Oregon Department of Justice

Attorney General Hardy Myers Reaches Landmark $62 Million Settlement With Eli Lilly Pharmaceutical Company.

Record multi-state agreement follows $58 million May settlement with Merck

Attorney General Hardy Myers today announced a record $62 million settlement with Eli Lilly and Company arising from alleged improper marketing of the antipsychotic drug Zyprexa. Myers, joined by Illinois Attorney General Lisa Madigan, led the 33-state action, under which Oregon will receive more than $2.5 million.

"By now, we hope the entire United States pharmaceutical industry is on notice that Oregon will not tolerate the deceptive and unfair marketing and promotion of prescription drugs," Myers said. "Not only are we securing significant changes in the operation of these huge drug conglomerates, but we are leading the way for our colleagues in the other states and territories to do the same."

In a complaint filed today along with the settlement agreement, Myers and Assistant Attorney General David Hart, lead attorney in Oregon's enforcement actions against the pharmaceutical industry, 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 year and a half investigation by the states, Eli Lilly agreed to significantly reform how it markets Zyprexa.

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.

Zyprexa belongs to a class of drugs traditionally used to treat schizophrenia and commonly referred to as "atypical antipsychotics." When these drugs were first introduced to the market in the 1990s, experts thought that atypical antipsychotics would be less likely to produce symptoms similar to those seen in Parkinson's disease (extra pyramidal 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 symptoms associated with first-generation antipsychotics, they also produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, and increased risk of mortality in elderly patients with dementia. Zyprexa has been associated with an especially high risk of weight gain, hyperglycemia, and diabetes.

Oregon's complaint alleges that Eli Lilly failed to adequately disclose these side effects and that the company promoted Zyprexa for a number of "off-label" uses including pediatric use, use at high dose levels, treatment of psychiatric symptoms rather than diagnosed disorders, and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia. "Off-label" uses are uses that are not approved by the FDA. 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 Eli Lilly will:

Promotional Activities

• 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;

Product Samples

• Only provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product's current labeling and

Clinical Research

• 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.

The 33 participating states in the settlement in addition to Oregon and Illinois are:  Arizona, Alabama, California, Delaware, District of Columbia, Florida, Hawaii, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.

Oregonians wanting more information about this case and others concerning the pharmaceutical industry and Oregon consumer protection issues may call the Attorney General's consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5729 (Portland area only) or toll-free at 1-877-877-9392. DOJ is online at www.doj.state.or.us.