end this historical anomaly and change the organization's name to the National Academy of Medicine. A change of this magnitude required a long series of approvals. When Shine approached Bruce Alberts, who was Frank Press's successor as head of the National Academy of Sciences, and the NAS Council, he received an encouraging response. The IOM Council was similarly positive. A final hurdle was the approval of the full NAS membership during its annual meeting. In this meeting, opposition to the name change surfaced. Dr. Francis Moore, a distinguished surgeon from Harvard who had earlier figured in the IOM's history as an opponent of the Board on Medicine's statement on heart transplants, argued against the change on the grounds that creation of the National Academy of Medicine would make it impossible for doctors to be elected to the National Academy of Sciences. Shine did not wish to push the matter on the floor of the NAS meeting; it was something that had to be done by consensus. The proposal died. Summing Up Walsh McDermott, who, as much as anyone, was responsible for the creation of the Institute of Medicine, would have applauded the decision to have the organization remain an institute, rather than an academy. In his work as head of the Board on Medicine, McDermott came to feel that an academy was an organization in which self-congratulation took precedence over action. He wanted an entity that was concerned not only with who would join but also with who would work on projects of social significance. It should not be an

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To Improve Human Health: A History of the Institute of Medicine organization that contained only medical doctors. Instead, he favored an organization that embraced people from a wide range of disciplines, who might be able to help in the consideration of key questions of public health. Issues such as access to medical care and the diffusion of medical knowledge mattered to McDermott. In the deliberations of the Board on Medicine, Irvine Page and James Shannon provided counterpoints to McDermott. Page felt that physicians needed an organization with the dignity of an academy to represent their interests. Although he too shunned the honorary aspects of an academy and sought a group of working members, he did not share McDermott's enthusiasm for the social aspects of medicine. He preferred that the organization be limited to physicians and to issues that affected the practice of medicine and the conduct of medical research. For this reason, he was wary of an entity contained within the National Academy of Sciences. In such a setting, the interests of physicians would be subsumed by other concerns. James Shannon, the former head of the National Institutes of Health, had still a different vision for the new organization. He wanted what John Cooper of the Association of American Medical Colleges described as an "honorific society for biomedical types."35 He favored an organization that concerned itself with research issues and did not become dominated by social concerns to the detriment of scientific matters. He saw the successor to the Board on Medicine as an entity that would become a staunch defender of NIH within the political process, encouraging NIH's mission to support basic science and deflecting it from political demands that it respond to the latest medical fad. McDermott won the argument in the short run. What emerged from the Board on Medicine was an institute, not an academy. The initial membership included not only distinguished academic doctors but also lawyers and social scientists. When it came time for the new Institute of Medicine to consider major issues related to public health and access to medical care, however, John Hogness, the first IOM president, found it difficult to initiate large-scale projects of the sort McDermott favored. Part of the reason was that the Nixon administration did not want to cede the political action on questions such as national health insurance to an organization whose political affiliation had yet to be tested. Congress and the components of the federal bureaucracy were more sympathetic, yet they did not offer the fledgling organization projects with a large philosophical bent but rather smaller projects with limited objectives. They wanted data on matters such as the cost of educating a physician, an empirical question many steps removed from the content of public policy.

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To Improve Human Health: A History of the Institute of Medicine Throughout the 1970s, furthermore, both Congress and the federal bureaucracy gained a greater capacity for doing their own quantitative and analytical work. Committee staffs and bureau chiefs discovered that it took the Institute of Medicine, which had to clear its work through the National Academy of Sciences bureaucracy, a great deal of time to complete a task. Since speed was so important to a policy system in which the window for change in a given area remained open for a very short time, Congress and the federal bureaucracy often looked elsewhere. The Institute of Medicine struggled. In the interim, before the IOM developed a large program of studies, it resembled nothing so much as an honorary organization of the sort that would have been more congenial to Irvine Page than Walsh McDermott. The highlight of the early Institute of Medicine was the annual meeting, a gathering with a great deal of intellectual content that yielded important papers on health policy but was a social occasion nonetheless. Here, members greeted one another and discussed who deserved to become part of the group. The Institute of Medicine threatened to deteriorate into a social club for the country's best physicians and medical researchers. This never happened. Foundations began to provide the Institute of Medicine with the support necessary to hire a core staff and undertake basic activities. Hogness and the IOM Council kept the organization focused on the important issues of the day, such as President Nixon's war on cancer or the Supreme Court's decision not to interfere with a woman's right to choose abortion. Still, the IOM failed to develop a source of sustained financial support or, because of the need to undertake any project the government offered it, much of a coherent program. The fact that Hogness served only three years and his successor Donald Fredrickson less than one accentuated the problems. David Hamburg, the IOM's third president, devoted much of his term to reorganizing the IOM into a set of divisions with distinct responsibilities. His six-division scheme, later compressed into four, served as the basis for the IOM's present structure. As the IOM became better known and better organized, it attracted more grants and research contracts. During the Hamburg years, the IOM undertook studies in health manpower, quality assurance, and the relative effectiveness of polio vaccines. Each of these topics emerged as enduring themes of the IOM's work. Hamburg also engineered an informal alliance between the IOM and the Carter administration, which led to what amounted to collaborative projects on such subjects

