FDA’s Recent Yaz, Yasmin Vote Under Scrutiny

A recent MedPage Today article printed in EveryDay Health* reports that four FDA medical advisors voting on the risks versus benefits of birth control medications, like Yaz and Yasmin, had ties to Bayer.

These FDA medical advisors had performed research studies, clinical trials, and/or consulting services either for Bayer, its sister company (Bayer-Berlex) or one of this partnering companies (Barr/Duramed). On top of that, they received either payment or funding in exchange for their work.

All of the panelists then voted in favor of oral contraceptive containing drospirenone, leaving the final outcome of the vote to be 15-11 that the benefits of popular Bayer AG birth-control pills outweigh the blood-clot risk.

While the panelists did disclose their affiliation with Bayer to the FDA and the FDA subsequently determined they did not have conflicts of interest, the disclosures were made in confidential rather than public documents.

Meanwhile, another panelist, Sidney Wolfe, MD, director of health research at the consumer advocacy group Public Citizen, was banned from voting because of his conflict of interest.

Dr. Wolfe is an author of the consumer guide “Worst Pills, Best Pills.” This guide warns its readers to avoid drospirenone-containing products because the ingredient increases the risk of blood clots. According to an FDA spokesperson Karen Riley, Dr. Wolf did not disclose this “intellectual conflict of interest” to the FDA, states news sources.

How is it that the panelists’ obvious financial gains were deemed not a conflict of interest? Well, the FDA has an answer: Financial conflicts of interest cannot disqualify unless they are ongoing or have occurred within the past 12 months.

But, like the article points out, the same goes for appearance conflicts, but the Riley explains this away by saying they didn’t identify the panelists as having an appearance conflict.

As if the conflicts of interest dispute isn’t enough, there is even more controversy. The article reports that court documents were unsealed days before the meeting. In these documents, former FDA commissioner David Kessler, MD, accused Bayer of: (1) not disclosing all the data on the blood clot risks associated with Yaz and Yasmin and (2) doing extensive off-label promotions to increase sales.

Yet, this information was not given to the FDA committee. Why? The FDA said it was because the date to submit such documents for review had passed.

http://www.everydayhealth.com/sexual-health/0113/fda-yaz-panel-had-ties-to-industry.aspx

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