Lilly Issues Response to British Medical Journal
December 31 2004 - 2:12PM
PR Newswire (US)
Lilly Issues Response to British Medical Journal INDIANAPOLIS, Dec.
31 /PRNewswire-FirstCall/ -- In response to the British Medical
Journal article dated January 1, 2005, entitled "FDA to review
missing drug company documents," Eli Lilly and Company has issued
the following statement: To our knowledge, there has never been any
allegation of missing documents from the Wesbecker trial or any
other trial involving Lilly. Further, it has always been Lilly's
objective to publicly disclose data about both the safety and
efficacy of fluoxetine. Lilly has made several requests to the BMJ
to obtain copies of the supposed "missing" documents; we still
await these documents. We are surprised and concerned that a
leading medical journal would not find it important to share these
documents with us so that we could respond to the public in a
meaningful way. The BMJ article addresses "activation syndrome." It
is important to point out that Lilly has published widely in the
area of activation syndrome as it relates to fluoxetine. Lilly has
consistently provided regulatory agencies worldwide with results
from both clinical trials and post marketing surveillance (safety
monitoring after drug approval), including those related to
fluoxetine. Based on this, Lilly believes that there is no new
scientific information to review on this topic. In addition,
contrary to what is stated in the BMJ article, it is well
established scientifically that fluoxetine does not act in the same
manner as cocaine. Lilly believes in full and appropriate
disclosure of clinical trial data and recently underscored this
commitment through the launch of Lilly's clinical trial registry
database, http://www.lillytrials.com/, which was noted as being as
among the most comprehensive database to date of its kind in the
industry. Lilly is committed to the health and safety of all
patients being treated with our medicines and to ensuring
healthcare professionals and families have the information they
need to make informed treatment decisions. (Logo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Morry Smulevitz, +1-317-651-5567, or
Angela Sekston, +1-317-276-5046, both of Eli Lilly and Company Web
site: http://www.lillytrials.com/
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