6
The Institute of Medicine and AIDS

We are losing a generation of well-trained and exceptionally talented men,'' lamented June E. Osborn, dean of the School of Public Health at the University of Michigan, in a plaintive comment delivered in the course of what one observer described as a "remarkable" speech about the AIDS (acquired immune deficiency syndrome) epidemic at the Institute of Medicine's (IOM's) 1985 annual meeting.1 She spoke at a discouraging time, when leadership in responding to the epidemic appeared to be lagging. President Ronald Reagan, for example, could not bring himself to utter the terms "AIDS" until the death of movie star Rock Hudson brought the subject into the open. Partly as a result of the silence of political leaders, the public appeared to be dangerously misinformed about the epidemic. At the same time that June Osborn, a student of Fred Robbins, gave her IOM speech on AIDS, a New York Times-CBS poll found that 47 percent of Americans believed that AIDS could be transmitted by sharing a drinking glass.2

In large part because of the IOM's activism on the AIDS issue beginning in 1985, the public began to receive better, more scientifically informed information on the subject, and the federal government made AIDS a higher priority in its research funding and public health activities. It would not be an exaggeration to say that the Institute of Medicine became the focal point of the nation's response to AIDS in 1986, and it continued to play a central leadership role in public policy toward AIDS in the years that followed. During the presidencies of Samuel Thier and Kenneth Shine, who became the head of the IOM in January 1992, the Institute issued two seminal reports on the nation's handling of the AIDS epidemic, conducted numerous workshops on nearly every facet of AIDS, and produced a series of reports on the government's management of the disease. In these ways, the Institute of Medicine realized its potential to serve as the voice of the scientific, public health, and medical communities in the face of a national emergency.



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To Improve Human Health: A History of the Institute of Medicine 6 The Institute of Medicine and AIDS We are losing a generation of well-trained and exceptionally talented men,'' lamented June E. Osborn, dean of the School of Public Health at the University of Michigan, in a plaintive comment delivered in the course of what one observer described as a "remarkable" speech about the AIDS (acquired immune deficiency syndrome) epidemic at the Institute of Medicine's (IOM's) 1985 annual meeting.1 She spoke at a discouraging time, when leadership in responding to the epidemic appeared to be lagging. President Ronald Reagan, for example, could not bring himself to utter the terms "AIDS" until the death of movie star Rock Hudson brought the subject into the open. Partly as a result of the silence of political leaders, the public appeared to be dangerously misinformed about the epidemic. At the same time that June Osborn, a student of Fred Robbins, gave her IOM speech on AIDS, a New York Times-CBS poll found that 47 percent of Americans believed that AIDS could be transmitted by sharing a drinking glass.2 In large part because of the IOM's activism on the AIDS issue beginning in 1985, the public began to receive better, more scientifically informed information on the subject, and the federal government made AIDS a higher priority in its research funding and public health activities. It would not be an exaggeration to say that the Institute of Medicine became the focal point of the nation's response to AIDS in 1986, and it continued to play a central leadership role in public policy toward AIDS in the years that followed. During the presidencies of Samuel Thier and Kenneth Shine, who became the head of the IOM in January 1992, the Institute issued two seminal reports on the nation's handling of the AIDS epidemic, conducted numerous workshops on nearly every facet of AIDS, and produced a series of reports on the government's management of the disease. In these ways, the Institute of Medicine realized its potential to serve as the voice of the scientific, public health, and medical communities in the face of a national emergency.

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To Improve Human Health: A History of the Institute of Medicine Facing Up to the Problem In the summer of 1983, the IOM Council first took up the matter of AIDS at the urging of its members. One call to IOM President Fred Robbins came from Dr. Robert Ebert, the head of the Milbank Memorial Fund and later an influential figure in mobilizing the Sproull committee, who suggested that the IOM review the current research in the field. When Robbins raised this suggestion with Ed Brandt, the Assistant Secretary for Health at the Department of Health and Human Services (HHS), Brandt told him that there was little the IOM could do, even though Brandt had called AIDS the nation's number one priority in public health. Because Robbins had no desire to embarrass or upstage Brandt, who was an important supporter of the IOM within the Reagan administration, he assured Brandt that the IOM would do nothing until it received a specific request from the government. Council members requested that Robbins press Brandt on the matter and Robbins did so, only to receive the same response. The two agreed that the IOM would postpone any activity related to AIDS.3 This enforced passivity did not sit well with either Robbins or the IOM Council. In the spring of 1985, the IOM decided, on its own initiative and with Fred Robbins' strong endorsement, to dedicate its annual fall meeting to the subject of AIDS. By this time, many IOM Council members, such as John J. Burns, a chemist with a distinguished background as a researcher in the pharmaceutical industry, wanted the IOM to become more involved in public policy toward AIDS. Although Robbins sensed and shared the members' restiveness on this issue, he continued to believe that there was nothing the IOM could do "without the support and encouragement of the Public Health Service."4 Robbins did all he could to keep the pressure on the Public Health Service (PHS), and near the end of his presidency he sensed that the PHS attitude toward working with the IOM was gradually shifting. Sometime over the summer of 1985, he heard from James Mason, the director of the Centers for Disease Control (CDC), who suggested that the IOM examine the issues surrounding school admission policies for children with AIDS. At the time, the school attendance of children infected with what later became known as human immunodeficiency virus (HIV), the causative agent of AIDS, was a sensitive issue capable of igniting mass hysteria in an affected community. At the end of August 1985, the Public Health Service issued a set a recommendations on this matter in which the CDC stated flatly that "casual person-to-person contact as would occur among schoolchildren

