Sawbones: A Marital Tour of Misguided Medicine - Sawbones: Clinical Trials

Episode Date: December 4, 2020

Dr. Sydnee and Justin have turned themselves into lab rats as they join a COVID-19 vaccine trial. But how did humanity discover the practices and policies that guide these sorts of human experiments? Listen and find out!Our primary source for this week's episode is this excellent article by Dr. Arun Bhatt.Pre-order The Sawbones Book paperback!Music: "Medicines" by The Taxpayers 

Sawbones is a show about medical history, and nothing the hosts say should be taken as medical advice or opinion. It's for fun. Can't you just have fun for an hour and not try to diagnose your mystery boil? We think you've earned it. Just sit back, relax, and enjoy a moment of distraction from that weird growth. You're worth it. that weird growth. You're worth it. Alright, time is about to books. One, two, one, of Miscited Medicine. for the mouth. Wow! Hello everybody and welcome to

Saul Bones, a marital tour of misguided medicine. I'm your co-host, Justin McAroy. And I'm Sydney McAroy. Hi, Sid. Hi, Justin. We've had an interesting week. Yes, yes we have.

It's always an interesting week if your eyes are open and your heart is ready for the world around you. There's always something fascinating around every corner. But that's a good way to look at it. That it has been a bit of a hard sell this year. That that sort of idea. I said I think there was a beautiful mystery behind every casanthamum and a wonder and delight in the smile of every child. So I really appreciate the world around me. Well, that's good. Good for you.

So for me, it was an exciting week because we participated in a vaccine clinical trial. Yeah, that's true. We led by your mom. My mom is not leading the trial. No, she did not design and she's not responsible for the trial. So do we want to walk through our experience or I was kind of thinking I would start with the history of clinical trials before we get into this. I don't want to dive into far.

Let's get into history and we'll talk about how one for us. Sure, because we did tweet about it. And so I know a lot of people are asking, how did we find out? What was it like? What was your experience? And I want to talk about that whole thing. But there's, I think it's kind of interesting first to look back into like, how did we figure out how to do this? Because it's so I think

that the scientific method parts of it seem very logical now. Not all of it. It still needs explaining, but just the idea of like let's test something to see if it works before we put it in our bodies. Makes sense. Well those in hindsight things. Well, of course. Well, obviously. But how do we get there? And so I think it's interesting to look back. If you're looking at what is regarded by a lot of people who write about these things as one of the first sort of clinical trials, so to speak. And this isn't anything like what we would call a clinical trial today, but a lot of people make references to a story from the Bible.

Oh, really? Yes, in the Book of Daniel. Bash no science. Uh-huh. Uh-huh. In the Book of Daniel, there's a story about King Nebuchadnezzar, who I remember from Veggy Tales. Yes, I think there's a lot of people's touch down for Nebuchadnezz. I believe he was played by Azuchini.

Yes, well that is actually factually historically accurate. Nebuchadnezzar was of course Azuchini. So he, I guess liked his soldiers to only consume meat and wine, thought to be the healthiest diet at the time. So we're proto-adkins. And he had a group of soldiers who said, you know, we don't want to eat meat. The wine is fine. Wine we're okay with.

But we don't want the meat. We would prefer lentils. And those are also, you know, that's a high-density carb. don't want the meat, we would prefer lentils. And... Those are also, you know, that's a high-density carb, a lot of nutrition packed into those legumes. Good stuff, lentils. And so this group of vegetarian or perhaps vegan, I don't know.

More be lentil, Terran. That's all they're all they like. Stead up and said, we don't want to eat all this meat anymore. Maybe they realize like we don't feel so good when we got to do our soldierine after we've eaten a bunch of meat. Yeah. So we'd rather eat lentils and he said, well, tell you what, for 10 days, you guys eat the lentils with your wine and everybody else is going to eat the meat with their wine. And we're going to see who's healthier.

They're gonna have a fight. They're wins. I don't know. Somehow it was judged that the lentil guys were healthier than the meat guys at the end of 10 days. I'm saying guys, that's not, I don't know the genders of these soldiers and I'm kind of assuming from the time period that they were probably. But either way, so the lentil people were healthier than the meat people and I know right now all of our like vegetarian and vegan listeners are going, uh-huh Yes

Well listen, nobody likes a note all so why don't you stop talking to your phone and just listen to the podcast, okay? And and I guess that could be considered a trial of sorts, right? Yeah, you had two groups. Yeah. You changed one thing about the two groups. You had one variable. Right. I don't feel like it was randomized necessarily. You just had the people who wanted to eat lentils and the people who didn't. Yeah.

