BMJ turns missing murder case documents over to FDA

[Guest guest]

Colleagues, the following is FYI and does not necessarily reflect my own

opinion. I have no further knowledge of the topic.

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Public release date: 30-Dec-2004

http://www.eurekalert.org/pub_releases/2004-12/bmj-btm123004.php

Contact: Emma Dickinson

edickinson@...

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BMJ-British Medical Journal

BMJ turns missing murder case documents over to FDA

FDA to review missing documents on murder case, BMJ Volume 330, p 7

The BMJ has turned over confidential drug company documents that went

missing from a 10 year old murder case to the US Food and Drug

Administration (FDA) for review.

The documents, which were sent to the BMJ by an anonymous source, appear

to suggest a link between the drug fluoxetine (Prozac), made by Eli

Lilly, and suicide attempts and violence. They also suggest 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 reportedly went missing during the case of ph

Wesbecker in 1994, who killed eight people at his workplace in 1989,

while taking fluoxetine. He then shot and killed himself.

In 1994, some of the relatives of the victims brought a civil suit

against Eli Lilly, alleging that the company had known about the side

effects of fluoxetine for years (including the fact that it might

increase violence). The company won the case, but was later forced to

admit that it had made a secret settlement with the plaintiffs during

the trial, which meant that the verdict was invalid.

One of the documents, dated November 1988, reports that in clinical

trials fluoxetine can cause behavioural disturbances. The FDA recently

issued a warning that antidepressants can cause stimulatory side effects

such as agitation, panic attacks, insomnia, and aggressiveness.

These documents provide " the missing link " between the recent FDA advice

and what Lilly scientists knew 16 years ago, says Harvard psychiatrist

Dr ph Glenmullen.

Dr Kalpit, the FDA clinical reviewer who approved fluoxetine,

said 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. "

Congressman Maurice Hinchey (Democrat, New York), who is currently

reviewing the documents to determine whether Lilly withheld data from

the public and the FDA, said: " This case demonstrates the need for

Congress to mandate the complete disclosure of all clinical studies for

FDA approved drugs so that patients and their doctors, not the drug

companies, decide whether the benefits of taking a certain medicine

outweigh the risks. "

Lilly has defended their drug saying, " 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 efficiency of Prozac is well

studied, well documented, and well established. "

--

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" Ask the Parkinson Dietitian " http://www.parkinson.org/

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