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.
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 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 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.