WEBVTT - Short Stuff: Frances Kelsey: Hero of the FDA

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<v Speaker 1>Hey, and welcome to the short Stuff. I'm Josh, and

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<v Speaker 1>there's Chuck and Jerry's here too, Dave Syar and Spirit.

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<v Speaker 1>This is short stays.

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<v Speaker 2>Of that's right right out of the gate. We should

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<v Speaker 2>thank our old colleagues at house stuffworks dot com and

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<v Speaker 2>Joanna Thompson who wrote the article that this one is

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<v Speaker 2>based on. And I thought she did a great job.

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<v Speaker 2>This is really kind of a great little packed in shorty.

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<v Speaker 1>It really is, And I think the gist of it

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<v Speaker 1>is it's a tribute to not an unsung hero, but

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<v Speaker 1>maybe one of the great heroes of the twentieth century

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<v Speaker 1>that you may not have heard of. A woman named

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<v Speaker 1>Francis Oldham.

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<v Speaker 2>Kelly was kind of sung.

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<v Speaker 1>Yeah, she was definitely in her lifetime, which is great.

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<v Speaker 1>I think that there was an award created by the

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<v Speaker 1>FDA and named in her honor, and they bestowed it

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<v Speaker 1>upon her, the first one in twenty ten. So she's

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<v Speaker 1>definitely gotten wrecked cognition. But I don't know that the

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<v Speaker 1>average American walking around knows her name.

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<v Speaker 2>Yeah, she's partially sung. She's like a lou Reid song.

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<v Speaker 1>She's semi sung, semi song, partially sung like a lou

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<v Speaker 1>Reed song.

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<v Speaker 2>Yeah, you know, he didn't really sing, oh gotcha.

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<v Speaker 1>Now, he talked a lot and he proto rapped a

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<v Speaker 1>little bit too.

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<v Speaker 2>I don't know about that. Okay, all right, so let's

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<v Speaker 2>talk about this this great woman in our American history.

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<v Speaker 2>That was a very stumbling way to say that, but

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<v Speaker 2>that's what she was. She worked for the FDA, the

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<v Speaker 2>FDA back in those days. And this was what the

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<v Speaker 2>nineteen fifty fifties that she was working there. Sixties, sorry,

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<v Speaker 2>into the sixties. I think she started in nineteen sixty okay,

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<v Speaker 2>Like I said, solably sixties. But the FDA back then

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<v Speaker 2>had a very different process for getting drugs on the market.

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<v Speaker 2>It was not as rigorous. I think they had about

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<v Speaker 2>six days to look over data on you know, testing

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<v Speaker 2>done usually on mice.

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<v Speaker 1>And their supervisor was going come on, hurry up, hurry up,

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<v Speaker 1>like over their shoulder the whole.

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<v Speaker 2>Time, basically, And that's kind of how it went till

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<v Speaker 2>Francis Kelsey came along. That was her name by marriage.

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<v Speaker 2>She was born Francis Oldham on Vancouver Island and was

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<v Speaker 2>very well schooled, got a master's in Montreal, got a

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<v Speaker 2>pH d and an MD. Her PhD was in pharmacology,

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<v Speaker 2>no surprise, from the University of Chicago, and she would

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<v Speaker 2>go on to work there where she met her husband,

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<v Speaker 2>doctor Fremont Kelcey, and she became then Francis Oldham Kelsey.

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<v Speaker 2>And you know, it seemed like they were birds of

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<v Speaker 2>a feather. They were both really into science, had a

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<v Speaker 2>couple of daughters, and then moved to d C and

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<v Speaker 2>she got a job at the FDA.

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<v Speaker 1>Yeah, that's a pretty great setup. Should we take a

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<v Speaker 1>break now?

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<v Speaker 2>Oh not take an early break?

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<v Speaker 1>Okay, So, Chuck, you sent us up perfectly. Doctor Kelsey

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<v Speaker 1>is at the FDA brand new position after about seven months,

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<v Speaker 1>and her position was to basically check scientific data to

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<v Speaker 1>approve or disapprove new drugs for the FDA right about

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<v Speaker 1>seven months after she starts, and she was just a

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<v Speaker 1>handful of medical people who were actually doing that, yeh,

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<v Speaker 1>and had sixty days to do it. But about seven

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<v Speaker 1>months after she started, a drug approval application for a

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<v Speaker 1>drug called philidamide m crossed her death and she said, oh, oh,

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<v Speaker 1>what's this she did?

