America's FDA Halts Bill Gates-Backed Coronavirus Testing Program (digitaltrends.com) 105
America's Food and Drug Administration "halted, at least temporarily, a Seattle-based at-home coronavirus testing program backed by Bill Gates," reports Digital Trends:
"Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the FDA told the Seattle Coronavirus Assessment Network (SCAN) in a memo, according to The New York Times.
"The FDA has not raised any concerns regarding the safety and accuracy of SCAN's test, but we have been asked to pause testing until we receive that additional authorization," according to an update on the SCAN website.
The delay "is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up," reports the New York Times: Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it was "bizarre" that the F.D.A. would halt such a project. The Seattle partnership that is conducting the testing, the Seattle Coronavirus Assessment Network, said in a statement that it had been in conversation with the Food and Drug Administration about its program for about 10 weeks and submitted data a month ago. "We are actively working to address their questions," the group said...
The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them. The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards.... "We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.
"The FDA has not raised any concerns regarding the safety and accuracy of SCAN's test, but we have been asked to pause testing until we receive that additional authorization," according to an update on the SCAN website.
The delay "is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up," reports the New York Times: Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it was "bizarre" that the F.D.A. would halt such a project. The Seattle partnership that is conducting the testing, the Seattle Coronavirus Assessment Network, said in a statement that it had been in conversation with the Food and Drug Administration about its program for about 10 weeks and submitted data a month ago. "We are actively working to address their questions," the group said...
The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them. The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards.... "We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.
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> No facts, no evidence, pure ad hominem.
You weren't alive in the 90s to see it. Bitrot makes your comment look insightful, when it's just ignorant. Carry on.
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Screw Bill Gates, he should leave us alone, just mind his own billions and stick them where the sun don't shine except on prolapsed bitches like him and Tim Cook! Also, Alex Jones says he is a satanist drinking children blood who wants to control us all with his nano-tech vaccine triggered by 5G, LOL!
There ya go. If Alex Jones rallies against someone, you can believe the opposite. Truth is I hated Gates most of my life. But he's gone soft, and decided to do what his wife wants, which is to help people. What's in it for Bill? Sure he can reverse his image before death, he'll no longer just be the evil software tycoon. But by giving away so much money ($36bil so far), he makes connections with the biggest players in health. When he gets the disease that threatens him, he'll know exactly how to fight it
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It has nothing with their "apparent loyalty to Trump". They are appointed for their prowess at the required core competency, which is boot-licking. That is the only qualification required. And being able to stand up vertically while still giving a good boot-licking is a highly sought after skill.
Re:Thanks, Trump! (Score:5, Insightful)
Actually, I wouldn't want to be the person who sent the memo to halt this program, as soon as Trump gets wind of this.
Ideally, this is the sort of thing you'd want someone high up in the food chain of the FDA to look at, apply some common sense and say "Coronavirus testing? Hmm, we need to go full speed ahead on these sorts of programs. There's no safety issue here, so let's authorize a temporary dispensation on my authority while the real permits get sorted out."
That it didn't happen this way is not a surprise. This is a bureaucracy, after all, and bureaucracies are gonna beauru. But now that it's gotten publicity, expect a fire-breathing call from someone WAY up the ladder to get some asses moving pronto to resolve this. My bet is that you'll hear something pretty soon about these tests resuming.
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Actually, I wouldn't want to be the person who sent the memo to halt this program, as soon as Trump gets wind of this.
Why? Trump would probably give that person a raise for fouling Bill Gates's evil plot. Also, Bill Gates was critical about Trump, so he deserves it.
Ideally, this is the sort of thing you'd want someone high up in the food chain of the FDA to look at, apply some common sense and say "Coronavirus testing? Hmm, we need to go full speed ahead on these sorts of programs. There's no safety issue here, so let's authorize a temporary dispensation on my authority while the real permits get sorted out."
Except that the higher-ups in the HHA (the political appointees) are incompetent.
Re:Thanks, Trump! (Score:5, Informative)
There's no safety issue here, so let's authorize a temporary dispensation on my authority while the real permits get sorted out.
There is a safety issue here.
If the tests come back negative for too many people, those people won't quarantine themselves.
Not only that, but having incorrect results can spoil contact tracing and the warning of others too.
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From the summary.
The FDA has not raised any concerns regarding the safety and accuracy of SCAN's test
No, I really think this is just about a bureaucracy making sure it stamps everything it needs to stamp, nothing more. WA state has already given the go-ahead.
