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Experts on FDA’s Yaz Panel Had Ties with Bayer

On December 8, 2011, health experts met at the request of the Food & Drug Administration (FDA) to determine whether popular birth control pills 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. The panel also recommended that stronger warning labels be added to the drugs.
But a new report reveals that at least four of the expert panelists had ties to Yaz/Yasmin manufacturer Bayer. Some even may have had financial conflicts of interest because they were paid by the big pharmaceucial company.
Experts with Financial Ties to Bayer
One of the experts with ties to Bayer was Dr. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School. Dr. Johnson was monetarily compensated by Bayer for work she did and had conducted a clinical trial for the company on a drug that contained Drospirenone, which 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 Johnson has denied any bias for Bayer or its products.
A second expert panelist was paid upwards of $10,000 by Bayer in 2010 as a consultant for the company. Two other experts on the panel had conducted studies funded by Bayer or companies that had agreements with Bayer. While all the relationships were disclosed to the FDA, no conflicts of interest were found.
At present time, the financial disclosure forms given to the FDA by all of the experts on the panel are not available to the public. According to FDA policy, the FDA does not release panelists’ financial ties with drug companies to the public, but rather conducts its own investigation to determine whether the panelists have conflicts of interest.
Interestingly, all four experts voted in favor of Yaz and Yasmin, and a four vote margin has persuaded the FDA to keep the drugs on the market.
Expert Who Has Spoken Out Against Yaz/Yasmin Not Allowed on Panel
One expert who was not allowed to serve on the panel was Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group. In his consumer guide entitled “Worst Pills/Best Pills,” Dr. Wolfe warns women that Yaz, Yasmin, and other Drospirenone-containing birth control pills should be avoided because of their increased potential to cause blood clots. The FDA removed Dr. Wolfe from the voting panel because it determined he had a conflict of interest, but allowed him to serve as a non-voting member.
Dr. Wolfe was removed because of an “intellectual conflict” of interest. But under FDA policy, potential expert panelists may be removed for financial conflicts only if they have ongoing relationships with the company or if they have been paid by the company within the past 12 months.
Expert Advice Flawed?
Although the FDA does not have to follow the recommendations of an expert panel, more often than not it does. In fact, in 2004 an FDA advisory panel found that dangerous drug Vioxx was safe and should remain on the market. Vioxx was later found to have caused 60,000 deaths and was taken off the market.
The Project on Government Oversight (POGO), a consumer advocacy group, has asked FDA Commissioner Margaret Hamburg to conduct a new expert panel meeting on the safety of Yaz and Yasmin. The group wants the previous December 8th vote thrown out because of the ties some of the experts had to Bayer.
In a study conducted by the FDA, researchers found that the risk of blood clots for women taking Yaz, Yasmin, or another Drospirenone-containing birth control was higher than for women taking other older generation birth control pills. And many consumer advocacy groups have argued that the risks associated with Drospirenone birth control pills do not outweigh the benefits, especially because safer birth control pills are widely available on the market.
The panel did not consider a recently released document produced by Bayer, showing that Yasmin was ten times more likely to cause adverse events like blood clots than other birth control pills.
Know Your Legal Rights
If you or a loved one suffered a blood clot or other adverse health event while taking Yaz, Yasmin, or another birth control pill that contains Drospirenone, you may be entitled to compensation for the injuries caused by the drug. Call Dallas Yaz injury attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 to learn more about your legal rights.

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