Testing is emerging as the key to stopping the COVID-19 pandemic. What’s clear is that the current testing scheme — which has people waiting on average 10 days or longer for test results — is not working. It runs counter to the primary reason for testing: to identify and localize any infection before it can spread through a community.
Suppose there was another way. A test with immediate results, that you could do at home every day. You’d have an immediate back-up method to double-check if you got a positive result. We could quickly isolate those who test positive, contact trace immediately, and — in the opinion of Dr. Michael Mina of Harvard’s T. H. Chan School of Public Health — stop the disease in its tracks.
Unfortunately, at the moment, while such a test exists, it has not been greenlighted for widespread use.
What’s needed, according to Dr. Mina, is to stop seeing testing exclusively as a diagnostic tool governed by complex FDA protocols, but rather as a public health tool subject to a completely different set of approval criteria.
Dr. Mina explains that if we had this testing from day one, we could have avoided lockdowns, hundreds of thousands of infections, tens of thousands of deaths, and we could have this pandemic completely under control.
Trying to understand why we haven’t initiated an “operation warp speed” kind of effort for this testing plan is what fuels the frustration you hear from Dr. Mina in this week’s podcast.
An assistant professor of epidemiology at Harvard’s School of Public Health, Dr. Mina is also a member of the Center for Communicable Disease Dynamics, as well as assistant professor of immunology and infectious diseases and associate medical director of clinical microbiology in the Department of Pathology, at Brigham and Women’s Hospital at the Harvard Medical School.
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|Jeff Schechtman:||Welcome to the WhoWhatWhy podcast, I’m your host, Jeff Schechtman.
If you are one of the millions of people that have gotten or tried to get a COVID-19 test, you probably waited days, if not weeks, for the results. By the time you got the results, if you tested positive, you may have already developed symptoms and before doing so may have been in contact with dozens of people.
|Jeff Schechtman:||If you tested negative, you had the added anxiety of just waiting days for the results. It’s clear that the failure of the current testing scheme, the length of time it takes for the results defies the very reason that widespread testing was considered so important. My guest, Dr. Michael Mina, explains that there is and that there should be a significant difference between diagnostic testing and public health testing. The rules should be different as the needs are different.|
|Jeff Schechtman:||And there exists today a kind of rapid paper strip test that you can do at home each and every day for less than a dollar a day. If we all did this, we could truly isolate contact trace and stop the spread of the disease in real time. So why aren’t we doing it? We’re going to talk about this with my guest, Dr. Michael Mina. Dr. Mina is an Assistant Professor of Epidemiology at Harvard’s TH Chan School of Public Health; he’s a member of the Center for Communicable Disease Dynamics as well as an Assistant Professor in Immunology and Infectious Diseases; and an Associate Medical Director in Clinical Microbiology in the Department of Pathology at Brigham and Women’s Hospital at the Harvard Medical School.|
|Jeff Schechtman:||Dr. Mina is leading the fight nationally and globally for this new kind of testing. It is my pleasure to welcome Dr. Michael Mina to the WhoWhatWhy podcast. So much has been made of the whole idea of testing being linked to the number of cases that we have. In some situations we’re seeing the amount of testing drop in certain states and at the same time, we’re seeing the positivity rates drop. When those two things happen, what does it mean? What does it indicate?|
|Dr. Michael Mina:||That generally implies, and this comes with huge caveats, but that implies anyway that the case numbers are actually falling. This happened in Massachusetts, for example, whereas cases started to come down, people began to loosen up in terms of the craze to get tested and so you ended up getting fewer and fewer people getting tested, which isn’t always a bad thing.|
|Dr. Michael Mina:||And this is really where we want to get, we want society to have such a low overall prevalence of disease and infections that we can actually, in an ideal world we would have no more infections and we’d be able to stop testing. Of course, we’re not getting there anytime soon, New Zealand was able get there although I presume they’re still testing. So when they’re both going down, it usually means that the cases are surely going down.|
|Dr. Michael Mina:||When testing is going up and the rate of new infections and the proportion positive are going down, it’s very difficult to tell if that’s just because testing is going up or because cases are actually going down and we’ve been trying to work on ways to decipher that in the research space now.|
|Jeff Schechtman:||Given all of that, what would the ideal testing scenario be? If you could wave your magic wand and say, “This is what I want to do with respect to testing,” what does that look like?|
