Minding The Pharm

Healthcare experts and federal regulators knew that the use of Avandia created a greater risk of heart attacks by as much as 43% way back in 2007, but recommended to the FDA that it stay on the market. Why?

When it comes to drug safety, they say, you can’t make an omelet without breaking a few eggs.

One key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety. “Only the grossest, most commonly occurring things will show up in clinical trials designed to determine efficacy,” said Sydney Wolfe, director of health research for the advocacy group Public Citizen.

Suppose a drug saves 3 people and kills 1 person… is that a good reason to keep it on the market?

See David Lazarus at the Los Angelas Times