The agreement is the largest multi-state, consumer-protection-based pharmaceutical settlement on record. The previous largest was a $58 million multi-state settlement with Merck regarding its product Vioxx. New Jersey also participated in that settlement.

 New Jersey’s share of the Eli Lilly settlement is $1.88 million. In addition to New Jersey, 32 other states are party to the agreement, including lead states Illinois and Oregon.

In a complaint filed today along with the settlement agreement, Attorney General Milgram and other participating Attorneys General alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for “off-label” uses, and that it failed to adequately disclose the drug’s potential side effects to health care providers. Following a year-and-a-half-long investigation by the states, Eli Lilly agreed to change how it markets Zyprexa, and to stop promoting it for off-label uses not approved by the U.S. Food and Drug Administration (FDA).   
    
    “This drug appears to have been useful as part of a treatment regimen for certain mental health patients, but it also has been associated with harmful side effects,” said Attorney General Milgram. “This settlement is important because it requires more accountability from Eli Lilly in promoting Zyprexa, requires that patients and health care providers have access to clearer, more accurate and more objective information about the drug, and that medical professionals – not marketing professionals – take the lead in generating that information.”  
                            
    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 FDA has approved Zyprexa for 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 anti-psychotics.”  When these drugs were first introduced to the market in the 1990s, experts thought that atypical anti-psychotics would be less likely to produce 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.

    However, while these drugs may reduce the risk of symptoms associated with first-generation anti-psychotics, 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 treatment and/or chemical restraint of elderly patients suffering from dementia, for treatment of symptoms rather than clinically-diagnosed conditions and for use at high dosage levels. 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 multi-state settlement agreement provides that Eli Lilly shall not make any written or oral claim that is false, misleading of deceptive regarding Zyprexa. The agreement also mandates that for a six-year time period extending beyond the patent term for Zyprexa, Eli Lilly shall:

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 Attorney General signed onto the settlement agreement with 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.

           Attorneys General from Illinois and Oregon spearheaded the investigation into Eli Lilly’s marketing and promotional practices.  In addition to New Jersey, states participating in the settlement include:  Arizona, Alabama, California, Delaware, District of Columbia, Florida, Hawaii, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.

         Deputy Attorney General Gina M. Betts and Deputy Attorney General Jennifer D. Dougherty of the Division of Law’s Consumer Fraud Protection Section handled the matter on behalf of New Jersey.

Trenton, NJ – One of three crew members aboard the Susan II, a 69-foot commercial fishing boat that sank off the Manasquan Inlet on July 2 after crashing into jetties near the inlet, was indicted today for the illegal discharge of diesel fuel, Attorney General Anne Milgram announced.

     Keith Rose, 46, of Wellfleet, Massachusetts, was indicted on one count (fourth degree) of violating the state’s Water Pollution Control Act for negligently discharging oil into the Atlantic Ocean and the Manasquan Inlet.  

    The Susan II, a commercial fishing boat owned by Northstar II Fisheries of Gloucester, Massachusetts, was docked in Point Pleasant when it left a marina shortly before midnight on July 1. Witnesses told authorities that the boat crashed into the jetty on the north side of the Manasquan Inlet after nearly crashing into the jittery on the south side. One of crewmen radioed for help as the boat began to take on water and all three crew members were rescued by the Coast Guard.
    
    Diesel fuel from the boat leaked into the ocean, causing a sheen of two miles. The boat sank approximately one-half mile from the inlet in 30 feet of water. When the boat was salvaged from the ocean floor eight days later, there was a hole of approximately 2 feet by 8 inches in its bottom.

        Investigators determined that Rose was responsible for taking the boat out that night at the time of the accident, which occurred after midnight on July 2.

    The pollution case was investigated by Detective Dawn Ryan of the Environmental Crimes unit and presented to the state grand jury by Supervising Deputy Attorney General Edward R. Bonanno, the chief of the environmental crimes unit in the Division of Criminal Justice Major Crimes Bureau.

Fourth-degree crimes carry a maximum sentence of 18 months in prison and a fine of $50,000. Indictments are merely accusations and the defendants are presumed innocent until proven guilty.

The indictment was handed up to Superior Court Judge Linda Feinberg in Mercer County.  Rose will be ordered to appear in court at a later date to answer the charge.