As I understand it, this program isn't replacing traditional COVID-18 testing. Rather, this is attempting to test a very broad demographic sampling of Seattle's population in order to get a better idea of what the actual infection rates are, and how effective social distancing is in preventing the disease from spreading. You know ho
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You know how everyone keeps saying how the infection rates are probably a lot higher than what is currently reported? This may help answer that question, among others.
Which is what the "open the doors because I'm losing money" crowd does **NOT** want. Countries doing adequate testing are finding very low rates of SARS-2 antibodies among the general population, which implies that the self-quarantine and social distancing is working the way they're supposed to.
That's what the FDA thought too (Score:2)
> As I understand it, this program isn't replacing traditional COVID-18 testing. Rather, this is attempting to test a very broad demographic sampling of Seattle's population in order to get a better idea of what the actual infection rates are, and how effective social distancing is in preventing the disease from spreading.
Yeah that's what the FDA thought too, and it's approved for that purpose.
> They likely already know what the error rate is, and can factor that into the statistical models.
Which is v
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I hope you're right that it's just a few questions and will get resolved quickly. I have a hard time believing this research group (look at the credentials) would do something as irresponsible as even hinting to people that just because they've tested positive for antibodies, they are therefore immune to COVID-19. And IMO, it's irresponsible to halt the program in the meantime.
To me, the key issue here is that doing nothing seem more dangerous than whatever theoretical damage could be done by this program
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> Given that a number of people disagree (or are you just playing devil's advocate? hard to tell), I guess maybe it's only obvious to me.
I don't *disagree* with your general sentiment. I've been told that in some cases lately instead of filing a big package of formal paperwork to officially amend an application and then waiting a couple.of months for someone at FDA to get around to reading it, researchers and FDA people have exchanged quick emails and phone calls to clear things up. That's good.
It's less
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Absolutely, I'm not advocating recklessness. I hardly think this falls in that camp even in a realistic worst-case scenario. We're not talking about a drug that might have potentially long term or even life-threatening side-effects we don't know about. It's just testing, and moreover, it's testing on a relatively large scale, something we desperately need right now.
Note that I indicated that the review process SHOULD take place, just that the program shouldn't necessarily be halted in the meantime. This
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the program shouldn't necessarily be halted in the meantime
Its a clinical trial for a testing program - it's not a treatment, it's not a vaccine, it's not a cure - it's a test. We've got over a dozen different test programs available right now - this would be just another test on the list of options.
The delay would likely be on the order of a couple days, and anyone taking this EXPERIMENTAL, UNPROVEN Covid-19 test is doing it to help the test program get approved, no doctor is basing patient treatment on the results of these EXPERIMENTAL, UNTESTED Covid-19 tests.
Th
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Yes, this is a reasonable step for FDA, if you strip out the emotion around the words "Covid-19", "Testing", and "Trump". If this were the only test available, or if this test was somehow unique and special, then possibly. We've conducted 10 million Covid-19 tests to date, anyone that reasonably needs a test TODAY can get one TODAY. All the drama around test scarcity two months ago has been resolved.
The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them. The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards.... "We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.
They submitted paperwork for one kind of testing, conducted another kind of testing, and the FDA wants the pa
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No, I really think this is just about a bureaucracy making sure it stamps everything it needs to stamp, nothing more.
I'm sorry, but unless you work in that field, you couldn't possibly know that yourself.
We've already had one Theranos, we don't know another one.
Rather, this is attempting to test a very broad demographic sampling of Seattle's population in order to get a better idea of what the actual infection rates are.
And that's fine, as long as you don't return those results to the people being tested, but clearly, that's not what was happening in this case.
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That it didn't happen this way is not a surprise. This is a bureaucracy, after all, and bureaucracies are gonna beauru.
This lines right up with the right wing model of providing incompetent government leadership so they can later complain that government is incompetent.
Trump is only one man, so he is not going to be personally involved in every decision like this. But his appointees are. This is one of the largest dangers of incompetent leadership; it trickles down.
Re: Thanks, Trump! (Score:1)
The fruit rots from the inside out.
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The incompetence was with the people running the clinical trial - they sought approval for one type of study, ran a different type of study, and now people like you are blaming the folks that noticed they filed the wrong paperwork.
