Federal health officials have established a special task force to address serious concerns among them over how proposed so-called "parallel track" human studies of experimental AIDS drugs will operate, Assistant Secretary for Health James O. Mason announced Thursday.
Mason said that virtually everyone in the federal health community agrees with the broad concept that promising AIDS drugs should be made much more accessible while they are still being studied but that critical problems must be resolved before such a program can begin.
"Implementation of this initiative will occur as we resolve the difficult questions such a program raises," he said in testimony before the House Energy and Commerce subcommittee on health. "We are confident, however, that we can resolve these issues and thus develop and implement this initiative rapidly."
'Parallel Track' Trials
Last month, Dr. Anthony Fauci, director of AIDS activities for the National Institutes of Health, proposed that a more flexible program be created that would enable AIDS patients who are not qualified for traditional highly structured clinical trials to get experimental drugs through what he dubbed "parallel track" trials. The drugs would be made available after their safety had been established but before their efficacy in treating the disease was proved.
The idea was praised by AIDS activists, who long have argued that, because the disease is fatal, AIDS patients should have the choice of whether or not to take unproved drugs. But it also drew pleas for caution from AIDS researchers who are worried that participation in traditional trials would suffer and that scientific integrity would be compromised.
Mason said that, among other things, the federal government must first devise ways of identifying and evaluating unexpected deaths or serious illnesses associated with the experimental use of these drugs and that it must also develop a process for determining who will be eligible to receive them.
The first potential problem was dramatically illustrated several weeks ago when an AIDS patient participating in an unauthorized trial of a Chinese drug known as Compound Q died, possibly from its side effects, another committed suicide and several others developed serious complications.
Further, Mason said, issues regarding legal liability and management of the parallel track trials would have to be settled.
Federal health officials have met at least twice within the last two weeks to discuss these issues and have failed to resolve them, according to sources within the Department of Health and Human Services.
AIDS activists, who are largely responsible for persuading government regulators to institute these new procedures, complained Thursday that they are beginning to lose patience.
Dissatisfied With Results
"We feel it is time for the voice of patients to be given first priority," said Martin Delaney, co-director of Project Inform in San Francisco. "After eight years of patience and cooperation, we are increasingly dissatisfied with the results."
Jeff Levi, executive director of the National Gay and Lesbian Task Force, agreed. "Forming a committee is the usual bureaucratic response to avoid difficult decision-making," he said.
Mason said that he has asked the panel, which will be under the auspices of the Food and Drug Administration--which regulates the approval of new drugs--to report back to him no later than Aug. 21.
He said that the parallel track studies would be run as an "open protocol," meaning that there will not be a simultaneous control group to use for comparison. "It does not signify that the investigational agent is made widely available without restriction," he said. Only patients who are not eligible for structured trials will be accepted for parallel track studies.