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Grassley blasts FDA on Vioxx

October 8, 2004 7:00 AM UTC

Sen. Chuck Grassley (R-Iowa) is accusing FDA of muzzling an agency scientist who raised concerns this summer that Vioxx rofecoxib from Merck (MRK) was associated with adverse cardiac events.

On Wednesday, Grassley's staff interviewed David Graham, associate director for science in FDA's Office of Drug Safety, as part of an investigation into FDA's handling of information about safety issues associated with Vioxx. Graham led a team that reviewed records of over 25,000 Kaiser Permanente patients treated with Vioxx from Jan. 1, 1999, to Dec. 31, 2001, and determined that there was a three-fold increase in heart attacks and stroke in patients who received over 25 mg per dayof the COX-2 inhibitor. The study, which involved over 1.3 million patients, found no increase in cardiac events in patients who received Celebrex from Pfizer (PFE). ...