Sawbones: A Marital Tour of Misguided Medicine - Thalidomide

Episode Date: August 24, 2021

In the 1950s, Thalidomide was rolled out very quickly and what followed was a tragic story that highlighted perils of greed and hidden agendas. This week on Sawbones, Dr. Sydnee and Justin attempt to untangle this murky narrative, and highlight the doctor who heroically kept this disaster from claiming many more lives.Music: "Medicines" by The Taxpayers

Saubones 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, talk is about books. One, two, one, two, three, four. Hello everybody and welcome to Salbones, a Marl d'Or of Miss Guy and Medicine.

I'm your co-host, Justin McRoy. And I'm Sydney McRoy. And I'm so excited to, because we're returning to proud Salbones tradition of the combo. That's right, Justin. You, I was going to say last week, but I guess we missed a week in there. Yes, that's true.

Sorry about that. So sorry about that, but we're back. To continue, you talked about VIX. I did. You gave a history of a brand. Yep. What really it was. Medically relevant.

And that was for one, thank you again for doing that, because you had to do more work than me for once. And secondly, it led to another story that we wanna tell this week. We alluded to it in the last episode, but it was much bigger. It merited much more than a mention. I like the alliteration of that stuff.

Much more than a mention. It merited much more than a mention. Yes, very good. So that is the story of another drug. We talked about VIX and their VAPO rubs and all of their other products. But VIX is part of a company Richardson Merrill that you talked about. Yes. And they also created another, well they didn't create.

They were bringing to market, attempting to bring to market, another drug called Kewadon. Right, and this is one that we sort of like, idly, I think I'm not mentioning it in passing and so we'll return to it. And this is us returning to it. There are a lot, I just wanna say before we get into Kewadon, there are a lot of wild drug names, no doubt, that people come up with is like the brand name for something.

Kewadon is way up there for me. Really? What? Well, it sounds like a robot Kevin. I guess it does kind of sound like a robot. That's not where my brand immediately went. Do you know what I guess it does kind of sound like a robot Kevin? If you heard Kavadan, would you ever think, oh, that's a pill I should put in my body?

No, but I don't think I'd necessarily think robot named Kevin. Because what you said presupposes that Kavadan is the'd necessarily think robot named Kevin because what you said presupposes that Kevin Don is the name of the robot named Kevin. So is it named Kevin or is it named Kevin Don? It's well, I think of a Kevin that becomes a robot. Okay, half Kevin half robot out of hero. No, it is Kevin Don. Yeah, Kevin Don The medication Kevin Don not a hero Okay, I don't want any of the blood. No, it had already been, so, okay, before it was named Kavadon, it had other names, we're going to get into.

And as Richardson-Marrow tried to get the medication, Kavadon marketed and sold in the US, it was already being used widely throughout Europe as like a sedative like a sleeping pill mainly. It had a little bit of cure all rhetoric around it a little bit of like it can help with coffee, it can help with fatigue. It's a good all-around drug. But mainly for sleeping and for nausea, it was an anti-emetic meaning it would stop puking. So unfortunately, there were some side effects of which not many people were aware when Richardson Merrill applied to the FDA to begin marketing the drug in the late 50s, 1950s, because overseas, this drug, it was known by a different name. It was not Kavadan. It was not a robot of any kind.

It was known as Thalidomide, which you have probably heard of. Yes. That was a called Thalamid, sometimes, or Contragann. Contragann. Contragann. That was the original thing that came out to the market in Germany was Contragann. The history of Thalidomide, and this is, I'll be quite honest.

For a change. No, I'm always honest. But the history of this, it's funny because I think that we figured out, I mean, as soon as Thalidomide, because most people already sort of know the story that Thalidomide was a drug that caused problems and had to be removed from the market very quickly. So it was not prescribed for a very long time in the grand scheme of things. And so a lot of the problems with it and the history of it was written soon after that. But our perception of all the events and people around that really shifted when only in

the last like decade or so, we have, there have been a lot of other documents related to it, like from the companies that created these meds and from court documents. There's been a lot that has been uncovered more recently that has shifted our understanding of how did this happen and who was responsible. So, and I wanna put that out there because when you're trying to research the history of this,

it's really important to look at like when the article or whatever the archival piece, whenever it was written, when it was, when it came out. Because we got some new dirt since then. It shifts the narrative a bit. I mean, the detail, I mean, like the major plot points are basically the same. But if you're, if you're sitting there at the end of this going, how did this happen? The answer is probably a little different now than it was a decade ago. And that's history, it's always evolving, or we're always finding out new stuff. Yeah, that's true.

