Biological Drugs in the time of COVID - What are they?
In this solo radio‑style episode Dr. Paul Anderson answers listener questions about the terminology and science behind biologic medicines and how they intersect with COVID‑19. He begins by defining biologics (drugs derived from or engineered using biological sources) and notes that they now represent the fastest‑growing segment of the pharmaceutical market, often costing thousands to hundreds of thousands of dollars per year. He walks through familiar examples – insulin, monoclonal antibodies such as Humira, Herceptin, Avastin/Lucentis, Botox, clotting‑factor concentrates, and emerging gene‑therapy products – explaining how they are produced, how they work, and why they can carry risks like increased infection or cancer susceptibility. The discussion then shifts to COVID‑19‑specific biologic strategies. Dr. Anderson describes convalescent plasma (human‑derived antibodies from recovered patients) and laboratory‑produced monoclonal‑antibody cocktails, emphasizing that they are most effective when given early in infection. He explains mRNA vaccines (Pfizer/BioNTech, Moderna) as lipid‑nanoparticle‑encapsulated messenger RNA that instructs cells to make the SARS‑CoV‑2 spike protein, and contrasts them with traditional viral‑particle vaccines. He also outlines DNA‑based approaches (plasmid DNA, adenoviral vectors such as the AstraZeneca‑Oxford vaccine) that deliver genetic instructions to cells via different carriers. Regulatory context is clarified: most COVID‑19 biologics have been released under Emergency Use Authorization (EUA), which effectively places the public into a large‑scale Phase 3 trial, unlike the usual pathway where Phase 3 data are collected before FDA approval. Dr. Anderson stresses the unknown long‑term safety profile of these novel platforms, noting that post‑marketing (Phase 4) surveillance often reveals adverse effects years later. He concludes by urging listeners to become informed, discuss options with their healthcare providers, and consult his newsletters for deeper detail.
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Good day and welcome to Medicine and Health with Dr. Paul Anderson. That's me, I'm Dr. Paul. And today, we had a lot of questions after the last radio show/podcast that I did around, you know, COVID and therapeutics and, you know, all these different sort of update things that we talked about last time. And so one of the biggest themes that came up in the questions that I got were really around some— well, it's around terminology. But really what it's about is what do all these terms mean that we keep hearing about? Because they seem to be, you know, maybe things we haven't heard a lot in the past, or we've heard them in other instances, certainly not for COVID. And now we're hearing about COVID And so there's some terminology, and I want to get into that with and kind of make it real by talking about, you know, what's behind it and what does it mean for treatment or therapeutics or things of that nature. And then the other side of the questions, again, you could look at it as, you know, terminology is confusing, etc., is a lot of questions I got with respect to What, what does it really mean when we have something that we're being given that's, say, under an emergency use authorization versus, you know, an FDA-approved product? Is that the same thing? What are the differences, if there are any? What does it mean to have a drug or a treatment in phase 1 versus phase 2 versus phase 3 and maybe even phase 4 trials, clinical trials? there's certain things that say they're still in phase 3, but they're out in the public now. So there's a lot of, you know, just really good questions and legitimate, I think, confusion around a lot of those things. Because for most people, unless you're working, you know, with these sorts of things and working with things that are being studied, you know, you're not really supposed to think about all of those types of— types of topics. So you might see me drinking more water than normal today. My throat is— throat's a little bit dry. So I want to be able to get all this out for you. So starting off in the beginning, I want to kind of do this in 2 chunks because I think it divides up nicely that way. So the first part, I really want to talk about biopharmaceuticals or biological drugs or biologics. They're all the same basic thing if you look them up. And the reason I wanna start there is it's turned out like with a lot of modern medical advances, the field of biological medicine and biological therapeutics is very much at the forefront when it comes to COVID. And it's very much at the forefront if you look at oncology, it's very much at the forefront when you look at autoimmune disease and rheumatology and a number of other things. And so it makes some sense that we would be seeing a lot of biopharmaceutical activity with respect to something like a novel virus that they're trying to search for, you know, either preventive or treatment type of strategies for. The other thing to keep in mind as we discuss biopharmaceuticals or biologics is it's the most rapidly growing segment of the pharmaceutical industry. And so it generally is going to have like the most research dollars behind it. It's going to have a lot of drive from the companies that create biological medications and therapies to, you know, get their versions to the market, or if they're innovating to get their innovative version to the market, et cetera. And I think that, you know, it's a lot of people, again, if you're not thinking about medications and stuff, you may not, you know, you may not be aware of that, how big of a segment of