|Dr. Michael Mina:||The status right now, the entirety of this epidemic, we keep trying to take diagnostic tests and use them for public health surveillance but diagnostic tests are limited, they are necessarily limited. They have to be extremely high quality in terms of their precision and accuracy for what they’re trying to get. They’re usually run in diagnostic laboratories because of that, so that means they literally have to get bottlenecked and funneled through doorways to get into a lab literally.|
|Dr. Michael Mina:||We’re starting to see distributed types of tests like Vidall and Abbott and BD and a few others and these are helping, but none of these are public, these aren’t helping at the level of public health. They are helping to just create more diagnostic tools. But what I’m proposing as a way to use testing to our advantage is a way not to just keep diagnosing people. Because diagnosing people doesn’t do much for public health good, it’ll actually stop the outbreak.|
|Dr. Michael Mina:||In the same way that we know that would anyone care if we could give you a vaccine that worked for two days, would we be running to get it? No, we would understand that a vaccine that only works for two days is not a useful vaccine. We would want a vaccine that works for a year or 10 years and that would be a useful vaccine. And so we keep trying to use these diagnostic tools that just tell us about what’s going on, in somebody’s life, once every couple of months when they may be get tested and it’s doing nothing to stop transmission chains.|
|Dr. Michael Mina:||And in fact, I would say that PCR using it as a diagnostic tool, not only tells us it offers very little for breaking transmission chains, but it actually is putting us down the wrong road because PCR remains positive long after somebody has been infected with the virus and transmitting the virus. It’s why the CDC comes out and says, “You don’t necessarily need a negative result to come out of quarantine after you’ve been positive, just wait 10 days,” because if most people wait until they’re actually negative on a PCR test, it could be weeks or months before they turn negative.|
|Dr. Michael Mina:||But we recognize that they’re not a danger to society after about 10 days because their transmissible period is done and they just have RNA that’s residing in their nasal pharynx. In the same way that people’s DNA is in their hair, if you find somebody’s piece of hair, it doesn’t mean the person is in front of you, it’s just their piece of hair. That’s the same thing that’s happening here. And so what I think we need to do is change the target. We need to not use PCR positivity status as our public health metric because what it means is that we’re contact tracing millions of people who don’t need to be contact traced because they were actually infectious weeks ago, we’re also quarantining millions of Americans for 10 or 14 days who haven’t been transmitting for weeks by the time they got their results.|
|Dr. Michael Mina:||And this isn’t even taking into account the fact that result times are still delayed. So what I would like to see happen is to start using testing out of the diagnostic realm and as a true public health tool to break transmission chains. In the same way that we know that masks can serve to decrease transmission, I want to use tests to decrease transmission. And the way to do that is to use cheap tests that are highly accurate to detect somebody at the moment they’re transmitting. But they don’t look accurate because we’re comparing them against PCR positivity which stays positive for so long after transmission.|
|Dr. Michael Mina:||So I want these tests that will tell somebody that they’re accurate, that they’re transmitting at the time that they’re transmitting and people can act on it because they’re getting immediate results. And I want them to take it every single day or every other day. And these can exist, there can be $1 a day tests. The government needs, we need a project work speed for these tests and the reason is we have put so much effort into vaccines and therapeutics and billions of dollars. We’ve put trillions of dollars in stimulus for the country, we have a workable solution today that if the federal government actually said, “We will put billions of dollars or a billion dollars into really pushing the technology for $1 paper strip tests, that can be printed in the millions…” Which they can be, “… and get a package of 50 in every American’s hands, over the next month.” Or not even every American, it could just be in Texas and Arizona and Florida right now because those are the states that are seeding infections to other states.|
|Dr. Michael Mina:||So really take all of this as a big public health umbrella approach. And if we can do that, if we can get a test that everyone wakes up, just like they put in their contact lenses, they take a test and if it turns positive, they stay home and they take a test the next day and they stay home until the test turns negative or for some set number of days, maybe seven days. And that’s it. That alone if everyone’s doing it, or even just a majority of people are doing it, then it will stop the vast majority of transmission and it will cause these outbreaks to disappear in a matter of weeks.|