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<v Speaker 2>It came in from the American version was from the

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<v Speaker 2>Richardson Merrill company, and they were really eager to get

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<v Speaker 2>it going because this drug had been kind of the

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<v Speaker 2>hot ticket in Africa and in Europe and I think

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<v Speaker 2>a couple of other places around the world. It was

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<v Speaker 2>huge in Germany, very big in West Germany. They did

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<v Speaker 2>not approve it in East Germany, so they it was

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<v Speaker 2>a sedative. It was an anti anxiety drug basically. It

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<v Speaker 2>was developed in the fifties. It was a post war drug,

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<v Speaker 2>and they were like in every way, so were like,

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<v Speaker 2>people really need to settle down, and they need sedatives.

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<v Speaker 2>People need to sleep. So this thing Solidemi does a

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<v Speaker 2>great job at that. And so people started taking it

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<v Speaker 2>and they were like, hey, not only does it help

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<v Speaker 2>me sleep, but it helps my tum tum feel better.

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<v Speaker 2>So all of a sudden, pregnant women were like, this

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<v Speaker 2>is really working well for my morning. Yeah.

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<v Speaker 1>And this had been going on. I think it came

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<v Speaker 1>out in nineteen fifty two. This is nineteen sixty when

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<v Speaker 1>doctor Kelsey gets the application. So, I mean it had

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<v Speaker 1>been kind of proven effective and safe essentially throughout the

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<v Speaker 1>rest of the world. So there was an expectation, I'm

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<v Speaker 1>sure by the drug company that this would you know,

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<v Speaker 1>just sail through rather easily the application and review process.

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<v Speaker 1>But doctor Kelsey was a bit of a stickler, fortunately,

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<v Speaker 1>and she said, let me really take a look at

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<v Speaker 1>the science. And she found that there were reports of

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<v Speaker 1>neuropathy where people like lose sensation in their extremities, their

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<v Speaker 1>nerve endings are basically damaged. And it's true when you

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<v Speaker 1>stop taking polidimide, the sensation came back to your extremities,

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<v Speaker 1>but that's kind of weird and she didn't really understand that.

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<v Speaker 1>She also found that that pregnant women taking it off

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<v Speaker 1>label for morning sickness. There was basically no studies on that.

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<v Speaker 1>So as far as doctor Kelsey was concerned, there was

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<v Speaker 1>not enough scientific data coming across her desk for her

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<v Speaker 1>to approve this and she wanted more.

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<v Speaker 2>Yeah, and a couple of remarkable details here. The company

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<v Speaker 2>Richardson Merrill. They came back to her six times trying

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<v Speaker 2>to get this thing through, and we're putting the heat

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<v Speaker 2>on her in a big way. And the other thing

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<v Speaker 2>is he said they didn't do any tests on pregnancy.

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<v Speaker 2>This is because at the time doctor still didn't think

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<v Speaker 2>that drugs that pregnant women took could pass the placental barrier.

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<v Speaker 1>Oh okay, so she was.

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<v Speaker 2>Sort of ahead of the curve in a lot of

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<v Speaker 2>ways by thinking like, well, maybe something is happening here,

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<v Speaker 2>even though doctors say that's impossible, maybe we should look

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<v Speaker 2>at it closer, which and she held her ground through

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<v Speaker 2>those six times. Yeah. It turns out the West Germans

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<v Speaker 2>who developed this drug only test or at the time,

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<v Speaker 2>I guess, only tested drugs for toxicity and you know,

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<v Speaker 2>stuff like neuropathy and other like side effects.

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<v Speaker 1>So you give it to somebody and be like did

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<v Speaker 1>it kill you?

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<v Speaker 2>Yeah, no, it was the toxic so they let it ride.

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<v Speaker 1>Yeah.

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<v Speaker 2>Uh. And you know the history of pholidimi and I

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<v Speaker 2>mean Billy Joel included it in we didn't start the

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<v Speaker 2>fire for a reason.

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<v Speaker 1>That was a big deal. Yeah. So doctor Kelsey's holding

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<v Speaker 1>her grounds. She just wants more scientific data and the

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<v Speaker 1>company's not giving her what she wants. And meanwhile there's

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<v Speaker 1>two doctors, one in Australia named doctor William McBride, one

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<v Speaker 1>in Germany doctor Vidu kun Lnz. Did I say that right?

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<v Speaker 2>Thanks?

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<v Speaker 1>And they both started to notice that there was a

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<v Speaker 1>cluster of children being born with birth deformities, and that

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<v Speaker 1>they were very specific but very rare birth deformities, in

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<v Speaker 1>particular feet and hands protruding directly from shoulders and hips.

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<v Speaker 1>That's a very specific kind of birth deformity that you

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<v Speaker 1>can have, but exceedingly rare. So a bunch of kids

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<v Speaker 1>suddenly being born with that birth defect is it caught

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<v Speaker 1>their attention, and they started to do some investigating and

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<v Speaker 1>they figured out that the one commonality that all of

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<v Speaker 1>those mothers had was that they had taken thilidamite early

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<v Speaker 1>in their pregnancy for mourning sickness. And they published a

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<v Speaker 1>paper as fast as they could in the lands that

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<v Speaker 1>saying stop prescribing philidamine.

