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

• 0:04
  Speaker 1: Hey, and welcome to the short Stuff. I'm Josh, and
• 0:06
  Speaker 1: there's Chuck and Jerry's here too, Dave Syar and Spirit.
• 0:08
  Speaker 1: This is short stays.
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  Speaker 2: Of that's right right out of the gate. We should
• 0:14
  Speaker 2: thank our old colleagues at house stuffworks dot com and
• 0:17
  Speaker 2: Joanna Thompson who wrote the article that this one is
• 0:20
  Speaker 2: based on. And I thought she did a great job.
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  Speaker 2: This is really kind of a great little packed in shorty.
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  Speaker 1: It really is, And I think the gist of it
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  Speaker 1: is it's a tribute to not an unsung hero, but
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  Speaker 1: maybe one of the great heroes of the twentieth century
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  Speaker 1: that you may not have heard of. A woman named
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  Speaker 1: Francis Oldham.
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  Speaker 2: Kelly was kind of sung.
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  Speaker 1: Yeah, she was definitely in her lifetime, which is great.
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  Speaker 1: I think that there was an award created by the
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  Speaker 1: FDA and named in her honor, and they bestowed it
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  Speaker 1: upon her, the first one in twenty ten. So she's
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  Speaker 1: definitely gotten wrecked cognition. But I don't know that the
• 1:01
  Speaker 1: average American walking around knows her name.
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  Speaker 2: Yeah, she's partially sung. She's like a lou Reid song.
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  Speaker 1: She's semi sung, semi song, partially sung like a lou
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  Speaker 1: Reed song.
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  Speaker 2: Yeah, you know, he didn't really sing, oh gotcha.
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  Speaker 1: Now, he talked a lot and he proto rapped a
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  Speaker 1: little bit too.
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  Speaker 2: I don't know about that. Okay, all right, so let's
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  Speaker 2: talk about this this great woman in our American history.
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  Speaker 2: That was a very stumbling way to say that, but
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  Speaker 2: that's what she was. She worked for the FDA, the
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  Speaker 2: FDA back in those days. And this was what the
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  Speaker 2: nineteen fifty fifties that she was working there. Sixties, sorry,
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  Speaker 2: into the sixties. I think she started in nineteen sixty okay,
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  Speaker 2: Like I said, solably sixties. But the FDA back then
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  Speaker 2: had a very different process for getting drugs on the market.
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  Speaker 2: It was not as rigorous. I think they had about
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  Speaker 2: six days to look over data on you know, testing
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  Speaker 2: done usually on mice.
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  Speaker 1: And their supervisor was going come on, hurry up, hurry up,
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  Speaker 1: like over their shoulder the whole.
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  Speaker 2: Time, basically, And that's kind of how it went till
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  Speaker 2: Francis Kelsey came along. That was her name by marriage.
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  Speaker 2: She was born Francis Oldham on Vancouver Island and was
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  Speaker 2: very well schooled, got a master's in Montreal, got a
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  Speaker 2: pH d and an MD. Her PhD was in pharmacology,
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  Speaker 2: no surprise, from the University of Chicago, and she would
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  Speaker 2: go on to work there where she met her husband,
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  Speaker 2: doctor Fremont Kelcey, and she became then Francis Oldham Kelsey.
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  Speaker 2: And you know, it seemed like they were birds of
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  Speaker 2: a feather. They were both really into science, had a
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  Speaker 2: couple of daughters, and then moved to d C and
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  Speaker 2: she got a job at the FDA.
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  Speaker 1: Yeah, that's a pretty great setup. Should we take a
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  Speaker 1: break now?
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  Speaker 2: Oh not take an early break?
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  Speaker 1: Okay, So, Chuck, you sent us up perfectly. Doctor Kelsey
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  Speaker 1: is at the FDA brand new position after about seven months,
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  Speaker 1: and her position was to basically check scientific data to
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  Speaker 1: approve or disapprove new drugs for the FDA right about
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  Speaker 1: seven months after she starts, and she was just a
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  Speaker 1: handful of medical people who were actually doing that, yeh,
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  Speaker 1: and had sixty days to do it. But about seven
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  Speaker 1: months after she started, a drug approval application for a
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  Speaker 1: drug called philidamide m crossed her death and she said, oh, oh,
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  Speaker 1: what's this she did?
