BMJ Retracts Article on Prozac, Apologizes to Eli Lilly
BMJ on its Web site on Wednesday published a "correction and apology" retracting an article that accused Eli Lilly of concealing documents that linked the antidepressant Prozac to suicide and aggressive behavior, the Indianapolis Star reports (Swiatek, Indianapolis Star, 1/27). BMJ on Jan. 1 published an article based on company documents that said Lilly has "long concealed evidence" that Prozac can cause "violent and suicidal behavior."
The documents, sent anonymously to BMJ, were part of a 1994 lawsuit against Lilly filed on behalf of victims of a man in Kentucky under treatment with Prozac who allegedly killed eight individuals and himself. The jury decided in favor of Lilly, but the company later disclosed a previously reached settlement with the plaintiffs. According to BMJ, 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 of the documents found that 38% of patients who took Prozac in clinical trials reported "new activation," which includes symptoms of agitation and aggressiveness, compared with 19% of those who took a placebo, BMJ reported.
According to BMJ, the document on Prozac, sold generically as fluoxetine, is dated Nov. 8, 1988, but was never submitted to the FDA reviewer responsible for approval of the medication. An FDA advisory committee in 1991 found "no credible evidence" of a link between Prozac and increased risk for suicide. On Jan. 5, Lilly officials said that the company shared the documents cited by BMJ with FDA regulators 10 years earlier and that the documents included "no new clinical or scientific information." Lilly also submitted 16 annotated pages to FDA to explain the documents that BMJ said the company had concealed. The annotations included a chronology of submissions and communications between Lilly and FDA officials (California Healthline, 1/6).
On its Web site, BMJ posted a statement that said, "The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents. ... The 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." BMJ said it conducted a "detailed investigation" and found that "all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit."
Lilly on Wednesday said, "It is Lilly's policy to be honest in our dealings with the public, the media, regulatory bodies and our customers. 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."
However, attorney Andy Vickery, who has represented more than 20 plaintiffs in lawsuits against Lilly over Prozac, said that while BMJ "clearly needed" to clarify what it meant by "missing," he believes the "damning information (about) the association between Prozac and suicide/violence was withheld from the public for over a decade" (Indianapolis Star, 1/27). The correction is available online.