The FDA's Restrictive Regulation of Home-Testing Devices (2017)
scholarship.law.duke.edu
scholarship.law.duke.edu
The context that is missing here, which I am super curious about: Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? Is there any real organized opposition at all to the FDA doing this that one can attach themselves to?
Unlike real scholarship, legal "scholarship" is only reviewed by third year law students. It's pretty worthless stuff.
> Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument?
This looks like a student's thesis.
The author, also, appears to be in agreement with you and is hoping to push information to help cause a stand:
From the conclusion:
> These restrictions illustrate a disturbing trend with major consequences for current and future technologies. Ultimately, the FDA’s decision to act as gatekeeper, limiting consumers’ access to their medical information, is premised on an impermissible value judgment that significantly restricts individual autonomy.
Similar to the CSA, I'm sensing a theme
Mammograms are a very useful diagnostic tool, but only when applied in the right circumstances because of the rate of false positives. It's recommended for 50+, but when given to a 30-year old, the results are meaningless in most cases (it becomes more likely to get a false positive than a real positive).
Knowing when to take tests and interpreting test results are sometimes an important part of the test.
Having said that, imposing an age restriction on at-home Mammogram testing kits would mitigate the problem. However, Mammograms are probably not the best choice for at-home testing given that they involve X-rays!
Mammograms under 50 give MORE false positives that real positives. That means it's not even a useful data point. If you have a positive result, it's you're more likely you do NOT have cancer than you do.
You really have to understand your base rate of expected occurrence and the effectiveness of the test. These can wildly affect how to interpret the results and tell you if you should even take the test in the first place.
Here's a somewhat related Numberphile about false positives: https://www.youtube.com/watch?v=M8xlOm2wPAA
The main issue with universal screening is cost. Medicine is far too expensive and now we need to divide up a scarce resource. The 2nd issue is subclinical cancers that would not kill you before you die of something else. But we don't spend much time on the 2nd issue because we don't screen as much as we could if we made healthcare cheaper.
Further, some screening methods involve radiation exposure, and in large population groups, the effects of that additional radiation starts to have a significant effect and may overtake the delta between "screen who we estimate needs it" and "screen everyone", which means you've given cancer to more people, looking for cancer.
Wrist injuries are a pain in the ass to x-ray looking for broken bones, but CT scans are very reliable. But...CT scans involve a _fuckton_ more x-ray exposure. They're also more time consuming, use much more expensive equipment, generate a lot more data, and require more work to analyze. So generally, ERs continue to use x-rays to check for broken wrist bones.
Also, since you replied to a comment about breast cancer: breast cancer is among the most diagnosed, most successfully treated, and most survivable cancers. There is no scientific basis for easing or promoting more breast cancer screenings.
I can't help but suspect that the brilliant success of machine learning in some tasks with a ludicrous amount of data available has blinded us a bit. "Just use more data" is a seductively easy answer to all questions if we ignore any and all factors beyond what is theoretically possible in the 'true Turing machine on a perfectly flat friction-less plane...' sense.
Mammograms are used for preliminary screening. They are cheap, relatively easy to perform, and close to as (physically) noninvasive as you can get for something reasonably called a test.
So immediately most data is simply unavailable without obviating the entire point of doing better preliminary screening. Any data we can consider without making the entire endeavor pointless will be extraordinarily challenging to work with. Even if you use the magic hand-wave to move few 'little' fields like probably most all of NLP into the realm of the trivial, this is an extremely challenging problem. Even if you can magically encode the entire medical history, you'd have what, a massively sparse set of massively sparse time series? And lots of information is going to be in the relationships of different time series, but also you have to deal with doctors not being a single immutable entity... and doctors can only see so many patients in a day, and they only work so many years, and and andandand...
So many difficulties, so many confounding problems, and so little data to brute force the solution.
And if we somehow rally the world to our cause and somehow throw enough resources at it to amazingly solve all the problems... what do we do for the world? Let's use the best imaginable case. The new test is perfectly accurate, specific, and sensitive. It is instant, risk-free, and otherwise just free in all ways you can imagine, to the point that all breast cancer is now detected at the literal possible earliest moment. Not only that, we can do way better. We can even determine if it should be treated or not.
Almost 13% of women in the US will get invasive breast cancer in their lifetime, but only 2.6% die of it [0]. We can spare that 10% or so of dreadful side effects from chemo, radiation, major surgery, and all that. Just to put the icing on the impossibly-large cake, we can even suggest optimal treatments, so that none of those 2.6% die from treatment. We have effectively eradicated death by breast cancer in any way.
