Pharma: Not Their First Rodeo – Umberto Meduri & Paul Marik on DarkHorse
**At 6:35 Umberto says “in 2000” instead of the intended “in 2020”Umberto Meduri is a professor of pharmaceutical sciences, and a former professor of medicine at the University of Tennessee Health Science Center, in Memphis Tennessee.Paul Marik is quadruple boarded in Internal Medicine, Critical Care Medicine, Neuro Critical Care, and Nutrition Science. Paul Marik was a tenured professor of Medicine, and chief of the division of pulmonary and critical care medicine at the University of Virgin...
The delay, the delay, the delay, the closure of the investigation to achieve a statute of limitation.
Why?
Because in between, I discovered a host of things that were absolutely amazing.
A completely departure from any ethical, moral, professional guide.
It's amazing.
What they have done was absurd.
I said, I couldn't believe this.
So they delayed the delay and then two, three days before the statute of limitations, they met with me actually two, three weeks before they said there is no misconduct.
Hey folks, welcome to the Dark Horse Podcast.
I have the distinct pleasure of sitting this morning with Umberto Maduri and Paul Merrick.
Many of our listeners will know Paul, probably most will not know Umberto, but this I think is going to be a very important podcast.
We are going to address some issues surrounding pharmaceutical science and the way it is conducted that I think will shock people both In terms of how familiar some of the patterns are, based on what we've seen in recent history, and how unfamiliar the particular story is.
Umberto Maduri from Verona is a professor of pharmaceutical science and former professor of medicine at the University of Tennessee Health Science Center.
And Paul Merrick, who many of you will know from Johannesburg, South Africa, is a former professor at Eastern Virginia Medical School.
Paul, your credentials are complex enough that I'm going to ask you to describe them.
You have four certifications, if I'm not mistaken.
You want to tell us about what your specialties are?
Yeah, so sure.
Thanks, Haybret.
So, in the United States, I'm board certified in internal medicine.
In critical care medicine, in neurocritical care, and in nutrition science.
In addition, I do have advanced degrees in pharmacology, as well as anesthesia and tropical medicine.
Excellent!
Well, Paul, Umberto, welcome to Dark Horse!
Thank you!
Now let me say that I don't know how exactly to unpack the story that we want to discuss here today.
It largely surrounds your work, Umberto, and your discovery of Useful therapeutics that ran into a pattern of obstruction, clearly coming from pharma.
In this case, we know something about who was creating this antagonistic force.
But in any case, I'm hoping that the audience will come to understand That something that has shocked us about what the response to the COVID pandemic was is actually a special case of a generic pattern of scientific interference that others have discovered in areas that were not related to COVID or only later became related to COVID, in your case, Umberto.
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You won't be sorry.
Do you want to describe where does the story begin?
Well, we have conducted at the University of Tennessee Health Science Center research on corticosteroids or glucocorticoids for about Since the mid-1980s.
And one, based on our experience, based on the knowledge that we acquired, we were extremely concerned about the decision by the WHO in January of the year 2000 not to recommend the use of an anti-inflammatory treatment in patients with severe COVID-19
They were dying from massive inflammation of the lung, from the condition known as acute respiratory distress syndrome, where I devoted most of my research time on in my group.
The decision that was made was based on a justification that was inadequate.
They left out multiple studies.
The largest studies actually were not included in their analysis.
And they told physicians, in essence, not to routinely give systemic corticosteroids for the treatment of severe viral pneumonia caused by SARS.
In their analysis, they left out a lot of information that was readily available but was not included.
Information-related studies involving thousands of patients, mainly from China and other countries, related to the SARS pandemic, related to the H1N1 pandemic and the MERS pandemic.
They clearly stated that steroids should not be used because they are ineffective and are dangerous, when instead, A careful review of the literature, looking at large studies that look at the different components of steroid treatment, showed that they were highly effective, associated with a mortality reduction of 50%, both in SARS and H1N1, and they were not beneficial.
50%, 5-0%.
Which is a consistent finding in randomized study or observational study, that they use corticosteroids correctly, and I will go there in a minute.
And also they reported one reason as to do it was a series of complications.
What they failed to show that this unusual complication, number one, they were never reported with exception of hyperglycemia in other randomized study using corticosteroids and critical illness.
And in the study that they reported then, they were using very high doses for prolonged period of time.
That information that was not provided in their review.
They also stated that when you use steroids, there is a danger of decreasing the ability of getting rid of a virus.
We call that viral clearance.
It's impacted in a negative way.
And they quote always the same paper.
If you look at that paper that comes from an investigator in Saudi Arabia, they show that when you use steroids for less than seven days, there is no improvement.
In a clearance, there is a reduction in clearance, but if you use it for more than seven days, and I'll go into the recommendation in a moment, then there is not only no impact on clearance, but there is, guess what, a 50% reduction in mortality.
So they lived out all this study that they use a protocol that I will describe in a moment that seems to be effective also in severe viral Okay, okay.
I want to pause you there.
I want to make sure that our viewers and listeners understand what you've described so far.
So, we're starting more or less at the end of the story.
We're starting with the WHO's failure to recommend corticosteroids for the treatment of severe respiratory distress in COVID patients.
Despite the fact that there was substantial evidence that these drugs would be effective, likely producing something like a 50% reduction in mortality, which is obviously a huge reduction.
Now, to clarify several things.
Corticosteroids are a class of drugs.
Am I correct about that?
It's not a single drug.
These are a class of drugs that has been in wide use for decades.
Yes.
How far back?
Oh, we're talking about 50 to 70 years.
50 to 70 years.
So in general, the drugs in this class that we know best are drugs that are so far out of patent that presumably they are widely available and inexpensive.
Is that fair?
Correct.
Okay, so you're talking about a case, and this will begin to sound very familiar to viewers of Dark Horse, where you have drugs that doctors know very well, have proven themselves over a very long period of time, where the set of side effects to be expected from them are thoroughly understood.
Have I said anything wrong so far?
extremely promising in the case of COVID, both because they work in related diseases and because the symptoms that kill people who get COVID and then die from it are exactly the symptoms both because they work in related diseases and because the symptoms that kill people Have I said anything wrong so far? - No, perfect. - Okay.
So now I wanna do a little bit of clarification.
As you know, I'm a biologist and I really like to understand the underlying biology, not just the clinical picture, right?
It makes it much more obvious to me, at least, why things are taking place.
So one problem that I often have when we talk about inflammation is that we tend to talk about inflammation as if it were simply bad.
And that can't be the case.
It is very unlikely that this is simply bad because it is something induced by systems of the body involved in maintaining health.
So, when one gets an infection, is it fair to say that some inflammation is part of the healing process itself?
Correct.
So, inflammation is of a body response to get rid of a pathogen, of a foreign substance, whatever that has entered your body.
And inflammation is a way to kill it.
And so it's extremely important.
So it's the first mechanism of defense.
The key is to resolution, is that inflammation then, once I get rid of a bad bug or whatever the virus, then it's going to come down and allows the body to restore the anatomy and function that has been damaged by the inflammatory process per se.
Okay.
So inflammation at first is part of the body's healing process.
In people who die from severe inflammation, something has gone awry, where that inflammatory process has become a positive feedback or has been maintained for much longer than would be useful in improving health, and it becomes unrecoverable.
Is that also fair?
Yes, and if I can add, in 2001 when our story started, when we go back, we completed a study providing for the first time evidence at cellular level.
in patients with the RDS, that is the condition that kills patients with severe COVID-19, end up in the ventilator, et cetera, that the problem was that inside the cell there was inadequate what we call glucocorticoid receptor function.
In other words, how glucocorticoids or corticosteroids work.
The glucocorticoids that is produced by the adrenal gland normally, or is given in the form of medication, goes inside the cells and binds to the glucocorticoid receptor.
Once the steroids, glucocorticoids, bind to the receptor, then we have an action at DNA level in production of proteins.
So what we found out is actually inadequacy at cellular level by the glucocorticoid receptor.
It's what leads to the inability to regulate down the inflammatory response.
But there are good news!
There are good news!
If you give an exogenous glucocorticoid in the form of methylpenicillin, dexamethasone, hydrocortisone, the number of glucocorticoid receptor goes up, the function goes up, and for function we mean ability to regulate down the inflammatory response followed by The receptor helping in every action related to restoration of anatomy function.
Okay, so I want to put a biological hypothesis on the table about what's going on in this case, and you can tell me.
I don't know that medicine is going to know the answer to this question, but I'd be interested in both of your opinions on the likelihood that this hypothesis is right.
When you get sick with a pathogen, something like a coronavirus, of which COVID is not the only one that infects people.
That pathogen really has no interest in making you sick.
It has an interest in spreading, and in general, the less sick you are, in other words, the more capable of walking around and engaging with other people you are, the better off the pathogen is.
But it has to make you somewhat sick in order that you are pumping virus into the environment when you breathe and things like that.
So it's engaged in an evolutionary balance between making you sick enough that you're actually contagious and not making you so sick that you're alone lying somewhere.
Right?
So that balance breaks down in a patient who is critically ill.
And at that point, it may be that a pathogen goes from keeping you on your feet to just creating as much virus to expel into the environment as it can, because you're going to have to spread from wherever you're lying.
And so it may be that what we have so far described that your initial inflammatory response is part of the body fending off a pathogen that in fact it is recruiting immune cells to the location of your infection and that is inflammatory but that when that process gets out of control it may be that the pathogen has captured it and it sounds Umberto like you're describing
receptors that become either less common or less sensitive to the endogenous, that is the steroids you yourself produce to reduce the inflammation, and so you go into this hyper inflamed permanent spiral, right?
And the question medically would then be how do you shut down the pathogens control and restore the body's ability to turn off the inflammation which is no longer serving you?
Is that plausible?
Yeah, so actually the question that you have or a question that we had about 20 years ago, we addressed that question.
What we found was very interesting.
We found that those with ARDS that develop pneumonia, that is a common complication for patient of mechanical ventilation where the defenses that you have of the upper way sector are gone in essence, was more common in patient with high level of inflammation.
So the question was, how is it possible that I have more pneumonia when inflammation is high and inflammation is the one that is supposed to kill the bugs, you know?
So that question that was followed by a series of studies, and I'll summarize now the finding, which is fascinating.
So what we found actually, that the patient was not dying from the pneumonia.
Because the prediction of death was available based on inflammatory levels days or one week before that, okay?
So we postulated that maybe the infection was was not directly the cause of death, but was one of the events that occurred because of the process.
And what is the process?
The process is what we call dysregulated inflammation.
Inflammation out of control, they not only destroy the organs, but also favors the growth of bacteria.
So we did a series of studies on the bacteria that we find in patients with the RDS.
And what we found is that when they were exposed to higher, higher concentration of cytokines, there was more growth, growth, growth.
No, there was little growth at the beginning, equivalent to the level we find in survivors.
But when we go to the level we find in the survivors, there was more, more, more growth.
