2 ms·

I think that last comment is over-calling things a bit. There are no studies supporting the conclusion that anti-obesity drugs save lives (this is not to say th

• Symmetry 16y ago
  Don't decide that the FDA is risk averse on that one example, but I hope you can see how, in general, the FDA has every incentive to be too cautious. If the FDA approves a drug and people die then there'll be political hell. If the FDA delays the approval of a medicine by a year and a few people die during that year who could have been saved pretty much no one will say anything, and even if they never approve a needed mediation then only if its for a disease with a well organized group of sufferers (think AIDS or breast cancer) will there be a political price. Its a testament to the altruism of the people who work at the FDA that they approve things at all, since the politics of the situation are so against them. I've only seen one study researching whether the FDA is too risk adverse overall. If you look at the number of drugs denied approval to, you find that the FDA saves about 2,000 lives each year, which is really awesome. On the other hand if you look at drugs that are later approved but which are delayed in testing you find that the FDA causes between 5,000 and 20,000 excess deaths each year, which sort of sucks. All of this doesn't include the effects of making drug companies more careful about which drugs they try out, which really might go either way in its effect. Remember when looking at those number that there's a definite diminishing returns effect with each additional level of inspection saving less lives but costing the same amount. Of course, this is only one study but its the only one I've seen. If anyone could point to more data I'd be quite grateful.
  • stevenbedrick 16y ago
    > All of this doesn't include the effects of making drug companies more careful about which drugs they try out, which really might go either way in its effect. Let's not underestimate the magnitude of this effect... the FDA is the way it is for a reason. As incredibly and hair-pullingly frustrating as the approval process can be, it's necessary. I'd rather have an FDA that errs on the side of caution than one that relies on the good will and stringent standards of the pharma industry. Not to disparage the drug companies too heavily- most of the people who work in the industry developing and testing drugs have their heads on straight, and would be in favor of doing things the right way even without the FDA looking over their shoulders... but companies are companies, and ensuring drug safety is not something that should be left up to profit-maximizing entities. The story about the scorpion and the frog comes to mind...
    • Symmetry 16y ago
      I think you believe I'm trying to get rid of the FDA here. I'm not, I just want it to approve new drugs more quickly. Generally I'm in favor of things like the late 80s/early 90s reform which reduced the gap in approval speed between the US and Europe * , or like HR.6270 (which never made it to vote) which would let terminally ill patients use drugs that haven't been proven safe yet. There's no reason to get rid of the FDA, its probably both better and politically easier to reform it. *Europe generally approved drugs much more quickly than the US (well, United Kingdom, France, Spain, and Germany at least) and there wasn't any statistically significant difference in the number of bad drugs let through. People noticed that and hence the reforms in the early 90s. For instance, you could use propranolol to treat hypertnsion in most of Europe by '68, but not in the US until '78. That cost 10,000s of lives right there. Luckily the modern FDA is better - though it still needs improvement.