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Medical journal retracts story on Prozac, apologizes to Lilly.

INDIANAPOLIS -- The British Medical Journal (BMJ) has retracted a controversial article about Prozac and has apologized to Eli Lilly and Co., manufacturer of the prescription antidepressant. Through its web site BMJ published a correction and an apology retracting its article, which accused the pharmaceutical company of concealing documents linking the medications to suicide and aggressive behavior.

Early last month BMJ published an article based on company documents that said Lilly "long concealed" evidence that Prozac can cause violent actions. The documents, which were sent anonymously to BMJ, were part of a 1994 lawsuit against Lilly that was filed on behalf of victims of a Kentucky resident under treatment with Prozac. The man allegedly killed eight individuals as well as himself.

A jury decided in favor of Lilly, but the company later disclosed a previously reached settlement with the plaintiffs. The BMJ article asserted that the documents, which were not presented during the trial, indicated a possible link between Prozac and an increased risk for violence and suicidal thoughts.

One document found that 38% of patients who took Prozac in clinical trials exhibited symptoms of agitation and aggressiveness, compared with 19% of those who took a placebo.

The original BMJ report charged that the document on Prozac is dated November 8, 1988, but was never submitted to the Food and Drug Administration reviewer responsible for approval of the medication.

But Lilly noted that it had, in fact, shared the documents cited in the article with FDA regulators 10 years earlier and that the data included no new clinical or scientific information.

On its web site the BMJ statement noted that the publication "accepts that Eli Lilly acted properly in relation to the disclosure of these documents. BMJ is happy to set the record straight and to apologize to Eli Lilly for this statement, which we now retract, but which we published in good faith."

The journal noted that it conducted a detailed investigation and found that all of the documents supplied to it that were either Lilly material or in the drug company's hands had been disclosed during the suit.

"It is Lilly's policy to be honest in our dealings with the public, the media, regulatory bodies and our customers," the drug company said in the aftermath of BMJ's admission. "We accept the apology and retraction with the understanding that both our organizations are committed to providing doctors and patients with accurate information about medications."

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Title Annotation:Branded Drugs
Comment:Medical journal retracts story on Prozac, apologizes to Lilly.(Branded Drugs)
Publication:Chain Drug Review
Geographic Code:1USA
Date:Feb 28, 2005
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