In the early part of this decade, physicians — at the urging of drug maker Eli Lilly — prescribed Zyprexa for elderly patients with dementia. But the drug was not approved to treat dementia and was ineffective, and Lilly apparently knew that, some health insurers claim.
Unsealed company documents reveal Lillys marketing campaign for the drug, originally approved for use as an anti-psychotic. The documents have been presented as evidence in litigation against Lilly for overpayment.
One such document summarizes a 1995 company study showing that Zyprexa "did not show efficacy" in treating behavioral disturbances in elderly patients who were suffering from dementia.
Last year Zyprexa was Eli Lillys best-selling medication, bringing in more than $4.7 billion in sales. But while some doctors were apparently prescribing it for patients suffering from dementia, the company told the Food and Drug Administration in late 2003 that data from a number of studies failed to show Zyprexa was helpful for patients suffering from Alzheimers disease or other forms of dementia.
Eli Lilly entered a guilty plea earlier this year to illegally marketing Zyprexa for off-label purposes to elderly consumers. But the company says that occurred only during a narrow window of time -- from late 1999 through early 2001.
A company spokesman said the plaintiffs have released "one-sided, cherry-picked" documents that do not tell the whole story, and that Lilly will contest the charges in court.
The released documents also allege that Eli Lilly produced a number of articles about Zyprexa, showing the drug in a positive light, and asked doctors to submit them to medical journals as their own work. The documents also allege that Lilly assembled a guide to selecting scientists who would write favorable articles.
The documents saw the light of day only because of suits against the drug marker brought by health insurers and pension plans. These plaintiffs are seeking to recoup the money spent on Zyprexa to treat elderly policy holders with dementia.
The plaintiffs also demand that Lilly pay $6.8 billion in damages for soft-peddling Zyprexas health risks and marketing it for unapproved uses.
In January Eli Lilly settled with the U.S. Government and a number of states, paying $1.42 billion to resolve off-label marketing allegations. The company has paid out $1.2 billion so far to settle more than 30,000 individual consumer claims, according to a company document.
Zyprexa has produced a number of complaints to Consumeraffairs.com, but mostly about side effects.
"I ... took Zyprexa and it was a nightmare; gained a lot of weight; sleepless nights among other side effects," Denise, of Fresno, Calif., said.
Linda, of Vallejo, Calif., said she took Zyprexa for depression, but the side effects were worse.
"Caused severe weight gain, serious insomnia that could not be helped with medication. A kind of 'zombie' feeling during the day," she said. "It caused my children and friends to question my ability to think for myself. It made the depression worse."