In this week’s episode, we speak with Elizabeth Bernstein of The Wall Street Journal about how to strengthen and nurture our relationships with family, friends, and even ourselves during these turbulent times.

TRANSCRIPT

Jeffrey Freedman: Hello, and welcome to the RP HealthCast by RooneyPartners. I am your host, Jeffrey Freedman. It seems that 2020 is the year that keeps on giving. If it was not the pandemic, it was the election or it was one of several natural disasters occurring across the country. Times right now are tough, and it is tough all over. Whether you are a large family all living under one roof and on top of each other or if you are living all alone and trying to deal with the isolation that this pandemic created over the past nine months, holding it together is not easy. To top it off, this past month finally put an end to a very bitter and divided election season. While we are happy, it is over and we can now move forward as a nation. It is really hard to believe how divided our country really is with almost an exact fifty-fifty split and political differences. This election, or should I say political rhetoric has torn friendships and torn families apart. What I want to talk about today is not the divisiveness we are facing as a people, but rather the hope. We have an opportunity right now to move forward and to strengthen and build upon our relationships. We could strengthen and mend our relationships with our families, our friends, our neighbors, but also with ourselves. We are coming into the thanksgiving and holiday season right now with an opportunity to give thanks for the good things in our lives and to move forward and to start anew. To discuss this with us today, I am delighted to have a very special guest, Elizabeth Bernstein. Elizabeth is an award-winning journalist. For the past twenty years, she has been a writer for the Wall Street Journal where she currently writes the Bonds column and that is about psychology, emotions, communication, and relationships. Elizabeth, thank you so much for joining us today.

Elizabeth Bernstein: Thank you so much for having me.

Jeffrey: In my introduction, I mentioned that you write the Bonds column for the Wall Street Journal. If 2020 was not a year for the need to better understand our bonds and personal relationships, I do not know what was. Can you talk to us a little bit about your column and what you cover?

Elizabeth: Sure. I write a column called Bonds. As you said, I have been doing this for the past ten years, this column. I really think of it as a self-help column that looks at our relationships with others and with ourselves. How can we improve both of those things? How can I improve my relationship with anybody else in my life I care about? How can I improve my relationship with myself? I look at a lot of research in Psychology, Communication, Sociology, that kind of thing. Right now, I look back and I feel like, “Wow. I am almost writing this sort of guide book for the pandemic. How are we going to get through this with all of our relationships and maybe our sanity intact?”

Jeffrey: I think this interview is almost going to be a self-help guide for me as well, listening to you. You are absolutely right. These past eight months in this pandemic has been hard. It is been very hard on relationships. Personally speaking, I have been working out of my house along with my wife who is also working from home. We have three kids ranging from grad school to college to high school, and all of which are taking classes at home now with us. So we have five of us. We have two dogs. We have a hamster. We are all under one roof, but I know we are not the only family getting under each other’s feet and starting to get pandemic fatigue. What are you hearing across the country, not just for families, large families like ours but individuals that are isolated? What are you hearing? What advice are you giving to us about how to keep it together?

Elizabeth: I am just hearing every single person no matter what their particular situation, their individual situation as every single person is having a really tough time. From the people who are single and writing this out alone, loneliness is on the rise. People like yourself with a family with a bunch of kids at home all under one roof trying to go to school and work. You have got the parents of young children. That may even be the hardest I think, trying to home school and become full-time teachers at the same time that they are both working it on. There are people like myself. I have a partner I live with but also I take care of elderly parents or help to take care of them. All the stresses of trying to steer your elderly parents through this pandemic, keeping them safe, and checking on them. It is just very very hard. And then on top of all of our stressors, we are all on top of each other. The little things are adding up. We were not meant to just stay in the same few rooms all together all the time, so there is that. We do not have normal. It just goes on and on the challenges. We do not have a normal sort of mental help relief. We do not get to go out. We do not get to do these things we love that are stress release. It just goes on and on. I hear of these people under deep stress. Everybody is under deep stress. We are on top of each other. We do not have our normal stress relievers. There is all of that. But on the flip side, I am hearing something that over and over, too is, “Wow. We are getting closer.” This is sort of a special time even as much. We sometimes want to pull each other’s hair out. We are getting closer in this time. I am hearing both of those things. People on top of each other. People trying to get along a lot more stress, a lot more fear and worry. What I tell people is really to be mindful of the relationship. Sometimes, some of the best advice I believe that I have seen over and over is when someone is driving you crazy, try to stop yourself right there in your head and look at what you love about that person. Yes, your spouse left the light on or left the proverbial towel or sock on the floor, you want to scream again, but try to remember why we love each other. Sometimes, we forget everything that the other person is doing to help us. Try to remember. Try to actively focus yourself on the good in the relationship, the good in the other person, even the smallest things that are good, and that will keep you I think on the correct track. Try to sort of letting some of the other stuff roll off of you. That is one of my biggest pieces of advice, focus on the positives. But another piece of advice would be, “We need to communicate more clearly right now.” This is always the case. We do not always communicate very clearly with each other. But right now, if someone is annoying us and if something is going wrong rather than waiting a week or two till you are about to explode because you are furious, we need to learn to communicate clearly and early about the things that are not quite going right so we can sort of again, get ourselves back on track. That is one, and then I guess another one is just trying to see this time for a very special time like time out of time almost, the stolen time you get to be with yourself. You are with your children. I know it is hard, but if you were not all there, if there was not a pandemic, they would be all off running around doing their school things off at school. I try to tell people, “Remember this, we will miss something about this time. Maybe, not much but we will miss something about this time later and try to stop and remember that now.” Already, I do not know about other people, but I think I do speak for others. I think that we are already missing a little bit of that early pandemic when we are baking bread. It seems like the stress of it and the heaviness of it has picked up. Even this moment now, we will miss it in the future. I sound like a bad country song. But we are going to miss some of this, I know we will. Try to focus. The best thing and really almost the only thing we can do is to keep trying to focus on the positives and build up the positives now. It is really almost the only way out of it.

Jeffrey: Great advice. All right. Let us talk a little bit about families. How can we control our own emotions? You wrote an article for the journal entitled The Art of the Pandemic Meltdown. I thought that was phenomenal. When you give advice in your own words, you called it ‘losing it the right way’. Can you talk a little bit about this and tell us about what this was about?

Elizabeth: Yes, I can. The Art of the Pandemic Meltdown, I would believe most people know about these things too because we have got to all be having them. I cannot be the only one. A meltdown is where you temporarily lose control of yourself. You maybe snap it. Often times, the one that we think of is suddenly the toddler kicking and screaming and yelling and crying and rage. Sometimes these pandemic meltdowns can look like just checking out. I have to go to bed in the afternoon. Oftentimes, men in fact become quieter. Women will be the ones who are crying and carrying on, but they are both meltdowns. I want to be clear about that. This idea of temporarily losing control and often nowadays is the smallest things that push us over. For me, you hold it together for so many big things. Some serious fear of COVID, election stress, homeschooling, any loss of a job, all of the big things. For me, it was the backspace key on my keyboard on deadline that just popped off and would not go back on. The littlest thing just sends you off the edge and suddenly you are just ranting and raving. This is the pandemic meltdown. What I wrote about is that these meltdowns are actually can be good for us if you have them the right way. You do not want to have them too often. You certainly do not want to take out this loss of control in someone else. A good sort of private meltdown can really help you because you are getting rid of the stress and you are getting rid of these really painful emotions of fear and anxiety moving it out of the way and then you can regroup and go on. I wrote, “You need to accept it. Do not judge yourself for it and try to have a good meltdown.”

Jeffrey: It is a lot healthier to do it that way than many other ways. I think that is great. We talk about families and we talked about ourselves. Let us talk for a minute about our friendships and our neighbors. You wrote an article entitled ‘Bring Fun Back Into Your Friendships – Despite The COVID Pandemic’. Tell us about the advice you gave to strengthen our bonds with our friends, even if this strengthening is remotely and we cannot do it in person?

Elizabeth: I liked this article in particular because I had seen research that showed that we are happier with our friends than we are with our family or our coworkers or our kids. Which does sound really amazing if you think about it that we are actually happier with our friends. Part of the reason is probably that we do more fun things with our friends. With our family, with our co-workers again, with our kids we tend to do chores and there is a lot of things that come with those relationships that are not pure fun, and our friends are often mostly fun. I wanted to look at what is special about friendships and why we need them now. I think many of us that are what we are missing. We can see our families, but we are not seeing our friends. We are not even having time to talk to our friends as much. How can we put that fun back? I wanted to look at that and a large part of it because I really miss my friends. A few pieces of advice if you are missing your friends, you want to reach out to them. Do not wait for them. I hear this often, “Well, so and so never calls me.” “Have you picked up the phone? Call them. Take the initiative to keep these relationships going, to keep them again, on track.” Right now, I think a lot of when we do reach out to our friends were rehearsing. We are going over and over all of our stressors. “How are you?” “Oh, well. This happened and that bad thing happened. I am anxious and on and on,” but how about putting that aside for now and trying really consciously to put the fun back into your friendships? It sounds light and silly, but it is actually pretty profound. You want to keep these friendships going and we want to keep the joy in them because that will buoy us up right now in a really difficult time. You could have not socially-distant fun, maybe you could take a hike or ride bikes together or meet in an outdoor cafe if that is something you are comfortable with. You could also have a socially-distant project. I gave an example in the article of my friends and family all got together and just did this resilience challenge to raise money for the Leukemia Association a month ago. We all tried to move 50 miles in one month and we did it online with each other and we had videos. It was actually really fun. It had the added goal that we all got off the couch. You could do that. You could try to have some kind of group thing from afar that is kind of a fun thing. Another piece. When you are doing this, try to call your friends, try to have some fun with them. Another piece of advice is to let us think more carefully now about dialing down the therapy sessions. Let us dial back the anxiety. If I am missing my friends, I am missing that fun. I do not have to call them all the time and just go over and over what is wrong in my life where everything that they are worried about. How about trying to get back to something joyful in these friendships? That is really what I was writing about.

Jeffrey: We have been talking a lot about the pandemic, but another recent event that caused a lot of anxiety and relationship issues has been the election. Even though the election, I want to say, is behind us,
the wounds caused by this bitter partisan divide is going to be with us for quite a while now. We are a week away from Thanksgiving and we will be sharing the dinner table both virtually and in-person this year. You wrote an article last month entitled ‘Loathe Your Loved One’s Politics? Here is Some Advice’. We are going to need this. We are going to need some advice here. What did you share in that article about how to get along with those family members, those friends that you do not have the same political affiliations?

Elizabeth: This is maybe one of the toughest ones right now. As you mentioned, we have a very partisan situation in our country and it has been going on for a number of years. I hear it from people all the time. This is really a very large sticking point for them in their relationships. I hear just heartbreaking stories, politics killing marriages right now, parents not talking to children. It is really a tough one. So I cannot solve all of that but I did talk to some experts and try to get some good advice to people. As we come upon Thanksgiving, it is always whenever agreeing-problem at every holiday meal, “Oh, here comes uncle Bob with his politics and now we have to talk about it.” Here is sort of a quick primer. It is going to be tough. It is tough right now to talk about politics, but we have got this isolation going on where we are all isolated from our loved ones as well. I really caution people to try to dial it back and to try as hard as you can to not let it ruin the relationships with the people you care about. I do get letters all the time saying, “Well, you do not understand so and so ideas are immoral.” I cannot abide by, not just politics, but their values. Let me be clear. If you really find somebody in your life that you cannot abide by their values, that is for you to decide whether or not to have them in your life. What I am talking about is when you do have people in your life and if you have people you care about, this is how you can make it better. Number one advice on politics, for someone you want to keep in your life, do not talk about it. I am really clear that people want to argue with me, “Oh, no. What if no?” Do not talk about it. It is a lose-lose situation if you are going to talk about politics with someone that you do want to get along with. Just let it go. We have this fantasy that we are going to be exactly like every single person that we care about. It is not true. You can have different ideas from your father, and you and your father can be a good person. Both of you be good people. For our loved ones, do not talk about politics. How do you do that? You have some catchphrases. At Thanksgiving, you can say, “Hey, we are just not going to agree on this so let us enjoy our day. Let us enjoy the turkey. Let us enjoy each other. We do not get to see each other much.” You can just have these phrases that are a pivot away from the political talk. You just want to pivot from it. That is my biggest biggest tip for politics right now, “We are not going to do this. We cannot discuss it fruitfully. Let us enjoy ourselves.” The idea is to preserve the relationship. You are not going to win the argument. You want to remind yourself. “Hey, what is good?” Uncle Bob might be a little crazy, but maybe you loved him for other reasons. Remind yourself of the good.

Jeffrey: That is great. Thanksgiving and then, we are going to go into the holiday season, and then it is a new year. We are talking about divisiveness and anxiousness. The New Year is a time for hope and for grace and for moving forward. What are some parting words you can give advice to people that are anxious about heading into the holiday season?. What could we do to expel this fog of uneasiness?

Elizabeth: It is super hard, I think one thing right now is to give yourself some credit. Do not judge yourself. If you are upset, if you are worried, if you are anxious, this is a very hard time. I think just saying that to yourself, “Do you know what? It is a really hard time and I am getting through it,” I think that is one. Another one, “I tried to do it for myself. It is hard, but I try to put as much joy as I can into every single day.” In this world that we are in, we are forgetting that. I try even if it is getting down on the floor and playing with the kids or the dog, reading a good book, calling a friend, and trying to have a laugh, anything that is a joy for five minutes, for one minute for an hour. Whatever you can do, try to build those blocks of joy into your day. That is one that I really am sticking to. Another one. This is a good sort of self-control technique. Think of the future. Think of this time next year. There will probably be good ways out of this, God willing. Think of next year and try to imagine what would you like next year to look like. You got a handle on it. You would like to be with your family, like to have your job going well, maybe you would like to be a little thinner. Whatever it is, how would you like to see yourself in a year? What can you do today to make that next year happen? Play the long game here and try to build joy into our lives right now, including whatever we can for these holidays. I think that that is a good plan.

Jeffrey: I think that is great, little mental vision boards. I am wishing you lots of blocks of joy in the upcoming year. Thank you so much for your time today. Your advice is fantastic, and it was great to have you here.

Elizabeth: Thank you so much for having me. I appreciate it.

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 Lauren Young from Reuters about technology and working from home. Depending on your stage of life, your family situation and your access to technology, remote work has required quite a significant learning curve, and, in some cases, it presents a hardship

TRANSCRIPT

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

Jeffrey: Election day in the United States is finally behind us. But the pandemic is, unfortunately, still very much alive and increasing in intensity as we move further into this second wave. Now, as a bit of pandemic fatigue starts creeping in, the cold weather has also started to arrive here in the Northeast and in other parts of the country, and that is setting the stage for another spike of new cases.

Jeffrey: While we long for a return to normalcy, going out and spending time with friends, these past eight to nine months have created a sense of isolation for many of us. I mean, days previously spent working in an office or commuting and socializing with our peers, they now reduced to working home alone at a home office or at a kitchen counter. It could be surrounded by a family of all ages. I mean, we are trying to be as effective as possible while attempting to maintain a semblance of good cheer for our own sake as well as for our loved ones.

Jeffrey: Now, for some, this remote work, it has been standard operating procedure, especially with the expansion of the gig and freelance economy where telecommuting has always been the norm. But for the rest of us steeped in office culture, adapting to the remote work environment has been a challenge. I mean, depending on your stage of life, your family situation, and your access to technology, remote work has required quite a significant learning curve and in some cases, it presents a hardship.

Jeffrey: So to discuss this with us today, we are delighted to have Lauren Young. For the past ten years, Lauren has been a writer and editor at Reuters, and her journalism career has spanned over thirty years and includes stints at BusinessWeek, the S&P, and Dow Jones. Lauren, thank you so much for joining us today.

Lauren Young: Thank you for having me.

Jeffrey: Now, you are currently an editor of Digital Special Projects at Reuters, and I saw one of the areas you cover is World at Work. Now, I would say the World at Work has changed quite a bit this year. Before we get into some of your coverage, I want you to tell us how has your world of work changed this year?

Lauren: Well, I am literally sitting in my bedroom in Brooklyn right now that I had to move a desk into, much to my dismay, because I am working from home like so many people. I have been to my office at 3 Times Square once in the past seven months. My husband is screaming on the phone in the other room. He is a lawyer. Then at any given time, we have three sons and depending on where they are and what is happening, they might be home doing work too. So, it is crazy. But we feel very lucky we have got, thankfully, a space to spread out a little bit and a good internet connection. It is crazy pants, I will tell you that. I can not believe it if you had told me I would not be in the office for as long as it has been and I really, really miss it, Jeff. I miss it so badly. I need it. I need to commute. I need the colleagues. I need the creativity and collaboration. I need it all.

Jeffrey: You are not alone. One of the things you touch upon is you said you had a great internet connection, bandwidth connection. That is really one of the big things we are going to talk about as part of this. Now, you recently wrote a very interesting article entitled “Technology matters, but how real are our virtual lives at work and play?” The premise of the article was how digital culture can improve our professional as well as our personal lives. Can you tell everyone a little bit about the article and your findings, and especially how it relates to this new world we are living in with having to work from home?

Lauren: Yes. So that is actually an interview with Mary Gray, who is an anthropologist and she is one of the recently named MacArthur genius fellows, MacArthur fellow. So, I spent some time talking to her and it was really interesting. She has written a lot about digital culture and about the gig economy, and it really dovetailed nicely with the things I cover. So we had a really interesting conversation talking about her work experience. I would not say that she said it was okay all the screen time that we are not now because we are all online all the time. But I got a little bit of confirmation as a parent not to feel so guilty that when kids are playing video games, for example, they are learning to collaborate, they are imagining, they are doing things. It is just not things that we necessarily did when we were kids, but they are connecting, which is so important when everybody is very isolated right now.

Jeffrey: Yes, I would say. I mean, I spent last year yelling at my sons to get off the computer and go outside. Now, this year, I am yelling at him to come back inside and get on your computer.

Lauren: Exactly. So it is such a strange thing. So look, I mentioned that I have a strong internet connection. We actually upgraded the first week of the pandemic in early March when everybody was online because there were five people at home trying to do classes and work and whatnot. I upgraded our router and everything and was very lucky to have like timed it very well. But one of the things I spoke about with Mary Gray is she was talking about income inequality, and we do not think about income inequality in terms of the digital divide, but it really is. So, people who live in rural places and do not have access to great Wi-Fi, and can not connect, they are much more isolated and it also, you know, is particularly not everybody is working from home. It lessens their opportunities, economic opportunities for work, for school, and all these things that, frankly, I take for granted.

Jeffrey: Right. I mean, I called Verizon, I upgraded, and you know, within a couple of weeks they are here. I can imagine those living in rural areas, your wait is going to be a long time as well.

Lauren: Yes, and there is not the infrastructure for it as well. So there are many factors at play and the cost. So it is something we take for granted but as I said, I am very thankful to be able to do this, to be able to sit here. We had to connect with each other a few different ways, but we figured out a way to make it work. In 2020, there are certainly plenty of ways to connect with people, that is for sure.

Jeffrey: Now, you talk about income inequality, but what were some of your findings related to people at different stages of their lives? I mean, you mentioned you and your husband work at home. You have three kids in school doing schooling. But what about even outside those boundaries, have you done any research on single people living alone or older people? How are they coping?

Lauren: I have. Frankly, we have talked about two cohorts that I am really worried about. It is a lot to expect. My 86-year-old father has a flip phone. Interestingly enough, Mary Gray, who I interviewed for this piece, I asked her, like, what is the one piece of technology she could not live without? We had ended up, she said she is spending a lot of time talking on the phone with people, old school. I said, “Well, do you FaceTime with your parents?” She said, “No.” Her dad has a flip phone too. So I can not FaceTime with my dad, she cannot FaceTime with hers, and there is something really nice about being able to at least look.

Lauren: I do not know if you have remembered Pee-wee’s Playhouse? But he had the videophone and he would go into the booth and he would pull down the backdrop and he put on a hat, he would be all ready, it could be a farm or it could be a trucker or driving a train, but he would have a little get up. But I think about that every time I am on FaceTime with somebody. So that is one cohort for sure, and I really, really in this time, have worried so much about my colleagues or along with the young single ones. Like I am older, I got people around, I got a family, I got a dog, but to be alone at this time is really really isolating and hard. I just do not think technology can cut it. I really do not. It does not replace human interaction. It certainly can not replace when it comes to brainstorming or thinking in a group. It does not translate on them.

Jeffrey: Yes, I know from like an office culture, in our sense, we have Junior Associates that were doing a great job that we are mentoring in the office. But as you try to work and bring on new people and bring on new associates. I mean, do you feel that this sense of technology, are we going to be able to continue to grow the economy and grow our employees without that person-to-person?

Lauren: So we have done a few stories in a workplace coverage about starting a new job in 2020 and we just interviewed somebody who also has started a new job and has not met any of their colleagues yet. It is so strange when you have not met a person, for me, like, unfortunately, I do not think we have ever met in person, I am not sure. But I do not have a clear image of who you are. So, if we were to meet, my conversation with you would be different because we would have a familiarity and you can not recreate that familiarity online, at least I can not.

