1 00:00:04,240 --> 00:00:06,200 Speaker 1: Hey, and welcome to the short Stuff. I'm Josh, and 2 00:00:06,200 --> 00:00:08,840 Speaker 1: there's Chuck and Jerry's here too, Dave Syar and Spirit. 3 00:00:08,960 --> 00:00:10,760 Speaker 1: This is short stays. 4 00:00:10,400 --> 00:00:14,160 Speaker 2: Of that's right right out of the gate. We should 5 00:00:14,160 --> 00:00:17,800 Speaker 2: thank our old colleagues at house stuffworks dot com and 6 00:00:17,920 --> 00:00:20,759 Speaker 2: Joanna Thompson who wrote the article that this one is 7 00:00:20,800 --> 00:00:23,520 Speaker 2: based on. And I thought she did a great job. 8 00:00:23,560 --> 00:00:27,760 Speaker 2: This is really kind of a great little packed in shorty. 9 00:00:28,440 --> 00:00:32,000 Speaker 1: It really is, And I think the gist of it 10 00:00:32,040 --> 00:00:36,080 Speaker 1: is it's a tribute to not an unsung hero, but 11 00:00:36,640 --> 00:00:40,280 Speaker 1: maybe one of the great heroes of the twentieth century 12 00:00:40,320 --> 00:00:42,360 Speaker 1: that you may not have heard of. A woman named 13 00:00:42,360 --> 00:00:43,479 Speaker 1: Francis Oldham. 14 00:00:43,960 --> 00:00:44,920 Speaker 2: Kelly was kind of sung. 15 00:00:45,720 --> 00:00:48,800 Speaker 1: Yeah, she was definitely in her lifetime, which is great. 16 00:00:49,680 --> 00:00:52,599 Speaker 1: I think that there was an award created by the 17 00:00:52,680 --> 00:00:56,280 Speaker 1: FDA and named in her honor, and they bestowed it 18 00:00:56,360 --> 00:00:59,160 Speaker 1: upon her, the first one in twenty ten. So she's 19 00:00:59,200 --> 00:01:01,600 Speaker 1: definitely gotten wrecked cognition. But I don't know that the 20 00:01:01,640 --> 00:01:04,200 Speaker 1: average American walking around knows her name. 21 00:01:04,840 --> 00:01:08,520 Speaker 2: Yeah, she's partially sung. She's like a lou Reid song. 22 00:01:08,640 --> 00:01:13,440 Speaker 1: She's semi sung, semi song, partially sung like a lou 23 00:01:13,520 --> 00:01:14,120 Speaker 1: Reed song. 24 00:01:14,880 --> 00:01:17,280 Speaker 2: Yeah, you know, he didn't really sing, oh gotcha. 25 00:01:17,360 --> 00:01:20,560 Speaker 1: Now, he talked a lot and he proto rapped a 26 00:01:20,560 --> 00:01:21,240 Speaker 1: little bit too. 27 00:01:22,319 --> 00:01:26,800 Speaker 2: I don't know about that. Okay, all right, so let's 28 00:01:26,840 --> 00:01:31,080 Speaker 2: talk about this this great woman in our American history. 29 00:01:32,040 --> 00:01:33,720 Speaker 2: That was a very stumbling way to say that, but 30 00:01:33,760 --> 00:01:37,240 Speaker 2: that's what she was. She worked for the FDA, the 31 00:01:37,319 --> 00:01:40,800 Speaker 2: FDA back in those days. And this was what the 32 00:01:40,880 --> 00:01:45,200 Speaker 2: nineteen fifty fifties that she was working there. Sixties, sorry, 33 00:01:45,840 --> 00:01:49,520 Speaker 2: into the sixties. I think she started in nineteen sixty okay, 34 00:01:49,640 --> 00:01:53,160 Speaker 2: Like I said, solably sixties. But the FDA back then 35 00:01:53,200 --> 00:01:56,960 Speaker 2: had a very different process for getting drugs on the market. 