The Dr. Hyman Show - What You Need To Know About COVID-19 Testing with Steven Kleiboeker

Episode Date: April 6, 2020

Multiple times a day, even multiple times an hour, we’re hearing new information about COVID-19. Some of the most common questions I’ve received have to do with testing. We had our first case of novel coronavirus the same day South Korea had its first case. Yet they are much further ahead of us when it comes to testing, something that has helped them quickly control the virus in a way we haven’t been able to do in the US. They also rapidly took on measures like quarantining and tracing the transmission of the virus. Of course, there are so many different components that go into successful testing and quelling a pandemic of this size. Today on The Doctor’s Farmacy, I hope to shed some light on those with my guest Dr. Steven Kleiboeker. Throughout our conversation, we cover who should be tested, when, and how, and what kinds of tests are currently available or soon will be. He is the Vice President of Research and Development for Viracor, and is responsible for the scientific direction and oversight of the company's research and development programs as well as the BioPharma and Clinical Trial Biomarker Services research services. Dr. Kleiboeker is board certified as a high-complexity laboratory director, technical supervisor, and clinical consultant by the American Board of Bioanalysis. Over his career, he has published more than 60 scientific manuscripts and serves on editorial boards and as a reviewer for several virological and microbiological journals. *For context, this interview was recorded on March 31, 2020. Here are more of the details from our interview:  What we know today about coronavirus, how and when is it transmittable, and why good hygiene is so important as a protective measure (2:29) The difference between the South Korean and American responses to initial cases, which were both reported on the same day (5:33) Issues with the Centers for Disease Control and Prevention’s initial COVID-19 tests and testing protocol (7:53) The COVID-19 test that is currently approved for use (the RT-PCR test), what exactly it tests for, and why there is variation in how long it takes to get test results back (9:47) Issues with scaling-up the supply chain for all necessary components of coronavirus testing (13:53) The current approach to coronavirus testing and how it differs from what testing would look like in a perfect world (21:03) The roll out of coronavirus antibody testing, what antibody tests tell us, and can you get COVID-19 more than once? (28:46) What we could learn from quantitative testing, or knowing the viral load that an individual is carrying  (33:25) What should you do if you have COVID-19 symptoms? (36:29) Is it too late to do extensive testing to stop and slow the spread of COVID-19? (42:49)

Coming up on this episode of The Doctor's Pharmacy. There has been a significant ramp up by American industry to begin catching up to the demand. Welcome to The Doctor's Pharmacy. I'm Dr. Mark Hyman and that's Pharmacy with an F. F-A-R-M-A-C-Y, a place for conversations that matter. And if you care about what's going on with coronavirus today and coronavirus testing, this is the podcast you should listen to because it's with a leader in the field of testing from Viracore Urofins Lab, Dr. Stephen Kalbacher, who's a board-certified laboratory director, technical supervisor, and consultant in the American Board of Bioanalysis. He's published

more than 60 scientific manuscripts and serves on the editorial boards and reviewer of many virological and microbiological journals, which is exactly what we should be listening to right now as people who understand this stuff, because a lot of us are just in the dark. And today's podcast will shed some light on what we know about coronavirus and coronavirus testing in particular. And what's interesting is that the company Virocor Eurofins is that they have been doing testing in the space of virology for a long time. And they got right on the target as soon as coronavirus emerged and developed a test which is available.

So we're going to talk about testing and all the issues around testing. And the thing that I really am concerned about is what should the average person listening know about testing? What should they do if they think they're sick? And who should be tested? And where do we get tested? And what are the tests out there? And we're going to answer all these questions and more. So welcome, Stephen. Thank you. Thank you. Thanks for your time. Of course. Well, this is an unprecedented time, a once in a hundred year pandemic. It's a time for us to be level-headed, to be open-hearted and focused on what we can do to protect ourselves, our families, and our communities, and to be kind to each other. But it's also creating a pandemic of fear and a pandemic of concern about getting

infected, spreading infection, and every day we hear something different. Today I read, for example, that our advisory to not wear masks is being thought up because maybe people who are asymptomatic don't even know they have it and have no symptoms are spreading it. So maybe we should all be wearing masks. So it's really concerning. So can you tell us what we know today about coronavirus that you that you're aware of and what we should be alert to specifically around this particular virus? Yeah. So there's a lot of topics to really think about and be aware of. The first is that there's a lot that we don't know. So while it is frustrating, and I certainly feel for lay people and those who aren't steeped in the sciences, as some of us are virus that do appear to be similar to other respiratory viruses like flu, for example. But there's also some real differences too. And it's only going to come out with a period of really concentrated research to answer questions. I think one that