Lauren: So I do believe with all this talk about real estate and the office is going away. But I think people will crave being together again. It may not be exactly the same and certainly, managers will understand now that people can work remotely. By the way, I have been working from home one day a week for the past since my son was born, so sixteen years. So I have always been home one day, I know how to do it. But for people who have never done it before, it is weird. It is really weird.

Jeffrey: Yes, and that it is. So we have talked about some of the drawbacks and it is not going to replace that sense of camaraderie or face-to-face. Have you found any negatives or has it just been the isolation that people talk about?

Lauren: In terms of what it is to work from home?

Jeffrey: Yes, just the drawbacks of having the technology. Have you found that people, besides feeling isolated, are they more anxious? Are they not sleeping? Is too much technology a bad thing in certain instances?

Lauren: That will be yes, yes, and yes.

Jeffrey: I am leading the witness, I guess.

Lauren: Yes. No, all of those things. I mean, there are some good things about obviously the flexibility. We as a family, when everybody’s plans got all upended, we spent a month in Montana this past summer, which we would never have been able to do under any other circumstances, you know, work particularly for the two parents who have jobs. So we had this great experience as a family. So that flexibility is fantastic, but that said, yes, the anxiety, people just not leaving their homes, not having the separation. How do you separate your work day from your life? It is all blurry together. Actually, all the studies show that people are working more now because they can not detach themselves from their computers.

Jeffrey: Yes, I absolutely see that.

Lauren: So from a productivity standpoint, that is actually not good. It is not good for people but it is probably not bad. People have managed to rise up in a way and produce in a way that no one expected.

Jeffrey: They have. I mean, this is ongoing, right? For those of us that work in Manhattan or in New York City that we have to maintain this and we have to maintain this sense of experience of working from home and that enthusiasm. I read a statistic that I think eighty-five of all office workers in New York are still working from home, and we are at a point, though, that some companies need their employees to come back to the office.

Jeffrey: For example, I was reading an article from The New York Times entitled “These are the perks that companies are using to get workers back to the office.” The article was saying that while companies want their employees back, there is still a lot of fear from the employees about coming into the city. The management understands this but in order to entice the workers back, they need to offer additional perks not just a promise of a safe work environment. They are offering significant incentives. Have you seen any of this in your research or any in your reading?

Lauren: A little bit. I mean, it is more active. I do have. I live in a building with seventeen units and it is interesting because my neighbors, my husband have been going into the office a couple days a week. My first husband, who is also a lawyer, I only marry lawyers, he has also been going to the office, and both of them say they can get so much more work done because they have space and they have their stuff. But I am not like perk-wise, free lunch and all those things in Silicon Valley were doing to their workers, is that really going to incentivize people?

Lauren: I think people are worried about safety, certainly the commute. I know traveling on the New York City Subway right now. I have gone a few times but every day, I got a full-detailed report on who did not have a mask on and who was sleeping on a row of seats. So I get for my husband, you know, these updates, it makes him nervous. It makes him anxious. I mean, we would ride bikes if we could but it is kind of far to go to Midtown from where we are, just so you know. I do not know, it is like if there are logistical things. I have driven into Manhattan a few times living in New York City and I realized for people who do not live in New York, it is not the same thing. I have been in Philadelphia and I have driven around Philly too. But it is weird.

Lauren: I think given where we are now in the pandemic, things could change again if we do really have the second wave that we are seeing in Europe. But people are like they are just itching to get out and I do think they do want to go back to the office, it is just what is safe. Sitting at your desk all day long with a mask on, it really sucks, and to try and talk with a mask on is awful. So I do not know how that is going to work.

Jeffrey: It is going to be hard. I mean, it is going to be hard. If you were to gaze into your crystal ball though, everybody is itching to get back, a lot of people are itching to get back, I would say, when do you feel that we are going to be able to make the shift where employees come back to the offices or you think our technology and skills as remote workers have gotten so good that we are going to be having a hybrid model and allow employees the option to work from home full-time or part-time?

Lauren: For sure, some Industries will be hybrid, but manufacturing can not do that, that is not going to happen. For the office, white-collar office worker, I do think that there will be more flexibility. But I also think really what the tipping point of my crystal ball and I have been really gung-ho about this is testing. When we have some reliable rapid testing system available to us, which is available in other countries, and we can not seem to get it together, that really could move the needle because people will have a level of comfort that they are safe and wants to have that level of comfort that they are safe and they will be willing to go back to work or to go to the theater or is it, you know, go to a restaurant, whatever it is. I do not think it is that far away, but I have now come to the realization that, yes, a vaccine, we need it. But what we really need right now is reliable testing. We want to get things going again.

Jeffrey: Okay. So as a New Yorker, I mean, you live and you work in New York City, you know, in New York, it is going to take a while to recover, right? What are you seeing? What is your assessment of the outlook for New York City? When is that vibrancy? When is that theater? When is all that shopping’s [?] be about?

Lauren: So what I did not say is my husband actually works in the theater industry. He is a Broadway lawyer. So one of the marquee things for New York literally and physically is Broadway. It is such a draw for tourism. So we need tourists to come back. The theater and the museums are open. I have had lovely experiences at the Metropolitan Museum of Art and at MoMA. I have to say in a way, it is nice not to be with zillions of tourists because you can walk around and enjoy it. A really lovely experience and not feel that you are in a throng of people.

Lauren: But, obviously, we need the hustle and bustle for New York City. From a real estate perspective, obviously, the office market and you know, certainly some of these large apartment buildings, people do not want to be in big buildings. The elevator, so those considerations. I live in Brooklyn, Brownstone, Brooklyn, which apparently is hot right now and people want to be here and it is lovely. It does not really feel like there is anything going on except that people are wearing masks and, obviously, some places have closed down and sitting outside, there are changes. But life is pretty normal in my neck of the woods.

Lauren: So there is like a million different things going on and, obviously, from a revenue perspective, I mean, our tax base has really been decimated in New York City. Without that money, it is going to be really challenging. There is going to be, you know, school or so many things, services, we need the funds to do them. We were on such a good track but in a way, I also think that the creative culture of New York, I really hope. It is just in the Upper West Side of Manhattan felt like you were in a shopping mall because every chain store, there was nothing personal about it, and all the artists had left this village and gone, you know, into the bush wick or wherever.

Lauren: But I really do hope that if Broadway comes back and, obviously, this is the center of the art world, if the artists come back and the creative culture comes back, that would be really one’s overlining to all this madness.

Jeffrey: Yes, that it would. Well, Lauren, thank you so much for your time today. This has been a wonderful conversation. We learned a lot so thank you.

Lauren: Well, Jeff, I hope that your world of work continues to be good and that everybody who is listening thrives and prospers in crazy times and just take a deep breath, we will get through this.

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.

[END]

In this week’s episode we speak with Monique Brouillette, from Scientific American who explains the varying stages a patient may go through after contracting the novel coronavirus — and the importance of receiving the proper treatment at each critical phase.

TRANSCRIPT

Jeffrey Freedman: Hello and welcome to the RP Health Cast by Rooney Partners. I am your host Jeffrey Freedman.

We are about ten months since this pandemic, and into studying the effects the novel coronavirus has on the human body. Now, scientists are learning more and more about the virus and how it affects the body each and every day. But a terrifying thing about the disease is that it appears to affect people very differently depending on their age, on their gender, and their genetic makeup.

Now, it is almost nine million Americans and forty-five million people globally affected by the virus, the scientists have been able to classify the disease into several different stages. And by doing, so they can begin to treat the symptoms and the underlying disease much better. And this is lowering the hospitalization rates and the mortality rates.

So last month, with the announcement of President Trump contracting the disease, these lessons learned along with new medical findings were certainly put to the test and the doctors and scientists at Walter Reed Medical Center were able to provide unprecedented treatment to the world’s most famous patient.

To talk to us today about the different stages of the disease and the potential different courses of treatment, we are very lucky to welcome Monique Brouillette. Monique is a freelance science journalist who covers Synthetic biology, Genetics, and Neuroscience. She currently writes bylines in many different Science publications including Scientific American, National Geographic Science, and WIRED, to name a few. And over the past year, she has written in-depth pieces about the coronavirus including most recently the President’s infection and his road to recovery.

Monique, thank you so much for joining us today.

Monique Brouillette: Sure. Thank you for having me. It is my pleasure.

Jeffrey: Now, you wrote a fantastic piece in Scientific American this month about the different stages of disease progression a coronavirus patient may go through. And you applied or you kind of superimpose these stages on the President’s infection. Now, I would like to start the discussion today, at first from a very high level. And if you could talk about those different stages that a patient may go through in terms of the disease journey. And can you talk to us about what they may be experiencing?

Monique: Yes, sure. Absolutely. So, just to begin, back in January when the pandemic started, doctors really did not know very much about how COVID-19 progressed. In the early days, if there is a new virus, doctors were scrambling to figure out what treatments to use. Of course, there was no test and treatment, and doctors were really just experimenting. Calling each other on the phone, comparing notes. I actually wrote another piece about this, too, in Scientific American. But now, it is October, we are ten months into this pandemic, and I think doctors have a much better understanding of how to treat their patients. And what is really emerging, is this idea that COVID-19 progresses in predictable stages, and these stages have important implications on how the disease is treated.

So, let us just start with the first phase, which is known as the viral phase. This typically happens in the first week, give or take, there is no hard-and-fast sort of deadlines. This is when the virus enters your body, starts replicating. Most people, of course, do not know exactly when this is happening, but about two to fourteen days later, they go on to get symptoms. And those symptoms are just kind of symptoms you would feel with any other virus, fever, aches and pains, cough. One thing with COVID that is unique is that people tend to lose their sense of smell and taste. And this is not like when you get a cold and you have a stuffy nose and you have congestion that gets in the way of tasting food, but it is actually just caused from the virus itself.

So, this is a very contagious part of the disease, and treatments during this phase are treatments that are targeted at the virus itself and fighting the virus. So, monoclonal antibody is for one. This is the ones that Trump received from Regeneron. These sort of, kind of act to mimic what your immune system would do if it were actually vaccinated. [Inaudible] artificial antibodies that shore up the virus and stop it from entering yourself.

Another treatment for the viral stage is the Remdesivir, which is an antiviral and stops the virus from replicating. This should also be given, I guess, during this phase of the disease. Now, many people will go on and get better after this phase. Many people would not even need these treatments. But if they do not get better, what tends to happen is they go into this second immune feed and that happens around the second week. Around seven to eight days, you will see people getting into this. And what they will see is that they are going to see their oxygen levels drop in this phase. They are going to have some difficulty breathing and this is really when most people head to the hospital. And it is there that they can go on to get that cytokine storm syndrome, which is this hyperactive response of the immune system. And your immune system releases all these chemicals called cytokine that signals the body it is under attack and they need to ramp up the production of other immune cells, macrophages, fever gets ramped up, inflammation happens. And in doing so, the immune system can actually start to cause harm to the body. This is when you see those telltale signs in the lungs that organ damage is happening there and sometimes this business is what causes the difficulty breathing. It can lead to a patient needing to get on a ventilator. There can also be damage to other organs like the kidneys and the heart.

Another treatment at this stage is geared towards the immune system. So that is when people will tend to get steroids. Steroids are going to tamp down the immune system. And you do not want to give steroids, usually, when patients are in that viral phase because in the viral feeds, you really want the immune system. They are kind of fighting off the virus. But in this phase where the immune system is the one doing the damage, that is when you will get steroids and things like that.

And so, after this phase, most doctors agree that there are two phases to COVID. There is a barrel phase and there is this inflammation, hyperinflammatory immune phase. But there are other things that happen with COVID that some doctors are calling separate phases and some of that has to do with some of the complications that arise from the inflammatory immune stage like blood clotting. The doctors I talked to said the one thing that is really unusual with COVID, I mean it can happen with other infectious diseases, but they are seeing a lot more with COVID is that people are getting blood clots. They are getting them in their veins. So they will have deep vein thrombosis in their legs or they are having pulmonary embolisms blocking the lungs and they are also getting arterial clotting which can cause stroke. And another thing that doctors are seeing are bacterial infections of the lungs, and even sepsis which is a bacterial infection of the blood. And that can happen as a result from this inflammatory immune phase.

And then the last phase of COVID is what people are now calling like that long tail or these people who are referred to as long haulers. And it is patients like one to three months out that is still just cannot seem to feel better. They are still having trouble breathing. They may still be tired. A lot of patients complain about brain fog, trouble sleeping. This is kind of the final phase of COVID.

Jeffrey: Right. And that does not necessarily have an end date.

Monique: Yes, I do not think so. I think we are still learning, [inaudible] ten months.

Jeffrey: So, all right. Let us start over a little bit and you mentioned in the first phase, in the viral replication phase. There is that exposure or incubation period and a person may not even know that they are sick. They do not have any symptoms. Could they still be contagious at this point? Or could they be contagious?

Monique: Yes. And actually, that is one of the biggest problems. I think with COVID is that patients, I have seen some studies suggesting they are the most contagious, maybe a day or two before they get symptoms. And I think a lot of people are attributing that to why this virus has been able to spread so well.

Jeffrey: Yes. So, using the word spread. I mean, we are hearing a lot about that with what happened to the President. What took place at the White House, it was called super spreader events. Now, can you explain what a super spreader event is, and could the President have gotten sick at one of these events?

Monique: Sure, yes. So, a super spreader event, this happens when one person infects a disproportionate number of people. I do not know if you have seen these statistics around COVID, they say that each person who is sick can infect like two to three people, but we know though that there are instances where they can infect many more. In fact in my hometown of Boston back in February, there was this infamous meeting at Biogen where all these executives were flown in from around the world, about two hundred people were there. Two days later, about a hundred people left with COVID. They went back to their respective places and spread it further. So, I think these events, now, we are kind of understanding these events are actually playing a big role in this pandemic. For example, there was this research out of Hong Kong showing that between ten and twenty percent of infected people are actually responsible for about eighty percent of the coronavirus has spread. So, did this happen with President Trump? Did this happen at the White House? Anthony Fauci said it did. So, I will agree with him. [Inaudible]

Jeffrey: I will always agree with Anthony Fauci.

Monique: For sure.

Jeffrey: So, you mentioned that most people head to the hospital after this, when things get so severe in terms of if they have trouble breathing or if these symptoms get more than a little annoying. And they are put on a whole regiment of, if it is pre-steroids, they are put on the Remdesivirs. It seemed like the President got everything all at once or at least that is what he was saying when he went to Walter Reed. Is that a normal course of treatment?

Monique: No. I do not think there was anything normal about the course of treatment from what I understand. So, I guess if we go through the timeline. Trump, officially Trump said he started feeling sick on Thursday night, which is when he got a COVID test. And then the next or early in the morning Friday, he tweeted that he had tested positive. At that point, I guess he was reported to have had congestion and a fever. And he was given a course of those monoclonal antibodies from Regeneron, which would have been appropriate for that phase, if he was in the viral phase. And then Friday, he went to Walter Reed, I believe it was on Friday. And I think there was just a lot of confusion about that because his doctors were saying he feels fine. He is at Walter Reed and we hear he gets dexamethasone. And he was also put on Remdesivir I believe, which would also be appropriate for the viral phase. But the [inaudible] doctors administered steroids is a bit confusing because as I said, steroids can actually be damaging to somebody in those early phases. You do not want to hurt your immune system’s ability to fight off that virus. And I have seen some explanations for that.

Some people have sort of postulated maybe because he got these antibodies. They just wanted to, they figured well his immune system has these artificial antibodies that will fight off the virus. Let us give them the steroid to make sure that just as a preventative. But then I heard what is more probably likely is that when he went to the hospital, maybe on that Friday, he was actually entering the immune phase. And so, maybe he was not, like his timeline, I guess he said he started getting symptoms Thursday, maybe that is true. People can get symptoms anywhere between two and fourteen days after they are infected. But I think what is becoming clear is he was probably entering that immune face because later we also found out, well, his oxygen levels dropped. He had some quote-unquote expected findings in his lungs and I am not sure anyone really knows and I am not sure anyone has gotten more clarification on that. But I think that is probably the likeliest explanation, which would explain why he got the steroids and it would actually mean that his doctors were just following the standard protocol.

Jeffrey: Okay. And you mentioned that immune overdrive phase and tied that with cytokine storms. Can you explain what exactly that does in a body? Like a cytokine storm, what are some things that may come of it?

Monique: Yes. So, the cytokine storm is basically your body is overreacting, releasing all these chemicals that say that ramp up inflammation, ramp up immune cells, ramp up fever. And it is really an overreaction and as I said, this can go on to cause organ damage. People are having heart issues, kidney issues. And then the biggest, I think with COVID again, it is like the biggest issue is this clotting. It is that people are, and even you hear, when I reported a story for Scientific American back in the spring, all these doctors were puzzled in New York during the surge. They said people would go home, they would get this cytokine phase, they would be in the hospital and then they would start to feel better and go home, and then come back a week later and suddenly they could not breathe well and they were having all these issues. And finally, they just pieced it together. Well, these people are experiencing blood clotting, and they are coming back in because they have pulmonary embolisms and lodged in their lungs now and they cannot breathe. And this, I believe, is when the
clotting starts is during that immune overdrive. It has something to do with that but inside of your blood vessels get hypercoagulable and you start getting these clots. And I really think that is one of the biggest issues with COVID and the biggest long-term effect of that cytokine storm.

Jeffrey: Right. And we still do not know enough about it or nearly enough about it. But that is different than what you mentioned before about the long haul, right? So, the long haulers, if you will, and I guess long haulers, those are people that have recovered from COVID-19, but they are still having recurring symptoms. They cannot get their health back to what it was pre-COVID-19. Are we treating, are they supposed to be getting treatment for these symptoms, or they just waiting it out?

Monique: Yes. I think they are. I think they are being seen as more outpatient sort of, in an outpatient way. People are, from what I hear from doctors, they are just treating them, like they are treating the symptoms. So, patients who have muscle and joint pain are getting non-steroidal anti-inflammatory drugs like Advil and such. People who are having insomnia, they are treating them with melatonin and antihistamines. People who have these long fevers, they just would not go away, they are just giving them Tylenol. I think increasing exercise, people who are really just, have lost that lung capacity, even, you know, they have started prescribing they work with physical therapists. And of course, for the emotional impact of all of this stuff, depression and anxiety, I think mental health referrals are up. So I really think it is just a treatment based, I am sorry, a symptom-based treatment strategy is what the doctors are doing.

I have talked to some doctors who say this is not so, I mean, this is unusual. We are seeing a lot of people with these problems, but they said it is not dissimilar to like chronic fatigue syndrome. These sort of long-term effects of maybe an infection, I am not sure what virus causes chronic fatigue syndrome, but they said there is some precedent for this. Yes. I do not think they have great answers and they are just kind of treating other symptoms with what we have.

Jeffrey: Okay. That is great. Thank you. That is very helpful. Now, as we are in the final days right now of the election cycle, thank goodness. But as you watch the President on the campaign trail now, he is talking about he is recovered, he is immune. A, could he be fully recovered by now? B, could he be immune? What does this mean in your eyes?

Monique: Yes. Well, I think he could be recovered. So, I know that his doctor, let us see. I am just looking at my timeline here. On October 10th, his doctor releases its memo and he says he is no longer infectious. And they did all these, I think they gave him a PCR test. And later, it was revealed that the PCR Ct value, and the Ct value of a PCR test is how many cycles it takes to detect the virus. And for somebody to be considered kind of recovered and non-infectious anymore, you have to have something like higher than 30s, a CT value of thirty-three. And I think he had something like thirty-four point five or something like that. So, he had cleared that viral face. He no longer had an infectious virus, so he was recovered in that way. Whether or not he is immune, I do not think anyone can say that for sure.

There are so many questions about, is anybody, what is the immunity to COVID-19? How long does it last? What does it look like? We are not even really sure [inaudible] immunity. Can we test people for antibodies? And if they do not have antibodies, which a lot of people who have had COVID-19 do not have antibodies, are we sure that, are they not immune, or did they be, they have another form of immunity through their T cells or some other sort of immune cells? So, we cannot really say for sure, I think, whether he is immune.

And I have also heard some people try and discussing whether or not the use of these monoclonal antibodies could have, which are basically synthetic antibodies that are kind of stand-ins for your own body’s antibody, maybe the people who get those will not actually develop their own antibodies to the virus. But again, I do not think there is anything definitely understood about this. But I think it is probably unlikely that he is fully immune.

Jeffrey: Okay. Still, too early to tell for any of this. It is incredible how much, how long 2020 has felt, but how short the time period is on how little we know about this.

Monique: Totally. Yes. I guess the last thing I would say is just that I think we have made a lot of progress and doctors have learned a lot just in the past ten months. I think in the beginning, treatments were being given may be out of sync with what is known about these phases and that may not have benefited patients, but now it seems like people are getting a better handle on it. And I mean, I am not optimistic[?], I think that is just going to improve and I think treatment is getting better for COVID-19. So, [inaudible] that is a positive thing.

Jeffrey: That is definitely a positive thing. And Monique, we have been talking about the disease as a standard thing, but there has been a lot of talk and a little bit of research done about the disease changing about mutations. And we hear about the flu every year, we need different flu shots because the flu mutates into a different virus. What do you hear about the coronavirus?

