So much for the FDA’s new conflict-of-interest guidelines.

The FDA is giving the thumbs up to three scientists, including two with financial ties to Merck, to serve on the April 12 athritis drugs advisory panel that will review Arcoxia. The follow-up drug to Vioxx is controversial because some leading experts are critical of studies showing a blood-pressure risk in some patients but less of a heart-attack risk than Vioxx.

The committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine.

The FDA also granted a waiver to Ken Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. The Integrity In Science Watch project says the FDA maintains Saag is an expert in analyzing large databases and the agency “was unable to find anyone as qualified.”

The panel chair, Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.

All three will be allowed to vote on Arcoxia’s fate. These waivers were granted at the same time the FDA was getting ready to trumpet its new proposed conflicts policy, which would ban outside experts with more than $50,000 in ties to drug and device makers - grants, consulting, stock - from serving on advisory panels. The guidance also would prohibit those earning less from voting, but waivers can be granted if an expert can’t be found.

Well, the FDA apparently didn’t look too hard. In Saag’s case, the agency admitted that it only scrutinized its current roster of advisers and NIH employees for candidates. Moreover, the Integriy in Science Watch folks point out that a recent analysis showed less than 10 percent of outside experts granted waivers earn more than $50,000 a year from their industry activities.

FDA waivers for Arcoxia panel members;
FDA guidance document on conflicts of interest;
Integrity in Science Watch.[tags]Arcoxia, Conflicts Of Interest, FDA, Merck[/tags]