So that's not really random. I may have been dead, but they gave them up for science. We don't know. I don't know if they wanted to eat lentils. But in 1025 CE, Avicena was really the one who kind of laid out, who sort of thought of as like the father of clinical trials, the one who wrote down basic ideas that we still use today when we're designing a clinical trial. So like we need two different groups to compare if we're going to decide if something is working

or not. We need to think about confounders, which are confounders are other things that you can't control in an experiment that might affect the results. Yeah, that might confound or mess up the results and lead you to believe something that isn't necessarily true. So you have to look out for those kinds of things when you're designing a study and reproducibility. This is something that I think we often forget just because a study leads to some sort of conclusion, doesn't mean that's it, we did it forever. We're done. You have to be able to like reproduce that result. If you get one answer one time and then the opposite

answer 30 times, well, then maybe you were wrong. The science is bad. There were also the Babylonians used to actually just have somebody who was like sick kind of stand in a public place and like have different people come up and offer advice. Okay. And like you could like you I'm gonna display my sick person and then different people can offer advice and we can compare advices like. Let a sick person know kind of where we're at. That's a way you could do it.

We also had kind of an example of an experiment, so to speak, from Samuel Peppas, who wrote about an experiment with a subject, a local college had hired what was described as a poor and debauched man to have some sheet blood led into his body. Mm-hmm. A life full. As an experiment. So I guess those are sort of...

I guess it's an experiment. Trials. Although that counts as an experiment, I've done a lot of things in my life that you get kind of as an experiment. I really just... I wouldn't call myself a scientist because I dumped a bunch of Spider-Man vitamins in my milk to see if it gave me super powers I like to mention Samuel Peppas because he's been misquoted widely on the internet these days. Mm-hmm Everybody thinks that he said some really like in in hindsight some really intelligent things about the plague That were applicable to the coronavirus today.

And when you see those memes circulating on Facebook and Twitter, those are actually not, he didn't really write that. It'd be really cool if he did. Don't get me wrong. If he was saying like, I'm not going in the bars because you're gonna get the plague there and we were all like see, see?

We knew in the 1600s, but he didn't write that. Oh, okay. Yeah, I just thought that that was worth mentioning. Okay. Is there any other bubbles he'd like to burst before he move on? We've talked about Paray a lot on this show because he did, he revolutionized a lot of, when we think about like surgical care in like good ways. And likewise, he sort of inadvertently

did one of the first early trials. In 1537, he was treating wounded soldiers. And at the time, the customary treatment would be to take boiling oil and just cauterize a wound. I mean, it's still rough. Right, it is. But the problem was there were so many wounded soldiers. He knew he didn't have enough oil.

There was no way he was going to be able to, you know, cauterize all these wounds. So instead, once he ran out, he started applying a mixture of egg yolk, turpentine, and rose oil. Just a guess. I have to imagine it's a wild guess. Here's the weird thing. So the next day he went to check on all of his patients and the ones that got the mixture of egg yolk, turpentine and rose oil actually were doing better.

Now is that a tribute to the efficacy of that blend or is it a tribute to just how bad it is to dump scorching hot oil onto winds? Bingo. It's not that this is good, it's just the other one is so bad. But this actually, it was important because it changed his practice and he talked about that. He wrote about that.

Like, I saw it head to head. It wasn't better. Now it probably led a lot of people to think that it was a good day. It was a good day. And Ego was a good mixture. But we've talked at length about Skurvy and James Lind. We did a whole episode on it. So I don't want to rehash that whole experiment, but it has to be mentioned if we're going to talk about the history of like the development of clinical trials, because what James Lynn did with Skurvy really is one of the earliest examples of like intended,

like I am trying to do a study. This is intentional. I am trying to set up like control groups and different variables. I'm trying to figure out what works best. And in 1747, he took 12 sailors who had scurvy, divided them up into six groups of two and gave each of the six groups a different treatment. So two soldiers, two sailors per group got either vinegar, this elixir that was like popular at the time, some sea water, some nutmeg, some cider, or oranges and lemons.

And then, of course, the citrus fruits. That did it. One out. That did it. You and I, I don't know that. And that immediately fixed scurvy. No, it didn't. Actually, it was 50 years before that recommendation would be adopted. And sailors would be issued lemon juice

and then later lime juice because it was cheaper. Because it was really expensive. That's why, did you know that? Really? It was just cost prohibitive. That James Lynn figured it out and the British Navy would be like, we don't know what he wanted to lemons. We don't know what he made of lemons.