Monique: Yes. Well, this is a contentious issue, I will say. And I have written about this. So, there is this mutation in the coronavirus. It is called D614G mutation, and it is sort of quickly, I am not sure when it appeared, but now it appears that most viruses circulating have this mutation. And there has been a lot of fear that this mutation makes the virus more transmissible. And I think in the beginning, people wondered if it made it more sort of deadlier [inaudible] the disease out course.

So, yes, there has been a lot written about this and I think I will just let you know what I have learned from virologists. Viruses do not fundamentally change that easily. And although there has been some experimental evidence suggesting these viruses with this mutation, it may be easier for them to get into cells. I am not sure this is fully been verified by actual laboratory experiments that show that the virus can get into animals and transmits better. And even if it can transmit, just slightly better. I think many virologists, even if those experiments are done and we find, “Oh, well, this mutation may make it easier to transmit,” and that turns out to be true through very infectivity studies where they take the virus and they actually tested it an animal rather than in a cell culture or just through a PCR test. If this turns out to be true, I think most virologists that I have spoken to you said it is really nothing that is going to affect the pandemic in a drastic way, even really in that much of an impactful way. The thing about SARS could be, too, is that it Is already really, really good at transmitting. So, that is, I think, a reassuring thing from virologists. And there is, of course, no evidence that it changes the disease’s severity.

I do not know. In fact, some virologists would say, that I have spoken to, what happens with most viruses is that they actually lessen in severity, like the disease lessens their severity over time. And in some ways, are we seeing that with SARS could be, too? I have been hearing that cases of severe COVID are going down. And we do not know. I think that is still an unknown, why is it going down? Is it just younger people getting sick? I think the answers to that are unknown. But as far as the actual mutation goes, I think there is really no cause for alarm.

But it is something that comes up. This comes up in every outbreak and it is like something that people latch onto. It came up with Ebola, people were worried that it was mutating and getting worse. I have even talked to historians who are like, “Oh, yes.” People have said that about the pandemic of 1918 and they are like, it is so crazy because nobody even sequence viruses back then. So there is actually no evidence, but people were worried about it. So this just seems to come up every time there is a pandemic.

Jeffrey: And with that, I want to thank you for your time today and really appreciate every insight that you have given us.

Monique: Okay, great. Well, thank you so much. This was fun. It is my pleasure to be here.

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

In this week’s episode we speak with Kimberly Leonard, senior reporter for Business Insider, about the upcoming Supreme Court hearing on the constitutionality of the ACA and what the ruling could mean for the US healthcare system.

TRANSCRIPT

Jeffrey Freedman. Hello and welcome to the RP HealthCast. I am your host Jeffrey Freedman. One of the most controversial issues in this year’s political race as well as part of the recent Supreme Court nomination is around the patient protection and Affordable Care Act also known as the ACA or Obamacare.

Jeffrey: Literally one week following the November 3rd national election. The US Supreme Court will hear oral arguments in a case titled California V Texas The case in which the Trump Administration and a group of Attorneys General are challenging the constitutionality of the Affordable Care Act.

Jeffrey: Now will the court strike down the health care law? Some of the key provisions. in this nine hundred-plus page act that was approved ten years ago, provisions are expanded access to health insurance, increased consumer protections, emphasize prevention and wellness, and expanded healthcare workforce, and a curb to rising health care costs.

Jeffrey: And one of its main aims was to extend health insurance coverage to about thirty-two million uninsured Americans, about ten percent of our country. And they do this by expanding both private and public insurance.

Jeffrey: Now for me, from a very high level point of view, one would think that these humanistic goals should have bipartisan support. I mean quality healthcare at affordable prices should be a right for every American, not a privilege.

Jeffrey: But I guess it’s how you package it and how you intend to pay for it. This is where we get into these heated debates. So to get into the details and to make sense of this health care debate. We are very lucky to welcome Kimberly Leonard.

Jeffrey: Kimberly is a senior health care reporter for Business Insider. Reporting about the intersection of policy politics and business and she often appears on and covers live political events for CNBC, MSNBC, Fox News, and C-SPAN. And she has written about the ins and outs of the Affordable Care Act. She has interviewed communities in the midst of the opioid crisis and she shed light on major social policies affecting our country today.

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

Kimberly Leonard. Thanks for having me.

Jeffrey: Great. Now today as you know, we are going to talk about and dissect the Affordable Care Act and discuss what makes it so controversial. For me, from a high-level point of view, that does not sound too bad. But what I want you to do if you could break this down for a bit and we are going to start at a very high level. What the ACA is supposed to do and what are some of the controversial issues? And after that, we are going to dig a little bit deeper into a few of these issues. Sounds good?

Kimberly: Definitely.

Jeffrey: Excellent. So why don’t you start telling us a little bit about the Affordable Care Act?

Kimberly: Well, the main portion of the Affordable Care Act that people sort of think of right away is that it gave more robust health insurance to more people. So about twenty million people were able to enroll through the Affordable Care Act. That means either getting government-subsidized, health insurance that is private insurance, or it means signing up through Medicaid, which is a fully government program that is for low-income people. But that is not really used in every state.

It also has a few other measures that make sure that insurance covers a lot more than it did prior to when the ACA passed. So, it allows it– obligates insurers to cover sick people. It obligates them not to charge them more than healthy people. That is what you hear about when you hear about protections for pre-existing conditions being talked about a lot on Capitol Hill.

It also allowed adults to stay on their parent’s health insurance until the age of twenty-six. That is another popular provision and created all kinds of other programs and portions of– and changes to the health system and the health insurance system that people might out not always know about. So for example, when you go into a chain restaurant and you now see calories on the menu. That is actually a direct result of the Affordable Care Act.

Seniors on Medicare pay less out of pocket for drugs because of the ACA. There has been a whole kind of new sub-agency created due to the ACA that allows the government to sort of test out different ways of paying for health care in order to improve health care but also pay less for it.

And so, there is this whole, wide-ranging, undergirding, I would say at this point of the Affordable Care Act that reaches into a lot of different parts of the healthcare system. And now that it has been over ten years, we have seen how it is interlocked with a lot of different parts of the industry.

Jeffrey: All right. Now that was great. Thank you. But we are going to start to get into these a little bit deeper. I mean everything that you said, talks about the healthcare system today and seems so important but it seems, when I opened the paper every day, there is so much controversy and that is what I want to figure out and figure out why right?

Jeffrey: So if we talk about some of these items, let us talk about you mentioned, pre-existing conditions. Now, obviously, we are in the middle of a global pandemic, right now. We have close to eight million Americans that have contracted Covid-19. And unfortunately, these eight million numbers is very highly skewed to the middle and lower-income wage earners, who have historically had issues getting health insurance to begin with.

Jeffrey: You talk about government-subsidized health care, you talk about Medicaid, what is going to happen here? What is the debate about and how could this be taken away?

Kimberly: Well, one of the problems that has really followed the Affordable Care Act all along was that it was passed along party lines. So it was passed only by Democrats and so for a long time, the fact that Democrats went at it alone with something that Republicans could attack in different campaign cycles. They could say that your health insurance was being taken away and that people would not get to keep the same doctors and so and so forth.

Kimberly: It is true that the ACA had some problems because it was disruptive at the beginning. When you tell people they can not have the insurance they had before, which by the way was not always very good insurance, and they are moved on to a new plan that is significantly more expensive because not everyone gets subsidies, then you got a lot of backlash there.

Kimberly: You also see that at the beginning of the ACA and we will get into this more I think later in the conversation, but there was a penalty that would be incurred on people who did not get health insurance. And that was an extremely unpopular part of the law.

Kimberly: On top of that, there were a lot of problems initially when they tried to set up these health insurance marketplaces. A lot of websites did not work for people to purchase insurance, there were all kinds of glitches, and waiting lines, and things like that.

Kimberly: And so, because it was not really handled so well, it definitely reflected poorly on what the law would look like and gave a political attack and one that definitely was probably something that people were very frustrated with. In order to say this is what happens when the government tries to take over your health care.

Kimberly: And so that led was the beginning underpinning of what we have today, which is that the Affordable Care Act is still controversial with Republicans, and it is facing another lawsuit. One of many. But this one will actually hit the Supreme Court one week after election day.

Jeffrey: Right and we will talk about that. So, besides the pride of the authorship issue that you are talking about, whereas this was written by Democrats without a lot of Republican intervention or say, there were growing pains. There was certainly a lot of consternation because this was a change This was something new. But you did mention some points that there were a lot of issues on the rollout. Is this still the ‘hangover’ from that?

Kimberly: I do not know if it’s still applies as much right now just because it has been a little while. I do think that probably one of the things that people are learning during the middle of this pandemic is that, if they lose their health insurance that often going to the marketplaces is not as affordable as they might like it to be.

Kimberly: Because you do get subsidies to pay for private health insurance, except if you make above a certain income threshold, which is roughly, for an individual about fifty thousand dollars a year. So anytime you get above that threshold you are responsible for this health insurance, which can be expensive and the deductibles can also be expensive.

Kimberly: So I think some negative feelings that remain about that have to do with affordability. Having said that, in some states because of the Affordable Care Act you can sign up for Medicaid which is almost no cost to the individual and is a popular program. And having that option in the pandemic and we have seen Medicaid enrollment grow in States.

Kimberly: We will probably see it grow even more. Depending on how all this shakes out. I do not know that people necessarily connect it to the Affordable Care Act very much, but it is one of the parts of the ACA that we have seen people who are enrolled in Medicaid plans have a positive experience with it. Pulls well with them.

Jeffrey: Now. one of the aspects to keeping the overall cost low and you started to talk about this was with the individual mandate. Now, as I understand it, this mandate said that either you have health insurance or you have to pay a penalty.
Now from again, just my understanding was basically forcing all Americans to have health insurance. But by doing that, it ensured that there were more healthy people entering the health insurance market which lowered the risk for the insurers and therefore, lowering the overall cost of health care insurance. Now is my understanding correct? Can you talk about the pros and the cons of this provision? And then what happened had that–?

Kimberly: For sure. You are correct in how it was argued into law. That was what they hope to achieve that the– it was it sort of the carrot and the stick argument, right? And that what is the stick the penalty enough to get people to purchase health insurance.

Kimberly: One of the things that we sort of largely found is that it did not seem to matter that much as to whether people purchase insurance or not. The penalty in a lot of cases was lower than what people would have paid for health insurance. And it also had a lot of exceptions. I had one person tell me, “You know, if you are paying the penalty, you are doing it wrong.”

Kimberly: Just because there were so many ways out of it. It was if you missed certain utility bills, or cell phone bills, and things like that. You could actually apply to not pay the fine for being uninsured. So it was unpopular just because I think that people do not like to be forced into purchasing something. Especially if they feel that it is something that is extremely expensive.

Kimberly: But I think one of the things that we have learned is that since the penalty was zeroed out as part of the Republican tax law, that President Trump signed into law and that took effect in 2019, is that what really causes people to sign up for health insurance is if they feel like they can afford it. And so because of a lot of the changes of– and I am not going to really get into it that much because a lot of the changes that the Trump Administration made to the health care law, it actually made it so that people are getting far more generous subsidies for health insurance.

Kimberly: And so, if they are paying zero dollars out-of-pocket, do you need a fine to encourage them to do that? Probably not. They will probably, gladly, sign up. It seems as though making health insurance more affordable is a more important mechanism to getting people to sign up for coverage.

Jeffrey: So as you said that penalty was zeroed out. So instead of it being a dollar tax or a dollar penalty went to zero, but it has still stayed on the books. So went to court, the individual mandate was upheld as a constitutional exercise of Congress, calling it a taxing power. But the individual mandate is still being litigated right now, and it has changed a little bit. There is you mentioned.
California V, Texas, and that is going in front of the Supreme Court the week after the election. So talk about that a little bit, how can this affect the ACA just this one portion of the ACA?

Kimberly: Right. And the AC has been before the court so many times just for a lot of its different provisions and also because it leaves a lot of role making up to an administration. So it has spent a lot of time in and out of Courts and at times its whole being has been threatened.

And so, back in 2012, the Supreme Court decided to uphold the health care law and they were asked to look at it because those opposed said that Congress could not force people to buy health insurance and the Supreme Court decided that they could. They decided that the mandate was important and crucial to making the rest of the health care law work, which is the Obama Administration argued at the time.

And so they upheld the law, most of it. And the reason why this whole question is back is a little bit different this time essentially Republican state officials after Congress zeroed out the find on the uninsured waged a lawsuit saying, “You argued that this fine was so crucial to the law working before and now there is no fine. And so obviously the law does not work anymore.”

Kimberly: This is an argument that many conservative legal scholars opposed even if they were opposed to the way the Supreme Court upheld the ACA back in 2012. And so that is the argument that they are looking at. It is an argument that the Trump Administration has sided with, but it is not one interestingly enough that republicans in Congress at least in the Senate side with.

Kimberly: The idea of striking down the entire law or the idea of only striking down provisions. Like protections for people with pre-existing conditions without having some sort of a backstop, and some sort of a plan in place, some sort of a conservative alternative, is not attractive to lawmakers, and it certainly is not attractive to them heading into a crucial election.

Jeffrey: Right, but this case in front of the Supreme Court has a chance of striking down the entire ACA act or law?

Kimberly: Well, I think that Democrats would like to frame it that way as they are looking at this confirmation happening. They do not see any way to stop it and they are hoping that voters instead will be motivated to go to the ballot box. So they are running on this confirmation means your health care will be taken away. That is their big message heading into the election there on that.

Kimberly: That is what the Senate is arguing. That is what the House is arguing. That is what you see the Biden campaign arguing. And I think that it is less clear where Justice Barrett would be? If she were to be confirmed? But as I mentioned earlier, this is not the same argument as in 2012, and it is not the same case that we had before.

Kimberly: And if you talk to a lot of conservatives who oppose the ACA they think this is a shaky legal argument. And so, it is hard to see how you get to an argument that is in favor of striking down the entire law. However, anything could happen for sure. And it does mean replacing a sure vote for the ACA with one, that is I would say a question mark.

Jeffrey: Now, is the ruling from this case would it be a binary type of ruling? Meaning that either they say no, and let things go on as they happen or if they vote against California be taxes and they say we are invalidating this tax or this penalty. Would that negate the entire ACA? I mean, are we at risk of losing everything overnight? I guess is the question.

Kimberly: Well even if they did go in that direction, that were probably be some sort of stay on the law and I think that is what a lot of Republicans are banking on. That even if they were to strike it down, which they do not believe it will. That there would be a sort of holding period until some back-up plan arrives.

Kimberly: So it is not as though people would lose their insurance overnight, but it does introduce a lot of chaos potentially. As I mentioned at the beginning of this podcast the ACA touches a lot of different parts of our health insurance system and a lot of different parts of healthcare. And so, that is where it becomes complicated, which parts of the law really relied on this penalty?

Kimberly: And as I mentioned it seems like, it was not even that important to begin with. Maybe they would have been better off never have had it in the first place. I am not sure. But it could go in a lot of different directions. They could just strike down the protections for people with pre-existing conditions. They could just roll the mandate unconstitutional and leave it at that, if there is a democratic House, Senate, and White House, they could reinstitute a very small fine if they wanted to, to just kind of quickly deal with the problem.

Kimberly: So it could go on a lot of different directions. I do not want to downplay necessarily the threat but it does seem as though if you talk to a lot of different experts on this, they would be shocked if this were to go through.

Kimberly: However, a lot of it is going to be up to whoever is in the White House. Whoever is in the House and Senate should just kind of getting everything on a more stable footing.

Jeffrey: All right. So I guess, you are saying the ten percent of Americans in the country, they are not at risk of losing whatever health insurance they have right now overnight, but this will kind of kickstart further discussion around where do we go from here? And what do we do?

Kimberly: For sure. And you know one thing I will point out is that House Democrats already have a sort of enhancement bill for the Affordable Care Act. A lot of the issues that I mentioned earlier on in the podcast about affordability, that is something that they do recognize.

Kimberly: And they have a plan called the Affordable Care Enhancement act that would actually pour a lot more money into these health insurance marketplaces. So that people would only pay about nine percent of their income or so on health insurance and the rest would be picked up by the government.

Kimberly: Now, is that the best way to get prices under control in this country? I am not sure. But that is their proposal and it certainly would reduce what individuals directly pay for their premiums.

Jeffrey: Right. That is interesting because it is been said by the president and I am quoting his words, “The ACA is a broken mess and awful for the American people.” We talked about a couple of controversial issues but what is the administration offered up? What if the Republicans have offered up over the past four years other than these complaints and using them as talking points for the election and scare people. What have they done to provide an alternative or solution?

Kimberly: Yes, I spoke with a White House official just very recently about this. They say that they are still working on a plan. They do not have a plan quite ready. My understanding is from speaking with folks who have left the White House, who had been there for a time, is that they are banking on the fact that A, it would not get repealed or B, that if it does then there will be time to figure it all out and that nothing would go right away.

Kimberly: One of the problems with presenting an alternative is that then you have something to fight against. So it is almost easier to be vague and I think both sides have realized this over the years. It was always really impactful and successful for Republicans to run against the Affordable Care Act and to run on repeal the Affordable Care Act, without having a unified replacement.

Kimberly: Democrats in 2018 ran on the fact that Republicans tried to get rid of the Affordable Care Act. Suddenly, its very being was threatened, it got more popular among voters. And so, sometimes, well, more often than not it helps to be vague and politics and if the administration were to provide a plan. Then that is when all the criticisms would come out and I think that is what they learned back when they tried to repeal the ACA.

Kimberly: Having said that, I do think that there are some actions the Administration has taken that they could point to. For example, they did allow these State waivers that provide Federal funding to health insurance marketplace, they are known as reinsurance. And they really helped to bring down the cost of health insurance it is state by state. So it is not across the country, but it is one way to help out.

Kimberly: They also created this rule in which employers instead of offering their own health insurance to their workers can say to the workers, “Okay some tax-free money and you can go buy your own health insurance on the marketplace.” Now, if there were to be a huge uptake in that it could really make a difference because you would see a lot more people on these ACA marketplaces and that would really help to bring costs down for health insurance. And we just do not know how much uptake there will be on that.

Kimberly: But they have also done a lot in terms of trying to get more information to patients, whether it is their doctor’s notes, whether it is having access to their own health information, whether it is having hospitals post prices of what they charge for different services. So they have done a lot of actions. They have not always unified and how to speak about them. And they also have done things that Democrats criticized in terms of providing what are known as short-term plans which, do not cover pre-existing conditions.

Kimberly: But at the same time, Republicans could argue. Well, the alternative is that people would just be uninsured. So is it better to have something than nothing? So that is the back and forth that has been going on and much more detail than we get on the campaign trail for sure.

Jeffrey: Right. Now you mentioned besides the government-subsidized insurance and the Medicaid insurance in either case for either party, is anybody looking to get away from private insurance as well? I mean, what is all the talk about socialized medicine as a whole for the country?

Kimberly: Well, former Vice President Joe Biden, if he wins has said that he would like to see what is known as a public option introduced which would give more people the ability to purchase a government plan instead of a private plan. That will be very hard to get across the finish line.

Kimberly: If there is one thing that health insurance companies love, it is the Enhancement Act the Democrats have put forward. They would go all-in against the idea of having to compete with the price of a public plan. And so that was something that the original makers of the Affordable Care Act wanted in there. It did not make it through. It be hard to do it again. But they may try.

Kimberly: I will say they are not really unified on how to do it. The question of whether to let more people sign up for Medicaid, whether to let people buy into Medicare, whether to sort of create like a Medicare Advantage plan. There is just all these different public option ideas that are floating around. And that they are not really unified on. Not to mention that progressives want to see Medicare for all, which would abolish private health insurance in favor of putting everyone into a public plan.

Kimberly: And so there is definitely a brewing battle coming even if Democrats do get unified control of government. There is a lot of intra-party disagreements about what the best next step will be for health care in this country. And I should mention one sort of final piece to this is that, another way to kind of think about going at this that former Vice President, Joe Biden has presented would let people buy into MediCare at age sixty. So basically, reducing that eligibility level.
So that is one that might be less controversial with ensures.

Jeffrey: That is a great segue. And for my final question and probably one you are going to hate, but it is crystal ball, right? What do you think? What do you see happening, to our Health Care system over the next four years or eight years, whether it be a Republican or a Democratic led government irrespective of that, What do you think of that?

Kimberly: I definitely think that Health Care will continue to get more and more expensive. This is the Affordable Care Act for all the things that it did do and it did do a lot. It did not really get a hold of the prices that you see for health care. What you are paying at the pharmacy, the surprise medical bill that you get when you go to the hospital, even when you think you have done all your homework and checked all the boxes to make sure that you understand the care that you get.

Kimberly: So, unless there is some major appetite to reduce what we pay for health care. It will be very hard to get a handle on that. One of the problems is, that as soon as you to talk about price-controlled. The question is, who takes the hit? Is it the doctor? Is it the health insurance company? And so that is why they tend to unite together against the idea of any sort of price controls.

Kimberly: I do think that if Democrats gained and I do not typically like to make predictions, but just based on what we are seeing and based on the battle lines, I sort of see being drawn and the fact that Democrats are basically running this whole, 2018 or 2020 election on Health Care just like they did in 2018.

