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FDA YAZ Conflict of Interest Concern Mounts

The FDA is under fire to hold a new hearing to evaluate the safety of Yaz and Yasmin birth control pills, after conflict of interest issues have been raised regarding some of its advisory committee members.

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Allegedly several FDA advisory committee members who voted to keep Yaz and Yasmin on the market had worked as consultants for, or received funding from, Bayer, the YAZ Yasmin manufacturer.

Project On Government Oversight Letter

The government watchdog group Project On Government Oversight (POGO) wrote a letter on January 11 to the agency’s commissioner, Margaret Hamburg, requesting that a new hearing be convened.

In December, the committee voted 15 to 11 that the benefits of Yaz, Yasmin and other drospirenone-based birth control pills outweigh the health risks, allowing Bayer to narrowly dodge a Yaz and Yasmin recall.

Subsequently, it has been discovered that at least four of the committee members had financial ties to Bayer.

The number of members who may have had conflicts of interest is the same as the winning margin of the vote to recommend that the FDA keep the drugs on the market.

According to POGO, “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. 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.”
Financial Conflict of Interest

According to POGO, 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.

These folks 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.

Discovery Documents made public

The documents revealing their connections to Bayer became public as a part of the discovery process in ongoing Yaz lawsuits and Yasmin lawsuits. The lawsuits are part of a federal Yaz MDL, or multidistrict litigation, which has centralized and consolidated claims by thousands of women.

Almost 11,000 women have filed a federal lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the risk of health problems from Yaz, Yasmin and other drosperinone-based birth control pills.

Drospirenone the Culprit?

Drospirenone is a newer type of synethetic progestin that is used in combination oral contraceptives. It was originally introduced by Berlex Laboratories in Yasmin. Berlex was acquired by Bayer Healthcare and an updated version of Yasmin was introduced called Yaz. Recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement.

Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah, all of which contain drospirenone.

The FDA released a report in 2011, that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. They also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.

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