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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 on this episode, we get an update on vaccine boosters. Dr. Munoz always great to talk with you. Thank you so much for your time.

George Munoz, MD (Guest): Bill, always a pleasure and excited to update our listeners on a few major topics that you are going to outline.

Host: Yeah. So let's talk about that. We're going to get an update on vaccine boosters from you and other things. So, let's start with that. Can you give us the update on vaccine boosters?

Dr. Munoz: Yes. This is a voluminous tsunami type of volume of material, scientific, and otherwise that physicians, scientists, the lay public politicians and policy makers constantly try to evaluate for what is real, what is not, what is what we call the signal, the signal of safety or the signal of danger in terms of dealing with the pandemic, since we began in March of 2020. So, the update right now, and what's really hot in terms of current thinking is what about the booster shots? So, for our country, the FDA has authorized Pfizer booster shots were older and quote unquote "for at risk Americans." Now, those who have received Pfizer BioNTech, as their first shot six months after completion of shot number two, the opinion has now been reached by the FDA to authorize the quote unquote "booster" or third shot for adults who received the Pfizer BioNTech originally. What is going to happen is questions of who should get the shot first? Should shots be given to everyone or to only certain individuals?

And then as far as ethics and global healthcare policy, or at least some semblance of understanding where we are as a global society, the question has been some countries who have not been able to vaccinate even with one shot while we're thinking about boosters. So, that's the overview. But as of right now, Dr. Janet Woodstock, the acting FDA commissioner said that authorization would allow booster doses for certain populations, such as healthcare workers, teachers, daycare staff, grocery workers and those in homeless shelters or prisons among others. Additionally to that, people who are over 65 or immunocompromised or patients with a history of malignancy or on anti-rejection transplant protocols would also be part of the grouping who are at higher risk and therefore could obtain at this time, the third shot or so-called booster. Some people don't think it's a booster. Some people are just calling it the third shot of the immunization process because that way, the thinking is that this is a necessity that certain individuals at higher risk really should be receiving. It's not simply a booster, in thinking, but rather a necessity. So Bill what's interesting is, is that the initial data said that both Moderna and the Pfizer BioNTech vaccines had approximately 94 to 95% effectiveness.

However, the data started to come in that the effectiveness of the Pfizer vaccine over time, seemed to be dwindling. And while it wasn't staggering, it was still significant enough for Israel, for example, that had vaccinated its entire population to go ahead and proceed with the third shot to fully protect as possible; especially with this Delta variant, the population at risk. We now have rumblings that perhaps Moderna is somewhat more effective than Pfizer, but both are very effective in preventing death in the vast majority. And we're talking over 90% of people, perhaps even greater than 95%, with the current vaccine protocol. The third shot is a reality. It's happening. We're going to get FDA authorization on an emergency basis, instead of fully approving it. And we've been down this road already. We had emergency use authorization for the vaccines when they first came out. Now we have FDA approval for both Pfizer and Moderna.

And now we're in the process of getting a third shot and vaccinating children under the age of 12 to five years old, which is the next step. So this is the new update.

Host: Well, that is a great update. So, you foresee then, fairly quickly in the foreseeable future where people under 65, then we'll also be getting the booster shot or as some people are just calling it the third shot. When do you think that'll happen? Like in six months, early part of next year?

Dr. Munoz: I think it's going to be way sooner, right? I think this is going to be happening, within the next 30 days.

Host: All right. Cause the guy that's 64 is like, great. I just missed the cutoff. Thanks a lot people. No, I'm kidding. So but that as good news and good to hear and good news on the children too. I think once we start getting all of these children vaccinated, I think that's going to help as well. So, can you also talk to us about information on diet quality, risk, and severity of COVID-19 and the healthcare disparities that we're seeing?

Dr. Munoz: So this is a fascinating topic and we've heard about the risk factors in COVID in terms of morbidity and mortality to include conditions such as diabetes, hypertension, chronic corticosteroid use, especially over 10 milligrams, but, the focus has not been really on diet per se, but rather obesity and implicit in obesity for most people, not all, but for most people is going to be some type of dysregulated diet.

