How Is Ozone Therapy Being Used To Treat COVID-19 in Europe? with Dr. Paolo Tordiglione

Coming up on this episode of the Doctor's Pharmacy.

The patients we treat with ozone did really have no side effects, did have a better quality, a life quality during the stay, during the infection. And we had none of the one that treated that went in the ICU.

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Welcome to the Doctor's Pharmacy. I'm Dr. Mark Hyman, and that's Pharmacy with an F-A-R-M-A-C-Y, a place for conversations that matter. And if you're struggling with the COVID pandemic, as we all are, you better listen up, because this might change everything, this podcast, because it's with an extraordinary physician, from Italy, Dr. Paolo Tarricone, who's an intensive care physician. He's an MD, PhD. In fact, he has his PhD in ozone in the brain. He works at a hospital in Rome treating patients with COVID using ozone therapy and other therapies as well. He's an expert in pain medicine and ozone therapy, has worked as the president of the Doctors of the World for Italy, founder of the Physicians for Human Rights in Italy, and the vice president of the Academy of Bioregenerative Medicine. and a member of the Molecular Medicine Academy. I've been in touch with him over the last year in terms of understanding what is happening in Europe around COVID, what therapies they're using that are different, and how we can learn the United States about things that may not be used here, but may be profoundly effective in the battle against COVID-19. Now, as we speak, there are 55 million cases, 1.3 million deaths around the world. The US has 11 million and about a quarter million deaths. this is not going away. It's getting worse every day. It's spiking here, it's spiking in Italy around the world. And I'm so excited to have you, Paolo, on the podcast. Welcome.

Thank you. Thank you very much. I'm proud to be here too.

So we got in touch early on during the pandemic to discuss the use of innovative therapies that are widely used in Europe, but not so much here. And for those of you listening, ozone therapy is a model of care that is used throughout the world, except not so much in the United States. And it was something that was introduced into the COVID treatment approaches early on in Europe with great effect. And so today we're going to talk with Paolo about what he's learned about COVID what he's learned about ozone, working in the hospitals, working the intensive care unit, seeing the overwhelming challenges we face with these patients and how we can think about dealing with it differently. So I'm very excited to get deep into this topic with you and talk about what you've learned around ozone. So let's just sort of get into it right away. You basically have been at the front line of COVID for the last eight or nine months. And it's really challenged us. It's challenged us from a public health perspective, from a physical perspective, from mental health perspective. Where are we now? In where we're recording now in November, where are we now in terms of our understanding of COVID-19?

Well, I'd like to take a step back and talking about the ozone treatment that goes all the way back to 2000. I mean, so it's about 20 years that I do work with this molecule with this extraordinary gas. So everything that comes out is going to be obviously settled and very deeply studied and looked upon. The COVID where we are, I don't know because it keeps on changing. It keeps on changing our sort of going beyond our expectations. And we were hoping actually, I was personally hoping that it was going to disappear after the first pandemic or the first spread of the virus. And instead it's back on as deeply and as aggressive as before. So we are back into into deep trouble, I would say, in Italy, because we have hospitals that are basically very differently equipped depending on the area of the nation. So some areas may get into a deep impairment and with just a few thousand cases. And on the other hand, other areas that can deal with a greater number of patients. What we could say about the COVID is that it is a viral infection that has different, complete different behavior depending on the patient. And I always say that for me, what's very important is how the patient is in balance or out of balance when he's caught into the viral infection. So there are lots of co-factors that are that do give a lot of different behaviors because I've seen 80 year old people that get out of COVID quite easily or even if they go through intensive care and then they come out and they are safe. And on the other hand, 40 year old people with no co-factors of or other diseases that-.

Pre-dispose them.

Pre-dispose them. die out of nothing, so out of the virus itself. So it is very, very, very interesting on one hand, very puzzling on the other.

Yeah, it can be unpredictable. And so right now we understand this as a disease that is driving multiple problems within our biology. It's an inflammatory disease. So the virus activates these inflammatory pathways, It damages our lungs, it damages the lining of our blood vessels, it increases blood clotting, and it leads to all the secondary consequences as a result of that. And the treatments we have so far don't seem to be working that well. We have learned a few things, and for example, in Taiwan, they use inhaled steroids. They're using combinations of different drugs around the world that seem to help to mitigate the the disease. But what are you finding are the most effective therapies now that are being used aside from ozone? Because we're going to get into that. But where are we at in the treatment? Because I think everybody's waiting for the vaccine is a panacea. And Pfizer and Moderna have said their vaccines are 90% effective. And we can talk about the vaccines in a little bit. But I do think that it's important to understand what is out there now in terms of therapies that are helping with the treatment of these patients. Because when you first started in the ICU in March, or in February with you guys in Italy, you were the first to get hit. There wasn't a lot we knew and there wasn't a lot that we knew what to do, but we were sort of guessing. Now, where are we at? However many months later we are now?

Well, we understood that absolutely there is a great important component given by the fact that we have to be able to impede or block the inflammatory process. And that is steroids in the short term, and with an acute dose. It is very interesting using the interleukin-6, Tocilizumab, which is the drug that we've been giving to all the patients that really show severe in the first step, or chloroquine, hydrochloroquine. So they are the drugs that we've been using standardly. Of course, we do not use instead, on the other hand, antibiotics if not necessary. If not, if we don't have a real concrete expression of the fact that patients do have bacterial infections, because otherwise it's going to even lesser the immune response of the patient, because antibiotics do affect and are to our experience not to be used on the first line. The other thing that we use, we've seen that improves a lot the outcome is using heparin, low dose heparin, low molecular weight heparin. And we use 4,000 units twice a day. So it is quite a therapeutic dosage. And it's according also, depending on the weight of the patient. But this is something that really helps patients not increasingly and rapidly deteriorate. so these are the things that work quite well up to now.

