Well, you certainly passed my low bar for rationale. I still can't agree though.
Any argument based on statistics is going to be strongly biased against the FDA's current procedure. It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. Furthermore, a simple utilitarian argument about the net lives saved is not how most people would comprehend the situation. The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have.
Being biased towards conservatism is appropriate at the scale of approving drugs and advertisement towards an entire country. Most people do not have the knowledge (even considering the internet) to appropriately evaluate a drug. I would wager that even doctors are not equipped to make this sort of safety evaluation for their patients. This is exactly the sort of thing that scientists taking a conservative approach should be doing.
Read the links I gave. I wasn't expecting you to be convinced just by what I wrote above.
Before 1962, the FDA was tasked to verify safety but NOT to verify efficacy. Everything you just wrote only argues for that - for keeping drugs off the market that "kill someone" when they take it. It does NOT argue for keeping drugs off the market that we know are safe but can't yet conclusively prove work "better than a placebo" or "better than the standard treatment" in a study.
After 1962, the FDA was tasked with determining efficacy. That is the part where the main problem lies. It turns out that proving that a drug probably doesn't kill people is MUCH easier than proving that a drug "works" at a level better than some metric.
To prove a drug is safe, we have models and processes to calculate the LD50 and verify that people who take it at expected dose levels don't get sick. But to prove it's effective is hard. Hard enough that, in practice, insisting on it it kills hundreds of thousands of people. As one popular example, when the FDA approved beta blockers for use in preventing heart attacks, the FDA's own press release claimed that the newly approved drugs would save 10,000 lives per year, based on the results seen in Europe where the drugs had been in use for the prior decade. Economists look at that and notice that seems to suggest keeping that one class of drug OFF the market in the US after it had been approved in Europe killed on the order of 100,000 people all told. That is a very large death count. The worst death count we've ever seen due to drugs that "slipped through the cracks" prior to 1962 is a few orders of magnitude smaller than that.
> The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have.
That is true, but in this case the "intuition that most people have" is WRONG. By any rational standard, killing a hundred people by preventing them from getting their medicine is MUCH WORSE than killing one person by letting him get his medicine...even if we know who the people affected are in the latter case and not the former. That is approximately the sort of tradeoff we're looking at.
> It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison.
It is difficult, but probably not impossible. One might look at the death rates attributed to medicinal prescription drugs under various regulatory regimes. In the US, you can compare drugs approved pre-1962 versus post-1962 - if the FDA's extra testing in the modern era were really valuable, there should be a bend in that curve in the correct direction (hint: there isn't). One can also compare with other countries that changed their regulatory regimes to be stricter or looser. Sure, you can't get an exact number of deaths, but you can make a plausible estimate. And this calculation WAY favors the FDA approach, due to the "what is seen and what is not seen" factor - people who die from taking a drug show up in newspaper headlines blaming the drug whereas people who die from NOT taking a drug do not show up in newspaper headlines blaming the FDA. :-)
BTW, one simple huge improvement would be to just say that any drug approved for use by some other country's regulatory apparatus could be used here too with a mere "not yet approved by the FDA" warning label.
I read two of the links and skimmed the third. They weren't terribly convincing. You certainly have a point about beta-blockers, there was already a natural experiment being conducted on a mass scale in Europe. If it looked like it was safe and effective, there's no reason why that shouldn't have been used as evidence to expedite the approval process in the US. This isn't an indication that the entire process needs to be overhauled though.
As far as determining efficacy, I prefer this to the alternative. Simply judging rates pre-1962 doesn't really capture the potential for abuse that exists in our current media-saturated lives. Many European countries completely ban drug marketing towards individuals. If the FDA allowed drug makers to market unproven drugs in the US, that would create a huge clusterfuck of false advertising and manipulation. You cannot responsibly advocate both positions.
>By any rational standard, killing a hundred people by preventing them from getting their medicine is MUCH WORSE than killing one person by letting him get his medicine
Yes, using the severely biased statistics that are available. In an environment where proof of efficacy were not required, one can imagine that the drug making business (in the US where direct marketing is allowed) would be even stronger with greater pressure to push drugs on the general population. At scale, deaths rates due to drugs will show up that are impossible to discover using small scale testing. It is known that generic Aspirin kills a hundred or so people a year around the world. More widespread usage of drugs, which is the direct result of what you're proposing, would undoubtedly cause more such cases.
Forget "marketing". Take that out of the equation. I don't care if you ban all marketing to individuals. (Well, I do, but that's an entirely separate argument, and a distraction from this one). The question here is just what drugs can legally be sold or prescribed, regardless of how people learn about them. Currently, "off-label" use is COMPLETELY ACCEPTABLE to the FDA! Once a drug is legal to use, you can use it for any condition at all, not just the condition it was proved efficacious for.
So we already have current widespread use of drugs that haven't been proven efficacious. It doesn't seem to have been a disaster. In fact, widespread use of drugs is one of the few forms of medical intervention that demonstrably makes people more healthy on net. Right now the rule is that it's legal to use drugs if:
(a) they got accidentally grandfathered in due to historical use (eg, aspirin and penicillin would NOT have passed the FDA's current standards), or
(b) they were patentable and turned out to be useful enough for treating SOMETHING that it was worth spending on the order of a billion dollars getting SOME use approved, even if it's not the use it's being prescribed for now.
Meanwhile, a drug that is just as effective but isn't patentable or treats a rare enough condition that it's not worth spending a billion dollars to get it through trials in the US...is not legal to prescribe.
Can you honestly justify that contrast?
If a drug has been legal in, say, Denmark, for five or ten years, has seen widespread use, and hasn't caused mass deaths THERE, why can't we just automatically make it legal to use here WITHOUT spending hundreds of millions of dollars redoing the same studies here? Do we think the FDA is somehow smarter and better at its job than its equivalent in every other country in the world?
The FDA faces the wrong incentives. It has no reason to take into account the huge cost of the harm it does, which is a matter of life or death to people with rare or serious diseases. It needs to be fundamentally overhauled or gotten rid of entirely. Yes, there would be costs to letting more people take more drugs...but every serious attempt to estimate it says the benefits would outweigh the costs. If you don't want sick people dying needlessly, you should be opposed to the FDA in its current form. It is an idea whose time has gone.
Any argument based on statistics is going to be strongly biased against the FDA's current procedure. It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. Furthermore, a simple utilitarian argument about the net lives saved is not how most people would comprehend the situation. The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have.
Being biased towards conservatism is appropriate at the scale of approving drugs and advertisement towards an entire country. Most people do not have the knowledge (even considering the internet) to appropriately evaluate a drug. I would wager that even doctors are not equipped to make this sort of safety evaluation for their patients. This is exactly the sort of thing that scientists taking a conservative approach should be doing.