The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.
Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.
Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.
Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.
But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.
“Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.
At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.
Laying aside what one might think of Lilly's conduct in marketing its drug, the federal watchdog agency, the FDA, hasn't exactly been looking out for consumer interests. The Times writes, "In 2003, after reviewing data provided by Lilly and other drug makers, the FDA said that the current class of antipsychotic drugs may cause high blood sugar." "It did not specifically single out Zyprexa, nor did it say that the drugs had been proven to cause diabetes."
Personally, I think we would be better off without the FDA regulating drugs. The FDA is in the pockets of the industry, and drug companies often hide behind an FDA stamp of approval to avoid liability. If the drug companies had to stand behind their own products without clinging to the FDA's skirt, they might be more forthcoming about their drugs' risks, and some drugs might not ever be put on the market.
Lilly claims the documents provided to the Times for this story were illegally disclosed. According to the story, Lilly has paid out substantial settlements to plaintiffs already--about $750 million involving 8,000 patients--and has potentially more product liability exposure.
It is also worth noting that Lilly has been a pioneer in the industry when it comes to treating diabetes. Bipolar disorder is one of the conditions Zyprexa is used to treat. Is it just me, or are there a lot of people being diagnosed as bipolar--what used to be considered a rare condition?