Merck's arthritis drug Arcoxia, developed in order to compete with Celebrex, may hold as many risks for the heart as the notorious drug Vioxx, according to FDA whistleblower David Graham.
Graham rose to national prominence two years ago when he informed a Senate panel that the FDA was "virtually defenseless" against a "tragedy and profound regulatory failure" like Vioxx.
In an editorial published in the Journal of the American Medical Association, Graham pointed out that Merck's study purporting to show that the risks of heart attack for Arcoxia were similar to those for diclofenac, an older arthritis drug, were seriously flawed.
The study design used, according to Graham, was "well-known to be especially poor at identifying safety risks between drugs, thereby stacking the deck in favor of [Arcoxia]." In addition, an analysis of previous studies shows that diclofenac raises cardiovascular risk as much as low-dose Vioxx, making the comparison between the two drugs deceptive.
A comparison with a drug that does not raise heart risks, such as naproxen, would have given a more accurate assessment of Arcoxia's risks.