Wednesday, February 23, 2005

News from the FDA

From various sources, including wire sources:

The big question: Will Friday's news change the legal climate surrounding these drugs, especially Merck's Vioxx? There's still a long medical, legal and political path between the advisory committees' votes last week -- endorsing Vioxx and Pfizer's Celebrex and Bextra -- and the Food and Drug Administration's final decision.

The agency doesn't always follow the recommendations of its advisory panels, and the close votes on Vioxx (17-15) and Bextra (17-13 with two abstentions) certainly raise questions among investors as well as doctors and patients. Celebrex was supported by a 31-1 vote.

"We believe the key benefit to Merck is not necessarily generating incremental sales but potentially limiting legal liability," said David R. Risinger of Merrill Lynch, in a report to clients. Merck voluntarily withdrew Vioxx from the market on Sept. 30, saying that research showed a higher cardiovascular risk among patients taking the drug for more than 18 months vs. patients receiving a placebo.