Coronavirus

FDA Should Get Out of the Way of At-Home COVID-19 Testing

Private-sector efforts to fill the testing vacuum run afoul of bureaucracy.

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Four different at-home diagnostic companies are planning to offer tests for coronavirus infection to health care workers and the public in the next week or so. One of the companies is the Austin-based Everlywell, which says it will make as many as 30,000 tests available to health care providers today. The company aims to return results to consumers within 48 hours after the labs receive the test samples, and it says it will offer telehealth consultations to folks who test positive. Positive results will be communicated to all mandated federal and state reporting agencies. The company says it will take no profits from the $135 test.

By working with multiple labs, the company plans to ramp up to a testing and diagnosis capacity for a quarter of a million people weekly. Compare this with the latest Centers for Disease Control and Prevention (CDC) report, which says just under 72,000 tests have been run in the U.S. so far.

Dr. George Rutherford, a physician at the University of California, San Francisco, who investigates the control of infectious diseases, thinks it's important for this to move forward. "Countries like South Korea have done 270,000 coronavirus tests trying to get this thing under control, and America has done far less than that," he told Fortune. "We need a lot of tests in many forms, and we need them now."

The Food and Drug Administration (FDA) has had a different response. "We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," declared the FDA's associate commissioner for regulatory affairs, Judith A. McMeekin, in a March 20 press release. The agency did acknowledge that it "sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space." Work harder, then.

Diagnostics companies like Everlywell believed that they were authorized to develop their tests under the latest FDA Emergency Use Authorization, which says that any lab that had been certified under the appropriate quality-control standards could start performing coronavirus tests. All four companies are using just such labs to test the samples they collect.

A couple notable cautions for folks who, once the FDA gets out of the way, may want to take advantage of at-home tests:

1. Getting a good sample for testing apparently involves a pretty uncomfortable deep swabbing in the back of your nose and throat. One benchmark is that the swabbing should make your eyes nearly water and make you feel like you're gagging.

2. For some tests, getting results back takes more than week. That is too long.

3. Testing negative is merely a snapshot in time. You are, of course, still at risk of getting infected later.

I am not endorsing these at-home tests. But I should note that I took an Everlywell cholesterol and lipids test a while back and compared its results with results from a test taken at my physician's office. They matched up nicely.

NEXT: No, It's Not Dangerous To Air Trump's Coronavirus Briefings

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  1. One benchmark is that the swabbing should make your eyes nearly water and make you feel like you’re gagging.

    So, it’s more comfortable than your current situation?

  2. I disagree. It is vital that the FDA ensure that any coronavirus tests are accurate. Bad tests giving wrong answers would undoubtedly cause illness and death. History shows clearly that in the absence of regulation, companies will sell quack products that harm the public.

    1. That’s what tort law is for.

      Regulation can be a bad thing. If regulators give the ok to something that doesn’t work, then the company is shielded from litigation because that would mean the government made a mistake.

      1. That’s what tort law is for.

        I disagree, but there’s a lot of ground between the two spaces. Without an entity like the FDA, you can’t effectively know that a diagnostics company is effecting a scam. I can’t count the number of times I’ve heard or made the joke about wiring the sample collector up to an RNG and no one would know the difference. I don’t agree with the FDA, but if we got rid of the FDA, we’d end up with something just as bad. Like a section 230 of healthcare diagnostics.

        1. Yes, and without an entity like the CDC, we wouldn’t have fraudulent tests on the government market place.

          Who tests the testers? And who holds the fraudulent testers responsible when said fraudulent testers are the government itself?

          1. Rule #1: Government is always right.

            Rule #2: When government is wrong, refer to Rule #1.

            1. You do realize that tort law is still the government, right?

              1. Um… yeah. I’m not an anarchist. Courts are a valid function of government.

                1. Except the judiciary, executive, and congress are distinct branches.

              2. When I say “I don’t think government should do this” I’m not saying “I don’t think government should do anything.”

                1. When I say “I don’t think government should do this” I’m not saying “I don’t think government should do anything.”

                  Me either.

                  Point being, you aren’t really saying “The government shouldn’t be doing this.” which is a libertarian argument as much as “This branch of the government shouldn’t be doing this.” which isn’t exactly a libertarian argument (assuming the ‘this’ isn’t e.g. regulating free speech and the branch in question isn’t Congress).

                  I don’t disagree with your stance but if all you’re calling for is rearranging deck chairs, I’m gonna need to see your work/thoughts on how we’re going to seat more/less people with the same/different number of chairs.

