Des Moines. Eli Lilly & Co. will pay $62 million and must change marketing practices under a settlement resolving allegations by state attorneys general that the drug company used unfair and deceptive practices in marketing its anti-psychotic drug called “Zyprexa.”
Attorney General Tom Miller said states alleged Eli Lilly illegally marketed the drug for “off-label” uses not approved by the U.S. Food and Drug Administration (FDA), and failed to disclose to health care providers the drug’s potential harmful side effects. Physicians are allowed to prescribe drugs for off-label uses, but law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
Zyprexa was first marketed in 1996 for use by adults with schizophrenia, and the FDA has approved the drug for treatment of acute mixed or manic episodes of bipolar I disorder and maintenance treatment of bipolar disorder. But Zyprexa also has been associated with a high risk of weight gain, hyperglycemia, and diabetes.
“Consumers must be able to rely on claims drug companies make for their products, especially when the drugs come with significant side effects,” Miller said. “Consumers’ health and safety are at stake, and this demands that drug companies limit their claims to those approved by the FDA.”
The states’ investigation resulted from Eli Lilly’s aggressive marketing campaign called “Viva Zyprexa!” As part of the campaign, Zyprexa was marketed for a number of off-label uses, such as pediatric use, use at high dosage levels, treatment of symptoms rather than diagnosed conditions, and treatment or chemical restraint of elderly patients suffering from dementia. Eli Lilly has faced numerous other public and private legal actions regarding Zyprexa.
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More background and detail:
Attorneys General for a total of 32 states plus the District of Columbia reached the settlement with Eli Lilly & Co. In addition to the $62 million payment, which will be used for consumer education and litigation by the states, the company must change how it markets Zyprexa and cease promoting Zyprexa’s “off-label” uses that are not approved by the FDA. Eli Lilly must not make any false, misleading or deceptive claims regarding Zyprexa in its promotional campaigns. (Details below.)
In Iowa, a lawsuit and a Consent Judgment settling the suit both were filed Tuesday in Polk County District Court in Des Moines. The Consent Judgment, which was entered by District Court Judge Michael Huppert, substantially limits future Eli Lilly promotional efforts for Zyprexa. [Go to lawsuit petition. Go to Consent Judgment.]
The $62 million payment in the settlement is the largest ever multi-state consumer protection-based pharmaceutical settlement, following the $58 million agreement with Merck regarding Merck’s product “Vioxx” in May 2008.
The Attorneys General of Illinois and Oregon led the investigation into Eli Lilly’s marketing and promotional practices. The participating states in the settlement are: AL, AZ, CA, DE, FL, HI, IL, IN, IA, KS, ME, MD, MA, MI, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, and the District of Columbia.
For the record -- Limits placed on promotional efforts for Zyprexa:
The Consent Judgment substantially limits future Eli Lilly & Co. promotional efforts for Zyprexa for a six-year period, extending beyond the patent term for Zyprexa. Requirements include:
- Not make any false, misleading or deceptive claims regarding Zyprexa.
- Not promote Zyprexa using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses.
Dissemination of Medical Information
- Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving the medical content for all medical letters and medical references regarding Zyprexa, including those that may describe off-label information.
- Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa.
- Require its medical staff to be responsible for the identification, selection, approval and dissemination of article reprints containing more than an incidental reference to off-label information regarding Zyprexa, and that such information not be referred to or used in a promotional manner.
Continuing Medical Education (CME) and Grants
- Disclose information about grants, including continued medical education on its Web site (www.lillygrantoffice.com), for at least two years and maintain the information for five years.
- Not use grants to promote Zyprexa, or condition CME funding on Eli Lilly’s approval of speakers or program content.
- Contractually require continuing medical education providers to disclose Eli Lilly’s financial support of their programs and any financial relationship with faculty and speakers.
Payments to Consultants and Speakers
- Provide each signatory Attorney General a list of health care provider promotional speakers and consultants who were paid more than $100 for promotional speaking and/or consulting by Eli Lilly.
- Only provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling.
- Register clinical trials and submit results as required by federal law; register Zyprexa Eli-Lilly sponsored Phase II, III and IV clinical trials beginning after July 1, 2005; and post on a publicly accessible Web site all Eli-Lilly sponsored Phase II, III and IV clinical trials completed after July 1, 2004.
Zyprexa and “atypical anti-psychotic” drugs:
“Zyprexa” is the brand name for the prescription drug olanzapine. Zyprexa belongs to a class of drugs traditionally used to treat schizophrenia and commonly referred to as “atypical anti-psychotics.” When these drugs were first introduced to the market in the 1990s, experts thought that atypical anti-psychotics would be less likely than other drugs to produce side effect symptoms similar to those seen in Parkinson’s disease (extrapyramidal symptoms), and motion disorders (tardive dyskinesia), and therefore could be used in long-term treatment of schizophrenia.
While these drugs may reduce the risk of these side-effect symptoms associated with first-generation anti-psychotics, they also produce other dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia, and other severe conditions.