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FDA Hearings on Celebrex, Vioxx Labels Could Be Crucial in Arthritis-Drug Fight

By GARDINER HARRIS
Staff Reporter of THE WALL STREET JOURNAL
 

A fight between some of the world's largest drug makers will tumble into the open Wednesday when a federal advisory panel will examine whether to soften warning labels on the mega-selling arthritis drugs, Celebrex and Vioxx.

Both drugs have labels that warn of ulcer-like side effects, a standard warning carried by an entire class of painkillers known as nonsteroidal anti-inflammatories (NSAIDs). These painkillers include aspirin, Advil and Aleve. But Celebrex and Vioxx were created in hopes that they wouldn't cause these side effects. Huge studies conducted recently by the drugs' makers in part support this contention. This week's panel may help determine whether the labels of Celebrex and Vioxx change to reflect these findings.

Pharmacia Inc. and Pfizer Inc., the marketers of Celebrex, appear before the panel Wednesday; Merck & Co., the maker of Vioxx, is scheduled to appear Thursday. The companies are locked in a fierce marketing war, and the meetings this week could prove to be a crucial battle.

So far, the companies are evenly matched. Most physicians see the drugs as twins, and the drugs have equal shares of new prescriptions. If the advisory panel decides that one deserves a better label than the other, it could be decisive. Most analysts, however, see such an outcome as unlikely.

The stakes are enormous. Celebrex had more than $2 billion in sales last year. Its launch in 1999 remains the industry's most successful drug introduction ever. Pharmacia & Upjohn Inc. bought Monsanto Co. in 1999 in large measure to acquire Celebrex.

Vioxx, meanwhile, had $2.2 billion in sales last year. Its launch is the industry's second-best ever, and its success allowed Merck to avoid losing its independence through a merger.

In the year and a half since Vioxx began competing with Celebrex, these companies have been shouting to doctors, patients and reporters about their own drug's benefits -- and whispering about the other drug's problems. This week, the companies get a chance to discuss the pros and cons of the drugs openly before a group of scientists who will advise the FDA about whether to change the drugs' labels.

A question that is likely to go unanswered is whether Vioxx and Celebrex are worth all the money that patients spend on them. Celebrex and Vioxx cost about $2 a day; their generic rivals cost about 10 cents. The two new drugs don't cure pain better than the generics. Their sole benefit is that they are less harmful to the stomach. And only 2% to 4% of NSAID users develop gut problems such as ulcers.

But so many millions rely on NSAIDs that this side-effect toll is enormous. In the U.S. alone, more than 100,000 patients are hospitalized each year with ulcer complications caused by pain pills, and about 16,500 die as a result.

Preventing these complications would be of huge benefit. But an 8,000-patient study overseen by Pharmacia found that if Celebrex patients simultaneously take low-dose aspirin to protect against heart attacks, then they are just as likely to get stomach problems as those who take other pain pills. And, of course, millions of elderly users -- the most vulnerable to ulcer complications -- need low-dose aspirin for their hearts.

Celebrex and Vioxx were developed after it was discovered that the enzyme controlling the pain of inflammation is distinct from the similar enzyme that protects the gut. Aspirin and ibuprofen inhibit both enzymes. Vioxx and Celebrex target just the enzyme controlling pain without interfering with the one that protects the stomach.

The question before the committee this week is whether the drugs succeeded well enough that the benefits should be announced in their labels. Both drugs have side effects that will be discussed.

"Anyone who suggests that the gastrointestinal NSAID warning is going to get deleted is either deluded or foolish," said Eve Slater, senior vice president of Merck's clinical and regulatory development. "But I think they will be sufficiently impressed to allow us to describe the results of these studies on our labels, and therefore allow us to use that information with patients and physicians." A label change could increase sales even more.

Sidney Wolfe, a consumer health advocate, will testify Wednesday that the drugs' warning labels shouldn't be softened. FDA officials will make the final decision.

Write to Gardiner Harris at gardiner.harris@wsj.com³

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