Of course, this would (very seriously) be extraordinarily great. I don't even have the words, so I'll just leave it.
This is best case scenario. Everything is impossibly perfect. We're probably at least a couple dozen plausible-actual-miracles deep. So how does this stack up? Well... 2.6% probably clued you in. Breast cancer is not a particularly huge cause of death. From [1] (if you forgive the year gap), we're looking at something on the scale of diabetes (2.7%). We're well below death by unintentional injury (4.4%). Heart attack (21.8%) and all cancer (20.7%) are the two major ones. But breast cancer, well, isn't the only cancer.
But the other side of the coin is that we expanded preliminary screening to young folks. So maybe if we save a lot of them, we've added more human-years-lived than it seems from total death rates.
Well... no. Mammograms are used later in life for a reason. Younger folks aren't very likely at all to have invasive breast cancer. At 20, 0.1% of women get it, and 0.055% die of it. At 40 (the age suggested in [0] to start offering mammograms) it's 1.5%/0.2%. You get the idea.
Maybe for some age it's at least a significant cause of death? Nope. [1] has a breakdown by age.
So frankly... absolute impossible best-case we mostly prolong the lives of a few percent of the oldest women. Large numbers obviously means there's more than a just a few younger women too, but the distribution of possible beneficiaries is rather skewed towards the oldest.
Still. It'd be unfathomably awesome to see for many reasons - both technical and humanitarian. But the degree of difficulty is extreme and the far, far upper bound isn't quite proportional. There's easier targets with better rewards. My random speculation from thinking about this for way too long to write this is that solving many of those huge challenges along the way would probably be the bigger boon for humanity in the end.
TL;DR (yes it's still long, but relative, okay?) * Preliminary screens need to be simple and non-invasive means way little data, means just throwing machine learning at it very hard * Many very hard problems means maybe tons of data is needed to push through with sheer weight of data, but human interactions can only generate so much data so fast * Not that many people of any age get breast cancer, and far fewer actually die of it * And the age distribution of those who get it skews substantially older... hence the entire reason for mammograms not being used on young folk in the first place... and hence this entirely way too long response to a rather short and probably not-much-thought-of comment
[0] https://www.cancer.org/content/dam/cancer-org/research/cance... [1] https://www.cdc.gov/women/lcod/2017/all-races-origins/index....
> Trying to detect disease early seems like an obviously good thing to do. But reality isn't always quite so straightforward, especially in medicine. If It Ducks Like A Quack is a series where I try to go beyond the hype and explore how complicated the apparently simple phenomena in medicine are.
One point from the video: five year survival rates of prostate cancer in the US are massively better than in the UK. However, roughly the same proportion of people die of prostate cancer in both countries. The US just screens a lot more.
It is not, and the issues are central to both statistics and medicine.
1) Medical tests have four quadrants--not 2. The accurate quadrants are "positive test--positive diagnosis" and "negative test--negative diagnosis". The problem quadrants are "positive test--negative diagnosis" and "negative test--positive diagnosis".
A positive test with a negative diagnosis can cause issues like they do for mammograms. The problem is that the followup procedures have a non-zero probability of killing the patient. Biopsies can result in infections. Anxiety from a positive test can cause heart attacks and strokes. If your test is only 99% accurate, then 1% of people being tested are incurring those risks when they don't have to. If you are testing a lot of people and the disease is relatively rare, you may kill more people with false positives than the disease itself.
A negative test with a positive diagnosis is problematic because people will tend to blow off other signs since "the test was negative". This can delay lifesaving treatment.
Finally, optimizing one of those quadrants generally occurs at the expense of another. So, which should a test prefer?
2) The body often clears a lot of diseases. Lumps that could be cancerous often disappear. Swellings come and go. Viruses do more and varied damage than we originally thought. The body repairs itself and reversion to the mean is a thing.
3) Diseases may not even be that problematic. Sure, aggressive prostate cancer is an issue. However, practically every single man will eventually get prostate cancer. Most men die of something else before prostate cancer is an issue. Is it worth risking becoming incontinent or impotent from a prostate cancer treatment?