But when we give metal penicillin, we're able to bring the cytokines or inflammatory markers down and reverse the excessive growth of bacteria.
It is interesting that in the randomized study that investigated steroids in patients with RDS, actually we reported, and the NHLBI has reported in the RDS network, a reduction in the number of infections.
We always thought that this was due to the fact that when you use steroids to decrease inflammation, you cut down duration of mechanical ventilation.
Now we know that in addition to that, you create an environment that is less favorable to the growth of bacteria.
We do not have this information on viruses.
So, to summarize what Umberto said, so normally you have an infection, the host gets rid of the infection.
There are some patients in whom the inflammatory response is too exuberant and so it's the inflammatory response, the out-of-control inflammatory response, which in fact is damaging and killing the patient.
And William Osler noted this in the early 1900s, when he said, patients don't die from the infection, they die from the host's response to the infection.
And therefore, from what Umberto is saying, it's pretty obvious.
When you have severe infection and overwhelming inflammation, you need two things, early antibiotics and corticosteroids.
It's as simple as that.
And it has to be both of them.
All right.
So this then strikes me.
I'm going to jump in here and Bertok, don't forget what you were going to say.
This strikes me as.
A classic case, then, where you have many different pathogens triggering the same symptom, which is critically threatening to patients.
And in such a case, you are not looking for the latest drug, which might be very precisely targeted.
You're looking for a drug that is very well known
that operates on the pathway that is overactive so that you can bring it under control so what you have both described is a situation where let's say a viral pathogen attacks the lungs there is natural inflammation to fend off the infection the natural inflammation either gets out of control or is taken advantage of before it gets out of control by bacteria which would ordinarily not be successful at attacking the lungs and so in a
In the case of a patient who's gotten a viral pathogen, they have runaway inflammation.
What you just said, Paul, is they need two things.
They need antibiotics to kill the bacteria that are taking advantage of the inflammation.
And they need an exogenous, that is to say some sort of externally provided steroid to bring down the inflammation.
And those two things will bring them back to a healthy condition.
Yes.
And so one other thing, Brett, which is interesting is you may ask, well, why do some patients have a normal response and get rid of the infection and others don't?
And it seems to be genetically determined.
So we have really good data that if a parent died of sepsis, then their siblings or the children are much higher risk.
And we see the same thing with twin studies.
So there is a genetic component that for some reason that the host responds with an exaggerated response to the pathogen, which may be genetically predetermined.
Well, I will say I'm suspicious.
It's quite possible to have something run in families and not be genetic.
So I guess these would have to be twins raised apart to show that it was genetic.
And, you know, frankly, there aren't that many twins raised apart.
So they tend to be small data sets if they exist at all.
But anyway, nonetheless, there's some factor that seems to be running in families.
That predisposes people to this overactive inflammatory response, it sounds like.
Yes.
Okay, go ahead, Humberto.
And actually, it's interesting, but the ones that are less likely to survive, usually a patient that has passed the ...capacity to reproduce, so mostly in the elderly.
Women, before menopause, are protected.
Younger people usually are more... I had septic shock, so I know what went about.
I was 17, so I survived.
It was a little bit bad, but not too bad, and everything went back to normal.
So younger people, the ones that need to reproduce, from the evolutionary standpoint, have more protection than the elderly ones.
Also, there have been studies that have looked at several patients, individuals, volunteers, that are completely normal, without any problem, and they found that one-third of the patients are resistant to steroids.
So, not all patients respond to endogenous steroids.
They may need help from the outside when they're sick.
I was going to add one more thing, if you don't mind.
Sure.
There are two elements to this relationship.
One is the glucocorticoid produced by the body or exogenous, the other one is the receptor.
And one thing, and Marek has written a lot about all this, Paul has written a lot, that we also need not just give glucocorticoids or corticosteroids, but give all the micronutrients that are essential to the vital function of the receptor.
So, vitamin D, vitamin C, thiamine are indispensable.
You cannot give one without the other, okay?
They are essential to maximize the effect of steroids and do a lot of other positive things on the endothelium, on the mitochondria, energy production, etc., etc., etc.
Okay, so, fascinating.
This sounds to me like an echo of the story that Heather and I have been embedded in, as you know, for more than three years now, where the obviously reasonable things to do for patients, both before they get sick and especially after they get sick, are conspicuously not recommended.
And, you know, the idea that nobody mentioned to dwellers of high latitudes that they were almost certain to be vitamin D deficient during winter months, and if they work indoors and don't spend a lot of time outside they might well be deficient all year, that that was not mentioned was preposterous because, first of all, there's Lots of behavioral remedy you can do without having to swallow anything.
You can just simply spend some time in the sun during hours when you're capable of making vitamin D and it is also likely that supplementing vitamin D is helpful.
You said thiamine was also important to the health of the receptors.
not a lethal thing to give people, even if it didn't work, the harm of giving them so you're certain they're not deficient in thiamine would be low.
Vitamin C, likewise, a very easily excreted and neutralized substance by the body, so giving it would be the cautious thing to do.
And then here we have the central player in this story, corticosteroids, right?
You have patients who are dying from inflammation and what you have is some very suspicious argument that you should not give these very patients the thing that any doctor would think to give them now that we know what the role of corticosteroids is in controlling inflammation, right?
you know, what's going on here that all of the obvious things to do, which do turn out to be useful and appear to work at a very high level.
I mean, glucocorticoids, you're saying 50% reduction in mortality.
That's nothing to sneeze at, right?
What is going on that these things are simply not being recommended as likely to be useful until proven otherwise and safe enough to administer in people who are otherwise threatened by their disease?
Well, it is fascinating.
So, So, one thing that I'm very disappointed with the WHO, and when they came out, we sent letters, tried to reach them, we did everything.
And finally, we were able to publish something in a new journal, Critical Care, and We made an analysis of how the WHO was completely wrong, missed everything, and this is the data.
And we also brought something that was new.
It is incredible that the WHO completely missed the publication in Spain about literally two, three weeks before COVID in Lancet, okay, so you cannot miss it, of a final study proving that corticosteroids Improve ARDS, decrease duration of mechanical ventilation, and mortality.
Completely missed.
So the chapter, do steroids work for ARDS, yes or no, was closed weeks before COVID-19 came out.
They left that completely out.
If they look at that, if they look at the guidelines that were published three years before when the task force and me and Paul were in, There was a task force of European and American Society of Clinical Chemists, which recommended, based on that knowledge tank, with a moderate degree of evidence, the steroid should be used.
And they say, we need a larger confirmatory trial to make it strong evidence.
That was published a few weeks before COVID came out, okay?
They completely missed it.
But then, The task force told them how to use it, and this is key.
You see, there is no money on steroids.
There is no drug company.
They educate universities or doctors on the proper use of steroids.
So the guidelines did, okay?
And the guidelines provide the rationale in how to use it correctly.
And one of the important things was tapering.
In other words, Slowly reduce the level of steroids at the end, once the disease is resolved.
Okay?
Why?
Because when you give steroids, the hypothalamic pituitary axis with the adrenal glands say, Hey, steroids are high, I don't need to produce them.
So they go to sleep.
So it takes about one week to 10 days to wake up and go back to normal.
And that's why you need to do that slowly.
And this is extremely important.
Because studies that have not included that give negative results, and the negative results are attributed to steroids instead of the fact that it did not have a correct protocol, okay?
So, the WHO missed everything!
There was data coming everywhere that something was working.
So, in a world, at some point during this podcast, I'm going to talk about the Predicament that pharma finds itself in.
As much as I have become beyond impatient with pharma's behavior, there is a hazard that their business faces, which is you never know when you invest in a drug You may invest billions of dollars pursuing some mechanism of action.
And when you finally have a drug, it may turn out to be too dangerous to use, or it may be disappointing relative to what you had before, and all of that investment is lost.
What I believe is going on is that pharma has invested in Hedging out that risk by taking command of the system that assesses both safety and efficacy.
Efficacy being the experimental version of effectiveness.
Effectiveness is how it works in patients.
Efficacy is how it works in a study, for those who wonder why we use those terms where we do.
But anyway, pharma seems to have invested in mechanisms that
mean that when they have invested in a drug that when it gets to the testing phase it can't miss which is terrible for patients because in general it is very hard to find substances that actually improve health especially in somebody who is in jeopardy so the likelihood of a drug working to the benefit of patients is low until you have such a drug right so if pharma has invested
In upending treatments that are known to work, thereby creating a niche for new drugs, and then interfering with the ability to assess how dangerous they are to patients, then this means pharma has now become a direct threat to our health.
And anyway, the reason I insert that there is that Umberto, what you are describing with the effect of Corticosteroids on ARDS, if you dose them properly, which means that at the end of treatment you taper off rather than just going cold turkey on the steroids, that if you don't do that you're creating a health problem of your own because the body has a mechanism for assessing
The amount of steroid in presumably the blood, and at the point that you have added steroids from the outside, it is not producing them endogenously.
And if you suddenly cut the supply from outside, then you have a sudden drop, which is not beneficial to health.
So, you have taken over feeding steroids into the system from outside.
You need to slow down that system of externally added steroids so the body can ratchet up its internally generated steroids in order to maintain health, right?
Now, but what you're describing is a system in which the underlying biology of steroids in the body gives pharma a gift.
If they wish to make steroids look dangerous, all they have to do is use a dosage protocol that does not involve tapering.
Right?
And we have seen in multiple cases that a drug which did treat COVID was misdosed and then declared to be either ineffective or dangerous.
In the case of hydroxychloroquine, a study was done with an absurdly high dose of the drug, making it toxic in and of itself.
And in the case of ivermectin, a drug which is very hard to administer enough of to create a toxic dose, they created a cryptic mechanism whereby the patients most threatened with COVID were systematically underdosed in multiple large randomized controlled trials.
So, again, the steroid story is fascinating for two reasons.
One, there's the particular details of the steroids.
And then two, because the attack on a drug in which there is no profit in order to create a market for drugs where there is profit but also great danger and much less effectiveness, that pattern seems to be generic.
You have to get rid of hydroxychloroquine.
Well, rig a study by putting so much drug into patients that they are sick from hydroxychloroquine In the case of ivermectin, underdose the people who are threatened by COVID so that the drug looks ineffective.
And in the case of corticosteroids, don't taper the dose at the end of the treatment period so the drug itself creates a pathology.
Am I right about this pattern?
Yes, and it's fascinating because I'm going to bring back to the WHO and their big mistakes.
About two years before COVID, we published an article in which we did a reanalysis of a government-run, the NHLBI ARDS Network randomized study, to confirm our original study published in 1998.
And the study, opposite to ours, did not include tapering.
In other words, they remove a drug in 36 hours.
That's not tapering, that's a joke.
This study was presented as steroids are dangerous, And they don't work.
That's the result.
But when you reanalyze the data, what we found, number one, they are highly effective.
During treatment, there was a 9.5 days reduction in Durational Mechanic Ventilation.
