Eli Lilly ( LLY) said late Tuesday that clinical test documents allegedly missing from a 10-year old product liability trial involving the drug Prozac weren't lost, contrary to the suggestion of a British health care magazine. According to Lilly, the documents that the British Medical Journal asserted had disappeared actually contained information that had been shared with the Food and Drug Administration and other regulatory agencies; had been published in medical journals; or had been made public through legal discovery motions, and were available "for more than a decade." "It is Lilly's policy to make available to regulatory bodies, healthcare professionals and patients important safety and efficacy information related to Prozac as well as other Lilly medicines," said Dr. Alan Breier, vice president and chief medical officer of Lilly, in a press release issued two minutes before midnight EST on Tuesday. "Our review of the documents shows Lilly has lived up to its commitment of full and important disclosures on this topic," he continued. "Lilly is greatly concerned that a reputable medical journal has relied on an anonymous source and published data without validating the information at hand or conducting standard peer review. This is a worrisome precedent that can have detrimental consequences to both patients and doctors." In a story published on its Web site on Dec. 31, the medical journal said that it had received documents from an anonymous source last month that "appear to suggest" a link between Prozac and suicide attempts and violence. The documents "include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimize their likely negative effect on prescribing," the publication said. Fluoxetine is the generic name for Prozac. The publication also said the documents were reportedly related to the trial of a man who, in 1989, went on a rampage in Louisville, Ky., with an assault rifle, killing eight people and wounding 12 before killing himself. The man had a history of depression and had been prescribed Prozac one month before the shootings.
Lilly said it had requested copies of the allegedly missing documents from the publication, but the company said it never received the information. Ultimately, Lilly said it had received copies of the documents from Rep. Maurice Hinchey (D., N.Y.), who had been given them by the medical journal. Hinchey's office is reportedly reviewing the documents to determine whether Lilly withheld data from the public and the FDA. Lilly said its review of the documents provided by Hinchey show the information is "largely comprised" of material provided by Lilly to plaintiffs' attorneys. "All documents that originated at Lilly are identified by a stamp as having been produced in discovery by Lilly in two Prozac product liability lawsuits in the 1990s," the company said. "All of the documents that originated with Lilly ... were indisputably made available by Lilly to plaintiffs' attorneys for use at trial." In another instance, Lilly said a supposedly missing medical document cited by the British Medical Journal was scientific data that had been published by the company in another medical journal 12 years ago. "It is also important to note that Lilly has systematically submitted to the FDA information on these and all adverse events from Prozac clinical trials and post-marketing surveillance," the company said. "Information on these events has also been reflected in Prozac product labeling information for years." Lilly's stock, which fell for three days after the British Medical Journal published its article, was recently up 24 cents, or 0.4%, to $55.74.