1 00:00:15,410 --> 00:00:28,170 Speaker 1: Pushkin in a neat Washington, DC office with pealing green walls. 2 00:00:28,810 --> 00:00:33,610 Speaker 1: Time is running out for softly spoken, incredibly thorough doctor 3 00:00:33,650 --> 00:00:40,770 Speaker 1: Francis Oldham Kelsey. It's November nineteen sixty, two months earlier. 4 00:00:40,930 --> 00:00:45,370 Speaker 1: A thick bundle of papers several phone books worth arrived 5 00:00:45,370 --> 00:00:48,730 Speaker 1: on her desk at the Food and Drug Administration. It 6 00:00:48,810 --> 00:00:51,770 Speaker 1: was an application for a new drug to be approved 7 00:00:51,810 --> 00:00:56,330 Speaker 1: for the American market. Francis and her small team had 8 00:00:56,410 --> 00:01:00,570 Speaker 1: been given sixty days to approve or refuse a drug, 9 00:01:01,010 --> 00:01:05,930 Speaker 1: and this application was expected to sail through. The drug 10 00:01:05,970 --> 00:01:10,250 Speaker 1: has been given the name Kevedon and reportedly a side 11 00:01:10,250 --> 00:01:16,770 Speaker 1: effect free sedative that can ease anxiety, insomnia, and morning sickness. 12 00:01:16,810 --> 00:01:20,570 Speaker 1: For years, it's been used by millions of people in Europe, 13 00:01:20,730 --> 00:01:25,810 Speaker 1: Africa and Australia. Manufacturer William S. Merrill is so confident 14 00:01:25,850 --> 00:01:29,010 Speaker 1: of a swift approval in the States. It's already printed 15 00:01:29,090 --> 00:01:33,130 Speaker 1: promotional material for the wander drug and gathered the ingredients 16 00:01:33,170 --> 00:01:39,090 Speaker 1: to make fifteen million pills. But something isn't sitting right 17 00:01:39,330 --> 00:01:42,970 Speaker 1: with Francis Oldham Kelcey. She would later say. 18 00:01:43,490 --> 00:01:46,370 Speaker 2: Here was a drug that it looked like it should 19 00:01:46,450 --> 00:01:49,210 Speaker 2: be No prodent, but at the same time there was 20 00:01:49,290 --> 00:01:52,770 Speaker 2: just a feeling that there was something in the data, 21 00:01:52,850 --> 00:01:56,170 Speaker 2: of the absence of data that was a cause of concern. 22 00:01:57,850 --> 00:02:01,250 Speaker 1: The trouble is Francis doesn't have any hard proof that 23 00:02:01,290 --> 00:02:04,250 Speaker 1: there is a problem with Kevidon, and the end of 24 00:02:04,290 --> 00:02:08,770 Speaker 1: her sixty day review period is fast approaching. If she 25 00:02:08,810 --> 00:02:12,330 Speaker 1: doesn't to prove it or reject it by then, the 26 00:02:12,410 --> 00:02:16,530 Speaker 1: company can sell it regardless. What can she do to 27 00:02:16,650 --> 00:02:22,210 Speaker 1: buy herself more time to determine the drug's safety. William S. 28 00:02:22,330 --> 00:02:26,530 Speaker 1: Merrill is pressing Francis hard. An approval for the mild 29 00:02:26,570 --> 00:02:31,690 Speaker 1: sedative in time for Christmas would be very lucrative. After all, 30 00:02:31,730 --> 00:02:35,010 Speaker 1: it's hugely popular in West Germany, where it goes by 31 00:02:35,010 --> 00:02:38,690 Speaker 1: the name of Contagan, in Britain, New Zealand and Australia 32 00:02:39,410 --> 00:02:43,810 Speaker 1: or it's called distaval, and in South Africa where people 33 00:02:43,850 --> 00:02:52,010 Speaker 1: take tero sediv. So many names for the same drug. Forlidamine, 34 00:02:53,410 --> 00:03:21,490 Speaker 1: I'm Tim Harford and you're listening to cautionary tales. Today, 35 00:03:21,810 --> 00:03:27,770 Speaker 1: solidamide is synonymous with babies born with terrible injuries suffered 36 00:03:27,890 --> 00:03:32,490 Speaker 1: during