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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.
Yeah I agree, and I think this is a much broader problem than just with the FDA. In general government organizations are extremely risk averse due to how damaging litigation can be.
It's swings and roundabouts. Bodies such as the FDA were set up because before that, in the unfettered and unregulated world of the free market, businesses were happily poisoning their customers. Then people got accustomed to "medicine is safe and indeed is a wonder drug" so any adverse effects were clearly somebody's fault and had to be paid for in punitive damages, which led to concerns by government bodies that "if we pass a medicine that later turns 1% of the population blue, we are gonna get slaughtered" and so caution became the watchword.
And now we're stuck between drug companies trying to get a return on their very long, very expensive, product development process where the bad examples are things like Aduhelm, and the calls by people who are (to be blunt) dying and desperate for Hail Mary cures so they want the FDA to rush through and license "this might extend your life by three weeks and it'll cost $5 million" drugs, where of course the cri-de-coeur is "every week of delay means another 1,000 people die!" (not considering that those people might die anyway because the cure is only speculative even if they go on the drugs or the treatment protocol).
I mean there’s good risk and stupid risk. It’s not good to release a drug with very serious side effects or that don’t work. I don’t think anyone is calling for that anyway. On the other hand, there are drugs that are clearly working (and in some cases approved for use in other countries) that are still required to go through decades of testing to prove that they work just as well here as they do in other places. That doesn’t help anyone. If the drug works in Russia and has been used for decades, it’s probably fine.
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