FDA to Consider Acomplia in June; Depression a Side Effect

Sanofi's hoped-for anti-obesity blockbuster will go before the FDA advisory committee on June 13, it says here. This application has been delayed before, so the tension will be mounting among the Sanofites all through the summer.

Couple of interesting things to consider:

First, although some reports have said that the drug's name might not be Acomplia but Zimulti, Sanofi is calling it Acomplia in its press releases and on its press page.

Second, this report by Decision Resources notes that Acomplia will become the 'gold standard' in weight loss treatment--despite side effects of depressiona and anxiety among users.

Hold on a second: depression and anxiety have caused havoc for Roche's Tamiflu and Lilly's Strattera (both linked to reports of suicide). I can't see the press giving Sanofi a free pass on this issue if those side effects are in any way significant.

Comments

[Joan Russo, Ph.D.]

This is a great post. I love your Blog and this comment comes with the best intentions. Excuse me while I hobble up on my soap box, but I take serious issue with you using the words "reports of suicide" in talking about these RCT results.

First, there were NO suicides in either group.

Second, suicide ideation, is very common in young distressed especially OBESE young adults (ah.. I am in a clinical trial cause mommy is worried about me).

Third, I think it is great that the kids FEEL like they can tell the research staff about their inner most feelings, that is, thoughts of death. Maybe we should all play some MM...

Fourth, in my many years of data analysis, and I say this with little hesitation: There are been very very few modifiers of antidepressant medication treatment that have been tested. And the modifiers that HAVE been tested (e.g., age, gender, racial ethnicity) have in general not been statistically significant. This is due to many factors: lack of statistical power due to small sample sizes, no real modification, capitalization on chance findings. HOWEVER, there have been significant modification of SSRIs treatment by education, SES and... my personal favorites - prior treatment history, baseline depressive severity level, chemical dependency status and education.

In my mind, the best way to tell if a kid has suicidal thoughts is to see if he/she is smoking or using drugs.

Kids will increase their dopamine when they are hurting, its evolutionary.

Cheers!!

Joan

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