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COVID-19 Update: Newswise Live Expert Panel
3D Printing life-saving equipment, the latest drug trials to fight the coronavirus, taking education virtual during social distancing, political and economic impacts of the COVID-19 crisis, and keeping physically active in self-issolation.
This Newswise Live Virtual Press Conference invites media to ask our Expert Panel their questions about the COVID-19 pandemic and the effects on all aspects of daily life around the world. Panelists include experts from institutions such as University of Arizona, Texas A&M, University of Rhode Island.
- Raymond L. Woosley MD, PhD - Co-Director, Division of Clinical Data Analytics and Decision Support - University of Arizona
- Michael Moreno - Assistant Professor, Director of Innovation for Engineering Medicine - Texas A&M
- Deborah Riebe - Professor, Associate Dean of College of Health Sciences - The University of Rhode Island
- Ronald Fricker - Associate Dean for Faculty Affairs and Administration - Virginia Tech
When: April 16, 2:00PM EDT
Where: Newswise Live event space on Zoom - https://newswiselive.zoom.us/j/7459578068
This live event will also be recorded and transcribed for use by media and communicators after it is concluded.
The transcript of this expert panel is available below.
THOM: Welcome to this Newswise Live virtual press conference. We have with us a panel of experts from different institutions and different areas of expertise related to the COVID-19 pandemic and aspects that are affecting daily life, as well as medicine and science behind fighting the crisis. Here we have Raymon Woosley who is Codirector of the Division of Clinical Data Analytics and Decision Support at the University of Arizona. We have Michael Moreno, he is Assistant Professor and Director of Innovation for Engineering Medicine at Texa A&M. We also have Deborah Riebe, Professor and Associate Dean of the College of Health Sciences at the University of Rhode Island. And we have Ronald Fricker, Associate Dean at Virginia Tech for Faculty Affairs and Administration. Thank you all to the experts for joining us, and to start with, Dr. Woosley, I have a few questions for you about testing some of the drugs that are being reported to possibly have effectiveness against the coronavirus and ask you if you can explain what are the issues with hydroxychloroquine and azithromycin, these are the two drugs that have been getting a lot of coverage, but there are often great risks involved in that, and you’ve studied that extensively. What can you tell us about that, Dr. Woosley?
- WOOSLEY: Thank you, Thom. These drugs have been available for decades, almost. We know a great deal about them. A lot of people are confused because they think they’ve been approved by the FDA, which means that they’re safe. But that doesn’t acknowledge the fact that they’re safe and effective when used as directed. Maybe to give you a little bit of background about why that’s important, in the 80’s we became aware that a lot of drugs were causing sudden death and arrhythmias and these drugs, hydroxychloroquine, chloroquine and azithromycin, are all in that category. About 14 drugs were removed from the market because they caused this, thankfully rare, cardiac arrhythmia and sudden death. But they were taken off the market because those effects were either more common or couldn’t be prevented. Drugs like hydroxychloroquine, chloroquine and azithromycin have medical value and needed to be kept on the market. So, the package insert for those drugs includes warnings that effects can occur and gives advice to doctors on what makes some people more likely to develop these problems. So, we know that if you have heart disease, if you have certain risk factors, in fact, being a woman doubles your risk, if your potassium is low, if you have low oxygen in your blood, these drugs are much more dangerous and much more likely to cause arrhythmias. Well, these are exactly the kind of patients that COVID patients are. So, the very sickest COVID patients are those at most risk for these life-threatening arrhythmias and cardiac effects, and that’s why it’s so important that we look carefully at how they’re going to be used, and what’s the benefit from that use. And right now we can only say that there is laboratory benefit, or evidence in the laboratory that they could be effective, but we do not have the evidence that we would like that they are effective for treatment of COVID in these very sick patients. So, that’s why we’ve encouraged everybody who wants to treat someone with those drugs to do so under a protocol. Now, we recognize that’s not always possible and there may be life-threatening situations when people would want to use them, and in that setting it’s just important to know that these effects can occur, be aware of them, monitor for them, and treat them appropriately if they do occur.
THOM: You mentioned some of the risk groups and in your opinion those are a high concentration of the patients being treated for COVID-19. With that in mind, what kinds of precautions need to be taken before prescribing these medications for those high risk types of patients? And also, what otherwise healthy people need to be aware of for potential risk factors, and for example, contraindications with other medications?
- WOOSLEY: Very good questions. The best source of advice on this comes from the FDA’s Emergency Use Authorization document, which has all of these adverse effects laid out and makes recommendations for how to treat a patient if the doctors choose to do so. The American College of Cardiology has issued advisories, so all the Cardiology community and the FDA recommend that if you’re treating a patient with COVID and it’s in this high-risk population, they should really be in the hospital and on a cardiac monitor. There are certain tests that ought to be done before and during the treatment. Now, unfortunately a lot of people have taken the hope that has been expressed about these drugs and said, well, I want to take them, or I want somebody to give them to me to prevent COVID. And there is absolutely no evidence that that is likely to occur. And then you only have the risk, which in a healthy walking around patient, like someone with arthritis might be, these drugs are generally safe and these side effects are rare, but they do occur. And we do not, and most people do not recommend that they be taken for prevention or prophylaxis at all.
THOM: Great, thank you so much. We have a question from one of our attendees; Dan Keller asks, these drugs and probably others are being used off label, so under an EUA, and if you could explain what an EUA is, that would be great, can the FDA require that all patients be entered into some kind of registry so that at least some data on the safety and efficacy can be collected?
- WOOSLEY: A very good question. An EUA is that Emergency Use Authorization that I mentioned earlier, that the FDA acknowledged that some people may need to be treated and they approved the use under certain circumstances, and they did not approve those drugs as safe or effective, they simply said they’re approved to be used under these circumstances, which were hospitalization, careful monitoring, watch for drug interaction, and only for adults or adolescents. So, they could have recommended everybody go into a trial, they could have recommended the creation of a registry, but that has not been done yet.
