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OUTLINE:
0:00 - Introduction
1:22 - At-home COVID-19 tests
11:25 - Medical devices and FDA classification
17:44 - Rapid test availability
34:07 - Who is in charge of public health?
50:46 - Testing privacy
58:02 - Biden's COVID-19 Action Plan
1:09:15 - Uncertainty, fear, and COVID
1:16:10 - Vaccines and herd immunity
1:24:50 - Meditation and consciousness
1:34:52 - Minimalism and Capitalism
1:38:28 - The future of humanity

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The following is a conversation with Michael Mina, his second time on the podcast.

He's a professor at Harvard doing research on infectious disease and immunology.

In my view, the most powerful, doable, and obvious solution to COVID-19 from the very beginning is rapid at-home testing.

This is what Michael has been talking about and writing about since the beginning of the pandemic.

The accuracy of these tests is high for the task of detecting contagiousness, which is what matters.

Hundreds of millions can be manufactured quickly and relatively cheaply.

Privacy and individual freedoms are preserved.

I believe that if you give people the power of information, information about whether they are contagious or not, they will do the right thing at scale, all while respecting their freedom and minimizing the destructive effects of the pandemic on our health and our economy.

This solution was obvious in May of 2020.

It was obvious when Michael and I spoke the first time a year ago, and it is obvious today.

We talk about why it has not yet been done and how we can still do it.

To support it, please check out our sponsors in the description.

And now here's my conversation with Michael Minna.

We spoke a year ago about rapid at-home testing, and I think you think it should have been, still should be a big part of the solution to COVID.

Where do things stand today in terms of rapid at-home testing?

Well, it's certainly something that you're right.

We've now had almost 20 months of living in anxiety, uncertainty, being afraid for our health, for our family's health, for our friends, you know, shutdowns, economic instability.

Everything has been uncertain because of this virus.

And it's the first time for many people that they are, they're using it and they're feeling empowered.

They're feeling like they can control their little slice of this pandemic.

So as these tests have come out and more and more and more Americans have had an opportunity to go and buy them from CVS or Walgreens or wherever they're at, I think that it's really shifting the tenor of the discussion.

For a long time, all of 2020, it was like I often felt like it was me and a few other people against the world.

These tests should be public health tools.

These tests are infectiousness indicators.

All of these different things, And we could, of course, go through and recap what the benefits and the metrics are that we should be looking at.

But the point is, last year and most of this year was about educating scientists, educating public health leaders, educating physicians to get them to understand that there is a different reason to test in a pandemic than purely diagnostics and transmission blockade and severing transmission chains is a big 1.

So now I think we're at a point where people are now understanding and they're understanding because they are feeling it.

They're holding it and they're doing it and they're feeling the delight of seeing a negative and saying, I feel more comfortable.

It's not perfect, but it's pretty darn close to perfect to allowing me to go and see my mom without mistakenly infecting her, or whatever the story might be.

And now that that's happening, I think all of a sudden we're seeing a massive change politically for these tests.

Biden just came out the COVID-19 action plan the other day, and 1 of the main pillars of it was testing and in particular, bringing rapid tests, scaling them up.

So on that front, I think finally there is success.

People are actually understanding and I haven't stopped beating this drum for far too long and I like hate rapid tests now.

Would you say most Americans have not taken a rapid at-home test?

Absolutely, most have definitely not taken a rapid test.

So like many of them probably don't know.

They kind of probably say testing, they have like memories of testing, like PCR testing, they have to go into somewhere and they have to swab deep in their nose and that's the experience.

Or maybe if you have to travel, like Canada or something like that, you have to get tested, that kind of stuff.

Yeah, so the rapid at-home tests are, I like to call them paper strip tests, simple.

They're simple tests that, I wish I brought some today, but I didn't.

They're simple tests that you swab, At the moment, most of them use a swab that you just swab the front of your nose.

So it's not 1 of the deep swabs that goes into your brain.

It's just like picking your nose, if you will.

And you put that swab into a little tube and the tube has some liquid in it.

And then you put a few drops of that liquid onto a paper strip or you drop the paper strip into the tube just like 1 of those indicators for the pool.

And if you, just like a pregnancy test, then if you get 2 lines, you're positive, 1 line you're negative.

It takes 30 seconds once you know how to do it of hands-on time, and you wait around 10 minutes, and then you read the result.

They are extraordinarily effective to answer 1 question, am I infectious?

