Hey, and welcome to the short Stuff. I'm Josh, and there's Chuck and Jerry's here too, Dave Syar and Spirit. This is short stays.
Of that's right right out of the gate. We should thank our old colleagues at house stuffworks dot com and Joanna Thompson who wrote the article that this one is based on. And I thought she did a great job. This is really kind of a great little packed in shorty.
It really is, And I think the gist of it is it's a tribute to not an unsung hero, but maybe one of the great heroes of the twentieth century that you may not have heard of. A woman named Francis Oldham.
Kelly was kind of sung.
Yeah, she was definitely in her lifetime, which is great. I think that there was an award created by the FDA and named in her honor, and they bestowed it upon her, the first one in twenty ten. So she's definitely gotten wrecked cognition. But I don't know that the average American walking around knows her name.
Yeah, she's partially sung. She's like a lou Reid song.
She's semi sung, semi song, partially sung like a lou Reed song.
Yeah, you know, he didn't really sing, oh gotcha.
Now, he talked a lot and he proto rapped a little bit too.
I don't know about that. Okay, all right, so let's talk about this this great woman in our American history. That was a very stumbling way to say that, but that's what she was. She worked for the FDA, the FDA back in those days. And this was what the nineteen fifty fifties that she was working there. Sixties, sorry, into the sixties. I think she started in nineteen sixty okay, Like I said, solably sixties. But the FDA back then had a very different process for getting drugs on the market.
It was not as rigorous. I think they had about six days to look over data on you know, testing done usually on mice.
And their supervisor was going come on, hurry up, hurry up, like over their shoulder the whole.
Time, basically, And that's kind of how it went till Francis Kelsey came along. That was her name by marriage. She was born Francis Oldham on Vancouver Island and was very well schooled, got a master's in Montreal, got a pH d and an MD. Her PhD was in pharmacology, no surprise, from the University of Chicago, and she would go on to work there where she met her husband, doctor Fremont Kelcey, and she became then Francis Oldham Kelsey. And you know, it seemed like they were birds of
a feather. They were both really into science, had a couple of daughters, and then moved to d C and she got a job at the FDA.
Yeah, that's a pretty great setup. Should we take a break now?
Oh not take an early break?
Okay, So, Chuck, you sent us up perfectly. Doctor Kelsey is at the FDA brand new position after about seven months, and her position was to basically check scientific data to approve or disapprove new drugs for the FDA right about seven months after she starts, and she was just a handful of medical people who were actually doing that, yeh,
and had sixty days to do it. But about seven months after she started, a drug approval application for a drug called philidamide m crossed her death and she said, oh, oh, what's this she did?
It came in from the American version was from the Richardson Merrill company, and they were really eager to get it going because this drug had been kind of the hot ticket in Africa and in Europe and I think a couple of other places around the world. It was huge in Germany, very big in West Germany. They did not approve it in East Germany, so they it was a sedative. It was an anti anxiety drug basically. It
was developed in the fifties. It was a post war drug, and they were like in every way, so were like, people really need to settle down, and they need sedatives. People need to sleep. So this thing Solidemi does a great job at that. And so people started taking it and they were like, hey, not only does it help me sleep, but it helps my tum tum feel better. So all of a sudden, pregnant women were like, this is really working well for my morning. Yeah.
And this had been going on. I think it came out in nineteen fifty two. This is nineteen sixty when doctor Kelsey gets the application. So, I mean it had been kind of proven effective and safe essentially throughout the rest of the world. So there was an expectation, I'm sure by the drug company that this would you know, just sail through rather easily the application and review process. But doctor Kelsey was a bit of a stickler, fortunately, and she said, let me really take a look at
the science. And she found that there were reports of neuropathy where people like lose sensation in their extremities, their nerve endings are basically damaged. And it's true when you stop taking polidimide, the sensation came back to your extremities, but that's kind of weird and she didn't really understand that. She also found that that pregnant women taking it off label for morning sickness. There was basically no studies on that.
So as far as doctor Kelsey was concerned, there was not enough scientific data coming across her desk for her to approve this and she wanted more.