|Dr. Michael Mina:||We don’t have to wait for a vaccine when we can essentially think of these as development of artificial herd immunity. We know that we don’t have to get a 100% vaccinated to stop transmission of this virus, we just need around 50 or 60%. The same thing goes here, but because they are tests that are giving people information about themselves, the holdup is that they’re defined as diagnostic tests. And as diagnostic tests, if you’re comparing them against PCR, they’re going to look bad and the FDA is not going to necessarily approve them for at-home use.|
|Dr. Michael Mina:||What I’m calling for is that there is a national movement to get these no longer defined as a diagnostic test but a public health tool in the same way that masks are public health tools, that checking somebody’s fever is a public health tool, it’s a screening mechanism for breaking transmission chains. And if we can get it outside of going through the CMS pipeline that puts them into the FDA and they become overseeing, for example, by CDC, maybe CDC comes out with some certification program for the tests to say, “This is a good test, this is not a good test for this use.”|
|Dr. Michael Mina:||We can truly build that up and if the federal government would create a project work speed surrounding this effort, we don’t need a vaccine tomorrow. We can buy ourselves potentially years of time before we need a vaccine. For one tenth of the recent stimulus, we could get one of these tests in everybody’s hand every single day for months or a year or so. And that would stop transmission. Doesn’t need to be a 100%, it just needs to be on to a lot of people.|
|Dr. Michael Mina:||And so there’s regulatory reasons why these aren’t out yet and it’s all surrounding just red tape, but we’re allowing red tape in this archaic view of what defines us. We don’t in this country have… We have so defunded and under-appreciated public health for so many years that we literally don’t have a recognition of the fact that there could be a test whose main goal is public health and not clinical medicine.|
|Dr. Michael Mina:||Everything is wrapped up in insurance reimbursements and FDA regulations as diagnostics that it takes a whole rethinking of what a test that somebody might use looks like and how it’s defined. And in this case, I want it defined as a public health tool that a state department of public health or the CDC can push forward and say, “This is just like a vaccine, how we’re going to deal with this epidemic.” And if we could do that, we could potentially have or greatly reduce or maybe by 90 or 95% reduce transmission in this country in the next few weeks, if everyone could have one of these tests tomorrow.|
|Dr. Michael Mina:||Of course, that’s not at the moment possible, but it could be if the federal government treated this with the same urgency that they’re treating a vaccine, which may or may not even work.|
|Jeff Schechtman:||In the larger framework of this, and this relates to the whole issue of regulation and FDA again, that was proposed by the Gates Foundation to do at-home swab testing. It seems that that had many of the same problems that the current testing scheme has, but even that couldn’t get approved.|
|Dr. Michael Mina:||I don’t see it as an alternative, all that we do is clog up our laboratories more. We turn it to have millions of Americans using at-home swabs that need to be sent into a laboratory or any centralized location. We already have two-week delays in some places. For getting results back, it would hamstring the whole diagnostic effort. And this is why we really need to figure out how to distribute these types of tests, get them out of the laboratory and preserve the laboratory space and the laboratory environment for true diagnostics.|
|Dr. Michael Mina:||If somebody is at the doctor’s office or the hospital because they are sick, they need a result back quickly and we have to separate these two ideas. Now, if there was some new technology that came out to really be able to massively take in millions and millions and millions of samples into a centralized lab that could work, but still one of the only reasons that this approach is really working that I’m suggesting is because it gives you real time information.|
|Dr. Michael Mina:||And so that initial effort to have home swabs, which we’re still pushing for various reasons but that was, again, just part of this overall thinking of trying to fit a square peg in a round hole, trying to get co-op diagnostics for public health surveillance and we’ve never dealt with such a dire situation diagnostically or testing-wise as we are currently that we just don’t have the capacity. We can’t build a capacity to do a 100 million tests a day in our laboratories in the United States.|
|Dr. Michael Mina:||I think though, that was devastating to see that come crashing to a halt and that was wrapped up in FDA and it frustrates me to no end when I’ve talked to senators, I’ve talked to people close to the White House, I’ve talked to congressmen, I’ve talked to heads of states of major countries and everyone says, “Why aren’t you doing this already?” My answer is literally that it is illegal to do this right now.|
|Dr. Michael Mina:||I mean, it’s insane that this is something that could stop outbreaks and epidemics as a public health tool and there is no clear path to legally introduce these tests without the companies making them getting shut down because they’re being viewed as a diagnostic and because they’re being viewed as a diagnostic using fairly archaic metrics to what is the approval metric to achieve. It’s a problem and it pains me to say that we have a tool that the federal government could build, that companies alone could build as needed, but I don’t think they should all fall on three-person companies or 10-person companies but it’s illegal. It’s crazy, it’s illegal to save lives right now. And it’s simplifying it a little bit, but that’s pretty much the message.|
