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Healthy Skepticism Library item: 11716

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Koroneos G.
Eli Lilly Sends Two Warning Letters—and Gets One Itself
Pharmaceutical Executive 2007 Oct 10
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=464037


Full text:

Eli Lilly mailed out two Dear Doctor letters for the drugs Zyprexa (Olanzapine) and Symbyax (Fluoxetine) and received one warning letter regarding labeling and marketing issues for Cymbalta (Duloxetine).

Letters to professionals for Zyprexa and Symbyax included new labeling warnings for weight gain and hyperlipidemia, and updated information in the warning for hyperglycemia, according to a release from the company.

The company stated that the updates stem from new information gathered from Lilly’s clinical trial data in adults and adolescents, as well as information from two non-Lilly studies of atypical antipsychotics and discussions with FDA.

“Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression,” said Sara Corya, global medical director for Lilly. “This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients.”

Additionally, FDA sent a warning letter to Lilly, posted October 2, stating that a mailer for Cymbalta’s professional advertising campaign was false or misleading and that it “overstated the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use.”

According to Les Funtleyder, a drug analyst at Miller Tabak and Co., “I don’t think there’s anything in the warning letters that people didn’t already know. The stock didn’t react, so the suggestion is that the letters weren’t that material.”

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909