FDA whistle-blower David Graham has blasted Merck's Arcoxia, a new painkiller designed to replace Vioxx, as unsafe. "The FDA, academia, and the medical research enterprise are once again faced with the opportunity to forsake common sense by willfully accepting misdirection and disinformation presented in the guise of science," Graham writes in the Journal of the American Medical Association. Merck researchers have compared the risk profile of Arcoxia, which has been submitted for FDA approval, to diclofenac, an older generation painkiller. But, as the link below illustrates, there's new data to show that diclofenac is unsafe. Graham, a drug safety expert, achieved prominence when he told a congressional committee that the FDA was ill-equipped to prevent a harmful drug like Vioxx from hitting the market.
- here's the article on Arcoxia from USA Today
David Graham was also vocal in his criticism of Ketek, Sanofi-Aventis' controversial antibiotic. Report
PLUS: Researchers have concluded that the data from 23 clinical trials demonstrates that the drug diclofenac, which sold as Cataflam or Voltaren, has the same risk profile as low-dose Vioxx. The pain drug, they conclude, increases the risk of heart attacks by 40 percent. Report