Speaker 1: Hey, and welcome to the short Stuff. I'm Josh, and
Speaker 1: there's Chuck and Jerry's here too, Dave Syar and Spirit.
Speaker 1: This is short stays.
Speaker 2: Of that's right right out of the gate. We should
Speaker 2: thank our old colleagues at house stuffworks dot com and
Speaker 2: Joanna Thompson who wrote the article that this one is
Speaker 2: based on. And I thought she did a great job.
Speaker 2: This is really kind of a great little packed in shorty.
Speaker 1: It really is, And I think the gist of it
Speaker 1: is it's a tribute to not an unsung hero, but
Speaker 1: maybe one of the great heroes of the twentieth century
Speaker 1: that you may not have heard of. A woman named
Speaker 1: Francis Oldham.
Speaker 2: Kelly was kind of sung.
Speaker 1: Yeah, she was definitely in her lifetime, which is great.
Speaker 1: I think that there was an award created by the
Speaker 1: FDA and named in her honor, and they bestowed it
Speaker 1: upon her, the first one in twenty ten. So she's
Speaker 1: definitely gotten wrecked cognition. But I don't know that the
Speaker 1: average American walking around knows her name.
Speaker 2: Yeah, she's partially sung. She's like a lou Reid song.
Speaker 1: She's semi sung, semi song, partially sung like a lou
Speaker 1: Reed song.
Speaker 2: Yeah, you know, he didn't really sing, oh gotcha.
Speaker 1: Now, he talked a lot and he proto rapped a
Speaker 1: little bit too.
Speaker 2: I don't know about that. Okay, all right, so let's
Speaker 2: talk about this this great woman in our American history.
Speaker 2: That was a very stumbling way to say that, but
Speaker 2: that's what she was. She worked for the FDA, the
Speaker 2: FDA back in those days. And this was what the
Speaker 2: nineteen fifty fifties that she was working there. Sixties, sorry,
Speaker 2: into the sixties. I think she started in nineteen sixty okay,
Speaker 2: Like I said, solably sixties. But the FDA back then
Speaker 2: had a very different process for getting drugs on the market.
Speaker 2: It was not as rigorous. I think they had about
Speaker 2: six days to look over data on you know, testing
Speaker 2: done usually on mice.
Speaker 1: And their supervisor was going come on, hurry up, hurry up,
Speaker 1: like over their shoulder the whole.
Speaker 2: Time, basically, And that's kind of how it went till
Speaker 2: Francis Kelsey came along. That was her name by marriage.
Speaker 2: She was born Francis Oldham on Vancouver Island and was
Speaker 2: very well schooled, got a master's in Montreal, got a
Speaker 2: pH d and an MD. Her PhD was in pharmacology,
Speaker 2: no surprise, from the University of Chicago, and she would
Speaker 2: go on to work there where she met her husband,
Speaker 2: doctor Fremont Kelcey, and she became then Francis Oldham Kelsey.
Speaker 2: And you know, it seemed like they were birds of
Speaker 2: a feather. They were both really into science, had a
Speaker 2: couple of daughters, and then moved to d C and
Speaker 2: she got a job at the FDA.
Speaker 1: Yeah, that's a pretty great setup. Should we take a
Speaker 1: break now?
Speaker 2: Oh not take an early break?
Speaker 1: Okay, So, Chuck, you sent us up perfectly. Doctor Kelsey
Speaker 1: is at the FDA brand new position after about seven months,
Speaker 1: and her position was to basically check scientific data to
Speaker 1: approve or disapprove new drugs for the FDA right about
Speaker 1: seven months after she starts, and she was just a
Speaker 1: handful of medical people who were actually doing that, yeh,
Speaker 1: and had sixty days to do it. But about seven
Speaker 1: months after she started, a drug approval application for a
Speaker 1: drug called philidamide m crossed her death and she said, oh, oh,
Speaker 1: what's this she did?
