Tag: senate

@20:00: It was a dangerous assumption. To assume there’s nothing that one can do for a fatal infection, is enormous blunder. It’s a blunder by citizens. It’s a blunder by health responders. And it’s a massive blunder by agencies. Can you imagine, let’s make an assumption. And could our assumption lead to the absolute worst possible outcome, which would be hospitalization and death. Or we could make another assumption. And say, “You know what? It’s treatable. We’re going to try to treat it.”

Which dangerous – which assumption is more dangerous? Absolutely the dangerous assumption is to do nothing. The dangerous – you can take any example. Let’s make an assumption on… traffic safety. You can assume that traffic safety rules and lines and stop signs and seat belts do something. Or you can assume they don’t. Let’s try. And let’s have a free-for-all out on the streets right now and see what happens versus paying attention to some rules.

@21:00: We never make assumptions that are dangerous to people. And the thing that really worried me about this whole thing is this series of extraordinarily dangerous assumptions. Can you imagine a senior citizen who has heart and lung disease, recovered from cancer, has some kidney disease, is handed a diagnostic test result and says, “Here. You have covid-19. Now you have your fatal diagnosis. Our recommendations, based on the assumption we can’t do anything, is: go home, and wait it out. – And when that panic, and that fear, and that breathlessness, and fever, is SO overwhelming, when you can’t bear it anymore! – then, go to the hospital.”

And how do people go to the hospital? They call family members. They contaminate all their family members. They call EMS. Uber drivers. Taxi drivers. Every hospitalization in America was a super spreader event.

So this “assumption” that there’s nothing we could do, and giving somebody a fatal diagnosis, with no instructions, led to a massive amplification of cases. So what we could have assumed, and what I did assume, was that there are some principles we could adopt from other precedents.

For example, every form of pneumonia known to man does better if treated early. Even influenza. And that’s the reason why, Tamiflu, as an example, and there’s an analogous product, are FDA approved for the treatment of influenza. They have some partial effect. Now do we ever use Tamiflu alone? No! We typically combine it with other drugs to get patients through the illness. There are supportive respiratory drugs. There are forms of inhalers. What’s called beta agonist inhalers and steroid inhalers. We use those liberally in forms of emphysema, pneumonia, asthma, allergic pneumonitis.

There’s other things that we can do to help patients get through the syndrome. The inflammatory nature of this syndrome became very interesting. We understand that antihistamines, as an example, Montelukast, aspirin, steroids, corticosteroids, play an important role.

@23:17: If I had an asthmatic at home, I wouldn’t say, “Listen. Sit at home for two weeks until you can’t breathe anymore and then go into the hospital.” Are you kidding me? I’d put that asthmatic on inhalers, I probably would use some empiric antibiotics in that patient and then some steroids, and I’d prevent the hospitalization to the best I could.

So I approached covid-19, respiratory illness, like any other with the following thought. And we pretty quickly put together our approach based on other precedents including influenza, including asthma, including bacterial pneumonia, as follows: that this was going to be amenable to restratification, those under age 50 who had no pulmonary symptoms, they could simply ride through the illness.

@23:59: We had data suggesting that nutritional deficiencies seemed to increase the risk for hospitalization and death. And so that’s where the nutraceuticals came in early on, that there was supportive data – not curative – but supportive data for zinc, for vitamin D, vitamin C, and interestingly a polyphenol substance called quercetin. There was some others that were considered, including lysine, and N-acetyl cysteine, they became what we call the nutraceutical bundle.

So is it kind of reasonable to do that in patients? I would say yeah, if it’s linked to mortality, we don’t know anything else, there’s no harm in these supplements, they’re readily available, people can buy them. So we recommended the nutraceutical bundle for those under age 50, and really no medical treatment. That amounted to roughly of people getting ill at the time, probably 2/3 to 3/4 of patients really needing no treatment.

However, if someone below age 50 have medical problems, presented with severe symptoms, or over age 50 with medical problems, it became clear that the rates of hospitalization or death were greater than 1%, that was enough, greater than 1% – it’s kind of the magic number in this whole equation, that’s enough to do something. That’s enough to do something.

