Vioxx successor seeks approval

Helen Palmer Apr 12, 2007

Vioxx successor seeks approval

Helen Palmer Apr 12, 2007


SCOTT JAGOW: The drug company Merck has a new arthritis drug called Arcoxia. Today, an FDA committee considers whether to approve it. Arcoxia is a super-painkiller, like Vioxx. Remember Vioxx? Merck is still buried under thousands of lawsuits that claim Vioxx caused heart problems. And Pfizer pulled a similar drug called Bextra off the shelves. So, why is Merck trying to get another one of these drugs approved? Helen Palmer has some answers from our Health desk at WGBH.

HELEN PALMER: The market for these drugs has shrunk dramatically since Vioxx and Bextra were pulled off the shelves, but the one that’s left is doing nicely, thank you.

MARIA MARZILLI: Last year, sales of Celebrex, which is currently the one drug in this class that is still on the market, were around $2 billion.

Maria Marzilli analyzes pain drugs for Decision Resources. She says Merck’s spent half a billion dollars developing Arcoxia and it’s approved in 63 other countries.

MARZILLI: They’ve spent all the money in terms of the clinical trials, so it’s a kind of “why not” attitude. You know, $1 that they have today is a dollar they didn’t have yesterday.

But the company’s careful not to overstate the case for Arcoxia. Here’s Merck’s Scott Korn:

SCOTT KORN: This product has a favorable risk-benefit profile for those patients who suffer from arthritis and need a medication that’s stronger than what they can get without a prescription.

Korn says clinical trials with over 34,000 patients show Arcoxia’s no more dangerous for the heart than an older pain drug.

Other experts disagree.

CURT FURBERG: I would vote against approval under all conditions.

Curt Furberg served on the FDA Drug Safety Committee that recommended strong safety warnings on all these painkillers two years ago. Furberg says there’s no evidence Arcoxia’s more effective than the older drugs.

FURBERG: It’s no better, it’s extremely expensive, and it’s harmful. To me that’s enough to say, ‘Don’t put it on the market.’

There’s another interested group here: 46 million Americans with arthritis.

Arthritis Foundation rheumatologist Patience White:

PATIENCE WHITE: People with arthritis need choices and not every drug works for every person.

Arthritis costs $128 billion a year. A lot of that’s lost wages. That could be cut sharply if Arcoxia helped people manage their pain and keep working.

It would also help Merck of course. Estimates of what the drug might earn if approved vary from $50 million a year to over a billion. Analyst Maria Marzilli:

MARZILLI: It’s really going to depend on the physicians’ willingness to try a new drug. Will they be willing to try this before Celebrex? Probably not.

The arthritis panel votes today. The final FDA decision’s expected by the end of the month.

In Boston, I’m Helen Palmer for Marketplace.

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