The FDA under Fire
Though its targets were always multiple, throughout 1987 and 1988, ACT UP trained its attention particularly on the FDA, perceived to be the roadblock in the way of access to AIDS drugs. In March 1987, the FDA commissioner announced a new plan to create a special category of unapproved drugs called Treatment Investigational New Drugs (Treatment INDs), to be available on a compassionate use basis to patients with terminal illnesses whose doctors contacted the FDA. But in essence this was nothing more than a codification of existing, case-by-case compassionate use policies. AIDS activists were not mollified; "Drugs into bodies" was their war cry.
"Many of us who live in daily terror of the AIDS epidemic cannot understand why the Food and Drug Administration has been so intransigent in the face of this monstrous tidal wave of death," wrote Larry Kramer in an opinion piece published in the New York Times . "There is no question on the part of anyone fighting AIDS that the F.D.A. constitutes the single most incomprehensible bottleneck in American bureaucratic history…." "In addition to ribavirin, why is the F.D.A. withholding Ampligen; Glucan; DTC; DDC; AS 101; MTPPE and AL 721?" he asked in reference to some of the many experimental drugs that were rumored to be efficacious. Patients had no interest in paternalism, Kramer insisted: "AIDS sufferers, who have nothing to lose, are more than willing to be guinea pigs." Similarly, Martin Delaney, executive director of the San Francisco-based Project Inform, struck a chord that resonated deeply with U.S. political culture by painting the FDA as a would-be "Big Brother" and insisting on the individual's basic right to choose. In public debates and private meetings with AIDS clinical researchers and FDA officials, Delaney sought to reframe the very purpose of the FDA: rather than seek only to protect the public from ineffective or dangerous therapies, the FDA should take an active stance to promote the nation's health.
AIDS activists were not the only voices challenging the FDA. For years, conservatives from places ranging from the Heritage Foundation to the offices of the Wall Street Journal to—most recently—the corridors of the White House had been seeking to roll the "deregulation" bandwagon onward in order to focus on the pharmaceutical industry. The FDA was killing the drug companies and preventing useful products from getting to market, the argument ran; the best solution would be to repeal the Kefauver-Harris amendment, which had granted the FDA the authority to assess the safety and efficacy of drugs. "Especially considering who was the president, we had concern" about adding fuel to the deregulatory movement, recalled David Barr of ACT UP/New York: "But it wasn't enough concern that it would stop us from doing what we were doing." Soon an unlikely alliance had developed—usually tacit, but sometimes explicit—between AIDS treatment activists and conservatives, leaving consumer protection groups and traditional liberals on the other side.
When cancer treatment advocates connected to the ultraconservative John Birch Society had used similar grounds to press for access to laetrile in the 1970s, a confluence of interest with pro-market forces was perhaps less surprising. But when AIDS Treatment News plugged a Heritage Foundation report called "Red Tape for the Dying," describing it as proposing "a workable, politically possible change which could solve part of the AIDS 'drugjam,'" or when Project Inform began collaborating on a regulatory proposal with the Competitive Policy Institute, a conservative policy group, everything started to seem upside down, and liberal politicians might have been forgiven their bewilderment at becoming the target of criticism by their usual allies. Henry Waxman, the liberal chair of the health sub-committee of the House of Representatives, found himself in a peculiar plight when he raised objections to the Treatment IND proposal. The Wall Street Journal , suggesting that Waxman "has been to new-drug development in this country what the troll under the bridge was to forward progress in the Billy Goats Gruff," noted with evident glee: "If he opposes the administration initiative, it will be interesting to hear him explain it to AIDS victims in his West Hollywood constituency."
The FDA was being pressured from all sides, particularly by the increasingly flagrant flouting of the law by the AIDS treatment underground. Importing unapproved drugs had become an organized and global operation, with regular couriers flying in treatments such as dextran sulfate from places like Japan and then distributing them at
bargain prices to individuals all around the United States. Organizations called "buyers clubs" (sometimes also called "guerrilla clinics"), operating in a gray zone of legality, had sprung up in major cities around the United States, swapping information about treatments and selling a range of unapproved compounds and alternative therapies. By October 1987, Project Inform's newsletter reported ten such organizations in the United States, plus one in Vancouver and one in London. These organizations had benevolent motivations and, indeed, protected their customers from less scrupulous entrepreneurs seeking to profit from "quack" remedies. But the FDA was far from convinced of the wisdom of tolerating their operations. "This is a very fine line we're walking," said Frank Young, the FDA commissioner, acknowledging the practical limits of pursuing a strict enforcement policy against the buyers clubs: "Since there's nothing else available except AZT, we are trying to make available the opportunity for patients to get other drugs and treat themselves."
