A new analysis of the data from clinical trials of Vioxx suggests that early warning signs of danger were overlooked for years. Investigators pooled data from 30 randomized, placebo-controlled studies and discovered that as early as June of 2001 there was evidence that Vioxx increased the risk of heart attacks or death by 35 percent compared to placebo. The drug was not taken off the market until September of 2004. That means that millions of people were exposed to the dangers of this drug and thousands may have died as a result of this delay.
An accompanying commentary in the Archives of Internal Medicine makes a strong plea for FDA to share its data with physicians and patients as early as possible. The information should be presented in a way that is easy to understand. The authors have devised a prescription drug facts box modeled on the nutrition facts box that can be found on every food label. Doctors and consumers both deserve access to facts rather than marketing hype when it comes to decisions about new pharmaceuticals.
[Archives of Internal Medicine, November 23, 2009]
The People's Perspective on Medicine