Navigating the Pandemic: A COVID-19 Discussion with the Infectious Disease Community

Over the past twenty years, the world has faced several infectious disease outbreaks including; Ebola, Influenza A (H1N1), SARS, MERS, Zika virus and now COVID-19. With over 200k deaths worldwide, COVID-19 has brought an enormous strain on our health resources, but also has had a massive impact on human health and the economy. Join infectious disease experts as they share what we can do to be better prepared to prevent, detect, and respond to disease outbreaks.

Moderator:

Monika Schneider, Ph.D.
Managing Associate, Duke-Margolis Center for Health Policy & Chair, WIB-Capital Region

Panelists:

Kelly Cawcutt, MD, MS, FACP
Assistant Professor, Associate Director of Infection Control, Co-Director:Digital Innovation at UNMC

Jaclyn Levy, MS
Director, Science and Research Policy, Infectious Diseases Society of America

Megan Driscoll Greenstein
Former CEO PharmaLogics Recruiting and recovered COVID patient

Transcript:

John:

Thank you for joining us for our fourth webinar in our Navigating the Pandemic series. Today’s webinar will be A COVID-19 Discussion with the Infectious Disease Community. Today’s panel includes our moderator, Monika Schneider, a managing associate of the Duke-Margolis Center for Health and Policy, and chair of the Capital Region WIB, and our panelists are Kelly Cawcutt, an assistant professor and associate director of infection control, as well as co-director Digital Innovation at UNMC, Jaclyn Levy is the director, science and research policy at the Infectious Diseases Society of America, and Megan Driscoll Greenstein is the former CEO of PharmaLogics Recruiting, and a recovered COV patient. I’ll turn this over to Monika.

Monika Schneider:

Great, thank you, John, and good afternoon to everybody. I’m Monika Schneider, and I’m a managing associate at the Duke-Margolis Center for Health Policy. As mentioned, I’ll be serving as your moderator for today’s session, and as you all know the COVID-19 pandemic has been devastating. To date, more than nine million people have been infected globally, and almost half a million people have died as a result, including more than 120,000 Americans. The economic toll of this virus has been just as severe, and to better combat on infection we’ve seen massive collaboration, some sacrifices on a number of fronts from health care workers, to therapeutic and diagnostic developers, to regulators working to safely accelerate products, whether therapeutics, vaccines, and diagnostics.

Monika Schneider:

So, as we gain a better understanding of the virus and our immune responses to it, we will be able to develop more effective strategies to stopping it, and hopefully gain lessons on how to be prepared for future and emerging infectious diseases. So, today’s session we’ll dive into these topics, and our expert panelists will share ideas on what we can do to be better prepared to prevent, detect, and respond to the current, and to future disease outbreaks. So, next, I would like to turn it over to our panelists, and I would ask each of you to share who you are and where you’re working, as well as the perspective that you’ll be bringing to today’s talk. Right now I’ll turn it over to Kelly Cawcutt.

Kelly Cawcutt:

Hi, everyone, I’m Dr. Kelly Cawcutt, I’m an infectious disease and critical care physician here at University of Nebraska Medical Center. I am also an associate director for infection prevention and control at our institution. The perspectives that I bring are both from a frontline health care provider on infectious disease services, and as an ICU doctor who’s been working in our COVID ICU, and as someone who’s been writing hospital policy on how to take care of patients with COVID, how to protect our health care workers, and how to move through this pandemic while still taking care of all the critical non-COVID related health care problems we have.

Monika Schneider:

Great, thank you, Kelly. Next, let’s move to Jaclyn Levy.

Jaclyn Levy:

Thanks, I’m Jaclyn Levy, director of science and research policy at the Infectious Diseases Society of America. IDSA represents over 12,000 physicians, scientists, and public health experts who specialize in infectious diseases. So, as I’m sure you can imagine, most have been on the frontlines in some form or another throughout the COVID response. As part of our public policy and government relations team, I’ve been focusing largely on research and testing policy for COVID-19, including outreach to Congress and federal agencies, and forming stakeholder coalitions to educate Congress and help advance evidence based policy making. As a society, we’re also working on the COVID response from public health, clinical, and health disparities perspectives, and developing guidelines and resources for different audiences.

Monika Schneider:

Thank you, Jaclyn. And next, we’ll turn to Megan Driscoll.

Megan Driscoll Greenstein:

Hi, I’m Megan Driscoll, I’m the founder of PharmaLogics Recruiting, which is the largest science based recruiting company in the U.S., but the reason I was asked to be here today was more related to the fact that myself, my children, my husband, and my 75-year-old mother all had COVID, and all had very different experiences with it. So, just kind of bringing the patient perspective on how this affects us all differently.

