Dr. Harvey Risch: Fake Studies, Cherry-Picked Data, and Big Pharma’s Stranglehold on Medicine

“What we need is competition in the marketplace and all things medical,” says Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health and Yale School of Medicine. Three years since the start of the pandemic, we discuss what we know now about COVID-19, mask efficacy, vaccine harms, and treatment protocols.

“SARS-COV-2 is not the last virus we’re going to fight. And so we need to have this ability to use medications that work for viruses.… We’ve got to be trying and using all these things, and fighting back against the tyranny of pharma to suppress the ability to treat viruses until it gets to their level of economic benefit,” Risch says.

FULL TRANSCRIPT

Jan Jekielek:
Harvey Risch, such a pleasure to have you back on American Thought Leaders.

Harvey Risch:
Thank you, it’s really great to be with you again.

Mr. Jekielek:
Let’s talk about the state of the science around dealing with COVID-19. Why don’t we start with this recent Cochrane Commission study around masking, which is supposed to be the definitive answer that we’ve been waiting for.

Mr. Risch:
It’s interesting that you’ve raised a philosophical question about whether it’s definitive or not. I’ve argued in an essay for the Brownstone Institute that randomized trials are not the only kind of evidence that should be used. However, when done well, they are strong evidence. The Cochrane Commission issued a report on a meta-analysis of all available randomized trials on the efficacy of masking, both for what’s called source control, to keep it from spreading out from an infected person, and personal protection, to keep a person wearing the mask from getting it from someone else.

The end result of that analysis was that masks don’t do anything. It’s not that there wasn’t enough data to show that we don’t know whether they do anything or not. It was that we have enough data and they show that they don’t do anything. There are other studies that are not randomized trials that have also looked at the efficacy of masking.

There are more than a hundred, actually probably 150 of those studies, and they also show nothing. Whether you call the Cochrane Commission report definitive or the whole body of literature definitive, they should definitively show that masking is useless for control of spread of the pandemic.

Mr. Jekielek:
Of the virus?

Mr. Risch:
Of the virus.

Mr. Jekielek:
There were some studies that were referenced with great fanfare that said, “No, they work,” a few, if I recall. The evidence around them wasn’t strong. But in this kind of context, you can say that the body of the evidence says X, or the plurality of the evidence.

Mr. Risch:
One of the things that I always offhandedly remark when I teach my epidemiology students is, “For every epidemiologic study, there’s an equal and opposite epidemiologic study.” What this means is that there’s a lot of variability when you do epidemiologic studies, and you can always cherry-pick the ones that you want to make a case, if that’s what you’re going to dishonestly do in order to support a preconceived idea.

There are some studies that the CDC has cited claiming that masks have efficacy, but it’s not true, because they’ve cited 11 or 12 studies out of 160. The overwhelming picture from those 160 studies for respiratory viruses, not just SARS-CoV-2, but influenza as well, shows that masks do not help control the spread of the infection.

Mr. Jekielek:
Let’s jump into something different. I do remember an essay that you wrote for Brownstone, which is actually quite controversial, talking about how randomized control trials aren’t the end-all and be-all of evidence. I keep hearing about how they are. Why don’t you give me the picture here?

Mr. Risch:
The essay went to the ideas of plausibility versus scientific evidence. It’s easy to believe plausible ideas about science, but until you actually have evidence for them, you don’t know whether they’re true or not. They remain theories. The idea of randomization is a theory and it’s a very plausible theory.

The reason why randomization isn’t always workable is because it takes a lot more people to be randomized than you would think. The easy way to think about that is if you flip a coin 10 times, and you get seven heads and three tails or vice versa, then what good has randomization done, because you’ve got more than a twofold difference between heads and tails. That’s a big amount in epidemiology, twofold.

That can happen by chance, even though you’re randomizing by flipping a coin, that can happen by chance in 10 people. In order to get the same twofold difference, if you flip the coin a hundred times, that would almost never happen. Randomizing a hundred people is good, randomizing 10 people is bad.

In a randomized trial, it doesn’t matter that you’ve only randomized everybody that comes into the trial, you also have to have randomized all the people who are the outcome events, the people with the disease or who died, or whatever it is that the trial is studying. They also have to be randomized.

In the vaccine trials, where 44,000 people were randomized, when you only have eight people in one of the treatment groups in the vaccine group who had the infection, that’s not randomized. You’ve lost randomization because of that. That’s the problem, the size of a trial is not measured in how many people go in, but how many people come out, how many events there are. Nobody, except a few epidemiologists, recognizes this problem.

