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, 2008 /PRNewswire-FirstCall/ -- Eli Lilly and Company 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 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- -------------------------------------------------------------------- related psychosis. Elderly patients with dementia-related psychosis -------------------------------------------------------------------- treated with atypical antipsychotic drugs are at an increased risk of -------------------------------------------------------------------- death compared with those patients taking a placebo. --------------------------------------------------------------------
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.
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)
CONTACT: Tarra Ryker, +1-317-332-7502 mobile, or Marni Lemons,+1-317-532-7826 mobile, or Angela Sekston, +1-317-332-1593 mobile, all forEli Lilly and Company
Ticker Symbol: (NYSE:LLY)
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Posted: March 2008