That's basically what they said. Like, we don't have, we can't, what do you, there's no point. What's like, they can't do this. There's like eight lemons right now. Because look at can't do this. There's like eight lemons right now. Because look at the calendar right now. There's like eight lemons. Because of this May 20th is international clinical trials day.

I didn't know that because of this. Uh, what I enjoyed is that as I was preparing this episode, I was um, reading about James Lynn's trial and Charlie came and asked me what I was reading about and I explained it to her and her reply was, can we act that out with our toys? So you recreated this with who? I guess Peppa Pig families. Peppa Pig was in there, Minnie Mouse was in there, SpongeBob, Squidward, two dinosaur toys that I think we got from a fast food restaurant. All of

her favorite characters were in the group that got oranges and lemons. Oh, that's nice. Yeah, you want that. And then then once you didn't like as much, didn't get the good stuff. All right, I need generic dinosaurs. Sorry, you got scurvy. Josh from Blues Clues was James Lent in this. Oh, yeah. He was solving a mystery. He was. Peaceing together the puzzle. I love it.

Yeah, it was a weird thing for her to want to act out. But I'm not gonna lie, I was proud. Yeah. So in the late 1700s and early 1800s, the next big thing that was like a step forward for the idea of a trial of a regimented way of testing a therapeutic was placebo. Placebo was originally something that you would give a patient not necessarily to make them better, but just to make them happy.

That's nice. About it. Yeah. Initially, these weren't necessarily inert. A lot of the times we think about a placebo now is like a sugar pill, right? Something that has absolutely zero effect. Back then, a lot of the times a placebo

would be some sort of like maybe herbal or folk remedy that doctors didn't really think worked, but they knew patients liked and it pleased them. And so they would just say, well, just use that. That's fine. Well, in those days, like if a pill didn't give you diarrhea, you knew that it was not real. Like this can't be medicine. It didn't get me higher because of the diarrhea. Which makes sense because eventually

when that would be replaced with like sugar pills and bread pills and things like that. Tell me about bread pills. I mean, I'm assuming they're just pills made out of breath. Just tiny little pills made out of bread. But once they were replaced with those kinds of things, then you would know it wasn't doing anything. Or at least you would know it didn't have any very clearly demonstrable effects on your body. The way that some of

those early patent medicines probably did, even though they weren't necessarily treating your cure and anything. But these, again, these weren't necessarily for trials at first. These were more just for patient satisfaction. In 1863, a doctor Austin Flint kind of did a study using one of these herbal treatments as a placebo for rheumatism and then used and established like what he believed to be the real treatment in hospitalized patients and patients.

And this was the first time when people went, ooh, hey, we could do this in studies. Like, that's where this placebo stuff, that's where this business could be really helpful other than just like patient satisfaction scores. We could do it to learn something. Was the idea with placebo's not using fake placebo's was the idea of like, well, we'd like to do,

we wanna do something for them, even if it's not the medicine. Like, it was less scientific and more, well, I guess it's still scientific, but it's like, well, we want to help them in some way, maybe. Before they were used in trials, placebo's were very much, it was not a bad thing for a doctor to be giving you something

that they didn't know would work because our idea of what we knew would work was so different. I mean, what you're really talking about is this idea that if the patient seems pleased with the treatment they've received, you've done a good job. Which is very... Best of my fifth, this man. Well, and that's a very different goal

than I want something that I know works for the condition that this patient has. So if you gave somebody a placebo and then they, you know, a week later told you that they felt great and they told other friends about it and they're feeling, and they're back to work or whatever, then good. Yeah, great. And you did it, you know. So it wasn't so necessarily tied to like, is it real?

Is it real though, honey? Is it real? I don't know. I mean, if if you're patient, is it real? Yeah. The mind body link. You and I don't see eye to eye on this, but no. Well, I'm an empiricist. This is, this is, this is the conversation. I believe that the mind has incredible power to heal the body. So if your mind believes something is real, then then you still are getting a practical benefit. It's different. So there's a difference in opinion. I think that okay, before we delve into this sort of philosophical argument any further, Why don't we head to the billing department? Let's go. The medicines, the medicines that ask you

let my God for the mouth. So what we really think of? Wait, you didn't want to delve any more into the philosophical discussion of the mind body link. No, I was trying to distract you with ads. And it worked. You're always distracted by ads. Fair enough.