the pharmaceutical world it is. And so, for example, there are some biological treatments that can cost thousands of dollars per treatment. There are some biological treatment strategies, you know, that can cost $100,000 or more in a year. So these are not generally inexpensive sort of treatments. Now, that's not every single one of them. We're going to talk about some that are probably a little bit different, but just to give you some framework, that's, that's the, you know, where the economic impact of biological medications is. So what I thought I would do, because I got so many questions about people saying, for example, you know, one of the, one of the things that comes up is, well, just looking at the question here directly so I quote it right. Basically, I saw, you know, a post on Instagram or Facebook or somewhere like that. And it said, you know, the COVID vaccines aren't really vaccines, they're biological Biological drugs, and what in the world does that mean? You know, I I know kind of what a vaccine is. I've had a lot when I was younger, or maybe I've gotten a flu vaccine, and you know, I kind of understand, I guess, what that is. What's so different about the COVID vaccines, and are they really biological drugs, or what's going on there? And that's a really good question, and and you know, a good kind of concept to start with. Other things have come in questions. Such as, you know, I have ulcerative colitis and I take a biological medication and it's been very helpful with my symptoms, but I know I had to sign a release when they started to treat me with the biological medication that said that, you know, I could have an easier time getting infections or I could potentially even get some rare cancers or something like that, so I had to sign a waiver that I understood that this happened. How does that relate to what we're seeing with the development of a biological strategy for either a treatment with COVID or a preventive, like a vaccine? How do those things relate to this particular person saying, you know, I'm doing this for an, you know, an autoinflammatory condition? How do those cross over at all? And there was a number of other questions, but one of the things I was thinking that would be a really good thing to do would be to start out with, What generally does it mean in, in the pharmaceutical chemical world when we say this is a biopharmaceutical or a biologic drug, biological substance? So what it means is very broad, but these things all relate. So it's manufactured within Or extracted from, or semi-synthesized from a biological source. Now, biological source could be anything from a yeast that we would use to create something. They do gene transfers and things of that nature, to a Culture of an infectious agent that is then used— it's either taken apart and remanufactured, or pieces of it are used to create something like a vaccine or a toxoid or something of that nature. Or as it says, semi-synthesized, we replicate something that the body already has. Okay, so maybe it's really hard to get a molecule that's in the body that works in the immune system, but through modern technology and the really amazing things we can do with pharmaceutical science, we can actually make a lot of things that the human immune system makes as a semi-synthetic and then put that into somebody who's sick. So all of them, the thing that they have in common is that they're They're, as it says, you know, made from, extracted from semi-synthetic of some biological source. So this pretty much would include most standard vaccines. This would include a lot of drugs in the cancer world, as I mentioned, a lot of drugs in the autoimmune, autoinflammatory world, rheumatoid arthritis, Crohn's and colitis, and many, many other diseases like that. Okay. And so in order to put some flesh around this and show you just the variety of biologics that you may already know about or have heard about, I thought I'd talk about some of the more common ones. Now, we— there's no way we could go through all of them. Even when I teach a course for other doctors about biological medications and how they work pharmacologically, we never talk about all of them because it's just too many, but there's concepts around which they're based. And it's important, I think, for people to know, although modern biological medications or treatment strategies come from modern cell biology techniques and a whole lot of modern technology we have to make things, the important thing is that we've had biologics in medicine for literally hundreds of years. So if you use that definition and you went back to the, you know, the early experiments with, say, smallpox immunization around the time of, say, George Washington, you know, those were true, really crude original biologic sort of experimental drugs that turned out to actually work in many cases. So biologics have a very long history. It's just, they've been sort of relegated to things that we could do with old technology until really the last, you know, number of years with modern technologies. Like I was saying, gene transfer technologies and other things that we have that we can do now that we didn't used to be able to do. Now, one biologic that you could think of is a category of drugs that many people need that's life-saving, and that would be the insulin category of drugs. So you've, maybe you sell, you do yourself, or you know somebody or know people who inject insulin, and they do that because they have diabetes and they need to increase the outside, the exogenous insulin in their body. Well, there's different types of insulin, and insulin of the different types is sometimes mixed together to create longer