Kimberly: I think that probably the ACA enhancement act would be the direction they would go in first and then move on to other priorities after a stimulus. A stimulus would probably be first.But I see them more as trying to stabilize the ACA as opposed to trying to make any major changes. They will be under a lot of pressure to go bolder than that. I just do not know that it will be strong enough to persuade the entire party.

Kimberly: That would help to reduce what some individuals pay for their health insurance. I am not as persuaded that as part of that bill, there is actually the ability for Medicare to negotiate the price of up to two hundred and fifty prescription drugs that tucked into this bigger Health Care Reform Bill.

Kimberly: I am not as persuaded that they will be able to get that across the finish line as they promised to do that. Just because I noticed the way that patient groups which are often funded by pharmaceutical companies the way that they held back and did not criticize those that bill when Democrats passed it in the House knowing that it would go nowhere.

Kimberly: But if it was an actual threat, I just think that the backlash would be a lot stronger and the pressure would be a lot stronger. I think it is certain that prices will go up but I think that depending on who has control of government. I see them working first toward pouring additional funding and to the ACA.

Jeffrey: Kimberly, this is wonderful, You have educated me. I am sure all our listeners as well. And this has been terrific. Thank you so much for your time.

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 science writer, author, educator and photojournalist, Tara Haelle, to discuss the vaccine approval process and how political meddling could undermine the public’s perception of a coronavirus vaccine and their willingness to get it.

TRANSCRIPT

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

Jeffrey: Our government and our scientific Community have moved mountains over the past eight months to make the idea of a Covid-19 vaccine almost a reality. To give you some perspective, I mean, the quickest vaccine ever developed was for mumps, and the approval time for that was about four years. But for other diseases like HIV/AIDS, it is been over twenty years of research and we still do not have a vaccine.

Jeffrey: So the warp speed committee is aptly aimed.  We are racing at warp speed to develop this cure, but with speed comes certain risks and we are relying on our scientists on our medical professionals and our government agencies to assess these risks for us and to make sound decisions for the better welfare of our country and for the world. If public opinion in this process turns from trust to skepticism and the acceptance of these decisions creates an atmosphere of mistrust, all this hard work of creating an approvable vaccine could go to waste, especially if a large percentage of the population will not trust or take the vaccine.

Jeffrey: To help us analyze the situation and discuss all the variables in this we are delighted to have, Tara Haley. Tara is a health journalist who specializes in writing about vaccines infectious diseases and other medical research. Her work appears in the New York Times, NPR, Forbes, Medscape, all over including her evidence-based parenting blog, Red Wine & Apple Sauce.

Jeffrey: Tara is also the author of, The Informed Parent, a science-based guide to the first four years and young adult nonfiction book. Vaccination investigation. The history and science of vaccines, and she is written about a dozen children science books as well. She frequently speaks on vaccine hesitancy, including doing a TEDx Oslo talk, on why parents fear vaccines and on public health communication and on Mental Health.

Jeffrey: Tara, thank you so much for joining us today.

Tara Haley: Thank you for inviting me to be here.

Jeffrey: So in my opening, I was discussing Operation Warp Speed as both a blessing and a curse. On one side, we move mountains to get to this point and vaccine development, but now on the other side we are at risk of making force decisions here at the very end. This could jeopardize all the good and risk the public’s trust in the overall process. So what I would like for you to do if we can, let us start here with the very basics. When we hear talk about politicization of the vaccine process, what exactly does that mean? I mean, who are the players in the vaccine approval process, and what roles do they have?

Tara: Well in what I will call normal times when we are not in the midst of a global pandemic, there is a specific process that is followed with the development of any vaccine, and that is that you have various universities, research institutes and pharmaceutical companies all trying to develop different types of vaccines. They go through the standard process of trying to do the basic science to develop the vaccine candidate and then they begin Phase one trials and then if those are successful and do not show concerns on safety issues and show some level of effectiveness, then they move on to Phase two and Phase three. Once they make it through Phase three, which only gosh, I think less than ten percent of vaccine candidates ever make it that far, that is when they… the manufacturers go ahead and compile all the evidence from the clinical trials and submit that in an application to the FDA.

Tara: The FDA then has a committee that goes through and looks at all that data that committee is called, The Vaccines and Related Biological Products Advisory Committee. They look at that, and then they make recommendations based on that data and that particular committee is an open committee in the sense that the public can view those meetings and it is all very transparent. Whatever they recommend it then goes to like the FDA as a whole and the FDA decides whether to approve that vaccine for licensing to a license it for use.

Tara: If it does make it that far and all the way through it it is licensed for use, it is then kicked over to the CDC, and the CDC has a committee, ACIP, The Advisory Committee on Immunization Practices. The people of ACIP who are all independent non-conflicted experts in a very wide range of everything from Immunology to autoimmune disease to pediatrics, nursing, I mean, cardiology, a wide range of things. They look at the data and decide who should get this vaccine. How many doses should they get and how spaced-out should those doses be, and they decide the type of recommendation. Is it a recommendation where they say everyone in this age group should get this or they might say as they have with a couple other past vaccines only get this if you are doing X, if you are pregnant or if you are going to such and such a country or have a shared decision making with your doctor to decide whether you think you should get this or not.

Tara: What ACIP then recommends gets kicked up to the whole CDC which just about always implements exactly what ACIP recommended, and those become you are officially recommended vaccines. That is the full process. Politicizing that means that you have political actors getting involved in some part of that process. Either trying to influence the speed or trying to define how the FDA will assess the evidence. The FDA does have some called, an Emergency Use Authorization. An EUA, and that is a way to speed things along fast track them. But even if they fast-track approval and licensing that can only happen if the data supports it. It is not like they are skipping steps. It is just like they are getting in the fast lane but you still have to go through all the hoops that everything else goes through. There still has to be very solid efficacy data and safety data or it is not going to get the E-Way or at least it is not supposed to and this is where we get that politicization. We have already seen the use of two different E-Ways with non-vaccines, but with therapeutics with the convalescent plasma and with hydroxychloroquine, which the FDA issued E-ways for even though the evidence did not support it. And both of those were a direct result of the administration’s interference.

Tara: Now, I do not know all the details of what goes on behind those closed doors, but it was very clear that the FDA was not following the normal procedures that they would, because the data did not support the emergency use authorization. The concern is that that will happen with the vaccine. And we are especially seeing that right now because the president is touting the idea that the vaccine will be available before the election and there is absolutely no reasonable timeline in which that can happen at all. It is not going to happen. He is insisting on it. So there are concerns that he is going to try somehow to strong-arm someone somewhere to get an actual approval and get people in line that are getting it. I do not know what exactly he has in mind for that. It would be going down a bit of a rabbit hole to try and second guess what is going on in the president’s mind, but we can safely say that the rhetoric he is currently promoting does not match up with what the science flat-out allows for.

Tara: And so the politicization is any type of meddling, influencing, attempts to change, interfere with the process that is already laid out that we have been following for decades.

Jeffrey: All right, so I guess to sum up a little bit, you are saying that the president in order to help with his chances of re-election. And to assuage the country in his handling or show the country how well he is handling the pandemic crisis is strong-arming. If that is the right word. The scientific– is it scientific leaders or is it political appointees?

Tara: That is a really good question. Robert Redfield, the head of the CDC is a political appointee as is the head of the FDA. So both of them being political appointees theoretically can be dismissed by the president. However, you have an added complication here which is VRBPAC and ACIP, those two committees I mentioned. Those two committees are our safeguard, their both fully transparent. All of their meetings are broadcast on webinars. Any person can submit questions to it. Any person can view it and the members of those are not… they are not employees of CDC or FDA. They are independent non-conflicted independent experts. They are people with MDs and PHDs and DOs who are all experts in immunology, vaccinology, all the different fields you need to have something in to assess both the efficacy and the safety data and to look for can safely concerns. They have people on their explicitly for that purpose

Tara: The president cannot interfere with those committees. There is nothing he can do in those, and there is no reason to think that the members of those committees could be influenced by the president. The concern is what happens if those committees are skipped. Especially VRBPAC in particular since that is the licensing process at the FDA. If VRBPAC is skipped, you could not pay me enough money to get the vaccine myself and I say that as someone who is fully up to date on all my vaccines on a regular basis. So that is really what the concern is… there are certain bureaucrats that the president cannot easily dismiss such as people at the NIH or it is a very complex process but the head of the CDC and the head of the FDA are much easier to kick out. I am not sure that would serve any purposes. However, it would not do any good.

Tara: It is clear that President Trump wants to appear as though, he is providing the solution to the pandemic in the form of the vaccine and then delivering on a promise of a vaccine before the election. I do not know what is going to happen when that does not happen because it just I do not know how, I do not know what he is going to try to do to show that that has happened. I do not see any scenario in which that is plausible.

Jeffrey: Now, even though the FDA has kind of a magic fast-pass if you will with this Emergency Use Authorization. With this fast-pass, can a vaccine get into the public and to distribution?

Tara: Yes, I mean if they use an EUA that is still a path to licensing. It means that it can be used in the general public. That does not mean it can skip VRBPAC or other safeguards. It is still, you still have to have the data. The data that is provided to the FDA when they apply for licensing. All of that data is required to be public. So anybody, my grandmother, my next door neighbor, my kids, should be able to go to the FDA website and download that data. Now, that does not mean that any of those people would be able to understand that data, but we do have a lot of experts out there who can look at that data and offer their perspectives on it. I would say that if the FDA uses an EUA, and if there is evidence that they have somehow by past VRBPAC, it is going to be vital that we listen to the independent experts out there who are looking at that data and can tell us whether or not the licensing with the EUA is justified or not based on the data that is in those documents.

Jeffrey: Got it. Okay, thank you. And you talked about this transparency. That all these meetings are public, but honestly, I have been doing this for a while, but this is the first time that I can recall that form a companies have been so open about the trial design and process. I mean, you can go to clinicaltrials.gov at any point, but they are putting out press releases and holding investor conferences about the
number of patients, timing, primary and secondary endpoints. I mean, you have Moderna and Pfizer, some of the frontrunners, they have been completely transparent to the protocols. But you have other companies like AstraZeneca who had recent significant adverse event and almost pressured be more open about it. So do you think this, Advanced Transparency, do you think that is a good thing for the public’s confidence or does it open up the process to scrutiny that goes beyond the public’s real understanding? Like you said your grandmother kids, they can go back on and learn, but they are not going to get it. So especially if there are some additional adverse events, how do you think this transparency is going to affect the future of drug development or the acceptance of this?

Tara: I have two different answers to that. First, I would challenge the statement that this is necessarily more advanced in transparency than in the past. I have been covering vaccines and drugs for a long time as well and a lot of times this information is out there on Fierce Biopharma, on other websites at conferences. You can find it. You just have to actually be looking for it. And typically we do not have so much media focused on a singular effort in the same way. So you do– you are often able to find this level of transparency with different types of things. I am not going to say that is true with all vaccines per se, but it is not unprecedented.

Tara: That said, it is certainly more front and center and there are some companies that might be more open than they normally would have. I know in the beginning Moderna was holding the cards close to its chest and was criticized as such because it was hard to get good information about what exactly they were doing and how they were creating a vaccine which since it was an RNA vaccine, which is not been successfully license before. Finding out the details of that. All in all, I do think this is positive and I think it not only helps the public. I do think it is not just out of the kindness of their hearts. I do not think the pharmaceutical companies are thinking that this is a good public relations move for them. They want to be perceived as out front and center. They want to be perceived as transparent, reliable, honest straightforward, and that is in their best interest. So I would not argue that they are necessarily doing anything just for the ethics of it per se.

Tara: That is not to say that they are intentionally trying to bypass anything or they have in the past. I mean, there is there is a checkered history there in general but this is as much in their best interest as it is in the public’s best interest. That said, I think it is also important to realize that those that are out front and center may not be the winners at the end. We have got sort of a tortoise and a hare race going on right now. And that is some of the newcomers here like Moderna that you might think of Moderna as the rabbit, right? They were the first out of the gate. They were the one racing along, they have gotten a lot of the headlines. There is also vaccines being developed by MERCK. MERCK has developed more vaccines I believe than any other pharmaceutical company out there. They know what they are doing and it is quite plausible that Moderna has vaccine may not be as good as the vaccine that later comes along from MERCK or GSK or another veteran in the field. So I think that is also worth remembering as we consider this.

Tara: In terms of whether the transparency could backfire. I think that is always a possibility, especially in the social media environment we have. I also think it should never be used as an excuse to dial down the transparency. That is not going to do anyone any good anyway, and it just allows for more of an air of suspicion. I think it is valuable to be open about the adverse events because it provides opportunities for experts on social media and for the actual traditional media to explain, “Yes, this is good.” Knowing that there are adverse events tells us the process is working. It tells us that they are paying attention to this, and this is what that means, and this is the next step. So each of those, even though it might freak out people at first when they hear about it. I have seen some pretty good responsible journalism out there trying to explain it and I think in general if I put on my optimist hat which I will admit has been very difficult in recent years, really in recent months. But if I put on my optimist hat, which is the one I usually try to whereas with a journalism and back.

Tara: Journalists, and when I hat I would say that this sets the precedent for improved scientific literacy among the public at large. And that can only be a good thing. I could also put on a pessimist or cynical hat and give you a flip side of that. I will try to stick to the optimist version of that.

Jeffrey: All right, I like it. So keep the transparency, but dial up the education.

Tara: Exactly.

Jeffrey: That is a… perfect. All right, let us take just a step back from these particular.
Coronavirus vaccines. Let us talk about vaccines in general. Now, you have studied, wrote a lot about vaccine hesitancy and have even given a TED Talk about it I believe. There is a certain percentage of the population that is hesitant to taking any vaccines and I guess you call them the anti-vaxxer movement or what not. But can you talk about this for a bit? I mean, why would people still be hesitant to take a proven vaccines for things like polio or chicken pox or the mumps?

Tara: The one thing that is important to notice right off when you are talking about vaccine hesitancy and anti-vaccination attitudes is to recognize that there is a Continuum. It is not like you are pro-vaccine or anti-vaccine. That is the binary that we often hear people whenever I– when people find out that I read about vaccines the first question they want to ask me is are you pro-vaccine or anti-vaccine? And that is a gross oversimplification of what is actually out there.

Tara: In reality the number of truly anti-vaccine advocates the, “Anti-vaxxers.” I only define those as the people who are actively publicly advocating against vaccines and or spreading misinformation about vaccines. Either online, through websites or by testifying at legislative hearings for different states when they are looking at laws related to immunization. If they are actively pushing against sound scientifically supported policy on immunizations, that is an anti-vaxxer. They are rare. They are less than one percent of the population, but they have loud microphones, megaphones, I should say. They they are very good at PR and they network across social media platforms and they are sexy from the if it is bleeds it leads, way that journalism is still often done.

Tara: So that is one group, but then after you put those off to the side, you have got a huge Continuum of people that are hesitant. You have got folks who will get all the vaccines except for the flu vaccine and the HPV vaccine or there is one vaccine they do not like. I do not want the MMR or they will get all the vaccines but they will wait really long in between each one for their kids. Or they are comfortable with two vaccines, but not the rest of them. Or they are uneasy with how many vaccines kids are offered and then they talk to their pediatrician and over a period of several months. They feel more comfortable eventually acquiescing to following the CDC recommended schedule. So that is a really broad range and it you can not make broad oversimplifications about that group, especially since going on to your other question about why? You can you also cannot generalize about their reasons. Everyone thinks it is about autism. In reality there is at least two dozen reasons that people may not want to vaccinate. Some of them have philosophical beliefs that you do not put anything unnatural into your body and therefore if your body does not produce it or if it is not a germ floating around in the atmosphere, then you should not intentionally put it into your body.

Tara: Some people are against medicine at all kinds. There are people out there who are anti anti-antibiotics, anti-chemotherapy when it is the only thing that will treat a cancer. There are people across the board that exist like that. Then you also have people who think it causes other conditions not autism but this or that autoimmune condition or other issues that they will say that they worry about. And then finally you have the people who are looking at individual ingredients that they are worried about and that could be a scientific concern where they are afraid that a particular ingredient is toxic in some way in the body, or it could be a philosophical or faith-based one, such as having a problem with using vaccines that were developed using cell lines from terminated pregnancies. And that is something that the Pope himself is actually weighed in on and said that it is greater evil to allow children not to be protected by disease, then the evil of accepting a vaccine whose initial development had to do with cell lines from terminating pregnancies.

Tara: So you can not draw too many broad generalizations about that wide range, but you can look at when you are talking about why people would take proven vaccines, you could ask the same question of why do some people think the Earth is flat. Why are there some people who believe that there is a global conspiracy to… I do not know fill in the blank. There are people across the process who do not believe other scientific concepts. People who do not believe that climate change is occurring. So we could ask the same question about any of those and there is in fact a lot of crossover. If you did one of those fancy Venn diagrams with five different circles and you went at the people who have misbeliefs about GMO Foods and the people who refuse vaccines and the people who have doubts about climate change. There is a lot of overlap there.

Tara: So that goes into a bigger epistemological set of questions that would take a whole other hour to discuss and try to unpack.

Jeffrey: Okay. Now that is unbelievably helpful. Thank you and that answers the question and actually answered my next question. Based on the severity of the global pandemic, I think you are still going to have the same percentage of the population that is not going to want to take the vaccine. And that is, that Venn diagram group that sits in the middle regardless if it has some borders.

Tara: You are going to have a similar kind of Continuum there as well. You are going to have the anti-vaxxers who are not going to take that Coronavirus vaccine no matter what. But you also have people who will say, I want the coronavirus vaccine, but I am not sure about it when it is brand new. I am going to see what happens to other people first.

Jeffrey: Yeah, I do not want to be first. Yeah.

Tara: My mom texted me on the same day that she got her flu shot and said, “I will not get the vaccine until you do.” So now, she there is the ones that do not trust vaccines, but they trust that the people that they know who are following vaccines more right.

Jeffrey: Do you know are there any legal precedents where people have to take a vaccine for the sake of Public Welfare or for employment purposes? I mean, could a regular employer have the right to dismiss an employee for refusing to take the vaccine?

Tara: A lot of that is still being played out in the courts. There are legal precedents dating back to the early twentieth century looking at here in the United States and the Supreme Court looking at vaccine mandates. Some vaccine mandates were upheld as constitutional, and the alternative if you did not take the vaccine was a fine. So there still was a way out. But it there was a consequence to that. I do not see that being likely in today’s situation. I do not think it is likely that we are going to have the kinds of red, you saw if people have seen the movies where you get the vaccine and you get a bracelet thing. You have the vaccine, I do not see that happening here. What we might see happening is what is most likely is we see a situation with what we see right now in hospitals and the flu vaccine. That is where a lot of this is playing out most where you have hospitals that require their staff and nurses and doctors to get the flu vaccine and you have some people working at that hospital who do not want to get the flu vaccine. And it is, I could not easily summarized all of that case law. I will say that if people are interested in that they can look up the Scholar Dory Reiss. R-E-I-S-S. She is a legal scholar in California who does a lot of research on this and is very, very familiar with those cases and she writes a great deal about them. But looking at that, a lot of hospitals is has been upheld that they can require a flu shot or require someone to wear a mask.

Tara: In this case people are already wearing masks. So I do not know if they would take that further and say you have to get Coronavirus vaccine or you will be terminated. I do not know. I do think we will probably see some of that. What I think will be interesting is the businesses that are not in health care. In healthcare. It is a lot easier to justify requiring the workers to get vaccinated because they are there to take care of people’s health. I am interested in whether you see States saying teachers must get the vaccine or Airlines saying, if you are going to be a flight attendant you have to get the vaccine. I do not know whether that will happen or not.

Tara: I can see it possibly happening and I can also see that it is going to get challenged and there is going to be a lot of case law coming out of that. So it is probably going to get messy and it is really hard to predict right now how that will play out.

Jeffrey: That is really interesting also with with schools with children. I mean, I know my kids need to show a vaccination report. There is no plan or there is no timing put to it for pediatric version of the Coronavirus vaccine. Do you know anything about that?

Tara: I do not. I have been looking for that. In fact, trying to recall there was a publication in pediatrics, which was calling for better quality research in Covid-19 research for children, because they are basically just is not enough attention page to that. There was just recently an article published today and it is entitled Covid-19 trial enrollment for those who can not consent. Ethical challenges posed by a pandemic.

Tara: I think that is addresses that very question and it is not something that I can necessarily summarize. It is literally a full paper looking at case studies, but there are ethical challenges to enrolling kids in a trial like this and I do not know what all of them are. It is different from the longer time period that takes place with pediatric vaccines and there have been changes in policies since then for example, after the Coronavirus vaccine first came out, there was the discovery that some adverse events… there was a higher rate of intussusception, which is a telescoping of the intestines that appeared to be associated with that vaccine and that vaccine was eventually pulled. Later Coronavirus vaccines that came out then enrolled many more people in the trials instead of having about three thousand people in the trials. They had closer to ten thousand people in the trial so that they could detect rarer adverse events in there.

