Vioxx: another FDA failure?
by Guest Blogger, 10/2/2004
You've probably already heard about Vioxx -- the Cox-2 inhibitor arthritis drug that Merck just withdrew from the market because it learned, in the course of a clinical trial intended to prove that the drug could help with colon polyps, that Vioxx increased the risk of heart attack and stroke. It has seemed to prove that industry can actually monitor itself and do the right thing when presented with information that its products cause more harm than good.
Umm, not so fast. A scientist at the Cleveland Clinic just published an op-ed in the New York Times indicating that research has been available for years demonstrating a connection between Vioxx and increased risk of heart attack:
[D]espite studies showing the magnitude of the public health problem, for several years Merck did nothing to investigate. This surely represents a conflict between the interests of the public and the interests of a company with a blockbuster drug that had sales of $2.5 billion in 2003.
Instead of doing the requisite research in patients with heart disease -- who frequently have arthritis as well and are thus prime users of anti-inflammatory medicines -- the company undertook studies that avoided them. At the same time, Merck spent at least $100 million a year for direct-to-consumer Vioxx advertising, while the company's employees and their consultants published several papers in medical journals rebutting studies reporting Vioxx's heart attack risk. The Food and Drug Administration could have forced Merck to do the appropriate research studies, but instead it was a bystander.
--from Eric J. Topol, "Good Riddance to a Bad Drug," N.Y. Times, Oct. 2, 2004, at A27 (emphasis added).
UPDATE: Merck responds
