A government watchdog group is asking the FDA to convene a new meeting of its advisory committees to review the safety of the Yaz and Yasmin birth control pills sold by Bayer, following the disclosure that four of the 26 panelists who last month voted to allow the drugs to remain on the market had ties to the drugmaker. The FDA, however, did not disclose the connections to the public.

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).

Since four of the panel members either worked as paid consultants to Bayer or received research funding (read the back story here), the Project On Government Oversight has written FDA commish Margaret Hamburg and asked her to set aside the December vote and convene a new meeting; ensure that ethics guidelines currently under consideration include stronger requirements for public disclosure of conflicts; and post the financial disclosure forms filed by advisory board members online.

“It’s troubling that the FDA was well aware of the potential conflicts of interest, without discussing the ties at a public forum,” POGO executive director Danielle Brian says in a statement. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science not industry influence… How many more times will the FDA have to answer questions about potential conflicts of interest before it finally raises it standards?” (here is the POGO letter).

We have asked the FDA for a reply and will update you accordingly. [UPDATE: At 4:30 pm EST, an FDA spokeswoman left us a message saying "We are not able to comment on the letter, but will review it and respond accordingly."]

As noted previously, the episode underscores ongoing concern over agency handling of advisory panels and conflicted members. In recent months, agency officials - including Hamburg - have complained about a paucity of qualified experts to serve on panels who do not hold some type of conflict in a bid to loosen regulations. Meanwhile, though, panel vacancy rates have remained low and conflict of interest waivers granted have remained below target, suggesting the agency has not having as much difficulty finding qualified experts as officials maintain

The blood clot controversy has generated a substantial number of lawsuits against Bayer. The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and Bayer too aggressively promoted the pills without disclosing those higher risks. Earlier this year, a pair of studies found that women taking birth control pills containing drospirenone are more likely to develop blood clots than those who take an older oral contraceptive (see here and here).

Last fall, lawyers for some of the women who are suing Bayer had attempted to publicize the conflicts held by FDA panelists, but were prevented from doing so because the information was contained in documents that were deemed to be confidential (read here and here). Earlier this month, a federal judge ordered mediation before the first trial was to begin.

The panel conflicts were noted in an expert opinion given by former FDA commish David Kessler, who is working as an expert witness for the plaintiffs in the litigation. He wrote that Bayer wrongfully withheld safety information from the FDA after reviewing internal Bayer documents (here is his report). The report was unsealed prior to the advisory committee meeting last month, but became available after the deadline for submitting documents to the agency for use at the meeting, according to the FDA.

Ironically, the FDA did yank Sid Wolfe of Public Citizen Health Research Group from its Risk Management Advisory Committee - one of two advisory panels that were convened last month to review the Bayer pills - over an alleged ‘intellectual conflict of interest.’ Specifically, the agency cited a newsletter called ‘Worst Pills, Best Pills News’ and the WorstPills web site, in which the group has labeled both pills as ‘do not use’ (read more here).

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