We've got steroid dose, we've got an inflammatory blocker, which blocks this cytokine called IL-6 or interleukin-6. We use heparin and we use hydroxychloroquine, which has had mixed results. It really hasn't moved that much forward in eight months as the stuff that we sort of started trying right away. what is going on in therapy and the benefit of ozone within the hospitals that are being used in Italy? Because right now, you know, there is a number of clinical trials going on in Europe and in Italy on ozone therapy, randomized control trials are listed on clinicaltrials.gov, and we'll talk about the paper you recently published about the safety of ozone and the potential effectiveness. But what is the rationale for ozone therapy. And maybe you could start before you get into that, you know, what is ozone therapy? Where did it come from? What's the history? How safe is it? You know, what, what, what is the, the current state of understanding of ozone and ozone therapy?

Okay, so ozone is a, is a, is a natural molecule that is actually outside in our external layer of the, of the atmosphere, and it really bounces off all the ultraviolet that comes in. So the whole of the, in the ozone layer has been the reason why in Australia and many other areas that have been an increase in melanoma, the actual cancer of the skin. So it is as such a good molecule. Now, since the Second World War has been used and it was discovered by a German doctor, a German that actually used ozone or managed to create ozone because ozone is nothing but a three molecular, three atomic molecule of oxygen. So it's nothing else but oxygen at a very excited level. So it is nothing great, nothing strange, very natural. And when he used it with the curing, trying to cure wounds in the second world war, they had excellent results because it was extremely effective in destroying bacterias. Because what ozone does, it sort of reacts in its It breaks its molecular bonding and it transfers energy to these bacterias or virus or fungus. And they actually in vitro, and I have published a paper on this, it is extremely effective. So we were- It's the most powerful.

Germicide that we know of, right?

Absolutely, absolutely. And it does not give any pollution because it binds, as it destroys, it disappears and creates oxygen. So it is not a pollutant as a lot of chemical stuff we do use to disinfect. And it has a time lapse. That is the great problem as well as the great advantage of ozone because it has to be created at the moment and after a while it's gone.

So- It's got a very short half-life. It dissipates very quickly.

It depends on temperature, pressure and so on. But yes, it's quite quickly.

Isn't the machine that the ozone generator first invented by Nikola Tesla?

Well, there is something about that. I'm not very sure about the fact that Tesla did invented it, but he was a genius, so he was there too, probably. But the period of time was that. It's actually given to this German physician, which I don't recall the name right now. I'm very bad at names, but it was not Tesla. But I know that Tesla But the.

Application in medicine was developed by this German physician who found it was really incredible for infections when we really didn't have a lot to offer in terms of antibiotics.

Right, exactly. So, and we did test it in some time ago, it was in 2015 that I did this test in trying to see in vitro. So we were putting a known amount of bacteria. It was a multi-resistant bacteria from our from our library, say, let's call it the library of the University of Rome, with the most extremely non-sensitive and very antibiotic-resistant bacteria. And we put in Ozone. And it was incredible seeing that the water from being very dirty and as you would say infected, would turn into something which was rock water coming from a very, very clear, it was becoming transparent. extremely, it was incredible how the water would turn out to be purified the water. Transparent, purified. It was purified. So we could see just the little traces of the bacteria on the base of the of the vial and the rest of the water was purified, completely transparent. So from that we went on and the second step was to apply it to patients that were in the ICU and that were being treated for a long term stay because what I do is I'm an intensive care doctor and work in neurosurgery and I have a neurosurgical post-op intensive care unit. And there we had patients that were having a lot of problems with infections and treatments and they were in need for bacterial, I mean, antibacterial.

Any bacterials?

Yeah. Right. So what we were doing, we said, okay, let's give it. Let's give it a try. Let's try and give ozone to these patients. so I had again there with a lot of difficulties and approval from the ethical committee of the hospital of the University of Rome, La Sapienza. And we finally did that. And what happened was that not only patients were having a better outcome from a lesser, fewer episodes of seizures, Not satysemia, rather than pulmonary infections, urinary infections, and also gastrointestinal infections. And together with that, the most incredible results. And my students, my residents hated me because I said we have to collect everything because we don't know what, I don't know what we're looking for. And in this big amount of data we collected, what we found was that the lymphocytes, of these patients that normally dropped down, they were keeping on staying stable at a steady state and not only they were increasing to a good level of presence. And this to me is what the immune system was responding to ozone. So we were having patients that were having a good immune response. And the second and very interesting thing we had was that it turned to show that patients did not need any strong and third choice antibiotics. So they were happy with the normal and first line antibiotics that were giving results for a longer period of time and with greater and better results. So this to me was the basics on which I said, well, this ozone is working not only as a bacterial static or bacterial killing bacterias, but is enhancing the immune system. So that was the reason why we started on then thinking that ozone was going to be working also for immune response to viral infection. So going on to what, what you were asking me actually, why using it for COVID. Now, the reason why we think, and we, we suppose our, our thesis is that ozone is going to sort of shock the immune system saying, Hey, there is something that you have to respond to and you have to respond in a way that is balanced. So it really manages to activate the cell-mediated immune system and that is the one that is the one that is going to really detect, visualize and target the virus that otherwise has a very long or has a component of intracellular development that the body is not going to perceive, is not going to manage to, the immune system is not going to manage to tackle.

Find it.

Right. So it is, you know, it's like, it's like the, also the, the malaria.

No, with the, so it hides the virus hides and the, and the, and the ozone seem to stimulate the part of the immune system that goes after viruses in hiding and not only kills the bugs but also improves the function of the immune system by increasing your lymphocytes, which is one of the key white blood cells involved in fighting viruses.

Exactly. You couldn't have explained it better.

Well, what's really fascinating to me is that we're learning about COVID and the very things that ozone does are the exact ways in which COVID needs to be attacked.

Right?

