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Bill Klaproth (Host): Welcome to Oasis Rheumination, a podcast with Dr. George Munoz, Chief Medical Officer, and Founder of both the AOTRC, Arthritis and Osteoporosis Research Institute, the AARA, Arthritis and Rheumatology Association Care Center and the Oasis Institute, a fully integrative multidisciplinary clinic in Aventura, Florida.

And we are back with Dr. George Munoz. Dr. Munoz, always a pleasure to talk to you. It's always enlightening and informative, and we always learn things to help us in our world of health and how to be healthier. So, thank you for that. So, this is a special episode, three topics, one episode people, three topics, one episode. So strap yourself in. Here we go.

So, Dr. Munoz, thank you for your time as always. So, of course we always talk about COVID-19 or a lot of times we talk about COVID 19, because that's what everybody's still talking about. So, we're hearing about surges five and six. We've been through four already. I don't want five and six. Can we stop five and six? Can we just not have that? Can you help us not have that? So, what are we seeing and what can we realistically expect?

George Munoz, MD (Guest): That is so honest and that concept of please no more surges.

Host: No more.

George Munoz, MD (Guest): And I think the key thing, Bill, is for us to understand that the first, second, third, fourth surge, each time globally, we learned something. We've been learning to adapt as a nation, as a global society. What I can say on a positive front is as vaccinations continue to happen, and the populations of each country, are increased in terms of their vaccination percentage and numbers; that the peaks, the severity, the hospitalizations and the deaths, will actually begin to come down, even though we still have technically a surge and a surge means we have new cases.

So I wanted to review this because we've spoken about COVID and previously case numbers and some approaches in the past. But I think it's important for us to know that at 21,22 months into the pandemic, Europe is now experiencing technically it's fifth wave. And just a quick overview. Germany is scrambling to control what appears to be another surge, reported by the New York Times recently. French officials have said outright that it's fifth wave of COVID is happening there. And, you know, the US COVID total has reached almost 47 million cases since we started. Unfortunately and over 750,000 deaths since this began. And just to put that into perspective, the regular flu yearly tolls that we would statistically get would be anywhere in the 50 to 75,000 range of deaths. So, this is more than 10 times those numbers. And I think what's happened is, is that the numbers recently, seem to be dropping in certain areas. We've reached the plateau in the United States. I think that's an important fact to know.

The ability to have more testing and home testing and, and availability has helped. Also almost 1 million US children got their first dose of the Pfizer vaccine, after being authorized for children, ages five to 11, so that this is going to help in terms of allayin the spread. But certain parts of the country are in more of a flare, right? And so, we see that most of the cases right now, increasing in the Midwest. And in the west, whereas in the south we've been on a, stable plateau and the cases are actually lower after we had a severe outbreak due to the Delta variant. Especially here in Florida. So we've had plateau, lowering of numbers in the south. Yet, the two areas of our country that I just mentioned, the Midwest and the west such as, Arizona, Colorado, New Mexico; their numbers are rising.

And so this is a cycle. And so the cycle we see within our country is similar to the cycle that's seen around the world. And what we're hoping is, is that mortality and severity of cases, will continue to decrease, as the population with increased vaccination reaching about 60 to 62% of our country, Bill, begins to reduce the severity of wave one, wave two and wave three. And that's really the message that I wanted to leave you with that even though we're having surge five occurring; we do hope that by continuing the vaccination rates and increasing it now, to children age five to 11, which was recently authorized, and by those third boosters, that are now available to everyone, not just people who are immunosuppressed. So, after six months from your original last shot, you are now available and can access that third booster. Which adds protection since it's been shown that after six months, the amount of protection begins to wane at the six month mark. So, that's the main message in terms of what's happening as far as cases. We have some news though, on therapeutics, would you like to hear about that?

Host: Sure. So let me just comment on that. So these surges in the future, we're going to see lower case amounts, right? They're not going to be as high, the spikes, aren't going to be as high and we're going to have shorter duration. Is that, is that a fair statement for these surges that will come in the future, like surge five, which we're getting into right now?

