UPDATE 2-US panel sees no safety edge for Celebrex
WEDNESDAY, FEBRUARY 07, 2001 5:21 PM
- Reuters
(new throughout with quotes, background, byline)
By Lisa Richwine
GAITHERSBURG, Md., Feb. 7 (Reuters) - Scientific studies do not show that the blockbuster arthritis
treatment Celebrex, designed to be gentler on the stomach than traditional painkillers, is safer than older
remedies, a U.S. advisory panel said on Wednesday.
Celebrex maker Pharmacia Corp. (NYSE:PHA) (NYSE:PHA) is asking regulators to soften warnings
regarding the risk of painful ulcers and potentially deadly bleeding from the drug.
But an 8,000 patient study by Pharmacia unit Searle did not sway a Food and Drug Administration (FDA)
panel. Committee members said they saw no edge for Celebrex over treatments such as ibuprofen when
comparing rates of the most serious ulcers.
"The consensus of the panel is there is no clinically meaningful safety advantage in upper
(gastrointestinal) safety," acting panel Chairman E. Nigel Harris said.
The FDA has final say on whether to ease warning language on Celebrex, but the agency usually follows
its panel's advice.
Celebrex, which Pfizer Inc. (NYSE:PFE) co-markets, is locked in a marketing battle against Merck and Co.'s
(NYSE:MRK) Vioxx in the multibillion dollar anti-arthritis market. On Thursday, the FDA committee is
scheduled to consider whether Merck's data demonstrates a safety advantage for Vioxx.
Both drugs are part of a class known as COX-2 inhibitors that were developed with the hope they would be
safer than older painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs include
aspirin and ibuprofen.
While millions of Americans take NSAIDs to relieve arthritis pain, between 2 and 4 percent of patients
experience side effects such as ulcers and potentially deadly stomach bleeding.
An estimated 16,500 Americans die from those complications each year. People are most at risk when
they use the drugs long term to treat chronic conditions such as arthritis.
Critics are unconvinced that COX-2 inhibitors are a better choice. Studies show the drugs' effectiveness
are about the same, and COX-2 inhibitors cost about $2 per day, compared to pennies per day for most
NSAIDs.
"A seemingly magical bullet seems to have self-destructed ... It appears to have been grossly exaggerated
and oversold," said Dr. Sidney Wolfe, head of the Health Research Group at consumer group Public
Citizen.
But Searle officials argued that its study showed Celebrex fared better when researchers looked at more
ulcers than just the serious ones that can bleed and cause stomach perforations. In that respect, Celebrex
patients had about half as many complications than people taking one of the NSAIDs, Searle said.
"The NSAID problem is a large problem. If you can cut that in half, it's a lot of people," Searle consultant
Fred Silverstein told the panel.
While the panel said Searle's data did not prove a safety edge for Celebrex, some members stressed that
it did not rule it out, nothing that the drug might prove less toxic for certain types of patients.
"There is data here that it might be safer," said panel member David Wofsy of the University of California
at San Francisco.
NSAIDs suppress an enzyme known as cyclooxygenase or COX, which has two forms, COX-1 and COX-2.
Scientists believe COX-1 protects the stomach lining, while COX-2 causes pain and inflammation.
Suppressing both forms of the enzyme, they believe, can lead to bleeding and stomach damage. By
targeting COX-2 alone, as Celebrex and Vioxx do, the drugs' developers seek to relieve pain and minimize
stomach-related side effects.
Sales of Celebrex and Vioxx have soared even though the companies are prohibited from marketing them
as safer treatments. Combined sales for this year are expected to top $5 billion.
Industry analysts had predicted a less severe safety warning could boost sales even further.
Analyst Len Yaffe of Banc of America Securities said the panel's opinion would be a "disappointment" to
Wall Street, but he did not think it would hinder Celebrex sales.
"I don't think it will cause (market) share of Celebrex to decline. I just don't think it will increase," Yaffe said.
Rtr 17:21 02-07-01 Copyright 2001, Reuters News Service |