you just posed is a super important question. Is there a period of shedding the virus? In other words, releasing virus from one person before they get sick that can then infect other people. So they don't even know they're infected. They have no reason to believe they shouldn't be out doing at least the minimum to stay healthy and fed and in some cases like us going to work. Yeah, you're going to the grocery store. You feel fine. You know, are you infecting somebody? You're touching some vegetable. You put it back or you, you know, infect the cashier because you're grabbing something

that they had in their hand. Well, I do think, so I think without question, there is some what we call inapparent shedding of the virus going on. And that's not at all unheard of for other viruses as well. Most people who are sick are going to be shedding the virus, but in most infections with viruses, there is a period, it's usually short, in which you will have virus coming out of your nose, in most cases for respiratory viruses, before you start feeling bad. Or maybe you're just feeling a little off and you don't know, did you not sleep well last night? Is something troubling you at work or home that

maybe just makes you feel a little off? It could just be the early signs of a virus too. And so we don't know the importance of that. What we do know is that this virus is highly transmissible. It does appear to be more easily transmitted person to person than flu virus. And we know how serious that can be. So there's a lot we're going to learn. But one thing I would really emphasize is that good hygiene, washing your hands, keeping your hands out of your nose and face and mouth, that is still very important. I think you mentioned wearing masks.

That could be part of the protective measure too. But if you're lifting your mask and putting your hand on your nose anyway, then you're defeating a large portion of that protective measure just by not being careful, I guess I would say, as to how you use it. Yeah, so when we look at the whole testing scenario, it's quite fascinating because a lot of countries have done things quite differently than us. For example, South Korea and America both had their first case on the same day. Now U.S. has the most cases in the world 174,000 and South Korea is way down

near you know a very low level of transmission now and have really contained the virus and they are you know have 9,700 cases and we have 174,000 cases as of this recording on March 31st. So that speaks to a question of why is there that difference? And my understanding was that as soon as the coronavirus became a threat, Korea activated its innovation scientists and companies to come up with a test. And they did. And they came up with a test that was accurate, 98% accurate, produced 10,000 tests a day right from the get-go, and they tested everybody, and they tested their contacts, and they isolated them. And they've been able to have only a fraction of the cases that we have, taking a very different approach. And America, can you tell us what happened with testing

and what went wrong, and what can we learn about this for the next pandemic? Right, so really good question there, and also the background on South Korea is super important. Before I answer the questions about what went wrong, I will say that the classic epidemiology, the principles that have been taught in schools and practiced by epidemiologists for really decades, if not longer now, those are what South Korea used, and they work.

You mentioned test, quarantine, trace back to the contacts, test those. That's a super good example of what you can do if you hit it early, you hit it hard. That is the testing and the quarantine and the tracing of the contacts and what kind of impact that can have. Unfortunately, we didn't do that in the U.S. And so a lot of this is my opinion, but there was a very slow rollout of testing capabilities. And without, I suppose, sounding overly critical, we know that the CDC test, the one that was first rolled out, was far from an optimal test. And that test is still in use today. day. So basically what happened initially, my understanding is that the government said only the Centers for Disease Control and Prevention can perform these tests and all tests have to go

through the government. Right. That was the first mistake. Yeah, that was a slow rollout that I would point to. Now, if the test was accurate and it was abundant, maybe that would be okay. But it turns out that it wasn't accurate. Is that right? Right. Well, it's reasonably accurate. It's not robust. We have dealt with a few discrepant results in our lab versus the CDC lab. We know that there is a challenge with the synthesis of those reagents,

of the key pieces to the tests that are required. It's been well discussed. I started to say well published. It hasn't been well published, but it's been well discussed. And there's a lot of reason that the test is not working optimally. For one thing, you mentioned the capacity. They are using really four times the amount of material and reactions, tests that is, that they need to, to get a single answer. There was some initial recommendations to test multiple samples. That's great if you have multiple samples from the same patient, that is. That's great if you have a huge testing capacity. Sure, you know, test everything right. But what we did is we restricted that capacity. And quite honestly, the cat was out of the bag, to use an old well

worn phrase. And once you get a bunch of people spreading the virus in the community, you just can't gain control of it again in any sort of a rapid fashion. And that's exactly where we sit today. So the question is, let's just talk about testing itself and then we'll talk about who should get tested. So there are a lot of tests every day. There's a test. It's an hour test. There's a test. It's a 24 hour test. Do you have a test? It's a 24 hour to 72 hour test. What are the differences in the tests? You know, can they all be relied upon and you know, why is it such a mess?

So that's a really good question. There really is only one type of test out there today in terms of what is fully approved for use and widely available. Only one type of test. And that's what they call the PCR test. Or actually, if you want to get more technical, it's an RT-PCR test because the coronavirus is an RNA virus. But that may be a little bit more than most people want to think about in terms of technology.