Dr. Munoz: We don't know if the duration, if the width of the surge will actually be decreased, but we think the height, representing deaths and hospitalizations will be lower with each peak.

Host: Okay. And will this be, as in the last surge, basically a surge of the unvaccinated?

Dr. Munoz: And that's why I love doing these podcasts with you, Bill. That's a slam dunk. Yes. The answer is yes.

Host: Bam, see I set it up for you and you, you just bam. You hit it out of the park.

Dr. Munoz: You just slam dunked that and that's why the messaging is so important at this point that the science is showing us that the unvaccinated are at the highest risk. And whether you're vaccinated or unvaccinated, as you get older, starting at age 60, 60 to 70, 70 to 80, 80 to 90 for each decade of increasing age, the morbidity and mortality increases for both unvaccinated and vaccinated individuals, but it's worse if you're unvaccinated.

Host: Yeah, absolutely. So, another a word of warning that if you're not vaccinated, please, get vaccinated. So, and I know there's a lot of people that were waiting, not because they were making a political decision, but because they were just afraid of this and thought maybe there wasn't enough time passed. But as more time passes, and I think people will see that, okay, this is a safe vaccine, maybe it's time. And if we do get a big enough surge, even in the surge four, I know a lot of people were like, oh, okay, I'm going to get this thing now. So hopefully that'll continue to happen and we can finally be done with surges.

Dr. Munoz: That is a goal. And I do believe we will reach that goal. Eventually this will become like the common cold.

Host: Yeah, which would be, or, or like the flu, right? Every year we're going to get our flu shot. Or we're going to get our COVID shot. Right?

Dr. Munoz: Exactly.

Host: And then, you wanted to tell me about, I believe therapeutics, right? So kind of like a Tamiflu when you get COVID oh oh, you tested positive, start taking these pills to reduce the severity, right, to lessen the chance of hospitalization. So, is that on the horizon? Is that what you are going to tell us?

Dr. Munoz: That's our second topic for today, you know segueing from the case load to therapeutics. I'm gonna say that right now, we're following 33 Coronavirus treatments that are being evaluated for effectiveness and safety. One of them is FDA approved. Five have promising evidence, 12 have tentative or mixed evidence. Seven are being widely used. Six have been found to be not promising. And three have been labeled as pseudoscience. And just looking at a quick snapshot of these newer therapeutics. Recently, as of yesterday, November 16th, Pfizer asked the FDA to authorize it's pill called Paxlovid for emergency use, which is a new, oral antiviral agent, that reduces, morbidity and mortality significantly, by an oral route meaning you don't need intravenous therapy. It can be done as an outpatient. And this is now a breakthrough, in that we now have oral medication to offer the public. And it passed phase three trials in July.

Basically it was 89% effective in reducing hospitalizations or death, when given within three days after the start of symptoms. So, this is important, as a new therapeutic to bolster the strategy of increasing vaccinations for prevention. Now, if you acquire the infection, we have something orally that can be given to you in addition to the other therapeutics, which I'll mention real briefly. But I wanted to tell you about this pill, made by Pfizer. All new drugs have, they have a number? Okay. I'm not going to bore the audience with the number.

But there's a second pill. The second pill is still not fully approved. But again has a number, it's an antiviral. Originally designed to fight the flu. And Merck is basically collaborating with another company called Ridgeback biotherapeutics. And developed a treatment for COVID-19, which, unlike the intravenous drug that we do have available remdesivir, this medication is called molnupiravir. They pick tongue twister names Bill.

Host: They always do.

Dr. Munoz: But it's another pill. Another oral agent. That can be used to stop the disease early in its progression. And this has been evaluated in two studies, both phase two and phase three to reduce mortality and speedy recovery in patients. They're ending their trial in hospitalized patients. At this point, we now have Merck and Ridgeback submitting an application again for that emergency authorization to the FDA. So, that we will have two options both in the US and globally, to treat acute COVID-19.

