3 ms·

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 exp

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.

glenra 14y ago
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.

glenra 14y ago

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.