When Young appeared in Boston at the Lesbian and Gay Health Conference in July 1988, he confronted a hostile audience of one thousand; the first three rows were filled with ACT UP demonstrators holding signs saying "FDA, YOU'RE KILLING ME." While some demonstrators conducted a mock "die-in," others held up their watches with alarms ringing: for people with AIDS, time was running out. But to the surprise of the audience, Young had come to announce that the FDA would now permit the importing of unapproved AIDS drugs in small quantities for personal use. In a remark to a reporter after his talk, Young described his motivations: "There is such a degree of desperation, and people are going to die…. I'm not going to be the Commissioner that robs them of hope." But according to a reporter for Science , the change in policy "stunned" many in the research community: "One official in the federal government's AIDS Program went so far as to suggest that the FDA commissioner had gone 'temporarily insane.'"
AIDS activists, however, had no intention of letting up the pressure on the FDA—certainly not in response to the limited new policy of importation for personal use. Plans began in New York City, San Francisco, and elsewhere for a demonstration that would "shut down" the FDA. In an early example of what would prove to be periodic position papers on the state of AIDS research, ACT UP/New York distributed a thirty-five-page, closely argued document entitled the "FDA Action Handbook," designed to explain to the mass membership the medical and political justification for the action. "Many Federal agencies, not
to mention local and state ones, have been derelict in the fight on AIDS," wrote Jim Eigo and Mark Harrington, two of the authors: "Yet only one agency, the FDA, is actively blocking the delivery of promising drugs to PWAs and people with HIV infection." Sections of the handbook included discussion of topics such as "What Is the FDA?" "A Brief History of the FDA," "The Standard Drug Approval Process," "Drug Horror Stories," and "Exclusion of Women, People of Color, Poor People, People in Rural Areas, IV Drug Users, Hemophiliacs, Prisoners & Children from Experimental Drug Trials." The document is noteworthy for its use of "atrocity tales" and for its construction of an antagonist identity: "Like corporations, [government bureaucracies] consider the data of lives as raw material and grist for a perpetual-motion paper mill. Human need, suffering and death count for very little when compared to the imperatives of orderly process and well-maintained policies."
On October 11, 1988, following a national display of the Names Project AIDS Quilt on the Capitol Mall in Washington, D.C., more than a thousand demonstrators from around the country converged on FDA headquarters in Rockville, Maryland, to "seize control" of what some labeled the "Federal Death Administration." Protesters fell to the ground holding mock tombstones with caustic inscriptions: "I got the placebo. R.I.P."; "As a person of color I was exempt from drug trials." Two hundred demonstrators were arrested by police, who wore rubber gloves to protect themselves from the supposed risk of HIV infection.
It was a protest that, in the words of two chroniclers, "represented … a culmination of our early efforts. …" It also marked "a turning point in both recognition by the government of the seriousness and legitimacy of our demands and national awareness of the AIDS activist movement." The ACT UP/New York Media Committee had "distilled" the message of the "FDA Action Handbook" to explain it to the press in simple terms: Protesters demanded immediate access to drugs proven safe and theoretically effective in Phase I trials. Double-blind, placebo-controlled trials should be declared unethical and replaced with alternative trial designs. The FDA should make it clear that it would not tolerate trials that prohibited its participants from taking simultaneous prophylaxis against opportunistic infections. People from all affected populations—gays, injection drug users, and people with hemophilia; women and men; whites and people of color— must be given access to trials. Medicaid and private health insurance should cover experimental drug therapies.
"The meeting at the FDA two weeks later was very different," recalled David Barr, "because, not only had we been able to show our firepower out on the street, but when we sat down at the table we had a list of issues that we understood—we were very knowledgeable about them by that time. …" Significantly, activist strategies and tactics in negotiation with FDA officials differed considerably from the colorful display outside the building. That "was theater and we knew it was theater," explained Barr. "It was a much smaller group of people who were actually inside at the table, and we wouldn't go in there saying, `Okay, we want to go through these forty demands with you.' We were savvy enough to say [ahead of time], `What are our issues at this meeting with this group of people? Let's talk about these five things, and what is our priority'—and we learned how to do a meeting. …"
The simultaneous use of insider and outsider tactics meant, however, that activists needed to establish working relationships with the same people they had vilified in public statements and demonstrations. Similarly, activists needed to engage with the nuts and bolts of policies and research practices whose defects they had heretofore been content to paint with a broad brush. Though activists continued their bitter criticisms of government agencies and individual scientists, they resisted the notion—found, for example, in the animal rights movement —that the scientific establishment was "the enemy" in some absolutist sense. "I wouldn't exaggerate how polite we were," reflected Mark Harrington. "At the same time, I would just say that it was clear from the very beginning [that we recognized that], as Maggie Thatcher said when she met Gorbachev, `We can do business.' We wanted to make some moral points, but we didn't want to wallow in being victims, or powerless, or oppressed, or always right. We wanted to engage and find out if there was common ground."