The picture's always changing a little bit. That's true. Maybe not to this degree though. You think about history as a fixed thing, but it, and I mean certainly the events were, you know, there were facts. There were truths But because we weren't there for them our understanding of them and our perception it really depends on who's telling it right I think we've learned that many many times over in this country and every other one So the history of the litamide at least dates back to the early 1950s when a Swiss pharmaceutical company the chemical industry

Basil or Siba, developed it. Now, there's been some recent discussion that this drug actually may have been developed in the 40s, specifically by German scientists in the early to mid 40s. Which would be Nazi. Nazi scientists. Yeah. There has been Nazis. Nazis scientists. Yeah. There has been a lot of concern.

There has been a lot of concern after more recent documents were uncovered that this drug may have been developed and used and tested by Nazis. Either way, it had not been brought out to the market or sold or that kind of thing until we know the fifties. The initial compound when the at least as far as the Swiss pharmaceutical company was concerned was not that interesting. It wasn't thought to do much. And so it was not until a German, what was initially a soap manufacturer? Really? They made soap and then they kind of got into antibiotic steering world war two and we can imagine perhaps some other things. They did some more testing on it and found a like an active

metabolite of it that was a sedative sleeping agent and then decided that they wanted to do something with it. And most of the story as we move forward, this Kimmy Gruninthal is the company that was responsible for bringing it to market and for a lot of what ensued the bad parts, I should say. And again, it is in more recent years, it has been noted that following World War II, there were a lot of Nazi scientists and doctors who, if they did not have to flee the country, if they were not, I mean, the ones who were not captured. If they didn't flee the country, sometimes they could hide within these sort of big companies that were maybe willing to look the other way at their past or maybe had sympathetic employers. Maybe they start maybe they just they're all of a sudden they're dug

Smithson just a regular. Well, I mean, Joe Lunchbox like you and I. Probably still be a German name because we're still in Germany. Oh right okay. I don't think Doug Smithson is a popular German name. No. I could be wrong. No, I got you though. I said they're not hiding out in America. No or Argentina or something. These are these were people who continued on working and living lives without without having to run I guess and there's no I mean this is not I they're like Vrinderbombe Ron who is a you, literal rocket scientist that we brought over who was absolutely

Nazi. Yes. I mean, that this is not just Germany or this company. There were lots of big companies, and especially in the scientific, like, pursuit, who were willing to, which, I mean, I don't think you can ethically defend this at all, willing to look the other way on the fact that they were a Nazi and employ them for their scientific knowledge. So definitely there has been a lot of ties, like they have found that there were a lot of scientists working with this company who had this background, who had that past. But to focus on Thalidomide, I just think, I think that's an important part of the story because as we see what unfolds and how much damage is done before this drug

is pulled from the market, I feel for me, and my understanding of history, that informs it somewhat. Why maybe people kept looking the other way or ignoring what was right in front of them, considering the price that might be paid if they were wrong. So the initial research in animals and humans seemed to show that it was safe,

and it was marketed at first as like, this will be a good sleep aid, and pretty soon they figured out it was good for nausea. And that happens actually a lot with drugs, where like a good example of this is, you've probably heard of well butrin. It's an antidepressant. That's when it's well butrin. That's how we market it.

Does that the one that's smoking aid too? So after they started testing it for depression, they also found that people who took well butrin tended to quit smoking more easily. So then they did more studies to prove that it could also help with smoking cessation and market it under the name Zayban, but it's the same thing. That's just a little market expand, I understand. Exactly. It's just the same drug used for two different things. They figured out that this was really good for nausea, too, and specifically for morning

sickness, so the nausea of pregnancy. As a result, thalidomide or countergam, as it was first branded, was initially marketed very strongly to pregnant people for morning sickness. And I think that it's important to know, and this would be 1957, by the way, so it was released in 1956, and my 1957 is being very heavily marketed for pregnant people to help with morning sickness. Other adults were taking it for sleep and there were other side effects that we'll get to for them, but that specific indication was targeted right away.

