Do you have a dumb question that you're kind of embarrassed to ask in the main thread? Is there something you're just not sure about?
This is your opportunity to ask questions. No question too simple or too silly.
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Notes -
There's a lot about the COVID response that could fairly be described as insane, but I don't think the vaccine testing protocols were one of them. They are required to conduct multi-phase randomized double-blinded clinical trials to prove safety and efficacy, just like every other treatment marketed to the general public. For the COVID vaccines, the process was considerably accelerated by things like permitting the planning and organization of later trial stages before the results of earlier stages were fully analyzed and approved, which consists of things like setting up all of the trial sites, recruiting the necessary trial subjects, manufacturing and distributing the doses, etc.
It's possible to argue that the trial requirements should have actually been weakened. But considering the plans to effectively force virtually the entire population to take the vaccines right away, the new technology several of the vaccines used, and the widespread skepticism and resistance that was in fact present for the vaccines despite the standard testing protocols being followed, I think that's the last thing in the world we'd want to do. Pharmaceutical history is littered with the corpses of promising medications that turned out to have horrific side-effects and/or little to no efficacy against the thing they were supposed to be treating when they were actually properly tested. The backlash against the whole industry was bad enough as-is, just imagine how much worse it would be if one or more of the vaccines did in fact prove to be seriously dangerous.
Right off the bat, this is the part that you could just not do. It's amazing how just not threatening to do something even more damaging and dumb if you're not allowed to do something else damaging and dumb sort of just fixes the problem. This reasoning would be akin to saying, "If you don't let me impose onerous zoning and building regulations, I'll mandate that everyone lives in a shanty, so you better let me do what I want, even though it's dumb and damaging." There is an alternative; you could just not do either.
In any event, what do you know about vaccine development timelines for animals?
First off, I agree that, in my overall estimation of the disease and results, the vaccine mandates were a terrible idea.
In the larger picture, I want to agree with the overall Libertarian idea that it would be nice if we could both have individuals not be legally barred from taking any drug a company felt like selling at their own risk, clinical trials conducted and evaluated by one or more independent entities, and individuals can choose to pay attention to or ignore the recommendations of any of those trial entities on their own when deciding which drugs to take. But for better or worse, we're so far away from that world in the way our society currently runs that it's just not viable to cherry-pick one or two things from that world and try to just apply to them to ours.
The mandates certainly exacerbated the problem, but I think even without them, allowing such a vaccine to be let out into the world with no trials at all would still potentially be a monumental disaster. Who would take such a vaccine in a world with no mandates at all by anyone ever, including private entities free to choose their own policies? The Covid-maxxers, of course, the ones so radically terrified of it to be hiding indoors, wearing multiple masks, etc. They would jump to take it as soon as possible, as many millions of people did in fact do once they were released. And what then if it turned out to be far more dangerous than Covid itself, or even helped it spread faster, as quite a few drugs have in fact been discovered in trials to actually do? Now that would be one hell of a mess.
In any case, I don't know much offhand about animal drug approval process. A little googling turned up that the FDA claims to regulate regular drugs and medical devices for animals, but not vaccines for them, which apparently falls to the U.S. Department of Agriculture. They seem to have a FAQ page about it. I found a PDF of "New Firm Informational Packet for Live and Inactivated Vaccines", and the process listed there sounds broadly similar to the process for human drug and vaccine approval. I'm guessing it's probably somewhat faster than the approval process for human drugs, but not dramatically so.
It's not a matter of cherry-picking. It's simply stating that things are clearly good or bad. Mandates are clearly bad. FDA testing for information purposes, mixed in with insurance schemes, is probably mostly okayish, but it's clearly bad in a pandemic (in empirical terms, just looking at how it went). Banning people from taking risky but possibly hugely beneficial actions, regardless of their situation, is clearly bad.
Probably people who highly value the potential upside. For example, if you were someone who was older, perhaps with a comorbidity, and your line of work significantly depended on your ability to have in-person interactions with a significant number of people, there's a decent chance that you'd not just want to take the vaccine, you might even be willing to pay a lot to get one. There was plenty of chatter from wealthy business people who were saying that they would absolutely pay a bundle of money to get one, if only it wasn't banned. Any product has early adopters, even if that product has risks. People wondered about, say, the fire risk of EVs, but there were still plenty of early adopters... and they provided good data for others to understand the risks and value them appropriately. (Of course, now would be a good time to check in and see how you view the HCT/RCT debate, because this is a real, live, issue that people are debating, not just cherry-picking.)
This is one of the most common failure modes, perhaps even a typical mind fallacy. Because you think, in your situation, that you wouldn't want to take it, you think that no one would want to take it (or you think they'd have obviously wrong preferences, since they don't match up with your own). Of course, this comes with the converse typical mind fallacy, thinking that once the FDA has approved it, then since you would want to take it in your situation, everyone would want to take it. Of course, neither of those things is true, empirically. This also isn't cherry-picking; it's just observing what is true and what is not true in the world.
