Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
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Gay Men's Health Crisis: Treatment Issues, Volume 8 no. 9 - October 1994
David Gold
The backdrop to the hearing was discontent among some activists and researchers about the accelerated approval of ddC and d4T and a proposal by the New York-based Treatment Action Group (TAG) for a "large simple trial" (LST) of HIV protease inhibitors. (See Treatment Issues, August 1994, pages 10-12.) The FDA acknowledged the need for debate about the future evolution of the accelerated approval process.
Many of those who testified at the hearings feared that the proposal would delay approval of and impede access to protease inhibitors. They gave passionate statements supporting accelerated approval and the right to access experimental therapies for those with life-threatening conditions. In response, FDA director David Kessler, M.D., strongly reaffirmed his agency's commitment to accelerated approval.
In contrast to accelerated approval, the future of the TAG proposal seems far less assured. Hoffmann-La Roche and Merck, manufacturers of the two most widely studied protease inhibitors, claim that the drugs are far too expensive to produce for an LST. Large-scale expanded access programs, like those set up for ddI, ddC and d4T, are likewise extremely unlikely, company officials said.
Yet the TAG proposal did accomplish something significant. It focused attention on the lack of real data from which to make treatment decisions concerning anti-HIV therapies. Much of this gap stems from the failure of the FDA to require adequate post-marketing studies of drugs receiving accelerated approval.
One committee member, Donald Abrams, M.D., of the University of California at San Francisco argued that there probably was no real niche for a large, simple trial in the preapproval phase of drug development, other than collecting safety data at different dosages. But he said that after a drug was approved, LSTs could help answer strategy questions such as "when to begin, when to combine, and when to switch."
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