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.
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
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
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
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."
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
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
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
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
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
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
conceded that the development of an AIDS vaccine was still at least five years away. This meant that the nation should both support scientific research that would pay long-term dividends and invest in an educational campaign that represented the nation's best short-term hope. The educational campaign, according to the report, deserved just as much money as the scientific campaign, a pivotal concession from a group with NAS sponsorship and dominated by scientists. As for the terms of the education campaign, the committee recommended that it be targeted at high-risk groups, including homosexual men, intravenous drug users, sexually active heterosexuals, and teenagers. It was a time for plain speaking. The messages should be as direct and as explicit as possible, using whatever language people could understand and reflecting the basic reality that anal or vaginal intercourse with an infected person without using a condom was risky behavior.23
Nothing in the entire history of the Institute of Medicine attracted as much interest as the 1986 report on AIDS. The report received saturation coverage in the newspapers, including page one stories in both the New York Times and the Washington Post. The Times chose to highlight the political contest aspect of the story. Reporter Philip Boffey's piece led with the accusation that the federal response to AIDS was "dangerously inadequate." The third paragraph contained a quotation from David Baltimore about how he was "quite honestly frightened" by the potential of the AIDS epidemic, and the sixth paragraph featured a response from Robert Windom, an Assistant Secretary of Health and Human Services, to the effect that "there has been a conscientious effort to do a good job." The lead paragraph identified the report as from the National Academy of Sciences, whose arguments carried weight ''because of its reputation and function." Not until the eighth paragraph, which was buried inside the newspaper, did the interested reader learn that the committee had been assembled "by the Academy and its principal health unit, the Institute of Medicine.'' The price of collaboration with the NAS was subordination.24
The Post story, by way of contrast, mentioned the Institute of Medicine in the second paragraph and on equal terms with the National Academy of Sciences. Christine Russell's piece also highlighted the public health aspects of the report more than the Times. She quoted Sheldon Wolff as saying that "people should be told that they can protect themselves against the disease by using condoms during sexual experience—either anal or vaginal—with an infected or possibly infected person and by not sharing needles and syringes." Only toward the end of the story did Russell indulge in
political speculation, referring to some committee members' private complaints that "the White House has been very quiet on this issue" and giving Congress much of the credit for federal leadership.25
Although such nuances mattered to Washington insiders, most people received their news from television, not the newspapers. It was therefore highly significant that all three networks chose to lead their evening broadcasts on October 29 with the AIDS report. On ABC, the audience saw a text box that highlighted the report's major recommendations and heard interviews with Samuel Thier, health panel member James Chin, and David Baltimore. The network devoted nearly four minutes to the report, a substantial investment of network time. Dan Rather of CBS gave the report two and a half minutes, including interviews with Thier and Baltimore. Tom Brokaw and NBC spent more than four minutes on the report and ran a story, reported by Robert Bazell, that featured interviews with Baltimore, Chin, and Sheldon Wolff. The NBC coverage featured "cross-talk" between anchor Brokaw and correspondent Bazell on the subjects of human testing of vaccines and funding for research.26
Of all the participants on the AIDS committee, David Baltimore and Sheldon Wolff played the key roles, both in the composition of the report and in the public relations blitz that followed its release. "We should be decorating you as a combat veteran of the first 'fast track' study of the Institute of Medicine/National Academy of Sciences," Thier and Frank Press wrote to the pair. "Certainly you have noticed and contributed handsomely to the volume of news media coverage of the report, which must have established some high-interest mark for one of our publications."27
The 1986 AIDS report put the IOM at the center of the health policy universe, at least for a day. Not since the heart transplant statement issued in February 1968 had the IOM come anywhere near this level of influence. The contrast between the heart transplant statement and the AIDS report indicated some of the differences that had taken place since the founding of the IOM. In 1968, the Board on Medicine attempted to slow down the diffusion of heart transplant surgery. It saw the matter as one in which medical knowledge outstripped its application to human needs. In 1986, the Institute of Medicine sought to speed up the rate of research into the problems of AIDS. It saw the problem as one in which medical and scientific knowledge lagged far behind human needs. In 1968 the problems of medicine appeared to be those of controlling abundance: too many people in too many hospitals wanted to perform heart transplants. In 1986 the problems of medicine appeared to be those of coping with scarcity: too few people in too few hospitals wanted to care for AIDS
patients. The differences between the two situations illustrated how history could confound expectations. Few people could have predicted in 1968 that the IOM would gain its greatest fame for its efforts to come to grips with an infectious disease for which there was no apparent cure or clear medical treatment.
