Panel members had financial ties to Yaz maker
Consumer watchdog group Project on Government Oversight, or POGO, claims the government’s expert panel charged with reviewing safety data on the top selling birth control pills was compromised because four members had financial ties to Bayer, the pharmaceutical company that makes the pills.
The situation was a long time coming. Just as Bayer was enjoying large profits from its newer generation birth control pills and actively working to push back generic competition while formulating new folic acid-fortified versions of Yaz and Yasmin, a trend was developing. A large number of women, including teenagers, who were using the pills were developing serious health problems.
All birth control pills carry a risk for blood clots, but it appeared the risk was higher among women using Yaz and other pills that contained the hormone drospirenone.
Bayer funded three different studies and concluded that the blood clot risk with drospirenone-containing pills was no greater than oral contraceptives with other hormones. Bayer continued to stand by its pills, claiming they were safe.
Then, in October 2011, the Food and Drug Administration (FDA) released a study involving more than 800,000 women taking birth control pills from 2001 to 2007. The data showed that women who took Yaz typically had a 75 percent greater chance of developing a blood clot than women taking different contraceptives. This prompted the federal agency to order a safety review of the pills.
Typically, an expert panel is gathered to pore over data and make recommendations to the FDA. The FDA is not required to follow the advice of its panels, but it usually does. These panel members are to be objective and weigh the risks against the benefits.
But when the panel discussed the issue with drospirenone pills late last year, members fell short of recommending that the pills be removed from the market. Instead, they opted to have stronger warnings placed on the packages’ labels.
“The American public must be able to trust that the FDA and its advisory committees are making decisions based on science not industry influence,” said Danielle Brian, POGO executive director, in a letter to FDA Commissioner Margaret Hamburg. “It’s troubling that the FDA was well aware of the potential conflicts of interest, without discussing the ties at a public forum.”
BAYER®, the Bayer Cross®, YAZ®, Yasmin®, SAFYRAL®, Beyaz®, Aleve®, and drsp® are trademarks of Bayer.
Source: Daily RX