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To Improve Human Health: A History of the Institute of Medicine as the international dimensions of health, mental health policy, and the behavioral aspects of health. During the Hamburg years, the distinctive strengths of the Institute of Medicine became more apparent as well. In the case of polio vaccines, for example, the government needed an external body, with a reputation for objectivity, to judge the relative effectiveness and safety of the two types of vaccines. Because the IOM represented neither the manufacturers of vaccines nor a government agency with a vested interest in a particular outcome and because it could convene the nation's leading scientific authorities to consider the matter, it was an ideal organization to undertake the study. Some matters had to be taken from the realms of Congress and the executive branch to a setting removed from partisan electoral politics. In the field of medicine, the IOM provided such a setting. Not only did the organization serve as an impartial judge, it also validated decisions made by others. Hence, it provided an external sounding board for those who wished to advance a particular research agenda within the federal bureaucracy, such as putting more emphasis on behavioral science within the National Institutes of Health or, for those who sought a particular policy objective, such as an increase in the number of physicians engaged in primary care. The IOM gave advocates of the agenda or objective, particularly those buried within the federal government's considerable hierarchy, far more credibility and clout than they would otherwise have had. In this capacity, the IOM came close to realizing the objectives sought by James Shannon, who had wanted the Institute to serve as an advocate for NIH. Shannon might not have approved of the IOM's desire to broaden NIH to include social and behavioral sciences, but he would certainly have applauded its support of the NIH's basic mission and its desire to insulate NIH director from the whims of politicians. Indeed, advice to NIH on its organization and on the research programs of the various institutes became a staple of the IOM's activities. The Hamburg years demonstrated the IOM's potential weaknesses as well as its strengths. Although the embrace of the Carter administration raised the IOM's level of visibility and influence, it also undermined the stance of neutrality and objectivity on which its role in the policy process depended. When the Reagan administration began in 1981, many of its appointees considered the IOM a remnant of the past regime. It therefore became a point of honor not to include the IOM in important policy deliberations. Major changes occurred in health care financing patterns during the Reagan years, and the IOM played little or no role in them.

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To Improve Human Health: A History of the Institute of Medicine Between 1980 and 1985, Fred Robbins reaped what Hamburg had sown. The IOM divisions continued to produce reports on subjects of interest to a particular group or subset of the federal bureaucracy. In the role of impartial arbiter, the IOM investigated the retirement age of airline pilots. It also supplied data to Congress on federal subsidies for nursing education and on the proper regulation of nursing homes and to the Department of Defense on graduate medical education in the military. The IOM assisted CDC in the investigation of toxic shock syndrome and NIH in assessing the health effects of marijuana. Largely on its own initiative, the IOM conducted influential studies of for-profit investment in health care and the prevention of low birthweight. Despite these activities, some of which, such as the nursing home study, produced tangible results in the forms of new laws and regulations, the IOM faced financial stringencies that were, at least in part, the result of the Reagan administration's hesitancy to award large contracts to the IOM. At the same time, foundations, affected by the recession of the early 1980s, began to grow wary of the IOM, disappointed that their investments had not led to a more coherent program or a more sustained record of influence. The National Academy of Sciences, under the leadership of a new president, entertained doubts about the ways in which the Institute of Medicine combined scientific analysis and policy advocacy. These doubts about the Institute of Medicine culminated in a major investigation of its activities, funded by the foundations that supported the IOM and conducted by the NAS, in 1984. The authors of the Sproull report collected a great deal of seemingly damning information about the IOM—its lack of purpose, its uncertain place among organizations concerned with health policy, its lack of energy in raising money and seeking new projects, and its inability to issue decisive reports in a reasonable amount of time. Early in 1985, however, the National Academy of Sciences rejected the major conclusion of the Sproull report that the IOM be converted into the National Academy of Medicine and its research functions moved to the National Research Council. The NAS granted the IOM a reprieve. The IOM cooperated with the NAS in selecting Samuel Thier as the new IOM president at the end of 1985. Thier conducted an energetic campaign to raise a permanent endowment for the IOM. Circumstances that had conspired against Fred Robbins, such as the NAS's lack of faith in the IOM, the depressed economy, and Ronald Reagan's control of the nation's political agenda, turned around for Sam Thier. He gained the respect of Frank Press; the economy improved; Reagan's influence faded during his second term; and the foundations, having subjected the IOM to such a close critique, felt

