Dr. Steven Kleiboeker:
… There has been a significant ramp up by American industry to begin catching up to the demand.
Dr. Mark Hyman:
Welcome to the Doctor’s Farmacy. I’m Dr. Mark Hyman and that’s farmacy 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 a podcast you should listen to, because it’s with a leader in the field of testing from Viracor Eurofins lab, Dr. Steven Kleiboeker, who is a board certified laboratory director or a technical supervisor and consultant in the American Board of Bio Analysis. 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.
Dr. Mark Hyman:
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 their company Viracor Eourofins is that they have been doing testing in this 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 of the issues around testing. And the thing that I really am concerned about is what should the average person listening know about testing?
Dr. Mark Hyman:
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, Steven.
Dr. Steven Kleiboeker:
Thank you. Thank you. Thanks for your time.
Dr. Mark Hyman:
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 openhearted 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, they 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’re aware of, and what we should be alert to specifically around this particular virus?
Dr. Steven Kleiboeker:
Yeah, so there’s a lot of topics to really think about and be aware of. The first is, 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, that there is confusion. But to be honest, this is a new virus. There are some characteristics of this 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 the period of really concentrated research to answer questions. I think one that you just pose is a super important question.
Dr. Steven Kleiboeker:
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 it’s in some cases like us going to work.
Dr. Mark Hyman:
Yeah, you’re going to the grocery store, you feel fine, you’re affecting somebody, you’re touching some vegetable, you put it back. Or infect the cashier because you’re grabbing something that they had in their hand?
Dr. Steven Kleiboeker:
Well, I do think so. I think without question there is some, what we call an apparent shepherding 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.
Dr. Steven Kleiboeker:
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.
Dr. Steven Kleiboeker:
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.
Dr. Mark Hyman:
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 day. Now US has the most cases in the world, 174,000, and South Korea is way down near a very low level of transmission now. And have really contained the virus. And they have 9,700 cases, and we have 174,000 cases as of this recording on March 31st.
Dr. Mark Hyman:
So, that speaks to question of why is there that difference? And my understanding was that as soon as the coronavirus became a threat, Korea activated its innovation sciences and companies too 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. And 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?
Dr. Steven Kleiboeker:
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. And 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.
Dr. Steven Kleiboeker:
Unfortunately, we didn’t do that in the US. 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.
Dr. Mark Hyman:
So going back up. 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.
Dr. Steven Kleiboeker:
Right.
Dr. Mark Hyman:
That was the first mistake.
Dr. Steven Kleiboeker:
Yeah. That was a slow rollout. I would point too.
Dr. Mark Hyman:
Now, if the test was accurate and it was abundant, maybe that would be okay, but turns out that it wasn’t accurate. Is that right?
Dr. Steven Kleiboeker:
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.
Dr. Steven Kleiboeker:
But one thing, you mentioned the capacity. They are using really four times the amount of material and the reactions, now the test that is that they need 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 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 rapid fashion. And that’s exactly where we sit today.
Dr. Mark Hyman:
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 I read there’s a test, it’s an hour test, there’s a test, it’s a 24 hour test. Do you have a test that’s a 24 hour to 72 hour test? What are the differences in the tests? Can they all be relied upon? And why is this such a mess?
Dr. Steven Kleiboeker:
So that’s a really good question there. There really is only one type of test out there today in terms of what is a 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 a RTPCR 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 the technology, let’s just call it PCR test.
Dr. Mark Hyman:
And that tests with people that don’t know what that means. It’s a test that actually measures the genetic material of the bug.
Dr. Steven Kleiboeker:
Exactly.
Dr. Mark Hyman:
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.
Dr. Steven Kleiboeker:
Right. It’s a very accurate test and even the CDC tests that has what I consider to be important or lack of optimization for some aspects. It’s still an a very accurate test and it’s plenty accurate to get the job done if you had excess or ample capacity. The 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. Now 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 is accuracy in terms of the test is right.
Dr. Mark Hyman:
You can bank on the test.
Dr. Steven Kleiboeker:
You can bank on the test.
Dr. Mark Hyman:
Very few false negatives.
