Hold Tight Gently

by Duberman, Martin

  Eager to provide an alternative to the needlessly slow procedures of federally sponsored research, Mike, gay activist Ron Najman, Joe Sonnabend, and Mathilde Krim (co-founder of amfAR) decided in November 1986 to set up the Community Treatment Initiative. Its aim was to hasten the discovery of new treatments by bringing trials to the community and to expand access to them. In May 1987, the project was renamed the Community Research Initiative (CRI). Originally spawned by PWAC, CRI quickly took on a life and identity of its own. It embodied a self-reliant initiative, reached out to minorities, and brought together PWAs, community physicians, and clinical researchers in collaborative efforts to discover viable treatments. Community physicians tended to distrust the new organization (and amfAR as well), and the New York Physicians for Human Rights—a group of gay physicians—declined Sonnabend’s request for support. They sometimes supplied patients for trials, but most came of their own initiative.

  It was a remarkably bold, though not unprecedented, move. In San Francisco, community-based cancer research had existed for some time, and in 1985, the Community Constituency Consortium (CCC) had formed on the West Coast. It consisted of a group of doctors connected with San Francisco General Hospital who initially banded together with their AIDS patients to disseminate information and, subsequently, get involved in organizing community-based trials; amfAR, too, had started community-based trials.

  A multitude of cynics and detractors scorned the notion that community-based research could possibly match the high-tech, costly procedures of traditional trials. They couldn’t completely, though CRI did hire statisticians and contracted with specialist labs to study samples. What they could do superlatively well was to gather the relatively untapped resource of on-the-ground data represented by the patients of physicians in private practice, and further, they could establish a program for the controlled testing of promising treatments. At the time, the federal Public Health Service was sponsoring five experimental drug treatments at fourteen medical centers across the country, with an overall goal of enlisting two thousand participants. This represented a tiny fraction of those who might benefit from such participation. Similarly, a number of substances were being investigated at nongovernmental medical centers or administered by private physicians—but in both cases without formal protocols, which meant that data from such informal trials could not be properly evaluated. At the same time, a large number of individuals with AIDS, or at risk for it, yearned to volunteer for drug trials—far, far more than were being accommodated into the few trials that existed.

  To conduct additional trials, CRI proposed an Institutional Review Board (IRB) to pass on all proposed protocols in accordance with federal regulations, as well as a scientific and medical committee “to seek out, suggest and evaluate promising interventions.” The population for such trials would be drawn from the patients of private physicians in New York—ideally suited for testing experimental treatments because “they are highly motivated, geographically stable, and in many instances have expressed a strong desire to participate in research studies.”

  Launching CRI, Mike would later write, “was the most difficult, bloody, heart-and back-breaking project I ever attempted.” When he initially floated the project, everyone said it couldn’t be done, that it was too ambitious. Yet as CRI—and also CCC in San Francisco—soon demonstrated, it could be done. Protocols were designed that were as highly sophisticated as any put together by government health officials or university researchers—and far more speedily. NIAID, for example, spent a full year writing and rewriting its protocol for testing aerosol pentamidine.

  There were, of course, problems along the way. From the first, CRI had announced—with a sensitivity to race, class, and gender issues that was unprecedented—that it aimed at “making the demographics of CRI trials roughly reflect the demographics of AIDS in New York.” They did make slow and steady progress to that end, but the goal was never fully achieved. Still, CRI’s demographics were better than those of any federally conducted trial. CRI included populations heavily affected by AIDS but heretofore rarely among the subjects of study—IV drug users, African American and Hispanic people, prisoners, and women. By 1990, approximately 10 percent of the subjects in CRI trials were people of color, and the figure sometimes approached 25 percent. CRI also advertised its trials both in English and in Spanish and its representatives visited drug rehabilitation programs and community health centers further to publicize their protocols. Moreover, the group went to great lengths to ensure that in its work—as Vanessa Merton has documented in her important article “Community-Based AIDS Research”—“every precept of classic clinical research [was] either meticulously observed or else deliberately and rationally departed from.” Both CRI’s Review Board and its scientific advisory committee were staffed with distinguished clinicians and scientists.

