FDA Set to Review Controversial Avandia Clinical Trial

FDA Set to Review Controversial Avandia Clinical Trial

April 15th, 2013 // 2:22 pm @

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Nearly three years after the FDA greatly restricted use of the controversial Avandia diabetes pill over increased risks of heart attacks and strokes, the agency is convening a two-day meeting in June to discuss an independent review of a clinical trial.

The agency plans to hold the session on June 5 and 6 to discuss the results of a reassessment of a trial called RECORD that was, in part, the heated focus of a contentious 2010 FDA panel meeting held to review the Avandia safety record (here is the Federal Register notice).

At the time, GlaxoSmithKline was widely criticized for its handling of the trial. FDA scientists claim the study was flawed and undercounted cardiovascular events. And both the US Senate Finance Committee and the Journal of the American Medical Association chastised Glaxo for attempting to undermine its own scientific steering committee and squelching unfavorable results (more here).

Since then, you may recall, the FDA restricted Avandia use to only Type 2 diabetics who are unable to benefit from other diabetes medications. The agency also announced a Risk Evaluation & Mitigation Strategy, or REMS, in which patients have to enroll in an Avandia access program and the diabetes pill will only be available by mail from certified, participating pharmacies (see this).

Moreover, the agency also ordered Glaxo (GSK) to convene an independent group of scientists to review the RECORD trial. “During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings,” the agency wrote in its September 2010 announcement (here it is).

However, the decision to call a meeting surprised Steve Nissen, the Cleveland Clinic cardiologist, whose 2007 meta-analysis of Avandia clinical trials in the New England Journal of Medicine raised red flags about Avandia cardiovascular risk. “It seems ludicrous that the FDA would waste two days and a large expenditure of dollars re-examining a drug now taken by only 3,000 patients worldwide. The leadership of CDER (the FDA’s Center for Drug Evaluation and Research) must have some ulterior motive in conducting this advisory panel. It’s certainly not about the usage of the drug.”

Meanwhile, a Glaxo spokeswoman writes us that the “FDA requested this meeting we did not seek it nor have we requested any change in labeling of the REMs program. Since the last meeting, we have completed the re-examination of the RECORD trial and implanted a REMs program. We anticipate the need to report on those.”

As a practical matter, however, the review is unlikely to alter the commercial standing of the pill. The cardiovascular risks, which have generated countless negative headlines over the past six years, and subsequent FDA restrictions have assured that many physicians have become more cautious about prescribing the drug.

Just the same, the hearing is likely to revisit not only the Avandia imbroglio, but also serve as an unfortunate reminder of the sort of business practices that have plagued the pharmaceutical industry. The Avandia scandal, you may recall, became a prime example of a drugmaker being widely accused of failing to disclose unflattering data and factored into a $3 billion settlement Glaxo reached last year with the US Department of Justice.


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