FDA Suppressed Vioxx Studies Despite Evidence of Serious Health Risks

UPDATE: The New York Times reports on hearings regarding two related drugs, Celebrex and Bextra.

David Graham, an FDA drug safety reviewer, testified last week in front of the Senate Finance Committee that not only did the FDA ignore known risks from Vioxx and related drugs but that it tried to prevent Graham and others from publicizing their own research that proved the extent of these risks. Dr. Graham had to fight to present the preliminary findings of his extensive Vioxx study at a conference last year, and recently delayed the study’s publication in Lancet because of threats of retaliation by his superiors. After his testimony last week, the Government Accountability Project, which has been working with Dr. Graham for some time due to his fear of retaliation, received several anonymous calls claiming that this research reflected scientific misconduct; these calls were traced back to FDA management. Though Vioxx was pulled off the market by Merck on September 30th, Dr. Graham believes that it caused 30,000-55,000 deaths while it was on the market. He also named five other drugs whose safety is suspect, and noted that “the FDA as currently configured is incapable of protecting America against another Vioxx.”

» Government Accountability Project: Dr. David Graham's Full Story
» Dr. Graham's Senate testimony (pdf)
» MSNBC: FDA failed public on Vioxx
» Medical News Today: FDA tried to discredit whistleblower over drug safety claims
» The Economist: Vioxx Nation
» Drug Regulators Are Trying to Quash Study, Senator Says