Documents from a pending lawsuit reveal that Eli Lilly & Co. trained its sales force to downplay risks for Zyprexa and encourage doctors to prescribe the drug beyond approved uses for schizophrenia and bipolar disorder. Lilly’s research had shown some patients on Zyprexa gained as much as 80 pounds and that the incidence of high blood sugar at diabetes levels was 3.5 times higher than for placebos, according to documents obtained through discovery in a lawsuit brought by the State of Alaska. Internal Lilly documents revealed that the company knew doctors were already seeing a “logical link between weight gain and diabetes.” Lilly, by way of an instruction sheet, advised the sales force of that in 2002. The company wrote in the sales document:

We believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue, which was provided for the Alaska case. Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace.

Zyprexa became the company’s top-selling drug, with $4.76 billion in sales last year — about a quarter of Lilly’s revenue. Company sales representatives disputed or ignored the risks and pursued primary-care and nursing-home doctors as well as psychiatrists, according to the documents in the Alaska case. These documents had been under seal until Bloomberg News filed a motion to unseal them.

Lilly agreed to pay $15 million to settle the Alaska suit in March. The company has paid about $1.2 billion to resolve claims brought by more than 31,000 patients who said they weren’t adequately warned Zyprexa could cause weight gain, diabetes or inflammation of the pancreas. Lilly faces suits by nine other states alleging failure to warn and improper marketing, separate consumer-protection investigations in about 30 other states and an investigation of off-label marketing by the U.S. Attorney in Philadelphia.

Lilly pushed Zyprexa sales to primary care physicians and doctors in nursing homes for patients who weren’t diagnosed with schizophrenia or bipolar disorder. Most of the documents came from discovery in consolidated Zyprexa litigation in a New York federal court. The unsealed documents showed that about 550 sales representatives were greeted at an October 2000 meeting with a “Viva Zyprexa” version of the Elvis Presley song, “Viva Las Vegas,” touting the “many wonderful indications” for the drug. In fact, there were only two approved indications for the drug at the time.

Zyprexa wasn’t approved for use with Alzheimer’s or for elderly conditions. Lilly’s sales representatives were advised to focus on symptoms, not diagnoses, when dealing with primary care physicians or PCPs, according to the company’s documents. There are a number of Lilly internal documents and emails that are very damaging to the company. Lilly’s sales representatives encouraged doctors to prescribe for such non-approved uses, according to call notes produced in the Alaska suit.

Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It said Zyprexa was more associated with higher blood sugar levels, a risk factor for diabetes, than similar medications. Before the October 2007 label change, Lilly didn’t instruct its sales force to say Zyprexa’s diabetes rates were higher. It is clear that Lilly was not telling doctors about the diabetes issue. In fact, one document reads: “The competition wins if we are distracted into talking about diabetes.” It’s quite apparent that Lilly has serious exposure in this litigation. Without the information obtained by discovery in these lawsuits, neither the public nor the FDA would have known how Lilly was misleading and using the medical community.

Source: Bloomberg News

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