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To Improve Human Health: A History of the Institute of Medicine obligated to participate in its recovery. With more money came a better ability to disseminate the results of the IOM's work. The drab reports of the 1970s became the colorful and skillfully edited reports of the 1980s. More money also brought more independence and flexibility. Thier used the money and his newly won clout within the Academy to launch a public health crusade against AIDS. Money for the IOM's AIDS activities was not initially forthcoming from foundations or the federal government. To his credit, Thier decided to proceed on his own. The move paid off handsomely. This activity, more than any other, enabled the IOM to achieve a sense of visibility within the universe of health care policy. Furthermore, the Bush administration proved a much more willing ally of the IOM than the Reagan administration. As a result, the IOM remained close to AIDS policy even when the action shifted to the Presidential Commission. In the AIDS initiatives, the IOM came the closest to realizing Walsh McDermott's vision of a socially engaged organization tackling the toughest public health problems of its era. Ken Shine inherited an active and financially prosperous organization from Thier. The problem for him was how to maintain the sense of momentum in an era when the nation's health challenges did not present the same sorts of opportunities for the IOM that they had in the second half of the 1980s. The divisions, augmented by the addition of the Medical Follow-Up Agency and the Food and Nutrition Board, continued to pour out reports. It was Shine's job to interpret the IOM's mission so as to bring the organization's activities into focus and demonstrate that they centered on a coherent theme. As he did so, he sought to preserve the IOM's basic characteristic of being engaged, yet independent, as it brought credible data to problems in health care. As the history described here unfolded, the IOM's followers continued to seek measures of the organization's influence. In the early years, this influence of the IOM on health policy was small; in later years, particularly during the campaign against AIDS, this influence increased. Although the AIDS activities were a significant exception, the IOM gained the most influence in situations in which it faced a well-defined problem and in which outside political actors were prepared to act on the IOM's proposed solution. Hence, the IOM achieved more with its report on nursing home regulation than it did with its report on medical malpractice. Still, to dwell on political influence misses the point of many IOM activities. The IOM was different from a professional trade association, such as the American Medical Association, that

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To Improve Human Health: A History of the Institute of Medicine attempted to articulate and protect the professional interests of its members, or from an organization such as the Association of American Medical Colleges, often described in the popular press as a powerful lobby on behalf of academic medical centers. The difference was in part that the IOM sought to educate the general public and health policy decisionmakers on important aspects of health science and health practice. Public education took such forms as the Food and Nutrition Board's report on diet and chronic illness and the IOM report on bereavement or an even less high-profile report, such as the one on pain and disability. The Institute's convening functions represented a more private form of education. In the IOM's Forum on Drug Development, for example, administrators in the public and private sectors learned from one another. Meetings of the IOM Council, the various divisional boards, and the many steering committees all served as educational experiences for those who participated. Throughout its history, whatever its particular fortunes at the moment and whatever the results of a particular study, the IOM excelled at bringing talented and creative people together and letting them listen to one another. Even without solid empirical evidence of the sort needed for an IOM report, one can confidently assert that such interactions improved the quality of American health care. When Walsh McDermott, Irvine Page, and James Shannon conducted their debates in the Board on Medicine, observers tended to regard each of their outlooks as distinct. An academy of medicine was different from a socially minded group concerned with health, which was different in turn from a private entity that protected the federal research mission in health. As it turned out, each of the notions was realized in the IOM's subsequent development. The IOM became a high-prestige organization that responded to the problems of academic physicians, as Page wanted. It evolved into an ally of the National Institutes of Health as they pursued their basic research missions, which Shannon wanted. Finally, although it took some time, the Institute of Medicine ultimately became a catalyst for the nation's public health campaigns, as McDermott wanted. If the IOM began in modest circumstances, it celebrated its 25th anniversary as a major factor in the formulation of the nation's health care policy.

