FDA's Yaz Panel Influenced by Big Pharma
Looks like the Food & Drug Administration (FDA) will face pressure to take another vote on the popular birth control pills Yaz and Yasmin as reports surface that at least four of the experts had ties with manufacturer Bayer.
FDA experts met on December 8, 2011, to determine whether Yaz and Yasmin are safe for women to take. The panel voted 15 to 11 to keep the pills on the market, citing that the benefits of the pills outweighed the risk of blood clots.
Experts Received Money from Bayer
Dr. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, was one of the experts who served on the Yaz panel and had ties with Bayer. Before 2009, Dr. Johnson was paid by Bayer for work she did for the company.
Additionally, she conducted clinical trials for Berlex, a pharmaceutical company acquired by Bayer, studying the effects of Drospirenone. Drospirenone is the synthetic hormone found in Yaz and Yasmin that health experts believe may be contributing to the increased risk of blood clots in women taking the drugs. That clinical trial involved a hormone replacement therapy, not birth control, and Dr. Johnson has denied any bias for Bayer or its products.
Another expert on the panel who received funding from Bayer was Dr. Anne Burke. On a Bayer internal document, Dr. Burke is listed as a Bayer contraception expert. She received research funding from Bayer, but stated that this occurred several years ago.
Two other experts admitted to having either past financial ties or research ties with Bayer.
All four of the experts voted in favor of Yaz and Yasmin, noting that they believe the risk of blood clots associated with the birth control pills is outweighed by the benefits of the drugs.
One expert who was not allowed on the panel because of an “intellectual conflict of interest” was Dr. Sidney Wolfe of consumer advocacy group Public Citizen. Because he has criticized Yaz as being an unsafe drug in the past, the FDA determined that Dr. Wolfe was too biased to serve on the panel.
This recent development raises the question: To whom is the FDA really catering--consumers or big pharmaceutical companies? Based on the background of the Yaz panel, it would seem that consumers are taking a backseat to pharmaceutical companies with money to hand out.
To learn more about how big pharma influences the FDA, download my free e-book Prescription Drug Safety at www.vanweylaw.com.
