In a related matter, it was reported last month that Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the drug didn’t work for such patients. This revelation came about when unsealed internal company documents were made public because of litigation. In 1999, four years after Lilly sent study results to the FDA showing Zyprexa didn’t alleviate dementia symptoms in older patients, it began marketing the drug to those very folks, according to documents unsealed in insurer suits against the company for overpayment. In April 2005, regulators required Lilly and other antipsychotic drug-makers to warn that the products posed an increased risk to elderly patients with dementia.
The documents show the health dangers in marketing a drug for an unapproved use, called off-label promotion, according to Dr. Sidney Wolfe, head of the health research group at Public Citizen in Washington. Dr. Wolfe had this observation:
By definition, off-label means there is no clear evidence that the benefits of a drug outweigh the risks. The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed.
In 1999, when Lilly began its marketing push, Zyprexa’s only approved use was for patients suffering from schizophrenia, according to the FDA. In 2008, Zyprexa was Lilly’s best-selling drug, with $4.7 billion in sales, while antipsychotics as a group topped U.S. drug sales last year, with $14.6 billion.
In a request for a December 2003 meeting over a proposed label change, Lilly told the FDA that data from seven studies showed Zyprexa didn’t alleviate symptoms of Alzheimer’s or other dementia. The studies showed that death rates among older dementia patients taking Zyprexa were “significantly greater” than those who didn’t get the medicine, and the company knew it.
The internal documents also revealed Lilly officials wrote medical journal studies about Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting.” Lilly employees actually compiled a guide to hiring scientists to help promote drugs and combat unfavorable information about Lilly drugs. Documents, including a 2002 business plan, called for expanding prescriptions in off-label use. They also pointed to notes from Lilly sales representatives through 2003 recording efforts to press doctors to prescribe Zyprexa to elderly patients for mood symptoms, irritability and insomnia.
Lilly pleaded guilty in January to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date. All of this is bad news for Lilly, and unfortunately is typical of how the powerful drug industry operates.
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