It's true. So in the, uh, in the 1900s is really when we see like the, at the same time, the governments were figuring out how to regulate medicines and drugs and all that kind of stuff. We were figuring out how to test them more rigorously, right? Right. So, uh... Not much since in regulating them if you can't actually talk to them or if they're working or not. Well, and I mean initially there were just like counsels set up by like the American Medical Association where like a bunch of experts just went, we think this works, but that doesn't.

So, anyways. There it is. Um, but... We're going to lunch. In 1943, the Medical Research Council of the UK did an actual double blind randomized control trial with a drug called Patulin that was used for colds. And they enrolled over a thousand British people in it. They gave them either placebo or patulin. It didn't show that the drug worked, but it was a really good design.

I'm sure that was cold comfort to patulin. And in 1947, that was built upon with streptomycin. So there was a huge study that was designed in 1947 to see if streptomycin would be a useful medication for tuberculosis. And what's really interesting about this trial is that in this one, so the way they used to randomize patients, like if we're gonna test streptomycin, then you would just give it to every other patient.

Like if you come in, you get streptomycin, the next person who comes to the door doesn't, the next person who comes to the door does, and so on and so forth. Can you foresee what the problem with that is? Like, why would that not work? Why is that not an okay way to randomize patients? I don't know. So let's say that the next, first of all,

imagine doing that in a small town like ours. What are the chances that I'm going to know one of the people who walks through the door? Very good. And what if they walk through the door and they're a friend of mine? And you want to give them the good stuff? And I want to give them the good stuff because I really think it works. Or flip side. You don't want this stuff.

It's basically rat poison that we put orange flavor into. Do not. You cannot. I'm going to give you the fake stuff. So there's part of it. The other part of it is like, you might be tempted to, if somebody came in who was really, really sick and you thought,

well, it's kinda true, why, no matter how much I believe in this, I don't think that this is gonna work. Maybe you don't wanna include a minor starter. Yeah. I'm not saying that this all kind of human stuff. I mean, maybe you're like a huge racist. I mean, it doesn't.

It could be anything. There's so many ways that this could go wrong. So the idea was that can we really, let's randomize people in a way that we're even the person who's bringing them back, putting them to bed and giving them medicine doesn't know who's who. Take the control and that's the whole idea of like a double blind trial.

Right, so like the doctors don't know who's getting the real thing, the nurses don't know who's getting the real thing and the patients, the subjects don't know who's getting the real thing. Triple blind. Yeah, well, no, it's still like. Dr. D. nurses count as one group, yes. And so this was a big revolution.

Now we can do studies where we can really get good data. This study was like inspiring to many. We can get good data back to show us, you know, exactly what works and what doesn't. It, by the way, did show that Streptomyce was helpful. Oh, good. See, a win, a win for science. You know it's interesting. About the win for science. Now I will say do you know what the alternative was at the time? Nope.

Bed rest. Okay well, you could do that too if you want. So and I should say a Bradford Hill, Austin Bradford Hill, was the one who designed the study was a statistician and he was famous for this. He is known as one of the early, you know, like, scientists statisticians who really got this stuff and was able to like put it all together. Congratulations, Stan. And throughout the 1900s, you start to see like the protocols, okay, so now we know how

to do it, but like, so now we know how to do it But like how should we regulate this stuff? You can kind of imagine what sort of events drove Titer controls first After World War two and the Holocaust sure there were a lot more Regulations put in place as to like you have to tell people they're in trials and they have to agree to be in them. Yeah, and you can't just You have to let them out if they don't want to be in the trial and also there are you can't just experiment with anything on Anybody for any reason like you have to have reasons. Why do you think this works for this and that kind of thing?

Right We don't you know because otherwise you just harm right? Tuskegee is another good example of after that came to light that that is it's unethical to have a treatment for something and not give it to people just so you can observe the natural history of a disease. Yes, that is. And so things like that evolved into the concept of informed consent. Do you know that? I use that term because I use it all the time. Do you know what that means informed consent? I got the idea, but maybe.

