COVID-19 Transmission is Solvable

would be used in millions of transmission indicating tests. These are called antigen tests and can identify when people are contagious. They can help to quickly contain community spread of the virus. And they're already in product option. So what's the catch? They aren't easy to get through the FDA. How long is it going to take for me, Malcolm Globbwell to be able to go to my drug store and buy a hundred of these strips for twenty five dollars and

take one every morning. It's not just turning out to be a very very difficult task, but it's actually I think, inadvertently leading to potentially tens or hundreds of thousands of additional deaths that we don't need to be having. Michael Minna is an epidemiologist and immunologist at the Harvard School of Public Health and a physician at Brigham and Women's Hospital. My solution to defeating COVID is daily rapid tests that people could use in their homes every day to stop

transmission of the virus everywhere. With people dying every day, there's no more time to waste. Doctor Minna spoke with my co host Malcolm Gladwell about how to solve the spread of COVID. Here's their conversation. I wanted to start with a really dumb, obvious question, which is, can you describe to me all the ways in which you can look for the presence of a virus that a human being. Well, that's not an obvious question at all. Within each virus,

virus is just like any other thing. They have a genetic code, and then they have a bunch of proteins. And the genetic code of a virus is RNA, which is akin to a human's DNA. And so the same way that you could do a forensic investigation of a crime scene and use DNA to find if there was a human, a specific human at the crime scene, you can do a forensic investigation to look for RNA to know if there was RNA inside of a person. So that's one way, and that's this tool that these are

molecular tools that we call PCR. And then there's a different way. Instead of using the genetic makeup and the RNA to look for the virus in this case, you could actually look for the proteins that make up the virus. And that's where these antigen tests really shine. So you can either look for the genetic code or you could look for the proteins. I like to call these rapid

antigen tests transmission indicating tests. There's one other major way, which I'll just say quickly, and that's to look for the immunological response to the virus because humans are good at making immune responses to viruses. So it's a different way, and that's antibody based detection. But that's I put it in a whole different category because it usually comes after infection. Yeah, So the first way looking for the RNA is the

kind of gold standard. That's exactly right. And so if I go to the hospital and get a today and get a COVID test. They're looking for RNA. They're giving me they're using PCR to look to see if I have virus in my system. That's right, and what's the cheapest that a PCR test could produce a result? The actual price of a PCR test can be done for six bucks, maybe even less, so it can be really cheap. But the difference is the whole infrastructure around PCR tests.

They have to be done in labs, so you have logistics of transport, you have all of the people working in the lab, robots, and so generally it really drives the cost up. And as we've seen, the average test costs anywhere from thirty dollars at the absolute low end up to one hundred and fifty dollars for some labs that are charging it. No contrast PCR two antigen tests. How do antigen tests? What do they look like and what's their cost in time profile? They look like a

pregnancy test and they work like a pregnancy test. Actually, they can be made. It's a little piece of paper. Generally speaking, you put some of the sample, whether that be a swab that's been mixed with some sailing solution or saliva onto a paper strip and it shows up with a line it turns either, for example, red if it's positive or blue if it's negative, and those can be made in the huge numbers. They don't require instruments.

They don't usually require instruments. There's a few on the market right now that to get the sensitivity at the FDA wanted, they have some instrumentation associated. But in reality these are used for malaria, for a strap for all

these different infections. They've been around for a very long time, and they can be done just on a piece of paper in five minutes, and they could get down to you can produce them for fractions of a dollar, and they might be sold to the public or built by the government for a dollar a piece or something on those lines. So you're you've been perhaps the leading public proponent, public health proponent of using antigen tests much more broadly to fight this pandemic. And I wanted to the first

time I heard you give this argument. You convinced me in about two minutes. And I still don't understand why why don't we have this system? Because I can imagine in a world where if it's this, if they're cheap and that easy, then you know, every kid before they went to school in the morning, we'd take one of these fifty cents or one dollar tests and if they were positive, they would stay home, and if they're negative,

we would know they could go to school. Like or if I want to go to a restaurant, why can't I just set stand in the vestiable of the restaurant, take the test and wait for my response and if i'm if I'm negative, I get to go to the restaurant. Like it just strikes me as this is a way to get going again. Why are we not doing this? Can you explain that I can? And I have a few theories. I mean, they're not just theories, they're there. I'm in the middle of all of this. And so

these tests because of this whole sensitivity issue. Early in March or a really in January, the world decided that PCR was a gold standard for these tests. And I don't think and I know that this well, maybe we'll come across wrong for some people, but there hasn't been enough thought placed into what exactly does the PCR test mean and is it the right gold standard? The only pathway that we have to evaluate tests like this in

the United states are medical diagnostic pathways. They are pathways designed specifically to ensure that a physician like a detective, is getting all of the information they need to diagnose a sick person in front of them. So it's really