|Jeff Schechtman:||With respect to these paper tests that you’re talking about, how good are they? What’s the quality of them? What’s the accuracy of them? And is it realistically something that could be developed that fast? What is the status of the manufacturing of these at this point?|
|Dr. Michael Mina:||Yeah, so I’ll answer that in two different ways. So the first, the status is these tests do exist, they are in clinical trials, they exist in paper format, I have some here at my house and that we were testing in a laboratory. And so they exist right now, even a small company could build a million of them this week and that’s a small company. So they actually exist but I get this question a lot, “What is the status? How good are they and everything?” And this isn’t any offense to the question or to you or anything, I’m tired of that question being asked because what I would like to be asked is, “Does the technology exist?” The answer to that would be a clear yes.|
|Dr. Michael Mina:||“What should the federal government be doing to ensure that they create a federal response to produce these?” The tests exist but truly some of the companies that I’m talking to are three-person companies. And the fact that we’re even talking about a product that could potentially change the course of this pandemic, that we’re talking about a company that’s comprised of three people is ridiculous.|
|Dr. Michael Mina:||The government should be recognizing the potential for these tools as a core technology and should be enlisting the full might of the NIH and the same way that the NIH has the vaccine research center. And they should be pushing on the major manufacturers, whether it’s diagnostic manufacturers or companies like 3M who and I know 3M is potentially working on it, but they got a measly $500,000 from the government. That should have been a $5 billion investment from the government to ensure that 3M can produce these tests at scale.|
|Dr. Michael Mina:||And so the question shouldn’t be, where are we at and what can we do, the question should be, where can we be in three weeks if the government right now put $2 billion into it? And that’s what I would like to answer and if you asked me that, I would say, “If the government right now put a billion or $2 billion into even just getting out of any of the individual companies but just bringing these companies together, bringing the best minds in the country or the world together, to sit in a room for a month and figure out the optimal tests, get structural biologists, get whoever needs to be there to figure out how to make these tests as optimal as possible and then just start producing them.”|
|Dr. Michael Mina:||And the reason why it’s doable is because unlike a vaccine, this isn’t a tough technology to build, we’re pretty much there. We have workable tools, but we could optimize them even more and get the cost per test down even more. If it wasn’t a three-person company, but it was a massive company that has economy of scale. You could maybe build these tests at a reagent cost of 50 cents a piece or less. I mean, I think that they can get down to pennies in reality when we think of the true material cost.|
|Dr. Michael Mina:||And so if they’re being produced in the tens or hundreds of millions, then everything changes. But we’re treating it as though this is just business as usual, we’re going to let the free market reign, we’re going to let capitalistic pressures and forces work and hopefully the first three- or ten-person company will rise to the top. It’s really insane when I think about it.|
|Jeff Schechtman:||What does the middle path look like? What if the government did nothing with respect to trying to get these manufactured, but there was regulatory approval of them? How fast could they be produced then? Is it realistic without the government support of actually manufacturing these tests?|
|Dr. Michael Mina:||Yep. I think they can start producing them with small companies and small manufacturing plants, they could start producing a million a week, if they go to slightly larger manufacturing plants, if the regulatory hurdles were completely gone and the buyers were there, which I think they would be, they could find the manufacturing to go to 10 million a week. And these are still without the big guns coming in and participating. And so these are truly scalable solutions.|
|Jeff Schechtman:||You and your colleagues have been talking about this idea of rapid tests for a little while now, it’s gotten some traction, it’s gotten some media coverage, has there been any movement either with respect to regulatory agencies or anywhere within Washington at this point with respect to finding a way to move forward in all aspects of this?|
|Dr. Michael Mina:||So there’s been a lot of movement, I would say. I think that there’s a groundswell of support, people are seeing that frankly there aren’t… I don’t think of this as a last-ditch effort, I think of this as a very reasonable, simple effort and one that is just so, it’s dead simple, it just makes sense. And so I think that that is leading to a groundswell of support at the federal level and a lot of senators have called me up and signed on and said, “How can I help? Who can I talk to?” Governors, I hosted a pretty large round table meeting just yesterday with the mayors of some of America’s major cities, as well as leading scientists on this issue.|