36 00:01:57,360 --> 00:01:59,720 Speaker 2: It was not as rigorous. I think they had about 37 00:01:59,760 --> 00:02:04,960 Speaker 2: six days to look over data on you know, testing 38 00:02:05,040 --> 00:02:06,360 Speaker 2: done usually on mice. 39 00:02:06,240 --> 00:02:08,960 Speaker 1: And their supervisor was going come on, hurry up, hurry up, 40 00:02:09,080 --> 00:02:10,640 Speaker 1: like over their shoulder the whole. 41 00:02:10,480 --> 00:02:12,679 Speaker 2: Time, basically, And that's kind of how it went till 42 00:02:12,680 --> 00:02:17,360 Speaker 2: Francis Kelsey came along. That was her name by marriage. 43 00:02:17,360 --> 00:02:21,640 Speaker 2: She was born Francis Oldham on Vancouver Island and was 44 00:02:21,840 --> 00:02:25,440 Speaker 2: very well schooled, got a master's in Montreal, got a 45 00:02:26,440 --> 00:02:31,040 Speaker 2: pH d and an MD. Her PhD was in pharmacology, 46 00:02:31,080 --> 00:02:34,880 Speaker 2: no surprise, from the University of Chicago, and she would 47 00:02:34,880 --> 00:02:38,120 Speaker 2: go on to work there where she met her husband, 48 00:02:39,600 --> 00:02:44,080 Speaker 2: doctor Fremont Kelcey, and she became then Francis Oldham Kelsey. 49 00:02:44,680 --> 00:02:47,160 Speaker 2: And you know, it seemed like they were birds of 50 00:02:47,160 --> 00:02:50,000 Speaker 2: a feather. They were both really into science, had a 51 00:02:50,040 --> 00:02:53,280 Speaker 2: couple of daughters, and then moved to d C and 52 00:02:53,440 --> 00:02:54,600 Speaker 2: she got a job at the FDA. 53 00:02:55,160 --> 00:02:57,840 Speaker 1: Yeah, that's a pretty great setup. Should we take a 54 00:02:57,880 --> 00:02:58,400 Speaker 1: break now? 55 00:02:59,160 --> 00:03:01,080 Speaker 2: Oh not take an early break? 56 00:03:01,120 --> 00:03:24,360 Speaker 1: Okay, So, Chuck, you sent us up perfectly. Doctor Kelsey 57 00:03:24,480 --> 00:03:28,760 Speaker 1: is at the FDA brand new position after about seven months, 58 00:03:29,320 --> 00:03:34,440 Speaker 1: and her position was to basically check scientific data to 59 00:03:35,080 --> 00:03:39,560 Speaker 1: approve or disapprove new drugs for the FDA right about 60 00:03:39,560 --> 00:03:41,880 Speaker 1: seven months after she starts, and she was just a 61 00:03:41,920 --> 00:03:46,560 Speaker 1: handful of medical people who were actually doing that, yeh, 62 00:03:46,840 --> 00:03:49,600 Speaker 1: and had sixty days to do it. But about seven 63 00:03:49,640 --> 00:03:55,600 Speaker 1: months after she started, a drug approval application for a 64 00:03:55,680 --> 00:04:01,920 Speaker 1: drug called philidamide m crossed her death and she said, oh, oh, 65 00:04:02,000 --> 00:04:03,960 Speaker 1: what's this she did? 66 00:04:04,600 --> 00:04:07,280 Speaker 2: It came in from the American version was from the 67 00:04:07,400 --> 00:04:11,000 Speaker 2: Richardson Merrill company, and they were really eager to get 68 00:04:11,000 --> 00:04:14,240 Speaker 2: it going because this drug had been kind of the 69 00:04:14,280 --> 00:04:18,840 Speaker 2: hot ticket in Africa and in Europe and I think 70 00:04:18,880 --> 00:04:21,000 Speaker 2: a couple of other places around the world. It was 71 00:04:21,080 --> 00:04:24,480 Speaker 2: huge in Germany, very big in West Germany. They did 72 00:04:24,480 --> 00:04:28,760 Speaker 2: not approve it in East Germany, so they it was 73 00:04:28,800 --> 00:04:32,440 Speaker 2: a sedative. It was an anti anxiety drug basically. It 74 00:04:32,480 --> 00:04:36,479 Speaker 2: was developed in the fifties. It was a post war drug, 75 00:04:36,480 --> 00:04:38,560 Speaker 2: and they were like in every way, so were like, 76 00:04:38,560 --> 00:04:42,720 Speaker 2: people really need to settle down, and they need sedatives. 