The pandemic and rolling lockdowns were hard on us all — and it brought the subject of mental health to the forefront. In today’s podcast, we examine mental and emotional wellness during COVID-19, how society is coping, and the long-term ramifications of these challenging times.

TRANSCRIPT

Dr. Ronald Pies: I think it’s important to focus on what you can control and not ruminate about what you cannot control and to take good care of yourself.

Jeffrey Freedman: Welcome to the RP HealthCast. Science. Innovation. Life. One story at a time. And I’m your host, Jeffrey Freedman.

It’s wonderful that mental health and mental wellness are topics that are now, openly discussed. I mean, just a couple of years ago, these topics were taboo. They were off the table, but the change actually began. There were several actors and artists that publicly talked about their struggles with addiction, with anxiety, depression, and suicidality. This started opening up public discourse about mental health.

Now, the full year of the pandemic and the rolling lockdowns were hard. They were hard on all of us. And it really brought the subject of mental wellness to center stage. I mean, for some of us, this pandemic led to isolation. For others, it was joblessness. And for many, there were issues surrounding childcare, adult care, and homeschooling. I mean, there are just so many challenges this year, that have severely affected the mental well-being of so many people around the country, and around the world.

So, here we are, one year after it all began. And in today’s podcast, we’ll discuss and explore where we are today with mental well-being, how society in general is coping and what are the long-term ramifications from the pandemic.

My guest today is Dr. Ronald Pies. Doctor Pies is the Editor-in-Chief Emeritus of Psychiatric Times. He’s also a Clinical Professor of Psychiatry at Tufts School of Medicine in Boston and he’s the Professor Emeritus of Psychiatry at SUNY, Upstate Medical School, as well as being a renowned psychiatric author.

Doctor Pies, thank you for joining us today.

Ronald: My pleasure. Thanks for inviting me, Jeff.

Jeffrey: Today, we’re going to be talking about mental health and wellness. This past year, has been difficult on all of us. But it’s been difficult in different ways for different people, and we all process these issues very, very differently. Now, we’re one year into the pandemic. Can you talk to us a little bit about how the pandemic affected our mental health and what are some  statistics both here in the US and abroad?

Ronald: Well, first, thanks for inviting me to speak on this topic, Jeff. It’s an important one. And to answer your question, there’s good evidence that the pandemic has had adverse effects on mental health in many parts of the world. In addition, the pandemic has disrupted or even halted critical mental health services in something like 93% of countries worldwide. And unfortunately, at the same time, the demand for mental health services is increasing. So as far as the impact of the pandemic on mental health, let’s start with the United States.

Early on in the pandemic, the Center for Disease Control’s published a survey showing that in June of 2020, adults in the United States reported, and I’m quoting now, considerably elevated adverse mental health conditions associated with COVID-19, unquote. And using various screening instruments, the CDC survey found that almost 41% of respondents reported an adverse mental or behavioral health condition, including symptoms of anxiety disorder, depressive disorder, or trauma related symptoms, sometimes new or increased substance use, and thoughts of suicide. So that’s in the US.

As far as other countries, in the United Kingdom, a number of studies have found elevated rates of mood disturbance since the pandemic began. In one survey, 25% of the participants said that their anxiety and depression during lockdown had gotten significantly worse.

In Asia, there’s some evidence that maybe there are lower levels of distress in Asian countries. But in China, something like 35% of people were experiencing mental distress.

Jeffrey: All statistics considered. I mean, the pandemic brought about significant stressors. But let’s talk about the different age groups. So, different age groups have different issues and different problems; from children, to parents, to the elderly.

Ronald: Right. Well, there are actually some interesting age and gender findings, Jeff. For example, it’s a little counterintuitive, but most of the evidence suggests that the pandemic has affected older people’s mental health less severely compared with that of younger adults. But most of the data suggests that it’s the younger people who have suffered the most in this pandemic. Some people have speculated that as we age, we develop more resilience.

Just to touch on the age and gender issues. The Kaiser Family Foundation came out with a report in March of this year, finding that those hardest hit by the pandemic in terms of their mental health, have been younger people and women, including mothers with children under the age of 18 in their households, are among the most likely to report that stress and worry related to the coronavirus has had a negative impact on their mental health.

We also have data showing that among first-year college students, the prevalence of moderate to severe anxiety increased from 18% before the pandemic to about 25%, within four months after the pandemic began. And among these first-year college students, the prevalence of moderate to severe depression increased from about 21.5% to 31.7%.

So, we also have data from parents of teenage children. Researchers found that about 46% of parents of teens said that their child has been showing signs of a new or worsening mental health condition since the start of the pandemic, with teenage girls, more affected than teenage boys.

Jeffrey: Well, male, female, older, younger. I mean, it seems across the board, it’s pretty obvious that that these anxiety and stressors are there. So, what are some signs that people should watch out for to see if their mental health has become an issue? And when should they start seeking medical attention?

Ronald: Great question. Well certainly, anyone who’s experiencing symptoms of serious emotional or behavioral disturbances should seek professional evaluation, either by means of telemedicine, or in person, if possible, if it’s safe to do that. Some symptoms that I would worry about, would include feeling depressed nearly every day; the inability to carry out even simple activities of daily living like self-hygiene, showering, and so on; managing everyday chores; people who are experiencing consistently poor sleep, loss of appetite, significant weight loss, extreme or unrelenting anxiety, or panic attacks. All of these would be reason to seek professional evaluation and help.

Jeffrey: Yeah, and those are certainly the extremes before it gets that bad, right? If people are feeling anxious and stressed, before they go seek out medical attention, what can they do to self-correct without the medical intervention?

Ronald: There are a few things that are helpful. First of all, particularly for people who are kind of stuck at home, I would advise creating a schedule and a routine to structure their day. Don’t just stay in your pajamas or leggings all day.

I read an interesting quote from a young psychiatrist, actually third-year resident at UCLA, Dr. Anna Yap. Y-A-P. And she pointed out that as humans, we like to have something we’re moving toward and when we don’t even know when the endpoint of something is, which is true of the pandemic, how can we move toward that goal?

One way to counteract that feeling of just treading water, or killing time, is to change from your pajamas into clothes or moving from the bedroom to the living room to help you feel like you’re actually experiencing change during the day. These sound like very trivial minor things. But in my own experience, I think they can make a difference.

So my own recommendations for dealing with prolonged isolation and loneliness during the pandemic include first of all, exercise. Indoors or outdoors exercise is an excellent antidepressant. No side effects assuming that you’re in reasonably, good health.

And finally, finding ways of establishing some kind of community, whether that’s through Zoom sessions or phone calls or email. And of course, now as people are becoming fully vaccinated, it is becoming more feasible and safe for meeting with other vaccinated friends or family members. So that is, I think, a real positive that we’re seeing now, assuming we can keep these vaccination rates going.

Jeffrey: Now, has there been any other benefits for our well-being coming out of the pandemic or are we worse across the board?

Ronald: I would not say that we are all worse off in all respects. For example, there are people who clearly prefer working from home. It’s nice if you can do that, but of course, there are many people who cannot work from home.

There are also some interesting data from the UK and Portugal. Researchers there surveyed 385 caregivers, mostly mothers who had one or two children. And they found that as many as 48% of the respondents reported a renewed appreciation for their family during the pandemic. And specifically, the caregivers said that they were spending more time with their families and that this led to, as one participant put it, quote closer relationships and a better understanding of each other. So, that’s I think a plus for some people.

I’ll add that I’ve also seen some anecdotal reports suggesting that for some socially phobic or autistic individuals, the seclusion of the pandemic has actually provided kind of a safe haven in which they don’t have to face the social pressures they had to deal with before the pandemic. That may also be true for some kids who typically faced bullying or teasing in school prior to the pandemic. For some of them, the virtual schooling has actually provided a break from all that. So I wouldn’t say it’s entirely negative for everybody.

Jeffrey: Well, one year into this, we are starting to see the world opening up now with vaccines a little bit.

Ronald: Right.

Jeffrey: For those people that have had this sense of anxiety or dread. And I don’t want to say the serious cases, where they needed the medical attention, but living through life. And their life has gotten kind of difficult. Now that we’re opening up, can they expect for that to slowly go away on its own? Is there a light at the end of the tunnel for them?

Ronald: If we look back a year and compare it to how things are looking now, it’s kind of a mixed picture. On the one hand, with the end of the pandemic and side as millions of Americans and people elsewhere are getting vaccinated, it looks like the mental health impact has leveled off. For example, the March 2021 Kaiser Family Foundation report found that about half of adults, about 47%, continue to report negative mental health impacts related to worry or stress about the pandemic. But that’s actually a little lower than the 53% who reported these negative effects in July of 2020. It’s not a big decrease from 53 to 47, but it looks like some of the adverse effects are leveling off, maybe as people become more hopeful about vaccinations, and so on.

On the other hand, there’s evidence that a lot of people are experiencing what’s being called pandemic fatigue, which is considered kind of a burnout syndrome. At this point, there are people who are just tired of being cooped up, tired of restrictions, tired of bands on indoor gatherings, tired of wearing masks, tired of physical distancing, and are basically fed up with the so-called, New Normal.

So it’s really a mixed picture. Generally, things seem better in terms of mental health, but there’s also a lot of feeling like when is this thing going to be over?

Jeffrey: Dr. Pies, thank you so much for your time today. This has been highly informative. We very much appreciate it.

Ronald: My pleasure. Thanks for inviting me, Jeff.

Jeffrey: RP HealthCast. Science. Innovation. Life. One story at a time.

Dr. Pies Bio and links to some of his articles:

Ronald W. Pies, MD, is Professor Emeritus of Psychiatry at SUNY Upstate Medical U. in Syracuse, NY, where he is also Lecturer on Bioethics & Humanities. Dr. Pies is also Clinical Professor of Psychiatry at Tufts. U. School of Medicine in Boston, and Editor-in-Chief Emeritus of Psychiatric Times. Dr. Pies is the author of several textbooks on psychiatry, as well as works of fiction and poetry.

Links:

https://www.psychiatrictimes.com/view/one-year-with-covid-19
https://www.psychiatrictimes.com/view/are-we-really-witnessing-mental-health-pandemic
https://www.psychiatrictimes.com/view/psychiatry-dark-night-soul

Susanna Pollack: We are seeing that after the last 5 years to a decade of researchers, scientists, and universities, that have been conducting clinical trials and longitudinal studies, about the efficacy of games as digital therapies are now being released. The industry is now in a position to present games to clinicians and the public as viable treatments to address real healthcare concerns. 

Jeffrey Freedman: Welcome to the RP HealthCast. Science, Innovation, Life. One story at a time. And I am your host, Jeffrey Freedman. On this episode of the RP HealthCast, digital therapeutics, and how gaming and digital applications are becoming prescriptive therapy. The term digital therapy, it sounds like a very new age or holistic self-help way to make you feel better, but this could not be further from the truth. We have been easing into this world of digital therapy for many years now, and it has slowly become part of our everyday lives. We have been wearing fit bits or apple watches for several years, and these devices that originally told us how many steps we are taking,now can actually track our sleep patterns and our heart rates. We have been using apps to track what we eat and measure our calories, but during this pandemic, we have been using apps to even visit our physicians without leaving our couches. And also, this past year, the FDA approved the first ever digital application or game to be given by prescription from a physician to a patient. And new technologies like virtual and augmented reality, allow us to simulate real-world situations in safe environments, to explore things like teaching surgeries at a medical school, or even to better understand climate change or social injustice. Digital technology is certainly coming of age. And companies in this space are looking to solve some of the world’s largest healthcare issues, such as diabetes, congestive heart failure, obesity, and Alzheimer’s disease. To help us better understand this complex technology, I spoke with 3 experts in the field: Susanna Polack, the President of Games for Change. They are a nonprofit that empowers game creators and social innovators, to drive real world impact through games and immersive media. Dr. Walter Greenleaf, a behavioral neurologist and a visiting scholar at the Stanford University Virtual Human Interaction Lab. And Noah Falstein, a gaming industry executive and previously, Google’s chief game designer. Susannah, thank you so much for joining us today. Can you tell us a little bit about Games for Change, about what your corporate mission and your goals are? 

Susanna Polack: So Games for Change is a non-profit that has actually been around for quite a while. We have been around for 18 years, and have more or less grown up with a growing understanding that games can have a power beyond entertainment. And as an organization for the past, almost 2 decades now, we have been advancing this concept that games can be used as drivers for social impact, and across different sectors. So whether games can be used in education, in classrooms, to teach for math games, for young people, to games that are used to create build awareness around global issues, or in other contexts about how games can be used to help ensure wellness, and in some cases, address illnesses and conditions in the health industry. So one of our flagship programs is The Games for Change Festival, which we have been running for 18 years. So at the festival which this year will be virtual, for the second time, and offered free for the second time, will be held from July 12th to the 14th, and it’s 3 days of packed programming, where you can sample talks, panels, workshops, around one of the topic areas you might be interested in. 

Jeffrey Freedman: Now in terms of health care, and the way games can change the way we view ourselves, and the way games can be used to actually monitor our health, there has been a lot of development in this area. Now, there are both prescribed games, and then there are health care application type games. Now, I noticed on your website, you had a game that you are highlighting, and it is called Gris. Can you tell us a little bit about that? 

Susanna Polack: So Gris is a beautiful game that was made by an independent studio. It has won some terrific awards, including The Game with the Most Impact by The Game Awards, which is like the Oscars of the video game industry. The game itself follows a girl whose name is Gris, who wakes up in the palm of a crumbling statue of a woman. It is a beautifully designed game, which is one of the areas that kind of just draws you in, but the fact that it also deals with issues about revisiting childhood about memories, about relationships with your family, it deals with mental health issues, and it kind of pushes your imagination in a way that one, is just joyful, but also reflective. It stands apart from just an entertainment based game, to a place where you can actually explore grief, emotional well-being, and a lot of self-reflection, which is not necessarily what you would expect from a video game, but still find it incredibly rewarding to play, right? Like you feel like you have gone through an experience, you have enjoyed yourself, and you come out of it with a unique kind of perspective. 

Jeffrey Freedman: It is fascinating, that there is a whole ecosystem and infrastructure preparing us for the future of this health technology. It is a future where technology can have such a social impact and bring about real change. So, to further explore the convergence of technology and our well-being, I spoke with Dr. Walter Greenleaf. Dr. Greenleaf is a behavioral neuroscientist and a professor at Stanford University, and a visiting scholar at Stanford’s Virtual Human Interaction Lab. Walter, why don’t you tell me a little bit about your work at Stanford University first? I mean, what is the Virtual Human Interaction Lab? 

