PFPC Daily - February 3, 2005

Consumer Group Says Pfizer Hid Celebrex Study

Reuters, Jan.31, 2005

By Kim Dixon

CHICAGO (Reuters) - A U.S. consumer group on Monday accused Pfizer
Inc. of burying a study suggesting its painkiller Celebrex boosts the
risk of heart attack and stroke, a claim the No. 1 drug maker has
denied.

The accusation comes a week after the group, Public Citizen, filed a
petition urging the U.S. Food and Drug Administration to pull
Pfizer's arthritis drugs Celebrex and Bextra from the market because
of links to dangerous heart complications.

The study in question, which tested Celebrex as a treatment for
Alzheimer's disease, found that patients taking Celebrex had a 3.6
times greater occurrence of serious heart events compared to those on
a placebo, according to a Public Citizen analysis of the data.

Pfizer refuted the claim, saying that although the study showed a
greater likelihood of Celebrex patients suffering severe heart
events, Celebrex patients were four times more likely to have risk
factors for heart problems before taking the medication, making the
results inconclusive.

"Because of this marked imbalance in the health of participating
patients, definitive conclusions about cardiovascular risk cannot be
drawn from this study," the company said.

The trial took place from 1997 to 1999, according to a summary of it
on the Web site clinicalstudyresults.org, which includes study
results provided by drug makers.

Public Citizen accused Pfizer of trying to hide the study, because
when the company in December revealed that Celebrex more than doubled
heart attack risk in a large cancer-prevention trial it described the
results as new.

"There is no excuse for this study not being made more public," said
Sidney Wolfe, director the health unit at Public Citizen, which wrote
the FDA on Monday, adding the study to its petition for the drugs'
withdrawal.

Pfizer said it presented the study's data at a medical meeting in
2000 and submitted to the FDA in 2001.

Celebrex and Bextra are part of a class of drugs called Cox-2
inhibitors that have come under scrutiny since Merck & Co. in
September recalled its painkiller Vioxx after a study showed it
doubled the risk of heart attack and stroke.

The FDA had no comment on the latest Public Citizen submission, but
has said it is reviewing the case.

The FDA warned doctors in December to limit prescriptions of Celebrex
and Bextra in light of evidence they may raise the risk of serious
heart complications.

Pfizer, which has steadfastly supported the safety of the two drugs,
has agreed to stop advertising Celebrex as the FDA investigates the
class.

The Cox-2 drugs were marketed as a safer alternative to older
non-steroidal, anti-inflammatory painkillers, known as NSAIDs, such
as Advil, which can be hard on the stomach.