FDA panelists worked for Bayer, casting doubt on the advisory comittee.

Food and Drug Administration advisers, in a recent vote, said the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk. What the FDA didn't disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers or researchers.

Last month, an FDA advisory committee voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and so the drugs should remain on the market, albeit with added information about the risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies say the risk is evident (see this).

Jill Hartzler Warner, an FDA official who oversees advisory committees, said the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When picking committees, the FDA weighs "whether a meeting would affect the financial interest" of a panelist. The agency also does "look at whether past relationships would give the appearance of being a conflict," she said.

Steven Nissen, a frequent FDA panel member and prominent Cleveland Clinic cardiologist, said that, in general, if panelists have significant financial ties to a drug maker whose product is under review, it can "bias the proceedings." He added, "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Bayer said it had no role in selecting the committee, and defended the safety of its products, all four of which contain the active ingredient drospirenone. The potential conflicts of the three panel members were earlier reported in a joint article by the British medical journal BMJ and Washington Monthly.

Dr. Kessler's report contends that all three members' relationships are evidence that "the FDA advisory committee was not independent of Bayer and its recommendations and votes need to be viewed as such."
http://online.wsj.com/article/SB10001424052970203436904577153160177537828.html

http://www.pharmalot.com/2012/01/a-conflicted-fda-panel-bayer-birth-control-pills/

The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties:
http://www.washingtonmonthly.com/ten-miles-square/2012/01/the_yaz_men_members_of_fda_pan034651.php#