The issue of the randomization of the outcome people has to be over 50 in each arm, in order for it to be heuristically over 50. Then you get the effect of the beneficial effects of randomization. If you don’t have that, you don’t have adequate randomization.

Then, the problem is that the whole point of randomization is to control factors that you didn’t measure that could confound or bias the results, because there are imbalances in the people who aren’t randomized well enough—they’re imbalanced. That imbalance could affect who actually has died in the study or something like that.

Maybe all the males died in the eight people, and it was 50/50 for everybody else. Now, you have a big problem, because you don’t know whether it was the treatment or sex gender that mattered. That’s the problem that you need to be able to control for those things.

In non-randomized studies, investigators know this. We do this day in and day out. We control for everything possible that we can measure to be sure that we have accounted for all these extraneous factors that could bias the result. Whereas, in a randomized trial, that’s done with only small numbers of people, and they never adjust for anything. All these biases potentially creep back in.

There’s a lack of knowledge in randomized trials that don’t have enough people, as to whether the randomization worked well enough or not. That’s the problem. That’s why they are not gold standards, unless you have large enough numbers of people and there isn’t any kind of malfeasance, playing around with the results of the study, like Fauci did with the Remdesivir study.

He said, “It’s four days early, and continuing it to the end of the trial would just be dotting i’s and crossing t’s, but we really know the results.” What he said is, “We’ve stopped the study early and opened the blinding, because we actually weren’t blinded to the results, because we knew when it was going to show benefit and therefore we stopped it when it showed benefit.”

That is a completely unlawful procedure, a scientifically unlawful procedure, to interrupt a trial early at a state when you know it’s showing benefit. And yet, he did that on public TV under the plausibility guise of it’s not going to be anything different than had we let it go the four more days.

There are other kinds of biases that creep into trials like that. But the randomization one works only if you have enough subjects to make the randomization work. And that’s more than people think.

Mr. Jekielek:
Just to be clear, this is in a situation where you’re not doing a randomized control trial. You would control for sex gender, in that example that you gave earlier. You would control for all these different factors, so you could isolate the treatment as being the cause.

Mr. Risch:
The most important thing is to know about the disease you’re studying, the factors that created it and that raise risk for it. In the COVID treatment studies, the major one is the chronic conditions, the comorbidities. You see in the non-randomized trials that the people who took the active treatment medications were all sicker than the people who said, “I don’t really think I need this right now. I’m not so sick and I can maybe get along without taking the treatment.”

All of these studies had a hurdle to get over just to show benefit. They actually show more benefit than what’s being represented in the magnitude of their risk, because the people who took the drugs were sicker to start with. The criticism of these non-randomized studies is that they’re somehow biased to show a beneficial effect.

I’m saying that the empirical data of these studies, which is in most of the studies, and you can see it for yourself, is that they’re at a disadvantage to showing an effect, and yet they still show an effect.

Mr. Jekielek:
Now we’re talking about early treatment, correct? What is the state of early treatment today? The last time we talked, perhaps there were maybe 20 treatments that had some sort of positive efficacy in combination when early treatment was done.

Mr. Risch:
The main ones that have been studied are Ivermectin and hydroxychloroquine, and both have very substantial evidence of benefit. There are now nine or ten studies of hydroxychloroquine, and 12 or 13 studies of Ivermectin used on outpatients. Early treatment started in the first four or five days of symptoms. They both show a 50 percent reduction in risk of hospitalization.

Ivermectin shows about the same reduction in risk of mortality of death. Hydroxychloroquine shows a 75 percent reduction in risk of mortality. For hydroxychloroquine, the studies are completely consistent. For Ivermectin, there’s a little more variability. But the net result is what I said, they show significant benefit at magnitudes that are practical for use in clinical medicine, and for tens of thousands of patients in these studies.

For hydroxychloroquine, there are over 40,000 patients that have been studied. Also, there is what I would call an underground network of doctors who are quietly using these medications for treatment for outpatients, and have helped countless, hundreds of thousands of people in the United States over the last three years to survive the illness.

Now, the wrinkle about this is in the Omicron era, this has actually become less important, because most people survive Omicron without damage, either because they’ve had COVID before, so they have natural immunity, or they’ve been vaccinated and have some degree of natural immunity, or that Omicron itself is just not such a damaging illness.

In fact, it mostly doesn’t invade deep into the lungs, it stays superficial. That is the crucial fact of why people got hospitalized in the first place. Yes, there are some people who have chronic conditions that still get hospitalized with Omicron, but by and large, hardly anybody does. The main purpose of treating it is just to make people comfortable while they get through it.

Mr. Jekielek:
You can do that because from what I understand, both of these medicines that you mentioned have very limited side effects.