treatment strategies. Or if you look at some of the more modern types of insulin, there's a drug called Lantus, Which is insulin glargine, is the generic name for it, and that is a modified insulin that is made to last over a long period of time. So when it's injected into the person, instead of something like regular insulin that you would inject, you know, with a meal, let's say, that is used up really quickly generally, this Covers you in the background for a long period of time. And so it makes the control of blood sugar easier, provided, you know, you know what you're eating and your diet is matched up to the doses you're taking. Now, if you think about it, insulin is, you know, pretty much a true biologic because it's something that, you know, humans make. It's part of our body, right? So it fits with the, you know, either extracted from or semi- synthesized from, etc. Lantus, this more modern version, is, you know, fits the semi-synthesized, so it does the activity of insulin, but it's been modified in a way so that it meters out its, you know, its insulin activity over time. Now, another really common one there, it has its own, you know, its own TV commercials and radio commercials and all sorts of stuff, is Humira. Humira, or Humira, depending on what part of the country you're from. And this is an example of a really common type of modern biologic, and it's called a monoclonal antibody. And so what that means is that an antibody is often drawn as something that's got like a Y shape to it. And the Y shape of the monoclonal antibody Is part of what is semi-synthesized then as a new drug. Okay, so you inside of your body make antibodies, but you don't make certain antibodies, and that's probably a good thing because they would interfere with the way that your body works and the way your body does the business that it does. Right. So for example, with Humira, it is a human-derived monoclonal antibody. Monoclonal meaning that they all look exactly the same, they're clones. But what it does is it goes into the human body and blocks a particular signaling molecule that the immune system uses. And so people think, well, That seems odd. Why would we want to be blocking, you know, molecules that the immune system makes? Well, normally we don't want to do that, right? But if you look at Humira, and it's going to be used in autoimmune-type conditions, meaning that your immune system is attacking a piece of your body, okay? So you put in this monoclonal antibody that is against a piece of your immune-triggering system, and it binds it up. And it stops it from working. Now, if you have an overabundance of this immune trigger and you have an autoinflammatory autoimmune disease, that can decrease your symptoms and sometimes decrease the damage of the autoimmune disease. So that's the benefit of that sort of a strategy, putting a monoclonal antibody into your body That blocks something your body is trying to do. Normally you would never do that because, or you would rarely do that because your body probably has a reason for trying to do this. In autoimmunity, your body has gotten out of balance and it's trying to attack itself. And so you're trying to stop that attack. But what's the payoff, good and bad? Well, the good side is you can get some really good control. Yeah. over your symptoms, which is always nice. And if you have, you know, a debilitating disease, a gastrointestinal disease, or, you know, a joint disease or any of that, the reduction in symptoms can be life-changing in a positive way. What's the negative side of the balance? Well, this is what I was saying earlier when the person asked, well, you know, I have an autoimmune disease and I take a biologic drug for it, and I had to sign a waiver saying that I understood I might get this, that, and the other thing if I take this drug. Those are side effects. Well, why, if I give you this drug that's so marvelous for helping your immune system calm down and slowing down your autoimmunity, why would it have a negative effect of potentially turning on something like an infectious process that we didn't know was there or we didn't have before? Right. or even a cancerous process or any other thing. Why would it do that? Well, the good and the bad of putting this synthetic antibody in you to block the immune trigger, in this case of Humira, it's tumor necrosis factor. The downside of that is, yes, it's going to give you these symptom control on the other side for your autoimmune condition. But tumor necrosis factor is an important triggering molecule in signaling the immune system to do things. Now, of course, its name is tumor necrosis factor, which literally means something that eats tumors, right? So we found it originally in biology, and I identified this factor in tumors, and it was literally eating tumors, right? Right. causing them necrosis. So they named it tumor necrosis factor. Now we know there's different types of it and all this stuff. Well, originally it was thought, well, this is just a tumor-fighting thing. So if you think of, well, it's a tumor-fighting thing, that's one reason why you might have a higher propensity for certain types of cancers to start if you're on a tumor necrosis factor blocker. But what about infections? Why would I maybe get more infections on a tumor necrosis factor blocker? Well, the reason is, The tumor necrosis factor does way more than just tumors. It's part of the big— I've talked on the program before about the orchestration of, you know, the immune system and all of the different things that go into making it work. Well, tumor necrosis factor is part of what gets your immune system working and also keeps it on its toes