Lilly Sold Drug for Dementia Knowing It Didnâ€™t Help

June 16, 2009

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Margaret Cronin Fisk, Elizabeth Lopatto and Jef Feeley Bloomberg

June 12, 2009

Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients

with dementia, an unapproved use for the antipsychotic, even though the

drugmaker had evidence the medicine didnâ€™t work for such patients, according

to

unsealed internal company documents.

In 1999, four years after Lilly sent study results to the U.S. Food and

Drug Administration showing Zyprexa didnâ€™t alleviate dementia symptoms in

older patients, it began marketing the drug to those very people, according to

documents unsealed in insurer suits against the company for overpayment.

Regulators required Lilly and other antipsychotic drug- makers in April

2005 to warn that the products posed an increased risk to elderly patients

with dementia. The documents show the health dangers in marketing a drug for

an unapproved use, called off-label promotion, said Sidney Wolfe, head of

the health research group at Public Citizen in Washington.

**By definition, off-label means there is no clear evidence that the

benefits of a drug outweigh the risks,** Wolfe said. **The reason why off-label

promotion is illegal is that you can greatly magnify the number of people

who will be harmed.**

In 1999, when Lilly began its marketing push, Zyprexa*s only approved use

was for patients suffering from schizophrenia, according to the FDA. In

2008, Zyprexa was Lilly*s best-selling drug, with $4.7 billion in sales, while

antipsychotics as a group topped U.S. drug sales last year, with $14.6

billion.

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