Arena Phamaceuticals seems to have become the first victim of a new, more skeptical view at the FDA.
Its obesity drug, lorcaserin, has either been shot down or put into an FDA purgatory.
(This image is from Supersizedmeals.com, which celebrates big food, of a lunch sold recently just a few miles from my home. Is it lunch time yet?)
The Phase III trial results for the drug were published back in June, and Arena’s press release at the time said the drug offered “significant” weight loss and improved maintenance of a healthier weight.
But that’s not the FDA’s view. A panel voted 9-5 against approval in September.
There are concerns about tumors in rats, about a trial with diabetic patients and about marginal effectiveness. And it comes just a few weeks after the diet pill Meridia was pulled from the shelves.
Arena, which kept hope alive in a press statement calling the turn down “an important step” toward FDA approval (and investors are still with it) is facing two tough trends:
- The FDA is generally more skeptical of new drugs than a few years ago, as the impact of studies showing most studies are wrong sinks in.
- There are ways to cure obesity without drugs, including surgery and simple diet-and-exercise.
The skepticism may have scientific validity but it flies in the face of an enormous industry that won’t take kindly to a new policy. And approaching obesity from the supply side — policies that encourage production of local fruit and vegetable supplies — would fly in the face of another super-sized lobby, the food lobby.
Then there are all those regular folks who insist that reliance on self-discipline will solve the problem, or that there’s not a problem. It’s true that dietary discipline is the best way to lose weight, and keep it off.
But consider. What if you were morbidly obese right now.
Wouldn’t that picture look better than sex?