The RDS network has never achieved any of this.
The study that only achieved something was a two days reduction in Durational Mechanic Ventilation.
This is five times that, number one.
Number two, they found a reduction in shock.
They found a reduction in pneumonia.
They found a significant reduction in inflammation during treatment, increasing surfactant, and a lot of other positive things.
None shown, okay?
We dig them all out.
They just cursory went on that.
And they said, we recommend not to use steroids.
They never analyzed the data.
What happened?
If it works so well after you remove a drug, well, about 26% of the patients went back on the ventilator.
Now, when they went back on the ventilator, they were not restarted on steroids.
There was no information to the patient of the risk.
There was no information to the physician how to act if that happened.
What you have to understand is that the FDA has a big warning sign for steroids.
You must taper, otherwise there are life-threatening complications.
Okay, so they avoided that.
That study that we finally unmasked just a year before COVID, okay, was the one that was used over and over again to tell intensivists across the world not to use steroids.
And then I'll go back to what happened before that, which is fascinating.
Okay, Paul, I want to ask you a question here.
What would have happened if Doctors had been left to treat patients.
Without interference of guidance from the WHO, from the CDC, how would COVID have unfolded?
Would doctors have figured out that steroids were important?
Would they have reduced the number of people who went on ventilators?
Would the number of people who died from ventilators have gone down?
Am I right that that's the picture that's being painted?
Absolutely.
So, what we did, myself, Umberto, Pierre-Corey, is we put together a guideline in March of 2020, right at the beginning of the pandemic, because we knew what SARS-CoV-2 did to the lung.
It caused profound and overwhelming inflammation.
We knew that corticosteroids dealt with the inflammation.
So, in March of 2020, we were recommending the use of corticosteroids.
And obviously, at that time, the NIH, WHO, the CDC said, do not use steroids.
And so, unfortunately, doctors, particularly in the COVID era, you know, are lemmings.
They don't use independent thought process.
They're too scared to go against the narrative.
They just follow blindly like lemmings.
And so, you know, until the recovery study was published, patients just simply didn't get steroids and patients died needlessly.
Let me say that again.
Patients died needlessly because they were denied an effective, safe therapy once they had lung involvement from SARS-CoV-2.
So I want to drill down here a little bit because I'm 54 years old.
I remember how life was, medically speaking, before medicine was so centralized by managed care.
And I remember all of the fear that doctors legitimately had of being sued for malpractice.
And the problem is that medicine, while it is based on science, is in some sense an art.
And a patient is a delicately balanced system.
where they arrive at a doctor in some kind of imbalance and a doctor tries to restore that balance and it's very easy to screw it up and no doubt there was a tremendous amount of bad doctoring that got dealt with in a court but there is also just simply the fact that a good doctor may end up killing you by virtue of the fact that they took their best shot at saving you and weren't right about something or it didn't work for some underlying reason they couldn't have known
And I'm now thinking that this logic has flipped medicine on its head.
Where, during the pandemic, doctors like you guys, who recommended things that were not officially sanctioned, were in tremendous danger.
I mean, this was crippling to all of us.
You know, I'm not a doctor, but I certainly experienced crippling economic impacts of speaking
About the obvious absurdity of what the official narrative said but doctors, you know were ejected from the institutions that Were allowing them to practice medicine you you Paul very famously Had a direct run-in And we'll come back to exactly what happened to you, but I guess what I'm wondering is this
A doctor is supposed to take their best shot at saving their patient.
In the case that the WHO and the CDC and the NIH and the major journals and the medical schools are all singing the same chorus, About don't use that drug, even if a doctor has the hunch.
Actually, I'm looking at a patient.
They've got inflammation of the lungs.
I've seen this work 1000 times.
Obviously I should give it to them.
The fear that they will be crippled professionally for stepping out of line and giving something that they have been specifically told do not give to patients with this condition is.
It puts them in a situation where Their own health in their profession is now pitted against the health of their patients and I think many doctors blinked in the face of that and simply override, overrode their medical instinct to treat patients with drugs they know work for the conditions that those patients had.
Yeah, so Brett you're absolutely right.
I mean the clinician's basic responsibility is the patient is putting their life in the doctor's hands and he has the Hippocratic duty to do whatever he feels right to save that patient's life.
That's what his duty is.
His duty is to the patient.
And so I think, you know, the medical legal environment is complicated things.
But ultimately, if his intention and his determination is to do whatever he can for the patient and the patient's welfare, that's what our obligation is in medicine.
You know, we're responsible to the patient, not any outside organization.
And ultimately, the physician has to decide, you know, what is he going to do?
He's going to do what's best for the patient or what's more convenient for him?
More convenient and, you know, again, I want to talk about professionally what has happened to you both for standing up for patients.
But, you know, it isn't just convenience, Paul.
If you really want to get doctors to do the wrong thing for patients, it has to presumably come with a credible threat to their ability to continue practicing medicine so that the doctor will rationalize the incorrect treatment protocol on the basis that in the end they will end up saving more people than they harm or something like that.
I don't think most doctors uh would sign up for this nonsense i realize in some sense uh it's it's hard to describe the process but i think doctors were were fearful and legitimately so that they would lose their their ability to practice if they did the right thing and they talked themselves into believing that then the right thing must be something else The other thing that's really important is medicine is a science as well as an art.
There's the art of being a clinician, of being at the bedside.
If it was just a science we would have computers Managing patients.
There's very much the clinical acumen, the clinical judgment that comes into play.
And that's why it's never such easy as a right and a wrong.
The clinician uses his best clinical judgment and decides what's the correct path.
And there can never be an algorithm or a protocol Which will solve that problem because every patient is different.
Every situation is different.
And that's why the clinician uses his best or her best clinical judgment to do what's best for the patient.
If I may, two, three months into the COVID or four months into was in June.
We wrote a paper criticizing, finally was accepted.
Many journal rejected that because you cannot criticize the WHO or the CDC.
We wrote a paper explaining the wrongdoing by the WHO, explaining the new finding on ARDS, etc., etc., etc., and the correct literature.
That paper was published in one day.
One day, there were 20,000 reads, 20,000 doctors reading this, which is unheard of.
And on Facebook, people keep doing game changer, game changer.
They tell stories, I call the family, tell them grandpa was dying, I read this, I start on steroids and now five days later he's going home.
Okay, so I understand they were scared because they trust the WHO, they trust the CDC.
Okay, they just needed one excuse to use what they always use and it worked.
And what is fascinating is that the In September, the WHO finally agreed to recommend steroids based on this large English randomized trial.
And then the English government, nine months later, said that that treatment saved one million lives.
And the year after, another million lives.
So they tell you how many patients until then died unnecessarily because of this misinterpretation of the literature that is based on a strong bias that goes back to 20 years.
And maybe we can go back there eventually.
So I keep saying to various audiences and to people that what I now understand about what happened over COVID was that there was a coup staged by something that disguised itself as public health against the people.
against medicine, where medicine is a practice that is focused on patients.
And public health is supposed to be a corrective that deals with the fact that if you treat patients optimally, it may be suboptimal at the population level.
And so I am less and less convinced by that argument.
I mean, yes, there is a formal mathematical truth in it.
But if doctors have an obligation to serve the interests of their patients, then public health does not have the right to tell doctors to do otherwise.
And I think it is, therefore, if public health has a role Then what it must do is study population-level questions and persuade doctors that there is something in the interest of their patients that is worth doing.
The idea that public health gets to mandate things and to strong-arm doctors into behaving in ways that literally kill patients is an absurdity and it must never be allowed to happen again.
Do either of you resonate with the idea that some kind of coup was staged against medicine?
Yeah, absolutely.
But, you know, I think, Brett, this COVID shot a bright light onto a problem that's been there for a long time.
So there was no question that the agencies controlled the narrative.
Doctors weren't allowed to think.
It was a coup.
There's no question.
This was overt and not subtle.
But if you go back at least 20, 30 years, as Umberto knows, there has been an assault on medicine.
The integrity of academic medicine has been challenged.
But I think COVID brought this out so clearly into visible light.
I'm trying to figure out how to formulate this.
The problem with the business of pharma is that it is about things that doctors tell patients that they should have.
And doctors being responsible for the health of patients gets in the road.
Anytime something is not in a patient's interest, a doctor should be reluctant to give it to them.
In fact, the doctor should prevent the patient from taking it.
The way to overwhelm that system is to find all of the mechanisms outside of medicine that would adjust the conclusions of doctors.
And so public health is a loophole.
The fact that there is technically an argument for a population level analysis of something like a pandemic means that if you can get a hold, if you can capture the thing that decides what to do in a pandemic, then you can start telling doctors what to do.
And doctors are in no position to tell you not to because it sounds like what you're doing is trying to solve the problem for society.
So the capture of public health is in retrospect an obvious mechanism to get pharmaceuticals prescribed by doctors into patients.
Likewise, the ability of something like the CDC to advocate for mandates.
And likewise, the scientific apparatus That is capable of adjusting what doctors think will work.
So is the story here simply that doctors are the place where these drugs are prescribed, but there are lots of ways to control doctors and all of them have been captured?
Yep, that kind of summarizes it.
Unfortunately, the health system has been captured by Big Pharma.
So, we're talking about all the health care agencies.
The health care agencies actually work for Big Pharma.
We're talking about the medical journals.
We're talking about the medical schools.
They, pharma, direct the agenda.
And one has to be clear, pharma's goal is to make money, to sell drugs.
They're not there to improve the health care of the population.
So that's where the health agencies, they should be regulating the pharmaceutical company to ensure that the primary focus is the health of the population.
But if they are controlled by big pharma, then their direction changes, their vision changes.
So, Umberto, you mentioned that the story, or at least your part of the story, with respect to corticosteroids and treating of ARDS, goes back to 2001, is that correct?
Well, actually it started in the 1990s, but in 2001 something catastrophic happened in 2001-2002 that I like to address because you really see there the effort to destroy life-saving research by individuals with full knowledge of the results of a study.
It's something that is very difficult to justify ethically and morally.
But regarding steroids, you know, Steroids, when they were first introduced, there were three Nobel Prizes.
Everybody was excited.
We now have an anti-inflammatory, something we never had before.
Everybody knew the patient with acute respiratory distress syndrome died from massive inflammation that then progresses to fibrosis.
So, there was always an interest in seeing how an anti-inflammatory can work.
At that time, the drug was still under the pharmaceutical industry, was not off patent yet.
So the study they were made, they were made on using something that makes no sense now, but somehow they found the justification then, that was to use massive doses of steroids over 24, at the most 48 hours, but for ARDS 24 hours.
They use the equivalent of prednisone 10 milligram, one year supply, okay, over 24 hours.
And they spec to have a massive dose to overcome a massive dose of inflammation, okay?
It did not work.
It didn't make any sense.
There was no overdose, was not a treatment.
But what happened?
You know, the drug went off patent, steroids don't work.