Mr. Risch:
Correct, they have very little. The worst side effects of them are GI disturbances, a little bit of nausea, sometimes diarrhea, and that’s it.

Mr. Jekielek:
What about the acceptance of these drugs in general in the medical sphere? Has that shifted over the last year?

Mr. Risch:
Not really. The suppression motives of the government are still present. All of the messaging has still been, “That was discredited long ago. Why are you even thinking about that?” That’s to maintain the economic playing field of everything else that’s been in widespread use now.

Mr. Jekielek:
The thing that I keep thinking about with respect to these medicines, is that there is a profound ethical problem here.

Mr. Risch:
Yes.

Mr. Jekielek:
The disease isn’t that serious, so you don’t need to use these things as much. But on the one hand, there’s still this push for vaccination. At the same time, these things were debunked a long ago, but there’s still some people that could benefit.

Mr. Risch:
They weren’t debunked in the first place. The outpatient medications have never been debunked. They have been suppressed. There has been propaganda against them. There have been fake studies that have been carried out against them. There has been suppression of publication of the positive results in the medical literature, all suppressing knowledge about how well they work.

But that doesn’t change the science and the nature of that. They do work and work quite well. But as I said, because of Omicron, the need has lessened quite a bit. There are all sorts of things like inhaled steroids like Budesonide, other steroids, and antibiotics that were part of the regimen, and that are still part of the treatment regimen that can help.

Doctors who are actually engaged in treating outpatient COVID are still engaged in treating it, and they’re still using their various recipes that each one developed on their own. It’s a wild west of treatment that has happened. They use their best medical knowledge, as medicine has always optimally functioned to treat patients and achieve good results.

Mr. Jekielek:
In California, you’re not allowed to prescribe Ivermectin. Is this correct?

Mr. Risch:
Probably not.

Mr. Jekielek:
What I’m trying to get at is there is an ethical question. This is something that can help. It doesn’t have a lot of side effects. It’s a cheap product and seems good for everybody. But it’s being actively suppressed.

Mr. Risch:
It’s even worse. Because think about hydroxychloroquine, when I first wrote the first paper on it in May of 2020, there were no outpatient treatments. There were no other drugs. There was no treatment being given. What was demanded of this drug were randomized trials of efficacy.

Now, think about this. You have a drug that has no safety hazard, and has been given in tens of billions of doses for more than half a century without preventative testing of everybody to make sure they don’t have an adverse reaction. It’s been given in such widespread use and is available over the counter in many countries. There is no downside for using it without any evidence of efficacy at all.

You don’t need efficacy when you’re in a state of emergency, and you have no other treatments that this would be supplanting or blocking. There’s an ethical reason to use it, even without the knowledge of its efficacy. Actually, we had evidence of its efficacy, even if it didn’t qualify for the stilted reasoning of the FDA at the time. And yet, it was still suppressed.

Mr. Jekielek:
How does accountability happen here?

Mr. Risch:
Accountability happens with investigation. People are waking up to the amount of lying that the government has done throughout the pandemic. Justin Hart has a book titled Gone Viral, which is a lay level book. Each chapter is on a particular lie that the government has said. There are more than two dozen chapters talking about and debunking each government statement about how the virus and its management has gone through the last three years.

That’s been the problem here. And where’s the accountability for that? People say, “We’re sorry. We didn’t know at the beginning of the pandemic how this would be. We did our best job.” That just violates every tenet of ethical behavior, because all of the knowledge on how to manage a pandemic was laid out 15 years earlier by the same people who flipped.

Tom Inglesby wrote a paper in 2006 with Don Henderson who was the person who basically eradicated smallpox, saying that all of the things that we use now should not be used. Lockdowns shouldn’t be used, travel restrictions shouldn’t be used, and masking shouldn’t be used, all these things that got flipped in the current pandemic. In 2006 Inglesby wrote they should never be used in pandemic management. He was talking about influenza at the time, but there’s not a lot of difference in how you manage a large-scale epidemic between the two viruses.

All that got flipped with no explanation, except for plausibility. “Lockdown, it’s plausible—you’ll suppress transmission. Masking, it’s plausible—you put something in front of your face. Randomized trials—it’s plausible. Social distancing—it’s plausible.” All these things are plausible, but the scientific evidence is exactly opposite, as they had discussed 15 years earlier.

Mr. Jekielek:
We adopted the approach of mass vaccination to deal with the pandemic using these genetic vaccines here in the Western world. At this point, what do we know about these methods?

