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news.In response to charges made by consumer group Public Citizen concerning Celebrex and Bextra, Pfizer has defended its COX-2 medicines and denied the allegation that it delayed sharing appropriate safety data with the FDA.
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Pfizer said that it vigorously refutes claims by Public Citizen that safety data from a 1999 Celebrex study in Alzheimer’s patients were “undisclosed.” The study, Pfizer explained, 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’s president of worldwide development.
“Public Citizen’s cherry-picking of data is alarmist and misconceived,” he continued. “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.”
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, Pfizer stressed that there were differences in the underlying cardiovascular risk profile of the patients assigned to Celebrex compared with those receiving 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.
Pfizer stated that this single study is only one piece of information in the vast amount of data surrounding Celebrex’ safety profile in arthritis patients and Public Citizen acknowledged that 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.