Schizophrenia :: Eli Lilly’s response about Zyprexa for schizophrenia and bipolar disorder

Eli Lilly and Company (NYSE: LLY), vigorously objects to the characterization of company practices in a New York Times article based upon selective documents illegally leaked by plaintiffs’ lawyers.

“At Lilly, we do not engage in off-label promotion – as alleged in The Times article,” said Dr. Steven Paul, Lilly’s executive vice president, science and technology. “Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses. We have clear guidelines and extensive training for our sales representatives to help assure that they provide appropriate promotional information that is within the scope of prescribing information approved by the FDA.”

Lilly works to bring Zyprexa to physicians who are confronted with the need to diagnose and treat serious schizophrenia and bipolar disorder wherever they practice.

* About half of medical care for serious mental illness takes place in a primary care physician’s office. This is due to the fact a large number of people in the United States have no access to a psychiatrist or do not seek psychiatric care.

* Our experience in mental health has taught us that primary care physicians are asking for education on severe mental illnesses, since they see many of these patients in their offices.

* We believe that it is absolutely appropriate to discuss Zyprexa and its indicated uses with primary care physicians in the interest of meeting a critical medical need.

* It is important that the public understand that physicians can and do prescribe medications outside of their approved indications to meet the needs of their individual patients.

“While it is accurate to say that mental illnesses like schizophrenia and bipolar disorder begin early in life — with a higher prevalence during early adolescence and childhood — it is simply untrue to assert that these diseases somehow end — and therefore prescribing for them ends — in young adulthood,” added Paul. “To dismiss the devastating impairment of these disorders throughout a patient’s life is wrong.

“Bipolar disorder and schizophrenia are often treated in the offices of primary care physicians. In fact Lilly did research with primary care physicians and found that they were challenged in making the diagnosis of bipolar disorder. Many primary care physicians appreciate the educational outreach Lilly provides in mental illness,” he added.

The Times failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly’s conduct. As part of Lilly’s commitment to patients and healthcare professionals, many high-level Lilly physicians and researchers — along with researchers from outside Lilly — were engaged for a number of years to study the issue of Zyprexa and diabetes. Leaked documents involving these discussions do not represent an accurate view of company strategy or conduct.

Lilly deplores the illegal release of select confidential documents. This illegal and selective disclosure of incomplete information will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician. This is the unfortunate result we saw when plaintiffs’ lawyers aggressively advertised about Zyprexa in recent years while searching for clients.

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.


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