Mr. Risch:
It’s interesting that we’ve seen the virus mutate. Of course, the virus mutates in every person. The virus that comes out of a person has lots of differences in the virus that went in, because that’s how the virus succeeds in its niche of infecting humans. Some of these are strains that develop a better ability to spread and those are the ones that take over in the population.

We’ve seen five major waves of the pandemic in the United States, similar to most other parts of the world, largely because of differences in strains that have mutated out from the previous ones. What we’ve had to cope with is temporal changes in the ability of the virus to replicate in spite of whatever immunity had been accomplished in the population by that point.

Over the first year before the vaccines became available, there were two waves. There was the initial wave, it quieted down during the summer, and then we had a fall wave again. Then, the vaccines came out, and we had two more waves. I forget what it was, Beta, and then Delta at the end of 2021.

Omicron came about at that point and has gone forward, and everything has stayed Omicron throughout 2022 and into 2023. The substrains of Omicron have changed every eight to ten weeks. We have a new substrain of Omicron, except for XBB.1.5, the current one, which is lasting longer than previous ones, which makes me think that it’s accomplished a biological niche that has maximized out its ability to replicate, so that nothing else is competing against it in the face of a large amount of natural immunity and whatever vaccine immunity exists.

That’s why we had no winter wave this year. We’ve had a little bump, but not anything like a wave like we’ve had in the past waves, suggesting that this is not a seasonal virus, but it’s a behavioral virus. In other words, it creates waves when the immunity circumstances of the population change.

You have the vaccines that were created based on the characteristics of the original Wuhan strain virus, and that worked for a while. In the mRNA versions, the two dose regimen worked for a while. What we found is, in a combination of the loss of efficacy and the viral mutation because of vaccination rates, that by six months, those vaccines have zero benefit for getting infected. In fact, if you follow those people who’ve had only two doses, their risk of getting infected is higher than unvaccinated people after six months.

There were six months of benefit. It goes down to close to zero by six months, and that’s the characteristic of two doses. You add a booster dose of the original kind. Now we’re into strains of the virus that are different from the original one that the original vaccine was made for, but the first booster was still the original strain.

It’s a little bit out of date—stale, as I call it. It worked for maybe two months, and then efficacy declined as well. What you’re trying to do is play catch up in making new boosters like the bivalent booster, in the context of a virus that has already had lead time in mutating away from you. If it takes two months to come up with a booster genetically tailored to the current strain, that strain is more or less gone.

The reason why we have an idea of doing that is because this worked for seasonal viruses like influenza, where the Southern Hemisphere was six months ahead of us. You could go to Australia in their winter and get samples of that virus, make a vaccine for that, and six months later, get it into circulation in North America and Europe, where that virus is just making headway into its winter waves, and therefore, you have people vaccinated in time.

Now of course, that assumes that vaccine is actually efficacious. We’ve learned that the current flu vaccine only has about an 18 percent efficacy. But that changes from year to year, and it’s hard to know what to make of that. But in general, it comes from having such a long lead time. For COVID, since there’s no seasonality that we’ve been able to prove yet, we don’t have that Southern Hemisphere six-month lead time.

You only have a month or six weeks before the current new substrain has peaked, and is starting to go away. And now, you’re first bringing out the vaccine that takes two weeks before it even starts working. It takes dissemination time in the population. You can see that you’re already well past the time that the vaccine would’ve been useful for when it applies to that strain. There’s some overlap between new strains and old vaccines, but not great.

Because of this, you see the bivalent booster has largely failed to keep up with the XBB strain. There are four or five studies that have looked at antibody responses to the different substrains of Omicron and the bivalent booster. As you get later and later in the occurrence of these substrains, the antibody production goes down, to the point where for the current XBB.1.5, it’s pretty bad as a booster to get at least measured by antibodies.

The whole paradigm has failed to think that vaccination will reduce the spread of this illness as the primary method of control. It failed as a public health method of control, and CDC actually admitted to this and agreed to this. On August 11th of last year, they put out a statement saying, “The two dose vaccine has a negligible benefit for controlling spread of SARS-CoV-2, and the boosters provide a transient benefit that wanes.”

Now for me, as a public health person, transient means useless, because we need sustained benefit. We need stability, something that lasts for six months a year to be able to have something to use for control. Something that lasts for two months is not enough, because then every two months you have to repeat with something new. How is that useful?

Especially if there are potential hazards from the treatment that you’re applying, the vaccine that you’re applying. You can’t do that level of risk benefit every two months. It’s not a sustained measure that works for public health. At that point, they said that the vaccines have failed as a measure of public health. Of course, they said, “You should get vaccinated, because it’s going to control your risk of getting hospitalized and or dying.”

