FDA Stops At-Home Tests

TechCrunch…the U.S. Food and Drug Administration (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically bar the use of at-home sample collection. This means startups, including Everlywell, Carbon Health and Nurx, will have to immediately discontinue their testing programs in light of the clarified rules.

The FDA issued the updated guidance on March 21, and though some of the companies had already begun to ship their sample collection kits to people, and even begun to receive samples back to their diagnostic laboratory partners, even any samples in-hand will not be tested, and will instead be destroyed in order to comply with the FDA’s request

The tests are collected at home but the tests themselves are done in certified labs under quality-control standards (CLIA). It is of course possible, even likely, that tests collected at home are not as accurate as those collected by a trained nurse. But we don’t want trained nurses to be testing everyone–they have other things to do right now. Furthermore, some of these errors will be detected at the lab and can be fixed with a retest. False negatives are possible but going to a hospital or standing in line to get a test also comes with risk. False negatives will also become apparent to the extent that symptoms worsen at which time patients can seek medical assistance. Yes, of course, delay and false reassurance are also not without risk. Welcome to the world of tradeoffs. But at this point in time we need to unleash American ingenuity and enterprise and evolve our way to the frontier as conditions improve.

We need to learn now, regulate later.

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Who is the greater enemy of the American people, the FDA/CDC or the CCP? Even the oaf Trump looks pretty benign compared to these people.

I’m guessing the “oaf” will reverse this decision. Seems like the FDA wants to throw its weight around. The FDA and CDC have been useless.

Not sure 'useless' is quite the right word. It seems the FDA is a stew of bureaucratic inertia, applying regular procedure without any conception of whether or not it makes sense in context (or any context) Not sure at what level this behavior kicks in, but I'm guessing it's the direct reports to the director, or perhaps their direct reports.

It seems the CDC is a different problem, which is that they've hired people for their laboratories who aren't particularly good at their jobs who then made mistakes at just the wrong time.

It seems the FDA is a worse problem than the CDC at this point.

It was the CDC that threatened Dr. Helen Chu when she used her influenza study to test for Corona and identified community transmission in the US.

Remember she held off for 2 weeks (after repeated explicit denial of permission from CDC) on testing samples from the first week of February before she threw caution to the wind and broke the law.

We would have known about community transmission weeks ahead of time if not for the CDC. Thousands will die because CDC issued a gag order over IRB bullshit

Reread that last sentence as many times as necessary.

We can tell this because in all the countries that don't have our CDC, no one died.

You think this is some kind of 12 Monkeys scenario, where all we have to do is empower Helen Chu and everything is fine.

I'm sorry, but hell no.

A national response was missing, and a national response still is missing.

Helen Chu was not going to keep those spring breakers off Florida beaches. Helen Chu was not going to stop Fox news from calling us a hoax. Helen Chu was not going to stop Rand Paul from spreading the virus in the Senate gym.

Hahahaha. Good one.

affordable health insurance - http://plans7.com

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The FDA is acting like the English supply officer who refused to give ammo to units about to be overrun because...no proper paperwork.

I'm guessing that most of the same people who are cursing the CDC and FDA here, are the same people who want the CDC and FDA to guarantee - guarantee - that any drugs or treatment they receive are totally safe and effective.

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"We would have known about community transmission weeks ahead of time if not for the CDC. Thousands will die because CDC issued a gag order over IRB bullshit"

There really should be a Congressional Investigation after this. And "I was just following orders" shouldn't afford automatic protection.

Sure. Let's investigate everything. Make sure to include this:

Trump Ignored U.S. Intelligence Warnings on Coronavirus, Report Says

.. or are you just picking CDC as scapegoat?

Don't be an idiot. We all presume that the House of Representatives will investigate Trump. They have continuously for the last 3 years.

Well, to lay it on you:

Good thing too, and too bad every rational person had not stood for removal after the Mueller Report. Because then we'd have President Pence (1) doing a much better job on the pandemic and (2) laying a much better foundation for the future of American conservatism.

Did you miss the critiques of VP Pence coming from the media and Democrats regarding the HIV outbreak when he was governor of Indiana? And with the way these two groups of people smeared Mitt Romney, what makes you think they would be any better had Trump not been in office? Take a look at the stimulus bill being discussed in the House and let me know if you think Democratic leadership exists. We can see how the political parties behave because it’s happening right in front of us. Trump is an obnoxious bafoon and probably making things worse but let’s not pretend the Democrats and media would be treating any generic Republican President differently. All politics, all the time.

Sure I noticed some Pence Derangement Syndrome. But it's kind of a good illustration that I'm not that.

And I think Pence could actually win them over. He knows how to project serious concern, probably because he actually has it.

If you think Pence could have won them over, why should any of your judgments be considered, much less trusted, as you obviously inhabit a world of Boomer delusion?

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So some anonymous guy talks to the Washington Post and you believe them. On the list they gave the President that day, where was the virus? #425? Or did someone talk specifically about it in detail? We don't know and the way it was presented in that article doesn't say.

The CDC and FDA messed up very badly. They did everything wrong; they had a single path for a test, they stopped people outside from working on it. That researcher in Seattle was told by the FDA that she needed to test it against SARS and a couple other viruses, the CDC told her that she couldn't have them because. It was classic bureaucratic nonsense.

Did you notice how quickly all the testing people came up with something once the regulatory clamp was removed? They were working on things, they were ready to go. They didn't tell the FDA or the CDC because they knew all those people would do is say no with a stick.

The CDC made some specific errors in testing and scaling, true.

But that's not the same as saying the CDC is in charge of American government, or has ever had a free hand on response.

Trump budget chief holds firm on CDC cuts amid virus outbreak

That was on March 10th. Almost 2 and 1/2 months after Hong Kong's emergency measures.