pregnancy. But in the nineteen sixties, no one appreciates 37 00:03:32,530 --> 00:03:36,690 Speaker 1: the danger. It's a very mild sedative, after all, freely 38 00:03:36,730 --> 00:03:41,930 Speaker 1: available in forty six countries only. Francis Oldham Kelsey stands 39 00:03:41,970 --> 00:03:46,450 Speaker 1: in the way of pelidamide entering the American market. Here 40 00:03:46,490 --> 00:03:49,770 Speaker 1: to tell us all about this incredible woman is Katie 41 00:03:49,850 --> 00:03:54,890 Speaker 1: Hafner of the Lost Women of Science podcast. Katie, Welcome 42 00:03:54,930 --> 00:03:55,810 Speaker 1: to Cautionary Tails. 43 00:03:56,370 --> 00:03:58,930 Speaker 3: Tim, Thank you so much for having me. It's a pleasure. 44 00:04:00,330 --> 00:04:03,490 Speaker 1: Now. A Lost Women of Science is a remarkable podcast. 45 00:04:03,570 --> 00:04:06,490 Speaker 1: Just give us the quick explanation of what it is 46 00:04:06,530 --> 00:04:06,970 Speaker 1: that you do. 47 00:04:07,410 --> 00:04:11,850 Speaker 3: Well, armantra Is, We're not mad, We're curious. Okay, we're 48 00:04:11,890 --> 00:04:16,930 Speaker 3: a little mad. So we started the podcast a few 49 00:04:17,010 --> 00:04:21,250 Speaker 3: years ago with the idea that for every Marie Currie 50 00:04:21,330 --> 00:04:25,450 Speaker 3: or Rosalind Franklin out there whose story has been told, 51 00:04:26,490 --> 00:04:30,690 Speaker 3: there are hundreds, if not thousands, of women whose stories 52 00:04:30,730 --> 00:04:34,850 Speaker 3: deserve to be told. And we have a growing database 53 00:04:35,050 --> 00:04:38,890 Speaker 3: of something like three hundred and fifty women, all of 54 00:04:38,890 --> 00:04:42,090 Speaker 3: whom did remarkable work in science, and we are just 55 00:04:42,210 --> 00:04:44,370 Speaker 3: chipping away at it and telling their stories. 56 00:04:44,930 --> 00:04:48,290 Speaker 1: Well, we're going to tell Francis Oldham Kelsey's story today 57 00:04:48,330 --> 00:04:50,530 Speaker 1: with your help. So just tell me a little bit 58 00:04:50,690 --> 00:04:51,650 Speaker 1: more about this woman. 59 00:04:52,290 --> 00:04:55,970 Speaker 3: Well, she was, as you say in your introduction, soft spoken, 60 00:04:56,290 --> 00:05:00,650 Speaker 3: a very serious scientist. She was an MD and a pharmacologist, 61 00:05:01,650 --> 00:05:04,690 Speaker 3: and she wanted to be a scientist from a very 62 00:05:04,730 --> 00:05:09,010 Speaker 3: early age, which was at that time fairly on new 63 00:05:09,170 --> 00:05:11,650 Speaker 3: usual for a woman. And this woman, by the way, 64 00:05:11,810 --> 00:05:16,010 Speaker 3: was Canadian. She was also a very wonderful mother. We 65 00:05:16,250 --> 00:05:20,770 Speaker 3: talked to one of her daughters in her spare time, 66 00:05:21,370 --> 00:05:24,210 Speaker 3: and I just love this. For a good time, she 67 00:05:24,250 --> 00:05:28,290 Speaker 3: would read medical journals with her husband, who was also 68 00:05:28,330 --> 00:05:31,930 Speaker 3: a pharmacologist after dinner. The kids remember, oh yeah, mom 69 00:05:31,970 --> 00:05:35,090 Speaker 3: and dad would do their romantic thing and discuss what 70 00:05:35,130 --> 00:05:37,650 Speaker 3: they just read in the BMJ. 71 00:05:37,610 --> 00:05:41,690 Speaker 1: Or kill upon the sofa and discuss the LA pharmacological trial. 