Eli Lilly minimized health risks of Zyprexa - Dec. 16, 2006

December 17, 2006

Report: Eli Lilly minimized health risks of Zyprexa - Dec. 16, 2006

Report: Eli Lilly hid top drug's risks

The New York Times says the drugmaker played down links between its

best-selling schizophrenia drug Zyprexa and obesity, among other health

risks.

December 16 2006: 8:53 PM EST

(REUTERS) -- Drug giant Eli Lilly has engaged in a decade-long effort to

play down the health risks of its top-selling medication, the schizophrenia

drug Zyprexa, The New York Times reported in Sunday editions.

Citing hundreds of internal Lilly (Charts) documents and e-mail messages

among top company managers provided by a lawyer representing mentally ill

patients, the Times said Lilly executives kept important information from

doctors about Zyprexa's links to obesity and elevated blood sugar, risk

factors for diabetes.

The drug company's own published data, which it told sales representatives

to play down in conversations with doctors, showed 30 percent of patients

taking Zyprexa gain 22 pounds or more after a year on the drug, with some

reporting gaining 100 pounds or more, the Times said.

The documents, which cover 1995 to 2004, indicate Lilly's concern that

Zyprexa sales would suffer it was more forthright about the drug's risk of

causing unmanageable weight gain or diabetes.

Company disputes claims

Lilly denied in a written response to the documents that its drug is more

likely to cause diabetes than other widely used schizophrenia drugs, and

defended its safety, saying the documents, release of which it called

illegal, had been taken out of context.

" In summary, there is no scientific evidence establishing that Zyprexa

causes diabetes, " the company told the paper.

Lilly said it had given the FDA all its data from clinical trials, reports

of adverse events and data from literature reviews and large studies of

Zyprexa's real-world usage.

With sales of $4.2 billion last year, Zyprexa is by far Lilly's best-selling

product, with some two million people worldwide taking it, the Times said.

The Times said the documents show the company worried about the drug's side

effects as early as 1999, and their potential to hurt sales.

" Olanzapine (its chemical name) associated weight gain and possible

hyperglycemia is a major threat to the long-term success of this critically

important molecule, " Dr. Alan Breier, now Lilly's chief medical officer,

wrote in a November 1999 e-mail to two dozen Lilly employees, the Times

reported.

And Lilly's marketing research found in 2000 and 2001 psychiatrists

consistently said many more of their patients developed high blood sugar or

diabetes while taking Zyprexa than other antipsychotic drugs, according to

the report.

The documents were collected as part of lawsuits on behalf of mentally ill

patients against the company, the Times said. Lilly agreed in 2005 to pay

$750 million to settle suits by 8,000 people who claimed they developed

diabetes or other medical problems after taking the drug; thousands more

suits are pending.

The documents were provided by Gottstein, a lawyer representing

mentally ill patients who is suing the state of Alaska over its efforts to

force patients to take psychiatric medicines against their will.

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