|Dr. Michael Mina:||And with all of this external support that we’re seeing, it’s clear that people are catching on. The problem is, I would say that we have seen very little movement overall. We had a meeting with CMS the other day and I would say that the meeting was pretty… It did not evoke a sense of urgency at the end, it ended as many meetings do with, “Okay, well, great to talk to you.” And FDA has shown little willingness or interest to move. And I can’t tell, I think what’s happening is FDA truly doesn’t… I want to get this out of FDA’s domain altogether, they are not an entity that is charged even with evaluating public health tools, they’re charged with evaluating diagnostic tools.|
|Dr. Michael Mina:||So until we can get this re-designated as a public health tool, in some ways I’ve been a little bit unfair to the FDA because I’m asking them to change their view. And it’s like asking a physician to treat patients with the mindset of the public health alone and this is a constant tension that exists in medicine and public health and they’re not always completely in line.|
|Dr. Michael Mina:||And so I think where we need to start is we need to have… I think frankly it needs to be something at the CMS level where CMS decides that there’s a different pathway that these can be not under CMS and CLIA regulations and then they don’t have to go to FDA. The other option which I think really needs to happen is Jared Kushner and the White House Administration are aware of this and I think that it needs to be potentially a process that’s promoted at that level to really change the course of this epidemic.|
|Dr. Michael Mina:||But otherwise I think we’re just stuck in this limbo where there’s nobody really feels that this is their problem. That these tests fall under their jurisdiction. And that’s what’s just infuriating.|
|Jeff Schechtman:||Even if this test can be manufactured at the scale where everyone would have one, talk a little bit about the advantage to being able to use them in nursing homes and long-term care facilities and schools, et cetera.|
|Dr. Michael Mina:||Yeah. I think that if we can use them every day, I think that they are an incredible boon. And the important thing to recognize here is I’m not saying we should get rid of anything else that’s already happening. I’m just saying we have another very strong layer of detection to know who is or is not a risk of bringing a virus into a place like a nursing home, into a place like a school and in so doing, dropping a potential community level transmission at the same time.|
|Dr. Michael Mina:||And so I think that these, if we can get every single staff member in a nursing home to be using one of these every day before they enter, it will at least do an immense job at cutting out potential avenues and sources of new exposures and entries of this virus into these facilities. I would not say, and a lot of people get confused and they say, “No, well, if you’re going to do that, how can you ensure that everyone’s is going to work perfect?” It’s not going to work perfect, but we have to look at what we’re doing now, I’m not saying to change anything else that we’re doing currently, but we have to look at what is happening today, which is nothing.|
|Dr. Michael Mina:||We essentially have no public health surveillance that’s actually useful to stop transmission chains. My best estimate on what the sensitivity of our current surveillance system of testing, which is costing millions of dollars and is just clogging up diagnostic testing, we probably catch in this country less than 3% of people in time to make a difference in their transmission patterns.|
|Dr. Michael Mina:||Less than 3% is our current sensitivity and so anything at this point is going to be hugely beneficial and I’m suggesting that we just change it, I’m not suggesting that these will be a 100%, but compared to 3% and I could talk about the math because it’s not hyperbole, less than 3% if we can bring that up to 50%, that would be a huge gain for us. And that alone could serve to stop the outbreaks that are happening in Texas, in Florida, California, but at the moment a 3% sensitivity with PCR to catch people when they’re infectious, is not going to cut it for any purpose.|
|Jeff Schechtman:||Explain for us what happened with the testing of Ohio Governor Dewine. He had a positive test then a negative test, I think people were confused by it and I think that it casts a certain confusion over this whole idea of instant testing versus the PCR testing.|
|Dr. Michael Mina:||Sure. This is not laboratory-based diagnostics, as well as these rapid diagnostics are never a 100%. Unfortunately the fact that this is making headlines, it just shows how sensationalized this has all been. And this is a very common problem, it’s a very common effect of testing people, especially when we get into testing people a lot when they have low of what we call pretest probability of being infected.|
