PFPC Daily - November 6, 2004

Pfizer Defends Celebrex Vs. Deaths Report

Forbes - Nov.4, 2004

Canadian health officials said Thursday they have received reports
linking Pfizer painkiller Celebrex to 14 deaths and numerous
heart-related side effects, but that it woudl be premature to to
issue a warning or pull from the shelves.

Canada Adverse Drug Reaction Monitoring Program, part of the federal
health department Health Canada, has collected 100 adverse-reaction
reports on Celebrex over the past five years. Those include 19 cases
of heart attack, cardiac arrest or heart failure, five strokes and
included 14 deaths.

Complaints are submitted to the agency directly by health
professionals and consumers, and its database is meant to serve as a
sort of early warning system for safety problems.

Dr. Maria Valois, director of marketed pharmaceuticals at Health
Canada, told reporters on a conference call she was awaiting more
information from the manufacturer on the drug's cardiac safety,
clinical trials and results from other countries and agencies. She
set a Nov. 18 deadline. Any further action would depend on the
material submitted, she said.

"It's still premature to conclude what intervention is required in
this case," Valois said.

The news conference as called after the database numbers were
published Thursday in Toronto's National Post. Health Canada did not
release the documents Thursday.

Canadian pharmacists filled about three million prescriptions for
Celebrex last year. It is used primarily to treat arthritis.

The drug is of class called Cox-2 inhibitors, which includes Vioxx, a
version manufactured by Merk that was pulled off the shelves Sept. 30
because it doubled the risk of heart attacks and strokes in patients
taking it longer than 18 months.

Pfizer called reports questioning the safety of Celebrex "misleading."

"The safety profile for Celebrex is well-established and is supported
by extensive clinical studies in Canada and around the world," a
Pfizer statement said. "It is essential to remember that the
information provided is uncontrolled and may be second hand or
incomplete."

Pfizer said millions of patients have been prescribed Celebrex since
its first approval in 1998 and large-scale clinical studies of up to
four years showed no increased cardiovascular safety risk.

Valois supported that contention, saying that of 20 pertinent reports
in the adverse reaction file, only six could be linked to Celebrex.

"Some of those reports were unassessable. Some of those reports add
significant confounders, that the patient was bleeding but they were
also taking an anticoagulant," she said.

Shares of Pfizer fell more than 6 percent on the news before
recovering later in the day, closing down or 39 cents, at $29.06 on
the New York Stock Exchange.

"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.

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."

Health Canada ordered Pfizer in 2002 to add warnings to the product's
labeling to alert users that it may cause an increased risk of
congestive heart failure, Valois said.

Asked if Celebrex is safe, Valois replied: "Any health product has
some benefits and some risks. . . The side effects of cancer drugs
are much more acceptable than a drug for a headache. No health
product is without risk."

"The safety of Cox-2 remains a priority of Health Canada," Valois
said.

Merck's stock plunged nearly 27 percent and the company lost $28
billion in shareholder value after Vioxx, a top-selling drug, was
pullled from the market. The company also faces lawsuits stemming
from Vioxx.

Steps available to Health Canada after reviewing the material on
Celebrex could be to update the drug's profile to include safety
concerns; a letter to health care professionals to alert them to
potential risks; a public advisory, which is equivalent to a public
warning by the FDA in the U.S.; or pulling the product from shelves.

SOURCE:
http://www.forbes.com/home/feeds/ap/2004/11/04/ap1635399.html