Having gotten the nation's attention, the IOM had to decide what to do with it. In November 1986, the IOM Council agreed, with no hesitation, that it wanted the IOM to continue its efforts in the area of AIDS. The consensus was for the IOM to form a small group that would monitor the implementation of the committee's recommendations and help facilitate international activities in the AIDS field and activities involving private pharmaceutical companies. In the spring of 1987, Thier and Press once again joined together to form an AIDS oversight committee.
In the fall of 1986 and the first months of 1987, the IOM waited to see how the Reagan administration and Congress would react to the 1986 report. At the end of June 1987, President Ronald Reagan announced that he would create a Presidential Commission on the Human Immunodeficiency Virus Epidemic. When the IOM Council learned in July who would be named to this commission, it expressed a collective sense of dismay. As Thier delicately expressed it, "The number of individuals on the commission with in-depth knowledge of AIDS was very modest." The Council decided nonetheless to adopt a "respectful and communicative attitude" toward the commission, "without being co-opted."
The presence of the Presidential Commission on the HIV Epidemic spurred the IOM to move ahead with its own AIDS oversight committee. The primary mission of this committee would be to review and update the 1986 report. In addition, the IOM hoped that the oversight committee would help focus the AIDS activities of the entire NAS complex, serving in a similar manner to the boards that guided the various IOM divisions. 28
Even before the oversight board started its work, the IOM initiated limited projects in the areas of epidemiology and AIDS drug and vaccine development. At the end of August 1987, the IOM held a Conference on Promoting Drug Development Against AIDS and HIV Infection. The conference followed directly from a recommendation in the 1986 report to "convene researchers from industry, academia, and the government to improve the development of drugs against AIDS
and the virus infection that causes it." As such, it provided an opportunity for basic scientists, federal bureaucrats, representatives from drug companies, and AIDS activists to discuss issues in the field. The group considered the state of science in AIDS drug development, current federal and industrial activities, issues in the clinical evaluation of drugs, appropriate levels of access to experimental drugs by AIDS patients, and whether or not there should be a "national strategy" in the effort to develop a drug treatment for AIDS. "I believe we are in a national emergency and the biomedical community will be judged in the future by how we respond," David Baltimore said in a keynote address that set the tone for the conference. David W. Barry, vice president of research at Burroughs Wellcome, FDA Commissioner Frank Young, Sheldon Wolff, and former Congressman Paul Rogers also spoke. Rogers, for one, was pleased with the outcome. An unfailingly courtly and courteous man, he wrote Sam Thier that the conference was "most successful.... I think this format is certainly helpful to the academic, industrial, and governmental sectors. Getting people to talk out their problems and what needs to be done is certainly an effective way for the Institute of Medicine to operate.''29
This was the main point of the conference: getting people to talk out their problems in a manner similar to the IOM's Forum on Drug Development and Regulation. The conference was intended to capture knowledge that could be shared easily among the loosely organized partners in the national AIDS drug development effort. Although Roy Widdus of the IOM's Division of International Health did not expect the conference to yield a product with a long shelf life, he and his staff prepared a report that became an IOM publication. In the traditional manner of IOM reports, it included a list of recommendations, the chief of which was that "systematic screening of compounds in the libraries of the world's pharmaceutical companies offers the best short term prospects and should be vigorously pursued." The report recommended that scientists, in effect, continue to "grind out" results. In the meantime, the public needed to receive as much information as possible, both to guard against false hopes and to keep people with AIDS or HIV infection away from the "expanding underground sources of potentially toxic agents." The drug area remained a particularly important part of the battle against AIDS, because the development of a vaccine appeared to be a long way off. The 1986 report had estimated a minimum of five years to produce a vaccine. "Things today seem, if anything, bleaker," David Baltimore told the conference participants. 30
