Eli Lilly in storm over Prozac evidence

Financial Times | December 31 2004

Eli Lilly, the US drug company, suppressed evidence that Prozac, its best-selling antidepressant, could cause behavioural disturbances, according to allegations published on Thursday in the British Medical Journal.

The US Food and Drug Administration says it would review confidential Lilly documents handed over by the BMJ, which received them this month from an anonymous source. The reports and memos appear to suggest Lilly officials knew in the 1980s that Prozac had troubling side-effects and sought to minimise their likely adverse effect on prescribing.

The journal says the documents “went missing” 10 years ago during a controversial product liability lawsuit filed on behalf of victims of Joseph Wesbecker, who shot eight colleagues dead, wounded 12 more and then killed himself. Mr Wesbecker had a history of depression and was prescribed Prozac a month before the shootings.

One document, a clinical trial review dated November 1988, stated that 38 per cent of patients treated with Prozac but only 19 per cent of those given a placebo “reported new activation”.

The FDA recently warned that Prozac and similar antidepressants could cause “activation” stimulating agitation, panic attacks and aggression.

In a statement defending its product, Lilly said: “Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has beenprescribed for more than 50m people worldwide. The safety and efficiency of Prozac is well studied, well documented and well established.”