Monika Schneider:

Great, thank you, Megan. So, to kick off the discussion, let’s talk a little bit about where we are with this pandemic, what’s the current status, and what have we’ve been seeing from both the health perspective, as well as from some of the treatment and vaccine perspective? Kelly, maybe we can start with you.

Kelly Cawcutt:

Sure, I’m happy to, it’s a lot of things to answer at once, too, but I think from a just overarching perspective, even if you just look at the U.S., we’re the leading number of cases in the world, we are still seeing states that are having complete outbreak scenarios, some states have had a second surge, some states had a single surge and have come down and are kind of at a plateaued level, but clearly still a lot of people getting the infection around the country. We’re seeing a lot of it around the globe still, and we still have a lot of concerns regarding the capacity to overwhelm health care systems in any given location, because we know not everybody’s gotten it, and we did all of this work on the idea of flattening the curve early, but the reality is we had to flatten the curve and then keep it flat.

Kelly Cawcutt:

And that’s, I think, the struggle we’re facing right now, because we don’t have a vaccine that’s available to the public, we don’t know all of the data we would like about durability of immunity, and if it will disappear over time, and result in the risk of reinfection or not, and we know there’s still a lot of people as we reopen who stayed home and stayed very isolated who are now having increasing exposures and at risk.

Kelly Cawcutt:

We have seen some advances with therapy, obviously. We’ve learned an awful lot about opportunities to improve our ICU and floor level supportive cares, we’ve clearly seen remdesivir come forward as a treatment option, we’ve seen a multitude of other medications debunked in literature as being effective, and we’ve seen other things still in evaluation with medications.. So, I think we’ve learned a lot, but there’s a lot we still don’t know, and we’re still in that potential critical point.

Monika Schneider:

Thank you. Maybe, Megan, from the patient perspective, can you talk about how you see the current status as far as understanding diagnosis, and treatment if any were given to you, and kind of the recovery process, and where we might improve going forward?

Megan Driscoll Greenstein:

Yeah, so we contracted COVID in early March in Boston before anybody even knew we had COVID in our area. The joke was that when my mom was finally brought to the hospital they were like, “She doesn’t have COVID, where’s see been?”, and really she had been to the grocery store and the gym, so she got it at one of those two places. But what I think has changed significantly as even at the … I think like mid-April my husband and I tried to get tested because we were having symptoms, and we were just told that unless we needed hospitalization we were not to go in and have tests.

Megan Driscoll Greenstein:

Luckily, at that time we were closed anyway, there was no way we were going to be infecting other people, the issue is now things are open, so if you are having symptoms you need to have access to testing so that you can confirm whether you do or don’t have it. In our case, my mom was very sick, but my husband and I had very disparate different symptoms. We didn’t have high fevers, my mom had 102 fever for 12 days. We didn’t have breathlessness, we had more shortness of breath, but nothing … it happened over the course of almost three weeks, and then my children had nothing. I mean, they had no symptoms whatsoever.

Megan Driscoll Greenstein:

So, I just think that access to testing and contact tracing, and then isolation and quarantine is really the only way that this country can move forward, because unless we’re going to stay closed, which clearly we’re not, the only way you’re going to protect people is by making sure they have access to testing. I was really disheartened to hear that the federal government’s not going to be paying for testing moving forward in the next couple weeks, because access to testing is huge. We were so frustrated that we couldn’t get tested, and we were people who knew we had a known … we were exposed, we knew we were exposed.

Megan Driscoll Greenstein:

The other thing that I think is really important just to note about this is that my exposure to my mother happened in a 15 minute car ride. I took her to the doctor’s office when she wasn’t feeling well. There were no masks available in early March, so neither of us were wearing a mask on the way there, but on the way home she did wear a mask. So, I believe my exposure was just in a 15 minute car ride, I sat in the car and waited for her while she went into the doctor’s office, and I think I just breathed in that air. So, I just think we really have to emphasize how important it is to wear a mask and not politicize this.

Megan Driscoll Greenstein:

Wearing a mask is for you to help others, and others are doing it for your benefit, and if everybody is wearing masks we’re going to cut down on those chains of transmission significantly. I wish I could go back in time and either not driven her to the doctor’s office, because then I wouldn’t have gotten it, my husband wouldn’t have gotten it, I gave it to my chiropractor. I mean, we were super spreaders for those couple days where we didn’t know we had it. I just would’ve done it differently. And now we do know, so shame on us for not following those directions now.

Monika Schneider:

Great, thank you. Jaclyn, do you have anything that you’d like to add on where we are in the current status of the pandemic, perhaps from the infectious disease perspective, or from the diagnostic perspective?

