A new study concludes that Celebrex is no safer than similar drugs that have been pulled from the market.

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Pfizer Painkiller’s Bad Data

A new study concludes that Celebrex is no safer than similar drugs

that have been pulled from the market.

March 1, 2006

New Zealand scientists said Wednesday that Pfizer’s painkiller

Celebrex is no safer than other drugs like Vioxx in the COX-2

inhibitor class that have been pulled from the market, adding to

questions about the drug’s future.

Unlike other COX-2 inhibitors, like Pfizer’s Bextra and Merck’s

Vioxx, Celebrex remains on the market with the U.S. Food and Drug

Administration’s strongest possible safety warning label.

The new study is published in the March issue of the Journal of the

Royal Society of Medicine. It is a type of mathematical review called

a meta-analysis that brings together data from lots of different

studies, often with conflicting conclusions, to provide an overall

answer to a scientific problem.

In the case of Celebrex, a trial called CLASS (Celecoxib Long-term

Arthritis Safety Study) has reported that the drug does not cause an

increase in major cardiovascular problems, including heart attack.

But another trial called the Colorectal Adenoma Prevention Trial

reported a 2.3- and 3.4-fold increased risk of cardio problems in

people who took daily doses of the drug of 400mg and 800 mg.

“This systematic review and meta-analyses provide evidence of an

increased risk of myocardial infarction [heart attack] associated

with the use of celecoxib [Celebrex’s scientific name], consistent

with a class effect of COX-2 inhibitors,” said the paper. “This

finding would suggest that the preferential risk/benefit assessment

afforded celecoxib over other COX-2 inhibitors by the FDA may not be

supported by the currently available evidence. "

Pfizer did not respond to calls requesting immediate comment on the

study. Wall Street ignored the finding, with Pfizer shares rising

$0.07 to $26.26 on Wednesday.

The company has previously maintained that it disagrees with the FDA

over the need for Bextra to be pulled from the market and Celebrex’

black box label, although it complied with the agency’s requests (see

Pfizer Yanks Bextra off Market).

The new analysis’ findings could have legal importance because Pfizer

has a date in an Alabama court next June. An American woman is suing

the company because she believes Celebrex caused a stroke she

suffered in 2005.

Merck is embroiled in several thousand similar trails related to its

COX-2 inhibitor, Vioxx (see A Merck-y View of Vioxx Cases).

The new analysis by researchers at the Wellington School of Medicine

and Health Sciences in Wellington, New Zealand, looked first at many

studies comparing Celebrex’ cardio risks with those of placebo. It

also looked at studies comparing its side-effects with those with a

class of common painkillers also linked to heart attacks and strokes

(see New Warning on Painkillers).

They found that Celebrex was associated with a 2.26-fold increased

risk of heart attack when compared to placebo, and a 1.88-fold

increase when compared with other painkillers.

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