THOM: Great, thank you. If anyone else has questions for Dr. Woosley, please do chat those to us. I want to go ahead and move on to Dr. Fricker from Virginia Tech, and ask Dr. Fricker if you could tell us a little bit about the statistics and the modeling of pandemics, and how unprecedented this COVID-19 pandemic is. Why is it so uniquely challenging to model these statistics and make predictions considering factors that we’ve heard about already, like the long asymptomatic or completely asymptomatic cases, other things like infectious period before showing any symptoms in those that do show symptoms, how do these things make your job harder to figure out what these statistics mean?
- FRICKER: Thanks, Thom. Maybe before we talk about COVID-19 in particular, just modeling in general. There are a couple of quotes to help us understand and illuminate the challenges of modeling. The first one is often attributed to Yogi Berra, and he says prediction is difficult, especially about the future. So, just the notion of predicting from models is a challenging effort, never mind the challenges associated with COVID-19. The other quote is from George Box, a famous statistician, and he says all models are wrong, but some are useful. And the notion is that modeling is an inherently sort of reductive exercise. We’re trying to capture the main features of some phenomenon in a mathematical model, and in so doing you have to leave out details and you have to summarize, but you hope when you’re done with that you can have a model that captures the basic idea of the phenomenon and is useful for decision making. So, in this case, we’re trying to model, if you will, the spread of the disease, let’s say, through the population and a key point is it’s a mathematical model by which we’re trying to parameterize, we’re trying to use data to inform the model to make the predictions, and there’s a lot we just don’t know about COVID-19, and you’ve named some of them. So, because we haven’t tested widely, we actually don’t really know the prevalence of the disease in the population. That’s a key parameter for a model to understand how much that it is going to spread, how much the disease will spread. We don’t really understand how and when people, when they’re asymptomatic, how much they can spread the disease. We have some ideas, I’ve heard estimates anywhere from 25% of the population with COVID-19 is asymptomatic and infectious. But we don’t have a really good idea about that. And then just how long can someone be infectious and spread it? So, without knowing those things exactly, that means that the different models are going to result in different projections. Add on top of that the fact that there are different types of models. Still a common type of model is the SIR model, Susceptible, Infected and Recovered. There are other kinds of parametric models like the IHME model we’ve heard about fairly frequently at the COVID briefings. All those models are different and therefore just in their inherent difference, result in different predictions. So, all those things are actually a challenge to do. The key thing we hope is to look to the suite of models, and across those models get some idea of what’s likely to happen.
THOM: So, with all those complications taken into consideration, what is your opinion about how this reinforces efforts of social distancing or other interventions like these stay at home orders and shelter in place, and things like that.
- FRICKER: Well, I think the key thing to know is that probably the one tool in our arsenal right now for combating COVID-19 is to stay at home until a vaccine is developed or until the virus itself runs its course through the population. Obviously we don’t hope that happens, but that is kind of the one tool, is social distancing. I think a key point from a modeling perspective is models are typically based on historical data which is what we have done up until this point in time in terms of policy, in terms of intervention. Going forward, we probably will want to change those as we go forward; either ease social distancing or perhaps strengthen it, perhaps we get a vaccine, and the interaction of those policy recommendations of the model is also a challenge and a big unknown.
THOM: So, with that taken into consideration, which models do you think are effective at predicting these things or at least giving some useful information, as you said? Or should we be looking at some kind of amalgamation of those models?
- FRICKER: Both. I think there are some informative models, but typically I recommend looking at an amalgamation or a suite of models, a suite of outcomes, because each model characterizes the future in a slightly different way. So, understanding what all those different futures might be, I think is helpful, from a range of things that are maybe optimistic, that we hope social distancing works well, we hope the vaccine comes online soon, to more pessimistic, things don’t work quite as well as we like. And so you can get a range of these sort of future scenarios and use those in your personal decision making or perhaps for policy makers in policy decision making.
THOM: Great, thank you so much, and we actually have a question from your colleague, Dr. Woosley, he would like to ask, how dependent are models on the testing data?
- FRICKER: Thank you, Dr. Woosley, you teed me right up, it’s incredibly dependent, and maybe I didn’t stress this enough; what’s really unknown is prevalence in the population of disease, the only way to know that is for widespread testing. Right now what we really know is among those who were sick enough to go to an emergency room with the right characteristics, they can get a test. So, we know among the sickest of us who is getting tests and what the results are, we don’t know the general prevalence of the population. That’s perhaps the key parameter in a model.
THOM: Great, thank you so much, Dr. Fricker. I’d like to go ahead next to Dr. Moreno. We’ve gotten some questions in the chat that we’re going to come back to Dr. Woosley for shortly, but I want to talk to Dr. Moreno and Dr. Riebe for a moment before we do that. Dr. Moreno, as a biomechanical engineer and working in the department there at Texas A&M of Engineering Medicine? Is that correct?
- MORENO: Engineering Medicine is actually a program that’s a collaboration between the College of Engineering, the College of Medicine and Texas A&M, and Houston Methodist Hospital in Houston, the Texas Medical Center.
THOM: Tell us about your views on how engineers are brought into that environment, working side by side with clinicians to come up with innovative solutions to a lot of unprecedented problems, and what are some examples that can help us understand that as kind of background? And then of course there are some great examples dealing with this COVID pandemic that you guys have worked on.