|Dr. Michael Mina:||You run into the issue of having potential false positives, this is the same with HIV. This is not a big problem though overall and I’ll get to that, but with HIV right now, when you have a low prevalence of HIV meaning that in general pregnant women, we screen them for HIV. Many of them have a very low pretest probability for being infected and as many as half in a place like Massachusetts for example, of the positive screens that we get are false positives.|
|Dr. Michael Mina:||This is common and we have a very simple solution and that’s that we have an immediate reflex to a confirmatory test. And we have what we call two different types of tests that are orthogonal. And what I mean by that, is you have one test that looks for one type of material and differences. For example, one piece of the virus and another test that looks for a different piece of the virus and that can be used as confirmatory. And we do this all the time in laboratory diagnostics all the time. This is a very common theme.|
|Dr. Michael Mina:||And what happened with the governor is the system frankly worked as it should have, and it would have been quicker and wouldn’t have been any issue if the confirmatory test was available right then and there, but it wasn’t in his case and it’s not because we don’t have wide scale testing available, every day for everyone at this point in time. But what happened was exactly what we would expect to happen, was he got a false positive and sure it threw off some of his plans and because he’s a governor going to visit Trump, it made the news. But at the end of the day, it just caused him a few hours of annoyance and he got his confirmatory test and it came back negative.|
|Dr. Michael Mina:||And that’s a whole lot better than if we weren’t testing him at all and he was positive and he went in and infected a lot of people. And so this is a common theme and what my solution for these rapid tests would be is that, if the feds or other people are producing with every box of 50 tests that somebody buys for 40 or 50 bucks, you get a test that’s going to last you two months or you get a box of tests that will last you two months and with every set of 50, you have five additional tests that are orthogonal, they’re also a dollar a piece to make.|
|Dr. Michael Mina:||And so there’s very simple solutions to these issues that just aren’t being discussed because frankly most people who are discussing these problems are not laboratory medicine doctors who do this. The whole… It’s the media, it’s scientists, it’s everyone has generally allowed everyone to have similar levels of voices. And so we have all of these people who are complaining about things who don’t normally deal with infectious disease diagnostics, but if you talk to infectious disease diagnostic physicians, they’ll say, “This is a common problem, not to worry.” In the same way that immunology, you really talked to good immunologists, you know what they’re talking about? They’ll say, “Waning antibodies aren’t unexpected.”|
|Dr. Michael Mina:||And so I just think the fact that this made headlines is beyond frustrating to me because the system ended up working as it should. And instead what it did was is a knock again against a rapid test that could be lifesaving, but at the end of the day, we saw that it worked well and okay, so the governor didn’t fly to see Trump, so be it. The alternative of doing no testing on him, if the rapid test wasn’t available and he was infected, it could have been much worse. I think we always have to keep that in mind.|
|Jeff Schechtman:||Michael, we already have these antigen tests that are being sent out as we touched on before to nursing homes and long-term care facilities. Is that enough if we don’t do anything beyond that, is that helpful? Is that enough?|
|Dr. Michael Mina:||Yeah. So they are being rolled out, these antigen tests that are being rolled out, won’t be enough to test everyone every day, for example. There’s been a lot of news and a lot of discussion about these antigen tests being introduced and including the six governor pack a couple of days ago led by Maryland to purchase 3 million tests collectively, 5,000 per state. These are still fairly expensive and low throughput, not low throughput but each test still needs to go through a machine, then well, many of these machines are hundreds of thousands of dollars.|
|Dr. Michael Mina:||And so the tests that are being approved and used today are not quite the same tests that I’m referring to. I put them in two different camps, one of them, I put these sort of rapid tests into two bins. I would say that the tests that are being deployed now are like the Nespresso machine models. These are tests that require instrumentation, they require… And they’re like duloxetine Nespresso machines. There’ll be a big startup cost to get it going and then each individual test will be expensive and so relative to what I really want are the instant coffee versions where a cup of coffee using instant coffee as pennies versus a dollar for and just scale as appropriately. I wanted $1 thing versus a $20 thing per test.|
|Dr. Michael Mina:||And the other bit is that the antigen tests that are being distributed to all the nursing homes, they’re just not going to, because they’re more highly manufactured. They will have a difficult time getting the scale to where it really needs to be to make an impact on population level. For the nursing homes that can get them and get enough tests in so that they can test all the staff members before they come in each day, it will be game changing for that nursing home.|