Dr. Steven Kleiboeker:
Yeah, very few false negatives and unfortunately when you’re 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 and accuracy, 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 try to do the testing. There’s a lot of different formats.
Dr. Steven Kleiboeker:
And so Abbot for example, and Sapphire they have these 15, 5 minute or 45 minutes test results that you can get. And those are very similar to the testing that we perform, that the CDC performed. The only difference is those are typically point of cared 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.
Dr. Steven Kleiboeker:
And that’s just 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 tests 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.
Dr. Mark Hyman:
No, I actually had your case 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 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 all the components of the test that have to be available for the test to work.
Dr. Mark Hyman:
There has to be the swab, the medium. So for example, we had all these tests 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, 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 seemingly to be pretty quickly. Because this is a kind of thing we do a lot. We do PCR testing a lot in America.
Dr. Steven Kleiboeker:
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.
Dr. Steven Kleiboeker:
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.
Dr. Steven Kleiboeker:
But nonetheless, to go back to your question about why are we struggling with a 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. So, it’s a business philosophy in a way that got us to where we are today.
Dr. Mark Hyman:
But we should be able to mobilize, I mean, during world war two, Ford motor factory converted to making B24 bombers and they made a bomber every 63 minutes. Right? So, if we can make a fricking airplane in 63 minutes, why can’t we make reagents, and masks, and swabs, and media? I just don’t understand.
Dr. Steven Kleiboeker:
Right. That’s a great question. I do think we are seeing that, as you pointed out that 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, and certain reagents that we’re using now certain reagents being the special chemicals that go into making these tests, we are seeing an improvement in supplies. So, there has been a significant ramp up by American industry to begin catching up to the demand.
Dr. Steven Kleiboeker:
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 is passed, once you have it in your large cities like New York, and Seattle and other larger cities that are, really seeing the strain on their healthcare system, you can’t turn back the clocks of time.
Dr. Steven Kleiboeker:
I’m sorry, the hands of time. And so, we know that, that time has passed, all as we can do now is prepare for the future. And I do feel like we are getting that ramp up, but it’s certainly not fast enough.
Dr. Mark Hyman:
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. 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. There may be almost 2 million people today in America with COVID-19 and they’re just not diagnosed.
Dr. Steven Kleiboeker:
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 there. Their excellent response in there, in the early phases of this pandemic.
Dr. Mark Hyman:
So, how’s your test different than other tests for the virus out there?
Dr. Steven Kleiboeker:
So as I said, it’s an RTPCR 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 through 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.
Dr. Steven Kleiboeker:
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 in 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 are really indicated, it’s detecting virus when it’s there, and it’s just as silent and negative as it can be when viruses not there.
Dr. Steven Kleiboeker:
So we focused on the design. We knew we needed a robust assayed 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 tests 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.
Dr. Mark Hyman:
So STAT in medical terms means like, right now.
Dr. Steven Kleiboeker:
Exactly, yeah. So if the physician says, this patient. So we have hospital program 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 at an extremely accurate result out within literally a few hours of the sample hitting our doors, about six to eight hours of this hitting our doors.
Dr. Mark Hyman:
That’s amazing. So, in a perfect world what should be our approach to testing?
Dr. Steven Kleiboeker:
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 ad no virus infection. I have no virus, 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, severe respiratory infections.
Dr. Steven Kleiboeker:
So test to patients that need the most. But in a perfect world, we will expand our testing capabilities, 10 fold even from where it is now. And in what, 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 too. We’ll 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.
Dr. Steven Kleiboeker:
Let’s 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.
Dr. Steven Kleiboeker:
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 with a second test. Or you have the opportunity to self quarantine.
Dr. Mark Hyman:
How do you have to confirm if they’re so accurate and sensitive and specific.
Dr. Steven Kleiboeker:
Yeah, the key reason to confirm is really psychological or psychosomatic if you will. So, you assure the person, “Yes, you really are positive. You really do need to stay home and self warranting.” I agree. I don’t-
Dr. Mark Hyman:
The shortage of tests, does this make a good idea to double check.
Dr. Steven Kleiboeker:
One, we have a shortage of tests that would never hit anyone’s list. You’re right. But then the followup 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, not even 14 days, but maybe the person could be again to see if they’re still shedding. Say they never got sick. They just had what we call an independent 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.