- MORENO: Sure, I’ll just start by describing, because I think it addresses much of what you’re asking, the ENMED program itself, so, Engineering Medicine, this ENMED program that I told you about, this kind of tripartite collaboration, it’s got two primary components. So, one is this research component, where as you said we’re trying to connect engineers with clinicians to solve medical problems or problems with medical technologies. The other part of this is a medical school program where you have students that have undergraduate degrees in engineering or maybe computer sciences, technical degrees, that want to go into medicine. So, what they can do through the ENMED program is get a degree in medicine but also a graduate degree in engineering in just four years. And so you might ask, how do you do that? Because most people who do a MD/PhD or an MD with a master’s in engineering have to take additional years. And the way we do that is through blending the curriculum. We blend the engineering and medicine curriculum together. So, we can view the body as an engineered system, or for example, when we’re talking about respiratory therapies or respiratory physiology on the medicine side, we might talk about technologies to diagnose, treat, monitor patients that have respiratory illness. So, we’re going this kind of simultaneously. The other thing about it, the engineering itself is actually focused on design, innovation, and translation of medical technologies. So, students in this program are learning about different ways to prototype medical technologies, regulatory pathway concerns, how you get funding, even, so there is a little bit of an entrepreneurial element to this as well. The idea here is that I’ve actually worked with doctors, I set up a research lab with the Department of Orthopedics at a hospital that was local, and we would have weekly research meetings. So, I’ll give you an example that really kind of describes the importance of training this kind of “physicianeer” as we call them, who have this background in engineering, but are practicing medicine. So, we were having these weekly research meetings and the department head comes in one day and says, hey, we’ve got somebody here who wants to talk to the doctors, do you mind if he presents to everybody here before we start the meeting? And I said sure. He comes in, and he starts talking about ACL repair, ACL is the ligament that kind of holds your knee together, and he’s talking to these orthopedic surgeons, and he says you know how when you have to drill through the bottom bone of your leg, the tibia, and you’ve got to come in and then hit the femur, so that you can pull this repair for the ACL, you can never get that drill to go right where you want it when you’re coming into this upper bone of your leg, and you could see all the surgeons kind of nodding their heads, and he says, well, check out our drill, and he comes through, and he just kind of bends his finger, and he’s basically describing how he can steer the drill. And, of course, all their eyes get wide open and as soon as the guy leaves the room, they tell the department head, we want that device, we need that device. So, whenever they’re done, I’m basically going, guys, you’ve been at a table with an engineer for two years and you never told me that was a problem. But that’s the way a lot of the clinicians who don’t have a background in engineering are thinking. They’re thinking that this is just the way it is. And so they’re providing suboptimal care, they’re not able to treat the patients in the way that they want to, and they just accept it that way. But people coming through our medical program aren’t going to think like that. They have a background in engineering, and when they encounter problems like that, they’re going to be, oh, there’s got to be a better way, and they’re going to design solutions for those kinds of problems. So, that’s kind of the medical school element. Then me, myself, as just an engineer, who does not have a degree in medicine, well, how do I connect? Well, I just talk with people on the front line. I talk to the doctors and ask them. My first patent came as a graduate student from talking to a cardiac surgeon who was telling me about a problem that he was encountering with a vascular device. I think that’s kind of the key take home here. Whenever this started to take effect, I opened my line of communication with the people down in the hospitals that I had been associated with anyway, and the thing that was really interesting in talking to them is I think everyone anticipated that there was going to be a shortage of masks, there was going to be a shortage of ventilators, but these things started emerging, these other things that were not anticipated. And so the first one was they wanted to treat patients with metered dose inhalers instead of using nebulizers, because nebulizers might aerosolize the disease, so it’s not a safe way to do it. So, now I’m talking about patients...
THOM: I’ll go ahead and share an image of that for you, while you describe this, Doctor.
- MORENO: Okay, there you go. So, you can see the metered dose inhaler there is kind of the greenish-blue teal colored device there, and then the diffuser, the spacer, is the white thing that we attach to that. So, basically if you’re somebody who is an asthmatic, and this resonated with me because I am, so I’ve used these devices my whole life, I don’t really need the spacer or diffuser, because I can synchronize my inhalation with triggering the device. But people that aren’t familiar with them cannot synchronize that. So these make this really a lot easier to use. And so that’s one thing we’ve done with them. The other thing that we’ve done, as we kind of solved this problem with the shortage of the spacers, they started saying well now the problem is that we’re going to run into a shortage with the inhalers. The inhalers have 200 doses on them, which is more than you need if you’re a COVID patient, so they started wondering, is there some way we can use one inhaler for multiple patients? And so we started making adapters for these spacers that you can build in, these are valves that you can put on each end of this, and so now you can load the spacer up with the inhaler, with the doses that you want to deliver to the patient, so you load it up and then hand this to the patient, so this never comes in contact with the patient or anything that the patient comes in contact with, because these, after the patient uses it, can be removed and sterilized, if you want to reuse them again. So, the thing that I’m seeing is now that we’re having this shift in focus where they’re really starting to try and treat these patients when they’re in the early stages of the respiratory illness. They were really concerned about ventilators as an anticipated problem, and the focus is starting to shift toward what are these before they get to the point that they need a ventilator, what can we do, because we’re shortages here, as well. And so that’s just one example, I could give you more if you wanted.
THOM: That’s great, thank you so much, and such an interesting synergy to hear about what engineers can do to contribute to fighting this crisis. And we do want to talk some more of those with you here shortly, but I want to first move on next to Dr. Riebe, and talk about all of us on lockdown, on stay at home, all these different advisories and different rules for quarantine. How are people getting the right amount of physical activity to stay healthy in this crisis? Dr. Riebe is a kinesiologist and I’d love for you tell us, first of all, what is the minimum daily dose of physical activity and why is it so important to avoid extended periods of sitting?
