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.