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Chart: Lilly Gilds Zyprexa Study, Violates FD&C Act With Sales Rep Chats

Executive Summary

Lilly's settlement with the government on charges of off-label promotion of Zyprexa resulted in a record-setting fine (see following story). Documents from the U.S. v. Lilly case illustrate the dramatic impact shifting standards can have on company dissemination practices. Although one study suggested Zyprexa was effective in treating Alzheimer's disease, other studies confirmed the antipsychotic was no better than placebo. Because it could not substantiate Zyprexa's efficacy in AD, Lilly abandoned efforts to secure regulatory approval for Alzheimer's psychosis in November 2001. The practice described below violates a number of recommendations in the new reprint guidance, including the lack of comprehensive bibliography and lack of studies showing evidence to the contrary (see preceding story). Below is an excerpt from the U.S. Attorney's take on how Lilly crossed the line.

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