This is a big breakthrough, you know, and just to review, we've had a number of things since the pandemic began 22 months ago. We had convalescent plasma Bill, which right, plasma from people who actually had COVID. And then that was infusible in into patients. Yep. And that was kind of a crude, but it did help. But it was a narrow use that the FDA allowed. And then we went on to have specific antivirals that have been used to treat other viruses, such as HIV and hepatitis C and that drug, remdesivir are made by Gilead, did gain full approval from the FDA, for the treatment of COVID-19. And that medication was originally tested and used against Ebola and hepatitis C. So, revisiting what we've used in other infectious diseases against viruses has been, changed and reformatted for COVID-19 because we were desperate.

And that was a five day treatment course that would have to be given usually in the hospital or an intravenous setting. So, the oral agents that I just told you about are a big improvement since you don't have to be in the hospital. You could literally get these medications from your local pharmacy. And they're usually a five day treatment. We're very excited that we now have options for people that can keep them out of the hospital and, and prevent death when they're, when they're treated early.

Host: Well, this is the kind of the one, two punch, the vaccine, and then therapeutics, like you're talking about. This really will, I don't want to say, put an end to it. Cause I think we're going to have this probably forever. Just like the flu, but we'll really be on a course of fully being able to manage this and get all of our lives back to normal, where we don't have to have masks, or worried about going into a restaurant or bar without a mask, et cetera. So thank you for that. Topic one, loved it. Topic two. There's a new medicine discovery with a novel target for pain. Could this be the way out of our opioid crisis? It's a new model for non-opiate pain treatment. Dr. Munoz, what is this new discovery?

Dr. Munoz: So Bill, I really am always scouring the literature.

Host: I like it when you scour.

Dr. Munoz: Scientifically.

Host: You're a good scourer.

Dr. Munoz: I am a good scourer. And looking for hints of new breakthroughs that could help us help people with chronic pain. And get away from chronic opiate complications, overdoses, addiction, and death.

Host: I like that.

Dr. Munoz: We've had a huge number, unfortunately again, during the pandemic, of people overdosing on opiates.

Host: Well it really made it worse. Right. People are stuck inside. Can't go out, lost their job. Can't see family, isolated. It just made everything worse.

Dr. Munoz: Yeah, those are all the makings for loneliness. Having chronic pain, trying to deal with it, but at times, perhaps, even unwittingly unpurposefully, taking too much and causing accidental and sometimes non-accidental overdoses. So, what I wanted to share with you and the audience was, in our basic science literature recently out of Pub Med, there is a journal called Science Translational Medicine. And what that means is, is that scientific findings, at the molecular level of biology or molecular biology or genetics can be used by following the downstream products of these molecular mechanisms and products and identifying proteins that create an effect, reaction, or a desired event that can help an individual, a patient, society. So that's what I want to share with you.

This article, that was recently published this month, November 10th, 2021 Science Translational Medicine. We are up to date. We report on the latest. And this is from the Department of Pharmacology College of Medicine, the University of Arizona, Tucson. By Sung Kai et all. Okay. It's like they have like 25 authors here. Song S-O-N-G Cai, C-A-I and I hope I'm pronouncing it correct. And if I am not, I apologize to Dr. Song Cai, et all.

But this is a selective and new target to consider developing medications for reducing pain. Now this is what's called an animal model in rodents. You know, in science, this is how a lot of drug discovery occurs, clinical and preclinical data identified that something called a sodium channel, a salt channel is a promising target in the cells for treating both acute and chronic pain, that up to now, there's been no channel blockers, sodium channel blockers of this category. It carries a name it's called Nav 1.7. Na stands for sodium.

So, this sodium channel was manipulated. And when it was manipulated, the interacting protein that it interacted with and reduced the expression of in cells wound up reducing acute and chronic pain, in the animal rodent model after oral administration. So this could be given orally, a pill. It doesn't have to be injected or doesn't have to be given intravenously, so that makes it more viable, easier to administer.

This is what we call when you target post-translational mechanisms, as an effective approach to reduce pain and what's called in science, anti-nociceptive effects. In plain English, that means changing the proteins that control the sensation and detection of pain in the body by affecting this particular sodium pump and changing its interaction with its specific protein. So, in a vacuum, this sounds like a really like boring experiment. But the implications are that we now have another option to be able to offer and explore the use of non-addictive analgesics without eliciting addiction. Without it eliciting rewarding properties, and that are not neurotoxic.

