PFPC Daily - January 5, 2005

Lilly attacks BMJ's Prozac claims

Financial Times - Jan. 5, 2005

By Clive Cookson

Eli Lilly on Wednesday hit back at claims in last week's British
Medical Journal that confidential company documents showed new
evidence of behavioural disturbances caused by Prozac, its
best-selling anti-depressant.

The US drugs company said it had reviewed the documents, which the
BMJ received from an anonymous source, and found that they "reveal no
new clinical or scientific information".

Their content had already been shared with the US Food and Drug
Administration and other regulators, published in journals or made
available at legal trials for more than a decade, according to Lilly.

The BMJ last week said the documents "went missing" 10 years ago
during a product liability lawsuit filed on behalf of victims of
Joseph Wesbecker who went on a shooting spree and then killed himself.

The documents allegedly included data showing that patients treated
with Prozac were twice as likely to show symptoms of psychological
"activation" - such as agitation, nervousness and aggression - as
those taking placebo in clinical trials.

But Lilly denied that the controversial documents had ever gone
missing and went on to attack the BMJ.

"Lilly is greatly concerned that a reputable medical journal has
relied on an anonymous source and published data without validating
the information at hand," said Alan Breier, chief medical officer.

"This is a worrisome precedent that can have detrimental consequences
to both patients and doctors."

Kamran Abbasi, the journal's acting editor, on Wednesday night
defended its conduct and accused Lilly of being "disingenuous".

The information was validated, he said. "The BMJ has acted perfectly
appropriately in the public interest by making this information
available to the relevant regulatory authority [FDA]."

SOURCE:
http://news.ft.com/cms/s/84a8a6ac-5f45-11d9-8cca-00000e2511c8.html