Dr. Walter Greenleaf: It is a research group at Stanford, founded by my colleague, Jeremy Bailenson. And the focus of the lab is to look at how immersive technologies, augmented reality, virtual reality technology, and mixed reality technologies and others, how our behavior is affected by the use of these environments, and also how these very engaging environments can be used to both measure attitudes, and moods, and cognitive states, and also influence attitudes and moves in cognitive states. So some of the example projects are how we can use virtual reality to measure, and perhaps increase empathy for people who are in a different social status situation that we are in, or from a different age or ethnic background. Other examples might be how we can increase understanding and awareness of the effects of carbon dioxide in our atmosphere, on ocean acidification. Essentially, the power of virtual environments is that we can create an experience, and through those experiences, people learn, and people change their attitudes, and that is what we study at the lab. 

Jeffrey Freedman: Walter, why don’t you set the table for us about what the topic is today, which is digital therapy? Can you define that for us? What is digital therapy? And are these devices, or are they apps and games? And are they supposed to replace a healthcare provider, or actually heal somebody? 

Dr. Walter Greenleaf: Well, we are entering into an era where, I would like to say that the continents are colliding, that the advent of some of the technology titans to get into health care, such as Apple with their Apple watch for cardiac monitoring. What used to be some hard lines of division, there was a big Pharma industry, and the medical device industry, and now, it is getting mixed up with so many other players coming in to improve the way we provide health care, and that line between consumers interest in health and wellness, and clinician’s interest in seeing and working to help a patient improve, it is sort of blurring. Consumers are now becoming more engaged and interactive with their healthcare journey. And through the advent of some really powerful technologies such as wearable sensors, machine learning, to make sense of all the data, the use of the heuristics from the entertainment and gaming industry, to help make some of the applications that are used in healthcare, promote adherence, so people will stay with the often difficult thing they need to do. It is really evolving quite fast, and we are seeing the advent of combination therapy, where a medication might be used in combination with a digital app. We are seeing the combination of medical devices, with platforms that are used to collect information both before, during and after the use of the medical device. So what used to be separate zones are merging in a very powerful and meaningful way, and it is also happening very fast. 

Jeffrey Freedman: So as a consumer, as a patient, as somebody that is in need of healthcare assistance, how do I know what is right for me? I mean, there are so many different options and choices. 

Dr. Walter Greenleaf: That is such an excellent question, it is a bit of the Wild West. One can go to different websites and sign up for different programs, one can download apps through the Apple App Store for example. There are some really amazing products on their way that can make a big difference in some difficult problems, like multiple sclerosis, or stroke rehabilitation, or addressing anxiety and depression. It is fantastic that there are such powerful, innovative solutions out there right now, and on their way to come out in either another stronger format, but it is hard to identify which ones are the best. And because digital healthcare apps are not always in the zone that is regulated by the FDA, because they are more often in the health and wellness arena, it is hard to see which ones are the best, which ones have been vetted and accepted. I think there will be eventually an evolution of curated platforms, where clinical societies or groups that are looking out for the benefit of the user, will sort out, and score, and evaluate some of the existing systems that are out there. But right now, it is very difficult to identify those that are the best. 

Jeffrey Freedman: Now, you mentioned that a lot of these applications are not regulated. I know there are some apps that are FDA approved, and I believe Akili has an app called EndeavorRX, and that certainly crosses the line from a wellness app or a medication reminder. Now, what is the difference? I mean, why do they need to be FDA approved? And what are they trying to do, versus the app you could download from the App Store? 

Dr. Walter Greenleaf: The difference is validated clinical claims. If a product, like the one that you just mentioned by Akili, wants to make a claim that it can be effective as a treatment for a particular clinical problem, then they do need to go through the FDA review process. On the other hand, if a product wants to say that it improves your mood or it helps you reduce feelings of worry, that is very different than saying it cures depression or it treats anxiety. In order to be able to make those stronger claims, you need to have taken the trouble to do the hard work of validating through research. What I think will make a difference though, is that now that many of the pharmaceutical and medical device companies are getting involved in this arena, they have both the resources, financial resources, but also the expertise on how to conduct clinical trials, how to validate an intervention. We are in a better position now to create a dynamic healthcare system that extends beyond the clinic, and allows the clinicians to check in with patients and see how they are doing, that’s not every 3 weeks. Information flows in when people elect to provide it, to use a metaphor from the gaming arena, it can be a quest, with people assisting you along the way. So instead of having these very punctate experiences that are limited in time and space, it becomes something that the patient or user can participate in an active, engaged way to take agency over their healthcare journey, and have a more dynamic interaction with the healthcare system. I think that is going to really change things quite a bit, to be able to have the user or patient have more information, to have more points of contact, and more powerful tools to help them along their way.

Jeffrey Freedman: Walter and the Virtual Human Interactive Lab are doing some amazing work in bridging the gap between the real world and the virtual world, to potentially solve some of the planet’s biggest issues from social inequity, to climate change, to curing disease. To better understand how gaming, in particular, can affect our health, I spoke with one of the world’s leading game design executives and thought leader, Noah Falstein. Noah, aside from being a game developer himself for over 20 years, recently left Google as their chief game designer, to focus his time solely on health related projects using gaming or gaming technology. Noah, thank you so much for joining me today. Now I spoke with Dr. Greenleaf earlier about his work at Stanford University, and he kind of set the table for us about what digital therapeutics are all about. Now you, among many other things, are a lifelong game developer, and you approach things a little bit differently than him. Technology has obviously changed dramatically over the 20 plus years that you have been programming and being part of game design. So, the question is, are we having that tipping point of being able to meld serious medical therapy at home, at your fingers, on our phone, or phone devices? 

Noah Falstein: Absolutely, I think the technology has been advancing so rapidly on a lot of different fronts, and they all are complementary to each other. So certainly, computers in general, and what I do with video games, is worlds apart from what I did at the beginning of my career. It is just mind-boggling to me how many orders of magnitude, faster, and more memory, and all the other things we have. At the same time, medical imaging, a lot of medical science devices, particularly things like EEG and FMRI have also been advancing. And it feels to me like we definitely have hit, not necessarily a tipping point, but certainly a minimum level of quality on all those things together, that we were able to do some amazing things, and if it is anything like the games industry that is just going to continue to accelerate and get better, over the next few decades. 

Jeffrey Freedman: As you say, things have been advancing. Now, what are some examples? What are some innovative examples that you have seen? I mean, you are there day-to-day. So what are some great examples of digital therapeutics or gaming that helps the healthcare of individuals? 

Noah Falstein: Well, there are so many now, the one that I have been most directly, and I would say, long-term involved with Akili Interactive. They are currently cleared by the FDA, for doctors to prescribe their video game that they make to treat teens with ADHD. It’s very exciting for me to see that because I started working with Dr. Adam Gazzaley on this. Actually, on our predecessor, that moved into this about 12 years ago, and it has been a very long slog, the FDA clearance just came in last year, and even now they are still scaling up, because getting doctors to prescribe a video game as treatment is a big deal. But that is a great reflection of what I was just saying because Dr. Gazzaley, he was head of brain imaging at UCSF, and the kind of work he was doing, seeing what is happening in brains as people are multitasking, was really at the foundation of him turning to video games as a way to do testing, and then treatment for exactly those kinds of disorders. 

Jeffrey Freedman: Well, what are the limitations of these types of games? I mean obviously, you have to be under the prescription, under the guidance of a healthcare provider. But what does the game actually do for the individual? How does it make them better? 

Noah Falstein: Well, the majority of these games are treatment oriented, because a treatment is only one of the modalities that games and health are using, but when they are treatment oriented, tends to be for neurological issues, anything from ADD, ADHD, to PTSD, to depression. Just mood elevation in general, all sorts of things along those lines. I do not expect that we will see a game that will treat cancer directly. I did work on a game that helped teach teens why they need to stick with their chemotherapy regimen, when they have had cancer and are trying to recover. So it is that kind of thing. One of the major limitations is that it doesn’t no change your chemical makeup, except to the extent that your brain can do that itself. But neurology, things that the brain can do, are still pretty amazing, and so many things, the ones I mentioned and many more that can be treated that way. I am really excited that it will continue to expand and find new areas in all sorts of brain oriented areas that can be improved. 

Jeffrey Freedman: I guess with the advancement of virtual therapy, virtual reality, and augmented reality, the brain takes on a whole different approach. So where does it end? I mean, where does it begin? What is real? I guess from the study of psychology or psychiatric disorders, that could be quite helpful. 

Noah Falstein: Yeah, one of the earliest ways that VR was used, even back around 20 years ago, when the quality of VR was much lower, was for treating post-traumatic stress disorder or phobias by putting people into environments where they experienced a trauma, or something that they are scared of, and letting them gradually desensitize by starting with something very simple and scaling up from there. It is kind of one of the simplest ways of doing that. But virtual reality, because it takes the whole world away from you and presents you with a world completely under control of the clinician, it’s very powerful that way and it seems to affect people’s emotions more strongly than most other media that we have encountered. 

Jeffrey Freedman: Alright. So if you were to have a crystal ball, and to look out 3 years into the future, where do you see the industry going? 

Noah Falstein: Well, I think there are a lot of really exciting things that people miss when they think about digital therapeutics, or specifically, I will just talk about the combination of games and digital therapeutics that is my specialty. People hear that, and they think oh, this is something for kids, or this is something where the games can maybe make people feel a little calmer or distract them. But it goes so much beyond that, beyond, in the sense of treatment as I have already mentioned. But there are companies that are using games to train physicians and caregivers in really innovative ways. I would say, my totally informal and unscientific survey, has been that it seems that at least 90, if not 95 percent of recent graduates of med school were video game aficionados somewhere along the way. So it is really natural for a lot of them to continue their studies that way. An area that has just barely begun to be touched upon, that I think we are going to see a lot more of, is using games, possibly everyday entertainment games, with special modules that will measure how people are using them, and how their keystrokes on a keyboard or their use of game controller or joystick, is changing over time to diagnose the possible early onset of degenerative diseases, things like Alzheimer’s or Parkinson’s, but also just neurological things that hit people at any age that can be picked up by the different ways that people actually play those games, or the kinds of speed and accuracy of their keyboarding. So those are just some of the areas that I would not be surprised if it becomes a normal thing for many games to include that kind of diagnostic information, with people being able to opt in if they wish to be able to be told if they find some reason that they might want to check with the doctor about their conditions. 

Jeffrey Freedman: I would like to thank our guests today, Susanna Polack, Dr. Walter Greenleaf, and Noah Falstein, for giving us a well-rounded perspective of how technology and gaming is helping to lead us to better health outcomes. To learn more about them and the projects they are working on, please check out their bios and their links in our transcript. RP HealthCast. Science, Innovation, Life, one story at a time.

This episode explores how artificial intelligence and machine learning allow biopharmaceutical companies to quickly and cost-effectively bring new products to market. This exciting new technology unlocks the door for discovering therapies in rare diseases and other unmet medical conditions that were once too costly and time consuming to develop.

TRANSCRIPT

Dr. Solomon: As opposed to high throughput screening and other ways that are more laborious on one hand and non-obvious on the other, that AI might take us to the promised land if you will. Better, faster, cheaper simply by doing predictive work. It is like in the game Go or like in Chess, AI allows machines to win. 

Jeffrey Freedman: Artificial intelligence or AI and machine learning are two buzz words that sound like they are out of a science fiction movie. But in fact, this advanced technology is reshaping the way biotech startups and big pharmaceutical companies are conducting their drug discovery and drug development programs. 95% of rare diseases don’t have a single FDA treatment. The reason for this is traditionally pharmaceutical companies don’t focus their efforts on treatments for these types of diseases because the return on investment or ROI, doesn’t warrant the time and the cost it takes to develop these therapies – it’s just too expensive. So the need for a technology that can lower the cost for drug development and shorten the time period to bring a therapy through clinical trials is huge. 

Welcome to the RP HealthCast. Science, Innovation, Life. One story at a time. 

And I am your host, Jeffrey Freedman. 

First, to get a better understanding of AI, I spoke with Ed Miseta, the executive editor of Clinical Leader and Life Science Leader magazine. Ed, can you start us out here? Let’s start with the basics. What is AI and how does it work? 

Ed: So, if you were to go online and look up the technical definition of that, I think you would see something about that it is a science that is building smart machines that can do things that would typically require human intelligence. But I like to flip it around instead of saying what is AI to look at it from the perspective of why do we need AI and why is it important. So if you have a certain amount of data and we need to look at this data and pick out some trends or information from it. If you have a small amount of data, that is not difficult. So, for example, if you had information that said – here are the temperatures in Chicago for 365 days of the year and here our sales of ice cream on those same 365 days. Anybody could easily look at that and say oh, okay, so it looks like when the temperature got warm, we sold a lot of ice cream. When the temperature got cold, we didn’t. That is pretty simple to do. Plug the information into Excel, create a graph, and you can immediately see that. But what happens though when you have lots of data, hundreds of variables and millions of data points that you are looking at, you quickly get to the point where you have this big data problem where you have so much information that it is impossible for a human to look at that and be able to pick out trends or information from that data. This is where you need a computer to basically take that data, and where we can tell it here is what we are looking for – here is what we want you to find. And let the data or let the computer go in and look at all that data and see what it can pick out from it. The more exciting part of that is the machine learning part, where if that computer comes back to us with some results that are not what we are looking for, that we can actually tell it okay, this is not what we were looking for and here is why. And then the machine gets smarter and then in the future it doesn’t make those mistakes and can basically come up with better information for you.  That I think is necessary right now in Pharma, because in Pharma, we do have a data problem. The number of trials is growing. The number of data points we are collecting is growing. We are getting data now from sources that we never have in the past. Patients are wearing smartwatches and they are supplying data. Patients are writing in an electronic diary and submitting that. All these wearable devices and things that we are using in trials now that we didn’t in the past, all that is creating massive amounts of data that have to be looked at and obviously analyzed. I think I read something recently that said the amount of data being collected in clinical trials is growing by 40% per year. That is a lot of data, and that is something that is absolutely going to require some type of AI solution. 

Jeffrey: Yeah, that is a fantastic explanation and really allows us to visualize, if you will, exactly what the technology is. But I guess now we are at the question of “so what”, right? So it can look at the data. What does it do with it then, right? So let’s take practical examples. How can you say it can transform the pharma industry by looking at the data? What does that mean? How does that help pharma or biotech companies?