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<v Speaker 2>Yeah, I mean not only prescribing in West Germany. It

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<v Speaker 2>was over the counter, so you could just grab the

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<v Speaker 2>stuff and take it. In the end, about ten thousand

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<v Speaker 2>kids were affected the aforementioned Billy Joel's children of phlidamide

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<v Speaker 2>and so what they were known as about forty percent

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<v Speaker 2>of those died at birth because it was not only

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<v Speaker 2>like these deformities of the limbs really is what grabbed

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<v Speaker 2>their attention, but heart troubles and stuff like that was

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<v Speaker 2>also a big problem. And you know, forty percent died

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<v Speaker 2>sort of around birth or at birth. Most of these

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<v Speaker 2>kids were in West Germany, like I said, because they

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<v Speaker 2>developed the drug, and so I just think it was

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<v Speaker 2>more heavily used.

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<v Speaker 1>There and over the counter like you said, yeah.

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<v Speaker 2>And over the counter yea. And Kelsey said no, no, no,

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<v Speaker 2>we're not going to do it before anyone else did,

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<v Speaker 2>and she is the reason that it was never released

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<v Speaker 2>in the United States, although a handful of kids in

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<v Speaker 2>the United States were born. Maybe I didn't see an

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<v Speaker 2>explanation of how that happened. I think there was like

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<v Speaker 2>less than twenty, but I guess they got their hands

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<v Speaker 2>on some philidimid somehow.

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<v Speaker 1>Yeah, their parents could have been traveling in Europe, especially

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<v Speaker 1>if you take the little mightde early in pregnancy.

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<v Speaker 2>Yeah, that makes sense.

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<v Speaker 1>So they knew that philidamide led to a whole just

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<v Speaker 1>grab bag of different birth defects like you were saying.

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<v Speaker 1>But it wasn't until about sixty years after it got

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<v Speaker 1>pulled from shelves that they finally figured out why. And

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<v Speaker 1>what they realized is that with most drugs, it goes

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<v Speaker 1>and binds to a specific receptor site and maybe it

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<v Speaker 1>prevents the reuptake, say serotonin, so you have more serotonin

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<v Speaker 1>flowing through your system and that helps balance that neurochemical well,

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<v Speaker 1>phelidimide binds to all sorts of different stuff, specifically lots

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<v Speaker 1>of different proteins, and those proteins do things like turn

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<v Speaker 1>genes on and off. And because it's so non preferential

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<v Speaker 1>with what proteins it binds to, it can bind to

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<v Speaker 1>all sorts of different proteins that are responsible for all

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<v Speaker 1>sorts of different genes. And when those genes aren't turned

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<v Speaker 1>on or aren't turned off, you can develop a foot

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<v Speaker 1>on your shoulder, that kind of thing, and that that's

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<v Speaker 1>why pholidami cause all those birth effects.

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<v Speaker 2>That's right. And in the end, like you mentioned, Kelsey

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<v Speaker 2>was somewhat sung in her lifetime. That was a big

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<v Speaker 2>and this article points out from how stuff works that

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<v Speaker 2>she probably would have been unsung had it not been

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<v Speaker 2>for this great article on the Washington Post that was

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<v Speaker 2>published back then in nineteen sixty two about her, and

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<v Speaker 2>that caused President John F. Kennedy to stand up and sayer,

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<v Speaker 2>here is the President's Award for Distinguished Federal Civilian Service

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<v Speaker 2>for doing that thing you did.

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<v Speaker 1>That was more a Teddy Kennedy.

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<v Speaker 2>I think Teddy Kennedy. But more importantly, the Cathalver Harris

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<v Speaker 2>Amendment went into law, which was the legislation that really

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<v Speaker 2>tightened up how the FDA approves things, and not only

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<v Speaker 2>tightened up, but lengthened and made the process more rigorous.

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<v Speaker 1>Yeah, and she stayed on for forty five more years

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<v Speaker 1>and helped kind of shape the approval process for drugs

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<v Speaker 1>at the FDA.

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<v Speaker 2>I hope she got a better office.

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<v Speaker 1>I hope she did too, a corner one too. And

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<v Speaker 1>there's a plenty of stuff you can say about the

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<v Speaker 1>approval process at the FDA, especially these days, but it's

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<v Speaker 1>better than sixty day window.

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<v Speaker 2>That's true, Chuck said, that's.

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<v Speaker 1>True, everybody, and that triggers short stuff being out.

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