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To Improve Human Health: A History of the Institute of Medicine appears to pose no risk.'' Simply put, the CDC wanted company in making these sorts of pronouncements and sought out the IOM to add its authoritative voice and validate the CDC's conclusions. Robbins suggested that perhaps the time had come to pull together an IOM task force that would consider all aspects of the AIDS problem and identify the specific things that the IOM could do.5 On October 16, 1985, the IOM devoted its annual program to the subject of AIDS., Chaired by Philip Leder, the head of the Department of Genetics at the Harvard Medical School, and staffed by Enriqueta Bond, the meeting considered the scientific, ethical, sociological, and financial issues related to AIDS. The key speakers were government officials who reported on the scope of the epidemic and detailed the government's response. These included James Curran, chief of the AIDS branch of the CDC, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH); and Robert C. Gallo, chief of the National Cancer Institute's Laboratory of Tumor Cell Biology. The meeting generated such interest that with the aid of funds from Hoffman-La Roche and the National Research Council (NRC), and with the assistance of Bond and science writer Eve Nichols, the IOM transformed the talks into a coherent volume that Harvard University Press published in 1986. 6 The volume served as a careful compendium of information related to AIDS. Written in accessible language, similar in tone to the IOM report summaries of the period, the book was intended to reach a wide audience of educated, but not scientifically sophisticated, readers. Here one could find a journalistic description of the epidemic's human face—"in cities across the United States, homosexuals describe the anguish of watching one friend after another weaken and die"—and an epidemiological description of the epidemic's course—"experts expect that a total of 14,000 to 15,000 new cases of AIDS will be diagnosed in 1986 and that at least 7,000 AIDS patients will die." The book also explained how scientists identified the virus that causes AIDS, unveiled the virus's genetic code, and produced an effective test for presence of the virus. Still, the volume could hardly be read as an ode to scientific progress. "These monumental achievements," Eve Nichols wrote, "do not mean that there will be a rapid solution to the AIDS problem.''7 The problem for the nation and the world was how best to encourage a solution and what to do in the painful interim. On the day after its annual meeting, the IOM, with the encouragement of Frederick Robbins, held a follow-up workshop in which the invited participants tried to define an appropriate role for the IOM in

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To Improve Human Health: A History of the Institute of Medicine combatting the AIDS epidemic. The discussion centered on applied science, such as the development of an AIDS vaccine or an antiviral drug. Less was said about the provision of care to AIDS patients and the many medical, social, and behavioral issues involved. Whatever their particular take on the problem, the participants agreed that AIDS was an appropriate subject for the IOM to consider.8 By the time the IOM Council next sat down to discuss this matter, Samuel Thier, rather than Fred Robbins, presided over the IOM. For at least two reasons, Thier wanted to finish what Robbins had begun. First, the subject of AIDS interested Thier, who had seen a large number of AIDS patients as chief of medicine at Yale. Second, Thier recognized that because the IOM's response to AIDS was largely unformed in November 1985, it would be amenable to his influence. AIDS had the potential to become one of the IOM's signature activities, a demonstration of the Institute's competence and newfound sense of activism. In November 1985, the IOM Council unleashed a torrent of ideas about how the IOM should respond to AIDS. John Burns suggested that the IOM might coordinate trials for the antiviral drugs that were being developed to combat AIDS. Although it seemed unlikely that the IOM would usurp the role of the Food and Drug Administration (FDA), other activities appeared more plausible. Burton Weisbrod, an economist from the University of Wisconsin, said that the IOM should insert a calm and reasoned viewpoint into an often unreasonable debate because, as matters stood, too many people with too many irresponsible ideas threatened to dominate the discussion. If the IOM were to survey the field, Weisbrod argued, it would have to do so quickly, possibly completing its study in three months, because information moved too fast for the IOM to undertake one of its leisurely two-year studies. Gilbert Omenn, dean of the University of Washington's School of Public Health, countered that the subject was too important and too complex for such a cursory examination. Listening to the conversation, Thier decided that "there was a strong sense among Council members that IOM should be involved in the AIDS issue." He announced his intention to meet with National Academy of Sciences (NAS) President Frank Press to discuss an Academy-wide, multifaceted approach to the issue. With such an approach, the IOM could speak to the government and scientific communities interested in vaccines and drugs, the public health community concerned with the provision of care, and the government and private insurers involved in financing the costs of care. Thier envisioned one overarching group to coordinate the process, with subgroups formed as necessary. 9

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To Improve Human Health: A History of the Institute of Medicine Organizing an NAS response to the AIDS epidemic became Thier's top priority and the first project he tackled as IOM president. In less than three months, he persuaded Frank Press and the Council of the National Academy of Sciences to join in the effort, and he and Press convinced the National Research Council to support the project with its own funds. Thier and Press appointed an 11-person steering committee, cochaired by David Baltimore of the Whitehead Institute for Biomedical Research in Cambridge and Sheldon Wolff of the Tufts medical school, to develop "a national agenda on research and health care for AIDS." David Baltimore, a biologist from the Massachusetts Institute of Technology (MIT) who had won the Nobel Prize in 1975 for his work on retroviruses, headed the Research Panel. Among its members was Howard Temin of the University of Wisconsin, who had shared the 1975 Nobel Prize with Baltimore. Sheldon Wolff, the chair of the Department of Medicine at Tufts and an expert on infectious diseases, led the Health Care and Public Health Panel. It consisted of 10 people concerned in one way or another with public health, including June Osborn of the University of Michigan and David Fraser, the president of Swarthmore College.10 Toward the 1986 Report These individuals were expected to produce a comprehensive report on AIDS in six months. On the scientific side, the National Academy of Sciences directed the committee to consider the appropriate actions necessary to develop, test, and distribute a vaccine and to develop "chemotherapeutic or chemoprophylactic agents." On the public health side, the NAS wanted the committee to provide advice on appropriate measures to protect the public from the disease and on the best means of treating the affected population and financing the treatment. The need to move so quickly was dictated by the size of the problem. At the time the Academy took action, public health authorities estimated that 20,000 Americans had full-blown AIDS, with few expected to survive for more than 18 months. The CDC hypothesized that between 1 million and 2 million Americans were HIV-positive, with at least 45 percent of these individuals expected to develop the disease. Rough estimates of the Medicaid costs of treating an AIDS patient in California over the course of the illness were about $59,000 per patient. Each of these statistics was an indication that "the spread of the disease has outdistanced public and private efforts to identify and coordinate the actions that are needed."

