Vioxx Data Suggest Risks Started Earlier
By THE ASSOCIATED PRESS
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TRENTON, May 18 (AP) — Previously unpublished data from the study that led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
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
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.