And from my understanding of the research, it's germicidal, so it can literally kill the virus. Two, it can actually regulate the immune system and it does through multiple different pathways that are pretty well worked out. There's a fair bit of research on this. I mean, you have your PhD and ozone. This is not some whack job therapy, even though it's considered that in the United States. clinics have been shut down for saying they're going to treat COVID with ozone. Although I think, you know, it hasn't been quite proven yet. We're getting there. It helps to inhibit the inflammatory system and it improves the anti-inflammatory system. It also, right? And it also improves our ability to use oxygen in our tissues, which is a problem in COVID. It also activates our antioxidant defense systems. It improves something called nitric oxide, which is incredibly important in dilating blood vessels and reducing blood vessel and endothelial inflammation. We know that the endothelium, which is the lining of all our vessels, our circulatory system, that is what's attacked by COVID. And so it improves nitric oxide. We've had Louis Ignarro, who's the Nobel Prize winner, who discovered the molecule nitric oxide or NO, that's actually now being used as a COVID therapy. We have had him on the podcast talking about how inhaled nitric oxide can actually help, but ozone also helps to boost our nitric oxide and also reduces blood clotting. And we know there's a huge phenomena of increased blood clotting. So, so many different mechanisms that have been established in the science pre COVID about how ozone works seems to help it function. Is that, is that your understanding?

Yeah, absolutely. What you're saying is perfectly right. And it does work that way. I mean, ozone does as it as a practice, maybe I'll get into a little bit of practice, the actual use of oxygen, ozone. Ozone can be used with a local application, it can be used with injection, with the infiltration in different districts of your body, but the one that we use for COVID is the one that is a systemic therapy of ozone. That is intended as something that we draw an amount of blood from the patient, it goes from 100 to 300 mLs of blood and we mix it with the ozone and then we put it back in. So we actually don't add anything but the reaction of the ozone with the blood. So what happens is that we do create a reaction with the cells that are get in touch with the ozone outside of the body. So it is very safe, extremely safe. once they go back in, the induced reactants of the stimulation that ozone creates is what you were saying, what happens in the body. The phenomenon of the creation of nitroxide is that at the nuclear level, the cell is induced in producing nitrous oxide synthetase. which is an enzyme that is going to create from the endothelium of the vessels something that dilates the veins. And this improves incredibly the circulation of the blood. And this is what helps also the patients that we were treating with ozone and saying, they were saying, Doctor, I feel so much better because I can breathe better. And of course, patients are affected by COVID have that experience of suffocations rather than breathing in a non-proper way, obviously, because the saturation of the blood, the oxygen, blood lowers incredibly. With the ozone treatment, they were immediately feeling better. So this is one of the reasons that is encouraging and was giving a lot of help to these patients. And as you were saying, my PhD was focused on in neuroscience, and I investigated how patients were getting advantages in blood flow in the brain due to ozone treatment. and we had results up to 40% of blood flow increased in patients from the third to the sixth hour, to six hours after the use of this treatment. I did myself six times in an MRI in order to understand whether it was getting the best outcome. And it turned out to be from the third to the sixth hour, the best moment in which we were observing, you know, an increase in the flow up to 40%. So this is the same. Now, the brain is what I studied, but to the lungs, it's the same thing that happens to the lungs because it's a general phenomenon that is induced by the ozone. So we have the breathing that is going to become so much more improved. It is transient because ozone then goes away. That's why we, we treated patients for twice a day for seven times seven days in a row. And we had such an improvement. But on the other hand, the immune system, the stimulation of the lymphocytes, as you were saying, is something that goes on and manages the body to react much better than the others. We had in these preliminary results of the study we conducted a much quicker negativity or say they were turning out of, they were not anymore contagious.

Oh, they turned their tests are negative.

So the viral infection, the virus infection was getting out, was getting away so much quicker, so much more effectively compared to the other patients. Because some patients, one of the problems we have is that patients keep on being contagious and so they have to be kept in isolation for such a long period of time. So, if not only that intuition we have that is not statistically significant but is quite interesting is true, only that would be the good reason for using ozone. Because patients have their immune system that go better and they improve, they defeat the virus and they get virus free. So, they get out of the hospital right away and leave room for others. So, that would be already one of the reasons why I would use ozone as a practice for COVID infection.

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What's remarkable is that you're in a traditional hospital in Rome. and you're using ozone therapy in the hospital to treat sick patients. And we've chatted earlier, but you explained to me how some of these patients see dramatic improvements. Their oxygenation improves, their viral load goes down and they convert to negative very quickly. Their inflammatory markers come down and they don't end up going to the ICU and there doesn't seem to be any adverse side effects. Can you talk about some of the patients you've treated and cases? And we'll talk about some of the research, which is more complicated, but I do think it's important to share with people that this is actually being used in hospitals in Europe, not just in Rome, but all over Italy and Spain, even in China. And the clinicians who are doing it like you on the front lines are seeing these patients transform compared to all of the other therapies in ways that the other therapies aren't doing. Is that fair to say?

Well, Mark, of that, I'm quite scientifically driven, so I don't go all the way that far saying that they improved dramatically. I can see that the patients we treat with ozone did really have no side effects, did have a better quality of life during the stay, during the infection, and we had none of the ones that were treated that went in the ICU. So all patients that were critically going downhill and really hitting the base where the only solution was going in the ICU were not, did not eventually go. So that for me is already a result. Now that ozone cures from COVID that is something that I'm not ready to state. And as a man of science, I'm sort of saying, that's not something I can say. And that also goes along with what we published. But the research is interesting. the results are extremely interesting. The lymphocytes are reacting and the population we are studying the population of the lymphocytes, how they reacted and what the sialic acid levels in the blood that we drew to study the different phenomenon and different reaction and different chemical components in the blood is something that is ongoing. And of course, in Italy, one of the problems we have is obviously available, supplies and investment in clinical studies such as ozone. But obviously compared to big companies such as you were mentioning before, we don't have any of that. So it's really given by the goodwill of my chief of the department of anesthesia intensive care, this is Francesco Pugliese. He was He was wise, he was beyond. He understood, he believed in ozone. And he said, okay, guys, go ahead and do it. Let's give it a try. We gave it into the ethical committee, and that was a big, big step because in Italy, none of that had ever been done before. And so this is what we had.

