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Sanofi Study Looks Like Image Rehab for Diet Drug Linked to Suicides

By Jim Edwards

Updated on: August 14, 2010 / 12:15 PM EDT / MoneyWatch

Two years after authorities stopped a trial of Sanofi-Aventis (SNY)'s diet drug Zimulti (rimonabant) because a few people killed themselves, the researchers have published an analysis of their truncated data in the Lancet. Reading between the lines, the move is arguably an implicit criticism of the European Medicine Authority's decision to halt the trial, and a rehab of the drug's image. The authors of the study make this conclusion:

A drug that was being marketed for weight loss, but being tested for improving cardiovascular outcomes, induced a level of serious neuropsychiatric effects that was deemed unacceptable by regulatory authorities, and both the drug and the trial were abruptly terminated.

That sounds benign but scientists all know that it is unfair to study a drug for one result (CV outcomes) and then draw conclusions about it based on another (suicides). The interpretation thus seems to suggest that regulators weren't playing by the accepted rules of science. Based on the study's primary endpoint -- cardiovascular events -- the drug was no different than a placebo, the study says:

After one year of treatment with rimonabant, there was no significant difference in the primary end point of cardiovascular death, MI, or stroke compared with placebo.

The study also notes that the drug could have saved lives despite the suicides:

... patients administered rimonabant saw an 8.9 percent decrease in all-cause mortality.

The lead author of the Sanofi-funded article, Dr. Eric Topol of Scripps Clinic in La Jolla, Calif., suggested that Zimulti (also called Acomplia) was less risky than some of the other anti-obesity alternatives that have been approved by the FDA:

Bariatric surgery carries a death rate that is not trivial, and that is far greater than what was seen in this study with respect to suicides ... Four suicides in the rimonabant group is a very small number. So I disagree with the editorialists in that respect. I think once you have obesity and cardiovascular disease, there may be an acceptable tradeoff.

He also suggested that if Zimulti patients were prescreened for various genetic dispositions, the drug might be safer.

Could Sanofi be hoping to resurrect Zimulti, which was expected to be a billion-dollar blockbuster before it was spiked? If the company wants the FDA or EMEA to take a second look, then this would certainly be a good first step.

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Image by Flickr user colros, CC.