So, this is an opioid receptor that is not affected in the usual way by a different class of molecule that's been discovered, that has to do with the sodium pumps. And a protein called 194. So this is a first in class protein inhibitor. We're going to keep an eye on this because this is big. This is, this is big. This is big. And so we came from a lab finding, so now the next step is to create the actual molecule. And then to begin what would be called pilot studies and then randomized testing, controlled trials in humans to determine safety, dosing. And then the last would be phase three effectiveness compared to standard models of pain medication.

Host: I love it.

Dr. Munoz: So, very exciting.

Host: Yeah, really, really good news. And we thank you for reading Science Translational Medicine, see what you bring to us. Thank you so much. Okay, that was topic number two. So we're rolling topic. Number one, COVID-19 worldwide update. Topic number two, new model for non-opiate pain treatment. And that brings us to topic number three. There's novel training in rheumatology fellowship training at the Larkin Rheumatology Program at the Larkin Hospital in Miami, Florida. Dr. Munoz, what is this rheumatology training?

Dr. Munoz: So I'm plugging the Rheumatology Fellowship Program at Larkin as it's new Associate Director next year to become the Director of the Fellowship. Currently, Dr. Barry Waters has been the Director of the Fellowship for the last eight years. It's a new rheumatology program compared to other fellowship training programs around the country. And what's novel about this program, is that it is focused on training Residents who choose to go into the field of rheumatology as Fellows, competitively applying through the national matching programs called ERAS, E-R-A-S. Interviewing and being selected in a highly competitive environment. We're talking about an application process that clearly is accepting. We have two spots per year. It's a two year fellowship. So four fellows total. And this year we had close to 200 applicants for two spots.

Host: Wow. Okay.

Dr. Munoz: So the percentage of applicants that get in is approximately close to 0.5-0.6% under a percent. Now, just to give people an idea of how competitive this is. Ivy league colleges, accept between three and 5% Harvard, Columbia, Princeton. It's like four to 5%. Our acceptance rate is one 10th of that.

So this is highly competitive. The focus of the Larkin Rheumatology Fellowship training, which is novel is, is that we're training rheumatologists of the future in community based practice settings, as opposed to in a single silo of a hospital with large clinics and inpatient services exclusively and outpatient clinics. That's a different model. We are training the rheumatologists on how to interact with patients in a community setting. How to diagnose, evaluate and treat the rheumatology patient, the modern rheumatology patient, in our changing healthcare environment. They're learning all the aspects of care, all the modalities, including evaluation, the differential diagnosis, how to interview, how to speak to patients, how to listen to patients, how to evaluate for multicultural, ethnic factors that can change their perception or they may not have previously evaluated patients in this deep a fashion. How to communicate with patients and explain very technical scientific terms in language that is understandable by their patient. So they're being taught at multiple layers, both energetically, physically, mentally, spiritually. And getting passed on, in many cases, anywhere from 20 to 35 years of rheumatology knowledge by our attendings in their clinics. Almost on a one-to-one mentoring basis, Bill.

Host: Hm. Yeah. That is novel, right. So what do you think the results will be from this? Do you think this will revolutionize rheumatology training? Do you think it will take hold?

Dr. Munoz: I think it will be a factor in revolutionizing rheumatology, and possibly other subspecialties training models, not to be exclusively hospital university based. Because they're just not producing enough numbers of specialists and physicians to handle the baby boomer population, which is increasing. Number two, sometimes in academic centers and I trained in these academic centers. So, you know, and I'm not putting them down. I'm just saying that times have changed. And that the clinical rheumatologist for the community has to have a lot of practical experience that is not emphasized in strict academic settings that are going to focus on research and not primarily on outpatient clinical medicine. That's the difference.

Host: Okay. Got it. It sounds like you're in favor of this.