and keeps it focused. So in the world of a drug that stops that, if you don't get and develop something like cancer, you can, you can have infections that you literally don't know are going on in your body because your tumor necrosis factor is very effectively blocked. And now your immune system is sort of shut off in that one area. So this is just an example that most drugs in total, but especially most biologic drugs, come with a good and a bad side. Yeah. And a lot of the things that we see as the negative side of a biologic drug, we don't find out for a long time. So we might do trials with these things that go on for a long period of time. And then we get them into larger groups of people and larger groups of people, and then they get approved. And we still look at what happens. And, you know, 5 years after a drug is out, sometimes they'll put a new warning on the drug saying, oh, well, we've discovered that this happens. And we didn't know that for about 4 or 5 years. Yeah. Now there's other drugs that people wrote in and said, well, is this a biologic drug? And, you know, a lot of people had questions of, well, I— this is a biologic drug, is it going to be used for COVID? And that might seem a little weird when you think that most biologic drugs are used in these other areas. But actually, if you look, and if you look at my newsletter, which you can go on my Instagram, it's just DRA Online, Dr. A Online, there's links in the Linktree to the newsletters. But If COVID therapeutics newsletter, you'll see that you know there's literally hundreds of of things that have been drugs and treatments have been proposed for use in COVID, many of which have nothing to do with COVID and very little to do with infectious disease. So it's not really a stretch to think well maybe you know maybe that biologic drug you're taking might be on the list. A couple that are are biologic drugs but aren't on the list right now for COVID, you may have heard of really. Popular common drug in the oncology world is Herceptin. And Herceptin is another one of these monoclonal antibodies that's made by humans. And its job is to literally go and block a particular type of triggering receptor site on breast cancer cells. Now, Herceptin, and it's mostly used in breast cancer, there are some other cancers they're trying it out in, but Herceptin is literally a HER2, that's a receptor type blocker. And there's a lot of other cancer drugs that go in and either block or turn on receptors. So they're like a targeted therapy to go do that. Now, in some people, Herceptin can be very, very useful. It can extend life and slow down tumors, all of that. It's really quite a drug. It's not quite the same as the tumor necrosis factor drugs because it's mostly targeting something that's largely on cancer cells. So it's a little bit more of a targeted therapy. There are side effects, but they're just different. Now, in the world of both cancer and ophthalmology, there's drugs— these 2 are really similar. One is Avastin, which is used now more in oncology, and then Lucentis, which is a similar drug to Avastin that's used in ophthalmology. And you think, what, what, how would we have a connection between, you know, eye problems and cancer? Well, there's a pathological thing that goes on in both many cancers and things like wet macular degeneration, a big cause of loss of vision and blindness, where the body inappropriately grows new blood vessels. So you've probably heard in cancer, you know, that the tumor sometimes will get its own blood supply and steal your nutrients and all this. So it's how they Well, there's a target called VEGF, vascular endothelial growth factor, and Avastin and Lucentis go in and they slow that down, VEGF. And so in the rapidly progressive eye disease and certain types of cancer, those drugs are used to slow the blood supply down to the pathology. Now, they do have side effects as well, but generally speaking, if they're used at the right time, they work quite well. Just as a little parallel aside, although it's not considered really a biologic drug, it's interesting to note that vitamin C also slows down VEGF as well. And we use vitamin C infusions in people with certain types of cancer and with macular degeneration with, with success as well. Another one I think everyone's heard of, and a lot of people make jokes about, is Botox because it's botulinum toxin. So that's another, you know, derived from a biological agent. Then there are like clotting factors. If you have hemophilia, you might be given a synthesized clotting factor as a treatment. Very important. And then there are many other things like gene therapies, etc. Now that's the world of biologic drugs. And so they, as I said, are either synthesized from a part of, or a semi-synthetic of a biologic agent. So what about with COVID What do we see with COVID that would be a biologic type approach to COVID? Well, the things that we've heard about, and I want to explain a little bit, And again, you can— if you— the newsletter, COVID Therapeutics Newsletter, it goes way deeper into this. But the first one that we started to hear about really early on was called convalescent plasma. And you might think about, well, convalescent, you know, is it just sitting around or resting? Or, you know, what does that really mean? Well, Well, what convalescent plasma is, is it's a true non-synthetic biologic. And so what happens is you take somebody who's already had COVID, and they built up some antibodies early on, and you take their blood literally from them, not all of it, obviously, a little bit at a time, and it goes through a filtration process. Okay. And so the antibodies that that person's