The FDA simply wants this Clinical Trial to abide by our Clinical Trial regulations - it's actually a pretty reasonable thing.
While this study is on hold, people will not be getting EXPERIMENTAL, UNTESTED Covid-19 tests - they'll simply get one of the dozen other tests available f
Re:Thanks, Trump! (Score:5, Informative)
That's actually somewhat reasonable. Population studies can successfully use tests with a fairly high error rate, as long as the know what the error rate is. Individual diagnosis requires either much higher accuracy, or multiple independent tests.
Now we don't know that the tests weren't sufficiently accurate, but a huge number of them haven't been accurate enough for diagnostic use.
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Now we don't know that the tests weren't sufficiently accurate, but a huge number of them haven't been accurate enough for diagnostic use.
Doesn't seem to have stopped the Trump Administration from promoting Abbott Labs' test kit [slashdot.org]
Re:Thanks, Trump! (Score:5, Funny)
Abbott labs? I am sure the tests from Costello Labs are much more reliable. Abbott is almost always out of work happily doing nothing while Costello is always working hard, hence the expected results!
https://en.wikipedia.org/wiki/... [wikipedia.org]
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WHO backs this measure?
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Oh god I forgot about Abbott and Costello. Abbott took a new and dumber meaning when Australia had Tony Abbott as a prime minister, and man with such a big brain that he ate a raw onion because ... well when you're doing an interview with a farmer a politician needs to hold the farmers produce and obviously taste it on camera.
Oh with skin on.
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Even if the virus is harmless to most people, it’s killing far more people than other viruses in the wild right now. But that doesn’t agree with your open-everything-up-now narrative....
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it’s killing far more people than other viruses in the wild right now.
No, it isn't - Covid-19 has a mortality rate of about 1.5% (and dropping), Ebola almost 40%, and SARS almost 10% - all in the past 20 years.
Source: https://images.app.goo.gl/Benm... [app.goo.gl]
Seasonal Flu kills between 250K-650K people world wide annually.
Source: https://www.medicinenet.com/sc... [medicinenet.com]
Is it a problem, yes. Is it an unprecedented virus? No, not if we consider the recent history of the past 20 years.
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Unfortunately, the Abbott Labs test is pretty much the only one fast enough to screen people who're, say, reporting for the start of their work shifts - which is why the White House has been using it internally. (It also demonstrates some of the more subtle perils of coronavirus testing. There's some suspicion that the way the samples were taken and stored may have caused the bad results described in that article, which is also part of the reason the FDA is leery of at-home coronavirus testing. The UK does
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Also the UK testing program isn't keeping up with demands. But I haven't heard any reports about its accuracy.
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Since the error rate is fixed, a test with high false result rates can tell you a lot about *trends*.
This is a generally useful strategy in any kind of real-world reasoning-from-numbers tasks, where the information you have is questionable: trust the trend in the numbers more than the numbers themselves.
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More than that, at the population level if you have a test with a known error rate and you know the number of tests administered, you can estimate the true positive rate. If the FP and FN rate are the same you can even just use the number without correction.
An example of what you mentioned, BMI isn't a very good metric in individuals, but it works quite well at the population level, particularly for monitoring trends.
Regulations (Score:5, Funny)
I'm beginning to understand why both Musk and Bezos are sinking so much money into space travel.
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And they will be space emperors. What makes you think they will handle a pandemic any better?
Herding cats is difficult, and much much worse in humans.
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The study is good and really says "yes- keep doing randomized trials, there may be something here."
But it does not show that the drug regimen itself reduced mortality. It merely shows that it's possible it did, or that bad luck tainted the non-zinc group with confounding variables.
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The Medcram video is interesting. It said, with qualifications, that getting zinc into cells before the disease becomes severe statistically improves patient outcomes. Hydroxychloroquine helps get zinc into cells.
Michael Savage has supported the use of quercetin with a different form of zinc, where quercetin helps the zinc transport.
Others, particularly those supporting the use of supplements, also think zinc use is a good idea.
WARNING. The use of zinc in the quantities that may be therapeutically useful i
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And they will be space emperors. What makes you think they will handle a pandemic any better?
Well for one thing, they would be social distancing a whole planet away...
For another, Musk and Bezos would just make whatever the hell was needed immediately, and probably already have warehouses of it to start.
What on earth makes you think they would not be vastly better than any government has done?
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1) politics.
2) Even if they are perfect, they will die one day, and then, politics.