Jaclyn Levy:

Sure, from a policy perspective there are a couple additional thoughts. As Megan alluded to, there were announcements yesterday that federal funding would be pulled for testing sites in, I believe … 13 sites at the end of the month, seven of which I believe are in Texas, so I would agree that that is incredibly concerning. FDA has certainly been continually streamlining its process for emergency use authorizations, but access to adequate rapid testing still certainly lags in many regions. On Capitol Hill it’s been over a month now since the House passed the $3 trillion Health HEROS Act, yet without a response from the Senate, and so without additional stimulus legislation the current coronavirus financial protections passed in March are set to expire next month. One other thought is that Senator Lamar Alexander, who’s chairman of the Senate Help Committee, has issued a white paper focused on preparing for the next pandemic. So, IDSA and a number of other stakeholders have put together thoughts to weigh-in in hopes of informing future policy.

Monika Schneider:

Great, and you mentioned the FDA has been putting in place some accelerated pathways. I know on both the therapeutic front, as well as on the vaccines and diagnostics front. Can you speak a little to, perhaps this is asking you to predict the future here, but the likelihood of having some sort of treatment or a vaccine available, and some of the considerations that we’ll need to quickly distribute that to patients and non-infected people in need.

Jaclyn Levy:

Well, that’s certainly the million-dollar question, and now is definitely the time to consider ways to build out and supplement existing infrastructure, supply chains, things like that to survey the gaps and determine the areas for public/private partnership, which is discussed a bit in that Alexander white paper I just mentioned. In terms of vaccines, therapeutics, I think the last thing we’ve heard is that more than 100 vaccines are currently being studied globally, but I believe less than a dozen have begun testing in humans. So, with the federal government’s goal of a vaccine ready by January 2021 is certainly going to be a push.

Jaclyn Levy:

The White House has formed Operation Warp Speed, which consists of a public/private partnership to sort of push the development, and the testing, and the manufacture of a vaccine with the original goal of starting with 14 candidates and reducing it down to, I believe, eight, maybe less, but either way, the process has not been particularly transparent, so there are some concerns about public trust, although it is seeming to move along. Yesterday in his congressional testimony, Dr. Fauci also did hint that a vaccine may be available as early as the end of the calendar year, which is certainly heartening to hear, but there are again, still outstanding questions about scalability, and also equitable distribution that need to be addressed.

Monika Schneider:

Yeah, thank you, those are all great points, and from the distribution access side, Kelly, maybe you can talk a little bit about where are going to be some areas of greatest need once we do have a vaccine available, and where might be some challenges that we’ll have to think about when it is available to the public?

Kelly Cawcutt:

I think that’s a great question, and I think there’s a lot of scenarios in which we’re going to struggle with this. So, when we look at protecting … we want to protect the public, but we’re not going to have the number of vaccines right out of the gate. There’s going to be areas in which our frontline health care workers are still working, and especially in areas where there’s outbreaks, they may be working in the face of continuing limitations in PPE. There are still some supply chain issues with maintaining adequate supplies, and so I think, one, is how do you decide which health care workers are going to get vaccinated, how do you decide which other frontline workers get vaccinated, like our law enforcement, our emergency medicine teams, our firefighters, all of those people are high risk scenarios here, too.

Kelly Cawcutt:

We have a lot of patients with varying immune compromise and varying risk factors that put them at higher risk, and we certainly have seen substantial disparities based on race and socioeconomic status that have driven different outbreaks both in certain subsets of states and city areas where there’s inadequate testing in certain areas or access to health care, but also for some of our vulnerable populations that are in homeless shelters, or in longterm care facilities where there’s been larger outbreaks. And trying to triage the highest risk people, I think, is going to be very complex, and it’s going to rely very heavily on how much vaccine is going to be available to make those determinations of where the greatest valley lies, and the highest risk burden of getting infection.

Monika Schneider:

And from … I guess the current pipeline of treatments and vaccines are variable, and we can’t predict what is going to be coming up first, but can you speak to some of the different strategies that are being used to approach treatment or prevention, or even detection that we should think about going forward?

Kelly Cawcutt:

Sure, so I think, like Megan mentioned, testing is critical, and having access to it, but also remembering that although there are scenarios in which testing asymptomatic people makes sense right before a procedure, high risk contacts with other close contacts in the same home, like some of the children, as Megan mentioned with her kids, but testing, if you’re asymptomatic today, does not guarantee that you are still negative tomorrow. So, I think there’s a false sense of security for the idea of recurrent testing. We’ve seen a lot of variability in serologic testing, which also limits it, and remember, that only works after you’ve had the active infection, so it doesn’t help us with that contact tracing and isolation that Megan was mentioning. I think that remains the most critical thing.

Kelly Cawcutt:

Contact tracing, isolating, and keeping people separate with social distancing and masking, because there’s nothing else that we have thus far that shows prevention of acquisition of COVID-19 infections. So, I think that is critical, and there’s a lot of what people have dubbed quarantine fatigue, and it’s hard, and it’s hard for the public, it’s hard for all of us who are working on the frontlines, we’re tired of wearing masks all the time, and N95s, and the honest trauma and things that are happening just related to wearing masks all the time, but it’s still the right thing.