Now this is where, depending on what stuff you read, you'll get a very different picture of the scientific milieu around this. So at that time, and the drug company in court documents would argue this very adamantly, at that time, it was not widely accepted that drugs could cross the placenta. So the idea that you could take a pill, and it would affect the baby. And it would affect the baby. That was not well accepted. Now, to be fair, a figure that we're going to bring in at the end of this, Dr. Francis

Oldham Kelsey, had been involved in studies back in the 40s that proved that drugs did indeed cross the placenta. So some scientists knew, but I think it is at least fair to say that it was still a matter of contention. Do any drugs cross the placenta in any meaningful amount? Could it be possible that a pregnant person would take a pill and it could harm the developing fetus? Is that possible? So the drug company would argue that nobody knew this,

nobody believed this. Other doctors would argue, well, I mean, yes, some of us knew. Yeah, it was out there, like you could have figured this out. The other thing is, while it's true that at the time doing research in pregnant people was perhaps not the standard, doing more testing in humans and considering the effects on the reproductive system in general and pregnancy

and the pregnancy. All of that was part of it. The drug company again argued that a lot of the testing they did was really just enrodance at first. There was very little human testing that was done before this drug was given to people. And they argued that, like, well, yeah, maybe we've changed that now, because the court case would be a decade after all this. But we didn't know back then. We didn't do that back then. We didn't do that. That's not quite true either. There was a lot that they didn't do as they brought this to market

that even at that point, even though it was early in the history of like pharmaceutical safety and monitoring, it probably was done. Certainly not the standard we would hold it to today, but even by the standards of the day, they probably, I mean, I think it is very fair to say, not probably, it's very fair to say that they weren't

doing everything they should do. All that being said, they were selling a ton of this stuff. It really became a very popular drug very quickly, very much so in Germany, and I should say West Germany, at the time, it was actually never approved in East Germany. They didn't feel that there was enough It did not fill an emergent need and so since they hadn't done a lot of studies It would have sort of like we talk about

Medication if it fills an urgent need you can get an emergency use authorization, right? That was kind of the way East Germany looked at it like well You haven't done enough research for us to approve it. And it's not emergent. Yeah, so we're not with it. So it was never approved there, but it wasn't less Germany. And then all throughout Europe, it was being sold. And a lot of the times it was just being sold, by the way, not prescribed. Oh, and a lot of these places where contragan was marketed, you could just walk in and

buy it over the counter. This is also the original C II.B.A. the chemical industry. No, this is now Kimi. What did I say their name is? Guteninthal. Gruninthal. Got it. Gruninthal. Kimi Gruninthal is the one pushing this out there. So sales are increasing. I mean, and at this point, the drug is incredibly popular. In West Germany by 1960, they were, West Germans were consuming a million doses a day of solidamide, which is on average, which is a wild amount of this drug.

So much right. So as contragan is sold in Europe and Germany, it is licensed and marketed in the UK, Australia, New Zealand, as a distavol. So this is like a fast rollout. There pushes it, pushing out a lot of places. Yeah, this is all happening within about a two to three year period that all of this starts going because you'll see everything kind of falls apart by 61 and it started in 57. Marketing, as we'll see some of the things they might have known before 57, but marketing.

In Canada, it was called Talimal and overall 46 different countries would eventually market and distribute this medication under different names throughout Japan, different parts of Africa. I mean, all over the world. Geez. Now, part of why there wasn't immediate understanding of the risks of Thalidomide were because of the way that human pregnancy works, right? It's a 40 week process. It's so delayed. Yes.

40 week is it? Is it something that you would take regularly or was this like a, as it was as needed? So, but I mean, it... Some people are probably popping a lot more, some people are popping a lot less. Well, and if you think about like, if you are someone who has a lot of morning sickness

during your pregnancy, you might be taking quite a bit of this. And it's also at the very worst time in terms of being formative. Yes, because that was the most damage where the early trimesters. If you only took it in the third trimesters, there's a chance you could have gotten away without any damage. Are there some drugs that you like are supposed to avoid in the first trimester that are okay later on?

