Just as Yaz and Yasmin were given the green light by the Food and Drug Administration to stay on the market, information surfaced that called into question ethics and operations of the FDA panel that determined the drugs’ fate. Four women’s advocacy groups sent a joint letter (see it here) to the FDA pointing out that members of the committee, which met in December 2011, had recent financial associations with Yaz and Yasmin manufacturer Bayer.
Committee Controls Fate of Yaz/Yasmin
In a 15-11 vote, the committee chose to allow Yaz and Yasmin to remain on the market, but to strengthen the warning labels for both life-threatening blood clots relating to these and other drospirenone-containing products. Obviously with such a substantial decision to make, the importance of an unbiased panel was paramount.
Define “Unbiased”
However, that didn’t seem to matter to the FDA when it allowed four members of the committee to participate, despite the conflict of interest created by recent financial ties to Bayer. But it doesn’t stop there.
Also called into question were the determining factors behind committee members’ comparison of Yaz and Yasmin benefits vs. risks. The committee members who voted to remove the products from the market compared the drugs to other oral contraceptives, which provide the same benefits (primarily pregnancy prevention) with lower risks. Yaz and Yasmin have been linked to a tripled risk of dangerous blood clots, when compared to other birth control pills. Committee members who voted to keep Yaz and Yasmin on the market considered the benefits and risks in the absolute sense, meaning they determined that the risks of the drugs were worth the benefit of preventing pregnancy, compared to using nothing at all and, of course, ending up pregnant. Basically, “yes” voters compared Yaz to using no birth control and then said, “If there is a minimal risk of getting a potentially fatal blood clot, it’s worth it to prevent pregnancy.” I would agree…if there were no other options on the market for continuous, reliable birth control, but that’s not the world we live in.
Shouldn’t Be True, But…
Thus, in essence, panel members weren’t even voting on the same topic! In most voting situations I’ve experienced, the most important thing to establish before voting is the actual topic that is being voted on. One voter who chose in favor of continuing Yaz sales actually said she would have voted to remove the product if she felt the committee was being asked determine if Yaz and Yasmin were safe compared to other hormonal birth control pills. Well yes, that would make logical sense since there are other hormonal birth control pills. (Does everyone else want to rip out their hair at this point?)
Somehow, in the face of questionable financial motives and completely convoluted voting standards, the FDA saw fit to support and put into effect the panel’s decision!
Needless to say, based on these recent revelations, concerns still run very deep over the danger of drospirenone-induced thrombotic events (blood clots). We will keep you tuned to developments in the fate of Yaz, Yasmin and other dangerous drospirenone-containing products.
In the meantime, let us know in the comments below what you think of this decision and the procedures used by the FDA to make it.