                  1. I don’t disagree with your stance but if all you’re calling for is rearranging deck chairs, I’m gonna need to see your work/thoughts on how we’re going to seat more/less people with the same/different number of chairs.

                    No.

                    That’s like saying “If you don’t like central planning, tell me what to replace it with! Be specific!”

                    I don’t know the solution. That’s the beauty of markets. Someone smarter than me will figure it out, rather than some idiot in a government office. Spontaneous order and all that.

                    1. That’s like saying “If you don’t like central planning, tell me what to replace it with! Be specific!”

                      You’re shooting a 100-yr.-old vampire with the silver bullets that didn’t kill the werewolf that was enacted by the previous administration.

                      I’m not in favor of werewolves or vampires. Get better bullets.

          2. Who tests the testers? And who holds the fraudulent testers responsible when said fraudulent testers are the government itself?

            Ideally, the voters, which is why I don’t agree with the FDA/CDC as is. However I’m dubious that if we dissolved the FDA, that we would get something more federated, more tort-driven, or more directly beholden to the voters.

            1. Voters? You must be dreaming of some small jurisdiction where your vote matters.

              Perfect example: government-run schools. It’s one thing to have government-funded schools, another entirely to be government-run. The only excuse for government-run is indoctrination.

              If you can’t separate the two, you are an idiot.

              Same with courts and tort law as a substitute for government control. You seem to think they are the same. They are not. Private people bring suit. This is different from government edicts, government fraud, and government coverup for government fraud.

        2. Or a private company could step in evaluate products. Get the Consumer Reports seal of approval. Doctors won’t want to prescribe quack meds. They’ll want some testing. Just because government does it now doesn’t mean nobody else would or could. Would it be perfect? No. But neither is the current system. I’m sure a private sector solution would be a hell of a lot cheaper, faster, and much more efficient.

          1. Get the Consumer Reports seal of approval. Doctors won’t want to prescribe quack meds. They’ll want some testing. Just because government does it now doesn’t mean nobody else would or could. Would it be perfect? No. But neither is the current system. I’m sure a private sector solution would be a hell of a lot cheaper, faster, and much more efficient.

            See AMA, APA, etc.

            Considering that the AMA helped usher in the ACA, would treat vaping much the same way it treated tobacco, would treat gun crime as a disease, and would raise the legal drinking age to 21, I think libertarians should be a little more nuanced in their calls to end the FDA/CDC lest more self-righteous and oppressive organizations take up the slack.

            1. You know more about this than I do. I was thinking from 30,000 feet. Yeah. Details suck.

            2. Yes, that would be awful. But not nearly as awful politicians doing it.

              The AMA is flawed because the AMA is comprised of flawed individuals. But guess what the government is comprised of? The same flawed individuals! Except now they have power!

              None of the bad stuff you mention the AMA doing would have been possible without the willing cooperation of the government.

              1. A. The AMA has the government seal of approval and depends on that for its coercive power.

                B. Government paychecks turn flawed individuals into wise, benevolent, know-it-all slavers mini-dictators bureaucrats whose only joy in life is helping peons.

            3. “Considering that the AMA helped usher in the ACA, would treat vaping much the same way it treated tobacco, would treat gun crime as a disease, and would raise the legal drinking age to 21, I think libertarians should be a little more nuanced in their calls to end the FDA/CDC lest more self-righteous and oppressive organizations take up the slack.”

              What do you think the CDC has been doing for the past 10 years?

      2. That’s what tort law is for

        Of course. See Elixir Sulfanilomide

        That said. I really do think we are in dire need of the periodic death counts that apparently cease to be effective over time in informing us as to what sort of society we want to create for ourselves. The bureaucrats just grow like kudzu in order to protect their fiefdoms more than anything else. And fundamentalists increasingly pretend that the invisible hand solves everything.

        It’s been a while since we’ve had raspberry-flavored antifreeze sold to us. We need a new go-round of same – now marketed by Dr Kim Kardashian on YouTube.

        1. Oh yeah. You’re the FDA, can’t trust evul corepourations guy.

          I don’t know what you just said. It’s word salad to me. Lots has happened since the 30s. We have more information than we know what to do with.

          Lets get government out of the way and use this information effectively.

        2. Can;t you Keep Up With The Kardashians? She’s going to be a lawyer, not a doctor.

      3. Tort law would fail for a few reasons:
        1. If someone gets sick because of a false negative that a stranger received, how would they even know who to sue. It would also be impossible for them to prove causality.
        2. There could be many plaintiffs, all with huge losses, so lets say they do sue and win. The companies would just declare bankruptcy and they end up with nothing anyhow.
        It is better for the tests to be verified before they hit the market.