Let's just call it a PCR test. And that test, for people who don't know what that means, it's a test that actually measures the genetic material of the bug. Exactly. So rather than taking a culture and growing it in a medium like we used to do, or checking an antibody to see if maybe you had the infection, it's actually measuring the infectious agent in your blood. It's measuring part of their DNA, whether it's RNA or DNA. And so that's a very accurate test. It's not something that's equivocal. If it's positive, it's positive. Right. It's a very accurate test. And even the CDC test that has what I consider to be important or lack of optimization for some aspects, it's still a very accurate test.

And it's plenty accurate to get the job done if you had ample capacity. There are real challenges with capacity, but nonetheless, there are dozens of PCR tests out there, the ones that, as you said, they detect the genetic material of this virus. There's dozens of tests out there. They all work fairly similarly, and they all have very good accuracy. They have good, what we call sensitivity and specificity, or you can just think of that as accuracy in terms of the test is right. You can bank on the test. Yeah. There's false negatives. Yeah. Very few false negatives. And, and, and, and fortunately, and when you're testing for a pandemic like this, you just have to be right. Most of the time, you don't have to

be perfect because you do know there is going to be some spread. It's just a matter of knowing with great precision or inaccuracy, say 98% precision would be an awesome tool. And that's what PCR is. But again, we just don't have the capacity. Now you mentioned the time to do the testing. There's a lot of different formats. And so Abbott, for example, and Cephia have these 15, five-minute or 45-minute test results that you can get. And those are very similar to the testing that we perform, that the CDC performs. The only difference is those are typically point-of-care types of tests. And so, yes, you can get a result from one sample in 15 minutes, but the type of testing we do can give you the results from 100 samples in an hour and a half. And that's just the one part of the test. So you get all these

different times. It really depends on how many samples you're testing. And then in our particular case, we strive for 24-hour turnaround time. We've been really overwhelmed by the number of samples, so it has taken us longer just to get through the test, but any individual test could, of course, be performed in a few hours. It's just this large increase in cases that lead our lab and others to be, quite honestly, struggling to keep up with the work, and of course, that just means the days get longer, the nights get shorter, and sometimes the work carries over into the next day. You know, I actually had your test because when I came back from a three-week trip on the road, as COVID-19 was blanketing the country, and I'd been on planes and shaking hands and with,

you know, literally thousands of people on my book tour, I was reassured to get my negative results, which I was not sure I was going to get, even though I felt fine. The challenge is not just the test itself, but they're all the components of the test that have to be available for the test to work. There has to be the swab, the medium. So, for example, we had all these test mediums, but we didn't have the swabs. And then you need the reagents. And every step along the process, there are ingredients or things you need to actually complete the test. And my question to you is this.

You know, in a place like South Korea, they were able to mobilize and do this very quickly. But in one of the greatest economies in the world, why are we failing to be able to get swabs and medium and reagents for the test that should be able to be scaled up seem to be pretty quickly? Because this is the kind of thing we do a lot. We do PCR testing a lot in America. Right, right. That's a really good question. And first of all, I wish I knew more about how the South Koreans did scale up so quickly. I suspect that they had some sort of strategic reserve of these key chemicals and swabs, as you mentioned. And I don't want to go too far off on a tangent here, but we all should have been thinking about this, right? I have been in infectious diseases for 25 years, and there's never been a shadow of a doubt in my mind that at some point we were going to be

faced with another flu pandemic, for example. Well, this is not flu, but it's close enough. It's a respiratory virus. So why do we not have strategic stockpiles of all these key reagents? Because there's never been any doubt that we would be faced with something akin to this at some point in the future. It's just a matter of when. It's not if. I mean, we had a bit of a scare in 2009 with the H1N1 pandemic. But nonetheless, to go back to your question about why are we struggling with the supply chain, I think it really is American business philosophy to run lean and to run with things like just-in-time delivery, low inventory levels so that you're not carrying expensive items sitting in your warehouse for months on end. Like it's a business philosophy in a way that got us to where we are today.

But we should be able to mobilize. I mean, you know, during World War II, Ford Motor Factory converted to making B-24 bombers, and they made a bomber every 63 minutes, right? So if we can make a freaking airplane in 63 minutes, why can't we make reagents and mass and swabs and media? I just don't understand. Right. That's a great question. I do think we are seeing that. So as you pointed out, there's a lot of points in the supply chain that have been stretched thin, and in some cases, quite honestly, have just been stretched to the point of breaking. But I am in certain reagents that we're using now,

and reagents being the special chemicals that go into making these tests, we are seeing an improvement in supply. So there has been a significant ramp up by American industry to begin catching up to the demand. But of course, it's that lag phase that is, it's two things. It's very painful and troubling because here we sit in one of the greatest industrial economies ever, and yet we can't keep up with the demand like this. And two, the early phase of any epidemic is where you can do extraordinarily powerful things with less effort. But once the early phase has passed, once you have it in your large cities like New York and Seattle and other large cities that are really seeing know, really seeing the strain on their healthcare system.