So how many patients have you treated in the hospital there with ozone?

We have treated thousands of patients because we use ozone as a painkiller because I do being an anesthesiologist and being pain medicine. We've seen that many times like drugs were giving so many side effects and with ozone we were having infiltrations that were working. Patients were coming back and being happy without pain. But that's another story, another mechanism. Then we after that, so that's the way we got the ozone into the hospital. After that, we started to say, okay, let's try with patients that were having, especially women that had breast cancer and were going through chemotherapy. We did a protocol there, and it's under, we're publishing it. We're actually evaluating and reading the data with the statistical team. Statistician. And it is interesting there too. We did not cure from cancer because obviously it was treated with the chemotherapy. but the life quality of these patients was incredibly better, was so much better. They had a better lifestyle, they had no less side effects from the chemotherapy, and they had less complications, way much less complications. And this is another professor, a professor from an oncologist that was really wise and said, let's try this. After that, the ICU experiment I told you about with the patient in the ICU, and then we were ready. It was a sort of something that had to mature, to write into something so advanced as using it in with the COVID in such a difficult condition. But with this background, we then managed to place it and have it accepted from the ethical committee of the hospital. so that's, that's it. I mean, the patients we treated, going back to your question with the COVID right now and the ozone are 30 patients.

Just 30 patients in your hospital.

Yeah, 30 patients. And we, we're building up to, to more. And we, the, the studies are actually a multi-centrical study. So there are other centers that are giving their, their, their their will to participate. But again, it is difficult because there's no money behind it. There's no interest.

There's not billions of dollars being spent to fund the research like there is for vaccines or other therapies. That's part of the challenge is that this is not something that is going to make somebody billions of dollars. The machines are relatively inexpensive. Each machine can treat thousands of patients. The equipment you need is very inexpensive. And so the incentives for pushing this are low, unfortunately, which considering the state of our economy and the shutdown, the human, the economic, the social cost of COVID it would seem that somebody or some government or some philanthropist would step up and go, wait, we better study this, because if there is even a 5% chance or 10% chance that this could have an impact, it's unconscionable that we wouldn't look at it. And unfortunately, it's not really being looked at in the United States for this. What really heartens me, though, is to see the numbers number of trials. I mean, there's literally hundreds of patients being enrolled in trials in multiple hospitals throughout Italy and Spain and China. And I think this is hopefully going to be showing one, the safety and two, the efficacy of this, because I've, on case reports over and over, I've seen these patients with COVID respond dramatically well to ozone therapy in terms of the reduction in the symptoms, the improvement in oxygenation, the reduction in the actual biomarkers. And, you know, case studies are, are a, you know, a basic form of, of looking at data. They're not as clearly as good as randomized controlled trials, which, which are actually underway in many places. But, you know, there was a report published out of Europe of 50 cases, which I thought was, was quite good. And again, these weren't randomized control trials, but it essentially looked at, at 50 hospitalized patients with covid-19 using multiple treatments over many days. And they found that what was really impressive was that levels of inflammation came down, oxygenation improved, and a lot of the biomarkers, whether it's D-dimer, LDH, C-reactive protein, interleukin-6, these all a ferritin, these all drop, these are all medical tests that look at inflammation. They all dropped dramatically, and patients were able to be virus free earlier. They were able to be discharged earlier. They didn't end up in the ICU. So So one, there seems like there's something there. And two, it seems like the safety is there. So based on that, what's your sense of how these randomized trials are going to play out?

Well, it is quite difficult to, I mean, as you were saying, that being interest-free, the ozone, if not just for the practice that we bring forward as clinicians, it is for sure that when it's going to come out, true and it's going to be real. I can tell you that on top of what we were saying, I have my practical, my private practice where I do treat patients with ozone and I have a lot of patients that do ozone consistently as a sort of preventive therapy that I practice very much. And I had patients that had COVID and did not even realize they had yeah. So they went through it without even realizing that they had the COVID They didn't found out just with the immunoglobulin from the blood sample. So it is incredibly effective if we're talking about patients that are not so critical. But the critical ones are, I mean, the one that we treated went really, really well. Now, the idea that the cytokine goes.

Down.

The blood clotting is mild and more or less critical, is also due to the fact that these patients are undergoing traditional medicine or traditional medication. So I don't know how much to give it to the ozone or to the other treatments. So this is honestly scientifically what I always look upon. I have a very critical and skeptical vision or whatever. I don't like to take all the advantages or all the goods from medical treatment. So I like to understand and we need numbers. We need numbers, a greater amount of numbers. So you were saying that the case reports and all the studies that have been done are very clinically or scientifically sort of, you can discuss them. But again, the interesting thing is that the benefits are there. So, I mean, we see them. We have them.