        1. How does government fraud improve on your hypotheticals?

          Statists are always comparing in ideal theoretical State with messy reality.

        2. Right… And heaven forbid when we buy a computer monitor an empty box doesn’t just show up.

          Worshiping the almighty federal government is EXACTLY the disease our founders were worried about.

    2. So your answer is to not have testing because regulations protect us from “quack products” but also from good products that haven’t had time to go through the process yet.

      1. Testing needs to be reliable to be useful.

        1. And the key element to any successful business is TRUST. Government doesn’t offer that choice.

    3. Yes, and the CDC agrees with you, since their test was a fraud.

      Your mistake is the typical statist one — that government paychecks make people smart clever honest know-it-alls with all information readily at hand, as opposed to the general public, who are all naive rubes who wouldn’t know how to pour piss out of a boot if it weren’t printed on the bottom.

      1. +100000; Well said!

    4. It entirely depends on how they set up the test. A hospital run test is focusing on patients who are likely positive already, whereas a home test is focusing on patients who are likely negative. Set up your sensitivity and specificity correctly and it’s fine.

    5. So what’s an acceptable false positive/negative rate for you? Zero percent? Most tests would have to be withdrawn from the market.

      1. So what’s an acceptable false positive/negative rate for you? Zero percent? Most tests would have to be withdrawn from the market.

        How would an individual libertarian, the victim of a false positive/negative, go about seeking justice without violating property rights or the NAP? How many such libertarians engaged in such class action would, effectively, represent an oppressive social/government regime?

        I’m not section 230 ‘new technology… imagine the potential influx of court cases’ spit balling here. We’ve got “libertarians” saying we should test everyone.

        1. I’m not sure there’s grounds to sue for it. Tests will have a certain percentages of false outcomes. If that’s known, I don’t see where the damages lie.

          Unless you’re doing a Bayseian analysis to dispute the false rate. Good luck with convincing a randomly selected jury.

        2. “libertarian”? There’s no purity test. Some are more lib than others.

    6. How many must die so that the FDA can keep its’ monopoly on testing? The tests needs to be approved in some manner, of course. But if we’re supposed to be “more like Europe”, then why does Europe get cheap and plentiful *private* tests for COVID-19, while we in the US have to ask permission politely from our betters? And who the fuck make then our “betters” in the first place?

      1. “And who the fuck make then our “betters” in the first place?”

        Not who, what — that government paycheck.

    7. “History shows clearly that in the absence of regulation, companies will sell quack products that harm the public.”
      See: Homeopathy.

      1. So let’s enslave everybody because a few of them are so damn stupid as to do stupid things with stupid friends in stupid places at stupid times.

        By your standards, governments would cease to exist around day two for having made some stupid mistake.

      2. And governments never sacrifice lives in the name of “safety”.

        See: Thalidomide (now called Thalomid).

        You see, this drug was banned by the FDA because it caused birth defects under certain circumstances. Decades later, it was found to slow the progression of cancers by stopping a biological process called angiogenesis. Despite the efficacy that thalidomide displayed, the FDA slow-walked its approval for cancer treatment.

    8. “History shows clearly that in the absence of regulation, companies will sell quack products that harm the public.”

      What’s funny is you think the FDA/CDC prosecute regulation violators like law does except they don’t!!! They just create monopolies and sky-high prices so of course the quacks are lining up to make an easy buck.

    9. You’re totally right. It’s not like fraud is illegal.

      The reality is that these can adequately be guarded against with both civil and criminal law that’s already on the books. Sell a 1000 quack tests in a pandemic? Congratulations you’ve got free room and board for a thousand consecutive sentences.

      The paradigm of “we need the FDA to approve these things because some people might sell quack devices” is blatantly guilty until proven innocent.

      Far more harm is done by testing being unavailable, than a small fraction of false tests.

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  4. Mr. Bailey, your article is just wrong = Compare this with the latest Centers for Disease Control and Prevention (CDC) report, which says just under 72,000 tests have been run in the U.S. so far.

    Through 6pm yesterday, over 295K tests were conducted through CDC and public health labs. Private hospitals and private labs have not yet reported in, they are transmitting data as we speak.

    Please issue a correction.

    1. I think you’re right. I’ve been looking at some states where it seems very clear they aren’t testing in hospitals/staff – but they are testing anyone who want a test at the doctors office. This has already become more of a money-maker than a public health issue. It’ll be interesting to see how those different strategies play out.

