ot:BMJ turns missing murder case documents over to FDA

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http://www.vidyya.com/vol6/v6i366_1.htm

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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