Three FDA Panel members linked to Bayer, maker of Yaz

Jan. 16, 2012 - PRLog -- A recent article by the Wall Street Journal has many people, including the lawyers here at ZKB Law, contemplating whether or not the FDA Advisory Panel’s decision on Yaz birth control was completely free from bias.

The Journal reported that three of doctors who sat on the advisory panel had financial ties to Bayer Corporation, the maker of Yaz, Yasmin and Ocella birth controls. Working as researchers, consultants and speakers for the mega pharmaceutical company, the doctors were paid by Bayer but also asked to be on the FDA’s panel.

The December 8, 2011 joint meeting between the FDA’s Advisory Committee for Reproductive Health Drugs and the FDA’s Drug Safety and Risk Management Advisory Committee was held to discuss the FDA’s preliminary findings that women using birth control pills containing the hormone drospirenone have a 1.5 to 2 times greater chance of developing a blood clot than women using the older types of birth control pills.

Bayer Corporation’s Yaz, Yasmin, Ocella and their generics are the only pills on the market that contain drospirenone.

The panels convened, and voted 15-11 that the benefits of the drugs outweighed the risk of the blood clots. But with the three of the panelists tied to Bayer Corporation, it seems that the Advisory Committee’s role is compromised.

According to the article, the FDA advisory committees “are designed to give the agency independent judgments on medical issues. The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to ‘ensure … transparency.’”

Frequent FDA panel member and well-known Cleveland Clinic cardiologist, Dr. Steven Nissen, agrees. He states, “if panelists have significant financial ties to a drug maker whose product is under review, it can ‘bias the proceedings.’ Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

For more information on the Yaz birth control litigation, or for answers to questions about blood clots, stroke or pulmonary embolisms while taking Yaz, contact us toll-free at 888.841.9623, email us at Anneke@ToledoLaw.com or visit www.ZKBLaw.com.

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ZOLL, KRANZ & BORGESS, LLC is an advocate for pharmaceutical drug/device safety and a recognized leader in nationwide litigation involving defective medical drugs and devices, as well as other types of Multidistrict (“MDL”) & Class Action Litigation.