- RIEBE: Well, those are both great questions. So, there actually are national guidelines for physical activity and there are guidelines both for cardiorespiratory activity and also for resistive activity. So, when we think about cardiorespiratory exercise, we think about volume, typically weekly volume, we also think about intensity or how someone works. So, with cardiorespiratory fitness, for moderate intensity physical activity, it’s 150 minutes per week. Moderate intensity is considered 3.59 METs. A MET is kind of easy to understand. When you are sitting you’re working at 1 MET, if you’re working at 3 METs you’re essentially working 3 times harder than at rest, so there is 3 times as much energy expenditure, 3 times as much oxygen usage, 3 times as much caloric expenditure. If you work at a vigorous intensity which is 6 METs and up, you need 75 minutes per week. Or again, you could do some type of combination. So, for cardiorespiratory fitness, 75 minutes of vigorous physical activity or 150 minutes of moderate physical activity. Some people like to say, well gee, moderate activity might be walking and vigorous might be running, but that’s a little bit misleading because exercise intensity is relative to the individual. So if I’m unfit, even walking could be something that’s more vigorous than someone who is more fit. So it really is relative to the individual. The national guidelines also recommend 2 days per week of resistance training, again, at least a moderate or vigorous level. It’s a really good question that you ask about sitting. Sitting and sedentary behavior has emerged as a new science. Now, when we talk about someone being physically inactive, that means that they are not meeting national guidelines for physical activity. But extended periods of sitting or extended periods of physical inactivity have emerged as really quite a cardiometabolic risk. Prior to this, we know that people spend 50-70% waking hours sitting, and that’s with national studies that are done, both questionnaire and then of course with accelerometry where it can be measured. We don’t know yet if people are sitting more, now that they’re at home, but FitBit, again, not a scientific study, has done some reporting because they actually get data in from their devices, and it actually appears that the amount of sitting we’re doing is going up. And again, long periods of sitting without breaking it up is really associated with obesity, a lot of cardiometabolic risk factors, premature death, diabetes. So extended periods of sitting was a problem before we started this, and again, it’s quite a concern as we move into people staying in their homes.
THOM: So, imagine somebody in a large city, say New York, and they live in a small apartment on the 10th floor, what is your advice for someone in a situation like that, where they’re under a stay at home order, how does that type of person get an adequate amount of physical activity?
- RIEBE: That’s a great question and I think people need to be a little bit creative right now. If I live on the 10th floor, there must be some stairs somewhere. Very often they hide them in buildings, try to find them, but again, there’s hallways, there’s stairs, and they can actually be used quite effectively. People will pay for a membership at a fitness center to go use a Stairmaster, there are stairs in your home. Resistance training is quite important. Again, you can do body weight exercises, lunges and pushups and planks, and those types of things, just to maintain some semblance of strength. The reality is if you are a person who exercises, your cardiorespiratory fitness will start to decrease within two days of stopping exercise. Strength is actually maintained substantially longer. So, I think a good goal is just try to maintain some semblance of fitness while this goes on, and then hopefully we’ll get back to being able to go outside and do a little bit more.
THOM: If anyone in attendance has questions for Dr. Riebe about fitness and exercise under the current crisis, we’d love to see those in the chat. One more question for you, Dr. Riebe, talk about motivation and how motivation plays into physical fitness when we can’t go to the gym, when we can’t meet up with friends for a workout or playing team sports, what kinds of things are okay to do outside of maybe engaging in socially? And also, what other strategies might you recommend for keeping accountable with friends and being social with fitness even in a period of social distancing?
- RIEBE: You know, I think it is hard to stay motivated, and it’s something that you really have to work toward. And it’s a little bit different for people who are active than or people who aren’t active. But if we take individuals who do regularly exercise, they’re really missing their time with friends with sports, or going to the gym with their friends, and I think there is a little bit of disappointment, it’s like well, I don’t have access to everything I usually have access to, and there can be a little bit of ‘why bother,’ you know, I guess I’ll have to worry about it later. So, I think socially connecting is an important thing to do. A lot of facilities are holding online classes with Zoom and they’re actually leading people through exercise there. I know a lot of people are meeting on Zoom and online and exercising together. I think that’s important. Certainly, depending where you live, you can do some walking or go outside. I think team sports is a little bit more difficult to participate in because it’s hard to maintain the social distancing, but again, thinking about are there skills that I can work on, I may not be able to go and play golf or play basketball, but are there skills that I can work on or conditioning that I can work on now, so that when I can go back and play, that I’ll be able to do things a little bit later.
THOM: Okay, thank you so much. I want to go now back to Dr. Woosley, and we have a couple questions from reporters in attendance. I want to go ahead and give Dan Keller the floor to ask his question to Dr. Woosley.
- KELLER: Is there any putative mechanism for hydroxychloroquine or even azithromycin or ivermectin to work against coronavirus? Hydroxychloroquine is antimalarial, ivermectin is antifilarial, azithromycin is antibacterial. Obviously, viruses carry out mechanisms to replicate and be processed, but is there any real biochemical basis behind these drugs? Especially and ivermectin and hydroxychloroquine to work against the virus?
- WOOSLEY: Yes, there are. There is a lot of invitro data for those drugs as direct toxins to kill parasites mostly and that’s why one of the patients who died, who took a big teaspoon of chloroquine that was supposed to go into his fish tank, died, because that’s antiparasitic use. So, the biochemists can tell you the exact mechanism, it’s probably, I think it’s free radical mediated, but it’s direct toxicity and there is no evidence that that effect is occurring at the doses that we see in humans. These antimalarial drugs have been used as antivirals in the past and weren’t found effective. The reason a lot of people are using those two drugs which also are approved for arthritis, because they’re anti-inflammatory, and so is the antibiotic, azithromycin, it’s anti-inflammatory. So, they’re being used mostly because of the ability to suppress inflammation, which is a big part of the COVID problem. It’s the inflammation that’s thought to be causing a lot of lung disease. The problem with all of that is that the use of those drugs for anti-inflammatory effects is fine for people who have arthritis or other infections, but we don’t know that that effect is going to manifest itself in the dosage that we’re giving to patients with COVID.
THOM: Thank you, Dr. Woosley. Dan, any other followup about that?
- KELLER: Yeah, there have been a couple of studies on different doses of hydroxychloroquine and both of them proved to be fairly toxic. They were given a couple times a day, things like that. Since these may be anti-inflammatory, has there been any research on compounds that may be more specific, such as tocilizumab for anti IL-6, if you’re fighting inflammation in the lung.
- WOOSLEY: A very good question. There are studies underway, but I haven’t seen any results from any of those. There have been a couple of small studies that have been neutral or negative, but I haven’t seen any positive effects from those drugs.