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  Speaker 2: It came in from the American version was from the
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  Speaker 2: Richardson Merrill company, and they were really eager to get
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  Speaker 2: it going because this drug had been kind of the
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  Speaker 2: hot ticket in Africa and in Europe and I think
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  Speaker 2: a couple of other places around the world. It was
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  Speaker 2: huge in Germany, very big in West Germany. They did
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  Speaker 2: not approve it in East Germany, so they it was
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  Speaker 2: a sedative. It was an anti anxiety drug basically. It
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  Speaker 2: was developed in the fifties. It was a post war drug,
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  Speaker 2: and they were like in every way, so were like,
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  Speaker 2: people really need to settle down, and they need sedatives.
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  Speaker 2: People need to sleep. So this thing Solidemi does a
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  Speaker 2: great job at that. And so people started taking it
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  Speaker 2: and they were like, hey, not only does it help
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  Speaker 2: me sleep, but it helps my tum tum feel better.
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  Speaker 2: So all of a sudden, pregnant women were like, this
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  Speaker 2: is really working well for my morning. Yeah.
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  Speaker 1: And this had been going on. I think it came
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  Speaker 1: out in nineteen fifty two. This is nineteen sixty when
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  Speaker 1: doctor Kelsey gets the application. So, I mean it had
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  Speaker 1: been kind of proven effective and safe essentially throughout the
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  Speaker 1: rest of the world. So there was an expectation, I'm
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  Speaker 1: sure by the drug company that this would you know,
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  Speaker 1: just sail through rather easily the application and review process.
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  Speaker 1: But doctor Kelsey was a bit of a stickler, fortunately,
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  Speaker 1: and she said, let me really take a look at
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  Speaker 1: the science. And she found that there were reports of
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  Speaker 1: neuropathy where people like lose sensation in their extremities, their
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  Speaker 1: nerve endings are basically damaged. And it's true when you
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  Speaker 1: stop taking polidimide, the sensation came back to your extremities,
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  Speaker 1: but that's kind of weird and she didn't really understand that.
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  Speaker 1: She also found that that pregnant women taking it off
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  Speaker 1: label for morning sickness. There was basically no studies on that.
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  Speaker 1: So as far as doctor Kelsey was concerned, there was
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  Speaker 1: not enough scientific data coming across her desk for her
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  Speaker 1: to approve this and she wanted more.
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  Speaker 2: Yeah, and a couple of remarkable details here. The company
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  Speaker 2: Richardson Merrill. They came back to her six times trying
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  Speaker 2: to get this thing through, and we're putting the heat
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  Speaker 2: on her in a big way. And the other thing
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  Speaker 2: is he said they didn't do any tests on pregnancy.
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  Speaker 2: This is because at the time doctor still didn't think
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  Speaker 2: that drugs that pregnant women took could pass the placental barrier.
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  Speaker 1: Oh okay, so she was.
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  Speaker 2: Sort of ahead of the curve in a lot of
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  Speaker 2: ways by thinking like, well, maybe something is happening here,
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  Speaker 2: even though doctors say that's impossible, maybe we should look
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  Speaker 2: at it closer, which and she held her ground through
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  Speaker 2: those six times. Yeah. It turns out the West Germans
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  Speaker 2: who developed this drug only test or at the time,
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  Speaker 2: I guess, only tested drugs for toxicity and you know,
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  Speaker 2: stuff like neuropathy and other like side effects.
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  Speaker 1: So you give it to somebody and be like did
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  Speaker 1: it kill you?
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  Speaker 2: Yeah, no, it was the toxic so they let it ride.
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  Speaker 1: Yeah.
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  Speaker 2: Uh. And you know the history of pholidimi and I
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  Speaker 2: mean Billy Joel included it in we didn't start the
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  Speaker 2: fire for a reason.
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  Speaker 1: That was a big deal. Yeah. So doctor Kelsey's holding
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  Speaker 1: her grounds. She just wants more scientific data and the
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  Speaker 1: company's not giving her what she wants. And meanwhile there's
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  Speaker 1: two doctors, one in Australia named doctor William McBride, one
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  Speaker 1: in Germany doctor Vidu kun Lnz. Did I say that right?
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  Speaker 2: Thanks?
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  Speaker 1: And they both started to notice that there was a
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  Speaker 1: cluster of children being born with birth deformities, and that
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  Speaker 1: they were very specific but very rare birth deformities, in
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  Speaker 1: particular feet and hands protruding directly from shoulders and hips.
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  Speaker 1: That's a very specific kind of birth deformity that you
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  Speaker 1: can have, but exceedingly rare. So a bunch of kids
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  Speaker 1: suddenly being born with that birth defect is it caught
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  Speaker 1: their attention, and they started to do some investigating and
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  Speaker 1: they figured out that the one commonality that all of
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  Speaker 1: those mothers had was that they had taken thilidamite early
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  Speaker 1: in their pregnancy for mourning sickness. And they published a
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  Speaker 1: paper as fast as they could in the lands that
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  Speaker 1: saying stop prescribing philidamine.
