Merck Acknowledges Vioxx Study Error
Merck admitted yesterday that it had committed a statistical error in a key study that showed that Vioxx only increased heart risks after 18 months of continuous use.
Two weeks ago the company released the final data from it’s APPROVe study, on which it had based its 18-month theory. Outside scientists analyzed the data and concluded that Vioxx showed risk for heart problems as early as 4 months into treatment.
Merck’s error stems from the use of a logarithmic statistical method, as opposed to a linear method, to interpret the data from its study. Merck concluded that the linear method – which does not support Merck’s long-term use theory - was a better statistical gauge.
Other studies have also revealed that Vioxx caused heart problems earlier than the drug maker maintained. These studies together with this recent admission could seriously undermine the company’s core defense – that Vioxx does not carry early or prolonged risks.
“There was never any evidence for the 18-month story,” said drug safety expert Dr. Alastair J.J. Wood.
The drug maker is currently facing 11,500 Vioxx-related lawsuits. So far, Merck has lost three of the six cases that have gone to trial. In two of the three cases the company lost, the plaintiffs had used Vioxx for less than 18 months.