The 1986 report had called attention to the international aspects of AIDS and recommended that the United States be "a full participant in international efforts against AIDS and HIV infection." As a step toward facilitating this involvement, the IOM organized a workshop, held in October 1987, that focused on the epidemiology of AIDS in an international context. The United States Agency for International Development funded the small workshop that was intended to review "the art of modeling of HIV transmission and the demographic impact of AIDS." Burton Singer, head of Yale's Department of Epidemiology and Public Health, chaired the steering committee, which also included authorities from Europe, Canada, and Africa. Participants at the workshop came from around the world, but all spoke a common statistical language. Despite the elegance of their methods, the epidemiologists and demographers admitted that the "development of reliable, specific long-range predictions was out of reach of current or foreseeable model capabilities and data." The data did suggest that the number of AIDS cases "was certain to grow for many more years" and, in particular, that AIDS in Central Africa would cause "substantially increased mortality in the general population.'' Participants agreed that they needed to know much more about sexual behavior—the frequency of sexual contacts, the duration of partnerships, the selection of partners—in order to understand the course of the epidemic. They realized, however, that the ''ethics of answering questions about sexual behavior" differed from country to country, complicating the process of creating an international data set. In the end, the workshop on modeling AIDS, like the conference on drug development, highlighted problems rather solutions. It also served as a forum for a much-needed international discussion on the size and shape of the AIDS epidemic.31
At the end of 1987, the IOM held a third workshop on AIDS, this one concerned with vaccine development. Support came from the Pharmaceutical Manufacturers Association, the National Cancer Institute, and the National Institute of Allergy and Infectious Diseases. David Baltimore headed the small steering committee for this conference, which included experts in immunology, retrovirology, vaccine design, and vaccine evaluation. Baltimore began the conference with another gloomy assessment about the prospect of a vaccine. He vowed, however, to continue the work "along every possible line of attack because the only way that science can produce its surprises is if we keep working at it, but I suspect that in the long run we are going to need more than a standard surprise." The conference was intended to be a meeting of scientists talking to other
scientists, with the focus on the science itself rather than on public policy issues associated with the management or conduct of science. 32
Because data on AIDS changed so quickly, the conference report was less valuable than the conference itself, even though the steering committee did prepare a short summary with some preliminary conclusions. Much of this summary contained what to nonscientists was an impenetrable description of HIV infection. Part, however, focused on the more accessible, and very important, issue of the conduct of clinical trials. A majority of conference participants felt that tests on humans should not be done until there was evidence of "protective efficacy from animal tests." The steering committee recommended that a vaccine should proceed to clinical trials only after it had been shown to be effective in chimpanzees, macaques, or some other suitable laboratory animal, unless the vaccine's design was based "on a fundamental new understanding of relevant human immune responses that cannot be adequately modeled on animals." In all likelihood, such clinical trials lay far in the future. ''Experimental evidence has not yet justified any hope for an effective vaccine in the next few years,'' the steering committee concluded.33
Toward the 1988 Report
By the time the conference on vaccine development took place in December 1987, the AIDS Oversight Committee had begun to meet. Samuel Thier selected Theodore Cooper to head the eight-person committee. An M.D.-Ph.D. with a background in cardiovascular surgery and a major figure at the IOM for a long time, Cooper had served as director of the National Heart and Lung Institute in the late 1960s and 1970s, before becoming an Assistant Secretary for Health in the Ford administration and then the provost for health affairs at Cornell. In the fall of 1987, Cooper held the positions of vice president and vice chairman of the board of the Upjohn pharmaceutical company. Joining Cooper on the committee were David Baltimore, Howard Temin, political scientist and Rockefeller Foundation official Kenneth Prewitt, Oregon State Health Division administrator Kristine Gebbie, international health expert Donald Hopkins, AIDS health care authority Paul Volberding, and Stuart Altman, an economist with expertise in health financing. With the exception of Baltimore and Temin, who respected but often disagreed with one another, each committee member had a well-demarcated area of expertise that gave him or her a distinctive niche and enabled committee members to work effectively with one another.34
