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Lilly Urged Zyprexa Use Without Proper Diagnosis

Eli Lilly (LLY) tried to persuade primary care doctors to prescribe Zyprexa to elderly patients with dementia even when those doctors believed patients should be seen by a psychiatrist first or that there was no diagnostic basis to prescribe the drug, according to a federal court ruling. Internal Lilly documents tell reps that "Even if the doctor does not have diagnosis, he should treat anyway" when it comes to Zyprexa and dementia and/or schizophrenia.

The strategy was part of Lilly's "LTC Strategy," the ruling states. Lilly did not have approval from the FDA to promote Zyprexa for dementia; its main approval was for schizophrenia, the Mississippi ruling says.

The ruling gave a surprise victory to Lilly, a win that becomes even more surprising once you read all 117 pages of it. The judge said the state had not proved that off-label promotion of Zyprexa had wasted the state's Medicaid dollars because the state only offered "generalized expert analyses" instead of individualized proof. That judgment came despite the fact that Lilly earlier pleaded guilty to illegal promotion of the drug.

The ruling states that Lilly targeted the elderly in long term care facilities for dementia "But Lilly never followed through with its attempt to obtain FDA approval for a dementia indication."

Lilly's strategy was to target primary care physicians, not psychiatric specialists. If those doctors were reluctant to prescribe Zyprexa -- perhaps they felt their family care experience was not enough to make an informed decision -- reps were to tell them to write the drug anyway, the ruling states: If the primary care docs objected, reps were given this script:

Patients with moderate to severe symptoms of schizophrenia and bipolar disorder should be treated by a psychiatrist. However, in your own practice there are probably patients who may experience symptoms such as elevated mood, emotional withdrawal and agitation who may benefit from Zyprexa. Keep in mind that referrals can be expensive, time consuming, or logistically difficult.
If the doctor still resisted, reps had these last-gasp strategies, including one which suggests that docs should write the drug because everyone else is doing it: "Early adopters are prescribing it for the elderly."

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