CONFIDENTIAL drug company documents appearing to suggest a link between a popular anti-depressant and suicide and violence have been handed to authorities in the United States, it emerged today.
The British Medical Journal (BMJ) received the documents concerning the drug fluoxetine (Prozac) from an anonymous source and has now turned them over to the US Food and Drug Administration (FDA).
The papers reportedly went missing during a lawsu
it filed on behalf of victims of a workplace shooting carried out by Joseph Wesbecker in Louisville, Kentucky, in 1989.
Wesbecker, who had a long history of depression and had been put on Prozac a month before the shootings, killed eight people and injured 12 others before killing himself.
In 1994, some of the relatives of the victims brought a civil suit against Eli Lilly, the makers of Prozac, alleging the company had for years known about the side-effects - including the fact Prozac might increase violence.
Although the company won the case, it was later forced to admit it had made a secret settlement with the plaintiffs, making the verdict invalid.
The documents sent to the BMJ include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that Prozac had troubling side-effects and sought to minimise their likely negative effect on prescribing, according to Jeanne Lenzer, writing in the journal. One of the documents, dated November 1988, reported that in clinical trials, Prozac could cause behavioural disturbances.
The FDA has recently issued a warning that anti-depressants can cause stimulatory side-effects such as agitation, panic attacks and aggressiveness.
Dr Richard Kapit, the administration’s clinical reviewer who approved Prozac, told the BMJ that he was not given the Lilly data. "These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it," he said.
The administration has agreed to review the documents passed on by the BMJ.
The documents are now being reviewed by the office of Congressman Maurice Hinchey to determine whether Lilly withheld data.
"This is an alarming study," Mr Hinchey said. "This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so patients and their doctors, not drug companies, decide if the benefits of taking a certain medicine outweigh the risks."
In a statement to the BMJ, 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 been prescribed for more than 50 million people worldwide.
"The safety and efficacy of Prozac is well studied, well documented and well established."
The full article contains 473 words and appears in The Scotsman newspaper.