4) Will the positive test even lead to a correct request for treatment? People demand antibiotics for viral infections all the time. My body never gets rid of strep throat, so I will force my doctor to give me a quick strep test when I have a persistent sore throat. The first time I did this my doctor was literally stunned when I simply thanked him and got ready to walk out since the test came back negative. Everyone else will demand antibiotics even if the test is negative.
You take the test, but you do not know what it is screening for, or what the results mean. It tests for N things which can be economically packaged.
The results can then be used to produce a recommendation for additional consultation with a doctor.
The solution to false positives is not "let's not test and bury our heads in the sand". The solution to false positives is to test a lot more to monitor the progression of disease.
> Biopsies can result in infections ... If you are testing a lot of people and the disease is relatively rare, you may kill more people with false positives than the disease itself
This is junk science. People troll through records looking for correlations and publish when they find them. Many prospective studies show that biopsies don't increase mortality rates.
> A negative test with a positive diagnosis is problematic because people will tend to blow off other signs since "the test was negative". This can delay lifesaving treatment.
If you have symptoms you will be given a test anyway. So you need to deal with base rates, false positives, etc, regardless.
> 2) The body often clears a lot of diseases. Lumps that could be cancerous often disappear. Swellings come and go. Viruses do more and varied damage than we originally thought. The body repairs itself and reversion to the mean is a thing.
So the solution is to monitor them constantly.
> 3) Diseases may not even be that problematic. Sure, aggressive prostate cancer is an issue. However, practically every single man will eventually get prostate cancer. Most men die of something else before prostate cancer is an issue. Is it worth risking becoming incontinent or impotent from a prostate cancer treatment?
Yup. I said that above. The problem is that without universal screening we don't know anything about which cancers are going to be a problem and which are not. And we don't have data to target drugs and interventions. The solution is to have universal screening and regular followups, then use the data to narrow down who needs treatment.
> 4) Will the positive test even lead to a correct request for treatment? People demand antibiotics for viral infections all the time. My body never gets rid of strep throat, so I will force my doctor to give me a quick strep test when I have a persistent sore throat. The first time I did this my doctor was literally stunned when I simply thanked him and got ready to walk out since the test came back negative. Everyone else will demand antibiotics even if the test is negative.
You can demand whatever you want. What does that have to do with anything?
That means if you randomly take a test and it has a positive result, it's more likely you do NOT have the cancer than do.
More detection of cancer and earlier is great. But testing has it's limitations and the general public doesn't always understand the statistics involved to apply the tests correctly.
It seems like we as society should be tackling that problem and part of tackling that problem seems like getting more scans of denser breasts so we can develop better techniques for detecting cancer within them. Restricting access by age makes it so that we are optimizing detection for later age. Something has to change in our current approach to help figure that part of the problem out, perhaps loosening restrictions should be one such change.
MRI can work, but it is much more expensive, and finding the exact location of the abnormality on MRI can be trickier.
How many developers have created what they think is a pretty intuitive UX only to find out users can’t figure out shit?
It’s the same with medical device (which tests are). Hell, when I worked with a pharma company their compliance rates with just taking pills as prescribed was 60%.
Yeah, 40% of patients failed to take their medicine 2x per day. A simple task like that.
So the problem with a covid test is not the test itself, it’s what patients do with that info. If 40% screw up the test, it says negative, so they go to a football game in a stadium, what is the implication.
What if they didn’t have the test? Would they just stay home? Is that better.
Oh, I get it... I just think it is immoral. I also believe that the software developers who go around thinking they are gods that should get to decide whether other people should be allowed to install an app on their phone or an extension in their browser because "people are (apparently) universally too stupid to have such functionality" are also deeply immoral, and have spent over half my life at this point--ever since I started working publicly on network scanners and decompilers through all of my work on jailbreaking the iPhone and now my latest efforts in decentralized systems--fighting against people who think like that (and I am even a politician now!).
I strongly believe that people have a right to know things and get access to things that help them know things, and you aren't doing the world any favors by preventing such: you are just going to make people--100% correctly--distrust you and your motives. FWIW, I do see a job for the FDA, and I do appreciate some of the work they do... I would even have sympathy if this were "the tests are inaccurate or unproven, and the FDA doesn't want people to claim a test works that doesn't actually work and has never been tested" (note: I still have issues here, but I would at least have sympathy).
But for a test we know works and can legitimately be used correctly in a home (but might theoretically be used incorrectly, sure) but we are just afraid people will do something bad with the information as they don't understand statistics enough to deal with false negatives or whatever? That is just evil, and it mostly stands in the way of actual good work being done.