Yep. Yeah, there are definitely some that we know theester that are okay later on. Yep, that is, that there are definitely some that we know the biggest risks are while, sort of all the, if you just think about it from a very general perspective, while all the pieces are still being made. Yeah. And then by the third trimester,

a lot of what's happening is just growth. Yeah. So there are things that would be more dangerous early on and safer in the third trimester, which can be true about the litamide, although that being said, the recommendation as you may imagine now, is do not take this drug in pregnancy period,

make sure you are on a form of some sort of prevent pregnancy at all costs while you're on it. Oh, so we're, okay, you know what, you're gonna head yourself because I wanna hear. Yes. Okay. Because, so it took a while.

There were some adults that had already started raising concerns, non-pregnant adults, who were taking it for probably the sedative effect. And there was a letter published suggesting that like there was some nerve damage that could be occurring, if you've heard peripheral neuropathy, like nerve pain in your periphery, so handsome feet. There had been a lot of cases of that starting to be reported. So there was some concern about that.

Like the US started to be concerned about that, which we'll get into. That was a lot of what East Germany was concerned about. And in addition, pretty early, you get some reports, scattered reports coming out of initially German hospitals, because West Germany is where it was being used the most, that there was something else wrong with Thalidomide. Actually, one of the pharmaceutical company, Kimmy

Grunenthal's, one of their own chemists had actually given Thalidomide to his wife while she was pregnant, and subsequently she gave birth to a child with some congenital syndromes. Subsequently, she gave birth to a child with some congenital syndromes. So, and there were multiple, and so like one case like that, perhaps that's not enough. There are multiple cases though, like that, that we're beginning to sort of pop up here and there, that people were writing to the company,

doctors in Germany, and we're reaching out to them. Is there really is 1956, even before it was really mass marketed. Like I said, it was released in 56, 57 was the big push. As early as 56, there were some reports on earth that people were riding them going, I think something's wrong. There was a journalist who observed like two of his family members who used the drugs,

had some, had gave birth to children with some issues. But every time somebody reached out to the drunk company with some concerns, their response was pretty much, huh, we've never heard that. So we heard. Every time, no matter how many times they heard it, huh, we've never heard that. And so it wouldn't be until 1961

that because of a couple of doctors, we finally figure out what's going on. And I want to tell you about that. But first let's head to the billing department. Let's go. Let's go. Let's go. Let's go.

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The cure for your f*** news overload, available on MaximumFun.org, or wherever you get your podcasts. Said the cracks had begun to show in a pretty major way when we left for our foray and the crash commercialism. So in 1961 is when I think there's been a critical mass of all these different reports that you start to get a lot of noise being made by the medical community. First, in November of 61, there's a German pediatrician,

Wydukand Lins, who kind of connects the dots and puts together a lot of data showing that there are a large number of pregnancies where the little might is prescribed and then the babies all tend to have these same issues. And he was a geneticist, so he was seeing a lot of this. Like, because when the babies were born, there was a thought that they might have some sort of genetic condition.

He was the one being called to see and put it together. And specifically, and to, I'm gonna get into everything, but specifically the thing he kept getting called to see was if a newborn had photomilia, which is Greek for seal arms, but it's underdeveloped arms or legs. Which is because, if you're interested, the litamide can interfere with the growth of blood vessels, and as the limbs are developing,

obviously they need blood supply. So if the blood vessels cannot develop, then the limbs cannot develop. And there was no known genetic syndrome that explained all of those specific constellation of symptoms. And he began to put together the thalidomide with that. He reached out to Gruninthal with concerns about the drug in November. And within just a few days actually, Dr. William McBride, who was an Australian OBGYN,

wrote a letter that was published in the Lancet. Very respectable. Yeah, with very similar concerns. One of his nurses, actually, Sister Sparrow, had raised the issue to him because she worked with different physicians. And only the, she noted that only the babies that he was delivering, that he had managed the pregnancies

were being born with these problems. He was the only one prescribing to live my life. Yep. And I'm brushing over the, I want to get to another part of the story, but I should say like there are whole histories behind these other two, these two dudes I just mentioned, like they're both controversial figures. There's both a lot of other than anyway. I don't want to, well, I don't want to get into like Dr. McBride kind of spent like I think a good bit of his career after that.

