2004-11-25
Whistleblower and FDA safety officer David Graham, M.D., created major headlines when he claimed the FDA pressured its own scientists about Vioxx and heart attacks and other cardiac concerns. Vioxx was taken off the market in September 2004, after a study discovered Vioxx patients have a 50 percent greater likelihood of heart attacks and sudden cardiac arrest than people taking standard painkillers.
Graham estimated as many as 140,000 people may have suffered Vioxx and heart attacks, resulting in as many as 30,000 to 40,000 deaths. The Vioxx and heart attacks discovery created an immediate frenzy, calling into question the safety of the entire class of drugs it belonged in. A special panel of experts convened in February 2005 to discuss the events leading up to the Vioxx and heart attacks and other cardiac effects discovery, as well as to discuss the future of all COX-2 drugs, which includes Vioxx, Celebrex and Bextra.
The expert committee made a controversial decision in an almost even split vote of 17-15 in favor of Vioxx returning to the market. The experts did not say Vioxx and heart attacks risks were not of concern, merely noting the entire drug category should come with strong warnings about the heart attacks and strokes risks.