From the beginning, the Oversight Committee realized that it had to respond to two different audiences. One was an external audience of members of the Washington political and health policy communities; the other was an internal audience of National Academy of Sciences officials. To reach the political audience, the Oversight Committee hoped to issue an update of Confronting AIDS in time to influence the 1988 party platforms. After the election, the committee expected to present a short version of the report to the President-elect. The internal NAS audience required not policy recommendations so much as advice on the coordination of the Academy's AIDS studies. In this capacity, the Oversight Committee would evaluate project proposals and try to keep one branch of the NAS aware of what the other branches were doing. As a practical matter, preparation of the update took precedence, because the committee, which met for the first time in October 1987, faced a short deadline for its completion. 35
Because Samuel Thier regarded the work of the AIDS Oversight Committee as having the highest priority of any IOM activity, it frustrated him that funds for the committee and for other AIDS projects were difficult to raise. In November 1987, he told the Council that money for the report update was "being pieced together," with the bulk of the support coming from the National Research Council. Part of the problem was the presence of the Presidential Commission on the HIV Epidemic, whose work was being done simultaneously with that of the Oversight Committee. It was natural for funders to wait until the commission reported before supporting another such group. Hoping to get money from the Department of Health and Human Services, Thier told Assistant Secretary for Health Robert Windom that a natural division of labor existed between the two groups, in which the IOM concentrated on science and the commission on other public policy matters. In fact, however, Thier held the commission in low esteem and expected little of it. When the commission requested IOM assistance, Thier replied that he wished to be as helpful as possible, but in the privacy of the IOM Council, Thier said that he did not want the IOM identified with the commission and would not subcontract with it. He told Leighton Cluff, president of the Robert Wood Johnson (RWJ) Foundation that the "problems of the President's Commission," in particular the fact that many scientific and medical problems ''appear beyond their capacity to address," only underscored the need for the IOM committee. "Given ... the difficulties the commission has been experiencing, it seems more important than ever we proceed ... and expand our efforts," he wrote.
Although Cluff might have agreed with Thier's take on the situation, he still turned down the request for funds. He argued that RWJ had already given the IOM a large grant for its endowment and this precluded the foundation from making specific project grants.36 In order to publish and disseminate the update report, the IOM spent $50,000 of its own money, a good example of how the drive to raise an endowment enabled the IOM to accomplish things it might not otherwise have been able to do.37
In the spring of 1988, the AIDS Oversight Committee came to an agreement on the recommendations for its update of the 1986 report. In general, the committee used the 1986 recommendations as starting points and then looked at what had occurred in the interim that might cause them to be modified or changed. Despite the presence of the Presidential Commission, the committee remained convinced of the need for a "permanent AIDS commission" with both congressional and administration representation. Within the committee, Cooper argued for this recommendation on the basis of the fact that the Presidential Commission had been ineffective and that there had been a lack of leadership on the part of the Reagan administration. He had in mind a commission similar to the one that had investigated Social Security financing and helped to produce an agreement leading to legislation in 1983. This group had been successful because it contained administration and congressional representation. When Paul Volberding complained that the Reagan administration's conservative nature made it unable to deal with the AIDS epidemic, Cooper replied that this was exactly why Congress had to be involved. Thier concurred in this decision and did not seek to carve out an expanded role for the IOM in any commission that might be formed, believing that the Congress and the President were the responsible political actors. In a similar manner, the group came to agree that scientists, like the physicians in the IOM, should not manage the nation's response to AIDS; rather they should be insulated from political pressure and left alone to do their work.38
In reviewing the nation's response to the AIDS epidemic, the committee discovered that reducing AIDS transmission among IV drug abusers constituted "the most serious deficiency in current efforts to control AIDS in the United States." Donald Hopkins, who took the lead for the committee in this area, said that prevention and treatment of IV drug abuse was a "big hole."39 The committee considered both long-term and short-term strategies for dealing with the problem. In the short run, Hopkins proposed "rapid expansion of drug abuse treatment slots'' and "immediate extension of serologic testing and counseling." In the long run, he suggested efforts to
dissuade teens and others at high risk from taking drugs and an evaluation of the efficacy of providing users with sterile needles.
