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Cardiologist and Mass Tort Attorney Discusses Recent Yasmin/Yaz FDA Advisory Panel Decision

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Southlake, TXAn FDA advisory panel convened last December 2011 to look into the safety and efficacy of all oral contraceptives containing drospirenone, including Yasmin and Yaz. Dr. Shezad Malik, a cardiologist and attorney, discusses the outcome.

This advisory panel is made up of medical experts who make recommendations to the FDA regarding whether the benefits of the drugs outweigh the risks. In this case, the panel voted 15-11, finding that the benefits outweigh the risks.

LawyersandSettlements: Dr Malik, does this vote mean that Yasmin and Yaz will stay on the market?

Dr. Malik: Obviously this vote was very close and the panel did not find the need for a recall on these drugs. But more importantly, key evidence from federal litigation was not submitted at this meeting.

LawyersandSettlements: Why would important evidence be withheld from the panel and, ultimately, the public?

Dr. Malik: Because a deadline was required to submit these new documents and unfortunately it was missed. The court would not release those records under seal because they contain confidential materials and trade secrets of the pharmaceutical companies, including Bayer, the maker of Yasmin and Yaz. Unfortunately, the plaintiffs' attorneys were not able to present them in time to be reviewed by the panel.

LawyersandSettlements: Was this the fault of plaintiffs' attorneys, i.e., missing the deadline?

Dr. Malik: Not at all. Attorneys would have to approach the court to get the records unsealed—and they tried. The unsealing process was vigorously defended by the defense attorneys. Eventually some key documents were released, but they were still too late for evaluation by the advisory panel.

LawyersandSettlements: What was the deadline and when were their documents submitted?

Dr. Malik: The deadline for submitting written testimony was November 23, 2011. Plaintiffs' attorneys missed the deadline by just a few days.

LawyersandSettlements: It makes you wonder whether the FDA is being pressured by the big guns, i.e., Bayer in this case.

Dr. Malik: I can say this much: An expert's report was provided by Dr. David Kessler, the previous director of the FDA. He came out with a report on behalf of the plaintiffs stating that Bayer kept very important safety data away from federal regulators.

LawyersandSettlements: Can you expand upon Dr. Kessler's testimony?

Dr. Malik: He gave expert testimony that Bayer misled the FDA on purpose about Yasmin and Yaz safety by selectively presenting data on the risk of thromboembolic events to make the drugs appear safer than they really were. The expert written testimony was rejected—it was revealed after the deadline.

LawyersandSettlements: Why wasn't his evidence submitted sooner?

Dr. Malik: I don't know why Dr. Kessler didn't get it in sooner; the panel could have easily postponed or allowed the material after the deadline. It is an arbitrary deadline so they could have easily pushed the deadline to allow this evidence from Kessler, along with the unsealed documents.

LawyersandSettlements: What is the FDA doing in this scenario?

Dr. Malik: I believe the FDA panel was derelict in its duty. Their duty is patient safety first and foremost, and not profits before people. Their actions were basically the latter—protecting the pharmaceutical companies. The FDA unfortunately has no teeth when it comes to Big Pharma. The Big Pharma lobbyists control the FDA and Congress.

One good thing came out of this panel, however. They voted 21-5 that the birth control label should be updated to provide clearer risks for blood clots, just falling short of a black box warning.


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