Report shows Vioxx dangers with short-term use
Merck, which has consistently argued that Vioxx was of no danger to patients before 18 months’ use, apparently had—and chose not to publish—data to the contrary. A number of prominent doctors say the company has misrepresented data in a variety of ways.
Merck officials say that data from a follow-up of patients one
year after they stopped taking Vioxx proved that the risk of heart attack and stroke ended
soon thereafter—and that patients who went on to develop
such complications have no legitimate basis on which to sue. Several
doctors, however, believe the data instead showed
that those risks persisted for at least a year.
According to Dr. Steven Nissen, the newly published data show that increased cardiovascular risk with Vioxx
use probably begins within four months and only grows with time. “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,” he says.
The study in question, known by the acronym APPROVe, included more than 2,500 patients, half of whom took Vioxx and the other half placebos for three years. Patients were
enrolled between February 2000 and November 2001.
By September 2004, the Vioxx group had experienced twice the number of
heart attacks and strokes, leading the New Jersey-based
company to issue a Vioxx recall. Even as Vioxx lawsuits went over the 11,500 mark, Merck insisted there was no increased
risk until 18 months—a key point in its legal strategy.
In February 2005, when Merck first published the APPROVe data in the New England Journal of Medicine,
it only included complications that patients had within two weeks of stopping
the drug, even if they stopped early. But a key graph in that report didn’t
show higher risk until after 18 months.