Eli Lilly and Company Statement Regarding Today's New York Times Article - December 21, 2006
INDIANAPOLIS, Dec. 21 /PRNewswire-FirstCall/ -- 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(R) (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.
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 http://www.lilly.com.
Corporate News C-LLY
Zyprexa(R) (olanzapine, Lilly)
SOURCE Eli Lilly and Company