72 00:05:42,250 --> 00:05:45,890 Speaker 1: I love that Francis had a PhD in pharmacology. I 73 00:05:45,930 --> 00:05:47,930 Speaker 1: believe she was the first woman in the United States 74 00:05:48,450 --> 00:05:53,810 Speaker 1: to earn a PhD in pharmacology. And she had early 75 00:05:53,890 --> 00:06:01,690 Speaker 1: dealings with the FDA because her mentor, EMK Guiling, had 76 00:06:01,730 --> 00:06:06,210 Speaker 1: been asked by the FDA to look into a medicine 77 00:06:06,290 --> 00:06:11,850 Speaker 1: called Elixir sulfonilamide, which was this cherry flavored cold medicine 78 00:06:11,890 --> 00:06:15,650 Speaker 1: that was suspected of having killed over one hundred people 79 00:06:15,730 --> 00:06:19,450 Speaker 1: many of them children. So in the late nineteen thirties 80 00:06:19,850 --> 00:06:22,770 Speaker 1: he was asked to look into that. Was Francis Oldham 81 00:06:22,850 --> 00:06:25,570 Speaker 1: Kelsey involved in that investigation or just here about it? 82 00:06:25,610 --> 00:06:26,170 Speaker 1: Second hand? 83 00:06:26,610 --> 00:06:30,650 Speaker 3: She was involved, and I think it planted a seed 84 00:06:30,730 --> 00:06:37,210 Speaker 3: in her head about the need for strict, rigorous requirements 85 00:06:37,570 --> 00:06:40,890 Speaker 3: for FDA approval for drugs. It was really kind of 86 00:06:40,890 --> 00:06:43,610 Speaker 3: a free for all, yeah before them, which is how 87 00:06:43,650 --> 00:06:45,570 Speaker 3: this crazy anti freeze thing happened. 88 00:06:46,290 --> 00:06:50,770 Speaker 1: Yeah, so this drug had an anti freeze diathleene glycol, 89 00:06:50,890 --> 00:06:53,530 Speaker 1: which is potentially deadly to kill people. 90 00:06:53,690 --> 00:06:55,810 Speaker 3: I mean, can we just stop for a second and say, 91 00:06:55,850 --> 00:06:56,610 Speaker 3: how crazy is that? 92 00:06:56,770 --> 00:06:59,530 Speaker 1: Okay, yeah it is. I Mean one of the points 93 00:06:59,650 --> 00:07:03,490 Speaker 1: that last Women of Science mentioned, which I just thought 94 00:07:03,530 --> 00:07:08,290 Speaker 1: was fascinating and horrifying, is that the FDA wasn't actually 95 00:07:08,330 --> 00:07:11,090 Speaker 1: in charge of me making sure that that sort of 96 00:07:11,090 --> 00:07:14,330 Speaker 1: thing was safe. It wasn't the FDA's job to make 97 00:07:14,370 --> 00:07:18,290 Speaker 1: sure that the cough medicine wouldn't kill you. It was 98 00:07:18,290 --> 00:07:20,450 Speaker 1: the FDA's job to make sure that the cough medicine 99 00:07:20,570 --> 00:07:24,170 Speaker 1: had what the manufacturers said it had in it. So 100 00:07:24,210 --> 00:07:25,930 Speaker 1: they said it had anti freeze in it, and it 101 00:07:25,930 --> 00:07:28,010 Speaker 1: did have anti freeze in it, so there's no problem. 102 00:07:28,210 --> 00:07:30,850 Speaker 1: The law changed after that, understandably. 103 00:07:30,410 --> 00:07:32,730 Speaker 3: Right, and we're going to see later on how the 104 00:07:32,810 --> 00:07:35,370 Speaker 3: law changes even more thanks to her. 105 00:07:36,130 --> 00:07:38,090 Speaker 1: And the other thing that she did that I think 106 00:07:38,130 --> 00:07:43,850 Speaker 1: would later become important as a young scientist was to 107 00:07:44,010 --> 00:07:49,490 Speaker 1: investigate quinine, which is a drug used for a malaria medication. 108 00:07:50,330 --> 00:07:53,130 Speaker 1: And one of the things that she and her colleagues 109 00:07:53,210 --> 00:07:59,130 Speaker 1: discovered was that that drug could pass the placental barrier, 110 00:08:00,090 --> 00:08:02,730 Speaker 1: so it would get into the fetuses of pregnant animals 111 00:08:02,770 --> 00:08:03,650 Speaker 1: who were given quinneen. 112 00:08:04,130 --> 00:08:06,810 Speaker 3: Yes. In fact, this is how she met her husband. 