F.D.A. Requiring Suicide Studies in Drug Trials (NY Times)

I vowed not to use this blog as a soapbox, but surely we'll keep posting long after The Tulip and The Bachelors have closed, and surely the need will arise. I'll try to keep my rant brief and just offer the information for your consideration.

It appears that the FDA is starting to impose stricter rules on drug companies - regarding clinical trials - demanding a more-detailed exploration of the potential for suicide that seems to accompany many medications. There's quite a long list, including pills for acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections, insomnia, obesity, urinary incontinence, epilepsy, smoking cessation, and depression. It's no news that some of those pills are antidepressants administered to children.

Of the several glaring atrocities listed, this one really got me:

"Then it [the FDA] received an application for rimonabant, a much-heralded obesity drug developed by the French drug giant, Sanofi-Aventis. As agency medical reviewers pored over the drug’s clinical trial data, they discovered hints that it could cause psychiatric problems, too.

Unsettled by their experience with antidepressants, agency reviewers again mandated the use of Dr. Posner’s system. The assessment found that the drug doubled the risks of suicidal symptoms. In June, an F.D.A. advisory committee voted unanimously that the agency reject rimonabant because of its psychiatric effects, and Sanofi-Aventis withdrew the application although the drug is sold in Europe."

Maybe Sanofi-Aventis felt that the questionnaire applied during these trials wasn't the best or the most accurate, leading them to continue selling rimonabant in Europe. Looks to me, though, like their sole concern is their profit.

Here's the article.