OT: Pfizer's Celebrex Lifts Heart Attack Risk in Trial

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Pfizer's Celebrex Lifts Heart Attack Risk in Trial

 

By Ransdell Pierson

 

NEW YORK (Reuters) - Pfizer Inc. on Friday said its popular Celebrex

arthritis drug more than doubled the risk of heart attack in a large

cancer-prevention trial, a setback that comes just weeks after Merck &

Co. recalled its similar Vioxx drug due to heart safety risks.

 

Shortly after the Celebrex news, the New England Journal of Medicine

carried a letter in which Vanderbilt University cardiologists questioned

the safety of Pfizer's newer arthritis drug, Bextra, and recommended

doctors not prescribe it.

 

Shares of Pfizer, a component of the Dow Jones industrial average, fell

11.1 percent following the double blast of bad news.

 

Merck recalled Vioxx on Sept. 30 after a study found that long-term use

of the drug doubled the risk of heart attack and stroke. Both Celebrex

and Vioxx belong to a class of drugs known as COX-2 inhibitors, as does

Bextra.

 

" It is now a fair question to ask whether Celebrex and Bextra could be

removed from the market, " Prudential Equity Group analyst Tim Anderson

said in a research report.

 

Some analysts have estimated Merck faces tens of billions of dollars in

potential future liability claims from former users of Vioxx. Anderson

said Pfizer must be concerned about its own legal risk if Celebrex and

Bextra remain on the market.

 

" This does not bode well for COX-2 inhibitors in general, " Ira Loss, an

analyst at Washington Analysis, said of the Celebrex trial. " The sense

had been that Celebrex is somehow different from the others. "

 

Dr. Richard Hayes, a cardiologist at New York University, told Reuters,

" This raises my concern about Celebrex and all the COX-2 inhibitors, so

I will no longer be prescribing any of them. "

 

A Pfizer spokesman said the company has no plans to pull Celebrex off

the market. It is one of the drugmaker's biggest products, with 2003

sales of $1.9 billion. Bextra had sales last year of $687 million.

 

The U.S. Food and Drug Administration said it was reviewing the new

Celebrex data and will determine " appropriate action. " Meanwhile, it

urged doctors to consider alternative treatments.

 

Pfizer shed almost $24 billion in market capitalization, its stock

closing down $3.23 to $25.75 on the New York Stock Exchange and dragging

down the Dow Jones industrial average as well as other pharmaceutical

stocks. Pfizer is off almost 30 percent this year.

 

MORE TROUBLE FOR COX-2s

 

Pfizer said the Celebrex trial, sponsored by the National Cancer

Institute, involved patients taking 400-milligram and 800-milligram

daily doses of the drug to prevent tumors known as adenomas that grow

from glandular tissue. High doses of the anti-inflammatory drug were

being tested on the theory that inflammation is a cause of cancer.

 

Vioxx and Celebrex both work by selectively blocking a protein called

COX-2 that has been linked to inflammation. They were both launched in

1999 and quickly became top-selling drugs, helped by massive television

and print advertising.

 

Pfizer also said on Friday that Celebrex was not shown to increase heart

risk in a second long-term trial designed to see if the drug could

prevent colon polyps. Negative findings in a similar trial led to the

withdrawal of Vioxx.

 

New York-based Pfizer said National Cancer Institute officials decided

to halt the Celebrex trial on adenomas after confirming " an

approximately 2.5-fold increase " in the risk of fatal or non-fatal heart

attack in patients taking the drug, compared with patients taking a placebo.

 

Pfizer Chief Executive Officer Hank McKinnell on Friday told CNBC

television he does not believe the continuing negative news on COX-2

drugs, including Celebrex and Bextra, will spell their eventual demise.

 

" I don't believe they're doomed, " he said, arguing that older standard

painkillers cause ulcers and gastrointestinal bleeding that kill 16,500

Americans each year and that the COX-2 pills are gentler on the stomach.

 

Amid concerns about the safety of all COX-2 inhibitors after the Vioxx

withdrawal, Pfizer plans to begin a major new trial next year to verify

the heart-safety of Celebrex in arthritis patients who have had a recent

heart attack.

 

The company has also defended Bextra's safety, although Pfizer's newer

treatment raised the risk of stroke and heart attack in two small

clinical trials of patients taking it after coronary bypass surgery.

 

In other fallout from the Celebrex news, Moody's Investors Service on

Friday said it revised Pfizer Inc.'s outlook to negative from stable but

affirmed its long-term debt ratings. (Additional reporting by Edward

Tobin and William Borden in New York, Susan Heavey in Washington and Kim

Dixon in Chicago)

 

12/17/04 16:45

 

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