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Annals of Crisis

A Peek Back at TAG's First Year Shows How Much, and How Little, Has Changed

"Homing in on Basic Research"

By Mark Harrington

tagline 2002 January/February

The beginning of this year marks TAG's tenth anniversary as the nation's only organization focused exclusively on advocating for more and better AIDS research; and speeding discovery, development, approval, and distribution of better treatments, a cure and a vaccine. While the latter two goals remain elusive, the past ten years have seen significant progress -- much of it instigated or accelerated by TAG. The NIH AIDS research budget has tripled in size, from $800 million to $2.4 billion per year. After TAG's pivotal 1992 report,

AIDS Research at the NIH: A Critical Review, the AIDS research program at the National Institutes of Health was reformed and reorganized.

In the mid-1990s, TAG played a major part in forcing the drug companies developing protease inhibitors to study the drugs more rapidly and to provide more reliable information on how to use them. TAG also played a critical role in speeding up research on the opportunistic infections and cancers which were the leading killers of people with HIV. Since 1996, with the introduction of highly active antiretroviral therapy (HAART), protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and viral load testing, antiretroviral treatment strategies have undergone a revolution.

Over the past seven years AIDS mortality dropped by two-thirds in the U.S. and other industrialized countries. Nonetheless, significant problems remain with anti-HIV drug adherence, cost, resistance, and toxicity. As people with HIV live longer, new problems such as lipodystrophy and liver disease now cause more problems among people with HIV living in the United States. Meanwhile, internationally, despite several years of intensified mobilization, the HIV pandemic spreads unchecked by effective prevention and existing treatment, let alone an HIV vaccine. TAG remains committed to completing our mission.

As we move forward in 2002, we will also look back at the work which brought us here, investigating key TAG projects and campaigns, interviewing leading researchers and activists who worked with TAG, and remembering those we have lost. Our first article focuses on TAG's formation in 1992, its dual missions of direct action and critical research analysis and oversight, our critique of the NIH AIDS research program and our call for an increased emphasis on the basic science of HIV infection -- all themes which remain timely despite the progress of the past ten years. Mark Harrington transports us back to the dark days of the early 1990s.

1992 was a year of crisis for people with AIDS. Twelve years into the epidemic, despite the mobilization of thousands of activists, the deployment of millions of dollars in federal and pharmaceutical research funds, and significant accomplishments in speeding development and approval of three drugs for HIV and several more for its associated opportunistic infections, AIDS research was at a low point.

AZT had been approved by the FDA in 1987 and recommended for wider use in 1991, the same year that the FDA approved ddI (Videx), the second antiretroviral. These drugs extended life and health by just a year or two, and failed to durably suppress the virus. In 1992 it was still unclear whether hoped-for new therapies such as inhibitors of the HIV tat or protease enzymes would prove effective. In the meantime, the AIDS and death tolls mounted relentlessly.

Activists had won entrée into the councils of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) AIDS drug development programs and oversight bodies, and had helped to broaden the research agenda to include more research on the opportunistic complications of HIV -- and on women and children with HIV. Nonetheless, the prospects for treatment looked unpromising.

Scientists did not yet have a clear picture of the pathogenesis of HIV infection. It was still widely and incorrectly believed that HIV "hid" somewhere in the body in the period between acute infection and the development of AIDS ten years later. Available tests to quantify viral levels in the body were crude at best. Only a few researchers were looking for the virus in body compartments such as the lymphoid tissue, as opposed to the easier to sample bloodstream. It was not yet known how HIV destroyed the immune system and led to AIDS.

Without a better understanding of how HIV led to disease, it would be difficult to develop better treatments. Yet at NIH, despite an AIDS research budget that had steadily mounted to almost $800 million per year, the research effort was poorly coordinated. It lacked a central place where the overall research agenda could be planned, budgeted, and evaluated. Eighteen different NIH institutes each conducted their own AIDS research programs as they saw fit. Scientists in the field were depressed about the lack of progress on both the therapeutic and on the preventive vaccine fronts.

The political situation was also troubling. During twelve years of Republican presidencies, most federal action on AIDS had been instigated by -- and sometimes obstructed by -- Congress. The country had just emerged from a distracting war in a far-off Islamic country, and it was in recession. Health care costs were rising uncontrollably, and increasing cries were heard for the government to do something to broaden access to health care. It was difficult for AIDS and health care activists to get the attention of President George Bush.