Discrimination was one area in which the committee felt the need for action, not evaluation. Since the 1986 report, even more evidence had arisen to show that discriminating against people with AIDS or HIV because of the health risks they posed to others in the workplace or housing was not justified. Hence, legal measures to prohibit discrimination against people with AIDS remained "a vital part of public health efforts."40
Health care financing marked another area in which the AIDS Oversight Committee sought to expand the work of the original NAS-IOM committee. Stuart Altman developed a proposal that the committee debated and ultimately endorsed. He pointed out that the health care financing system was pluralistic and unlikely to be centralized in the near future and that most people were concerned that the nation was spending too much, not too little, on health care. Furthermore, AIDS patients were themselves a diverse group and the severity of their medical problems varied widely. He recommended a categorical grant program under which federal money would be distributed to localities for the treatment of people with AIDS or HIV under a managed care system. Kristine Gebbie wondered if AIDS should be a special case or whether the nation should instead fix the entire health care financing system. The committee decided that AIDS should indeed be a special case.41
The 1988 Report
On June 1, 1988, the committee issued Confronting AIDS: Update 1988 , which argued that despite progress in biomedical research and public education, inadequacies—in particular a failure to combat AIDS related to drug use—remained in the nation's response to AIDS. The committee urged a multipronged approach that included the expansion of research facilities, the targeting of public education programs on the groups most at risk, the expansion of drug treatment programs, and the health care financing plan that Altman had outlined. The 1988 report made much stronger statements on the relationship between HIV and AIDS than the 1986 report. The 1988 group recommended that "HIV infection itself should be considered as a disease" and cited the view of analysts who believed "that virtually all HIV-infected individuals will eventually develop AIDS." It also pointed to the efficacy of education efforts, such as those of U.S. Surgeon General C. Everett Koop, and urged their expansion,
"including the use of paid advertising on television," rather than bland, and often unwatched, public service announcements. As for research, the report stressed the points made by David Baltimore that "we are no closer to having a licensed vaccine against HIV than we were two years ago" and that drug development offered "the best hope of slowing the epidemic through research."42
Release of the 1988 report brought another avalanche of publicity to the IOM. In this case, however, coverage was tempered by the fact that the administration no longer presented such a large target. For one thing, Surgeon General Koop had emerged as a public health hero, widely praised for his advocacy of safe sex practices. For another, the Presidential Commission on the Human Immunodeficiency Virus Epidemic, once vilified as ignorant and stacked with what Science described as "homophobic right-wing ideologues," appeared on the verge of issuing a report with recommendations that mirrored those of the IOM. In fact, the IOM report used cost data from the Presidential Commission to bolster its call for increased spending on public health and educational efforts. Agreement was always less of a story than disagreement. Finally, and most importantly, the presidential campaign was well under way in June 1988, and whatever the outcome, Ronald Reagan would no longer be President in 1989. Although the Times ran the story of the AIDS update report on page one and reprinted excerpts from the report, it mentioned that the report was only the "opening salvo in an unusually busy week for appraising the AIDS epidemic" and referred to the fact that James D. Watkins, chairman of the Presidential Commission, would issue its final conclusions that day. The Times also reported that the IOM's recommendations to increase drug treatment facilities added weight "to similar recommendations by the President's AIDS Commission." Instead of writing a story on the IOM report, Science chose to highlight the consensus between the two reports.43
Even if the IOM could no longer lay exclusive claim to the field, its two reports served as important catalysts for action. As the Times noted in its story on the 1988 report, the 1986 report had "provided a benchmark by which many members of Congress and analysts judged the effectiveness of the nation's effort to combat AIDS." No doubt, the report helped to spur legislation that nearly doubled federal spending against AIDS from fiscal year 1987 to fiscal year 1988 and motivated the payment of U.S. dues for WHO programs on AIDS. According to the IOM, the 1988 report led to amendments to the Public Health Service Act that authorized $1.5 billion for research and public health measures related to AIDS and permitted the CDC to develop AIDS-related advertisements and put them on the air.44
Advice for the President
