The F.D.A. halts a virus testing program backed by Bill Gates

An innovative coronavirus testing program in the Seattle area — promoted by billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.

Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases in a program based on home test kits sent out to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns.

But the research groups and the public health department of Seattle and King County, which had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the U.S. Food and Drug Administration directed the partnership to cease its testing and reporting until the agency grants further approval.

Here is the NYT link, ahem.

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An election stunt, sadly.

This really is Trump trying to limit testing as the results are not favorable to the market. Jared was caught in the act of slowing down testing to salvage the market. This is not regulatory failure, this is outright political corruption. Kleptomania at work, Kling calls it looting.

Imagine believing that Trump and Kashmir know what the market wants.

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"Federal officials are seeing additional information about how the swabs are handled and also have concerns about whether the group is really conducting surveillance testing, since results are being shared directly with patients.""

So the FDA is stopping this because it might be a HIPPA violation? Sure guys keep following your bureaucratic rules, because that's more important than public safety!

The point is that the rules, and following them, are meant to ensure the bureaucrats' safety!

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So we are just under 11 million tests, with about 375,000 tests in the last day, about 7% positive and you think Trump is suppressing testing?

They do not "think" anything.

This is their last gasp. Like Hitler in 1945 hearing that FDR died, they actually believe that the Wuhan Flu is the thing that is going to bring them the 2020 Election Victory.

It's going to go equally well for them. And it's going to be hilarious.

Gonna go well for people who are still so uninformed that they don't know the difference between an influenza virus and a coronavirus.

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No, Trump halted it because his backers are not reaping monopoly profits or economic rents.

To Trump, et al, Gates as a Keynesian, is a socialist, or maybe communist.

Gates wants to pay workers to build both ttestng capacity and vaccine capacity, ie, capital, until capital is no longer scarce, thus testing is no longer scarce, and vaccines are no longer scarce, thus profit/rent is forced to zero.

Once this SARS-Cov2 pandemic is controlled, the excess capital will seek out other diseases that are epidemic and eliminate scarcity of testing and where possible, scarcity of vaccines.

Note, WWII created an extreme scarcity of capacity, and one the governments directed resources building capital, ie, factories, skilled workers (women), after the war ended, the capital was turned to eliminating scarcity of vehicles, houses, shopping places, utilities services.

Milton Friedman argued too much capital was bad because it eliminates profits.

Trump is so many things. He is as at once a racist bafoon and on the other hand he is the master market manipulator.....

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Perhaps mulp is really the pseudonym of Joe Biden.

https://reason.com/2020/04/27/joe-bidens-latest-campaign-trail-target-is-milton-friedman-but-why/

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The FDA is 15,000 employees, all unfireable union, employee-for-life employees.

That people think either political appointees or the President has any influence in this is hysterical. Extend this to Obama as well, partisan hacks.

Public choice, public choice, public choice.

If that is your logic, how can any individual in the FDA have any responsibility either?

I think you just set everyone free.

"Public choice, public choice, public choice."

According to you. And no personal responsibility for anyone.

No one in the FDA has any accountability. That's why they can march in, demand life-saving activity halt pending their approval, and get away with it. Civil service protections.

Even if this test was halted because it is a violation of the HIPAA law Congress passed, the idea that this move happens without the political leadership of agency pushing it forward is laughable.

Why?

I have personal experience with just these sorts of bureaucratic moves where folks raise some BS HIPAA concern and tell us to stop doing things. Yet when we pushed back, long before we hit the political leadership, we found people in the chain of command who were clueless, apologized, and instructed the people under them to let us move forward.

And this has been my experience with multiple administrations.

I have had to substitute inferior medications because the government treats tablets different than capsules for reimbursement in official descriptions and I could not get a bureaucrat to let me give the patient the medication they needed because of a poorly written memo (unless of course the patient wanted to pay cash). I have had a government bureaucrat tell me that a patient I deemed to be a suicide risk was perfectly safe to discharge based upon their guidelines (though never having laid eyes on the patient); said patient killed themselves before the discharge was complete while being watched by a sitter.

I have had plenty of government bureaucrats do things that risk patients' lives rather than deal with poorly worded regulations.