This is the reason why diabetics I know have had to hack into their hardware to cobble themselves full-loop control mechanisms. This attitude would have--in the story presented here--prevented people from having access to pregnancy tests... which should simply feel preposterous at this point in time when clearly at home pregnancy tests are extremely common (seemingly having required a legal challenge to the FDA over it!).
And really... if you want to apply population-level analyses, that shouldn't even be the job of the FDA: that's the job of the CDC. And neither the CDC nor the FDA did a good job here of reacting quickly to this pandemic. A covid test even with relatively low accuracy can do wonders for neighborhood-level tracing efforts, but not only did the CDC never mobilize any kind of voluntary test sweeps, the FDA was proactively shutting down efforts by local universities to do it themselves. In the words of a friend of mine who is much more passionate about this than I am: "they have blood on their hands".
But no matter how often that happens, nobody thinks that every new UI should have to get approved by a federal government board before users are allowed to see it.
Clearly a different outcome.
Just this week I was looking to get a continuous glucose monitor. I’ve heard it can really prevent diabetes and help you understand what foods spike your levels.
The fda won’t allow anyone to get these if they aren’t already diabetic.
There’s so many ways we aren’t “free” in this country to do what we want with our bodies.
I don’t think you’re taking this on as your own but I’ve lost all empathy for that position. We have other mechanisms to remedy fraudulent or substantively anti-social behavior.
I was actually in the same boat as the previous commenter but my daughter has Type 1 diabetes so hardware scarcity wasn’t the limiting factor. Actually nothing was. I was able to monitor my blood glucose level continuously for a month and it answered my questions. I’ll likely do it again in a few months.
Well maybe for a lemon car, but literally the FDA was started because people would take medications and medical advice from scammers and die. Like I said, they can be overzealous and I’m not arguing that certain things should be allowed (like glucose monitors, probably), but you also have to realize that for every one of you who understand what the monitor does, there’s probably 50 people who would drink bleach solution to cure cancer and 50 more who would sell those 50 the bleach solution.
Type 1: FDA approves something that ends up killing people. Many die. Type 2: FDA doesn't approve something that would cure disease. Many die.
The FDA, and public discourse is only about Type 1, and it is the one FDA is very focused on minimizing. As a result, many Americans - probably millions over the decades - die from Type 2 errors.
> you also have to realize that for every one of you who understand what the monitor does, there’s probably 50 people who would drink bleach solution to cure cancer
If you honestly think 98% of Americans would drink bleach for their health, I understand why you favor a strict approach.
The numbers weren't quite that high, though
[0] https://www.dallasobserver.com/news/dallas-qanon-cult-member...
It’s possible to get ~50,000 lives lost over the last 80 years assuming your overly pessimistic when running the numbers, but that generally assumes people can speed things up without any negative consequences from less stringent procedures. In practice the FDA is likely moving to fast rather than to slow and would save significantly more lives long term by requiring more data.
Basically if someone gets a terminal illness and doesn’t seek medical attention, then the disease is blamed for their death.
If that same person does seek medical attention and dies anyway, it’s still the disease that killed them as long as the doc followed the FDAs runbook.
BUT if the doc tried anything new and the patient dies, well then obviously the doc killed them and they should lose their license and die bankrupt.
Clearly just letting docs go cowboy isn’t likely to have great outcomes either, but something in the middle may.
The rules are very loose for studies on terminal people, but allowing random treatments without being part of a study has minimal utility. Something might prolong someone’s life but you have no way to verify and cancer treatment very often kills people before the cancer.
Of course, that's the point I'm trying to make. Doctors have very limited opportunity to replace the runbook with a specific treatment plan because, at least based on my limited observation, they are not allowed to create specific treatment plans without the runbook.
>The rules are very loose for studies on terminal people,
The patient I was working with was terminal and the only rule that was loose seemed to be the ability to abandon a treatment plan early when it stopped showing promise.
>but allowing random treatments without being part of a study has minimal utility. Something might prolong someone’s life but you have no way to verify and cancer treatment very often kills people before the cancer.
Minimal utility to medicine maybe, but not to the individual. If a person invests hundreds or thousands of hours investigating adjuvant therapies, reviewing trial outcomes and talking to PI, researchers, clinicians and trial coordinators, I'm of the opinion their primary oncologist should at least entertain a suggestion, not just dismiss the conversation with 'that's not standard of care'.
