BMJ Article Suggests Eli Lilly Concealed Data on Prozac RisksEli Lilly allegedly had "long concealed evidence" that its antidepressant Prozac could cause "violent and suicidal behavior," according to an article published Jan. 1 in the British Medical Journal, the New York Times reports (Belson, New York Times, 1/1). The documents, which were 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 (Schaefer-Munoz, Wall Street Journal, 12/31/04). According to the BMJ article, the documents, which "went missing" during the trial, "appear to suggest a link" between Prozac and an increased risk of violence and suicide attempts, Bloomberg/Philadelphia Inquirer reports (Dooley/Britt, Bloomberg/Philadelphia Inquirer, 1/1). 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, Wall Street Journal reports (Wall Street Journal, 12/31/04). 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.
FDA, Congress Reviewing Documents
BMJ said that the documents, which had been missing for more than a decade, have been turned over to FDA and Congress for review, the Times reports. FDA spokesperson Kathleen Quinn said she could not confirm whether or not the agency has received the allegedly missing documents (New York Times, 1/1). According to BMJ, the office of Rep. Maurice Hinchey (D-N.Y.) is examining the documents "to determine whether Eli Lilly had withheld data from the public and the FDA," the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 1/1). Hinchey, a member of the House Appropriations Committee, which oversees FDA, said the documents include memos between Lilly employees that "clearly show a link between Prozac and actions of violence perpetrated by people taking the drug against themselves and against others." According to Hinchey, "The documents we have show that the company was instructing its employees to hide this information. We're seeing evidence here that it was a conscious act on the part of the company" (New York Times, 1/1). He added, "This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later" (AP/Las Vegas Sun, 1/1).
According to the Times, FDA's possible reaction to the Prozac documents is "unclear," but even if the evidence does not result in legal or regulatory action, the documents "could sully Eli Lilly's image," which is "closely tied to Prozac." The company has "long defended" itself against claims that is has "suppressed relevant information" about Prozac, the Times reports. Lilly in a statement said that it was unaware of "any allegation of missing documents," adding, "Lilly has consistently provided regulatory agencies worldwide with results from both clinical trials and postmarketing surveillance," including data on Prozac (New York Times, 1/1). "Based on this, Lilly believes that there is no new scientific information to review on this topic," the statement said. The statement also noted that the company has made several requests to BMJ to obtain copies of the documents, saying, "[W]e 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 in a meaningful way" (AP/Las Vegas Sun, 1/1). Morry Smulevitz, a communications manager for Lilly, said the company could not comment directly about the documents because it has not yet obtained copies. Smulevitz said the company is "committed to the public disclosure of all clinical trial data to ensure that health care professionals and families have all the information they need to make informed decisions about all of Lilly's medicines" (Wall Street Journal, 12/31/04).
The BMJ report is available online.