Editor's Notes:
This article provides yet more grist for the litigation mill, recounting new studies in a recent issue of the Journal of the American Medical Association detailing the relative risks of Vioxx compared to other widely used painkillers:
Vioxx, which is no longer on the market, may have posed heart risks that a similar drug, Celebrex, and other painkillers do not, according to two papers published yesterday by The Journal of the American Medical Association.
In one paper, three researchers at Harvard examined 114 clinical trials of Vioxx and other drugs and found that Vioxx was linked to substantially higher rates of increased blood pressure than was Celebrex, a similar painkiller, which is still sold.
In the other paper, two Australian researchers found that Vioxx appeared more dangerous than Celebrex or several older painkillers in observational studies, which examine the safety and effectiveness of drugs in real-world settings after they are approved.
These conclusions were hardly surprising. Merck, which makes Vioxx, stopped selling the drug in 2004 after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.
But the papers provide new grist for the debate over whether all painkillers raise heart risks, or whether Vioxx is uniquely dangerous.
This article reminds us that pre-market clinical trials are often too small to detect safety signals that may only emerge when a drug is used by a large population. Some observers have used this logic to advocate for longer and larger pre-market trials to rule out rare side effects.
A better approach would be to encourage companies to conduct postmarket surveillance studies in return for protection from punitive damages suits, and in connection with an administrative compensation system modeled on the Vaccine Injury Compensation Program.
After all, we don't want fewer new medicines—we just want to use the ones we have with greater safety and effectiveness.