Transcript Part 2:
Ms. Hazan:
That was the beginning. When clinical trials didn’t work, I would do a procedure called fecal transplant, taking stools from a healthy donor and putting it into the patient with C.diff. That was eradicating this problem for 99 percent of my patients. It was amazing because you might have a patient that was dying.
One of my first cases was a physician that was dying in the hospital, and we had to transfer him to Beverly Hills to do his case. Miraculously, he lived after a fecal transplant. All we did was take the poop of his wife and put it in there. That was the beginning of the microbiome. What is going on in there? What’s happening?
Mr. Jekielek:
When you were able to transplant the microbiome from a healthy person, suddenly 99 percent of the patients were recovering.
Ms. Hazan:
That’s huge.
Mr. Jekielek:
That’s a very high rate.
Ms. Hazan:
Yes, and this is the thing. These companies come to you and they say, “Why don’t you try this drug, and why don’t you try that drug?” A lot of us that have been doing this for years said, “Why would we try the drug when this procedure is giving us a 92 to 99 percent success rate, and you don’t have to see the patient? Back then, we didn’t have the technology that we have now to see what we were doing in the microbiome.
That’s why I went into the space of the microbiome leading the technology. I thought, “If I’m achieving an improvement in C.diff, I’m going to understand C.diff better, because now I have the technology to look at these microbes. Then, I might achieve improvement not only in C.diff, but also in Alzheimer’s, which was my first case years ago. A patient had Alzheimer’s, and I was putting him on a clinical trial for Alzheimer’s, and he failed.
In the middle of trying to be in the trial, the family called me and said, “He has C.diff.” I said, “Okay, we’re going to use the stools of the wife and give it to him.” Then next thing you know, his Alzheimer’s started improving after fecal transplant. Because I had tried to do the clinical trial on him, I knew his mini-mental status. I repeated the mini-mental status at three months and six months, and it went from 21 to 29.
That was the case that basically started all this for me. I went to Dr. Finegold who wrote the book on anaerobic infections. I said, “What am I seeing when I’m improving Alzheimer’s?” He said, “You’re seeing these microbes at play, and when you get your machine to sequence the microbiome, you’re going to understand what I’ve been culturing for years.”
The Woolsey Fire happened. He passed away. I inherited all his books, his patents, and everything. I said, “I guess I’m dealing with the microbiome.” His big passion was autism, and sure enough, within the week, I got my first patient with autism all of a sudden. It just was one thing after another.
When Covid hit here, I had already opened a genetic sequencing lab. I opened it mainly out of curiosity, because what I was seeing out there with genetic sequencing was just flawed with the testing of stools. You saw the company uBiome, that basically was selling stool kits to everyone, but there was no validity. There was no clinical data. These patients were getting these reports on these microbes, but they didn’t know what these microbes were doing.
To me, it was like, “Where are we in this field when the doctor is not included in this, and we’re the ones fixing these problems?” That’s when I really started opening the lab. Then when Covid hit, I felt, “I’ve got a genetic sequencing lab. I’ve got a clinical research company that basically submits protocols to the FDA. We have a portal. We know how to write these protocols. We know how to run them. Let’s get involved.”
Mr. Jekielek:
You’re basically an expert at running clinical trials, correct?
Ms. Hazan:
Yes.
Mr. Jekielek:
You’ve got this sequencing, and you have this new paradigm that you’ve been seeing profound improvement even in some diseases that you didn’t expect. That’s absolutely fascinating.
Ms. Hazan:
Yes, it was fascinating because when I found Covid in the stools, and when I saw that hydroxychloroquine/Z-Pak had an impact on Covid in the stools and started the creation of my protocols and writing my protocols, I felt, “Wow.” This was divine intervention almost, because I said, “I have a genetic sequencing lab. I have a CRO that’s running these clinical trials.” When the protocols of hydroxy became political, I was shocked, because I said, “I can’t believe I’m involved in this.”
Mr. Jekielek:
Before we continue, Z-Pak, that’s azithromycin, correct?
Ms. Hazan:
Yes.
