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Dr. Helen Chu, a doctor in Seattle who was running a study on flu prevalence back in February 2020, ... realized that she could test her flu samples for coronavirus, did it, and sure enough discovered that COVID had reached the US. The FDA sprung into action, awarded her a medal for her initiative, and - haha, no, they shut her down because they hadn’t approved her lab for coronavirus testing. She was trying to hand them a test-and-trace program all ready to go on a silver platter, they shut her down, and we had no idea whether/how/where the coronavirus was spreading on the US West Coast for several more weeks.
Although the FDA did kill thousands of people by unnecessarily delaying COVID tests, at least it also killed thousands of people by unnecessarily delaying COVID vaccines. ...
Every single thing the FDA does is like this. Every single hour of every single day the FDA does things exactly this stupid and destructive, and the only reason you never hear about the others is because they’re about some disease with a name like Schmoe’s Syndrome and a few hundred cases nationwide instead of something big and media-worthy like coronavirus. I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every f@$king time there is some story about the FDA doing something exactly this awful and counterproductive.
Quoted from: https://astralcodexten.substack.com/p/adumbrations-of-aducanumab
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While this is definitely worth a discussion towards Americans,
I, as a government shill, do want to call into attention that this might be more of a /townhall/ discussion.
But thank you for the insight.
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Looking at it from the outside, I think it's clear that there's no malicious plot underlying the issue.
But it can be worth to put in view the kind of issues that arise with bureaucracy and ponder where to draw the border.
Helpful treatments may be held back unnecessarilly, while on the other hand, patients may be fed bleach because someone out there said that it is the most sought-after panacea.
I can understand that it's probably a tough to decide line to separate both.>>9566
What's your current though on the pandemic and the vaccine anyway?
Are you one of the "enlightened" folks who believe in masks, social distancing and the power of vaccines?
Or do you fit with the sceptics who think it's an overblown hoax and who think the vaccines are a risky procedure to cow the people while various highly effective and safe medicine is being held back?
>>9568>Looking at it from the outside, I think it's clear that there's no malicious plot underlying the issue.
I think it is mainly CYA from an agency that usually gets blamed a lot more for approving an unsafe or ineffective pharmaceutical than for denying approval for a safe and effective pharmaceutical.>>9568>Are you one of the "enlightened" folks who believe in masks, social distancing and the power of vaccines?
Yes. I'm fully vaccinated and I still wear an n95 mask when I go shopping indoors. The vaccines do have some risk, but so does breathing the same air as other people especially if unvaccinated. I think a cost/benefit analysis clearly favors getting vaccinated for anyone who regularly comes in contact with other people.>>9568>Helpful treatments may be held back unnecessarilly, while on the other hand, patients may be fed bleach because someone out there said that it is the most sought-after panacea.
One thing that Scott suggested was to separate out the evaluations of safety and efficacy and allow doctors to prescribe medicine if its safety has been reasonably established even if there are questions about its efficacy.
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Do you have any thought on the story of medicine that is said to cure Covid on the spot?
Like HCQ or Ivermectin?
Do you think it should be possible to pop a pill and get rid of the illness without relying on vaccines?
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IIRC, later clinical trials showed that hydroxychloroquine wasn't super-effective against COVID-19.
In regards to ivermectin, Zvi Mowshowitz noted:
While I am not looking into such questions in general Because Of Reasons, I did see this notice that [one of the Ivermectin studies was withdrawn](https://www.theguardian.com/science/2021/jul/16/huge-study-supporting-ivermectin-as-covid-treatment-withdrawn-over-ethical-concerns
) due to ‘ethical concerns.’ Where the ‘ethical concerns’ in question appear to be ‘massive fundamental discrepancies in the data’ which is a nice way of saying ‘complete and utter fraud.’ Figured I’d pass it along. How this impacts your model of the situation otherwise is up to you – among other things, I didn’t check to see how fundamental this evidence was to the case.
""" ( https://thezvi.wordpress.com/2021/07/22/covid-7-22-error-correction/
)>Do you think it should be possible to pop a pill and get rid of the illness without relying on vaccines?
Probably not. The problem is that, by the time you realize you need to take the medicine, the virus has already inflicted considerable damage to your body. The consensus nowadays is that COVID-19 anosmia is due to the virus damaging the olfactory region of the brain rather than damaging the nose (see, e.g., https://astralcodexten.substack.com/p/what-should-we-make-of-sasha-chapins
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I'll be honest, most of the rightful debates with people of that corner on the internet I had, were along the lines of the vaccine being faulty, ineffective or even more dangerous than the virus, but pushed on the population by big pharma while there's great safe and reliable alternatives that are just being held back purposely by Big Pharma and WHO / FDA.
