FDA Standards Good Enough for Government Work?
Unfortunately, many people here in the US have an image of the FDA as a governmental agency that is constantly on the vigil to protect an unsuspecting public from the pharmaceutical companies. Not quite so romantic.
This editorial does a nice job of outlining one of the major problems with the FDA approval process. It’s not that the FDA has lax standards, it’s just that their approval process does not have much application in the real world. Many times, in initial clinical trials of a pharmaceutical, the drug is compared to placebo in a patient that is at an extreme of a condition (the article illustrates this with Redux, which was tested in patients with severe obesity).
But in the real world, the drug reps convince physicians to prescribe for much milder conditions, thus skewing the risk benefit ratio.
