Rimonabant Denied - Fallout From Vioxx and Avandia?

Yesterday, the FDA's advisory panel said "NO" to the approval of rimonabant - a long-awaited drug for weight-loss that has engendered tremendous enthusiasm among overweight Americans, not to mention the manufacturer (Sanofi-Aventis) and its shareholders. The bottom line: rimonabant does indeed produce modest weight loss, but available studies have not adequately characterized its side effect profile. Panelists were particularly concerned about data suggesting the drug is associated with an increased incidence of suicidal thoughts. Rimonabant should not be approved, the 14-member panel said unanimously, until adequate safety studies have been performed. (Those of you who have followed DrRich's commentary on rimonabant will not be surprised by this latest turn of events.)

Studies with rimonabant adequate to satisfy the safety concerns of the panel do not yet exist. Once they are underway, if they ever get underway, they would need to be conducted for a period of several years to satisfy the panel's recommendations. At this moment it looks like rimonabant is at best a long way from approval.

This action on rimonabant will no doubt serve as a major wake up call to the pharmaceutical industry. The FDA is in no mood at the moment for any more Vioxx or Avandia fiascos - that is, episodes where highly popular, FDA-approved drugs turn out to demonstrate a long-term risk of side effects that were unknown (and indeed, were unknowable) after the relatively short-term studies that led to the drugs' approval. For now, at least, it appears that the path to approval for new drugs will be far, far longer and far, far more expensive than it has been to date. Any guesses as to what that will do to drug prices?

In the meantime, the overweight had best prepare themselves for more of the assistance they have typically received from their doctors - advice to stop eating and get back on those exercycles.