Most times when a medicine gets mentioned, it is promoted by a (right wing or something) youtube channel with some anecdotal studies proposedly run with miracle effects.
but any medicine that I look up to are at best in early trial states and there's a lot of official news not to just rely on them.
Ivermectin, last i checked was still very shaky as it got administered within a cocktail of lots of medicine, which makes it hard to really check out its proper effects and thus it was not recommended for use.
But there's still a vital difference between the working of a vaccine and medicine. And here I may sound like an ignorant idiot.
Vaccines are given with an intent to prepare the body to handle an illness more adequately, especially against viruses. it triggers our natural immunity processes to handle diseases when they come by, either preventing them completely or at least stop it before it actually hits people hard enough.
Medicine can't usually be used to attack and kill viruses. So they basically work at retarding harmful reactions our body has to those viruses, mitigating fevers and swelling and other stuff. unfortunately, that seems to me mostly helpful in case our body is in a crisis and can lower mortality, but are not gonna prevent people from getting really sick and requiring assistance to get better.
At any rate, I don't know.
Wouldn't 'Medicare For All' and a move away from the uber-capitalist hell-on-Earth model undergirding American health care solve this?
Instead of 'If Bobby can't afford his pills, Bobby morally deserves to die, because such is the will of God's holy free market' being the norm, we could have health be considered a public good, akin to roads and firefighters, such that whatever needs to be paid to give people care gets paid, regardless of qualms.
Instead of corrupt, greedy, and irresponsible corporations creating risky drugs at extreme prices with the backstop of the FDA there hopelessly at a mix of being too strict and not strict enough, just have independent agencies developing medicines under strict ethical rules with clear-cut understandings that many materials will be fast-tracked into development.
Instead of pretending that medicine is a product without consequence or context, like buying a big television screen or whatnot, we finally accept the fact that it's a government responsibility based on human rights.
Hope springs eternal.
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>>9574>Wouldn't 'Medicare For All' and a move away from the uber-capitalist hell-on-Earth model undergirding American health care solve this?
I don't see how that would solve the problem of US government's simultaneous (1) incompetence at developing its own COVID test-and-trace program and (2) shutting down successful testing done by others such as Dr. Helen Chu.
Wouldn't have addressed the Omegaven thing either, where the FDA prevented doctors from saving the lifes of infants suffering from Short Bowel Syndrome and PNALD.
That said, it's true that the US health-insurance system is uniquely horrible, and I think a model like the UK NHS is better in many respects. In truth, I think either a minimally-regulated system or a government-run system (like in the UK or Singapore) would be better than the monstrosity that the US currently has.>such that whatever needs to be paid to give people care gets paid
The UK NHS has an explicit threshold of cost effectiveness (£30,000 per QALY, IIRC). I think this works a lot better than the bizarre and ineffective system the US uses to try to control costs. I'd like it be more personalized though, so that people with different utility functions can make different tradeoffs (like a trade-off of the pleasure of eating bacon vs a longer lifespan without eating processed meats).
The root causes of the problems that you're mentioning appear to follow rather logically from a U.S. system based around capitalism as a religious belief, whereby medicine is a product that certain people deserve as a privilege like any other luxury good or service.
It would be a change from the ground up if health care were a matter of human rights and if suffering horrifically due to medical problems wasn't considered just 'the way things are in America because capitalism said so'.
If you don't have money, and you're dying (or in terrible pain), why should other people help your health if their ethical system gives them no benefit to helping you?
In a world of cold, hard, soulless, and brutal utilitarian morality of pure rationalism, that's just that.
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Hmm, I think I see what you're getting at now. I'm not convinced that the FDA would have behaved any differently under a Medicare-for-All system, though. To me, the FDA's action seems more like the results of useless incompetent power-hungry bureaucrats.
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>>9581>cold, hard, and soulless rationalist morality whereby mass suffering of innocents is seen as not just 'normal' but 'desirable'.
Not sure what you mean by "rationalist", but all the self-identified rationalists I've seen on LessWrong/SlateStarCodex are the opposite: They see any suffering of sentient beings as being intrinsically bad. (Even the suffering of serial killers and child molesters is seen as intrinsically bad, and their punishment is justified only in terms of preventing worse suffering in the future.)
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Hmm, gonna put one point out there...
Everyone always wants free stuff and wants to have the best treatment for people.
We all scoff at amazon employees being treated like shit, being overworked and all that jazz.
