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States Reach Landmark Settlement with Eli Lilly & Co. Over Marketing of Drug Zyprexa
Oct 8, 2008 | Iowa Department of Justice
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.” -
Texas, 33 States Reach Landmark $62 Million Settlement With Eli Lilly & Co.
Oct 7, 2008 | The Attorney General of Texas
DALLAS Texas Attorney General Greg Abbott and 33 other state attorneys general today reached a $62 million settlement with Eli Lilly & Co. The states’ investigation found that the pharmaceutical manufacturer unlawfully marketed its antipsychotic drug Zyprexa to health care providers. -
Attorney General Announces Landmark Settlement with Eli Lilly
Oct 7, 2008 | Office of the Maine Attorney General
Today Attorney General Steve Rowe, along with 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. It is the largest ever multi-state consumer protection-based pharmaceutical settlement, following closely on the heels of the May 2008, $58 million agreement with Merck regarding its product Vioxx. Maine’s share of today’s settlement will be $1,020,609. -
33 States to Get $62 Million in Zyprexa Case Settlement
Oct 6, 2008 | The New York Times
By Alex Berenson
Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.
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States Reach Landmark Settlement with Eli Lilly & Co. Over Marketing of Drug Zyprexa
Oct 8, 2008 | Iowa Department of Justice
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.
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:
Promotional ActivitiesNot 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 InformationRequire 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 GrantsDisclose 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 SpeakersProvide 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 SamplesOnly provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling.
Clinical ResearchRegister 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.
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Texas, 33 States Reach Landmark $62 Million Settlement With Eli Lilly & Co.
Oct 7, 2008 | The Attorney General of Texas
DALLAS Texas Attorney General Greg Abbott and 33 other state attorneys general today reached a $62 million settlement with Eli Lilly & Co. The states’ investigation found that the pharmaceutical manufacturer unlawfully marketed its antipsychotic drug Zyprexa to health care providers.
The case stands as the largest multi-state consumer protection settlement brought against a pharmaceutical company. It follows on the heels of last May’s $58 million national settlement with Merck & Co. regarding its improper marketing of the former drug Vioxx.Zyprexa is known as an atypical antipsychotic drug, which, since 1996, has been typically prescribed for treating adult schizophrenia. Since that time, the U.S. Food and Drug Administration (FDA) has also approved Zyprexa for the treatment of varying degrees of bipolar disorder and for maintenance treatment of this disorder. While medical experts believed the new generation of drugs like Zyprexa reduced motion disorder symptoms and those similar to Parkinson’s disease patients, the drug also produced unforeseen side effects such as weight gain, diabetes, hyperglycemia, cardiovascular complications and others.
Nonetheless, Lilly began an aggressive deceptive marketing campaign in 2001, downplayed the drug’s harmful side effects and routinely marketed Zyprexa to health care providers for what is known as off-label uses. While a physician may prescribe drugs for off-label uses, the law prohibits a drug manufacturer from marketing drugs to physicians for off-label uses. In this case, Lilly promoted Zyprexa for pediatric uses, for uses at higher dosage level than recognized by the FDA, for the treatment of symptoms rather than diagnosed conditions and to induce extreme sedation as a way to restrain elderly patients suffering from dementia.
Today’s settlement mandates that Lilly implement a number of important reforms for a six-year period, which will extend beyond the 2013 patent expiration term for Zyprexa. First, the settlement prohibits Lilly from making any false, misleading or deceptive claims regarding Zyprexa. The company’s medical staff, rather than its marketing staff, will be exclusively responsible for approving the medical content of letters and references regarding the drug’s properties. Lilly’s medical staff also must provide accurate and scientifically balanced responses to requests from medical providers about off-label use information.
The company will also only provide Zyprexa samples to providers whose practice is consistent with the product’s current labeling. The settlement also requires Lilly to disclose to the Office of the Attorney General the amount of speaker fees it pays to physicians who give presentations to other physicians on the company’s behalf about Zyprexa. -
Attorney General Announces Landmark Settlement with Eli Lilly
Oct 7, 2008 | Office of the Maine Attorney General
Today Attorney General Steve Rowe, along with 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. It is the largest ever multi-state consumer protection-based pharmaceutical settlement, following closely on the heels of the May 2008, $58 million agreement with Merck regarding its product Vioxx. Maine’s share of today’s settlement will be $1,020,609.
In a complaint filed today along with the settlement agreement, Rowe 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 long 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).
“Eli Lilly engaged in a marketing practice that put the lives of Maine consumers at risk,” Rowe said. “This settlement should send a message to prescription drug companies that the states will not tolerate those who put profits above the health and safety of consumers.”
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 (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 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:
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.
Rowe added, “The conditions of this agreement are an important part of the enforcement action against Eli Lilly. Drug companies must recognize that the responsibility they have to shareholders does not supersede their responsibility to their customers.”
Maine joined Arizona, Alabama, California, Delaware, District of Columbia, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.
Assistant Attorney General Christina Moylan of the Attorney General’s Consumer Protection Division handled the case for the state of Maine. The agreement was filed in Kennebec County Superior Court.
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33 States to Get $62 Million in Zyprexa Case Settlement
Oct 6, 2008 | The New York Times
By Alex Berenson
Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.
The settlement, to be announced Tuesday, ends an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon, which contended that Lilly had violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need it.
It is the largest settlement paid by a drug company in a state consumer protection case, topping the $58 million that Merck paid to settle similar allegations about Vioxx, lawyers for the states said.
The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa.
“We know they’re working hard to get that settlement done,” said James D. Kole, the chief of the consumer fraud bureau for the Illinois office.
The states’ investigation and the Philadelphia case center on Lilly’s marketing of Zyprexa, a potent brain tranquilizer that calms thehallucinations associated with schizophrenia and bipolar mania. Internal Lilly documents and e-mail messages appear to show that the company marketed it for patients with dementia and milder forms of bipolar disorder, a violation of federal law.
Zyprexa can cause severe weight gain and an increase in blood sugar in many patients and is more likely to cause diabetes than most other medicines for schizophrenia and bipolar disorder, according to the American Diabetes Association.
Once the Food and Drug Administration approves a drug for sale, doctors can prescribe it for whatever disease they see fit because the F.D.A. does not regulate the practice of medicine. But pharmaceutical companies can market and advertise their medicines only for the uses specified on the drug’s label.
“The company’s deceptive marketing practices were illegal and highly dangerous,” Lisa Madigan, the attorney general of Illinois, said in a statement.
A spokesman and a lawyer for Lilly did not return a call and an e-mail message for comment.
David Hart, senior assistant attorney general for Oregon, said, “We’re trying to send a message to the pharmaceutical industry that consumer fraud is something we’re going to investigate and prosecute.”
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