Dr. Steven Kleiboeker:
But it’s a huge undertaking. Obviously, I’ve said lots of things require a lot of manpower and a lot of keeping for keeping it better.
Dr. Mark Hyman:
I mean, right now we may be have hundreds of thousands of tests. It seems like we need millions and millions of tests. How do we get there?
Dr. Steven Kleiboeker:
Yeah, so the ramp up is ongoing. Now 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 to get there. And so 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 the goal.
Dr. Mark Hyman:
That’s a lot. And there are many other companies who are also put out [inaudible 00:24:53]. Right?
Dr. Steven Kleiboeker:
Yeah.
Dr. Mark Hyman:
And so there’s a lot of other companies that are jumping out and helping to provide testing. So it just seems like we’re in a catch up phase now. And we hear all sorts of different things from the government, like, “Don’t get tested, just stay home. If you feel L don’t go in, don’t get checked.” Is that the right advice?
Dr. Steven Kleiboeker:
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 up testing begin to keep up with demands for anybody who has clinical signs. But I think one of the-
Dr. Mark Hyman:
I mean it seems like we only have to give that [inaudible 00:25:49] we’ve had a massive failure in our government, and our economy to ramp up testing early and disseminated 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 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.
Dr. Mark Hyman:
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 the flu is 0.1% and then we’re seeing terrifying stories about the rate of death, but how accurate is if we don’t know who has it. Right?
Dr. Steven Kleiboeker:
Oh yeah, that’s a great question.
Dr. Mark Hyman:
If three people die out of a 100 people who are tested positive, that’s a 3% death rate. But if actually it’s 10 times that who are sick a 1000 people, then the death rate is 0.3%.
Dr. Steven Kleiboeker:
Yeah. So I do think that the case fatality rate numbers, in my opinion they’re probably fairly accurate because most people who are sick to the point of a 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 our case fatality rates are probably… I would be surprised if they are off by more than 1 or 2%.
Dr. Mark Hyman:
But it doesn’t make sense to me. Because yeah, if you get the really sick as patient tested, yeah, you’re seeing who’s got be very sick. But if there’s 10 times that number who are barely sick or have mild symptoms, and you don’t know if they have it, then the death rate is much, much less.
Dr. Steven Kleiboeker:
Yeah. So to be a case, 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 the overall fatality for people infected. And you could have 10,000 people infected for tragically a 100 or a few hundred deaths. But those that end up in a hospital, I think that’s the numbers that I would guess are accurate.
Dr. Steven Kleiboeker:
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.
Dr. Mark Hyman:
Are you going to be doing that at Viracor Eurofins, antibody testing?
Dr. Steven Kleiboeker:
Yeah. So we’re in the process of developing methods now for antibody testing. And those will actually be super useful for the question that you just answered or asked, I’m sorry. About how many people are infected, versus how many gets sick, and then how many get sick, how many actually end up as a fatality.
Dr. Mark Hyman:
So let’s just sort of clarify for people who are listening who aren’t in medical field. A PCR test, there’s 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.
Dr. Steven Kleiboeker:
Right, exactly.
Dr. Mark Hyman:
So it doesn’t tell you if you have necessarily a current infection, but it tells you were exposed and infected at some point.
Dr. Steven Kleiboeker:
Yes, yeah.
Dr. Mark Hyman:
So it’ll tell you if you’ve been a basically a victim of COVID-19, whether you knew it or not.
Dr. Steven Kleiboeker:
Right.
Dr. Mark Hyman:
And that will help us get a better sense of if people are better now. One of the things we don’t know is if you get it, can you get it again?
Dr. Steven Kleiboeker:
Oh, a huge question. And you’re right.
Dr. Mark Hyman:
Because if you get an antibody, and it shows positive, you say, “Well, I’m immune. 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?
Dr. Steven Kleiboeker:
So in all likelihood, probably not.
Dr. Mark Hyman:
Because it mutates or?
Dr. Steven Kleiboeker:
Well, there’s certainly the mutation, but also respiratory infections generally do not instill lifelong immunity. So talking about how many colds you’ve had in your lifetime, especially those of us who have had young kids and-
Dr. Mark Hyman:
That you get the same called twice.