But we also want our free shipping the next day, we want our stores to be open on weekends and holidays and available after working hours.
we want our commodities delivered at very cheap prizes,....
While free healthcare seems like a no-brainer, it won't really be free. It would just mean that taxes will need to be increased and everyone will be paying for anyone's healthcare.
In Europe, I feel we have a lot of taxes, which I don't mind paying for myself as we get lots of good stuff in return. But even living in (one of) the most taxed country in the world, I get constant reminders how we're up to our necks in debt and even through all this, how many faults there are in all of the infrastructures and how often budgets need to get cut left and right, resulting in crazy circumstances.
Being a bit of a devil's advocat, since I definitely hope the American system won't take over in europe when it comes to healthcare or any other form of privatisation. But i can imagine why it's a model that exists and Europe might not be far from adopting stuff either.
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Welcome to Townhall, poster who will presumably receive an appropriate animal name, as is our way.
The story does seem a bit counter-intuitive because presumably the sars-cov-2 was present in the samples when other tests were being done, so the exposure was not much increased by doing another test. Perhaps all labs doing testing on flu samples without COVID-level bio-security should be shut down.
It's not really my field, but I can see the frustration.
>>9588>It's not really my field,
The ACX blog post linked in the OP explains it well: https://astralcodexten.substack.com/p/adumbrations-of-aducanumab
If I didn't know better, I might think that the FDA high-level bureaucrats sadistically took pleasure in prohibiting life-saving medication and watching the doomed patients die.
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>>9585>Everyone always ... wants to have the best treatment for people.
That is one of the biggest problems in America. A bunch of idiot politicians decided to criminalize basic no-frill healthcare plans, so that people would have a choice of only expensive gold-plated health insurance or no insurance at all. And, surprise surprise, this resulted in a lot of people having no insurance at all, because they couldn't afford the expensive gold-plated health insurance.
Another disastrous thing the bloodsuckers in Congress did is pass an unfunded mandate that hospitals give emergency treatment to people who have no ability to pay for that treatment. This worked exactly as horribly as one might expect it to, and yet our Congresscritters still haven't funded the mandate.
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>>9597>inflation would go up,
The wealthy bankers behind the Federal Reserve will ensure this happens in any case.>>9597>course it would cost loads
There is so much waste in the existing American health system that we could provide (UK NHS)-level universal health care (which is somewhat below median American healthcare, but still decent enough) as a baseline for US persons who lack additional health insurance without spending a single penny more then we already do.
The U.S. system is so bottom of the barrel, incorporating the worst of socialistic systems with the worst of capitalistic systems, somehow that like... I'd basically take any major system over ours. U.K.'s system, sure. Or Canada's one. Or Switzerland's one. Or Germany's one. Taiwan maybe. At least some sanity.
I'm kind of partial to the universal voucher idea though given that it'd be so straightforward of a change, with the U.S. already spending so much on tax subsides for employer health care as well as Medicaid systems and more. Just give people the money directly. Let them spend it.
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>>9599>I'm kind of partial to the universal voucher idea though given that it'd be so straightforward of a change, with the U.S. already spending so much on tax subsides for employer health care as well as Medicaid systems and more. Just give people the money directly. Let them spend it.
Seems like a reasonable idea, kinda like UBI but specifically for healthcare. The existing Medicaid system is particularly perverse in that people can lose their eligibility for it if they make too much money, which can effectively be a marginal income tax rate of over 100% for some people.
I think the government should also repeal restrictions that make it difficult or impossible for insurance companies to offer different plans with different thresholds of cost per QALY. This would also make the voucher idea more politically palatable, by reducing costs.
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>>9596>Another disastrous thing the bloodsuckers in Congress did is pass an unfunded mandate that hospitals give emergency treatment to people who have no ability to pay for that treatment.
Would it be better if patients get access to healthcare only if they can pay for it?
Like, if someone has a traffic accident and has broken some bones that they go "sucks to be you, but we can't put on a cast or relieve pain since you're basically broke"?
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About a good month ago, I was in a discussion on reddit about the vaccines and someone posted a video from right-wing America about how Ivermectin was the big cure for Covid.
His point was basically that people wage their lives on an experimental vaccine when they could be getting treated by a safe long time used medicine, but it was all covered up by big pharma.
Back then, I checked the CDC page on Ivermectin and I saw it was not yet recommended, but there may have been a basis for why it worked. However, proper trials were needed to check the efficiency.https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ivermectin/
Howaver, now I read that a fair share of people are rushing to get Ivermectin of the shelves as a miracle cure and are poisoning themselves with it.
