Ms. Hazan:
It’s a regulatory board. It’s an independent board that basically looks over the protocol with a fine comb and looks at everything. They say, “We don’t approve of this and you need to change that.” We have to make a case for what we do. We wrote this protocol. We had to research everything.
I’m going to show you this, because I think people don’t realize. We have two binders of this that were created in 10 days with no sleep, we wrote it. We had to study. There were two pages of drugs that were basically contraindicated for hydroxy and Z-Pak. We had to make sure everything in the protocol was perfectly fine. We had to make sure the patient signed a consent form. We had to develop a consent form by PandaDoc, essentially, because we were consenting people from different places of the country.
Here we are, we run it through the IRB, and it takes about 20 days to come out. They said, “Okay, you’re ready to run.” On April 20th, we got approved. Then all of a sudden on Twitter, a post goes off. “Dr. Hazan is doing unethical protocols with hydroxychloroquine, azithromycin, vitamin C and D, five drugs in an open label.”
I said, “Five drugs? First of all, it’s two drugs, two vitamins and a mineral. There were 100 protocols out there. “Why Dr. Hazan and ProgenaBiome? We’re a little small company trying to spearhead microbiome research.” I was shocked by this tweet, and it got retweeted 77 times with all sorts of comments about it.
The next thing you know there’s a Stat News report that goes off to all the agents of the FDA, which never made it to the media that basically said, “A tweet has been going around with Dr. Hazan doing five drugs in an open-label trial. We need to be doing placebo-controlled trials.”
I said to myself, “Placebo control in the middle of a pandemic?” I ignored it, right? On Monday, I got a letter from the FDA, “Dr. Hazan, stop your trials. You need to do a placebo-controlled trial.” I said, “In the middle of a pandemic? Can we just stop the fire first? Then, go back and see what’s happening, but first stop the virus from going its course.”
Basically, I went on to fight back and argue about this. I said to the FDA, “Look, I’ll do a placebo-controlled trial, but I’m giving vitamins on one arm, and the hydroxy/Z-Pak with the vitamins on the other.” My placebo was essentially not a placebo, it was vitamins, which got a lot of criticism.
I remember Harvey Risch at the beginning, because all these doctors were all doing their thing. Harvey said to me, “That’s a terrible design to be giving vitamins. You’re not going to have any data, because vitamin is doing its thing for the virus.” I said, “I don’t have a choice. I’m not going to let people die and I have to give them something. I can’t just enroll with a placebo that is a sugar pill.”
We went back to the IRB and said, “We’re ready to roll now. The FDA has approved us to do vitamins as the placebo.” The IRB takes a couple of weeks—meanwhile people are dying—and says, “We’re sorry. We can’t do your trial because we’re going to do the vaccine studies.” That’s when the vaccine trials started rolling.
That was interesting. I had to scramble and find another IRB to go through with this. At the same time, we were taking care of patients off-label. When the clinical trials started, that’s when it became political. Hydroxychloroquine became known. Everybody knew about it.
We started getting threatening phone calls, “How dare you give a dangerous drug to kill patients?” I said, “People are dying and you’re calling me to say that I’m killing patients. I’ve never lost one patient.”
Anyway, we tried to do that clinical trial. We enrolled about 120 patients. That was on my money and Dr. Borody’s money. We thought at the beginning, “We’re going to be a pharmaceutical company. We’re going to raise funds.” Nobody was interested in these protocols. We couldn’t raise any funds. We basically put in our money. Every patient was costing us about $3,500 to $5,000.
We were giving them a box that we were FedExing with a halter monitor. The drugs were basically like this, so you wouldn’t know if it’s a placebo. This was the Z-Pak and the hydroxy. You didn’t know if it was the placebo.
Then, we gave them these vitamins that we created because they all had to have the same vitamins. You couldn’t buy vitamins at CVS. You didn’t know the quality. We tested these vitamins, by the way, just to make sure it was pure vitamin C, pure vitamin D, and pure zinc, and that there was no arsenic in there that could kill the microbiome. Basically, that’s how we started.
