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Notes -
I decided to go back to my saved comments on here, and found a great one on the FDA and progress that made me think. Here's the text:
Okay? The FDA does not perfectly impede progress isn't a contentious claim. How about bromantane from my last link (An Iron Curtain Has Descended Upon Psychopharmacology):
Does that count as impeding progress?
It only took them nine years! Congratulations to Teva Pharmaceuticals on their achievement.
I suppose it also comes down to the baseline we're discussing. Does the FDA impede progress relative to what, and by how much?
I think that the FDA impedes progress relative to a theoretical-within-punishing-the-elites pharmaceutical regulator, and the difference is enough to make a material impact on a decent fraction of people.
endquote
Anyway, the reason I bring this up is that I'm very curious how the Trump admin has been doing tackling regulation. There's a lot of things going on, and regulation seems to have lost the spotlight, but I'm very much hoping that we walk away from the next few years with dramatically reduced regulatory agencies.
Anyone have thoughts on how the promised regulation reduction is going?
I do think the FDA has a thankless task. First, the very real risk of litigation means that if they fast-track anything and it ends up that oops, when it comes to millions of real world patients, the very rare side effects do crop up in noticeable numbers, then somebody is going to take a lawsuit to sue the pants off everyone. Hence, the risk-averse nature of "let's make really really sure this doesn't curl your hair" when it comes to the approval process.
Second, when it does fast-track something, for every person who goes "yay! warpspeed hastened through the covid vaccines!", you will have another person writing how the vaccines murdered and are murdering thousands of healthy young people by causing them to drop dead of cardiac events, and they'll reference studies like this one, so damned if you do, damned if you don't.
Not to mention the whole Aduhelm controversy, where the drug has been discontinued after it got fast-tracked due to a combination of the drug company getting Alzheimer patient support and activist organisations to put pressure on and behind the scenes politicking, where it caused upheaval within the FDA and besmirched its reputation.
I think like most things it’s a form of what I call Yarvin’s Disease which is the tendency of any bureaucratic system to avoid being to blame for anything. He talks about this quite a lot, but it’s generally the case that while the FDA can only be blamed if something goes wrong it can never get credit when things go right. As such, there’s zero incentive to take a risk going fast, even if the potential cure is world changing. If it’s going to turn people’s hair funny colors the FDA gets blamed for not doing enough tests. On the other hand, slowing things down doesn’t cause blame. If the cure for cancer is held up for twenty years because the FDA wanted the triple check that it doesn’t cause tummy aches, nobody’s going to call for investigations. So, going slow preserves the FDA which is the point.
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