Kelly Cawcutt:

As far as other treatments, so I’ll speak really for our institution, we continually are reassessing the guidelines as they come out, the latest evidence. Our standard remains very much supportive care. We do not put people on ventilators until we absolutely have to, we use DVT level chemical prophylaxis, but not other full anticoagulation at this point, and we use remdesivir. So, we’ve have both had the opportunity to have the randomized controlled trials with the first enrollments at UNMC for that here, and we’ve also had access to it through EUA. So, all of our patients are evaluated for the capacity to get remdesivir and that is our stronghold of therapy. We have not used any of the other medications to date that are being studied for COVID-19 infections.

Monika Schneider:

All right, great. Just a couple more questions before we turn to the questions we’ve been receiving from the audience, Megan, can you talk a little bit about your experiences with contact tracing, and some of the follow-up perhaps with serology test that you’ve experienced, and any sort of opportunities for improvement there?

Megan Driscoll Greenstein:

Yeah, I mean, so I also after sort of surviving COVID and everybody being well, my mom was on a ventilator only for two days, I mean, she’s like a miracle, we can’t believe she’s walking around, she still has … she’s, I guess, several months out now, but weird things happening, she’s losing all of her hair, which we don’t know what that’s all about. Otherwise feels fine, but she’s got some post-traumatic stress from being in the hospital for as long as she was obviously dealing with that. But I immediately was like, “Oh, I want to do something, I want to …” I had recently retired, and so I was expecting to have two years of blissful not working and then COVID hit, and I was like, “Oh, that didn’t work out that way.”

Megan Driscoll Greenstein:

So, I decided to join the contact tracing team through Partners In Health on behalf of the Department of Public Health in Massachusetts. I mean, I will say that I did that for a full month and I had to leave. It was heartbreaking, I can’t even describe to you, I felt … you feel bad for these frontline health care workers and you feel like, gosh, they’re really giving themselves, I mean, this is … but seeing it on a different level, like I heard those stories, and again, things aren’t real until you really get involved, but talking to a patient who’s at home, who’s been diagnosed with COVID, whose mom has just passed away from COVID, whose dad is in the hospital with COVID, whose children have COVID, I mean, the despair, they haven’t worked in months, they don’t have food, they have very food insecurity.

Megan Driscoll Greenstein:

It was so clear how disproportionately this disease affects minorities, people of color, and poor. They’re in frontline working positions, they’re getting COVID more frequently, and then they go home to these multigenerational homes, and are sort of super spreading within their own families to the detriment of the older people in their families. Usually the younger ones are surviving, but they’re losing a parent or two in the process. It is the only … I was so … the one thing I will say about working in that role for a month is I felt very confident that Massachusetts has it right. We have over 1,200 contact tracers, by the time I had left they had already gotten ahead of the curve. I mean, we were many, many, many patients behind, we were calling people a week after they’d been diagnosed, by the time I left we were within two days of diagnosis. It’s much easier to ask someone to remember what they’ve done in the last three days than it is to ask them what they did three days or a week ago.

Megan Driscoll Greenstein:

So, we really, I think, crushed coronavirus here in Massachusetts, and in the Northeast in general, because of our commitment to contact tracing, and isolation, and quarantine. We also have access to testing, I mean, testing is available everywhere, I think we probably have many, many, many more rapid tests, which again is another issue. When you have a test and it takes six days to get your test back, it’s really hard for someone to then go back nine days. So, you’ve really got to be testing and responding quickly, so rapid testing is definitely needed. But again, I was heartened by the contact tracing work that I did, and know that’s happening every day, because I do feel like that’s controlling the infection here, and is going to continue control outbreaks as they come in the fall.

Monika Schneider:

Great, thanks. Jaclyn, we just heard about some of the strategies and approaches that we’re using that we have at our disposal currently, what are some of the key challenges or key aspects that we don’t really understand about this virus that we’re going to have to learn in order to fully be able to eliminate?

Jaclyn Levy:

Yeah, there is so much we don’t know, in fact, back in May, IDSA tried to put together a list of sort of key COVID-19 just research questions, and even trying to focus it on the research alone ended up being a massive undertaking. But the idea being that ultimately we were able to put a lot of our outstanding questions in these buckets of sort of prevention, diagnosis, treatment, pathogenesis, and epidemiology, with the idea that the answers to these basic science questions will hopefully help translate into clinical use. Just a note, to continue what everybody is saying in terms of beating the drum on testing, it would really be great, as Dr. Cawcutt alluded to earlier, to have a better understanding of antibody efficacy and duration in preventing infection. Also understanding transmission, particularly in children, could help drive evidence based policy making and surveillance, and possibly reopening plans as well.