Mr. Jekielek:
Okay. I didn’t quite catch how you figured out that this combination of hydroxy and azithromycin was actually impacting positively on Covid patients.
Ms. Hazan:
At the beginning of the pandemic, I was reading everything. We were all reading. We were translating journals in Italian. We were translating papers. I speak French, so I read Didier Raoult’s paper. First of all, the first thing that impressed me was these men, because I was scared.
We are in March 2020. We don’t know what we’re dealing with. I don’t have a mask in my clinic. I’m about to see patients with Covid. I’m about to bring Covid to my family, my parents, and my kids.
There was a fear at the beginning. I was dressed like a space astronaut with my patients. There was that fear at the beginning. But then I saw Dr. Didier Raoult with his patients without a mask talking nonchalantly about Covid. People were lining up at his office to get treated, and he’s older than I am. I said, “If this guy’s okay, I’m going to be fine.”
I started looking at his protocol, and I started looking at it as a microbiome expert. I said, “Let’s look at why hydroxy.” Hydroxy has the capability of transforming the pH of the cells. When the virus goes into the cell, it’s basically exposed to an alkaline environment. I said, “Look at this, the virus is entering the cell. It probably gets killed by the alkaline environment of the cell.”
At the same time, I felt azithromycin probably killed the wall of the virus, and then zinc was blocking the virus from penetrating. That was my mindset on the hypothesis of why this combination was working for Dr. Raoult. What I added to this, and that was by looking at papers from Italy and Japan, was vitamin C and vitamin D. There was data. At the beginning of the pandemic, there were patients that were getting discharged from the hospital after IV infusions of vitamin C.
I said, “Okay, we’re out of the pandemic. It’s vitamin C.” I knew what vitamin C did to the microbiome. I knew what vitamin D did to the microbiome, because it increases your bifidobacteria, your good microbes, the microbes we found were lost after severe Covid. That was the formula that I started creating.
I said, “You know what?” I talked to Dr. Borody because he was always into combination therapy. He created the patent for H. pylori treatment. He was always the creator, the innovator for years, he’s 70-plus years old. He’s done 40 years of creating patents.
He and I started talking about it. He goes, “That’s brilliant. That’s a great combination. Patent it right away.” We thought, “Here we are. We figured this out right at the beginning of the pandemic. Let’s create a pharmaceutical company. Let’s do this.”
We created a company called Topelia Therapeutics. Topelia is the genus of the dove, the white dove for peace. We felt, “If anything, this virus is going to bring everyone together and unite the world, not divide the world.” Surely people want to get better. We created it and we started submitting it to the FDA. Actually, within 24 hours, the FDA called me at three o’clock in the morning and said, “Dr. Hazan, you can run your trial.”
Actually, the first letter we got was to proceed and that we didn’t even need a trial. Then, within 48 hours, they said, “I’m sorry, Dr. Hazan, you have to do a full-on clinical trial.” We had submitted it as a Phase I. We said, “It’s not really a Phase I because these are safe drugs. Can we move it to a Phase II?” You remember in clinical trials, it’s like Phase I, II, III, and then to market.
We convinced the FDA, and sure enough, that was the phone call at three o’clock in the morning that said, “Yes, you can proceed and do it.” We literally wrote the protocol mid-March, March 10 and 11. At the same time, I was treating people off-label. My first patient was a COPD [Chronic Obstructive Pulmonary Disease], cardiac bypass two weeks prior, CHF [Congestive Heart Failure], diabetic, overweight, totally your nightmare patient. He was at home, and the family didn’t want to bring him to the hospital. By nightmare, I mean multiple problems.
Mr. Jekielek:
Most at risk from COVID.
Ms. Hazan:
Most at risk, in his 70s, and he happened to be the father of a girlfriend of mine. I was even scared of telling him to take the hydroxy because I hadn’t studied everything. I said, “Just lick the tablet and take the Z-Pak.” Then, I gave him a couple vitamins. The next thing you know, he improved. I said to myself, “If this guy is improving, I’m going to be fine. I’m younger, and I’ll be fine.”