Anyway, I'm not going to change anything here on HN. Thanks for your time.
That killed 10,000 Americans a year, 170,000 total.
That's just one drug, that finally got approved.
Atenolol is actually vastly less effective than other beta blockers and it’s continued use has cost many lives. The FDA not approving it would have been a net benefit.
1. Exist as a significant force?
2. Are being stopped by these restrictions?
3. Would do more harm than the FDA promoting ignorance of blood glucose levels?
Because from a comfortable position in an armchair, that perspective seems to be extremely pessimistic about people's ability to make basic life choices. Pessimistic to the point where I don't see how society could function if it is in line with reality.
https://en.wikipedia.org/wiki/Food_and_Drug_Administration#H...
I took you up on it regardless, and it doesn't have much to do with snake oil salesmen according to the Wikipedia article.
Either way, nobody is arguing for the abolition of the FDA. The paternalistic attitude and restrictions are what the parent commenters have an issue with.
> By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.
> President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law on June 24, 1938.
But again, the issue is not deciding what's safe and what's effective. It's finding that something is effective and then telling citizens they can't use effective treatments (or even tests) arbitrarily.
I'm glad the FDA is testing the safety and effectiveness of tests and cures. That doesn't mean the grandparent commenter who wants to monitor their blood glucose levels should be dismissed.
I'm sure that someone could injure themselves really badly with a glucose monitor, but the risk profile probably isn't that different from the wide range of garden implements we let people run around with (like ladders or hedge clippers).
2. Not stopped from selling stuff which efficacy is not proven. Still stopped from selling stuff which is known dangerous.
3. FDA is just enforcing a CYA policy here. It shifts all decisions to doctors who can decide to prescribe a device or a drug, and are personally accountable for malpractice. No administration wants to lose political points and votes because it allowed something obscure, that something led to an accident, and the accident was turned into a national-level scandal by rage-hungry media.
Pregnancy/HIV/diabetes tests however should be rather easy to define baseline requirements/tolerances for.
And drugs are somewhere in between.
Audiophiles salesmen want to believe just as much as the customers.
Disclaimer: Built speakers and amplifiers in a previous life and never understood how people would fret so much about cables.
Consequences of any output from audiophile gear are normally not that serious. For a pregnancy test, it could be literally life and death: say, a murder from jealosy, or a suicide from guilt. This makes a strong case for regulation of what can have words "pregnancy test" and synonyms.
I'm fine with people being able to buy stuff that can kill them, be it a gun, a rope, or a substance. But I stand for clear and enforced labeling of such things, regulated proper packaging that prevents accidents, and other such measures that make sure the consumer has plenty of warning, and acts by deliberate choice.
With substances, it's much harder to assess if the thing in hand can kill you, than with a shotgun or a scythe.
Dietary supplements, homeopathic "medicine", chiropractic, essential oils, Goop and similar new age stuff ... Snake oil business is thriving and expanding if anything.
2. Something I've seen other T1s talk about - the scarcity of hardware, specifically given the current silicon shortage. While I'm not sure how much this directly affects, I do know that the Freestyle Libre sensor got significantly more expensive between 2019 till 2021 (from about $25ish to $60). But take this with caution as I moved countries and haven't continuously being using it.
https://www.fda.gov/drugs/postmarket-drug-safety-information...
2) You can treat high blood sugar with diet. You have to know you have high blood sugar though.
3) More demand generally means lower prices in the long run unless some specific component is constrained, which I doubt is the case for these sensors.
Insulin, sure. But why do you think Metformin is dangerous?
Why not oversee/regulate the market and allow good products while disallowing snake oil?
What are you even saying? We should restrict selling fish to only those who actually need omega-3 and vitamin-D? Or that we've been fishing too much for the past 50 years that the seas are dry? Or that we should restrict selling fish to those who really need it (how do you define that and who is you)?
Apologies for the fish analogy but you managed to sidetrack me from the beginning.
If there's short supply of home tests the US, the government as far as I'm aware is able to authorize production solely for a specific cause. No FDA intervention needed. But if there's no urgent need then a company can manufacture a product, and FDA can within reasonable (this is what is being argued) parameters decide who gets to sell what and to whom.
The issue outlined in the OP is that the FDA seems to be hellbent on having a monopoly on testing, whatever the testing is about. Are you able to refute that? Is there a shortage of testing going on right now?
