Medical journal apologizes to Prozac maker
BMJ retracts article that cited 'missing documents'
(CNN) -- A British medical journal has retracted an article and apologized for claiming that internal industry documents it received from an anonymous source had gone "missing" during a 1994 product liability suit against the maker of Prozac.
The documents, cited by the journal in a January 1 article, suggest a link between the antidepressant fluoxetine -- the generic name for Prozac -- and suicide attempts and violence.
The article said "the missing 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."
BMJ said it investigated its "missing" claim after Lilly complained.
"That investigation has revealed that all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit," BMJ said in a statement posted on its Web site.
"At the end of the trial, all the documents were preserved by court order or were disclosed by Eli Lilly to the plaintiffs' lawyers in related Prozac claims.
"The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing. 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."
In its original report, CNN reported BMJ's claim and Lilly's denial that the papers had ever been missing.
The London-based BMJ, formerly called the British Medical Journal, did not retract its contention that the documents show the antidepressant is linked to increased risk of suicide or violence.
"All we have retracted is the statement that these documents went missing," wrote acting editor Kamram Abbasi in an e-mail to CNN.
BMJ had written that the documents "went missing" during the 1994 lawsuit brought by relatives of victims of Joseph Wesbecker, who shot and killed eight of his co-workers at a Louisville, Kentucky, printing plant in 1989 and then killed himself.
Wesbecker, who had a history of depression, had been prescribed Prozac a month before the shootings.
One document cited by the BMJ article was a 1988 report that said 38 percent of depressed patients on Prozac reported such side effects as agitation and nervousness -- twice the rate reported by people taking a placebo.
Only recently has the FDA warned that antidepressants can cause "activating" or stimulating symptoms such as agitation, panic attacks, insomnia and aggressiveness.
Plaintiffs in the case tried to show Lilly had withheld key negative data from the FDA and that it was Prozac that pushed Wesbecker over the edge.
Lilly initially won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the journal said.
The company said Thursday the verdict of "no link between Prozac and the plaintiff's actions" remains valid.
"The first judge, who issued the language of 'dismissed with prejudice as settled' recused himself," Lilly spokesman Morry Smulevitz said in an e-mail. "The second judge accepted the court's initial verdict, and said that everything in the attorney general's report confirmed that there was no wrongdoing."
An advisory panel to the Food and Drug Administration in 1991 reviewed the data and concluded that Prozac was safe, though critics pointed out that several panelists had financial ties to Lilly.
Lilly said that the panel consisted of the experts in the field, as determined by the FDA and added, "Any attempt to impugn the integrity of the panel members is unwarranted."
Critics also note that other internal documents show that Lilly excluded 76 of 97 cases of reported suicides from the data.
Lilly responded that those 76 cases could not be included in the data analysis because they were not compared with any other compounds.
In addition, those cases were reported to the FDA, as are all serious adverse events, Smulevitz said.
In the article, the prestigious medical journal said it had sent the documents to the FDA for review.
The FDA said Thursday it is reviewing them.
"Our initial conclusion was that, to date, those materials do not alter the conclusions reached by FDA about Prozac," said spokeswoman Susan Cruzan.
About 54 million people worldwide have taken Prozac, a Lilly spokesman said.
The issue has re-emerged because of the upcoming trial of Christopher Pittman, a South Carolina teenager charged with killing his grandparents when he was 12.
His lawyers contend that Zoloft -- an antidepressant similar to Prozac -- was responsible for his outburst. The trial is scheduled to begin Monday.
