Posted on 01/19/2005 8:29:29 PM PST by Coleus
| An anonymous source sent confidential drug company documents that had been missing for more than 10 years to the British Medical Journal. The documents, which suggest a link between Prozac (fluoxetine, made by Eli Lilly) and suicide attempts and violence, will be reviewed by the U.S. Food and Drug Administration (FDA). The documents went missing during a 1994 product liability suit. They include reviews and memos indicating that as far back as the 1980s, Eli Lilly officials were not only aware that Prozac had side effects, but also they attempted to minimize those negative effects. The liability suit surrounded a 1989 workplace shooting in which a man, who had been treated with Prozac, shot and killed eight people and wounded 12 others before killing himself. The documents show that patients on Prozac are twice as likely (38 percent versus 19 percent on placebo) to display symptoms that can precede suicide or violent acts, including:
Another document displays an FDA official questioning how Lilly decided that suicide attempts in studies either weren't real attempts or were not related to Prozac. Compounding the Lilly documents are the words of Dr. Martin Teicher, a Harvard psychiatrist who has come out saying, "Lives were threatened and Americans treated like "guinea pigs" because Eli Lilly & Co. officials lied 15 years ago in denying there was any evidence the anti-depressant Prozac could cause suicidal behavior." In 1990, Dr. Teicher published reports showing a link between Prozac and suicide. However, months earlier Lilly officials had assured him that they knew of no such link. But according to Dr. Teicher, studies from the 1980s did show a risk, and German drug regulators refused to license the drug in 1985 citing "suicidal risk." Dr. Teicher says the studies were "cherry-picked" and negative trials were not published. Further, Dr. David Graham, associate director in the FDA's Office of Drug Safety, said that a problem with Prozac and suicide could not be ruled out given that many cases of suicidal behavior were left out of Prozac's safety record in 1990. British Medical Journal January 1, 2005;330:7 (Free Full Text Article) |
| The first 150 words of the full text of this article appear below. |
The US Food and Drug Administration has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. The documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence.
The missing documents, which were sent to the BMJ by an anonymous source last month, include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.
The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a
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