Ed: Predictive capabilities. I had one person describe AI to me as a telescope that allows you to look into the future. And if we can use AI to look ahead and see things that we otherwise would not be able to see, that is going to be basically a huge win for the industry. There are three major problems that clinical trials face. Number one is that they are too expensive. They cost way too much money. Second, they take way too long. But of course the longer a trial takes, the more it is going to end up costing. And then finally, it is that we have too many failures. And of course when you start doing a trial you get so far into it, if it fails and doesn’t work out then again that is a lot of time wasted and a lot of expense. I have seen predictions that will tell us the cost of a clinical trial averages I think about $2.6 billion dollars. So patients complain about how costly new medicines are. If you perform all these trials and have one drug that makes it to market, you not only have to pay for the research that went into that one. But you also have to pay for all those failures and all those drugs that we took to trials that didn’t work out. Therefore, instead of starting that trial, having trouble with the recruitment, canceling it, having it be a failure, we know ahead of time exactly how to conduct this trial before we even get into Phase 1. We know exactly how to run this trial that will give us the highest probability of success, which will lessen the timeline and reduce the cost simply by using AI to look into the future and project these things that we need to know. 

Jeffrey: Now that Ed gave us a better understanding of AI and machine learning, I wanted to speak with someone that is at the forefront of developing AI models for various aspects of drug development. So, I spoke with Dr. Olga Kubassova. Dr. Kubassova is a mathematician by training, and then received her PhD in the area of MRI Algorithm Development. She is now the founding scientist and CEO of IAG. Dr. Kubassova, thank you for joining us today. Can you tell us a little bit about IAG and how your DYNAMIKA platform is levering AI and machine learning in drug development. 

Dr. Kubassova: IAG is an image analysis group. We came into this industry over 13 years ago, quite some time ago, with an idea that we are going to bring quantitative image assessment into drug development. What does it mean? It means that we will replace or enhance the way medical images are analyzed by the human eye using computer science or mathematics. So we created a platform called DYNAMIKA, which incorporates a library of state-of-the-art and AI-driven methodologies. 

Jeffrey: To break it down a little bit, can you give us a real world example of how this is being used? 

Dr. Kubassova: So if you look at the assessment of quite sophisticated MRI scans, let’s say in solid tumors or neuro-oncology indications such as glioblastoma tumors. When a patient is responding to a treatment, it is not a very simple way to respond to treatment. So with advanced therapies, which are currently being developed, the tumor might not necessarily shrink. We would expect with traditional chemotherapies for the tumor to just go down in size and that would be indicative of a patient reacting positively to a therapy. However, today when we develop immuno-oncology therapies, or you are developing something which will activate your immune system, your tumor may get larger in size when we look at it in the image. However, though it does get larger in size visually, that size does not necessarily represent the tumor itself. It may represent inflammation around the tumor. It is literally impossible for a human eye to look at it and start saying, “Oh, yeah, this is inflammation and this is a tumor.” Because it gets quite sophisticated. So where AI plays a critical role here is really appreciating what each of the images is showing us. It is not recognizable by a human eye, but it is recognizable by a machine and interpretable by a machine. AI helps you to choose the combination which is most likely to succeed. The purpose of AI is really that fast, speedy choice and more targeted precise choice. We want to analyze the data related to patient response in a way that the human eye can’t possibly see. 

Jeffrey: To better understand how AI is being used in the drug discovery process, I spoke with Dr. David Horn Solomon, the CEO of Pharnext. Pharnext is an advanced clinical stage biotechnology company that leverages its artificial intelligence based Pleotherapy platform to develop novel first and class therapies for orphan and common diseases with high unmet needs. Dr. Solomon, thank you for joining us today. Can you tell us about Pharnext’s Pleotherapy platform and why it is important to your drug discovery program? 

Dr. Solomon: Our platform for drug discovery that uses AI really tries to leverage the ideas of Polypharmacology, the idea that multiple medicines often might alter different defective biochemical pathways in diseases and extract a better result for patients and ultimately their families. And so, we are focused on combination medicines that address the complexity of disease. That disease is sometimes caused by single genetic hits but is often caused by defects in multiple biochemical pathways. And so, when you have to sort out these pathways using traditional means, it is often not obvious. And using AI and Big Data, we are able to actually map, all the genetic pathways, all the biochemical pathways in any given disease given a search of the literature. And then ultimately we are able to use AI to start to map which of these pathways needs tweaking, and therefore which pathway is targetable and therefore which medicines we can develop against those pathways. And by doing that using AI in a predictive mode, we are really able to start to develop new approaches to medicines that are nonobvious and also innovative.

Jeffrey: Pharnext appears to be reaping the benefits of the platform. The late-stage therapy for Charcot-Marie-Tooth 1A in the second phase three trial, and you have another candidate in clinical trials for two other neurological indications. So now I think you touched upon it. But how would you say the use of AI has benefited Pharnext? Could a biotech such as yours with limited resources attempt to develop products in three indications like this without the use of AI? 

Dr. Solomon: It is much harder because you have to have much larger staff or much more robust high throughput screening to test a lot of the hypotheses that come from understanding the myriad pathways that are defective and how tweaking the right ones can get a good result and therefore cheaper. It is really the speed to get to the clinic that matters because you can spin your wheels in early discovery, not get to the clinic well or rapidly, and that is to the detriment of your shareholder value and ultimately of patients benefit. And so, we think AI here really helps us do this better, faster, cheaper as they might say. And we have done that now not only in Charcot-Marie-Tooth, but as you mentioned also now in Lou Gehrig’s disease and ALS and also to some extent in Alzheimer’s disease. 

Jeffrey: Now, it seems like you are focusing in neurological. Is that specific for your AI platform, or is that just areas that you are interested in as a company? Does AI tend to help in one area versus other therapeutic areas? 

Dr. Solomon: I think the AI approach here is agnostic to disease or indication. But we also have to marry our discovery platform in our development opportunities with commercial opportunities. What is feasible and what will ultimately benefit patients, especially with an eye to think about patients? Where is there diseases where there is no current therapy. And obviously ALS is a good example of that. Charcot-Marie-Tooth is clearly there. These patients are on an unstoppable downward decline. When you ask patients, whether it is in New York or Paris or even in the Amazon rainforest, they all say the same thing and that is that today will be the best day of my life because after this it is all downhill. And so, we think that our approach can actually be amenable to diseases where there are no current therapies. And so, that is why we picked those diseases. We also think that there is a significant value for stakeholders or shareholders in these approaches versus cardiovascular disease or diabetes, for example, where there are good existing medicines that are cheap and effective.

Jeffrey: What is next for Pharnext? 

Dr. Solomon: Well, keeping along the lines of neurologic disease and again, no promises because we are still in early, early discovery mode. But diseases like myasthenia gravis, they don’t change life expectancy but they make life really miserable for patients and their families, is one area we are very interested in among others. And so we look at the diseases. We look at where our platform is amenable to addressing those diseases and how we might come up with combination medicines. Another opportunity by the way is partnering with other pharma and biotech companies that might have a good medicine, but is not first in class or a leader, a best-in-class. And therefore by adding on adjunct medicines in combination with their existing medicine through perhaps a licensing agreement, we might be able to come up with a best-in-class therapeutic combination in a number of diseases. And so, we are pursuing this approach as well.

Jeffrey: Very interesting. So that is next for Pharnext. Where do you see AI or machine learning going in terms of drug discovery and drug development? 

Dr. Solomon: Well, tremendous, tremendous opportunities, just like we are seeing the expansion of AI in other areas. Not only can AI really help figure out how molecules connect to their targets, their receptors with incredible fidelity through a lot of mapping and predictive methods. We think the same is true in AI to develop new medicines. And so, we see many examples of these in the literature now and we think as opposed to high throughput screening and other ways that are more laborious on one hand and nonobvious on the other, that AI might take us to the promised land, if you will, better, faster, cheaper, simply by doing predictive work. It is like in the game Go or like in chess, AI allows machines to win. Where here to for, they weren’t able to in the human mind was better in terms of building experience and ability to challenge an opponent. So the same is true in drug discovery and we think in the next generation, AI will be a key tool. Again, it is a tool. It is only as good as you apply it. And so, if you apply it to the right diseases with the right thinking with the right molecules with the right targets, I think drug discovery can be greatly aided. 

Jeffrey: I would like to thank our guest today Ed Miseta of Clinical Leader, Dr. Olga Kubassova of the Image Analysis Group, and Dr. David Horn Solomon of Pharnext. I would like to thank them for giving us a well-rounded perspective of how artificial intelligence and machine learning is revolutionizing the way new drugs and therapies are coming to market. 

RP HealthCast. Science, Innovation, Life. One story at a time. 

The RP HealthCast is back! In our season two premiere, we speak with a scientist, researcher, and medical journalist about the devastating effects experienced by “long-haulers” — a growing group of people who still suffer from COVID-19 symptoms months after being infected.

TRANSCRIPT

Natalie: And I think what the world really needs to know is that for many people, COVID-19 is so much worse than the flu. For some people, COVID-19 turns into a debilitating chronic illness that we don’t understand yet, that we don’t have any treatments for, that is primarily invisible. And, you know, they’re having a hard time getting support from family members who don’t really understand what they’re going through. They’re having a hard time getting time off of work that they desperately need to feel better because rest is one of the most important things for this illness. It’s going to be, you know, a huge number of people and a very large percentage of those will have these long-term health problems. We need to support them now.

Jeffrey: Welcome to the RP HealthCast. Science, Innovation, Life. One story at a time. And I’m your host, Jeffrey Freedman.

Jeffrey: Coming up on our first episode of season two, we’ll be discussing the devastating effects of COVID-19 long-hauler syndrome and how it’s affecting millions of Americans.

Jeffrey: Dr. Anthony Fauci has said that the next health crisis our country may face, may be dealing with COVID-19 long haulers. In this episode, we’ll answer a couple of questions related to this such as what it means to be a long hauler? And what are these patients going through? Now to help answer these questions, we have several experts lined up for us to speak with. We have a medical researcher; Dr Natalie Lambert of the University of Indiana School of Medicine. We have a scientist, Dr. Mari Mitrani, the Chief Science Officer of Organicell Regenerative Medicine. And we have a medical journalist, Heather McKenzie of Biospace. Now let’s start with what is a long hauler? I talked to Dr. Natalie Lambert, associate research professor of medicine at the University of Indiana School of Medicine.

Natalie: Well, exactly how to define you know, who is a long hauler and who isn’t is something that is still very much for up for debate and part of it is because we only have about a year’s worth of data to understand what the long term symptoms are, and what the health impacts are, but we’re starting to zero on some particular things. So first of all, you know, if you look at the CDC’s website, it says that if you have a mild case of COVID you could expect to recover in about two weeks. So, it starts to tell us that people are taking longer than two weeks to feel better. They’re starting to get into that long haulers zone. From what I’ve seen is that, most of the people that I’m collecting data on they’ve been sick for actually many, many months. People are starting to settle out around perhaps after about 21 days. We could say that things haven’t resolved like we would expect for a viral illness and people are now long haulers. I think that we’ll have, you know, a medical definition soon, but to me, if it’s been over a month and you’re not getting better from COVID you are definitely a long hauler.

Jeffrey: Now that we have a better understanding of the disease. I wanted to speak with people that are actually on the front lines of finding a solution for these patients. I spoke with Dr. Mari Mitrani, the Chief Science Officer at Organicell Regenerative Medicine in Miami Florida. Organicell was recently identified by a number of leading publications as a pioneering biotech in this area and they’re working at the forefront for a therapy for long haulers. Dr. Mitrani, we’ve heard that you and Organicell are working on a therapy for a long hauler syndrome. Can you please tell us a little bit about the program?

Mari: We’ve developed this drug. We’ve been working many years in the biological or stem cell regenerative medicine space and we’ve been able through all of these years, manufacture a drug that can be consistent and that can actually have results in different things. So we’ve been – before the pandemic came, we were working with lung injury models and our work for COPD or the which is in adult problems where the lungs just start to degenerate or start to die little by little. So, that has been our focus in Organicell for many years besides the lungs, we’ve also been trained to pain or osteoarthritis, but the lung in the specific we’ve had many models with the BPD – bronchopulmonary dysplasia. So, those were our preclinical trials that led us into what we were able to file for COVID specifically, this last year in 2020.

Jeffrey: It’s interesting as we learned so much about COVID and the signs and symptoms that the patients have. Now, it seems that this syndrome has so many disparate symptoms. Now, how can one therapy address all of the symptoms?

Mari: Well, very interesting. Thank you, Jeffrey, for asking this. The protocol that was approved by FDA for our therapeutic, is an intravenous application. When you are putting a drug intravenously, you’re putting it in the entire system in the bloodstream, right? So, even though all of our therapy is centered to modulate the genes through the microRNA for the acute respiratory distress syndrome that COVID develops, we also have seen that the rest of the organs suffered this super inflammatory cascade and it’s so unique, little do we know about this virus? It’s only been one year and the whole medical and scientific community keeps learning day in and day out. First, understand what the acute infection was. I think we are all working towards finding new therapeutics, the preventative side of the vaccine and now, we are learning about the aftermath.The aftermath that is super different in every individual because the immune system reacts to that virus differently and it not only reacts in the lungs. We are, and I think throughout the years we will be coining this kind of viral infection as a multi-organ infection. So, depending on the specific individuals that immune system will react – totally specific for that Individual on the immune system. So, some people only experience symptoms in the lungs. So, you have a cough. Some people only have diarrhea, for example, they don’t have any of the upper respiratory and interestingly enough, we are working with cardiologists that are seeing twenty to forty percent of those patients – they are finding problems or echocardiogram findings in the heart that are not normal. So, imagine we’re talking about the heart, the lung, there’s digestive problems, neurological problems as well. We’ve seen these long hauler group of people that are experiencing fatigue, and fatigue that is an on-set already diagnosed – there’s a name coined already for this kind of problem. So, Jeff it is very very interesting what we’re finding, what we keep investigating in, researching, because this viral infection is not that we are treating the virus itself. We are going to treat the aftermath of what our soldier – our immune system is reacting to this virus.

Jeffrey: Right. Right now, you’re still in early FDA trials and I get that, so we can’t discuss that but can you give us a case study of maybe what you’ve seen in one of your patients because I know you’ve done some emergency I&D work.

