Lilly Affirms: No 'Missing' Prozac Documents and No New Scientific Information
Claims that documents went missing at trial are unfounded
INDIANAPOLIS, Jan. 4 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) 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 Clinical 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) Beasley C Jr., Sayler M, Weiss A, Potvin J. Fluoxetine: Activating and
Sedating Effects at Multiple Fixed Doses. Journal of Clinical
Psychopharmacology. 1992; 12(5): 328-333; Beasley C Jr, Potvin J.
Fluoxetine: activating and sedating effects. International Clinical
Psychopharmacology. 1993; 8:271-275; Beasley C Jr, Nilsson M, Koke S,
Gonzales J. Efficacy, Adverse Events, and Treatment Discontinuations
in Fluoxetine Clinical Studies of Major Depression: A Meta-Analysis
of the 20-mg/day Dose. Journal of Clinical Psychiatry. 1991; 61(10):
722-728; Beasley C Jr, Dornseif B, Pultz J, Bosomworth J, Sayler M.
Fluoxetine Versus Trazodone: Efficacy and Activating-Sedating Effects.
Journal of Clinical Psychiatry. 52(7) 294:299.
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SOURCE Eli Lilly and Company