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they need to research what a swallow can carry
African or European?
Also, how many you'd need to have an effect. One swallow does not a relationship make.
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IOW (Score:1)
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Re:IOW (Score:5, Funny)
What, the actor?!
WTF?!?! (Score:2)
WTF!
That is horrifically stupid!
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Yes, because doing so also tells all the other people you're testing that they're probably not infected and not a potential risk to others. Which as you can imagine is not a good thing if you get it wrong.
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There needs to be regulation around it.
If it returns negative when you are positive, then you may go around spreading the virus.
If it returns positive when you are negative, then you will overburden the healthcare system, especially when you catch your seasonal allergies.
The American FDA is a very slow agency, and conservative (not the political term) in its approach to allowing thing. I expect things are already going too fast for normal FDA processes.
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The FDA is slow and conservative until they approve something that turns out to have problems. Then they're reckless cowboys.
Kinda like the FAA....
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Solution seems quite simple to me. Simply shoot everyone tested in the head just because it is safer to be dead. This then leads to the obvious conclusion that there is no point in actually carrying out an expensive test, since it is irrelevant. Merely announce that you are offering "free testing" and kill anyone who shows up. Since bullets are significantly less expensive than actual tests, many more "tests" can be performed for the same amount of money expended.
Plus, the dead can be used for fuel to g
Re: You manage what you measure (Score:4, Funny)
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Trump thinks testing is overrated https://www.msnbc.com/11th-hou... [msnbc.com].
Why, because people people test negative for a while, and then all of the sudden, they test positive. https://thehill.com/homenews/a... [thehill.com] That is probably why the FDA is halting the program.
Testing will hurt numbers the same way as those cruise passengers he kept in port. https://www.rawstory.com/2020/... [rawstory.com]
Trump is hostile to the truth when it isn't helpful, and ignores it when a lie will be slightly more advantageous for even a news cycle. If tests are administered in useful numbers, the number of cases will skyrocket and objective guidelines for reopening will not be attainable. Instead he questions testing and outsources the actual irresponsibility to friendly state governers and armed local yahoos. His focus is on whether the next thing that happens is good or bad for him.
But however much he publicly dismisses testing, the people around him are tested frequently ("she tested very good for a long period of time and then all of a sudden today she tested positive"). He knows this doesn't make him look good, but he is willing to suffer this rather than risk getting sick.
Quoted against censorious troll mods. Then again, I certainly wouldn't have modded it up.
Foolish regulation implemented by the FDA (Score:1)
What do you say -- this regulation seems intended to centralize and control the flow of medical information.
The entire Covid-19 affair shows how lacking the medical profession is in many areas.
What are emergency authorisations for, if not this?
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Re:Foolish regulation implemented by the FDA (Score:4, Interesting)
It will tell how many people already had the virus and some politicians don't want that to be known. .
Actually, most politicians are desperate to find out because it is key to determining when the lockdowns can safely be lifted and how quickly. There's been a reasonably robust study across Spain that suggests around 5% of the population may have been infected - Spain currently has around twice the deaths per million population as the US, though the US rate is ticking up fast. Other studies have come up with similar rates. The highest rate found anywhere yet was New York City with around 20%, though the State average was closer to 10%. Nowhere has a figure as high as 30% yet been found. Of course, you probably believe the numbers are all fake but I'm afraid speculation does not trump data.
Lockdowns are a sign of public health failure - they could largely have been avoided if proper testing and tracing had been implemented early. Having failed once it would be particularly stupid to fail a second time by prematurely encouraging phsyical proximity while infections continue at a high rate.
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There's a more recent [bostonherald.com] study conducted by the same hospital on "a representative sample of asymptomatic Bostonians" rather than a small number of passers-by on the street in an area which has continued to make local and national headlines with its sky-high rate [bostonherald.com] of infections.
Properly conducted, the rate of antibodies in the general population was found to be around 10%. That's a long way off "herd immunity" and your assertion is unsupported by evidence.
Re:Foolish regulation implemented by the FDA (Score:4)
There's actually a good reason to restrict the use of diagnostic screening tests -- they give misleading results, even when the tests are excellent.
It has to do with the base rate fallacy. Right now the number of officially reported cases in the US amounts to 0.45% of the population; let's say the actual number of people who have antibodies was 5%. Supposed you administered a 95% accurate antibody test on this hypothetical population, what is the probability someone with a positive result has antibodies?