Mari: Yeah, so as soon as we got the approval for our trial, our placebo-controlled double-blinded trial early in April. We were able to submit many emergency or compassionate use I&D’s. These are specifically for single patients, where we can treat the patient under FDA approval and we were able to submit and get approval for eighteen different cases. From those eighteen cases, we have four that are approved for long haulers specifically and we were able to understand how our drug will potentially be able to work in these cases. Inflammatory reaction or overreaction of the body setting in different organs is what we are really trying to target in to see. So, our work in Organicell is to apply for this future broader trials, even though we have information on single patients, the goal is always to get bigger trials ongoing and that is our goal for this first quarter of 2021.

Jeffrey: Right. So, since you’re currently finishing up your initial clinical trial and your Phase 1 trials, how can patients get access to this therapy? When do you think you’ll be much broader in national trials?

Mari: Well, as of right now we are accepting those emergency cases where only physicians can request this kind of trial. So, have the physicians from the patients reach out to Organicell directly, to do those emergency cases but sooner we will be able to start enrolling for the long hauler trial specifically. Right now, we are enrolling in two different trials for the acute phase of COVID which are the mild cases and then moderate to severe cases. So, that’s where we are sitting and what we are willing to see in the future.

Jeffrey: Organicell’s work seems very promising. But just as there’s a need for more than one vaccine. I’m sure there will be a need for multiple therapies for post-COVID issues as well. To better understand what other long hauler therapies might be out there. I spoke with Heather McKenzie, a medical writer for Biospace. Heather’s been covering the pandemic for Biospace and has provided in-depth reporting on long hauler syndrome. Now Heather, it’s been reported that there may be up to two-and-a-half million patients in the US with post-COVID issues. What have you found in your reporting both here in the states and globally?

Heather: Yeah, and that does not surprise me. I’ve heard so many people, you know talk about this and you know, there are so many different symptoms. I was actually just speaking with a young entrepreneur from Stanford, the other day who was trying to gain awareness for the long haulers cause. His name is Rob Carlo Ramirez and he mentioned that he had a couple of young family members die from COVID but his sister was lucky and she beat it but now she’s dealing with this long-haul COVID syndrome. And he said she’s feeling a sense of real hopelessness because it’s been going on for about six months. She got it early and last summer and now it’s just it just keeps happening. So, symptoms like fatigue and depression, and even just muscle weakness. There was this one person who was basically a bodybuilder and he can still barely jog, and it’s been three months. So, it’s just really messing people’s lives up, turning them upside down.

Jeffrey: Yeah, it really is and while speaking with Dr. Mitrani, at Organicell and about their open therapy. I know you did some research. What else is out there? Is there anything currently in the market to help these people or in late-stage development?

Heather: We could say late stage. It’s really early stage. I feel like we’re still in the very early stages of this space – of this emerging space and the ones who are trying to break into it are really spinning off treatments that were originally intended either for another condition. Like everyone was doing with the vaccine and in 2020, but this time, they are spinning off treatments for acute COVID that were used in the ICU, and in different hospitals and now they’re trying to translate them to a long COVID because this is going to be the problem of 2021, and hopefully not too much further, but you never know. And some of those companies that I came across a couple of were – in an article I wrote on Christmas Eve. There’s one company called Puretech and I spoke with their Chief Innovation Officer, Dr. Michael Chen and they have LYT100. Which is an anti-fibrotic and anti-inflammatory oral small molecule, and they’re hoping that it can treat all of the residual lung fibrosis or lung scarring that happens with long COVID. So, that’s currently in a Phase 2 trial, that they launched already at the beginning of December I believe it was December 3rd, and they are going to see what happens with that, and I’m actually looking to speak with them later this week on a follow-up article to see what – where they’re where they are going with that two months later.

Jeffrey: It’s interesting. All right, so that’s definitely a different approach and everybody’s looking at different ways to now help these long COVID-19 patients as you said as opposed to the acute COVID patients. Now, you’ve spoken with a couple of them you mentioned the entrepreneur and his company and his family. Have you spoken with any other patients or know about some of their other concerns?

Heather: Yeah. I don’t want to mention any names here but the main thing that keeps coming up seems to be the lasting fatigue and just the muscle weakness and they are not being able to go back and live your life. I read one stat from the CDC, it was based on a phone call and it said that one in five young adults 18 to 34, three weeks after – after their case resolved. They still weren’t able to go back to functioning normally. Those are the people, we’re not really concerned about getting it that much, right? We’re more concerned about our parents and our grandparents getting it, but if we get it, it’s going to overhaul your life for a little while.

Jeffrey: It certainly seems to be, and the stories that we’re hearing are quite traumatic that these are life-changing issues for these people. Now, based on your research. What do you want to tell our listeners that either had long hauler syndrome or have loved ones that are affected by it?

Heather: I would tell patients people who are dealing with these people who have family members to keep trusting the biotech Industry because I really think they’re working hard on this. Just like what happened last year when the biotech and life sciences industry, in general, came together and found a vaccine in nine months. That was miraculous. I mean, that’s just that doesn’t happen but it did happen and there are different drugs – most of them seem to be in development for the lung fibrosis, the lung scarring but there are actually, there’s another one, Cytidine out of Vancouver Washington has a drug called leronlimab, and it goes against the cytokine storm. So, that you know, an overpowering way to overboard immune response, and that’s something interesting because I hadn’t seen a lot of other ones who were actually going against something other than just lung disease. And there’s another company, Bionano, who has created a diagnostic instrument for analyzing genomic DNA that could tell us why some COVID patients get sicker than others and why some people’s symptoms linger. This company I just talked to last night called Bionano. They’re just really interesting. They have this diagnostic instrument. It analyzes the genomic DNA and they did a study. Thirty people who had severe COVID and they found that all thirty had a duplicate – a gene duplication. And that was always making them so sick.

Jeffrey: I’d like to thank our Guest today; Dr. Natalie Lambert of the University of Indiana School of Medicine, Dr. Mari Mirani, the Chief Science Officer of Organicell Regenerative Medicine and Heather McKenzie of Biospace. Thank you all for giving us a well-rounded perspective of what it means to be a long hauler and what these patients are actually going through.

We hope you enjoyed this week’s podcast. If you have any questions, comments, or future story suggestions. Please reach out to us on social media. 

Thank you, and we hope you enjoyed the RP Healthcast.

For more information about Long-hauler’s please see: Therapeutics for ‘COVID-19 Long-Haulers’ Exploding onto the Scene as 2020 Ends | BioSpace

The RP HealthCast returns in 2021 with a fresh format, featuring captivating stories from innovators, journalists, medical professionals, and more!

In each episode our host, Jeffrey Freedman, goes beyond the headlines to explore different perspectives and discuss varying viewpoints on the latest advancements in technology and health.

Please stay tuned for our first episode premiering next week.

In this week’s episode, we speak with Zachary Brennan of Politico about the newly approved coronavirus vaccines, their distribution plans, and how these advances are poised to change the course of the pandemic.

TRANSCRIPT

Jeffrey: Hello and welcome to the RP HealthCast by RooneyPartners. I’m your host Jeffrey Freedman.

Jeffrey: I have never run a marathon, but I can only imagine that this is what it feels like towards mile marker twenty. I mean, it is 2020 and I am physically, mentally, emotionally drained right now. But I see an end. I could literally see the finish line in the distance. Just like my runner friends at mile twenty, who still have to push through and find that mental toughness to cross the finish line, our nation also, has to buckle down. We have to be safe. We have to find that mental toughness and wait for enough vaccines to get us through to the end of the pandemic. And again just like our runner friends at mile twenty, our country is at its most fatigue point in this pandemic. And because of that, we are at its deadliest. But this pandemic’s finish Line is in sight. The FDA has now authorized a second vaccine. And very shortly, millions of people around the country will start getting vaccinated.

Jeffrey: To talk about the two different vaccines and the distribution plans, I am delighted to be joined by Zachary Brennan. Zach is a healthcare reporter for Politico.

Jeffrey: Zach thank you so much for joining us today.

Zach: Thank you so much for having me.

Jeffrey: Yeah. Now 2020, it is almost behind us and we have some pretty good news on a couple of the vaccines. Now the first, the Pfizer-BioNTech vaccine, which has been pretty well documented, and it is already going into people right now, and now the vaccine from Moderna, which may get emergency use authorization later this week, can you talk to us a little bit about the types of vaccines that these are and what makes them different from vaccines we have seen in the past and what makes them different from each other.

Zach: Sure. So both the Pfizer and the Moderna vaccines are what are known as mRNA vaccines which have never previously been FDA approved or authorized to prevent infections from any other viruses. So what they effectively do is explain to ourselves the instructions on how to make this particular type of protein, known as the spike protein, on the coronavirus. And that is exactly what triggers a response in us and can protect us in the future from getting infected with the coronavirus. So as far as differences from each other, the Pfizer one actually requires a little bit colder conditions for distribution and storage. The Pfizer one has to be refrigerated for up to about five days and the Moderna one is more like up to thirty days. So there is a bit of an advantage for the Moderna vaccine there. But overall, in terms of safety and efficacy, I think the data have shown that they are pretty similar, both are about ninety-five percent effective overall. Both were tested and more than thirty thousand participants in each of their trials. And the Moderna one actually might be a little bit better at protecting against severe COVID. But again, the data is very limited and we really will not find out more until both of them are used in much wider general populations.

Jeffrey: Right. And you said this is the first time, anything like this mRNA type of technology is being used. I mean historically, we are so used to whether it be the flu or the chicken pox or the mumps. Those are like the infection that disease itself or dormant parts of that disease that has been given to us and you are saying this is completely different?

Zach: Yeah, exactly. So basically, this is inserting a piece of this mRNA in a certain way into ourselves. So as to teach our bodies how to fight against the coronavirus rather than introducing, as you mentioned, like a live attenuated vaccine or you are basically introducing a form of a piece of the vaccine straight into the body to teach your body in that way.

Jeffrey: Got it. Thank you. Now, listening to the operation warp-speed, press conferences months ago. They were talking about eight or nine different types of vaccines that were supposed to come to market and what happened to some of these others? What is going on with the AstraZeneca or Johnson & Johnson or Novavax’s vaccine?

Zach: Yeah. Exactly. So the federal government has funded six vaccine so far and there might be additional funding for more on the future. But right now, we are looking at these three upcoming ones from AstraZeneca J&J and Novavax. The AstraZeneca one has been a little bit of a surprise. US, early on, purchased about three hundred million doses of this vaccine and in early trials in the UK and Brazil, they showed that two doses of the vaccine was about sixty percent effective. But then for this other sub part of the trial, one and a half dose has proved to be about ninety effective. So they are still trying to figure out what is going on, why the dose and a half worked better than the two doses? Although there is a trial in the US still ongoing for the AstraZeneca vaccine that is two doses. And we should know more later this year or early next year. The J & J one is very interesting because it is a single shot vaccine. So unlike the Moderna or the Pfizer or the AstraZeneca or the Novavax, it is one of the only ones that is a single shot. And again, we should know more information about their trial in about forty thousand people later this year, sometime early next year. And then I would say Novavax is a little bit further behind than J&J and AstraZeneca. They have just completed an enrollment in a UK trial in about fifteen thousand people and they are hoping to start a US trial pretty soon, hopefully later this month or early next month, so we should know more.

Jeffrey: Yeah, I mean, it seems like hundreds of millions of dollars and maybe even billions of dollars are still being spent on the R&D and the research of all these different therapies in trial but from a financial point of view, or I actually I do not even know, if the expectation that the majority of Americans that want vaccinations are going to get vaccinations by the summer, what type of market is there going to be for these other vaccines?

Zach: So there actually should be a pretty big market for these other types of vaccines. We have heard estimates of anywhere from five to ten vaccines being necessary to vaccinate not just the US and Europe, but the entire world. So, we will have to wait and see how the data read out on these other vaccines but I think all estimates point to needing more beyond the Moderna and the Pfizer vaccines particularly for more rural areas of the globe. But yeah, I mean, hopefully the US market will be all set by late 2021.

Jeffrey: Okay. Earlier, you mentioned that being able to store these cold or distribute these cold and, we are talking the Moderna and the Pfizer vaccines, and the distribution plan seems very very difficult. The logistics for this is just astronomical. Can you talk a little bit about the distribution plans and how it is being handled and you know why is it so difficult?

Zach: Sure. So basically, the way that it is working in the US is that each state has pretty much come up with its own plan and designated certain sites where the federal government or Pfizer can distribute individual shipments of the doses to specific places. It is, again, as you said, very tricky because Pfizer’s are coming in batches of nine hundred and seventy-five doses and Moderna’s are coming in batches of a hundred doses. So, Pfizer, for example, you say[?] the first two point nine million doses that are going out earlier this week and later on this week and those went out to about six hundred sites nationwide. So, this is just an incredible amount of manpower in terms of getting all the doses in Pfizer’s case from their manufacturing plant in Kalamazoo to the various far-flung places across the country. And with the help of UPS and FedEx and some other companies, so I guess we will see over the next few months if there are any hiccups. If states need to kind of adjust the process a little bit to ensure that the appropriate people are being vaccinated at the right time.

Jeffrey: Yeah, I guess also to add another, I guess hiccup to this is you mentioned that with these vaccines, you need two doses. So, can you tell us how this is supposed to work? I mean, especially that the vaccine in such short supply. How do you know it is going to be available when you need it? And what happens if you miss the window? And one other question too, you just mentioned that Pfizer ships it in batches of nine hundred and seventy-five, now that is an odd number. So, it cannot meet the need.

Zach: Yeah. It is interesting that you asked that because that was actually a question that I asked operation warp-speed officials was if you have one shipment of the nine hundred and seventy-five doses and you send it to a hospital with 47 doctors, what do you do with the remaining doses? And that is where coordination among states and among the different jurisdictions is going to be really key and among the different sites within states is going to be really key to keep all available communications open so that they can quickly transport vaccines. As I said earlier, they need to be refrigerated for up to five days so there is only a limited window in which they can work. Going back to what you said, as you as you noted, they both require two doses either three three weeks apart for Pfizer or four weeks apart for Moderna, which does create all sorts of logistical issues. The government is providing everyone with this little piece of paper. That is a card that tells you when you should go in for your second dose, what vaccine you received. And some of the some pharmacies like CVS and Walgreens are also setting up a little bit more detailed reminder systems to provide everyone with information on what is going on and when they should come back for their second dose. But as we saw with the AstraZeneca trial, which was halted for a lot of month, pretty considerable time, they investigated as a safety event that was actually not a major issue. So but first say for the first batch of 2.9 million doses of the Pfizer vaccine, they actually have 6.4 million on hand. So they are only sending out the first batch to 2.9 million people to get their first dose and then saving another 2.9 million for all those who received their first dos.

