As a follow-up to the basic headline that an FDA panel nixed Merck’s Arcoxia, here are the impressions of one watchdog who attended the proceedings. Merrill Goozner, who runs the Integrity in Science Watch project for the Center for Science in the Public Interest in Washington, DC, had this to say:

“After listening to the company’s presentation, the FDA reviewer’s analysis, and a devastating critique offered by FDA safety officer David Graham, one could only wonder why Merck brought this Vioxx clone before the committee.

It also makes one wonder why over 60 European countries* have approved the drug, which appears to have all the same heart attack risks of other Cox-2 inhibitors. The evidence that the drug reduced the gastrointestinal side effects of other pain pills like ibuprofen or naproxen (sold over-the-counter as Aleve) was marginal at best, and was clearly outweighed by the more serious cardiovascular side effects.

And, the bottom line was that the drug provided no more additional pain relief than any other non-steroidal anti-inflammatory drug (NSAIDs). I could not believe this morning’s radio report by Helen Palmer on Marketplace. She called Arcoxia “super aspirin” and quoted a Merck pr flack claiming the drug was superior to other NSAIDs. The evidence offered at the hearing today was incontrovertible on that point: it provided no more pain relief than any other drug.”

*An astute reader has reminded us that Europe numbers slightly fewer nations. Pharmalot believes Merrill was referring to the number of countries - anywhere - in which Arcoxia has been approved. Our thanks to the worldly reader.

You can read his full report here.

[tags]Arcoxia, Merck[/tags]