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Comment by dantheman | Hacker News Reader

They trust their doctors. In the rest of the world there are not the restrictions on drugs that are found in the USA. Also, what about all the people that could be saved by a medicine that have nothing to lose if it doesn't work since they have no other options -- right now they SOL. The amount of people that die because they cannot receive medicines that may work is staggering and a great injustice.

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Do you have data on the number of people who die because the FDA has not approved a drug that may save their life? Note that this is different from people who die because they can't afford treatment.

I would be more comfortable with point 4 if we once again banned prescription drug advertisements.

> Do you have data on the number of people who die because the FDA has not approved a drug that may save their life?

That question wasn't directed at me, but finding out some data wouldn't be too difficult - you'd look up what life saving medicines had come to market since the stricter FDA regulations were enacted, what year the medicine entered trials, how many people died while they were in FDA trials before release. You could come up with some rough numbers for that, but the FDA doesn't post any information on added costs and deaths during trial periods. Obviously the safety trials save some lives, but the efficacy standard the FDA has is extremely high and adds millions and years to costs.

> I would be more comfortable with point 4 if we once again banned prescription drug advertisements.

The tough question is for drugs that people not be aware there's solutions for - erectile dysfunction, for instance. A lot of men just assumed that was something you had to live with when you got older before Viagra came out. Advertising for Viagra was probably a win for everyone involved - it educated doctors and patients that it's available, and obviously men and their partners were quite happy with its effects.

So some advertising definitely has positive benefits, but I see what you're getting at with snake oil claims if the FDA isn't as strict about playing gatekeeper. Something to think more about.

I think the effect of eliminating the efficacy standard would just be to shift the cost from one that is paid upfront by the company and then borne by the consumer to one that is wholly borne by the consumer. The cost of finding effective treatments would not be reduced, but just more hidden in the cost of having the market weed out more medications, misinformation around claims, etc. Just look at the supplementation market which the FDA does not regulate much. How many people waste their money chasing claims that have little or no effect?

In life or death cases, the FDA can grant a Humanitarian Use Exemption. eg. Experimental cancer treatment drug.

The key difference is in the "experimental" part, as that drug cannot be marketed until its fully approved.

The doctor would have to get permission from the patient, and their hospitals "Ethics Review Board"

I believe this is a question often studied in Economics journals, you may want to look there. If I remember correctly, it is referred to as "Type I vs. Type II" error. One type of error is when a drug is approved prematurely and people are harmed because of it. The other type of error is when people are harmed because a useful drug is kept off the market. Some economists theorize that the second type of error would be more common, because the first kind of error is more visual and visceral. I believe there have been studies attempting to find evidence for the theory, but I'm not an expert and have never kept up with the latest journals in economics.

Remember that the FDA in the US only requires that a drug be better than placebo to be "effective" in many cases the drug company just has to show 0.1% better than placebo to get passed.

They need to prove statistical significance. Getting a 0.1% better drug past would require a pretty large control and sample group, making the drug more expensive to continue to test. Also, the doctors are given the drug's effectiveness vs placebo, and no doctor is going to give a drug that give the patient a 50.05% rate of recovery when 50% is the base.

I don't have any hard numbers, but here is a good article from 2007 that may provide insight into the problem.

http://reason.com/archives/2007/07/25/dying-for-lifesaving-d...

In the rest of the world there are not the restrictions on drugs that are found in the USA.

I have lived overseas long enough that I have been treated by licensed medical doctors in another country, who prescribed to me drugs that are not permitted in the United States. That was not a happy experience. I eventually had to have FDA-approved drugs that ACTUALLY WERE SAFE AND EFFICACIOUS sent over to me as I continued my stay in that country. There are prescribing and dispensing biases in other countries that frequently cause the most safe and effective medicines to not even be available in those countries at any price, even long after FDA approval of the best medicines in the United States.

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