[NYAPRS Enews] Bazelon: Court Asked to Release Controversial Eli Lilly Documents on Psychiatric Drug

[Harvey Rosenthal]

Court Asked to Release Controversial Eli Lilly Documents on Psychiatric
Drug  

Bazelon Center for Mental Health Law    February 8, 2007

 

Washington, DC-Mental health professionals, researchers and consumer
groups told a federal court today that it should release evidence that
the Eli Lilly company's largest-selling drug, Zyprexa, prescribed for
treatment of schizophrenia and bipolar disorder, has a significant risk
of severe side effects.  

 

The group filed a challenge to a New York federal court's order
designating as confidential Lilly documents that have raised concerns
about the safety of Zyprexa and Lilly's marketing of the drug. The order
came in an ongoing lawsuit against Lilly by thousands of individuals who
had taken Zyprexa. 

 

"Regardless of whether the documents contain trade secrets, given the
sheer number of people taking Zyprexa, there is a strong public interest
in full disclosure of its potential risks," said Ira Burnim, legal
director of the Bazelon Center for Mental Health Law, a Washington-based
national legal-advocacy organization, which filed today's motion.

 

Approximately two million people worldwide took Zyprexa in 2005, and
more than 20 million people in total have taken the drug since its
introduction in 1996.

 

Today's motion asks permission for the group to intervene in the lawsuit
because "the public interest in disclosure is particularly high where,
as here, health and safety issues are at stake." 

 

"Bringing transparency to the pharmaceutical industry is vital," said
Dr. David Rothman, director of the Center on Medicine as a Profession,
Columbia College of Physicians and Surgeons and one of the proposed
intervenors. "Drug companies have built enormous walls around their
marketing strategies. To make good public policy, we need to understand
how they promote their products to physicians as well as to consumers." 

 

The documents at issue became public after they were obtained in an
unrelated case and leaked to The New York Times, provoking a series of
articles suggesting that Lilly's top company managers had "engaged in a
decade-long effort to play down the health risks of Zyprexa." The
documents were subsequently posted on several websites. 

 

In addition, the Times cited "internal Lilly marketing materials,"
stating that Lilly improperly "encouraged primary care physicians to use
Zyprexa," approved by the Food and Drug Administration only for
schizophrenia and bipolar disorder, "in patients who did not have either
condition." 

 

"The Times' articles make it clear that Lilly played down dangerous side
effects and at the same time encouraged physicians to prescribe Zyprexa
for dementia," said Burnim, who acknowledged that he had not read the
actual documents at issue. "This is an off-label use the federal
government has specifically warned against." 

 

The proposed intervenors include the U.S. Psychiatric Rehabilitation
Association, Mental Health America (formerly the National Mental Health
Association), Consumers Union, former heads of mental health systems in
Rhode Island, Virginia, South Carolina, New Hampshire and Illinois, and
leading professors of psychiatry and social medicine. 

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