Documents show drug marketed for unapproved uses

Monday, December 18, 2006

By ALEX BERENSON
THE NEW YORK TIMES

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, "Viva Zyprexa," Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to elderly patients with symptoms of dementia.

A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the FDA, as is required by law.

"We have extensive training for sales reps to assure that they provide information to the doctors that's within the scope of the prescribing information approved by the FDA," Anne Nobles, Lilly's vice president for corporate affairs, said Sunday.

Zyprexa is not approved to treat dementia or dementia-related psychosis and in fact carries a prominent warning from the Food and Drug Administration that it increases the risk of death in elderly patients with dementia-related psychosis.

Federal laws bar drug makers from promoting prescription medicines for conditions for which they have not been approved -- a practice known as off-label prescription -- although doctors can prescribe drugs to any patient they wish.

Yet in 1999 and 2000, Lilly considered ways to convince doctors that they should use Zyprexa on their patients. In one document, an unidentified Lilly marketing executive wrote that these doctors "do treat dementia" but "do not treat bipolar; schizophrenia is handled by psychiatrists." As a result, "dementia should be first message," of a campaign to primary doctors, according to the document.

Nobles said the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Elderly patients who seem to have dementia may actually have schizophrenia that has gone untreated, Nobles said.

Several psychiatrists outside the company said Sunday that they strongly disagreed with Lilly's claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said.

Zyprexa is by far Lilly's best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About 2 million people worldwide received it last year.

The Zyprexa documents were provided to The Times by James Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines

The documents were collected for lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other problems after taking Zyprexa.

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