Lilly denies off-label promotion allegations

The New York Times suggested that Eli Lilly encouraged doctors to use Zyprexa in patients who did not have the condition. Documents containing the details of the marketing practices were leaked by a lawyer, the paper said.

A marketing campaign, known as Viva Zyprexa, suggested that physicians prescribe elderly dementia patients with the drug. Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries an important warning from the FDA that it increases the risk of death in elderly people from this patient population.

Eli Lilly has denied the claims. Dr Steven Paul, Lilly’s executive vice president, science and technology 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 Times article said that Lilly advised that doctors “might prescribe outside of label.” However, Lilly stated that it is important that the public understand that physicians can and do prescribe medications outside of their approved indications to meet the needs of their individual patients.

Lilly went on to say that The Times failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided as part of the litigation process.