So they reach a simple conclusion, steroids don't work, instead to apologize to everybody that they overdosed patients and of course there is no impact with a 24-hour treatment.
So then we go to our experience and the experience of others that have found that if you use steroids the way we always treat inflammatory lung diseases, With a moderate dose for a prolonged period of time until you have resolution of hypoxemia, patient don't need oxygen, et cetera, steroids work.
So what we have at that time, there was no money for randomized studies.
There were one after the other, what we call observational study.
They will show you the oxygen level, okay, going level of oxygen requirement going up and up and up, you start steroids.
and everything gets better, and most patients survived.
Mortality was decreased to about 20% compared to the 70, 80% reported in the literature or by others.
I end up doing the same thing, and I produce the largest data set.
But at the same time, because I was working then in an environment that was very producive to clinical investigation, we decided to do open lung biopsy.
In other words, to understand exactly what goes on inside the lung, obtain serial blood sample from the patient and obtain fluid from the lung.
So we try to understand a serial interval during the course of a disease, exactly what happened, how steroids work, And we reported for the first time what now is called cytokine storm.
So what we reported, hey, level of inflammation at the beginning is what determines the outcome.
We know exactly if it's going to die or not by day three to five.
And then inflammation parallels improvement in lung function.
If it goes down, your lung improves.
If it does not go down, it does not improve, and eventually the patient dies.
And what we found is that when we give steroids, we go from the abnormal state to a normal state, the patient survives, the lungs improve, the patient is off a ventilator.
So, we reported 34 patients.
Small number, but loaded with information to help to understand what is behind from a biological standpoint.
So, now we receive a grant for a small randomized study.
We conducted a randomized study.
Long story short, this was an ethical study.
Now, this is another important issue.
There are ethical studies and non-ethical studies.
What is the difference?
The ethical study regards the well-being of the patient that enters research.
The non-ethical study is interested in the benefit of a future patient based on the results.
So, it's willing to compromise the safety of a patient that comes in research.
What was our ethical conduct?
We have enough data to say the steroids might work.
So what we decide, if a patient does not improve within five to seven days, or if they deteriorate any time before then, we cross over blindly, this is all blind, nobody knows, to the other arm.
If you get steroids and don't work, get off.
So we avoid any potential complication.
If you don't get steroids, but you get placebo, then you deserve a trial with steroids.
So, what we found is that we have essentially no mortality in the steroid group.
We had a significant improvement in lung function.
But regarding, I want to add one more thing about the ethical thing.
We also knew that when you use steroids, we learned from our prior experience in observational study, the patient may develop an infection in the absence of fever, a cardinal signs of an infection.
So what we did, we did surveillance to identify the infection in the absence of fever.
So the combination of the protocol that was well designed and ethical and the surveillance culture for infection allows to get excellent results.
It was immediately criticized by people that will be involved later on in what I'm going to tell you.
So now we finished this study, and the ARDS network that is part of NHLBI decided to reproduce the data.
But in this one, there was no crossover, and there was no tapering, no tapering of steroids.
And we'll go on that later on.
So we start a new study now.
We're going to look at the impact of steroids in early ARDS.
Wait, I think I need to stop you.
Okay, please do so.
You have mentioned the ARDS Network.
What is that?
So, the ARDS Network is an organization organized by NHLBI that is part of the NIH and is involved in lung research, heart research, blood research, etc.
And the purpose was to investigate new treatment intervention for ARDS with a good group of universities that can get this stuff done fast, okay?
And that was a great idea, okay?
They did a lot of good studies, but when it came to the one of ARDS, In an attempt to reproduce our study, they did a protocol for a host of reasons that was completely different, okay?
Except for the dosage, everything else was different.
The duration was different, the tapering, the lack of infection surveillance was different.
And the result will be published later on.
And that's the study that I mentioned before.
We published that just two years before COVID, showing that tapering is essential.
Okay?
That when you don't taper, there are problems.
That's the study.
So, after we finished the late ARDS, in other words, one week into mechanical ventilation, we start steroids and we saw good results.
For a host of reasons, we moved to every first three days of ARDS.
Now, let's see if we can get better results starting early.
In essence, we cut the dosage to half, we were conducting the study extremely well designed and well conducted, Let me tell you, I had the best four critical care research nurses that made this possible, so it's not my credit.
It's the people that really do the work that take credit for that.
Now, the Data Safety and Monitoring Board knows that the study is positive.
At the same time, other things were happening outside of the University of Tennessee.
And what happened to us, we found obstacle after obstacle after obstacle to the closure of a trial, even if we knew, or at least the people that did what they did knew, that was essentially complete.
Okay?
So this is in 2001.
Now, the listener will be very interested in what happened outside of Memphis, okay?
And now we have two groups involved.
It's doing randomized study in patient with severe sepsis.
Severe sepsis means severe infection.
A severe infection is the leading cause of ARDS.
So, it's a continue based on severity of inflammation.
So, wait, wait, wait.
I want to understand this better.
What is the precise definition of sepsis?
Sepsis is a way to, sepsis from the Greek means melts, melts bad, because that's how they used to call it then because infection were milling over skin with bedroom.
And essentially, in other words, it's a severe infection.
So if you go to the intensive care unit with an infection, you have severe sepsis in essence.
In other words, there has been enough damage to organs that warrant ICU admission.
That's severe.
So am I correct in inferring that a That sepsis inherently involves a body-wide distribution of an infection?
Correct.
Okay.
So what happens is the infection in the lung or where else starts a response that is systemic.
That means through the blood everywhere we have this inflammatory mediator that cause problem.
It's never just localized.
Okay, so that is important because we are talking about the interaction of ARDS and sepsis and it's not going to be obvious to most people what the connection is.
So ARDS progresses to sepsis in a very bad Is that correct?
No, it's almost there.
So, we have severe infection.
The severe infection causes a massive release of inflammatory mediators.
They go through recirculation.
Now, the lung is fragile.
It's very delicate because it allows gas exchange, okay?
Blood is fragile because it has a very vast surface of capillaries blood vessels, the equivalent to a tinnitus cord.
So it's the most vulnerable to an infection that goes through the bloodstream.
And through the inflammation, there is a leak.
So there is a leak that leads to flooding of plasma that is, in essence, everything but red blood cells from the blood inside the aldeolite that have the air sacs.
So now the air sacs get flooded, essentially.
A lot of changes with inflammation occur within them, okay, and the lungs stop working.
Cannot get oxygen across.
The patient develop severe hypoxemia, low oxygen.
So, okay.
Let's complete this.
First of all, you've also mentioned cytokines and you called them a marker.
Are cytokines not an inducer of inflammation?
across all lungs.
It does not allow the transfer of oxygen from the lung to the blood vessels.
So, okay, let's complete this.
First of all, you've also mentioned cytokines and you called them a marker.
Are cytokines not an inducer of inflammation?
Are they just a marker of...
They are both.
So we know that they heal inflammation based on the level of the inducer of inflammation in the blood.
Okay, so you have an infection.
Let's say you get some sort of a viral pathogen in your lung.
It takes up residence in your lung because it can spread to other people from there.
The body, in fighting it, creates inflammation.
If the inflammation becomes severe because this process becomes uncontrolled, then this very delicate surface at which your blood comes within a cell or two of contact with the outside world...
Right.
It has to come in very close contact with the outside world because that's how gas exchange happens over a very large surface area, as you point out, that in the case of inflammation, this creates leakage where creatures, bacteria that could not invade the lung are capable of getting in there.
The inflammation causes the leakage of plasma into these sacs, the alveoli, Which then means that the gas exchange is not happening, so the oxygen in the blood begins to drop radically, which means it's not supplying the organs and presumably they're not able to export CO2 and get rid of it through the lungs either.
Yeah.
So far so good?
Yes.
In addition to plasma, there are also neutrophils.
All the inflammatory cells go inside to cause a lot of damage.
So the white blood cells are the infection-fighting cells.
The inflammation is, in large measure, a mechanism that recruits those cells to the area where they need to fight the infection, but they are also destructive because they're not oxygen-transporting cells.
So they're, at the very least, taking up space at the gas exchange surface and excluding red blood cells.
Yeah, red blood cells, there are not that many.
They are larger.
Neutrophils are much smaller, so they can go across.
All right.
Okay, so I interrupted your story.
We now have cytokines as both a marker and inducer of inflammation.
People have heard of cytokine storm.
That was the hallmark that people may have first heard about during COVID, where patients went from being sick with COVID and headed towards recovery to being sick with COVID and possibly headed towards death because of this inflammatory cascade.
And what they should have been given was steroids.
You have now described that it back that the same pattern absent COVID was something that you had recognized back in 2001.
You had extremely powerful data suggesting A massive reduction in mortality.
I think you said a reduction in the time that people were on ventilators, the ventilators themselves being destructive of the lung.
And then your study was being replicated by the ARDS network, but they changed your protocol.
Correct.
You know, I don't know why they did, but they did.
I'm not gonna So, going back to 2001, now we move our research to early RDS, by the middle of 2001 was almost complete and those are things that I learned years later, showed a 50% reduction in durational mechanical ventilation and a 50% reduction in mortality.
Again, 50%, 50%, 50%.
So, there is a lot of obstruction going on, something incredible, one after the other.
We had no idea.
I go to my chairman of medicine, he tried to bring correct things, did not work.
But I have for a moment to bring you outside of what happened in Memphis.
In 2001, the New England Journal of Medicine receives two publications.
One from France and one international.
One, a study on corticosteroids in severe sepsis, severe infection.
Another one, the study on a new drug activating protein C in severe sepsis.
The study from corticosteroids was originated in France.
It was submitted to the New England Journal before the Eli Lilly Study.
It showed a 10% absolute reduction in mortality in the largest group of patients that have relative adrenal insufficiency.
I'm not going to go there.
It's not worth it.
But anyway, it was associated with a reduction in mortality.
The Lilly Study was the largest study.
The first was 300 patients.
The Lilly was about 1,500-1,600.
And there was a 6% absolute reduction in mortality.
And there was almost significance for severe complication, but not there.
Almost there.
Now, the New England Journal of Medicine rapidly reviews and publishes online, first, the Lilly Study.
Okay?
And this is associated with the tutorial, a huge campaign of propaganda from the industry.
The French study is not returned.
The French people look at the publication of the other study and say, hey, what's going on with our study?
OK?
And they say, oh, we're going to send it to you.
So five months after submission, they return the study to the French people.
I was one of the reviewers, so I know the story.
OK?
They return it to them and they say, you need to make changes.
They make the changes, they return it, and they don't hear anything.
Until three days later, the FDA approved the Lilly drug.
So, in other words, the New England Journal of Medicine kept for 11 months.
A very important study showed that there is a cheap, effective treatment for one of the most life-threatening diseases we have on Earth, okay?
And rejected after 11 months, okay?
Now, the Figaro, two years later, published an article.