And we spoke about in prior podcasts about the necessity to have an anti-inflammatory lifestyle of which proper nutrition that has healthy fats and not trans fats, that has minimal excessive sugars, such as high fructose corn syrup, which is part of sodas and candies and a lot of junk food, which is cheaper; so, that people of limited income who are not able to access higher quality food on a consistent basis, and also to feed their children higher quality food, are probably more at risk for complications and severity for COVID. This is also the same population, that's at higher risk for diabetes or pre-diabetes, high blood pressure, asthma inflammation in general, inflammatory bowel disease.

And so what we just got was an article that was published as nutritional original research in the last week or two right out of Harvard. And this is data that was, published by Dr. Andrew Chan at the Mass General Hospital. And they were able to show that poor metabolic health and an unhealthy lifestyle factors that I just described to you increased the severity and risk of COVID.

And previously this data was absent. I mean, they used data from more than a half a million participants and they used smartphone technology based, questionnaires to be able to come up with the statistical analysis, showing that diet characterized by healthy plant-based foods, really lowered the risk and severity of COVID. Whereas the opposite type of food pattern, what we would call the SAD diet, the Standard American Diet, high in unhealthy fats, high in processed sugars, salt and devoid of minerals, vitamins and micronutrients; the SAD diet was really associated with an increased risk for COVID, morbidity and mortality.

Unfortunately, and this is my point. This association was particularly evident among individuals living in areas with higher socioeconomic deprivation. So, that's my point of this data in something that we as society have to begin to not just talk about it. And we had spoken about it on the podcast previously. When we talked about diet and nutrition with our nutritionist, Isabella Garcia. Now even with COVID, the increased risk is being affected in this subgroup of population that includes children, young adults, adolescents, adults, and the elderly.

And the food we eat, the quality of the food that they eat has to be supplemented from a societal standpoint. Quality access has to be improved. It can't just be whatever is affordable for everyone because we all pay as a society. We pay in human costs. We pay as a society in increased healthcare costs. And the bottom line is, is that reversing this socioeconomic disparity would be a major step in future health issues, future pandemics, which is a possibility, as we have seen. Cause we never foresaw this coming now. And just in terms of chronic care of the morbidities that we have seen, really put people at risk for cardiovascular disease, for cancer and made unnecessary and premature healthcare problems.

Host: So all this data is coming out now, and we're really starting to understand that a poor diet, the SAD diet as you call it, the Standard American Diet could result in more severe infection of COVID-19. Is that correct?

Dr. Munoz: That is correct. And this is not something that is staggeringly, unexpected, but it really helps to have these type of data and scientific documents that really form the chronology and the science basis for policy as we move forward. I mean, we're bailing out industry after industry. What about bailing out our society in focused ways without wasting money but targeting it to our vulnerable population? Many of them are our youth, who cannot yet vote, who do not yet have the voice and who represent our future, let's invest in our future.

Host: Amen to that. And you and I have talked about nutrition and food deserts before on this podcast and the results of that poor nutrition not only affects their health in a negative way, but now certainly it looks like it affects them when it comes to COVID as well. So, all of that just proves your point that we need to start working on health inequality in this country. That's for sure. So, let me ask you about something new at Oasis, the AnP Curcumin Oasis Nutraceutical. It's a new health product formulated with different mechanisms of action. I love that. Tell us about that.

Dr. Munoz: I'm so excited to share with you, as the Chief Scientific and Medical Officer for Oasis Health, which is our nutraceutical company. As we've outlined previously, our factory is here in the US, everything is third party tested, and we have several main products that are geared for, designed by rheumatologists like myself as the chief formulator for the inflammatory rheumatic patient, the patient who lives in the rheumatology world, which is a world of inflammation, a world of pain, a world of swollen joints, a world of looking for treatments that are not more toxic than necessary, and that are actually safe and that are natural and plant-based, but have science behind them. So, AnP Curcumin is this product. This is our newest formulation and we have three plant-based components in the formulation that includes boswellia, curcumin and Resveratrol.