Tara: I do think it is a problem that we do not have trials that I am aware of that are explicitly looking at the Covid-19 vaccine in children. On the one hand, It is clear that the threat to children is not nearly as great as it is for older adults. On the other hand, we have also seen that the most recent evidence regarding transmission shows that children are just as transmissibility… the children transmit the disease just as much as adults do. So while a child’s actual life and morbidity may not be as high a risk as an older adult, their ability to pass that virus along to relatives and family members and teachers is still a threat. I am not sure what is going to happen with that. I think that we have to give more attention to that and I do not see that happening right now. So, I would actually say that is the biggest gap that I see right now related to vaccine research.

Jeffrey: We also do not know, I mean, yes, there are unfortunately some children have died from this, but we do not know the long-term effects for those children that
it have succumbed. You know that had that I have had the virus.

Tara: Exactly. We do not know if there could be long-term tissue damage, especially not only in terms of lungs or lung scar tissue, but cardiac types of long-term damage is quite plausible given what we know about the way this virus interacts with the circulatory system and the creation of blood clots.

Jeffrey: So we should still get ready for additional homeschooling even after the announcement of a vaccine.

Tara: I can tell you that my children currently still doing distance learning and they will definitely be doing distance learning through May, because I will not send them to school before then, and I do not expect that I will have an opportunity to get a vaccine any earlier than next summer and that seems like a stretch. That seems like the very, very, very earliest of if all the stars aligned correctly. So it is we are still in this for a while. I think a lot of people have not quite come to terms with the long-term nature of the emergency that we are in right now.

Jeffrey: Well Tara, thank you so much for your time today. This has been incredibly educational, informative and entertaining. So thank you so much.

Tara: Yes. Thank you very much for inviting 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.

In this week’s episode, we speak with Andrew Dunn from Business Insider to discuss the COVID vaccine timetable; who are the players, who are the front runners, and when will a vaccine be made available to the general public.

TRANSCRIPT

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

With the election cycle in full swing, the pandemic is obviously front and center of both parties’ talking points. But one of the only things that both sides can agree on is the need for a vaccine. The unfortunate part of these vaccine discovery discussions is the potential for turning science-based decisions into political ones. I think as a country or even globally, we believe a safe and effective vaccine is in our near future. But knowing that these vaccines have been safely vetted and not rushed to the market for someone’s personal agenda is really what concerns us. Even after getting a vaccine approved, we have drug makers, we have our local and federal governments, healthcare insurers, even the militaries, they all get to need to collaborate on mass production, collaborate on creating a fair and orderly distribution plan, and then even collaborate to convince the public that it is safe and necessary for everyone to get vaccinated. The speed that all this is happening is unprecedented and there are so many different players involved. It is really tough to keep track of who is getting close to product approval and with different companies approaching these vaccines in different ways, it is hard to tell if one therapy is going to be better than the other or work differently on different people. To make sense to of all this we have our guest this week, Andrew Dunn. Andrew is a healthcare reporter at Business Insider covering the pharmaceutical and biotech industries. Since the pandemic began Andrew has been reporting exclusively on coronavirus vaccines and therapies. His stories have taken an in-depth look at vaccine discovery and clinical trials for these potential therapies. Andrew, it is great to have you back.

Andrew: Thanks for having me, Jeff. I am happy to be here.

Jeffrey: Let us just get right into it. What is going on with what you write about? Every day, we either hear a different story from a different person. Either the vaccine is coming as early as the end of the month or sometimes we hear we are not going to see one until next summer. Your job here today with us is to separate fact from fiction. Is it just wishful thinking or is it hyperbole for political gain? Let us start with how many vaccines are currently under development and how many are in the final stages? Who are they?

Andrew: Overall, there is a ton of work going on around the globe. There are well over two hundred vaccine research projects ongoing. Obviously, two hundred is a lot to keep track of. A lot fewer are in human testing so that is a sort of the first barrier I think of is, are these vaccines on lab benches still being optimized, still being tested in test tubes and beakers, and animal models, that type of stuff, or have they actually entered the clinic and started human testing. When you think about human testing, there are a few dozen. The number keeps going up every week but maybe thirty to thirty-five vaccine candidates that had started human testing. Obviously, the basic steps of the drug development vaccine development process you have phase one testing small numbers, making sure it is healthy, and the healthy people making sure it is relatively safe. Then you start phase two, phase three testing, where you go from dozens of people to hundreds to thousands of volunteers. Eventually these phase three trials, these are the ones we are really focused on right now in our effectiveness driven study. They are actually looking to see does this vaccine actually prevents infection, does it prevent disease. Actually, it answers the question do these shots work? As far as phase three vaccines, there are about half a dozen across the globe that are in this final stage of testing. Most of them centered around the U.S. Some doing global trials. With that as sort of the way of the land then I think it is probably helpful to get a little bit into who are the front runners, who are the ones we always keep hearing about these companies, and where they are at currently. There are sort of three leading efforts for these past few months that have been generating most of the tension and sort of leading the pack, those are Moderna, Pfizer, and AstraZeneca. Moderna, there were the first to start human testing back in March. They started their phase three study in late July. Again, this is a study that is recruiting thirty thousand volunteers, randomizing them between Placebo, and getting two doses of Moderna’s vaccine, and then following them up to see when there is a meaningful difference between that Placebo group and the ones getting Moderna’s vaccine. The same thing is going on with Pfizer and Beyond Tech. They have a very similar timeline, they also started phase three trial in late July. They expanded that trial from thirty thousand to forty-four thousand volunteers. They are also looking at pretty similar endpoints as far as what they hope to see from their vaccine. The main difference here between Pfizer and Moderna, as far as the timeline expectations their CEOs have put out, Pfizer’s CEO has been a little more bullish. He said over and over for the past few weeks that he expects results in October, showing it is effective, which is by far the most aggressive timeline out there. Speaking with Stéphane Bancel, who is the CEO of Moderna, he sees a base case scenario of November for results. He calls it unlikely but potentially possible to see results for Moderna in October. But again, base case scenario in November and he says, if the virus starts to spread less, if we see less cases within the people in the study, it could extend out until December as kind of his worst-case scenario.

Jeffrey: You name the top three or the three that have been in the news every day. Obviously, we have J&J Janssen, we also have Novavax, so that is five, right? You also said that there are a hundred ninety-five other companies working on vaccines. It is hard to believe that these frontrunners could be out by the end of the year. We are hoping the entire world gets vaccinated within a year from that or two years from that. Are two hundred vaccines even necessary? Is it physically irresponsible? But I guess that is a question for another day. But with two hundred different vaccines going on and certainly the top four or five, how can they be different? What is so different? Is one going to be better than the other? I mean, is one going to be better for a certain demographic, like one better for the elderly versus pediatric. Do they even know anything about pediatrics? Or across ethnic or gendered lines?

Andrew: Yes, it is a great question. I think that is what on everyone’s mind. If you have two hundred vaccine candidates or whatever the number is, how do you distinguish between these and prioritize them and actually craft a coherent plan on who gets what vaccine. I think a big part of this is waiting for the day that speaks for itself. Waiting for phase three results to be published with specific data and hopefully, some of those answers become self-evident as far as if we are talking about a subpopulation of the elderly, or particularly young people, or people with comorbidities. If you look at those individual subpopulations, is one vaccine just clearly better than the other? That would make some of these decisions a lot easier. If for whatever reason vaccine B works well in for the elderly let us make sure vaccine B goes to the elderly. People say unprecedented, it feels like every day around the pandemic but there is nothing I have seen like it or read about in the history books or in previous clips that compares to finding this balance of just the overwhelming urgency for an answer to this pandemic and getting something A.S.A.P. to people. When, whatever the number is, eight hundred, nine hundred, a thousand people are dying a day in the U.S. and around the globe. I think, we just passed the one million death marker. There is an outstanding urgency to get something as soon as possible when you see the calamity that is going on around us. At the same time, you want to make sure you get it right. You want to go through this rigorous scientific process that requires time. If they are going to approve something early as an emergency use authorization, even if they are going to give an emergency approval for a small group of people early on this year, they still want to see a median safety follow-up time of two months, which is super, super long, but at least that is something as far as if you have sixty days of data on most people to see for side effects, and safety, and tolerability, that gives the FDA some level of confidence in saying, okay, the risk-benefit calculation here, we feel confident enough to issue an emergency use authorization. Even something that basic has become controversial with President Trump saying this is a political decision or this sounds political and that this might slow down getting access to vaccines down the line. It is really two compelling balances as far as the urgency to get something to people as soon as possible, but you also want to make sure it is safe, and you want to make sure it is effective.

Jeffrey: A couple of things that make this political is a few folds. The names that you mentioned they are in the news every single day. Our government made a huge bet, huge bet, financial bet, on these companies and backing these companies. It is in the country’s best interest, obviously, for all of these products to work out, and that was through something called Operation Warp Speed. From a very high level, can you just talk about it and why these vaccines, in particular, are so important to it and how does Warp Speed affect them both from financially and operationally to the market?

Andrew: Operation Warp Speed, that is the U.S. government’s coronavirus vaccine initiative which is basically this very broad sweeping public-private partnership that is pulling together people from HHS, the Defense Department, the few people from the CDC alongside the drug industries, the largest drug makers, and other stakeholders, sort of bringing them all together with the goal of as fast as possible getting a safe and effective vaccine out to Americans. There are also no mRNA vaccines on the market so some people raised concerns as far as this is an unproven platform and it is a pretty big bet to go with Moderna and Pfizer both on that. AstraZeneca, Novavax, Sanofi, Johnson & Johnson, those are all more proven platforms of either protein-based or vector-based vaccines that have generally been approved before as far as how you go from start to finish. Overall, you have these six vaccines under Warp Speed. To accelerate the process, one is doing multiple clinical trials simultaneously. Instead of sequentially doing phase one, waiting for that study to finish, reviewing the data, deciding if we should go to phase two, repeating that process in an orderly fashion, basically, these studies are running simultaneously. The phase one study with Moderna is still technically running. They are still following those patients that were dosed starting in March, getting that long-term safety follow-up, all of that is still going on. But at the same time Moderna started a phase two trial, they started a phase three trial, all of these are running simultaneously. The same thing is going on for Pfizer. The same thing going on for AstraZeneca. Johnson & Johnson just started a phase three trial remarkably quick with basically starting the phase one study in late July, September starting a sixty thousand-person phase three trial. I mean, Warp Speed is the accurate name for it as far as how fast that is going compared to typical vaccine development. One thing to bring up that I have asked about is the idea of you do have a diversity of different technologies that these are using but I think it is also worth noting that they are all going after the same protein of the coronavirus. It is called the spike protein. It is the spiky points, the stick out when you see the graphic, or the cartoon of the virus. From the signs that I have talked to you, they are very confident in it. They think that that is what a vaccine should target. If you have antibodies that neutralize and bind to that spike protein it will be really hard for that virus to get into people and cause disease at the end of the day. Operation Warp Speed is essential to all the work that is going on in the U.S., and sort of trying to coalesce it into an accelerated process and also get manufactured going at the same time. If one of these vaccines does show it works and is effective, there should be at least a few million doses scaling up very rapidly into tens of millions, hundreds of millions of doses throughout the course of the rest of this year and into 2021.

Jeffrey: That is great. Very interesting about the spike protein, I have not heard that before, but it makes sense. I guess with Operation Warp Speed, it is a twelve billion-dollar investment, that is a lot of money but I think it is going to the right places. It is a rush or it is a warp speed to approval, and I do not want to say rush, because that makes it sound like there is no scientific method here, and there is a scientific method. Something you pointed out also that is not looked at, I think, is the fact that Moderna, they did go into phase one, many many months ago and they are still following those people. I think that is helpful, but granted it is only probably twenty or thirty people as opposed to the thirty thousand that we are hoping for. Let us say the end of October or beginning in November, phase three data comes in, what does approval mean? We now have a vaccine that a few people have deemed great in the clinical trial, what does it mean to be approved? Is it FDA approved officially or they are going to say, we saw enough data that we are going to allow you to use it through an emergency use authorization, what is the difference?

Andrew: It is widely expected that any regulatory decisions around a vaccine in 2020 are going to be under the emergency use authorization. We ensure people call that emergency approval. You can contrast that with full approval which is going through a biologics license application. When you hear BLA, so think EUA or BLA, and EUA is most likely going to come first. That is what everyone seems to expect. It would be a stunning surprise if it was just a full approval right off the bat. Basically, with an EUA, it is a lower regulatory bar to allow the FDA to authorize something for use in the public. EUA also lets the FDA craft an approval or tailor an approval test to start in a subpopulation. A lot of the things with my talk to vaccine experts are it is very realistic to expect. If you have Pfizer or Moderna, one of these leading companies, if they have a positive readout that shows, hey our vaccine is effective, here are our two-month safety follow-up data on most of the people. That is a decent chunk of clinical results all around, as far as you get a good amount of short-term safety follow-up, you have that initial effectiveness result. Now, you still do not know what you do not know. You do not know the durability protection, you do not know if this vaccine is going to last three months, six months, a year, or longer. You do not know any long-term safety events and some of the rare serious adverse events. Even with the history of vaccines, you only figure those out honestly, when they are rolled out to the general public, overall. It is a one-in-a-million safety event. Even a thirty thousand person trial will have trouble picking that up just given the rarity of it. But accepting that uncertainty there will be most likely a EUA discussion whenever these results come out if they are positive. That will probably be limited, thinking of groups that are especially vulnerable, where the risk-benefit calculation of getting a vaccine might be more weighed to them, you think of the elderly or people with comorbidities, frontline workers or healthcare workers who are in hospitals with just above-average exposure to the virus. Those people might be tailored to that group specifically. In the EUA, that is going to be the conversation to debate around 2020. If any of this data does come this year and a BLA would come further down the line, I think it is still being worked out what to look for, but a reasonable estimate would be thinking six months of safety follow-up data on tens of thousands of people in the study, to have a real good sense of confidence before you roll it out to hundreds of millions of people that this is surely safe over a fairly long period of time.

Jeffrey: Let us say we do get Pfizer at the end of the month, Moderna a month later, J&J in December, do you think the FDA would wait on an emergency use authorization until all three or four of the first ones the data comes in or do you think it is first one in first one out type of thing?

Andrew: The FDA has committed to having an independent group of scientific experts called an advisory committee, meet, consider each individual coronavirus vaccine when the data supports that type of meeting. I would expect once the data is available for those meetings to be scheduled very quickly after. It is another thing where it is hard to say exactly how quickly this process will work because if you think of a normal application process, it normally takes six or ten months after a company has submitted their data package. The FDA will take six or ten months to look it over, review it, discuss it internally, and make a regulatory decision. It seems inconceivable that they would have that much time just given the urgency here.

Jeffrey: Right.

Andrew: But they have committed to having that independent expert group. I would expect each vaccine to get their own, once that data is ready, I would expect an advisory committee meeting to be scheduled promptly thereafter. There would not be a gating factor as far as wait for the first three. If that first vaccine, if there are enough merits in that data alone to approve it, I think the FDA would make that decision.

Jeffrey: Okay. Pfizer is at the end of the month, immediate meeting and they could be off to the races. Let us combine that thought with the topic of Warp Speed and layer on top of that the question of getting everyone vaccinated, and how all is that going to work. I have a number of questions for you to walk through. Whether it is Pfizer alone, or Pfizer and Moderna, is the government going to grab millions of doses of those first couples of vaccines and just start inoculating as many people as they can whether it just be all the elderly or all the frontline workers. If we find out that, let us say, the J&J or Janssen vaccine in December, has much better clinical trial data than Pfizer that was approved several months earlier, do you think they would stop giving out the Pfizer one and move to J&J? How do you think this is going to work?

Andrew: It is a great question. I have been asking people a lot smarter than me that question for the last few weeks. I think it is just going to be fascinating. I do not know for sure how it is going to work out. I do not think anyone knows a hundred percent how this will all play out. I can say that one thing that we know for sure is these Warp Speed contracts, they basically pre-purchased vaccine supply for all six of these. So for Moderna, Pfizer, whatever company, if it does work, the U.S. government has agreements where they have already bought. For most of these, talking a hundred million doses, most have options where the U.S. government could extend that to buy several hundred million additional doses of those vaccines. So, there is a supply already set up, there are agreements with these companies to get some doses basically immediately once the data supports an approval if it does. What that means as far as if one is superior to the other vaccine, that is a really interesting question that I do not know. There is a lot of ethical considerations in that as far as if you are sitting on, imagine if you have vaccine A and vaccine B, you have data on both, you have pre-purchased supply agreements for a hundred million doses of both that have already starting to be made, and vaccine B look superior, who in the right mind would want to get vaccine A. At the same time, it is an extremely supply constraint where the option for these people might be vaccine A or no vaccine at all. It is really complicated. I do not have a clear answer. I have asked Moncef Slaoui, the head of Operation of Warp Speed, a very similar question maybe forty-five days ago or so when I last spoke with him and he basically sorts of punted on it and just said hopefully, the clinical data, subpopulations, will be enough distinctions where that will work itself out. I mean what you want to see here and this is sort of playing out in real-time is the FDA set clear guidelines on what they want for this data before we see the data. I think that is the fairest way of doing it and that is what I have been talking with experts about is what would you actually like to see in the data? What does a good vaccine look like? What does an adequate vaccine look like? What does an excellent vaccine look like? As fas as getting the idea of six thousand people who have received two doses and been followed for at least two months. If that is the safety database, what does that tell us? What would not that tell us about the vaccine? The American public has to feel confident in the regulatory process and the fact that these decisions are made by science instead of politics. If they are going to even consider getting a newly approved vaccine and it has been remarkable to see some of the tension play out in public between the FDA and the White House. That has really surprised me. The FDA several months ago, this was a really good job by them, as far as when you look at hindsight, they put out guidance around that full BLA. So thinking about that full approval and they basically said, we are not going to approve any vaccine that is less than fifty percent effective, and they outline the safety data they would want. That has sort of established this idea of, okay, to get that, these companies are going to run studies with thirty thousand people and then you see that number reflected in the studies and so on and that has worked well as far as those goalposts were established. They are very clear, they are publicly available, it is transparent. The emergency use authorization that is what is being caught up in this controversy within the government to some extent, especially around this two-month safety follow-up data. We are talking goalposts there, those have not been publicly stated formally yet by the FDA for EUA. So, that is something to watch these next few weeks, if they are able to do that or if we are just going to roll into data, it will be a little more free-flowing to sort of think about it as far as — You could imagine if something comes out that is fifty-five percent effective, it cleared the bar for BLA approval, and get FDA approval, but that would still leave a lot of room for improvement for future vaccines to be more effective.

Jeffrey: Right, and getting people excited about taking that vaccine that is only fifty-five percent effective. It is going to be tough as well.

Andrew: Right. I think the other point that is still not really as evidence to the public as it probably needs to be, in terms of expectation setting, is the idea that even when you get a vaccine, especially it is most likely going to be partially effective to some effect, it is not going to be getting a vaccine and you cannot go throw away your mask the next day and start going to bars, and stop social distancing, and whatnot. Getting out of the pandemic, it is a kind of a vaccine is an incredibly valuable tool and the toolkit here against the pandemic. It is seen by experts as yes, you get the vaccine, and you wear a mask, and you socially distance. When enough people do multiple of these measures that is how the pandemic ends much more quickly.

Jeffrey: Right.

Andrew: It is kind of a bummer to here as far as you here all the time. Until we get a vaccine XYZ, when there is a vaccine, even when there is a vaccine, there is a good chance we are still wearing masks and socially distancing as that distribution goes out. You need hundreds and millions of people to really have a sense of community protection.

Jeffrey: Andrew, thank you so much. This has been, as usual, your insight knowledge of this area is fantastic and we very much appreciate you sharing that with us.

Andrew: Thanks so much for having me on, Jeff. I really appreciate it and I love the podcast. Keep doing it.

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 Larry Light, editor for Chief Investment Officer and writer for Forbes.com, to discuss how the current political and economic turbulence influence the markets and what socioeconomic variables create the largest volatility.

TRANSCRIPT

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

Jeffrey: If you follow the financial markets, it seems that any piece of significant news right now creates a much larger than normal swing in stock and index prices. But this is understandable- I mean people are nervous. Market players are always nervous about not being in the game and missing a big run, and conversely between a pandemic and an ugly political season. Really need nerves of Steel to even be playing at all.

Jeffrey: There is so many huge levers that could be pulled at any moment that could create big change- a big ticket items that affect our economy, such as what could happen in a U.S. presidential change, or if there is also a change in control on the Congress.

Jeffrey: What happens if our employment numbers do not continue to dramatically rise? And what is going to happen to our economy or our entire industry sectors like travel, or to entertainment if there is a delay in creating or distributing a vaccine? Well to answer these questions and to break it all down for us this week, is our guest Larry Light. And Larry is a thirty-year veteran of the financial markets. He has written for institutions such as the Wall Street Journal or Forbes, BusinessWeek and Money Magazine. Larry is currently the markets editor for a chief investment officer and a writer for Forbes.com.

Jeffrey: Larry, thank you so much for joining us today.

Larry Light: Glad to be here.

Jeffrey: Now, you have been a financial writer for over thirty years, right? You have been writing for the likes of BusinessWeek and Forbes and the Wall Street Journal to name a few of the companies.

Larry: That is right.

Jeffrey: Knowing the markets like you do and what readers want to read, how do you find or identify story ideas for your columns week after week? I mean, there is so much going on. What do we look for to make an interesting story week after week?