I don't know; some people could regret doing it; some people could regret not doing it. Did the FDA evaluate the fire risk of EVs through extensive trials and testing before anyone was allowed to buy one? Or autonomous vehicles? What if they turned out to be really dangerous? I guess we have one hell of a mess. Using an analogy I've used here before, what would the world be like if we just let people work on their own cars? (I.e., this world.) We didn't make every repair procedure have to be completely and thoroughly evaluated by the FDA and only dispensed by licenced mechanics. Different people would have different risk assessments! They'd make different choices! It would be a mess!
I get that you feel like it is your personal responsibility to make sure that enough people (not even just enough; presumably you will personally ensure that it's magically the right people magically at the right time) choose to take it, but not if it's those other people, who you personally don't want to take it right now. It is your job to decide for them. I'm sorry, but it's not your job. It's not your job to decide if I should diagnose my own check engine light or not, either.
Or even, say, bitcoin. Some people were early adopters. Others still don't have any. "Who would buy bitcoin, a silly little string of numbers, with no mandates or FDA approval? The bitcoin-maxxers, of course. And what if it then went to zero and they were all wiped out financially? (It could still happen!) Now that would be one hell of a mess." Eh. Some people could regret doing it; some people could regret not doing it. It is not only literally impossible for you to prevent all regret in all people everywhere, it is not your job.
I mean, I guess it's somewhat possible for you to prevent all regret in all people everywhere; you can just mandate/ban literally any action they could take. Give them no choices. Then they can't regret those choices, because you wouldn't allow them to choose otherwise anyway. That said, they'd probably regret appointing you as the No Ragrets Czar, because you'd almost certainly make choices that are bad for them in hindsight (like, for example, not letting them get a COVID vaccine). Many people are truly regretting the trillions of dollars, years of our lives, the social development of our children, etc. that were wasted by putting folks like you in power.
Shame.
I think it is. A possible reasonable alternative system is, no Government agency exists to approve medical treatments, instead, several independent organizations (possibly including a Government one) make recommendations based on their own criteria, but individuals are free to take what they want. In such a system, those one or more organizations are already set up, and people are used to making their own decisions and taking responsibility for them. I believe that basically nobody thinks that way now. I don't think you can just overnight in a crisis switch to the regulatory framework of that system and expect people to change their thinking overnight. It is perhaps telling that no country in the world currently works like this.
A lack of willingness to take responsibility for my own medical decisions is not my opinion at all. I am fine with doing this myself, but it is my belief that 95% of American citizens are not prepared to do this. This is based on observations of how they actually behaved during the actual Covid period. Which gets me to what I really want to object to:
Please refrain from putting words into my mouth or assuming what I think. I already said I would personally be fine with taking responsibility for my own decisions. I think it's the American people, and the people in pretty much every other country too, who are unwilling to do this. You may disagree that they think like this, or dislike it, but don't tell me what I think personally.
If we did allow people to take any treatment without testing, warned them hundreds of times that it was untested and anything could happen, and it turned out to be a disaster with hundreds of thousands of casualties, I would be any amount of money you care to name that they would all scream their heads off at the Government for allowing it to happen, vote them out of office, probably storm the gates of all the Pharmaceutical companies and lynch people, etc. Roughly 10 people would say, oh well, they did warn me it was untested, guess it's on me. If watching how people behaved during Covid didn't convince you of that, then I don't know what to tell you.
We're also talking pretty vaguely here, why don't you spell out exactly how you envision your ideal system working?
On the topic of people getting mad and yelling at the government for every bullshit thing they see (including the decisions they choose), but us mostly ignoring them when they're being dumb, this week's Short Circuit summarized a hilarious case thusly:
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What are you talking about? This seems irrelevant.
Yeah, again, what are you talking about? I did not say that you had a lack of willingness to take responsibility for your own medical decisions. I said that you were taking upon yourself the ability to make medical decisions for everyone else.
Why? I don't get this at all.
Do they all scream their heads off at the government when a person is allowed to work on their own car, and they sometimes screw up? Do they scream their heads off at the government when Bitcoin goes down and the people who bought it lose a bunch of money? Do they scream their heads off at the government when Bitcoin goes up and they weren't mandated to buy it, so they missed out on the gainz? Even if so, maybe we should build better norms toward ignoring stupid people who get mad at every bullshit thing they see and yell at their government for stupid stuff.
Let's start with just the basics. In a pandemic, you can obviously do better than what was actually done. Of course, now would again be a good time to check in and see how you view the HCT/RCT debate, because this is a real, live, issue that people are debating, not just cherry-picking, and you didn't respond last time. I think even you could agree that you shouldn't further delay things in order to try to swing an election. Moreover, you shouldn't even threaten mandates in order to justify performing so poorly, much less actually implement them.