The first protocol was that treatment. The other one was the prophylaxis, hydroxychloroquine. That was two pills with just vitamins the rest of the time. That protocol was interesting because it started recruiting all the doctors.
All the doctors that didn’t want to be vaccinated joined my trial. We called it the Schindler’s List protocol because they were like, “I don’t want to be vaccinated. Can I just join your trial and this way you can just follow me?” I said, “Sure, join my trial.”
They joined the trial, and the key for that protocol was basically if you were exposed to patients and you weren’t wearing a mask, you were at high risk and the protocol was just two pills of hydroxy every three months, plus the vitamins every day, four vitamins every day, compared to vitamins alone.
From there, we recruited a lot of patients in that study. Then, with the discovery that ivermectin had a role, because at the same time it was like playing with ivermectin, doxycycline and zinc in some patients.
I realized, “Ivermectin and doxycycline are pretty safe.” Ivermectin is given to babies with scabies, and doxycycline is given to kids for acne. The two combinations should be fine with zinc, vitamin C and D. Basically, when we started that protocol, we called it Ziverdox. We started in July. We got approved by the FDA in August. There were about 30 patients, so it was easy to run. At the same time, I was treating people. Now, because I was blinded, I had to watch these people carefully.
Mr. Jekielek:
Because you didn’t know which was just the vitamins and which was the full treatment.
Ms. Hazan:
Correct. I was in the dark. I’ll always remember the first trial, the hydroxychloroquine and Z-Pak. I enrolled 29 patients at the beginning. I’m blinded, and I don’t know. All of a sudden this patient in Malibu calls me, and he’s crashing. His oxygen is like in the 80s. I don’t know if he’s gotten hydroxy. I don’t want to overdose him on the hydroxy. I can’t give him ivermectin. I don’t have it at my disposal.
I had some hydroxy in my house. It was seven o’clock in the morning, and they didn’t want to go to the hospital. Basically, I had to unblind myself for the first 29 patients and flaw the whole protocol. In other words, I had to start all over again. I wasted about 29 patients on this protocol, because I didn’t want to overdose him.
I called and found out what he took, and it was the placebo that he got. I gave him the real hydroxy. I gave him the Z-Pak, and he started improving, and then he survived. All these patients I had to watch very carefully because I didn’t know if they got the real stuff or the placebo or the sugar pills. A lot of them crashed because they were getting placebo.
Mr. Jekielek:
Again, your placebo was vitamins, not sugar pills?
Ms. Hazan:
Yes, but in the ivermectin, doxycycline and zinc, even the vitamins were placebo.
Mr. Jekielek:
Oh, I see.
Ms. Hazan:
It was a complete placebo trial. Those patients, because it was like we had to enroll 30 patients, that was a more manageable trial. Those patients, I didn’t know what they had, but essentially when they crashed, I started giving them different things. That’s when I started combining hydroxy, Z-Pak, ivermectin, vitamin C, and vitamin D and then realized, “Wait, their oxygen is going up.”
Now, when the oxygen started going up, that’s when the hypothesis started in my mind that perhaps Streptomyces is working by increasing the bifidobacteria at the time of the cytokines storm. My hypothesis, anyways, was that the bifidobacteria would just take the cytokines and flush it out of your system, letting the lungs start circulating those cytokines back into the colon.
In other words, flushing out the cytokines from the lungs to the colon, and then flushing them out into the septic or into the toilet and letting the lungs start breathing again, because you’ve now released those cytokines and you’ve increased the bifidobacteria. That was my hypothesis, essentially.
Mr. Jekielek:
What happened in the end with these clinical trials?
Ms. Hazan:
The hydroxychloroquine/Z-Pak, we just put on hold and we said, “We’re just going to watch what’s happening,” because we never finished them. We’re still monitoring all these patients because we’re going to write the data. This whole research of mine is a story being told.
