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Executive Summary

ACTIVASE AND STREPTOKINASE SIMULTANEOUS APPROVALS BY FDA in November 1987 for I.V. use against myocardial infarction were questioned by Chairman Weiss (D-NY) at a Government Operations Subcommittee hearing on Sept. 29. Weiss asked Victor Marder, MD, co-chief of hematology at the University of Rochester to comment on the approval decisions for both drugs. Weiss asked Marder for a comment on FDA's use of "a new group of investigators" to review data on Genentech's Activase in the six-month period following an initial decision by the Cardio-Renal Drugs Advisory Committee to recommend against approval in May 1987. Marder was skeptical of the coincidence of final approval. "On May 29, the advisory committee said that streptokinase should be approved and TPA should not be approved," Marder noted. "It then took six months until the FDA approved both agents, within one week of each other." The University of Rochester doctor said: "I don't know why it took six months to confirm that it was reasonable to approve streptokinase, when they [FDA] already had a one-year follow-up of mortality benefits." He suggested that "to have them both approved within one week of each other suggests that there might have been some purposeful delay [of one product] and acceleration of the other." Marder was testifying at the Weiss hearing as one of three original members of the Policy Advisory and Data Monitoring Board for review of two streptokinase trials and the initial TIMI TPA trials. The House hearings are a continuation of a congressional examination of alleged cases of scientific fraud or bias in NIH-sponsored research. Although he questioned the timing of the two thrombolytic approvals, Marder did not second-guess the appropriateness of TPA's eventual approval. "I think it is entirely appropriate and correct that TPA is approved and streptokinase is approved for I.V. use." He reiterated that "the process could probably be improved and the advice could be sought by persons who are entirely unassociated with the study." Rep. Lightfoot (R-Iowa) asked Marder if he felt that the TPA studies "were designed in a way that would protect [them] against any conflict of interest?" Marder responded that "the trials were conducted in a way that even if someone were biased the data could not be changed." The Weiss subcommittee has alleged that two members of the NIH executive committee overseeing TPA trials had stock and stock options in Genentech.

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