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Eli Lilly and Company, after reviewing a collection of Prozac documents, now says that the documents reveal no new clinical or scientific information. The information in the documents has already been shared with the U.S. 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." |
 This statement from Eli Lilly is very important since there was already speculation of a
Prozac
recall. But the other question to ask is if FDA has messed up as it did in the case of
Vioxx recall. It had the information about adverse side effects but did nothing with it.
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.
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 19921. 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.
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