It’s like finding the loss of bifidobacteria in severe COVID, finding vitamin C increases the bifidobacteria, finding ivermectin increases the bifidobacteria, and finding vitamin D increases the bifidobacteria. It’s a whole story that gets told. Then after that, look at the data to see what hydroxychloroquine does. And then, you go into the clinical trials of the placebo control and say, “This is what we suspected.” It’s like a story being told.
Mr. Jekielek:
It’s a story that hasn’t ended yet?
Ms. Hazan:
It has not ended…
Mr. Jekielek:
That’s very interesting.
Ms. Hazan:
… because we haven’t published it.
Mr. Jekielek:
What about these other trials that you did with the ivermectin and doxycycline?
Ms. Hazan:
The ivermectin/doxycycline trial finished. We had the FDA in our office. We have a whole binder of things they photocopied. Essentially, the ivermectin/doxycycline finished. They came and they audited us. They found that we had a form that we didn’t submit to the IRB on time. Therefore, we got a 483, which is not a fine, but a reprimand.
Mr. Jekielek:
A black mark.
Ms. Hazan:
It’s a black mark. It’s so funny because I’ve been doing clinical trials for almost three decades and I’ve never had a 483. I’ve had the FDA in my office at least three times, even the European FDA in my office, and we never had a 483. It’s always, “Dr. Hazan, you’re adhering to the ICH GCP guidelines.”
Basically, I got a 483 on a form that I forgot to submit, because I’m treating patients that are sick. Sometimes we were treating 52 patients a day, and my staff was just going crazy. You’re exposed, you’re stressed, and you’re running around. The paperwork falls behind sometimes. With the IRB, I didn’t realize the year had passed. The last three years have just gone fast, I don’t even know where my life was. It was like before COVID, and after COVID, is what was caused by COVID.
Mr. Jekielek:
What’s the bottom line with that trial that finished?
Transcript Part 3: Mr. Jekielek: What is an IRB?
Ms. Hazan: It’s a regulatory board. It’s an independent board that basically looks over the protocol with a fine comb and looks at everything. They say, “We don’t approve of this and you need to change that.” We have to make a case for what we do. We wrote this protocol. We had to research everything.
I’m going to show you this, because I think people don’t realize. We have two binders of this that were created in 10 days with no sleep, we wrote it. We had to study. There were two pages of drugs that were basically contraindicated for hydroxy and Z-Pak. We had to make sure everything in the protocol was perfectly fine. We had to make sure the patient signed a consent form. We had to develop a consent form by PandaDoc, essentially, because we were consenting people from different places of the country.
Here we are, we run it through the IRB, and it takes about 20 days to come out. They said, “Okay, you’re ready to run.” On April 20th, we got approved. Then all of a sudden on Twitter, a post goes off. “Dr. Hazan is doing unethical protocols with hydroxychloroquine, azithromycin, vitamin C and D, five drugs in an open label.”
I said, “Five drugs? First of all, it’s two drugs, two vitamins and a mineral. There were 100 protocols out there. “Why Dr. Hazan and ProgenaBiome? We’re a little small company trying to spearhead microbiome research.” I was shocked by this tweet, and it got retweeted 77 times with all sorts of comments about it.
The next thing you know there’s a Stat News report that goes off to all the agents of the FDA, which never made it to the media that basically said, “A tweet has been going around with Dr. Hazan doing five drugs in an open-label trial. We need to be doing placebo-controlled trials.”
I said to myself, “Placebo control in the middle of a pandemic?” I ignored it, right? On Monday, I got a letter from the FDA, “Dr. Hazan, stop your trials. You need to do a placebo-controlled trial.” I said, “In the middle of a pandemic? Can we just stop the fire first? Then, go back and see what’s happening, but first stop the virus from going its course.”