The answer isn't 0.95; it's 0.48. More than half the people running around thinking they were immune because of their test results would actually not be. And false positive rates for many of these tests are a lot higher than 5% -- 29% is the highest I've seen.
That doesn't mean that screening is useless. It means it has dangerous unintended consequences. Whether or not to screen depends on how you plan to use the results; if you haven't thought that part through, it's better not to screen.
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It's also worth noting that the majority of physicians can't correctly work the calculation you just did, so "anyone with half a fucking brain understands" (quote from comment on this story) is dangerously incorrect.
Regulations (Score:1)
Why are they suppressing testing? (Score:1)
The FDA has shut down every single home testing kit that was seeking approval. ALL of them. And the antibody tests that have approved have some oneruous restrictions on them.
The Mt. Sinai developed test kit can only be used at Mt. Sinai hospital. Hospitals can only Abbott Labs antibody test kits after they seek and receive FDA approval to use the kits.
I tried to get a LabCorp antibody test, but you can't just go and get one. You have to take a survey. And after they survey they told me I was not eligib
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We can't let uncontrolled testing mess up our carefully crafted statistics.
reports? (Score:1)
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Gates is smart.
He actually has more power now, then he would have if being elected into government. Being a billionaire, he can just use his money to get what he wants done. And not really being tied to any one parties election, means he can work with officials from different parties without stupid backlashes. (That we may see during primary season, where Congressman X just isn't Conservative/Liberal enough for you. and shows a picture of them talking to the political opponent that Cable News tells you
Re:Nobody elected Bill Gates (Score:5, Insightful)
He has no medical background or expertise.
He does now. If most politicians in this world understood infectious diseases as well as Bill Gates, chances are COVID-19 would have been nipped in the bud and we wouldn't even be in this crisis. Wasn't it himself who warned what, 5 years ago, that the world wasn't ready for a pandemic [youtube.com]? So please direct any 'unqualified' attacks to other people who in fact... are.
Imho it's a bad thing that individuals like Gates have the power to decide how billions get spent / at what effort(s) such funds are directed. So much money (read: power) should not be in the hands of a single individual - period. But that's not a problem with the billionaires themselves. That is a problem with this society's economic and political system, that allows billions to be put in the hands of individuals. If you hate the fact that billionaires like Gates, Bezos, Musk & co. are walking this earth, or think the billions sunk into their pet projects are wasted, don't attack them but attack the economic / political system that enabled them to become billionaire at considerable cost to the rest of society.
And regardless what you think of Bill Gates as a person, or his business practices back in the Microsoft days, fact is he (with the Bill & Melinda Gates Foundation) has done a lot of good over the past decades.
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That may be a new record for the most pointless Godwin-ing of a thread ever.
Re:Nobody elected Bill Gates (Score:4, Insightful)
No, Bill Gates still doesn't have any medical background or expertise. What is has is tons of money, which means he can hire people to tell him things - that does not make him an expert; it makes him a mouthpiece.
At the same time, no, it isn't impressive to say 5 years ago that "the world isn't ready for a pandemic" - people have been saying that (correctly) since the early 1900s! Hell, the US federal government ran an exercise in 2001 called Operation Dark Winter [wikipedia.org] that quite clearly demonstrated that the modern US state and federal governments were in no way capable of handling the simulated pandemic. This exercise was so well known that it became the basis for movies, books, and even video games.
Making predictions of the obvious, and bringing it back up every time a new disease outbreak is discovered doesn't make him Nostradamus, it makes him the old man that cried wolf.
Re:Nobody elected Bill Gates (Score:4, Interesting)
No, Bill Gates still doesn't have any medical background or expertise. What is has is tons of money, which means he can hire people to tell him things - that does not make him an expert; it makes him a mouthpiece.
This is 100% correct and sadly the world would be in a lot better place if more people in power behaved like him, he listens to what the experts say and acts as the mouthpiece for them, unlike certain individuals who tell the experts to shutup and dribbles out whatever brainfart comes to mind in the last 30 seconds.
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I am questioning whether you can really compare different countries' death count, not every country counts in the same way; some country are more likely to count a 'suspected' corona death than others. I suspect even different countries are impacted differently wrt traffic related deaths and pollution related deaths, which would impact the total amount of deaths. And there are a number of other factors impacting corona-deaths (pop density, #international flights, ..., even vitamin-D deficiency is a factor a