Peter Attia's on the edge of medical care--guaranteed that some to many of his interventions aren't going to stand the test of time, but he's what you get if a highly educated doctor gets a money hose to point at "live better, longer". It goes without saying that he's a huge fan of Dexcom, and has patients in his practice wear them intermittently.
https://peterattiamd.com/are-continuous-glucose-monitors-a-w...
https://www.abbott.com/corpnewsroom/strategy-and-strength/ab...
So this has nothing to do with the FDA.
edit:
just as I thought, even abbott's site wants you to get a prescription:
I suspect such devices are far from inexpensive.
I see it as nothing more than authoritarians in the health domain. They know what’s best for everyone, and clearly don’t trust that freedom empowers people.
This is at the heart of many of the issues the public has had with the US government’s response to the pandemic.
An individual getting vaccinated or not has some externalities for the rest of society. The answer from orthodox economics is to measure / estimate these externalities, and then apply taxes and/or subsidies appropriately.
The vaccines are already free for the patient, that's a generous subsidy. If that's not enough, they could give everyone who gets vaccinated fifty bucks or tax unvaccinated people some extra fee.
Another example: in Singapore the government used to cover everyone's covid hospitalization costs, recently they changed to only covering them for vaccinated people (or those with a medically valid excuse).
Mainstream economics takes the preference of some people to go unvaccinated serious. The idea would be to arrive at an accurate estimate of the externalities, and then charge that (or alternatively, subsidize the vaccinated to that amount). So that people can make accurate decisions that take their preferences _and_ the costs and benefits to wider society into account.
The idea is NOT to apply an ever increasing spiral of costs on people who make decisions we disagree with.
Over time as vaccines get better the size of the externalities might even go down. In the idealised extreme case of a vaccine that is 100% effective and can be taken by anyone who wants it, there's no externality from anti-vaxxers at all.
(In reality, there are some people who can not get vaccinated for medical reasons, and our available vaccines don't even seem to be good enough to give herd immunity at the moment.)
AFAIAA, no COVID vaccines confer "immunity" - they confer resistance. Vaccinated people can still catch and transmit COVID. The vaccines are effective at preventing you being hospitalised; this protects health services from being overwhelmed, and reduces the chance that you'll die.
I don't think that even catching live COVID confers immunity. I imagine that live COVID confers better resistance than a vaccine, especially a vaccine such as these mRNA vaccines that target a specific spike protein. But I have no reliable source for that notion (/me not a doctor or researcher, just some dude on the internet!)
If vaccines provide enough resistance (or whatever) to bring r0 below 1, that's herd immunity: any infection transmittion chain (or tree) fizzles out.
The difference is the "new normal" can be used to push mandates, censorship and other measures permanently, the same way the patriot act and TSA is still around. We're already seeing the rhetoric shifting from absolute to relative risk. For instance, the current public health narrative for vaccination (of non-risk groups and people with existing antibodies) against the new dominant omicron strain which appears much milder, is "the infection risk is reduced compared to not taking the vaccine" which is a trueism and at best misleading in terms of risk of serious disease.
That said, Omicron appears contagious enough to saturate populations even in tightly locked down regions, which would be novel even for this pandemic.
The American Public is quite possibly the most propagandized citizenry in the world. That has very high costs, and we don't talk about that anywhere near the degree we should.
What you just wrote is part of that cost.
I'm not excusing them, nor advocating their position on this, but a quick look at all this from their point of view can be illuminating.
They have been lied to, ripped off, fear mongered, and manipulated to a point where they can, do and are experiencing genuine ambiguity rooted in a basic lack of trust and inability to reason well, when said reason crosses various politicized or over exploited (manipulated) lines.
And, it's not free! We are all paying for it, and that's fine. I'm a fan of such things and feel our tax dollars could be delivering a much higher net value for all of us given a different set of priorities, but I also digress, save to point out those people will tell you it's not free, and that fact coupled with the lies and manipulation mixed in with for profit medicine issues are all more than sufficient to trigger mistrust and or reluctance to buy into what they may see as an overblown crisis.
To be clear, we are in a pandemic, yes we all need to get the shot, and we will benefit from those things in a number of ways, all of which are important.
Now, I'm stopping there with the intent of making a point: Blaming people, calling them too stupid, or crazy, or whatever basic, issue is assigned to "the problem" does not help any of us. Doing that actually makes it worse, and it makes for a more impotent conversation aimed at solutions, progress, improving on things too.