Mar 10th is 7 weeks after Trump concerned the Corona task force and 6-1/2 weeks after closing travel with China, yes?

jan 29 was the date of the CV Task-force deployment. 5 weeks. not 7. besides that.. i was reading about this virus back in OCT you dumbfuck. i dont blame trump very much about this CV death wave, and waves come in multiples. The blood of the dead is on the hands of the ones who put this shit-stain in office!!

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The thing that really kills me about this "blame the CDC for delaying" stuff is that the Wohan flareup was Common Knowledge at the same time we were supposedly waiting for Helen Chu to confirm it in Seattle.

In a global pandemic you do not need to wait until you detect it in your back yard. You just need to see pandemic spread. We saw that in China, and we knew that international flights were leaving there in all directions.

Dateline December 31, 2019:

Hong Kong takes emergency measures as mystery ‘pneumonia’ infects dozens in China’s Wuhan city

There was plenty of information available for a rational government to act.

So you are saying that the FDA and CDC, the experts in these matters should have figured out that there was something serious going on and have already way before the time the emergency declaration was made have expedited any covid19 test certification procedures? That knowing someone was working on the virus, in Seattle of all places, they would have rushed to see what she was doing, asking first what she needed so they could bring it along?

These are the experts. The level of response should be calibrated to the urgency that the experts are communicating?

Is that what you are saying?

According to the CDC and FDA at that time there was no hurry. No need at all to develop multiple tests knowing the likelihood of one path not working. No communication between agencies so that there were clear guidelines and access to resources necessary to meet the guidelines.

These agencies are necessary and valuable when they work.

I am observing that Trump apologists, like you the very odd duck Canadian, are trying desperately to lay *everything* at the feed to the CDC.

When, in the US government, the CDC is a *division* of the Department of Health and Human services, which has it's own boss, Alex Azar, appointed by Trump in January 2018.

The buck stops nowhere.

We do know that the buck stops with Trump when its convenient to make him responsible for the actions of every government worker and we have a glorious deep state resistant movement to thwart Trump when that is the appropriate narrative. The head of a company, captain of a ship, head of government is always the one that is ultimately responsible. However, to say that this person is the reason for the failures is entirely another.

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This is all classic anonymous. Mood affiliation rules over any other consideration.

My enemies must be held to the absolute highest standards and any variance must be met with the harshest response.

My friends actions must be interpreted in the most charitable light and any punishment deferred because they meant well.

lol, how many links did I just drop on you?

Classic Trump apologist to pretend there were none, and it was all (like yours) unmoored bias.

lol, as though links are automatically evidence that make your case.

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+1. TDS is his current raison d'etre.

"US Inspector General to investigate federal response to coronavirus

The investigation comes one day after Sen. Patty Murray said the FDA and CDC made "grave errors" in their coronavirus response in a letter to the Inspector General."

Link

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The original post says, 'False negatives will also become apparent to the extent that symptoms worsen at which time patients can seek medical assistance.'
More relevant is that a false negative will lead some to conclude they have only a cold and proceed to behave so as to infect others.

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Conspiracy theory 1.

The FDA and CDC are following White House directions to minimize the official number of Corona Virus cases as much as possible. Can't make the POTUS look bad. Of course, that will inadvertently make the mortality numbers look far worse than they actually are, but no one seems to have thought that through.

Conspiracy theory 2. Making the mortality % look worse by occluding the number of total infected is actually the goal. Whether driven by people looking to harm Trump or by hedge fund managers looking to buy cheap assets in a panic sale (or both?) is your call.

Total BS. The number of tests being done by private labs dwarfs the CDC and public labs. Where do you think the rising numbers of cases being endlessly reported by the MSM come from? As of yesterday’s CVTF briefing, 313k tests done with results reported and 41k positive (13%). As of yesterday the CDC had done less than 5K tests and public labs about 75k:

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/testing-in-us.html

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The FDA and the CDC have not changed their spots. It's past time we dropped the notion of the tripartite system and the "Executive Branch."

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"Conspiracy theory 1/2"

Never attribute to malice that which is adequately explained by stupidity -Robert J. Hanlon

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The FDA and CDC are following White House directions to minimize the official number of Corona Virus cases as much as possible.

Trump explicitly stated that he didn't want the Grand Princess to dock because he thought it would make the coronavirus numbers look worse. So it's not completely unfounded.
I kind of doubt that the head of the CDC was personally involved in shutting down Helen Chu though. It sounds like typical bureaucratic BS.

How is this fact-free hyperbole helping anyone?

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Major drop today in the number of new cases in the US. Things have really turned the corner quickly.

False

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I'm assuming this is sarcasm. In less than a week the US will be number 1 in the world. But hey, the market surged today, so what's to worry about.

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You appear to be the only "oaf" here... Trump is the greatest President since Lincoln! CDC and FDA are mostly useless trash agencies.

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"Who is the greater enemy of the American people, the FDA/CDC or the CCP? Even the oaf Trump looks pretty benign compared to these people."

Let's see, Trump says Obama did everything wrong because Obama hates America and was not a US citizen so Trump is doing the opposite of Obama in everything. In particular, Obama was wrong in 2009:

"Rapid antigen tests played a unique role throughout the 2009 influenza pandemic. The first case of pandemic influenza in the United States was diagnosed using an investigational rapid test device (Meso Scale Diagnostics) being evaluated in a clinical study in San Diego, CA (13). Subsequent to the emergence and spread of the pandemic virus, rapid antigen tests for influenza were utilized in several clinical settings, both before and after the availability of more sensitive molecular assays for specific detection of the new virus. Of the 7 FDA-cleared tests available in April 2009, 2 tests were Clinical Laboratory Improvement Amendments (CLIA) waived, making them valuable for providing rapid diagnosis in physician's offices and emergency rooms, both of which were sites with substantial test volumes during enhanced surveillance performed early in the pandemic. In addition, the tests were also utilized by the majority of laboratories without molecular capabilities."

https://cmr.asm.org/content/25/2/344

Furthermore, in 2014, the FDA approved a Theranos $9.07 herpes test, for which Elizabeth Holmes is charged with fraud.

