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Comment author:DanArmak
02 October 2016 05:48:42PM
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This raises some interesting questions.
If the end result is fraud and bad medicine, whether you regulate more or less, is that a reason to regulate less so money isn't wasted on mandatory fraudulent studies?
Regulation raises the the barrier of entry to selling medicine. Does this reduce the amount of fraud because it's harder to to sell completely untested medicine and there's at least some quality control by the regulator? Or does it increase the amount of fraud because once a drug costs huge amounts of money to develop and approve, companies are less willing to take a loss if they discover the drug doesn't really work, and so lie more?
Comment author:DanArmak
03 October 2016 12:55:14PM
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If you don't regulate truthfullness of published efficacy info, then companies will compete on advertising and bad studies to claim efficacy of their products. I don't think that would lead to a marketplace where non-experts could reach correct conclusions about efficacy.
I have no real idea about the efficacy of most non-regulated things I'm sold, from deodorants and toothpaste to computer software. It's just that with these things, the risk of occasionally buying something bad and learning not to use that anymore is acceptable. Not so with medicine.
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Comments (18)
The FDA actually does regulate less than the CFDA in this case. The FDA doesn't disapprove 80% of the drug seeking approval for misbehavior.
If you look at the Ranbaxy case the FDA is quite bad at detecting data forgery of generics companies.
This raises some interesting questions.
If the end result is fraud and bad medicine, whether you regulate more or less, is that a reason to regulate less so money isn't wasted on mandatory fraudulent studies?
Regulation raises the the barrier of entry to selling medicine. Does this reduce the amount of fraud because it's harder to to sell completely untested medicine and there's at least some quality control by the regulator? Or does it increase the amount of fraud because once a drug costs huge amounts of money to develop and approve, companies are less willing to take a loss if they discover the drug doesn't really work, and so lie more?
Don't regulate efficiency. Regulate consistency of formulation, at most.
There are plenty of actors interested in efficacy. Really, everyone else involved.
What's generally regulated is side-effects.
If you don't regulate truthfullness of published efficacy info, then companies will compete on advertising and bad studies to claim efficacy of their products. I don't think that would lead to a marketplace where non-experts could reach correct conclusions about efficacy.
I have no real idea about the efficacy of most non-regulated things I'm sold, from deodorants and toothpaste to computer software. It's just that with these things, the risk of occasionally buying something bad and learning not to use that anymore is acceptable. Not so with medicine.