In the 31 years that I've been monitoring the Food and Drug Administration, what has gone on in the last five and six years is unprecedented. There have been an unprecedented number and percentage of drugs taken off the market; in many cases, drugs with known problems before they came on the market.
There's an unprecedented turnover of top scientists and physicians at the FDA. We now have three former FDA scientists on our staff. The absence of congressional oversight to sort of hold the FDA accountable has also been devastating. So the outcome of all of this is that we've had more drug safety-related problems in the last four or five years than really almost any comparable period of time.
The sad thing is these were preventable. They could have been avoided. In most, if not all of the cases, there were strong danger signals even before the drug came on the market that there was a problem. In all cases, once they came on the market, there was a very dangerous and reckless slowness to respond to the signals that came after marketing -- signals in the terms of deaths and serious injuries to people who took the drug once it was on the market. So I think the combination of problems in the pre-approval phase, combined with a very defective system for post-market safety surveillance have really been devastating.
Full Article by Sidney Wolfe, M.D.
# posted by madthumbs @ 6:38 PM
