Stuff You Should Know - Short Stuff: Frances Kelsey: Hero of the FDA

Episode Date: May 10, 2023

Who is Frances Kelsey? Well, she's a semi-unsung hero of the FDA whose work helped save a lot of kids from congenital disorders and even death. Listen and learn!See omnystudio.com/listener for privacy information.

America loves its founding fathers, but that's a tough act to follow as a founding son. I'm Bob Crawford. Join me, Patrick Warburton, and Nick Offerman as we bring the sixth president to life. Was there ever witnessed such a barefaced corruption in any country before? Let justice be done, though the heavens fall! Listen to Founding Son, a curiosity podcast on the iHeart Radio app, Apple Podcasts, or wherever you get your podcasts. Hey, and welcome to the Short Stuff.

I'm Josh, and there's Chuck and Jerry's here, too. Dave's here in spirit. This is Short Stizoff. That's right. Right out of the gate, we should thank our old colleagues at HouseStuffWorks.com and Joanna Thompson, who wrote the article that this one is based on, and I thought she did a great job. She's 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 20th century that you may not have heard of, a woman named Frances Oldham. Yeah. She 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 upon her the first one in 2010. So she's definitely gotten recognition, but I don't know that the average American walking around knows her name. Yeah. She's partially sung. She's like a Lou Reed song.

She's semi-sung. Semi-sung? Partially sung like a Lou Reed song. Yeah. You know, he didn't really sing. Oh, gotcha. Now, he talked a lot. That's where the talk sings.

Proto-wrapped 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 stumbly 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 1950s that she was working there.

60s. Sorry. Into the 60s. In 1960. Okay. Like I said, solidly 60s. 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 60 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 until Frances Kelsey came along. That was her name by marriage. She was born Frances Oldham on Vancouver Island and was very well schooled, got a master's

in Montreal, got a PhD 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, Dr. Fremont Kelsey. And she became then Frances 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 DC. And she got a job at the FDA. Yeah.

That's a pretty great setup. Should we take a break now? Oh, why not? Let's take an early break. Okay. What is Elon Musk doing to Twitter? And what's this blue sky thing I've been hearing about? Will TikTok be banned?

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iHeart Radio App, Apple Podcasts, or wherever you get your podcasts. So Chuck, you set us up perfectly. Dr. 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. About seven months after she starts, and she was just a handful of medical people who were actually doing that and had 60 days to do it, but about seven months after she started a drug approval application for a drug called philodomide, crossed her desk.

And she said, 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 it was a sedative. It was an anti-anxiety drug, basically. It was developed in the 50s. It was a post-war drug, and they were like in every way, so like people really need to settle down, and they need sedatives, people need to sleep. So this thing, philodomide 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 sickness. Yeah, and this had been going on, I think it came out in 1952. This is 1960 when Dr. 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 just sail through rather easily the application and review process.

But Dr. Kelsey was a bit of a stickler, fortunately, and she said, well, 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 thalidomide, the sensation came back to your extremities. But that's kind of weird, and she didn't really understand that. She also found that pregnant women taking it off-label for morning sickness, there was basically no studies on that.

So as far as Dr. 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, because at the time, doctors still didn't think that drugs that pregnant women took could pass the placental barrier.

Oh, OK. That would make sense. You know, the head 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, and she held her ground through those six times. It turns out the West Germans who developed this drug only tested drugs for toxicity, and not stuff like neuropathy and other side effects. So you'd give it to somebody and be like, did it kill you?

Yeah. Those are the toxics, so they let it ride. And the history of thalidomide, I mean, Billy Joel included it, and we didn't start the fire for a reason. That was a big deal. Yeah, huge. Very big deal. So Dr. Kelsey's holding her ground.

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 Dr. William McBride, one in Germany, Dr. Wede Kuhn-Lenz. Did I say that right? Yes. 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 it's exceedingly rare. So a bunch of kids suddenly being born with that birth defect, 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 thalidomide early in their pregnancy for morning sickness, and they published a paper as fast as they could in the Lancet saying, stop prescribing thalidomide. Yeah. I mean, not only prescribing in West Germany, it was over the counter.

Yeah. So they just grabbed the stuff and take it. In the end, about 10,000 kids were affected. The aforementioned Billy Joel's children of thalidomide is what they were known as. About 40% 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 40% of them 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. Yeah. 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 20, but I guess they got their hands on some thalidomide somehow. Yeah, their parents could have been traveling in Europe, especially if you take thalidomide early in pregnancy. Yeah, that makes sense. So they knew that thalidomide led to a whole just grab bag of different birth defects, like you were saying, but it wasn't until about 60 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 of, say, serotonin. So you have more serotonin flowing through your system, and that helps balance that neurochemical. Well, thalidomide 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's why thalidomide caused all those birth defects. That's right. And in the end, like you mentioned, Kelsey was somewhat sung in her lifetime. There 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 1962 about her. And that caused President John F. Kennedy to stand up and say, here is the President's

Award for a Distinguished Federal Civilian Service for doing that thing you did. That was more a Teddy Kennedy, I think. Teddy Kennedy. But more importantly, the Kefalver-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 45 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 plenty of stuff you can say about the approval process at the FDA, especially these days, but it's better than 60-day window. That's true. Chuck said that's true, everybody, and that triggers short stuff being out.