been first and foremost a regulatory hurdle. We have so devalued and defunded public health across our country and really across the world, that we actually didn't we don't have a regulatory pathway to approve a test who is primary objective is one of stopping an epidemic versus one of diagnosing a sick person, and that has really led that's

held everything up. All of the companies that could be producing these these really rapid tests in the millions and millions, they have been sitting on these tests, trying to hone them, trying to get them just a little bit better, just a little bit better so that the so that they can pass their FDA standards as a medical diagnostic. It's not just slowing down their approval and getting them out

to the public. It's actually bottlenecking the companies into creating tests that are not going to be as scalable because they're having to use more expensive reagents they're starting to put them with instruments and package them more. You know, they have to actually become more expensive, highly manufactured tests, when in reality they're just these little pieces of paper that if we can do the cheap version of them,

they could be made very fast. But they just won't get through the FDA at the moment, And I don't. I'm still so I find it, So I find your explanation. I'm convincing. How dumb is the FDA, Like, don't they understand that they can't be they can't be a group of people who are wholly wedded to only one way

of understanding how to deal with the virus. You can't if you make the exact argument you just made to me, to someone at the FDA, who is everybody is smart or smarter than I am and knows a mountain more about medicine, they're not going to say, I see a logic. Well, you know, it's not that they're not smart, it's that this is a regulatory body. They just don't have a pathway. They literally you can't go and apply for FDA approval

for a public health test tool. In fact, they say it strongly in their FA ces and their facts that say we do not evaluate public health tools, and so that might make you say, well, that's great, so why bother getting FDA approval. Unfortunately, these tests are defined by the FDA as clinical diagnostic tests, which has a pretty broad definition of a test that gives somebody information about themselves that could cause them to change their behavior is

a clinical diagnostic test. So this is this catch twenty two where they're saying, you know, we don't want to have anything to do with public health the proving public health tools, but we also don't want to change our definition to allow you to say that that's not a clinical diagnostic test. And so they've gotten stuck in this regulatory bureacratic nightmare of just regulation for regulation's sake. And there is precedent at the FDA, for example, to think

about public health tools. Vaccines are one of them. They have outright been willing to say we will accept a vaccine that has fifty percent efficacy, and that's because, whether they recognize it or not, they're taking into account the public good part of a vaccine that they understand that it will lead to herd immunity. But they have none of that thinking in diagnostic tests because it's just driven by this very antiquated view of what a diagnostic test means.

And in our country everything has been you know, the medical establishment is extremely strong. We can't we can't. You can't go to get a cholesterol test without getting a prescription from your doctor, Like, why is that not? Why can't we know that? You know, it's all through this very very heavy medical lens and changing that moving, getting

that that big ship to turn is turning. You know, it's not just turning out to be a very very difficult task, but it's actually, I think inadvertently leading to potentially tens or hundreds of thousands of additional deaths that we don't need to be having. You know what this reminds me of. There's a fascinating book that was written about tanks. Tanks are invented in the First World War and then they just kind of sit on the shelf

for twenty years. Everyone realizes they're a breakthrough in a revolution and they've changed war for forever, but no one can figure out who where to put them? Do they belong with the infantry? Not really right? Should they take the place of cavalry? Will kind of but those guys are really into horses, you know, like you can go on and on like and they can't. So literally it just sits around for twenty and then the Germans, who don't have a military, was destroyed by the Allies. They

get to start over and they put it. They knew where to put them right because they're starting from scratch. They don't have any legacy systems that are inhibiting them. How I want to go back to how many different companies are could make one of these things if asked, and how fast would it? I mean, if I want to said, let's say the FDA Commission comes to you,

Michael and says, okay, you win, rest go tomorrow. How long is it going to take for me, Malcolm Globbel, to be able to go to my drug store and buy one hundred of these strips for twenty five dollars and take one every morning. Yep. So they're actually becoming available now sort of. Abbot just came out with a new test called the Buynex. Now it's it's literally a

piece of cardboard. And these have now been approved but only for medical diagnostic use again because they're being approved through the FDA, and so they're being approved for a physician to order, for example, for patients, they'll be able to make about a million a day, but again that's because they're the slightly more manufactured ones. If you take one of these super simple paper strip tests, the blueprints for how to make these are publicly available, no IP.

You can get royalty free, non exclusive rights to just produce these, And I think governments should just be contracting with major manufacturers, manufacturers that have the machines to make them, but it's not particularly sophisticated machines needed to make these things. In our case. The US government should be should just be taking the reins and creating a Manhattan Project like effort to just say, print thirty million of these a

day for thirty million Americans to use every day. And if everyone's using it every three days, then you've covering ninety million Americans could be using these tests every third day. That is more than enough to suppress all of the outbreaks where they're occurring today. How can you describe how your experience trying to promote this idea has made you feel? Oh? Well, um, I would say it's um, it's been it's been fraught.

