Healthy Skepticism Library item: 18504

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Edwards J
The Sanofi Suicides: Who Knew What About Failed Diet Drug?
BNet 2010 July 30
http://www.bnet.com/blog/drug-business/the-sanofi-suicides-who-knew-what-about-failed-diet-drug/5201

Full text:

A federal judge has reinstated a shareholder lawsuit against Sanofi-Aventis (SNY) that claims the company hid data linking its failed diet drug to suicides, a move that may solve the juicy mystery of how Sanofi bungled what was supposed to be a €4.5 billion blockbuster.

It’s also a case study that shows managers how being fully transparent can reduce your liability to litigation: Although the company claims it disclosed all the side effects of Zimulti (also called Acomplia or rimonabant) it was not clear from the company’s press releases how serious the risks of suicide and suicidal thoughts were for patients on the obesity drug. Bloomberg reports that the FDA rejected Zimulti because:

… people who took the drug were twice as likely to have thoughts of suicide as those who took a placebo. Three patients taking the drug killed themselves during clinical trials.

Now look at how Sanofi described those risks in two crucial press releases prior to the FDA rejecting the drug. On Oct 27, 2006, the company said:

Side effects were mainly mild, transient, self- limiting and occurred early in the treatment period. The most frequent side effects included … anxiety (5.0% for rimonabant 20 mg once daily vs. 2.6% for placebo).

The most frequent adverse events leading to discontinuation were depressed mood disorders, nausea and dizziness.

On Dec. 5, 2006, the company said:

The most common side effects with placebo and rimonabant 20 mg reported in the SERENADE trial were … anxiety (3.6% vs. 5.8%), depressed mood (0.7% vs. 5.8%), … The rate of serious adverse events was 3.6% for patients in the placebo arm versus 6.5% for patients in the rimonabant 20 mg.

… The most common adverse events leading to discontinuation for the placebo and rimonabant 20 mg patients, respectively, were nausea (0% vs. 2.2%), depressed mood disorder (0% vs. 2.2%) and paraesthesia (0% vs. 2.2%) .

The same day, according to an earlier ruling in the case, Sanofi executives on a conference call with Wall Street analysts investors said:

… in fact, there is a numerically smaller number of cases of depression in rimonabant 20 milligram, indicating that whatever we’re seeing in this general area, seems to be mild …

The word “suicide” or “suicidal” occurs in neither of the company’s releases. When the FDA nixed the drug, the complaint claims, the stock fell from $44.94 to $41.33 in two days.

The earlier ruling rejected the case because the company revealed all the information it had regarding Zimulti’s risks and shareholders (although it’s hard to read Sanofi’s statements and conclude that the drug’s suicide risk was double). The new ruling – which doesn’t explain what’s changed – says the shareholders have cured the “fatal deficiencies” in their first complaint and will be allowed to file an amended one. The question is, has a new smoking gun emerged?