|Dr. Michael Mina:||So I am not at all knocking that effort. I think it is what we need to be doing right now until we get this instant coffee version or even in addition to when we get this instant coffee version, cheap point of care at-home test for everyone. We need to be trying as much as we can to focus the testing where it’s going to be most effective at saving people’s lives and that would be nursing homes in this case. And these are very good solutions, they will go a long way to stopping transmission if a nursing home is asking every staff member to test themselves, even if it’s not every day, if it’s every other day then it’s like wearing seat belts.|
|Dr. Michael Mina:||If you wear your seat belt most of the time, then most of the time you’ll have some added protection but not wearing it one day doesn’t mean that all the days you do work on countenance. It’s similar here that this is a risk mitigation strategy and this is an important one that you’re asking about.|
|Jeff Schechtman:||You’ve talked a lot about the FDA and regulations. There was a report a couple of weeks ago that the FDA was looking at these rapid at-home tests that there was some light it seems in terms of loosening up the regulations for these, where does that stand? What was that all about?|
|Dr. Michael Mina:||Yeah. So I was initially excited and then taken aback by it. Essentially it was one step forward and that the FDA came out and said, “We are providing you with a template and we’ve heard your cries, we want to open a pathway to getting rapid at-home over the counter tests to become available.” And so that was the step forward that they actually put the idea out there or they put the template out there to suggest how it might work. When you then go and read what they have in the template in terms of the metrics they will be looking for, pretty much what they have done is taken five steps backwards towards the use of these as a public health tool.|
|Dr. Michael Mina:||And that’s because there’s two major criteria, they are still asking for it to be 90% as sensitive as PCR based diagnostics, which as I first said when we started this conversation, we have to change this message, we have to get the point across even to scientists and the FDA and the CDC aren’t completely aware of this issue, which is that we can’t expect an antigen test to meet that criteria because most PCR positive results in much of this country are representing RNA positive samples with no live virus in them anymore.|
|Dr. Michael Mina:||And so the requirement of 90% sensitivity against PCR doesn’t add up. It needs to be a different metric. We need to stay 90% sensitivity to detect people and they’re transmissible. What I would like to do though, is get out of all of that and say, “This is a public health tool and heck for public health. If it means we could even just catch 50% of people that are transmissible, we would immediately drop incidents across the whole population and that makes everyone safer.”|
|Dr. Michael Mina:||So the requirement for this 90% sensitivity was one knock on it. The other big one was, they said, “We expect that any test that is used by anyone, that the tests will come with some mechanism to report to the departments of public health the result of that test, negative or positive.” So that immediately takes away, imagine how much a pregnancy test would cost if it had to be connected to the department of health, it’d have to come with a wifi signal and all this stuff and it would have to be a Nespresso machine model.|
|Dr. Michael Mina:||So you can’t have a paper strip test and still have the expectation that there’s going to be some direct way for it to connect to the department of health. It’s essentially asking these diagnostic companies which are already small and over stretched to become software companies as well. So maybe some third parties can get involved and collaborate, but it adds months to the effort of getting these things out and we need them today.|
|Dr. Michael Mina:||It’s a tool that can stop infections today. It would be like saying we can’t use the vaccines unless the vaccines had a little code on them that could ensure that we know exactly who’s getting vaccinated when and maybe that will happen because we’ll have healthcare administrators or healthcare personnel administering the vaccines, so it’s a little different but we wouldn’t hold up the vaccine program because of that and we shouldn’t be holding up these tests because of that.|
|Jeff Schechtman:||You and some of your colleagues have been calling for these tests since back in March or April. Why hasn’t there been more action on it when it seems so obvious that this could have such huge advantages.|
|Dr. Michael Mina:||I am hopeful that the groundswell of support that we’ve seen from people who have federal voices in the Senate and then were getting conversations with the NIH and the FDA and CMS and actually not the FDA, unfortunately CMS and the White House and Congress, Senate. We are making some headway and having these conversations and I think it just takes explanation. I take some responsibility for this because one of the first ways that I started talking about this was calling low sensitivity. I even called them crappy tests and that unfortunately got picked up, but I’ve changed the way that… I’ve decided that there needs to be a different way to call these. And this isn’t just me changing my… These are not necessarily low sensitivity, they’re low analytical sensitivity compared to PCR, RNA, but these are high sensitivity, you could call them more accurate tests for knowing when somebody is infectious.|