Dr. Steven Kleiboeker:
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 chicken pox. 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 chicken pox shingles as an adult. And so I was re-vaccinated.
Dr. Steven Kleiboeker:
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 quite a while before we know how long people can stay immune to SARS coronavirus II. 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.
Dr. Mark Hyman:
People are talking about, “Oh, well you’ll just give everybody anybody tests and those with antibodies, they can go back to work because they’re not [inaudible 00:31:22] and they can be helpful on rebooting me economy. Is that a good idea?
Dr. Steven Kleiboeker:
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 a 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.
Dr. Steven Kleiboeker:
So time will tell, but the antibody tests will… I don’t want to throw cold water on that idea that either. They will be very helpful. The antibody tests will be extraordinarily helpful.
Dr. Mark Hyman:
That Boston heart lab, it’s one of your sister companies. It’s launching it in April?
Dr. Steven Kleiboeker:
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. Let me just back up a little bit. The PCR tests, 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.
Dr. Steven Kleiboeker:
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 oof what you have than say, a PCR test.
Dr. Mark Hyman:
And currently the tests are mostly qualitative, it’s on or off, you have it or you don’t. But PCR testing can also be used to measure quantitative tests, measure how much viral load do you have, and what’s the dose, let’s say of your virus.
Dr. Steven Kleiboeker:
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 approving 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 and some valuable information. We’re working with some of the frontline companies on the drug manufacturing front and they want quantitative results.
Dr. Steven Kleiboeker:
A little bit of virus is bad, but a lot of virus is a lot worse. So 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.
Dr. Mark Hyman:
That’s right. This was something that 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 decisions around therapy, right?
Dr. Steven Kleiboeker:
Exactly.
Dr. Mark Hyman:
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-
Dr. Steven Kleiboeker:
It’s a little late though.
Dr. Mark Hyman:
… it’s a little late. And also if you can show that you could cut the viral load in half or cut it by 90%, then that is really meaningful and we should be actually studying it. Is anybody studying that right now?
Dr. Steven Kleiboeker:
So it is included in the papers that I’m seeing. We’re including a measure of the viral load. But 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 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 out programs for SARS-CoV-2 drugs, and they are all interested in quantitative testing.
Dr. Steven Kleiboeker:
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.
Dr. Mark Hyman:
Yeah. And it’s true the antibody testing is a blood test, but the current PCR COVID coronavirus testing is a nasal swamp.
Dr. Steven Kleiboeker:
Yes, exactly.
Dr. Mark Hyman:
It’s basically a very tiny thin Q-tip that you jam up your nose, and you rub it around and you stick it in a tube, and you send it off to the lab.
Dr. Steven Kleiboeker:
Yeah.
Dr. Mark Hyman:
That’s what the current testing is. 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 achy, tired. What do I do?
Dr. Steven Kleiboeker:
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 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 health. 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.”
Dr. Steven Kleiboeker:
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, a 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-
Dr. Mark Hyman:
And they go off a cliff.
Dr. Steven Kleiboeker:
And so I think that’s where you calling your physician, who understands your particular health risks is really good. Of course, staying in touch with them if 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 really is an important physician driven decision about how to proceed here.
Dr. Mark Hyman:
But just to play devil’s advocate, data was recently published that only 12%, 12% in Americans are metabolically healthy. Which means right, 78% of Americans, no.
Dr. Steven Kleiboeker:
88, yeah.
Dr. Mark Hyman:
88, that’s terrible amount, 88% of Americans are metabolically unhealthy, which are the most at risk.
Dr. Steven Kleiboeker:
Right.
Dr. Mark Hyman:
So aside from being an incentive to take care of yourself, which I’m recommending.
Dr. Steven Kleiboeker:
Yes.
Dr. Mark Hyman:
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 think people 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.
Dr. Mark Hyman:
They did in South Korea, they had drive through testing centers where there’d be someone in full protective gear, and they would 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?