77 00:04:42,760 --> 00:04:47,320 Speaker 2: People need to sleep. So this thing Solidemi does a 78 00:04:47,360 --> 00:04:50,000 Speaker 2: great job at that. And so people started taking it 79 00:04:50,040 --> 00:04:51,800 Speaker 2: and they were like, hey, not only does it help 80 00:04:51,880 --> 00:04:55,479 Speaker 2: me sleep, but it helps my tum tum feel better. 81 00:04:56,240 --> 00:04:58,120 Speaker 2: So all of a sudden, pregnant women were like, this 82 00:04:58,279 --> 00:05:01,119 Speaker 2: is really working well for my morning. Yeah. 83 00:05:01,160 --> 00:05:02,720 Speaker 1: And this had been going on. I think it came 84 00:05:02,720 --> 00:05:06,520 Speaker 1: out in nineteen fifty two. This is nineteen sixty when 85 00:05:06,640 --> 00:05:10,840 Speaker 1: doctor Kelsey gets the application. So, I mean it had 86 00:05:10,880 --> 00:05:16,080 Speaker 1: been kind of proven effective and safe essentially throughout the 87 00:05:16,120 --> 00:05:18,840 Speaker 1: rest of the world. So there was an expectation, I'm 88 00:05:18,880 --> 00:05:21,080 Speaker 1: sure by the drug company that this would you know, 89 00:05:21,200 --> 00:05:26,120 Speaker 1: just sail through rather easily the application and review process. 90 00:05:26,600 --> 00:05:30,320 Speaker 1: But doctor Kelsey was a bit of a stickler, fortunately, 91 00:05:30,839 --> 00:05:33,080 Speaker 1: and she said, let me really take a look at 92 00:05:33,080 --> 00:05:36,520 Speaker 1: the science. And she found that there were reports of 93 00:05:36,680 --> 00:05:41,000 Speaker 1: neuropathy where people like lose sensation in their extremities, their 94 00:05:41,160 --> 00:05:45,279 Speaker 1: nerve endings are basically damaged. And it's true when you 95 00:05:45,320 --> 00:05:49,400 Speaker 1: stop taking polidimide, the sensation came back to your extremities, 96 00:05:49,800 --> 00:05:52,960 Speaker 1: but that's kind of weird and she didn't really understand that. 97 00:05:53,360 --> 00:05:57,400 Speaker 1: She also found that that pregnant women taking it off 98 00:05:57,480 --> 00:06:01,240 Speaker 1: label for morning sickness. There was basically no studies on that. 99 00:06:01,600 --> 00:06:04,920 Speaker 1: So as far as doctor Kelsey was concerned, there was 100 00:06:04,920 --> 00:06:08,120 Speaker 1: not enough scientific data coming across her desk for her 101 00:06:08,200 --> 00:06:09,760 Speaker 1: to approve this and she wanted more. 102 00:06:10,520 --> 00:06:15,520 Speaker 2: Yeah, and a couple of remarkable details here. The company 103 00:06:15,760 --> 00:06:19,400 Speaker 2: Richardson Merrill. They came back to her six times trying 104 00:06:19,400 --> 00:06:22,080 Speaker 2: to get this thing through, and we're putting the heat 105 00:06:22,120 --> 00:06:24,640 Speaker 2: on her in a big way. And the other thing 106 00:06:24,680 --> 00:06:26,400 Speaker 2: is he said they didn't do any tests on pregnancy. 