Eli Lilly Made Public Documents on Link Between Prozac, Suicide Risk in 1994, Company Officials Say
Eli Lilly on Wednesday, in response to allegations brought forth last week by the British Medical Journal, said it shared documents that showed a link between the antidepressant Prozac and the risk of suicide with regulatory authorities 10 years ago, and the documents showed "no new clinical or scientific information," the Wall Street Journal reports (Abboud, Wall Street Journal, 1/6).
BMJ on Jan. 1 published an article alleging Lilly has "long concealed evidence" that its antidepressant Prozac could cause "violent and suicidal behavior." The documents, sent anonymously to BMJ, are part of a 1994 lawsuit against the company filed on behalf of victims of a gunman in Kentucky who allegedly killed eight people and himself while being treated with Prozac.
The jury found in favor of Lilly, but the company later disclosed that it previously had reached a settlement with the plaintiffs. According to the BMJ article, the documents, which were not presented during the trial, could suggest a link between Prozac and an increased risk of violence and suicide attempts. BMJ reports that one of the documents found that 38% of patients taking Prozac in clinical trials reported "new activation" -- which includes symptoms of agitation and aggressiveness -- compared with 19% of patients taking a placebo.
According to BMJ, the report on Prozac, which is sold generically as fluoxetine, is dated Nov. 8, 1988, but was never given to the FDA clinical reviewer responsible for approving the drug. An FDA advisory committee in 1991 concluded that there was "no credible evidence" linking Prozac to suicide. FDA in October ordered drug makers to include "black box" warnings on labels of antidepressants, including Prozac, stating that the drugs increase the risk of "suicidal thinking and behavior in children and adolescents."
A recommendation from U.K. regulators had previously advised doctors to avoid prescribing certain antidepressants, but not Prozac, to children and teenagers (California Healthline, 1/3).
The documents were made public Wednesday by Rep. Maurice Hinchey (D-N.Y.), who received copies from BMJ (Wall Street Journal, 1/6). Lilly said that it received the documents on Monday from Hinchey's office and that they bore a stamp showing they were used in the 1994 trial.
In a statement, the company said, "The information in the documents has already been shared with [FDA] and other regulatory bodies, published in medical journals or produced through legal discovery and (made) available for use at various legal trials for more than a decade." Lilly said the study on Prozac and suicide was published in the Journal of Clinical Psychopharmacology in 1992 and also was presented in the 1994 trial (Swiatek, Indianapolis Star, 1/6).
Alan Breier, Lilly's chief medical officer, said, "Our review of the documents shows Lilly has lived up to its commitment of full and important disclosures on this topic" (Wall Street Journal, 1/6). He added, "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."
Jeanne Lenzer, who wrote the BMJ article, said that "there is a question what the FDA saw," adding that Lilly "may have presented in piecemeal fashion bits and pieces" of the documents showing a higher suicide risk among patients taking Prozac. "[A]t some point it appears they effectively disappeared" from public view, she said, "That's why we handed it over to the FDA" (Indianapolis Star, 1/6).
Kamran Abbasi, acting editor of BMJ, said, "The BMJ has acted perfectly appropriate in the public interest by making this information available to the relevant regulatory authorities" (Wall Street Journal, 1/6).
Cindy Fitzpatrick, a spokesperson for FDA, said the agency received the documents from BMJ but had not finished reviewing them (AP/New York Times, 1/6).
Susan Cruzan, another spokesperson for FDA, said that so far the agency has not seen any documents that would lead it "to question the conclusions of the (1991 scientific advisory) committee," which found no link between Prozac and increased risk of suicide.
Martin Teicher, a Harvard University psychiatrist who in March 1990 published case reports about a possible link between suicide and the use of Prozac, said Lilly "culled patients from their worldwide trials, they cherry-picked the studies, leaving out the trials showing problems." Teicher contends Lilly officials told him they "never heard of" of link between increased risk of suicide and Prozac.
Lilly spokesperson Morry Smulevitz said the company was "not aware" of such a conversation with Teicher.
David Graham, associate director of FDA's Office of Drug Safety -- who reviewed the safety data on Prozac in 1990 -- said, "Lilly excluded so many cases of suicidal behavior that I felt a problem couldn't be ruled out" (Elias, USA Today, 1/6).
Nancy Zettler, one of the plaintiff's lawyers in the 1994 trial, said, "That (document) obviously wasn't missing because it was used in the trial," but she added that Lilly "absolutely" did not disclose all information related to Prozac and suicide to FDA.
Hinchey plans to ask FDA to review the documents to make sure they were properly submitted to the agency, according to spokesperson Jeff Lieberson. "We're trying to figure out exactly what was made public," he said (Indianapolis Star, 1/6).