That's why Trump has ordered all rapid tests banned because Obama was a very very very bad leader and total loser.

No, Trump has not banned rapid testing.

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There is evidence that Coronavirus is consistently in the saliva of those infected. So, yes, the take home test kit should be accurate considering that they used a saliva sample as a back-up test.

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Hi, I am a long time user of this website. I have a random question, and was hoping that somebody is willing to help me out.

Prior is a frequent commenter on this website. Is he the fellow that was previously employed at GMU and subsequently terminated for misconduct? His current grievances on this website are due to that then?

Why is he still so persistent after so many decades? Is he mentally ill (in a medical clinical sense) or this is merely just a more extreme case of employee discontent? I am sort of curious about him, after noticing him for so long.

Thanks in advance to the people who take the time to satisfy my curiosity, appreciate it. :)

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No one really knows all the details except for prior, or even who he is. He originally used the handle: prior_clockwork, then prior_approval. Now he's switched to typing in phrases for his author name.

He's admitted previously to living near GMU and working there 20-30 years ago, lives in Germany now and originally attacked GMU, the Mercatus Institute and Tyler and Alex continuously. Now he mostly posts passive aggressive posts that tend to attack America (especially in comparison to Germany), the US government, the Trump administration, etc.

"just a more extreme case of employee discontent? "

This seems to be the case. He seldom posts the strident screeds he did a few years ago.

He often makes intelligent posts, but they are generally one sided. His comments are rarely what anyone would considered balanced. You never see him admit the "other side" has a good argument or did something correctly. Though they are usually factual, but often obfuscate an argument rather than directly addressing it. Indeed, for a while he was posting walls of copy pasted text responses instead of directly responding to arguments.

"Is he the fellow that was previously employed at GMU and subsequently terminated for misconduct? "

To answer this questioned, he stated that he was an ex-employee. I don't know if he ever admitted to being terminated for "misconduct" though his extremely bitter comments left the distinct impression that he was indeed fired.

Thank you!

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There was a discussion of the Nasopharyngeal (NP) swabs used in the comments recently. This is not covid19 specific, though it is intended for Respiratory Outbreaks in Long-Term Care Facilities, according to the Ottawa Public Health when collecting samples in a home -
With the person's head in a neutral position
1. Insert the dry swab through one nostril straight back (NOT upwards), along the floor of the nasal passage until you reach the posterior wall of the nasopharynx - generally one half the distance from the corner of the nose to the front of the ear (about 4 to 6 cm or 1.6 - 2.5 inches)
2. Rotate the swab gently then leave in place a few seconds
3. Carefully remove the swab without touching the sides of the nostril

It would seem as if doing it yourself is close to worthless. Though worth a fair bit of money to whoever is selling services that revolve around collecting samples using NP swabs.

When will the term efficacy become common in connection with such posts?

There's an overall profound lack of understanding and medical insight in most of the posts, and the vast majority of reader comments. As you note, if the collection method for the home test kits is fatally flawed, then the resulting misinformation could easily do as much harm as good. I recall posts here about the coming revolution in home medical diagnostics, driven by the fraudulent promise of Theranos. That Theranos turning out to be a big con was no surprise to any doctor, since doctors know very well how few diagnoses are made based on laboratory analysis of blood.

In the same way, this website assumes ventilators = COVID-19 cure (against the SARS-CoV2 pneumonia, ventilators are akin to chemotherapy for colon cancer - many people die anyway, and those who survive often have pulmonary fibrosis, not to mention cognitive decline). And around here mortality is the key metric of disease severity ignoring how devastating and consequential the illness can be among those who survive).

Assuming someone can make home test kits that eliminate issues with self-collection of samples, then it's probably a good thing. The CDC and the FDA haven't covered themselves in glory so far, so skepticism about this decision is warranted, but it may not be a simple matter of bureaucratic overreach.

Clearly we should wait for the FDA/CDC to develop an at-home test.

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"That Theranos turning out to be a big con was no surprise to any doctor, since doctors know very well how few diagnoses are made based on laboratory analysis of blood."

It was a surprise to at least one doctor, former GOP Senator Bill Frist who sat on Therano's board.

You have proof that it was a surprise, compared to a nice sum of money?

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All the Theranos board members were old big-name political white guys, including Frist. Frist was a relative latecomer to that board, and as a former surgeon, his medical expertise and experience was of no relevance to what Theranos claimed to be doing. Still, he should have known better, since Theranos was epic-scale snake oil.

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Alex and Tyler are economists. Obviously there is an overall profound lack of understanding and medical insight in most of the posts.

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That you Kevin.

I think the problem often is that they lack information or perspective on how things can go wrong in the product development stage and what can be the consequences.

The companies that are developing the at home kits aren't going to stop developing them, they are just going to have to do tests and prove they work.

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Thank you Find the Flaw. And, again, thank you Kevin

I am getting so mad with misinformation

Or incomplete sensational presentations,

I want to stick a swab up someone's nose

And, begin the slow, slow, exploration of the sinus cavity

While extracting it so carefully as not to contaminate the sample.

The starting premise always seems to be the FDA, CDC, etc. are irrational, there to interfere with the perfect, etc.

Step back and ask questions first, get more information, and question sources if you are going to publicize.

Someone could have just called the FDA or the companies and found out what the reason for the holdup was.

Also, you notice, that the errors in the test could always be fixed with a retest. More money, unless the error is that you have it and you tested negative. How likely is it you will pay for the retest? You will if you tested positive, but not if you tested negative.

That being said, if this test is administered by a pharmacist or dentist, or dental assistant who has been trained and has a sterile environment, I might be ok with it, but not with a hairdresser.