THOM: Dan, maybe we can put out a query to our members with your question about those other drugs, and see if any of our other members have any experts that have looked at those studies and get you a response about that. I’ll ask Craig if he can connect with you and maybe figure out helping you to do that. I want to go next to Tina at Science News who also has a question for Dr. Woosley. Tina?
- SAEY: Hi, Dr. Woosley, I wanted to ask you about remdesivir. There was recently a study published that looked at compassionate use of remdesivir and they found some promise there, but that’s not a placebo-controlled clinical trial. So I wanted to ask you, what sort of data can you get from placebo-controlled trial that you can’t get from one of these compassionate use trials?
- WOOSLEY: The gold standard is the placebo-controlled, it’s very difficult to do placebo trials in a lethal illness, so it depends on the population. Remdesivir is being studied in several aspects of the population, there have been a couple neutral studies that were uncontrolled, in the sense that there was no good comparison group. So, I think the data continue to look positive or look encouraging, I should say, they’re not positive. I think it’s just too early to say whether it’s going to be effective. I sort of had a déjà vu with the early AIDS epidemics, when AZT looked so good, and we eventually found that there were much better drugs. And maybe remdesivir will have some benefit to get us where we have some very effective drug. But obviously, none of the things we’ve tried so far are immediately clearly effective to stand out. We just have anecdotes at this point in time, unfortunately.
THOM: Thank you. Tina has a question also for Dr. Fricker. Tina, if you’d like to go ahead ask that now, too.
- SAEY: Yes, Dr. Fricker, I was going to ask about what our current testing capacity is, especially in light of a recent investigation from the journal, Nature, that showed there are lots of university labs that are ready and willing to do testing, but they’ve been blocked from doing so because of bureaucracy. Are there provisions that are now in place that would bring those labs online and contribute to our testing capability?
- FRICKER: Well, I would hope so, I guess I’m not an expert in the regulations that have to do with that. I would say in my own university we have successfully brought a testing capability online. My understanding is, for example, at Virginia Tech, we can do 1000 tests a day. So there is, I would say, a lot of untapped expertise out there and a lot of untapped capability. But I can’t really speak to your question about the regulatory inhibitors to that.
THOM: Dr. Fricker, another question for you from one of the attendees, Leslie Mertz at Pulse Magazine. You mentioned that widespread testing is needed to determine prevalence. What would you classify as widespread? And what percental of the population needs to be tested, and is that really feasible?
- FRICKER: Well, at the moment it seems that it’s not. But I would say in the best cases when we look at New York, we look at Louisiana, we look at California, the data shows that we’ve been testing maybe 2-3% of the population in total. That is clearly far too low. In the ideal case I guess we would do what the President said, which is everyone that wants a test can get a test, but at the very least it’s that, plus also testing over time. So, I would say at a minimum we’re looking at tens of millions of tests. I think right now we said we’ve done 3 million across the country, so it is probably an order of magnitude or perhaps, too, larger than what we can do right now.
THOM: Tell us the difference in your opinion as it goes into the modeling of testing all but confirmed cases versus testing suspected cases, versus testing any healthy person that wants to get tested, and where are we in that range of things? And where do you think we should be?
- FRICKER: What we really need, maybe just step back on that, what we really need to know is this idea or prevalence, that is, among the people in the population, particularly among the asymptomatic cases, what is that prevalence? What is the fraction of the population in a given location that have the disease in some form, whether it’s asymptomatic and eventually having symptoms? That’s the part we don’t know, that’s the part that’s so critical for the model, because we do know, I think we’re pretty sure now that the asymptomatic are driving a lot of this. So, until we know how big that is, it’s pretty hard to understand how prevalent it is and that is how it affects the model.
THOM: Thank you, Dr. Fricker. We have another question from the chat for Dr. Moreno, this again from Leslie Mertz at Pulse Magazine. For Dr. Moreno, there are lots of cool, innovative projects underway, but how can those projects move quickly as we obviously need them to now from cool projects to actual manufacture and FDA approval, and then leading to something actually in the clinic? Tell us a little bit about preapproved devices and how some these things can be fast tracked.
- MORENO: That’s obviously a very good question and what I will say is, for example, right now I’m talking to you because of some of the things I’ve come up with, but let’s be clear, it wasn’t just me burning the candle at both ends, it was the legal people, people who are doing contracts both for the hospital and for the university. At our university we have a very good manufacturing facility, if you will, that we don’t normally do manufacturing, but we’re capable of doing it. And of course, that required a special contract. In this case of the diffuse, you’re talking about an expired patent, so that was fairly easy. But there are definitely technologies that are not as easy to go. That said, you have the EUAs that have already been talked about. I think I spoke with one of you previously about these isolation chambers which are designed to protect the clinicians when they’re doing different procedure on patients.
THOM: Let me show a picture of that for you while you describe it.
