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FDA Yaz, Yasmin Advisors Had Relationships with Bayer

Jan 11, 2012 | Parker Waichman LLP

Last month, an advisory panel for the U.S. Food & Drug Administration (FDA) voted to recommend by a four vote (15-11) margin that the benefits of Yaz, Yasmin and similar pills made with the synthetic progestin, drospirenone, outweighed their risk of dangerous blood clots. Now it's been learned that three of the FDA advisors who voted with the majority had ties to Bayer AG, the maker of the drugs, that were not disclosed by the agency.

According to a report from The Wall Street Journal, those advisors were:

•    The panel's chair, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, told the Journal in an email that she has been an "investigator in four research studies from Bayer or Berlex [a Bayer unit]," including one that involved the use of a drospirenone product in post-menopausal women.  In her email, Dr. Johnson said she had t she has "received no funding or grants" for her work.
•    Paula Hillard, an obstetrics professor at Stanford University School of Medicine, who Bayer documents said ""enables us to now have another huge ... Yasmin advocate here in Nor Cal—she will be well utilized!" Another Bayer "tactical brief" from 2010 describes a video clip the company planned at the time with Dr. Hillard to deal with the blood clots and other safety issues.  She told the Journal she received $10,000 for her work.
•    Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, who declared in published articles that she received research funding from Bayer.

While all three  backed the safety of Yaz and Yasmin, two did later voted to encourage stronger labeling about blood clot risks.  Their ties to Bayer were not revealed by the FDA, which is not permitted to make public information from the financial disclosure it requires  the outside experts that serve on its panel to provide. According to The Wall Street Journal, the panelists' Bayer ties were first disclosed in a joint article by the British medical journal BMJ and Washington Monthly.  Details of their work with Bayer also were revealed in documents in the ongoing Yaz and Yasmin litigation in federal court in Illinois.

The fact that the three were allowed to vote at all, however, does raise some questions.  Dr. Stephen Nissen, a cardiologist with the Cleveland Clinic and frequent FDA advisory panel member, acknowledged that significant ties between committee members and drug makers could result in biased recommendations

"Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process," Nissen told the Journal.

It should also be noted that one panelist, Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the FDA because he had publicly criticized the drugs' safety in newsletters published by the group.




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