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To Improve Human Health: A History of the Institute of Medicine Hence, the Institute of Medicine and the National Academy of Sciences sought to play a leadership role on AIDS.11 Two things about the nature of the effort were noteworthy. First, the Institute of Medicine took the lead in developing the AIDS report and the National Academy of Sciences acquiesced. The report of the Committee on a National Strategy for AIDS appeared in October 1986 as a publication of the Institute of Medicine, rather than the National Academy of Sciences or the National Research Council. The IOM staffed the effort on behalf of the Academy, with Roy Widdus, staff director of the IOM's Division on International Health, detailed to the committee. The fact that the NAS allowed the IOM to direct such an important, high-profile activity of the Academy complex represented a vote of confidence in the IOM and its new president. It demonstrated that the stigma of the Sproull report was beginning to fade. Second, the IOM decided to initiate the project without waiting for an invitation from the CDC, NIH, HHS, or some other component of the federal government. Contrary to the usual rhythms in health policy, the Institute of Medicine moved more quickly than did the federal government. The Committee on AIDS resembled nothing so much as a presidential commission, yet it was the IOM, not the federal government, that did the commissioning. In effect, the IOM filled a void left by the government. In the past, the IOM had often evaluated actions taken by the federal government. In the AIDS effort, the IOM acted in advance of the federal government. The committee's efforts got under way at the beginning of March 1986, with a special workshop on AIDS epidemiology and disease burden projections that was intended to provide the committee with a good road map on the size and shape of the problem. J. Thomas Grayston, a professor of epidemiology at the University of Washington, who headed the epidemiology working group advising the committee, chaired the meeting, which showed just how difficult a topic AIDS was. Part of the problem was the lack of reliable information that came from the news media. As James Curran, the medical epidemiologist who worked on AIDS for the CDC, stated, "A lot of the stuff is a bunch of garbage that you read in the newspapers." Another part of the problem was the fact that no one had a good handle on the potential size of the epidemic. "How many people are infected?" Curran asked. "The answer is, and this is open to challenge, no one knows." As for the ultimate case fatality rate, Curran believed that ''the ultimate case fatality will be higher than 10 percent. Whether it is 50 percent or 100 percent or 40 percent is unknown, in my opinion.''12

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To Improve Human Health: A History of the Institute of Medicine Against this backdrop of uncertainty, the steering committee and the two panels met for the first time on March 13, 1986. The first meeting produced less posturing and turf protecting than usual at the start of an IOM project, in part because all of the committee and panel members understood the gravity and urgency of the task and in part because the committee and panels covered such a wide range of professional backgrounds and expertise. The general attitude was one of wanting to get up to speed on the topic of AIDS as quickly as possible. Even as committee members took a crash course on the AIDS epidemic, they grappled with the practical problems that inhibited action in the field. They decided, for example, to conduct two public hearings, one on either coast, so as to counteract the charge, in David Baltimore's words, "of being insensitive to the perspective and needs of the communities which are now shouldering the burden." The community of male homosexuals was chief among these, and as the committee learned, the fact that the syndrome disproportionately affected an already stigmatized group greatly complicated the politics of public health. Jerome Groopman, a hematologist at the Harvard Medical School, told, for example, of hearing rumors that money to educate members of the gay community on safe sex practices was not distributed because of a belief that such effort "directly discussed gay sexual practices" and hence "essentially condoned sodomy." The risk of reinforcing socially unacceptable practices applied even more to intravenous (IV) drug users because lessening the transmission of AIDS for this community meant making it safer to take illegal drugs. As one committee member expressed this idea, "At what point does education for the risk group be seen by some group as license or teaching people how to be addicts effectively and how to be gay?''13 Complicating the situation, the public appeared to favor repression over license and denial over action. At first, public health officials could not get anyone interested in AIDS. Walter Dowdle of the Public Health Service told the committee that 1981 and 1982 were "very discouraging years" in which it was difficult to get local communities to believe "it was something that we did have to pay attention to and indeed this was a problem that was going to affect all of us." Once past the smug reassurance that AIDS was something that happened to someone else and would soon succumb to the march of modern science, people reacted with hysteria. Again ignoring the best advice of public health experts, state legislatures considered bills calling for suspending HIV-positive individuals from handling food or prohibiting HIV-positive children from attending school. Paul Volberding of San Francisco General Hospital, on the front lines of

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To Improve Human Health: A History of the Institute of Medicine the nation's fight against AIDS, said that "people enjoy the thrill of the fear of AIDS and don't want to hear the reassuring things." 14 Not only was AIDS a public health challenge, it also posed considerable problems for the scientists on the committee's Research Panel. As Irving Weissman of Stanford Medical School put it, "This virus stretches our knowledge." As a result, producing a vaccine to prevent AIDS looked to be a complicated matter. In the near future, at least, it did not appear as though the AIDS crisis would end, as the polio crisis did, with the introduction of a new vaccine. "I think it is very important," said Howard Temin, "that the report not be able to read that a vaccine is soon going to come." Although David Baltimore agreed, he thought it important for the committee to give some sort of timetable for the development of a vaccine, such as 10 years. Most of the scientists accepted the fact that a great deal of useful work had been done on the AIDS virus and agreed on the need for further work. Where they disagreed was on how to structure research activities. Maurice Hilleman of the Merck Institute for Therapeutic Research called for "a coordinated national effort" involving both the public and the private sectors. For his part, Howard Temin worried about a top-down, "centralized" campaign. He preferred to have "lots of different groups, very well supported, working on the common problem." In other words, Hilleman saw the fight to eradicate AIDS as something like the Manhattan Project, in which scientists and engineers banded together under central direction and produced the bomb. Temin believed that the attempt to halt AIDS should be science as usual, only more so: more investigators, more experiments working not in concert but on a common intellectual problem. Although most of the scientists did not disagree with Temin, they still felt the need to create "some kind of group over and above the battle to take a look at it" and to make sure that all appropriate resources had been brought to bear on the problem. In this spirit, David Baltimore closed the first meeting of the Research Panel on a fervent note. ''What I am interested in, "he said,"... is the number of people who accept immediately the fact that we are in a situation of national need, maybe not in the form of a Manhattan Project, but certainly on an order of magnitude that we have not seen in our lifetime."15 The message from the scientists was that a "cure" for AIDS would take a long time to develop, even under the warlike conditions that scientists hoped to create. This made it all the more important for the health care system to learn to treat patients with AIDS. In this area as in others, the committee discovered that AIDS confounded conventional wisdom. Because AIDS patients developed so many problems in so many different parts of their bodies, their treatment

