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Even though his disease is life-threatening, his seizures are worsening and he continues to lose white matter, we'll need to prove that it's safe.

A good argument could be made, that bureaucratic regulators who get nothing if your son is cured, but could get in trouble if something they allow hurts him even more, are partly responsible for slowly killing him.

For individuals in a dire enough state, a more intelligent set of regulations could be something like if enough well known and respected doctors agree this is worth trying, go for it. But bureaucracies are rarely intelligent.

It's just that most of the time bureaucratic involvement creates frustration, costs money, takes time, kills economic growth, etc.

But when it comes to life threatening disease and potential cures, bureaucratic involvement might actually cost lives. Because it is not optimizing saving lives, it is optimizing "safety" over lives, because it is actually optimizing bureaucratic ass covering.



The FDA has a concept of http://en.wikipedia.org/wiki/Compassionate_use which would allow them to use the drug even without any proof.


Much as I might complain about the FDA sometimes, things have changed for the better since the days when thousands of people were dying for lack of treatments that had been approved in most European states a decade ago.


Thanks for answering the whole issue I came here to complain about, always a nice change to see laws functioning semi-rationally.


I find this to be a very interesting idea, although I'm still a little dubious about it. I first heard it from an interview with famous Libertarian [Milton Friedman][1] (whom I adore) in his twilight years. The self-regulating mechanism of a system like this would be tort law, allowing consumers to sue companies if they haven't done adequate research and testing on their drugs before selling them. I have mixed feelings about this because I have a hard time picturing a class action suit being able to adequately take on a large pharmaceutical company with its own dedicated legal department.

[1]: http://www.youtube.com/watch?v=KUDV0YII6lk&t=4m10s


People win class action suits against big corporations quite frequently.

And the pharma industry's own actions show that they know they're vulnerable to torts. That's why they lobbied for laws like the Vaccine Act of 1986, which limits their liability for damage caused by vaccines.




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