ELI LILLY DENIES PROMOTING OFF-LABEL USE, HIDING RISKS OF ZYPREXA

Eli Lilly is denying assertions in two articles in The New York Times that claim the company's own internal documents show that it sought to promote off-label use of the drug among elderly patients with mild dementia.

The newspaper cited internal company emails and marketing documents that it said it obtained from James Gottstein, a lawyer representing mentally ill patients who have sued the state of Alaska for compelling patients to take psychiatric drugs against their will.

Eli Lilly "deplores the illegal release of select confidential documents," Steven Paul, executive vice president, science and technology, said. "Our concern is that this illegal and selective disclosure of incomplete information will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician. This is the unfortunate result we saw when plaintiffs' lawyers aggressively advertised about Zyprexa in recent years while searching for clients."

As to the off-label marketing accusation, Paul said, "At Lilly, we do not engage in off-label promotion, as alleged in the Times article. Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses. We have clear guidelines and extensive training for our sales representatives to help assure that they provide appropriate promotional information that is within the scope of prescribing information approved by the FDA."

The report had one high-ranking member of Congress calling for action. "This appears to be another clear example of how drug companies are putting profits before drug safety," said Rep. Rosa DeLauro (D-Conn.), the ranking member of the House Appropriations subcommittee that funds the FDA. "As the agency in charge of preventing the marketing of off-label uses of prescription drugs and ensuring drug safety, I strongly urge the FDA to investigate this marketing campaign that is putting patients at risk."