Quoted from http://www.bloomberg.com/news/2011-12-05/bayer-withheld-yasmin-clot-risk-data-from-u-s-ex-agency-head-tells-court.html
Bayer Withheld Yasmin Data: Ex-FDA Head
By Margaret Cronin Fisk and Jef Feeley - Dec 5, 2011 3:56 PM ET
A Bayer AG unit’s researchers found increased reports of blood clots in users of its Yasmin birth- control pills and the company withheld the information from U.S. regulators, the former head of the Food and Drug Administration said.
David Kessler, the former FDA commissioner, in a document unsealed today in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin safety provided to the agency.
The report also didn’t include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft.
“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said. The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler said.