body made, so not the lab, the antibodies that person's body made are filtered out. And there's ways to do this now with modern, you know, blood and antibody technology. And then those antibodies are taken. So these are human antibodies are taken and the rest of the blood is put back in the person. And then they are purified, and then they are used as a therapy. So literally, if you get convalescent plasma therapy, what happens is you are going to be infused with somebody else's antibodies that their immune system made. Now, this might sound a little strange, or some people think it's kind of gross or whatever, but— If used at the right time, convalescent plasma can be very helpful. Now, there's a couple of problems with convalescent plasma, and that is you have to find enough people who have had the disease. You have to know that they're making antibodies, and you have to be able to do the blood extraction and purification process with them to get these types of antibodies built up. So it's, if you want to look at it, it's more of a production slowdown for convalescent plasma and COVID. So what happened really rather early on was the people who make antibodies in the lab, remember we talked about monoclonal antibodies against tumor necrosis factor and VEGF and and Herceptin with breast cancer and stuff. Well, same technology can just be used to make a COVID antibody, okay? So when you hear about these, these are synthetic COVID antibodies that didn't have to be taken out of a patient who had COVID. And what's the benefit of this? Well, the benefit of this is because we can already synthesize antibodies like crazy, once we know what the ends of the antibodies are supposed to look like, which we do, we can in the lab go and make the template to create these antibodies. And so the— and these are in the newsletter as well, the COVID Therapeutics Newsletter. And they have these long names, but they end in MAB, which means monoclonal antibody. And right now there's a pair of monoclonal antibodies that can be infused into a patient. Who has COVID. Now, the trick with this is, like with your regular normal immune system your body has, if you get an immune antibody response when you're on the upswing of your illness, it's more likely to do you some good. If you have a delay in your immune antibody response during your illness and you get really sick and, you know, you're fatally ill, and so you're in the hospital hospital, maybe you're in the ICU, etc. Antibody treatments don't work as well when you get that sick. So these are the sort of things, whether it's convalescent plasma or the synthetic antibodies, the monoclonal antibodies, that you really want to get into your system before you're terrifically ill. But the idea of using antibodies and antibody therapies are nothing We just have technology to process them, whether they come from other people or a lab, much better than we used to ever in history. So it makes a lot of sense to have antibody therapies to an infectious process that is going on, because that is what your body normally would do. Now, people have posed the question, which is a very good question. Well, What about my antibodies, you know, that I make? Do I have to go get somebody else's antibodies, or do I have to go get synthetic antibodies to fight off an infection? And the answer is no, you don't. The reason that these either human or humanized synthetic antibodies are being used is that this type of coronavirus, the SARS-CoV-2, is one that we haven't seen as humans in this particular form. It's a family we've seen, but this, this particular one we haven't seen. So a lot of people's immune system is slow at recognizing it. Because remember, if you've had a disease before and you get exposed again and it's the same infectious disease, your body already has memory cells that make antibodies and T cells and other stuff that will just reactivate and block the thing from coming in. That's how the immune system works. If you've never seen it before, so they call it novel virus, that means it's new to us as people, then if you have this going on, it's gonna take your body a while to make its own antibodies, okay? Now there's also, there's a lot of people in the world who might be on therapies that would slow the immune system down. Certain types of anti-inflammatory therapies will do this that people may have to be on. Certain other types of problems that folks will have, you've probably read or heard or heard, you know, a lecture or YouTube or something about, well, people with, you know, diabetes have a worse time or people with this disease have worse time. Well, part of the reason is that those are things that have an impact. Those are diseases have an impact on the immune response. So yes, of course, in a perfect world, you would want to be as healthy as possible when you're exposed and, you know, all of that. But even at that, you know, with a brand new virus, if it hits your body just the right way, then, you know, you're, you're going to have a worse time. So in that case, then we have some antibodies that we can give you. Now, is there a common use of outside antibodies that maybe people have heard about, But may not have put two and two together. Well, hopefully it's never happened to you because it's terribly uncomfortable in many ways, but it's fairly common, and that is the acute disease of hepatitis A. So hepatitis A— this is not B or C, it's A— hepatitis A is the acute disease that people get where they have food that has gotten hepatitis A virus into it. And you'll see outbreaks in, you know, your local area. The news might say, you know, if you ate at this restaurant on these days, you have to