2nd Feb 2005 07:00
Pfizer Acted Responsibly in Sharing Celebrex Alzheimer's Study Data With FDA Public Citizen Charge is Misleading and Unfair to Patients NEW YORK, Feb. 1 -- Pfizer Inc said today that it remains confident in its COX-2 medicines as important treatment options for arthritis patients and that it has acted responsibly in sharing all appropriate data with the U.S. Food and Drug Administration. Pfizer vigorously refutes claims by Public Citizen that safety data from a 1999 Celebrex study in Alzheimer's patients were "undisclosed." The study was monitored by an independent panel of safety experts, an abstract of the results was presented at a scientific congress in 2000, and the completed study report was submitted to the FDA in June 2001. "Pfizer acted responsibly in sharing this information in a timely manner with the FDA," said Dr. Joseph Feczko, Pfizer president of worldwide development. "Public Citizen's cherry-picking of data is alarmist and misconceived," he said. "It is not possible to draw clinically meaningful cardiovascular conclusions from this study alone given the variations in patients' medical history, their advanced age and other significant study limitations. This flawed use of data is misleading and unfair to a reasoned scientific discussion of these issues." In fact, this single study is only one piece of information in the vast amount of clinical trial and other data supporting the safety of Celebrex in arthritis patients. The 12-month study, which was designed to assess the potential of Celebrex in slowing Alzheimer's disease progression, showed that Celebrex did not significantly influence the course of the disease. While patients who received Celebrex experienced more cardiovascular events versus placebo, there was a large difference in the underlying cardiovascular risk profile of the patients assigned to Celebrex treatment compared with those who received placebo. For example, more patients assigned to Celebrex had hypertension, diabetes, took aspirin or had undergone a previous heart by-pass surgery than those patients taking placebo. Even Public Citizen acknowledged the study "was not large enough to demonstrate a statistically significant increase in any individual serious cardiovascular event." On February 16, an FDA advisory committee will begin a rigorous scientific evaluation of the risks and benefits of all COX-2 medicines, including Celebrex and Bextra. Pfizer has provided the agency with an extensive analysis of all available safety data for its COX-2 medicines and continues to cooperate fully with worldwide regulatory authorities. "The FDA advisory meeting is the appropriate forum for these important public health issues to be fully addressed and put into context," Dr. Feczko said. SOURCE Pfizer Inc 02/01/2005 /CONTACT: Mariann Caprino of Pfizer Inc, +1-212-733-4554/ /Company News On-Call: Pfizer's press releases are available through PR Newswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html / /Photo: A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom, PC or Macintosh, that can accept overhead transmissions. To retrieve a logo, please call 972-392-0888./ /Company News On-Call: http://www.prnewswire.com/comp/688250.html / /Web site: http://www.pfizer.com / (PFE) ENDRelated Shares:
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