That is a, for a lay person, it makes sense. In the medical world, that concept of informed consent is incredibly important. And I think it is more than just its words. Obviously, before I do a procedure or give you a medicine or whatever, you give me consent. I asked, do you want it or not? And you say yes or no. The informed part is hugely powerful, because I have to inform,

I have to make sure that I feel confident that you understood why I think it's a good idea for you, why someone else might not think it's a good idea. What are the risks? What are the benefits? But also, you know that I know exactly what that means. What am I, what am I acquiescing this means? And that's, it can sound very simplistic,

but it really is, I mean, you can spend, if you're good at your job, this will take you a long time, sometimes. I mean, sometimes really easy, right? You have strep throat, here's the antibiotic for it. If you don't take it, here's what happens. If you do take it, you'll get better. You know, it's, sometimes it's really straightforward, but informed consent sometimes is not that straightforward and takes a lot more time to really make sure that you and the patient are on the same page. you know, it's sometimes it's really straightforward, but informed consent sometimes is not that straightforward

and takes a lot more time to really make sure that you and the patient are on the same page. So that concept took a long time to evolve alongside the idea of it. In the US, as I mentioned, initially evidence-based medicine was guided by like the American Medical Association, the AMA and the FDA, Initially, evidence-based medicine was guided by the American Medical Association, the AMA and the FDA. They kind of moved from, like, at first, how would you decide if a medicine worked? Well, a doctor just said it did, to, like, these pooled observational kind of studies where, like, let's get different doctors from all over and all of their opinions and come up with a consensus. An expert consensus opinion is still used to

guide practice to this day in areas where we have an absence of data. But that was replaced, especially with the use of the FDA by like actual rigorous studies and trials. This was driven forward by a couple incidents in 1938. There was an antibiotic sulfanelomide that was released which was good and did work. It sounds bad. Well, it's one of the early sulfa drugs. The name seems just sounds bad. The drug is not bad.

The problem is that it was when it was prepared, it was put in a solvent of diethylene glycol, which you probably know by the name antifreeze. Oh no. Yes. And so that's not solving anything. Exactly. A hundred people died because they were given an antibiotic that would have worked had it not been mixed with antifreeze. She's a peat. And there were a ton of new regulations put in place after that incident because they didn't test the final compound. They tested the sulfonilamide, but they didn't test the final thing

they were about to put in human bodies, right? Right. So that changed things. And then the litamide in 1961 would lead to a lot more oversight and regulation. I will belabor that because I think that's a whole episode in and of itself. And over time, the other big change that has been made slowly is initially when you would do these studies, you might focus on like, oh, one, there was an idea of you needed a population

that could handle it and two, who you had access to and that kind of thing. And so there are, you know, there were definitely, and we've talked about it on the show times, when populations who did not have control over, you know, like a population that was imprisoned would be used for these trials. But also sometimes it would just be, you would do a whole trial of young, healthy, cis, straight white men. Yeah. And like eventually they had to say, well, I mean, maybe these trials should not only

have men in them. And maybe we also need to check on the elderly because they can respond to things differently. And maybe also kids, we need to know what works for them and what doesn't work for them, because their, you know, their bodies can react differently. And beyond ethnicity, there were a lot of things that had to change to get truly diverse sample populations to check a drug in to see, does it really work or not? Which isn't just about inclusivity. It's safer for everybody. Yeah, it's safer for everybody. And it makes sure that the pill that I'm recommending to you would work for you and not just

for a group of people who are completely unlike you, you know, that helps us for a lot of reasons. So I want to talk a little bit about our experience now because we, so how did we find out about it first? That's one big question. So your mom mentioned it to us, but I actually, you know, it's not hard. You can Google like COVID-19 trials in your area. Vaccine trials. Vaccine trials in your area. And if one's going on, you know, or I think there are some services like match you with a trial in your region. I kind of thought it would be like jury duty where they'd have to like call you

if they wanted to, but no, you just apply to do it. Yeah, it was actually really easy. So my mom was very proactively looking for one. Yeah. And found this one. And immediately enrolled both her and my dad. And then after asking our permission, enrolled. She enrolled us.

Yeah. Enrolled both of us and my sister Riley as well. And then also pass that information on to like 30 other people in our area. Which I've been doing the same thing. Like, hey, this shot, I've been surprised at how many people have been like, I'm just gonna wait until it's done before I participated in any sort of trials.

So I want to tackle that right away because I think that bleeds into the next point. So it's done before I participated in any sort of trials. So I want to tackle that right away because I think that bleeds into the next point I wanted to make, which is people have asked why, why did we get involved in this trial. To fold for me personally, one is, you know, there's a decent chance that we're going to, I mean, there's a decent chance we get're gonna, I mean, there's a decent chance we'll get the vaccine. Also, decent chance we'll get the placebo. It is a better chance that this study design, which by the way was the AstraZeneca slash Oxford vaccine is the one

that we have either gotten or gotten placebo of. Yeah. The first dose at this point. Yeah. There are two doses, 28 days apart. We have received the first one. And it isn't, if you're interested, you can read about it. This is 28 days apart. We have received the first one. And it isn't, if you're interested, you can read about it.