You can't turn back the clocks of time and I'm sorry, the hands of time. And so we, we, we know that that, that time has passed. All we can do now is prepare for the future. And, and, and they do feel like we are getting that ramp up, but it's, it's certainly not fast enough. Yeah. I mean, South Korea is an interesting lesson, right? Because, you know, as of today, they had 9,700 cases. We have 174,000 cases. They test everybody. They do 10,000 tests a day. They probably have a more accurate number. It's been estimated that for every person diagnosed in America, there may be five to 10 times that. So there may be almost two million people today in America with COVID-19,

and they're just not diagnosed. Yes, 100%, yeah. So I think, quite honestly, South Korea, when the dust settles, I believe they will be an excellent case study in how to do this right. And I hope we can all learn from their excellent response in the early phases of this pandemic. So how is your test different than other tests for the virus out there? So as I said, it's an RT-PCR or a PCR-based test. And it really is, at the basic level, quite similar to the other tests that are available. We've done a couple of things that we think do make a very important difference in the test. And the first is that we threw a large design team on the project as soon as we knew it was going to be a project.

And so our goal was to design the most robust, accurate test that we could in the very shortest period of time. Normally, you think when you rush through a design phase, you end up with less than optimal work. I'll editorialize and say I think that's what happened to the CDC. Fortunately, we were able to hit upon a very robust design. We've run over 20,000 of these tests just in the last few weeks, but probably closer to 30,000 now. And we're seeing excellent signal, and that's what we call the test when it turns positive. We see excellent results that really indicate it's detecting virus when it's there, and it's just as silent and negative as it can be when virus is not there. So

we focused on the design. We knew we needed a robust assay that would just work day in and day out without problems, without flaws. It was easily manufactured and we achieved that. And then the second thing that makes our test different is that we really do focus on turnaround time. So we actually have stat testing for our most critical patients. We do get those results out literally within hours of getting the sample. So stat in medical terms means like right now. Exactly. Yeah. So if a patient, if a physician says this patient, so we have hospital programs sending us hundreds of samples. And if the physician prioritizes a small handful of samples, we respect

that to the utmost degree. And so our goal is to get them an extremely accurate result out within literally a few hours of the sample hitting our doors, about six to eight hours of the sample hitting our doors. That's amazing. So in a perfect world, what should be our approach to testing? So right now, obviously, we're not in a perfect world. Right now, I think the approach is to test those patients who are at the highest risk of shedding virus. And those, of course, are the clinical patients. We don't want to be isolating and using a ton of PPE for

a patient that only, I'm using that a bit in air quotes and sarcastically, only has an adenovirus infection. Adenovirus, flu, we can treat that, right? We don't need to have the extreme measures for some of the less important, I shouldn't say less important, less severe respiratory infections. So test the patients that need the most. But in a perfect world, we will expand our testing capabilities tenfold, even from where it is now. And I would say within a month, we will be able to test pretty much anybody who has clinical signs, regardless of whether we think it's the common cold or coronavirus, SARS coronavirus 2, will also be able to test anybody who's been in direct contact with those patients to see if they're perhaps shedding the virus

and therefore possibly infectious to others before they start showing signs. And then, of course, we can even envision an outer ring of people who are not in direct contact. But say you shared office space. You came into your office because you're an essential worker. You didn't shake hands with the person. You didn't eat lunch with them. But their desk was across the room. Let's test that whole office building.

I think that's what a perfect world looks like. And then to follow up on those results, first of all, you need to get the results out quickly. Seven days doesn't cut it. I think in a perfect world, we'd have the results available in one to two days. And when a patient has a positive test, if we want to confirm that, say in a perfect world again, if we have a testing capacity, okay, you came up positive on this test, let's confirm it with a second test, or you have the opportunity to self-quarantine. I would have to confirm it if they're so accurate and sensitive and specific. Yeah, the key reason to confirm is really psychological or psychosomatic, if you will. So, you know, you assure the person, yes, you really are positive. You really do need to stay

home and self-quarantine. I agree. I don't, you know. And a shortage of tests doesn't seem like a good idea to double check. As long as we have a shortage of tests, that would never hit anyone's list. You're right. But then the follow-up would be that those individuals would stay home. And then just one final little piece of the perfect world puzzle is that after a period of time, say, you know, not even 14 days, but maybe the person could be tested again to see if they're still shedding, say they never got sick. They just had what we call an inapparent infection. Okay, seven days, you can get retested. And if you're still positive, you have another seven days and then get retested.