I do also hear people say that Ivermectin as a cure apparently has been properly debunked, as the paper talking about its effectiveness is retracted. But it seems to be the new facepalm worthy "miracle" in fighting Covid.
I'll stand by my point that any medicine promoted to cure Covid is gonna be way more experimental than the vaccine.
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>>9621>I'll stand by my point that any medicine promoted to cure Covid is gonna be way more experimental than the vaccine.
If you're talking about oral medicine, I'll agree with you. But I think monoclonal antibodies and convalescent plasma are well supported by evidence. But they need to be adminstered by an IV line, and people typically don't get them until they're already sick enough to need to go to a hospital. So I'd still say that they're vastly inferior to vaccines.
Zvi Mowshowitz recently noted a study that found: "Fluvoxamine reduces hospitalization from Covid by 31% in preliminary results, Ivermectin found to have no [statistically significant] effect."https://TheZvi.wordpress.com/2021/08/19/covid-8-19-cracking-the-booster/https://vimeo.com/585708651https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094534/
>>9628> But I think monoclonal antibodies and convalescent plasma are well supported by evidence.
I am getting emails from red cross that due to Covid and other events, they really need to find donors to resupply the blood bank.
So, I suppose that while it is effective, it's gonna be dangerous to completely rely on it for continuously upcoming waves.> Fluvoxamine reduces hospitalization from Covid by 31% in preliminary results
I have to say, googling fluvoxamine at least doesn't land on a bunch of pages saying that it is not advised.
Can fluvoxamine be taken when you catch the disease? Or is it also only used when you are in the ICU?
Maybe it's not the place for my input, everything I know is pure anecdote and personal experience. But I'll say.
My hospital still does, but most hospitals in my company no longer offer convalescent plasma. Maybe there are some studies that can irk out statistical significance but in a clinical setting the results do not reflect what we need for a front-line treatment. It's hard enough getting the essentials so I'm not sure how much blood bank resources should be dedicated to niche unreliable treatments when the exact same patients are absolutely chewing through cryo.
When you think about it convalescent plasma makes a really bad pharmaceutical for respiratory infection. Titers are low, supplies are unreliable, plasma carries numerous hazards, and the immunoglobulins are wrong. IgMs don't cross mucous membranes and IgEs are not in plasma. That leaves the only viable class of immunoglobulin as IgG, which isn't particularly useful without the sensitized cells. There is some
effect, but with low titers and ambiguous avidity it's hard to say how much it can be relied on. Monoclonals might work better. Easier to get the titer up with recombinant immunoglobulins, but it's not my department so I haven't looked into it at all. I don't even know if they're IgG or IgM.
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>>9629>Can fluvoxamine be taken when you catch the disease?
Yes. It is administered orally as a pill.>Or is it also only used when you are in the ICU?
The results of this study are that fluvoxamine reduced the need to even go the hospital in the first place.>I have to say, googling fluvoxamine at least doesn't land on a bunch of pages saying that it is not advised.
Fluvoxamine is an SSRI that is routinely used by psychiatrists as a first-line treatment for obsessive-compulsive disorder and social anxiety disorder. Other SSRIs (e.g., fluoxetine) also showed promising results in observational studies but AFAIK haven't been tested in RCTs yet.>>9630
Hmm, you seem to know a lot more about this than I know, so I'll defer to your judgment.
As an addendum...
What I'm seeing a lot of lately, especially in our younger covid patients who have expired, is signs of DIC and other coagulopathies. I've been doing this for 4 years and I've given out more cryoprecipitate plasma (a concentration of coagulation proteins) over the past week than over my career combined. DIC is pretty well known medically as something that modern birthing practices prevents. In the disease blood starts clotting in the veins. In addition to the risk of pulmonary emboli, clotting factors in blood are in limited supply and get consumed so that the patients lose the ability to repair microscopic damage to the vessels and they start bleeding out into their body compartments. Cryo was made to treat factor 8 deficiencies like in hemophilia, but it's also packed with factor 2 so it's the best option for DIC when combined with heparin. It's still a very dangerous condition to treat even with modern medicine since it involves giving blood thinners to a person who is bleeding out, and then giving fresh plasma which in addition to Factor 2 contains Factor 7, the antidote to heparin treatment, so dosing is an absolute bitch.
Furthermore, nobody has much cryo on hand. It's use is very niche in treating fringe coagulopathies associated with shake bites and amateur midwives. Cryo is the most complicated blood product to handle due to very strict temperature and time requirements and producing it involves wasting 10 units of precious plasma to produce one bag of cryo.