As expected, Merck & Co, Inc. said today the Food and Drug Administration has blocked its pain killer Arcoxia from commercial release. That's "cox" as in "COX-2 inhibitor," the same class of pain killer as Vioxx, Merck's blockbuster that went bust in a big way and is the subject of lawsuits across the country. COX-2s were considered a breakthrough for patients whose stomachs couldn't handle anti-inflammatory pain killers until they showed a greater risk of causing heart attack. The rejection was given after an agency advisory panel voted 20-1 against Arcoxia two weeks ago, but it still highlights the question: Is the F.D.A. too risk-averse? That's what the drug industry claims. The latest salvo to give patients more risk choice comes from Biogen Idec CEO Jim Mullen who penned an op-ed in today's Wall Street Journal (subscription required). Mullen also urges Congress to move slowly on biogenerics. No surprise, given his company has no generic competition until Congress creates a biogeneric approval framework. There are scientific reasons to go slowly, too, and the debate should prove one the industry's most intense in coming months. Add to those two issues the hornet's nest of direct price negotiation for Medicare (so far Republicans in the Senate have blocked Democratic efforts), and health care should be one of the hottest buttons in the lead-up to the 2008 elections.—Alex Lash
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