Yeah, and a couple of remarkable details here. The company Richardson Merrill. They came back to her six times trying to get this thing through, and we're putting the heat on her in a big way. And the other thing is he said they didn't do any tests on pregnancy. This is because at the time doctor still didn't think that drugs that pregnant women took could pass the placental barrier.
Oh okay, so she was.
Sort of ahead of the curve in a lot of ways by thinking like, well, maybe something is happening here, even though doctors say that's impossible, maybe we should look at it closer, which and she held her ground through those six times. Yeah. It turns out the West Germans who developed this drug only test or at the time, I guess, only tested drugs for toxicity and you know, stuff like neuropathy and other like side effects.
So you give it to somebody and be like did it kill you?
Yeah, no, it was the toxic so they let it ride.
Yeah.
Uh. And you know the history of pholidimi and I mean Billy Joel included it in we didn't start the fire for a reason.
That was a big deal. Yeah. So doctor Kelsey's holding her grounds. She just wants more scientific data and the company's not giving her what she wants. And meanwhile there's two doctors, one in Australia named doctor William McBride, one in Germany doctor Vidu kun Lnz. Did I say that right?
Thanks?
And they both started to notice that there was a cluster of children being born with birth deformities, and that they were very specific but very rare birth deformities, in particular feet and hands protruding directly from shoulders and hips. That's a very specific kind of birth deformity that you
can have, but exceedingly rare. So a bunch of kids suddenly being born with that birth defect is it caught their attention, and they started to do some investigating and they figured out that the one commonality that all of those mothers had was that they had taken thilidamite early in their pregnancy for mourning sickness. And they published a paper as fast as they could in the lands that saying stop prescribing philidamine.
Yeah, I mean not only prescribing in West Germany. It was over the counter, so you could just grab the stuff and take it. In the end, about ten thousand kids were affected the aforementioned Billy Joel's children of phlidamide and so what they were known as about forty percent of those died at birth because it was not only like these deformities of the limbs really is what grabbed their attention, but heart troubles and stuff like that was also a big problem. And you know, forty percent died
sort of around birth or at birth. Most of these kids were in West Germany, like I said, because they developed the drug, and so I just think it was more heavily used.
There and over the counter like you said, yeah.
And over the counter yea. And Kelsey said no, no, no, we're not going to do it before anyone else did, and she is the reason that it was never released in the United States, although a handful of kids in the United States were born. Maybe I didn't see an explanation of how that happened. I think there was like less than twenty, but I guess they got their hands on some philidimid somehow.
Yeah, their parents could have been traveling in Europe, especially if you take the little mightde early in pregnancy.
Yeah, that makes sense.
So they knew that philidamide led to a whole just grab bag of different birth defects like you were saying. But it wasn't until about sixty years after it got
pulled from shelves that they finally figured out why. And what they realized is that with most drugs, it goes and binds to a specific receptor site and maybe it prevents the reuptake, say serotonin, so you have more serotonin flowing through your system and that helps balance that neurochemical well, phelidimide binds to all sorts of different stuff, specifically lots of different proteins, and those proteins do things like turn
genes on and off. And because it's so non preferential with what proteins it binds to, it can bind to all sorts of different proteins that are responsible for all sorts of different genes. And when those genes aren't turned on or aren't turned off, you can develop a foot on your shoulder, that kind of thing, and that that's why pholidami cause all those birth effects.
That's right. And in the end, like you mentioned, Kelsey was somewhat sung in her lifetime. That was a big and this article points out from how stuff works that she probably would have been unsung had it not been for this great article on the Washington Post that was published back then in nineteen sixty two about her, and that caused President John F. Kennedy to stand up and sayer, here is the President's Award for Distinguished Federal Civilian Service for doing that thing you did.
That was more a Teddy Kennedy.
I think Teddy Kennedy. But more importantly, the Cathalver Harris Amendment went into law, which was the legislation that really tightened up how the FDA approves things, and not only tightened up, but lengthened and made the process more rigorous.
Yeah, and she stayed on for forty five more years and helped kind of shape the approval process for drugs at the FDA.
I hope she got a better office.
I hope she did too, a corner one too. And there's a plenty of stuff you can say about the approval process at the FDA, especially these days, but it's better than sixty day window.
That's true, Chuck said, that's.
True, everybody, and that triggers short stuff being out.
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