And that is the public health question that we need to answer and consistently ask during this pandemic.

Because it's only when we know that we're infectious that we can be empowered to not mistakenly infect others.

And we can go into the pros and cons, but 1 of the major differences is that a PCR test gets a lot of people talking about the PCR test say it's much more sensitive.

It can detect 1 molecule instead of 100,000.

But for public health, we don't want a test that can detect 1 molecule.

In fact, that has created a net negative for public health.

And to know that question, to know if I'm infectious, I only need a test that is going to be positive if I have a high viral load, like a million.

And when you're, and the virus grows so fast, it will grow from 0 to a billion in a day.

So You don't really need, even on the front end of an infection, you don't need better sensitivity if the tradeoff is that you don't get the result for 1, 2, or 3 days.

You absolutely want a rapid result that can tell you, yes, you're infectious, you're transmitting to others right now, and I'm going to give you the results right now.

So it is a much more effective tool because it's fast, because it's accessible.

And there's some issues with using them at home.

We can talk a little bit about what those issues are, like reporting and how do you, is everything on the honor system if you have a test that you're taking at home and you use it to go to work.

It takes a lot of time for somebody to get a PCR test.

They either have to go online and order it, it takes the next day for it to come back, they swab themselves, they ship it out the next day, and then they get a result 2 days later.

And at that point you're not even infectious even if you did happen to be infectious when you first ordered the test.

So it's really the speed of these tests and the accessibility and distribution of them that makes them so immensely powerful.

So you have this amazing graphic you tweeted.

It's exactly what you're saying, which is a rapid antigen test answers the question, am I currently infectious?

And you have, I think, a comparison of 3, sorry, 7 different tests based on the viral load.

And based on the viral load across these different tests, you look at the likelihood of infectiousness.

I think it's just really nice and really clear.

Yeah, so what that's showing is that we can never ask what's the sensitivity of a test and just let that be the answer.

We have to say, what is the sensitivity of the test to detect what?

And so we can have different viral loads.

For example, you can have a viral load of 1 or

of 1 or you can have a viral load of a trillion.

And a PCR test will tell you that you are positive regardless of whether it's 1 or a trillion.

Now, so we can't ask the question how sensitive is a rapid test compared to PCR, because that covers the whole gamut.

What we really want to say is how sensitive is the rapid test to detect me if I am infectious?

And that gets to about 97% or so sensitive.

If the question is how likely is it to detect me if I'm a super spreader, that's a really important 1 to be able to detect.

So if you have extraordinarily high viral loads to the point where you might be a super spreader, these simple rapid tests will essentially always catch you and tell you you're positive.

And then as you go down the line, if you're no longer infectious at all, then these rapid tests might have a 0% sensitivity compared to PCR, but That's actually a good thing.

The FDA and others look at it as though it's a bad thing because they average it all together and say, oh, this is only a 40% sensitive test compared to PCR.

But that's not the right way to look at it.

You want to say, well, out of all of the samples, How many of them were not transmissible?

How many were mid, moderate, high, extremely high, super spreader?

And you should at the very least create a weighted average based on transmissibility potential.

You know, and that's why nobody in America has these tests because, or that's why they're very rare, Because we have slowed down their authorization because of that misunderstanding that they don't have to be 80 or 90% sensitive compared to any time PCR positivity.

They need to be 80 or 90% or more if you're infectious.

And for that question, they're like 95 up to 100% sensitive when you're most infectious.

So when you have a lot of viron particles in you, so that's what it means when you say viral load, that means you're going to be very infectious.

The more you have, the more infectious you are.

And this test is basically very good at detecting when you're very infectious.

So you said there's a bit of confusion, FDA is involved, you've talked about, you continue to talk about that these at-home tests are classified as, I guess, medical devices.

And so because of that, FDA is looking at them differently than they probably should be looked at.

Can you sort of explain what does it mean to be a medical device?

When we declare something as a medical device and we evaluate it as a medical device, then it makes sense that the comparison, if you're trying to get a new 1 onto the market, that the comparison would be against a gold standard medical device for that purpose.

So PCR is currently the gold standard, or at least in the eyes of the FDA, the PCR test is the gold standard medical device.

And as a physician, that's because it's so sensitive.

As a physician, I have 1 patient in front of me at a time.

And that patient comes to me and I don't have to care about the 99.9999% of people in the world who are not in front of me.

