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by jcranmer
2852 days ago
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A lot of these kind of proposals share the same basic misconception: they assume that once a company identifies a drug candidate, then it's because it works, and the regulatory hurdles it needs to clear to be approved are just bureaucratic paperwork. But the actual evidence of the drug approval process is that said model is completely the opposite of reality. Most drug candidates--around 90%--ultimately fail. Half of all candidates advanced to Phase III (the main efficacy trial) fail. Any serious proposal needs to start from the basis that a drug probably won't work, until proven otherwise. There is, as it turns out, an existing market segment for drugs that are safety-only-no-efficacy-required approval status. It's the herbal supplement industry, and it makes Big Pharma look like saints in comparison. There's been plenty of exposes showing that many supplement companies can't even be bothered putting the active ingredients in their products. |
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Also any proposal needs to take into account that drug trials kill something like 1-2% of patients and inflict lifelong damage on a further 5-10% of them.
Yes, even the ones "proven" to be safe (in the very short term) to use on normal healthy people.
We've had "free to choose" medicine before, and time and time again there is a screwup where 50 or so people (sometimes more) get subjected to incredible damage or killed because of a confluence of factors (pregnancy is a factor that is particularly famous for messing with drugs in a thousand different ways, as is alcohol, parasites, and certain types of bacteria. But it is very hard to know beforehand, there's even a few drugs that have different effects on different races)