Fact is when we invest in people, we get returns. Fact also is when we spam people with BS non stop for decades, we get costs.
What makes you think so? Have you looked at other countries in detail?
There is a lot published about this. Might be worth a bit of time when you have an idle minute or few.
As a starting point, repeal of the fairness doctrine (Reagan) coupled with media deregulation (Clinton), transformed mainstream media. Today, access journalism, massive media consolidation, poor clarity programs (fact is poorly differentiated from opinion), and an AD driven culture make for quite the barrage of information, much of it contradictory when viewed as a whole.
We may not be at the top, and sorting that kind of thing out is very highly debatable anyway, but we are up there. It's not hard to understand how very large numbers of us struggle to make sense of the information available today.
Sidebar: There is struggling to make sense and say coming to a wrong, or very poorly supported conclusion. That's one potential. The other one is far more subtle, and that is being confused, being aware of it, feeling one isn't capable, or lacking in time, perhaps education, and seeking authorities to trust. That is more the kind of thing in play regarding vaccination struggles we see today.
People quite literally do not trust public institutions because of the political games they have seen played, poor performance of government, and generally unclear mainstream media. It's been going on for a while now, and it's starting to really add up. (in my view, of course)
End sidebar
Intrigued? I was.
Best way to start is to tune out for a while, say a few months. During this time, seek original documents, if you have a need to be informed, and you might not. It's nice to just tune out for a while, get grounded, sort of reset.
When you do seek something, get original documents, say a report, paper, whatever it is. Then compare and contrast to media on the same topic. When I did this some time back, I was frankly shocked at basic things, such as elevating speculation to fact, or cherry picking from documents to emphasize something the authors did not intend.
I don't have good answers other than to encourage people to use more diverse media sources and seek original documents where they are available and make sense to read.
> We may not be at the top, and sorting that kind of thing out is very highly debatable anyway, but we are up there.
OK, so it was just hyperbole.
I would have had hoped for a comparison to eg Soviet Russia or PR China; or perhaps Berlusconi's Italy?
See also eg https://astralcodexten.substack.com/p/dictator-book-club-orb... or https://astralcodexten.substack.com/p/book-review-the-new-su...
On the face of it, those countries seem quite a bit more 'propagandized' than the US with its relatively free access to information and competitive news landscape. American public institutions are still well working compared to eg many poor countries. (And we have to make that comparison here, since you made a universal claim.)
Wikipedia suggests that the abolish of the so called fairness doctrine might have been a good idea _against_ propaganda: https://en.wikipedia.org/wiki/FCC_fairness_doctrine#Use_as_a...
Competitive News Landscape
The US media is owned by a few large entities. It does not do reporting from a labor point of view, as one example. Indie media is under active suppression, as is any meaningful dissent on a number of fronts. What many see as "competition" is actually theatre, and is also not inclusive coverage, again labor being a super easy example to see, missing important points of view.
As for the fairness doctrine, I agree with it's impact being debatable, but doing that along with media deregulation was a one - two punch, leading directly to the death of investigative journalism and the rise of newstaiment and access journalism. This is now News Corp got started, birth of FOX, et al. State mouthpieces basically. We are currently prosecuting a journalist to death for exposure of war crimes and corruption, just to add on to what is not a ringing endorsement here.
My point in this is the current state of the US in this sense is not good, and that has a clear impact on the people. You are attempting to make a not bad point, and implying a low impact on the people.
Notably, neither of us is making a definitive good assessment.
That aligns more favorably with my point above than your counterpoint here, and the context is people refusing vaccines and other behaviors one would associate with an unclear, propaganda laden body politic. There is a lot of BS being fired at people non stop and it starts right at the top from the consolidated media, by the way currently marked as authoritative by many entities online despite it having clear conflict of interest and a poor record on a number of fronts associated with those conflicts. (war machine, economic policy, media oversight (lol), health care policy)
I've got reasonable support for that and the body of my comment.
Finally, the overall assumption being challenged here is whether to blame the people, and I do continue to reject that idea for it being unproductive and toxic to all of us.
Oh, people come up with unhealthy fads all the time by themselves. It's consistent with propaganda, but not really any evidence for it.
> Finally, the overall assumption being challenged here is whether to blame the people, and I do continue to reject that idea for it being unproductive and toxic to all of us.
Not sure about blame. The media gives people what they want, and people want drivel.
The whole point of stuff like 'fairness doctrines' etc is paternalism: given people who 'know better' the power to give people media that's supposedly better for them than what they would have chosen by themselves.