Well, it's true. I think what we're seeing is in this country, there's an effort to get the FDA to approve some clinical trials because case reports are great, your initial reports and the safety are encouraging. But we need large-scale clinical trials, randomized clinical trials in major institutions to really look at this therapy among all the other therapies. And I think right now we're having a surge in cases, it's probably a good time. And I also think this is, as you say, this is not just for people in the hospital or people who are very sick, although clearly we want something that's going to prevent ICU admission, prevent deaths, and you're using it in outpatient settings as a preventive or even as a treatment when you didn't know it was treating it. And I've seen many cases here in the United States among colleagues where patients come in with COVID and they do get treated with those and they do get better and they don't end up progressing. Now, again, we need more clinical trials, but it just seems to me that given the scope of this pandemic, the destruction to our economy, the social impact, the incredible mortality and morbidity of this disease, the fact that it actually is not just an acute problem, but that there's this whole phenomena of post-COVID syndrome or long hauler syndrome where people get the virus and then they really don't recover. They get chronic fatigue syndrome, they get chronic shortness of breath and muscle aches and all these secondary symptoms that seem to be ongoing even after they are not infectious. and this is what really concerns me. And so it seems like we need a model of treatment that can incorporate things that aren't actually now in the conversation like ozone. And I think that we are neglecting a very important part of science, and you've been deep in that science. So when we talk about ozone therapy and COVID, you published a recent study I'd like you to talk about that that talked about very few cases. And just to help people understand with science, you need numbers to get to statistical significance. So there may be a trend toward a positive outcome, but unless you have a certain number of patients with a certain change in the outcomes, you can't say this works or doesn't work, right? But you can show, for example, that it's safe or that didn't hurt anybody as the first step. And this is what your trial did, and it's really meant to be not just 30 patients or 28 patients that you but literally hundreds of patients before we can get a real sense. But let me to share, you know, the study that's undergoing, that's underway now at your hospital and what you found in the research and talk a little bit about it.

Yeah, I mean, we did want to publish these preliminary results because the actual study power, the empowerment of the study needs 178 patients per group. So it's a total of about 350 patients somewhere around there in order to have a statistical impact or significance. Now, what encouraged us or pushed us in publishing these 30 cases is because we really wanted to, first of all, give the scientific community something that was concrete, that was quite stable, and was stating that ozone was not harmful. It was actually with no side effects that was helping actually, apparently, and not statistically significantly, the patients that were going in deep impairment or in crisis due to the COVID infection. And what the results were that was that the patients did have none of the patients of the group with ozone went in the ICU. We did go catch them in a moment in which they were bound to go. So they were not good patients. They were not patients that had COVID and were meant to stay in the ward. They were calling us because they wanted them to go in the ICU. So it was just a step before getting in that room where they were getting into intensive care treatments. So they were critical patients. just a step before, none of the one we treated went in the ICU. So that is to be quite interesting, quite significant. We can't state it from a statistical point of view, but it is an important trend. Yeah, it's an important trend. It's an important result as itself. It is not a number that can say this is good because it is too small to be evaluated. And I have to say honestly that also the patients from the control group went quite well, even though one went to the ICU, I mean, sorry, two went to the ICU and one of the two died. So out of 15 on each group, to me, it begins to sound as something that there is a difference. Okay. So a human life is human life. And when we have patients, those are human beings. So for me, it is interesting or quite a difference. But from a statistical point of view, we can't say it. We need these big numbers that you're saying. The other important thing that I focus on and that we have to deal with this data later on is that patients that were treated with ozone did become negative or COVID free, virus free earlier than the others and had less to my opinion, this is my personal opinion, and this is to be done once the study will be completed. To my opinion, they had less consequences with the fatigue, as you were saying, less consequences with the lung injury because the COVID when it develops and it goes with the inflammatory business that takes over, a big section of the lung is damaged. And I wonder how long it takes to get it back and how long if it goes back. to proper functioning. So we might have a big deal with all the patients that were COVID and critically COVID and go back to their lives because it's not just the dead people that turn out to be from the infection, but all the consequences of this viral aggression.

You're thinking that ozone could be a treatment for this post-COVID long hauler syndrome that would help relieve some of these symptoms.

Absolutely, yes, yes, yes, absolutely. It's a triple yes. And what was really interesting is it generates, as you were saying, the mechanism with which it acts the ozone, beyond the fact that it dilates the vessels and it improves the immune system. The other thing that it does, it stimulates in the nucleus with the activation of a Keep1 protein from the NRK1 that unbinds and moves onto the nucleus and it's a messenger that says to the nucleus of the cell, regenerate. It means re-activate the natural enhancement that you have when you have a damage. So ozone does work there in a very effective way. And we have the luck of having, it was my professor actually, the professor Bocci, that is one of the most, it used to be because he passed away a year ago. And he has been doing the most accurate physiological research on ozone. And that is something that is well stated, well proven, that cells do activate and become, you know, more regenerative.

Well, what you're talking about is this whole idea of therapies that are regenerative that help the body activate its own healing responses. And ozone is like that. It's very much what we call a hormetic treatment. In other words, it's a stress to the body. that then creates a secondary benefit. It activates the body's healing response. So when you lift weights, for example, you're tearing muscle fibers, but it comes back stronger. When you do cryotherapy, you go in an ice bath, it's a shock to the body, but it actually creates a healing mechanism in response in the body. Ozone is what we call an oxidative therapy. It creates oxidation, which we all think, maybe that's terrible. We don't want oxidation because we're all taking antioxidants to prevent oxidation. But the oxidation is a normal part of our biology. And when you actually trigger oxidation in the body along with the germicidal effects, it kicks in the body's healing response. So your anti-inflammatory system comes online, your antioxidant system comes online, you increase nitric oxide, you decrease blood clotting, you create all these secondary benefits that happen as a result of the ozone. And what's really striking to me is that it's so safe that, that in this country, the FDA has said it's not safe to use, and it isn't safe if you breathe it in. It's dangerous to the lungs. If you breathe in ozone, it's bad. But if you don't breathe it, you can put it in every other orifice and you can inject it in your blood. You can use it rectally. You can put it in your ears. You can put up your nose and sinuses. As long as you don't breathe, you can drink it. It's very powerful. But if you use it as an inhaled gas, it's very dangerous. So I think we need to sort of help demystify ozone and help people understand that there's a lot of research out there it describes the underlying biological mechanisms. There's textbooks on it. It's used all over the world. In Spain, there's incredible cases. In China, there's cases. And, and in your paper that was published in the Journal of Virology, there are a number of clinical trials that you listed that are published on the clinicaltrials.gov website that are underway looking at randomized control trials for ozone therapy. And my wish is in America that we step up being the country with the number one cases and start to look at this seriously. We need people to fund it. We need scientists to take this seriously. We need an approach that actually can evaluate this in a rigorous way that is done with complete scientific integrity. And I'm very encouraged by the results. And it kind of horrifies me that we're really neglecting looking at this in this country. And I'm excited about what's happening in Europe. You must be aware of other colleagues who are working on this. and other centers that are trying it. What are you hearing out there on the street in terms of what other scientists are finding and doing around COVID? And what are your perceptions about that?