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"The CDC and the FDA haven't covered themselves in glory so far, so skepticism about this decision is warranted, but it may not be a simple matter of bureaucratic overreach."

Are you saying the FDA has done no good in evaluating the testing of test systems in the past three decades of CLIA and CDC funding of innovation in test methodologies has produced zero results in the past three decades when it began using and promoting such methods as whole gene sequencing and also rapid test systems?

Or are you pointing to the three plus years under Trump management.

If the FDA and CDC can't act as quickly as they did under Bush and Obama since Trump took office, is that a failure of the FDA and CDC?

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Why would it seem as if doing it at home would be close to worthless?

You did read the instructions, and you still have a question about things being done properly? Because that is the very first thing that has to be done correctly, or the test is close to worthless.

Second, why not try an experiment, and see whether you can follow those instructions, either on yourself or someone else. I might be able to on someone else (rather not on myself, thanks), but then I also know how to suction lungs without damaging them or infecting someone - with an adequate supply of gloves, as each time you do it, you need to use a pair of sterile gloves.

So they can improve the instructions or make a video. Maybe they can stress the importance of getting it right. They could strongly suggest you get someone to help you.

Do I have to do all the thinking myself?

Well, you pretty well covered the first point at a basic level..

Did you bother to try the second point, or read about a couple of the people pointing out that such swabbing is actually not easy, and that doing it poorly is worthless? Along with it being pointed out that the U.S. currently has zero swabs to waste?

"doing it poorly is worthless"

Do we know this?

Did you read any other comments? It seems that several people here share that opinion, in part because they seem to have actual experience in using such swabs.

Really? All I see is this: "You will have a high false negative rate if you just twirl the swab around the front of the nares."

You honestly can not figure out why a high false negative rate is a serious problem?

Is there any way to get your recommendation/arguments without the added scoop of douche bag?

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Re: " All I see is this: "You will have a high false negative rate ..."

You're comment is a joke, right?

Post below: The answer to the question: What is the purpose of the test?

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Remember in Total Recall, to get the tracking beacon out of his brain, Arnold has to shove that gun-looking thing up his nose, pull the trigger, and the thing automatically extracts that ball-shaped beacon out through his nostril? Somebody could probably make an automatic nasal-swabber like that with little difficulty. Just jam it up your nose and press the button.

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Yes! I’m extremely confident that I could follow those directions. Most people could. Few things more annoying than the superiority complex of many medical professionals.
I remember my GP telling me that I should schedule a *surgery* to drain my cauliflower ear when wrestling, because there was “no way” I was qualified to clean an ear and aspirate it, like it was some act worthy of a gold medal in gymnastics.

I am not a medical professional at all, just someone who was taught how to suction lungs. And reading those instructions, I wonder how many samples would be truly worthless, especially considering the requirement listed for 3. How about 1 in 10? 1 in 3? There are currently shortages in all the resources involved in this testing - why should any level of waste be encouraged, particularly if the results of those spoiled tests are worthless, except to the company's bottom line.

You’re a moron. Like a mechanic arguing that his profession is holy and nobody could ever work on a vehicle without professional training (which no mechanic would actually argue because they’re not stuck up douchebags). If I can learn how to fix a u-joint without destroying a driveshaft I’m pretty sure I can learn how to stick a swab up my nose.

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If there are "currently shortages in all the resources involved in this testing", then the companies are working at capacity anyway, so the bottom line will not be affected. If the bottom line will be affected, then there is capacity not being otherwise used.

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Talk about NP swabs is a red herring.

There's no good reason to use NP swabs for COVID-19, period. Simply testing saliva is better in every way: nicer for patient, less risk to doctors, and, we've known for weeks, has a lower risk of false negatives: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3543605.

Labs previously accepting at-home samples (including my employer) were already working with cheek swabs due to the supply shortage of NP swabs. Preventing at-home testing doesn't mean we swap. It simply means that the patient needs to leave their home and travel to a collection site with a nurse and put that nurse and everyone they pass on their way at pointless risk to ultimately have their sample collected in the same way and get the same test.

(All the above is my possibly flawed understanding as someone who works for a US lab in this space, but only as a programmer working from abroad.)

In Hong Kong (as of 5 days ago), they are using a deep throat saliva sample, not a cheek swab, which is considerably more invasive than a cheek saliva sample. Possibly less of a problem at home, if you are able to control your gagging reflex and get deep enough for long enough.

It is possible you do have a somewhat flawed understanding of what is involved, but it is still a fair point that other swabs than NP swabs can be used.

Could you give us a demonstration on how to deep-throat stuff without gagging, then? You've got plenty of experience, I'm sure.

Sorry, the joke wrote itself there. I disclaim responsibility.

Get it?

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+1. The tests are absolute garbage if they can't be done correctly, which they obviously will not be in this case.

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Most importantly, the trade-offs are a function of the scale of preference of each individual. A binary decision is sub-optimal by definition.

What is the problem of these guys? Their actions have already killed people, and they had their reputation destroyed. Still, they keep putting their nose in free people lives.

Here's a suggestion:

Their problem is that they are public employees. Public employment commonly recruits and retains people who do not improvise. Sometimes, that's not so bad. You don't want accountants or prosecutors or hearing examiners who get creative with their jobs.

The job of the FDA has for decades been to prevent unintended consequences of innovation. See thalidomide. They keep getting in the way because that's the institutional culture, and, as they hire unadaptable people, they do not act in ways which violate that culture until they are directly ordered so to so by superordinate employees immersed in that culture.

"not immersed in that culture"

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The other job of the FDA has for decades been to prove efficacy. And clearly, this is the sort of thing only a bureaucrat would say. “There are those who lean to the point of giving hope and saying give that person the option of having access to that drug,” Fauci said. “And then you have the other group, which is my job as a scientist, to say my job is to ultimately prove without a doubt that a drug is not only safe, but that it actually works.”

