Eli Lilly in storm over Prozac evidence [View All]

http://news.ft.com/cms/s/903824a4-5a98-11d9-aa6e-00000e2511c8.html

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.

...more...

Here's some background on Wesbecker:

http://www.geocities.com/HotSprings/7776/PROZACBK.HTM

Everyone in Joseph Wesbecker's life disappointed him. His father died in an accident when Wesbecker was only a year old. His mother was not up to the challenges of parenting and placed him in an orphanage. His first marriage was destroyed in part by arguments over what to do about the kids: a younger son with scoliosis, an older son repeatedly arrested for exposing his genitals to strangers. A second marriage ended over hostility with stepchildren. At age 47, Wesbecker was alone.

If anything, Wesbecker's occupational life was even worse. He hated -- even feared -- his job. The high-speed printing facility in Louisville, Kentucky, where Wesbecker worked repeatedly put him "on the folder," a cramped space surrounded by switches. There, subjected to noise and vibration comparable to being inside a jet engine, he was responsible for operating seven three-story-high presses. Wesbecker's co-workers teased him for begging to be given less stressful duties, and his superiors made him work multiple shifts.

Several years earlier Wesbecker made vague threats about harming his second wife's first husband and her daughter. In 1988 he started buying guns: an AK-47 assault rifle, several semiautomatic pistols, hundreds of rounds of ammunition. Wesbecker told a friend he was acquiring weapons "in case he needed them for his bosses"; he told the union president that he "could come in and wipe the whole place out." Wesbecker's threats -- like Wesbecker himself -- were treated with disdain.

He fought against his descent into mental illness. He made twenty-one visits to a psychiatrist, Dr. Lee Coleman, who tried a succession of medications. On August 10, 1989, Coleman put Wesbecker on Prozac, the antidepressant manufactured by Eli Lilly and Company that had been approved as a prescription drug by the F.D.A. two years earlier. But there were some things about Prozac that Lilly never told the F.D.A. and, consequently, that Coleman did not know.

Coleman did not know Lilly had reason to believe that Prozac might exacerbate "suicidal ideation." Suicidal ideation is associated not only with suicide but with acts of violence generally. Since a significant percentage of people suffering from depression experience suicidal ideation, it could reasonably be expected that perhaps 8 percent of people taking an antidepressant like Prozac would already be obsessed with suicidal thoughts. If Prozac did in fact intensify suicidal ideation in some patients, it had the potential of increasing both suicide and externally directed violence in a significant number of people.

...more...