Nor is the scale an issue. I have seen multiple hospitals in multiple states take it on the chin for millions of dollars because some paper-pusher deep in the bowels of the regulatory state decides something inane and it is only the political appointees who can straighten things out.

So do tell, why on earth is this unique and cannot be the basic civil servant avoiding errors of commission at the expense of many lives lost through omission? I see that one all the time.

This is the most high profile economic and public health issue in decades. ____This did not happen without leadership knowing.___

They may well end up walking it back due to the backlash, even if the specific regulatory issue has not been addressed. In fact, I'd expect it.

To state the obvious, the examples you're pointing to aren't comparable to this issue. And again, even in your experiences, the political leadership are the ones who "fixed" things. In this case those folks are exactly the ones who signed off on this.

So just to be clear, so we're all on the same page:

This is the most high profile economic and public health issue in decades. ____This did not happen without leadership knowing.___

Your contention is that this decision was decided by the head of the FDA? Or even just with the knowledge and approval of the head of the FDA?

Yeah, I would take that bet. It's flabbergasting as to why you would think this would even make it that far up the chain

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This is the biggest thing in decades. That's fine. My colleagues tell me that we had similar stupid petty crap happen back when HIV was the biggest thing in decades and lest we forget has still killed more people than Covid by at least an order of magnitude. Or take the opioid epidemic, again the biggest thing in a decade with death counts, every year, that rival Covid. Remind me again, why medication assisted therapy needs its own army of enforcers and petty regulations?

Though just for consistency's sake, you then believe that entire Covid coverup in China was directly ordered by the top CCP officials? Not that they made mistakes. Nor that the civil servants in the system had bad incentives, but that the CCP intentionally choose to bury it and then spring it on an unsuspecting world?

After all this is the biggest thing that the Chinese organizations have ever come across.

In my experience, the trendline runs the other direction. Political appointees typically are far less likely to do utterly dumb things. They have no civil service protections, they are looking to cash out to some cushy gig in maybe four years, and they have a bigger scope for their decisions. The more inane and utterly divorced from reality a decision is, the more likely it is to be some low level civil servant who is doing things to the letter of the law. They face zero downside for that approach and can only get in trouble for being too independent.

Sorry, I just don't buy it. It goes against everything I have heard about medicine during the early AIDS crisis. Everything I see during the Opioid Crisis goes the other direction. And every noticeable trend suggests to me that this is most likely some overzealous turf warrior.

On the other hand, you must remember that China and the current federal administration don’t follow the same impulses and are not comparable. You underestimate the role of simple, petty hatred in this current farce of a government. The appearance of success vs. actual success vs. the manifestation of animus are usually apparent in some unfortunate combination, with the idea of success being more present in China, and the personal grievance more present in the US. The middle point of looking successful exists here and there, but that pivot swings differently when decisions are made.

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The world will continue to turn even if you act like a child and demand that it stop.

Bureaucracies follow incentives. Throw the political appointee bums out if it makes you feel better about the world.

It won't change anything.

So we would be no worse off with President Hillary Clinton?

Do I think the Corona-chan pandemic in the US would be worse if Hillary were in charge? No, that's idiotic, your partisan buffoon.

The outcomes would be the same sans the idiocy about bleach.

Exactly. The outcomes would be the same sans the idiocy about (insert any stupid thing the narcissist in chief has said). The media, including pundits and entertainers, is absolutely rife with people who see themselves in Trump and so focus on his character. They just want to disassociate themselves from his epic self absorption and so make that the focus of their critique. The hoi polloi sense this and it's going to backfire.

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We would undoubtedly be far worse off with President Clinton.

The single most important thing for us is for people to voluntarily choosing to not take actions that increase infection risk. President Trump at least pays some lip service to effective social distancing and has acknowledged that Covid is an actual threat (with a not terrible estimate of the IFR).

President Clinton would do all of these things. Arguably a bit more in line with expert consensus.

But the pushback would be far worse. For around a third of the country Clinton is utterly untrustworthy and her being for things like line spacing, mask wearing, and lockdowns would mean that they were vehemently opposed to it.

I shudder to think about the size of the anti-lockdown rallies a President Clinton would be facing.

Trump, mercifully, has an opposition whose tribal markers are "listening to experts" and live in the areas most directly affected. They have opted to oppose his containment strategies by being more Catholic than the Pope.

