Lilly Ferociously Defends Its Top Seller
By Matthew Herper
September 09, 2004

NEW YORK - The market for schizophrenia drugs is worth $12 billion globally, and it's growing at 30% per year. But sales of Zyprexa, the market's top seller, are actually falling over concerns of diabetes risks tied to the drug.

Twelve-month sales of the drug in the U.S. fell 3% from last year. Now, to make matters worse, the trial lawyers are getting involved, but drugmaker Eli Lilly (nyse: LLY - news - people ) is defending the Zyprexa franchise ferociously--and will help physicians do the same. But the diabetes concerns that are drawing the lawyers' interest are not likely to subside. With Zyprexa sales totaling $4.3 billion annually, the drug is Lilly's best seller, and the company would like to keep it that way.

In a letter to physicians obtained by, Lilly rails against advertising campaigns from attorneys seeking to bring class-action suits related to the diabetes risk against Lilly and physicians. The letter is signed by Robert Baker, the associate director of medical neurosciences at Lilly. Baker warns that such advertisements can lead seriously ill patients to stop taking their medicine--and points to statements from patient advocacy organizations fretting over this danger. He writes that Lilly has contacted the law firms running these advertisements, asking them at the very least to tell patients never to stop taking their medication without consulting a physician.

Then Baker drops a surprise: Lilly will help physicians who have been targeted by personal injury lawyers defend themselves. "We plan to vigorously defend Zyprexa against any and all lawsuits," the letter says. "Lilly will also provide selected resources to any party (e.g., a physician) named as a co-defendant, including scientific expertise, assistance in finding experts, and coordination with counsel."

Lilly spokeswoman Marni Lemons says the company would have liked to go further and offer indemnity to doctors who prescribed Zyprexa--a measure the company took with lawsuits brought against Prozac. But guidelines from the American Medical Association prevent it from doing so. Henry Nasrallah, a psychiatrist at the University of Cincinnati who has been critical of Zyprexa for its diabetes risk and who does not consult for Lilly, said Lilly's defensive measure appears to be appropriate. "Lilly has always been good at providing legal support," says Nasrallah.

"I think they're sort of being forced into this by the personal-injury lawyers who now see this as a source of revenue," says Jeffrey Lieberman, a psychiatrist at the University of North Carolina, Chapel Hill, who is conducting a trial comparing major schizophrenia drugs for the National Institutes of Health. "It's all very unpleasant and unseemly so it has a bad flavor or odor about it, but this is basically an ugly and potentially bitter active battle."

Rachel Abrams, an attorney at Hersh & Hersh in San Francisco whose firm has filed 20 cases against Eli Lilly in connection with Zyprexa, says that most cases are focusing on Lilly, not on individual doctors. At issue, she says, is why Zyprexa's package insert did not warn of the risk of high blood sugar until relatively recently. Such warnings might have led doctors to measure the blood sugar of patients on Zyprexa regularly, preventing at least some deaths. For this reason, Lilly is the focus of the case, not the doctors who are prescribing the drugs.

Lieberman conducted pivotal trials on Abilify, a schizophrenia drug from Bristol-Myers Squibb (nyse: BMY) and Otsuka Pharmaceuticals that has made its lack of weight gain a major selling point. But he does not see giving up on Zyprexa yet, even as a first choice. Less than half of patients on the drug gain significant weight, he says, and many physicians are comfortable prescribing it. Instead, he sees drugs with less potential for making patients fat, such as Abilify and Pfizer's (nyse: PFE) Geodon, as options for switching patients who have trouble. Young patients also might benefit, he says, as they are more likely to gain weight on Zyprexa and more likely to stop treatment because of it.

But Lilly may have a tough time re-igniting Zyprexa's once rapid growth as many doctors focus on the diabetes risk of schizophrenia medicines. There is no evidence that any one antipsychotic is more effective than another, says Nasrallah, but Zyprexa and Novartis' (nyse: NVS) little-used Clozaril cause more weight gain and more risk of diabetes, according to an opinion paper from the American Diabetes Association. The Food and Drug Administration has added similar warning language regarding diabetes to all schizophrenia drugs, on the assumption that all these medicines are part of the same class. But Lieberman says that decision "flies in the face" of available evidence.

The problem is not just diabetes, but also heart diseases. Daniel Casey, a psychiatrist at Oregon Health & Science University, says that schizophrenia patients are already at higher risk for heart attacks than other people. Three-quarters of them smoke, he says. Abilify and Geodon don't cause weight gain and is giving both of them some traction in the market--although sales are still considerably less than Zyprexa's. Says Casey: "We don't want to impose an addition health burden in people who are already at high risk for cardiovascular disease."

Even if Lilly fights off the lawyers, that kind of talk from doctors can't be a good thing.

Diabetes Risk And Antipsychotics
Drug Drugmaker Weight Gain Diabetes Risk Cholesterol
Clozaril Novartis (nyse: NVS) Strong Effect Clear Increased Risk Clearly Worse
Zyprexa Eli Lilly (nyse: LLY) Strong Effect Clear Increased Risk Clearly Worse
Risperdal Johnson & Johnson (nyse: JNJ) Some Effect Conflicting Data Conflicting Data
Seroquel AstraZeneca (nyse: AZN) Some Effect Conflicting Data Conflicting Data
Abilify* Bristol-Myers Squibb (nyse: BMY) and Otsuka Little Or No Effect No Effect No Effect
Geodon* Pfizer (nyse: PFE) Little Or No Effect No Effect No Effect
*New medicine; less data is available. Source: Diabetes Care, Volume 27, No. 2, February 2004.


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