107 00:06:26,680 --> 00:06:30,320 Speaker 2: This is because at the time doctor still didn't think 108 00:06:30,360 --> 00:06:34,480 Speaker 2: that drugs that pregnant women took could pass the placental barrier. 109 00:06:34,800 --> 00:06:36,920 Speaker 1: Oh okay, so she was. 110 00:06:36,600 --> 00:06:38,080 Speaker 2: Sort of ahead of the curve in a lot of 111 00:06:38,080 --> 00:06:41,760 Speaker 2: ways by thinking like, well, maybe something is happening here, 112 00:06:41,839 --> 00:06:45,360 Speaker 2: even though doctors say that's impossible, maybe we should look 113 00:06:45,360 --> 00:06:47,640 Speaker 2: at it closer, which and she held her ground through 114 00:06:47,640 --> 00:06:51,760 Speaker 2: those six times. Yeah. It turns out the West Germans 115 00:06:51,880 --> 00:06:56,560 Speaker 2: who developed this drug only test or at the time, 116 00:06:56,600 --> 00:07:00,359 Speaker 2: I guess, only tested drugs for toxicity and you know, 117 00:07:00,400 --> 00:07:02,599 Speaker 2: stuff like neuropathy and other like side effects. 118 00:07:02,680 --> 00:07:04,280 Speaker 1: So you give it to somebody and be like did 119 00:07:04,320 --> 00:07:04,920 Speaker 1: it kill you? 120 00:07:05,160 --> 00:07:08,000 Speaker 2: Yeah, no, it was the toxic so they let it ride. 121 00:07:08,120 --> 00:07:08,360 Speaker 1: Yeah. 122 00:07:08,839 --> 00:07:11,520 Speaker 2: Uh. And you know the history of pholidimi and I 123 00:07:11,560 --> 00:07:14,560 Speaker 2: mean Billy Joel included it in we didn't start the 124 00:07:14,560 --> 00:07:15,320 Speaker 2: fire for a reason. 125 00:07:15,440 --> 00:07:19,640 Speaker 1: That was a big deal. Yeah. So doctor Kelsey's holding 126 00:07:19,680 --> 00:07:22,720 Speaker 1: her grounds. She just wants more scientific data and the 127 00:07:22,760 --> 00:07:26,520 Speaker 1: company's not giving her what she wants. And meanwhile there's 128 00:07:26,560 --> 00:07:30,560 Speaker 1: two doctors, one in Australia named doctor William McBride, one 129 00:07:30,560 --> 00:07:35,760 Speaker 1: in Germany doctor Vidu kun Lnz. Did I say that right? 130 00:07:36,120 --> 00:07:36,480 Speaker 2: Thanks? 131 00:07:37,360 --> 00:07:39,640 Speaker 1: And they both started to notice that there was a 132 00:07:39,840 --> 00:07:45,800 Speaker 1: cluster of children being born with birth deformities, and that 133 00:07:45,920 --> 00:07:50,400 Speaker 1: they were very specific but very rare birth deformities, in 134 00:07:50,480 --> 00:07:55,960 Speaker 1: particular feet and hands protruding directly from shoulders and hips. 135 00:07:56,080 --> 00:07:59,400 Speaker 1: That's a very specific kind of birth deformity that you 136 00:07:59,400 --> 00:08:02,680 Speaker 1: can have, but exceedingly rare. So a bunch of kids 137 00:08:03,000 --> 00:08:07,640 Speaker 1: suddenly being born with that birth defect is it caught 138 00:08:07,680 --> 00:08:11,000 Speaker 1: their attention, and they started to do some investigating and 139 00:08:11,080 --> 00:08:14,480 Speaker 1: they figured out that the one commonality that all of 140 00:08:14,480 --> 00:08:17,200 Speaker 1: those mothers had was that they had taken thilidamite early 141 00:08:17,200 --> 00:08:20,040 Speaker 1: in their pregnancy for mourning sickness. And they published a 142 00:08:20,040 --> 00:08:22,000 Speaker 1: paper as fast as they could in the lands that 143 00:08:22,120 --> 00:08:24,520 Speaker 1: saying stop prescribing philidamine. 