Vioxx Data Suggest Risks Started Earlier

Published: May 19, 2006

TRENTON, May 18 (AP) Previously unpublished data from the study that led the drug maker Merck to halt sales of its blockbuster painkiller Vioxx appear to show the drug raised the risk of heart attack and stroke within just a few months, not after at least 18 months' use, as Merck has consistently argued.

The company disputed that Thursday, saying it was "not scientifically appropriate" to draw conclusions based on a key graph in a 108-page report on the data. The news, first reported by National Public Radio, comes after prominent doctors said Merck misrepresented other data from the same study last week.

Merck officials said last week that the new data, from a follow-up of patients a year after they stopped taking Vioxx, showed heart and stroke risks ended soon after they stopped taking it. The officials also said patients who later had such complications did not have a legitimate lawsuit. But several doctors said that depending on how one interpreted the data, the heart and stroke risks could persist for at least a year or longer.

Now, a closer look at that same data indicates that the increased cardiovascular risk with Vioxx use most likely begins as early as four to six months and then gets bigger, said Dr. Steven Nissen, a Cleveland Clinic cardiologist and frequent Vioxx critic who is leading an international study of the risks of 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," Dr. Nissen said.