We knew somebody at age 60, for instance, would face about an 18% chance of hospitalization and death. 18% chance, that’s too high. In my field, cardiology, our guidelines say anything more than 5% is high risk. 1 to 5% is moderate, less than 1% is low risk. In general, for anything less than 1%, we don’t go after it. So in this low risk group, we didn’t go after it. But age over 50, young people presenting with severe symptoms, we went after it. So it was nutraceutical bundle.

What did we know next? The timeline was very interesting. We knew from SARS CoV-1, SARS 1, that’s 80% similar to SARS CoV-2. We knew from studies dating back to 2006 that hydroxychloroquine, a drug that’s used for lupus, used for rheumatoid arthritis, it’s used for other rheumatologic conditions, including dry eyes, as well as malaria: safe, was effective in reducing the viral replication in SARS CoV-1, we knew that. And so the United States knew that.

@26:17: In fact, that drug was stock-piled by the United States government, Australian governments, some European governments, the hydroxychloroquine was on boarded appropriately, and ready to rock and roll. In fact, many countries front-lined hydroxychloroquine for high risk patients and still do so today. People go to Athens, Greece, Rome, Italy, across all of eastern Europe, central and South America; hydroxychloroquine is the lead drug. India and East Asia, hydroxychloroquine is the lead drug. So hydroxychloroquine played a role.

We also knew that by the summer, we knew that ivermectin played a role. This is an anti-parasitic drug used for scabies and other illnesses. Safe and effective.

So these drugs – how – the reason why they work against the virus is they get inside cells. A lot of antibiotics like penicillin doesn’t get inside the cell. But these, what’s called intracellular anti-infectives do. Japan, had an influenza drug that had the exact same activity as remdesivir – their first U.S. approved inpatient IV drug; that drug’s called favipiravir. And the Japanese had data to suggest that favipiravir, like oral remdesivir, would play a role early on. And it was readily approved by 5 countries, FDA approved – FDA equivalent approved in those countries to treat covid-19.

So we had hydroxychloroquine, we had ivermectin, we have favipiravir, we combine it with either doxycycline or azithromycin, and those are antibiotics Americans know about. They get inside of cells, they’re also intracellular anti-infectives, and they were slightly assistive in a couple ways. They cut down on some of the bacterial super infection that would occur in the sinuses or respiratory tract.

And we knew from some studies that there was about a 3% overlap between covid-19 and what’s called atypical pneumonias. Which would be mycoplasma, chlamydia pneumoniae, and these would also be responsive to these. So quickly, hydroxyzine, azithro, ivermectin and doxy – these were common – favipiravir and doxy outside of the United States, became common intracellular anti-infectives.

But those alone didn’t carry the day. Because what happened is the viral replication tipped off what’s called cytokine storm, or the immune system going haywire. And so doctors early on in the hospitals started using steroids. And we had some confusing literature – are they hurting, are they helping? And the British helped out a lot with the study and inpatient study called ‘the recovery trial’. And the recovery trial picked an odd corticosteroid, which was dexamethasone, in an odd dose, 6 milligrams a day. We typically use like 10 milligrams, 4 times a day. So an odd dose, but did show a small reduction in mortality.

And there was a meta-analysis published, looking at hydrocortisone, prednisone, it turned out any steroid worked, in some reasonable dose. So in the United States we quickly adopt using prednisone, which we use in asthma frequently. And then another trial in the UK was done called the ‘stoic trial’ using inhaled budesonide.

@29:13: Now that was a very interesting development, because there was a maverick doctor, former military doctor, Richard Bartlett from west Texas. He even made the national news by saying, “You know what? I think inhaled budesonide works.” And he said this early in the spring. And he was on national news, he says, “I’m trying it. I’m a doctor, I’m trying to help my patients, I am using empiric treatment. I know there’s no randomized trials.” But he was doing the right thing. That’s what American doctors ALL should have been doing, is trying to help their patients by taking empiric choices on drugs that make clinical sense, and he tried it! And indeed it worked. The British did the stoic trial, and sure enough, there was over an 80% reduction in hospitalization if we just used inhaled budesonide in outpatients with covid-19. So that made it on board.

