Lilly Issues Response to British Medical Journal

December 31, 2004

Friday December 31, 3:12 pm ET

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, 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.

bin/prnh/20031219/LLYLOGO )

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