See https://slatestarcodex.com/2014/12/17/the-toxoplasma-of-rage... for an exploration of that dynamic. https://slatestarcodex.com/2015/09/11/book-review-manufactur... might also be interesting.
This has been done elsewhere, such as in Europe. For example, Supersapiens offers a similar service [1]. However, as you may note when you visit their page in the U.S., it's not offered in the U.S. This appears to be due to the fact that the sensor used, the Abbot Libre Sense [2], is not available in the U.S.
* [0] https://www.theverge.com/22794594/levels-health-glucose-fitn...
So, the next best thing is to get one, hack it, whatever. Beyond that, making one.
1. You need to get a doctor to write you a prescription for it. Any doctor will do, even your Primary Care Physician (PCP).
2. Medicare will only pay for it if you are diabetic (HbA1c > 7.5%).
3. You can reduce your out-of-pocket payment for it by using Pharmacy Discount Coupons from GoodRx and the type.
You are "free", you just need to get the facts right.
Also related: https://www.propublica.org/article/this-scientist-created-a-... https://www.nytimes.com/2021/09/21/briefing/rapid-testing-co...
https://www.bostonglobe.com/2021/12/22/nation/man-behind-rap...
There was a shortage of self-test lateral flow tests a couple of weeks ago, but that's over - they have plenty in stock now. I can go to the NHS website and order a pack of 7 tests, and they'll arrive the next day. They're free.
Teachers and medical staff don't even have to order them; they're provided (required) at the place of work.
I happen to be signed-up for a survey by the Office of National Statistics; they send someone round every week to get a swab from me for PCR testing. I get the result from that by email, the next day. I have more confidence in the LFT than the PCR test, because some of the PCR test labs have been shown to be dodgy.
The ONS is doing PCR tests because the PCR test gives them information about variants, that you don't get from the LFT. The ONS cares about variants and how they are mutating and spreading; I don't. LFT is good enough for me.
I'm going to do an LFT right now, because I'm about to attend a family gathering.
#146 – Michael Mina: Rapid Testing, Viruses, and the Engineering Mindset Lex Fridman Podcast
where Mina details what the tests do and how horribly corrupt the US gov has mismanaged rapid self testing
Link for those interested:
> The Biden Administration Rejected an October Proposal for “Free Rapid Tests for the Holidays” ... The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide “Testing Surge to Prevent Holiday COVID Surge” ... An administration official who attended the meeting told Vanity Fair that, while everyone present shared the same goal of expanding rapid testing as soon as possible, the plan could not be implemented at that time: “We did not have capacity to manufacture over-the-counter tests at that scale.” The problem, in essence, was twofold: The FDA had authorized only a handful of different home tests, and those it had authorized could not increase manufacturing fast enough.
23andme also has privacy implications/externalities for close relatives to people in their database.
Law enforcement usage of DNA databases has also been controversial.
The author's age really shows when she mentions AIDS tests. AIDS for a while was a near guaranteed death sentence and also carried incredible social stigma, and not just because of the assumptions about you made (ie that you were gay, or a drug user.)
I don't think people younger than 40 or so understand how big a deal it was when Princess Diana shook the hand of a person with AIDS in front of TV cameras.
Receiving a positive AIDS test result could be deeply traumatic, and reaction to it could be life-altering on its own. It was 100% a good idea to require counseling...especially when we progressed treatment to the point where it was no longer a death sentence.
If people are allowed to learn about and act on their genetic risk factors, is it possible that certain medical practices stand to lose a lot of money? Is it possible that cheap preventive care could replace expensive procedures/drugs that you are forced to purchase later, once your diseases become unmanageable?
I find it very strange, and incredibly hard to believe that the risk of people overreacting from their medical information outweighs the positive impacts of having the knowledge.
The effect on the masses is that if the test is negative they will send their children to school, use public transportation, go to work even if they are sick as a dog. It's not Corona so it's fine.
The end result is none Corona "normal" winter flue/cold/infections are being spread like never before.
Jag sku finna dina kommentarer moderatligt underhållande om de var nån annanstans än på HN.
I found this page, which suggests a relatively normal flu season so far: https://www.icuregswe.org/en/about-sir/nyheter/influensasaso...
I don't see any cold data. Though I found a chart for australia: https://www.iqvia.com/-/media/iqvia/images/body/blogs/2021/1...