Zach: The sites themselves will administer one dose, too for every dose that they have. But it is the federal government, that is controlling the supplies, is holding back the second shot for each person that they sent out the first dose for.

Jeffrey: It just adds another layer of risk to the logistics to ensure that these deliveries get there in time. But you also mentioned that it is okay to get it past the three week or for week timeline. It is just not good to get it before that three-week or four-week timeline. Since these are in such short supply and you said they are both made from an mRNA technology, this is probably a silly question, but can you take the Pfizer vaccine if your first shot was the Moderna version?

Zach: No. So they have not run any trials yet in terms of mixing and matching doses between the different vaccines. So no, that is not a possibility yet. But hopefully at some point there will be a little interchangeability between some of the doses.

Jeffrey: Okay. And you mentioned before, that you mentioned the efficacy for those two are 95 percent approximately. You also said they seem to be safe so far, but I understand there are some side effects and there was a warning and I guess it came up in the UK that people with significant allergies probably should not take the shots. Can you talk a little bit about that?

Zach: Sure. So yeah, as you mentioned, in the UK, on the the first day that the visor vaccines were actually administered, two people had severe reactions and both had had a history of severe allergic reactions in the past. And this was not a group of people who were included in the Pfizer trial. So I think that is kind of why people were a little bit surprised. But basically, the FDA said in the warning section of the Pfizer label that those with a history of allergies to vaccine ingredients or other components should not take the Pfizer vaccine. There was a lot of discussion at the FDA advisory committee meeting on this topic and the members actually seem to suggest that the warning was very necessary because there are millions of Americans with these types of allergies and who carry an EpiPen with them in case something like this pops up, but overall they did not seem to think that this was going to be a major concern that would slow the launch of the Pfizer. vaccine.

Jeffrey: Okay. That is great. Now, lastly, while these vaccines coming for wishing[?] are certainly turning point in our fight against the pandemic, in terms of what is going on right now in the world, the severity of the spread, what do you see happening over the six to nine months to the majority of the country gets vaccinated? Do you think we are in the worst of it right now? And do you see it scaling or sliding down or? What is your opinion? What are you thoughts on this?

Zach: Yeah. I mean we have heard recently that COVID cases will hopefully peak sometime in January, but this month, next month, and February are really going to be difficult months for this country and hopefully vaccines will help some of the more vulnerable populations. But it really will not have as big of an impact until we get into, say, later next summer or even later next fall. And again, hopefully by then, we will have more than just the Pfizer and the Moderna vaccines and we will have hundreds of millions more doses of some of these other vaccines that proved to be effective and can really do some damage against this virus.

Jeffrey: Do you think people will have choices in which vaccine they will be able to take? Or you get what you get?

Zach: Yeah, so I get that question a lot. I do not think so. Certainly, not in the beginning of 2021 but hopefully by the end of 2021, there will be enough vaccines that are marketed either via approval or authorization and everybody will get to pick whichever one they want. But no, hopefully by then the entire American population has already been vaccinated. So we will see.

Jeffrey: And I hope they do. I mean there is a whole rash of vaccine hesitancy, which I have covered a few times over the past couple months. But I think, well, let me get your opinion. Do you think that the FDA has handled this approval process? The EU, emergency use authorization process wisely? Would you have liked to have seen them do anything different?

Zach: Yeah, I think that they have done a really good job in kind of explaining all of the safety concerns that they have had with both the Moderna and the Pfizer vaccine and they have been very upfront that they have not seen anything significant and yes, there are minor side effects like, injection site pain and fatigue and headache but you know overall there were not concerning trends and they are going to be following each and every person who has been vaccinated very closely and very carefully to make sure that they really hone in on whatever side effects are out there. So I guess I am confident in the system working. But it is going to get really difficult, especially when you know some members of the elderly or other people that are prone to heart attacks and other things, get sick and there needs to be a little bit of process where they try and figure out whether or not it is vaccine related and things like that. So there are going to be bumps along the road ahead of us. For sure.

Jeffrey: Yeah. I hope those bumps are slight and I, for one, am very much looking forward to taking the vaccine. I probably will not be until the middle of the year, when when my number comes up, but I look forward to it.

Jeffrey: Zach, thank you so much for joining me today. This has been really educational and very helpful and insightful. So, thank you so much for your time.

Zach: Excellent. Thank you for having me.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions ,comments or future story suggestions, please reach out to us on social media. Thank you, and we hope you enjoyed the RP HealthCast.

In this week’s episode, we speak with medical journalist, Charlotte Huff, about the mental and physical hardships that nurses are facing as the coronavirus pandemic appears to be entering its deadliest phase. 

TRANSCRIPT

Jeffrey Freedman: Hello and welcome to the RP HealthCast, by RooneyPartners. I am your host Jeffrey Freedman.

In New York City back in March and April, the pandemic was new. It was scary. It was overwhelming. Governor Cuomo ordered all non-essential businesses closed and people were afraid to leave their homes due to the severity and deadliness of this unknown illness. Our essential businesses had to remain open. Our frontline workers had to go to work every day. Those working in the healthcare ecosystem were very quickly became overwhelmed. They were overworked, they were underprepared, and they were just as afraid as the rest of us.

So as a community and as a united front, we needed to show our frontline workers how much we appreciate it them. So it is seven o’clock every night. We opened our windows. We stepped out onto our balconies or rooftops, and we made noise for two minutes. We screamed, we clapped, we bang pots and pans, and we made music, but most of all we gave thanks and we gave gratitude to all the frontline workers who are risking their lives for us every day.

That was eight months ago and thankfully due to the restrictions that were put into place and the uptake on masking and social distancing. Things in New York dramatically turned around, but unfortunately, our seven PM show of thanks, like everything else is falling off. Some instances it transformed back into five PM happy hours. Because of this, because of pandemic fatigue, it led us into a very strong second wave and this is going on across the country and in the large number of states we are back at peak hospitalizations.

In this week’s podcast, we are going to take a look at this next wave through the eyes of our frontline workers and in particular our nurses and discuss how this Deja vu is affecting them. So to help me with this, I am delighted to have Charlotte Huff. Charlotte is a medical journalist and rights for Kaiser Health News and for genome stat and people and many other news organizations.

Charlotte, thank you so much for joining us today.

Charlotte Huff: Thanks for inviting me.

Jeffrey: In my introduction, I spoke a little bit about the early days of the pandemic in New York. Our hospitals were overloaded and it was a very scary time, but there was a huge show of gratitude towards our nurses and our frontline workers. Now, can you talk a little bit about the rest of the country and what you were seeing in the early days of the pandemic in terms of our nurses and our frontline workers?

Charlotte: Well, I am based in Fort Worth, Texas. So we were kind of living and a bit of a limbo, the first few months of the pandemic. I mean, we could see what was going on in the news and the horror of the cases and New York City and also the Seattle area, but it was kind of a surreal stretch because we were unlocked down, the hospitals were warning us, the cases were coming out. We were not really going anywhere, but the really was not that much happening here, it was a sort of the sense of a come before storm, but we did not really know if the storm was ever going to happen. We waited and waited and then really the uptake here started coming off of Memorial Day weekend and then pretty much got worse into July and after July, although was not nearly the situation that we are looking at in the country right now and in Texas, too.

Jeffrey: Yes. I mean, it certainly was wave, heading across the United States, but I mean in terms of your discussion with nurses and what you said, you saw it happening in New York and you saw what was going on. Did they feel that it was going to come there or was it an isolated situation to an East Coast problem?

Charlotte: That is interesting question. In a local folks here that the clinicians here they got ready, but I think there was a sense of anticipation was going to come to Texas and then it did not happen. I think, based on talking to some of the clinicians and this area, they were– even doctors and nurses staff, well, maybe it is not going to happen here for a stretch and I am talking about the period before we hit Memorial Day weekend.

Jeffrey: Right. Wow. So it sounds like they were almost caught unaware when it finally did and it did come.

Charlotte: Yes.

Jeffrey: Yes. With our frontline workers there, I know here we really appreciate it. They are coming into work and taking care of us every day, but I do not think we appreciated some of the conditions they were put through at the time. Now, in your reporting, can you talk a little bit about some of the issues that the healthcare workers and our nurses in particular, what they were facing at work every day?

Charlotte: Right. I mean, in the early days and actually it is still a problem even now the personal protective equipment was really short and certainly when I was reporting this article and they were reflecting back on what happened in the spring, they said they were being forced to wear a single N95 mask for much, much longer than it was safe and sometimes even as long as a week at a time. Also, we know so much more about the virus now, we have to think back to then and no one was really sure how the virus was transmitted. So the nurses would come into work and they said it seemed like almost every day there were sort of different guidance and how to protect themselves as they were learning more about whether it was on surfaces or how much it was transmitted through the air.

The other thing was just kind of keeping themselves protected and messed all that stress and there was one nurse I talked to for this story who I was not able to get into the story, but has been working at Brigham and Women’s. She said during the early days, she remember taking care of a patient and doing some really intense treatment for about an hour and then came out and then realized that she had her two masks on it incorrectly. So she basically had not been protected during that stretch. So there was the constant and there still is the push-pull between trying to protect yourself, but yet give the maximum care that you can to the patient that is in front of you.

Jeffrey: Right. That is a scary story from nurses and it is not isolated, I have heard that as well from others. You are talking that that was the early days of the epidemic and as the saying goes that was then, this is now, and hospitals now again are filling up again all over the country. I guess, from a from a nurses point of view, they have to be in disbelief that they have to go through this all over again. You talked about your article and it was a very moving piece you did for Kaiser Health News and it was also recently published in People Magazine. It was entitled “Nurses Feeling the Strain of the Covid Pandemic, Say the Resurgence is Paralyzing.” Now, can you talk a little bit more about this article and the some of the other stories you were told by these nurses?

Charlotte: Yes, I cover a lot of other medical stories besides Covid related, but whenever I spoke with nurses for any reason, they would quickly come back to the fact that the cases had dipped for the time being, that they were waiting and thinking that they were going to come back because everyone was so afraid of some kind of surge happening in the fall or the winter time. So that constant kind of fear in that it was a temporary situation. I mean, when it started, the case of started going up, I thought about this nurses who really had not had much of a break of a longer than say a few months. Sometimes in the summertime in some parts of the country they had a break and it was not terribly long.

Even before, this latest search they have witnessed so much death and they have to turn around and do it all over again. There is a nurse that I focused on quite a bit in the article or her name is Christina. She was typically a post-surgery nurse and in the spring in Massachusetts in Worcester and her unit was suddenly she walked in one day and her unit was converted into a Covid unit and suddenly she was only taking care of Covid patients. She described how she had one woman who early on who is in her 80s, who she said when she came to her unit. She did not even know why she was there. She did not even seem like she was sick, she was very energetic and she deteriorated very quickly. Less than a week later, she died and Christina not only spent all that time with her, but then she actually was one of the people who carried this woman’s body down to the morgue. It was clear that this was just imprinted on her memory and when I got on the phone with her, almost immediately she said, I said, “How you doing? Are you worried about the case is starting to go up?” She said, “They are walking in and now suddenly under unit again, they do not just have surgery patients, they have Covid patients all over again. It is paralyzing.” She just said that straight out and just the thought of facing it all over again.


I mean, one thing that people also do not realize is it is not just nurses in the hospital they are impacted, nurses who work in all kinds of areas of healthcare who are trying to both take care of patients and keep themselves safe as well. Another nurse I interviewed, Giuliano. He was treating patients in a psychiatric hospital and also he is a traveling nurse. He moves around, so he was also at an outpatient dialysis clinic. He said that it was a constant worry as we were trying to figure out how the virus transmitted and he had inadequate personal protective equipment. He was also trying to keep the potentially Covid patients separate from the ones who did not have Covid, say in dialysis area. He said it was very stressful and he felt no constantly like he was either putting himself at risk or potentially putting the patients at risk as well.

Jeffrey: My bad. I mean, one of the things that I love about your pieces it was the fact that was told from a nurse’s perspective, right? I do not think we see this very much. Before we get further into some of the reporting, let me ask you, why do you think nurses do not appear more frequently in pandemic coverage or even much reporting on the health care system over all?

Charlotte: Right. Yes. I am a long time medical reporter and I done a lot of reporting for daily newspapers before I started having family members land in the hospital. It is really illuminating to be in a hospital room day in and day out and see how it is, of course, it is at the doctors who are making the treatment decisions, but it is really the nurses who spend so much time with the patients and that mean, we as family members get to know them and even after hopefully our loved ones go home, it is often the nurses names remember the most. I find from a reporting perspective that it is really difficult to get their voices into articles and stories about healthcare. It is really in large part because they are employees and they are saying the hospital or hospital employees and if they talked to me as a reporter, without getting the hospital’s permission, the risk getting fired. Often hospitals even when nurses asked, would rather not have them not talk to the media because they want to stay out of the press in anyway. So for this particular article, I talk to, I would say four or five nurses who wanted to be interviewed in either were afraid to talk to me or when they went to their hospital press staff were basically barred from talking to me, even though they were not saying anything directly critical about the hospital but more talking about just the strain and stress of treating Covid patients. I mean, one of the things I have noticed recently and I wonder if there is going to be a shift here but I have seen more nurses speaking out on Twitter and kind of other social media outlets. Doctors for sure but also nurses and in maybe they will start becoming more public and expressing what is going on healthcare moving forward.

Jeffrey: Well, I hope so. I think you did a great job in chronicling some of these heroic stories. In your article, you mentioned, I am going to quote this, “Researchers are concerned that nurses working in a rapidly changing crisis like pandemic, can develop a psychological response called moral injury.” Now, I have never heard of that before. What do you mean? What is moral injury?

Charlotte: Yes. Moral injury is traditionally been discussed more in a military context with combat veterans essentially. It is the trauma that they experienced when they are forced to participate or witness a horrible situation which conflicts with their own personal values and beliefs that they carry with them sort of in a non wartime situation. We often hear of post-traumatic stress disorder and there is some overlap between moral injury and post-traumatic stress disorder. Really in the last few years, it is very, very recent. Health care workers have begun to discuss how they also can develop moral injury related to their work and it probably for similar reasons when there is a conflict between what they think should be done for their patient in terms of treatment or care and what they are able to do based on maybe constraints or strictures of some kind that is put on them by either their job description or other forces with my healthcare system. For a doctor that could mean it is something as simple as just messing with all the documentation and insurance authorizations prevents them from kind of getting the treatment that they want to to the patient because say they are denied by the insurance company.