It reveals all this and clearly states that if the FDA had received information The study was published concomitantly, would have been very important for scientists, for doctors to see two things comparing each other.
The Lily Study would not have been approved by the FDA.
Why?
Because the approval was 10 to 10.
The approval of the drug, not the study.
The FDA would never approve the drug.
It was divided into 10 and 10 on each side.
And what they say, they receive, before the approval, the FDA call for comments.
I send comments.
They say, hey, look, there is another study here.
You better make a comparison.
That was the French study.
The French people sent all the information about their study.
But the reason why they did not look at that study is because it was not published.
So, in other words, the New England Journal of Medicine assisted a private company in achieving FDA approval by blocking an inexpensive drug that was highly effective and more effective publication.
This is incredible, okay?
Absolutely incredible.
I just wanted to say that this is one of the things people do not understand about the peer review process.
People think that the peer review process just means that science will be reviewed by scientific peers, and it is anything but.
A secret anonymous mechanism whereby competitors both, you know, the joke is it's peer preview.
Peers get a preview of what you're going to release informationally.
This is a place where people who are not powerful in their fields have things stolen very frequently.
But it also provides a mechanism in which you can tie up a result over a long period of time.
And the New England Journal of Medicine, which you would assume, you know, based on its title and based on its long history, is just simply interested in publishing good studies that will allow people to understand better what's taking place.
But in this case, it appears to be acting on behalf of a private company that has an inferior drug in which it is invested who knows how much money and wishes to bring it to market and have doctors prescribe it.
They're actually intervening against doctors, comprehending the comparison between two substances, one long known and well understood, the other new and expensive.
And this is certainly resulting in patients getting inferior care, to say the least, some of whom will die from that inferior care.
Have I understood it correctly?
Yes, there is no doubt.
There is a lot of, I won't say a lot, but there is corruption out there in their interest.
And you know, since civilization started, money counts, money talks.
So people that are powerful can influence things, even if they're not apparent, but they can do it.
You say there's a lot of corruption, and having been focused on corruption for several decades now, I can tell you it does not spark the correct image in the mind that capture is closer, because what we're really talking about is not just a lot of corruption, we're talking about a preponderance of corruption, where
The majority of influence over what drug gets prescribed is coming from perversely incentivized companies rather than properly incentivized researchers who have no stake in whether a drug looks good or bad.
It's obvious that we in the public should want people who have no stake whatsoever to study these questions, to tell us what they found and how they found it, and then we should discuss what is the right thing for patients.
It is obvious that if you put Pharma, in a position to fund studies, to contract them, to incentivize the system of scientific evaluation in various ways, both obvious and not so obvious, that they will end up creating a world in which, lo and behold, their drugs are exactly what patients need.
The drugs that might otherwise be given to patients are too dangerous and not effective enough to be given.
And doctors are left with no choice but to expose themselves to professional and financial risk if they depart from this phony orthodoxy.
I mean, I feel in hearing your story, here's what I know.
I know that this isn't something that happened related to COVID.
I know this goes back at least two decades, and probably farther than that, and that the degree of control is far beyond what I had imagined.
I mean, in essence, in hearing your story, I can't help but feel embarrassment over my own naivete on the matter.
Yeah, and then Brett, we need to talk about Umberto's study because Umberto did a randomized double-blind study in which there were serious issues.
Maybe you want to tell us what happened.
I mean, essentially, Umberto was doing a study looking at corticosteroids in ARDS.
He was blinded to the results and his study was shut down because he was essentially accused of scientific misconduct.
Yeah.
Because the agencies or the pharmaceutical company did not want his study to be completed.
Let me go into the story, which is absolutely fascinating.
So now the FDA approves the new drug, Zygris, okay?
And a Wall Street Journal, a Pulitzer Prize winner journalist for the Wall Street Journal, started to look into, because he heard about, he wants to know about this drug more.
And he talks with a lot of people, both in Europe and the United States, Canada, etc.
And people say, hey, why don't you call Madhuri?
He has something to tell you.
Because I was a proponent of steroids as an alternative to the one-molecule treatment.
Steroids just take care of almost 10,000 genes, not just one.
They're very important.
But anyway, So, he calls me and he says, yes, I sent a letter to the FDA.
I sent him a copy.
I think that there is another study in France.
I think there should be a comparison study.
It will be very important.
It is possible that the combination works better either one alone, but, you know, we cannot just go out and then there are serious risks of this treatment.
So, he says, okay.
He calls more people and then he sends me an email or phone call.
I forgot now.
He says, look, I want to come and visit you.
So, announce the visit of the World Research Journal to our research group that meets once a week.
And the news went out.
So, now they're getting ready.
Long story short, he comes, he spent three days with us, he wrote a beautiful article, and comparing drug companies versus, you know, off-patent, inexpensive treatment that gets no support when it's a ton of money that goes to the other side, etc., etc., etc.
And then he goes back, he calls me a couple of questions for clarification.
I show to him the new study that we have completed and submitted for publication that goes into the cellular mechanism of steroids and for the first time explains why they work so well, okay, in taking care of downregulated He used that in the Wall Street Journal picture that is in the journal once it was published, and now he published, okay, front page.
I was shocked it was front page.
I get letters from the two Senators, NIH Director... No, no, maybe you should tell what the title of his paper was.
Okay.
The title of his article is really important.
Oh my God, I have so many copies.
Where is it?
You can just tell us what the title of his article was.
Yes, I'm trying to find it.
It's White Sheep Drugs.
Hold a sec.
Can you read it?
I cannot.
Okay.
Why cheap drugs that appear to halt fatal sepsis go unused?
Steroids need big human trials, but pharmaceutical makers lack incentive to find one.
Dr. Miduri 15 years quest.
So that's the copy of the article.
And it's very well written.
And actually, But something happened.
Within a few days of the publication, my research program was shut down.
Shut down.
Shut down.
There is a positive trial that needs to be submitted for publication.
There is the largest blood specimen repository of this kind in the world shut down.
So I know nothing about this.
They called me from the foundation that supported the study.
One in the video telling, hey Umberto, and the foundation was interviewed and he's also in the journal by the journalists.
The chancellor of the university called the foundation, tell you you're under investigation for scientific misconduct to stop all funds.
I said, what?
I knew nothing about this.
This is complete news.
I called the chancellor.
The chancellor was a great person, an ethical person.
He got misled, okay, by the one that directed all this, the work under him.
Anyway, You mean you don't know this?
No, I never heard about this before.
I never heard the word scientific misconduct investigation.
So I go to the Office of Research Integrity website, I read all about the histories, and I call them back, hey, you did all wrong.
You cannot do this.
Well, it's already done.
Long story short, I was submitted to misconduct.
There is a lot of things.
The university lawyer then took over this, under my request.
He will later be disbarred, but anyway, he was in charge of this.
And they delayed, they delayed, they delayed the closure of the investigation to achieve a statute of limitations.
Why?
Because in between, I discovered a host of things that were absolutely amazing.
A complete departure from an I mean, ethical, moral, professional.
It's amazing.
What they have done was absurd.
I say, I couldn't believe this.
So they delay, they delay.
And then two, three days before the statute of limitations, they met with me actually two, three weeks before.
They say there is no misconduct.
We found some errors that needs to be corrected, something like that.
Actually, I told you, you don't know what that was not true anyway, but anyway.
And then with my lawyer was there.
And then they wait for two, three days before, after they told that there was no misconduct, after they told the document of the analysis there is no misconduct, and they say, the lawyer say, now you have to sign a waiver of liability that you will not take any action against the university.
And I said, this is ridiculous.
What are you talking about?
You're threatening me now?
After all this, you also threaten me?
And so I talked to my lawyer.
My lawyer said, you're crazy, guys.
You cannot do this.
Guess what happened?
That night, they met at night.
They removed all the evidence that I submitted in my favor.
They've changed and removed all this stuff, and they fabricated misconduct.
Okay.
So after you had already been exonerated?
After I was, they told me and my lawyer, there is nothing.
They changed everything that night after I refused to sign a waiver of liability.
So let me see if I understand the story.
You are favorably covered in a story, Wall Street Journal, is that right?
Yes.
And the Wall Street Journal says, The title again was something like, Why Drugs That Successfully… Cheap Drugs That Appear to Halt Fatal Sepsis Go Unused.
Why Drugs That Appear to Halt Fatal Sepsis Go Unused, covered in the Wall Street Journal, prominently.
Front page, was it?
Yes.
And days later, out of nowhere, with no hint that anyone has leveled any allegation against you about scientific misconduct, you find that your research is threatened.
An investigation finds no evidence that you have engaged in any misconduct.
They come up with some, you know, small Observations, which of course would be findable in anything you can come up with, you know, the research is hard.
There are little errors to be corrected all over the place, but they come up with something to save face.
They tell you you've been exonerated.
They demand that you sign a waiver of liability to prevent you from holding them responsible for damage done to your reputation.
You refuse to sign because, of course, why would you?
They meet at night.
Remove the evidence that you submitted in your defense and reinstate the accusation or maybe the finding of... Yeah, so they can make up with all this misconduct stuff.
They made up stuff.
This is the amazing... Yeah.
What kind of misconduct were they alleging?
So, some reporting of improvement.
The question was equal or more versus more only.
It's stupidity.
And a couple of other little things.
I'd be happy to post this online anytime.
The interesting thing is that the Chancellor, no, the Chancellor, no, the Chancellor was a decent guy.
The Dean calls me, okay?
First of all, I was out of town, they mandate a meeting in which they inform all my fellows, and then in a separate day, all the faculty that I was guilty, and they read to them all the punishment that I was subjected to.
They never called me.
I was out of town.
Now I'm back.
I go to the Dean.
The Dean reads everything.
You have to retract all your prior publication on steroids.
You have to stop this study, ongoing study on steroids.
Okay?
And then a few other little things that are irrelevant.
And then I was shocked.
I was completely shocked.
I took my glasses off.
I told the Dean, look at my eyes.
And I say, I've done nothing wrong.
This is life-saving treatment.
The truth will come out.
The guy turned pale and started shaking, and I left the office.
Okay?
I refused to upset the disciplinary action.
I went with my lawyer and said, there is only one way to save this research.
We have to go to court.
So that's what we did.
If I would have let them do what they wanted to do, today, there would be no knowledge about steroids for COVID.
Okay?
They would have succeeded in achieving what they wanted, but they didn't.
I tried to bring attention to the federal organization that is responsible for supervising all this, but they've done nothing.
The ORI, Office of Research Integrity, is run with a complete lack of professionalism.
They don't care about what happened to folks that are falsely accused.
There are even articles in the New England Journal of Medicine telling them, hey, you need to improve what you do, but they don't do it.
A bunch of... I have no positive comments on that organization.
Okay, so an observation or two, and forgive me for this, but I believe this is the proper use of such terms.
Can I just intervene?
Oh, please.
You know, what was interesting was the person who reported Umberto to the dean or his administration for scientific misconduct It was the statistician who was overlooking his study, who knew the results of his study.
