Is it Vioxx redux?
If Nissen’s research does stand up, Avandia may become the latest of a series of disgraced blockbusters whose risks have been found to outweigh their benefits. Baby boomers still are reeling from the loss of Vioxx, the infamous arthritis drug withdrawn in September 2004 for heart safety concerns. Then there’s Pfizer’s $800 million gamble, torceptrapib, an experimental drug that appeared to be medicine’s best hope of clearing clogged arteries because it raised good cholesterol by 60%. Torceptrapib caused heart problems rather than preventing them. And hormone therapy for postmenopausal women caused the heart attacks it was intended to prevent. But torceptrapib and hormone therapy don’t raise the same questions about drug regulation that have cropped up with Vioxx and Avandia, because regulators apparently knew of potential problems with Vioxx and Avandia long before they took action. “What did the FDA know and when?” says Yale cardiologist Harlan Krumholz. “That’s an open question. Here