Dr. Steven Kleiboeker:
So I think if there’s a 1000 health care facilities in the country right now, there’s more than that I know. But I think there’s probably 1200 solutions. I think that there’s a lot of customized bandaid. We’re making decisions as we go here. But 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 Viracor.
Dr. Steven Kleiboeker:
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, and 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.
Dr. Steven Kleiboeker:
And so each physician is going to know I’m, “Okay in my health care 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 instance, or two or three days.”
Dr. Steven Kleiboeker:
And so how it actually happens I think is at best at about patchwork quilt design right now across the US, and now we’ll get better at that. So for example, let’s just take a well-known pathogen like hepatitis C. There is 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 its in 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 their results back, it’s just we’re not there yet.
Dr. Mark Hyman:
And 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 is 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 their regular lab tests that they need to get? How do we get around that?
Dr. Steven Kleiboeker:
Yeah, 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 and then-
Dr. Mark Hyman:
I don’t want to get my cholesterol checked after some guy came in and got COVID-19 testing done. Right?
Dr. Steven Kleiboeker:
Yeah. I think a lot of the routine annual physicals for example, that is just been really been put on hold until we know first of all, know what we’re dealing with. Because as we pointed out a couple of times already, we don’t really know how many people are infected in the US, and it’s going to be awhile before we know that. But yeah, 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. I’m at this thing about protecting the next patient, as you pointed out.
Dr. Mark Hyman:
Well, let’s say, we didn’t have the perfect world where we can all get tested. Like tomorrow there was millions of tests, and everybody can 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?
Dr. Steven Kleiboeker:
No, I don’t think it’s too late. I mean, it would be a much larger effort if it was 1X effort. Three weeks ago, it would be a 10 or maybe a 20X times a greater effort today to do that. But honestly, there is no other answer.
Dr. Mark Hyman:
So we need to do that as a society.
Dr. Steven Kleiboeker:
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 measure some sooner than others. I mean, we saw spring break parties in Florida when other cities are also issuing a stay at home orders.
Dr. Mark Hyman:
In New York, they’re arresting people for going to parks, yeah.
Dr. Steven Kleiboeker:
Yeah, exactly. So I mean, we do need a 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 there’s 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.
Dr. Mark Hyman:
So Steve being in the MP center, 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?
Dr. Steven Kleiboeker:
Yeah, my sense is really three to four, maybe six weeks. And 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 lab like ours, we’re adding equipment, trying to increase our capacity. But we have a lot of new labs coming online.
Dr. Steven Kleiboeker:
And I do have some concern that new labs are going to have some growing pains to do this testing because it’s not… If I watch Patrick Mahomes just to pull a name out of the hat, play football, it looks darn easy. I might go out there and do that.
Dr. Mark Hyman:
Yeah, I can throw that 70 yard pass, no problem.
Dr. Steven Kleiboeker:
I look like a fool. So I think there could be some growing pains as our testing capacity ramps up. But nonetheless, it’s important to do. So. I think we’re going to see a nice ramp, say in the next five, six weeks that will really allow us to test a lot of people. And so the help is admittedly late. As a society, I feel like I share in this responsibility. We’ve failed our mission. We were not ready as we should have been when the flag went up. I mean, we’re all in this together.
Dr. Mark Hyman:
When did you go into the war room mode of starting to develop the test?
Dr. Steven Kleiboeker:
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… Going back to our original part of the conversation, that allowed us to design a really robust what we call bulletproof around here assay.
Dr. Mark Hyman:
So you were early out of the game. You were right there on track with South Korea, you just couldn’t produce 100,000 tests a day?
Dr. Steven Kleiboeker:
Right. Yeah. I mean that was the challenge. Sorry about the phone. Yeah, that was the challenge, yeah.
Dr. Mark Hyman:
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 tests. So I hope you’re staying safe, 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 whose got it, and who doesn’t and how to protect ourselves. This would be a lot worse, so thank you so much Steve.
Dr. Mark Hyman:
And thanks to Viracor Eurofins for doing the work they do, and all the labs in the country that are actually helping us understand this virus more and to protect ourselves through the testing. So thank you so much for joining us on The Doctor’s Farmacy.
Dr. Steven Kleiboeker:
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.
Dr. Mark Hyman:
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 Farmacy.