Umberto was blinded, so he didn't know.
The statistician knew the results and falsely accused Umberto of scientific misconduct, which is truly astonishing.
That is truly astonishing.
Let me say this.
Yeah, go ahead.
She was forced to.
So, Behind the scene, once the Wall Street Journal came to visit us, behind the scene, the people before the statistician put all this together.
All what was missing is somebody to come and bring charges.
Everything else was ready.
She came there and said, I don't have any charge of misconduct.
So what I told her, you will bring charges of misconduct and we will control the process.
Okay.
This is testimony.
Okay.
In our litigation, we have all this information.
And they did control the process.
And I'm telling you only minor details, but they completely disregarded every rules regulation, both of state and federal regulation.
Was she not, was she not guaranteed some kind of promotion if she went through with this?
No.
The one in charge of inquiry, So, one person involved was promised a promotion that that happened, with a salary increase, of course.
And how was the statistician incentivized to trump up?
I have no idea.
Okay.
Well, I have to tell you.
This sounds, the more I hear about it, like mafia tactics, right?
In essence, if you are a scientific researcher who wishes to continue to be a scientific researcher, you have to pay a protection racket
to support you and in this case the payment isn't a financial one but you have to support the narrative that results in the drug that pays sailing through evaluation comparison to cheaper better drugs all of that things and if you all of those things if you depart from this by studying the actual question of what's in the interest of patients
And you insist on publishing it, and then this gets noticed in such a way that it will actually affect what is being prescribed, then they come after your reputation, and they interfere with your ability to continue your research, they interfere with the flow of money that allows research to happen.
And they will threaten, intimidate in some way, people who are working with you to betray you, presumably to save themselves.
And lo and behold, you end up facing charges of misconduct.
Now, I would point out, this isn't limited to research scientists.
In fact, the three people involved in this podcast have all had a version of this happen.
Umberto, you have had phony charges of research misconduct brought against you.
Paul, congratulations.
You have recently been completely vindicated of a vile accusation of scientific fraud that was leveled by What's his name?
Sheldrick?
Kyle Sheldrick.
Kyle Sheldrick.
A despicable human being who went after your good name as a doctor and again completely exonerated as you were Umberto.
And if you will go to my Wikipedia page, you'll find that pharma shills have made me sound like a terrible person who's distributed medical misinformation with no thought to how it would affect people's health.
It's the same story everywhere.
All you have to do is what you were trained to do to evaluate evidence to practice medicine to conduct scientific research if you do any of these things and it creates a problem for these
pharmaceutical companies, then it is your ability to continue to do the job for which you trained that will be threatened, your reputation will be destroyed publicly, you will be humiliated.
It's the same pattern.
Am I wrong that this is just simple mafia intimidation tactics dressed up in lab coats?
No different.
This is mafia tactics.
You're right, Brett.
Yeah, and you know, the fact that the public does not understand that the very people it should be listening to are the people who are being accused on the basis of no evidence of these things.
That's exactly who you want to listen to.
Do I want steroids if I have ARDS downstream of COVID or some other condition?
Do I want to listen to a chorus of doctors who are easily intimidated into prescribing some alternative drug?
Or do I want to listen to the person being slandered by his own university over research misconduct that they can't prove because it doesn't exist?
It's as obvious as it's as plain as day. - And what's worse is the regulatory agencies which should be regulating the activities of Big Pharma are basically collaborators and co-conspirators with them.
So that Big Pharma has, there are no checks and balances.
They can really do what they want to do.
And the regulatory agencies who should be regulating these companies are actually on the payroll of Big Pharma.
That's true, and again, I cannot get away from this idea about the coup against medicine, because I know none of this would be possible if doctors were just simply left alone to practice medicine, right?
If doctors were simply left alone to practice medicine, then they would Know that there was a controversy about steroids.
They would try giving steroids to patients who were threatened by ARDS.
They would discover that it worked.
And even if they didn't publicly say anything, they would privately say, look, You don't want that expensive drug.
I'm going to give you this one and we'll see how that goes.
The information would bubble up naturally in a grassroots medical discovery of the kind that used to exist as opposed to having every conceivable centralizing force in science and medicine all selling a phony story about novel drugs that It's the same time and time again.
Not only is this a novel drug that we cannot know the full range of hazards that come along with it, but the likelihood that it is better than the well-known drug that interferes in a safe way in a system that does not require a precisely targeted drug.
The fact that steroids work generally on inflammatory symptoms that have gotten out of control means you found the thing you were looking for.
You're not actually looking for a new drug.
It's pharma that's looking for a new drug because they can't make money on the one that exists.
That's it.
Right?
It's a very clear story and who knows how many drugs this is repeated over.
Yes, Humberto.
So, I want to let you know what happened.
So, finally everything went to the Office of Research Integrity, an organization that I highly dislike and incompetent, but they found no misconduct.
We sent all the data set, the statistician was so impressed with the results.
So, I was cleared by the Office of Research Integrity, but the university refused to accept that.
Okay, now finally the good Chancellor comes back.
He was gone for one year and when he was coming back everybody was concerned because they knew he was going to clear me.
But what was I going to tell you?
I'm sorry.
Oh, in between, I apologize.
So, I'm sorry, I got lost for a second.
I was fortunate enough to have two individuals, one at NIH and one in Rome, Italy, that heard the story, okay, and gathered 50 of the leading investigators worldwide, including many that were editors of journals, to write a letter to the President of the University.
And finally, that allowed me The university got two additional independent reviewers.
They found that everything was just right.
Actually, they were very complimentary about the study.
And they finally cleared me.
However, that did not stop Eli Lilly at his headquarter to tell all the rep that I was under investigation for misconduct.
And so the news that I was under investigation for misconduct was spread all across the globe.
People were coming from Europe and other countries.
And that brought a sort of questioning the positive study that comes out from Memphis, okay?
And the results are very clear.
There was no randomized study from 2002, when this was finished, to 2020.
No randomized study in the United States or in Europe.
And then finally, in 2020, we have one from Spain, just before the COVID-19, and a few years before, there was one from Thailand.
That's it.
Nobody will ever talk.
You go to a national meeting, they don't talk about steroids, etc., etc., etc.
So, it had consequences.
Everybody questioned the validity of the data.
So it's just so utterly maddening because on the one hand what's downstream of this is a lot of patients for whom we have a treatment that works And they're not going to get it because of things that happen at conferences where some sort of a whisper campaign that was never validated by anything that the tribunal that met to test the question found against you.
But the accusation was enough.
The fact is, it is possible to ruin a career and to block the discoveries that were made during that career.
By creating a phony impression with a simple accusation that apparently pharma has enough influence to set in motion.
Right?
That is the long and short of this.
Now, we also, I think we have not talked about the Eli Lilly drug that was so threatened by your discoveries about corticosteroids.
But what can you tell us about that drug?
First of all, how much does it cost to treat somebody with it?
It was about $6,800.
$6,800 for a full treatment?
They had a lot of modality to incentivize doctors to use it.
Many stopped because there were complications, serious breathing.
And long story short, there was a study that showed it did not work.
So finally the European community, they got tired of spending so much money for something that may not work, forced Lilly to do an independent randomized trial to prove the drug was not effective, okay?
There was no difference between the placebo and the drug.
And that was called one of the biggest problems with the pharmaceutical industry.
So the drug was discontinued, that's it?
The drug has been discontinued because it showed no significant difference with the placebo.
Correct.
It cost close to $7,000 a dose.
Yes.
People who presumably got a drug that's no better than placebo and had severe inflammation of the lungs, many of them presumably died.
Is that right?
Yes.
Okay.
And every time somebody dies from a treatable condition, some family is needlessly devastated.
They have been robbed of a person who meant something to them.
I just can't fathom the callousness of derailing safe, effective, well-known, out-of-patent drugs in order to market Dangerous drugs that are no better than a placebo and cost a small fortune to administer.
Again, it is the kind of callousness that would be intuitive to us if we saw it in a mafia context.
It is not intuitive to us in an industry that is ostensibly fixated on helping doctors treat patients.
I want to let you know that the misinformation continues.
The WHO mandated study to experts in Canada to look at all the literature on ARDS and steroids and the COVID-19 steroids, okay?
They concluded the steroids are affected in both COVID, ARDS caused by COVID and ARDS not caused by COVID.
End of dictation.
It works, okay?
This is not open to question.
If now you go to the NHLBI website and look at the RDS treatment, they talk about oxygen, they don't mention there were steroids.
If you look at the top universities in this country supported by the NIH and you look at RDS, there is no mention about steroids.
If you go to the ARDS Foundation, that is the biggest source for private money donors to go through ARDS research, there is no mention about steroids, and the founder, that is a great person, was saved by steroids.
Okay?
So it is amazing that even now there is this censorship that goes across the whole United States by federally supported institutions.
Okay?
It's just above understanding how they can refuse to accept that and put that information in their website and to inform the patient.
Therefore, I do not know if physicians are aware of that or not.
I know that patients looking at website, they will get no information.
So yes, the control of information is really a key mechanism in this case and in the others that we have recently seen.
Can you tell me a drug, corticosteroids, capable of reducing mortality from this condition?
By the way, what is the A in ARDS?
I always lose track of it.
The ARDS network is a network of major universities studying together, conducting randomized study to study different interventions.
The A stands for acute.
Oh, I'm sorry, I misunderstood you.
Acute.
No, that's okay.
I apologize.
I don't know how common this condition is and how commonly people die from it, but how many people since, I guess, 2001, how many people who could have been saved from ARDS have been lost because of interference with the administration or the knowledge about this treatment?
What we know is that in the United States there are 200,000 patients a year.
The mortality is about 35%, so about 70,000 die in the hospital.
year.
The mortality is about 35%, so about 70,000 died in the hospital.
Then the mortality goes up to 100,000 if you look at one year's survival.
One very, very important thing about the RDS, the longer the duration of mechanical ventilation, more likely you have to have problems and die within one year and even longer.
The beauty about steroids, because they work at the core process of a disease, they really shrink down By 10 days with methylpenicillin, duration of mechanical ventilation.
So there are benefits, not just survival in the hospital, but long term.
Worldwide, you multiply all this by 10.
2 million people with ARDS every year in the world.
So we're talking about hundreds of thousands, if not millions, of patients that were denied over the last 20 years a simple, inexpensive, life-saving intervention that could have saved healthcare in this country billions, billions, not millions, billions.
The expense of a patient with a ventilator is $3,000 to $4,000 a day without counting the medications.
We're talking about a huge amount of expenditure that can be shrunk down with a simple intervention.
Wow.
Well, that is mind-boggling.
And the price, we talked about the price of the Eli Lilly competitor that's dangerous and no better than placebo.
What is the price of a course of treatment with whatever corticosteroid you would typically administer?
$200 for one month, including the expenditure of giving the patient medication.
So if you get off in three weeks, it's less.