  Despite these remarkably valiant efforts, CRI ultimately failed to produce any major treatment breakthrough. Of course, neither did anyone else during the decade that roughly spanned the years 1985–95. CRI, it can be argued, had a better record than other researchers simply because it continued to press the FDA on PCP prophylaxis. Again in 1988—more than a decade after the Hughes study—Dr. Margaret Fischl and colleagues proved that Bactrim could prevent PCP in an immune-compromised individual. But since some people couldn’t tolerate Bactrim, and since the AIDS establishment was discouraging its use, the need to win approval for aerosol pentamidine as an alternate prophylaxis seemed crucial. Yet in Joe Sonnabend’s opinion, pentamidine proved “a huge distraction.” The pharmaceutical company Lyphomed held the patent on pentamidine administered by aerosol, and paid CRI (and CCC in San Francisco) to do a trial, with Sonnabend as chief investigator. Because Fauci had dismissed Bactrim, Joe agreed to lead the pentamidine trial, since it was better to have an alternate, if inferior, choice than none at all. Ultimately, the use of pentamidine as a PCP prophylaxis more or less stopped in the 1990s.2

  What made this entire struggle all the more maddening was the contrast with the approval process for AZT. The trial that led to the expedited approval of that drug had been hailed by the FDA and other organizations as the gold standard of how proper AIDS research should be conducted. Yet one of the FDA reviewers, Dr. Harvey Chernov, had recommended against the approval of AZT—for exactly the same reason Fauci had turned down the superior drug Bactrim: “The available data are insufficient.” Yet the data for both Bactrim and pentamidine were in fact fuller and more persuasive than those for AZT.

  At a Columbia University forum in November 1988, Edward Bernard of Memorial Sloan-Kettering made this comparison: “Eighty percent of people on AZT not receiving [PCP] prophylaxis had a recurrent episode of pneumocystis. Among patients receiving aerosol pentamidine, only 5 percent in the 15-month period . . . developed a recurring episode. . . . This is a 16-fold reduction.” Earlier that same year, Mike had read in People magazine that the fifteen-year-old hemophiliac Ryan White—at that point probably the most famous person with AIDS in the country—was again in the hospital with PCP. Somehow Mike managed to track down Ryan’s family and discovered to his astonishment that Ryan’s doctor had never mentioned—or heard of—PCP prophylaxis. After Mike put Sonnabend in touch with the doctor, Ryan went on prophylaxis. The episode illustrated for Mike the different levels of access available to different segments of the population. As he put it, “ethnic minorities, IV drug users and the poor” lacked not only crucial information but also the money to afford private physicians with substantial expertise. The nonaffluent, as usual, were bearing a disproportionate burden of deaths. To Mike, this was “a scandal of unspeakable magnitude.”

  In the late eighties, the indifference of the Reagan administration meant that no coordinated AIDS program existed through which the exchange of data on the disease could be facilitated. Nor were the media focused on treatment issues. Some concerned health officials tried to alert various newspapers to the growing enormity of the AIDS crisis and to the resistance of the government t
o a more sustained effort to deal with it. Gossip, not protocols, entranced the media, who centered most of their limited attention span on whether the disease threatened heterosexuals or on speculation about which closeted celebrities had already come down with AIDS. After Rock Hudson’s death in 1985, the focus shifted between Perry Ellis, Roy Cohn, Michael Bennett, and Liberace. The New York Times obits almost never mentioned AIDS as the cause of death.

