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The other side of the Lilly/Zyprexa story II



(Earlier: Dec. 19.) Eli Lilly press release on New York Times story. I have no firsthand knowledge who is correct, though Lilly's account is more plausible than the Times' implication that Lilly submitted fake data to the FDA:

Yesterday, Eli Lilly and Company (NYSE: LLY) provided the following statement to The New York Times. Again, we were disappointed that only a small fraction of our viewpoint was contained in the Times story.

"Taking selected data points out of context can be very misleading. The illegally leaked document about which the New York Times inquired is, presumably, a summary given to Lilly's Global Product Labeling Committee in February, 2000. We are providing the following information to provide a context by which to understand this document.

As part of its ongoing safety monitoring, Lilly, in 1999, undertook an examination of its Zyprexa� (olanzapine, Lilly) clinical trial database to help us further understand whether a relationship between Zyprexa and diabetes exists. This database included, at the time, more than 75 clinical trials involving more than 5,000 patients. We were committed to proactively submitting the results of this analysis to the FDA for Zyprexa's label -- regardless of outcome.

As part of Lilly's final, standard quality check of the data -- which took place after the February report to GPLC -- Lilly scientists discovered that there were errors involving which patients were included or excluded in the analysis. The corrected analysis -- showing 3.1 percent of Zyprexa patients developed possible hyperglycemia or diabetes, vs. 2.5 percent of placebo patients -- was then submitted to the FDA for a label change. This is consistent with Lilly's policy of sharing new research or data about our medications and their effects with the FDA. In addition, Lilly shared this data externally with physicians.

It is important to remember that from the day that Zyprexa was approved, the labeling provided to physicians identified the potentially clinically- significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials, including diabetes, hyperglycemia and diabetic ketoacidosis."

In addition to our comments to the Times, we believe it's important for patients, physicians and the general public to understand the rigorous review our data undergo before that information is provided to physicians and the FDA.

To that point, there are separate groups within Lilly's medical and regulatory organizations that are responsible for oversight and review of the safety of our products and updating product labeling. These groups undertake a thorough process to evaluate any additional data from clinical studies, post-marketing data along with existing data and determine whether the additional data shed new light on product safety. These groups and the process are designed to ensure that all data and analyses are accurate. The data referenced in The New York Times article is the preliminary analysis -- not the final accurate analysis that was shared with the FDA -- and is therefore very misleading.


 

 


Rafael Mangual
Project Manager,
Legal Policy
rmangual@manhattan-institute.org

Katherine Lazarski
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.