Larry: Right now I work for chief investment officer magazine, which has high-end clientele. So in other words, they are their financial professional. And although it is available to the public it is a free site.

Larry: What I am always looking for is something that is not what you have read elsewhere. I try to be contrarian. Now, some contrarians just are just, “you say either as I say either” I want to make sure that if I am saying that something is not- there is some aspect of something that has been in the news that you have not really looked at, the way you might, that is farther for me. For instance. I did a story this week on SPACs which are Special Purpose Acquisition Companies, which is the latest alternative to an IPO and they are very popular with companies that want to go public like for instance DraftKings, which is a really hot company because it is online betting sports.

Larry: They went public by aspect but I pointed out that there is some problems with SPACs. It is not as investor-friendly as you think it is great for the issuers but leaves something to be desired for the average or an institutional investor. So that is the way I go at it. I am looking for something that you do not know about or you have not heard about, so that is what I try to do.

Jeffrey: And that is what keeps it interesting. That is great. Now, with the market, you know, SPACs coming to market IPOs are flying off the shelf. Like we saw today. Some have argued that the U.S. stock market right now that it is priced perfection and I guess you can always say that right? Supply always has to equal demand.

Larry: Right.

Jeffrey: From my point of view, with the continued spread of the coronavirus with about eight and a half percent unemployment, where is the perfection? We are trading at almost to thirty times multiple right now. Can you make some sense of those?

Larry: Sure. Well the stock market anticipates the future or what it thinks that future will be like and it is much rosier than life appears to be in the ground on the economy. It is as you say high unemployment with GDP for the rest of the year projected to be down. But if the stock market does not say, “Yeah, but it is going to get better”, projections are that the GDP will be down on the third quarter and we will be down on the fourth quarter, but not as much. It’s descent is slowing and next year, the projections are that it will be positive GDP. And of course that is what the stock market anticipates. It also looks at the virus vaccine efforts and takes heart in that. There has been a lot of positive noise from the pharmaceutical company about this and so that stock market looks at that.

Larry: Then of course, there is one other thing. The leadership of the stock market, it is dominated by top-tech stocks and that has not represented the entire market but they are the ones that are winning right now because they are, for the most part, immune from the vaccine- people are staying at home. So they want to be on Facebook more. They are ordering more stuff online. So that helps Amazon, etc.

Larry: And if you back that out of the stock market, the stock market is not doing this well. Take the S&P 500, it is up over five percent this year. But if you do equal weight it, it is down four percent. In other words, the outsized asset size of the tech stocks, is distorting what we see. But the S&P 500 is as I weighted. So, Apple which has an asset valuation of much more than many countries, is just pulling the train and it’s brothers are so. Frankly, we saw a hiccup last week for the tech stocks because some thought that they were too good that they were getting ahead of themselves. But that seems to have turned around because you know, they are so popular and momentum is a powerful force right now in the market.

Jeffrey: It really is. Now, I want to talk about this tech stocks and I will a little bit, but I want to talk about what you mentioned earlier about the Pharma companies came out with good news about a vaccine, a positive news and there was a hiccup, AZ’s halted their trial, you know in the market reacted now they restarted the trial and I guess that is the good news, but there is also growing concerns that the election calendar rather than science may be driving the timing of an approved vaccine, right?

Larry: Right.

Jeffrey: If these fears are born out, people are afraid of the vaccine, they are going to avoid it and possibly not take it, that could prolong the spread of the virus and that would have economic consequences and I understand what you are saying about the tech stocks and they may not be hit, but it is still our economy. People need money to spend and buy the technology. So if there was a second wave of the virus in the fall or if this wave is extended what would such a scenario mean to the market? What are the consequences and what are the expectations now?

Larry: Well if that occurs, then would count as a surprise and Wall Street and investors in general hate surprises and they have one narrative now and it is popular, that everything is going to be fine, that everything will work out well. But as you say there is a big resurgence of the virus and we can not manage it. The way we have been at least in certain parts of the country recently, then I think the stock markets going to take a big hit and it is not going to be pretty.

Jeffrey: I mean that makes sense. Sticking with like AstraZeneca and other Healthcare stocks, this past week, both political parties had very strong voices about pharmaceutical drug pricing. Do you think that is just political rhetoric or do you think either administration will really be able to bring a change or have an impact on drug pricing and I know Trump is now talking about price conformity between countries. Now if that happens, what would that do to healthcare stocks? Is that priced in or not?

Larry: Not yet, no. Because nobody believes it is going to happen. If it does happen, that again will be a big downside for Pharma and Healthcare stocks in general. The thing is that we have been talking about this for a long time. Trump has been saying this for a long time even when his party had both houses of Congress he was saying, but it never seemed to happen. Why? for one thing, the Pharma lobby is very strong. And for another, they make an argument and it is not something that is easily dismissed. And that is, yes, we pay more for for drugs and for health care in general in this country than others do. We do not have as good health as some of the other countries do which had “socialized medicine”, but we in effect are subsidizing the health care of the world and especially the Pharm aside.

Larry: So, the argument that the drug lobby makes is, “Look. Yeah, you want to take that away. We will just, you know, health care will not be as good for all. And besides in most cases, most people do not pay for health care. It is their companies or it is the federal government or somebody else, the third party payers, who cares.” And that combination has worked in the past to stymie control of Pharma prices from prices and probably will again. I am highly skeptical that we will ever see or at least near term see government mandates, their whole down by Fiat, the prices of drugs because what will happen will be. And Pharma people are not wrong that their innovation will not be as robust as it has in the past.

Jeffrey: Okay. So a lot of rhetoric, I guess both parties have to talk about it. But the ability to take action on it is probably pretty limited.

Larry: Yes, it is.

Jeffrey: So staying with government intervention. I heard last weekend, the Attorney General’s office is about to launch or will launch a large antitrust case against Google right before the election. Could this also have rippling effects throughout all large tech companies and the Fang stocks and the Fang indexes?

Larry: A lot of them are under the gun. Facebook in particular, because of politics because it is alleged and for good reason that it is being used used by Russian trolls and whoever else to harm our electoral process, but in terms of Google, it reminds me of the IBM antitrust suit against Microsoft in the 90s and they both emerged but they paid a fine. They said they were not going to do certain things but IBM continued for a long time as a dominant player until history just caught up with a bad. Nothing new with the antitrust. Same thing with Microsoft. Microsoft paid a fine of I do not know, something slightly under a billion dollars which for them is around in there. And so it did not hurt them. It did not hurt them at all. The things that he has said, “Okay fine. So when we sell a suite of our software we will not automatically favor Microsoft apps in there. Okay, we will give you that.”

Larry: But they still win, they still continued to dominate for a long time until they granted some trouble but then they resurrected themselves, by going heavily into the cloud. Point is, I do not think that history shows that attacks against big tech ever really works very well. Yes, there will be some cosmetic changes. But the big boys will still be the big boys.

Jeffrey: So again, probably a little more political posturing and if anything happens, it will not be for years- [cross-talk]

Larry: That is right. Until forever.

Jeffrey: All right, so then let us stay with political questions. Recent observers and political pundits are raising the concerns that if President Trump, would not concede the election in a close race, that would prompt a constitutional crisis. What would happen to the market? So you think if the final results dragged out until December?

Larry: Yes, that is another one that will hurt the markets because right now the market is not looking at that possibility. I mean, there has been a lot in the news about preparations in both parties for litigation, in many states contesting he had come. I would not be too surprised to see that kind of a disaster which would not be good for the markets. But there is one thing the Constitution says that there shall be a new president sworn in on January the 20th. So unless that is somehow changed and I don not see how it can be, there has to be an end point to it. In other words, it can not drag on into the new year and to 2021 forever, month after month. There has to be an endpoint. And I suspect that if November the third comes and goes, where there are lots of recounts and then there is Tolkien tested and then everybody is in court and what not, I can see that being a two and a half months of nightmare. But then it will end somehow.

Jeffrey: Okay. And being the market looks forward, not present, we would probably find a lot of volatility but not necessarily finding a direction swing because of that.

Larry: Yeah. Well, it will be volatile all right.

Jeffrey: So let us talk about direction swing. So another election scenario, suppose there was what they call a blue sweep, if Biden wins and the Democrats reclaim the Senate and retain a house, what would a blue sweep mean for the stock market? I guess there would be great in some places it would not be so great in others. Who do you think would be the winners and who would be some of the losers?

Larry: Well infrastructure would probably be a big one. Biden wants to spend and so do the Democrats in the house and the Senate. We have blown through any restraints that we ever had. The Republicans have been happy to go along with it, at least for the first round. For the second round, because we are getting close to the election, they are being much more conservative. But even so, they still want to spend heavily, just not as heavily as the Democrats. In other words, there is a spending tilt that is now taking effect and it is largely by parts of thought.

Larry: If we get in, Biden will go heavily in infrastructure. He said that will probably trim back some of the the military spending that Trump has fattened up, but not a lot of it, and some of the Weapons Systems might be drawn out in terms of when their delivery dates are so they do not have to pay as much this year this kind of look like you don not play games. But I do not see a massive shrinkage of the military. So you will also see a bid to enhance Obamacare which will be costly, and nobody is talking about single-payer plan other than Bernie Sanders and AOC and those guys. But I suspect the one thing that will come out of it, there will be more Health Care spending which is good for Pharma, it is good for health insurers who will probably be still administering the healthcare system in paying for it. So those would be some of the winners right there.

Jeffrey: So I have been hearing you say a lot about spending. A lot of spending here, a lot of spending there. From a government point of view after the pandemic here, we have laid out a lot of money. The only place this money can come from then is from taxpayers. Right?

Larry: Yes.

Jeffrey: So if we pay more money in taxes, we are spending less money, on Main Street, so would there be a negative effect on those other type of retail establishments and Retail stocks?

Larry: Yeah that could happen. I mean there is no Biden says and I suspect he will stick to this, because he would be suicidal if he does not, that he will not raise taxes on the “average American”. He will raise it on the rich folks and he wants to boost up the corporate income tax. It was thirty five percent for a long time and under the trunk tax cut, it went down to twenty-one, and Biden wants to put it up to twenty-eight notice, not thirty-five. One of the reasons it was reduced was so the U.S. would be more competitive in trade terms against countries that have lower corporate income taxes, which is just about everybody else. So that would still keep us competitive. So I see a move to try to soak the rich, but I think once again it will be less effective than the Biden would have us believe. Now if Trump wins, there will not be any tax increases at all. He wants to give some special tax breaks to specific industries to help them keep jobs in the United States or possibly determine which. It will be a cold day in hell but because it is still cheaper over there than it is here. So I can see that would just be a stasis, whereas Biden will try to increase taxes and may be able to and but it
will be marginal.

Jeffrey: All right, so far all the possibilities we have been discussing suggest a tough stock market outcome for a little while or at least a ton of volatility and swings, right?

Larry: Sure.

Jeffrey: What is your insight on- what will it take for the market to continue this upward trajectory that we are seeing- what is going to happen?

Larry: Well, it will take it in an effective vaccine. It will take an increase in economic activity, people going back to work in offices and factories and so forth. It will take a turn around in the travel industry, although that is going to take a long time if people do not trust it. Well, then a lot of people do not want to get in an airplane, but what it takes is just some notion of an upward trajectory, which we have seen some of but right now it is mostly based on hope but we will have to see some actual increases in GDP as opposed to drops in GDP. And if everything comes true, and indeed it is so important that they get a vaccine that really works, P.S., I do not think that everybody is going to get inoculated at once. I do not want to get inoculated at once. I want to see what happens, and I am sure a lot of people will be like that. But over time, if more people will get inoculated and it is effective, then that will really help.

Jeffrey: I agree. I think that is great. Last question, as markets now are still at all-time highs and if people are now worried about retaining their market gains if they are afraid of this volatility coming up potential short-term dips, what can they do to protect these markets, the gains that they have there? What is your best advice on how to thread that needle?

Larry: A friend of mine said back in April, he said to me, he does not know much about the stock market, but he said, “Look, I am thinking about going all cash” and I said, “Do not do it. Just stick it out. Look, the market goes up, the market goes down, but the trajectory of the United States since after World War II has been generally a better economy and pants a better stock market. The only time that we saw a stock market that just went nowhere, but down was at was during the Great Depression from 1929 to 1952 to get the stock market back in 1929 levels, because of the Great Depression and of course World War II.”

Larry: So those are cataclysmic events. Who knows we might we might have another cataclysmic event that dwarf even covid. Who knows? but if things go down, my advice to anybody, is just to stick with it. And of course be sure you have a well balanced portfolio. The classic one is sixty-forty, you know sixty percent stocks forty percent fixed income or equivalent. And that is your ballast with stocks being the window and the sub-basement. And I happen to have a none other than Warren Buffett himself who agrees with that. So if it is good enough for Buffett, it is good enough for me.

Jeffrey: On that note. Thank you.

Larry: Glad to be here.

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.

Brian Bremner, Executive Editor of Global Business for Bloomberg News discusses how the largest countries in the world have responded to the pandemic. With the US having more than 20% of the deaths worldwide, what are we doing wrong in containing COVID-19, and which countries are leading the way in doing it right?

TRANSCRIPT

Jeffrey Freedman: Hello, and welcome to the RP HealthCast by RooneyPartners. I am your host, Jeffrey Freedman. Fall is here in the Northern Hemisphere and public health concerns about a second wave of coronavirus cases are mounting. In this week’s episode, we are going to take a look at what is going on across the globe in terms of a potential second wave. In Europe, the UK, Spain and France, are now seeing spikes in coronavirus cases and Sweden’s early decision not to lockdown has resulted in a higher per capita rate of cases than all of their neighboring countries. It has been written that their government was seeking to reach herd immunity by not shutting the country down and therefore letting a majority of its population get infected. Speaking of herd immunity, President Trump has added Dr. Scott Atlas to the US coronavirus task force.

Dr. Atlas is an advocate of and is previously voice support on Fox News for a herd immunity approach here in the United States. That brings us to the three largest most impacted countries. Obviously, the US, Brazil and India. India is now the fastest growing pandemic epicenter in the world with over ninety thousand cases per day. Both the US and India have been reporting more than a thousand new deaths per day, and Brazil following with about eight hundred and fifty. The World Health Organization is recording new global cases at a rate of over three hundred thousand people per day. Nine months into this pandemic, what are we doing wrong in containing the virus, and which countries are leading the way in doing it right? What can we learn? So to help us address this, we are delighted to have with us Brian Bremner. Brian is the executive editor of Global Business for Bloomberg News. Brian oversees the global coverage of the coronavirus for Bloomberg, and this is actually Brian’s return to the RP HealthCast. Brian, it is so nice to have you back.

Brian Bremner: It is terrific to be back.

Jeffrey: Well, thank you for taking the time to help us understand what is working and what is not when it comes to the public policy response to the coronavirus. Last time you were on the podcast, you helped us understand the geopolitical challenges confronting a world seeking a cure to the pandemic. But today, we would like to take a spin across the globe with you to discuss the latest coronavirus hotspots and what is going on in these regions. Sounds good?

Brian: Sounds great.

Jeffrey: All right. Let us start in India, the world’s second most populous country with about one point four billion people, but they have been recording the world’s largest daily increases in coronavirus cases for almost a month now. They just passed Brazil for having the second largest number of cases in the world. Can you bring us up to date on what has been driving the coronavirus caseload in India and why is it so bad? What is the Modi government been doing to arrest the spread of the infection?

Brian: Well, you are quite right. I mean India has gone viral, I would say over the last month, and they are now kind of getting daily case growth. You know, very close to one hundred thousand per day, which is just absolutely astounding and that is kind of geometrical growth and it is conceivable, actually, that India could end up overtaking the US as the absolute epicenter of coronavirus sometime later this year. India is interesting and disturbing in a couple different senses. I mean, it is a huge, vast, vast country of seventy percent of the population actually live outside the major cities and what is really kind of happened in recent weeks is that the virus is really taking off in rural India, which is a huge public health challenge because these areas tend to be underserved by the healthcare system. It does not quite match what you would find in Mumbai or Delhi or Chennai, big major cities. It is another perplexing problem for the Modi government because of the economic hit that India has taken.

A lot of people do not realize this but in the April to June quarter, the economy actually contracted by nearly a fourth, nearly twenty-five percent, which is in relative terms, one of the biggest economic shocks that we have seen from the pandemic. Prime Minister Modi lifted the restrictions on the lockdown back in June, and there was like a bit of quiet and then the virus took off. India is facing the worst possible situation in that if it does nothing, the virus will just run riot across this fast subcontinent and unfortunately, make a lot of people ill and kill a lot of people, or you go back to a lockdown. But in India, a lockdown is really destructive because so many of the workers are living on subsistence wages. So you take that away from them, with very little government support, they go into extreme poverty. You could actually lose a lot of people to malnourishment or suicides or other kind of mental health issues that come from extreme poverty. That is the dilemma that the Modi government faces. Here we are in mid-September now.

Jeffrey: Yeah, I mean you talk about their economy. I mean, it is such a bifurcated economy. It would be between the haves and the have nots in India with so many people living in poverty and living together and on top of each other. So I mean, I cannot imagine testing has been that frequent or big in all parts, especially the rural parts of the area of the country. I mean do they have to wait like Sweden and try for herd immunity. I mean, is there any way to help it aside from that?

Brian: Well, herd immunity in India, it is hard to imagine what that would look like. It would be… I do not think there are anywhere near that level of infection rate. The destructive impact both economically in terms of public health would be really high if that is the strategy that they opt for. I mean, right now, they are kind of in a middling area where they are trying to take preventative measures where they can, but stop short of locking down the entire economy. The other thing about India that is interesting is kind of its global impact. I mean, obviously ,the people in rural India face unique challenges, but in Indian economy, that is really paralyzed by the virus has a spillover effect because you have a lot of companies – Facebook, Walmart, others – that view and are investing quite heavily in that market. The other thing about India that is interesting is that it is actually one of the major, if not the major vaccine production center. So when we eventually get to a vaccine, when we get approval on several of them, some of them may actually be produced by kind of contract manufacturers in India. So if the economy is in really grim shape and there is a public health crisis, on a massive scale, it is not just the Indians that are going to be coping with that that. In some sense, the rest of the world will be as well.

Jeffrey: Wow. That is a great point that I have not heard anybody bring up before. Thank you. Let us continue for a moment. Let us stay in the Southern Hemisphere and a country we mentioned with the third largest coronavirus count, Brazil. What has been the government’s response to the virus, and why does it continue to struggle to contain it? Has any of this changed since its president actually contracted the coronavirus?

Brian: Well, Brazil’s approach has been interesting as well. I mean the challenge that Brazil has is that you have got incredibly diverse urban and economic pockets throughout the country. In the major urban centers of Sao Paulo and Rio de Janeiro, you have got quite a population density characteristics that are wonderful for a virus, right? That has been a challenge. In the other parts of the less-developed parts of Brazil where the Amazon Rainforest cover is there you have got a very kind of developing healthcare system. Then you have a government led by Bolsonaro who is kind of a populist. He did not like resorting to any kind of lockdowns that would affect his political standing and deliver an economic hit to the country. He is a big fan of hydroxychloroquine, which is a treatment that it is very controversial because there is very little evidence that it actually helps COVID-19. He has been anti-mask. He fired a Health Minister who actually did call for more extreme containment strategies that might have made a difference and I do not believe they have actually replaced him. You have got Latin America’s biggest economy without a health minister in the middle of a global health crisis. It is not an ideal situation. Things seem to have plateaued a bit. You are not seeing the really extreme case growth that was happening in Brazil, like maybe two months ago. India’s problem is accelerating, so that is why India overtook Brazil not that long ago.

Jeffrey: Is there any rhyme or reason that it has declined a little bit in Brazil?

Brian: I do think people are kind of waking up to the threat. So there is probably a little bit more mask-wearing despite the political messaging. I think the treatments of COVID-19 were now kind of like eight, nine months into the crisis, healthcare providers have better strategies for dealing with people who become infected. That has probably helped as well. I do think social distancing is you are seeing more of that than you did three or four months ago in Brazil. Cumulatively, I think all those things have helped.

Jeffrey: Okay, so it is a little more education, a little more common sense and that certainly seems to be going a long way in Brazil. So that is good. Bolsonaro’s approach has been kind of somewhat similar to President Trump’s in a way in the beginning, back in the early part of the pandemic here. In the United States, we have only four percent of the world’s population, yet we have approximately twenty percent of its total coronavirus cases. We are, unfortunately, leading the world on that. If you could break that down for us a little bit. What are you seeing as a state of play here in the US now, especially as you are looking at it from the outside in, and with that, if you can also discuss both what role universities are playing and everybody going back to school and how our election year dynamics impacting the crisis?

Brian: Well, if you look at the US experience, we had those awful months, late March, April and May, where the pandemic was primarily focused on the northeast and New York got hit quite hard, of course. You saw fatality rates, two thousand people dying a day, and then things calm down a bit. The good news. is that some research has crusted and has plateau. Now, you are starting to see in pockets in the Midwest and the mountain states where the virus case growth is occurring and you mentioned the universities reopening and it is starting to look like a bit of a concern. A number of schools tried to open up, and then quickly had to go to online classes pretty fast, couple weeks in, because you are not getting a lot of compliance from young kids in their twenties who want to go out to bars or have fraternity parties and things like that. That is a concern, but I think the bigger concern is that the infectious disease professionals are all looking ahead to the late fall, when the weather cools off more people are inside and the projections are not terribly heartening. I mean, right now, the US is very close to hitting the two hundred thousand mark in fatalities. We are just days away from that happening.

