TRENTON, N.J. – Unpublished data from the Merck &Co. study that led the drug maker to halt sales of Vioxx appear to show the blockbuster painkiller raised the risk of heart attack and stroke within a few months – not after 18 months of use, as Merck has consistently argued.
The company disputed that Thursday, saying it was “not scientifically appropriate” to draw conclusions based on one graph in a 108-page report on the data.
The news, reported by National Public Radio, comes after doctors said May 11 that Merck had misrepresented other data from the same study.
Merck officials said last week that the data from a follow-up of patients a year after they stopped taking Vioxx showed that heart and stroke risk ended soon after patients stopped taking the drug, and that patients who later had such complications didn’t have a legitimate claim.
But several doctors said they believed the data instead shows the heart and stroke risks persisted for at least a year.
The newly released data show the increased cardiovascular risk with Vioxx use may begin as early as four to six months after starting to take the drug, then gets bigger, said Dr. Steven Nissen, a Cleveland Clinic cardiologist who heads an international study of the risks of several other painkillers.
“It didn’t really make a lot of sense that nothing happened for 18 months, and then all of a sudden you would see a hazard,” Nissen said.
The study included 2,586 patients, with half taking Vioxx and half taking dummy pills over three years. Patients were enrolled in the study from February 2000 to November 2001.
By September 2004, Merck said it was clear the Vioxx group had about twice as many heart attacks and strokes, leading the Whitehouse Station, N.J.-based company to pull the drug from the market.
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