Insiders stacked advisory vote in favor of Yaz

January 13, 2012

The Project On Government Oversight has requested that the Food and Drug Administration (FDA) disregard a joint advisory committee’s support of the controversial birth control pill Yaz because four members of the panel had ties to either the contraceptive maker or the maker of a generic version.

The watchdog group questioned why members with ties to Bayer HealthCare Pharmaceuticals were allowed, in essence, to endorse the company’s second-best-selling franchise without announcing their ties during the meeting.

“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 told the media. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science not industry influence.”

The FDA joint advisory committee met Dec. 8 to consider whether the benefits of the oral contraceptives Yaz and Yasmin outweighed the risks of the drugs, which have been linked to fatal blood clots in some women who have taken the pills. The joint committee voted 15-11 in favor of the contraceptive.

Dr. Paula Hillard of Stanford School of Medicine, Dr. Julia V. Johnson of the University of Massachusetts Medical School and Dr. Anne E. Burke of The John Hopkins Bayview Medical Center had all received past funding from Bayer. The fourth, Dr. Elizabeth Raymond of the Gynuity Health Projects in New York had received research funds from a company which has a licensing agreement with Bayer for generic versions of Yaz.

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  • Dixie Thompson January 13, 2012 at 1:48 pm

    This is another in a long history of issues regarding pharmaceuticals where the real issues are clouded by emphasis on politics rather than science. The fact is that hormonal birth control has risks, but risks of pregnancy and birth are far greater. It is the responsibility of clinicians to educate and present risk vs. benefits of any therapy, and alternative options.
    The relationship between pharmaceutical companies and researchers is unavoidable for research and development of new therapies. It is not without some risk of unethical conduct, however, and we must rely on professional ethics and science to inform policy. If research were funded from a neutral source, these doubts could be laid to rest. Most healthcare professionals are genuinely devoted to giving the best of evidence-based care to their patients.