This is a far better opposition dynamic than having Clinton harangue the deplorables and then having them all flout public health guidelines.

+1 Good analysis.

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Lol, FDA employees get fired every year. But mostly they go to work for companies where they can make way more money. :-)

It's called regulatory capture.

Another obvious takeaway from public choice, public choice, public choice.

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Or maybe it’s just a bureaucracy doing what at bureaucracies do.

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We are all libertarians now.

An Egad!
--
https://www.newsmax.com/newsfront/virus-outbreak-aircraft-carrier/2020/05/15/id/967632/
In a statement Friday, the Navy said that, while onboard, the five sailors self-monitored and adhered to strict social distancing protocols.

“These five Sailors developed influenza-like illness symptoms and did the right thing reporting to medical for evaluation,” the Navy said, adding that they were immediately removed from the ship and put back in isolation. A small number of other sailors who were in contact with them were also taken off the ship.

Stray thought: does anyone really "test negative"? Surely they merely fail to test positive? So if, for example, you take a swab but fail to swab the right part of their nose/throat, you presumably report "negative". Had you swabbed a millimetre to the right, as it were, you might have reported "positive".

This is mere conjecture: would anyone who knows about this stuff care to comment?

The virus is pretty well diffused throughout your mucus and also saliva if you have it. It’s not like a skin task where it only infects part of the surface. If there’s little enough of the virus, then it might by chance not be detected, but that’s a concentration issue rather than a matter of where you swab.

Local reports in my area suggest a false negative rate of 30% for covid tests. How does that square with what you're saying?

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Bureaucrats at the FDA stopping testing because of potential HIPPA violations is pretty much the opposite of Libertarian policy.

If you think this is bureaucrats simply enforcing the law that Congress passed, you are a bit naive. This kind of thing does not happen without the Trump-appointed political leadership at the agency pushing it through. Absolutely would not happen given the sensitivity of this issue.

That's an adorable view of the FDA.

I'll happily eat my words if it turns out Trump squashed the Gates testing.

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I dunno about that. A lot of petty tyrants have leapt out of the bushes over the last few months.

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Unsurprising

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Time to do an Elon Musk and tell the FDA to go to hell. I doubt that the administration will have the balls to send in the FBI or the army to stop Bill Gates and King County.

The administration could start with just sacking whomever at the FDA is responsible for this idiotic decision.

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Certainly a bit awake for Trump opponents, though, to have to argue that we don't need a unified federal policy and that Trump should defy his subject-matter experts and instead go with his gut.

I doubt that actual subject matter experts at the FDA are driving this. It's the political appointees heading the FDA who are calling the shots.
As to your exposure of hypocrisy in the machinations of our political leaders: Congratulations? Sorry, it's not much of an achievement.

Who are you kidding

This is what the FDA lives for. SMEs don't make any decisions at federal agencies, they're on contracts and they have deliverables.

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A somewhat random thought. Does anybody remember the lung illness associated with vaping that popped up late last year? Coincidence?

https://time.com/5753947/vaping-lung-disease-outbreak-peak/

Great science: We found that A causes X. Of course, we can't say whether or not B, C, and D also cause X, and of course, A,B,C,D and god knows what else may cause Y, BECAUSE WE DIDN'T TEST FOR ANY OF THAT.

Bureaucrats covering their asses, as usual.

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You mean the deaths that were from the summer and more or less entirely involved people who smoked black market stuff with a certain ingredient that caused it? That definitely were not contagious?

Yes, the people who tend to congregate in closed spaces and blow copious amounts of air droplets, and whom we assume were not contagious!

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And then read

https://www.theguardian.com/commentisfree/2020/may/15/humans-resources-coronavirus-democratise-work-health-lives-market

What does this even mean?

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Right wing ideology masquerading as left wing ideology. It reads like a religious text....

At the end of the day, it’s a weak argument for expropriating party in a soft handed communist kind of way.

All the left has done in 2020 is replace expropriate with democratize.

If you want to democratize work then simply democratize work.

Have the workers start their company and call it a day.....

Could you imagine running a company in the same way someone runs a condo association?The horror....

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"now needs approval directly from the federal government"

Duh. This is why we have a Federal Government to run everything.

