Debate Renewed Over Fast Approval for AIDS Drugs

The Food and Drug Administration Monday reopened the contentious debate over the speedy approval of new AIDS drugs in response to a growing split within the usually unified network of AIDS patients and their advocates.

The activist community continues to support a 1992 decision by the agency to license therapies based on early signs--known as “surrogate markers”--that may predict, but do not prove, future clinical benefits. Some activists, however, have become increasingly unhappy over what they view as inadequate follow-through by drug companies and the FDA.

This has led to a lack of sufficient information about clinical benefits, “forcing people with HIV infection to make treatment decisions in the dark,” said the Treatment Action Group, a New York-based activist organization that has spearheaded the effort to reopen the discussion.

The FDA’s antiviral drugs advisory committee sponsored a meeting to listen to opinions on the subject but is not expected to make any immediate decisions or changes in the current policy. The panel is scheduled to make its views known today.

Insisting that it still favors accelerated approval, Treatment Action Group nevertheless said that the agency “has not insisted on adequate and well-controlled confirmatory studies, and industry has not provided sufficient post-marketing information on whether accelerated-approved drugs actually work.”

FDA spokesman Jim O’Hara said the agency “remains committed to accelerated approval but we’ve always realized that it could well be subject to mid-course correction.”

Nevertheless, many speakers Monday--including some who told poignant personal stories--said they feared that the current discussion would endanger the accelerated approval policy, which they believe it is crucial to maintain.

Dr. Thomas McGee, a Los Angeles physician with an AIDS practice, complained that his patients were being “protected to death,” when they were denied access to experimental therapies.

Martin Delaney, founding director of Project Inform, said he thought it “unfortunate that this meeting has linked the discussion of how to get information from clinical trials with the issue of accelerated approval.

“It would have been preferable to raise the legitimate issue of getting better data as an independent concern, rather than making it a forum for debating the merits of accelerated approval,” he added. “The issues can and do stand on their own.”