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Comment by leonth | Hacker News Reader

But the argument still stands, right? Who will be responsible if the "extremely well-understood drugs" have some problems in the US? They don't care about US population because it is such a small market for them. Let's say we lower teh barrier of entry by waiving these "extremely well-understood drugs" from proper research in US. There are instances of drugs that exhibit different side effect profile due to genetics in different population, and this sometimes tip off the risk-to-benefit balance, how do you account for that?

The more barrier you place for drug approval, the safer it will be. It is a classical risk-versus-benefit trade-off. If there is an option that may be slightly more effective than current practice but has unknown (or perceived less certain) side effect profile, healthcare industry mindset prefers the status quo.

"First, do no harm." http://en.wikipedia.org/wiki/Primum_non_nocere

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I would be on the same page as you if the FDA and the American medical establishment had a great track record of protecting Americans from harm. As it is there's massive over-prescription of dangerous chemicals doing serious harm. Remember Vioxx? Remember estrogen hormone replacement therapy? There's currently massive, dangerous over-prescription of statins, amphetamines for kids, female hormones, and SSRIs.

Consequently I take a bit of a more libertarian perspective on pharmaceuticals. You can't really trust the government or most doctors anyway. So people might as well be more free to find helpful chemicals.

Over-prescription is the problem of the prescribers' and their incentives, not FDA. FDA opens the tap, prescribers put the water in the cup and give to patients. Patients do not access the water directly. Your concern is better directed to American Medical Association (AMA).

If you think you can find helpful chemicals on your own, you are either very confident to use your own body as a guinea pig or suffering from http://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect .

The FDA specifically on-label approved ritalin for kids, hormone replacement therapy, and statins for people with high cholesterol but no signs of heart disease. Your faith in regulation is misplaced. If you take FDA approval and a doctor's recommendation as proof a prescription is safe you are misguided. (The AMA is a lobbying organization to which about 15% of doctors belong and is irrelevant here.)

There is no reliable government organization out there stopping harmful medical treatments. I just want to acknowledge that as fact rather than pretend otherwise and deny people choices.

> The FDA specifically on-label approved ... statins for people with high cholesterol but no signs of heart disease.

You say this as if it were bad, but the net effect is to save lives (at a cost of money and increased diagnoses of diabetes). Statins are an example of the FDA and the industry actually doing the job they are supposed to do.

I may not be as well-informed as you, but I don't see a problem on those on-label uses you mentioned.

If you want to evaluate the safety of a prescription, I hope you have the right degree for that. Things can look safe on one paper and not safe on another. Or your condition may warrant a risk of greater side effect with the upside of better efficacy. It's true that doctors and FDA can make mistakes, but they are the best people you have.

Uh oh... Didn't know that your AMA is such a place. Do you have a association that represents all prescribers? Prescribing habits should be looked over by them.

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