I think that's what a perfect world would look like with testing and controlling this virus. But it's a huge undertaking, obviously. I've said a lot of things that require a lot of manpower and a lot of caregiving, et cetera. I mean, right now, you know, we maybe have hundreds of thousands of tests. It seems like we need millions and millions of tests. How do we get there? Yeah, so the ramp up is ongoing. Eurofins is our corporate goal, and this is worldwide.

It's not just the US, but our corporate goal is a million tests a day. I mean, we want to see if we can, our CEO has challenged us to get there. And so we may, that's an incredible goal to take from going from, we do about 10,000 Eurofins wide today. So that's a 100x increase. That's, that's a lot. there are companies that are jumping out and helping to provide testing. So, you know, it just seems like we're in a catch-up phase now.

And, you know, we hear all sorts of different things from the government, like don't get tested, just stay home. If you feel ill, don't go in, don't get checked. Is that the right advice? So when testing is as restricted as it is now and has been since the beginning of this, yes, I think that probably is good advice because it's very difficult to get a test and to get the results in a reasonable period of time. I think in the coming weeks, three, four, maybe five, six, seven weeks, we'll see the ramp of testing begin to keep up with

demands for anybody who has clinical signs. But I think one of the... I mean, it seems like we only have to give that because we've had a massive failure in our government and our economy to ramp up testing early and disseminate it widely. I mean, it's not like that's a good idea to just stay home if you think you're sick and not get tested. It's because we failed massively to scale up in time. And, you know, like South Korea, I'm just going to reiterate this. They had their first case the same day we had our first case. And look where we are and look where they are. I think the testing makes all the difference because then they identify who's sick, they can identify all

their contacts, and they can isolate everybody who needs to be isolated and confirm the cases. And that's why they see the mortality rate being different. So let's talk about that for a minute because people are hearing mortality rates of 4%, 3%, 2%, and then the flu is 0.1%. And we're seeing terrifying stories about the rate of death. But how accurate is it if we don't know who has it? Right? Yeah, that's a great question. If three people die out of 100 people who are tested positive, but that's a 3% death rate. But if actually it's 10 times that who are sick, 1,000 people, then the death rate is 0.3%. Yeah.

So I do think that the case fatality rate numbers are, in my opinion, they're probably fairly accurate. Because most people who are sick to the point of potential mortality are getting tested. There probably was a brief period of time initially where they weren't. But it's my understanding that the testing is focused on those who are the sickest today. And so I think case fatality rates are probably, I would be surprised if they were off by more than 1% or 2%. But that doesn't make sense to me because, yeah, if you get the really sickest patient tested, yeah, you're seeing who's got it, who's very sick. But if there's, you know, 10 times that number who are barely sick or have mild symptoms and you don't know they have it, and the death rate is much, much less. Yeah. So to be a case, that's the classic definition, that's a clinical case. And you're right, there are probably a bunch of people who

have the virus. So the overall mortality rate associated with infection is, as you say, I'm sure that's much lower than what we're hearing about in terms of the case fatality. So of course, there's the overall fatality for people infected, and you could have 10,000 people infected for, you know, tragically 100 or 200 deaths. But those that end up in the hospital, I think that's the numbers that I would guess are accurate. But overall, the number of people infected is just a wild guess at this point. And it's one that we will, especially as we get antibody tests online here in the next few weeks. Are you going to be doing that at Viracore Urofins antibody testing? Yeah. So we're,

we're in the process of developing methods now for antibody testing and those will actually be super useful for the, the, the, the question that you just answered or ask, I'm sorry, about how many patients, how many people are infected versus how many get sick and how many get sick, how many actually end up as a fatality. So let's just sort of clarify for people who are listening or in medical field, a PCR test is the actual virus in your blood. An antibody test measures your immune system's response to the virus, which shows up after your body starts fighting it. Right, exactly.

So it doesn't tell you if you have necessarily a current infection, but it tells you you were exposed and infected at some point. So it'll tell you if you've been basically a victim of COVID-19, whether you knew it or not. And that will help us get a better sense of if people are better. And one of the things we don't know is if you get it, can you get it again? Oh, that's a huge question. And you're right. Because if you get an antibody and it shows positive, you say, well, I'm immune. Like I have the measles vaccine. I have the measles antibody. I'm not going to get it because I have antibodies. But is that true for COVID-19?

