JOHN YDSTIE, host:
This is MORNING EDITION from NPR News. I'm John Ydstie.
RENEE MONTAGNE, host:
And I'm Renee Montagne. New results from a large scientific study show that the risk of heart problems and death from the painkiller Vioxx are long lasting; they remained even one year after patients stopped taking the drug.
NPR's Snigdha Prakash reports.
SNIGDHA PRAKASH reporting:
These new results are from a study called Approve. In it, patients were given either Vioxx or a sugar pill for three years. The study was stopped in 2004 just before it was to end, after scientists saw that Vioxx patients were almost twice as likely to have heart problems as those on the sugar pills. Merck & Co. took Vioxx off the market.
But scientists tracked the patients in the approved study for one more year. At that point, none of the patients was on Vioxx. They found that the group that had taken sugar pills developed 16 heart problems; the former Vioxx patients developed 28.
Dr. STEVEN NISSEN (Cardiologist, The Cleveland Clinic) :I must tell you, it was very surprising to me. I had always assumed that if you stopped taking the drug the risk would go away.
PRAKASH: But this data shows that's not true, says cardiologist Steven Nissen of the Cleveland Clinic.
Dr. NISSEN: What it shows us is that you can stop taking Vioxx and, based upon this study, for the next year, you're still at increased risk. And, in fact, the amount of increase is almost exactly the same as we saw during the three years that people were actually taking the drug.
PRAKASH: Vioxx patients were 75 percent more likely to develop heart problems in the year after they went off the drug. In the three years they were on Vioxx, they were at 90 percent higher risk of heart problems.
Nissen says the study suggests that Vioxx raises the risk of heart problems by doing long lasting damage to the arteries, perhaps by increasing the buildup of plaque in them.
In a press release, Merck, which faces more than 11,000 product liability lawsuits from Vioxx patients and their families, portrayed the results as good news.
The company pointed out the number of heart problems once patients had stopped taking Vioxx was so small that you can't be sure if Vioxx was causing the problems.
Clinical trial expert Curt Furberg of Wake Forest University says it's true the numbers are small. But, he says, they show a clear trend, and he's worried.
Dr. CURT FURBERG (Clinical Trial Expert, Wake Forest University): I think they should not hide behind technicalities. My take from (unintelligible) is there is persisting risk with Vioxx, at least for a year. Does it continue for another couple of years or beyond that, no one knows, and I'm not sure we'll ever know.
PRAKASH: By some estimates, Vioxx may have caused more than 138,000 heart attacks and 58,000 deaths. Nissen says these new results suggest the toll on American public health may be greater than previous estimates.
Dr. NISSEN: If all the risk goes away when you stop the drug, then taking the drug off the market makes this public health problem disappear. But this study demonstrates that risk does not go away, that it continues. So we have more people at continuing risk than any of us previously believed.
PRAKASH: Merck says the results will no effect on its strategy of defending each product liability case in court. Six cases have gone to trial so far, the company has won three and lost three.
Snigdha Prakash, NPR News, Washington.
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