Women’s Groups Cite Irregularities in FDA Panel Vote Against Yaz Recall

A coalition of women’s health groups indicates that an FDA advisory committee may have recommended a recall of Yaz, Yasmin and related birth control pills if there had not been irregularities and conflicts of interest affecting the committee’s vote on whether the risk of blood clots outweighs the benefits provided by the oral contraceptives. 

The letter was sent on March 9 to Dr. Margaret Hamburg, commissioner of the FDA, expressing concerns about the hearing held late last year. The letter was sent by the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network and Our Bodies Ourselves.

Concerns were raised about the independence an FDA advisory committee hearing on birth control held in December.

In December 2011, the FDA convened an advisory panel out outside experts to review the safety of Yaz, Yasmin and other newer birth control pills that contain the “fourth” generation progestin drospirenone. The committee narrowly voted 15 to 11 that the benefits of Yaz, Yasmin and other birth control pills using the progestin drospirenone continue to outweigh the risks, allowing Bayer to avoid a potential Yaz recall.

Following the vote, mounting information has surfaced that raises questions about the committee. At least four of the members may have had conflicts of interest, having worked as consultants or conducted research for Bayer, the makers of Yaz and Yasmin.

The letter by the women’s health groups indicates that not only were there conflicts of interest, but there was also confusion about what the advisory committee was being asked to decide. Those who voted “no” were reportedly under the impression that they were comparing the safety of Yaz and Yasmin to those of other birth control pills available to women. Many who voted “yes” however, were comparing the risks of Yaz to the risks of being pregnant.

The group also pointed out that there were several OB/GYNs on the committee who had already made decisions in their own practices on whether to prescribe the pills. The letter contrasts that likely bias with the FDA’s decision to bar Dr. Sidney Wolfe, of the consumer watchdog group Public Citizen, from voting because his group has spoken out about Yaz and Yasmin health risks and petitioned the FDA for a recall.

“The different handling of the financial conflicts and the intellectual conflicts regarding prescribing decisions and publicly expressed concerns clearly biased the vote,” the group’s letter states. The letter goes on to explain that if the question had been more specific and had Wolfe been allowed to vote, or had all the members with conflicts of interest been prevented from voting, then it is likely that the committee would have voted for a Yaz and Yasmin recall.

While some have asked for the panel to be reconvened because of the issues, the groups who wrote this letter only urge the FDA to re-examine its policies and to weigh the likely biases on the committee in any future decisions regarding the birth control pills.

Drospirenone is a newer type of progestin that is used in combination oral contraceptives that also include estrogen. It was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare, an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement. Generic versions of Yaz and Yasmin are also now available from a number of manufacturer, which are sold under the names Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

Prior to the hearings, the FDA released a report that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. The pills also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.

Over 10,000 women throughout the United States have filed a Yaz lawsuit or Yasmin lawsuit against Bayer, alleging that the drug maker failed to adequately warn about the risk of health problems from Yaz, Yasmin and other drosperinone-based birth control pills. The complaints have been filed on behalf of women who have sufferd a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), gallbladder disease or other injuries that were allegedly caused by side effects of drospirenone.