5 ms·
It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of
by Symmetry 12y ago
It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of which are helpful and some of which are harmful. But you don't have any perfect means of figuring out whether a drug is good or bad. If you start from no screening it's very easy to stop a lot of bad drugs without stopping many good drugs, but as you apply tighter and tighter criteria the ration of good drugs you accidentally stop for each bad drug you stop gets higher and higher.[1]
In practice, of course, some of the rejected drugs aren't explicitly rejected by the FDA but rather rejected by the system because they are never put through the FDA screening in the first place, but the principle is the same.
One would ideally want to set the difficulty of getting through FDA testing to maximize some quantity, such as the average effect of an approved drug on people's Quality Adjusted Life Years. But it's clear that this is not actually what happens. When the FDA rejects a drug people never hear about the lives that were not saved by it, but if even a single person is killed by a drug that was let through FDA screening. Every study on the matter that I've seen says that the FDA is actually way too restrictive in how it regulates drugs. And I should mention that this is in contrast to other countries such as most of Europe or Canada or Japan which have much saner drug regulation regimes.
I should also say that this is only a criticism of the FDA in it's role as a drug regulator. It seems to do a pretty good job as a food regulator. I suppose the number of voters involved in food production dwarfs those involved in drug production.
[1] You get more type 1 errors for each type 2 error.
http://en.wikipedia.org/wiki/Type_I_and_type_II_errors http://en.wikipedia.org/wiki/Type_I_and_type_II_errors
- refurb 12y agoYou have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FDA does a dam good job to be honest. Mistakes are made, but I'd give them an A- overall. The other thing to keep in mind is that the US has pretty lenient "supplement" regulations. As long as you can prove it's safe and don't make efficacy claims you can't backup the FDA will often leave you alone. I'm often amazed at what the FDA allows regular citizens to buy.
- Symmetry 12y agoI'll admit that on average the FDA has gotten better over the last few decades. They are genuinely better than when they caused 10,000 excess deaths a year for a decade due to their refusal to permit beta blockers during the period they were in use in other countries. But you can't say "Both Type 1 and Type 2 errors are occuring, so they must be balanced."
- refurb 12y agoI think the point stands that the FDA get almost no credit when it rejects drugs that could have harmed Americans and get fully blamed when any drug causes excess deaths in the US. That's the big problem. In addition, the public has little appetite for conversations that start with "We balance risk so only a handful of Americans die..." The public has zero tolerance for any mistakes the FDA makes, which I think is unfair, but that's the world the FDA lives in.
- dmm 12y agoThalidomide was very effective in treating morning sickness, it "just" wasn't safe. Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments?
- ewoodrich 12y ago> Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments? ... because it wasn't safe for use by pregnant women? Am I not understanding part of what you're saying? I wouldn't consider that to be truly "effective" when the side-effects are quite serious. And by the nature of the medication, all pregnant women taking the drug are necessarily at risk of these side effects.
- Symmetry 12y agoThe big debate is whether the FDA should approve a drug as being "safe and effective", or whether it should just declare a drug "safe" and then leave it to doctors to decide what they use. The later is what most of the world uses and what reformers want the FDA to adopt. Moving to the later would not have done anything to prevent the Thalidomide tragedy.
- cbsmith 12y ago> And I should mention that this is in contrast to other countries such as most of Europe or Canada or Japan which have much saner drug regulation regimes. Except for example, Canada tends to just accept whatever the FDA accepts.