Monika Schneider:

I think what you just mentioned about looking at all the literature for some of the answers, one of our listener questions is asking about how doctors are making sense of all the different, and really the kind of fire hose of information that has been coming out in different journals, either on pre-print or being published, and how you sort through information that maybe hasn’t necessary been peer reviewed before it’s coming out.

Kelly Cawcutt:

Sure, so that’s a great question. We have never seen the amount of literature coming out in pre-print before peer review than we’ve seen now, and on the same note, we’ve never seen as much global collaboration and collaboration across physician teams within states and countries that I think we’re seeing right now with this. So, for myself, for my teams that I work with, for some of the teams in the Midwest, it really is a lot of assessment. If something comes out as a news release, something comes out as a pre-print, we’re very cautious, and really going to the actual article as soon as we can to look at the quality of the study, to look at the analysis, to try to see if it’s something that we think is high quality and unbiased, or I shouldn’t say unbiased, minimizing bias as much as possible, everything has its own biases in research, and then there’s a ton of conversation happening.

Kelly Cawcutt:

So, none of us are really looking at these studies in isolation, we are trying to utilize our experts, so when we’re looking at how to manage someone in an ICU it is our infection control team, it is our infectious disease experts, it’s our global health experts, it’s our critical care experts, it’s our research experts. And every article that comes out that we think carries potential weight, where there is a data behind possible improvements, we’re looking at that very consistently as a group, and we’re actually coming up with consensus recommendations for the institution so that our practices are as standardized as we can be, and we’re as equitable for our patients as we can be.

Kelly Cawcutt:

But it is hard, and I will tell you it is exhausting for us all to try to stay up on that, but also as an academic physician, trying to be part of those solutions, trying to find time to help drive the appropriate data that we need to make decisions, to help set up the research that we need to understand ,it’s very burdensome for all of us right now in these roles to do all of those things, and do all of them well.

Monika Schneider:

Yeah, I can imagine it’s an overwhelming task overall. Let’s see, we have a question about at-home testing, and I think this is particularly relevant given, Megan, your experience in that you think transmission occurred while you were driving your mother to get tested. So, what are some of the changes that need to be made in order to accelerate the regulatory process for getting more at-home tests available? Maybe Jaclyn you can take this one.

Jaclyn Levy:

Certainly, the at-home testing was one of the early categories in which FDA had said, “This will not be authorized at this time.” Since then, a few have come up online, and those are tests where patients will purchase and then send the sample back to a reference laboratory for analysis. So, it’s not an antigen test really in the sense of a rapid strep test, for example. Although as a bit of an aside, very sensitive, highly available antigen testing would be a wonderful thing to have, and I think FDA did approve its first one late last week.

Jaclyn Levy:

But that being said, to get more at-home testing, there are issues that have to do with reimbursement that have not yet really been worked out. It’s been a bit of a sort of a de novo pathway that we’ve heard from manufacturers who have worked FDA on this issue. It’s heartening to see that there are a few now, I know one is … Rutgers has a couple, there are saliva based tests, there are also interior nasal swab tests. With a bit of variable sensitivity and specificity, although not as much as the antigen from what I understand, but certainly anything that Megan or Dr. Cawcutt has to add, it’s a big landscape.

Kelly Cawcutt:

So, the only thing I’ll add is it is, it’s a huge landscape, and from the infection control standpoint when we look at patients coming in we’re incredibly worried about making sure we have the highest sensitivity and specificity that we can, because that really drives the isolation practices, our PPE use, and the contact tracing, and if we miss cases we’re contributing to the risk to our other patients, to the public, to the health care workers. So, I think making sure that we have good samples, and one of the things that we have definitively seen is if you don’t get a really good swab of the nares, and the lab isn’t doing a quality check to make sure there’s adequate cellular material, it is not an effective test. So, a little different than doing at-home strep tests where it’s a little easier to do it, there’s definitely technique to some of these non-saliva based tests that cannot be minimized, because otherwise it’s a false sense of security if we get a negative test and we don’t have a quality check to make sure that it’s actually adequately performed.

Monika Schneider:

We have some questions about disease severity, and maybe a couple of questions bundled into one here, whether or not severity will impact the results of the test, or how likely you are to get a correct test result, and then also around whether there are any correlations between disease severity and any sort of demographic, or age, or any connections between demographics and severity, as well as whether we have any biomarkers that might be able to indicate who is going to have a more severe case?

Kelly Cawcutt:

I don’t know if anybody else wants to tackle that, but I’ll start and then I guess people can throw that in. So, severity is difficult. We definitely have seen risk factors come through in the literature, certainly there’s increased risk with age, the older the age the higher the risk of severity. We’ve seen a lot of data regarding having increasing comorbid medical conditions, so more patients with diabetes, hypertension, underlying lung disease, carrying higher risk of severe disease. But honestly, that would’ve been true historically for most of our respiratory viral syndromes also, so it’s really consistent in that line.