Speaker 2: It came in from the American version was from the
Speaker 2: Richardson Merrill company, and they were really eager to get
Speaker 2: it going because this drug had been kind of the
Speaker 2: hot ticket in Africa and in Europe and I think
Speaker 2: a couple of other places around the world. It was
Speaker 2: huge in Germany, very big in West Germany. They did
Speaker 2: not approve it in East Germany, so they it was
Speaker 2: a sedative. It was an anti anxiety drug basically. It
Speaker 2: was developed in the fifties. It was a post war drug,
Speaker 2: and they were like in every way, so were like,
Speaker 2: people really need to settle down, and they need sedatives.
Speaker 2: People need to sleep. So this thing Solidemi does a
Speaker 2: great job at that. And so people started taking it
Speaker 2: and they were like, hey, not only does it help
Speaker 2: me sleep, but it helps my tum tum feel better.
Speaker 2: So all of a sudden, pregnant women were like, this
Speaker 2: is really working well for my morning. Yeah.
Speaker 1: And this had been going on. I think it came
Speaker 1: out in nineteen fifty two. This is nineteen sixty when
Speaker 1: doctor Kelsey gets the application. So, I mean it had
Speaker 1: been kind of proven effective and safe essentially throughout the
Speaker 1: rest of the world. So there was an expectation, I'm
Speaker 1: sure by the drug company that this would you know,
Speaker 1: just sail through rather easily the application and review process.
Speaker 1: But doctor Kelsey was a bit of a stickler, fortunately,
Speaker 1: and she said, let me really take a look at
Speaker 1: the science. And she found that there were reports of
Speaker 1: neuropathy where people like lose sensation in their extremities, their
Speaker 1: nerve endings are basically damaged. And it's true when you
Speaker 1: stop taking polidimide, the sensation came back to your extremities,
Speaker 1: but that's kind of weird and she didn't really understand that.
Speaker 1: She also found that that pregnant women taking it off
Speaker 1: label for morning sickness. There was basically no studies on that.
Speaker 1: So as far as doctor Kelsey was concerned, there was
Speaker 1: not enough scientific data coming across her desk for her
Speaker 1: to approve this and she wanted more.
Speaker 2: Yeah, and a couple of remarkable details here. The company
Speaker 2: Richardson Merrill. They came back to her six times trying
Speaker 2: to get this thing through, and we're putting the heat
Speaker 2: on her in a big way. And the other thing
Speaker 2: is he said they didn't do any tests on pregnancy.
Speaker 2: This is because at the time doctor still didn't think
Speaker 2: that drugs that pregnant women took could pass the placental barrier.
Speaker 1: Oh okay, so she was.
Speaker 2: Sort of ahead of the curve in a lot of
Speaker 2: ways by thinking like, well, maybe something is happening here,
Speaker 2: even though doctors say that's impossible, maybe we should look
Speaker 2: at it closer, which and she held her ground through
Speaker 2: those six times. Yeah. It turns out the West Germans
Speaker 2: who developed this drug only test or at the time,
Speaker 2: I guess, only tested drugs for toxicity and you know,
Speaker 2: stuff like neuropathy and other like side effects.
Speaker 1: So you give it to somebody and be like did
Speaker 1: it kill you?
Speaker 2: Yeah, no, it was the toxic so they let it ride.
Speaker 1: Yeah.
Speaker 2: Uh. And you know the history of pholidimi and I
Speaker 2: mean Billy Joel included it in we didn't start the
Speaker 2: fire for a reason.
Speaker 1: That was a big deal. Yeah. So doctor Kelsey's holding
Speaker 1: her grounds. She just wants more scientific data and the
Speaker 1: company's not giving her what she wants. And meanwhile there's
Speaker 1: two doctors, one in Australia named doctor William McBride, one
Speaker 1: in Germany doctor Vidu kun Lnz. Did I say that right?
Speaker 2: Thanks?
Speaker 1: And they both started to notice that there was a
Speaker 1: cluster of children being born with birth deformities, and that
Speaker 1: they were very specific but very rare birth deformities, in
Speaker 1: particular feet and hands protruding directly from shoulders and hips.
Speaker 1: That's a very specific kind of birth deformity that you
Speaker 1: can have, but exceedingly rare. So a bunch of kids
Speaker 1: suddenly being born with that birth defect is it caught
Speaker 1: their attention, and they started to do some investigating and
Speaker 1: they figured out that the one commonality that all of
Speaker 1: those mothers had was that they had taken thilidamite early
Speaker 1: in their pregnancy for mourning sickness. And they published a
Speaker 1: paper as fast as they could in the lands that
Speaker 1: saying stop prescribing philidamine.