Snake oil salesmen have always hated the FDA, and always will.

Well, we've now heard from an FDA employee, who hasn't quite figured out that doctors in respiratory ward are treating near-terminal patients.

That is a real surprise to read after spending years suctioning the lungs of someone who was clearly not near-terminal. To be fair, they were not in a respiratory ward either.

It should be pointed out that a lot more people are going to need lung suctioning in the next period of time, regardless of whether they are on a ventilator or not. Or to be a bit more explicit, particularly after not being put on a ventilator at all, since none will be available.

I should add that the person mentioned is dead, and likely would never be placed on a ventilator as the pandemic grew anyways. Just keeping someone whose lungs are suctioned multiple times a day and night from getting any lung infection at all requires strict adherence to a sterile procedure, something that is already becoming very difficult, with the ongoing shortage of necessary supplies. That lack of supplies is likely to kill a large number of ALS patients, though they are certainly on the more than near-terminal list already, from a certain perspective.

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Let me defend for once the ancient and noble profession of the snake-oil salesmen. They were real entrepreneurs, at least those in the Old West, possibly the archetypal snake oil salesmen. What they sold were usually potions with up to 50% morphine, according to the following text of the great Prof. Whitebread. As he states in his hilarious speech: “Whatever your ailment, I can guarantee you will fell better after drinking a 50% morphine liquid”. They sold the real thing, because their business model was to keep selling through the towns drugstores. They were not, as the movies imply, bite-and-run operations.

Reputation and markets were already working fine when they approved the Harrison Act, there was no need of the FDA.

Regarding the talidomide, nobody suspected it was teratogenic. I frankly don’t understand why everybody mention the talidomide when defending the FDA. Do they think phase III trials include pregnant women?

Sorry, forgot the above mentioned hilarious attachment:

http://druglibrary.org/schaffer/History/whiteb1.htm

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The good news is that the disease is starting to retreat in the US. Yesterday saw a slowdown in the acceleration of new cases and today we are already WAY down in terms of raw new cases. Bad news about the FDA but it looks like we see the light at the end of the tunnel already.

Huloo, post your source below. Provide a link.

I've tried posting the link twice but my comment is not appears. Anyway you can easily search on Google for today's count of new cases. We are really turning the corner.

There are two alternatives.

You are lying
Or
You are really good at it.
This is the second time.

Name the site without a link.
Post below.

Also, you know the difference between acceleration and increase in acceleration, but the average reader doesn't.

Well even right here https://www.ft.com/coronavirus-latest
The rate of acceleration is decreasing - while the number of cases increases every day, the second derivative is starting to bend.
And today the number of cases is way down, a bit over 2000 new cases right now vs. over 10,000 yesterday. It is already late in the day so probably we won't see anywhere near 10,000 today.

The US is vast and has multiple clusters. Furthermore, testing is ramping up, probably more quickly than the virus is growing. So it's optimistic to assume this means that the actual growth rate is on a long run downward derivative track.

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What do economists say? Don't reason from a change in numbers?

Too early. The rate of testing and reporting is not constant. Watch over a week.

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I knew you were trying to mislead people.

Constant rate of acceleration and increasing acceleration.

But, maybe you didn't.

What is the final speed of a car going 60 miles an hour with a constant rate of acceleration of 2 miles an hour after 2 days. Or, same hype, what is the final speed of a car accelerating at 10 miles an hour starting at 60 mph and acceleration declining at .5 miles each hour over a period of two days.

Bill, I think he happens to be wrong. But there's not indication he's deliberately attempting to mislead. It's foolish to assume malice on the part of those who disagree.

I wonder. If you were seeking to disinform a part of the population that would not likely to be compliant, which place would you go to sew chaos and non-compliance.

I think he is deliberately seeking to misinform. There have been several other posts that fell in that category, including yesterday's on WHO.

I think if someone wants to clean themselves of a label, they should post their sources if they are claiming to be fact based.

I challenged him yesterday, and he again did not post a reply or source. Unless he is the source.

"I wonder. If you were seeking to disinform a part of the population that would not likely to be compliant, which place would you go to sew chaos and non-compliance."

It sounds as if you believe this is an active disinformation campaign. That's bizarrely paranoid.

Yeah, the internet is populated only by your friends.

On another post he says that the US death toll will only surpass 800, and he has still not responded to my challenges.

Either you or he is naive. Or both. What could be the case is that he goes to some site like Infowars and reposts what he saw here. He has no support for what he is saying.

Don't be naive. If a foreign government, like Iran, would like to see our military tied down with dealing with a pandemic, what do you think they would do.

By the way, here is an article at MIT on disinformation covid . https://cyber.harvard.edu/story/2020-03/heres-how-social-media-can-combat-coronavirus-infodemic

"Don't be naive. If a foreign government, like Iran, would like to see our military tied down with dealing with a pandemic, what do you think they would do."

Again you sound paranoid. If that's the best our enemies can do, then we're very lucky indeed.

Again, you are naive.

You seem to be saying: If I see it on the internet it must be true. And, anyone challenging a person who offers not evidence, when challenged, is paranoid.

There must be a mental health diagnostic code for people who are too trusting of what they read on the internet.

If you believed everything on the internet you would be schizophrenic.

Bill I didn't say any of that. Try reading what I wrote:

"So it's optimistic to assume this means that the actual growth rate is on a long run downward derivative track. ..Bill, I think he happens to be wrong."

Then you conclude: " If I see it on the internet it must be true. "

"And, anyone challenging a person who offers not evidence, when challenged, is paranoid."

No, I challenged him. You challenged him appropriately but then questioned his motives. Then you went off into some paranoid delusion about foreign agents posting misinformation on an Economics blog.