And so when I get a sample from that patient and that patient's saying, Doc, you know, I don't feel well, I haven't been feeling well for the last few weeks.

Well, for that question, I want to have the absolute best sensitivity test, regardless of what it means for transmissibility because my patient isn't sitting in my office saying, doc, do you think I'm infectious?

They're saying, doc, do you think I have recently been or am infected?

And if the patient's infected, you know, the time isn't of the essence because they're sitting there in my office.

I can say, look, I'm sorry you're not feeling well.

We'll be able to tell you if you have any evidence that there has been recently an infection inside of you, and you'll get the result in a couple days.

And it might be expensive, and so insurance is going to pay for it.

And you're just 1 person, and so I don't really care how many resources it takes to get you this answer.

On the other hand, there's rapid and there's public health testing.

And public health testing is, it has to account for all of the people you're not seeing as well as the person you're testing at the moment.

So accessibility becomes a central theme.

Frequency of tests, it has to account for all the days that you're not sitting there in front of your doctor's office getting a test as well as the 1 you are.

What if you're infected tomorrow but you're at the doctor's office today getting a negative COVID test, that PCR test at the doctor's office today is going to do nothing to let you know that you get exposed and infected tomorrow.

The only way to know that is to be testing yourself frequently.

So and the reason it matters is that these tests can be accessible if we are okay with saying the real purpose of a public health test is to answer the question, am I infectious?

The reason we want to answer that is if you're infectious, that's when you isolate.

We actually don't want to isolate PCR-positive individuals who are no longer infectious.

If I haven't been infectious for 3 weeks, I don't want to have somebody tell me that I need to go and isolate for 10 days just because I happened to use a PCR test today, 3 weeks after I was infectious.

And furthermore, I definitely don't want the public health agency to come and, you know, round up all the people I was with last night and say, you guys have to quarantine for 14 days because you were with Michael who wasn't infectious yesterday.

And it's a huge disincentive to actually get tested.

People, if it's too sensitive, especially with flights, things like that, we shouldn't be stopping people from taking a flight if they haven't been infectious for 60 days.

And to be clear, people are only infectious for somewhere between 3 and 7 days, but can be positive on a PCR test for 30 to 70 days.

So, I mean, it's potentially a tenfold difference in terms of how long you're PCR positive versus how long you're infectious.

So we don't want to be taking people during those 30 to 70 days and saying you need to isolate just because you go and get a swab or you can't go on your trip just because you had COVID last month.

So the reason we don't have these tools right now is because when we evaluate a rapid test as a medical device, the FDA says, well, this has to achieve the properties that we expect from a medical device, which again, doesn't have to take time into account, doesn't really have to take cost or resources or scalability or access into account.

It only takes sensitivity and specificity to catch molecules.

And so just by definition, I mean, it is a mathematical fact, you know, that if you have a perfect public health test for COVID, which means that it would be 100% sensitive and 100% specific for contagious people or for the infectious stage of an infection, then it literally can't, it is an impossibility for that test to achieve an 80% sensitivity at a population level against a medical device, which is what the FDA asks for.

And that's because you're only infectious for maybe 20%.

So theoretically, it should only have a 20% sensitivity against the PCR while still being a perfect medical, a perfect public health test.

And the test is answering the question, am I infectious?

That's what you're testing for, not for the exact counting of the viron particles in your system.

So have you had conversations with folks?

You said that there's a bunch of leaders that are kind of starting to wake up to this idea, but why is this taking so long?

Why don't we still have hundreds of millions of at-home tests?

The reason it's taking long, I think, is because every agency in government is generally deferential to the FDA.

And in this context, I would argue that government hasn't been particularly creative.

So for example, last year, when Trump was still president, I would, or in the transition, I recall talking to the White House a number of times and saying, here's a plan to give us our lives back.

I think that was actually the title of the Atlantic article.

It can allow society to keep running and could have prevented the outbreaks of last winter and fall and saved hundreds of thousands of lives.

So when I bring that to the White House or to the government, the federal government, whoever it might be, and I say, here's a plan like this, this would work.

They say, what I get back is, this sounds really interesting, Michael.

It looks like it checks out, but there's 1 problem.

We don't have the test, there's no scale.

It's like this defeatist attitude of like, oh, don't have the test, so we can't act on it.

Well, and so that's really where things have been.

It's always been this like esoteric thing that yeah, maybe 1 day we'll get around to it, but really it's not that important.

But this was like 100% predictable, everything that's happening today.

