The Crisis in Clinical AIDS Research
by Mark Harrington, December 1993
In November 1989, AIDS activists attended our first AIDS Clinical Trials Group (ACTG) meeting. We were not given a warm welcome. After many months of struggle, activists and people with HIV were integrated into the ACTG system and given voting representation on each committee, and many ACTG sessions were opened up to community observers. Four years after those events, however, many of the initial criticisms of ACTG research remain relevant. Moreover, new problems have emerged which demand changes in the design, conduct and analysis of clinical trials for AIDS and HIV-related conditions. In addition, hard-won victories by activists (e.g., parallel track, active-controlled studies, accelerated approval) have produced a new set of issues of their own which must be addressed. Finally, results of recent, relatively large-scale clinical trials have been disappointing; despite substantial aggregate improvements in quality and length of life since the mid1980s, the hoped-for long-term benefits of early or combination intervention with antiretroviral therapies have not materialized. Those designing the latest batch of clinical trials have tended to ignore these setbacks, proceeding as though nothing was wrong with the assumptions, some of which are now undermined by the data, underlying these studies. This report is an effort to critically assess the current impasse.
Basic Research on HIV Infection: A Report From the Front
by Gregg Gonsalves, June 1993
TAG decided to ask thirty-six leading basic scientists working on AIDS in the United States to outline the scientific challenges for the field in the years ahead and the ways in which they thought their work could be better facilitated. The following report is a synthesis of the comments of these researchers. It is intended to provide a survey of the state of basic research on HIV infection from the scientists at the bench. We also hope that the report will highlight the importance of the work being done. Unlike clinical research in AIDS, basic research has not had a powerful constituency to advocate on its behalf. The relevance of basic science to the lives of PWA's is far less apparent than clinical studies which hold the promise of proving a new drug's efficacy. Yet, new treatment options for people with HIV and a vaccine to protect the uninfected largely depend on the success of basic investigation. Finally, the report offers an assessment of the non-scientific obstacles confronting these scientists in their day-to-day work and practical recommendations to move these hurdles aside.