Why is the FDA holding Avandia hearings? Agency critic has ideas

Steven Nissen

Two weeks from today, an FDA advisory panel will be wrapping up a meeting focused on the now-restricted diabetes drug Avandia. Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.

Nissen contends that the FDA is trying to justify its earlier foot-dragging on Avandia's safety risks. Others speculate that the FDA may be looking for a reason to restrict the drug further and perhaps even withdraw it from the market.

In a column for Forbes, Nissen details Avandia's record, from early signs of heart attack risks set aside by its maker, GlaxoSmithKline ($GSK), and the FDA in 2006. Nissen's analysis made its debut the next year, setting off public debate about the drug's risks, but it wasn't until 2010 that an advisory panel reviewed long-term safety data on the drug from the RECORD study.

Some independent researchers, along with FDA staffers, poked holes in that safety study, and the panel ultimately voted to either withdraw or restrict it. Since then, the number of patients using Avandia has dwindled to 3,000, Nissen says, and Glaxo itself admitted to concealing Avandia's risks as part of its $3 billion Justice Department settlement.

So why is the FDA taking another look at that RECORD study now? Glaxo didn't ask for the meeting, he says; in fact, the company has publicly stated that it did not request for modifications to Avandia's restrictive label. The FDA, then, has its own reasons, Nissen concludes, namely letting itself off the hook. And as usual, Nissen minces no words in criticizing the agency for its choice.

"If [the FDA's Center for Drug Evaluation and Research] is allowed to rewrite the history of Avandia, this vital FDA Center will continue to funciton as an unsupervised, self-regulating bureaucracy, accountable to no one," Nissen says.

We won't get any more clues from the agency about its intentions until documents for the committee are posted by the FDA a few days before the hearings, scheduled for June 5-6. FDA reviewers' comments don't necessarily jibe with the agency's overall agenda, but they do define the questions up for discussion. So stay tuned for that unveiling.

- read the Forbes column

Special Reports: GlaxoSmithKline - Paxil, Wellbutrin, Avandia- Pharma's Top 11 Marketing Settlements | Avandia - Top 10 Warnings and Recalls