Kelly Cawcutt:

There is some evidence that sustained longer contact, like Megan was talking about having 15 minutes in the car with her mom, but if you’re in close, tight contact with people with higher exposure burdens, there may be an association there with severity. It hasn’t borne out in all of the studies that I’ve seen to date, so I think that those are all pieces in there. As far as how that relates to testing, so there is definitely impact of severity of disease. So, we see people who test negative who are asymptomatic and truly negative, or asymptomatic in what we would consider a presymptomatic phase, meaning they’ve gotten the infection and in several days they’re going to have symptoms and test positive, but they test early before there’s a lot of viral replication. Our tests don’t test everything perfectly, there’s still going to be a chance of missing very, very small viral loads.

Kelly Cawcutt:

As you get into increasing symptoms and more severity we do see more positivity with the nasal swabs, the oral swabs were not as good, so many place have abandoned those. In the most severe cases we can see loss of positivity in the nares, but we need sputums or lower respiratory tract specimens to then see subsequent positivity. So, there certainly is some shifting both in duration of illness, severity of illness, with the testing that we see. And I think that’s true with the early data that we’re seeing on serology too, the more severe the disease the more likely you are to have really good antibody titers later. There’s some early data suggesting that in some of the milder very minimal disease states there may not be significant immunity derived.

Jaclyn Levy:

And then I could add just in terms of the part two about demography in addition to what everybody has already discussed about disproportionate impacts to communities of color, African American, LatinX, disability, et cetera, IDSA has also been putting together resources for special populations in settings, and so that would include things like guidelines and guidances and recommendations for intensive care, immunocompromised patients, cancer patients, cardiac, pediatric, prenatal, HIV. Again, there’s still so much more to know, but just trying to drink from that fire hose in a bit more of a strategic way.

Monika Schneider:

Great, thank you.

Megan Driscoll Greenstein:

The only thing that I would say with regard to how it transmits or how we all response to it, my mom is 74 and she has diabetes, so it was not surprising that she would have a pretty significantly severe case of coronavirus. What I did find kind of interesting is that my husband and I both I would call mild, meaning we didn’t feel good, but I wouldn’t have gone to the doctor under normal circumstances anyway. I mean, I wasn’t feeling that bad. But when we went and had our antibodies tested, which was a full four weeks after we had all recovered, all four of us, even my two kids who had no coronavirus symptoms at all, all tested positive for IgG antibodies. We don’t get the level whatnot, but I do know that we all had them, we all produced antibodies at that point, and we all had varying degrees of disease. So, I thought that was kind of interesting.

Monika Schneider:

Great, thank you. I have a policy question here, and maybe Jaclyn you can address this around when vaccines are finally available, what is the coverage and reimbursement going to look like from the payor side, and I don’t know if this is something that you necessarily have insight into, but perhaps you can speculate on that.

Jaclyn Levy:

Yeah, I would say that my insight is relegated to a lot of the testing, as far as reimbursement is concerned we have found that there have been unexpected issues surrounding some of that. So, for example, there are respiratory panels that are sometimes requested before providing a COVID test, but those panels may or may not be reimbursable. So, a lot of the clinical steps that go into these recommendations may or may not have coverage attached to them. So, I’m not sure how that will or will not expand to vaccines, but I think it will be important for a diverse group of stakeholders to come together to put together all of those considerations in as quick and as broad a manner as possible.

Monika Schneider:

Kelly, from a provider perspective, have you seen any issues with any of the reimbursement for tests, or potential issues to flag for reimbursement and coverage of vaccines?

Kelly Cawcutt:

So, one of the things that I think we can’t forget is as we’ve been talking about disproportionate levels of disease, and burdens of disease in certain populations, many of those populations are uninsured. So, that is going to translate to out-of-pocket costs to people who are heavily hit by lack of income from the shutdown that we’ve seen, from illness amongst family members, from creating substantial debt burdens arguably for health care, and there’s one thing to talk about reimbursement when it comes to people who have insurance, whether it’s state, federal, county, local, private, and then people who have zero insurance, and if our most heavily hit populations have no insurance, that is going to be a huge area that we need to address, and address very well on how to provide care and vaccines to those groups.

Monika Schneider:

That leads very nicely to a next question here that I think I would be interested to hear from all of you on, whether or not you think that some of these disparities in who’s being infected, and some of the … in addition to unemployment on the rise and people losing insurance, whether this will lead to fundamental changes in how our health care system is currently run, and where we might want to think about making changes to best provide quality health care for the majority of the population.

