News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
Lawyers for consumers and injured people.(No advice on this blog, though)
Thursday, April 07, 2005
Bextra withdrawn - the FDA's Elephants in the Room
Bextra was withdrawn at the request of the FDA. News can be found everywhere.
FDA Advisory Panels: Elephants in the Room is the title of a well written article by John Mack. His complete article can be found here. Here is an excerpt:
The New York Times recently reported that "Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers..." (10 Voters on Panel Backing Pain Pills Had Industry Ties, NYT, 2/25/2005).
If these 10 panelists were taken out of the voting, which would be expected if FDA policies on conflict of interest were adhered to (they weren't -- more on that below), then the committee would have voted to take both Bextra and Vioxx off the market (12 to 8 against Bextra and 14 to 8 against Vioxx).