It seems like looking for something else like this, accusing other drugs of having problems and maybe some of them didn't. It's kind of a one-hit wonder. Well, I mean it's... It's a cataractous form of glory. Dr. Lens's father was a very prominent Nazi and what eugenics, I should say eugenics proponent associated with the Nazi party. I think what Siniya is, if you're wondering why we didn't park the car here in this paragraph

and visit the, the museums and statues dedicated to these people, it's because they're going to try to find by with a little bit of like, oh kids, that's a complicated one. We don't really have this. It's not, it's not, it's rarely lauded as heroes. It really took me a long time to research this episode because I knew, I knew the end thing that I wanted to tell you about the part that I think is interesting and relevant to today and was a good story. And as I was digging into this further and I started to find these very concerning connections about this pharmaceutical company and maybe there were not these scientists working there. And then I started reading about these other two guys

and how like, I mean, they did this good thing. I'm not saying that this wasn't good that they called attention to this because somebody needed to, but I don't know, that's history though, right? Like a lot of complicated figures. And if we're talking about the 1940s and 50s, a lot of in medicine, a lot of, yeah. Well, moral quagmire, conjuries that we don't necessarily have the ability or bandwidth to.

I can't tell all these stories in one. I do have a relevant story I want to get to though. So anyway, with the issue raised, people all over began to put it together. The litamides seemed to cause, like I said, nerve damage in adults, and then tragically more severe problems for the fetus if someone was pregnant while they were taking it.

So it could cause definitely miscarriages. There are a lot of cases, and that was probably why some of this wasn't caught too, is that in many cases, the litamide didn't necessarily cause birth defects, it caused the pregnancy to end prematurely. It's truly necessarily, I mean, that happens. It's tragedy though, maybe you wouldn't necessarily like make the connection.

It's not visible. It's not, yeah, right. And it's not such a, like you were talking about, we didn't know what would cause this other thing. So like you'd go looking for cause. So the severe issues like a cause were like I said, Focomilia heart disease blindness. There were different some specific malformations of the ear, internal organ damage, nerve damage. internal organ damage, nerve damage. Overall, worldwide around 100,000 people were affected either because the pregnancy ended in a spontaneous abortion or miscarriage is the colloquial term. Spontaneous abortion is the technical scientific term for that.

Or through these sorts of congenital syndromes that were developed. It would take years for the drug to completely disappear from all the markets. There were a lot of places, like I said, where it was still being just sold over the counter. And it would take a long time for the company first to stop marketing in second for it to just completely vanish for them to like call all the doctors they'd given it to and tell them to destroy their samples and so on and so forth. Now two quotas that I want to kind of cover to this story are first of all as you can imagine even after you know the pharmaceutical company groaning thought even after the pharmaceutical company, Groen and Thal, even after they pulled it from

the shelves and told everybody not to take it and so on and so forth, there was a court case, of course. Yeah, actually. It was another thing that, like I said, secret documents were uncovered many decades later that sort of gave it a different light. It ended in a big settlement. They weren't ever like, prosec, like they weren't held criminally liable. They just settled it by giving like

a hundred million of their currency at the time. I forget which one it would have been in. But anyway, it would have been a hundred million. It's almost always a lot. It would have been equivalent to But anyway, it would have been a lot. A hundred million is almost always a lot. It would have been equivalent to like 24 million US dollars or something like that. So a lot of money. But it was for all, it was like a fund for everybody

to like claim out of. So it ended up not actually being, I know it sounds like a lot of money. My point is that it wasn't sufficient. It actually was not, they got off pretty sounds like a lot of money. My point is that it wasn't sufficient. It actually was not. They got off pretty well with this is the point. All things considered and especially since like, it wasn't just about money. Although these families did need money because they needed money to help them take care of

their children, you know, that lifelong issues that may arise. There was also the fact that this company, I mean, I think, you know, by today's standards, we could say acted with negligence. And so it's not just about paying for your misdeeds, it's about, can we trust you with continuing to make drugs? And I don't think they ever really had to deal with that question. Yeah. They just paid a lot of money and moved on. And it seems like with documents that have been uncovered since then that perhaps there was a lot of backroom

dealing with the government and stuff at the time to just make this go away, which is unfortunate. Interestingly, I would say the drug Thalidomide has been found to have other uses since then, specifically for things like leprosy and multiple myeloma. This is what I was gonna say. I didn't realize it's still like a going concern. But just obviously never, never for a pregnant person.

