Healthy Skepticism Library item: 735

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

The ASSOCIATED.
Lilly Says Prozac Documents Contain No New Information
The New York Times 2005 Jan 5

Full text:

Eli Lilly & Company said Wednesday that internal documents about the safety of its popular antidepressant Prozac – reported in a British medical publication to be long missing – were given years ago to federal regulators and to lawyers suing the company.

The British Medical Journal said last week that it had given United States regulators confidential Lilly documents suggesting a link between Prozac and a heightened risk of suicide attempts and violence. Lilly, which is based in Indianapolis, said it received copies of the documents on Monday from the office of Representative Maurice D. Hinchey, a Democrat from New York, who had been given the records by the publication.

Lilly said in a statement late Tuesday that the same records had been given to the Food and Drug Administration and other investigators more than a decade ago. “Our review of the documents shows Lilly has lived up to its commitment of full and important disclosures on this topic,” Alan Breier, Lilly’s vice president and chief medical officer, said in the statement.

Kamran Abbasi, the medical journal’s acting editor, said Wednesday that the journal had validated its information, and he defended its handling of the documents. A spokeswoman for the F.D.A., Cindy Fitzpatrick, said Wednesday that the agency had received the documents from the British publication but had not yet completed a review of them.

The Jan. 1 issue of the publication reported that the documents, which it said it had received from an anonymous source, had been missing for a decade and that they indicated that Lilly was aware in the 1980’s that the drug could have potentially troubling side effects.

The report said that the documents played a role in a 1994 lawsuit against Lilly on behalf of victims of a workplace shooting in Louisville, Ky. Joseph Wesbecker, who killed eight people and himself in Louisville in 1989, was prescribed Prozac a month before the shootings.