So in all likelihood, probably not. Because it mutates? Well, there's certainly the mutation, but also respiratory infections generally do not instill lifelong immunity. So think about how many colds you've had in your lifetime, especially those of us who have had young kids. But you get the same cold twice? You can get versions of the same cold twice? You can get versions of the same cold twice. There are a lot of different cold viruses. But what we do know is that the immunity does wane over time. So even with something like, let's use the example of chickenpox. Now we have adults in my age bracket who are getting the shingles vaccine, right? Even though I had chickenpox as a child, I don't have

lifelong immunity. I can still get the adult version of chickenpox shingles as an adult. And so I was revaccinated. So we don't know, there's a huge, huge unknown about the duration of immunity for SARS coronavirus. It's only been around for a few months now worldwide. So it'll be, it'll be quite a while before we know how long people can stay immune to SARS coronavirus too. SARS coronavirus 2, and also whether it's actually a protective immunity. Some people will have an antibody response and could still get reinfected if there was, as you said a moment ago, a slightly mutated strain that happens to emerge at some point in the future.

People are talking about, oh, well, you'll just give everybody antibody tests, and those who have antibodies, they can go back to work because they can be helpful in rebooting the economy. Is that a good idea? That's an okay generalization. But I think we want to study that carefully, too, because there is no doubt. We know this from all the other infectious diseases that are studied that some people with antibodies can get the disease again. There is no perfect immunity, just like there's no perfect test or drug. For example, drugs don't cure everybody that gets treated with them,

even though we have a lot of very good drugs for a number of diseases out there. So time will tell, but the antibody tests, I don't want to throw cold water on that idea either. They will be very helpful. The antibody tests will be extraordinarily helpful. Now that Boston Heart Lab, it's one of your sister companies that's launching it in April? Yes. Yeah. Their goal is to be live actually within a very short period of time, hopefully within a week, and be able to provide antibody results. And they'll be one of the first labs in the country to do that. And as I said,

that's going to be very helpful. It's certainly a lot more information than what we have now. Just the piece, let me just back up a little bit. The PCR test, as you said, detects the virus that's in your body or actually coming out of your body through the respiratory system. That can go on and off. So it's not at all unusual for some people to shed virus, especially if you're otherwise healthy. You can shed virus a little bit, then you stop for a day or two, or maybe the sample that was collected is just not quite as good. But on the opposite end of the spectrum, an antibody assay, it comes out of your blood. And so it's a very well mixed sample. And once you turn antibody

positive, that test is highly reproducible, again, for a short period of time, maybe weeks, well, probably maybe months, maybe years. Antibody immunity does wane. It does go away, but it's a much more consistent marker of what you have than, say, a PCR test. And currently, the tests are mostly qualitative. You know, it's on or off. You have it or you don't. But PCR testing can also be used to measure quantitative tests. How much viral load do you have?

What's the dose, let's say, of your virus? Exactly, yeah. And so we've been a big proponent of quantitative use, as you just described. Unfortunately, that has been, I just would say, frowned upon by the Peruvian authorities at the FDA and CDC. They don't want to use quantitative tests because we don't know what it means. I think we miss a real opportunity there at some valuable information. We're working with some of the frontline companies on the drug manufacturing front, and they want quantitative results. A little bit of virus is bad, but a lot of virus is a lot worse. So it's important to have that additional piece of information. We think over time that there will be a shifting in those priorities, and we'll have the opportunity to provide quantitative results. That's right. So something you're very curious to me, because

if you know that the risk of severe complications and death correlates with a high viral load, then knowing that and knowing what influences the viral load can help you drive the decisions around therapy, right? So for example, people are using high-dose intravenous vitamin C or different herbs or different medications. And if we could actually measure the impact on viral load, we would know, are we doing something good or not? And that's really an immediate feedback. Yes, death and severe complications is an outcome, but it's a little late. And also, you know, if you can show that you could cut the viral load in half or cut it by 90%, that's really meaningful. And we should be actually studying that. Is anybody studying that right now? So it is included in the papers that I'm seeing. We're including

a measure of the viral load, but it's not, I don't think it's really being studied in terms of response to therapy yet. That's only because we don't have good targeted studies underway yet to look in a controlled trial, clinical trial fashion at the impact of treatment. But we certainly will. As I said, we're working with a few of the drug companies that are starting up programs for SARS-CoV-2 drugs, and they are all interested in quantitative testing. And so we see a great opportunity there to generate some very good clinical trial results for their efforts, but also to learn more about the virus in general. Yeah. And it's true that, you know, the antibody testing is a blood test, but the current PCR COVID coronavirus testing is a nasal swab. It's basically a very tiny,

thin Q-tip that you jab up your nose and you rub it around and you stick it in a tube and you send it off to the lap. Yeah. That's what the current testing is. So, so if I'm listening to this and I'm sitting at home and I've got a fever and I'm coughing a little bit and I feel a little achy, tired, um, what do I do? Yeah. So very best next step is to call your physician. Don't go in and see him or her, call them, talk to them. There's of course, a very unfortunate, but there's an increased risk for people with underlying health conditions. So that's where your physician can really help assess your risk. If you're an otherwise healthy individual and you take good care of yourself, then your physician may say, okay, self-quarantine, stay home. I could collect a sample from you, but I'm not going to find out

