The New England Journal of Medicine has issued an unusual correction to a paper it published last year on the painkiller, Vioxx. The change undermines a key feature of drug maker Merck's defense against thousands of product-liability lawsuits.
Vioxx was withdrawn from the market in 2004 after a study called APPROVe showed that the painkiller doubled the risk of heart problems.
The FDA approved Vioxx in May 1999. Seven years later, more than 23,000 people are suing Merck, alleging the drug caused heart attacks and strokes. A look at how Vioxx's demise unfolded.
In court, Merck has argued that the risk to patients didn't begin until 18 months of use, and that short-term use of Vioxx was safe. Many experts disputed that, but Merck's position was strengthened by a carefully worded statement in the New England journal, which said the risks "became apparent" 18 months after the study began.
Independent analysis of data sent to the FDA show that the cardiovascular risks from Vioxx begin shortly after a patient starts taking the drug. The data also indicate that the risks from Vioxx remain long after patients stop taking the drug.
The journal corrected those statements today. It said that a statistical error by Merck undermined the evidence for them. The journal deleted two references to the 18-month delay, and weakened two others.