Did An FDA Advisory Committee Just Approve Another Vioxx?

The Food and Drug Administration advisory panel system got another black eye tonight. The Journal of the American Medical Association just released a study reevaluating the evidence behind a new diabetes drug from Bristol Myers-Squibb and Merck. The drug, muraglitazar, lowers blood sugar levels but more than doubles users risk of serious heart trouble. There are already a number of drugs on the market that do the same thing.

This new drug was approved by a 8-1 margin at an advisory committee meeting that met in early September. The FDA staff, which has yet to approve the drug, almost always follows the advice of its advisory committees. But now they’re going to have to pay attention to this new study, which was actually a reevaluation of the data submitted to the FDA.

Three cardiologists at the Cleveland Clinic, including Steve Nissen and Eric Topol, found muraglitazar more than doubled a diabetic’s risk of suffering death, heart attack or stroke compared to other drugs on the market. The authors concluded that “this agent should not be approved to treat diabetes until . . . safety is documented” in a clinical trial designed to test its cardiovascular safety. Recall that Topol was among the first to raise the alarm about the cardiovascular risk from Vioxx, and in a 2001 article called for a dedicated trial that would measure its safety -- a trial that was never conducted.

Although only one member of the committee had direct ties to the manufacturer (see GoozNews, September 9th), the FDA appears to have picked an especially lame group of advisers in this case. A companion editorial in JAMA pointed out that the two drug companies proposed monitoring safety concerns by sending out questionnaires to about 15,000 diabetics taking the drug once it was on the market. The advisory committee bought it.

Right. Subject hundreds of thousands of diabetics to a possibly dangerous drug while sending out unscientific questionnaires (i.e., not in a controlled experiment) to a relatively small number of people taking the drug. Concluded JAMA: “A premarketing safety trial . . . will provide more secure evidence and has an additional advantage of limiting risk only to study participants while safety concerns are being assessed.” The question now, the editorial concluded, “is which safety message will the FDA buy?”