I personally don't have or want the ability to make medical decisions for everyone else. The "everyone else", being the American People, have more or less voluntarily given the Federal Government that power through the existing democratic process.
I haven't really expressed much in the way of opinions about how things ought to be in this thread. I'm mostly just talking about how the system currently works and why it works that way, and what issues any potential changes to the system would need to address. That shouldn't be confused with actually advocating for the system to work in a specific way.
Your other comment about the Glock lawsuit issue is kind of funny by itself, but also IMO serves to illustrate how the current state of the system is the product of how a bunch of things tie together.
For example, in the current system, all potential new drugs, even if created by some tiny team of independent scientists or university lab, are taken up by pharmaceutical giants to take to the market. They have the financial backing to take these drugs through the lengthy and risky clinical trial process, absorb the losses from ones that fail, and also weather any lawsuits filed by people unhappy with the drugs. They're mostly happy with the Government-run trial process partly because, if they get sued, they can say at trial that their drug went through those Government-monitored trials and was approved for sale by the Government.
Quite a few of the Covid vaxx-skeptical were concerned that the PREP Act rules made everyone associated with manufacturing, distributing, and administering the vaccines immune from lawsuits. They do have a point... but how could you possibly release a new vaccine that fast, or even faster yet, without that legal immunity? How would you convince the pharma companies to go ahead and release without that, when part of the reason why they exist and are structured as they are is to manage that risk? Or would you go for much broader legal immunity? Like it or not, lawsuits are a great way to throw sand in the gears of a new drug release.
That's one reason why I'm skeptical about your vague ideas to apparently cut more restrictions and go even faster yet. Which is why I'm asking in order to try and nail things down more specifically:
I'm not actually asking about an ideal system for handling pandemics. I don't think that's possible. We've got 20/20 hindsight for Covid now, of course, but if you were making a system for all pandemics, you'd have to handle Covid, plus Aids, plus Ebola, plus everything else that's come down the pike, plus whatever the next pandemic may be, which none of us can predict.
What I'm actually asking is your ideal system for how to go from what some scientists think is a promising new drug to something that the average person can buy or be prescribed to treat some disease or condition. How do you think that should work exactly during normal times, and how should it be changed during a "pandemic", whatever we might define that as?
I skipped over the "HCT/RCT debate" question because I honestly have no clue what that is. A few google searches didn't provide much insight. What is this debate?
That's a hell of a thing to drop this far into a conversation about pandemics.
Do you honestly think there are no differences between conceptual schema or patterns of behavior/regulation that can be applied across different flavors of pandemics? There are no better or worse ways of doing things in advance?
We can get to the rest of your comment in a bit, but we really ought to stop here for a second, because if I'm hearing what I think you're saying, most of the rest of the discussion might be pointless.
HCT is Human Challenge Trials; RCT is Randomized Controlled Trials. I do kinda sorta think that you might just not be very exposed to any of the debates going on about how to improve our systems for the possibility of new pandemics. I guess I'm not sure why you would be, given that you seem to think that it's pointless to even try. I guess I'd just wonder which came first. Did you decide that it was pointless to try, and thus never went and learned anything about what factors might be considered? Or is it just that you have no idea what factors might be considered, and so you concluded that it must be pointless to try?
I'd say I'm certainly open to hearing ideas and possibilities, but I'd like to hear something more specific than just we should go faster or we should skip trials. Which trials are we skipping, how are we dealing with the effects of skipping those trials? In my view, I've been trying this whole conversation to get out of you exactly what specifically you want to do, ideally something more generally applicable than, we did this specific bad thing during Covid, let's not do that. I mean, yeah, that's technically true, but how do you generalize that beyond, we should put better people in charge?
The mind boggles a bit trying to come up with general principles for addressing pandemics that would apply well to both of, let's say, Covid and Aids. If you can come up with some that don't just reduce down to putting better people in charge, by all means, let me know.
I am aware of what Human Challenge Trials are. Randomized Controlled trials are what we're already doing. I've got no problem with Human Challenge Trials, sounds like a good idea to me. It's at least a specific and actionable proposal. Liability might be a concern, but that ought to be solvable with waviers or some minor legislation. It's a relatively modest modification of current practice. It would likely result in full market availability somewhat sooner, though probably not dramatically so. The number of people accepted into such a trial would likely be modest. Though I gather you seemed interested in much more dramatic changes? Operation Warp Speed as it was actually executed produced far more dramatic timeline reductions just by bureaucratic optimization. Certainly nothing wrong with going even faster yet, but no need to forget what we actually did accomplish.
Another thing I'd note is that medical technology continues to advance incredibly fast. As far as I know, this was the first time in history we had a vaccine candidate ready for trials within weeks of the target viruses genome being isolated. That's freaking amazing! Can we come up with ways to get it verified and out to the public even faster than we actually did? Probably! But let's not beat ourselves up too bad, this stuff is all pretty new.
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