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That would be nice. Yesterday new cases only increased about 10% more than the day before, but deaths were up more than 20% and these things bounce around- we've even had a few days where the new cases were less than the day before (in the past) but also days where new cases were 70% more. Too early to say anything about today, but I really hope the lockdowns are starting to have some effect.

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Yesterday saw a slowdown in the acceleration of new cases

The third derivative is negative! Hooray!

In other words, the number of new cases still accelerating. It's just accelerating less rapidly, that is if the number isn't a temporary one day blip due to someone filing record 5 minutes after midnight instead of 5 minutes before.

Epidemics follow a sigmoid function curve. So that would be good news.

Except, this is a pandemic with multiple clusters, so you're naturally going to have temporary drops as a hot cluster goes over the inflection point and multiple cool clusters are still relatively small.

And testing has been delayed in the US and we are having an upsurge that's more to do with tests catching up than the actual growth of the virus population.

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Unleashing American ingenuity and enterprise, Silver Solution is the answer to the prayers of those who want to keep Covid-19 away from themselves and their cherished loved ones. Like a miracle, Silver Solution provides effective protection against all the plagues which afflict us, and is still available for shipping to your home, today.

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Do these products have a good system for preventing customers from accidentally smearing their snot on the outside and perhaps infecting the Fed Ex man?

Steve is there any level of death that you would be willing to admit you kind of panicked and let you typical skepticism and rationalist desert you?

My theory is the people that seem to be panicking most and calling for the most onerous crackdowns are boomer parents with kids in the house who know they can’t impose any kind of restriction on their socializing so they need the government to do it for them.

Another reason colleges should not have been suspended and a perfect cherry on top of boomers parenting reflex- I want my kid to think I’m cool so I’ll let the government intervene on this. And then I’ll prove I’m even cooler by occasionally helping them skirt the restriction.

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This is probably a good decision. The testing procedure is technical and a bit uncomfortable. You will have a high false negative rate if you just twirl the swab around the front of the nares. There are costs to this - people will feel more empowered to be out and about and spread.

Drive thru testing is probably the best way to make widespread testing possible.

Furthermore there is a national shortage of swabs. It's best to save them, just like PPE, for professionals.

Be careful about instantly jumping on any piece of news that fits with your biases (libertarian in this instance). Just because something is new doesn't necessarily mean it's more useful than harmful.

Pushing high dose zinc or vit C for COVID won't do much harm to the user, but if someone loudly promotes high dose chloroquine as a treatment for a condition and enough people take it and die, will we say "Hail Darwin" and let them die from their own stupidity or should we push back (not even regulate) against disinformation?

https://www.cnn.com/2020/03/23/health/arizona-coronavirus-chloroquine-death/index.html

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+1

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We all know economists are superior to all other social sciences (the "queen" of the social sciences) so no knowledge of those fields is required. From many of the comments it is also clear that economists have no need for medical expertise either. I am not suggesting we should trust the CDC - there are plenty of reasons to be skeptical. But I fail to see the value in deciding that we know they are either messing up or protecting the public. A more valuable contribution would be to recognize there are issues and try to use expertise that actually knows something - knowing that government agencies can fail is not the same thing as knowing that this particular decision is a failure.

I have increasingly stopped reading the comments because they are so useless. My only use of this blog is that I occasionally see stories that I wouldn't know about. Even that is getting strained - when I see the story is referencing something from Twitter, I stop reading further immediately.

The post is about the FDA.

Reading comprehension. It's great stuff.

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How about at test kits with tele-medicine? A nurse instructing use. Nah, just ban it.

That's not how it was sold nor is there a validation that that method works.

Yeah, I just got a false negative. Now I can go out and have a party and invite you to it.

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I don't know if you all have seen the diagrams, but swabbing for this virus is an extremely invasive procedure. People make fun of Trump for shaking his head at it, but they stick that thing through your nose and way back in your head.

From what I've seen, they need to do that in order to get a good sample of the virus if you have one, especially in the early stages.

And so sure, I get what Alex is saying about false negatives. What if you don't swab good, get a "clean" bill of health, and decide to go about your business?

Is "blame the FDA" really a useful answer to that?

Here is the picture, how many people do you think can really do that to themselves?

https://health.ucdavis.edu/coronavirus/coronavirus-testing.html

yeah, that is the old test.

So, any link to see the new one?

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That is not the test. That is the collection.

Now your implied argument is that there is some newer test that is so sensitive and accurate that sloppy collection doesn't matter.

Provide that link please.

Cheek swabs are way easier and routinely used at home for DNA tests and all kinds of stuff. The picture on that site you linked to is not even anatomically possible.

As noted above, you do not need NP swabs, as Hong Kong is using deep throat saliva sample. That is not the same as a cheek swab - a q-tip is no where long enough, to start with.

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That's the problem here. Their product was nose swabs, and now you changed it to cheek swabs because the nose test had difficulty in self administration.

If it is a cheek swab, point to the literature for these specific companies that shows it is a cheek swab. Post below.

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Um, those cheek swabs?

There for collecting cheek cell dna. Not foreign dna at all.

And that might be a rather critical problem when you don't want cheek cell dna you want foreign dna.

(Or rna as the case may be.)

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Please provide a link to an actual FDA document that states this policy. https://www.fda.gov/media/135659/download does NOT state this. It just says the policy does not apply to home test kits. The giveaway that this is not an official statement is the obvious misuse of "compel" instead of "comply" in the following phrase: "in order to compel with the FDA’s request"

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I think they will be as useful as the at home DNA tests that tell you you’re 1/1024 Native American.

So, pretty goddamn useful?

Maybe if you take all the DNA tests and consult with an expert to understand them. One test is not very useful.

https://www.livescience.com/63997-dna-ancestry-test-results-explained.html

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So, pretty useful if you want a job at Harvard Law Schoool!

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Can we say fraudulent? See https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits

It might well be bad reporting. The references I see aren't from large reporting organizations and I don't know if any of it's involved feed back from the FDA. It might well be a misreading of a technical update.

