Feb 21, 2005
A federal drug advisory panel just recommended that the Food and Drug Administration allow the painkillers Vioxx, Celebrex, and Bextra back on the market.
Last summer David Graham, the science director at the FDA Office of Drug Safety, presented findings showing that the painkiller Vioxx increased the risk of cardiovascular disease. Graham's evidence, along with findings of its own that Merck had kept from the public, was enough to force Merck to pull Vioxx off the market.
When Graham tried to get his findings published, the FDA threatened to fire him. When he tried to get whistleblower status, someone at the FDA accused Graham of having bullied them.
When Graham asked to present his findings at the recent drug advisory panel meeting, the FDA refused. The Lancet finally went ahead and published Graham's findings. In the article, Graham wrote that Vioxx caused an estimated 88,000 to 140,000 cases of serious coronary heart disease, with 44% of them being fatal.
Embarrassed by the publicity surrounding the whole affair, the FDA reversed itself, allowing Graham to present his findings to at the drug advisory panel meetings. So what did the advisory panel do with his findings? They ignored them.
The panel proclaimed that the benefits of these painkillers to people with arthritis and other illnesses "outweigh the risks" of heart disease that come with them. It may be true that the benefits of these drugs outweigh the risks – in some people, with very serious illnesses. But these drugs were marketed and given widely, to anyone with even a twinge of knee pain.
Drugs like Vioxx, Celebrex, and Bextra were touted as replacements for aspirin because they supposedly avoided the problem of stomach ulcers linked with aspirin. Unfortunately, they do not have the same ability as aspirin of thinning the blood. On the contrary, they can cause blood clotting.
The drugs will now again be marketed widely. At most, they might carry a strong warning, but that is not the same as restricting them for narrow use. Nor is it a real balancing of benefits against risk.