Each of these have anti-inflammatory physiologic benefits and actions in the body to reduce inflammation. In rheumatology and immunology and pharmacology, we talk about how drugs and, different pharmaceutical components work. And this is called the mechanism of action, MOA within this formulation of AnP curcumin, we have three plant-based products that have different MOAs. They work differently. So, that if one way doesn't work in the body, you've got two others that could work, or they could all work in an individual, but sometimes we might find an individual where they've had, for example, side effects from one prescription anti-inflammatory, a second one worked temporarily or worked, but then they develop the side effect. These natural nutraceutical products have potent anti-inflammatory benefits and effects with different mechanisms of action, MOAs that are overlapping. They're not the same. Therefore, we have more chance to help someone with arthritic pain and inflammation to respond with significantly fewer side effects.

And that can also be integrated into a classic conventional medical regimen of medications with safety. So, curcumin has been around for tens of thousands of years. We've talked about it previously. It comes out of the sub-continent of India and it is attached to NAC N-Acetyl-l-Cysteine, an amino acid. And in fact, each of the plant-based components is attached to NAC.

That's how the cell takes up these plant-based components of boswellia, of curcumin and Resveratrol. Once in the cell, the N-Acetyl-l-Cysteine is able to be changed to glutathiamine, which is a potent antioxidant in and of itself. So, we've been able to put these plant based molecules, attach them to NAC, and they travel into the cell and they do their thing. They reduce inflammation. Many of these plant-based components, if you were to just take them over the counter or in the regular nutraceutical OTC, over the counter or mail order type of system, they're not formulated. They're not put together in this fashion.

So as to increase effectiveness, increase absorption, and therefore get the result that the patient or person needs to reduce pain, to reduce inflammation, safely, at a very reasonable cost; that's what I wanted to share with our listeners that AnP Curcumin is now an amazing product that we have to offer for joint pain, for rheumatoid arthritis, for inflammatory arthritis, for osteoarthritis, low back pain. And it is an amazing product that has a great safety profile and that we are using actively in our clinics all across the nation.

Host: So AnP Curcumin sounds like a terrific product. Is that a powder? Do you take it through pills? What is that?

Dr. Munoz: They are capsules that could be opened up. The capsule is a small capsule. It can be taken with food or without food, the capsule could be opened up and put in, for example, apple sauce or yogurt, or even a juice. But the absorption is fast. It's a bottle of 30 pills, that you can take once a day or twice a day.

Host: So multiple ways, however you like to take it, you can take it in the capsule form, or like you said, you can kind of split it open and pour it in apple sauce if you like.

Dr. Munoz: Correct. And oasishealth.care is the URL where people could go on and order.

Host: So go to oasis.Care to see all of the products and the new AnP Curcumin. Is that right? I love it. Okay. So talk to us about what's new in rheumatology, in the clinical practice for our patients like targeted therapies using blood molecular signature. What is that?

Dr. Munoz: Boy, that's a mouthful isn't it. So, that's part of why I went into rheumatology. We had all this immunology to evaluate and all these blood tests to try and figure out what patients complaints might be from, and the detective medical activity is one of the things that really attracted me to the field of rheumatology immunology.

So I'm so excited that our field has been progressing. It seems that at light warp speed in the last couple of years, and certainly in the last 14 years, we've had remarkable changes and advances in the field of rheumatology using advanced biologic therapies. These are medications that suppress certain parts of the immune system, Bill that are overactive or have gone awry in these auto-immune conditions.

For example, like rheumatoid arthritis and lupus and arthritis with psoriasis, which we call psoriatic arthritis, but there are many others, including psoriasis, including inflammation of the bowel, inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. And there are genetic and predisposing factors for all of these.

And we are able to treat more of what the origin of the immune dysfunction is rather than simply treating symptoms as we had previously done. We've been able to due to scientific advances and pharma, really being able to produce these amazing medications, get people to walk and eliminate the vast majority for need of wheelchairs in our waiting rooms.

Because when I started practice in 1985, I had a waiting room full of wheelchairs. In fact, I needed a wheelchair traffic cop, and now we hardly see an individual in a wheelchair or needing one in comparison.

It's been an amazing change. Here's the problem the medicines are extremely expensive, which is part of our healthcare costs rise, the medicines work, but they don't work on everybody. They seem to work at about 60% say of individuals, maybe 65, but that means that 35 to 40% of patient A who was put on drug number one, 35 to 40% of them are not going to respond Yet the way the model is set up right now, all the patients pretty much are going to go into therapy with drug number one.

