Yaz News: FDA Safety Panelists Had Ties to Bayer Corporation
The Wall Street Journal reported today that three doctors who served on a Food and Drug Administration advisory panel that in December examined the safety of newer generation birth control pills, including Yaz and Yasmin manufactured by Bayer, had served as consultants, speakers or researchers for Bayer.
The committee voted 15-11 that the benefits of its oral contraceptives outweighed the risks of blood clots developing in women. All three of the doctors with ties to Bayer voted with the majority, though two of them later voted to encourage stronger labeling.
As noted in the Wall Street Journal article,
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.’ However, committee members must disclose potential conflicts only to the FDA, which doesn’t generally make the information public.
Steven Nissen, a frequent FDA panel member and prominent Cleveland Clinic cardiologist, stated to the Wall Street Journal that, in general, if panelists have significant financial ties to a drug maker whose product is under review, it can “bias the proceedings.” He added, “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”
The December hearing was filled with emotional testimony from patients and family members. Joan Cummins of Hackettstown, N.J., told of the death of her 18-year-old daughter, Michelle Pfleger, in 2010. Ms. Pfleger, a freshman at Elon University in North Carolina, was taking Yaz. She collapsed and died of cardiac arrest from a blood clot in her lung, her mother testified. Lieff Cabraser represents Ms. Cummins in a wrongful death lawsuit against Bayer charging that Yaz caused her daugther’s fatal blood clot.