go check in with public health because there was a hepatitis A outbreak. And people with hepatitis A can get very sick, a lot of digestive complaints, You can get jaundice, you know, where your eyeballs turn a little yellow. All sorts of things happen with hepatitis A. Well, hepatitis A is as pathogenic, as bothering to the body as it is because most of us hadn't seen it before, right? Thankfully, because it's very, very not a good disease. So what they often do, you go into your doctor or public health, is they give you a shot, usually in the large muscle in your hip, of gamma globulin. Well, a gamma globulin injection is, is an immunoglobulin, okay? So when we talk about monoclonal antibodies, that's in the family of immunoglobulins, means it's immunoprotein. Well, the gamma globulin means it's IgG, but what it really is, is a premade antibody against hepatitis A. So it's the same idea. They give you that so that you don't have, you know, liver failure and other problems that can come along with hepatitis A, and it shortens your disease state. Also, you're less likely to transmit it. So they give you outside injected antibodies in order to do this. Now, in the case of COVID whether it's the convalescent plasma or the monoclonal antibody cocktail they talk about, those are infused like in an IV setting, and there was even in the early days of the, you know, it seems weird to say early days of the immunizations or the vaccines, but because it's still the early days, but in the very early days, there was a location in the United States where the distribution center was setting up and they were doing vaccination, but one part of the distribution center got the wrong orders and was actually giving people the IV infusions of the monoclonal antibody against COVID cocktail. There's no harm from that, but if they didn't have COVID, it really isn't going to do them a whole lot of good. Now, other COVID-related biologics. The 2 that we hear about a lot right now are the mRNA vaccines, they'll call them. And those are, you know, whether people say, well, I got the Moderna one or I got the Pfizer one, they're basically the same technology. So what that is, of course, is not an antibody. It is a messenger RNA, literally chunk, that goes into the human body and is protected in what they call a liposphere. Because if, if you just injected messenger RNA into anywhere in your body, there's enzymes around that would just eat it up and it would do no good at all. So the messenger RNA goes in and it's in these little packets and it gets delivered to your cells. Then what happens, at least technically speaking, is this little chunk has instructions to have your cells make some of this spike protein that we hear about that's on COVID. So this is really a biological drug strategy to enlist your cells or trick your cells, whichever way you want to look at it, into making something that they don't normally make. So they're making a particular protein that is the same or basically the same as something that's on the outside of the virus, the COVID virus. Now, the upside of this is, well, that goes out, your immune system sees it and says, whoa, what's this? And makes antibodies and T cells against this protein that's floating around. That's, that's the upside. So the theory is, if you then get exposed to COVID, you're gonna have these antibodies and probably some T cells that are gonna go and they're gonna attack it faster. Okay, now how's that different from most of the vaccines you've probably had? Well, most of the vaccines you probably had, they're still under the umbrella of being a biologic drug because vaccines fit under biologics in a particular category, but they're very different. Most are what they consider viral particle vaccine or infectious agent-derived vaccine. So if you think about it, you get a vaccine against a virus, it's usually an attenuated or altered dead virus, and viruses really aren't alive, but not active virus, and it's grown, and then they put it so much into an injection, they inject it into you, and then your immune cells see it and say, gee, who— what's this? And they make, you know, memory against it, etc. So with a vector, a viral vector, or an infectious disease agent vector vaccine, which are most of what you've had, you're literally getting a usually a piece of, or a dead version of that particular, say, virus, etc., or sometimes some bacteria parts, and it's triggering your immune response. In the case of the mRNA vaccines, they're not giving you any piece of it, they're enlisting your cells to make a piece of the virus. Now, the other, and I want to mention it here because it's related but it's slightly different technology that's coming along, is, so we heard of mRNA, so we hear of RNA and DNA, and, you know, cell replication and all that. Well, the mRNA are the ones, the 2 that are out right now, okay, the Pfizer and the Moderna. There's also DNA strategies. And you think, well, okay, if we're going to trick the cells into making stuff, it's probably going to be either through a vector that's an RNA piece or some kind of DNA manipulation. Some, and as I mentioned in the previous show and in the COVID Therapeutics Newsletter, some of the vaccines are are a lot more on the forefront of probably being out, you know, in the next year. But there's, I think, about 160+ vaccines that are actually in development. And there's 300 other types of drugs that are in development. So there's a lot of drugs in the pipeline, but the DNA ones are likely to be one of the next things out. Now there's different types of these. There's a DNA plasmid type strategy, and that basically has a real similar mechanism to the