FDA Advisors who Backed Yaz, Yasmin had Ties to Bayer

Several of the outside experts who recently made safety recommendations for Yaz, Yasmin and other drospirenone birth control pills had ties to Bayer AG, the maker of the drugs. However, those ties were not disclosed to the public by the U.S. Food & Drug Administration (FDA).

A number of studies have linked oral contraceptives made with drospirenone, a synthetic progestin, to an increased risk of blood clots compared to other birth control pills. Currently, more than 10,000 lawsuits claiming the drugs caused young women to suffer dangerous blood clots and other serious side effects are pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in federal court in Illinois. Plaintiffs’ lawyers have cited reports of at least 50 deaths tied to the pills from 2004 to 2008.

On December 8, an FDA advisory panel voted 15-11 that the benefits of the Yaz, Yasmin and other drospirenone birth control pills outweighed their risks. According to a report from The Wall Street Journal, three advisors with ties to Bayer voted with the majority. However, two of them later voted to encourage stronger labeling about blood clot risks. Bayer played no role in choosing the panel members.

Despite the three panelists’ relationship to Bayer, the FDA allowed all of them to vote. However, one panelist, Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the agency because he had publicly criticized the drugs’ safety in Public Citizen’s newsletters.

Documents unsealed recently in the Yaz and Yasmin MDL disclosed the details of the panelists’ ties to Bayer, the Journal said. The advisors with Bayer ties included Paula Hillard, an obstetrics professor at Stanford University School of Medicine, who company 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. Dr. Hillard told the Journal in the email that she notified the FDA she attended two Bayer meetings in 2010, and said she received less than $10,000 for her 2010 work. However, she would not answer other questions.

The second panalist with Bayer ties was 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. One filing in the Yaz and Yasmin litigation, a report authored by plaintiffs’ expert and former FDA Commissioner David Kessler, describes her as a “Bayer contraception expert.” “It is my opinion that certain members of the advisory committee did have conflicts of interest such that a reasonable person with knowledge of the relevant facts could question the member’s impartiality,” Dr. Kessler wrote.

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 ,” including one that involved the use of a drospirenone product in post-menopausal women. In her email, Dr. Johnson said she has “received no funding or grants” for her work.

According to the Journal, the FDA requires its advisory committee members to declare any financial relationships to the relevant drug maker; however, the agency is prohibited from giving the public any information contained in a financial disclosure,

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.