For nurse, it could be things like just. I mean particularly in this context currently with the surgery going through right now where they have more patience than they really feel like they can provide the best care for. I mean, either just the Sheer Medical Care or certainly the emotional support for these patients, who often need understandably so hand holding and emotional help. Because their family members frequently are not left in the hospital. The idea is over time as they have these interaction, there is almost like many kind of micro assaults that overtime kind of develops into something called moral injury.

Jeffrey: Yes. Even being turn between wanting to do more and just not being able to do any number of issues. I mean, that is…

Charlotte: Yes, exactly. You know, in reality and I actually had not about this too much until I started pouring the piece. I mean, nurses are really caught in the middle. I mean, they are implementing the treatment decisions of the physicians and or they are following say policies that the hospital has laid down. For example, how many are whether family members can come into the hospital itself and so they are kind of caught kind of betwixt and between. So they are often the ones who are having to implement decisions that they do not really have any control over and then keep in mind. They are the ones who spending the most sustained time with the patient as a patient is going through all this and they are kind of– it is not quite the right term but they are serving as a bit of a go between almost I think someone described it to me as the center of the spokes in the wheel the healthcare system a lot of them connect back to the nurse at the bedside.

Jeffrey: From this then, this is the second way of some place it is third wave. I mean, what are some lessons learned that these nurses can use to help themselves from a mental health point of view? What resources, you know, if any of these nurses are available to help those that are helping us?

Charlotte: Well, I mean, a lot of these nursing groups like the American Nurses Association, they compiled various online resources, and they have recommendations, meditation, talking to someone, taking time out. When I talk to people for the article, there is a registered nurse and bioethicists and rushed in at Johns Hopkins and she is done a lot of work in moral resilience. She said that nurses and hospitals need to do a kind of more rituals to wrap up each day when the nice ones that she kind of describe was. When a nurse is leaving, a chef and they are kind of doing that last– excuse me, they are doing that last hand washing as they leave the shift at the end of the day to take that time to really reflect on what they have done the best that they could that day and kind of focus on the good and not just the bad. This might be a little bit of a corny image, but it kind of resonated with me kind of focus on that, the bad of the day kind of going down the drain as they are washing their hands. So they are not carrying it at home with them at the end of the day.

Another nurse I talked to described how that they are trying to do more regular huddles, I mean, obviously with the virus you cannot hold too close and in fact this is one of the constraints right now for nurses in generals, they cannot literally hug each other or lean on each other as it coping with these awful days, but gather together the nurses and the other clinicians and kind of debrief and what was difficult and frustrating but then have, you know, every person talk about a couple of good things that they had been able to achieve during that shift before they wrap up. Stepping back, it is some of it is just the big picture stuff. I mean, there is going to have to be a real attention paid to staffing and nurses around the country. We hear it in the news everyday now or just stretched to the limit and if we do not want to burn them out, wipe them out, they are going to– administrators are going to have to find ways to give them breaks and not stretch them to then. Help them with basic stuff like back them up on child care or help them with groceries or food when they get home at the end of the day.

Jeffrey: That is great. That is great stuff and that is certainly from a hospital point of view. Let me flip it around, lastly. What can you recommend? What can we do to help? In all your discussions with nurses and frontline workers, what are a couple things that we as patients as people that appreciate, everything that they are doing for us? What can we do on a daily or weekly basis that could have a positive impact for them?

Charlotte: Right. I heard a lot of kind of griping and wariness about being called Heroes, that is the jargon that is thrown around a lot. They say they are just doing their job, they do not want to be called Heroes but that they get really– you know, I do not know frustrated is the word or really they say angry when they talk about working these horrible long shifts and then going about on their errands and seeing people out about maybe in groups, maybe not wearing mask. Yes, it almost makes them feel like it is, all this effort and all this risk that they are taking is for not. I know, I mean, they send an interviews to me. I mean, do not call me a hero, just take better care of yourself and then that way, I will not see you in the Intensive Care Unit at my hospital.

Jeffrey: Right. So just follow the guidelines and they do not want to see us at their office.

Charlotte: Exactly, exactly.

Jeffrey: Charlotte, thank you so much. Thank you for telling these stories and getting their voices heard. People that we do not hear from and their stories are so important. So thank you and thank you for being here with us today.

Charlotte: Thank you. I really appreciate the opportunity. They are amazing people. They really are.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions, comments, or future story suggestions, please reach out to us on social media. Thank you, and we hope you enjoyed the RP HealthCast.

In this week’s episode, we speak with Lisa Gill from Consumer Reports about the ever increasing trend of unpaid medical debt in America. Lisa discusses real-life scenarios, what to look for on your bills, what to ask for when getting treatment, and who you can go to if you get overburdened with costs.

TRANSCRIPT

Jeffrey Freedman: Hello and welcome to the RP HealthCast by RooneyPartners. I am your host Jeffrey Freedman.

Jeffrey: With coronavirus cases reaching all-time highs in the United States. Several hospitals around the country have already exceeded capacity and overall we are at our highest level of Hospital admissions we have ever seen. That being said our Frontline workers, our scientists, our physicians our nurses, the have done a miraculous job in learning how to treat this disease and without trying to downplay any of the pain and suffering the patients are currently going through. A vast, vast majority are going to go home and they are going to make a full recovery.

Jeffrey: And in this week podcast, we are going to take the next step. We are going to take a look at what happens after the patient comes home a week, maybe two weeks, maybe even a month later. These patients are going to receive a bill for the medical services they just received. In fact, they may receive several bills from an ambulance, from a clinic, Physicians practice, lab or hospital.

Jeffrey: And yes. Well, approximately 90% of us have some form of insurance. A very large percentage of people are underinsured or have high deductible plans or not even sure what their insurance covers. These people that just escaped a life changing medical scare are now going to receive life-changing medical bills that they never thought imaginable. And frankly, a lot of people just cannot cover.

Jeffrey: Thousands and thousands of people in our country are going to have to think about making trade-offs in their daily lives just to begin paying off their medical bills. So, to discuss this issue with us today. We have Lisa Gill, Lisa has been a health and Medicine investigative reporter at consumer reports for the past 12 years.

Jeffrey: Lisa thank you so much for joining us today.

Lisa Gill. Oh, it is such a pleasure to be here. Thanks you so much for having me.

Jeffrey: Great. Now, you have written quite a bit about the burden of medical bills and how they are affecting society. Now, during the pandemic our hospital system has been overwhelmed and with more and more people seeking medical help every day. We are now at record levels, but every single one of these people going to their doctors right now or hospitals or clinics. They are all going to get a bill of some kind or another. And with the volume of the people now in the system coupled with the slowdown of administrative work at the hospitals. It is going to be an awful lot of people getting horrible surprises around holiday time. Now, can you talk about this from high level about what you have been hearing and talking to people about over the past eight months of this pandemic?

Lisa: Sure. So, the concept of surprise medical bills or just even medical debt. This has been a very serious ongoing problem even as we were rolling into the pandemic. I mean, we have been planning this kind of coverage for actually quite some time and because medical debt poses such a unique problem to the American household. In that, you do not really save for it. You do not really plan for it. A lot of people do not really understand what type of insurance coverage they have until they really are hit with an acute problem.

Lisa: Again, it is easy to accumulate medical debt. It is difficult to track it down. It is difficult to understand what you actually owe and when. And so, this issue has sort of been an on-going sort of like slow motion, a different type of medical crises. And as we as we get into this pandemic, starting right in March and we start to see people losing their jobs. That was lot of people that we had interviewed. Losing their jobs, losing the health insurance that that is connected to their jobs and then being saddled sometimes with medical debt from pre-pandemic or even medical debt accrued during the pandemic. We are headed into like a type of medical debt financial crisis. Unlike I would say anything that we have ever seen in the United States and we are not quite there. But we are just about there and I think as we get closer to the end of the year. Lockdowns continue, covid continues, it is a problem that I am afraid does not quite have an end to it at the moment. It is a little [crosstalk] frightening.

Jeffrey: It really is and it is exponential with the way things are going right now. And all rights, get into this. I mean even before somebody gets sick and I was under the impression that if you wanted to get a covid test even at a clinic or hospital. That the tests were free or their paid for by the government or your insurance but then I read a bunch of articles recently that people were getting these outrages bills for testing. Right?

Lisa: Right.

Jeffrey: So, unbeknownst to them. They were getting not only a covid test but a full viral panel which includes flu testing and all these other things. And this was done so these clinics could charge even more money. And I saw in some instances they were even being charged for phone calls telling them if there were positive or negative and these bills that were running like a thousand dollars. Now, is there anything people can do to protect themselves from this?

Lisa: This is those stories are examples of doctor offices and medical providers and even just sort of like pop-up testing centers that are taking advantage of a crisis, right? A severe medical crisis in the US and what I can say is from the reporting that we– there lots of reports out there about this problem. From the reporting we did. Yes, there are a few things to just kind of like keep in mind and I will kind of just generally walk through them. But the federal government passed two bills earlier this year that guaranteed people, well most people I should say, who have most types of health insurance that they would– including Medicare and Medicaid that they would be provided a free covid test if they had symptoms of covid or if they believe they have been exposed to somebody who had covid. It also guaranteed that the copay for your doctor visit, for that test specific test would be covered. But there is a whole host of things that does not cover and one.
good thing about those two Federal bills is it also promised people that they could still go get the test and go to the doctor even if they had met a deductible.

Lisa: So, half of employer plans in the United States or even half of really most health insurance plans in the US have a high deductible but usually about $1,200 or higher that a person has to meet before their insurance actually kicks in. So the bills were trying to protect that scenario, so they did not have to actually meet 1,200 dollar deductible. But for everything else. So just exactly what you described. Flu shots or I am sorry flu tests and other viral test, any test that a doctor thought might be related to covid is not actually the covid test that stuff is not covered. If you go to a provider who who does those tests who are out of network for your insurance that is not covered. If you get sick with covid that is not covered. And you actually have to be hospitalized and treated for it that is not covered. Your insurance would cover that.

Lisa: We ran into some people who went to go get a covid test and the other went to the doctor’s office. But they did not actually get a test. They got everything else. They got basically, got to work up but no covid test. They wind up with bills that are not related to the test. It also can be the case that your insurance just is not comprehensive and the one type of insurance that did not– was not really mandated that they cover covid testing our short term insurance plans. And a lot of people do not realize if they have one of these but you would buy it on the open market. You would not get it through an employer. And it is usually for coverage, it is about six months or less but it can be maybe even 12 months or less. So, if you have that kind of insurance your covid test will not be covered. There was also the situation that some people that did not have insurance thought that their covid test would be free and it is but you have to apply once you actually get the test something called the Provider Relief Fund which you can look up online. It is not hard. It is just like another multiple administrative steps that somebody has to do.

Lisa: There is one other thing too. If your employer is requiring a test just as a just as a course of business just you know, if you have to show up to work and pass covid test that kind of cut it and you try to turn into your insurance and that might not be covered. Hopefully, your employer will just directly pay for it but if you try to run it through your regular insurance that is likely not to be covered. The main tips are things like really understand what your insurance coverage is. Go to an in-network provider, when you are at the doctor’s office make sure that– you can ask it every single point. What is this test? And is it covered by, is it free, is a free covid testers at something else. And if it is something else how much it is going to cost?

Lisa: We have been writing about this for a long time whether it is drugs, screening test, diagnostic test, any anything. Before you could do it, ask. How much will this cost me? And if they tell you I do not know ask them to call the insurance company and find out. The only thing you can do is look up in the blue book what the cost of something would be ahead of time. But that is– I like putting it on the healthcare provider and really getting them involved in your financial situation before they send you down, long alleyways of different tests and treatments and do not know what they were cost.

Jeffrey: That is a great advice and especially with the prices these days and you really have to be your own self advocate and really ask these questions.

Lisa: It stinks. It really stinks and unfortunately when you ask, are the things that people can do to protect themselves the answer is yes and there is a lot of them. It should not have to be that way. You should not have to especially if you are old enough, you were sick. The last thing you want to do is pick up the phone and start calling insurance company, start calling a hospital or testing center to find out how much is this going to cost? Is it covered? And we have interviewed people who even after being assured something was covered they still wind up with surprise medical bills and it is sometimes just really unfortunately, an unavoidable sort of symptom of a bigger problem.

Jeffrey: Yeah.

Lisa: Yeah.

Jeffrey: Yeah. Now, going back to those interviews you were talking about you recently wrote an article that was published in November’s Consumer Reports entitled “Could your medical bills make you sick that debt does not just hurt your bank account. It could harm your health too, what you must know?” So a lot of what you are talking about is coming out of this article and it was terrific. So, you also discussed several stories of real people and the effects their medical bills are having on their lives and on their health. Can you share a story…

[crosstalk]

Lisa: Sure.

Jeffrey: …from the article?

Lisa: There are people made all kinds of trade-offs in all different kinds of ways and that was really what the article is looking at is. What are the things that people do or do not do as a result of having medical debt or just when their faced with high medical costs. I spoke to Devin Barrington Ward a really terrific guy out of Atlanta, Georgia. He was about 30 years old. He went to an emergency room earlier this in January 2020. He had a really acute stomach problem.

Lisa: He did not have insurance and because of that he did not take an ambulance even though his family was urging him to take an ambulance. Instead, he got his one of his relatives to drive him to the emergency room. He had a battery of tests. He saw multiple doctors and health care providers and at the end had a medical bill really right at $10,000. It is only the hospital does not provide any kind of charity care. There was no way to apply for like a free health care because there may be a non-profit hospital and he was on the hook for 10,000 bucks. He was not paid it. So here we are many, many months later. It was an unpaid medical bill. He says he is not going to be able to afford it. And he told us that he started his own business. He was also trying to save for a house. He wants to get married and he wants to start a family. He wants to get down, he wants to take those different Milestones those financial Milestones really like take advantage of, whether it is housing market or starting up a small business and cannot because he got this medical that hanging over his head.

