FDA Panelists Who Noted Beyaz Side Effects Outweighed by Benefits Had Ties to Bayer

February 3, 2012, 5:00AM. By Charles Benson

Washington, DCUS Food and Drug Administration advisers, in a recent vote, said the benefits of four popular Bayer drugs outweigh the blood-clot risk, despite the reported Beyaz side effects. However, the FDA didn't disclose that three of the advisers have had ties to Bayer, serving as researchers, speakers or consultants, The Wall Street Journal reported.

According to the news outlet, the three doctors were members of a special safety committee convened last month to provide an assessment of the safety of the products, called Yaz, Yasmin, Beyaz and Safyral. Bayer's own studies show a lack of excess danger, but other research including an FDA-commissioned study suggests there is one.

The news source reported that the committee voted 15 to 11 that the benefits of the pills outweighed the risks. All three of the doctors voted with the majority, though two of them later cast votes to encourage stronger labeling. FDA advisory committees are designed to give the agency independent judgments on medical issues.

According to the news outlet, the FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant company, as this would help to ensure transparency. However, committee members must disclose potential conflicts only to the FDA, which doesn't usually make the information public.

Jill Hartzler Warner, an official from the FDA who oversees advisory committees, noted that the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When selecting committees, the FDA considers "whether a meeting would affect the financial interest" of a panelist, according to the news outlet.

Warner also noted that the agency does "look at whether past relationships would give the appearance of being a conflict."

Reuters reported that a US watchdog group urged the FDA to hold a new vote about the blood clot risks associated with the popular birth control pills, as a fourth adviser also had a connection to a manufacturer of one of the drugs.