For the Oversight Committee, preparing a white paper on AIDS for the next administration became an immediate priority after issuing the update. Earlier in the year, the presidents of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine had decided to produce a series of short issue-oriented papers on critical issues in science and technology, with the incoming administration as the intended audience. AIDS emerged as an obvious choice for such a paper, with the 1988 update report serving as the basic source of data. It fell to Robin Weiss, director for AIDS activities at the Institute of Medicine, to summarize the update report in a way that highlighted actions George Bush and his administration should take to stem the epidemic.45
In the interim between the update report and the white paper, an important piece of legislation, the AIDS Amendments of 1988, changed the political outlook on AIDS. This legislation followed the advice of the Institute of Medicine and established a National Commission on Acquired Immune Deficiency Syndrome. Under the term of the law, the President would appoint two members to the commission and would in addition ask the Secretary of Health and Human Services, the Administrator of the Department of Veterans Affairs, and the Secretary of Defense to serve ex officio as nonvoting members. In the white paper, the IOM urged the President-elect to choose "senior experts" on AIDS, without regard to political ideology. Congress was to play the dominant role in the appointment of voting members, with five Senate and five House appointees to be chosen.46
The white paper had the compressed tone of a document written to attract the attention of a busy person. Aware that the President-elect would not have time for a leisurely examination of even a 13-page document when he received it in December 1988, Frank Press and Samuel Thier wrote a 3-page cover letter in which they summarized the white paper. They began with the stark fact that during George Bush's term in office, AIDS would kill 200,000 Americans. Another 1.3 million were infected with HIV, and most would die. Press and Thier urged Bush to "use the newly legislated national commission on AIDS to develop a forceful and coherent national policy," to encourage antidiscrimination legislation, to express support for an "aggressive, unambiguous education program," and to recognize America's "special responsibility in international efforts to control the spread of HIV infection." "Your Administration inherits the opportunity to harness our knowledge and turn the tide against AIDS," wrote Press and Thier.47
Having invested time and effort in creating the white paper and composing the cover letter, Thier set out to get Bush to read it. At Thier's urging, Monroe Trout, chairman of the board at American Healthcare Systems, wrote to Barbara Bush asking her help "to get a paper read by George." He advised Mrs. Bush that she might want to read the paper herself, "even though it is not the most pleasant of subjects." Trout then told Thier that he had sent off the material to the Vice President's office and "hopefully he will read it." How Bush felt about the white paper or whether or not he read it remains unclear. Thier and Press did receive a letter from him thanking them for the white paper and containing some general remarks about AIDS. "The work of the National Academy of Sciences and the Institute of Medicine has strengthened my determination to see to it that out of this international tragedy some good may come; and that America's unparalleled medical resources [will] be stronger for having fought this fight," wrote Bush.48
The Institute's AIDS Activities
After the excitement of preparing the update, the AIDS Oversight Committee settled into the role of advising the IOM on its AIDS activities. One of the first projects scrutinized by the committee was a proposed IOM evaluation of the NIH AIDS programs. David Baltimore regarded the evaluation study as a way of continuing the IOM's leadership in the field. It would offer an opportunity to evaluate the NIH response to the epidemic, to suggest an "ideal" research program, and to offer insights on how NIH should respond to future public health threats. A good study could also examine how money to fight AIDS was divided among the various institutes, explain why NIH responded so slowly to AIDS, and determine how NIH coordinated its activities with other parts of the Department of Health and Human Services. The Oversight Committee even suggested names for the steering committee and created a detailed plan of action for the study, complete with a list of people who should testify at a public hearing.49
For all of the hopes of the AIDS Oversight Committee about the many things the study might accomplish, it was similar to many other evaluations of the government's research programs that the IOM had undertaken over the years, and it was likely to produce the same sort of recommendations. In this case, the IOM responded in 1988 to a specific request from James B. Wyngaarden, the director of the National Institutes of Health, and Anthony S. Fauci, the associate
director for AIDS research, to consider such questions as the effectiveness of NIH's use of advisory groups in the AIDS program. The general idea was to examine the NIH approach to AIDS research after five years of intensive activity. Headed by William Danforth, chancellor of the University of Washington in St. Louis, the 15-person IOM committee met five times between October 1989 and September 1990 before issuing The AIDS Research Program of the National Institutes of Health in 1991.