  5. Of all of the turf-defending federal agencies, the FDA is among the worst, if not at the very top.

  6. CXY: Just checked the official CDC website again (updated to March 23 at 4 pm) and the numbers are now up to 79,912. I would be delighted to review a link to the stats you cite. Glad to see that you’ve apparently become more interested in the state of testing nowadays.

    1. Ron – I think private/state labs using the non-CDC kits no longer send their negative results on to CDC if their test fits CDC results on the positives. So states have moved from the previous ‘presumed positive’ (pending confirmation) to simply cases. Problem is I don’t think anyone is formally compiling those negative results above the state level. The three states I have family are the only ones I’ve been tracking – CO (taking it seriously) we’re up to 6240 tests (so 11.6% positive). TX (not serious yet imo) 10100 tests (so 7% positive). MT (taking it seriously) 1700 tests (so 2.7% positive)

  7. Hmmm… What exactly has the FDA/CDC done to eliminate COVID-19? Not a thing that I can think of; seems local doctors, local business, and local people are doing all the work to contain this – the almighty federal government just wants to advertise it to death.

  8. The FDA controls everything with guidance documents which are not law. These companies only have to follow the laws passed by Congress. Diagnostics companies have been brainwashed that guidance docs are law.

    From the EUA document: FDA’s guidance documents, including this guidance, do not establish legally enforceable
    responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
    be viewed only as recommendations, unless specific regulatory or statutory requirements are
    cited. The use of the word should in Agency guidance means that something is suggested or
    recommended, but not required.

  9. Likely EverlyWell gets Federal subsidies & financial support, possibly connected with some kleptocrat & politicrony, … Also, such entities sarent obligated to keep your health & other information private. Many scams exploiting this ruse & many duped into indulging them.
    Also, instead of being so apathetic by complaining instead become involved with civic duty, constructive criticism, & oversight … Among reasons situation so fouled up.

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  11. There is a reason for this behavior. My 2001 book Natural Process (https://www.naturalprocess.net) had a section in it discussing this behavior pattern as applied to environmental regulation titled:
    Problems Are Assets
    Government programs are self-perpetuating because they do not derive rev¬enue without problems to justify funding. The financial assets of a govern¬ment agency are the problems, themselves.
    It is human nature for people to cling to their problems. Whether it is child or spousal abuse, drugs, thrill seeking, or merely a bad habit, they adhere to the familiar to the end. When those problems are a source of income, or a sense of power or purpose, just try prying them loose. If you want a place to spend infinite cash and watch it all go down the drain while the problem gets worse, you couldn’t find a more entangling welfare case than The Environment.
    The ostensible reason these problems perpetuate? Over the last forty years we have all heard it, “insufficient funding.” We could fix it if only we had the money. The unfortunate corollary is, ‘If we don’t do it right, then it won’t work at all.’ Does this mean that, if they don’t get what they really need, they will quit their jobs because the effort is futile? Of course not.
    The masses of classes of environmental graduates are just as indentured by their next review as is the welfare claimant by his or her next check. They have little training to get a job creating new products or services. The acculturated hysteria with which they have been trained is a self-fulfilling prophecy of horrific potential. It is a tragic waste of human intellect and a betrayal of their individual commitment.
    There are tens of thousands of these people in the regulation industry. They collect paychecks and watch them disappear just like everybody else. It would be daft to assume that they are, by virtue of either their individual intent, either evil or beneficent. There are, however, many who believe that their ends are so important and, by virtue of their intent, inherently beneficial, that they are willing to subordinate their integrity to a “deeply subjective experience.”
    Given the laws of hierarchical bureaucracy, finding that the problem is bigger than expected is a way to earn a promotion. This is usually done by association of the problem with direct causes and thence to an ever wider range of indirect causes. The bigger is the scope, the bigger is the budget. We tie their paycheck, the very existence of their job and their personal sense of self-worth, to the perpetuation and expansion of environmental problems.
    Their assets ARE the crises that justify administrative cash flow.
    The entire worldview of these people is distorted by the compulsive forces by which they are directed and, thence, redirected upon the victims under their jurisdiction. Deep ecologists have combined a misanthropic belief system, a hatred for industry, the armed power of the State, and personal career requirement for a continuing legal justification, with the power to control the factors of production. It is terrifying to contemplate how much damage these people will do in service to such beliefs.
    They know not what they do.
    The reason this motivational architecture in government is so perilous is that there is no recourse to it.
    It is an armed monopoly in the business of managing and solving problems..

    Mark

  12. From what I read the FDA is not giving approval on accuracy concerns but how the results are communicated to the patient.FDA requires a health care professional to do this.

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