The big news in the world of obesity therapy was that yesterday an FDA panel, in an outbreak of good sense, declined to approve rimonabant, AKA acomplia, or Zimulti, as it was going to be called in the U.S.
According to the New York Times:
The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.
The panel’s vote was a blow to Sanofi-Aventi, the French company that makes the drug, which is sold in many countries under the brand name Acomplia. As the advisory committee finished voting, the company’s stock, which trades in this country as American depositary receipts, closed at $43.07, down $1.31 or 2.95 percent. It fell another $1.02 in after-hours trading.
Sanofi had expressed hope that the drug would be a $3 billion seller, with much of that market in the United States, a country with a growing obesity problem.
In a statement issued after the panel’s vote, the company said it would continue to work with the F.D.A. to address the panel’s concerns, which included worries about a high dropout rate in clinical studies of the drug, evidence of a doubling of psychiatric events and questions about whether the drug induced seizures.
The fact that this panel voted against the drug doesn’t mean that the FDA will follow the panel’s recommendation, but it probably will.
According to Bloomburg, countless Americans are traveling to Europe to get this drug, while others are ordering through foreign websites.
In my opinion the FDA panel did the right thing. If this drug is approved, zillions of overweight people will rush to take it, virtually all will discover that it’s not a magic bullet (there is no such thing) and that substantial weight loss will still require denial and will power. Along the way there will be a ton of side effects and a bunch of people will die or be severely incapacitated. Many will sue contending that they didn’t realize the risks or they would never have taken the drug. Sanofi-Aventi will earn several billion dollars, it will pay out a few tens of millions in legal fees and awards, the FDA will withdraw the drug, and a lot of lawyers will get rich. And the population doesn’t get any thinner. Why not simply avoid the entire fiasco and not approve the drug in the first place.
That’s why I think the panel had an outbreak of good sense.
Interestingly, yesterday, the same day that rimonabant went down in flames, was the first day that another awful and ineffective anti-obesity drug hit the over-the-counter market. Alli (nee xenical), which I posted on earlier in the year, became available to anyone who wants to buy it without a prescription. If you decide to take the plunge with this drug, make sure you have a plunger because you’ll need it. And don’t say I didn’t warn you.
In the next post I’ll tell you about how the low-carb diet accomplishes the same thing that rimonabant tries to do, but without all the side effects. And much more effectively. I’ll explain how the low-carb diet acts to make leptin more effective in the prevention of hunger. Stay tuned.