Product News and Recalls

Doctor wrongly excluded from Yaz panel

A physician affiliated with public health watchdog group Public Citizen released a statement on Dec. 6, 2011, regarding his removal from the U.S. Food and Drug Administration advisory committee meeting to discuss the risk of blood clots from the Yasmin line of birth control pills.

Dr. Sidney Wolfe M.D., is director of Public Citizen’s Health Research Group. He was originally supposed to be part of an FDA panel tasked with examining whether Bayer’s Yasmin line of oral contraceptives, among the world’s most popular, should remain on the market.

A number of studies have indicated that pills with the compound drospirenone carry up to three times the risk of potentially deadly blood clots compared to other oral contraceptives on the market. Pills with drospirenone include Yasmin, Yaz, Beyaz and Ocella.

Less than 48 hours before the start of the panel meeting, the FDA informed Wolfe that he could not participate because of a supposed “intellectual conflict of interest” based on his previous criticism of the pills.

According to Wolfe, he argued it was “likely, if not certain” that other panel members had come to their own conclusions about the advisability of using the pills beforehand, based on their knowledge of the studies.

As it turns out, Wolfe’s statement was prescient. The panel voted narrowly to keep the pills on the market. Afterward, that decision attracted a good deal of criticism when investigators discovered that four members of the panel — enough to sway the vote — had professional or financial ties to Bayer.

Patients should consult their doctors before making any changes in their medication. A consultation with a Beyaz lawyer is also important if there are significant injuries while on Beyaz or similar birth control pills.

See the statement here:

http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3472