Montreal Heart Institute, one of the leading overall randomized control trial centers in the world, got funding from the National Institutes of Health, Gates Foundation, Canadian authorities, and tested a gout drug which works against the immune system, particularly works against the white blood cells and their ability to proliferate toxic granules and assemble microtubules, that drug is called colchicine. And so Americans would recognize this as a gout drug. They carried out and conducted a prospector randomized trial, double blind for 30 days, the best quality trial done in all of covid-19, and they demonstrated that there was a marked reduction in hospitalization and deaths. So colchicine came on board.

And so the last thing that we really had to look at was blood clotting. And to this day there has not been a single outpatient study of drugs to impair platelet aggregation or antithrombotics, however we can learn from inpatient studies and there’s been very good analyses, they all agree, the use of full dose aspirin in the hospital is associated with reductions in mortality, and the use of full dose anticoagulation, whether that be injectable low molecular heparin, full heparinization, or we could even use oral anticoagulents as an outpatient, is associated with reductions in mortality.

So what I had been doing is I was working with the Italians, looking at how these concepts were coming together, and I published a paper in the American Journal of Medicine on August of 2020. And I have to tell you, when I looked at the literature through the spring, working with the Italians… (long pause)… there had been, by the time I submitted the paper on July 1st, there were 55,000 papers in the peer-review literature. Not a single one taught doctors how to put drugs in combination and treat the virus.

And it seems so odd to me. We knew this was a fatal viral infection; in fatal viral infections single drugs never work! We knew this in HIV. We knew that we needed multiple drugs in HIV. We knew this for hepatitis C. We knew this for all the other fatal viral infections. We use drug combinations. Never single drugs. And the only thing we can do at that time is look at studies of single drugs, and find signals of benefit, acceptable safety, and then assemble them into regiments.

The clinical trials testing a 4 to 6 drug regiment… those haven’t even been planned yet. I mean, the mortality rate would have been astronomical if somebody didn’t step forward and have the courage to publish the concepts. And I guess that’s what my role is in world’s history for this.

@32:44: I published a paper called the “Pathophysiologic Rationale for Early Ambulatory Treatment of Covid-19”. And it was published in the August issue of 2020 of the American Journal of Medicine. To this day, that’s the most widely downloaded paper from that journal of all topics. And, it went viral. And… literally. It went viral because the world was thirsting for an approach to covid-19.

Now, quickly after that was published I was managing all different types of communications regarding the paper; scientific and then also media related, and we have supportive data now coming in strong for ivermectin, for colchicine, for inhaled steroids, and Operation Warp Speed had delivered monoclonal antibodies directed against the spike protein, the pathogenic part of the virus. And they included a product from Lilly and another one from Regeneron.

So I needed to update the algorithm, and I put that together and published that in the journal that I edit “Reviews in Cardiovascular Medicine”, but with a separate issue and a separate unbiased editor that I didn’t have influence on to make sure that was fully peer-reviewed and vetted, which it was, and that was published in “Reviews in Cardiovascular Medicine” in August of 2020.

@34:00: By that time there was a 100,000 papers in the literature, and outside of my first paper, there wasn’t a single other paper that actually proposed a regiment or protocol to treat patients with covid-19. It was almost extraordinary, that we were over 9 months into a fatal pandemic influencing the world, and no one could come up with an original idea? Of how to put drugs in combination to treat the virus?

We didn’t have the Harvard protocol, we didn’t have the Johns Hopkins protocol, we didn’t have UCLA, we didn’t have a World Health protocol… So this was extraordinary, that all the firepower we had in academic medicine, couldn’t – they just drew a blank. Matter of fact, if you look at these centers across the United States and across the world, they never opened up covid treatment centers. They didn’t have outpatient covid treatment centers. They didn’t attempt to study or help a single outpatient with covid-19.