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To Improve Human Health: A History of the Institute of Medicine threatened the "subspecialty approach to medicine." As one doctor from San Francisco told the committee's Health Care and Public Health Panel, AIDS "is a much more complex disease than most others that we've faced.... All areas of medical care end up being involved in these patients." Diseases that affected the general population in one way affected AIDS patients in another, upsetting traditional treatment regimens. For a health financing system coming to depend on "diagnosis-related groups" (DRGs) that matched particular diseases or procedures with a pattern of hospital reimbursement, AIDS posed a considerable challenge. One official told the committee that ''if you try to make one DRG out of AIDS, it would be one of the worst DRGs in terms of homogeneity, in terms of length of stay within that DRG that we've seen."16 The first meeting of the committee ended with only a general agreement that the nation needed to do more to respond to AIDS. The chief points of disagreement continued to be over how such an effort should be organized. The disagreements, in turn, reflected different readings of recent history. For some, such as David Baltimore, the war on cancer had been a great success, and as one participant put it, "the thing that made the difference ... was simply dangling money in front of people." For others, such as Sheldon Wolff, the war on cancer was a "total flop." The difference in opinion was also one of perspective. For the scientists, the war on cancer was a success because it had led to great deal of creative science. For the clinicians, the war on cancer was a more limited success because it had not put an end to the disease. Similar considerations applied to AIDS. The nation would have to decide how much to spend on the promise of cure through basic science and how much to spend on care through public health and clinical measures. In the mid-1980s, unlike the early 1970s when the war on cancer was declared, the choices were more stark. "We live under Gramm-Rudman," said Sheldon Wolff, referring to an agreement in place to limit the rate of growth in the federal budget, "it is not business as usual." David Baltimore regarded AIDS as the leading health problem in the country, requiring the diversion of funds from other priorities. Sheldon Wolff believed that AIDS was a very serious problem but that others were also serious. Hence, the committee should be cautious about declaring war on AIDS if this meant diverting funds from other areas of health policy, particularly because funds were so tight.17 The committee continued to debate these issues through the spring and into the summer of 1986. Often the committee heard from AIDS activists in public and from leading scientists and public health researchers in private. The public hearings took on the aspects of a

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To Improve Human Health: A History of the Institute of Medicine ritual, in which a person representing a particular group, such as the National Association of Gay and Lesbian Professionals, made a short statement for the record. The committee members who attended the hearings in New York and San Francisco almost never asked questions of the presenters. By way of contrast, they had many questions for the experts, such as health statistician Dorothy Rice, who briefed them on various aspects of the problem.18 Inside the Research Panel, scientists debated, as they had from the very beginning of the effort, whether to recommend some sort of central committee to coordinate and evaluate AIDS activities. In arguing for a committee, Baltimore pointed to such bureaucratic failures as the lack of close collaboration among the institutes of NIH, the failure of the Department of Defense to take advantage of resources at the CDC and NIH, the absence of contact and the presence of competition between the CDC and NIH, and the lack of interchange between NIH and the external scientific community. Each of these factors indicated that the government was not responding as effectively to the AIDS crisis as it might. Baltimore's remedy was an "ongoing commission" to monitor the course of the disease, evaluate research efforts, and catalyze coordinated efforts. The panel both accepted and tempered this argument. It did not favor a commission that had the power to allocate funds to particular researchers or research establishments. Instead, it decided on an advisory commission, perhaps operated by the Institute of Medicine, that would operate through moral suasion and public relations and would be independent of the federal government. In fact, the panel recommended a commission much like itself.19 The 1986 Report In the final report, issued on October 29, 1986, Baltimore's recommendation of an ongoing commission took the form of a National Commission on AIDS appointed not by the Institute of Medicine but by the President of the United States or jointly by the President and Congress. It was the committee's way of indicating that AIDS required the attention of the nation's political leaders, not just the medical and scientific communities. In general, the committee tried to bring a sense of urgency to the problem. On the public health side, it called for a "massive media, educational and public health campaign to curb the spread of the HIV infection." On the scientific side, it advocated "substantial, long-term and comprehensive programs of research in the biomedical and social sciences intended to

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To Improve Human Health: A History of the Institute of Medicine prevent HIV infection and to treat the diseases caused by it." The committee advised that these programs would cost $2 billion annually by the end of the decade, all part of "the most wide-ranging and intensive efforts ever made against an infectious disease."20 Beyond these major recommendations, the committee also addressed many other aspects of the AIDS crisis. To curb the spread of HIV infection, the committee suggested that more people receive serologic testing, although it favored voluntary testing with the results kept confidential. The committee also cautiously recommended that clean needles and syringes be more freely available to IV drug users in order to reduce the sharing of contaminated equipment. To treat AIDS patients, the committee called for more planning and training so as to cope with an increasing case load of patients with HIV infection. The committee sought to emphasize care in the community, keeping hospitalization to a bare minimum. To further the research effort, the committee cited the need for basic research in virology, immunology, and viral protein structure, as well as the need for more epidemiological research to trace the spread of the HIV infection. Academic scientists could be encouraged to participate in research against AIDS through an increase in funding for investigator-initiated research proposals, but the federal government should also solicit the participation of private industry in this effort. A key part of the research infrastructure that required attention was an expansion of "experimental animal resources," with careful conservation of the chimpanzees that were used in AIDS experiments. The United States should also recognize the international dimensions of the AIDS crisis and become a full participant in international efforts against the epidemic, including support of World Health Organization (WHO) programs.21 Not content to stop there, the committee also addressed questions related to civil rights, making the flat statement that "discriminating against those with AIDS or HIV infection because of any health risk they may pose to others in the workplace or in housing is not justified and should not be tolerated." Further, the committee worried about discrimination against individuals simply because they were members of high-risk groups and recommended that "any form of discrimination against groups at high risk for AIDS should be prohibited by state legislation and, where appropriate, by federal laws and regulations." 22 Viewed as a coherent document, rather than a laundry list of recommendations, the report reflected an interesting blend of scientific, medical, and sociological concerns. On the one hand, the report praised federal research efforts. On the other, the report

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To Improve Human Health: A History of the Institute of Medicine 1985, more than 12,000 recipients of blood transfusions also became infected with HIV. This situation raised a host of questions and led to a search to assign blame for this apparent breakdown in the nation's system of public health protections. Hemophiliacs, in particular, lobbied Congress in an effort to affix blame and seek redress.58 In April 1993, Senators Edward Kennedy (D-Mass.) and Bob Graham (D-Fla.) and Congressman Porter Goss (R-Fla.) requested that the Department of Health and Human Services investigate what had happened. Responding in July 1993, Secretary of Health and Human Services Donna Shalala agreed on the need for an investigation. For her and the Democratic party, such an investigation offered an opportunity to delve into an apparent mistake that had been made by a Republican administration. On the surface, at least, it looked as though this mistake stemmed in part from an overzealous reliance on the private market to maintain the public's safety. Because Republicans had allowed the CDC and the FDA to deteriorate as a result of a predetermined belief in the futility and inefficiency of federal regulation, a tragedy of epidemic proportions had occurred. Furthermore, the Democrats in Congress and in the executive branch realized that hemophiliacs and recipients of blood transfusions were, along with children who had been infected by their mothers, the perfect victims of this tragedy to exploit for political purposes. Unlike homosexuals who engaged in anal intercourse or drug abusers who injected poison into their veins, neither hemophiliacs nor blood transfusion recipients, such as tennis player Arthur Ashe, could be said to have brought AIDS on themselves. Aware of these political overtones, Shalala made sure to cast the project not as a retrospective witch hunt but rather as a future-oriented effort to draw lessons that might be relevant to future threats to the safety of the nation's blood supply. To make sure it was not labeled the product of a partisan administration, she commissioned the Institute of Medicine to do the study, which got under way in 1994.59 Harold C. Sox, Jr., head of the Department of Medicine at Dartmouth, chaired the 14-person committee. Half of the people on the committee were physicians. The other half consisted of a nurse, an ethicist, one of the nation's leading historians of medicine, a prominent student of administrative law, a political scientist who had written widely on public administration and bureaucratic behavior, a sociologist, and a lawyer. It was an extremely able and intellectually versatile group, with no concessions made to the many interest groups who had pushed Congress to investigate the matter. Not until April 1994 did this group begin to meet in a serious way. The composition of

