Zyprexa Sales goal was 6 Billion just for PTSD?

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.”

Zyprexa Sales

Lilly officials in 2002 reported Zyprexa sales grew due to “an expanding prescriber base in primary care, off-label use including PTSD and sleep,” according to a document called “Zyprexa Business Summary,” referring to post-traumatic stress disorder. The company’s goal was to reach $6 billion in sales by 2006, according to a July 2002 Zyprexa marketing plan.

Common Adverse Effects

In June 2004, Paula Rochon, a senior scientist at the Institute for Clinical Evaluative Sciences in Toronto, published a literature review in the British Medical Journal showing there were only five trials available analyzing antipsychotics’ effect on the elderly, and that in those trials, adverse effects were common.

In May 2008, Rochon found that atypical antipsychotics triple the risk of a patient’s death or hospitalization within a month of starting therapy, according to research published in the Archives of Internal Medicine. About 17 percent of nursing home patients suffering from dementia are prescribed an antipsychotic within 100 days of their admission, according to her study.
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