Eli Lilly hid side effects of Zyprexa drug, say internal documents leaked to New York Times

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The documents -- which include emails, marketing material, sales projections and scientific reports -- show instances where sales representatives were told to downplay the risks of unmanageable weight gain when talking to doctors for fear that the information would hurt sales. Zyprexa -- generically known as olanzapine -- earned Eli Lilly $4.2 billion last year, but the documents -- which cover a period of time between 1995 and 2004 -- include study data showing a 22-pound weight increase in 30 percent of patients on Zyprexa. Some patients even reported a gain of 100 pounds or more.

"Watchdogs in the natural health community have been trying to warn the public for years about how psychotropic drugs promote diabetes and obesity," said Mike Adams, a consumer health advocate and critic of the medical industry. "Now it seems that Eli Lilly had evidence all along that they refused to share with doctors."

James B. Gottstein, a lawyer representing mentally ill patients who are suing Eli Lilly, originally sent the documents to the New York Times. Eight thousand people drew up lawsuits against the drugmaker in which they claimed they contracted diabetes or other medical problems while on Zyprexa. Last year the company paid $750 million to settle those suits, and thousands remain pending.

"Patients should be told the truth about drugs like Zyprexa," Gottstein said.

After the New York Times story broke, the company denied the diabetes link, claimed that the documents were illegally released and taken out of context, and maintained that Zyprexa was safe. Eli Lilly spokespersons said that Zyprexa was an important drug for bipolar and schizophrenic patients, and feared that releasing the documents may "cause unwarranted fear among patients that will cause them to stop taking their medication." It further cited studies of Zyprexa's use in real-world cases and said all data regarding Zyprexa had been given to the FDA.

In the summer of 2003, company insiders noticed a drop in Zyprexa sales, as concerned psychiatrists were turning away from the drug. That is when the company began to admit the link between Zyprexa and severe obesity, but continued to claim there is no scientific evidence that links the drug to diabetes. However, Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York, said of the drug, "When somebody gains weight, they need more insulin, they become more insulin resistant.

Indeed, the damage may already be done, as some psychiatrists no longer feel able to trust Eli Lilly.

"From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives," said Dr. James Phelps, a psychiatrist in Corvallis, Ore. "Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company."

Adams agreed, saying, "In my opinion, these actions by Eli Lilly are nothing less than a public health fraud."

The Eli Lilly documents show that in-company concerns about the drug were voiced as far back as 1999. An email by Eli Lilly's Chief Medical Officer Dr. Alan Breier, written in November of that year to Eli Lilly employees who made up an "executive steering committee for olanzapine-associated weight changes and hyperglycemia," illustrated the worries.

"Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule," he wrote. Another email between Eli Lilly managers stated that a group of diabetes doctors that the company had tasked with investigating the links recommended transparency on the issue, in case the problem got out of hand. Yet documents show the company rejected plans to educate psychiatrists in diabetes treatments in order to protect Zyprexa's reputation, and attempted to market the drug to less-informed primary care physicians, under the pretence of being a "safe, gentle psychotropic" for people with mild mental illnesses.

"Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," wrote an Eli Lilly manager in a 2002 email.

The American Diabetes Association and other critics have said that Zyprexa has a better chance of causing diabetes than other schizophrenia drugs. Even the company's own marketing showed a consistent sampling of psychiatrists who reported more Zyprexa patients developing diabetes or high blood sugar than those on any other antipsychotic drug. Although the results are not acknowledged by Eli Lilly, four surveys were conducted by the marketing department in 2000 and 2001, and 70 percent of the polled psychiatrists reported at least one Zyprexa patient developed high blood sugar or diabetes, compared to 20 percent with Johnson & Johnson's Risperdal and AstraZeneca's Seroquel.

Still, experts say it is unlikely that use of Zyprexa will be discontinued, even as knowledge of its side effects spreads. Phelps said that he still prescribes Zyprexa, noting its fast-acting nature makes it an excellent emergency medicine for people with suicidal behavior, but he tries to get his patients off the medicine or avoid using it altogether because of the side effects. Some top psychiatrists agree that Zyprexa is more effective as an antipsychotic for severe cases than most other drugs, but others say it is, at best, the same.

The FDA said it had reviewed Eli Lilly's data, and warned that high blood sugar may stem from the use of the current class of psychotic drugs. The statement did not mention Zyprexa specifically, nor did it say the link had been proven.

Adams says that he believed the FDA had been acting in conspiracy with Eli Lilly to withhold the damning information from the public and the medical community. "I also believe there is overwhelming evidence to support the existence of this conspiracy, and that it is a conspiracy designed to maximize drug company profits at the expense of public health," he added. "In a time when diabetes has become an epidemic among the American people, it is unconscionable -- even criminal -- to promote drugs that are clearly shown to cause diabetes and weight gain."

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