Basically, I went on to fight back and argue about this. I said to the FDA, “Look, I’ll do a placebo-controlled trial, but I’m giving vitamins on one arm, and the hydroxy/Z-Pak with the vitamins on the other.” My placebo was essentially not a placebo, it was vitamins, which got a lot of criticism.
I remember Harvey Risch at the beginning, because all these doctors were all doing their thing. Harvey said to me, “That’s a terrible design to be giving vitamins. You’re not going to have any data, because vitamin is doing its thing for the virus.” I said, “I don’t have a choice. I’m not going to let people die and I have to give them something. I can’t just enroll with a placebo that is a sugar pill.”
We went back to the IRB and said, “We’re ready to roll now. The FDA has approved us to do vitamins as the placebo.” The IRB takes a couple of weeks—meanwhile people are dying—and says, “We’re sorry. We can’t do your trial because we’re going to do the vaccine studies.” That’s when the vaccine trials started rolling. That was interesting. I had to scramble and find another IRB to go through with this. At the same time, we were taking care of patients off-label. When the clinical trials started, that’s when it became political. Hydroxychloroquine became known. Everybody knew about it.
We started getting threatening phone calls, “How dare you give a dangerous drug to kill patients?” I said, “People are dying and you’re calling me to say that I’m killing patients. I’ve never lost one patient.”
Anyway, we tried to do that clinical trial. We enrolled about 120 patients. That was on my money and Dr. Borody’s money. We thought at the beginning, “We’re going to be a pharmaceutical company. We’re going to raise funds.” Nobody was interested in these protocols. We couldn’t raise any funds. We basically put in our money. Every patient was costing us about $3,500 to $5,000.
We were giving them a box that we were FedExing with a halter monitor. The drugs were basically like this, so you wouldn’t know if it’s a placebo. This was the Z-Pak and the hydroxy. You didn’t know if it was the placebo.
Then, we gave them these vitamins that we created because they all had to have the same vitamins. You couldn’t buy vitamins at CVS. You didn’t know the quality. We tested these vitamins, by the way, just to make sure it was pure vitamin C, pure vitamin D, and pure zinc, and that there was no arsenic in there that could kill the microbiome. Basically, that’s how we started.
The first protocol was that treatment. The other one was the prophylaxis, hydroxychloroquine. That was two pills with just vitamins the rest of the time. That protocol was interesting because it started recruiting all the doctors.
All the doctors that didn’t want to be vaccinated joined my trial. We called it the Schindler’s List protocol because they were like, “I don’t want to be vaccinated. Can I just join your trial and this way you can just follow me?” I said, “Sure, join my trial.”
They joined the trial, and the key for that protocol was basically if you were exposed to patients and you weren’t wearing a mask, you were at high risk and the protocol was just two pills of hydroxy every three months, plus the vitamins every day, four vitamins every day, compared to vitamins alone.
From there, we recruited a lot of patients in that study. Then, with the discovery that ivermectin had a role, because at the same time it was like playing with ivermectin, doxycycline and zinc in some patients.
I realized, “Ivermectin and doxycycline are pretty safe.” Ivermectin is given to babies with scabies, and doxycycline is given to kids for acne. The two combinations should be fine with zinc, vitamin C and D. Basically, when we started that protocol, we called it Ziverdox. We started in July. We got approved by the FDA in August. There were about 30 patients, so it was easy to run. At the same time, I was treating people. Now, because I was blinded, I had to watch these people carefully.
Mr. Jekielek: Because you didn’t know which was just the vitamins and which was the full treatment.
Ms. Hazan: Correct. I was in the dark. I’ll always remember the first trial, the hydroxychloroquine and Z-Pak. I enrolled 29 patients at the beginning. I’m blinded, and I don’t know. All of a sudden this patient in Malibu calls me, and he’s crashing. His oxygen is like in the 80s. I don’t know if he’s gotten hydroxy. I don’t want to overdose him on the hydroxy. I can’t give him ivermectin. I don’t have it at my disposal.