Meanwhile, the AIDS activist movement itself was in crisis. The largest activist group, the AIDS Coalition to Unleash Power or "ACT UP," was increasingly riven by infighting, while many of its leaders and members were falling ill or dying.

Within ACT UP's Treatment + Data (T+D) Committee, a dozen treatment activists were determined to focus their efforts on research and treatment advocacy. Infighting was getting in the way of that focus, and so in January 1992 they split off from ACT UP and formed the Treatment Action Group. TAG's early focus included a series of direct actions targeting drug companies whose development plans were too slow: Dai-Ichi pharmaceuticals, for their glacial development of an anti-Kaposi's sarcoma (KS) angiogenesis inhibitor; whose expanded access programs were inadequate: Hoffmann-La Roche, for refusing to provide expanded access to ddC; or whose prices were too high: Astra, for the excessive price of the anti-CMV drug foscarnet. Despite widespread publicity, these civil disobedience "zaps" were becoming less effective than they had been in ACT UP's early days.

The litany of drugs which the FDA did approve over the course of 1992 showed just how slow the research progress was, and how grim the prognosis for most people with HIV. The third anti-HIV drug, Roche's ddC (Hivid), was approved in June -- even though there was no evidence that ddC improved health or prolonged life. It was approved based on minute and transient increases in CD4 cell counts. ddC would go on to be the least widely used drug of its class. Then, in a rush of year-end drug approvals, the FDA approved two drugs for advanced AIDS -- Adria's rifabutin for prevention of mycobacterium avium complex (MAC) and Unimed's dronabinol (Marinol), an appetite stimulant, for treatment of HIV-associated anorexia and weight loss.

An additional TAG focus was analyzing and reforming the AIDS research program of the NIH. Starting in February 1992, TAG's Gregg Gonsalves and Mark Harrington gathered information on every NIH AIDS research grant and program. By the International AIDS Conference that July in Amsterdam, they published AIDS Research at the NIH: A Critical Review. The report called on Congress and the Administration to strengthen the NIH Office of AIDS Research (OAR) and to provide it with the authority and ability to plan, evaluate, and budget a coordinated, streamlined, accelerated AIDS research program across all the NIH institutes and centers.

We also called on the government to double the entire NIH budget for biomedical research. That summer and fall, TAG worked on building an alliance with AIDS researchers across the country who would be willing to support the reform efforts when legislation was introduced in Congress during early 1993. TAG also met with NIH Director Bernadine Healy and the directors of the NIH institutes -- particularly Tony Fauci at NIAID and Sam Broder at the National Cancer Institute -- although the institute directors generally were opposed to any plan which would subject them to evaluation or oversight. With the election of Bill Clinton as President in November 1992, the stage was set for Congress to enact sweeping reforms of the NIH AIDS program in the reauthorization legislation of early 1993.

Finally, during 1992 TAG was the first activist organization to call on researchers to refocus the AIDS research effort on fundamental basic research dedicated to elucidating the pathogenesis of HIV disease and AIDS. TAG's pathogenesis project met monthly. We began working with basic scientists as well as with clinical researchers as we had in the past. In his 1992 speech at the Amsterdam AIDS conference, TAG's Mark Harrington spoke on "Pathogenesis and Activism" and showed slides of his own HIV-infected lymph node as an example of how activists and people with HIV could contribute to and participate in basic research as well as in clinical trials.

It was clear that progress would be slow. Over the course of 1992, 79,595 Americans were diagnosed with AIDS and 41,623 of them died of the disease. At the time it seemed that those numbers would only go up for the foreseeable future.

Many of TAG's founding members were HIV-infected themselves . Among the many activists who died of AIDS in 1992 were ACT UP/San Francisco's Michael Wright in January, TAG's Scott Slutsky in May, artist/writer David Wojnarowicz in July, and ACT UP/New York's Mark Fisher -- just before the November elections. When we marched uptown on election eve, 1992, bearing Mark's body to Bush's New York City campaign headquarters in midtown, most of us felt that it would only be a matter of time -- and not too long -- before we too died of AIDS. But we were determined to push for changes in the research system so that later generations of the infected would have a better prognosis and a chance for a longer life.