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US: Eli Lilly E-Mail Discussed Unapproved Use of Drug

by ALEX BERENSONThe New York Times
March 17th, 2008

ANCHORAGE - John C. Lechleiter, an Eli Lilly official who is about to become the company's top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.


Mr. Lechleiter's comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.

The e-mail message was discussed this week in an Anchorage courtroom in a lawsuit against Lilly by the State of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa.

The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.

Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it "off label" for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug.

The federal government has investigated drug companies before for off-label promotion of their medicines, but Mr. Lechleiter's note provides rare documentation of a senior drug executive's openly discussing the practice.

A spokeswoman for Eli Lilly said Mr. Lechleiter was not advocating off-label promotion in his note but simply wanted the company to respond to physicians' requests for information.

In his e-mail message, Mr. Lechleiter discusses 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 such doctors, he said.

"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 wrote in the message.

He also encouraged Lilly to get data on the use of Zyprexa in treating "disruptive kids" in order to increase the drug's sales.

The company declined to make Mr. Lechleiter available for comment.

Because of Zyprexa's physical side effects, many psychiatrists now say it is appropriate only for severely mentally ill patients. Clinical trials have shown that its tendency to cause dangerous weight gain appears to be especially pronounced in younger patients. The Food and Drug Administration has for more than a year declined to act upon an application by Lilly to broaden the drug's label to allow its use in people under 18.

Mr. Lechleiter's e-mail message has not previously been discussed publicly. In the Alaska trial, after plaintiff lawyers presented it without the jury present, Judge Mark Rindner said it could not be admitted into evidence in the trial because off-label use was not at issue in the case.

Its 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.

>From 2000 to 2002, internal Lilly documents show that the company tried aggressively to expand Zyprexa's sales into markets for which the drug was never approved, including elderly patients with dementia.

To settle that investigation, and related investigations by several states, Lilly is negotiating with federal prosecutors in Pennsylvania on a deal that could result in the company's paying $1 billion to $2 billion in fines and restitution, according to people involved in the investigation. The prosecutors declined to comment on Friday.

Because Mr. Lechleiter, an organic chemist who is Lilly's president and chief operating officer, is a senior official about to become the chief executive, the public disclosure of an e-mail message in which he appears to have encouraged off-label promotion of Zyprexa could complicate the talks.

He is scheduled to become chief executive on April 1, succeeding Sidney Taurel, and is to succeed Mr. Taurel as Lilly's chairman at the end of the year.

Since 2003, as information about the drug's risks has spread, prescriptions for Zyprexa have fallen sharply in the United States. But Lilly has repeatedly increased the drug's price to counteract the slumping prescriptions, and Zyprexa remains by far Lilly's best-selling product, with worldwide sales of $4.8 billion last year, about half in the United States. Zyprexa now costs about $8,000 a year at commonly prescribed doses.

Marni Lemons, a spokeswoman for Eli Lilly, said Mr. Lechleiter's e-mail message was meant to encourage Lilly representatives to answer questions from doctors who were already prescribing Zyprexa off label to children and teenagers.

"Rather than driving physician demand, what he was doing was responding to demand from physicians, which we are allowed to do," Ms. Lemons said.

Federal law does let companies send "medical letters" with additional information about off-label uses to physicians who request the information, although sales representatives are not supposed to discuss it.

In the e-mail message, Mr. Lechleiter made several other references to off-label use of Zyprexa. He wrote, "We are losing scripts to Risperdal for treatment of disruptive kids, because Johnson & Johnson has the data and we don't."

Risperdal, made by Johnson & Johnson, is another drug for schizophrenia and bipolar disorder. Unlike Zyprexa, it has been approved for pediatric use.

Mr. Lechleiter also wrote that "Zyprexa is getting traction with some neurologists for treatment of pain," another off-label use of Zyprexa, which has never been approved for pain relief.

The Alaska trial over Zyprexa began March 5 in Anchorage and is expected to last until late this month.

In its initial complaint, the state tried to recover costs associated with Lilly's off-label promotion of Zyprexa. But just before the jury was chosen, Judge Rindner dismissed that claim. As a result, jurors have not been permitted to hear any evidence relating to off-label promotion in the case.
But lawyers for the state tried on Tuesday to introduce the e-mail message into evidence anyway. Although the judge ruled against them, the message became part of the court record.




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