There is no question that since the post-COX-2 era has been one consumed with risk and not so much focus on benefit.
But, as stated here many times, I am acutely aware of the benefit that drug and biologic interventions bring to the lives of many.
And so, while drug safety is always a paramount issue, if we focus on the matter of safety to the degree we diminish the benefit, is it possible we are doing ourselves out of future benefit by being so heavily invested in risk?
There are some in Congress who have self-appointed themselves guardians of the public safety when it comes to agencies like the FDA. Fine, they need to do something, particularly in a Congress that has been largely do-nothing. But in doing so, one must stop and consider the consequences.
At an FDA Advisory Committee meeting, it is the job of the FDA to show every wart in a drug and every hole in the argument put forth by a drug sponsor. As far as I’ve seen, and I’ve attended many, many of these meetings, they do a good job, sometimes focusing on the most minute aspects of a drug’s effects. One has to wonder, if the standards imposed today aren’t higher than of just five years ago. And if that’s the case, is there a chance that we are depriving ourselves of benefit that might be derived from drugs that designed and executed their clinical trials in the pre-COX-2 era of safety concern, but will have them considered by an FDA advisory committee in the post-COX-2 era of safety concern.
I would hate to think that protease inhibitors might have been delayed because of a concern about cholesterol levels. More people with AIDS would have died from their infection than from a heart attack. The drugs are not perfect, but they worked towards their primary purpose.
We must proceed with caution, but also with caution about our sense of caution. We cannot afford to lose our balance at a time when we could be on the verge of new breakthroughs.