for a week. That physician probably already has experience testing patients. They probably already know what they can get. On the other hand, if you have underlying health conditions, your physician would know that. He or she would say, hey, I really do need to take a sample because if it's just a garden variety, seasonal cold, I'm not going to worry overly about you. But if it is SARS coronavirus 2, we know that some of those patients get extremely ill. And what's most troubling is that they're not following a typical clinical course where one day you spike a fever and you feel horrible. With a lot of cases that I've read about, they'll feel okay, just not great, but not

terrible for a day or two. And then they'll just start a really steep downward decline. And they go off a cliff. And so I think that's where calling your physician who understands your particular health risks is really good. Of course, staying in touch with them. If, you know, things worsen, don't say, oh, well, he said I can't get tested, or she said it would be seven days to get the result. So it's, you know, it really is an important physician-driven decision about how to proceed.

But just to play devil's advocate, data was recently published that only 12%, 12% of Americans are metabolically healthy, which means, right, 78% of Americans, no. 88, yeah. Terrible amount. 88% of Americans are metabolically unhealthy, which are the most at risk. So aside from being an incentive to take care of yourself, which I'm recommending, you know, if I want to get a test, like what's the procedure? Are there mobile testing centers everywhere? Do you go to a parking lot? Do you go to your hospital? Do you go to the lab? Do you have a lab? Like, what do people do? Because I don't even really know where to go or how to get a test and where to find the testing center. And is it safe to go to the lab? I mean, people are terrified to be around other people. I mean,

there's drive-through. They did in South Korea, they had drive-through testing centers where there'd be someone in a full protective gear and they'd open your window, they'd stick the thing up your nose. That'd be the end of it. So how is that happening in this country? How are we rolling that out? How do we get to a million tests like this? So I think if there's a thousand healthcare facilities in the country right now, there's more than that, I know. But I think there's probably 1,200 solutions. I think that there's a lot of customized band-aid, you know, we're making decisions as we go here. But I think, for example, I'll just use a couple of the healthcare systems in our local area here. They have really, and we sit right on the

state line, so they really have three testing options. There's the state of Kansas public health lab, there's a state of Missouri public health lab, and then there are labs like Virocor. And so each of these healthcare facilities, since we're, what, about a month into this now, each of these healthcare facilities has had the opportunity to establish a relationship with a testing laboratory. Of course, Quest and LabCorp, the national behemoths, are also testing. And so I wouldn't want to be the first patient to go through their system, but their laboratories, their physicians, they do have a path now to testing. And so each physician is going to know, okay, in my healthcare system, in my practice, what

I want you to do is come into the clinic and go through the second set of doors. And that's where we have people who are going to get this particular test. We will swap you. We will send that test off. And in our system, we've been getting our results back in three to four days, for example, or two, three days. who are going to get this particular test. We will swap you. We will send that test off. And in our system, we've been getting our results back in three to four days, for example, or two to three days. And so how it actually happens, I think, is at best a patchwork quilt design right now across the U.S. And we'll get better at that.

So, for example, let's just take a well-known pathogen like hepatitis C. There's probably, I would say, very uniform methods of getting hepatitis C testing. Now, of course, you can't transmit that standing next to someone like you can SARS-CoV-2. But I think within a few months, we'll have a lot more uniformity in how these tests are collected, where they're collected, and how they're tested, and when they get the results back. It's just we're not there yet. People are scared of the lab. I mean, what if you have a thyroid problem, or you are on a blood thinner, you need to get your blood checked, you get your kidney function checked, or your liver's not right. I mean, you want to go to the lab. What are people doing? Are people staying away from labs? Are they not getting the regular lab tests that they need to get? How do we get around that? It's certainly reduced. I think the labs,

as far as I understand, the labs that are drawing these samples are definitely keeping the patient flow down. So they have much fewer patients in the waiting room. I don't want to get my cholesterol checked after somebody came in and get his COVID-19 testing done, right? Yeah, I think a lot of the routine, you know, annual physicals, for example, you know, that has just been really been put on hold until we can figure, until we know, first of all, know what we're dealing with. Because as we pointed out a couple times already, we don't really know how many people are infected in the U.S. And it's going to be a while before we know that. But yeah, the flow, keeping the people from bunching up and crowding in waiting rooms, taking the time to disinfect surfaces between patients. Of course, healthcare providers

have always done that, right? But I have to think that everyone is hypervigilant at this stage about protecting the next patient, as you pointed out. Yeah. Well, let's say we did have the perfect world where we could all get tested. Like tomorrow, there was millions of tests and everybody could get tested. Is it too late to do extensive testing, isolation of those infected patients, tracking of all their contacts and isolating them to slow and stop the spread. Is it too late to do that? No, I don't think it's too late. I mean, it would be a much larger effort if it was, you know, a 1x effort three weeks ago, it would be a 10 or maybe a 20x times greater effort today to do that. But honestly, there is no other answer.

