Inciting a major controversy over one of the world’s best-selling drugs, the New York Times has accused Eli Lilly of questionable, unethical, and possibly illegal marketing with regard to Zyprexa. After receiving thousands of internal Lilly documents and emails from a lawyer who represents mentally ill patients, the Times filed two potentially damaging reports this past weekend. The first report claimed that the drug maker intentionally downplayed the risks of obesity and increased blood sugar associated with Zyprexa. The second claimed that Lilly encouraged unapproved (off-label) use of Zyprexa (olanzapine), which is approved only for the treatment of schizophrenia and bipolar disorder.

According to Lilly documents received by the Times, the company has been aware of Zyprexa’s links to obesity for at least a decade, but deliberately minimized the significance of the risk factor–fearing that the drug’s sales would be jeopardized. Apparently, Lilly told its sales representatives to downplay the risk in their conversations with doctors, even though the company’s published data indicates that 30 percent of Zyprexa patients gain 22 or more pounds within one year of treatment–and some patients were reported to have gained more than 100 pounds.

According to the Times, Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that “olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” and also announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.”

Links between Zyprexa and diabetes have been cited by numerous doctors and researchers during the past decade, including a group of diabetes specialists that were on the Lilly payroll. The Times also reported that in 2005, the company agreed to a $750 million settlement in response to suits from 8,000 patients who linked Zyprexa to diabetes or other medical problems. Thousands of other suits are still pending.

In addition, the Times also accused Lilly of a major promotional campaign to encourage off-label usage of Zyprexa in patients who had neither schizophrenia nor bipolar disorder. “In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia,” said the Times. “Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis.”

Nevertheless, the Times suggests that Lilly’s marketing executives were specifically talking up the role of Zyprexa in the treatment of dementia and encouraging their sales reps to discuss the issue with doctors. It is not illegal for doctors to prescribe medication for off-label uses; however, drug companies are not allowed to promote their products for use in such cases. The company’s marketing of Zyprexa is under both federal and state investigation at this time.

With annual sales topping $4 billion, Zyprexa is Eli Lilly’s top-selling drug.

This entry was posted on Tuesday, December 19th, 2006 at 7:11 pm and is filed under Health Concerns, Legal News.