3 ms·

Why fight one-by-one. The highest impact use of money would be lobbying to disolve the FDA or, failing that, eliminating the requirement to show efficacy (leavi

by abtinf 9y ago

Why fight one-by-one. The highest impact use of money would be lobbying to disolve the FDA or, failing that, eliminating the requirement to show efficacy (leaving only the requirement to show safety, which is relatively cheap). Of course, I anticipate a number of replies telling me how wrong I am and that regulations are needed for safety; none of them will mention the trade offs involved.

obastani 9y ago
Why would disolving the FDA fix the problem? If you don't do clinical trials to establish efficacy, then how will doctors know which treatments are effective and which ones are bogus? Randomized trials are important here due to the causality issues inherent in establishing efficacy in hindsight.
jashephe 9y ago
For lack of a rebuttal to the FDA dissolution comment, which I'm sure others are more qualified to respond to, I wanted to address the efficacy/safety remark: A growing number of people have voiced objections to the burdens of the FDA's efficacy testing requirements, but it's worth at least thinking about why they're in place. The main issue is that "safety" in the context of pharmaceuticals doesn't mean "perfectly safe" or even "non-lethal" — it really means, "safe enough, given the benefits". Side effects of a chemotherapy drug that can completely eliminate a tumor, for instance, could be acceptably substantial, because it cures an otherwise terminal illness. Side effects of a drug mildly lowering cholesterol levels, by contrast, must be strictly limited, because many Americans may take such a drug for much of their adult lives, sometimes in combination if the effects of a single drug are too weak. It's hard to know if the benefits outweigh the risks if you don't know what the benefits are. Obviously, this efficacy testing carries a huge time and monetary burden, but without it, contextualizing acceptable risk would be difficult, if not impossible.
maxander 9y ago
"We're having issues with users forgetting their login password. We could implement password-recovery protocols to solve this on a case-by-case basis, but it's much more efficient to solve these issues once and for all by eliminating the login system altogether."

by abtinf 9y ago

obastani 9y ago

Why would disolving the FDA fix the problem? If you don't do clinical trials to establish efficacy, then how will doctors know which treatments are effective and which ones are bogus? Randomized trials are important here due to the causality issues inherent in establishing efficacy in hindsight.

jashephe 9y ago

For lack of a rebuttal to the FDA dissolution comment, which I'm sure others are more qualified to respond to, I wanted to address the efficacy/safety remark: A growing number of people have voiced objections to the burdens of the FDA's efficacy testing requirements, but it's worth at least thinking about why they're in place. The main issue is that "safety" in the context of pharmaceuticals doesn't mean "perfectly safe" or even "non-lethal" — it really means, "safe enough, given the benefits". Side effects of a chemotherapy drug that can completely eliminate a tumor, for instance, could be acceptably substantial, because it cures an otherwise terminal illness. Side effects of a drug mildly lowering cholesterol levels, by contrast, must be strictly limited, because many Americans may take such a drug for much of their adult lives, sometimes in combination if the effects of a single drug are too weak. It's hard to know if the benefits outweigh the risks if you don't know what the benefits are. Obviously, this efficacy testing carries a huge time and monetary burden, but without it, contextualizing acceptable risk would be difficult, if not impossible.

maxander 9y ago

"We're having issues with users forgetting their login password. We could implement password-recovery protocols to solve this on a case-by-case basis, but it's much more efficient to solve these issues once and for all by eliminating the login system altogether."