So we need to do that as a society. Absolutely. We could all shelter in place, but only for an indefinite period of time, right? People are eventually going to stop adhering to draconian measures, some sooner than others. I mean, we saw spring break parties in Florida when other cities were also issuing stay-at-home orders. In New York, they're arresting people for going to parks. Yeah, exactly. So it's not, I mean, we do need testing because that will help rationalize, that will help us strategize. And most importantly, that will help us focus our efforts where we can do the most good. And that's on the people who are shedding the virus, whether they're healthy or whether they're somewhere in between, whether they're just a little sick.

We have to know who's shedding the virus. And that's what testing will do for us. So, Steve, being in the epicenter of the testing of SARS-CoV-2, what's your sense of when we're going to be ramped up and have the tests we need? Is it a week? Is it a month? Is it more? Yeah, my sense is really three to four, maybe six weeks. I think then we're going to start seeing a lot of capacity. Now, the challenge is, so right now you've got people like us, labs like ours, who have been doing this for decades. And we quickly sprung into action. Now, we have a lot of other labs coming online. And, of course, labs like ours, we're adding equipment, trying to increase our capacity. But we have a lot of new labs coming online.

And I do have some concern that new labs are going to have some growing pains to do this testing because it's not, you know, if I watch Patrick Mahomes just to pull a name out of the hat, play football, it looks darn easy. And, you know, I could go out there and do that. I could throw that 70-yard pass. No problem. I look like a fool. I think there could be some growing pains as our testing capacity ramps up. But nonetheless, it's important to do so. We are going to, I think we're going to see a nice ramp and see in the next five, six weeks that will really allow us to test a lot of people. And so it's, you know, the help is admittedly late as a society. I feel like I share in this responsibility.

We failed our mission. We were not ready, you know, as we should have been when the flag went up. I mean, we're all in this. When did you go into the war room mode of starting to develop the test? Yeah, mid-January. We had all of our prototypes. Right after Christmas, we had all of our prototypes on the drawing board. And that allowed us to, going back to our original part of the conversation that allowed

us to design a really robust, we call it bulletproof around here assay. So you were early out of the game, you were you were right there in track with South Korea, just you just couldn't produce, you know, 100,000 tests a day. Right? Yeah, that was, I mean, that was the challenge. Sorry about the phone. Yeah, that was the challenge. Yeah. Well, it looks like you're in your office at work, which worries me, but I guess you have to be there in the lab to do the test. So I hope you're staying safe. Yeah. And taking care of yourself and practicing precautions. And thank you for being on the front line and doing the hard work and helping us understand the complexity of testing and what we should know, because without people like you on the front lines, helping us do the

hard work of figuring out who's got it and who doesn't and how to protect ourselves, this would be a lot worse. So thank you so much, Steve. And thanks to Virocor, Eurofins for doing the work they do and other labs in the country that are actually helping us to understand this virus more and to protect ourselves through the testing. So thank you so much for joining us on The Doctor's Pharmacy. Thanks for your time. I really enjoyed the conversation and wish you the best of luck and the best of health as well to you and your family. Thank you. And if you've loved this podcast, please share it with your friends and family on social media. Please leave a comment. We'd love to hear from you. Subscribe wherever you get your podcasts.

And we'll see you next time on The Doctor's Pharmacy. Hi, everyone. It's Dr. Mark Hyman. So two quick things. Number one, thanks so much for listening to this week's podcast. It really means a lot to me. If you love the podcast, I'd really appreciate you sharing with your friends and family. Second, I want to tell you about a brand new newsletter I started called Mark's Picks.

Every week, I'm going to send out a list of a few things that I've been using to take my own health to the next level. This could be books, podcasts, research that I found, supplement recommendations, recipes, or even gadgets. I use a few of those. And if you'd like to get access to this free weekly list, all you have to do is visit drhyman.com forward slash picks. That's drhyman.com forward slash pics. I'll only email you once a week, I promise, and I'll never send you anything else besides my own recommendations. So just go to drhyman.com forward slash pics, that's P-I-C-K-S, to sign up free today. Hi everyone, I hope you enjoyed this week's episode. Just a reminder that this podcast is for educational purposes only. This podcast is not a substitute for professional care by a doctor or

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