It's supposed to be an adenovirus vector vaccine. They use this harmless non-replicating virus to deliver. Technobabble. Anyway. So, I like the idea of one, I like the idea that whether or not I get the vaccine, I'm helping the, you know, we're kind of putting our money where our mouth is, our bodies, where our mouths are, which is part of our bodies,

know that I think, you know what I mean. We talked about vaccines a lot on this show, and I like the idea of being able to help a little bit with a vaccine. That's cool, makes you feel good. Also, be chill to have a vaccine against COVID, Sydney is a healthcare care worker and you know my I'm less worried about myself. And you live with me. That's why you're worried. You live with Sydney.

So yeah, I don't and you know her parents are my dad and stepmom are you know in their 12-year. You know, I would say that about them. They might listen, not like that. I would say that to my dad's face. But the point is we want to try to protect them too. So I don't know, this will be. I mean, those are pretty much my reasons. That's what I would say. I would couple to that.

First of all, I was not worried because even though a lot of people have used the word rushed in regard to these vaccines, I do not, I do not see them as rushed because the thing that usually hangs up vaccine or drug development is not that it takes that much time. It's not, I mean, it's not that you need necessarily more hours in a lab to figure out how to do these things or to make sure that they work or to make sure that they're safe. It's not really that. It's usually an issue of funding and also competition. So if you're gonna put a ton of money into a new vaccine or therapeutic,

you are gonna want to make sure that the thing you come out with, you're going to be able to make money off of, make that money back and then let's be honest. Make a profit. Yes. And so a lot of that time is in making sure before you throw more money into it, taking it very slow. Sometimes it's getting the funding for it.

And then sometimes a lot of drugs will make it to phase two, and people will just decide not to go any further because other drugs are out competing them already, you know, and might make it to market first and get the big share of the money and so on and so forth. So for all those reasons, that's why it usually takes so much longer. Those barriers weren't in place this time. These vaccine companies have had tons of access to funding to drive this as fast as it can go. This is... Maybe they're at warp speed. I would not use that word. This is how fast drugs can be made when all of our scientific and societal will is pushing in the same direction. This is the same energy that got human beings

up on the moon. This is what we can accomplish when we all have a common goal. The thing is that's not always the case. We're getting bogged down. Let's just talk about our experience because I think that there is going to be at least one episode just talking about why getting the vaccine is a great idea. So why don't we talk about our personal experience? So when we, first of all, we went to the center, which is about 45 minutes from where we live.

It was in a doctor's office. I think a lot of doctors can apply to have these trials at their facility. And so this was in like an outpatient office. We went to the waiting room, which was nicely laid out and socially distanced with like chairs and signs. Signed in, we had to fill out a, we had to read a very extensive informed consent form, which was actually very well written. It was very plain written, not a lot of what you would expect more lead leads. And it wasn't really that. It was more sort of a clear understandable here's what you're getting into when you sign

up for this. So it felt less like the stuff you click through when you're trying to install something. Yes. You know, it was not that. It was, I thought it was very well done. And it asked the questions exactly, why would I do this? Why would I not do this? What are the risks to it? What are the risks of, I mean, of the procedures that are around it, because like they do have to draw your blood first, they do store your blood somewhere. All those different things were very explicitly explained and you had to check that you understood every single page. Before you could have a thing where if you hit to go to the next one too quickly,

it'd be like you didn't really take your time with that. Do you want to take another look and see? It recorded how long you spent on each page. Yeah. So once you read all of that, if you were in agreement, you signed it, you turned all that in, and then we were called back first for basically an HMP, a history and physical. So a doctor came in and asked a ton of questions about my health history, my current symptoms. Wanted to establish that I was at risk for getting coronavirus. What were my risk factors for actually getting the disease, which as a healthcare worker, that was pretty much it.

But because if you never leave the house and you'll never be exposed, we won't know if the vaccine really worked or if you just never encountered it. Which is always a possibility, but you want at least some risk for your subjects. They had me take a pregnancy test to ensure that I was not pregnant. Anyone of child bearing age was expected to do so. And then they drew blood. Not the most pleasant, but it was fine. It was fine, I did not bother.

I didn't look and I was a big tough guy. Part of it was for like a genetic study that they were doing in conjunction with us. And then I believe part of it is to check for antibodies ahead of time. But they don't look, they don't like condition what you get on that, because they can't get the results that fast.

