Pfizer Defends Celebrex Vs. Deaths Report
http://news.findlaw.com/ap/f/1310/11-4-2004/20041104124505_08.html

Nov 2004

NEW YORK (AP) - Pfizer Inc. defended the safety of its painkiller Celebrex
on Thursday after a newspaper reported that documents from Canadian health
authorities linked the drug to the deaths of 14 people who were taking it
over the past five years.

The documents include more than 100 adverse-reaction reports on Celebrex
over the past five years, including 19 cases of heart attack, cardiac
arrest or heart failure and five strokes, the Canadian newspaper National
Post reported.

 
 
"Voluntary spontaneous event reporting to health authorities is not
designed and cannot be used to determine cause and effect," Pfizer said in
a statement. "It is essential to remember that the information provided is
uncontrolled and may be second-hand or incomplete."

The company said that millions of patients have been prescribed Celebrex
since it was first approved in 1998 and large-scale clinical studies of up
to four years showed no increased cardiovascular safety risk.

Pfizer said the Canadian agency, Health Canada, has noted that "there
hasn't been a causal link established" between the events and Celebrex. The
agency has also noted that incidence reports didn't contain information
about other underlying medical conditions that the patients might have had,
Pfizer said.

A Health Canada spokeswoman declined to comment to Dow Jones Newswires.

Celebrex has been touted as a safer alternative to Vioxx, the painkiller
Merck & Co. pulled from the market in September after it led to higher
rates of heart attacks and strokes. Pfizer, which is based in New York,
actually plans to conduct a long-term study of Celebrex to see if it helps
the heart.

However, questions remain over the safety of the whole class of drugs,
called Cox-2 inhibitors, which also includes Pfizer's drug Bextra.

"Given the absolute numbers described here, and the fact that hundreds of
thousands of Canadian patients have been exposed to this drug, we believe
that the reported incidence of events is not in any way alarming," Deutsche
Bank Securities analyst Barbara Ryan wrote in a Thursday research note. "In
fact, the absolute number of events would be expected to be higher in a
population of this size - with no causal effect - in our opinion."

She went on to say that unless more definitive information becomes
available, "we would discount the importance of this specific news report
and view the weakness in (Pfizer) as a buying opportunity."

Deutsche Bank owns 1 percent or more of Pfizer's stock and the firm was a
member of the syndicate that underwrote one of Pfizer's public offerings in
the last five years.

Canadian pharmacists filled about 3 million prescriptions for Celebrex last
year, the National Post story said.

Dr. Patrice Roy, Pfizer Canada's director of scientific affairs, told the
National Post that the Health Canada adverse reaction information is
important but far from conclusive.

Celebrex hasn't posed a threat to cardiovascular safety in clinical
studies, he said.

"You have to look at the data accumulated over time," Roy said. "This drug
has been studied in 30,000 patients, has been prescribed to over 40 million
patients worldwide, there are studies actually sponsored by the FDA ... and
basically we haven't seen anything."

Health Canada collects adverse reaction reports from doctors, drug
manufacturers and others as a sort of early warning system for safety
problems, the paper said. The agency notes that the side effects are only
suspected by the people reporting them and they don't take into
consideration the patients' other potential medical conditions that could
have led to the adverse reaction.

Pfizer's stock fell on the news, with the shares down 2.5 percent, or 73
cents, at $28.72 on the New York Stock Exchange.

2004-11-04     20:29:08 GMT