Dr. Munoz: I am in favor of it. And I didn't realize how novel and how different this was because one could say, well, there isn't enough hospital experience here. But rheumatology has changed, Bill in the last 10 to 15 to 20 years. The rheumatologist hardly ever goes to the hospital. Why is that? Because we keep our patients much healthier, and they don't have to go to the hospital. What a concept.

Host: What a concept. Wow.

Dr. Munoz: So we employ imaging, x-ray, ultrasound, infusion, do procedures, injections, evaluate complex laboratory biomarkers of auto immune disease. And at the same time, can take care of more simple in what one might consider mundane conditions, such as normal aging arthritis, osteoarthritis, as well as complex auto-immune disease. So we are now looking at the ability also as an integrative rheumatologist, which is how I practice; to teach the Fellows about lifestyle. We've we've talked about nutrition and lifestyle.

Host: Absolutely.

Dr. Munoz: So, we can now teach the Fellows how to utilize those disciplines and put together a whole package, including conventional rheumatology, integrative rheumatology, lifestyle medicine, the best of science as well as mind, body interventions, physical activity, stress reduction, nutrition, diet, and supplements along with their advanced biologic and immune suppressive medications that are complex therapies. And teach them how these work together, not mutually excluding each other. This gives the future rheumatologists many more options to be able to show their patients, treat their patients, and offer their patients a whole wide variety of the palette of colors. Not just black and white.

Host: Yeah. That makes sense. It sounds like what your current practice and others have evolved into, as you said, times change. It sounds like the stuff that you're doing now, you certainly weren't taught when you went to school, but it sounds like what you've learned and what you've evolved to, not you personally, but the industry. It sounds like you're taking today's right, rheumatologists and teaching it now to people that want to become rheumatologists. Is that correct? You just taking everything that is learned. You are just put it all together. Now we're going to teach them right at the beginning of how all this works together. Is that a fair statement?

Dr. Munoz: That is a comprehensive and as usual, right on the money statement by Bill.

Host: I get lucky. I hang around with smart people, like you, Dr. Munoz. See, I mean, you read Science Translational Medicine. See that rubs off on me. See how that works.

Dr. Munoz: I like it. I like it.

You

Host: like it. It's good. Well, I love how you're willing to say that. Obviously you're a very experienced and tenured doctor medical professional. I think it's refreshing for you to say, you know what? This is a positive change and this is the way it should be. This is the way we should be teaching it. I would think, many would be entrenched in that's not the way we did it back then. We need to do it the same way that I was taught. And you're willing to go, no, we need to change this to reflect the current state of the industry today. I think that's really cool. And open-minded about you that you look at it that way and are willing to look at these new things and go, wow, this, this is a better approach to teaching rheumatology today.

Dr. Munoz: And thank you for recognizing it and look, we're excited. We're excited to be able to impact these young people, the future of medicine, in our country and we now have amazing therapeutics that did not exist 20 years ago, that didn't exist when I first started practicing.

Host: Right, yeah, advances.

Dr. Munoz: Yeah, we used to have wheelchairs in our waiting room. We don't have hardly ever have a wheelchair in our practice at this point.

Host: Oh my right. Well, again, times change. And that's a testament to the good work that rheumatologists are doing today.

Dr. Munoz: And the basic translational scientist.

Host: That's right. Let's not forget that. That is it. Well, there you have it Dr. Munoz, three topics, one episode, jam packed with great information. As we talked about COVID-19 in an update, a new model for non-opiate pain treatment and of course this novel training and rheumatology fellowship training. Dr. Munoz, thank you as always for your insight and your knowledge. We appreciate it. Always great to talk with you. Thank you again.

Dr. Munoz: Bill, it's a pleasure. And I really appreciate your sharing the time and keeping us company and helping our audience digest and navigate some of the messaging that we have the privilege of giving.

Host: Well, thank you. That's what I do. I'm a good wing man. All right, Dr. Munoz. Thank you again. And once again, that is Dr. George Munoz. And this is the Oasis Rheumatology Podcast. For more information, please call 305-682-8471, that's 305-682-8471. Or you can visit the Oasisinstitute.com. And thank you for listening.