State/local governments & private citizens (like Bill Gates) can not be trusted ... and must be carefully supervised/regulated by Federal experts.

A powerful central governments is the only thing preventing chaos in America. Trump & Pelosi are our salvation. {sarcasm}

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typical newyorktimes.com sandwich narrative doesn't say
what issue prompted the temporary halt of the virus testing program

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This is the point where Bill Gates tells the FDA to screw off.

What are they gonna do, arrest Bill Gates?

Always easy to spot a Democrat.

"You can't arrest him for his obvious crime. DON'T YOU KNOW WHO HE IS????"

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Just to understand your position clearly, Tyler, and assuming for a moment that public health people of Washington or Seattle were not included in this. Are you against:

1) the specific decision of the FDA, that is obviously stupid, or,

2) The fact that the FDA has a role at all in this? Because in my opinion, if it was money of private individuals and what they were doing was clearly explained to the tested subjects, the FDA should not even have the right to get involved, not to mention to stop the effort. If there is a reason to think that it is some type of fraud, should not be an issue for the police? I could consider acceptable a role for the FDA, only if the police intervenes, and it decides it needs the experts of the FDA to provide technical expertise.

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If Trump can’t take the credit, then it’s going to get shutdown until all involved figure out how to give Trump credit

Trump is all things. He and his FDA is simultaneously allowing too many bad tests on the market and now they are being to severe in regulating tests.

It’s amazing how Trump is always all things and how little continuity there is in the criticism of him.

I am willing to grant that bureaucratic forces are more likely involved here, but i can also see a narrative that is consistent with trump both allowing bad tests, and regulating-to-death good tests. Anything that lowers or calls into question positive test results could be plausibly be directed by Trump. If he thought that Gates was going to produce believable numbers that make trump look bad, then squash it. If he thinks crappy tests will call into question all numbers, then let it run wild...I'm not saying that that is actually happening, but i can see them coexisting.

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Does anyone know what the legal authority for the action by the FDA was?

I just don't see how testing can be seen as a risk area even if the test is not an FDA approved test. Or is there something "technical" like sending potential biohazard materials as part of the process that the FDA can then step in to halt?

Normally you do need FDA approval for such testing, but there is an Emergency Use Application for this pandemic.

They say they are halting because the emergency use application was not complete.

One caution here is that this may be a bad test, and if it is the FDA may end up looking good.

Remember

https://www.nbcnews.com/health/health-news/abbott-covid-19-test-used-white-house-could-be-inaccurate-n1207466

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Also if I read correctly this organization might have been fine if they simply did a population survey, but in reporting back to patients they became medical providers.

That is perhaps the crux, if you are going to tell someone whether or not they have it you should be .. right?

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Off little off topic,
But
A shout out to
Alex Taborrok
For being on of the first persons publicly
To discuss her likely success for
Using plasma from covid recovered individuals.

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Suddenly the same people who say Trump was blameless because the state should take action, say Trump is blameless because the FDA is stopping the states from taking action.

Uh, who does have ability to fire anyone at the FDA?

Maybe the details on this will end up being interesting, but right now it is astonishing to me that Trumpists think think that somehow this isn't their exoneration.

You are in charge, nimrods.

"Trumpists think that somehow this is their exoneration"

It’s absolutely adorable that you think the president can fire FDA employees.

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I thought that it was the duty of the permanent bureaucracy to #ResistTrump.

"They called me mad. They called me insane. They called me looney. They were right!”

That's kind of the point, that paranoia is a bad answer here.

You have a chief executive, but you want to give him a pass on 100,000 deaths.

One thing I did hear from a real leftist today did give me pause. "How many people died at Benghazi again?"

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Embrace the power of and

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one rather than on
the rather than her

Sorry.

This should have been to the comment one above anonymous

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Ha! Was anyone concerned that Tyler seemed to be gaining a clue? Well, fear not. I give you:

>The F.D.A. halts a virus testing program backed by Bill Gates

Understand that he things this is a BAD thing. He actually wants you to be SCARED and OUTRAGED that this is happening.

Because... well.... Bill Gates is a straight, white, billionaire businessman, apparently. His opinion is supposed to outweigh the zillions of tests that the FDA is required BY LAW to conduct in order to ENSURE YOUR SAFETY. If a successful rich white man wants it, well, dammit, he's supposed to have it!!

