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Today the New England Journal of Medicine issued an unusual correction. It concerns a scientific study that figures prominently in the Vioxx product liability cases. The study was published in the journal in 2004. It said the painkiller Vioxx doubled the risk of heart attacks and strokes. Those results led Merck to pull the drug from the market.
Well, today's correction from the New England Journal concerns how soon Vioxx increased cardiovascular risks for patients in that study. The point could cost Merck billions of dollars in payouts to plaintiffs.
And as NPR's Snigdha Prakash reports, Merck and the New England Journal disagree about the correction.
SNIGDHA PRAKASH reporting:
This has been an important study for Vioxx manufacturer Merck. The company has maintained that the study showed Vioxx could be safely used for 18 months and that it was only after that period that Vioxx caused heart problems. And in lawsuits around the country, the company's lawyers have used the study to argue that short term users of Vioxx have no basis to claim that their heart attacks or strokes were caused by the painkiller.
Then, last month Merck announced that one statistical test that it used to reach that conclusion contained an error. But Merck said the error didn't change the final results. The New England Journal of Medicine editor in chief, Jeffrey Drazen, says the Journal reached a different conclusion. The correction published today undercuts that 18 month safe period for Vioxx or rofecoxib.
Mr. JEFFREY DRAZEN (New England Journal of Medicine): Rofecoxib has a cardiovascular risk, but one cannot say - based on the information - that there is a length of time which is safe for the use of rofecoxib as a pain reliever that doesn't carry with it some degree of cardiovascular risk.
PRAKASH: In other words, the paper no longer provides any assurance that Vioxx is safe to use for 18 months as the paper had originally suggested. Cardiologist Stephen Nissen of the Cleveland clinic agrees with the change.
Dr. STEPHEN NISSEN (Cleveland Clinic): There is no longer any statistical evidence that there is an 18 month delay in the risk occurring. There is no scientific basis for suggesting that the risk is any different earlier compared with later.
PRAKASH: But in a five page open letter to the scientific community published this afternoon on its website Merck disagreed. It said, quote, the correction does not reflect our view of the data and the results of the study, close quote. The company said it stands by its original interpretation, that there was an increased risk for cardiovascular problems beginning after 18 months of continuous daily treatment with Vioxx.
Mr. DRAZEN: They have a right to disagree with the correction. Usually when we go back and forth, and I think we have in this case gone back and forth, that we then publish the correction and everybody's happy. This is a case where that's not what's happened.
PRAKASH: New England Journal editor Jeffery Drazen says Merck wanted to use an analysis that wasn't agreed to when the study was designed. He said the Journal stands by its correction.
Mr. DRAZEN: The correction is the correction and I think that we stand behind it. It's based on very firm scientific approach to data analysis. You don't look at the data and think of the best analysis. You make that assessment ahead of time, before you see the data and then you stick with it.
PRAKASH: Drazen said this was the first time in his tenure at the head of the New England Journal that a correction has been contested in this way.
Snigdha Prakash, NPR News, Washington.
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