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Yaz FDA Panelists Served as Consultants, Speakers, Researchers for Bayer

New questions are being raised about the validity of an FDA advisory committee that voted against recommending a Yaz and Yasmin recall last month. 

In December, an FDA advisory panel voted 15-11 that the benefits of Yaz, Yasmin and other birth control pills using the progestin drospirenone outweigh the risk of blood clots, stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease and other side effects of Yaz and Yasmin.

Documents recently revealed through the ongoing Yaz and Yasmin litigation now show that at least three members of the panel previously worked with Bayer, and in some cases the company heralded them as Yaz champions.

In one document, Bayer celebrates Dr. Paula Hillard, one of the panelists who voted that Yaz benefits outweighed the risks. The document, which is undated, calls her a “huge” Yasmin advocate. In another document, the company suggests using footage of Dr. Hillard on the phone placating a patient concerned about Yaz side effects. Hillard claims she has been paid less than $10,000 for her previous work with Bayer.

Documents also revealed ties between Bayer and Anne E. Burke, another advisory committee member and a professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, Maryland. She is described as a Bayer contraception expert by the company, and Bayer has funded some of her research.

The third committee member linked to Bayer was its chairman, Professor Julia V. Johnson, of the University of Massachusetts Medical School. She has been an investigator in four research studies for Bayer, but claims she never received funding or grants from Bayer for that research, the most recent of which was 2008.

The ties to Bayer were known by the FDA, but not disclosed until they were uncovered during the discovery process involving hundreds of Yaz lawsuits and Yasmin lawsuits involved in a federal multidistrict litigation (MDL) in Illinois.

This is not the first controversy surrounding the panel, as less than 48 hours before the beginning of the meetings, Dr. Sidney M. Wolfe, a prominent expert who has voiced concerns about the safety of Yaz and Yasmin, was notified that he would not be allowed to participate as a member of the Drug Safety and risk Management Advisory Committee.

Although Dr. Wolfe had served on the committee for more than 3 1/2 years, he was excluded based on what the FDA called an “intellectual conflict of interest,” citing a newsletter published by Wolfe that categorized the birth control pills as “Do Not Use” because of the risks associated with the medications.

These developments have led some to suggest that there may have been a conflict of interest that affected the outcome of the panel’s vote.

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