Statement from Eli Lilly and Company: Response to Today's New York Times
Article, 'Lilly E-Mail Discussed Off-Label Drug Use'
INDIANAPOLIS, March 14 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) today called the assertions in a New York Times online article
'flat out wrong.' The Times report in question focused on the State of Alaska
v. Eli Lilly and Company trial that is underway and attempted to interpret a
2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and
chief operating officer. About this email and the Times report, the company
makes the following statement:
-- The Times article not only mischaracterized Dr. Lechleiter's email,
which the court deemed inadmissible, but significantly minimized
Lilly's perspective on this topic, resulting in a very skewed and
inaccurate article.
-- At the time of the email referenced (2003), Dr. Lechleiter was the
company's vice president of pharmaceutical products and corporate
development, overseeing the area of the company that is responsible for
developing new products and conducting late-stage clinical programs to
address the most pressing medical questions and also to ensure Lilly
made successful regulatory submissions. Importantly, he did not
oversee or direct promotional or marketing activities.
-- Additionally, in 2003, no atypical antipsychotic treatments were
approved by the FDA for children or adolescents suffering from
schizophrenia and bipolar disorder; yet physicians, desperate to
improve their young patients' lives, were already prescribing these
medicines, albeit, with limited information on their safety, efficacy
or dosing considerations in these special patient populations. Dr.
Lechleiter had just returned from a trip where he had direct
interaction with healthcare professionals who made clear their need for
this important information.
-- Dr. Lechleiter's email was nothing more than a call to action to ensure
Lilly's development organization placed a high priority on conducting
clinical trials to address these important medical questions. His
specific reference to "the opportunity to expand our work with
Zyprexa(R) (olanzapine)" referred directly to clinical development
already underway, not promotional activity. This email indicates his
support for continued company investment and focus in gathering this
critical information (such as data on safety, efficacy and dosing in
these special populations) to ensure it was not only submitted to
regulatory bodies, but also accessible so that doctors and caregivers
could make informed treatment decisions.
-- Of note, since this 2003 email, Lilly has since completed studies and
presented their findings at major peer-review venues such as medical
meetings, included these data in our medicines' product label (in the
safety information section) as well as submitted these data to the US
Food and Drug Administration for approval consideration.
-- As stated on many occasions, Lilly is committed to the highest ethical
standards and to promoting our medications only for approved uses. This
steadfast commitment begins at the top of our organization -- and
remains an utmost priority of both our current and incoming chief
executive officer -- and is carried throughout the company. Although
we realize the above point does not make for exciting news
copy, it is information that anyone who read the Times coverage should
know.
Zyprexa Background
Zyprexa is indicated in the United States for the short- and long-term
treatment of schizophrenia, acute mixed and manic episodes of bipolar I
disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was
introduced in 1996, it has been prescribed to approximately 23 million people
worldwide. Zyprexa is not approved for patients under 18 years of age.
Zyprexa is not approved for the treatment of patients with dementia-
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related psychosis. Elderly patients with dementia-related psychosis
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treated with atypical antipsychotic drugs are at an increased risk of
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death compared with those patients taking a placebo.
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In addition, compared to elderly patients with dementia-related psychosis
taking a placebo, there was a significantly higher incidence of
cerebrovascular adverse events in elderly patients with dementia-related
psychosis treated with Zyprexa.
Hyperglycemia, in some cases extreme and associated with ketoacidosis or
hyperosmolar coma or death, has been reported in patients treated with
atypical antipsychotics, including Zyprexa.
While relative risk estimates are inconsistent, the association between
atypical antipsychotics and increases in glucose levels appears to fall on a
continuum and olanzapine appears to have a greater association than some other
atypical antipsychotics. Physicians should consider the risks and benefits
when prescribing olanzapine to patients with an established diagnosis of
diabetes mellitus, or who have borderline increased blood glucose level.
Patients taking olanzapine should be monitored regularly for worsening of
glucose control. Persons with risk factors for diabetes who are starting on
atypical antipsychotics should undergo baseline and periodic fasting blood
glucose testing. Patients who develop symptoms of hyperglycemia during
treatment should undergo fasting blood glucose testing.
Undesirable alterations in lipids have been observed with olanzapine use.
Clinical monitoring, including baseline and follow-up lipid evaluations in
patients using olanzapine, is advised. Significant, and sometimes very high,
elevations in triglyceride levels have been observed with olanzapine use.
Modest mean increases in total cholesterol have also been seen with olanzapine
use.
Potential consequences of weight gain should be considered prior to
starting olanzapine. Patients receiving olanzapine should receive regular
monitoring of weight.
As with all antipsychotic medications, a rare and potentially fatal
condition known as NMS has been reported with Zyprexa. If signs and symptoms
appear, immediate discontinuation is recommended. Clinical manifestations of
NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of
autonomic instability (irregular pulse or blood pressure, tachycardia,
diaphoresis and cardiac dysrhythmia). Additional signs may include elevated
creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal
failure.
Also, as with all antipsychotic treatment, prescribing should be
consistent with the need to minimize Tardive Dyskinesia (TD). The risk of
developing TD and the likelihood that it will become irreversible are believed
to increase as the duration of treatment and the total cumulative dose of
antipsychotic increase. The syndrome may remit, partially or completely, if
antipsychotic treatment is withdrawn.
Other potentially serious adverse events include low blood pressure,
seizures, elevated prolactin levels, elevated liver enzymes, cognitive and
motor impairment, body temperature elevation, and trouble swallowing.
The most common treatment-emergent adverse event associated with Zyprexa
in placebo-controlled, short-term schizophrenia and bipolar mania trials was
somnolence. Other common events were dizziness, weight gain, personality
disorder (COSTART term for nonaggressive objectionable behavior),
constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia,
increased appetite and tremor.
Full prescribing information, including a boxed warning, is available at
www.zyprexa.com.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers - through medicines and information
- for some of the world's most urgent medical needs. Additional information
about Lilly is available at www.lilly.com. C-LLY
Zyprexa(R) (olanzapine, Lilly)
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
Tarra Ryker, +1-317-332-7502 mobile, or Marni Lemons, +1-317-532-7826 mobile,
or Angela Sekston, +1-317-332-1593 mobile, all for Eli Lilly and Company
