Last week we reported that there was something fishy going on with the safety panel that was convened in order to review the very controversial drugs, Yaz and Yasmin. Apparently there were several reviewers that had ties to the drug maker. The FDA, however, did not disclose the connections to the public, and the panel’s review gave the all clear for the controversial drugs.
Now in response to the discovery that 4 of the 26 panelists had ties to Bayer, 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.
The 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.
Since four of the panel members either worked as paid consultants to Bayer or received research funding, the Project On Government Oversight has written the FDA’s commissioner 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.
“We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011,” the POGO letter states.
“Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded.”
According to the letter, committee members Drs. Paula Hillard, Anne E. Burke, and Elizabeth G. Raymond received research funding or were paid as consultants for Bayer or one of its subsidiaries. Internal Bayer e-mails referred to Hillard as a “huge” Yasmin advocate. Julia V. Johnson, the acting chair of the committee meeting, conducted clinical trials on Bayer products, but says she did not receive research funding from the company for her work.
All four voted to recommend that the FDA allow the birth control pills stay on the market, despite research that suggests an increased risk of blood clots, pulmonary embolism, stroke, gallbladder disease, deep vein thrombosis, heart attack and sudden death associated with side effects of Yaz and Yasmin.
“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?”
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.
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