Product News and Recalls

Women’s health advocates criticize FDA panel

A group of women’s health advocates recently sent a letter to U.S. Food and Drug Administration Commissioner Margaret Hamburg, M.D.  The letter expressed the their concern about an FDA committee that voted to keep birth control pills containing the compound drospirenone — including Yaz, Yasmin, Ocella and Beyaz – on the market.

Signing the letter were the executive directors of the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network, and Our Bodies Ourselves.

“… There were several irregularities that seem to have resulted in a vote that was interpreted as being in favor of keeping these contraceptives on the market, although there is strong evidence that they are less safe than more than a dozen other, less expensive and equally effective oral contraceptives that are readily available,” the letter states.

The FDA committee that voted on drospirenone, a joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, met on Dec. 8. Committee members were asked to consider the question of whether “the benefits of the (drospirenone-containing) oral contraceptives for prevention of pregnancy outweigh their risks,” and eventually voted 15 to 11 that the benefits do outweigh the risks.

But the signers of the letter detailed problems with that vote, several of which were reported by Lopez McHugh in January.

First of all, according to the letter, committee members were asked afterward to explain the reasons for their votes. Those who voted to keep the pills on the market were apparently under the mistaken impression that they should compare the risks of these birth control pills with the risks of pregnancy, rather than with the dozens of other proven oral contraceptives currently on the maket. And three of those members, enough to change to vote’s outcome, “expressed strong concerns and said they were not sure the benefits outweighed the risks compared to other oral contraceptives.”

The letter also mentions subsequent news reports that four of the committee members who voted to keep the pills on the market turned out to have financial ties to Bayer, the manufacturer of Yaz, Yasmin, Ocella and Beyaz.

“In contrast, committee member Dr. Sidney Wolfe was not allowed to vote because of ‘intellectual conflicts of interest’ that were based on his previously expressed strong concerns about Yaz and Yasmin,” the letter says.

The letter-writers conclude by asking the FDA to reconsider the policies that led to the panel’s questionable composition. It also found fault with the vaguely-worded question that was voted on, which seemed to cause confusion.

See the letter here: http://www.center4research.org/2012/03/letter-to-fda-commissioner-yaz-drospirenone-contraceptives/

This letter, by women’s health advocates is the latest in a series of open letters questioning the validity of the Yaz/Beyaz vote. In January, the non-profit group Project on Government Oversight published an open letter to the FDA, calling for it to put aside the committee vote and hold new hearings, this time with experts that do not have ties to Bayer. Whether the FDA addresses the Project’s concerns remains to be seen. Updates will be posted here.

If you suffered blood clots, pulmonary embolism, or stroke while on Yaz, Yasmin, Ocella, or Beyaz, then you should consider calling for a free case evaluation. You can contact Lopez McHugh using the form on the right, or by clicking here.

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