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Executive Summary

The parallel track proposal for expanding the use of investigational compounds to patients outside of controlled trials could bring the agency's drug approval procedures in for a round of tough Capitol Hill second-guessing in the future, University of California -- San Francisco Pharmacy Dean Jere Goyan predicted at a Dec. 13 seminar for FDA staffers at the agency's headquarters in Rockville, Maryland. "Although everyone says [that the parallel track system] is okay," Goyan observed, "I still would maintain that when the first serious toxic deaths occur from it, people are going to be suing everyone in sight including the FDA." The former FDA commissioner during the Carter Administration warned that a drug failure in a parallel track setting would lead to "oversight hearings in which the FDA will be accused once again of not knowing what they are doing because they allowed this to happen." Goyan's comments reflect concerns expressed by top FDAers when the agency first discussed the parallel track approach four months ago. One FDAer at the time commented, for example, that it will be necessary for all the parties involved in the concept to be willing to take "collective responsibility" for problem drugs that emerge from the testing procedures. The parallel track approach has been urged by AIDS patient lobby groups and has been supported in concept by top FDA officials, although no specific plan has yet been proposed. At the Food & Drug Law Institute's annual educational meeting on Dec. 13, FDA Center for Biologics Evaluation & Research Director Paul Parkman promised that a statement on the parallel track initiative will be forthcoming "soon." Parkman noted that a working group was convened when FDA unveiled the concept of parallel track studies in late August ("The Pink Sheet" Aug. 21, pg. 10). "We have made a commitment to producing a viable initiative," he declared. The experimentation with Compound Q in San Francisco can be viewed as an unsanctioned prototype of parallel track trials, Goyan commented. "If I was going to say anything about [that experimentation] what I would say is that it is an example of the first parallel trial," Goyan said. In lieu of the parallel track approach, Goyan said he agrees with Robert Temple, director of FDA's Office of Drug Evaluation I, who recently suggested the use of trials designed carefully to include most potential patients would be preferable to the parallel track approach ("The Pink Sheet" Nov. 27, T&G-2). Goyan said he was "very pleased" with Temple's approach. "My response to that," Goyan declared, "is basically 'Amen!'" Trials with less restrictive entry criteria "are not going to be as efficient as the classical randomized clinical trial," Goyan pointed out. However, he noted, "in some ways they are more humanitarian. And they are responsive to a changing societal context that the AIDS epidemic has prompted." Parkman used similar language to describe FDA's attempt to approach drug development with a sense of "compassion for the needs, hopes, and rights of the desperately ill." Noting "that potential efficacy has become more important in the area of AIDS than potential toxicity," Goyan expressed concern that some elements of the drug research and testing community might push for the expanded use of drugs prior to any signs of efficacy. In response to a question from an FDA staffer about the likelihood of renewed efforts to do away with efficacy criteria, Goyan said he is optimistic that that will not occur. He noted that a leading figure in the ACTUP AIDS lobby group recently made the statement "that he did not want to see the AIDS epidemic result in a destruction of what is basically a good system requiring that a drug be shown to be effective as well as safe." Goyan reminded the FDAers that the efficacy requirements have survived attacks in the past -- including criticism from President Reagan in campaign statements during his first run for the presidency. Goyan suggested, however, that changes in clinical trial design to permit more involvement by community practitioners would be an improvement in the long term. "I do think we are going to see more use of community practitioners for clinical trials," he commented. He said he has been astonished to "discover that [some clinical trial investigators] are actually to the point where they are running out of patients for oncology studies. And they are going to have to make more use of patients in the community in order to carry out the trials." The SouthWest Oncology Group has done some community trials, Goyan noted. "I have talked to some of the people in that group and I suspect that if you do it right you can get better adherence to protocol in a trial of that nature in a community than you often can in a university." He observed that "university professors always feel that they have better ways of doing things and have a tendency to improve on the protocol if you don't watch them carefully. The community practitioners are seldom guilty of that sort of thing."

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