- MORENO: So, they’re actually classifying this as a PPE, so this is being treated like a mask or a gown that the clinician would wear, and it’s clearly not a mask or a gown, but that was the mechanism that was used to get this cleared by the FDA. The other thing I’ll say about that system is that if you scour the internet you’ll see that there are hospitals who are fabricating on their own things like that, so we’ve kind of reached that point where even in hospitals their handymen that they have hanging around the hospital normally are now being brought in to try, like, design me a box that will protect me while I’m trying to do an intubation procedure or a bronchoscopy. The system that we designed is a bit more sophisticated, it’s got a HEPA filter on it, you can use it if you’re treating a patient with a nebulizer or nasal cannula. In fact, the Labor & Delivery people at Methodist are wanting this, so we’ve been working with MD Anderson Cancer Center, Methodist Hospital, Memorial Hospital, they all have similar needs and a lot of these things that I’m talking about are things that were unanticipated. They don’t fit into the mask ventilator kind of thing. But what I will say is I’ve noticed there are two things happening. One is just a shortage of supply, so that’s the mask, the diffuser that I was talking about, a shortage of supply. The isolation chamber is something that’s just a new need, it’s not a shortage of supply issue, it’s can you create something that will make us safe. And so there have been a few of those kinds of things, and that’s where you really start to get concerned about the regulatory pathway because can you fit it into one of the EUAs that have already been approved by the FDA and make it work that way, but even then, I can tell you that you’re talking, a lot of time goes by before it makes its way to the clinic. From the time that I report, hey, we’ve got something that works, the clinic likes it, can we get it to them, it’s at least several days, and that’s if it goes smoothly, to get it there. The last thing I’ll say on this, you can see also how concerned people are becoming, if you look on the internet, again, you will see these do it yourself masks, I don’t know if you’ve seen those, but there are literally now hundreds of videos for how to make your own mask and so one of the things that we’ve been doing is filtering tests on different materials. So in the ENMED website, I’m going to put this up because people misspell it sometimes, enmed.tamu.edu, but if you go that website, the STL files that we do for this, we’re making them freely available so you don’t have to rely on us to make this for you, you can go download the file and find a person who has a 3D printer, and they can make them. We’re doing that with all of these different things that I’m talking about that we’re designing. I don’t have a company, we’re doing instructional videos, here is how you would build this isolation chamber that I’m talking about, here are the STL files for 3D printing different parts that are required for the chamber. This thing that we’re talking about here, the files for that are freely available. And that’s one thing I do like about this, is there are a lot of groups working that way. I’ve been collaborating with a group at Imperial College in London who have a simplified ventilator that they’re making freely available to people. So it’s not working at the same level as what you would see in an ICU, I would put it more like what you might see in a vet clinic, so it doesn’t have all the features, but the hospitals are doing a good job of identifying niche applications. So they’re saying, alright, we won’t use this ventilator on an ICU patient, but what an IMU, an intermediate care unit, or we’re just using it to transport. So, they’re identifying, they’re recognizing that it’s simplified and they’re identifying applications where it might be appropriate to use that system, and then they free up the more sophisticated systems that they have for the ICU patients. But, it’s a very complicated issue, I agree with that.
THOM: Thanks, Dr. Moreno. We have a couple more questions in the chat for Dr. Woosley, another from Dan Keller, I want to go ahead and give Dan the floor to ask his question.
- KELLER: Hi, testing is necessarily cross-sectional. Should it be longitudinal on people who have recovered from coronavirus to look for prospective viral carriage and possible continuing ability to transmit it? Serological testing would not talk about non transmissibility or whether the virus is still lingering, a big example is Ebola.
- WOOSLEY: Excellent question, Dan. And you raise an important point. It needs to also be longitudinal for the reasons you point out. But there is another aspect of it, it needs to be a blast, because unfortunately we sort of let testing grow like grow like topsy in this country, and we haven’t had a pulse of testing that allows us to really capture the full nature of the exposure. And the problem is right now, we have somebody, a town will set up testing and a lot of people drive through and will be tested, but then next week, next month, they will be exposed, and how do we know what their status is. So, we need to capture a big enough spotlight of who is infected, and we also need to be able to answer the question you raised, and that just means a tremendous amount of testing. Some of that is being done, but it’s all being done in such small samples that it’s outdated by the time you get the results. I think that’s the biggest concern. Back to testing in general, the FDA did early on hold up development of testing because they were waiting for the problems that had been identified at CDC to get worked out. The initial testing at CDC had some flaws, and the FDA was afraid those might carry over into the commercial sector, so they held up for a while. But they hold up slightly, I wouldn’t call them bureaucratic, what they’re asking for is data on false positives and false negatives, which are difficult to combat, but are essential, because that could be just as big a threat as the nontesting. Doing a lot of testing with too many false positives and negatives could not serve our needs. I think turning it over to the commercial sector frankly is not the right way to do this. They don’t have the ability to capture enough data that we need for a national problem like this.
THOM: We have another question on the subject of testing for Dr. Woosley from Tina at Science News, Tina, go ahead.
- SAEY: Either for Dr. Woosley or Dr. Fricker. Right now people are pretty much being told that they can’t get a test unless they have a fever of 103 or 104, but we know that there is a wide range of symptoms associated with this disease and a fair amount of asymptomatic infection, as well. Does that mean that we should just do away with this criteria for who should be tested and allow everyone to get a test if they want it?
- WOOSLEY: I think that criterion is really a clinical one. It’s testing to help manage that patient. The other problem is we need testing that allows us to know where the illness is in our community, and that’s a very different reason, and it means that you need to test people that are asymptomatic, people who may have had the disease, and you’d like to know was it really influenza and not COVID. So, I think you should keep that criterion as a clinical criterion, but it doesn’t address the broader problem and the need for testing epidemiologic data.
THOM: Dr. Fricker, anything to add to that?
- FRICKER: I think Dr. Woosley said it very well. I think also what has driven our limitations on testing are the fact that we don’t have enough tests, so we’re sort of reserving them for those clinical cases where it’s most important, but that does not obviate the need for us to do this widespread testing, and longitudinal, as Dr. Woosley said in response to Dan’s question. We need to know where the virus is and how it’s spreading, and who is getting it.
THOM: Dr. Woosley, anything about the other regulations or bureaucratic hurdles about testing that you would like to mention?
- WOOSLEY: No, I was at Georgetown for many years and worked closely with the FDA and I know they are some of the most dedicated public servants anywhere. They want to get the best product out there for everybody, and I think they’re working hard to do that. I don’t think it’s over regulated, I think it’s just science is not something you can snap your fingers and get.
THOM: We have another question from the chat, Christina Trapaga has this question, are there studies that show the incidents of serious side effects in otherwise healthy patients treated with hydroxychloroquine and azithromycin.
