NEW YORK, Feb. 1 2005 – LAWFUEL – The Law News Network – 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.
