Lilly Issues Response to British Medical Journal

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, [phone], or Angela Sekston,

[phone], both of Eli Lilly and Company



Web site:  http://www.lillytrials.com/ 

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