The report recommended that the period of rapid buildup in AIDS research, which led to expenditures of $805 million in fiscal year 1991, or nearly 10 percent of the total NIH budget, should give way to long-term planning. In terms of emphasis, the committee suggested that NIH should increase its activities in behavioral science, basic science, patient care research, and vaccine development. As William Danforth explained to a congressional committee, major progress depended on "better understanding. The best way to increase this understanding is to provide support for scientists studying how viruses work.... Such basic research may not be glamorous but it is our only real hope." In the meantime, according to Danforth, the nation was forced to depend on "behavioral change" for improvements in mortality and morbidity related to AIDS; therefore the country needed "to know more about human behavior and how it might be modified." The committee estimated that implementing its recommendations would lead to an increase of 25 percent in the NIH budget for AIDS but cautioned against siphoning resources from other parts of the research program. Hence, any budget increases should be "new funds."50
The 1991 report amounted to a synthesis of the IOM's AIDS concerns, as developed in its 1986 and 1988 reports, and the IOM's traditional interest in improving the management of the NIH and insulating it from politics. The IOM approved of the way in which NIH organized its AIDS activities. Despite the size of the problem, NIH chose not to create an AIDS institute. Instead, NIH managed the program as an "institute without walls" from within the Office of the Director, with an associate director for AIDS research, a national advisory council, an executive committee of senior program representatives, and an executive office for staff support. Such an approach meshed with the recommendations of the 1984 IOM report on the management and organization of the National Institutes of Health, which had cautioned against creating new institutes. In the 1984 report and elsewhere, the IOM had tried to cushion NIH from the yearly vicissitudes of the budget process and from political directives that disrupted the orderly conduct of research. In this
spirit, the 1991 report advised that instead of basing the AIDS program on the annual budget process, NIH should develop a five-year plan to set priorities and identify research fields that needed to be strengthened. The IOM study group also suggested, as had the 1984 group, that the NIH director be given more discretion over resource allocation in order to be able to respond to health crises. The committee recommended an annual discretionary fund of $20 million and the authority to transfer up to 1 percent of each NIH appropriation account.51
In addition to the study of NIH, the AIDS Oversight Committee took particular interest in the Roundtable for the Development of Drugs and Vaccines Against AIDS. Establishment of the Roundtable, which met for the first time in February 1989, reflected the use of the Institute's convening function. The idea was to "help resolve impediments to AIDS drug and vaccine development" by bringing together representatives of government, academia, the pharmaceutical industry, and patient advocates for regular conversations on pertinent topics. Harold Ginsberg, a professor of medicine and microbiology at Columbia, and Sheldon Wolff cochaired the sessions. Robin Weiss supervised the staff, which was headed by Richard Berzon.52
At its first meeting, the group discussed the state of vaccine development, with one conferee noting that the search for a vaccine was "in abeyance," and identified more promising topics for workshops or conferences. The group selected clinical trials as a subject worthy of special discussion, wondering, in particular, about using "prolonged survival" as the sole criterion on which to base FDA approval of new HIV drugs. Perhaps more important "surrogate endpoints," such as particular levels of "p 24 core antigen" or particular points on quality of life scales, could be identified. The discussion led to a conference on this subject in September 1989 attended by FDA Commissioner Frank Young and NIH Associate Director for AIDS Anthony Fauci.53
On June 26, 1989, the Roundtable used its regularly scheduled meeting to discuss the potential value of consortia in the AIDS drug and vaccine development processes. The discussion took the form of a workshop in response to a congressionally mandated request for information on this topic and led to a formal Roundtable report to the Public Health Service. The group, which consisted of the usual Roundtable members plus four outside experts, decided that the development of animal models, in particular, could benefit from collaborative efforts through research consortia. Such an approach might ease the problem of what one Roundtable member described as