Well, I'd like to hook on to what you said at the beginning. And it is a real pity that in the States, no one gets the act together and brave enough to counteract what the FDA stated in 1997, I think. And it was a big misunderstanding because they were talking about inhaled ozone that is dangerous.

It's dangerous.

I mean, I don't want to be offensive to anybody, but the FDA at the time being stated such a mark because it was really thinking of that. So it had no clue that ozone could have been used the way we use it. And I can assure you, I've done thousands of patients in my private practice. I would be in jail rather than being here talking to you guys. Because it would have been, you know, I would have really harmed so many people. So this is extremely interesting and it's so, to me, such a shame that, you know, the states are behind from this point of view. What's happening on the street is that, unfortunately, again, The fact that is the single doctor, the single physician that does it itself and has the income, say, or the advantage of using the ozone, he keeps it for himself. And there's nothing that structures ozone and builds it in a network in order to have that big statement that lacks and that is coming. But it's coming because in Spain, it is used a lot. in Germany, they use it a lot. And all the clinics, the regenerating clinics or places where you have also complementary medicine practice, it's being used all over. In Switzerland, I went in Switzerland to learn some techniques and they were using ozone in a very, very standard way with this blood systemic treatment. treatment. So, I mean, there are a lot of centers that use it, and it obviously has been spread in countries that have less of a, of a, of a economical power. As a matter of fact, one of the most experienced country in the world is Cuba. Cuba has, yeah, Cuba has one of the best experience in ozone treatment, and they have a national health system that is quite functioning. They have some excellencies that are, that are really worldwide known. And they have a great experience in the use of ozone. It's greater from the rectal insufflation, which is the most inexpensive, but also the most non-scientifically validated.

Yeah.

Yeah.

Well, you know, I just want to share a little bit about my experience with ozone because a number of years ago, as many of my listeners know, I got very sick. I had a root canal that went bad. I had to take an antibiotic called clindamycin, which caused an infection known as C. Difficile or C. Diff, which kills about 30,000 people a year. It didn't kill me, thank God, but it did cause severe gastrointestinal symptoms and led to colitis. I also broke my arm at the time, and had a lot of anti-inflammatories for the pain. I didn't want to take narcotics. I was taking Advil and Aleve and ended up having total GI dysfunction, just gastritis, colitis, that led to me to lose 30 pounds. I was vomiting all the time. I ended up, you know, just driving an autoimmune disease. And I felt like I was in a cytokine storm. I literally felt my entire body as a physician, I understood what was happening. I felt my whole system just break down. And I was struggling to, as a functional medicine doctor, to recover using all my normal tricks. And I knew about ozone because many of my patients had used it and reported that when nothing else worked for their chronic illnesses or chronic fatigue or Lyme disease, viral infections that often ozone would help. And so I did a bunch of research and I found a practitioner and I, I started to do ozone therapy and I had complete brain fog, complete exhaustion, fatigue. My gut was a mess. I was going to the bathroom 20 times a day, bloody diarrhea. And then within two days of ozone therapy, my brain cleared out, my energy came back, my colitis went away. It was pretty shocking. And if I hadn't experienced it myself, I wouldn't believe it. Now, that's just an N of one. It's one case, but I have been using ozone therapy with patients and seeing the results. And often when other things fail, it and it's definitely a hurdle for people to get over mentally because it seems like ozone is dangerous, it's a gas, we hear all these bad things about it, but it's actually extremely well researched. It's extremely safe and it has the potential to help solve the biggest pandemic in 100 years, and yet it's almost invisible in the conversation.

Yeah. Yeah, one thing I like to romantically add on to what you were saying is that I had experiences with my patients that were very similar to what you just testified. And it is incredible because ozone, I like to call it as a ghost because it really interacts with the blood and then vanishes. So the consequences are incredibly active and they do make a big change because it sort of shakes the body in order to react. And so that's why I call it a ghost because actually when you re-infuse the blood, there's not no moro zone.

So it's actually 95 to 99% oxygen and a little bit of ozone. So when you say ozone therapy, it's actually oxygen therapy. And we do that with ECMO. It's one of the treatments that's being used for COVID, which is literally taking the blood out putting it through an artificial lung and putting it back in, which costs bazillions of dollars. And this is a very simple way to actually do a very similar thing. You're hyper-oxygenating the blood, plus you're giving a little bit of ozone gas, and it seems to have incredible benefits.

Yeah. One of my ideas was actually to use in the ECMO also ozone, because there are some special filters that can be the ozone resistance, like you can add on and, and, and by doing it to the whole blood, that, because the ECMO takes to explain to the, who's listening, the ECMO takes the blood, puts it through a sort of a mechanical lung and then puts it back in the body. So the lung is put to rest and, and you have the oxygen in and the carbon dioxide out. And by, by adding ozone there, it could be incredibly effective because you have at low dose ozone. some, really the immune response rather than the anti-inflammatory response, which could be incredible. Yeah.