mRNA, but it's, it's going through a different route that's tricking your cells into making the spike protein. The other one that we hear a lot about is the AstraZeneca DNA platform vaccine, AstraZeneca-Oxford combo, and this one's a little bit different in that instead of Putting the mRNA into little packets that are made out of a lipid, a fat, that's a synthetic fat that's wrapped around it. Instead of that, what they have done is they've taken a chimpanzee cold virus, so a chimpanzee adenovirus that humans supposedly haven't seen before. And they, they do— they basically go into the virus and they substitute a piece of the viral DNA for a piece that will encode for this process of tricking your cells into making, you know, something that your immune system will respond to against COVID. So instead of sending mRNA in, in little packets to do this, in this case it's using a— they call it an inactivated chimpanzee cold virus or adenovirus that they've substituted a piece into that will again go in and drop off this genetic material into your cell to make, you know, parts of the COVID that the immune system responds against. And that's a very Very generalized description of a very long discussion about what that is. I wrote more about it in the newsletter. And also, if you just look up DNA COVID virus, there's a lot of really great pictures of how the— how they manipulate the chimpanzee virus. So there's a lot of different ways to do this. These are all biological methods. Now, Now, as I've always said on this program and anywhere else I get interviewed, I am a doctor, but I'm not your doctor. So I'm not giving medical advice. I'm answering questions that people ask about sometimes very complex ideas, especially around something as touchy and, you know, as sensitive as COVID. And people just want information about how do these things work. So, you know, when it comes to something like— so let's say, you know, heaven forbid, but let's say you contract COVID. Well, it's going to be up to you and your doctor whether or not using, say, convalescent plasma or the monoclonal antibodies or some of the non-biologic things that we've talked about, like ivermectin or some of the other anti-infectives or the antivirals. Would we do that? Okay, that's, that's going to be up to you and your doctor. The more educated you are about it, usually the better that conversation goes. But it's very individualized as to, you know, how sick are you and when, when do you and your doctor decide to do these things and all of that. So my goal here in doing this is to give information so that you then, if you have a deeper desire to look into something, You can look at the newsletter I wrote or look at the resources in there, or you can just go on and search yourself because you have the, you know, the basic understanding of how these things work. So it's not my job to tell you that, you know, the biologic vaccine strategies are good or bad. I'm just telling you what they are and how they work. Now, there's also— we talked about mRNA and DNA strategies for the vaccine. There's also a viral platform that's being developed. which would be more of a traditional— you'd think of it sort of like a flu vaccine type of a strategy. And we don't really know where that is. I mean, we know it is in the pipeline, but we don't know, you know, will it be out or not. The concerns, which are legitimate concerns, with these genomic platform Vaccines, so mRNA and the DNA ones, you know, with the chimpanzee or the non-chimpanzee ones or whatever, is not so much we don't understand the mechanics of how they work in the beginning. If you talk to most people who've gotten the first or the second shot, they had flu-like symptoms. Well, that's because their immune system was activated to do its job. That's the upside. What we don't know And this is not just, you know, maybe we don't know this. This is not just, you know, some fringe group of people are talking about this. This is in hardcore immunology literature that's being published all the time right now. So the people who are into vaccines and know all about it, what they are publishing that they don't know is, okay, we know the front end, we know the upside of it, that we can make these things to get your cells to make these proteins and have an immune response. What we don't know is what's the tail end effect of that, the long-term effect, and we don't know. And if you look at the immunology literature, they say all of these— there's a whole list of things that they they know that they don't know. Okay, now remember last week, if you were listening, I said we have to be very careful, you know, especially with news releases and stuff where it says something about, let's say in this case, the mRNA vaccine. A lot of what's being said is using those qualifying words that I talked about, which are things like, you know, may, could, possibly, but they're not definitive. Because we haven't had these things in humans long enough to know not the short-term but the long-term effects. Now, that doesn't mean that it's good or bad. That's just the fact that has to be thought about and dealt with. And as I said, it's not, you know, it's, it's not, you know, crazy fringy people who are writing about this and talking about it. In a scientific manner. It's being published in hardcore immunology scientific publications where people who know how these things work are just laying out, you know, immunology and saying, okay, front end, we kind of know. Here's all the things that may or may not go wrong on the back end, because we're having the human body do something that we haven't done with humans in the past. Right. Yes, we've developed