South Dakota and 32 Other Participants Reach Landmark $62 Million Settlement with Eli Lilly
PIERRE, S.D.- Attorney General Larry Long and 32 other state attorneys general reached a record $62 million dollar settlement with Eli Lilly and Company arising from alleged improper marketing of the antipsychotic drug Zyprexa. The case stands as the largest ever multi-state pharmaceutical protection settlement. As part of the settlement, South Dakota will receive over $950,000.00 in settlement funds from the company.
In a complaint filed today along with the settlement agreement, Attorney General Long alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and for failing to adequately disclose the drug’s potential side effects to health care providers. Following a 1.5-year investigation, Eli Lilly agreed to change how it markets Zyprexa and to cease promoting its “off-label” uses, which are not approved by the U.S. Food and Drug Administration (FDA).
Zyprexa is the brand name for the prescription drug olanzapine. The drug was first marketed for use in adults with schizophrenia in 1996. Since then, the Food and Drug Administration (“FDA”) has approved Zyprexa for the treatment of acute mixed or manic episodes of bipolar I disorder and for maintenance treatment of bipolar disorder. While these drugs may reduce the risk of these symptoms associated with first-generation antipsychotics, they also produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other severe conditions. Zyprexa has been associated with a high risk of weight gain, hyperglycemia, and diabetes.
In 2001, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” As part of that campaign, the company marketed Zyprexa for a number of off-label uses. For example, it marketed Zyprexa for pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia. While a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
The settlement mandates that for a six year time period extending beyond the patent term for Zyprexa, Eli Lilly shall:
· 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. This information shall not be distributed unless certain criteria are met;
· 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; and
· 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.