Eli Lilly and Company (NYSE: LLY) called the assertions in a New York Times online article ‘flat out wrong.’ A report in The New York Times that said a senior executive had encouraged the promotion of its schizophrenia drug Zyprexa for a use not approved by federal regulators.
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.
Source: Eli Lilly and Company, USA