Right, obviously. And if you look at, I've seen pictures of some of the pills of Thalidomide since then where they have like Pictures of a pregnant person with like a line through it like on the pill. Yeah. Oh my gosh You can find on you know Any I've never heard that before I I have not seen it on a pill before but I was on acutane when I had acne as a teenager and the It was it came in one of those punch-out

pill packs and every single... Oh, I'm looking at it. Yeah, that's why. Yeah, every single punched-out pill has a picture of a pregnant person in a line through it on it. So, I have seen that before. And you know, I don't know. It's interesting.

I know that selidamide can still be used. I certainly, let me say this, I don't know. It's interesting. I know that solidamide can still be used. I certainly, let me say this, I have never used it. It's got restricted distribution, but it is still listed as a treatment that you can use. So I have never, I have never done that, but I know that it is possible. It is never, now here's the, here's the, the other interesting part.

Let me get to the other store. I'll tell you. Because it's taken us a long time to get here. The other story is from the US. So I told you about all this that happened all over the world. And you may have noticed, I mean, we are in the US. Usually I try to tell stories about the US, because that's the things I know, and the things I learned most about.

Why didn't this happen in the US for the most part? Which I didn't even realize. Like, it was not, because I had heard about it so much growing up, I didn't realize that it wasn't like anywhere near the sort of calamity it was globally. No, it was nowhere near the problem here that it was elsewhere. Now there were 17 cases in the US.

So I don't want to, any suffering, especially that could have been prevented with the proper protocols is not okay. So I don't want to minimize that. 17 is 17 too many. But obviously we did not have the large numbers that they did in other countries. You may also be wondering Justin Sidney, why is this a story that you want to be talking about at this exact moment in history?

That's understandable. About the evils of big pharma pushing untested medicines on people without any knowledge of the risk. Well, Sydney, tell them, tell them why it's such a relevant story. So, uh, I want to tell you about Dr. Francis Kathleen Oldham Kelsey, uh, originally from Vancouver Island, born in 1914, studied in Chicago, the University of Chicago, and went to medical school, became an MD, became a, I believe, a general practitioner. So sort of like what I am, a family doctor, same idea. A little different now, but same idea. And the reason I want to tell you about her is because right before all this would happen, she had been appointed to the Food and Drug Administration hired to work there. And the first drug that came across her desk to review the application for was Kavadon. So it just, you know, sometimes this was September of 1960, by the way, if you need a timeline.

If you remember at this point, by 1960, this drug was being widely used around the world. It had not taken hold in the US yet. And while there were scattered reports of concern, we didn't know what it was yet. So the company that Justin told you about last week, Richardson Merrill, a pharmaceutical company out of Cincinnati, applied to the FDA in 1960 to market Thalidomide as Kavadan in the US. Again, for sleep, but also to be used for pregnant people who have morning sickness. The stuff that, and I should say when they submitted their application because it was already so widely used, the thought process was, this is just a formality.

This is just needs to be rubber stamped, cut through the red tape, get through the bureaucratic nonsense, and whoever this doctor Kelsey is, get her to sign off on it, and we're going to make ourselves a ton of money. And it was not uncommon for these drug manufacturers to lobby very hard directly at these FDA scientists and doctors that was at the time, that was very common. They submitted their application, and she looked it over and thought, I just don't think this is enough. It's funny, she even at one point when, because what she did was say, I need more information.

I don't really think that this is enough for me to approve the drug. There's a lot. You didn't include in terms of studies and efficacy and safety and toxicity and all these things. And they were curious. They actually called her boss. And we're like, who's this lady?

I think she is. She's telling us that our drug isn't good and get her fired or whatever. And to their, especially for the time, to their credit, they stood by her. As you can imagine, a female physician working in that position in 1960, it would have been very easy to just say,

oh yeah, this lady didn't know what she's doing. She actually at one point had to run it by her husband who was also a scientist. We do that a lot in our house. Pretty common. So that he could say, no, she's totally right. In the initial application, they said stuff like this, drug has no toxic, no lethal dose. Well.