I lost the fear at that moment. Then, I started treating more and more kids and people, and 100 patients later, nobody dies. A thousand patients later, nobody is dying. Even the worst of the worst, with oxygen in the 70s, weren’t dying. I treated them at home with an oximeter like this little thing.
Mr. Jekielek:
Let me just stop you for a moment. You were treating people in an outpatient setting with these very low oxygen levels?
Ms. Hazan:
Correct, because they didn’t want to go to the hospital.
Mr. Jekielek:
Fascinating. Then, this combination that you devised was actually helping them.
Ms. Hazan:
It ended up becoming not the combination of a hydroxy, Z-Pak, vitamin C, D, and zinc. Actually, for the severe, it was a little bit more. We had to add the ivermectin, and ivermectin became important for those with low oxygen. At the beginning of the pandemic, we got away with hydroxy, Z-Pak, vitamin C, vitamin D. Then, as the virus became stronger during the whole Delta period, we needed to up the game a bit. We knew we needed to destroy the virus.
At that point, we had figured out vitamin C and vitamin D increases your bifidobacteria. We had also figured out that severe cases of Covid had zero bifidobacteria, and high risk exposure had a lot of bifidobacteria. We realized bifidobacteria was a key point, so we started focusing on nutrition with patients, fermented food, and ivermectin.
Why ivermectin? Because ivermectin, when you look at what it is, it’s a fermented product of a bacteria called Streptomyces. If you look at Streptomyces, it’s in the same phylum as bifidobacteria. Because I was doing fecal transplant and I knew that it’s replenishing the gut with good microbes, I felt, “Maybe the fermentation of Streptomyces is feeding the bifidobacteria to increase it at the time of the cytokine storm.”
Mr. Jekielek:
Which is something that happens when you’re going through the COVID disease.
Ms. Hazan:
Yes. Just to backtrack a little bit, I was doing these trials, and the FDA had approved me. The FDA basically said, “Look, you can go ahead.” Now, we hire an IRB [Institutional Review Board], and the IRB was New England IRB.
Transcript Part 2: Ms. Hazan: That was the beginning. When clinical trials didn’t work, I would do a procedure called fecal transplant, taking stools from a healthy donor and putting it into the patient with C.diff. That was eradicating this problem for 99 percent of my patients. It was amazing because you might have a patient that was dying.
One of my first cases was a physician that was dying in the hospital, and we had to transfer him to Beverly Hills to do his case. Miraculously, he lived after a fecal transplant. All we did was take the poop of his wife and put it in there. That was the beginning of the microbiome. What is going on in there? What’s happening?
Mr. Jekielek: When you were able to transplant the microbiome from a healthy person, suddenly 99 percent of the patients were recovering.
Ms. Hazan: That’s huge.
Mr. Jekielek: That’s a very high rate.
Ms. Hazan: Yes, and this is the thing. These companies come to you and they say, “Why don’t you try this drug, and why don’t you try that drug?” A lot of us that have been doing this for years said, “Why would we try the drug when this procedure is giving us a 92 to 99 percent success rate, and you don’t have to see the patient? Back then, we didn’t have the technology that we have now to see what we were doing in the microbiome.
That’s why I went into the space of the microbiome leading the technology. I thought, “If I’m achieving an improvement in C.diff, I’m going to understand C.diff better, because now I have the technology to look at these microbes. Then, I might achieve improvement not only in C.diff, but also in Alzheimer’s, which was my first case years ago. A patient had Alzheimer’s, and I was putting him on a clinical trial for Alzheimer’s, and he failed.
In the middle of trying to be in the trial, the family called me and said, “He has C.diff.” I said, “Okay, we’re going to use the stools of the wife and give it to him.” Then next thing you know, his Alzheimer’s started improving after fecal transplant. Because I had tried to do the clinical trial on him, I knew his mini-mental status. I repeated the mini-mental status at three months and six months, and it went from 21 to 29.
