As the COVID-19 pandemic unfolded, healthcare providers on the front lines encountered a dilemma — how to treat the sick when the usual hierarchy of evidence does not exist. Randomized controlled trials are the gold standard for scientific research, but they are time-consuming and expensive. The lack of existing evidence about how to treat COVID-19 has inspired creative reasoning in emergency rooms and critical care units across the globe. In the United States, drugs have received emergency use authorization, and treatment protocols have arisen based on failure to harm. In this clip, Dr. Roger Seheult describes his personal experience treating COVID-19 patients in the hospital.
Dr. Seheult: You know, I grew up in the scientific world of, you know, the hierarchy of evidence. So you've got epidemiological evidence, case-control studies, but really the thing that you need to have to be able to look a patient in the face and say, This is going to help you is a randomized control trial. And those types of trials take a long time, they take a long time. And the problem in this is that the system that we've set up of randomized controlled trials, applications to the FDA, these are great for diseases and conditions that are with us chronically. And that moves slowly. But they're not adequately designed to really help the majority of people in a worldwide pandemic, because people are dying very, very quickly. And you want to come up with answers very, very fast. And these things take time.
So that's one thing that I learned very, very quickly, is that if you want to try to save lives, and, you know, all of us look at this, from a different point of view. I guess I'm coming from the point of view of Yeah, I understand the ivory towers, I understand the people at the FDA, I understand the people that people are relying on them to say, here's something that we've tested, that looks good, and it works. But on the other hand, I'm working in the trenches too. So I'm looking family members in the face. And they're looking at me and it's like, "What can I do for our loved one? What is going to work?" And what we have to do is marry those two concepts together and come up with things, I believe that may have plausibility to work. But if we're going to institute something, if we're going to do something, it's got to have very, very low risk.
And so what you've seen, is you've seen a wide variety of things now that have gone through the FDA that probably never would have been approved under a normal situation. But because of the pandemic and the flexibility that we need to have, we need to move quickly because as things get out of hand, more and more people are dying. So for instance, convalescent plasma was approved using emergency use authorization through the FDA. And there was no controls in that study. So that's just an example of the type of things that we're doing. We're moving quickly here, we're in a pandemic, and we have to be creative. And we have to be understanding that this is not business as usual.
But if you find any kind of pharmacological intervention, be it hydroxychloroquine, be it ivermectin, and we can talk about those things. Those things have to be scaled so rapidly, and to such a high degree that as soon as you say, this medication is efficacious, you can't find it in the pharmacy, it's gone.
And so, what this has done, to me as an individual, has really looked at plausible, biochemically plausible, rational, efficacious remedies that are not a cure-They're not going to fix you or protect you 100%, but may in a population type of setting swing things enough so that we can deaden [SP] the blow of the pandemic.
Dr. Patrick: And are you talking in a sense about lifestyle factors? Things that are low-hanging fruit?
Dr. Seheult: Oh, yeah, absolutely. Absolutely. So lifestyle factors. But not just lifestyle factors. Because what are you going to do to somebody who has not been practicing the proper lifestyle and now they get COVID-19? What do they do? It's too late for them to institute lifestyle changes that are really long-lasting, but what do they do? And I think there is a science behind some of the things that we can do.
It's an all of the above type of thing. It's not just any one thing that's going to help. It's like, for instance, when you go to the operating room, right, we want to prevent infections. And so we don't think that just the doctor or the surgeon wearing the mask is going to solve everything. We also have a negative pressure or a positive pressure operating room, and we make sure that we use betadine or ChloraPrep on the incision. We're doing multiple things because nothing, particularly by itself is going to be effective. And so some of the stuff we've been talking about today, like hydrotherapy, or we're talking about vitamin D, none of those things by themselves is going to, you know, wipe out the pandemic. We have to do all of the other things that we know work. Think again about the fact that 80% of all symptomatic COVID-19 patients, 80% never need to go to the hospital. Why? Because their innate immune system does the job. It takes care of the virus. Twenty percent end up going to the hospital. If we could somehow increase that 80% to 85% ,90%, that would have a huge impact on the number of people that are seeking medical attention right now
A medication used to prevent and to treat malaria. It is also occasionally used for amebiasis that is occurring outside of the intestines, rheumatoid arthritis, and lupus erythematosus. Currently it is being researched as an antiretroviral in humans with HIV-1/AIDS, an agent in chemotherapy for cancer, and its ability to inhibit lysosomal degradation of protein products during autophagy.
An infectious disease caused by the novel coronavirus SARS-CoV-2. COVID-19, or coronavirus disease 2019, was first identified in Wuhan, China, in late 2019. The disease manifests primarily as a lower respiratory illness, but it can affect multiple organ systems, including the cardiovascular, neurological, gastrointestinal, and renal systems. Symptoms include fever, cough, fatigue, shortness of breath, and loss of smell and taste. Some infected persons, especially children, are asymptomatic. Severe complications of COVID-19 include pneumonia, sepsis, acute respiratory distress syndrome, kidney failure, multiple organ dysfunction syndrome, and cytokine storm. Treatments currently involve symptom management and supportive care. Mortality varies by country and region, but approximately 6 percent of people living in the United States who are diagnosed with COVID-19 expire. 1
The use of water of varying temperatures for health promotion or the treatment of disease. Examples include use of steam baths or hot tubs, or the application of hot, wet towels. Hot hydrotherapy has been proposed as a means to mimic fever to treat or reduce the risk of some illnesses, including COVID-19.
A common antimalarial drug that is also used to treat rheumatoid arthritis and lupus. Hydroxychloroquine is relatively safe with a few side effects. In 2017, it was the 128th most prescribed medication in the United States with more than five million prescriptions. It was used to treat COVID-19 early in the pandemic, but multiple high-quality studies subsequently showed no benefit from the drug.
The body's non-specific defense system. The innate immune system relies on a group of proteins and phagocytic cells that recognize and quickly destroy pathogens. Some viruses, including SARS-CoV-2, the virus that causes COVID-19, suppress the activity of the innate immune system.
An essential mineral present in many foods. Iron participates in many physiological functions and is a critical component of hemoglobin. Iron deficiency can cause anemia, fatigue, shortness of breath, and heart arrhythmias.
An antiparasitic drug used to treat round worm infections. Ivermectin exerts both anti-viral and anti-inflammatory properties. It has been proposed as an adjunct treatment for COVID-19.
The highest level of intake of a given nutrient likely to pose no adverse health effects for nearly all healthy people. As intake increases above the upper intake level, the risk of adverse effects increases.
A fat-soluble vitamin stored in the liver and fatty tissues. Vitamin D plays key roles in several physiological processes, such as the regulation of blood pressure, calcium homeostasis, immune function, and the regulation of cell growth. In the skin, vitamin D decreases proliferation and enhances differentiation. Vitamin D synthesis begins when 7-dehydrocholesterol, which is found primarily in the skin’s epidermal layer, reacts to ultraviolet light and converts to vitamin D. Subsequent processes convert D to calcitriol, the active form of the vitamin. Vitamin D can be obtained from dietary sources, too, such as salmon, mushrooms, and many fortified foods.
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