Costs nothing.
It's so cheap.
It's generic.
Yeah, so I think, you know, one of the things that I've realized in delving into these questions surrounding COVID is that COVID was unique perhaps in the scale and the speed and the awareness of patients, but it is
A generic manifestation of what I would say is a jaw-dropping callousness of the pharma system at interceding
in medicine such that its products are prescribed, turned into what is erroneously called the standard of care, and then, you know, in a worst case scenario, mandated.
This is a racket.
It has gamed medicine.
But the thing I can't look away from is That there's some dollar figure.
And it's not a high dollar figure at which pharma is willing to cause death in order to increase the profit at its bottom line.
There is a price on all of our lives and it is willing, it does not matter the level of devastation, it does not matter the level of harm that is done to our families, it does not matter how many good doctors and scientists need to be publicly disgraced They will engage in this to increase their profits to, you know, maybe the generous way to say it is to increase shareholder value.
They will actually allow people to die needlessly and they will ruin the best scientists and doctors in order to do it simply for profit.
And I think that is now so visible across so many different stories, including yours, Umberto, that it is now unmistakable.
And there is a question about whether it is even possible to rescue medicine from this appalling disaster.
If I may comment, the things that really disturb me more than anything else, we have by February March, April, May, article after article, news after news, the hospital at clogged, we don't have enough intensive care, we don't have enough ventilators.
This was not only here, it was nationally and internationally.
It was a nightmare.
And in front of this nightmare, with patient removal of a ventilator because, you know, you're not going to make it, Okay, family completely destroyed.
I can't believe that a tall physician not to use a treatment that works and is safe.
It's above my understanding.
Maybe at the beginning you got it, but by the time they went to the second round of treatment in March, we were in the middle of a nightmare.
Everybody, the economy was shut down.
And the reason why it was shut down in great proportion is related to what happened to intensive care unit and intensive care unit was due to ARDS.
It's really ridiculous how callous they can be.
So this is yet another dimension of this.
The destruction to the economy that came over the threat of our medical, of our hospitals being overwhelmed with patients in acute respiratory distress.
That cost was astronomical, right?
Well beyond the people who actually were threatened by COVID.
And that was in large measure the result of the fact that we weren't applying drugs that would control that progression of disease that then threatened to overwhelm the health system.
We had the tools at our disposal to protect the economy from COVID.
Two weeks to flatten the curve was not about preventing people from getting sick.
It was about controlling the rate at which they got sick so that our hospitals wouldn't be overwhelmed.
But our hospitals wouldn't be overwhelmed if we had patients administering this safe, effective treatment for the very thing that would have overwhelmed the hospitals.
So, when you look at it this way,
The needless death of patients who might have walked out of the hospital, the destruction of small businesses, the disruption to the economy as a whole, these things are, to what extent we will surely never know, but to a large extent the result of the fact that somebody was blocking our access to tools that we already had.
That is a shocking conclusion to me.
You know, JAMA recognized that the introduction of steroids was a game changer.
And then we start to see a reduction in everything that happened, the burden of the hospital and societies in general.
So we knew, so we have the evidence that blocking that has had tremendous results.
Okay.
It's very hard to wrap your mind around.
It's just simply a matter of the human dimension here, which makes this so difficult to understand.
The fact that people could actually do this, that while the globe was terrified of COVID, that somebody was scheming to sell its drugs and to exclude useful treatments that wouldn't have made anybody rich.
It's hard to get more cynical than that.
To be scaring other people about the danger of this pathogen, that this is not a moment in which you are allowed to navigate your own course, while you are in fact betraying a globe full of people by keeping away from them the drugs that would make this a much less scary disease is so unconscionable that we can't contemplate it.
What's really astonishing is that the narrative was that you can't treat this disease, whereas we know today, as we did years ago, That there are over 20 drugs that have proven to be effective for the early treatment of SARS-CoV-2.
So it's not just ivermectin and hydroxychloroquine.
There's excellent data, irrefutable data, that there are at least 20 drugs that have proved highly effective for the early treatment of SARS-CoV-2, yet this information was deliberately suppressed by design.
Deliberately suppressed by design and, I would point out, Effectively mandated.
That what we were exposed to was a protocol in which you were literally supposed to not treat the disease until it was critical.
You were supposed to go home and endure it rather than be treated with drugs that could manage it until it was too late in the disease progression and you would have to engage in, you know, emergency interventions.
I'm sorry to, you know, I'm not telling you guys anything that you don't know.
And in general, I'm probably not telling Dark Horse listeners anything that they wouldn't assume, but it is not.
It is simply hard to accept that what we were told to do Could not have been better designed to create a health problem if it had been intentional.
That the idea that an industry which sells drugs when people are sick had control over the public health establishment, the journals, the medical schools, the universities, and not insignificantly, the social media platforms, had sufficient control over those things.
To inflict on the public a set of protocols that would guarantee large demand for novel, expensive, dangerous, Pharmaceuticals, much more than would have been the case if doctors had simply been left to treat with the things that would obviously be called for in the case of the pathologies they were seeing in their offices.
I mean, I don't know how many different ways to say it, but somebody is interfering with health because unhealthy people need drugs.
And the fact that it looks to be the pharmaceutical companies is a morally shocking fact, but it is not a logically surprising one.
Yes, pharmaceutical companies profit from unhealthy people, and it wouldn't be terribly logically surprising if that resulted in the growth of callousness on their part in terms of disrupting good science, good medicine, and patient health.
What have we missed that people need to know to understand this story?
Yeah, it's interesting that No one is ventilating steroids in the United States now or in Canada.
I mean, there is so much advancement that needs to be made.
We were ready to make this in what we call personalized medicine 20 years ago before it became popular.
All this research that was blocked here and other research needs to be done.
There are We can learn so much and improve.
There is always room for improvement and this stuff works and we need to know more and know how to use it even better.
Because it does not apply only to ARDS, it applies to almost many other diseases because the glucocorticoid receptor is involved in everything.
So, modulating that is important for a host of diseases.
For instance, interesting, I'm sorry to bring this up, the so-called effective cardiovascular treatment that has increased so much mortality, like statins, etc., they work on the glucocorticoid receptor, beta blocker, ACE inhibitors.
So, everything that brings inflammation down has to go that route.
And that's how they work!
So this was a generally threatening discovery because of course the massive success that would have been observed if corticosteroids had been applied to ARDS for the last two decades, that success would have immediately led to the question of what other conditions
have a primary inflammatory component to which these molecules, which would still not be profitable, might be applied.
Is that fair? - Yeah.
- Yeah, I mean, you can say the same question for IV vitamin C and sepsis.
It's the same story.
And as Umberto said, corticosteroids and vitamin C act synergistically with each other.
And so, you know, the whole vitamin C has been demonized just because it's a cheap repurposed drug.
Yeah, nobody's going to get rich on vitamin C. All right, gentlemen, I think there are three issues that we should address before we close this out.
The first one is to – we've talked a little bit about it, but to try to give people a sense of scale for the consequence of what happened to Umberto in 2001, 2002, and
By consequence, I mean not only what happened to patients worldwide who might have benefited from corticosteroids, but the change in the course of research over that period and what it resulted in.
Can we quantify... Umberto, did you say 2 million people a year get ARDS?
Yes, worldwide.
Global.
Worldwide.
- That's global. - That's worldwide.
And you said 30.
35% is a very optimistic outcome.
In reality the mortality in one year is 50%.
So 35% is a conservative number for how many of those 2 million worldwide cases of ARDS we should expect to die?
Yeah.
And then Treatment with corticosteroids would be expected to save half of the people who would have died absent them.
And so that means that something like 350,000 people a year needlessly die for lack of this treatment?
That's a conservative estimate, yes.
Actually, it would be much more.
And also, will prevent for the others to have long-term consequences and to get out of the hospital much earlier and save a lot of money.
So, the other consequences you're talking about.
So, for the people who didn't die but were untreated with corticosteroids, it's not like the fact that they recovered means that they're back to where they were.
What does it mean?
So, the longer you stay on the ventilator, the longer you have a lot of things going on in your body that have long-term consequences.
And the long-term consequences increase mortality of one year, so another 10-15% dying within one year, or a lot of things, fibrosis, the brain, the heart.
This is systemic inflammation, so multiple parts of your body are affected long-term.
So, people who have this Cytokine storm, inflammatory, runaway inflammatory response, who are untreated with these drugs but recover, are still health compromised.
They've lost likely years of life and much quality of life because of the fact that the inflammation was allowed to progress and because they likely stayed in a ventilator longer and the ventilator is in itself destructive.
Yeah, it's like a tornado.
The longer the tornado goes around with more damage, the more difficult it is to put it back where it was supposed to be.
So the shorter the duration of a storm, the more likely you're recovering.
So, very conservative estimate.
350,000 people a year needlessly die.
That does not count the people who die shortly thereafter, and it does not count the destruction of capacity of other organs that people then suffer from down the road.
That's a massive cost for failures to administer these things.
And on the research side, There's this period after you were punished for your work until 2020 where your work would have been central to our treatment of COVID.
It would have allowed the world not to lock down to prevent overwhelming hospitals.
But what about the gap in research?
Yeah, go ahead.
So it's a good question.
I mean, nobody wants to research a drug which is off patent, because you're not going to make money.
So that's the big problem is that, you know, they want randomized controlled trials.
The only people who can afford randomized controlled trials are pharma, because they have the money.
So the agencies don't want to spend money on drugs that they can't get a patent on.
And the other big problem is doctors cannot talk about any of these issues.
So there's no research.
And then doctors are really sensitive.
They can't talk about these issues.
And, you know, all of this, you know, I keep saying the same thing in different ways.
But the fact is all of the things that are really in a patient's interest, you know, give me the drug that you know the most about the side effects of.
That's an old drug, not a new drug.
Tell me about preventive care, right?
Suppose I don't want to get to the point of needing a drug.
How could I avoid it?
What might I do early?
You know, things like vitamin D. All of these things are sure to get in the way of pharma profits and so While they would normally be assumed to be the stuff of proper medicine, where your doctor tells you, here's what you should do so you don't get sick and don't need a prescription.
All of those things are interrupted by an industry that is all about prescriptions.
And so that results in a lack of research, which then sets us up for the disaster of COVID, because it means that the knowledge that should have accumulated over the past two decades just simply wasn't there.
One comment.
After I was finally freed from the misconduct charges, I was able to complete my research.
I presented the data at the national meeting where the ARDS people were there, the ARDS network people.
They sent me an email the following day.
We are so excited.
We decided we're going to go back and do steroid research.
And I have everybody's name there.
Blocked.
Blocked.
What is interesting, the director, the one in charge of deciding what study gets in and out, is the same principal investigator of the Zygrie study.
The industry guy works also at the RTS network to decide what study gets done.
And the steroid study, despite the willingness from good university people, very good scientists, to do research, this is too important, they say we're enthusiastic about this.
