Pfizer said it acted responsibly in sharing COX-2 dataPfizer said it acted responsibly in sharing all appropriate data regarding its COX-2 drug Celebrex with the FDA after acknowledging earlier this week that a 1999 trial found elderly patients taking the drug were at a greater risk for heart problems.
In a statement this week, Pfizer refuted earlier claims by Public Citizen that safety data from the 1999 Celebrex study in Alzheimer's patients were "undisclosed."
Pfizer said that particular study was monitored by an independent panel of safety experts, with an abstract of the results 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 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."
Sidney Wolfe, director at the consumer advocacy group Public Citizen, said earlier this week that the trial's findings added further reason for the Celebrex to be pulled from the market and on Monday renewed its call for the FDA to immediately ban Celebrex and Pfizer's other controversial painkiller, Bextra.
On Feb.16, an FDA advisory committee will begin its evaluation of the risks and benefits of all COX-2 medicines, including Celebrex and Bextra.
Pfizer said it has provided the agency with an extensive analysis of all available safety data for its COX-2 drugs 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," Feczko said.