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Just because someone in the government thinks something is fraudulent does not mean we should deprive people of a cure, like that provided by Silver Solution, a balm to the soul in these trying times. It is truly the answer to the prayers so many have made, a true blessing in trying times, protecting those with the faith to use it in the spirit in which it is sold, shipped directly to your home.

a cure is a product that has been proven safe and effective for that purpose, not something that is anecdotal or based on prayer.

But true believers know that Silver Solution is the answer to their prayers, even if non-believers in NY threaten legal action. “Your show’s segment may mislead consumers as to the effectiveness of the Silver Solution product in protecting against the current outbreak. ... Any representation on the Jim Bakker Show that its Silver Solution products are effective at combatting and/or treating the 2019 novel coronavirus violates New York law,” she wrote.

Then, these people piled on - §Bakker, a disgraced TV preacher in Branson, Mo., has long peddled “Silver Solution” as a cure or treatment for a number of aches and ailments, which medical professionals and the federal government have roundly rejected. Missouri Attorney General Eric Schmitt is asking a judge for a temporary restraining order to stop him from hawking the bogus cure as a way to treat coronavirus. The virus has so far infected more than 1,000 people and killed 31 in the United States as the federal government scrambles to control its spread."

From a certain perspective, one could say the fact that Silver Solution is still being peddled is simply another total failure of the incompetent bureaucrats at the FDA.

Go somewhere else you pathetic troll.

Is there a home test for detecting sarcasm?

Or is it just me, because it seems glaringly obvious that whoever is posting about Silver Solution is savagely mocking not only a fraudulently worthless product, but the lack of regulation that allows it to be sold.

I understood the sarcasm. It's just his usual passive aggressive attacks on the idea of relaxing FDA regulations. He just posts in this manner to avoid having to defend his arguments with actual logic.

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In this thread prior_approval uses the Streisand effect to accidentally push bogus fake medicine on the internet.

You mean there are people who would ever take Silver Solution seriously at MR? People ignorant enough of even basic medical knowledge or the long history of fake cure peddlers?

Though to be fair, below is a comment showing that people can do dumb things when desperate, so you might be right about acting irresponsibly.

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"In this thread prior_approval uses the Streisand effect to accidentally push bogus fake medicine on the internet."

He might actually be fine with that. After all it only affects those stupid Americans and not the superior German culture he's embracing.

My apologies. That was uncalled for. It's not good for me to attack someone's unstated motives.

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I have no idea if the test makers have managed to make self-administered tests robust enough to deal with the fact that many of these tests will be done improperly giving rise to a lot of false negatives.

This is not something you fix with a second test. We want people who test negative to be negative, not being cleared for things like patient care or deliveries to nursing homes. Because that is what will happen if their NPV is too low.

Likewise, we are talking about mass shipment of infectious material. Again, the down side is not a test that we have to repeat, it is sparking a bunch of infection clusters in the major distribution networks.

When we send these things out, we use couriers. We do not mail them to our cousins to drop off at the lab because couriers are expensive. We do not skimp on the biosafety precautions because we don't know them or cannot implement them.

With only some hyperbole we are talking about shipping around live grenades. Maybe we should have some data that this will not cripple our logistical network before we go for haphazard implementation.

Now do not get me wrong, the FDA and CDC have been prioritizing all the wrong things repeatedly, but Covid is not a well functioning market. Information is not clearing currently. Prices are taking a long time equilibrate and God help you for price equilibrium in international markets. Externalities abound.

Yeah command economy sucks. So too does hoping for normal economics to respond appropriately when the fundamental perquisites simply are not there.

In the real world our responses will need to be on a continuum. Somethings will work best with market responses - throw money and masks and give increasing premiums for increasing rates of production. Some things will not - be damn certain before we start mass shipment of infectious media that we are not going to spark outbreaks in our vital logistical capabilities and if that means tamping down on demand and supply for home testing, so be it.

If economics has taught me anything, it is that in the real world there are tradeoffs; optimum policy is rarely blind adherence to a single ideology. But hey maybe we should just gamble that the transportation network can handle a bunch of biohazardous material of questionable safety without crumping. I mean it is not like we are attempting to massively retool the economy and transshipping the components for vital equipment in the millions … oh wait.

Yeah, shipping infectious material is not a small thing. HAZMAT shipment requires document retention for five years. Plus, what are the holding times? Holding temperatures? Do you ship Priority Overnight? First Overnight? FedEx Ground? On ice? On dry ice?

To someone familiar with sampling protocols these are obvious questions to ask (and usually the answer is obvious). To, say, Jimbob in Accounts Receivable, these are obscure and arcane questions that would never occur to him.

Further, shipments mean spreading things, by definition. If you're spreading toilet paper and jury summons, that's fine; if you're spreading a FREAKING PANDEMIC, not so fine. A FedEx driver rendered infectious by an improperly shipped sample will spread COVID-19 pretty far (I've heard reports of the virus surviving for up to 17 days on some surfaces). That's reason enough--absent the questions of proper sampling procedures--to question the advisability of an at-home test.

If we want to do at-home testing, we need to establish a way to get results at home. Think of pregnancy tests: you don't pee on the stick and then take it to the doctor, you pee and get the results. Onsite analysis is never as good as lab analysis (non-experts using sub-optimal equipment; what can you do?), but they get the job done. I have no idea if such a test can be developed for COVID-19, and personally I'd prefer efforts go towards a vaccine--but if we're going to do at-home testing, we need to do at-home analysis as well.

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+1, both great and informative responses

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Well said. "Learn now, regulate later" - I wish people are reading and listening. We have rushed headlong into this and perhaps caused more harm than what the virus may have - and we seem to want to do the same thing as before the virus hit. Unleashing innovation IS the solution.