- WOOSLEY: We have a lot of reports to the FDA and to the WHO of adverse events. We don’t have incidence figures because those are voluntary reporting systems. But there are hundreds of cases of cardiac arrest, sudden death, cardiomyopathy with both of the antimalarials. For azithromycin there is actually a very good study from Wayne Ray at Vanderbilt, who looked at massive amounts of data with azithromycin, and estimated that the excess deaths caused by cardiac arrest and sudden death, azithromycin, a very safe drug given to millions of people still has a death rate that ranges somewhere between 6,000 and 13,000 people each year. So, there is no doubt that these drugs have this problem. The question is who is most likely to get it? And unfortunately the amount of information you need to answer the question is more than most doctors can handle. So, many hospital systems, and we just released a website which will allow doctors and healthcare professionals to enter the data about their patient, to utilize in the drug list that will tell them what other drugs, and there are 200 other drugs that prolong the QT and make these drugs more dangerous. And then calculate a risk score and make suggestions. It’s the new model of clinical decision support, to have the data that we have in the medical record, the data we know about the patient and their medications, to be managed by a computer, because it’s just too much for the human brain to handle, and use that to guide the identification of the high risk and the precious monitoring that some of those people will need.
THOM: Your organization is going to be issuing some kind of a report next week, I believe you said. What else can you tell us about that, and can reports find out more information?
- WOOSLEY: We have a press release which we can send them right now, but the press release will be announced on Monday. It’s a free website available for anybody who wants to register. They can enter the patient’s data, it’s their own data, it’s not being used for any other purposes. We encourage healthcare providers to do that. Many hospital systems can do this for you, but it only tells you when there is a problem. It doesn’t allow you to do this risk assessment online and this is available for anyone with an internet connection, and it’s being made possible by a nonprofit called the Arizona Center for Education and Research on Therapeutics, which is a federally funded site for the last 20 years on drug safety.
THOM: Would Roxanne be the best person to contact about that paper?
- WOOSLEY: Exactly.
THOM: Okay, great. For any reporters interested in that paper from Dr. Woosley’s organization, I’m going to chat the PIO’s contact there at their organization, her name is Roxanne, and if you contact her, she can hook you up with that paper. I want to go to Dr. Riebe for some more fitness and exercise topics real quick. Dr. Riebe, I think a lot of people are familiar with the concept of the Freshman 15, college students gaining some weight during their first year at university, there have been some jokes on social media about us all getting the Quarantine 15. How can we avoid that? What are your tips for monitoring weight, food habits, other kinds of things during this crisis that can help us stay at a healthy weight?
- RIEBE: Weight and weight gain is very complex, but to simplify, it really boils down to energy in, energy out, or what you’re taking in as food, and your physical activity. So, again, we had an obesity problem prior to this social isolation and staying home. So again, I think people really need to be very mindful about what they’re eating. When they do get out and go to the grocery store, very mindful about what they’re purchasing. Maybe there’s a tendency to buy some comfort foods or out of boredom to eat more frequently during the day. So it’s really important that you think about that. And again, certainly being mindful of just how many hours that they’re being inactive, particularly with no breaks, and really thinking about maybe scheduling physical activity, some structured physical activity into their schedule, so they make sure that they’re doing it every single day. Self monitoring is important anyway, we know that from studies that have been done with people that have been able to maintain large amounts of weight. Most people that lose weight regain, but there is a small percentage who actually maintain their weight loss, and we know that self monitoring is actually quite important for their ability to maintain weight loss. So here we might be just talking about maintaining weight or preventing the Quarantine 15, but again, I think keeping physical activity records, monitoring what you’re eating, and even getting weighed daily is shown to be an effective way to prevent weight gain. So, those are some things people can do to make sure that they don’t gain weight during this time.
THOM: Thank you. I want to go to one of our attendees again, Dan Keller, he has another question, I think this will be good for Dr. Woosley, as well. Dan, you want to go ahead and ask that?
- KELLER: Sure, just a comment first, talking about cardiac arrhythmias. It’s not only combining drugs that both cause cardiac arrhythmias, some drugs affect metabolism and elimination, something like ritonavir, where the drug may increase serum levels, so you may get toxic effects from one drug just because the other one is changing serum levels, so I think doctors and patients have to consider that if they look up what should be used and what shouldn’t be used together. My question is testing depends on sensitivity and specificity, and that usually applies to the actual laboratory environment, but how do you QC the pre-analytic process in testing? The sample collection storage and transport, if they aren’t done right, you can get false negatives, and also if you cross-contaminate in the field, you can get false positives. So, who is QC’ing what is going on in the collection process?
- WOOSLEY: You really ask good questions. That’s a real concern that the FDA has about these, because a lot of organizations are doing a lot of laboratory QC, but they don’t take into account the field and what happens out there. There is very clear data that if you use one nose swab versus two, versus three, the sensitivity is increased dramatically, and the number of false positives is going to be dependent on how well you collect the sample. There are new studies underway that maybe saliva could be better than a nose swab because it’s a little more reliable. Well, true, unless you’ve just had a soft drink. But those are the kind of testing challenges that have to be taken into account, and that’s why the regulators would like to have those checked off before they recommend approval. But everything now is risk and benefit, and the risk of not getting a test out quickly is a part of the consideration, too. A quick comment about your comment. You’re absolutely right. The drug interactions can be lethal and the package insert for hydroxychloroquine and chloroquine that there are other drugs that block their metabolism, so the new application that we’ve created includes giving credit or discredit when you use drugs that block the metabolism of a potentially dangerous drug. So, drug interactions and drug action need to be part of the consideration when you’re treating these patients.
THOM: Thank you, Dr. Woosley, and thank you for your questions, Dan. We have just enough time maybe for one more question for the other experts besides Dr. Woosley. For Dr. Fricker, I wanted to ask you, in your opinion how has the public and the media responded to information coming out of scientists and other experts in this crisis, and does it give you hope that public faith in science and academics is on the rise?
- FRICKER: The short answer I think is yes. When we think about what does our society look like coming out of this pandemic? I think one of the bright spots is we’ve seen I think is more faith in science, more following of science, than perhaps we thought before. I would say the public is receiving an awful lot of mixed messages and yet folks like Dr. Fauci are really making a difference. I also give the media a lot of kudos here, because of the fact, just like this panel here and the reporters here, they are getting the word out to the public. We have implemented social distancing far faster and far more effectively than I would ever would have predicted a month ago. And that’s clearly the public getting the message and taking action, including our local politicians. So, I’m actually quite hopeful.
