The British Medical Journal has apologized to Eli Lilly & Co. for claiming in a Jan. 1 report that Lilly documents outlining a heightened risk of suicide use among Prozac users were missing for a decade.
The Associated Press quotes the journal's statement: "The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims.
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."
The original BMJ report said editors had given U.S. regulators internal company documents it had received from an anonymous source, indicating Lilly officials were aware in the 1980s that the antidepressant could have potentially troubling side effects, and that those documents vanished during a 1994 lawsuit against Lilly.
But AP reported that, on Jan. 4, 2005, Eli Lilly officials maintained the company had given those records to the U.S. Food and Drug Administration (FDA) more than a decade ago, and the documents had not gone missing during the court case.
After further investigation, the journal said it had determined that Lilly had indeed disclosed the documents during the lawsuit, according to the AP.
However, the journal added that whether the FDA had been given the documents is still being investigated.
The papers have been turned over to the U.S. Food and Drug Administration.
Amid the pile of internal reviews and memos, according to the journal, is a document dated November 1988 that reports Prozac (fluoxetine) had caused behavioral problems, including agitation and panic attacks, in clinical trials.
Smulevitz said he had requested the documents from Jeanne Lenzer, a Kingston, N.Y.-based medical investigative journalist who received them and then sent them on to the BMJ and the FDA.