Eli Lilly to pay $25 million for improper use of Zyprexa

ATTORNEY GENERAL ANNOUNCES LANDMARK $25.1 MILLION AGREEMENT FOR ILLEGAL MARKETING OF ZYPREXA

          Connecticut  Attorney General Richard Blumenthal today announced a landmark $25.1 million agreement with drug maker Eli Lilly and Company for allegedly marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug’s serious side effects, for more than a decade.

            Blumenthal sued Eli Lilly last year for corrupting physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children.

            Blumenthal’s lawsuit was filed pursuant to the Connecticut Unfair Trade Practices Act and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) in coordination with Chief State’s Attorney Kevin T. Kane, Department of Consumer Protection Commissioner Jerry Farrell, Jr. and Department of Social Services Commissioner Michael Starkowski.

            Blumenthal’s settlement recovers $25 million for money improperly spent on Zyprexa as a result of its illegal marketing, and penalties for Eli Lily’s egregious conduct.

Today’s settlement also requires stronger standards for marketing and transparency to prevent Eli Lilly from rewarding physicians and others for their prescribing practices.

“This illicit multi-billion dollar drug marketing scheme corrupted health care at the expense of taxpayers, senior citizens, children and others who suffered serious side effects from Zyprexa,” Blumenthal said. “Eli Lilly was aided and abetted by so-called independent physicians paid handsomely to promote Zyprexa for unapproved off-label uses — ghost writing articles, downplaying dangers, and pitching the product.

            “Propelled by profits, Eli Lilly promoted Zyprexa recklessly – regardless of danger or FDA rules. Eli Lilly illegally marketed Zyprexa for unapproved uses in children to treat depression and Attention Deficit Disorder, and other uses never approved by the FDA. The result was catastrophic, causing severe weight gain, diabetes and cardiovascular problems in patients.”

Starkowski said, “This huge settlement is good news for Connecticut taxpayers on a number of levels, including a major infusion of revenue and protection of the integrity of our health coverage programs.  We appreciate the work of the Attorney General’s Office, the Chief State’s Attorney’s Office and Department of Social Services staff who were instrumental in bringing this action to successful conclusion.”

Kane said, “The State of Connecticut took a leadership role through its own action in investigating and addressing the improper conduct on the part of this company. The result is a record settlement that sends a clear message that we will not tolerate the misuse of taxpayer funds. I thank the Office of the Attorney General and the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney for their outstanding work on this matter.”

            Blumenthal added, “Countless consumers continue to suffer needless physical and financial damage from unapproved promotion and prescribing of Zyprexa.”

“Eli Lilly promoted Zyprexa with deceitful determination for more than a decade with sham educational events, ghostwritten promotional articles and suspect studies. This meritless marketing misled countless physicians into accepting peer recommendations and prescribing Zyprexa for unapproved and unsafe uses.

“More than the money, this settlement stops future harm, preventing practices that may deceive doctors and deprive patients of the right to make informed medical decisions. My office will continue the fight to hold accountable Eli Lilly — and others we are pursuing — who disregard deadly dangers to make a profit.”
Despite only limited studies on its efficacy and safety, and only limited federally approved use, Zyprexa has become the third best-selling drug in the world as a result of Eli Lilly’s illegal promotions.
The Food and Drug Administration (FDA) approved Zyprexa, or olanzapine, only for use in treatment of schizophrenia and bipolar mania. In order to maximize profits, Eli Lilly created illegal enterprises to promote Zyprexa for unapproved uses, while trying to avoid federal prohibitions against off-label drug marketing.
Doctors, falsely claiming independence, urged peers at “educational forums” to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.
In reality, Eli Lilly paid these “independent” physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties. In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.
Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder.
Through the Connecticut Medical Assistance Programs (CMAP), the state pays for part or all medical benefits for enrollees, including pregnant women and newborns, adults with disabilities, people age 65 and older, and people living in nursing homes.
Between 1996 and 2006, the CMAP spent millions on Zyprexa — and millions more to treat injuries related to the use of Zyprexa.
Blumenthal thanks Assistant Attorney General Robert Teitelman for his work on this case.