THOM: Thank you, Dr. Fricker. For Dr. Moreno from Leslie at Pulse Magazine, what are some other technological approaches that are becoming helpful in the fight against the coronavirus such as new tech for testing vaccines and PPEs? You can tell us about some of the other projects that you’re working on or things that you’ve seen other scientists doing and getting coverage in the news the Leslie might like to know about.
- MORENO: I can’t say much about the vaccines, mostly what I’m working with are people that are dealing with devices, and then like you said, PPE. The main trend that I’ve seen is this shift towards how can we better treat patients before they reach a point where they need a ventilator. And so there are number of different ways to do that, different technologies that will isolate the patient, including helmets that isolate the patient, you saw the patient isolation chamber, with respect to the mask, people are looking at a lot of different ways to make stuff that’s reusable. So that’s another thing that’s been kind of interesting. In the field of medicine, a lot of the PPE is designed to be disposable. A lot of things, like filtering, that you have in the ventilators, or in anesthesia machines are designed to be disposable. So, are there components that can be reused? And so that’s one of the things that we have been developing, different kinds of reusable, certainly the housing, and then you can just replace the filter material. This would be less expensive overall than throwing away a mask every time you use the mask. So, in terms of sterilizing these things, we’ve had some success using UV, actually the big one that looks promising for us is E-beam, and so we’re in the middle of now doing the filter efficiency testing, because the only concern with E-beam is that while you can decontaminate material, do you compromise the filtering efficiency of the material? And so far, preliminary results suggest that you don’t. So, if that actually pans out to be true, you’re talking about being able to test 5,000 to 10,000 masks a day and decontaminate 5,000 to 10,000 a day and be able to reuse those. And the nice thing about it, too, is that the way you would do that is you just package them up, put them in a box, you don’t have to unpack them. The E-beam is penetrative. It goes through the packaging and everything.
THOM: And just to clarify, E-beam is electron beam?
- MORENO: Yeah, that’s right. It’s penetrative, it goes through everything, and that’s I think a very promising kind of technology that’s being pursued by some of my colleagues here. The UV is also working well, it’s not quite as efficient in terms of the productivity, but it’s also something that is more common. Most of the hospitals have UV systems. In fact, we started by using one of the UV robots that kind of just go around the hospital, sterilizing the hospital. But now putting the mask on a structure where the UV is hitting the mass. It’s not penetrative like the E-beam, so it’s not as efficient, but there is some trust in it because it’s already being used in other applications. So, just finding ways to be able to reuse the stuff I think has been another big initiative.
THOM: Great, thank you Dr. Moreno. For Dr. Riebe, tell us about the importance and the value of things like journaling. And so you mentioned how weighing yourself every day can have an impact on maintaining healthier weight. What about things like food journaling and exercise journal as other kinds of self monitoring strategies? And how do these help people to stick with it?
- RIEBE: You know, it really doesn’t matter how people keep track of what they’re doing. For some people journaling is too much and they might do it for a day or two, and then unfortunately they don’t continue with that behavior. So I think it’s individualized how you keep track. There are some very simple ways, simply using a calendar with some kind of marking, a gold star if you exercise that day, or if you eat healthy that day, just somehow writing that down. And then there are people that will respond better with a more extensive journal. But for a lot of people, unless they’re really into health and fitness, extensive journaling is sometimes a little bit overbearing, just like we don’t really recommend people count calories anymore, because there is so much to it. So, I think the message is it doesn’t matter how someone keeps track, I think they need to find what is going to work for them. But whatever it is, whether it be as simple as an adherence calendar or journaling, it’s being able to see that physical, tangible evidence of what they have or have not been doing that can be effective in helping them stay on track with both their diet and their exercise.
THOM: And the evidence suggests that any range of this kind of thing can be effective long-term, it doesn’t have to be a proscribed kind of report.
- RIEBE: Correct, it does. And much of that is individualized with what is going to work for every person.
THOM: That’s great, thank you. I’m sure there are a lot of people who are missing being able to go to the gym that will find that useful to know if they haven’t tried that before. One more question for Dr. Woosley before we conclude, and I think that will be all we have time for today. From Robert Adler, a freelancer in attendance, he asked about ivermectin, I think this was mentioned a little bit earlier as an anti-parasite medication that might have potential against the coronavirus. Can you comment further about that for Robert?
- WOOSLEY: Only that it is an antiparasitic that has effects on viruses in vitro in the laboratory, but I’m not aware of any clinical data, I’m also not aware of anyone who is using it in clinical treatment, even off label at this time.
THOM: Okay, thank you for clearing that up for us. If any of the reports have any further questions, we’re going to make sure to share with you all the contact information for all of our panelists, communication offices at their university, as well as a video and a transcript of today’s event. Thank you so much to all of our experts for joining us today. Before we conclude, I want to just turn it over to my colleague, Jessica at the main office at Newswise, Jessica is our CEO, and I wanted to ask, Jessica, if you have any closing thoughts you want to share before we finish up.
- JOHNSON: I just want to thank everyone, it was a great conversation, there is a lot of interesting information you all shared. I think we need to all stand up, Dr. Riebe, we need to get up out of our chairs and get moving after this one hour. So, thank you all. And to the communication offices, thank you for connecting us with the experts at your universities, we really appreciate that, and for Dan and Tina, and Leslie, you guys contributed great questions, it makes it much more interesting, the whole event. So, thank you.
THOM: Absolutely, thank you so much to all the media in attendance and for your great questions. I hope we got to as many of them as possible, I don’t think we left any on the table today. In conclusion, Dr. Woosley, Dr. Fricker, Dr. Riebe, and Dr. Moreno, thank you all very much. Stay safe, stay healthy, and good luck.