That wasn’t true either, but that’s more of a debatable issue. At least they’ve said that the only real government interest is controlling spread, so that people who don’t want to be infected get protected from being infected. But since it doesn’t work for that, then there’s no more government interest in all this. There’s no more mandate interest, according to rational reasoning.

In the next month, in September, the CDC also said that there’s no difference in any of the ways that you manage vaccinated and non-vaccinated individuals. They were talking about healthcare workers, and they were saying, “Testing, quarantine if they’re infected or test positive, and masking, with any of these things, the vaccinated and unvaccinated people should not be treated with any differences.” Okay. That’s crucial for them. For the government to have admitted that is an official statement that all of this has failed.

Mr. Jekielek:
You mentioned that the virus isn’t seasonal, and it has some other way of functioning. Please explain how we can best understand how it works at this stage?

Mr. Risch:
My PhD dissertation was on mathematical modeling of infectious epidemics. One of the things that I discovered is that according to the models which are still in use today, the fraction of the population that eventually gets the infection is not dependent upon how you start the infection at all. It’s not dependent on whether five cases or 50 or 5,000 people who are infected enter the population. What matters is the balance of the infectivity of the virus itself versus the susceptibility of the population.

Susceptibility is not just the biological susceptibility of each person, but it’s how closely they live in proximity to each other, how often they attend schools, houses of worship, and other behaviors where they can exchange the virus. We live in an atmosphere, and it would be like thinking, “If we were living under water, we’re breathing water in and out, and that water is a substance that transmits everything around to everybody all the time.”

Because we are social we are all breathing the same air, and the same water, so to speak. This is our environment, and it’s all around us all the time. The virus knows that or deals with that and uses that to spread itself in a passive way, but that’s what’s always around us in larger or smaller concentrations.

The degree that we concentrate ourselves and make that process easier for the virus makes us more susceptible to getting larger numbers of people infected. It doesn’t matter how it started. What matters is all of these dynamics and balances between the viruses’ properties and the population’s properties. That’s what has determined the behavior of the waves and the pandemic.

The virus has gotten more infective, and it’s also gotten less toxic. A virus that kills people, keeps it from spreading. Because optimally, what you want for a virus is to make people cough and sneeze and go to work, and that they’re not so sick that they stay home. They stay home, you only infect the people at home. You go to work, you affect everybody at work. You want to be slightly sick, but not so sick that it changes your interaction behaviors.

That’s how viruses mutate until they solve their replication problem by maximizing their niche in the population, which is that dynamic balance between how a population absorbs and reflects the virus in its midst and balances all of that.

Seasonality causes people to change their behaviors; they all go inside, they all work inside, they all go to school inside, and then they exchange the virus better. The virus takes advantage of that and spreads better.

Mr. Jekielek:
And effectively becomes seasonal, but it’s not actually seasonal.

Mr. Risch:
Right.

Mr. Jekielek:
It’s actually working within this dynamic that you just described.

Mr. Risch:
Right, it’s not just that cold temperatures make the virus do better, or something like that, or lack of humidity, or something like that. That may play a role, but it seems all of this stuff all put together in a very dynamic way is hard to quantitatively describe. But that doesn’t seem to be what has been controlling the behavior of COVID-19. The seasonality hasn’t mattered this year, it mattered last winter. We had waves last winter and the winter before we had a wave, but that may have been just coincidental.

Mr. Jekielek:
Right now, you’re saying there hasn’t been a wave, the virus is endemic, it’s just going to be around, some people will get sick, and most of them won’t have too many problems with it, because it’s not toxic.

Mr. Risch:
Right.

Mr. Jekielek:
You said that the vaccine approach has failed. How do we deal with it?

Mr. Risch:
The interesting thing about this is that when you have an illness that gets to the level of things that are socially accepted or tolerated, and taken in stride by the whole society, there’s nothing stigmatizing that illness anymore. COVID has gotten to that point. It’s been that point for a while with Omicron.

Influenza affects millions of people every year, or at least it usually did outside of the COVID years. Some 40,000 plus or minus a few thousand die from influenza every year. They are people who basically have other chronic conditions. Most healthy people don’t die from the flu, even though it can be pretty uncomfortable like COVID, and we accept that.

We’d like to have vaccines that work. We’ve used vaccines. The vaccines have not been that hazardous, the flu vaccines. By and large, they’ve been tolerated pretty well. We take that in stride. That’s been our model for taking it in stride. We take car accidents in stride, we don’t make people have to get vaccinated for car accidents.

