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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 $5 million" drugs, where of course the cri-de-coeur is "every week of delay means another 1,000 people die!" (not considering that those people might die anyway because the cure is only speculative even if they go on the drugs or the treatment protocol).
I mean there’s good risk and stupid risk. It’s not good to release a drug with very serious side effects or that don’t work. I don’t think anyone is calling for that anyway. On the other hand, there are drugs that are clearly working (and in some cases approved for use in other countries) that are still required to go through decades of testing to prove that they work just as well here as they do in other places. That doesn’t help anyone. If the drug works in Russia and has been used for decades, it’s probably fine.
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I think like most things it’s a form of what I call Yarvin’s Disease which is the tendency of any bureaucratic system to avoid being to blame for anything. He talks about this quite a lot, but it’s generally the case that while the FDA can only be blamed if something goes wrong it can never get credit when things go right. As such, there’s zero incentive to take a risk going fast, even if the potential cure is world changing. If it’s going to turn people’s hair funny colors the FDA gets blamed for not doing enough tests. On the other hand, slowing things down doesn’t cause blame. If the cure for cancer is held up for twenty years because the FDA wanted the triple check that it doesn’t cause tummy aches, nobody’s going to call for investigations. So, going slow preserves the FDA which is the point.
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No, because you can just go down to the store and buy fish oil for 30$? Not to mention eating fish oil isn't progress, we've been doing it for I don't know how many years. Lovaza is different in that it is manufactured in a GMP facility, with GMP protocols and supported (I presume, I don't follow the fish oil literature) by expensive clinical trials. Maybe you don't care when it comes to fish oil, but you probably care that your hideously complex chemo drug is both 1) effective and 2) safe.
Would the libertarians paradise where drug manufacturing and prescription was completely unregulated, and savvy consumers learned which manufacturers were reputable and which drugs were efficacious by word of mouth be better than what we have now? No idea, although it's worth noting that we effectively had that paradise in the era of snake oil salesmen and sulfanilamide killing over 100 people. We had thalidomide, we had SV40 contaminated polio vaccines, and other incidents I can't remember off the top of my head. I think it's reasonable to question whether the FDA in it's current state is net positive and how it can be reformed, but I'd wager that the vast majority of the 'FDA delenda est' crowd have no idea why this fence was built in the first place.
As some other anecdata, if you like, until recently many Chinese people prized medicine (and other goods!) manufactured in the USA. Largely due to the regulation and processes you dislike.
Difficult for me to comment as I'm about up to date on epipens as I am on fish oils, but the rejection seems pretty opaque. Are you confident that the entirety of the issue here is the FDA just sitting on their application/dragging their feet, or were there actual major problems with the design?
What does 'theoretical-within-punishing-the-elites pharmaceutical regulator' mean?
Regardless, at the end of the day you face tradeoffs between safety and cost. The ideal number of pharmaceutical recalls/killed patients isn't zero, but it's hard to say what the optimal number is.
If you're curious, the Chinese have significantly deregulated. They also use a lot more 'phase zero' clinical trials that allow smaller biotechs to get clinical data much more easily and, as a result, are on a trajectory to wreck the US biotech ecosystem in the next 5-10 years. That said, I'd bet they've had some nonzero number of patients in clinical trials develop serious adverse events that were kept hush-hush in a way that's impossible to do in the USA.
Well, he appointed an HHS secretary (who oversees the FDA) who fucking hates the pharmaceutical industry. As far as I can tell, the twin north stars of RFK Jr. are 1) pharmaceutical companies are evil and 2) COVID was manufactured in a lab and facilitated by NIH money. I don't think he's a man who wants to maximize the number of drugs large pharma companies can get approved. They've also (as far as I can tell) entirely cut off government grant money to at least Harvard, Brown, Columbia, Cornell, Northwestern and others which probably isn't optimal for progress. He's threatening to block government scientists from publishing in top medical journals and is instead promoting his personal weird one. Biotech in the US is probably dead in the water, and the future is Chinese.
Ah yes, the same China that had the melamine added to baby formula scandal in 2008 and 2012 contamination with mercury.
Granted, being able to execute people who do this probably will make deregulation less risky, but I am not filled with optimism that somebody won't try taking short cuts there, at least on the level of "repackage cheap product as premium and charge the higher prices".
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Koremlu, a popular depilatory whose active ingredient was thallium acetate.
Radithor, giving people radiation poisoning for ten years.
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I'm in favor of the libertarian paradise option.
There are two failure modes of the FDA:
The natural and personal and business incentives already heavily align towards getting good drugs out there, and not taking bad drugs.
You seem well informed, I'm surprised you even mention a drug killing a 100 people. I would shrug my shoulders at a thousand. FDA drug delays have estimated kill rates in the hundreds of thousands for some heart medications.
Optimal situation in my mind would be to switch FDA over to a certification regime rather than a licensing regime. This is basically the same thing I say about all government regulation, but I say it about everything because I think its a good idea. Certify that a thing is safe and not harmful, but do not require that certification for selling or consuming of the substance. Companies can submit their drugs to be certified, and the FDA runs those tests. They also run some number of public interest tests every year, like for fish oil or whatever.
And yeah, who knows wtf will happen with JFK at the helm.
Ok, that's it. I criticized the Democrats for hiding Buden's decline, so I can't, in good conscience, support Trump when he's appointing literal corpses.
I think he just sounds like a corpse but is relatively healthy. He has some voice condition.
Or did you mean he is a corpse because he is a Kennedy family member in politics?
RFK Jr. sounds like a corpse.
You said JFK. Barring some new information, he is a corpse.
I enjoy telling conspiracy theorists that JFK survived his assassination, donned blackface, and changed his name to Tupac.
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No, it's just a silly joke based on you getting the first initial wrong. Unless I there's another Kennedy in the admin that I'm not aware of.
Ah whoops
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Yeah, you can buy medications online that are totally for your dog, bro. Few choose to do this.
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Great counterpoints! The abuses of the medical system in the past were pretty horrific now that I think of it. The stuff we have today isn't great but could definitely be worse.
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And now we're being told that after all maybe fish oil does nothing, or might even be harmful. Nobody knows nothing about nutrition.
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