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TRENTON
-- Attorney General Anne Milgram announced
today that New Jersey has entered into a
record multi-state, $62 million settlement
agreement with pharmaceutical maker Eli
Lilly that resolves allegations the company
improperly marketed its anti-psychotic drug
Zyprexa.
The agreement is the largest multi-state,
consumer-protection-based pharmaceutical
settlement on record. The previous largest
was a $58 million multi-state settlement
with Merck regarding its product Vioxx.
New Jersey also participated in that settlement.
New Jersey’s share of the Eli Lilly
settlement is $1.88 million. In addition
to New Jersey, 32 other states are party
to the agreement, including lead states
Illinois and Oregon.
In
a complaint filed today along with the settlement
agreement, Attorney General Milgram and
other participating Attorneys General alleged
that Eli Lilly engaged in unfair and deceptive
practices when it marketed Zyprexa for “off-label”
uses, and that it failed to adequately disclose
the drug’s potential side effects
to health care providers. Following a year-and-a-half-long
investigation by the states, Eli Lilly agreed
to change how it markets Zyprexa, and to
stop promoting it for off-label uses not
approved by the U.S. Food and Drug Administration
(FDA).
“This drug appears to have been useful
as part of a treatment regimen for certain
mental health patients, but it also has
been associated with harmful side effects,”
said Attorney General Milgram. “This
settlement is important because it requires
more accountability from Eli Lilly in promoting
Zyprexa, requires that patients and health
care providers have access to clearer, more
accurate and more objective information
about the drug, and that medical professionals
- not marketing professionals - take the
lead in generating that information.”
Zyprexa, is the brand name for the prescription
drug olanzapine. The drug was first marketed
for use in adults with schizophrenia in
1996. Since then, the FDA has approved Zyprexa
for treatment of acute mixed or manic episodes
of Bipolar I disorder, and for maintenance
treatment of Bipolar Disorder. Zyprexa belongs
to a class of drugs traditionally used to
treat schizophrenia and commonly referred
to as “atypical anti-psychotics.”
When these drugs were first introduced to
the market in the 1990s, experts thought
that atypical anti-psychotics would be less
likely to produce symptoms similar to those
seen in Parkinson’s disease (extrapyramidal
symptoms), and motion disorders (tardive
dyskinesia), and therefore could be used
in long-term treatment of schizophrenia.
However, while these drugs may reduce the
risk of symptoms associated with first-generation
anti-psychotics, they also produce dangerous
side effects, including weight gain, hyperglycemia,
diabetes, cardiovascular complications,
an increased risk of mortality in elderly
patients with dementia and other severe
conditions. Zyprexa has been associated
with a high risk of weight gain, hyperglycemia
and diabetes.
In 2001, Eli Lilly began an aggressive marketing
campaign called “Viva Zyprexa!”
As part of that campaign, the company marketed
Zyprexa for a number of off-label uses.
For example, it marketed Zyprexa for pediatric
use for treatment and/or chemical restraint
of elderly patients suffering from dementia,
for treatment of symptoms rather than clinically-diagnosed
conditions and for use at high dosage levels.
While a physician is allowed to prescribe
drugs for off-label uses, law prohibits
pharmaceutical manufacturers from marketing
their products for off-label uses.
The
multi-state settlement agreement provides
that Eli Lilly shall not make any written
or oral claim that is false, misleading
of deceptive regarding Zyprexa. The agreement
also mandates that for a six-year time period
extending beyond the patent term for Zyprexa,
Eli Lilly shall:
Promotional
Activities
-
Not make any false, misleading or deceptive
claims regarding Zyprexa;
-
Not promote Zyprexa using selected symptoms
of the FDA-approved diagnoses unless certain
disclosures are made regarding the approved
diagnoses;
Dissemination
of Medical Information
-
Require its medical staff, rather than
its marketing staff, to have ultimate
responsibility for developing and approving
the medical content for all medical letters
and medical references regarding Zyprexa,
including those that may describe off-label
information. This information shall not
be distributed unless certain criteria
are met;
- Provide
specific, accurate, objective and scientifically
balanced responses to unsolicited requests
for off-label information from a health
care provider regarding Zyprexa;
- Require
its medical staff to be responsible for
the identification, selection, approval
and dissemination of article reprints
containing more than an incidental reference
to off-label information regarding Zyprexa,
and that such information not be referred
to or used in a promotional manner;
Continuing
Medical Education (CME) and Grants
-
Disclose information about grants, including
continued medical education, on its Web
site (www.lillygrantoffice.com),
for at least two years and maintain the
information for five years;
-
Not use grants to promote Zyprexa, or
condition CME funding on Eli Lilly’s
approval of speakers or program content;
-
Contractually require continuing medical
education providers to disclose Eli Lilly’s
financial support of their programs and
any financial relationship with faculty
and speakers;
Payments
to Consultants and Speakers
-
Provide each Attorney General signed onto
the settlement agreement with a list of
health care provider promotional speakers
and consultants who were paid more than
$100 for promotional speaking and/or consulting
by Eli Lilly;
Product
Samples
-
Only provide product samples of Zyprexa
to a health care provider whose clinical
practice is consistent with the product’s
current labeling; and
Clinical
Research
-
Register clinical trials and submit results
as required by federal law; register Zyprexa
Eli-Lilly sponsored Phase II, III and
IV clinical trials beginning after July
1, 2005; and post on a publicly accessible
Web site all Eli-Lilly sponsored Phase
II, III and IV clinical trials completed
after July 1, 2004.
Attorneys General from Illinois and Oregon
spearheaded the investigation into Eli Lilly’s
marketing and promotional practices. In
addition to New Jersey, states participating
in the settlement include: Arizona, Alabama,
California, Delaware, District of Columbia,
Florida, Hawaii, Indiana, Iowa, Kansas,
Maine, Maryland, Massachusetts, Michigan,
Missouri, Nebraska, Nevada, New York, North
Carolina, North Dakota, Oklahoma, Pennsylvania,
Rhode Island, South Dakota, Tennessee, Texas,
Vermont, Washington and Wisconsin.
Deputy Attorney General Gina M. Betts and
Deputy Attorney General Jennifer D. Dougherty
of the Division of Law’s Consumer
Fraud Protection Section handled the matter
on behalf of New Jersey.
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