Prescription Drug Giant Eli Lilly Played Down the Risks of Zyprexa
December16, 2006
By The New York Times / 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
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.
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 longterm 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 James 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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