Kelly Cawcutt:

I think it has clearly highlighted where our system is broken, and I can tell you as an individual institution organization it is something we’re looking at. We opened specific collaborative testing locations that are drive-thru in areas now in our higher need areas where there was not adequate access to care necessarily. Now, that being said, it probably wasn’t fast enough, we probably didn’t have the resources and the testing available in the timeline we wanted, but I don’t think health care is ever going to look the same again. The amount of telehealth that’s moved forward in a speed at which it never had before, the shifting dynamics and how people access care are just so different, and I don’t think there’s a capacity to say, “We’re going to go backwards.”

Kelly Cawcutt:

I think we do need to very aggressively look at how do we get care to our populations that need it, how are we financially sustainable to provide health care to our patients, and how we move that forward, I don’t know, it’s definitely out of my realm of expertise in total, but certainly that is what the physicians that I work with, and our frontline providers that I work with, that’s what everybody’s advocating for is we need to make those changes, and we need to figure out how to do it, and we’re going to make mistakes on the way, no doubt, but we definitely need to improve that structure.

Megan Driscoll Greenstein:

Yeah, and I would just say from my perspective of just speaking to people who were really, really terribly affected by this in communities of color, in poor communities in Massachusetts, when I asked them the question of, “Do you have a health care provider? Do you have somewhere you can go?”, the answer in Massachusetts was always, “Yes, I do, there’s a community health center.”, because we mandate health care coverage in Massachusetts it is a different kind of environment. I do think health care is a right, and it’s something that we need to ensure is available to every American so that they can get the kind of care that they need, even for just basic things beyond COVID. The only way we shore up these disparities is to not put people in bankruptcy because of a health care condition, that’s just … it’s not tenable, clearly.

Jaclyn Levy:

I very much agree with both and would just add that beyond the individual patient perspective, I think this has also highlighted a lot of the gaps in our public health infrastructure, and will hopefully provide a blueprint, or at least the right set of questions in which to expand that and fortify it so that surveillance, and detection, and prevention can all be adequately deployed in an evidenced based manner for the next pandemic that’s coming down the line, and for the continuous waves that we may or may not be expecting from this one.

Jaclyn Levy:

I think, too, which is a bit of a straddle between policy, public health, and patient care is just the regulation of diagnostic testing overall. This is something that’s sort of been kicking around legislatively and regulatorily for a number of years, and there are some proposals on the Hill at the moment that may severely curtail the ability of many academic medical centers and clinical laboratories to develop and provide well-validated testing to patients. So, I think seeing some of the more challenging regulatory hurdles from earlier in this pandemic, we just want to remember the lessons learned from that, and ensure that access to testing is something that we are definitely providing, both on the development and on the patient care side.

Kelly Cawcutt:

I would just echo that, too, just from a straight development of an academic institution test, we had our own test here available that was created, and had far more of that than we had of the CDC test available. We had some of the first tests rolling in the country and they weren’t the fastest, it wasn’t smooth right away, but we had access to testing earlier than many other people did, and that is a huge part that helped us, but we would’ve never had that capacity if we were restricted on being able to build a research based laboratory test. So, I do think it is incredibly critical to allow those permissions to continue, because that then helps, A, bridge some gaps, and drive improved testing for everybody when we allow that.

Monika Schneider:

Along the lines of that, and maintaining our testing capacity, there are some thoughts that we have not completely flattened the curve, we might see a resurgent of infections in the fall or winter, and that this can be complicated by influenza infections going up during that time as well. So, are there any key lessons that we’ve learned during this initial period that we will want to keep in mind and try to apply to make our response better if we do have resurgences in the future?

Jaclyn Levy:

I mean, I’d say building on what Dr. Cawcutt just mentioned, preserving access to development, which is not just testing, but also includes things like reagents, and necessary supplies, allowing flexibility within the pipeline and the supply chain for those sorts of things, for example 3D printing of swabs when that sort of thing is necessary. A lot of the original restrictions on these emergency use authorization pathways did not allow for that flexibility, and so there’s still certainly a number of regulations that these laboratories have to follow, and they must comply with a very high degree of complexity, et cetera, but that flexibility in the manufacturing, and development, and dissemination of those tests will play a huge role. There’s certainly more to it than that, but it’s been under very acute consideration for some time, and like Dr. Cawcutt said, going backwards just doesn’t make sense in these circumstances.

Kelly Cawcutt:

I would echo the same thing actually with our PPE use the capacity to use extended wear of masks or to use UV radiation to preserve masks, or to have different ways to disinfect our face shields, and to maintain the best and safest environment we can, when we go into another respiratory viral season where everything is also droplet spread, it’s still going to be masks, and eye protection, and N95s, and gowns, and gloves. And if we continue to have potential pipeline issues, we need to be able to preserve the capacity to have adequate PPE supplies used intelligently to conserve for the right scenarios, and to extend them as much as we can.