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To Improve Human Health: A History of the Institute of Medicine the committee and the delay in initiating the project led to a certain amount of restiveness in Congress. Although Congressman Goss and Senator Graham called attention to the NAS's "integrity and professionalism in conducting complex and sensitive studies," they shared the fears of their constituents that the study "would drag on too long and yield inconclusive results."60 To do its job, the committee had to delve into the decisionmaking processes that governed the control of the nation's blood supply between 1982 and 1986. This required the committee to assemble an archive of documents from government agencies such as the Food and Drug Administration, consumer interest groups such as the National Hemophilia Foundation, private groups involved in the blood supply system such as the American Association of Blood Banks, and suppliers of blood and blood products such as the American Red Cross. To make sense of these documents, the committee studied the nation's complex system of acquiring, distributing, and regulating the quality of its blood supply. The committee had to determine how consumers of blood products, the doctors who cared for these consumers, and public health authorities came to be aware of AIDS and of the fact that HIV could be transmitted through blood. The events between December 1982, when the first report of AIDS in a patient with hemophilia appeared, and the 1985 decision to undertake routine screening of blood for HIV were particularly crucial. As the committee tried to understand how the system worked and what had caused it to go wrong, it received a great deal of help from study director Lauren Leveton and from others who worked for the IOM's Division of Health Promotion and Disease Prevention.61 From the beginning, the committee heard from the victims of tragedy. On May 16, 1994, it met with Dana Kuhn, who spoke on behalf of the Committee of Ten Thousand, a national organization that provided peer advocacy and support to persons infected with HIV through tainted blood and blood products. On March 26, 1983, Kuhn, a medical doctor and hemophiliac, received HIV-and hepatitis-contaminated factor VIII, one of the naturally occurring proteins in the liquid part of the blood (known as plasma) that aided coagulation. He developed AIDS and, before he became aware of his condition, transmitted HIV to his wife through heterosexual intercourse. She died in 1987, leaving him with a 6-year-old and a 4-year-old to raise and with the expectation that he too would soon die. The committee also heard from Mr. Richard Valdez, the president of the Peer Group Association, who spoke about the death of one of his sons and the terminal illness of the other, as a result of using a blood product known generically as a "factor concentrate." In September, the

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To Improve Human Health: A History of the Institute of Medicine committee heard the testimony of Jonathan Wadleigh. "I have severe hemophilia and AIDS," he said; "I lost my brother to hemophilia-associated AIDS in 1986." He proceeded to relate his story, telling the committee that he had never had life-threatening bleeding due to hemophilia but that he had decided to use antihemophilic products to support his "active lifestyle." According to Wadleigh, "I was never told about the risks associated with the use of antihemophilic factor concentrates or given a choice as to what products I used. My experience is typical.''62 As the evidence mounted, the committee had to decide what to make of it. The dilemmas that the committee faced were those of the historian and the policy analyst. The evidence was, by its very nature, ambiguous—the product of faulty memories and differing perceptions of reality. Although contemporary documents helped to firm up times and dates, they too were subject to interpretation. Bureaucratic memoranda, for example, were written for many purposes, for example, to put forward a point of view or shape the course of future events, not merely to set down events for the record. Reading the documents, the committee had constantly to keep in mind that the participants in the events of the early 1980s did not know how things would turn out. People acted on the basis of available knowledge, which in retrospect could be shown to be flawed. Once the committee agreed on a version of what happened, it still had to tease out the significance. The danger was that the committee would base its recommendations for future actions on the basis of past behavior, without allowing policymakers to explore the similarities and differences between a past event and a future occurrence. In other words, the committee had to guard against recommending that the public health community fight the last war. The problems that the committee faced showed just how hard it was to create a usable past and, in general, how difficult it was to come to terms with the AIDS epidemic.63 In the July 1995 report, the committee presented a nuanced, balanced history of decisionmaking during the AIDS crisis and made reasoned recommendations designed to improve the nation's performance in a future crisis. The committee concluded that the events it analyzed "underscore the difficulty of personal and institutional decisionmaking when the stakes are high, when knowledge is imprecise and incomplete, and when decisionmakers may have personal or institutional biases." Whatever the difficulties, it was clear in retrospect that the system "did not deal well" with blood safety issues. The committee decided that "unless someone from the top exerts strong leadership, legal and competitive concerns may

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To Improve Human Health: A History of the Institute of Medicine inhibit effective action" by federal agencies. Further, the Food and Drug Administration lacked "a systematic approach to conducting advisory committee processes" and relied too heavily on the entities it regulated for data analysis. The lack of both strong leadership and an effective advisory committee process inhibited public agencies from thinking ahead and led to a cautious, and ultimately destructive, response to the crisis. To remedy these perceived problems, the committee made 14 specific recommendations. Some were bureaucratic, such as the suggestion that the Secretary of Health and Human Services "designate a Blood Safety Director at the level of deputy assistant secretary or higher" or that the Public Health Service "establish a Blood Safety Council." Others were strategic, such as the recommendation that federal agencies support and respond to the CDC in its responsibility to ''serve as the nation's early warning system for threats to the health of the public" or that the FDA encourage the blood industry "to implement partial solutions that have little risk of causing harm" in cases where ''uncertainties or countervailing public health concerns preclude completely eliminating potential risks." The committee also cautioned physicians and patients "faced with a decision in which all options carry risk" to "take extra care to discuss a wide range of options." To facilitate the flow of reliable information, the committee recommended that the Department of Health and Human Services convene an expert panel to inform people about the "risks associated with blood and blood products" and about the safety and efficacy of available alternatives. 64 The Committee on HIV and the Blood Supply did exactly what Secretary Shalala hoped it would. It stepped away from the emotional context of the situation and produced a dispassionate, yet thorough, analysis of the problem. It also made recommendations that showed sophistication about the ways in which bureaucracies and the political process worked. Secretary Shalala responded to these recommendations almost immediately, designating the Assistant Secretary for Health as the DHHS Blood Safety Director and creating a Blood Safety Committee composed of the heads of the FDA, CDC, and NIH. The report revealed the effectiveness of letting people with differing intellectual perspectives examine a problem in order to arrive at a useful synthesis. The ability to assemble a group with a wide range of interests and capabilities to examine a controversial problem without fear of political reprisal constituted a great strength of the IOM. The report on HIV and the blood supply not only showed these attributes to best advantage but also demonstrated that the