It'S pretty striking. So I'm anxious to see what these clinical trials show coming out of Europe and Spain and Italy and China. I'm also anxious to try to get something going here in the United States because we're the epicenter and I think we should be turning over every rock and the clinical trial for this would not be that expensive. These drugs we're studying, the vaccines, it's so much money going into these things. And it would just take a little bit of a fraction of, you know, a 0.001% of whatever that money is to really prove this model. I also think that what's unfortunate is that we're not looking at other therapies that are also potentially effective. And when President Trump got COVID, I was surprised to see in the New York Times reporting that in addition to therapies with the monoclonal antibodies and the steroids that he got, they also gave him vitamin D and zinc, which you don't really hear talked about. So in your experience in Italy, are there other adjunctive therapies that are being used to support the immune system nutritionally or through supplements that are making a difference?

Well, supplements to me are an incredible tool. And I think that using supplements is so important, especially in the, in the, in the preliminary preventing approach, which is, which is important. And adding to zinc and vitamin D, I believe very much in quercetin. in lactoferrin, which is two molecules that are very effective in helping to prevent the infection from the COVID And what I also use in my practice, I don't know if it's a general practice in Italy, but I can tell you my experience. I use a lot also medical mushrooms such as Ganoderma and Cordyceps. They're two that are immune active and I see together with these elements we just talked about are very effective and they are so much helpful in, you know, defeating rather than preventing the infection of COVID Together with also probiotics. that actually the one we used actually in the protocol we published and we did for ozone, we also added on the use of Bifidobacterium 450 million of those every day, twice a day, because the bacteria itself sort of killed the virus. It's a direct sort of interaction, negative interaction to the virus. so these are things that I, I believe very much work and, and they can help, especially patients that are not in so critical. But, you know, that's right.

I mean, we, we're really not talking about a sort of widespread Public Health message that incorporates the science of how to boost your immune function through food or through nutraceuticals. And I think it's really a tragedy because in America and Italy is not so bad, but in America, 88 of us are metabolically unhealthy. and if you're overweight or obese, your risk of getting COVID, your risk of ending up in the hospital in the ICU and dying is much, much higher. So we don't focus on how to eat in a way that helps reduce inflammation and boost immunity, which is basically a whole foods, low glycemic diet with lots of phytonutrients. And we don't talk about this whole idea of nutritional immunology, which my friend Dariush Mozaffarian at Tufts was the dean of the Tufts School of Nutrition, Science and Policy. has tried to get a study on, and he's the dean of a major, major academic center looking at the research. And they have a department of nutritional immunology where they are looking at the research on, on way different nutrients activate immune response, zinc, vitamin C, vitamin D, selenium, and even some of these plant compounds you talked about, like the mushrooms or catechins or quercetin that are the green tea. These are all things that are, are low cost, low risk, and potentially effective in modulating immune response. And I certainly, I certainly take them on a regular basis given this COVID situation we're in now. I mean, we know just if you're, if you're low vitamin D, your risk of getting COVID is like 70 or 80% more if you have low, if you have hot, higher vitamin D levels, your risk of getting in the ICU is reduced by 95%. I mean, if there was a, a drug that could reduce your progression, the ICU by 95%, don't you think it.

Would be front page news?

We're not hearing about it. We're not hearing about it.

Yeah, yeah, yeah.

That's why your work is so important because you are a MD, PhD, intensive care doctor working on the front lines of COVID in the hospital using ozone therapy, seeing its impact, seeing one its safety and two, seeing the changes in these patients that happens very quickly when they get the ozone, their oxygenation improves, they feel better. We do need to have larger studies. We do need these randomized trials to continue. We do need to enroll more patients. But I think right now we're in this really critical moment where we thought maybe, oh, who knows, maybe this will get better, maybe the virus will die out, maybe it won't become so virulent, maybe it won't become so contagious, it'll mutate. But what we're seeing now is just terrifying. As we head into the holiday season, the caseloads are just skyrocketing and the hospitalizations are skyrocketing in America. and we are really in this horrible situation hoping for a vaccine that will save us. But even if we get a vaccine, I don't think it's going to solve the whole problem because one, it may not be effective in everybody. Two, everybody may not take it. And three, we just don't have long-term data on it, so we really don't know. And I'm curious to hear your perspective on vaccines and the role they'll play and where where they fit in the whole spectrum of our thinking about this?

This is a big question anyway. Yeah, I was, because by listening at you, I was, I was thinking that one thing that I would really love, and it would be so, so nice for the United States of America to get in this research, because it has method, it has economical background or support and scientific method that I believe is the best in the world. It's the leader in the world under this point of view. So it can give the right sort of organization or project manager to this ozone understanding. Because what we want to know is understand it. Because, you know, either it doesn't work and we kick it out or we do use it. And it's, is it something that is going to work with kobe and not only with COVID because Covid is one of the infections. Who knows how many we're going to.

Face in the future pandemics? Right, right, exactly.

So we have to be ready. Why not have something that we know it works, put it there and use it as a weapon in order to defeat other infections because it is not targeted like, you know, like vaccines. Ozone is a general mechanism that can help in any way, in any infection. So this is An extremely interesting, what if you could, you know, understand that we could find a vaccine that works for any virus that comes over? Yeah, exactly. So this is the same reasoning, the same thinking. Now, about vaccines. Now, this vaccine is different from the ones we're used to because it's not used, I mean, it's not going to immune stimulate the body on a killed virus. It's going to interact with the arm and it's going to mRNA. So it is something that I have no experience. I'm not an immunologist. I'm not into that very deeply. So I think that if it works, of course, very welcome. But I have my thoughts are what is going to happen with interacting with the nucleus activation of the RNA. MRNA.

MRNA. Yeah.

MRNA.

Yeah.

So that is something that is, you know, it's, I mean, out of knowledge, it's a question. So it is quite, so it's a.

Novel kind of vaccine that uses mRNA, which is part of the genetic material of the virus to interact with in a different way than typical vaccines.

