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Was Yasmin Birth Control FDA Panel Vote Conflicted?

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Washington, DCA recent decision by an expert panel convened under the auspices of the US Food and Drug Administration (FDA) regarding Yasmin birth control continues to be mired in controversy. Now, recent revelations suggesting conflicts on the part of some panelists add further substance to arguments by some that the panel vote should be overturned, the panel recast and the debate reopened.

The Yasmin/Yaz duality of new-age birth control pills containing the synthetic hormone drospirenone has been linked to a higher incidence of Yasmin blood clots in some studies; although manufacturer Bayer has always maintained Yaz side effects and corresponding adverse reactions inherent with Yasmin are no worse than any other oral contraceptive currently on the market.

To address growing concern over the product, the FDA convened an expert panel on December 8. While voting overwhelmingly to require more strident warnings on Yaz and Yasmin labeling (stopping just short of requiring a black box warning), the panel narrowly voted 15-11 to keep the two products on the market in spite of Yasmin DVT and other corresponding concerns.

Now, according to a recent issue of the Washington Drug Letter (1/23/12), as many as five of the 26 panelists possessed what many view as a conflict—either having received research funding from Bayer or had worked for the manufacturer as a paid consultant.

If three of those five favoring Yasmin and Yaz had voted the other way, the outcome would have been very different. It is a long-held belief that the FDA rarely strays from the recommendations of its expert panels.

The December 8 panel decision was already marred by the absence of expert testimony suggesting Bayer had withheld key data from the FDA that was unfavorable to Yasmin and Yaz. As articulated by noted cardiologist and attorney Dr. Shezad Malik in a recent interview with LawyersandSettlements.com, a deadline to submit information to be included on the panel agenda was missed by a few days, due to the time eaten up in legal arguments required before the documents could be unsealed.

Thus, the damning testimony by a former director of the FDA, obtained as part of a Yasmin lawsuit, was never presented to the panelists. Although released a few days prior to the panel convening, the missed deadline meant the documents and their contents could not be considered by the panelists.

The most recent criticism involving perceived conflict of interest amongst five of the expert panelists has prompted groups such as the Project on Government Oversight (POGO) and Public Citizen to call for the panel's December 8 recommendations to be vacated. POGO has formally asked FDA Commissioner Margaret Hamburg to repopulate the panel with individuals verifiably free from conflict, re-launch the discussion and redo the vote.

The FDA has signaled it is in receipt of the request and will respond following due consideration. One former FDA associate told the Washington Drug Letter that the conflicts or perceived conflicts would have been known to the FDA prior to the expert panel convening. Those conflicts were not publicly disclosed. The issue has prompted some critics to accuse the FDA of protecting the interests of the manufacturer and the drug industry as a whole, rather than safeguarding the health of Americans.

Yaz lawsuits and those of its sister product Yasmin have alleged the products have resulted in serious health issues, and even death.

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