December 6th, 2011

Bayer Withheld Yasmin Data From U.S., Former Agency Chief Says

By Margaret Cronin Fisk and Jef Feeley

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said.

Bayer’s Berlex unit came up with a plan to hire Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women’s health issues, “to engage in off-label promotion” of the Yasmin line of contraceptives, John Abramson, a Harvard medical school professor, concluded in his report. Berlex officials said in an e-mail they’d agreed to pay Reichman $450,000 in return for her willingness to “mention off-label benefits of our products,” Abramson noted. The doctor was planning an upcoming book on women’s health issues. The company also planned to purchase 10,000 copies of the book, which contained “off-label claims” about the Yasmin line of contraceptives, the doctor noted. The purchase was part of a “strategy to have the book appear on the New York Times bestseller list,” Abramson added. In her 2005 book, “Slow Your Clock Down,” Reichman wrote that Yasmin may help women with PMS-related symptoms such as “fluid accumulation and bloat,” or with depression.

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