Some of the more bearish forecasts are that we could actually double that and by the end of December have four hundred thousand people that we have lost if the worst case scenario happens. But these are pretty reputable people who are making these projections, critically the University of Washington, which has been one of the key modelers for their coronavirus taskforce that President Trump set up. These are pretty reputable people and I think the expectation is that things are going to kind of get bad again, unfortunately, as we get toward the end of the year. The election dynamics are front and center because the virus response has been so politicized and right now, the disconnect between President Trump and his scientific advisors is quite bewildering to behold. I mean we are getting very close to some Phase Three trial results in major vaccine programs, but President Trump seems to be insisting that the vaccine is going to be widely available by the end of this year. His top science advisors say they certainly hope that is the case but more realistically, you are probably looking at virus approval toward the end of this year, but it is going to be well into 2021 before a vaccine is widely available. So we are probably looking at living with this virus probably close to another year which I do not think has really sunk in on the public yet.

Jeffrey: That is helpful, but one thing that I know I am having questions about is I know there is probably about a hundred forty different vaccines under development right now. We have some elected officials, some healthcare officials that are saying we will have a vaccine ready as early as November, let us say. What does that mean? Does that mean that the first vaccine that is rushed through will be ready or is it that the best vaccine is going to be available? Are there going to be many vaccines available to everybody. What is going to be the state of play? Where do you think it all falls out? Is there just one that they have bought millions of that they are going to give to everybody, or different people going to get different things, or is it the first to market?

Brian: I think you are probably looking at a scenario where there will be several approved vaccines of varying efficacy and some of them might be double doses were you take one shot and then another month soon after you take another. We are getting very close to the end of the regulatory approval process to these Phase Three trials in which we have a large groups of human participants. Some of them are given a placebo. Some of them are giving the vaccine and you get a sense of the antibody reaction to it and how effective they are. There is a possibility that there might be emergency authorization where there is a slight shortcut. If they feel really confident about how Phase Three trials are going, they might cut it short and say, we are going to approve this one on an emergency basis.

So that is a possibility and that might speed up the process, but in terms of the vaccine coverage, I mean who is going to get it when, I think most experts assume that their first approved vaccines will go to public health worker. I mean the frontline healthcare workers and then high-risk groups, people with pre-existing conditions or older citizens, maybe above sixty-five years old that are at risk if they get the virus. if everything goes well, that might happen toward the end of this year or early 2021. But before the mass public has access to this, it is going to be a huge like a D-Day logistical challenge to really scale up and to get this from the factory into people’s arms. That is going to take into 2021, probably in the middle of 2021. So that is kind of the time frame. When can we get back to normal? Well, we cannot really get back to normal until a big chunk of the population has been immunized and that is as I said well into 2021.

Jeffrey: Got it. Okay. Thank you. Back to our tour of the world, of the globe if you will. A little closer to home for you, turning to the United Kingdom where you live in or based, the office of national statistics reports there were about forty thousand new cases of the virus in England during the first week in September. That is about eleven thousand more than the previous week or it was a thirty percent jump in the week. Also, the rise in the R number, the reproduction number, describes how many others each infected person passes the virus onto and that is one of the measures indicating the virus is spreading more widely in the UK. So if the R number is higher than 1 as it is now, the numbers infected are growing and with higher number indicates that cases are multiplying more quickly. With higher R numbers right now in the UK, what do you think the explanation is for the uptick, and do you this is indicative of Europe as a whole?

Brian: Well, I think in the UK, there are couple things going on. First of all, they fade out a lot of the lockdown measures that they had in the spring and early summer. So most of the restaurants now are back open. A lot of the pubs are. There certain restrictions on mass gatherings. The schools are back up. We are seeing the virus kind of rear its head again. The issue in the UK is kind of multi-faceted. I mean, a lot of people do not realize that a lot of the case growth is certainly in London, but also in the Midlands, around Birmingham, the second largest city. That area has been really hard hit as well. I think that third factor is the European travel season where British tourists were leaving the country and then coming back, and what we are seeing across Europe particularly in Spain and France are also flare-ups as well. So Europeans like they take their vacations very seriously and it looks like that is also fed into this a bit. So in Europe, depending on how you define it, the case growth is actually, if not neck and neck with what is happening in the US. Some days, it is actually exceeding the growth in the US. So unfortunately, Western Europe now is starting to emerge as a problem area again, and I think the World Health Organization basically said that recently that they are getting concerned about Europe again.

Jeffrey: So, you would think with common sense measures of staying home a little more, wearing mask, social distancing, we could probably get a handle on this, but everybody is getting a little stir crazy. So between vacationing and the nicer weather, people are just going out and forgetting.

Brian: Yeah, it has been a long battle. It is hard to sustain the intensity of… A lot of the virus dynamics really come down to individual decisions that people make everyday. If you get enough people behaving in a high-risk manner, this virus has proven itself as highly transmissible. It can be, as we know, it is an airborne virus. If you are in a room with a high viral load, you place yourself at risk of picking it up. The other thing, again, we have learned from the very beginning almost is a lot of people carry around the virus and do not show symptoms. There are like the this is stealthy quality to this pandemic.

Jeffrey: Yeah, and it is a great segue way. Let us talk about, starting from the very beginning, and let us circle back to Asia and China. China, the most populous country, also probably were the first instance and certainly, the first breakout of the virus started. Their government took a very strong decisive action and precautions and remedies to get the virus in check. Where does China stand now? Did they see a second spike? In being the world’s most populous country, they are not in the top three with us.

Brian: : No, they are not. One of the big ironies of this entire pandemic is that it all started in China, but China arguably has come closest to kind of vanquishing the coronavirus and definitely containing it. I mean if you go travel around Wuhan where it all started, you will see a city that existed pretty much before the pandemic. I mean, there are certain safety measures now. I mean hand dispensers. You probably see more people with masks, but everyday life, concerts, sporting events, going to the theater, going out to a restaurant, that is all happening in China right now. So what was it about the Chinese experience that is different from the rest of the world that is still struggling with it?

I think a lot has to do with the fact that the Chinese system is autocratic and fifty million people were quarantined regardless of whether they liked it or not, regardless of whether they wanted to participate in that or not. That does not happen in Western democracies, which depending on your viewpoint is a great thing in normal times, but when you are fighting this particular virus, the Chinese actually has had some advantages. I think that has been hard for the rest of the world to replicate. The other thing that I do not think is fully appreciated is the Chinese vaccine programs are pretty far along as well. I believe the Chinese are pretty confident that they will have a vaccine ready to go toward the end of this year and that they will put the full force of the state behind a massive rollout and the Chinese are pretty good about executing those kinds of public policy moves. It would be interesting to see if the Chinese also are the first ones to have a big part of their population fully immunized from the coronavirus. We will have a better idea of whether that happens by the end of the year.

Jeffrey: So it will certainly be telling in that regard. But let me ask you a question about you spoke where China the government said shut down, they shut down and they squashed it. Yeah, I guess our fear in the US is if you shut down, it is going to kill our economy. What happened to China’s economy when they shut down?

Brian: Well, they definitely took a hit. Their first and second quarter numbers were really depressed by this and they are definitely not growing. I mean the Chinese economy consistently has been growing at six percent, seven percent annualized rates and they are not going to come close to that this year, but they are not going into a severe recession like other parts of the world are. They were able to make their lockdown matter because they were able to sustain it long enough and then lift it very, very gradually and it seems like they did it long enough to make a difference. I mean, they definitely had flare-ups. There have been flare-ups in the Northeast and around Beijing, but they do a pretty good job of zeroing in on it, locking down selectively where they need to, and then doing contact tracing. They have got tons of people that they throw at these little outbursts and they have a track record of containing them relatively quickly.

Jeffrey: Thank you. Brian, traveling across the globe has been fantastic with you. Thank you. Thank you for your help and for sharing your knowledge as to what is going on. Next time we do it, I hope it will be in healthier times.

Brian: Yes, my pleasure. Thank you.

Jeffrey: Thank you.

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 Health Cast.

In this week’s episode we speak with Claudia Wallis, an award-winning health journalist for Scientific American, about what it is about a person’s genetic make-up that could make them more at risk to COVID-19 than others.

TRANSCRIPT

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

Jeffrey: As our children head back into the classroom and we find ourselves trying to gain a sense of normalcy and routine in this continuing pandemic, our global experts in science are still trying to determine the best way to combat this virus and to reduce its symptoms. In fact, we have thirty-seven vaccines currently in human clinical trials and at least ninety-one preclinical vaccines under active investigation. So, with all this research and billions of dollars, we should be hopeful that some sort of vaccine is on the near horizon.

Jeffrey: But the reason there are so many different compounds and different approaches to combating the virus is that we still do not know all there is to understand about it. Why are some people super spreaders? Why do some people get much sicker than others? We understand that pre-existing conditions could affect some people’s immune systems, but could a person’s inherent genetic makeup make them more vulnerable?

Jeffrey: Well, to answer some of these questions and explain the science behind this is our guest today. She is an award-winning science journalist, Claudia Wallis.

Jeffrey: During Claudia’s long career at Time Magazine, she served as a science editor and editor at large. And in fact, she authored over forty Time Magazine cover stories in addition to hundreds of other articles. She was the founding editor of Time for Kids magazine. She also served as managing editor of Scientific American Mind from 2015 to 2017 and Claudia is currently a contributing editor at Scientific American.

Jeffrey: Claudia, thank you so much for joining me today.

Claudia Wallis: Oh, it is my pleasure.

Jeffrey: Great. Now, as a science and healthcare writer, you have obviously been covering the coronavirus story very closely. But as I learned from one of your articles, the pandemic became very personal for you right away. You are a New Yorker and you live in New Rochelle. Now, for our listeners not in the area, New Rochelle was the epicenter. It was the first real hot zone in New York. And you wrote about this experience in early March before our shutdown in an article entitled “Life in the Containment Zone.” Can you take us back about six to seven months and tell us how your community changed almost overnight?

Claudia: Well, it was pretty scary. All of a sudden, we got reports that not only was there an outbreak in my city of New Rochelle, which is a small city. I think it is the seventh-largest in the state, but it is not a big city. We got word that there was an outbreak of the coronavirus illness and it was centered less than a mile from my house. There happened to be a synagogue called, I think, Young Israel. An attorney, who was a member of the congregation there, was one of the early people to contract the coronavirus and get sick with COVID-19. He and his family got the sickness and I guess he has spread it to that community within that Jewish center. The governor declared it to be a containment zone with a one-mile radius extending from that synagogue and I happen to live within a one-mile radius.

Claudia: That was pretty dramatic. That was the first half of March, but it was closer to mid-march. Everything that we went through, everyone else has gone through since. It was just that we were a little bit on the leading edge. Anything that I would describe to you, which seems so dramatic then, they shut down all the businesses, no large gatherings, and we were asked to remain at home. Masks, as I recall, were not even part of the picture yet, which in hindsight was a mistake. They even sent in some National Guard to clean certain public buildings. It was really the early dose of what was coming with this pandemic.

Claudia: Personally, I did not feel terrified or anything because I was not part of that community that had the exposure. But it did make me think very long and hard about going to something like a CVS Pharmacy that was just a block or two from the synagogue. I did not set foot in there and normally that was kind of where I go.

Jeffrey: It must have been so scary right in the very beginning. New Rochelle had something like five to ten times the amount of people with the virus than all of New York City, I believe, at that point.

Claudia: Well, I think the statistic I had was of a hundred and seventy-three cases in New York state, a hundred and eight were in New Rochelle. That is well more than half. We were off to a big start. We had three times as many cases as New York City, even though we are less than a hundredth the size of New York City. It was pretty dramatic, but, sadly, the city soon caught up and surpassed us and so did so many other places.

Jeffrey: Absolutely. But your personal connection to the pandemic response does not end there. I understand your daughter is a New York City Contact Tracer.

Claudia: Yes. That is true. I am quite proud of her. She spends her days making phone calls to people who have either received a positive test result and then she has to find out who were their contacts within the previous two weeks and also calling the contacts of people. It is challenging. Not everybody wants to cooperate with those kinds of questions that people feel like they should be more private. But it is really important that people cooperate. I think the contact tracing is one reason New York has done quite well.

Jeffrey: Well, I agree. Hats off to her and the team that she works there. It is almost a thankless job in a sense, but it is so important. I very much appreciate her. Thank her on our behalf.

Claudia: [chuckles] Okay.

Jeffrey: Personally, I head up the Medical Communications Department at RooneyPartners and I am always working on and interested in educational programs for physicians and the health care community. You wrote a fantastic article- Well, you wrote many, but the one, in particular, it says “Why Some People Get Terribly Sick from COVID-19: Beyond factors such as age and sex, underlying aspects of biology and society influence disease severity.” I want to dive deep into this story. You start the article off very broadly with different categories of people who face a greater risk of getting sick from COVID-19. Before we dive into the specifics, you took broadly what are the categories.

Claudia: I think, at this point, a lot of people are familiar with the categories. Being an older person is the single largest risk group. There was a time when the CDC specifically spoke about, I think, people over sixty or sixty-five. We do not really have a hard cutoff anymore. It is kind of like your risk goes up with your age. And then another group, frankly, is men. Men are much more apt to have a serious case and to die of COVID than women are. That has been consistent around the globe.

Claudia: And I think a lot of people are familiar with the idea of what doctors called comorbidities. This means existing conditions or illnesses like heart disease, obesity, diabetes, hypertension, and several others that put people at greater risk. This includes anything that involves a suppressed immune system like people who have had a heart transplant, lung transplant, kidney transplant, and are taking drugs that suppress the immune system. That is another group. There is that whole group of people who are more vulnerable there.

Claudia: More recently, there has been a question about whether pregnant women should be considered to be at higher risk. Of course, there are groups of people who are at higher risk for sociological reasons such as African Americans, Hispanic Americans, and some Native American groups, particularly the Navajos, who have been hit very hard. This is not really due to biology but more other kinds of factors that put them at risk, which we can talk about.

Jeffrey: Yeah, I definitely want to break that down with you. One of the analogies you used, which I thought was great to get this mental picture about all this stuff up, you wrote that an individual’s risk factor stack up like the layers of a Russian nesting doll. I thought that was fantastic. Explain to everybody what you mean by that.

Claudia: Yeah. That idea came to me because I was trying to think about all the things as an individual. If you are one person, you are thinking about yourself, and if you picture yourself as a Russian nesting doll, what is on the inner core of who you are? Your inner core, part of it is going to be your genetics. Whether you have an extra Y chromosome, which is relevant to risk. And a part of your inner core is your age because all your cells are aging according to how many years you have lived. People do age at slightly different paces, but you cannot really escape Father Time. That is part of your inner core, your age. That is gender, age, and genetics. At least three components there.

Claudia: And then as you go outward to the next level, I was thinking of things that you have acquired that were not part of who you were in the beginning, but maybe you have acquired diabetes, heart disease, you have got a lung condition or obesity. That is sort of the middle layer.

Claudia: And then on the exterior, the outer layer of who you are, the you that faces the environment around you. Your exposure to toxins; your exposure to air pollution; your exposure to, in the case of some ethnicities, prejudice, discrimination, and stress that is related to that; and poverty and crowded living conditions. All of those things, including even your occupation. What is your occupational exposure? All those exterior, on the outside of that Russian doll, also play a role.

Jeffrey: That is great. We discussed already a little bit about how age impacts immunity. Can you talk about your research? Do you think this is changing at all as the virus mutates? Are you talking about the severity of illness versus the actual chances of getting the disease? We have heard in the beginning that the elderly are more at risk, but now it seems that a larger percentage of the people that are getting it are a younger population. The kids in college now, for example.

Claudia: Let me answer that in a few different elements. The elderly remain at the highest risk of having a severe case and not surviving. That is for multiple reasons. As we age, our immune system starts to lose some of its oomph. Our ability to generate antibodies takes a bit of a hit. We do not produce them as effectively or as efficiently. They do not work as well. That is why, for example, for people who get the flu shot, if you are over sixty-five, you get a stronger dose. In general, some of my sources said to me that elderly people do not have much of a response to the flu vaccine at all. Our ability to generate these antibodies becomes much lower, and so does our ability to fight illnesses with other elements of our immune system. That is sort of an unavoidable truth except if you really do a great job maintaining your health and exercise a lot, you could probably sustain the strength of your immune system a little bit longer.

Claudia: But the other elements for the elderly, and I will come to the college students in a moment, are just the conditions in nursing homes. We did a poor job as a country protecting people in nursing homes. I think that a huge percentage of cases we have were in nursing homes. I read something like forty percent of deaths, but I am not entirely sure of that statistic. But it is a huge hit and that is because you have people who are not physically strong, so they are vulnerable. They may have a lot of comorbidities. They may have all these different kinds of ongoing chronic illnesses. They are living in very close quarters, in very close contact, and with low paid workers who go in and out, coming and going, and maybe going home to crowded conditions at home because many of them are barely paid a living wage. They are also picking up exposure at home. So, all of that combines to make a pretty dangerous situation for the elderly.

Claudia: However, we have kind of caught up with a lot of it in recent months and there are better procedures in a lot of nursing homes and far more aware of how to protect people. The pandemic has gone on for so long that the warm weather came in, bars began to open up, and all kinds of fun things that young people like doing started to open up. I think that is the reason we have seen numbers get so much higher in young people. Although they continue to have a lower risk of any kind of severe outcome, numbers have gone higher in young people just because of all these loosening up that has happened in the colleges. That is why we see a shift in cases.

Claudia: But still, to emphasize, the young people have a much lower risk of becoming severely ill.

Jeffrey: Got it. You talk about that, also, from a biological front. You wrote about the importance of how B cells and T cells work in the elderly population. You touched upon that. As you get older, the T cells are not there, and are not working as hard. Do you think that is going to have an impact on coming out with a universal vaccine? Are they going to be testing enough on the older population or are they afraid that it is going to skew the results?

Claudia: Let me answer the first part first. I think, among the experts on immune system aging that I spoke with, there definitely was a concern that the vaccine, when we have one, will be much less effective in older people because, basically, all vaccines are less effective in older people. So, why would this one be any different? It is probably not going to work as well in the elderly. But if we get enough people vaccinated and the vaccine is really effective, we will have herd immunity. That will really help the elderly. That will help protect them because there just will not be as many viruses in the environment. There will not be people walking around with active cases.

Claudia: Again, there are a couple of cautions. The vaccine has to be effective, it has to generate a good antibody response, and people have to be willing to take the vaccine, which is another ball of wax that I am worried about. And then the other part, in terms of the elderly, I do not know if there is not enough testing. I doubt very much we will be testing a lot of elderly people to see if they have generated a good immune response. That might probably only happen in a formal trial. That is my guess. The trials, hopefully, will tell us what kind of response people in different demographic groups have.

Jeffrey: Okay. Let us switch topics a little bit. Something you mentioned earlier, I found interesting and, honestly, a little bit scary. Men were twice as likely to die from the infection as women. Can you talk about that data and do you have any hypothesis as to why?

Claudia: Well, I am a mere journalist. [laughs] But I have absorbed some hypotheses from people who would know far more than I know. I can share those. But yes, men are roughly twice as likely to die of the infection as women, but the exact numbers vary from place to place. In Italy, seventy percent of the people who died by the spring were men. In the U.S., it was closer to sixty percent. There is a little bit of bouncing around with different places. However, as to why, it is actually probably a combination of biological factors and social factors.

Claudia: Biologically, we know that the female immune system is simply stronger than the male immune system. Estrogen, the female hormones, tend to amp up the immune system. Androgens, the male hormones, tend to dial it back. Women have a stronger response to an infection in general. There is an interesting hypothesis as to why this is the case. The people I spoke to said that the reason for it is probably because women, when they give birth, have to pass a lot of antibodies and immune warriors over to a newborn. Maybe that is why women evolved with such a strong immune system, perhaps.

Claudia: The downside of the strong female immune system, though, is that women have a much higher risk of autoimmune diseases where the immune system attacks our own cells. That is part of it. Also, men do have more of those comorbidities. They have more heart disease, hypertension, and diabetes at younger ages than women do. When men start to get to about their fifties, they tend to develop a lot more of these conditions, which puts them at greater risk. Whereas women develop these ailments a little bit later. Those are some of them. There may also be genetic factors. There are a lot of genes on the X chromosome that are related to the immune system. There could be other things going on.

Claudia: But just to take a moment to say what the non-biological factors are, there have been studies that show that women are fifty percent more likely than men to wear a face mask, wash their hands, and to avoid public transit during a respiratory disease epidemic. During this pandemic, actually, we have seen that women, just in surveys, seem to take it a little more seriously. I think we cannot discount that kind of element as well.

Jeffrey: I have not had anybody explain that to me like that before regarding the women’s health. That was fantastic. Thank you for that.

Claudia: There are some very smart researchers out there.

Jeffrey: That is very well said. I think that was great. The last topic I want to talk about, you touched upon issues and hazards of inequality and racism. Now, it is tough to understand at times how prejudice or racism can affect health in a pandemic. Can you talk a little bit about this? Do you feel that this is mostly a U.S. issue or has this been seen globally as well?

