Coalition Proposes Criteria for AIDS Drug Trials

A coalition of 15 AIDS and gay rights groups proposed criteria Wednesday for selecting patients to participate in “parallel track” trials of experimental AIDS drugs to ensure the tests “will not compete with, but rather complement,” more formal studies.

Coalition members said the guidelines, unveiled on the eve of a public hearing on the parallel track process, envision that patients accepted for formal, controlled drug studies should not be permitted to choose parallel track drug trials instead.

If parallel track testing is approved, it will make potentially promising but not thoroughly tested experimental drugs available to thousands of AIDS patients who would not be able to participate in traditional drug studies.

Seen as Reassuring

The coalition’s position that patients should not be able to opt out of traditional studies “should reassure the medical and scientific communities that the AIDS activist community has no desire to undermine the ability of clinical trials to recruit research subjects,” said Jeff Levi of the New York-based Gay Men’s Health Crisis, one of the coalition groups.

The Food and Drug Administration has scheduled a public hearing today to discuss the issues surrounding the parallel track process, which was proposed in June by Dr. Anthony Fauci, director of AIDS research activities for the National Institutes of Health.

Fauci, under increasing pressure from AIDS activists, suggested the adoption of a separate track of studies of experimental AIDS drugs to serve individuals who are not qualified to participate in traditional, highly structured clinical trials.

The idea has received widespread praise from AIDS activists and others who believe that the deadly urgency of AIDS requires that there be speedier access to promising drugs, regardless of their potential risk. But it has been attacked by formal AIDS researchers and those who are concerned that the rigorous scientific process will be damaged and that dangerous or worthless drugs could proliferate in an uncontrolled fashion.

The 15 organizations--ranging from the radical AIDS Coalition To Unleash Power (ACT UP) to the more mainstream American Foundation for AIDS Research--recommended that the eligibility of patients to participate in parallel track trials should be “determined by qualified physicians on a case-by-case basis.” But the groups also stated that “the same general access criteria should be used in all decisions.”

The coalition proposed that parallel track treatments should be limited to individuals with a condition for which no standard treatment exists, those who cannot tolerate standard treatments for their condition, and those who are failing under standard treatments.

Other candidates for the special drug treatments would be patients who must take other medications forbidden in traditional clinical trials of experimental drugs, those who live too far from clinical trial sites and those too sick to participate in a controlled trial.

So far, the antiviral drug AZT is the only medication that has been approved as a treatment for AIDS’ underlying viral infection. Most formal clinical trials of experimental AIDS drugs use AZT for “control group” comparisons instead of medically worthless placebos. Some patients, however, cannot tolerate AZT.

The coalition’s statement, which was sent to Assistant Secretary for Health Dr. James O. Mason, did not propose steps to ensure the scientific integrity and success of formal clinical trials. Neither did it specifically recommend that patients qualified for formal trials be excluded from parallel track studies.

But representatives of several of the groups said the general feeling of those who endorsed the proposals was that individuals eligible for formal trials should participate in them and not in parallel track tests.

“If you’re eligible--and selected--for one track, that’s the track you should follow,” said Tom Stoddard, executive director of Lambda Legal Defense and Education Fund, a gay rights organization.

Dr. Newton E. Hyslop Jr., principal investigator for the Tulane-Louisiana State University AIDS clinical trials unit, said he was concerned that the establishment of a parallel track process would affect the selection process for formal trials in a way that could bias the outcome because participants would no longer represent a statistically valid sample group.

Also, Hyslop said, denying an individual access to a parallel track study could raise some “difficult ethical problems” for researchers.

“If you make it impossible for someone who fits the research criteria to get the drug through parallel track, then you have an ethical problem,” he said. “You’re denying drug availability because the study needs to be satisfied.”

Dr. Robert T. Schooley, acting director of the AIDS clinical trial unit at Massachusetts General Hospital, expressed similar concerns.

“You have to be careful about denying access to parallel track to people who fit (formal) trial entry criteria, because you then force people into trials under duress,” Schooley said.

Stoddard said he was “certain that some researchers will continue to be nervous about this subject because it represents an entirely new way of doing business. But the old rules were wrong, and they did harm to a significant number of people.”

Rep. Henry A. Waxman (D-Los Angeles), chairman of a House subcommittee that recently held hearings on the parallel track proposal, called the coalition statement a “promising first effort.”

“If the parallel track works, it will give people access to experimental drugs--both the good ones and the worthless ones--long before data are available,” Waxman said. “If it fails, it could cripple AIDS research.”

The organizations, noting that the parallel track process “offers the best hope to address some of the most urgent problems posed by the AIDS epidemic,” said the process should be overseen by an advisory committee composed of representatives from the Federal Drug Administration, National Institutes of Health, AIDS primary care physicians, AIDS patients and community-based AIDS research groups.