  After Mike returned to New York from his frustrating meeting in 1987 with Fauci, he told the CRI board members that they themselves would have to come up with supporting data sufficiently full and technical to persuade NIAID to take action on pentamidine. Mike’s long-standing advocacy of self-empowerment was about to find new applicability. CRI, along with CCC in San Francisco, proceeded, in a precedent-setting move, to effectively demonstrate through community-based research what NIAID proved unable to do itself. Mike was rightly furious at the federal response, denouncing it as “sluggish, inhumane and frankly, third-rate.”3

  His anger went up another notch when he learned that Fauci had been forced under oath to admit to a congressional oversight committee that the Office of Budget and Management had approved only eleven of the requested 127 new full-time staff positions for AIDS research during fiscal year 1988. The lack of personnel, Mike felt, had undoubtedly contributed to the fact that out of twenty-four AIDS drugs identified by a NIAID Selection Committee as “high priority,” eleven were still not in clinical trials.

  Why couldn’t the government understand, Mike justifiably raged, that they were living in wartime. Most of the citizenry, he wrote in one article, “don’t hear the bombs dropping and shells whizzing past your head, don’t have to step over the bodies of friends and loved ones.” For those “scratching and clawing in a desperate attempt to stay alive,” the national indifference amounted to “passive genocide.” As early as 1987, Mike had testified before a House Energy and Commerce subcommittee on Health and the Environment—called by Representative Henry Waxman, one of the few people in Congress who seemed to care—that the “U.S. government’s track record in terms of treatments for AIDS is nothing short of scandalous.” A full six years into the epidemic, only about three thousand people had ever been enrolled in trials and a paucity of compounds had been tested. And most of the few trials that had been conducted had continued to focus almost exclusively on gay white men, though more than half of all AIDS cases were by then occurring in people of color. Federal research priorities were largely being set by academic scientists devoted to endless bureaucratic protocols and review boards. The federal trials claimed to have run into great difficulty in finding patient populations willing to participate; in contrast, community physicians had a plethora of patients lining up to volunteer.4

  Two months later Mike, in the name of PWAC, called a press conference to announce that “for the first time in the human history of epidemics, a group of people with a disease have banded together to sponsor top-notch treatment research in an effort to save our own lives and the lives of those who may eventually be diagnosed with AIDS.” The NIH, he declared, not only was obsessed with the notion that it alone knew how to run proper clinical trials, but was also hog-tied by “the placebo fixation of federal treatment research design”; such double-blind trials might be the “cleanest” way to get good data, but they weren’t the only way, and “given the reality of AIDS, it is unreasonable to expect us to participate in placebo trials.” What CRI proposed was nothing less than “the creation of a Manhattan Project for treatments which would essentially pursue every reasonable lead with all due haste.”5

  Mike was also able to announce at that press conference that CRI had signed a $400,000 one-year contract with Lyphomed, the pharmaceutical company, to conduct a trial involving two hundred subjects to determine—yet again—the efficacy of inhaled aerosol pentamidine in preventing PCP. Within the AIDS activist community in general, there was considerable criticism of Lyphomed for the price increases that it claimed were necessary to fund research (research, Mike felt, that the federal government should have paid for). He didn’t claim to know if Lyphomed’s argument for hoisting prices was justified, but he did know that Lyphomed was “the first company to put their money down in a gamble on an experimental approach to AIDS treatment research.”

  In preparing the trial, CRI followed standard state and federal regulatory procedures: it established its own IRB (Institutional Review Board), and staffed it with experts from medical ethics, law, and medicine, as well as PWAs (including Mike himself), to ensure that research subjects were protected from undue risk. CRI also made sure that its clinical trials would be open to all, irrespective of race and gender. As well, it set up a scientific advisory board of AIDS medical experts (chaired by Sonnabend), which included Dr. Donald Armstrong, head of infectious diseases at Memorial Sloan-Kettering, Dr. Michael Lange of St. Luke’s-Roosevelt Hospital Center, Dr. Mathilde Krim, co-chair of amfAR, and Dr. Bernard Bihari, director of Kings County Addictive Diseases Hospital. The scientific advisory committee would review and revise all protocols as well as generate protocols of its own. Mike made it clear that CRI did not view itself as in competition with federal research efforts, but rather “as a creative addition to AIDS treatment research. . . . Surely in a crisis of the magnitude of AIDS, there is room for creative solutions.”

