BMJ TURNS OVER MISSING PROZAC DOCUMENTS TO FDA; LILLY DENIES ANY MISSING DOCUMENTSJan 4, 2005 | www.pharmexec.com The British Medical Journal (BMJ) sent the Food and Drug Administration documents submitted by an anonymous source that seem to show a link between Eli Lilly and Co.’s Prozac (fluoxetine) and suicide attempts and violence, according to a BMJ press release. BMJ also said the documents imply that Lilly officials were aware of Prozac’s side effects but tried to minimize any negative effect on prescribing the drug. Lilly denied any knowledge of such documents in its own press release.
According to the BMJ, the documents were lost during the trial of Joseph Wesbecker who killed eight people at his work in 1989 and then shot and killed himself. He was taking Prozac at the time. One of the documents, dated November 1988, reported that clinical trials showed that Prozac might cause behavioral problems.
Lilly won a civil suit brought by some relatives of Wesbecker’s victims in 1994 but later said it had secretly settled with the plaintiffs during the trial, making the verdict invalid.
Dr. Richard Kapit, the FDA clinical reviewer who approved Prozac, said he was not given the Lilly data. Kapit told BMJ, “These data are very important. If this report was done by or for Lilly, it was their responsibility to report it to us and to publish it.”
In a press release responding to the BMJ, Lilly said, “To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly. Further, it has always been Lilly's objective to publicly disclose data about both the safety and efficacy of [Prozac]. Lilly has made several requests to the BMJ to obtain copies of the supposed 'missing’ documents; we still await these documents. We are surprised and concerned that a leading medical journal would not find it important to share these documents with us so that we could respond to the public in a meaningful way.”