We take cigarette smoking deaths in stride, and that’s ten times the problem. Half-a-million people die every year from tobacco-related diseases. The society is inured to that and takes that in stride. Why are we somehow singling out a virus that might now have 40,000 plus or minus or 50,000 deaths attributed to it each year? It’s probably less.

But it follows the same paradigm of really only people with very serious multiple comorbidities, chronic conditions, who are the ones really at risk of dying. Most everybody else does pretty well, even with the so-called long COVID, which is really not long COVID, but a long viral syndrome that occurs after flu, and other respiratory viruses also. Usually, it is resolved after a few months.

Why are we taking this any differently, when it’s now behaving exactly the same as things that we, as a society, take in stride? Why are we stigmatizing people with vaccination? Why are we demanding vaccination in spite of the fact that it doesn’t work? When we’re talking about an illness, it’s no different than a cold or a flu or RSV.

Mr. Jekielek:
That’s a great question.

Mr. Risch:
Right, we shouldn’t be. That leads to a point that I’ve been trying to make since the beginning of the pandemic, which is that cases don’t count. Infections don’t count for how you manage a pandemic. Pandemic is managed by how bad the illness is, not by how many people have gotten it.

Nobody is cataloging cases of the cold in the United States, daily counts of colds. Because, by and large, it doesn’t matter. It’s annoying, but it doesn’t matter, because it’s not life-threatening for most people. People do die of the common cold. But for most people, they don’t.

The same is true for COVID, we don’t really care that people get it. We care that people do poorly with it. The way you manage this is to manage hospitalization and mortality and maybe long COVID, if necessary. But those are the ways that you implement public health strategies to prevent the bad outcomes of the illness, not the illness itself. The illness is not the bad outcome, it’s the bad outcomes that matter.

Now, we’ve got really poor registration of tests. We have official testing and we have unofficial, at-home testing that doesn’t register cases. Nobody wants to register that they tested positive, because then they can’t go back to work for ten days. They know that they’re going to be well in seven days, and they don’t want to stay home all that time. Whether that’s socially acceptable or not is a different ethical question. But the point is, there are a lot of off-the-book cases.

It doesn’t matter, none of that really matters. What matters is that people who go to the hospital or who died from this, they’re the ones who matter. That’s why we need early treatment. We’re actually doing so well, because it’s gone to the level of endemic annoyance right now. Even with the bump that we’ve had in the winter, it’s still quite low level and that will go down over time.

It’s really remarkable to see CDC’s weekly charts of the proportions of the different subvariant strains of the mutant strains that come out each week, and how they percolate through the population. You can see over history that they come up in about four to six weeks, and they go away about four to six weeks when the next one that does better comes up and has this cyclic process.

XBB started that, and XBB.1.5 continued that. But are there still other newer ones that come up, and are they going to take over XBB.1.5? The answer is no. They’ve come up and they’ve gone back down. That’s why I’m very optimistic about this. We’ve gotten stuck in a much longer and optimized strain for current conditions.

So many people have had COVID and there’s so much natural immunity that it’s keeping this ability to mutate against the vaccines subdued. XBB has accomplished what it needs to do in order not to have to mutate in order to stay there in the population.

Mr. Jekielek:
I want to build on something you just mentioned. You talked about the ability to mutate against the vaccines. What do you mean there?

Mr. Risch:
A vaccine that completely blocks a person from getting infected, in other words, that the immune system is so ready to fight it off, when the virus comes, it gets clobbered and can’t get out.

Mr. Jekielek:
That’s sterilizing.

Mr. Risch:
That’s called the sterilizing vaccine. Vaccines like that work, and that’s what you need in order to suppress the pandemic. Those vaccines have to be given largely before the pandemic occurs, not in the middle of it. We didn’t have that, and the vaccines that we have had still allow the virus to replicate and mutate.

What happens is that if there are variations to the degree that the immune system fights different strains, because of the mutations that occur, the vaccine immunity will suppress the strains that it was made for or the closely related ones. But when the virus mutates in such a way that that immunity doesn’t work well, then it just keeps mutating, gets out of that person, gets into the next person, and starts its own wave. That’s what happens.

The vaccines don’t create new mutant strains, but they select for ones that are successful against vaccination. If something gets out and gets propagated, then it has more or less free reign against the existing vaccination climate that doesn’t work for that particular new mutant strain.

Instead of putting up a wall against the virus, and having the virus have to fight, and work its way up or through the wall, what we’ve done is put up a chain-link fence, which has kind of blocked the virus, but let some of it through. What gets through is enhanced, compared to getting through another chain-link fence. It allows the virus to adapt. The only way to combat a virus that can adapt so quickly, is to have a vaccine that adapts just as quickly. Since we couldn’t possibly do that, the virus has mutated faster than the vaccine has mutated.