Lisa: So what we want– one issues, there was a cascade of events with unpaid medical bills and one really bad thing is that these things can wind up going against somebody’s credit, a credit score. And so, not only do you may have even have ten thousand dollars in medical debt but your credit takes a hit. So when you try to go maybe get a loan or mortgage, for example, you might have a very very ugly surprise when they start looking deeper into credit reports. And that was something we found with another woman who wanted to move into an apartment, a larger apartment. She was taking care of her mother who face dementia in a one-bedroom apartment. She worked full-time and she applied to get a two-bedroom apartment but because of– listen this for like a really low amount, I think this medical bill was under Two Thousand dollars might have been about 1,500 bucks. She had paid all kinds of medical attention, she paid on time but one bill slipped through the cracks went into collections and wound up on her credit report. And when she went to go try to get a two-bedroom apartment. She was stopped and could not do it because of this this silly bill. Eventually, it got taken care of. She got really just some angels rip medical debt is a firm that purchases old medical debt at a deeply, deeply discounted price. They purchase it in the aggregate and then they pay it off for people. So they had actually paid off her medical debt and kind of offer credit report eventually but it took a long time.

Lisa: Those are financial consequences. Then we did a nationally representative survey asking people about their number one, their highest medical bill in the last 12 months and we learned that in order– once they got that bill and they were faced with other decisions in there lives. It affected that and people told us that they put off, 40% told us that they put off a doctor visit because they owed money on a medical bill. A lot of people, third of the people told us they treated themselves at home 20 percent said that they declined a test or a procedure, 15 percent said that they did not fill a prescription and 14 percent said they wanted to be using Telehealth instead of going into a doctor’s office which is actually a good thing at least they saw a doctor. But people made not know they have financial trade off. Some of these are pretty serious. I mean, when you do not fill a prescription for something that– in the reason that you are not doing it is because you cannot afford it or you are trying to cut back costs.

Lisa: It is hard for any of us to really understand what the physical consequence of that is. But it is probably not very good if your doctor has gone to the trouble to write a prescription for you. We saw in a Kaiser Family Foundation a similar survey from about a year and a half ago showing that people who did that very thing by not– they did not seek treatment because of cost about one in eight people saw the condition for which they had sought treatment worsen. So we know there is a health consequence with some percentage of those people. And it is a dangerous situation and looking at, I mean think about other areas of your life where you cut back because you cannot afford something and maybe it is one thing if you like cut the cable, you are like “Okay. We are not gonna have cable anymore because we cannot afford it.” That is maybe a lifestyle decision, but it does not affect your health necessarily or maybe you do not get your car fixed, you delay maintenance. But there is countless examples of these but when you start messing with not going to the doctor, not filling prescriptions, not getting tests that are really needed. There can be pretty serious consequence and I think that is the overall health of the nation is quite a risk as a result of high medical bills and the fear of medical debt.

Jeffrey: Yeah. It sounds like a vicious…

[crosstalk]

Lisa: It is a cycle. I mean really and [inaudible]

Jeffrey: Yeah. Now, to follow along with that you also recently penned another article that for me was extremely eye-opening. It was entitled “Veterans saddled with debt”. In your whole article, I personally was under the impression that veterans had insurance and the insurance was through the office of Veteran Affairs with the VA and our veterans were taken care of and this regard. But your article mentioned that veterans, a combined– I think it was a billion dollars in medical debt. That is crazy to me. Can you tell us a little bit more about this?

Lisa: I discovered this accidentally and once you discover it you realize there has been a lot out there in the world about this problem but it is not very well communicated. And I came across it as a result of interviewing the co-founders a Rip medical debt who is I mentioned earlier purchase large, they purchased aggregate amounts of medical debt heavily, heavily discounted so that they can pay it off. They are nonprofit, they are do-gooders. Right? And the the co-founders come from the collect debt collection world. I mean, they were like the quote bad guys for a long time and they switch sides. So Rip Medical Debt has a very special line into veterans debt and they start talking to me about this problem. And I did not quite grasp it at first until I started to look a little deeper and I learned that like you, I assume that all veterans had medical coverage through the VA.

Lisa: But what I found was in fact that if they had a disability that would that was, the VA classifies disabilities by percentage amount. And I do not have enough articulation about how they arrived at those percentages. But what I do know is that if your disability is 50% or less you can wind up being on the hook for all kinds of copays and other health care costs. If you have insurance like commercial insurance through an employer and that is where things get very much into a gray zone for a veteran. If they for example, whether if you do not have any disability or you have disability of less than 50% and you maybe go to the emergency room and that emergency room either is not covered by your employer’s Insurance, you have insurance through a job or there is bills or there is anesthesiologist or somebody not covered or you have not met the deductible. You have to pay that, the federal government does not pay that, that is one problem The second problem I learned too is that if the VA sends you, the VA does not provide Health Care of all types and when they cannot provide it they contract with doctors in the community or healthcare providers in the community.

Lisa: And not all of those costs might be covered and veterans can be on the hook for those costs. So there was sort of multiple strange avenues where a veteran can arrive at having medical debt they did not expect. And then the most curious thing is that if you were a veteran and you have, whether you were disabled or not and you do not have any insurance and you launch yourself into the Healthcare System even outside of the VA. You would not have to pay for any of it. It is really only when you have Commercial Insurance that it gets into this place where you can be on the hook.

Lisa: So, here you are trying to do something, you are trying to do the right thing by using your insurance if you are getting through your employer. And you can wind up paying, I mean thousands and thousands are being on the hook for thousands and thousands of dollars. It is strangely, there is actually multiple lawsuits about this and there is one ongoing that we that we wrote about and it is just sad situation, it really– it should not happen. I mean, it is just simply should not be the case.

Lisa: I hope it gets resolved in the courts and I know it is going around the major one is going around again, and hopefully it would clarify what the VA will and will not cover. I think that would go a long way toward helping veterans.

Jeffrey: Yeah. That would be great and what an incredible story and you know people should be more aware of this. So you write it as communication issue and I hope we can figure this out. All right. So, finally if someone finds themselves overburdened with medical debt or finds themselves in a hole and they are struggling. With all your research, what is some advice that you can provide? What can they do with this?

Lisa: There was a couple– there is actually quite a bit and it depends on where you are in the in the arc or the lifespan of your medical debt. I will say this and I will jump to like one of the most important things. If you are overwhelmed with medical debt and the bills are coming in and whether it is coming directly from a hospital or it is coming from say it was gone into collections. You were getting hounded by collection agencies. I woud say at this point, your best resource is the Patient Advocacy Foundation. They are a non-profit group that specifically exists. They have got counselors on hand. You call a phone number, we interviewed a couple of people that work with them and who got medical debt down from you know tens of thousands of dollars down to just something very manageable. Those counselors are are both financial counselors but they are really, they are Health Care experts in dealing with medical billing and dealing with hospitals and doctors offices.

Lisa: If I were being overwhelmed medical debt that is who I would turn to. It is PatientAdvocacyFoundation.org. They are absolutely wonderful. They are there to help you. I am looking for their phone number but you can look up online patientadvocacyfoundation.org. That would be the first thing. If you face simply one medical bill where you are like, “Whoa, that is really expensive” and it is not what you expected. That is earlier in the life cycle and my tips about, we wrote quite a bit about that and the weirdest thing is do not automatically pay a bill when you get it if you have insurance. And I know it is counterintuitive and it is a little frightening because you are like, “Whoa, here is a medical bill from a hospital. But wait, I have insurance.”

Lisa: We tell people not to do that because they are the providers sending you the full bill but they have also have your insurance information. They are sending that bill to your insurance company insurance. Your insurance company needs to decide how much it is going to cover. So, what you are waiting for is an explanation of benefits from the insurance provider that shows you at that point what you are actually on the hook for. So that is and then at that point you start to take action.

Lisa: So let us say that now you have gotten medical bill, but it is really your insurance company says, “Hey, Jeffrey, you are on the hook here for $5,000” and you are like, “Wait a minute. I thought it was I thought it was going to be a lot less than that.” The next thing to do is to go to the provider, the hospital or doctor’s office and ask for an itemized bill. You want to see line-by-line everything that you were charged. We have interviewed people who were charged for nights and hospitals that did not exist. Test that they never got or they were, they did get a test but they got charged twice for it and we learn from the Patient Advocacy Foundation that half of all medic[?], listen this half 50% of all medical bills contain errors. People are being overcharged or they are being double charged or charge for things that just they never got.

Lisa: So you have got and then you got to go through that. Once you get that itemized list, you go through it with a fine-tooth comb and make sure everything is legit. Once you settle on that, start trying to compare prices especially for something that looks really high like a CT scans or MRI any kind of test but just looks you are just like, “Whoa, that is way more than I thought it would be” we suggest people go to the healthcare bluebook.org and go take a look at the average prices. And your going to do that because you are going to go back and try to negotiate with the hospital or doctor’s office. And they say look you guys are overcharging me for these different procedures. You also double charge me here and you charge me for stuff. I did not get over here.

Lisa: So you are going to try to basically adjudicate that bill. And this is so annoying especially if you are sick and we talked about this earlier. I mean, it is really terrible that the patient is on the hook for they are all of her own administrative billing. But there was really no other way. Otherwise, you are going to end up paying potentially awful lot of money. I mean, could be into the thousands of dollars for stuff that you do not even know. From that point, when you are negotiating with the hospital or doctor’s office. Ask them if they will reduce the amount that you are on the hook for if you pay it all up front. Sometimes they will do that and it is worth asking if you cannot do that. You want to do a payment plan ask for a payment plan and ask for a reasonable term whether it is 12 months and whatever the amount you can pay per month.

Lisa: Do not go overboard, do not prioritize as medical bill before you prioritize things like rent or mortgage, groceries, utilities, your car when you need all the basics in your life in the medical bills actually should be one of your last priorities. The other thing that you can do, there is actually a couple more things. If you have a problem, I talked to some folks not necessary for this particular article. But whose family members face like almost $100,000 in debt and or they were really struggling with all the tips I gust described because there were too many bills and it was just too much administrative work.

Lisa: You can get ahold of somebody a group called The Alliance of Professional Health Advocates. And we also, you can also hire an attorney. We learned that about a quarter of people who face this problem hire attorneys to help. To help serve deal with those bills and negotiate down in the case that you do not have any insurance and you are stuck with gigantic medical bills from a hospital. Ask them if they provide any level of charitable care. Most nonprofit hospitals in order to retain their Federal nonprofit status must offer by law some percentage of their care free to the community. It sounds really good. The only problem is that there is a lot of administrative burden on the consumer to do this but we interview people who are successful at it. And able to fill out all the paperwork and get ten, twenty, thirty thousand dollars in medical bills covered.

Lisa: One thing to know about that, that is extremely important. They may eat charitable hospitals with these kinds of programs are often will not let you know. They will not offer it to you. You will actually have to ask and this is where being an advocate comes into play. So when you face any kind of medical bill whether you are insured or not. Ask the hospital, what are the different payment options including charitable care, do I qualify for ending financial assistance of any kind and or any additional discounts for upfront payment. The Health Advocates can also help with this situation. It is advoconnection.com and you can look up advocates in your area based on the ZIP code.

Jeffrey: Lisa, these stories are eye-opening and in your advice is fantastic and is going to help a lot of people. So, I want to thank you so much for your time today.

Lisa: It was such a pleasure to be here. Thanks so much for having me.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions comments or a future story suggestions. Please reach out to us on social media. Thank you, and we hope you enjoyed the RP HealthCast.

[END]

In this week’s episode, we speak with Brandon May, a NYC-based medical journalist and writer, about how the healthcare industry has had to quickly evolve to meet the needs of patients during the pandemic.

TRANSCRIPT

Jeffrey Freedman: Hello and welcome to the RP HealthCast by RooneyPartners. I am your host Jeffrey Freedman.

Throughout these past seven months of the pandemic, our hope for a return to normalcy coupled with the fears and anxieties for the welfare of our family and friends has waxed and waned. This is all very highlighted right now. We have the hope and the near reality of a vaccine around the corner, but you contrast that with peak infection rates all over the country as we head into the holiday season. The shutdown and the slow down and now, shut down again of certain sectors of our economy, while it is necessary to halt the spread of the disease, it has had significant harm to many sectors of the economy. On the podcast, we have spoken about a few of these sectors over the past couple months, such as travel, entertainment and the restaurant industries.

Today, we are going to talk about how the pandemic has affected the healthcare industry. In healthcare, there has been some terrific adaptations and technological improvements in the space. I mean, you look at Telehealth, direct-to-patient medication fulfillment, and even look at Project Warp Speed, but other areas of the healthcare ecosystem have not been so lucky. Hundreds of clinical trials for ailments such as cardiovascular disease, autoimmune disease and cancer have been halted. That can significantly delay some breakthrough therapies in the coming years. Patients have put off or hospitals have delayed surgeries and routine visits. Children have not been receiving on time vaccines or going to their well visits. All of these issues, they are going to have a trickle down effect on our healthcare, on the future of the healthcare system and our own health.

To discuss these issues with us today, delighted to welcome Brandon May. Brandon is a New York City-based medical journalist and writer. His byline has appeared in publications like Medscape, Infectious Disease Advisor, ASCO Daily News, BioSpace, CenterWatch Weekly and several others. Brandon, thank you so much for joining us today.

Brandon May: Hi. Thank you for having me.

Jeffrey: Now, in my introduction about you, I spoke about issues caused by the pandemic that could have kind of a trickle down effect on our healthcare ecosystem. I brought up the fact that a lot of clinical trials were either temporarily halted or stopped altogether. Now, you cover this area pretty regularly. Can you talk to us and tell us what you have seen over the past seven months with the stopping, and then restarting, and maybe stopping again of some of these clinical trials? For those that have resumed, what safety measures were put in place to restore the trials?

Brandon: Yes, I have been covering this probably since early to mid-March. It has been a really hot topic. I write for a clinical trials publication. One thing that I noticed straight away was a lot of surveys were being tossed around across the globe. There was, I think, one survey I remember writing a story about in March showing that I think maybe sixty-five percent of the clinical trials across the globe just halted altogether clinical trial enrollment. I think even higher percentage of this non-COVID trials just completely stopped. There was definitely a significant impact on the clinical trials industry as a whole. There are several measures that have been put in place within clinical trials now, both non-COVID-19 clinical trials as well as COVID-related or those that are studying vaccines and therapies.