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  Speaker 2: Yeah, I mean not only prescribing in West Germany. It
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  Speaker 2: was over the counter, so you could just grab the
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  Speaker 2: stuff and take it. In the end, about ten thousand
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  Speaker 2: kids were affected the aforementioned Billy Joel's children of phlidamide
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  Speaker 2: and so what they were known as about forty percent
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  Speaker 2: of those died at birth because it was not only
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  Speaker 2: like these deformities of the limbs really is what grabbed
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  Speaker 2: their attention, but heart troubles and stuff like that was
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  Speaker 2: also a big problem. And you know, forty percent died
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  Speaker 2: sort of around birth or at birth. Most of these
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  Speaker 2: kids were in West Germany, like I said, because they
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  Speaker 2: developed the drug, and so I just think it was
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  Speaker 2: more heavily used.
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  Speaker 1: There and over the counter like you said, yeah.
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  Speaker 2: And over the counter yea. And Kelsey said no, no, no,
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  Speaker 2: we're not going to do it before anyone else did,
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  Speaker 2: and she is the reason that it was never released
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  Speaker 2: in the United States, although a handful of kids in
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  Speaker 2: the United States were born. Maybe I didn't see an
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  Speaker 2: explanation of how that happened. I think there was like
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  Speaker 2: less than twenty, but I guess they got their hands
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  Speaker 2: on some philidimid somehow.
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  Speaker 1: Yeah, their parents could have been traveling in Europe, especially
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  Speaker 1: if you take the little mightde early in pregnancy.
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  Speaker 2: Yeah, that makes sense.
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  Speaker 1: So they knew that philidamide led to a whole just
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  Speaker 1: grab bag of different birth defects like you were saying.
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  Speaker 1: But it wasn't until about sixty years after it got
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  Speaker 1: pulled from shelves that they finally figured out why. And
• 9:52
  Speaker 1: what they realized is that with most drugs, it goes
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  Speaker 1: and binds to a specific receptor site and maybe it
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  Speaker 1: prevents the reuptake, say serotonin, so you have more serotonin
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  Speaker 1: flowing through your system and that helps balance that neurochemical well,
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  Speaker 1: phelidimide binds to all sorts of different stuff, specifically lots
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  Speaker 1: of different proteins, and those proteins do things like turn
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  Speaker 1: genes on and off. And because it's so non preferential
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  Speaker 1: with what proteins it binds to, it can bind to
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  Speaker 1: all sorts of different proteins that are responsible for all
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  Speaker 1: sorts of different genes. And when those genes aren't turned
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  Speaker 1: on or aren't turned off, you can develop a foot
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  Speaker 1: on your shoulder, that kind of thing, and that that's
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  Speaker 1: why pholidami cause all those birth effects.
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  Speaker 2: That's right. And in the end, like you mentioned, Kelsey
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  Speaker 2: was somewhat sung in her lifetime. That was a big
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  Speaker 2: and this article points out from how stuff works that
• 10:45
  Speaker 2: she probably would have been unsung had it not been
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  Speaker 2: for this great article on the Washington Post that was
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  Speaker 2: published back then in nineteen sixty two about her, and
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  Speaker 2: that caused President John F. Kennedy to stand up and sayer,
• 11:00
  Speaker 2: here is the President's Award for Distinguished Federal Civilian Service
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  Speaker 2: for doing that thing you did.
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  Speaker 1: That was more a Teddy Kennedy.
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  Speaker 2: I think Teddy Kennedy. But more importantly, the Cathalver Harris
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  Speaker 2: Amendment went into law, which was the legislation that really
• 11:20
  Speaker 2: tightened up how the FDA approves things, and not only
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  Speaker 2: tightened up, but lengthened and made the process more rigorous.
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  Speaker 1: Yeah, and she stayed on for forty five more years
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  Speaker 1: and helped kind of shape the approval process for drugs
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  Speaker 1: at the FDA.
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  Speaker 2: I hope she got a better office.
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  Speaker 1: I hope she did too, a corner one too. And
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  Speaker 1: there's a plenty of stuff you can say about the
• 11:40
  Speaker 1: approval process at the FDA, especially these days, but it's
• 11:44
  Speaker 1: better than sixty day window.
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  Speaker 2: That's true, Chuck said, that's.
• 11:49
  Speaker 1: True, everybody, and that triggers short stuff being out.
• 11:57
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