The Latest Advisory Committee Stumbles at FDA

December 7, 2011
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(Addendum: The advisory committee discussed in this post narrowly approved keeping drospirenone-containing oral contraceptives on the market).

Is the Food and Drug Administration stacking the deck against a negative decision at tomorrow’s safety hearing for oral contraceptives that contain drospirenone, include Bayer’s Yasmin? Or is it laying the groundwork to combat lawsuits by Bayer should the agency decide to pull the drug, which the FDA has already warned increases the risk of blood clots?

The agency took two actions this week sure to anger safety advocates, especially in the women’s health community. First, it ruled that Public Citizen’s Sidney Wolfe could not take his usual post as consumer representative on the Drug Safety Advisory Committee because his widely read newsletter, “Best Pills, Worst Pills,” has already called for pulling Yasmin from the market. The agency accused Dr. Wolfe of an intellectual conflict-of-interest.

Then, as both Bloomberg News and FDAWebview reported yesterday, the advisory committee staff ruled that a 196-page report on the drug by former FDA Commissioner David Kessler, prepared for attorneys suing Bayer on behalf of the more than 10,000 women who claim to have been harmed by the drug, would not be included in the advisory committee record because it was submitted too late. The lengthy legal brief, which you can read here, claims that the drug is unsafe and the company illegally marketed it for off-label uses. The court where the cases are being held didn’t unseal the document until late October.

According to Bloomberg, plaintiff attorney Ned McWilliams told the FDA in an email that “the American public would want to know why FDA has refused to consider important safety information that Bayer did not consent to be released to the public or FDA until after the submission deadline. Why not look at the documents and make your own independent objective evaluation?” An FDA decision to pull the drug would obviously help McWilliams and his clients.

The FDA last October warned that Yasmin increased the risk of blood clots by 74 percent. The FDA adverse events reporting database reportedly has at least 50 cases of deaths associated with the use of the contraceptive. The advisory committee will presumably hear much of the safety information contained in the report. Why else hold the meeting? The briefing book for advisory committee members contains a long report from the FDA’s epidemiology and safety office reviewing the safety signals in clinical trials involving the drug. Dr. Kessler’s brief is a powerful indictment of Bayer’s alleged efforts to cover up or ignore those signals. Whether those legal issues are appropriate for an advisory committee devoted to discussing the science and where the company will get equal time to present its own spin on the data is an interesting question. He should at least be given adequate time during the public portion of the meeting to present his findings.

And as for Dr. Wolfe, there’s something to be said for going into an advisory committee meeting with an open mind. But concerns about these drugs have been around for a while. And there are two ways to deal with intellectual bias under the Federal Advisory Committee Act that sets the parameters for agencies that employ outside advisers (writings that take a point of view are a legitimate way to demonstrate bias). One is to exclude someone with a preconceived bias from the committee. The other is to recognize that bias, unlike financial conflicts of interest, can be counterbalanced with someone with either no bias or who has a different bias. In this case, since this is a joint meeting of the drug safety and reproductive health advisory committees, there will be another consumer representative on the panel — Michele Orza, Sc.D., a health policy analyst at the National Health Policy Forum who specializes in evidence-based medicine. She will be able to give a different perspective from Wolfe.

The crucial vote will come on question four. Do the benefits outweigh the risks? And if they do not, is there a subset of patients for whom the benefits outweigh the risks? If the advisory committee answers “no” to both those questions, and the FDA follows its usual course of following advisory committee recommendations, the drug will presumably be pulled the market. Dr. Wolfe should have been allowed to serve, and the FDA should have let the chips of future lawsuits fall where they may.

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2 Responses to The Latest Advisory Committee Stumbles at FDA

  1. [...] Silverman and Merrill Goozner have contributed some very thoughtful additions to the conflict of issue discussion. I’d [...]

  2. Joleen Chambers on December 12, 2011 at 5:28 am

    As a taxpayer and as a woman, I want the Patient Representative to be “biased” toward safety and effectiveness! Other profit agendas conflict with the FDA mission and have sullied the process. This endangers patients and puts them in further peril when FDA cleared products harm them and the snail- paced legal system denies justice by delay.

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