Will Celebrex and the other Cox-2s follow the Vioxx path? Indications from Canada based on 14 reported deaths suggest that they might. Meanwhile Pfizer is initiating an ambitious and potentially risky clinical trial to try to prove that Celebrex is good for your heart (or at least not as bad for it as Vioxx!) Given that the risks of Vioxx were known for several years by Merck and some others, is the FDA paying enough attention to the safety of the nation’s drugs? I don’t know and I’m sympathetic to the argument Sydney made in Medpundit a while back about the good of the many taking Vioxx versus the incremental risk for the few. However, John Abramson, the author of Overdosed America: The Broken Promise of American Medicine is pretty sure. He writes this for THCB:
Research on Vioxx done for my book, Overdosed America, was included in Monday’s Wall Street Journal article. The lack of public discussion about the two most important lessons to be learned from the Vioxx recall guarantees that this debacle will be repeated again, and again, and again.
The VIGOR study that Merck completed in March 2000, comparing the safety and efficacy of Vioxx to naproxen (Aleve), showed clearly that even among those without a previous history of cardiovascular problems, Vioxx doubled the risk of heart attacks, strokes, and blood clots. Vioxx actually increased the number of serious cardiovascular problems more than it decreased the number of serious gastrointestinal problems. The FDA’s cardiology reviewer wrote in February of 2001 that the increased risk of cardiovascular complications with Vioxx "could lead one to conclude that naproxen…would be the preferred drug."
And the most important finding of the study: The people who took Vioxx developed 21% more serious complications (the kind that cause hospitalization or death).
The problem is that neither of these two findings was included in the November 2000 issue of the New England Journal of Medicine. So doctors were left believing that, even though Vioxx is no more effective at relieving arthritis symptoms and cost many times more than naproxen, Vioxx was the better drug for their patients.
The more general issue (and the primary theme of my book) is that most of even the best information available to doctors and patients is produced and disseminated by commercial interests with the goal of improving their bottom lines, not the health of the American people. Seventy to 80 percent of our clinical studies are now funded by the drug and medical device companies. Among the highest quality research, the odds are still 5 times greater that commercially sponsored studies will favor the sponsor’s drug than will non-commercially funded studies.
If the health care market is to serve the interests of society, the quality of the information that provides the basis for health care decisions must be impartially overseen. The situation that we now have with drug companies funding and controlling most of our clinical research is like a professional football team generously providing the referees for its games.
Many people say that the last thing we need is another federal regulatory body. But not even libertarians suggest that the government should back out of its role in the enforcement of business contracts. In our "information age," accurate medical knowledge is as fundamental to the quality (and cost) of our health care as is the enforcement of contracts to the function of markets.
The fundamental "lesion" in American health care is the normalcy of commercial bias in our medical knowledge–which now grows toward corporate profits the way that plants grow toward sunlight. Until this problem is addressed unsafe and unnecessarily expensive drug like Vioxx will continue to achieve "blockbuster" status, and Americans will continue to pay more than twice as much for health care yet have the worst health of 22 industrialized nations.