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To Improve Human Health: A History of the Institute of Medicine IOM and its staff had developed a sort of collective expertise on the subject of AIDS that could be put to a variety of uses.65 In 1994, the Institute of Medicine published a report on substance abuse and mental health issues in AIDS research that resulted from a congressional request for the IOM to investigate the AIDS-related research programs of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). In making this request, Congress specified that the evaluation be similar to the one the IOM had already performed for the National Institutes of Health. The final report contained references to no fewer than six previous IOM reports that were relevant to the specific subject of AIDS and behavior. H. Keith H. Brodie, president emeritus and James B. Duke Professor of Psychiatry at Duke University, chaired the advisory committee. A reorganization in the Department of Health and Human Services that took effect on October 1, 1992, made his job particularly difficult. Under this reorganization, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health moved to the National Institutes of Health; the service-providing components of ADAMHA became part of the Substance Abuse and Mental Health Services Administration. In addition, a bill passed in July 1993 changed the allocation of money for AIDS research within the National Institutes of Health. Hence, the committee faced a moving target. As with the study of HIV and the blood supply, the Committee on Substance Abuse and Mental Health Issues in AIDS research found a slow response on the part of the federal bureaucracy to the AIDS crisis. In the meantime, AIDS continued to grow as a public health problem. By the end of 1992, AIDS was the leading cause of death among men 25–44 years of age. Not until 1987 did the National Institute on Alcohol Abuse and Alcoholism devote more than 1 percent of its expenditures to AIDS research, and similar patterns applied to the other NIH institutes under study. When these institutes did start to spend a substantial amount of money on AIDS research in 1987, such as $139.3 million by the National Institute on Drug Abuse, they concentrated most of it on biological research and neglected behavioral research. Part of the problem was a political taboo against such activities as a "federally sponsored, national survey of sexual behavior to help determine the nature and level of risk for HIV transmission in the general population." The committee found numerous other gaps, for example, describing the effect of AIDS on those already suffering brain disorders as "remarkably understudied," and offered specific suggestions on how to close the gaps. It recommended that the three NIH institutes study how individuals

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To Improve Human Health: A History of the Institute of Medicine from diverse backgrounds "cope with the reality of having family members who are infected with HIV." It also suggested that they develop new programs "to encourage and facilitate innovative, collaborative, and cross-disciplinary proposals." To make sure AIDS received the proper emphasis at these institutes, the committee recommended that each establish "a full-time AIDS coordinator.'' Each institute should also "develop initiatives to support research on the role of social, cultural, and structural factors in HIV/AIDS transmission, prevention, and intervention.''66 Of necessity, AIDS and Behavior was a diffuse document, in part because of the original congressional mandate and in part because the subject did not lend itself to an overarching theme. Unlike the 1986 report and its 1988 update, the behavior study did not represent a general call to arms as much as a fine-tuning of bureaucratic priorities. The presence of such a study showed how the IOM addressed two substantively different audiences on the subject of AIDS. On the one hand, it sought to address the general public and the top levels of political leadership through studies such as Confronting AIDS. On the other hand, it attempted to reach the professional research community and the inner levels of the federal bureaucracy through studies such as AIDS and Behavior . Both groups listened. The Institute and AIDS In the decade between 1985 and 1995, AIDS became one of the IOM's signature activities, as Samuel Thier had hoped it would. The Institute could take credit for urging federal action to combat the epidemic at a time when the top levels of government preferred to ignore it. The 1986 and 1988 reports set the stage for the nation's response to AIDS and made the Institute of Medicine visible to the public for the first time. Many of the recommendations in these reports were written into law by Congress or put into operation by the federal bureaucracy. In August 1990, for example, Congress passed the Ryan White Comprehensive AIDS Resources Emergency Act, which established a federal grant program to cities that were affected by the epidemic. Congress patterned the program after the one that Stuart Altman had devised and the Oversight Committee on AIDS had recommended in 1988. The very existence of the congressionally mandated National Commission on AIDS, which served from 1989 to 1993, could be traced to recommendations in the 1986 report. In 1991, the Office of AIDS Research in the National Institutes of Health

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To Improve Human Health: A History of the Institute of Medicine issued a plan for AIDS research that marked a response to the IOM's report on AIDS research at the NIH. On the subject of AIDS, therefore, the IOM's recommendations brought strong responses. During the discussion of the Sproull report, a foundation executive had remarked that if the IOM did not exist, something similar would have to be invented to take its place. Whether or not this was true at the time remains a matter of debate. In the case of AIDS, however, the statement carried an undeniable element of truth. Simply put, without the IOM, the federal government's response would certainly have been delayed and, in all likelihood, different. The Institute of Medicine succeeded in letting the nation hear the opinions of doctors and scientists in the CDC, NIH, and elsewhere whose advice was largely ignored at the upper levels of the bureaucracy. Through the offices of the Institute of Medicine, these physicians and scientists joined their academic and private-sector counterparts in demanding that more attention be paid to the science, epidemiology, and patient care aspects of AIDS. In the case of AIDS, the IOM made a difference. The IOM could not have played such a prominent role on AIDS if Samuel Thier had not won the respect of Frank Press. Because Press trusted Thier, he allowed the IOM to take the lead on an important aspect of science policy. Thier earned this respect in part through efficient management, in part through his ability to raise money, and in part because of his understanding of how scientists approached a problem. As a result, the AIDS activities of the IOM were true collaborations between the IOM and the NAS. The fact that Nobel Prize-winning scientists and the nation's leading medical authorities both contributed to the 1986 and 1988 reports made these reports all the more effective. The AIDS activities of the IOM created their own sense of momentum. General, overarching reports led to requests that the IOM organize workshops, create forums, and conduct studies on more specialized and focused topics. This meant that the IOM's reputation in the field of AIDS was not tied to Samuel Thier and could continue under his successors. This was fortunate, because the size of the epidemic made it necessary for the IOM to have a continued involvement in activities related to AIDS. As the IOM's Committee on Substance Abuse and Mental Health Issues pointed out in 1994, the rate of increase in AIDS cases was alarming. The first 100,000 reported cases occurred within an eight-year period; the second, in a two-year period. As the IOM entered its second quarter century, the AIDS epidemic remained a constant presence in American life.