Speaker 2: Yeah, I mean not only prescribing in West Germany. It
Speaker 2: was over the counter, so you could just grab the
Speaker 2: stuff and take it. In the end, about ten thousand
Speaker 2: kids were affected the aforementioned Billy Joel's children of phlidamide
Speaker 2: and so what they were known as about forty percent
Speaker 2: of those died at birth because it was not only
Speaker 2: like these deformities of the limbs really is what grabbed
Speaker 2: their attention, but heart troubles and stuff like that was
Speaker 2: also a big problem. And you know, forty percent died
Speaker 2: sort of around birth or at birth. Most of these
Speaker 2: kids were in West Germany, like I said, because they
Speaker 2: developed the drug, and so I just think it was
Speaker 2: more heavily used.
Speaker 1: There and over the counter like you said, yeah.
Speaker 2: And over the counter yea. And Kelsey said no, no, no,
Speaker 2: we're not going to do it before anyone else did,
Speaker 2: and she is the reason that it was never released
Speaker 2: in the United States, although a handful of kids in
Speaker 2: the United States were born. Maybe I didn't see an
Speaker 2: explanation of how that happened. I think there was like
Speaker 2: less than twenty, but I guess they got their hands
Speaker 2: on some philidimid somehow.
Speaker 1: Yeah, their parents could have been traveling in Europe, especially
Speaker 1: if you take the little mightde early in pregnancy.
Speaker 2: Yeah, that makes sense.
Speaker 1: So they knew that philidamide led to a whole just
Speaker 1: grab bag of different birth defects like you were saying.
Speaker 1: But it wasn't until about sixty years after it got
Speaker 1: pulled from shelves that they finally figured out why. And
Speaker 1: what they realized is that with most drugs, it goes
Speaker 1: and binds to a specific receptor site and maybe it
Speaker 1: prevents the reuptake, say serotonin, so you have more serotonin
Speaker 1: flowing through your system and that helps balance that neurochemical well,
Speaker 1: phelidimide binds to all sorts of different stuff, specifically lots
Speaker 1: of different proteins, and those proteins do things like turn
Speaker 1: genes on and off. And because it's so non preferential
Speaker 1: with what proteins it binds to, it can bind to
Speaker 1: all sorts of different proteins that are responsible for all
Speaker 1: sorts of different genes. And when those genes aren't turned
Speaker 1: on or aren't turned off, you can develop a foot
Speaker 1: on your shoulder, that kind of thing, and that that's
Speaker 1: why pholidami cause all those birth effects.
Speaker 2: That's right. And in the end, like you mentioned, Kelsey
Speaker 2: was somewhat sung in her lifetime. That was a big
Speaker 2: and this article points out from how stuff works that
Speaker 2: she probably would have been unsung had it not been
Speaker 2: for this great article on the Washington Post that was
Speaker 2: published back then in nineteen sixty two about her, and
Speaker 2: that caused President John F. Kennedy to stand up and sayer,
Speaker 2: here is the President's Award for Distinguished Federal Civilian Service
Speaker 2: for doing that thing you did.
Speaker 1: That was more a Teddy Kennedy.
Speaker 2: I think Teddy Kennedy. But more importantly, the Cathalver Harris
Speaker 2: Amendment went into law, which was the legislation that really
Speaker 2: tightened up how the FDA approves things, and not only
Speaker 2: tightened up, but lengthened and made the process more rigorous.
Speaker 1: Yeah, and she stayed on for forty five more years
Speaker 1: and helped kind of shape the approval process for drugs
Speaker 1: at the FDA.
Speaker 2: I hope she got a better office.
Speaker 1: I hope she did too, a corner one too. And
Speaker 1: there's a plenty of stuff you can say about the
Speaker 1: approval process at the FDA, especially these days, but it's
Speaker 1: better than sixty day window.
Speaker 2: That's true, Chuck said, that's.
Speaker 1: True, everybody, and that triggers short stuff being out.
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