That's in the email.
Blocked.
So what do you mean blocked?
Blocked?
Nothing happened.
Somebody blocked it.
Somebody blocked it?
Yeah.
And the primary investigator or the head of the ARDS network did you say was the primary investigator?
No, the head.
The guy in charge of deciding what study gets done.
Ah.
The person who decides what research gets done was the person who headed the study on this Eli Lilly drug that was no better than placebo and was dangerous.
So this reminds me then of the revolving door that we see in Washington where people go from regulating an industry to the industry where they get their delayed bribe.
You know, the idea that you're going to bounce back and forth between roles where you're really doing somebody's bidding in both cases is it's certainly very familiar.
So let's talk about an issue that I'm not sure if we broke the story here on Dark Horse or we're just very early, but nonetheless, in an early Dark Horse where we were talking about what had taken place with Ivermectin,
Heather read the documentation that goes along with emergency use authorization and her point was emergency use authorization requires that no existing treatment be available in order for it to be granted.
So of course The vaccines which were sped through the regulatory process under emergency use authorization required that treatments that were available were not capable of addressing COVID.
So the importance of this is potentially massive, not just for ivermectin, also for corticosteroids.
I mean, Am I missing something?
That this seems like a major player in this story?
Yeah and I think that's one of the main motivations why Ivan Mactan was so defaced and you know was to protect the vaccines because if it would have been very embarrassing if Ivan Mactan proved to be a safe and effective drug for COVID.
So they had to go on this massive offensive and campaign to demonize it.
And that's what they did for the sole reason, or probably the main reason, is the EUA, to protect the EUA or the vaccines.
So I want to advance another hypothesis here.
It's one I think, you know, we can have opinions on, but we're not going to be able to evaluate it beyond a certain level.
Looks to me as a biologist like the mRNA technology in particular in the so-called vaccines.
is in one way a remarkable breakthrough.
It solves one of the huge problems that has dogged gene therapy since it was first proposed, which is how the heck are you going to get enough cells to be altered to produce enough product to be useful in treating conditions for people who lack the ability to produce that product themselves?
And so the mRNA technology does that, but On the flip side, with no way to regulate which cells take up the mRNA, it's an absolutely lethal technology that should never have been injected into any human being.
It's a technology that's decades away from being safe enough to be used, if it can ever be used.
You need a targeting mechanism to get it into the right cells so that they're cells you can afford to lose.
Because the cells that get transfected with the mRNA are going to be destroyed by the immune system inevitably.
And you can't afford for that to happen in your heart, for example.
Yeah, absolutely.
I mean, it's non-directed therapy with the nanoparticles going to every organ.
It's non-directed.
And the other thing is, we don't know how long the mRNA lasts for.
Right, and especially with them having stabilized it with pseudouridines across what would have been every uracil in the mRNA, apparently these things are now extremely long-lasting.
So, who knows?
They may, you know, when a cell is destroyed because it's producing foreign protein, those mRNA transcripts in their hyperstabilized form may spill out and they may transfect other cells.
So, it's like an ongoing pathology.
But anyway, my point was going to be, if you were pharma, And you knew that any value from mRNA technology was decades away because you just didn't have a way of solving the core problem, which is getting them into cells you can afford to lose and keeping them out of cells you can't.
Then the pandemic provides a mechanism to bypass that obstacle to making a profit on them.
In other words, you can use the fear that people have from a disease that doctors are effectively forbidden from treating To force an emergency use authorization so that suddenly the public is being injected with this stuff, even though it just absolutely was at best a prototype that was ready to test on animals, but not people.
Right.
We're now past that.
We're now into how many doses of this stuff are you willing to get?
And so anyway, the hypothesis is that not treating COVID and not acknowledging
What drugs doctors had at their disposal, in fact, effectively forbidding doctors from using those things, created a profit center from mRNA technology in the here and now where that would have been decades out if it had gone through any normal process.
Does that strike you as a plausible hypothesis for what happened?
Yeah.
All right.
Well, anyway, I guess I'll just leave it on the table then.
Maybe someday after these people are done slandering us, somebody will find out what actually happened inside of Pharma, and we'll get to see whether discussions of how to accelerate the profit center that is mRNA, so-called vaccines, is what I thought it is.
The last issue I guess that remains is, although one of the tricks that was played was to get all doctors and hospitals to do the same thing, Thereby obscuring the pattern that would otherwise be studyable between different protocols.
There were some hospitals, at least a couple of them, that did not adhere to the public health narrative on treatment.
And so there is some evidence of disparities in rates of harm and death between different treatment regimens.
Do you want to speak to what that pattern tells us?
Either of you.
Well, we did not use, we use our own FLCC protocol.
So we knew the steroids work.
We've done that for 20, 25 years.
And we had what I believe were reasonable outcomes.
We were too busy to keep track of records.
It was a nightmare.
And the physician used to come in for two weeks, sleep in the hotel at night for two weeks so they don't contaminate their family and then go back and then recover and then two weeks.
So it was very hard.
But what I know is that fellows of mine that work in other institutions, in which they use corticosteroids, active, you know, vitamin C, D, the old FFCC protocol, instead of their colleagues from other institutions that were not sensitive to the FFCC protocol, they reported to me, hey, everybody asked me why my patient do so well, and I keep telling them, why don't you use the protocol?
And some of them replied because the WHO, the CDC, does not support the use of this drug or that drug.
And so, and I think that the experience of Paul, you know, speaks for itself.
I mean, he had excellent outcomes and maybe Paul can comment on that.
Yeah, so, you know, we came up in 2020, March-April, with the MathPlus protocol for hospitalized patients just because the treatment was Supportive care, which is kind of absurd.
The NIH and the CDC said there's no treatment.
It's supportive care, which is absurd when you have patients dying on ventilators.
So we came up with a math plus protocol.
And so while there has been some controversy, the mortality with the hospital mortality with the math plus protocol was between about 7 and 10 percent.
And that compares to an average of about 20 percent in the world.
So, you know, with that protocol, conservatively, we were able to reduce the risk of death by half.
Again, 50%.
Okay, so obviously, you know, those are jarring numbers of people who are Dying in in hospitals you don't end up in the hospital unless you're very sick So you should expect a high number even though the case fatality rate for kovat was very low Of those hospitalized it was not low, but you're telling me 50% reduction using the math plus protocol for hospitalized patients
Tell me the numbers again.
What percentage did you see?
So, we actually published a paper where we looked at the world average for the deaths, the hospital mortality.
The mean with a small standard deviation is like 20%.
Our worst outcome was 10%.
Yeah, so 50% or better reduction in mortality.
That is obviously a spectacular number, especially, you know, the comparison between the degree to which our
Governmental officials appeared to be obsessed with protecting our health, while at the same time neglecting treatments and prophylactic molecules that could have saved Hundreds of thousands, millions of people, certainly hundreds of thousands in the U.S., millions worldwide, is staggering, right?
The juxtaposition of those two things, the callousness on the one hand, at the same time they were pretending to be so concerned about the health of the public.
Well, this has been a fascinating, if disheartening, exploration of some themes, some of which are very familiar and some of which are new.
Is there anything that we should add here before we close this out?
No, I just want to comment that in my 20 years experience, it was not easy.
Absolutely.
I think that when you go through terrible times, you grow.
So that's the good part.
But I also want to say, yes, there are a lot of individuals that are essentially self-serving, and they have a low standard for ethics and morality, but there are a lot of good people.
So I really need to, I rely on a lot of good people that throughout this period, they supported me, including all the LFSCC family.
Absolutely.
I love you guys.
Okay.
My family, my lawyer, You know, Don Donati, you met him.
I mean, he's an incredible person.
If it was not for him, there would be no steroids in the world now.
They would succeed completely eliminating this molecule from the treatment of critical care patients.
So, there are evil people, but there are a lot of good people that keep fighting.
So, that's what I want to tell to your listeners.
That is true.
Crisis seems to reveal People with excellent character, and I must tell you, it is heartening to see how many such people exist, including both of you, who I certainly would not have encountered had it not been for this terrible and despicable crisis that the world has been through.
Paul, you have any final thoughts?
Yeah, I mean, it's what, you know, the It's so difficult to put this into perspective because, you know, the goal of the health system should be to promote the health and well-being of its citizens.
And it seems that that's the least That's what they're least interested in.
And that's what this whole thing is turned upside down.
And the whole healthcare system is broken and dysfunctional.
It has nothing to do with promoting health, improving people's well-being, improving their happiness.
It's all about exploitation and making money.
And it's the entire healthcare system now, which is completely dysfunctional.
We need a new healthcare system and, you know, God help those people who get sick.
I don't know what to say.
It's an embarrassment to me, you know, as a physician that I have to say this.
And probably the safest, the most dangerous place for a sick person is the hospital because you just, you become victimized.
You have no rights and they do what to you as they want to do.
Well, I don't know.
It's very disheartening.
So, I wonder about this formulation.
Pharma is supposed to be about supplying useful drugs for the treatment of patients.
But what we see is that their fingerprints are all over the demand side of the equation.
That they are creating demand for their products and that is exactly not what they're supposed to be doing.
They must be held to doing only that which improves patient health rather than creating sick people who need their products.
And I guess in response to what both of you have said, My hope is that as terrible as the COVID crisis was, and as terrible as, as staggering as the costs that have accumulated over the last two decades since they started interfering with your work, Umberto, The most important thing is the future.
We cannot change the past, but we do have the capacity to recognize the clear signature of a criminal racket that is interfering with health, that is clearly willing to kill people, and we can pry our health out of their grasp so that we can go back To worrying about other things.
But if we don't recognize the signature of what's happened, it won't be done and we'll be back here next time.
I mean, Brett, you summarized it perfectly, but this is a mafia organization in that they can do recklessly whatever they want to do for their own benefit.
They are the mafia of medicine.
I wish it was an exaggeration, but it just isn't.
Once you see this up close, you realize that, you know, the tools are different.
These aren't Tommy guns, but the effect is the same.
And we can't allow it.
Medicine is too important.
The tragedy is too great when people are maimed or killed needlessly when there were drugs sitting in the pharmacy that could have saved them.
So, you know, I guess it's just time to stop beating around the bush.
It's a criminal conspiracy and it's time to put an end to their hegemony.
Yep.
So let's do it.
Well folks, this brings us to the end of a fascinating episode of Dark Horse.
I must say, I know Umberto, you have been waiting decades to tell your story, and not only to make sure
that other doctors are aware of the tools at their disposal and the fact that someone has been interfering with their knowledge of how to wield these things but also personally that you have suffered a terrible reputational cost and it I'm sure has been unbearable to live under that weight for all these years so
Let me say I do feel honored that you were willing to tell your story here for the first time.
I appreciate the trust that you put in me with that and it is a pleasure to hear that story told and to know that the public will from here on out Be aware of what was done to you and to them with respect to corticosteroids so thank you and I could say similar things about you Paul and your work.