I mean, and he said that seems very, like, almost, I mean, yes, there are drugs that have incredibly high lethal doses, but it's very weird to say that there is no amount of this drug that you could take that would be dangerous. Right, yeah. have incredibly highly thildoses, but it's very weird to say that there is no amount of this drug that you could take that would be dangerous. And there was a lot of stuff that they said, that she said was a lot more testimonial about the evidence they produced, not actual clinical studies to show that it worked, but just a lot of people took it and thought it was great. So certainly this is okay, right? So she refused. They

threw in some more information. She refused again. This would happen five times, by the way, four times. She sent it back and refused. The fifth time, as we'll get to, she didn't get to refuse that because they'll actually withdraw their application before she gets the chance to refuse the fifth time. time she did and throughout this entire time the drug company is getting furious and they are writing and calling everybody they know in washington putting pressing as many levers as they can to put pressure on doctor kelsi to just let them get their drug out there this is ridiculous the germans love it the brits love it they love it in australia they love it in Australia, they love it in Japan,

all over the country, all over the world. Like what is wrong with you that you won't let us do this? It was okay at the time I should note that even though it had not been approved by the FDA, it was okay back then for them to send out samples of it as like a pre-marketing thing to doctors in the US. Right, right. So they sent out like around 1200 to 1200 doctors or so samples of the litamide for them to

give their pregnant patients to prevent morning sickness or to treat morning sickness, even though it had not been approved at this point. So she continues to say no, she continues to say no, she's concerned about the fact that she knows because she was involved about the fact that she knows because she was involved in the early studies that show like well, some drugs do cross the placenta actually. She already knows that. She knows that they can affect the different drugs can affect pregnant people and fetuses differently than they do, adults who are non-pregnant. These are all brain, these are all concerns. And then when the initial report from the British

Medical Journal comes out about the peripheral neuropathy, she really starts to become concerned. So later in 1961, when we start to get all this information from the other two doctors I mentioned in Germany and in Australia, then Dr. Kelsey is really concerned. Right. So at that point, you know, the Richardson Merrill had once more put in an application by early 1962, they withdraw this last application to the FDA because they've realized that, you

know, we do have a problem. This drug is an issue. We've got a change course. But because of that, the only reason we didn't have this giant problem with the litomide in the United States that they did in so many other countries is because of Dr. Kelsey, because she rigorously adhered to the process to the scientific method, to data. I need data. This isn't about politics. This isn't about personal opinion. It's that you have to prove these certain things. And then once, because even in 1961, even in 1961, 1962, the years that this was going on, even then, we already had some of these

protections in place. Now, because of Dr. Kelsey, there would be a lot more protections put in place, because like I said, the only children who were harmed in the United States by these drugs were, I told you that they were allowed to send out those samples. Those were the only cases that people were able to access this drug, which, you know, obviously you can't do today, thank goodness. But because of this, she would be awarded by President John F. Kennedy in 1962, the Distinguished Federal Civilian, President's Award for Distinguished Federal Civilian Service, which is like the highest honor of civilian getting the U.S. And since, and that very year 1962, they made the FDA even stronger than it already was, put in all kinds of new protections in the years that followed a lot more of these sort of loopholes

that Richardson Merrill was attempting to pass through that Dr. Kelsey stopped them, were closed. And that is why the process is as rigorous as it is today and why when something like the COVID-19 vaccines make their way through the process and are given emergency use authorization, and I think by the time this podcast airs, at least the Pfizer will have full FDA approval. I don't know that for sure, but based on what we know so far, it looks- So you're inside sources.

No, based on all the news articles that have come out about it, I think that this will be true. But that is why it is so safe, is because we've been there, is because we've seen what happens when you don't follow science, when you don't look to clinical studies, when you don't do all that stuff, and why we won't repeat it again, because we've made that mistake before. And we have laws put in place, and people who learned from this and watched this and saw Dr. Kelsey do it and were inspired and moved to do the same thing. Well, here are two quick fun facts about Dr. Kelsey. Yeah.

