[Infowarrior] - Another reason to distrust big pharma

[Richard Forno]

Lilly Sold Drug for Dementia Knowing It Didn’t Help, Files Show
By Margaret Cronin Fisk, Elizabeth Lopatto and Jef Feeley

June 12 (Bloomberg) -- 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  
didn’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 didn’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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http://www.bloomberg.com/apps/news?pid=20601109&sid=aTLcF3zT1Pdo