It's all in one visit. And then once they had done all that, I went a very brief physical exam. Yeah, not much of anything to write them about. Yes, very, very minimal. And after that, they came in and I rolled up my sleeve and they administered something. Sailing? Either a saline injection or the vaccine itself. So let's talk about the reactions that we've had in our coister.

So immediately I had a little bit of redness and a little bit of swelling and warmth at the injection site. Nothing painful, I didn't feel anything, but you could see it on examination. I think I was the only one who had an injection site reaction on that first day. Nothing else, I felt fine. The next day I had some swelling and some sortness at the injection site. As did Riley, and a little bit of a red circle at the injection site. As did Riley and a little bit of a red circle at the injection site. My arm was sore the following day, again,

about what I would expect with other vaccines I've received, things like the flu shot or a T-dap or something like that. I had some symptoms. I did have a headache. I had some body aches. And I never had a symptoms. I did have a headache. I had some body aches. And I never had a fever that I recorded, but I felt like some subjective,

like chills and sweats and that kind of thing. Your mom had a similar reaction. My mom had a similar reaction. Riley had a similar reaction. So maybe it's genetic, who knows? I don't know. You did not, you just felt a little tired. A little rundown, not too bad.

Of course, that could be honestly, so worse since the symptom to try to distinguish between psychosomatic and not, because it could very well have just been than it was just tired. Like that is entirely possible. A little bit of nausea too. We all had a little bit of nausea. My dad felt nothing. Nothing. Not a single of any of the things I've mentioned

in my dad feel. Now as to who got it and who didn't, we don't know. Yeah, that's cool. The, what we do is we go back in 28 days, we get our second, whatever, placebo or vaccine. And then my understanding is after at least two weeks after that, there is some period of time after that, we will be made aware of what we got. And at that point, the other thing that they did say, and also they will be drawing antibodies periodically as we move forward to look to see if we're creating antibodies. We're also going to have to keep going for the next two years, or should we keep checking up on us,

and we're going to continue to be participating in this study. So it's not just a quick and easy way to get a vaccine. It's going to be frequent drives of Charleston for quite some time. It's not that frequent. It's not that bad, and we may have gotten the vaccine, so it's worth it, and we're furthering science. That's a real exciting part. That's the big thing.

Of course, they'll be looking to see if any of us get coronavirus. We're supposed to report immediately if we have any symptoms so that they can find out. And they also, in addition to continuing to measure our antibodies, they are following up on like symptoms and side effects and that kind of thing. That's the other thing they are checking for.

So they'll be calling us, you know, a week from when we got it, so in a few days to find out how we're doing. Yeah, there's been like, I've gotten some email, I don't know if you've been getting emails about like asking me to log my symptoms. Yeah, there's like an I got some email. I don't know if you've been getting emails about like asking me to log my symptoms Yeah, there's like an app to check things on and I should mention all the symptoms we had were gone within like two days Yeah I would I would call them mild and I would say that I would do it again if that means I got the real deal I would happily go forward again

It was no worse than what I've ever seen from any other common vaccine. One thing that I think is important to know, they made it clear that if at any point a vaccine became available to us was approved and available other than this vaccine, then they would tell us which one we got to allow us the possibility to get that vaccine. So we are in the AstraZeneca trial. If at some point we had the opportunity to get the Moderna vaccine or the Pfizer vaccine. Or the Pfizer vaccine.

We could ask that people of our trial, like, hey, do we have the wrong thing? Because if not, you know, I'm gonna go get it this. Yes, and ethically they have to tell us at that point. They've made that very clear. Which on the assuming we bumped you out of the trial, right? It would. Yeah. You'd be removed from the study.

And you can leave the study at any point. They they make that very clear and I just want to I One quick note one a lot of people ask why are there placebo's and vaccine trials? Do you remember Justin? Well, it's so because you have to compare how many of those people who got the placebo also got COVID so you know how effective your of those people who got the placebo also got COVID, so you know how effective your vaccine is. Right, because you accept that most vaccines aren't 100%. So somebody's gonna get COVID. And if you didn't have a control group,

what do you compare those numbers to? The other thing is I do wanna make a note, a lot of times when we talk about the hesitancy of trying a new drug or therapeutic or vaccine, a lot of people point this out that's a very valid concern. Populations in this country that are marginalized or have been abused or taken advantage of in our society have been unfairly targeted for these types of things in the past.