|Dr. Michael Mina:||And I would just say, it doesn’t make as good headlines as saying Harvard professor calls for crappy tests to save the world or whatever, but it does change the narrative. And I think that if we can start calling these high sensitivity, high accuracy to detect transmissible people or to detect highly transmissible people tests, that’s something that politicians can get behind and really push.|
|Dr. Michael Mina:||And if that type of mindset and labeling of these, that message can start getting across that these are public health tools, they’re accurate tools and powerful tools to detect people who are transmitting and they will break transmission chains. And we forget about how well they work as diagnostic purposes because they are different things, then all of a sudden they become very powerful and the public message really can change around them.|
|Jeff Schechtman:||Given the issue of the FDA regulations, all of the things that we’ve talked about, why aren’t we seeing this moving forward in other countries? Why aren’t we seeing this moving forward in other countries, or are we, or other countries taking a look at this and what might we learn from that experience if they are?|
|Dr. Michael Mina:||So the idea is fairly new in terms of using these daily for everyone to, as a public health metric, but in the last couple of months, yes, there have been, I think Senegal is starting to trial them. I’ve been personally talking with the heads of numerous countries in different parts of the world to essentially bring the companies together that can produce them, to have them start to be rolled out in other countries. And I would love for them to be rolled out in the United States, they’re being developed and invented in the United States.|
|Dr. Michael Mina:||The reason that other countries aren’t quite there yet is there is some reliance in some ways on the companies that are producing them in the US to… The companies that are producing them in the US don’t currently have a huge incentive to go to market with them at the moment just because they’re usually looking at the US market. As things are progressing, there is a lot of discussion at this point about how to roll these out in other countries and there’s been a tremendous interest from the heads of states of other countries that I’ve spoken with as high as they go.|
|Dr. Michael Mina:||And so I do believe that we should expect to see some of these companies start to be manufacturing them to be exported pretty soon. Other countries, I was just talking to somebody on the other side of the world, I won’t say the country, but they’re just laughing at how complicated the US system has gotten that we can’t find our way around this problem. And again, it’s because we’ve undervalued public health for so long that we truly don’t have a language even at the regulatory level to know where these tools for public health fit.|
|Dr. Michael Mina:||There is no regulatory body surrounding public health biological tools like this. And so other countries are wondering what the heck we’re doing over here and not getting our act together to use these things and they’re saying, “Okay, well, we’ll take them.” And I think that’s what I’m not involved day to day with it, but I’m putting them all in touch with the companies to hopefully get them manufactured and sent over.|
|Jeff Schechtman:||Dr. Mina, I want to thank you for your time, for your thoughts and really for showing us another possible way to deal with the crisis that we’re all dealing with today.|
|Dr. Michael Mina:||These are our hope. We don’t have a vaccine tomorrow, we don’t have anything but shutting down the economy tomorrow and keeping schools closed. This can work and I just hope that it gets across to the people who it needs to get across to. And this is a tool that tomorrow could start to go into production and within a few weeks time could start to change the whole course of outbreaks in major cities in America and in so doing make all of the United States safer. We can’t realistically open up schools and colleges the way we would want to because there are cases burning and outbreaks burning across the country.|
|Dr. Michael Mina:||We’re a connected country and we need to figure out how to get these outbreaks under control and this is a solution. And we have the power to actually turn it into the solution vaccines, we can’t speed up very much therapeutics, we can’t speed up very much. This is something we could actually do at work speed and make it happen. And I want to really push that message.|
|Jeff Schechtman:||Thank you and thank you for spending time with us here on the WhoWhatWhy podcast. And thank you for listening and for joining us here on radio WhoWhatWhy. I hope you join us next week for another radio WhoWhatWhy podcast. I’m Jeff Schechtman. If you like this podcast, please feel free to share and help others find it by rating and reviewing it on iTunes. You can also support this podcast and all the work we do by going to whowhatwhy.org/donate.|
Related front page panorama photo credit: Adapted by WhoWhatWhy from Navy Medicine / Flickr.
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