INDIANAPOLIS, Jan. 4 /PRNewswire-FirstCall/ -- Eli Lilly and Company today confirmed, after reviewing a collection of Prozac documents that had been alleged ‘missing’ in the January 1 issue of the British Medical Journal (BMJ), that the documents reveal no new clinical or scientific information. The information in the documents has already been shared with the US Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals or produced through legal discovery and available for use at various legal trials for more than a decade. Lilly received these documents yesterday evening, not from the BMJ, but from the office of Congressman Maurice Hinchey (D-NY), who had been provided the documents by the BMJ.
“It is Lilly’s policy to make available to regulatory bodies, healthcare professionals and patients important safety and efficacy information related to Prozac as well as other Lilly medicines,” said Alan Breier, MD, vice president and chief medical officer, Eli Lilly and Company. “Our review of the documents shows Lilly has lived up to its commitment of full and important disclosures on this topic,” Breier said. “Further,” he continued, “Lilly is greatly concerned that a reputable medical journal has relied on an anonymous source and published data without validating the information at hand or conducting standard peer review. This is a worrisome precedent that can have detrimental consequences to both patients and doctors.”
Documents Largely Comprised of Old, Already Produced Documents
Lilly’s review of the collection of documents provided by Congressman Hinchey confirms that it is largely comprised of documents produced by Lilly to plaintiffs’ attorneys to be used in court. All documents that originated at Lilly are identified by a stamp as having been produced in discovery by Lilly in two Prozac product liability lawsuits in the 1990’s. All of the documents that originated with Lilly have Lilly’s stamp and therefore were indisputably made available by Lilly to plaintiffs’ attorneys for use at trial. In fact, several were already used by the plaintiffs as exhibits at trial in the Wesbecker case.
Activation and Sedation
The BMJ article discusses activation (a term used to group individual adverse events of nervousness, anxiety, agitation and insomnia) and sedation (a term used to group individual adverse events of somnolence, asthenia). The BMJ article cites only one example of alleged missing scientific data (38 percent of fluoxetine-treated patients that reported new activation versus 19 percent on placebo); contrary to this BMJ assertion, this finding was published by Lilly in the Journal of Psychopharmacology in 1992(1). Lilly has conducted multiple studies and published comprehensive information on the topic of activation and sedation in several other leading peer review journals (also noted below (1)). Collectively, Lilly’s published studies report a range of activation of approximately 18-40 percent depending on study and treatment dose, which is a rate accepted by physicians.
It is also important to note that Lilly has systematically submitted to the FDA information on these and all adverse events from Prozac clinical trials and post-marketing surveillance (drug safety monitoring). Information on these events has also been reflected in Prozac product labeling information for years.
Disclosure of Scientific Information
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 among the most comprehensive database to date of its kind in the industry. Lilly has already populated lillytrials.com with pediatric data for Prozac and is continuing the process to fully populate the website with Prozac data. Lilly is committed to the health and safety of all patients being treated with its medicines and to ensuring healthcare professionals and families have the information they need to make informed treatment decisions.
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/.
P-LLY (1) Journal of Clinical Psychopharmacology, 1991, Vol. 11, No. 3; International Clinical Psychopharmacology, Vol 8, 1993; Journal of Clinical Psychiatry 52:7, July 1991; Journal of Clinical Psychiatry 61:10, October 2000. (Logo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGOPRN Photo Desk, photodesk@prnewswire.comEli Lilly and Company
CONTACT: Morry Smulevitz, +1-317-651-5567 or Angela Sekston,+1-317-276-5046, both of Eli Lilly and Company