  True to Mike’s feminist orientation, CRI fought aggressively for the inclusion of women in its clinical trials; when a drug company submitted a protocol on a “hot” drug that excluded women entirely, CRI’s IRB demanded a counterproposal that unconditionally included women—and won. In several other protocols, CRI got the age limit lowered to twelve, though it didn’t attempt any pediatric trials. Its initial trial for aerosol pentamidine, moreover, proved conclusively that it was a successful prophylactic against PCP. One year later, the FDA sent a team to CRI to inspect its procedures and results and issued a report that concluded that the group was engaged in “good science.” Thereafter, the FDA formally approved aerosol pentamidine. CRI had pulled off an astonishing feat of self-empowered scientific rigor—and saved many lives.6

  Yet community-based research lacked the resources of NIAID and other federal agencies. Rumors continued to multiply about the many possibly effective drugs that were languishing on the shelves due to the apathy of the Reagan administration and the FDA’s traditionally slow protocols and drug approval process. By 1987, there was a notable uptake in demonstrations against the stalling and red tape that had characterized the testing of potentially useful drugs—and against the appalling focus of the drug companies on the profit motive above all other considerations.

  Some of these unruly and defiant direct-action protests preceded the formation of ACT UP and sprung up in a variety of locales. Several protests involved only a few participants, who the police easily dispersed. But others—like those organized by the Lavender Hill Mob in New York City—involved hundreds of angry protesters in a series of scattered demonstrations and “zaps.” Desperation and rage were unquestionably building—and early in 1987 exploded at New York City’s Gay Community Center when Larry Kramer gave an emotional speech (which Mike admitted and applauded) demanding that the gay community take action. Tim Sweeney—GMHC’s associate director—then encouraged a follow-up meeting. From that meeting, ACT UP came into being. Its series of media-savvy demonstrations and actions began with a sit-in on Wall Street and expanded rapidly thereafter. By spring 1988, ACT UP chapters existed across the country and for nine consecutive days protests were mounted on a set of issues ranging from the global impact of AIDS to the plight of those in prison.

  Fortunately, an unexpected ally from within the Reagan administration arose in the person of C. Everett Koop, the surgeon general. Koop had an impeccably conservative background, including strenuous opposition to abortion, and his appointment in 1981 as surgeon general had horrified liberals across the country. But Koop proved to be his own independent man. Throughout 1986, he immersed himself in the literature on AIDS a
nd then—without notifying the White House in advance—went public with a Surgeon General’s Report on Acquired Immune Deficiency Syndrome. It came as a profound shock to all parties.

  The Koop report was nothing less than a call to arms. He not only advocated AIDS education at “the earliest grade possible”—his critics translated that as giving condoms to eight-year-olds—but also championed safe sex, denounced mandatory testing, and characterized any suggestion of quarantine as “useless.” Yet as the political scientist Cathy J. Cohen has pointed out in The Boundaries of Blackness, Koop “seemed to collapse efforts to deal with AIDS among African Americans with policies targeting Haitian communities; this was symptomatic of the institutionalized ignorance of issues relating to race that skewed many of the white reactions to AIDS in minority communities.” But the opposition that arose in the White House to Koop’s report was hardly based on racial sensitivity. Education Secretary William Bennett and White House adviser Gary Bauer led the assault on Koop, arguing furiously that his report should have been “more morally judgmental.” Skillful in influencing the media, Bennett and Bauer fought Koop at every turn. They insisted on “value-based education” that taught teenagers to apply Nancy Reagan’s jingle “Just Say No” to sexual activity. Bauer got the president to further emphasize the message in an April l, 1987, speech in which he stressed that AIDS education in the schools should focus on the importance of sexual abstinence. The Bennett/Bauer position continued to dominate the Reagan administration’s policies, though it failed to silence Koop’s ongoing call for compassion—and condoms.7