(Emphasis mine all over the place below.)
From The Wall Street Journal:
The Food and Drug Administration Monday said Acomplia, a proposed weight-loss drug by Sanofi-Aventis SA, was effective at promoting weight loss but appeared to double the rate of suicidal thoughts and behavior.
And that’s not all!
Rimonabant [the generic name] is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.
And oh, I’m not done yet!
The FDA also said there was a higher rate of other psychiatric side effects among rimonabant users and the drug increased the risk of seizures. The agency said one set of studies showed 26% of patients on the 20-milligram dose of rimonabant reported a psychiatric side effect — ranging from depression to insomnia — compared to 14% of patients in the placebo group.
What’s the upside? A 15-pound weight loss over the course of a year. (People on the placebos lost an average of 3 pounds.) That’s not even 10% of an “obese” person’s body weight, unless said obese person is under 5 feet tall. But they also had “gains” in good cholesterol and lowered triglycerides. No numbers on those, but I’d lay dollars to donuts (mmm, donuts) the patients in the study didn’t make any gains they couldn’t have achieved with moderate exercise. Which, you know, alleviates depression. And is free.
In its briefing document, Sanofi said that the “overall benefits in body weight, waist circumference and metabolic parameters…outweigh the risks that are manageable in clinical practice.”
Wait, I’m confused. Let’s go over this one more time.
Benefits: 15-pound weight loss, slightly improved cholesterol and triglycerides.
Risks: Insomnia, depression, seizures, unspecified mood disorders, neurodegenerative disorders, and fucking suicide.
What outweighs what again?
Acomplia is sold in several European countries and the Paris company is seeking approval to sell the drug in the U.S., a key market that would likely propel it to blockbuster status of $1 billion or more in annual sales.
(Thanks to Laurie for the tip.)