Lilly accused of off-label Zyprexa promotion

22 December 2006

The New York Times says that Eli Lilly promoted its blockbuster antipsychotic Zyprexa (olanzapine) for off-label use and withheld side effect data from physicians. The US newspaper made the claim based on Lilly's internal marketing documents that it received from an undisclosed lawyer who represents mentally ill patients.

Zyprexa is Lilly's best-selling drug, generating 30% of the firm's total revenue. In third-quarter 2006, it netted the Indianapolis-based company $1.08 billion, a 5% rise on the comparable period in 2005 (Marketletter October 30, 2006). The documents forwarded to the NY Times include a message from an unnamed company executive which suggests that sales representatives promote the drug for dementia, an indication for which it is not approved, as primary care physicians "do not treat bipolar [disorder]; schizophrenia is handled by psychiatrists."

Zyprexa is indicated in the USA for short- and long-term schizophrenia, acute mixed and manic episodes and bipolar disorder. The NY Times article claims that, in its off-label promotion drive, Lilly created typical Zyprexa patient profiles for its sales reps to discuss with doctors, which included one patient who was too young to present with schizophrenia for the first time and without the core symptoms of that disease or bipolar disorder, and whose symptoms were more likely describe dementia. Lilly told the paper that it no longer uses this profile in its promotion of the drug.

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