Pfizer Says Reports of Additional Celebrex Data Unfounded

Pfizer's top executives have denied reports that the company's fourth quarter earnings report contained references to additional clinical data that could be used to argue that its Cox-2 inhibitor Celebrex poses heart risks.

The executives' comments came in response to reports suggesting that a question-and-answer section included in Pfizer's fourth quarter 2004 earnings package revealed for the first time that a National Cancer Institute (NCI) study contained additional data that could shed further light on Celebrex's (celecoxib) safety risks. The NCI study was what initially prompted Pfizer to issue a December 2004 alert warning consumers that Celebrex may pose cardiovascular risks.

The statement in Pfizer's earnings report that sparked the controversy read, "Within this accumulated body of [NCI] data, there were certain studies in which there was an increased percentage of specific cardiovascular events for patients taking Celebrex versus patients taking placebo or other drugs; in other studies there was a decreased percentage of specific cardiovascular events."

Joe Feczko, Pfizer's senior vice president of worldwide medical operations and regulatory affairs, said the comments in the earnings report were simply intended to shed some light on how the NCI data is being analyzed.