Did Eli Lilly sweep concerns about its schizophrenia drug Zyprexa under the rug? The New York Times claims it did, though the company insists it did not.
In a weekend story, the Times cited hundreds of internal company documents and emails suggesting that Lilly spent ten years trying to gloss over the drug's side effects.
The documents, which the Times said it received from a lawyer representing patients who took the drug, seem to suggest the company withheld important information from doctors about Zyprexa's links to obesity and its tendency to raise blood sugar.
Zyprexa is a top money-maker for Lilly, with sales of $4.2 billion last year. More than two million people worldwide took the drug in 2005.
"We believe it is critical to physicians and patients that Lilly state some important and relevant facts about our lifesaving medication Zyprexa that are missing from the New York Times article," said Steven Paul, M.D., Lilly's executive vice president of science and technology.
"First, contrary to incorrect statements in the Times article, Lilly has conducted more than 23 years of research on Zyprexa. And in the last ten years that the drug has been on the market, Lilly, government bodies such as the National Institute of Mental Health, and competitors -- in numerous studies that sought to show a causal link to Zyprexa and diabetes -- have not found that Zyprexa causes diabetes."
Zyprexa was approved by the FDA in 1996 and the company said it has been used by more than 20 million people worldwide.
The drug is widely prescribed to deal with both schizophrenia and bipolar disorder. The company insists the drug is of enormous benefit to when accompanied by appropriate labeling regarding benefits and risks.
"From the day that Zyprexa was approved, the labeling provided to physicians identified the potentially clinically-significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials," Paul said.