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

TRANSCRIPT

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

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

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

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

Zach: Thank you so much for having me.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Zach: Excellent. Thank you for having me.

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

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

TRANSCRIPT

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

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

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

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

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

Charlotte, thank you so much for joining us today.

Charlotte Huff: Thanks for inviting me.

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

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

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

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

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

Charlotte: Yes.

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

Charlotte: Exactly, exactly.

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

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

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

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

TRANSCRIPT

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

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

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

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

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

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

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

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

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

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

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

Lisa: Right.

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

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

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

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

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

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

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

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

Jeffrey: Yeah.

Lisa: Yeah.

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

[crosstalk]

Lisa: Sure.

Jeffrey: …from the article?

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

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

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

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

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

Jeffrey: Yeah. It sounds like a vicious…

[crosstalk]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[END]

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

TRANSCRIPT

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

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

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

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

Brandon May: Hi. Thank you for having me.

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

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

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

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

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

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

Brandon: Exactly.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Brandon: Exactly.

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

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

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

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.

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.