That was the case that basically started all this for me. I went to Dr. Finegold who wrote the book on anaerobic infections. I said, “What am I seeing when I’m improving Alzheimer’s?” He said, “You’re seeing these microbes at play, and when you get your machine to sequence the microbiome, you’re going to understand what I’ve been culturing for years.”
The Woolsey Fire happened. He passed away. I inherited all his books, his patents, and everything. I said, “I guess I’m dealing with the microbiome.” His big passion was autism, and sure enough, within the week, I got my first patient with autism all of a sudden. It just was one thing after another.
When Covid hit here, I had already opened a genetic sequencing lab. I opened it mainly out of curiosity, because what I was seeing out there with genetic sequencing was just flawed with the testing of stools. You saw the company uBiome, that basically was selling stool kits to everyone, but there was no validity. There was no clinical data. These patients were getting these reports on these microbes, but they didn’t know what these microbes were doing.
To me, it was like, “Where are we in this field when the doctor is not included in this, and we’re the ones fixing these problems?” That’s when I really started opening the lab. Then when Covid hit, I felt, “I’ve got a genetic sequencing lab. I’ve got a clinical research company that basically submits protocols to the FDA. We have a portal. We know how to write these protocols. We know how to run them. Let’s get involved.”
Mr. Jekielek: You’re basically an expert at running clinical trials, correct?
Ms. Hazan: Yes.
Mr. Jekielek: You’ve got this sequencing, and you have this new paradigm that you’ve been seeing profound improvement even in some diseases that you didn’t expect. That’s absolutely fascinating.
Ms. Hazan: Yes, it was fascinating because when I found Covid in the stools, and when I saw that hydroxychloroquine/Z-Pak had an impact on Covid in the stools and started the creation of my protocols and writing my protocols, I felt, “Wow.” This was divine intervention almost, because I said, “I have a genetic sequencing lab. I have a CRO that’s running these clinical trials.” When the protocols of hydroxy became political, I was shocked, because I said, “I can’t believe I’m involved in this.”
Mr. Jekielek: Before we continue, Z-Pak, that’s azithromycin, correct?
Ms. Hazan: Yes.
Mr. Jekielek: Okay. I didn’t quite catch how you figured out that this combination of hydroxy and azithromycin was actually impacting positively on Covid patients.
Ms. Hazan: At the beginning of the pandemic, I was reading everything. We were all reading. We were translating journals in Italian. We were translating papers. I speak French, so I read Didier Raoult’s paper. First of all, the first thing that impressed me was these men, because I was scared.
We are in March 2020. We don’t know what we’re dealing with. I don’t have a mask in my clinic. I’m about to see patients with Covid. I’m about to bring Covid to my family, my parents, and my kids.
There was a fear at the beginning. I was dressed like a space astronaut with my patients. There was that fear at the beginning. But then I saw Dr. Didier Raoult with his patients without a mask talking nonchalantly about Covid. People were lining up at his office to get treated, and he’s older than I am. I said, “If this guy’s okay, I’m going to be fine.”
I started looking at his protocol, and I started looking at it as a microbiome expert. I said, “Let’s look at why hydroxy.” Hydroxy has the capability of transforming the pH of the cells. When the virus goes into the cell, it’s basically exposed to an alkaline environment. I said, “Look at this, the virus is entering the cell. It probably gets killed by the alkaline environment of the cell.”
At the same time, I felt azithromycin probably killed the wall of the virus, and then zinc was blocking the virus from penetrating. That was my mindset on the hypothesis of why this combination was working for Dr. Raoult. What I added to this, and that was by looking at papers from Italy and Japan, was vitamin C and vitamin D. There was data. At the beginning of the pandemic, there were patients that were getting discharged from the hospital after IV infusions of vitamin C.
I said, “Okay, we’re out of the pandemic. It’s vitamin C.” I knew what vitamin C did to the microbiome. I knew what vitamin D did to the microbiome, because it increases your bifidobacteria, your good microbes, the microbes we found were lost after severe Covid. That was the formula that I started creating.
I said, “You know what?” I talked to Dr. Borody because he was always into combination therapy. He created the patent for H. pylori treatment. He was always the creator, the innovator for years, he’s 70-plus years old. He’s done 40 years of creating patents.