I had some hydroxy in my house. It was seven o’clock in the morning, and they didn’t want to go to the hospital. Basically, I had to unblind myself for the first 29 patients and flaw the whole protocol. In other words, I had to start all over again. I wasted about 29 patients on this protocol, because I didn’t want to overdose him.
I called and found out what he took, and it was the placebo that he got. I gave him the real hydroxy. I gave him the Z-Pak, and he started improving, and then he survived. All these patients I had to watch very carefully because I didn’t know if they got the real stuff or the placebo or the sugar pills. A lot of them crashed because they were getting placebo.
Mr. Jekielek: Again, your placebo was vitamins, not sugar pills?
Ms. Hazan: Yes, but in the ivermectin, doxycycline and zinc, even the vitamins were placebo.
Mr. Jekielek: Oh, I see.
Ms. Hazan: It was a complete placebo trial. Those patients, because it was like we had to enroll 30 patients, that was a more manageable trial. Those patients, I didn’t know what they had, but essentially when they crashed, I started giving them different things. That’s when I started combining hydroxy, Z-Pak, ivermectin, vitamin C, and vitamin D and then realized, “Wait, their oxygen is going up.”
Now, when the oxygen started going up, that’s when the hypothesis started in my mind that perhaps Streptomyces is working by increasing the bifidobacteria at the time of the cytokines storm. My hypothesis, anyways, was that the bifidobacteria would just take the cytokines and flush it out of your system, letting the lungs start circulating those cytokines back into the colon.
In other words, flushing out the cytokines from the lungs to the colon, and then flushing them out into the septic or into the toilet and letting the lungs start breathing again, because you’ve now released those cytokines and you’ve increased the bifidobacteria. That was my hypothesis, essentially.
Mr. Jekielek: What happened in the end with these clinical trials?
Ms. Hazan: The hydroxychloroquine/Z-Pak, we just put on hold and we said, “We’re just going to watch what’s happening,” because we never finished them. We’re still monitoring all these patients because we’re going to write the data. This whole research of mine is a story being told.
It’s like finding the loss of bifidobacteria in severe COVID, finding vitamin C increases the bifidobacteria, finding ivermectin increases the bifidobacteria, and finding vitamin D increases the bifidobacteria. It’s a whole story that gets told. Then after that, look at the data to see what hydroxychloroquine does. And then, you go into the clinical trials of the placebo control and say, “This is what we suspected.” It’s like a story being told.
Mr. Jekielek: It’s a story that hasn’t ended yet?
Ms. Hazan: It has not ended…
Mr. Jekielek: That’s very interesting.
Ms. Hazan: … because we haven’t published it.
Mr. Jekielek: What about these other trials that you did with the ivermectin and doxycycline?
Ms. Hazan: The ivermectin/doxycycline trial finished. We had the FDA in our office. We have a whole binder of things they photocopied. Essentially, the ivermectin/doxycycline finished. They came and they audited us. They found that we had a form that we didn’t submit to the IRB on time. Therefore, we got a 483, which is not a fine, but a reprimand.
Mr. Jekielek: A black mark.
Ms. Hazan: It’s a black mark. It’s so funny because I’ve been doing clinical trials for almost three decades and I’ve never had a 483. I’ve had the FDA in my office at least three times, even the European FDA in my office, and we never had a 483. It’s always, “Dr. Hazan, you’re adhering to the ICH GCP guidelines.”
Basically, I got a 483 on a form that I forgot to submit, because I’m treating patients that are sick. Sometimes we were treating 52 patients a day, and my staff was just going crazy. You’re exposed, you’re stressed, and you’re running around. The paperwork falls behind sometimes. With the IRB, I didn’t realize the year had passed. The last three years have just gone fast, I don’t even know where my life was. It was like before COVID, and after COVID, is what was caused by COVID.
Mr. Jekielek: What’s the bottom line with that trial that finished?