Marcia Angell has an interesting article in the New York Review of Books on the case of Vioxx, the painkiller drug that was withdrawn after it was found to cause heart attacks. (She cites an estimate of tens of thousands of heart attacks caused by the use of Vioxx and related drugs, referring to Eric J. Topol, “Failing the Public Health—Rofecoxib, Merck, and the FDA,” The New England Journal of Medicine, October 21, 2004.) Angell writes,
In late 1998 and early 1999, Celebrex and then Vioxx were approved by the FDA. They were given rapid “priority” reviews—which means the FDA believed them likely to be improvements over drugs already sold to treat arthritis pain. Was that warranted? Neither drug was ever shown to be any better for pain relief than over-the-counter remedies such as aspirin or ibuprofen (Advil) or naproxen (Aleve). But theory predicted that COX-2 inhibitors would be easier on the stomach, and that was the reason for the enthusiasm. As it turned out, though, only Vioxx was shown to reduce the rate of serious stomach problems, like bleeding ulcers, and then, mainly in people already prone to these problems, a small fraction of users. In other words, the theory just didn’t work out as anticipated.
Furthermore, people vulnerable to stomach ulcers could probably get the same protection and pain relief by taking a proton-pump inhibitor (like Prilosec) along with an over-the-counter pain reliever. So the COX-2 inhibitors did not really fill an unmet need, despite the one seemingly attractive claim made in favor of them.
She also goes into detail on conflict of interest in the FDA advisory committees, and recommends that the FDA shouldn’t approve new drugs so hastily. This sounds like a good recommendation for Vioxx etc. (tens of thousands of heart attacks doesn’t seem good). But how many drugs are there on the other side—effective drugs that are still waiting for approval? I’m curious what Angell’s colleagues at the Harvard Center for Risk Analysis would say. Would it be possible to have an approval process that catches the Vioxx-type drugs but approves others faster?