We predicted it last year, you know, it's not, this isn't like rocket science or anything.

The variants and all those kinds of things.

So the FDA, we can start to understand why, but also like 1 question I wanna ask, is it possible to go around the FDA?

And why has nobody tried to push the FDA to change?

I think what the real reason is the FDA has 1 job around these tests, and it is to authorize them as medical devices.

They haven't been charged with doing anything else.

So in their eyes, they're doing exactly what they're supposed to do.

They're evaluating these tests as medical devices, and they're telling company after company after company, sorry, you don't make the cut.

And the only way to make the cut is really to kind of skew your clinical trials to favor the rapid test being positive, which isn't really good practice.

We shouldn't be trying to skew clinical trials.

It's been forced upon the companies to do that.

And so I think the FDA truly believes from the bottom of their heart that they are doing the right thing here.

And I would argue that to an extent they are.

I've been pretty hard on the FDA, but maybe the issue is a higher level issue.

Like the in vitro Diagnostics division is they get applications and they evaluate them and the applications are for medical claims That's however because there's been a misunderstanding of these tests and the company is only know to apply for these as medical claims Because there is no there's nothing else in this country to apply for Except a medical claim.

So we we don't have a public health pathway to evaluate a test and authorize a test.

It doesn't exist We have Defunded and devalued public health for so long that we literally don't have a language for it.

I call it a public health test because I'm trying to create a new definition here.

But that's why nobody's acted, because everyone says, well, there's no other pathway.

So the FDA in vitro medical diagnostics division is the only pathway.

So what I am trying to do is to say, look, the FDA very clearly states that they do not authorize or review public health tools, and they don't authorize or review public health tests for COVID.

So what I want the President of the United States to do is to utilize executive powers and take an executive action that can simply state like 1 line.

1 line could potentially change all of this.

And it's a pretty obvious and simple line.

And it is that any tools used for public health testing during this public health emergency will be designated as public health tools.

It's a tool used for public health, it should be designated as a public health tool.

If we can do that, if we can get that language out there so that that's the president's decision, then all of a sudden the FDA is off the hook.

They're not trying to cram a square peg through a round hole.

They can say, look, the antigen tests are not on us anymore, at least if they're going to be used for public health, like when you test 1,000 people at a time or test a school classroom if they've been exposed.

The CDC could say, OK, what are the metrics we are interested in?

And they could say, we're interested in a test that can catch you if you're infectious.

And hey, you know, if your test has been used in Europe for months and has performed extremely well, then we'll give you a certificate by right, you know, immediately.

And that could actually get hundreds of millions of additional tests into the United States tomorrow.

So you need some kind of classification from an FDA or from somebody to call it a public health tool in order for it to be manufactured?

Is it possible to just go around all of this and just for somebody to manufacture at scale tests?

if you did that and you just called them, you put a claim on them that called them public health tools, The FDA has a very weird view of this, and they will tell you that it's illegal, that it's a crime.

Is there a way to say like Elon Musk did with the flamethrower, it's not a flamethrower?

Believe me, I've tried to think of all the different approaches.

You know, there's major inconsistencies here.

So it's not like we don't have a precedent for a public health test, even during this pandemic.

We have companies like Ginkgo, right, based out here in Cambridge, that are working with 100 different labs around the country so that might mean not a ton of quality control over those labs.

I mean, I don't wanna say that they don't, I'm just saying the reality is if you're working with that many labs, it's hard to say.

They're running pooled testing of millions and millions and millions of kids.

So here you have a company that's testing in each pool 5 to 25 kids at a time, millions of kids in a pretty distributed way across the country in all these different labs.

So why does that have no oversight but a rapid test for the exact same purpose?

You're just giving people immediate results instead of two-day delayed pooled PCR results, so it's a much more effective tool.

Why is the RAPID test used for the same purpose not designated as a public health tool but requiring FDA authorization?

It's a ridiculous reason, and it's because the FDA says that if a test and this is actually CMS that says this and then the FDA adopts it, if a test alters your behavior, If you get a single result and it's going to alter your behavior, then that is a medical device.

But the thing that I find ridiculous is like, okay, but you can give a pooled test that alters 25 people's behavior at once.

And that's not falling, like that's more risky.

1 person turns positive in the pool and 25 people have to be quarantined.

So for people who don't know, pooled test is you're testing a small fraction of the people.

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Michael Mina: Rapid COVID Testing | Lex Fridman Podcast #235