I think the biggest thing that has been put in place and that has helped to resume a lot of these trials recently was the aspect of decentralized trials and the use of virtual medicine techniques, like Telehealth or telemedicine. I think that is probably the biggest modification that has been made to a lot of clinical trial protocols. Patients can now have visits in these studies without actually having to go into the clinic for fear of transmission, et cetera. A lot of things like direct-to-patient fulfillment or sending medications and investigational therapies to the patient’s home has also really helped. There has also been a lot of additional safety monitoring of historical data. A lot of clinical trials are also leveraging real world and historical data from other studies for controlled population, so they do not have to enroll new patients and they do not have to see patients in the clinic. That has been helping a lot to just sort of help rev up the clinical trials industry.

Jeffrey: That is really interesting. I definitely want to explore further with you about that whole Telehealth and telemedicine. Let us talk outside of the COVID trials, right? Those obviously did not stop. It is the wild west. Do you think these other trial delays, like you are seeing in autoimmune and CNS disorders or cancer, do you think they are going to have the effect of delaying some breakthrough therapies?

Brandon: I just do not know if there is like a good consensus on that yet. From what I have been seeing and writing about, it is very possible that there will be delays, especially for gene therapies for rare diseases. Just generally speaking, what I have seen and what I have been reporting on is that slow enrollment during the pandemic. Even now, even though the trials are just resuming and starting up again, slow enrollment coupled with the fact that rare diseases affect a small portion of the population, i.e. small sample sizes, it really impacts the development of these therapies. I would assume but I do not have an answer for that and I do not really know if there is a large consensus of that. I think decentralized clinical trials as well as, hopefully, greater understanding and control of COVID-19 may help. I guess we will just wait and see.

Jeffrey: Yes, I think that makes a lot of sense, too. You are saying, with the rare diseases, due to the fact that they are so rare, we do not have the real-world evidence; where maybe in a cardiovascular or diabetes type of thing, you have had so much real-world evidence out there.

Brandon: Exactly.

Jeffrey: That makes a lot of sense, yes. You mentioned before about Telehealth or telemedicine. Definitely in my eyes, that is one of the breakthrough technologies of this pandemic. It came out of nowhere. The technology has been around, but it had not been used. You cover this, why do you not talk a little bit how this came from nowhere? Do you think it is going to be still important in a year from now?

Brandon: Honestly, I wrote quite a bit about Telehealth and telemedicine even before the onset of the pandemic. Like you said, it was definitely floating around there, but it just was not widely used as it is today. I think now, more than ever, patients and even providers are finding that virtual visits are far more convenient. They definitely help to just sort of cut down on the exposure risk to COVID and also just other viruses that we have flying around. I think that there are so many benefits that are being realized by patients and providers. For example, you do not have to wait in a waiting room. You do not have to travel to the clinic or to the doctor’s office. When you are done, you can just go about your business as usual. I think the pandemic really has forced us, for lack of a better term, to try Telehealth and see its benefits. I do believe that there will be more wide-skilled adoption even after we gain some control over COVID. A lot of the stories that I have been covering on Telehealth and telemedicine, especially one that just show the benefits of it, a lot of patients report that it is less burdensome. That can ultimately have an impact on outcomes. We will have to, again, wait and see after we get control of the virus and of the pandemic. Yes, I think that a lot of patients are going to choose it more often, especially for visits that you do not necessarily need to be in the office for.

Jeffrey: Right, and that makes a lot of sense. It is certainly a lot less burdensome to wait on my couch. I think though from a HC, from a physician standpoint, I think from their satisfaction, I think Telehealth needs to evolve a little bit for the physician point of view to be as effective. What is your thoughts? Right now, I use it. My family uses it as a FaceTime call as you are saying with our doctors. Can you talk a little bit about the evolution of wearables or remote diagnostic technology? Do you believe telemedicine can take advantage of that and be as effective as an office visit? I would think even like for rural population where they do not have access. What are your thoughts?

Brandon: I actually I just use Telehealth for the very first time this year with a dentist and a dermatologist, and I loved. It was just for an initial consultation, so it was really helpful for me. I did not have to go into the office. I did not have to take the train from downtown Brooklyn into Manhattan which was really nice. I think that more practices as well as clinical trials alike will be utilizing remote visits as well as wearables. They were using wearables before clinical trials at least. From the provider perspective, I am not sure. I have not covered that in my own work, but I have seen that from what I have covered in terms of clinical trials at least. I have seen that wearables, remote diagnostic technology. It was already on the rise and they appear to be helpful for collecting and analyzing data in real time. I would assume that could just sort of generalize and to actual real world clinical practice. In regard to rural populations, I definitely believe, based upon what I have seen and what I have been reporting on for various publications, is that Telehealth and telemedicine has definitely provided greater access to care. It, potentially, will also result in more diversity and inclusion and clinical research, which is greatly needed.

Jeffrey: That is a great, great point that I do not think many people have thought over brought up. It is that diversity that is needed in these clinical trials. That is great. That is cool. All right. Switching topics a little bit. As New Yorkers, right? We are New Yorkers. We are almost on the beach head as COVID came ashore and swept through the United States. Living in New York in February, March and April, those were scary months. With the new disease and the healthcare providers, they were not even sure how to treat this. There were a lot of lessons learned for the first few months. As a society, we got a lot better at attacking the disease. I think a big turning point in bringing the mortality rate down was the effectiveness of some of the new drugs and therapies. Now, you covered in a couple of stories, the kind of launch, if you will, of remdesivir by Gilead. Now, can you talk to us a bit about what it took to get physicians to change their thinking on how to attack the disease and how do they start using this untested product?

Brandon: I think that whenever I get on the topic of New York, whenever it was rising, I was actually moving. I was in the physical process of moving from Boston to New York, to the most hardest of area. It was definitely scary and bizarre to be reporting on the hardest hit area while moving to that area. It was actually rather surreal and I was learning a lot about not only the virus, but also how we were trying to handle it and trying to bring things down. I think, like you said, New York did see a dramatic reduction in mortality. I think wearing masks has help. I walk around everywhere. In Manhattan and Brooklyn, I see everyone wearing masks. That is good and undoubtedly has, I would assume, contributed to improvements and control of transmission. In regard to remdesivir, I think, actually in the FDA in May, I covered a story that the FDA approved Gilead’s remdesivir which is an antiviral agent under emergency use authorization as a COVID-19 treatment based upon a study that showed it reach the primary endpoint. I think it helped to improve recovery time in hospitalized patients compared with placebo. Unfortunately, that state of survival benefit was not statistically significant, but it was still approved to just sort of help improve the recovery rate for those hospitalized patients.

I remember fast-forwarding a couple of months and the World Health Organization came out with a study. I think it was over eleven thousand patients in their study, showing that remdesivir, in contrast, had no impact on survivability in hospitalized patients and it did not decrease ventilation requirements. And then Gilead sort of clapped back saying that World Health Organization’s trial was inconsistent. The methodology of their trial had significant heterogeneity and trial implementation and patient population. There was sort of controversy back and forth between the WHO and Gilead remdesivir. Despite the WHO’s concerns and their trial, the FDA subsequently approved it for emergency use, I think, in it was just last month in October actually. I think I covered that story for BioSpace. That was approved for twelve years and older hospitalized patients with COVID-19. In that trial, there was a trend toward reduced mortality and statistically significant improvement in reduction in supplemental oxygen and mechanical ventilation requirements. That was promising. I think that just the more trial data that we have had, especially large late stage Phase Three trials, has really helped in, again, the wide scale adoption of the use of this drug. Also, I have covered stories about convalescent plasma and the potential utility there. There are still controversy back and forth between that therapy, but I think that was given an EUA, either in the United States, I believe so.

Also, there is a lot of companies right now that I have been reporting on that are combining their investigational products with remdesivir to see if it has an added benefit. For example, I recently covered a story about a study, I think, from Canada. I think it was the University of Alberta who was testing a feline antiviral with remdesivir. Basically, a drug that you would give your cat for a virus, combining that with remdesivir, to show that it had any benefit and I think it actually did inhibit the replication of human coronaviruses in cell cultures that were infected by SARS-CoV-2, which is the coronavirus responsible for COVID-19. I think many companies are actually jumping on the remdesivir bandwagon too right now. Just sort of attaching their drug to remdesivir. There has also been a couple of clinical guidance statements coming out recently. Like the American College of Physicians guidance, I covered that for another publication. They published a guidance statement for clinicians on how to use the drug in moderate and severe COVID-19. Based upon the studies that we have now, the emergency use, the authorizations, the approvals and all this guidance that we have coming out, it seems that the drug is here to stay.

Jeffrey: Yes, that is great. Why do you think though? The World Health Organization, I mean, it is strange. They had an eleven-thousand-person study. That is pretty well manned. Why do you think their results were just so against what we are seeing in real world evidence?

Brandon: The only thing that I can think of is, of course, Gilead. I mean it is their drug. They are going to have some bias there in stating that the World Health Organization had significant limitations in their methodology. Again, they said significant heterogeneity in trial implementation patient population, which they said produce inconclusive results. I am basically just going off of what Gilead is saying and what I have been reporting on.

Jeffrey: Brandon, in the media in actually all over the world, all eyes are on vaccines. We are on the threshold of actually having an approvable vaccine or two or three. Pfizer, today, even filed to the FDA for the Emergency Use Approval. If the FDA agrees with the safety and efficacy of the data presented, we could have an approvable vaccine by the end of the year and vaccines will start going out. Pfizer said that the second it is approved, they are going to start shipping it. The next question is how do we get it? President Trump announced that as part of Operation Warp Speed, the military will be helping in the distribution of the vaccine. I do not think Pfizer is a part of that. How are we supposed to get the vaccines?

Brandon: Yes, it is really exciting news to see that Pfizer and Moderna are having good luck with their vaccines. The high efficacy rates are exciting and I am really fortunate to be covering this in my work. I know that Operation Warp Speed definitely has its work cut out for itself. I know that President Trump sort of alluded to the military being involved, kind of somewhat painting a picture. It seemed like the military was going to be distributing the vaccine. Really from my work and how I am covering it and what I am seeing in researching is that the military, the US military, is actually going to be really more or less providing their expertise in just sort of logistics and their experience in applying that to the distribution. They are not actually going to be physically distributing the vaccine itself.

I know Pfizer, under Operation War Speed, will deliver the vaccine directly upon the EUA or the Emergency Use Authorization approval to vaccine locations. They will be delivering it. I think Moderna will be going through distributors and the distributors will be shipping the vaccine. Still, that being said, there is going to be some logistic challenges. I just covered a story this morning, actually, on the logistics of approved vaccines. I know that these vaccines that show high efficacy, the Moderna and the Pfizer vaccines, they have to be stored at really cold temperatures. That is going to be creating challenges in the shipping process. You are going to have appropriate refrigeration during shipping when it gets to wherever it needs to be at the vaccine sites. You have those temperature limitations. You also have rural areas that may have access issues as well, that may not have facilities to actually refrigerate and store these vaccines. That is going to be a challenge in how Operation Warp Speed or the government or these companies are going to be getting the vaccines to these populations?

Jeffrey: In terms of the distribution, the military is going to lend their knowledge, but has any of the stuff been disclosed yet? There have been tons of announcements about everybody providing support and it is going to go out. Has anybody seen or published what this logistics will look like, who will get it and when?

Brandon: No, it does not appear to be a grand consensus on just how it is going to be distributed. I know that, for example, Operation Warp Speed has a distribution plan in place on their website. I have utilized that in a couple of stories. But the specifics of distribution, it does not seem to be fully fleshed out yet. From my perspective, I do not see anything announced officially. It seems to be all up in the air and that is what also creates confusion for the public as well as journalists alike. We are trying to get this information to the public so that they can be better informed, but it creates challenges because we just do not fully know yet how many doses were going to be have available, for example, by the end of December. We do not know who is going to be getting it and how many vaccines are going to be available in each state or each city. It is quite frustrating actually.

Again, there is an urgent public health need of this vaccine, of therapies. I cannot imagine it just being withheld from large states cities that have been hard hit. I just cannot see that happening. I think just political power moves aside, I think the hurdle to vaccine uptake is the public’s willingness and acceptance of a vaccine which has been developed rapidly. I mean this vaccine has been developed at supersonic speed compared with many of the other established vaccines that we have for things like the flu virus, smallpox, chickenpox and things like that. You have the anti-vaccine movement, but you also have a larger subset of population who just does not understand the clinical trial process and may not be or who may be wary of taking a vaccine that was developed so quickly in spite of robust safety and efficacy data we have and we are procuring to support its use.

Jeffrey: All right. Brandon, you brought up a great point, that vaccine hesitancy, and there is a lot of reasons that people could be afraid of taking the vaccine. There are so many reasons for them to take the vaccine. What is your take? How can the media help in relieving the fears of the general public?

Brandon: To start off, I covered a story recently. It was a global survey. It was recently published in nature medicine, I believe. It was about the public’s acceptance of the COVID-19 vaccine and they surveyed more than thirteen thousand people across. I think it was like nineteen countries. Seventy-one percent of the respondents said that they would be very or somewhat likely to take a COVID-19 vaccine, but you have the other twenty-nine percent who say otherwise. That is approximately one third of the population. That is significant. I mean granted you should take survey data with a grain of salt, but it does provide kind of insight into at least right now, the public slides on a COVID-19 vaccine. I think also respondents are more likely to accept a vaccine if they said they trusted their government. I think that the best thing that we can do as journalists, especially medical journalists who are used to looking at examining and translating clinical trial data for both the professional audience as well as the public, I think we can really play a role in easing fears about COVID-19 vaccines and therapies.

Again, we are used to looking at these data that are coming from these trials and really knowing what is significant, what is going to actually impact patient care as well as, in terms of COVID-19, what is going to help reduce transmission, infection and improve the care of patients who are already infected. We ease there fears by reporting clear factual data points from these clinical studies, emphasizing safety data and highlighting, for example, how the vaccine is effective. Just making sure that we are clear, we are stating facts and we are, not necessarily fear-mongering or talking down to the reader, but definitely focusing on communicating the severity of the virus, as well as how clinical studies are showing independent safety boards who are evaluating these data, how they are showing that these vaccines and these therapies can ultimately help. I think when we can do that as journalists, we can ultimately play a role in helping people, the public, ease their fears, gain more acceptability about the virus and ultimately, get our lives and the world back on track.

Jeffrey: I think that is wonderful and you are spot on. You do not report on opinion. You report on data on science and facts. That is what people want right now is they want the truth and they want the facts and the data.

Brandon: Exactly.

Jeffrey: This has been so helpful. Brandon, thank you so much for your time today.

Brandon: Thank you so much for having me. It has been fun.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions comments, or future story suggestions, please reach out to us on social media. Thank you and we hope you enjoyed the RP HealthCast.