an "acute shortage" of animals "to test potential preventive and therapeutic agents against HIV." As for other aspects of the problem, the group was less sure about the value of consortia. Basic biomedical research, for example, had always been a matter for individual researchers and laboratories, and the group could not agree on whether it might be improved through a research consortium. The group could agree, however, on the need for a permanent consortium to examine present and future drug and vaccine issues, and some thought that the National Commission on AIDS might play such a role. As in all the activities of the Roundtable, the conversation was both candid and informal and gave attendees from one sector of the research establishment an opportunity to understand the differing perspectives of those from other sectors.54
A few months after the Roundtable meeting on consortia, the IOM held a special event that reflected the interests of both the IOM and the oversight committee in the international dimensions of AIDS. Arranged by the Academy of Medical Sciences of the USSR and the IOM, it consisted of an exchange of information between Soviet and American experts. Thier described it as a "serious working session" in which "we learn about our joint level of knowledge and about the progress of dealing with AIDS in both our countries." Dr. Vadim Pokrovsky of the USSR Ministry of Health told the audience in the NAS auditorium that the first documented case of AIDS in the Soviet Union occurred in 1987. This meant that the Soviet Union was a relative latecomer to AIDS and made it all the more important for Soviet public health authorities to study the American experience. The meeting gave the Soviets a panoramic view of this experience, with talks by the leading American authorities on such subjects as AIDS epidemiology, the treatment of HIV infection, and the prevention of HIV infection. Thier closed the meeting by reminding the participants that the purpose of the U.S.-USSR program was to put American and Soviet scientists in direct contact with one another and expressing confidence that the meeting would produce further interactions and collaborative research efforts. A participant from the U.S. Public Health Service described the results in the optimistic terms of the late Cold War era. If the two "most powerful countries in the world, which so long have been antagonists, can get together to work in areas of benefit to all," it would serve as a "role model for the world," break down ''global indifference to the spread of AIDS," and ''facilitate worldwide cooperation" in AIDS.55
It was, of course, only a meeting, just one of many that the IOM held on AIDS in this period. By this time, the AIDS program had moved well beyond the Confronting AIDS projects of 1986 and 1988 to
embrace nearly all of the IOM's divisions. In 1989, Robin Weiss and her special AIDS activities branch of the IOM supervised the evaluation of the National Institutes of Health research program, planned a conference to examine the issues surrounding prenatal and newborn screening for HIV infection, and staffed both the AIDS Activities Oversight Committee and the Roundtable for the Development of Drugs and Vaccines Against AIDS. At the same time, the Medical Follow-Up Agency was planning to locate and study a group of HIV-positive servicemen who had been lost to follow-up after discharge. The Division of International Health hoped to establish an International Forum for AIDS Research, and the Division of Health Promotion and Disease Prevention had formed a subcommittee to advise the American National Red Cross on AIDS program materials.56
If the job of the AIDS Oversight Committee was to stimulate activity, then the committee could count its work a success. In June 1991, the IOM disbanded its special unit on AIDS activities and moved its remaining projects to the Division of Health Promotion and Disease Prevention, noting that the move "did not indicate a diminished interest in AIDS-related projects at the IOM, which will be pursued as vigorously as in the past." By this time, thanks to the work of the AIDS Oversight Committee and its predecessor, an interest in AIDS was woven into the basic fabric of the IOM.57
Continuing Interest in AIDS
Two projects in particular demonstrated the continuing interest of the IOM in AIDS. One involved a large-scale study of the transmission of HIV through the blood supply in the early 1980s, and the other surveyed the AIDS research programs of what was known before 1992 as the Alcohol, Drug Abuse, and Mental Health Administration. Both studies stemmed from congressional mandates and reflected the traditional IOM mission to provide oversight and guidance to federal agencies. The fact that Congress asked the IOM to do these studies illustrated its confidence in the Institute's impartial judgment and its respect for the IOM's expertise on AIDS.
The project on HIV and the blood supply resulted from one of the many tragedies of the AIDS epidemic. In the early 1980s, as a result of using blood-based products, half of the 16,000 hemophiliacs in the United States contracted the AIDS virus. Before the development of an effective blood test for HIV, the introduction of HIV screening kits, and the routine use of antiviral heat treatment for blood products in
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
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
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
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
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
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
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.