this type of, especially the mRNA type of vaccines for, you know, things like Ebola and some other really bad things, but we don't have them in millions of people yet to kind of see where that's going. So again, doesn't mean it's good or bad. It just means these are thoughts we should have and conversations that we should have, you know, with, with our physicians and, you know, come to an understanding. About it. Now in the final bit that we have, something related to all this that I think is, honestly I believe is critically important, because I got probably the most, I don't know, the most questions around these. So when you get to, and if you look at I talk about that in the newsletter, the COVID Therapeutics Newsletter, especially. I say, you know, there's different levels of research before you send a drug out into the public. And the end of the trail, it's not really the end, is FDA approval. And then there's something usually called Phase 4 trial where they're post-approval monitoring, right? Right. Right. Then there's Phase 1, 2, and 3, which are increasing amounts of scientific scrutiny about a new drug or treatment. Okay. Almost everything that we have spoken about is at the Phase 3 trial level, which normally, when you don't have a pandemic going on, has not been released to the public. It happens, but it's very rare for the public to generally be given a phase 3 trial drug. Right now, in the mRNA vaccines are a prime example of it, and so are some of the antibodies and other stuff. They they don't have FDA approval. What they have is the EUA, the emergency use authorization. Which is a loophole built in by the government to say if something really bad happens, we can push something through faster than the normal you know trajectory. So under normal circumstances, a phase three trial drug might be given to a large number of people, but it's not released for sale to the public or distribution to the public. So we need to be aware of right now, and this goes back to that idea around well we you know we know the front end kind. of the basics, but we don't know the long term. The reason phase 3 trials go into so many people is to see, you know, what are the trends we need to watch for? What are the dangers that we need to be on guard for? What are the groups of people who probably shouldn't get this treatment? And that's all happening with the general public right now. It's not happening with people in a trial. Wow. So you do need to know, so if you or me or anybody else goes down and, you know, we get our first or our second, you know, COVID biologic vaccine, we are part of a very grand-scale phase 3 trial. It's not like other things that have passed that bar and are now FDA approved. Okay. Again, that's neither good or bad, but that's information that I believe is important, and it's very widely available information, but a lot of people ask questions about it because it's, as I said, it's happened before, but it's unusual to push a phase 3 trial drug out to the general population as quickly as we have with the mRNA vaccines, so people don't, in their, in their headspace, it's like, well, like, you know, isn't it FDA approved? Or, you know, what does that mean? What does emergency use mean? Literally, it means just that. It's an emergency use early release of a medical device or a drug. And so, again, not good or bad, but it's information that I think we all need to know and think about when we're trying to weigh, you know, what are we going to do? You know, are we, you know, a lot of people aren't, you know, you, there's the priority list and you may be way down the list anyway, so you may be a while and that may be great for you because you can kind of see, okay, we get it out to a few million more people, are there still adverse events, are these unusual and rare or more common, or what should we watch out for? Those are the kind of things that you normally have happened in a phase 3 trial before it goes to the public. So we're sort of, I mean, we have early data. Again, look at the COVID Therapeutics Newsletter. I kind of go into what we do and don't know. We have early data, but we don't have the kind of thing that we would normally have, which would be, you know, a lot bigger groups of people. Now, I said earlier, There's plenty of examples of FDA-approved drugs that got approved and didn't have side effects that we knew of, and 5 years later had warnings on them for side effects that we found out in the 5 years after the drug got approved. And I think that's a very important thing to keep in mind when you're going through, you know, the calculus of what to do. But again, best contact point is for you to be educated and then you to have conversations with your healthcare providers. and, uh, and have open, honest conversations. But we are out of time for today. And we've been talking today on Medicine Health with Dr. Paul Anderson about biological medications, drugs, and treatments, and specifically how that relates to COVID. And these are based on questions that I got that were really, really wonderful in the last week after the last radio program/podcast. But I'm Dr. Paul Anderson from Medicine Health with Dr. Paul Anderson, and I will see you all On the radio next week, and we'll have a brand new topic. And it might be like this week, it might be based on an avalanche of questions that I get. Anyway, you can check out most of the links on Instagram, DRA Online, Dr. A Online, and Facebook is DR.A Online. Those are avenues towards all of the online material, and you can get access to the newsletters there, etc. But I'm out of time. So thank you very much, and I'll see you next time. Thank you. Week.
