December 19, 2006
Lilly hid Zyprexa dangers, encouraged off-label promotion: NY Times
Eli Lilly encouraged off-label promotion of its blockbuster drug Zyprexa, while engaging in a decade-long effort to downplay the drug’s risks, The New York Times reported in a series of articles appearing in editions Sunday and Monday.
Citing internal Lilly marketing documents, Monday’s article reported that Lilly encouraged primary care physicians to use its powerful schizophrenia and bipolar disorder medication Zyprexa in patients who did not have either condition.
The marketing documents were given to the newspaper by a lawyer representing mentally ill patients and detail a multi-year promotional campaign that Lilly began in Orlando in late 2000. In the marketing campaign, called “Viva Zyprexa,” Lilly told its sales reps to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
A Lilly executive told The Times that she could not comment on specific marketing documents but that the company had never promoted Zyprexa for off-label uses and that it has always showed the marketing materials used by its sales reps to the FDA, as required by law.
“We have extensive training for sales reps to assure that they provide information to the doctors that’s within the scope of the prescribing information approved by the FDA,” Anne Nobles, Lilly’s VP for corporate affairs, told The Times.
In a statement following publication of the Times article, Lilly’s EVP, science and technology Steven Paul said, “We do not engage in off-label promotion – as alleged in The Times article. Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses.”
Zyprexa is not approved to treat dementia or dementia-related psychosis and carries an FDA warning that it increases the risk of death in older patients with dementia-related psychosis.
Federal laws bar drugmakers from promoting prescription drugs for conditions for which they have not been approved – a practice known as off-label prescription – although doctors can prescribe drugs to any patient they wish.
Meanwhile, an article appearing in Sunday’s Times said Lilly engaged in a decade-long effort to play down health risks of Zyprexa.
The Times article said, citing internal Lilly documents, that Lilly execs kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar – both known risk factors for diabetes.
The documents, spanning from 1995 to 2004, indicated Lilly was concerned that Zyprexa sales would suffer if it were more forthcoming about the drug’s risks of causing weight gain or diabetes.
In a written response to the article, Lilly defended Zyprexa’s safety and called the release of the documents illegal.
“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” Lilly told The Times.