Megan Driscoll Greenstein:

I was just going to just say in general that our heading into the fall in Massachusetts I feel so much better about where we are because of our contact tracing capacity and our access to testing en masse. So, we’ve crushed coronavirus, and I don’t think we’re going to go backwards. I mean, we’re probably going to see spikes, that’s going to happen as we open up and people go places and things like that, and schools open. But I believe strongly that every person in Massachusetts that’s getting a positive coronavirus test and the amount of testing that we’re doing in Massachusetts is going to produce positive tests, and those people are being called within 24 hours, and being told to isolate, and being contact traced, and finding all the people that they’ve come in contact with.

Megan Driscoll Greenstein:

So, I really believe we’re going to keep ahead of these spikes. I am concerned about states that have not taken that seriously, and that they will see a massive resurgence in the fall, whereas I believe we will have resurgence, but I feel like we will be able to maintain and manage that, because we’re taking that part of testing and tracing so seriously here.

Monika Schneider:

And to that end, what are some issues or things that you’ve seen that have given you reason to be optimistic? And this relates to a question that we received about how you convince people that we’re going to get through this, what are things that we can take hold of as a positive example of making progress?

Kelly Cawcutt:

I will say that, and Megan has highlighted this beautifully, she was not a frontline health care worker, she’s been very involved with contact tracing, she was a patient, she is a phenomenal advocate to say, “This is what we need to do.”, and although I am disheartened when I see all of the information about people who don’t want to wear masks, who don’t think it’s appropriate or safe, one, as health care workers as physician we’ve worn masks every day for hours and hours on end, we’ve done this, and none of us are getting super sick from wearing masks before that.

Kelly Cawcutt:

But I think trying to get advocates to continue to help share the evidence, share the right information, to help lobby legislature, to get the right regulations in place, the right policies in place, to me, seeing the growth of interest and dedication to community health in the face of this is phenomenal. Personally, I will say the outreach from our families, from the people when we’ve lost patients who come back to support us when we’re taking care of the next round of patients is truly a testament to the human spirit going through something this hard, and is something that I can tell you our teams are beyond grateful for.

Megan Driscoll Greenstein:

We can do hard things. We’ve done hard things, we can continue to do hard things, and I firmly believe this is not forever, people aren’t going to get to not see their grandkids forever, we’re not going to be socially distant forever, our school’s not going to be screwed up through virtual learning forever, but this is a period of time we have to come together and work as one. We have to have each other’s interest in mind and be thinking everybody knows somebody who could die of COVID, everybody does, so we should be thinking about them when we are not being socially distant, when we’re choosing not to wear our masks, we can do the right thing. We don’t need policy, we don’t need the government to do the right thing, because we know what’s right, and we can do the right thing, and in turn we can crush coronavirus nationally if we make those decisions. And they’re not hard decisions, these are not hard things to do, and yet we can do hard things, so it’s possible.

Jaclyn Levy:

From an infectious diseases community perspective, and really a researcher and provider perspective overall it has really been incredibly heartening to see the speed at which collaborations have advanced all of these discoveries. As it was alluded to earlier, just the rapid advancement of telemedicine, which had been sort of long waiting in the wings, a lot of these things that were a little bit more bleeding edge a couple of months ago have really now made their way to the forefront. All of these papers that we’re drinking through a fire hose to try and consume, yes, the peer review is still outstanding, but somebody is generating this. There are teams and public/private partnerships, and collaborations coming together with people who have never worked with one another but have these overlapping interests, and resources that really supplement one another, and to see these collaboratories that sort of span research development, policy, and industry is what gives me hope at least that there will continue to be advances that help combat this wave, and then anything forthcoming.

Monika Schneider:

Great, well, on a more positive note, I want to say thank you for all of you, and see if we have any final thoughts before we wrap up.

Kelly Cawcutt:

My only thought is to say-

Megan Driscoll Greenstein:

Go ahead, Kelly.

Kelly Cawcutt:

… thank you to everybody for everything that they are doing, to continue to do the right thing as Megan mentioned.

Megan Driscoll Greenstein:

Yeah, wear a damn mask. That’s my … and honestly, I wouldn’t want COVID again. I got through it fine, I didn’t … but it’s fearful, you don’t know how your body’s going to respond to a virus you’ve never had before. There were nights where we had some chest tightness where I was like, “Does this get better? Does it get worse? Am I better tomorrow? When do you call the doctor? How do you know? Do you go to the hospital?” You don’t want that feeling, and even though we know more about it today than we did before, you have no idea how your body’s going to respond to this disease. So, you don’t want it. I just think wear a damn mask, it’s so easy. Just wear a mask.

Monika Schneider:

All right, well, thank you all, and thank you to everyone who has tuned in today.

John:

Thank you for joining us in today’s webinar. For upcoming webinars, and to request samples, visit researcher.sanguinebio.com. Enjoy the rest of your day.