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/

Copyright