Conflicted Members of FDA Safety Committee Keep Yaz on Market

The British Medical Journal (BMJ) reports that at least four members of a recent special safety committee advising the US Food and Drug Administration on the safety of drospirenone had financial ties to its manufacturer, Bayer, raising questions about the rigor with which the agency minimizes potential conflicts of interest. Bayer sells drospirenone under four popular birth control brands – Yaz, Yasmin, Beyaz and Safyral, all of which remain on the market.

The FDA ordered the review by a special safety committee after three articles published in the BMJ found an increased incidence of venuous thromboembolism among users of drospirenone. However, the committee did not see internal Bayer documents in which Bayer scientists determined that Yasmin's rate of all serious adverse events was "10 fold higher than that with the other products."

The special safety committee of FDA advisers concluded that the benefits of these birth-control pills outweighed the risk of blood-clots. The committee’s decision ended with a 15-11 vote, with all the doctors linked to Bayer voting with the majority.

The FDA defends their action by stating that they never release panelists’ personal financial ties to the public. They also claim to always ensure that past relationships between panelists and drug companies do not affect their financial interests or give the appearance of creating a conflict.

Bayer documents unsealed through the federal litigation in Illinois concerning these drugs’ safety gave further insight into some of the panelists’ relationships with Bayer:

• Dr. Paula Hillard, a professor of obstetrics and gynaecology at Stanford School of Medicine, served as a paid consultant to Bayer;
• Julia Johnson conducted four clinical trials, including one of drospirenone as hormone replacement, for Bayer or its subsidiary Berlex, a manufacturer of drospirenone.
• Elizabeth Raymond, senior medical associate at Gynuity Health Projects in New York, conducted studies funded by Barr Pharmaceuticals, now part of Teva, which has a licensing agreement with Bayer for generic versions of Yaz.
• Anne Burke, assistant professor of gynaecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Durament, which has a licensing agreement with Bayer for Ygeneric versions of Yaz and Yasmin.

The FDA did allow all four of the panelists with connections to Bayer to vote, but did remove the voting rights of one individual. Public-Interest doctor Sidney M. Wolfe was not allowed to vote on the issue because he had publically criticized the drugs’ safety.