The State of Connecticut has filed suit against Eli Lilly and Co. alleging that the drug maker illegally marketed and concealed serious side effects of Zyprexa, its top-selling schizophrenia medicine. Connecticut Attorney General Richard Blumenthal is seeking 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.” Lilly is already a defendant in a lawsuit filed by the state of Alaska. The trial in that case, which began last month, has similar accusations involving marketing and side effects associated with Zyprexa, which is by far Lilly’s biggest product. Lilly had sales of Zyprexa of $4.76 billion in 2007, $2.24 billion of which was in the U.S.

Lilly is accused of promoting Zyprexa for unapproved uses, including the treatment of children, and of hiding dangerous side effects, such as increased risk of diabetes, weight gain, and heart problems. Attorney General Blumenthal made this statement when he filed the suit:

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. Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety.

The Attorney General accused Lilly of promoting the drug for anxiety, depression, and attention deficit disorder in children despite its not receiving FDA approval for those uses. Although doctors may prescribe medicines in any way they see fit, companies are allowed to promote them only for uses approved by U.S. health regulators. The drug maker was accused of corrupting doctors, pharmacies, and public officials nationwide. Between 1996 and 2006, the Connecticut Medical Assistance Programs spent more than $190 million on Zyprexa, and millions more were spent to treat injuries caused by Zyprexa. The Attorney General has been involved in private negotiations with Lilly over Zyprexa, and a settlement with federal prosecutors may be in the works.

An interesting development occurred during the trial. John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in March 2003 that encouraged Lilly to promote Zyprexa for a use not approved by federal drug regulators. His comments were sent to other Lilly executives after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors. In his e-mail message, Mr. Lechleiter discussed the use of Zyprexa by children and teenagers. Mr. Lechleiter, who was then the company’s executive vice-president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with these doctors. Mr. Lechleiter wrote in his email message:

The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population.

Mr. Lechleiter also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales. The trial judge wouldn’t allow the email to be admitted into evidence because off-label use isn’t at issue in the case. This disclosure nonetheless comes at a sensitive moment for Lilly, which is also under federal criminal investigation for the way it promoted Zyprexa and played down the drug’s risks to doctors. Internal Lilly documents show that from 2000 to 2002 the company aggressively tried to expand Zyprexa’s sales into markets for executive on April 1st, succeeding Sidney Taurel, and is to succeed Mr. Taurel as Lilly’s chairman at the end of the year. The trial in Alaska is being watched carefully by other drug companies.

Source: Reuters & New York Times

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