Right. So this is, I mean, it's obviously, it sounds very effective, but is is it more than effective? Is it going to block also the reproduction of some of our mechanisms of action within the cell? So I'm a bit, you know, I don't have data to criticize, but I mean, it's obviously something that I would go on to just if really if necessary. And of course, I mean, vaccines are going to be produced, but I mean, before we get hold of, I mean, ordinary people get hold of a vaccination, is not going to be in such a near future. So in the meantime, I believe that the answer is in our food, in our well-being and, and immune activation and things that we, we may have in the everyday life.

Essentially, what you're saying is sort of the, the therapies of diet and nutraceuticals and ozone are all immuno rejuvenating they literally help us to become more immuno resilient and potentially fight it if get it and maybe even not get it at all.

Yeah, exactly. Or as I was mentioning before, patients that were doing my treatments did have it and didn't even realize it. They came to know that they had it because they did the blood test. So that is so incredible. Not for the people that don't even notice it, to people that go in the ICU for the same virus. It is something that has to do with our capacity to withstand and obviously it's also a genetical condition, but I would give it more into a unbalancing. And this is one thing that I'm trying to do. I mentioned to you privately that, you know, I'm trying to start up a company that is trying to do that. I want to give to people a right balance and trying to understand how to be at their best in their everyday life, because that is also facing infection in a better way.

Absolutely. And in terms of ozone therapy, it's been around for a long time and it's been used for a lot of other conditions. It's not a new therapy and you've been using it on thousands of patients. Many of your colleagues in Europe are using it. When you talk to your colleagues who are also doing research and these other clinical trials, what are they seeing? Have you talked to any of them? Do you have a sense of their experiences of how this working for COVID, because I'm sure there's a very few people doing it, but I'm sure there's a conversation going on about it.

Yes, there is. I mean, it's almost like a century, because if you go back to the Second World War, it's going to be like in 20, 30 years, a century, that we use ozone. From my experience, it is more than 20 years. And in the beginning, my colleagues were teasing me. They were saying, oh, this is Paolo Libero who goes on with this, what's this bull? Yeah, yeah. And, but then at the end, they're sending me patients. So they understood and they know from surgeons that neurosurgeons that used to always go with surgery right on when they had, you know, hernias and things like that. And they were having patients who go back suing them because the problem was not solved. And then they send me patients on in order to treat patients with ozone and having no lawsuits or rather than having results without being too aggressive. And this is from the local point of view or the sort of the painkillers. On the other hand, also patients that were being impossible to solve or patients that were not getting results with the traditional medicine. Then they were sending them and now they appreciate me. They tell me that I'm a crazy scientist and then I pull out things that work.

Well, that's what I appreciate about you because you are a rigorous scientist and you're doing the actual hard work or the research. And what I want to underscore is that you invited other scientists to participate in this clinical trial. And it is listed on clinicaltrials.gov we're going to provide in the show notes all the links to the studies you've done, to other research on ozone, to the clinical trials that are underway. And what you're saying is that other scientists from around the world can participate in a multi-center trial using the rigorous methodology you've set up and participate in the clinical trial to gather the data to help determine whether or not this is effective or not. And given that there's, you know, 180,000 patients a day getting COVID in America. It shouldn't be hard to find the patients and that hospitals are starting to be overwhelmed and that they're, I mean, I just heard a horrible story the other day of a woman whose sister had a heart attack and they couldn't find a hospital bed for her and she ended up dying of a heart attack because all the beds were filled with COVID patients. So we're seeing not just the consequences of COVID itself, but all the collateral damage that's happening to people who just can't get access to healthcare as a result. And it's not going to get better, it's going to get worse, particularly as the winter goes on. So I think we're far out of the woods and I think the urgency is there more than ever now to start to think about how do we look at everything that potentially could be helpful? And given your work and given, you know, the decades of research on the safety and efficacy of ozone for infections and for immune conditions and many other issues, we really should be looking at this. And I, this is really why I want to do this podcast with you, because it's not being talked about. I think there's a lot of suppression of information that would seem to be helpful. I'm not sure why. I mean, why aren't we talking about the benefits of lifestyle and diet on immunity? Why aren't we talking about basic nutritional supplementation? Why aren't we talking about innovative therapies like this that might be helpful in other countries? They're doing intravenous vitamin C, intravenous glutathione, intravenous NAD, all these things may be helpful in COVID. And again, there's no big drug company behind it. big funders behind this, the government's not putting money into it. It's kind of disheartening for me on the front lines because, you know, I see these patients, it's just heartbreaking to see they can't get access to the very treatments that I know would help them and that are safe and that are low risk and then have real potential.

Yeah, I mean, whatever I can do is I want to share and again, we published it because we want a scientific community to get hold of what we've got to now. So you're very welcome. I'm here available at any moment.

So if you're a scientist, if you're a philanthropist, if you're a policymaker, you're a doctor listening to this, look at the show notes, look at the data. If you're inspired, let's do this. Let's get a study going. Let's look at the data and be rigorous about how we approach evaluating it, but let's not ignore this because if what you're saying is true, and I think it is given my own experience and your experience and many others around the world, this could be an incredible addition to the armamentarium of treatments for COVID-19 and help put the world back together. Because I tell you what, I miss my friends, I miss hugging people, I miss community gatherings, and I'm sick of this. I don't know about all you people out there, but I'm so sick of this and I don't want to also don't go on to get sick and COVID's a real deal. so, Paolo, any other last words of wisdom you want to share about your experience with COVID and how you see things going and, and what's next for you?

We're gonna, we're gonna go through it. We're gonna, we're gonna get hold of it. And let's, let's do our best, that's all. I mean, let's use all Zone also and on all our knowledge because we're gonna win.

Well, thank you so much, Paolo, for coming from all the way from Italy to doctors pharmacy podcast.

Thank you.

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