Mr. Jekielek:
The one thing we haven’t talked about is how you understand the current level of the harms associated with these vaccines. We know that myocarditis has been documented a lot. There have been revelations from the Pfizer documents of many different side effects at different levels of occurrence. Please give me an overview of where you understand things are.

Mr. Risch:
The volume of side effects and adverse events that have occurred from these vaccines is astonishing. We can argue about the numbers, but any objective person will say there has been a huge amount that we have never tolerated in any vaccine program in the past.

The manufacturer, and the CDC and FDA, for that matter, have accepted that there is increased risk of myocarditis. Now that there’s increased risk of blood clots, we have objective evidence that the spike protein in the vaccine gets to almost every organ in the body. The carrier nanolipid envelopes that contain the genetic information of the vaccines enhances their ability to get into the brain and everywhere else.

We were told the vaccine stays in the muscle and goes to the lymph nodes and that’s where it makes the immune response. That’s not actually true. It was never true. The FOIA documents show that, and public statements of the scientific people in, of the vaccine manufacturers have said that the vaccine would always be known to go to various places in the body.

What wasn’t known was the toxicity of the spike protein in all those other places. For example, it’s established and admitted that the clotting problems occur because the spike protein gets onto the surface of red blood cells. They get onto basically everything in the bloodstream, get onto the lining of blood vessels, and they trigger a clotting process in response to this strange molecule on the surface of those cells.

That may have minor or major consequences depending on the idiosyncrasies of the particular person, which we don’t really know about. Quantifying this is an issue and studying it is an issue, but we know that it exists. With the lists of all the possible things that could go wrong, manufacturers have to do that to cover themselves in the context of legal indemnity. I don’t take much stock in the thousands of possible things that could go wrong. That, to me, is a theoretical list, not a practical, realistic list.

The things that have largely gone wrong are inflammatory issues like myocarditis, neurological issues that have been seen in many people, clotting issues that have been seen in many people, and perhaps fertility issues that we don’t really have a good handle on yet. There are arguments on both sides. There’s a lot of anecdotal people.

When the vaccination first started, I started getting reports from nurses in various hospitals in Connecticut that were emailing me saying, “I’ve never seen more menstrual irregularities. People are coming to the hospital with abnormal bleeding. Sixty-year-old women are coming to the hospital with menstrual bleeding,” There was all this stuff going on in anecdotal reports. What consequences would that have for fertility? I don’t know.

This kind of evidence is not strong in a scientific way, but it’s still raising the possibility that there are things going on. This is going to take another five to ten years of study to really have a better handle on it, if we’re able to do that, if we can surmount the institutional resistance of discovering hazards of the vaccines, and the vaccination process. It needs to be done for a sense of rightness of our public health approach to things.

Mr. Jekielek:
From what I’m hearing here, there is not very much efficacy, and significant known harm. What sense does it make to keep these things on the market at this point?

Mr. Risch:
I think it doesn’t. Until a few months ago, I was even thinking that maybe in elderly people with lots of comorbidities, chronic conditions, who are at really serious risk of dying from COVID, that maybe the vaccines would be useful. But then it turns out that they’re just as much at risk of dying from the vaccines as from COVID.

How do we know what the balance is? We don’t even know what the balance of benefit versus risk is in them. Given that we know that there are hazards of the vaccines as they stand, then where’s the rationale for using it at all? I’m not clear that there is one.

Mr. Jekielek:
We keep coming back to the original off-label drugs that were used that are safe and don’t have as many interactions.

Mr. Risch:
Yes.

Mr. Jekielek:
It always stuns me to think about the fact that we’re avoiding these drugs.

Mr. Risch:
My line of thinking is that this is not the end of the story by any means. If there’s a silver lining in this, it’s that there are lots of drugs that are antiviral to greater or lesser degrees, and SARS-CoV-2 is not the only virus we’re worried about. RSV is a virus, and perhaps people have hypothesized why we’re seeing RSV in older children and adults. That never happened before. You see it in very young children and elderly people, and never in the middle.

Now we’re seeing it in the middle because those people are vaccinated and their immune systems have been altered in such a way that it lets the RSV gain a better foothold and infect them. That’s a serious potential risk. But here we have all these antivirals that could be used to treat it. As long as these genetic antiviral, generic antivirals are being suppressed because they’re cheap, we have a big problem. That is the problem.

