[BurningFrog]

Discussing FDA type regulation you need to consider both costs and benefits. As with everything else, of course.

The Thalidomide argument points out the benefit: These regulations avoid releasing medications with bad side effects to the population. Nobody denies this is a good thing.

The costs are more rarely discussed. I think these are the main ones

1. When approval of a medication is delayed 10 years, everyone who would have been cured/helped by it during that time pays. Often with their life.

2. The high cost of FDA level trials makes medication more expensive. It also makes some medications economically unviable, with similar costs as in 1.

I'm not aware of any study trying to quantify these effects, but my wild guess/gut feel is that the costs are ~100 times bigger than the benefits.

The PR problem is that victims of bad medications are seen. The Thalidomide sufferers became world famous. But the ~100k Americans who died while the FDA took 17 years extra to approve beta blockers had no idea why they died.

[matt4077]

Having worked a bit in the industry, changes in regulation aren't actually the main problem. There are two trends combining: some tightening of the rules, yes (although the 'hockey stick phase of regulatory interference' was after WW2) and, much more importantly, a complete collapse of research success.

We're still basically following the process established in 192x (Bayer, sulfa drugs) of throwing any structure we can think of onto some essay, into some mice, then humans. Educated guesses have become more educated, but not much better.

Regulation has only become a burden because we're chasing ever-decreasing improvements. Even placebo got better over the last decades, which may have doomed a few potential blockbusters.

It's obviously a problem of the lower-hanging fruits having been picked, and not all is bleak (kicking HIVs butt these days). But a cell just happens to be 35mill lines of self-modifying, multi-layered, self-evaluating, quantum-effects-using complexity and we're far away from a rational, hypothesis-driven drug discovery process.

Deregulation wouldn't actually help. While it is possibly attractive for a patient now, that comes at a certain and significant disadvantage for future patients: If you could sell everything you wanted, there'd be no incentive for studying efficacies – it'd just be random stuff that may work, competing in a dysfunctional marketplace.

Dysfunctional because nobody would know anything. Even with the somewhat professional studies we have today, and even for professionals, it is a major undertaking to form a solid opinion on a drug. Throw in patients who have nothing to lose and it'd probably be worse than it ever was.

It's not like experimental treatments aren't available today. Almost every cancer patient is enrolled in one or more trials, unless she immediately responds to existing drugs. Quite a few people have traveled to Asia for some stem cell snake oil (less money, nice tan, no improvement, life-threatening complications being the usual outcome).

[Fomite]

We do however have both historical examples of pre-regulation pharmaceuticals and the supplement industry to examine, and neither one is a shining light of efficacy or safety.