I would say, I think it's It's been a reality check that you know, we are in a culture and country and world that is so driven by regulation. We've just overregulated in some ways. And I'm not against regulation by any means, but when we can't recognize that there is a national, a global crisis happening and come up with different, more creative pathways, you know, this is a tool. There is no vaccine coming tomorrow for us. Social distancing

clearly isn't working to suppress all the outbreaks masks. People aren't choosing to wear them in much of the country and the world, and here it is. This is a test that can that can be made for pennies essentially charged a dollar that could actually really serve to sit

in for vaccines until they come about. I mean, people are dying still, you know, people like we're becoming complacent, and that's just that's the frustration part, and that is generally what is the first gut reaction when you ask me that question. But at the same time, this is an idea that has caught on it and it has gotten a huge number of people. You know, it's kind of created a movement, i would say, and that has been just so inspiring. The number of people across all

every single day. Not a day has gone by for months now where I haven't gotten emails from everyone from governors of states and prime ministers of countries down to literally people who say, you know, I'm out of my job right now. I have no no idea you know anything about infectious diseases. I'm usually whatever their job is, and but how can I help? You know? I want

to help with this cause. And so it's been amazing to see the pouring by the average person in the public to really try to help get these things moving and to help move the needle in whatever capacity that might be. So that's been pretty it's just been inspiring and amazing to me. Are the things our listeners can

do to make this solution more likely. First, get more information, and we've actually set up with well I barely did anything, but there's been this kind of small army of people who are springing up to really help with these issues and pushing the FDA in the government in the right direction. And that's rapid tests dot org one word, rapid tests dot org. And there's we're trying to fill that website

in with increasing amounts of information. There's even links I believe at this point to help people and create letters to the representatives. There's been some really nice articles. If people want to follow me on Twitter, I tend to write about it a lot on Twitter and I try to be a responsive to people, and so my Twitter

handle is Michael Minna Underscore Lab. But all of that aside, I think one of the best things that people can do right now is to actually let their leaders and their representatives that whether it be at the county level, their state leaders, and their federal leaders know that that you know, this has been dragging on too long. Rapid tests still have not become available. They are a solution that, along with all of the other things like social distancing

and masks, will really help to combat this virus. And we need to have date and federal leadership getting on board to help get these through approval processes quicker and help get the production of these, ideally from the federal government up to speed and have tens of millions of these produced every day. And yeah, and I think it's already working, which is the good thing to keep the momentum up. One last question, why isn't there or is

there a black market in these tests? I mean, there's a you know, I don't use cocaine, but if I wanted to use cocaine, I'm pretty sure I could get it. I don't understand why if these things are cheap and easy to make, and they have such a profound impact on people's lives, why isn't there a thriving underground economy

and giving us cheap, cheap manage in tests. Well, i'd be lying if I if I were to say, I haven't thought a lot about just importing them from other countries, you know, But I think it's because we do still have laws, and we still have you know, tests aren't so extreme. You know, I might get there if they're really not get approved. At the end of the day, they can just sell them legally in other countries at the moment. So why bother doing something illegal in the

US when you know they can sell them elsewhere? Where? Where can I buy them? What country can I buy them legally in? Well, South Korea is making There's at least two companies. There's more. I'm sure South Korea has a company called SD Biosensor, and they're they're actually exporting them all over the world. Now, Canada in a nano he is starting to produce them, and they're I'm guessing

going for FDA clearance. But India is making them. Singapore, I believe, has some that they're making, so we're starting to see them. I think even Senegal is producing them, but South Koreans have the highest volume that they're currently making. Yeah, thank you so much. This is totally fascinating. I am once again filled with righteous anger at the inability of

our regulatarized system to handle. I mean, it's just not it's just like it doesn't seem like that big of a jump, Like it doesn't seem that hard given the fact that this whole thing's costing is I agree, I just it's frustrating, but I would I do have to say that, you know, the FDA has been willing to come to the table more frequently, and actually we're having the conversations, so maybe they're starting to to really warm

up to it. You know. I feel like, if you can you can convince the FDA on this one, you deserve not just a metal but one of those statutes. I will hold chip in for the statue. Well, well, thank you. I'm going to keep fighting this fight until and see it through until we start defeating COVID one way or the other. Michael Minne is an epidemiologist and immunologist at the Harvard School of Public Health and a

physician at Brigham and Women's Hospital. Remember to check out our show notes for links to the suggestions our guests make for ways that you can get involved. Next week, Unsolvable, we'll hear from chemist Eric Apple about a new solution for fighting wildfires before they start. And here's the teaser. It involves laying down something like a real life force field. You won't want to miss that conversation. Solvable is brought to you by Pushkin Industries. Our show is produced by

Camille Baptista, Senior producer Jocelyn Frame. Catherine Girardo is our managing producer, and our executive producer is Mia Loebell. I'm Jacob Weisberg.