A previously unpublished study by Pfizer Inc. of its arthritis drug Celebrex found more than four years ago that users had a potentially significant increase in risk of heart attacks and strokes, casting doubt on the company's insistence that it had no hint of the problem until recently.
The study of 425 Alzheimer's patients was completed in 2000 but was made accessible to the public only recently on a drug industry Web site. When posted last month, the report of the clinical trial did not initially indicate there was evidence of an increased cardiovascular risk from the drug. But an updated account of the study posted last week acknowledged that there was a statistically significant difference in the number of heart-related problems between users of Celebrex and of the placebo.
Pfizer dismissed the results of the Alzheimer's study yesterday, saying that it was too small to be meaningful and that it was unreliable because those in the Celebrex arm of the trial were found to have had considerably more cardiovascular risk factors to begin with than those in the placebo group. In a statement, the company also said that it had shared the study results with the FDA in June 2001 and that an independent panel of safety experts had monitored the 52-week study for any significant health problems.
Courtesy of the Washington Post 2/1/2005
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