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GP160 AIDS VACCINE PROPOSED TRIAL REVIEW PERIOD WOULD BE EXTENDED TO APRIL

Executive Summary

GP160 AIDS VACCINE PROPOSED TRIAL REVIEW PERIOD WOULD BE EXTENDED TO APRIL at the National Institutes of Health, FDA and the Department of Defense under an amendment proposed by Rep. Waxman (D-Calif.) on Sept. 30. A year ago, through a congressional appropriation, DoD received $20 mil. to conduct a large-scale Phase III trial of MicroGeneSys' gp160 AIDS therapeutic vaccine VarSyn. However, prior to the award of funding, the legislation stipulated that by April 6, 1993, FDA, NIH and DoD all had to certify whether a Phase III clinical trial should be conducted. Waxman's proposed amendment would extend the review period for the three agencies by 12 months from April 1993 to April 6, 1994. The House agreed to the amendment to the FY 1994 DoD appropriations and approved the appropriations bill (HR 3116) by a vote of 325-102 on Sept. 30. Congressional rules allow alterations to previously agreed upon appropriations; in the case of AIDS vaccine trials, the $20 mil. DoD appropriation was for a period of two years. Waxman's proposal keeps alive the controversy surrounding the clinical evaluation of the MicroGeneSys vaccine for HIV-Infected individuals. In a statement accompanying the amendment, Waxman noted that the three agencies have indicated that they are "prepared to certify that the trial should not proceed." Following the certifications DoD "will use these funds for their other AIDS research activities," Waxman said. During the week of Sept. 13, Waxman staffers met with representatives from NIH and DoD, as well as White House AIDS Policy Coordinator Kristine Gebbie, to discuss the status of the DoD appropriation. In his floor statement, Waxman noted that the amendment is "supported by the Administration." In April, DoD agreed to transfer the $20 mil. to NIH, which would have allowed the National Institute of Allergy and Infectious Diseases to conduct a multi-candidate vaccine trial that included VaxSyn. However, MicroGeneSys refused to provide NIAID with VaxSyn free of charge and the money remained with the DoD. Most recently, MicroGeneSys' gp160 development partner Wyeth- Ayerst agreed to reimburse the company for the cost of the product, enabling DoD to conduct a single-candidate trial ("The Pink Sheet" Aug. 23, T&G-2). Reflecting on the controversy, Waxman stated: "No one in this body wants an AIDS vaccine more than I do, and I have done all that I can to make that hope a reality. But I also believe the original provision in the 1993 statute was inappropriate." Waxman continued, "I do not want the Congress to force the expenditure of precious research dollars on a project that none of the agencies support." Indicating that the amendment may receive opposition in the future, Rep. Livingston (R-La.) asserted that "there is not unanimous support on this particular amendment, and I can assure the gentleman that there will be additional discussion" when the House and Senate meet in conference. The Senate defense appropriations bill does not currently contain a provision similar to Waxman's. However, the full Senate is scheduled to consider the bill on Oct. 13. When it does, Sen. Kennedy (D-Mass.) is reportedly planning to introduce an amendment similar to Waxman's. Both amendments appear to reflect a Sept. 27 consensus statement developed by extramural members of the NIH/FDA gp160 advisory panel. The consensus statement asserts that "the scientific evidence to date does not yet justify federal support for a large-scale Phase III study of either one or several candidate HIV therapeutic vaccines." The consensus statement contradicts the full committee's original recommendation that the $20 mil. appropriation should be spent on a multi-candidate comparative trial. The NIH/FDA panel met twice in late 1992 to develop the agencies" position on the appropriation ("The Pink Sheet" Nov. 23, 1992, p. 8). Rather than funding a clinical trial, the consensus statement suggests that "Congress clarify its legislative intent to allow the Army to distribute the $20 mil. appropriation...in a program of investigator-initiated AIDS research grants awarded under the guidance of an expert, objective peer review committee to be commissioned" by DoD. The awards should be open to basic, clinical, therapeutic, vaccine and behavioral AIDS researchers, the statement asserts.
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