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To Improve Human Health: A History of the Institute of Medicine Notes 1.   Quoted in Eve K. Nichols, Mobilizing Against AIDS: The Unfinished Story of a Virus (Cambridge, Mass.: Harvard University Press, 1986), p. 3. 2.   Allen M. Brandt, "AIDS: From Social History to Social Policy," in Elizabeth Fee and Daniel M. Fox, eds., AIDS: The Burdens of History (Berkeley: University of California Press, 1988), p. 153. 3.   IOM Council Meeting, Minutes, July 20, 1983, Institute of Medicine (IOM) Records, National Academy of Sciences (NAS) Archives; Allen M. Brandt, "AIDS: From Social History to Social Policy," p. 161. 4.   IOM Council Meeting, Minutes, March 18, 1985, IOM Records. 5.   IOM Council Meeting, Minutes, September 23, 1985, IOM Records; Centers for Disease Control, Morbidity and Mortality Weekly Report 34 (August 30, 1985), pp. 517–521. 6.   Institute of Medicine, Annual Report 1985, Program Plan 1986 (Washington, D.C.: National Academy Press), p. 4; Eve K. Nichols, Mobilizing Against AIDS, pp. 197–198. 7.   Eve K. Nichols, Mobilizing Against AIDS, pp. 2–3, 59. 8.   IOM Council Meeting, Minutes, November 18, 1985, IOM Records. 9.   Ibid. 10.   See front and back matter in Institute of Medicine, Confronting AIDS: Directions for Public Health, Health Care, and Research (Washington, D.C.: National Academy Press, 1986). 11.   "Develop a National Agenda on Research and Health Care for AIDS," January 22, 1986, IOM Development Files, Accession 91-045, IOM Records. 12.   Transcript of Meeting of the Epidemiology Workshop, March 6, 1986, pp. 4, 10, 12, 14, Accession 95-065, IOM Records. 13.   Transcript of Plenary Session, March 13, 1986, pp. 60, 106, 126, Accession 95-065, IOM Records. 14.   Transcript of the Public Health Panel Meeting, October 13, 1986, pp. 87–88, Accession 95-065, IOM Records. 15.   Proceedings of the Research Panel, March 13, 1986, pp. 42, 112, 117, 121, 126, 129, 150, IOM Records. 16.   Transcript of Public Health Panel Meeting, March 13, 1986, pp. 2, 11, 14–19, 35, 39, 75, 82, Accession 95-065, IOM Records. 17.   Transcript of Plenary Session, March 14, 1986, pp. 198, 242, 248, 265, Accession 95-065, IOM Records. 18.   Agenda for Meeting on Research, Health Care, and Public Health Strategies, New York Blood Center, May 15, 1986, and Agenda of Meeting of Committee on a National Strategy for AIDS, April 8–9, 1986, both in Accession 91-065, IOM Records. 19.   "AIDS Research Commission Proposal—Draft," June 2, 1986, Accession 95-065, IOM Records. 20.   "Blue Ribbon Panel Urges Greatly Expanded Education and Research Effort Against AIDS," IOM Press Release, October 29, 1986, Accession 91-045, IOM Records; "Confronting AIDS: Directions for Public Health, Health

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To Improve Human Health: A History of the Institute of Medicine     Care, and Research, Summary of Recommendations," Accession 95-070, IOM Records. 21.   Confronting AIDS, pp. 5–37. 22.   Ibid., p. 19. 23.   Ibid., pp. 9–12. 24.   Philip M. Boffey, "Federal Efforts on AIDS Criticized as Gravely Weak," New York Times, October 30, 1986, p. 1. 25.   Christine Russell, "Escalate AIDS Fight, Scientists Urge," Washington Post, October 30, 1986, p. A-1. 26.   Network Television Evening News Abstracts for October 29, 1986, Vanderbilt Television News Archive, Vanderbilt University. 27.   Frank Press and Samuel Thier to David Baltimore and Sheldon Wolff, December 17, 1986, Accession 95-065, IOM Records. 28.   IOM Council Meeting, Minutes, November 17–18, 1986, and July 23–24, 1987, IOM Records. 29.   Paul Rogers to Samuel Thier, September 3, 1987, Accession 95-066, IOM Records. 30.   Institute of Medicine, An Agenda for AIDS Drug Development: Report on the Conference on Promoting Drug Development Against AIDS and HIV Infection (Washington, D.C.: National Academy Press, 1987), pp. 1, 24; Transcript of presentation by David Baltimore, August 31, 1987, Accession 95-066, IOM Records. 31.   "Evaluation of the Modeling of the Spread of Infection with Human Immunodeficiency Virus and the Demographic Impact of Acquired Immune Deficiency Syndrome Worldwide," August 20, 1987, Accession 95-064, IOM Records; Roy Widdus to Frank Press, November 30, 1987, Accession 95-064, IOM Records; Institute of Medicine, Approaches to Modeling Disease Spread and Impact: Report of a Workshop (Washington, D.C.: National Academy Press, 1988), p. 1, 5–7; Confronting AIDS, p. 31. 32.   Samuel Thier to Gerald Mossinghoff, President, Pharmaceutical Manufacturers Association; Peter J. Fischinger, Deputy Director, National Cancer Institute, to Thier, August 8, 1987; Roy Widdus to Frank Press, November 19, 1987; and Transcript of David Baltimore remarks, December 14, 1987, all in Accession 95-068, IOM Records. 33.   Institute of Medicine, Prospects for Vaccines Against HIV Infection: Report of the Conference on Promoting Development of Vaccines Against Human Immunodeficiency Virus Infection and Acquired Immune Deficiency Syndrome (Washington, D.C.: National Academy Press, 1988), pp. 15, 20, 23. 34.   Roy Widdus to Frank Press, November 30, 1987, AIDS Oversight Committee Files, Accession 95-070, IOM Records. 35.   Robin Weiss, "Notes on AIDS Oversight Committee Meeting," October 24, 1987, AIDS Oversight Committee Files, Accession 95-070, IOM Records. 36.   IOM Council Meeting, Minutes, November 16–17, 1986, IOM Records; Samuel Thier to Robert E. Windom, September 17, 1987; Thier to Leighton Cluff, October 16, 1987; and Cluff to Thier, November 5, 1987, all in Accession 95-050, IOM Records.

