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Conflict and Confusion – The Story of The Yaz FDA Advisory Panel

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The original controversy surrounding the FDA’s advisory panel on the benefits and risks of Yaz and Yasmin birth control pills focused on the professional conflicts of interests of the panel members. Some members of the panel were revealed to have funding ties to Bayer, conflicts that the FDA did not disclose.

Now, new controversy and possible evidence of irregularities in the panel’s decision have come to light. A coalition of women’s health groups allege that key questions directed to the panel members were vague and confusing. The group also claims that a number of the panelists are currently practicing obstetricians and gynecologists, raising concerns over their intellectual conflicts of interests as they have made individualized patient decisions regarding the safety of oral contraceptives.

The confusing wording relates to how the FDA Advisory Panel was questioned regarding the risks versus benefits of using DSRP-containing oral contraceptives (such as Yaz/Yasmin). The Panelists were asked whether “the benefits of DSRP-containing oral contraceptives for prevention of pregnancy outweigh their risks.”

Those panelists that voted “no” (risks do not outweigh benefits) appeared to be comparing the risks of Yaz/Yasmin to the risks of those oral contraceptives not containing DRSP. These panelists further noted the availability of safer forms of oral contraceptives as their rationale.

On the other hand, those panelists that voted “yes” (risks outweigh benefits) appeared to be comparing the safety of oral contraceptives containing DRSP to the risks of pregnancy. Ann Burke, a panelist who voted “yes” explained her vote saying:

“I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be – to take the product off the market. I’m not quite sure that’s necessary at this point.”

As seen in the responses from both the “yes” and “no” voters, their understanding of the question greatly affected their focus and possibly their final decision on the benefits and risks of Yaz and Yasmin. The coalition of women’s groups has not asked the FDA to hold a new meeting. Instead, they request a review of policies to ensure this does not happen again.