The first is she continued to work at the FDA until she was 90 years old and lived another 11 years after that, lived to be 101 years old. The other thing that I think is interesting that I stumbled on when I was first looking into this, she did her undergrad work and then her masters and then there was a fellow named Giling, EMK Giling, who was a doctor who was turning up a new research from a college, she researched department in the University of Chicago

and she applied to do her postgraduate work there when he got the application. Is this true? I didn't know if this anecdote was true. I mean, it looks, I did it in an elective true to you. It looked real to me. Tell the anecdote. Okay.

This meant, it looked, see, this is from the account of the guy that was the person. I was looking meant, it looked, see, this is from the account of the guy that was there with him. I was looking for a corroborating source. Well, I trust you. I shouldn't say this is what Sydney read the same thing by her, maybe she doesn't pass the mustard. It's a good story regardless. Yeah, tell us the story and we'll say it might be apocryphal.

The, this guy, this dude that got the application was confused about the fact that F-R-A-N-C-E-S is traditionally a female name versus a male. With IS. With IS and he addressed Dr. Kelsey as a male in his like acceptance letter and she wondered to her sort of mentor that encouraged her to apply the first place. Like, should I like correct this cat?

He's like, no, you should sign and go work there. But there's a direct line though, work that she was doing with Giling was like got into like work on specifically crossing the placenta. That was, it got her into this path. Like it's only and her being in the path of this saved, you know, who knows how many lives.

Yeah, it really is. Another person might not have done it. It's really fascinating when you see the claims that the pharmaceutical company that Gruninthal was making in Germany that allowed them to sort of skate past that weren't necessarily true. And that Dr. Kelsey had done the research specifically to know why those claims were false

and why there was more to it. She'd actually been working on a malaria drug, a lot of docs were at the time. That was the most common thing. And there was a sort of quinine-like medication. And she knew what it did when it crossed the placenta and the effect that it had on rats that weren't and were pregnant and all this stuff. So her research had set her up to be the perfect person

to take this very like run of the mill, just rubber stamp it, run it on through, drug application and say, wait a second, something's wrong. And also I think like besides the fact that she had that knowledge base, she was a person who believed in doing things in science the appropriate way. We have a scientific method.

There's a reason we have these protections in place. There's a reason we do it. And while a lot of the time science can give us a good clue about what's going to happen, sometimes unexpected things, like with Philodamide, can happen. And if we do those proper testings and put those protocols in place at how to time, then we have our tragedy, which is again, what we've seen with the vaccines that have been approved, that have been granted emergency use authorization. They are because they went through all the proper testing,

all the proper protocols, they are incredibly effective, incredibly safe, and the best tool we have to fight COVID-19. Thank you so much for listening to our podcasts. We want to encourage you, you know, because we haven't done it in a while. Give back to me that if you have it, it's fun and easy and free and remind people that it is free. It's free. Ask about your insurance information.

It's just so they can charge your money, cropping monstrous insurance company. Instead of the government or whatever. Yeah, that's it. But you don't pay a penny. It's free. It's free. It's free. Please encourage people around you to get vaccinated.

Please have those conversations. They're hard, but you're more likely as a as a friend or a relative, as a trusted companion to convince somebody than I am as a faceless podcast voice. So really have those conversations. Please, when you're in, please, please wear your mask, especially if you're in school or sending a child to school. I would encourage masking. Pediatric hospitalizations are up. Pediatric cases are up.

Kids under 12 can't get vaccinated. Our best tool for them right now is a mask. Oh, there's some, been some talk about boosters too. Fouch says don't get your booster early. Quite a bad twerth. I think the big thing is like, we have a real problem worldwide with vaccine equity right now.

And if it is in all of our best interest, not just because like be a decent person, everybody deserves a chance to get vaccinated, but it is in all our best interest to vaccinate as many people as possible as quickly as possible worldwide, not just in the US, to stop the variants from evolving as fast. That is in all of our best interests. Yes. Variants are only fun when they're on low key. Thank you so much for listening to our podcast.

We got merchandise at McRoyMarch.com. And thanks so much for listening. We really are happy to have you. Oh, thanks, taxpayers. For the use of their song medicines as the International World Program, that's gonna do it for us this week. So until next time, my name is Justin McRoy.

I'm Sydney McRoy. And it's always, don't draw a hole in your head. Alright!