In fact, Congress set out to block that problem in the 21st Century Cures Act in 2016. Section 3022 says, “Regulatory agencies shall use all available evidence for deciding upon approval of agents and not just randomized controlled trials.” Of course, the FDA totally ignored that. They sailed through that, and demanded randomized trials of hydroxychloroquine, even though there was a pile of evidence already showing its benefit.

But that’s what Congress intended, because of large amounts of public pressure that FDA was demanding randomized trials, which was putting a stranglehold on the development of new medications, mostly for cancer. But now, it also applies to repurposed generic medications. We need an avenue for combating the pharma stranglehold, which says randomized trials or nothing. They say that medications can only be used if they’ve been randomized-trialed at up to $10 million or more per trial, which means no generic medication will ever be done that way.

This is our roadblock. There are medications, and there are antivirals. There is dogma from medical school that viruses have no treatments. Well, AIDS has a treatment and has antivirals. There is no single magic bullet for a virus. You approach a virus by multiple drugs all at the same time to clobber it. AIDS showed that. What we’ve learned now is that SARS-CoV-2 has exactly the same features.

Hydroxychloroquine, zinc, doxycycline, azithromycin, steroids and vitamin D—everybody should be taking vitamin D—all these things are the way that you attack a respiratory virus infection. They work, this works. This is a paradigm that’s been suppressed. But the whole point is, SARS-CoV-2 is not the last virus we’re going to fight.

We need to have this ability to use medications that work for viruses, just like we have them that work for bacteria. We’ve got these things and they have to be tried. Does hydroxychloroquine work for the flu? I don’t know, maybe. It has properties similar to SARS-CoV-2, so maybe it does. We’ve got to be trying to use all these things and fighting back against the tyranny of pharma to suppress the ability to treat viruses.

Mr. Jekielek:
There is maybe a silver lining here, because a pretty significant portion of the population has been alerted to the fact that there are all sorts of treatments for all sorts of things that were not the orthodox way. There were medical practitioners and scientific literature that would say, “Look, this can work for this situation.”

Mr. Risch:
Right. There is really a whole subversive industry opening up to do this—doctors who are treating COVID, and other things with their best knowledge in spite of the formal consensus statements of this medical society and the American Society of X doctors and the American Society of Y doctors and their contrived, fake consensus statements that have no bearing on the reality of it.

It’s only because they would lose their pharma funding if they don’t say that, or if they say something else. The whole corrupt medical system is just the rate-limiting step for acquiring adequate supported medical knowledge of how to treat various diseases that we’ve been coping with for three years or 30 years or longer.

Mr. Jekielek:
What do you see as the best way to normalize this type of approach to drugs as you’ve been outlining here?

Mr. Risch:
The marketplace dies without competition. What we need is competition in the marketplace, and in all things medical. That’s why alternative doctors’ groups that are using these methods work. The public knowledge of them gets into the public domain. Patients can choose to go to their orthodox practitioner and be limited to consensus, checklist medicine, or go to their unorthodox practitioner who uses the best, available evidence medicine. People should be able to have that choice, and freely make that choice.

Then, we’ll see what happens to the orthodox medicine and how it copes with competition. Of course, their first work will be smearing the unorthodox competition. When rational people see the smearing is not counter-evidence, the competition will improve, and eventually, the orthodox medicine will have to modulate into doing better than it does.

Mr. Jekielek:
There are some hurdles you’re intimating here. What is the single best thing that could happen now to help overcome these, because people are watching.

Mr. Risch:
Public pressure. Public pressure. People voting with their feet, voting with their wallets, and choosing the course of medical care that they want and choosing the course of outrage against the system as it is that they want. The control of medicine into substandard medical care, because of enforcement, checklists, generic ways of treating people not as individuals, has crippled quality medical care.

It gets away with it because of enforcement, and because of lack of competition. So many doctors today; primary care, internists, family care, and first line care providers, have been bought up by corporate medicine that enforces treatment limitations. There are medical care practices that say, “You can’t prescribe Ivermectin, you can’t prescribe hydroxychloroquine, and you can’t treat COVID patients.”

How would you ever, as a patient, get the medical care that you need if you go to a care system that says, “You can’t be treated for things that are treatable.” You vote with your feet, you write a letter, or you put an angry call to the CEO of that healthcare system, tell them you’re leaving, and you go and find care somewhere else that treats you as a real person with dignity and compassion and good quality care.

Mr. Jekielek:
Dr. Harvey Risch, it’s always good to have you on.

Mr. Risch:
Thank you, pleasure to be with you.

Mr. Jekielek:
Thank you all for joining Dr. Harvey Risch and me on this episode of American Thought Leaders. I’m your host, Jan Jekielek.

This interview has been edited for clarity and brevity.