Eli Lilly Sued Over Illegally Marketing Zyprexa

For ADD, Depression, Anxiety

HARTFORD — Physicians prescribing Zyprexa to children diagnosed with ADD, and others suffering with depression and anxiety, may have been duped by a sophisticated marketing program when the antipsychotic drug never actually received FDA approval for those treatments. This week, Attorney General Richard Blumenthal sued Eli Lilly and Company, Inc, for illegally marketing that antipsychotic drug for unapproved uses, and concealing the drug’s serious side effects, for more than a decade.

The attorney general claims that Eli Lilly reportedly corrupted 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.

That deceptive marketing campaign included deliberately concealing risks associated with Zyprexa, like patients developing diabetes, cardiovascular problems, and experiencing significant weight gain once they begin taking the drug.

“The illegal marketing campaign exploited children and senior citizens — causing severe weight gain, diabetes, and cardiovascular problems,” Mr Blumenthal said. “This scheme involved payments to public officials, bogus educational events, and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression, and attention deficit disorder in children when it was never approved for any use in children and caused serious side effects.”

In a lawsuit, Mr Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa.

“Through a complex series of illegal rackets and lies, Eli Lilly built a multibillion-dollar drug enterprise at the expense of taxpayers, consumers, and patient lives. Today’s action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa,” said the AG.

“Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety,” Mr Blumenthal added. “Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies, and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly’s illegal, senseless schemes.”

Mr Blumenthal sued pursuant to the Connecticut Unfair Trade Practices Act (CUTPA) and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) on behalf of Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr, and Department of Social Services (DSS) Commissioner Michael Starkowski.

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, prescribed to more than 12 million people and grossing an estimated $22 billion to date.

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 unlawful enterprises to promote Zyprexa for unapproved uses, while trying to avoid federal prohibitions against off-label drug marketing, the suit claims.

Under the façade of independence, doctors at “educational” forums urged peers to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, while 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, Mr Blumenthal’s suit alleges.

The action claims Eli Lilly paid these “independent” physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties. And in some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants, and other compensation.

Mr Blumenthal said in a release that 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 more than $190 million on Zyprexa. Millions of additional dollars have also been spent to treat injuries related to their use of Zyprexa.

According to a release from the Attorney General’s office, Eli Lilly’s illegal marketing enterprises and schemes included the following:

Peer-Selling Enterprise: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended “educational” events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors’ financial ties with Eli Lilly.

The Role of Pharmacies: Eli Lilly targeted pharmacies, particularly those that serviced long-term care facilities. Typically, an Eli Lilly sales representative and a pharmacy would agree that the pharmacy formally request funding from Eli Lilly in order to present an “educational program” — for example, a program on the treatment of dementia.

Both the pharmacy and the Eli Lilly representative would agree that the program include a presentation by a doctor, handpicked by Eli Lilly, who would promote off-label use of Zyprexa for dementia. The Eli Lilly sales representative would file a formal request for funds from Eli Lilly for an educational grant. Eli Lilly would issue a check to the pharmacy and the pharmacy would issue a check to the doctor, concealing compensation from Lilly to the physician.

Publication Enterprise: Eli Lilly created a “Publication Enterprise” that hired writers to create articles, and then paid specialists to “author” the articles. The articles only included favorable results of Eli Lilly’s own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa’s efficacy for bipolar disorder.

Public Payer Enterprise: Eli Lilly captured the Medicaid and Medicare markets by paying officials in various states, paying them substantial sums of money to spread falsehoods regarding the efficacy, safety, and side effects of Zyprexa and to promote off-label use. Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid — among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to overmedicate senior citizens in nursing homes and adolescents in detention centers with antipsychotics.