And it's similar mechanisms of action. For example, TNF drugs, stands for tumor necrosis factor and there are a number of them. So that's, someone's say hypothetically with rheumatoid arthritis, who's not responding to the initial entry-level medications, which we call DMARDs, disease, modifying drugs would win the trip into biologic land to be able to control their disease.

And the first grouping of those biologics are these TNFs, but I just told you, 40% approximately aren't going to respond. They have to take the medicine for at least three to four months. I just told you that the costs of these drugs are very high, but there's also the human cost. My patient, the suffering, the deformity, the disability, that 40% of them aren't going to respond.

But yet we have to go through this process. So, what I wanted to share with you and our listeners today is that we have some new tests finally, that can help us predict who is going to respond to the TNF drugs and who is not so that we can pre-select the responders to go for that type of medicine, the TNF medications of which there are a number.

And if they are not predictive by their molecular signature of their immune cells to show activity, to respond to that class of medicine, we can go a different way, to a different medicine that they're more likely to respond to right from the get-go. And this is an exciting thing, both for the patient and the rheumatologist.

And it should be to also for the payer, the insurance company, because the payer I'm speaking to them now, you won't have to pay for drugs that aren't going to work for three to four months, times tens of thousands of people. And to my patients, hey, we can get you to a more effective treatment faster, so you can feel better, have less structural joint damage or internal organ damage because this test is allowing us to see whether you will get better with the TNF sorte of medicines or not.

So, molecular signature that can be tested through new laboratory tests called PRISM RA are an amazing advance and very helpful to the practicing rheumatologists to make timely, pointed and specific recommendations to our patients to get them targeted therapy.

Host: What an advancement. And you were talking about what drew you into this field is kind of the detective work. This is like CSI Rheumatology.

Dr. Munoz: Absolutely. And we have lots of toys.

Host: Yeah, this is, amazing. Being able to go in and have your blood tested to say, you know what, you're going to be receptive to this type of medicine or you're not, how powerful is that? So, you're not wasting three or four months, like you said, for the 40% of people that this type of treatment won't be effective for, you can go, you know what? We can rule this out right now. I don't have to put you through four months of this. We're going to go with this. Cause you'll be more receptive to it.

Dr. Munoz: Absolutely. And so it's a win-win for everyone, the advancement of this type of testing now to other types of treatments other than the TNFs is the next step. And I hope that the development of this testing protocol and paradigm for other types of molecular signatures, for other classes of drugs, proceeds, because this is needed to be able to get a filtering and a therapeutic profile of what the advanced, modern rheumatology patient needs in this new era of value-based care. I mean, let's give our patients the value. Let's give the payer the value, let's give the rheumatologists and the healthcare team the value and the consistency and the results that everyone requires and merits. So we can improve our results in controlling disease, inflammation, mortality, morbidity, and at the same time using our dollars wisely. So, that's where the value comes. Not wasting money and time.

Host: Right. And as you say, that's not only good for the patient. It's good for the payer, too. So it definitely is a win-win. Wow. This is unbelievable targeted therapies using blood molecular signature. This is amazing Dr. Munoz. And I know a lot of people that are going to be excited to learn more and to potentially see if this helps them in targeted therapy and helps treat their arthritis and other things. This is amazing.

Dr. Munoz: We're really happy and excited about it Bill. To our listeners, if anybody is suffering with a rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, or any of these autoimmune conditions, speak to your treating physician, speak to your rheumatologist about the appropriate testing for molecular signature to determine whether the medication, the TNF or other drugs could be utilized in your case. I strongly suggest it.

Host: Great information and thank you for sharing that with us. Well Dr. Munoz, another great episode, we appreciate all the information and knowledge that you drop on us on every podcast. This is amazing. And we thank you as always for your time and your knowledge. Thank you again.

Dr. Munoz: My pleasure, Bill, always a pleasure to be with you and thank you for your time and for your erudite questioning and ability to extract the information that's needed.

Host: Wow. And, and the words you use are like voluminous. You know, you don't get to hear the word voluminous very often. Only you Dr. Munoz. So we thank you for that too.

Dr. Munoz: Thank you

Host: This has been a voluminous episode and, and, and we love it. So thank you again.

Dr. Munoz: Thanks Bill.

Host: 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. If you're looking to purchase any of those products, you can go to a oasis.care and thank you for listening.