March 23, 2012

How the FDA really works

From a January letter to the Food & Drug Administration from the Project on Government Oversight: 
 
We recently learned of industry ties among four members, including the acting chair, of a joint meeting last month of two FDA advisory committees—ties that were not disclosed to the public at the committee meeting.

On December 8, 2011, two FDA advisory committees met to consider the benefits and risks of the oral contraceptives Yaz and Yasmin and related contraceptives containing the drug drospirenone. Yaz and Yasmin, manufactured by Bayer HealthCare Pharmaceuticals, are among the most popular and profitable oral contraceptives in the U.S.

The FDA scheduled this joint meeting because of growing concerns, reported in the medical and lay press, about the risks of Yaz and Yasmin to the health of the women who take them. According to some medical experts, these women—who received “roughly 13 million prescriptions for Yaz and two generic versions of the drug” in 2010—are at significantly higher risk of venous thromboembolism than women taking contraceptives not containing drospirenone. Venous thromboembolism is a potentially lethal disorder that begins with deep venous thrombosis (clots forming abnormally within veins). The clots may dislodge suddenly (thromboembolism) and travel to the lungs, where they can cause serious injury or sudden death.

A majority of the joint committee (15 of the 26 voting members) voted that the benefits of Yaz, Yasmin, and other drospirenone-containing oral contraceptives outweigh the risks. This conclusion, if accepted by the FDA, could allow the sale of Yaz and Yasmin to continue unhindered...

Certain highly relevant information was not examined at the December 8 joint meeting. In particular, former FDA Commissioner David M. Kessler, M.D., introduced an expert report in an ongoing lawsuit against Bayer. In it, he cites internal Bayer documents. According to Dr. Kessler, in June 2004, Bayer employees wrote in a draft paper that

"Compared to the three other OCs [oral contraceptives], Yasmin has a several fold increase in the reporting rates for DVT [deep vein thrombosis], PE [pulmonary embolism] and confirmed VTEs [venous thromboembolism].…When considering only serious AEs [adverse events], the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude." ...

One advisory committee member, Paula Hillard, M.D., professor of obstetrics and gynecology at Stanford University School of Medicine, had financial arrangements with Bayer that appeared to have created a financial conflict of interest...

In addition, three additional joint committee members had past financial arrangements with companies with a stake in the December 8 meeting’s outcome. One of these three was the acting chair of the December 8 joint meeting on Yaz and Yasmin.

At no point during the meeting was there a disclosure of Dr. Hillard’s or the following three joint committee members’ past ties to Bayer...

During the meeting, the designated federal officer stated there were no members of the joint committee with conflicts of interest, according to the transcript. The FDA officer stated that the “FDA has determined that members and temporary voting members of these committees are in compliance with federal ethics and conflict of interest laws.” The officer added that committee members and temporary voting members had “been screened for potential conflicts of interest of their own, as well as those imputed to them...."

All four joint committee members with past or current financial ties to companies with a stake in the decision voted “yes” on whether the benefits of the drospirenone-containing oral contraceptives outweighed the risks. The vote of the whole joint committee was 15 “yes” and 11 “no.”

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