Claudia: I know it has been seen in the U.K. It was documented there. I would suspect that anywhere where you have a disadvantaged population, it might not be Black-White, it might be Hutu-Tutsi, it might be some other Hindu. I am just expecting. I have not seen the data that anywhere where you have a disadvantaged population, you would see these kinds of discrepancies. But it is definitely documented in the U.S. and England.

Claudia: The person who just did such a great job explaining this to me in my interview with her was Camara Phyllis Jones, who is a family physician and epidemiologist. She is an expert on this. She said racism puts you at risk through two mechanisms. One is a greater risk of getting infected because of exposure at home, on the job, and in the community. I will break that down in a moment. The other is that people of color are less protected. Once they get infected, they are more likely to have a severe case and more likely to die.

Claudia: Why are they more exposed? Well, think of the jobs that a lot of people of color have. Think of where they are living. There is a much greater proportion of them working in low-paid but public-facing jobs. These jobs are all high-exposure jobs and put people at risk of getting an infection. And then if you consider where people of color are more likely to live, a lot of people of color live in high-density, low-income neighborhoods. You might have a large family packed into a small space. There might be multiple generations, grandmother and grandchild living in a small-ish apartment or home. Someone in that household may be going out and doing these high exposure jobs and coming home and bringing the virus home. You have got all of that going on in terms of exposure. Let us say you have got the virus. What happens next?

Claudia: We know that Black Americans have poor access to medical care and that they face discrimination within the American health care system. To be specific about COVID-19, many of the testing sites early on were located in more affluent neighborhoods or required access to a car for drive-through testing. That was not helpful to people who did not live in those neighborhoods or did not have a car. And I would add, also, that Black Americans do have a lot. They have a forty percent higher rate of hypertension, a sixty percent higher rate of diabetes than white Americans. They are also carrying a burden of disease and a lot of those diseases, Camara Jones would tell you, are diseases that are related to poor environment, poor opportunity, poor living conditions, no safe place to exercise, and food wastelands where there is nothing but junk food.

Claudia: There are all these things that come together. There is actually this stress of discrimination as well. And there is a body of research that looks at this. It is almost like premature aging. If you are living with constant discrimination, nothing brings at home more than we have seen recently with the police attacks on young Black men. There is an atmosphere of discrimination and inequity. That takes a tremendous toll on physical health and mental health.

Jeffrey: That stress was certainly brought to light based on those issues. Thank you for that explanation. Thank Dr. Jones for explaining it to all of us. The last couple questions I want to ask you about is a completely different topic, if you will. I know you are a big advocate of stopping the spread of misinformation about the disease and you are also a huge proponent of ensuring that politics stays out of science, and science dictates the decisions of the FDA the CDC of the HHS.

Claudia: Yes. [chuckles]

Jeffrey: You have written about and have known Dr. Anthony Fauci for years. What is your take on all the news right now about the politicization of finding a COVID-19 cure? Do you believe sound decisions based on science will reign supreme at the end of the day?

Claudia: I cannot believe that we are in the position of having to worry about this. I have been interviewing people at the CDC for more than thirty years, and I have noted that with every administration, not just this one, it is more layers of protection there, more difficulty getting to the experts, and finally it got to the point under the Trump Administration where if you want to talk to a CDC expert, your request is relayed to Washington DC HHS rather than going through Atlanta. At least that was what I have been told off the record. It is very politicized, yes. Sunlight, no. I have been shocked by some of the things that have happened in the last few months because as a medical and health reporter, I always thought the CDC was pretty sacrosanct. Sure, they are going to make mistakes, but they are going to correct them as better data comes along. They are trustworthy and always operating in the interest of the American people. That is how I saw it.

Claudia: The FDA has long been subject to the influence of the pharmaceutical industry that it regulates. There has always been tension there. But still, some of the things that we have seen in the last few months, the overblown statement about the benefits of convalescent plasma, for example, was absolutely a wrong statement from the head of the FDA. Completely misstating the data on that when we do not really know how good convalescent plasma is. Maybe it is good, but we do not know that it is great. He had to walk that back. And then we are getting advice, the pressure that was put on the FDA to grant a temporary approval of hydroxychloroquine and that they cave to it for a while. That, also, just blew my mind. That was sheer political pressure on the FDA. There was nothing to support that in terms of high-quality data and that had to be walked back to.

Claudia: And now, with the vaccines, we really already have in this country something like thirty percent of people who say that they will not take the vaccine. We have the Anti-Vaccination Movement that has been going on for years. I have written a lot about that over the years. Now, we have a real need for a vaccine and we need people to believe in it. We need for people to trust it. We need enough people to be willing to take it that will get to herd immunity. But the political games that have been going on with promising a vaccine before election day, frankly, terrifies me. Not only because I personally would not trust such a vaccine, but all sorts of other people will not trust it and it kind of adds to an already bad situation in this country where people are not trusting of vaccines. Vaccines are just about the most powerful thing we have got as a public health tool. If you are going to further undermine belief in vaccines because the coronavirus vaccine gets politicized, that is just a disaster.


Jeffrey: Listen, you are passionate and you are passionate for a reason. We do not want to undermine the words of our leaders and our scientists. If we do not have trust in this, we are not getting out of it. With that, I want to say thank you. Thank you for your passion, for your writing, and for your articles. It is very much appreciated. Great job today. Thank you.

Claudia: You are very welcome. Thank you for asking such good questions. [chuckles]

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.

While still categorized as a Schedule 1 substance—and not approved by the FDA—some form of cannabis is legal in more than 60% of the country. In this week’s episode, we speak with Anthony Noto from Benzinga, where he gets into the weeds of this multi-billion dollar industry and the issues it faces.

TRANSCRIPT

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

Jeffrey: A very controversial yet almost mainstream subject over the past couple of years has been around cannabis. Whether it is from the potential medical benefits of CBD, which was tattered almost as a miracle cure for all elements, to medical marijuana dispensaries in certain States, or to approving cannabis for recreational use like they did throughout Canada last year. The bottom line is pots become big business. Cannabis, CBD, and medical marijuana have become large tax generators for the certain states that have legalized its use.

One of the interesting things about all of this is the lack of federal guidance and the actual powers that the state government has here. You see, eleven states have fully legalized recreational use of marijuana. Some states fully rejected sale and others have more of a wait-and-see approach. Why this is fascinating to me is because the federal government still classifies cannabis as a schedule one controlled substance. What does that mean? This is the highest level. This puts cannabis in the same category as heroin. To further the irony, thirty-three states plus Washington D.C. have approved medical marijuana for medicinal purposes under a doctor’s supervision and prescription. It is more than half the country, but the FDA whose sole purpose is to ensure the safety, efficacy, and security of all our approved medical drugs, does not even approve the use of medical marijuana, nor does it control any aspect of its distribution and sale. To try and make some sense of this and to break it down for us is our guest today, Anthony Noto. Anthony is an editor for Benzinga, and he covers the cannabis industry.

Anthony, thank you so much for joining us today.

Anthony Noto: Thank you so much for having me. It is an honor for me to be here. Usually, I am the one asking the questions and hosting folks for podcast episodes, so it is kind of a relief to be the one in the hot seat.

Jeffrey: Yes, so we are going to put the spotlight on you, but before we dive into your reporting on the cannabis industry, let us keep that spotlight. Let us talk about your career as a journalist and how you started even covering this industry.

Anthony: Yes, it actually started pretty recently last year. I actually did not write too much about it, but last year I met Tiki Barber of all people, and I have recorded a podcast with him. He launched a company called Grove Group, which is an investment firm that works with a lot of cannabis startups and CBD startups, and entrepreneurs in that space. I just found it fascinating. I realized that there was so much left to learn about the industry that I started looking into it more. I developed a lot of stories in that space on my own when I was with New York Business Journal. So when I saw that Benzinga was on the hunt for a cannabis editor, I basically said to them, I am your man. Then they were warm enough to welcome me on to their team. It has been great coverage ever since. I have learned a lot. Yes, it has been wonderful.

Jeffrey: Yes, I mean, the industry itself has gone through such an evolution in that time period. As you are saying, you are learning a lot and you are living in the industry, but for those of us that are kind of outside, there is a ton of confusion, misunderstanding, misinformation about all of these. So that is what I am hoping we could do right now on this podcast is talk about the facts. To do that, I want to start with some of the basics.Throw around some buzz words about the marijuana industry that people do not really get what is the difference between CBD and cannabis?

Anthony: Yes. This is a conversation that happens with a lot of folks especially those who are, no offense to seniors out there who might be listening, but a lot of folks do not know the difference, so that is a great place to start. I have had this conversation with my aunts and my mom. They have their aches and pains, and they do not want to take CBD because they are under the impression that it gets you high. That is the difference right there, CBD does not get you high. It is short for cannabidiol, which is not a fun word to say or it is for some folks, so they abbreviated to CBD. That high or that state of euphoria that so many people enjoy comes from the cannabis plant, but that has THC. CBD is extracted from that. It is put into a bunch of fun products like creams and gummies and such. You will hear about it from all over, from various celebrities, and former athletes who opt [?] in products that they say helps them feel better. It is true because it does make people feel better. It is used to alleviate anxiety and inflammation with little to no side effects. I actually do not know of any side effects that come with CBD products. Personally, I do not use them because I do not have aches and pains, thank goodness, but for the folks who do, like soccer stars Rachael Rapinoe and Brett Favre are into it now, and pro wrestlers promoted it on their podcast. It works, and it is not a an addictive substance like some prescription anxiety medications can be.

Jeffrey: Yes, it is interesting. So your statement of, so it works and there is a lot of people that use it. I think one thing we have to point out is, CBD is an unregulated supplement. Right? It is not approved per se by the FDA. It is touted as a miracle cure though for everything, from arthritis to depression to sleep disorders. Now the FDA, I will not say now, but over the past several months the FDA stepped in and started penalizing companies for making these health claims. All right, so can you talk a little bit about that in how we feel, in a lot of people that have taken CBD and believe in it, how we feel so strongly it has its benefits.

Anthony: Yes. Well if anybody touts anything as a miracle cure, it should be suspect because that is something that people have been doing for so long with the the snake oil salesman, that whole thing. You should be cautious. It should not be promoted as such. So when it comes to being a miracle cure, it is not but it certainly is a supplement. It is an in addition to the traditional things that could help that are as serious as cancer.

Jeffrey: Have there been any FDA trials or peer-reviewed reports about the benefits of CBD?

Anthony: No, they just started. I think like this year, they talked about it. So there are currently no, although there is one we talked about. There are no FDA approved drugs that contains CBD other than the epidiolex which was approved. That was when they had like zero other options for this particular type of condition. It is an oral solution for the treatment of seizures. There are literally no other options, so that is when the FDA was like, okay. They looked at GW pharma and they were like, you know, sixteen week trial went well, let us approve it. There are other things that CBD is used for, that FDA -well let me take it back a little bit because there was an announcement in March where the FDA said they just started to advance work in CBD related products. So, great they had to wait until 2020. I mean it is been years now that people have been using it to self-medicate. That is what people wants. They want just more studies done. They want more federal oversight. They want it legal. It is something that both conservatives and liberals on both sides really want according to polls. So it just kind of baffles me that, they had to wait until the middle of a pandemic when these businesses were deemed essential businesses, and people were flocking to their local dispensaries to stock up because they knew that they would lose it. They would not be there. The lines would be really long I guess. So yes, it is just bizarre that it just took this long.

Jeffrey: Yes, okay. So GW Pharmaceuticals and epidiolex that was FDA approved, I think in 2018 or 2019 for one small indication for seizures. I think they have expanded that indication. I think there are also three other synthetic cannabis related drugs that have been approved, but again all for very very small indications like for nausea with chemotherapy, and there was one for anorexia.

Anthony: Yes. I looked into it, and it seems like they were looking for options, healthy options to boost appetites. So the science of it, I will be honest I have not looked into it too much, but the science of why they approved those particular products that kind of escapes me. Whatever they did to disentangle the THC from the treatment, I think that is what helped the FDA process along, but to do that takes a tremendous amount of research in time. That is the key here medical marijuana is medical because you medicate with it. It is as simple as that. People self-medicate with a lot of things. The FDA does not approve medical marijuana because of the euphoria it brings about. It is baffling because there is so many other legal medications that make us feel weird. It is just this whole – they are still hung up on the War on Drugs pretty much. Until that changes, the stigma is till going to be with it, but I think we are headed in the right direction.

Jeffrey: Yes. I find that fascinating the term medical marijuana. It is approved in thirty-three states in the country, medical marijuana, yet the FDA, who is in charge of everything medical does not approve this. It is a class one drug along with heroin, so it is a bit of a hypocrisy .

Anthony: Yes. I have spoken to so many folks who are in the industry. They are doctors. They are investors. They are lawyers. They are financial advisors. They are accountants. They are food and culinary specialists. It is just every title you can imagine that you would find in other industries. All the regular players you see crop up in other types of spaces, and it is just like anything else. They drop various types of deals with each other, merger agreements, venture capital deals. In other industries no one bats an eye, but because these folks are in cannabis, they are left at a serious disadvantage in this. It is a long list of things that they cannot do because of this particular industry that they chose to work in. Even if you are not a user, I am not a user in my own right, but the folks that I have spoken to and our coverage in Benzinga, you just learn a lot and just from the perspective of someone who lives in America, where we dump our chest at the beauty of capitalism and how anyone can create any business here without anyone holding them back. It is just not true because some states have come around, like you said that thirty-three states plus Washington D.C., but only eleven of those states allow recreational use. A lot of those states, the social equity programs that are in place are faulty. In some areas it work, in some areas it does not, so a lot of folks have trouble getting licenses and that sort of thing. It is not fair, just from that perspective alone. I mean considering, America is supposed to be about. It is just incredibly difficult to get involved in an industry like this where our viewpoints are just so different depending on what state you live in.

Jeffrey: Our neighbors to the north, up in Canada, year and a half two years ago, full legalization, correct, of marijuana.

Anthony: Yes.

Jeffrey: Of the flower, I should say.

Anthony: Yes.

Jeffrey: Now, what are some of the things that we have been seeing from there? How has it been working? Has it increased crime? Have all these devastating effects that the non legalization people here in the states are foreboding, foretelling? Have we seen that happen in Canada due to their legalization?

Anthony: I do not think of anything about crime. I have not seen that. I think that if anything that was probably less crime because legalizing drugs is just probably the best way to get rid of crime. It is funny you mentioned CanEx. We just posted something today that throughout August the cannabis industry added forty-six stores across Canada. So they have I think close to one thousand one hundred stores across Canada. Since the start of 2020 Canada welcomed like four hundred and thirty new stores and that is a pretty big growth rate.

Jeffrey: It is big growth rate. It helps out the local economies based on the taxes that those stores pay and the retail.

Anthony: Yes. The interesting thing about it is that there is no one dominant player. Okay. So when you think of something like e-commerce, there are a lot of companies that do e-commerce, but Amazon is the champ in that respect. So that comes to mind when people think of ordering stuff on demand and when you think of streaming platforms. There are so many, there is literally a streaming – everybody has a streaming platform, but people Netflix and chill and people do not Hulu and chill, you know what I mean? So there are these names that stick out in every industry, but with cannabis there really is not. It really is a level playing field. A lot of mom-and-pop companies are just trying to hustle in their own right and get access to capital just like any other business.

Jeffrey: Because of the diversity of the states and the state laws, everything is different here in the United States versus Canada, where it is federally approved everywhere. We have other issues such as banking and finance issues, such as taking product across states and across state lines for your supply chain. Can you talk about these things, especially the banking or finance issues?

Anthony: Yes, that is something that actually drew me into the space to begin with. That was something that Tiki Barber was talking about, that is why he started Grove Group because these entrepreneurs do not have access to traditional financing. He has done some VC deals. He has done a couple of private equity type deals. It is tough for folks to break into this space, and that is beginning to change over the past year. I interviewed someone who is involved in lending, and her pipeline is tremendous. She has got a lot of activity in the works. So when you disadvantaged people like that in terms of entrepreneurs and in any other industry, they have the ability to seek financing from traditional banking, and in cannabis it is a lot tougher.

Jeffrey: A lot tougher. Maybe the industry is changing or coming back again, but if we take a look at over the past year with some of these cannabis stocks and cannabis companies – like one company that I followed for a while was company called Medmen. Medmen owned retail stores, as you were talking about. Walking into these types of new cannabis stores, it is like walking into an Apple Store as opposed to like an old-fashioned head shop or the back of a Spencer’s Store. Right? Now Medmen had an incredible rise and also an incredible fall which has been very well documented. Can you talk a little bit about companies like this that were such high flyers and kind of how that is paralleling the industry a little bit and what is going on now?

Anthony: Yes. One of the other companies that I started writing about last year before I joined Benzinga was a company called Anthus. I forget the exact debt number but I think that they are pretty saddled with that unless they find a financier or maybe they just filed for chapter eleven, who knows, but that will really hurt a company. So it varies in every situation, but the situation with Medmen, it is not something that is exclusive to the cannabis industry. I think it is a parallel to just industries in general. The mistakes that they made are very familiar. You get a company that is new. It is flashy. They brag. They scale very quickly. Then they go, well wait a minute. They start cutting costs, laying people off, and shutting down production facilities. That happens with a lot of companies in all types of industries. Every industry has that story. So WeWork was the, like I said, like every industry has like this dominant player, like Uber is the biggest on demand taxi service. WeWork wanted to be like the Uber of workspaces and a flexible work environment. They had a lot of competition, but everybody knew WeWork because it grew like it was on steroids. You had somebody like Adam Newman who spent money like a fool to be honest, and the people who had faith in him and ran those office spaces for him suffer the consequences. He gets paid. He splits. In the end you look at a narrative like that, and you learn what not to do. I think that was the situation, I am not saying it was exactly like that with Medmen, but it was very sour.

Jeffrey: So the early mover to an industry that makes a heck of a lot of sense may not have done the right things but had started the revolution?

Anthony: Yes, exactly.

Jeffrey: Thank you, that makes sense. Switching topics, before we laughed when I mentioned the word flower up in Canada. There is a number of consumer brands and spokespeople, right? You have mentioned a couple. Some spokespeople you kind of expect to be in the space like Snoop Dogg, Willie Nelson, Bob Riley’s family, but as I was doing my research, there are other names that surprised me a bit. You mentioned Tiki Barber. I saw Whoopi Goldberg, Montel Williams even Martha Stewart, right? So you mentioned Tommy Chong. What did he have to say? What was he like? Most of your interview like?

Anthony: Yes. Well, to just preface that with not every situation is the same. Different products are geared toward different things because the truth is not everybody wants the high and that is okay. Senior citizens want something for example that helps them with arthritis or an athlete might want a cream that helps them recover quickly. That is where you see folks like Rachael Rapinoe and Brett Favre and Tiki Barber. That is what pulls them into this space as well. Celebrities will hack anything but when it comes from an athlete where they are saying, look we use this because this will help prevent athletes who get injured from getting addicted to dangerous drugs. I mean my ears perk up a little bit differently than I would with the average celebrity. With Tommy Chong that conversation number one was easy. As soon as he got on the mic, he broke news that he had welcome the grandchild into the world. So that type of spontaneity makes a conversation, when you are a journalist, it is so easy to work with that and just to warm up the crowd a little bit, so we do not get so businessy right away. It was so much fun to just start it off with that. Then from there, he goes into just how much it has helped him. I should say that it is genuine with Tommy Chong. I think he is the truest ambassador of the space because like I said, celebrities will hack anything, but he is not just another celebrity. He strikes me more as like the way Stan Lee was with Marvel Comics. Just the true ambassador of the space where you just get a different feeling hearing him talk and hearing his voice – there is a genuine aspect to it. Like I said, he went to jail for it. He relied on it when he was beating cancer twice. He is sharp as attacking, and he says, he has not get high off of it. He does not get big to whatever, that was all part of the comedy act and whatnot. He describes himself as a one-hit type of guy, that the only bad weed is no weed. He was just a lot of fun. I think that when people look for the types of products or the brands that they –  There is a lot of posers out there, and they want something true that has a genuine quality behind it

Jeffrey: Awesome. What do you see going on in the US market? Do you think cannabis is going to have any role? Do you think it is one side positive, more positive than the other side for cannabis legislation?

Anthony: Yes, because Joe Biden put forward a plan. He has one but as far as I am concern, I do not think the other side has one. I think you will not hear much talk of it going into November, on the presidential election. If you zero in on certain ballots, you will see it. I started paying close attention to what they are doing in New Jersey. I think that is on the ballot for this year. I think what happens in Jersey might influence New York, where I am based in the years to come hopefully 2021. The current administration is not going to vocalize a plan. I do not think, I do not know if it fits into their nativist agenda. If you are looking for that conversation to happen, you are probably going to want to lean the other way. It was clear to me when this poll came out that, this might not be exact I can look it up and correct it for you, but most Republicans want cannabis reform on both the right and the left. So if by me as your president, that bodes well for the folks who want that. It is just as simple as that.

Jeffrey: Well, thank you. This has been both educational as well as fun. So I appreciate you coming on, Anthony. Thank you so much for your time today.

Anthony: Thank you so much 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.