He and I started talking about it. He goes, “That’s brilliant. That’s a great combination. Patent it right away.” We thought, “Here we are. We figured this out right at the beginning of the pandemic. Let’s create a pharmaceutical company. Let’s do this.”
We created a company called Topelia Therapeutics. Topelia is the genus of the dove, the white dove for peace. We felt, “If anything, this virus is going to bring everyone together and unite the world, not divide the world.” Surely people want to get better. We created it and we started submitting it to the FDA. Actually, within 24 hours, the FDA called me at three o’clock in the morning and said, “Dr. Hazan, you can run your trial.”
Actually, the first letter we got was to proceed and that we didn’t even need a trial. Then, within 48 hours, they said, “I’m sorry, Dr. Hazan, you have to do a full-on clinical trial.” We had submitted it as a Phase I. We said, “It’s not really a Phase I because these are safe drugs. Can we move it to a Phase II?” You remember in clinical trials, it’s like Phase I, II, III, and then to market.
We convinced the FDA, and sure enough, that was the phone call at three o’clock in the morning that said, “Yes, you can proceed and do it.” We literally wrote the protocol mid-March, March 10 and 11. At the same time, I was treating people off-label. My first patient was a COPD [Chronic Obstructive Pulmonary Disease], cardiac bypass two weeks prior, CHF [Congestive Heart Failure], diabetic, overweight, totally your nightmare patient. He was at home, and the family didn’t want to bring him to the hospital. By nightmare, I mean multiple problems.
Mr. Jekielek: Most at risk from COVID.
Ms. Hazan: Most at risk, in his 70s, and he happened to be the father of a girlfriend of mine. I was even scared of telling him to take the hydroxy because I hadn’t studied everything. I said, “Just lick the tablet and take the Z-Pak.” Then, I gave him a couple vitamins. The next thing you know, he improved. I said to myself, “If this guy is improving, I’m going to be fine. I’m younger, and I’ll be fine.”
I lost the fear at that moment. Then, I started treating more and more kids and people, and 100 patients later, nobody dies. A thousand patients later, nobody is dying. Even the worst of the worst, with oxygen in the 70s, weren’t dying. I treated them at home with an oximeter like this little thing.
Mr. Jekielek: Let me just stop you for a moment. You were treating people in an outpatient setting with these very low oxygen levels?
Ms. Hazan: Correct, because they didn’t want to go to the hospital.
Mr. Jekielek: Fascinating. Then, this combination that you devised was actually helping them.
Ms. Hazan: It ended up becoming not the combination of a hydroxy, Z-Pak, vitamin C, D, and zinc. Actually, for the severe, it was a little bit more. We had to add the ivermectin, and ivermectin became important for those with low oxygen. At the beginning of the pandemic, we got away with hydroxy, Z-Pak, vitamin C, vitamin D. Then, as the virus became stronger during the whole Delta period, we needed to up the game a bit. We knew we needed to destroy the virus.
At that point, we had figured out vitamin C and vitamin D increases your bifidobacteria. We had also figured out that severe cases of Covid had zero bifidobacteria, and high risk exposure had a lot of bifidobacteria. We realized bifidobacteria was a key point, so we started focusing on nutrition with patients, fermented food, and ivermectin.
Why ivermectin? Because ivermectin, when you look at what it is, it’s a fermented product of a bacteria called Streptomyces. If you look at Streptomyces, it’s in the same phylum as bifidobacteria. Because I was doing fecal transplant and I knew that it’s replenishing the gut with good microbes, I felt, “Maybe the fermentation of Streptomyces is feeding the bifidobacteria to increase it at the time of the cytokine storm.”
Mr. Jekielek: Which is something that happens when you’re going through the COVID disease.
Ms. Hazan: Yes. Just to backtrack a little bit, I was doing these trials, and the FDA had approved me. The FDA basically said, “Look, you can go ahead.” Now, we hire an IRB [Institutional Review Board], and the IRB was New England IRB.