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To Improve Human Health: A History of the Institute of Medicine Notes 1.   Donna E. Shalala, ''25th Anniversary Keynote Address," in Institute of Medicine, 2020 Vision: Health in the 21st Century. Institute of Medicine 25th Anniversary Symposium (Washington, D.C.: National Academy Press, 1996), p. 108. 2.   Institute of Medicine, Molla S. Donaldson and Kathleen N. Lohr, eds., Health Data in the Information Age: Use, Disclosure, and Privacy (Washington, D.C.: National Academy Press, 1994), pp. 8, 10. 3.   Institute of Medicine, Gooloo S. Wunderlich, Frank A. Sloan, and Carolyne K. Davis, eds., Nursing Staff in Hospitals and Nursing Homes: Is It Adequate? (Washington, D.C.: National Academy Press, 1996), pp. 3, 4, 17–18. 4.   Nursing Staff in Hospitals and Nursing Homes, p. 9. 5.   Institute of Medicine, Barbara S. Lynch and Richard J. Bonnie, eds., Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youths—Overview (Washington, D.C.: National Academy Press, 1994), p. 5. 6.   Ibid., p. 4. 7.   Institute of Medicine, Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam (Washington, D.C.: National Academy Press, 1994), pp. 23–73. 8.   Ibid., pp. v–vii. 9.   Ibid., pp. 6–8, 16–21. 10.   Institute of Medicine, Sarah S. Brown and Leon Eisenberg, eds., The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families (Washington, D.C.: National Academy Press, 1995), pp. 2–5. 11.   Ibid., pp. 8–9. 12.   Ibid., p. 13. 13.   Joshua Lederberg, Robert E. Shope, and Stanley C. Oaks, Jr., eds., Emerging Infections: Microbial Threats to Health in the United States (Washington, D.C.: National Academy Press, 1992), pp. v, 1–2, 8. 14.   For the IOM's follow-up to the report, see Kenneth Shine's remarks at the 1994 annual meeting, unpublished typescript, IOM offices. 15.   Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (Washington, D.C.: National Academy Press, 1994), pp. 5–8. 16.   Ibid., pp. 8–28. 17.   Institute of Medicine, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies (Washington, D.C.: National Academy Press, 1994), pp. 5, 15. 18.   Institute of Medicine, Thomas R. Eng and William T. Butler, eds., The Hidden Epidemic: Confronting Sexually Transmitted Diseases (Washington, D.C.: National Academy Press, 1997), pp. 27–30. 19.   Institute of Medicine, William N. Kelley and Mark A. Randolph, eds., Careers in Clinical Research: Obstacles and Opportunities (Washington, D.C.: National Academy Press, 1994). 20.   Careers in Clinical Research, p. 12; Growing Up Tobacco Free, p. 22.

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To Improve Human Health: A History of the Institute of Medicine 21.   Institute of Medicine, Catherine E. Woteki and Paul R. Thomas, eds., Eat for Life: The Food and Nutrition Board's Guide to Reducing Your Risk of Chronic Disease (Washington, D.C.: National Academy Press, 1992), pp. iii, 6, 29; Institute of Medicine, Nutrition During Pregnancy and Lactation: An Implementation Guide (Washington, D.C.: National Academy Press, 1992). 22.   Institute of Medicine, Annual Report 1991 (Washington, D.C.: National Academy Press), p. 49. 23.   I am grateful to Mike Edington for supplying me with information on these matters. 24.   This account of the IOM's strategic planning activities relies on documents in the files of IOM President Kenneth Shine, some of which are not yet available to researchers. Institute of Medicine, "Action Plan, 1993," approved by IOM Council on November 15, 1993. 25.   "IOM Strategic Planning Activity, Conference Call with Foundation Officials," June 25, 1997, Shine Files. 26.   "IOM Strategic Planning Activity, Meeting with Association Executives," March 6, 1997, Shine Files. 27.   "IOM Strategic Planning Activity, Meeting with Health Reporters," March 13, 1997, Shine Files. 28.   "Summary of Discussion," Blue Sky Dinners, April 1, 1997, and April 8, 1997, Shine Files. 29.   Institute of Medicine, "Revised Mission, Goals, Objectives, Strategies—1997 Strategic Planning Effort," approved by the IOM Council October 21, 1997, Shine Files. 30.   "What Is IOM Doing About Health Reform?" IOM News, Volume 1, Issue 2 (March/April 1993), p. 1; Kenneth Shine, remarks at 1993 annual meeting, typescript obtained from IOM offices. 31.   "What Is IOM Doing About Health Reform?" 32.   Kenneth Shine's remarks at 1994 annual meeting, typescript, privately held by the IOM; "Protecting and Improving the Quality of Care Should Be a Key Element in Health Reform," IOM News, Volume 2, Issue 4 (July/August 1994), p. 1. 33.   Institute of Medicine, "Steering Committee on America's Health in Transition: The IOM Special Initiative on Protecting and Improving Quality of Health and Health Care," March 15, 1994, Shine Files. 34.   Copies of reports and examples of each of these undertakings are available in a specially prepared notebook, Institute of Medicine, "Special Initiative on Health Care Quality," updated October 1997, Shine Files. 35.   John Cooper, Interview with Harvey Sopolsky, Sproull Committee Files, Accession 89-013-5, IOM Records.