If you want to know how far gone Tyler is, consider these equivalent headlines:

> CDC halts testing of vaccine backed by Trump

> FDA halts testing of condiment favored by Trump

> MLB dismisses rule change favored by Trump

> Disney World shuts down ride enjoyed by Trump

All of these things would be celebrated by Tyler. Apparently being a straight white billionaire American businessman only conditionally allows you to impose your will upon the world, safety be damned?

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You have MASSIVE cognitive bias if you think this somehow Trump’s doing.

How do you even imagine that conversation going “Hi FDA bureaucrat lifer that hates me, this is Donald Trump. I’d like you to enforce section 123.23 B clause 7 on the Gates foundation and stop them from doing random testing.””

I certainly don't think Trump ordered Gates shut down.

But I ask you, if Trump had really pressed the FDA to open all testing, would this be happening?

Hell, do you even know which side Trump will take tomorrow?

Or will he keep his attention on the Space Force?

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The USA, after initially lagging in testing because of a technical hurdle, has performed more Covid tests to date than the rest of the world combined.

If Trump is trying to fudge the Numbers by PERSONALLY intervening to DECREASE the number of tests performed, he’s doing a really, really bad job of it.

But in TDS land, you’re able to hold that belief in your head even though it makes absolutely no sense.

That’s the definition of cognitive bias. You have it. You are blind to it. I’m out.

I have never made that argument in my life.

I'm making a different argument. I am asking whether it's really sensible for people to blame things on the FDA while holding the president blameless for their same actions.

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"more Covid tests to date than the rest of the world combined." --> Nope, not even close. https://www.statista.com/statistics/1028731/covid19-tests-select-countries-worldwide/

For the worst outbreak in the world, our testing rate is abysmal. https://www.statista.com/statistics/1104645/covid19-testing-rate-select-countries-worldwide/ https://www.washingtonpost.com/national/coronavirus-trump-testing/2020/05/11/c08766dc-938b-11ea-82b4-c8db161ff6e5_story.html

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“Hi FDA bureaucrat lifer that hates me, this is Donald Trump. I’d like you to enforce section 123.23 B clause 7 on the Gates foundation and stop them from doing random testing.”
----
Yes, this happened a few times. Trump gives medical advice then represses the government docs who object. He pushed the remdesivir though the tests were quite ambiguous. He interferes a lot, that is why a doc or two has resigned.

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I need a new wingnut scorecard. Can I please get a new scorecard, thanks. The one I have has been scratched out too many times. The last entry I have is that Bill Gates is the next evil swan of Hillary Clinton and George Soros.

Is he a brave and bold entrepreneur again? Sheesh, I wish you guys would make up your minds.

What groups of guys do you mean? What is a wingnut, do we have any here?

yes. yes we do.

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https://www.sciencemag.org/news/2020/05/t-cells-found-covid-19-patients-bode-well-long-term-immunity

Immune warriors known as T cells help us fight some viruses, but their importance for battling SARS-CoV-2, the virus that causes COVID-19, has been unclear. Now, two studies reveal infected people harbor T cells that target the virus—and may help them recover. Both studies also found some people never infected with SARS-CoV-2 have these cellular defenses, most likely because they were previously infected with other coronaviruses.

“This is encouraging data,” says virologist Angela Rasmussen of Columbia University. Although the studies don’t clarify whether people who clear a SARS-CoV-2 infection can ward off the virus in the future, both identified strong T cell responses to it, which “bodes well for the development of long-term protective immunity,” Rasmussen says. The findings could also help researchers create better vaccines.
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Layman version of the previous posed article on antibodies. This one is a bit positive, but it does not likely give us complete immunity.

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Disobey them. To hell with those idiots.

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Shame on Gates for circumventing the FDA! He is not a scientist; he is not a doctor; he is not an elected official; he is a billionaire brat using his money to bully his local health department into acquiring information to support his selfish agenda. If Gates truly want to help, he'd followed protocol and involved the FDA whose responsibility is to protect Americans. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. Gates needs to stop invoking fear so that ppl blindly take his UNAPPROVED vaccines. What kind of evil is he that he'd dishonor the process and obtain FDA approval first?

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