144 00:08:25,000 --> 00:08:27,720 Speaker 2: Yeah, I mean not only prescribing in West Germany. It 145 00:08:27,760 --> 00:08:29,960 Speaker 2: was over the counter, so you could just grab the 146 00:08:29,960 --> 00:08:33,320 Speaker 2: stuff and take it. In the end, about ten thousand 147 00:08:33,400 --> 00:08:38,719 Speaker 2: kids were affected the aforementioned Billy Joel's children of phlidamide 148 00:08:38,760 --> 00:08:41,720 Speaker 2: and so what they were known as about forty percent 149 00:08:41,760 --> 00:08:44,040 Speaker 2: of those died at birth because it was not only 150 00:08:44,400 --> 00:08:47,280 Speaker 2: like these deformities of the limbs really is what grabbed 151 00:08:47,280 --> 00:08:51,000 Speaker 2: their attention, but heart troubles and stuff like that was 152 00:08:51,040 --> 00:08:54,840 Speaker 2: also a big problem. And you know, forty percent died 153 00:08:54,880 --> 00:08:57,559 Speaker 2: sort of around birth or at birth. Most of these 154 00:08:57,640 --> 00:09:01,079 Speaker 2: kids were in West Germany, like I said, because they 155 00:09:01,120 --> 00:09:02,640 Speaker 2: developed the drug, and so I just think it was 156 00:09:02,679 --> 00:09:03,559 Speaker 2: more heavily used. 157 00:09:03,360 --> 00:09:05,800 Speaker 1: There and over the counter like you said, yeah. 158 00:09:05,640 --> 00:09:08,680 Speaker 2: And over the counter yea. And Kelsey said no, no, no, 159 00:09:08,720 --> 00:09:11,200 Speaker 2: we're not going to do it before anyone else did, 160 00:09:11,720 --> 00:09:15,160 Speaker 2: and she is the reason that it was never released 161 00:09:15,200 --> 00:09:18,760 Speaker 2: in the United States, although a handful of kids in 162 00:09:18,800 --> 00:09:23,560 Speaker 2: the United States were born. Maybe I didn't see an 163 00:09:23,559 --> 00:09:25,840 Speaker 2: explanation of how that happened. I think there was like 164 00:09:25,920 --> 00:09:28,840 Speaker 2: less than twenty, but I guess they got their hands 165 00:09:28,840 --> 00:09:30,120 Speaker 2: on some philidimid somehow. 166 00:09:30,200 --> 00:09:33,000 Speaker 1: Yeah, their parents could have been traveling in Europe, especially 167 00:09:33,040 --> 00:09:35,240 Speaker 1: if you take the little mightde early in pregnancy. 168 00:09:35,800 --> 00:09:36,680 Speaker 2: Yeah, that makes sense. 169 00:09:36,760 --> 00:09:39,720 Speaker 1: So they knew that philidamide led to a whole just 170 00:09:40,800 --> 00:09:44,440 Speaker 1: grab bag of different birth defects like you were saying. 171 00:09:44,880 --> 00:09:48,600 Speaker 1: But it wasn't until about sixty years after it got 172 00:09:48,640 --> 00:09:52,760 Speaker 1: pulled from shelves that they finally figured out why. And 173 00:09:52,840 --> 00:09:55,560 Speaker 1: what they realized is that with most drugs, it goes 174 00:09:55,559 --> 00:09:58,880 Speaker 1: and binds to a specific receptor site and maybe it 175 00:09:58,920 --> 00:10:02,199 Speaker 1: prevents the reuptake, say serotonin, so you have more serotonin 176 00:10:02,280 --> 00:10:06,480 Speaker 1: flowing through your system and that helps balance that neurochemical well, 177 00:10:06,600 --> 00:10:11,319 Speaker 1: phelidimide binds to all sorts of different stuff, specifically lots 178 00:10:11,320 --> 00:10:15,440 Speaker 1: of different proteins, and those proteins do things like turn 179 00:10:15,600 --> 00:10:19,160 Speaker 1: genes on and off. And because it's so non preferential 180 00:10:19,160 --> 00:10:21,520 Speaker 1: with what proteins it binds to, it can bind to 181 00:10:21,679 --> 00:10:24,120 Speaker 1: all sorts of different proteins that are responsible for all 182 00:10:24,120 --> 00:10:27,000 Speaker 1: sorts of different genes. And when those genes aren't turned 183 00:10:27,000 --> 00:10:30,040 Speaker 1: on or aren't turned off, you can develop a foot 184 00:10:30,120 --> 00:10:32,480 Speaker 1: on your shoulder, that kind of thing, and that that's 185 00:10:32,840 --> 00:10:35,400 Speaker 1: why pholidami cause all those birth effects. 186 00:10:35,679 --> 00:10:38,200 Speaker 2: That's right. And in the end, like you mentioned, Kelsey 187 00:10:38,360 --> 00:10:41,559 Speaker 2: was somewhat sung in her lifetime. That was a big 188 00:10:42,840 --> 00:10:44,960 Speaker 2: and this article points out from how stuff works that 189 00:10:45,480 --> 00:10:47,520 Speaker 2: she probably would have been unsung had it not been 190 00:10:47,559 --> 00:10:51,360 Speaker 2: for this great article on the Washington Post that was 191 00:10:51,400 --> 00:10:54,600 Speaker 2: published back then in nineteen sixty two about her, and 192 00:10:54,640 --> 00:10:59,559 Speaker 2: that caused President John F. Kennedy to stand up and sayer, 193 00:11:00,720 --> 00:11:05,240 Speaker 2: here is the President's Award for Distinguished Federal Civilian Service 194 00:11:05,320 --> 00:11:07,960 Speaker 2: for doing that thing you did. 195 00:11:07,960 --> 00:11:09,679 Speaker 1: That was more a Teddy Kennedy. 196 00:11:09,320 --> 00:11:15,520 Speaker 2: I think Teddy Kennedy. But more importantly, the Cathalver Harris 197 00:11:15,559 --> 00:11:20,040 Speaker 2: Amendment went into law, which was the legislation that really 198 00:11:20,320 --> 00:11:23,800 Speaker 2: tightened up how the FDA approves things, and not only 199 00:11:23,840 --> 00:11:27,040 Speaker 2: tightened up, but lengthened and made the process more rigorous. 200 00:11:27,120 --> 00:11:29,640 Speaker 1: Yeah, and she stayed on for forty five more years 201 00:11:29,679 --> 00:11:33,160 Speaker 1: and helped kind of shape the approval process for drugs 202 00:11:33,160 --> 00:11:33,880 Speaker 1: at the FDA. 203 00:11:34,280 --> 00:11:35,600 Speaker 2: I hope she got a better office. 204 00:11:36,160 --> 00:11:38,319 Speaker 1: I hope she did too, a corner one too. And 205 00:11:38,400 --> 00:11:40,800 Speaker 1: there's a plenty of stuff you can say about the 206 00:11:40,840 --> 00:11:44,400 Speaker 1: approval process at the FDA, especially these days, but it's 207 00:11:44,520 --> 00:11:46,120 Speaker 1: better than sixty day window. 208 00:11:46,960 --> 00:11:50,000 Speaker 2: That's true, Chuck said, that's. 209 00:11:49,840 --> 00:11:53,280 Speaker 1: True, everybody, and that triggers short stuff being out. 210 00:11:57,000 --> 00:12:00,199 Speaker 2: Stuff you should know is a production of iHeartRadio. More 211 00:12:00,200 --> 00:12:04,160 Speaker 2: podcasts my Heart Radio, visit the iHeartRadio app, Apple Podcasts, 212 00:12:04,280 --> 00:12:06,120 Speaker 2: or wherever you listen to your favorite shows.