And there is still a lot of hesitancy when it comes to trying an unproven, you know, drug or vaccine or whatever, among maybe members of the black community or people of color and indigenous people. And I think all of that is understandable and valid and deserves the time and attention to how do we overcome that together? How do we work together to make sure that people feel very comfortable that the thing they're receiving is not, we're not using it experimentally on you

because you're in a marginalized population. I always want to give voice to that because sometimes we're so easy to dismiss like, why would you be worried? Why would you be concerned? And we've talked about things like Tuskegee on this show before. Well, why do you think people would be concerned? Yeah, there is not a great track record there. Yeah, especially when it comes to the United States government and especially with the current administration, I can understand why people have hesitancies or fears, but I am going to tell you that Donald Trump has nothing to do with the production of any of these

vaccines. He's not in a lab. He's not working with test tubes or beakers or pipettes or petri dishes. He wouldn't know how. The scientists who are making these vaccines know what they're doing. The science is solid. The numbers are good. I am not worried about the stuff I've seen so far about the AstraZeneca vaccine. It didn't give me pause. Put it right in our veins, baby. The fact that it is shelf stable or the fact that it is refrigerated and as opposed to having to be kept in a deep freeze will be a big plus for like World communities like ours for sure and other parts of the world where a deep freeze vaccine would be very difficult

logistically All these vaccines are needed and let me just say I would have gotten any of them. Yeah, sure whatever trial I could have enrolled in I would have I'm not gonna enroll in multiple that would be bad Except for the mountain-do one. I'm not sure that's a vaccine at this point. I mean, it's made by mountain dew, what do they know about vaccines? I don't think they're making a vaccine. I assumed they would be. Actually, I'm not a mystery that had lined up. I think about it. Vaccines that mountain dew, COVID red. No, but I would, if it is something you're interested in, look in your area, there might be a trial near you. You'll be a little late at this point, but hey, go for it.

They're still there still going to face three trials. And there are other vaccines coming. These ones we've mentioned are the ones they've talked about because they're for this along. There are other vaccines still being trialed and they're working on. It's going to take a lot of vaccines to protect everybody. And it's going to take a lot of time to convince everybody that we need these vaccines. You should get them. They are safe. They are effective.

And not to be a, you know, all doom and gloom, but it is not easy to tell when you will be able to easily get a vaccine of your own. So, you know, if you are open to this, I might be worth exploring. And you're doing your part for science. If you can do it, if you feel comfortable, and if you are of a health that you can do so, this would this may be a good thing for you. Thank you so much for listening to our program. We hope you've learned a little something.

Hope you enjoy yourself. I want to ask you, right now, if you would be so kind, head on over to bit.ly-forthslash-saubernespaperback. That's right, the sobboons book is back and it is in beautiful paper. I mean, it's always been paper, but this is really great paper. December 29th, this new additional will be released.

And yes, it has a new content. We did some stuff about quarantines and the like relevant to today's world. Relevant to today, new illustrations by Sydney Sibling Taylor Smirl. And it's just great. And I really, it would mean a lot to us if you would be so kind as to go pre-order that bit.aui-ford-slash.

Salmons paperback. And you know, it'll be out December 29th. So maybe you'll leave a little picture under the tree. It's like, I got you this book. It'll be here soon. It's a beautiful gift. And you know, New Year's is just around the corner. So what better way to start?

Anyway, you get the idea. Bit.aui-ford-slash-salmons book. Sorry, Salmons paperback. Thank heard so much about Solman's book. Sorry Solman's paperback. Thank you so much to the taxpayers for these their song medicines. It's the intro and outro of our program. And thanks to you, Sid. Thank you.

For listening. That is going to do it for us this week. So until next time, my name is Justin McRoy. I'm Sidney McRoy. And as always, don't draw a hole in your head. Bye! Yeah! Maximumfun.org. Comedy and culture. Artist-owned? Audience-supported. Hey friends, Jesse here, the founder of Maximum Fun, and I have some really great news

to share with you. This year has brought a lot of changes for all of us, and one tradition that we were grateful to be able to hold onto is is our annual PIN sale to benefit charity. This year, through your generosity and love of PINs, you helped raise $95,400 for Give Directly. If you're a member and you bought PINs, they'll ship in January. In the meantime, your support will provide direct cash relief to families impacted by COVID-19 across the United States. Even in this incredibly tough year, the Max Fund community remains extraordinarily kind. And whether or not you bought pins, you can continue to help

by heading to givedirectly.org. That's always thank you. you