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To Improve Human Health: A History of the Institute of Medicine 37.   Robin Weiss, "Notes on AIDS Oversight Committee Meeting." 38.   "Recommendations from December 21, 1987, Meeting with Brief Discussion," Accession 95-070, IOM Records. 39.   Robin Weiss, "Notes on AIDS Oversight Committee Meeting." 40.   "Recommendations from December 21, 1987, Meeting." 41.   Ibid.; Stuart Altman to Robin Weiss, January 12, 1988, Accession 95-050, IOM Records. 42.   "Panel Cites Remaining Deficiencies in National Effort to Combat AIDS," IOM Press Release, June 1, 1988, Accession 95-070, IOM Records; Institute of Medicine, Confronting AIDS: Update 1988 (Washington, D.C.: National Academy Press, 1988). 43.   Philip M. Boffey, "Expert Panel Sees Poor Leadership in U.S. AIDS Battle," New York Times, June 2, 1988, p. A-1; William Booth, "AIDS Panel Converges on a Consensus," Science, June 10, 1988, pp. 1395–1396. 44.   Philip M. Boffey, "Expert Panel Sees Poor Leadership in U.S. AIDS Battle"; "Making a Difference," July 24, 1989, Yordy Files, Accession 91-051, IOM Records. 45.   "HIV Infections and AIDS: Recommendations to the President-Elect," Accession 95-070, IOM Records. 46.   Ibid., p. 2. 47.   Frank Press and Samuel Thier to Honorable George Bush, December 13, 1988, Accession 95-070, IOM Records. 48.   Monroe Trout to Mrs. George Bush, December 14, 1988; Trout to Samuel Thier, December 16, 1988; Thier to Trout, January 3, 1989; and George Bush to Thier and Frank Press, January 10, 1989, all in Accession 95-070, IOM Records. 49.   Notes, AIDS Oversight Committee Meeting, October 3, 1988, Accession 95-050, IOM Records. 50.   Anthony Fauci, Associate Director for AIDS Research, National Institutes of Health, to Robin Weiss, August 22, 1988, Accession 95-050, IOM Records; Weiss to Representative Henry A. Waxman, April 11, 1991, Accession 95-070, IOM Records; Testimony of William Danforth before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, March 7, 1991, Accession 95-070, IOM Records; Institute of Medicine, The AIDS Research Program of the National Institutes of Health (Washington, D.C.: National Academy Press, 1991). 51.   Testimony of Melvin M. Grumbach, Edward B. Shaw Professor of Pediatrics, University of California at San Francisco, before the Human Relations and Intergovernmental Relations Subcommittee, March 7, 1991, Accession 95-070, IOM Records. 52.   Robin Weiss to Phil Smith, November 17, 1989, Accession 95-070, IOM Records; "Roundtable for the Development of Drugs and Vaccines Against AIDS, Meeting Summary," February 17, 1989, Accession 95-050, IOM Records.

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To Improve Human Health: A History of the Institute of Medicine 53.   Ibid; "Surrogate Endpoints in Evaluating the Effectiveness of Drugs Against HIV and AIDs," September 11–12, 1989, Accession 89-013-5, IOM Records. 54.   "Roundtable for the Development of Drugs and Vaccines Against AIDS, Meeting Summary." June 26, 1989, Accession 95-050, IOM Records; "The Potential Value of Research Consortia in the Development of Drugs and Vaccines Against HIV Infection and AIDS: Report of a Workshop," 1989, Accession 95-070, IOM Records. 55.   "Summary of the Institute of Medicine U.S.-USSR AIDS Symposium, October 4–5, 1989," February 28, 1990, Accession 95-069, IOM Records; Transcript of Samuel Thier's remarks, October 4, 1989, Accession 95-069, IOM Records; Peter Hartwick to Robin Weiss, November 6, 1989, Accession 95-069, IOM Records. 56.   Institute of Medicine Annual Report 1989, pp. 59–60. 57.   Institute of Medicine Annual Report 1991, p. 35. 58.   "Proposed Study Plan," June 15, 1994, Records of the Committee to Study HIV Transmission Through Blood or Blood Products, and "Working Group Meeting Summary," April 5, 1994, both in Accession 96-004, IOM Records. 59.   Senator Bob Graham and Representative Porter Goss to Michael Stoto, January 24, 1994, Accession 96-004, IOM Records. 60.   Representative Porter Goss and Senator Bob Graham to Representative John Dingell, January 18, 1994, and "Committee Appointment," September 30, 1993, both in Accession 96-004, IOM Records. 61.   Lauren Leveton, Ph.D., to Reid Stuntz, Staff Director and Chief Counsel, House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, December 9, 1994, and "Working Group Meeting Summary," April 5, 1994, both in Accession 96-004, IOM Records. 62.   "Minutes," May 16, 1984, and Transcript of Proceedings of Public Hearing, September 12, 1994, both in Accession 96-004, IOM Records. 63.   Daniel Fox and Elizabeth Fee, eds., AIDS: The Burdens of History (Berkeley: University of California Press, 1988); Richard Neustadt and Harvey Fineberg, The Swine Flu Affair: Decisionmaking on a Slippery Disease (Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1978). 64.   Institute of Medicine, Lauren B. Leveton, Harold C. Sox, Jr., and Michael A. Stoto, eds., HIV and the Blood Supply: An Analysis of Crisis Decisionmaking (Washington, D.C.: National Academy Press, 1995), pp. 5–17. 65.   "Testimony of Donna E. Shalala at House Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations," October 12, 1995, Accession 96-004, IOM Records. 66.   Institute of Medicine, Judith D. Auerbach, Christina Wypijewska, and H. Keith H. Brodie, eds., AIDS and Behavior: An Integrated Approach (Washington, D.C.: National Academy Press, 1994), pp. v, vi, 1, 2, 15, 19, 23, 26–29, 31–33.