Senate Vioxx Hearing To Include Merck’s Gilmartin, FDA’s Crawford
This article was originally published in The Pink Sheet Daily
Executive Summary
A Nov. 18 Senate Finance Committee hearing on the withdrawal of Vioxx will include testimony from Merck CEO Ray Gilmartin
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A Nov. 18 Senate Finance Committee hearing on the withdrawal of Vioxx will include testimony from Merck CEO Ray Gilmartin. FDA Acting Commissioner Lester Crawford is also scheduled to testify. The hearing - entitled "FDA, Merck, and Vioxx: Putting Patient Safety First?" - "will mark the first time the leaders of the FDA and Merck, maker of Vioxx, will testify on Capitol Hill about Vioxx's safety problems," Committee Chairman Chuck Grassley (R-Iowa) said. The lead witness is expected to be FDA Office of Drug Safety Associate Director for Science David Graham, MD. Graham was the co-author of a retrospective HMO database study which found an increased cardiovascular risk for Vioxx. Grassley has charged that Graham's finding were suppressed (1 (Also see "FDA Sought To Suppress Vioxx Safety Data, Sen. Grassley Says" - Pink Sheet, 7 Oct, 2004.)). Other witnesses include Stanford Professor Gurkirpal Singh, MD, "a former Merck consultant with extensive knowledge and expertise on Vioxx" and University of Washington Professor Bruce Psaty, MD/PhD, an expert in cardiovascular disease and epidemiology who will discuss "various Vioxx studies and trials," the committee said. Psaty co-authored a 2003 editorial in The Journal of the American Medical Association expressing concern that mergers of large pharmaceutical companies lead to the cessation of ongoing trials. Grassley has requested documents from Merck and FDA as part of the committee's investigation into the withdrawal of Vioxx (2 (Also see "Sen. Grassley Seeks FDA Documents On Vioxx Labeling Changes" - Pink Sheet, 5 Nov, 2004.)). The hearing will take place Nov. 18 at 10 a.m. in room 215 of the Dirksen Senate Office Building. In addition to Grassley, other committee chairmen are also expressing interest in the Vioxx withdrawal. On Nov. 9, House Government Reform Committee Chairman Tom Davis (R-Va.) wrote Merck to request documents related to Vioxx. Davis' request includes information on the use of data safety boards in trials for the COX-2, as well as of correspondence relating to labeling changes and clinical studies of the product. - M. Nielsen Hobbs |