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I'm no fan of the FDA, but: It's obvious that you've never conducted sampling. Conditions at the time of sampling are CRITICAL for getting quality data, and no, you can't just fix it later. There's a reason that extensive training is required for collecting blood samples, environmental samples, and other samples. Things that you don't think would have an effect can make or break a sample. For hard-to-detect analytes (no idea of COVID-19 is one or not) this is even more true; often sampling requires what's called "clean hands/dirty hands" sampling, where the sampling efforts are divided between two people to ensure no contamination occurs. I know of one sampling method that requires you to use specific laundry soap because most commercially-available soaps leave a residue that can contaminate the sample.

I understand the frustration, but please consult someone who does sampling before issuing recommendations or criticizing these actions. Again, I'm not a fan of the FDA or CDC, especially since they botched this entire pandemic; however, there are a lot of factors involved that you simply aren't addressing, and don't appear to know you need to address. (I do not mean that as an insult; if I discussed economics you'd say the same thing to me. You're outside of your field of expertise here.)

+1, good info

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That pharmaceutical name matched the label on a bottle of chemicals that they used to clean their koi pond, NBC News reported. The fish tank solvent that treats aquatic parasites contains the same active ingredient as the drug, but in a different form that can poison people.

“I saw it sitting on the back shelf and thought, ‘Hey, isn’t that the stuff they’re talking about on TV?’” the wife, who was not named, told the network. “We were afraid of getting sick.”

The couple reportedly poured some of the fish tank cleaning chemical, chloroquine phosphate, into soda and drank it. They hoped it would stave off a coronavirus infection.

“Within thirty minutes of ingestion, the couple experienced immediate effects” that sent them to the emergency room, a Banner Hospital spokeswoman said in a statement Monday.

They felt dizzy and started vomiting. The husband died at the hospital, and the wife is under critical care, according to the hospital.

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Testing's overrated for the average person. Most health authorities are recommending self-isolation over urgent testing if you have mild symptoms (you can call a health line to be safe). If you aren't very sick, Just assume you have it and stay the hell away from others unless told otherwise.

Prevalence is an important factor in determining the nature and extent of preventive measures. When one limits means to better establish prevalence one ends up with draconian measures, sometimes necessary, sometimes not. It depends. Prevalence is an important variable in determining the best outcomes for the proverbial bang for your buck.

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I do not know exactly what we need to do.
but .....
I know this ----

If the bat-eating dog-slaughtering residents of Wuhan try and reopen that wet market - and I say this as someone who loves the Chinese people, I say this as someone who could talk to you for hours about the differences between the sublime Li Po and the almost even more sublime Tu Fu, as someone who could talk to you in an even more interesting way for even more hours about the unique triumphs of the Song Dynasty landscape painters and the unique triumphs of the portraiture of the painters in next several dynasties ----

I know this ....

if the small minority of Wuhan residents who support reopening their bat-eating dog slaughtering wet market, God help them, succeed in reopening that evil evil place ....

well ....

I am a kind-hearted gentle-souled person

cor ad cor loquitur, trust me .....

and as kind-hearted and gentle-souled as I am, I nevertheless KNOW THAT IF THEY REOPEN THAT WET MARKET AND START EATING BATS AND DOGS AGAIN THE WAY THEY USED TO

well then

there are about four billion people, none of them as gentle-hearted or kind-souled as me, who will make sure that the city of Wuhan is razed to the ground and every square foot of that wet market is plowed under with tons of salt and all the residents will be forced to live elsewhere and nobody will ever live in Wuhan again, we are gonna make it a memorial to all the people who were effectively killed by the worst of the Wuhan residents of 2019, with their bat-eating dog-killing ways .

Well, damn -- now I'm hungry.

I used to live near a North Atlantic saltwater bay, lots of disgusting looking things were delicious - squingilli and seagrass with salt, anyone?

Anyway, thanks for your humorous response. It made me laugh .

Please be aware that I pray for everyone who I have any interactions with, including you, and that I am praying for the Chinese people right now, they are in general a good hearted people and almost every single individual among them would agree with me that the consumption of bats must end, for the foreseeable future.

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FDA's side of story

FDA Warns Consumers About Fraudulent At-Home COVID-19 Test Kits
Mar 22, 2020 | staff reporter
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NEW YORK – The US Food and Drug Administration on Friday warned consumers to watch out for companies marketing unproven products for diagnosing, preventing, or treating COVID-19.

"We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable," the agency said in the March 20 consumer alert.

In particular, the agency said it is aware of companies selling unauthorized kits for at-home COVID-19 testing. The agency hasn't authorized any at-home test kits for this purpose, but is currently working with test developers to advance authorized kits that can enable at-home sample collection.

Earlier this month, the agency and the Federal Trade Commission jointly sent warning letters to seven companies who were marketing teas, essential oils, tinctures and colloidal silver for the treatment of COVID-19. "We expect additional such actions will be forthcoming," the agency told consumer in the latest alert.

In addition to warning letters, the agency can also issue injunctions against companies making fraudulent claims and seize unauthorized products. "We are stepping up enforcement at ports of entry, including international mail facilities, to ensure these fraudulent products that originate outside the country do not enter through our borders," the agency said, asking members of the public to report fraudulent test kits to the FDA.

To ensure that disciplined entities aren't continuing to sell products under a different name, the agency has said it will monitor social media and online marketplaces. A cross agency task force is also watching out for fraudulent COVID-19 drugs and tests, and has already worked with major retailers and online marketplaces to remove more than three dozen listings.

The agency cautioned that using fraudulent tests and other healthcare products can result in serious harm and keep some patients from seeking the medical treatment they need. The FDA advised consumers to follow the Centers for Disease Control and Prevention's guidelines and if they think they have COVID-19 symptoms, to speak to a doctor, who in turn will provide further guidance regarding testing if needed.

"The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health," the agency warned.

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