113 00:08:07,970 --> 00:08:10,770 Speaker 3: I love it, you say quinn, and we say quinine. 114 00:08:10,650 --> 00:08:13,570 Speaker 1: So okay, I'll allow it. So Yes. 115 00:08:13,770 --> 00:08:18,410 Speaker 3: This experience she had with the quinine work was really 116 00:08:18,450 --> 00:08:21,170 Speaker 3: important because again it planted a seed in her head 117 00:08:21,810 --> 00:08:25,730 Speaker 3: about the placental barrier, which then plays a very important 118 00:08:25,810 --> 00:08:30,250 Speaker 3: role in her concerns later about the litamibe. 119 00:08:30,770 --> 00:08:35,650 Speaker 1: Okay, So she's seen that drugs can pass into a fetus. 120 00:08:36,450 --> 00:08:39,290 Speaker 1: She's seen that the work of the FDA is incredibly important, 121 00:08:39,570 --> 00:08:43,730 Speaker 1: and if things go wrong, people die. So these are 122 00:08:43,770 --> 00:08:47,010 Speaker 1: two parts of her life story, and in nineteen sixty 123 00:08:47,410 --> 00:08:50,610 Speaker 1: she begins a new job as a medical reviewer at 124 00:08:49,930 --> 00:08:55,890 Speaker 1: the New Drug Application Division of the FDA, working in Washington, DC, 125 00:08:56,170 --> 00:09:00,050 Speaker 1: and just a few weeks later, in September nineteen sixty, 126 00:09:00,210 --> 00:09:04,890 Speaker 1: this application from the drug company william S. Merrill lands 127 00:09:04,970 --> 00:09:07,450 Speaker 1: on her desk. So just tell me a little bit 128 00:09:07,450 --> 00:09:09,970 Speaker 1: more about the company and about the drug they we're 129 00:09:09,970 --> 00:09:10,810 Speaker 1: trying to get approved. 130 00:09:11,970 --> 00:09:15,090 Speaker 3: The drug Poaltamide had been developed by the Germans not 131 00:09:15,250 --> 00:09:20,290 Speaker 3: long after World War Two. This company, Kemi, Grunenthal and 132 00:09:20,410 --> 00:09:25,210 Speaker 3: Merrill was the American company that was hoping to take 133 00:09:25,210 --> 00:09:29,650 Speaker 3: this thing to market. It was hugely successful in Europe 134 00:09:29,810 --> 00:09:35,010 Speaker 3: and elsewhere. Politimide was considered this wonder drug, a sedative 135 00:09:35,530 --> 00:09:38,850 Speaker 3: substitute for barbituates. In other words, it had none of 136 00:09:38,850 --> 00:09:42,290 Speaker 3: these hangover qualities. It wasn't addictive, there were no side 137 00:09:42,330 --> 00:09:47,330 Speaker 3: effects that could be determined, and it was taken for anxiety, 138 00:09:47,970 --> 00:09:52,010 Speaker 3: for insomnia, and later it was prescribed for morning sickness. 139 00:09:52,610 --> 00:09:56,810 Speaker 3: And people were taking this drug just popping them like 140 00:09:56,970 --> 00:10:01,490 Speaker 3: gum drops. And there was a very cozy relationship between 141 00:10:01,530 --> 00:10:05,570 Speaker 3: the pharmaceutical industry and the FDA, and a lot of 142 00:10:05,610 --> 00:10:08,610 Speaker 3: these drugs were just basically rubber stamped. And she was 143 00:10:08,690 --> 00:10:13,530 Speaker 3: new Francis Kelsey was brand new to the agency, and 144 00:10:13,890 --> 00:10:17,290 Speaker 3: everyone thought, well, you know, the new girl will just 145 00:10:17,690 --> 00:10:20,490 Speaker 3: stamp it, and this thing will be on the market 146 00:10:20,650 --> 00:10:23,050 Speaker 3: by Christmas and we're good to go. 147 00:10:23,690 --> 00:10:25,930 Speaker 1: Yeah, the new girl, who's we should say, I think 148 00:10:25,930 --> 00:10:27,890 Speaker 1: it's in her forties at this point, but yeah, sure, 149 00:10:27,930 --> 00:10:28,250 Speaker 1: then you go. 150 00:10:29,890 --> 00:10:31,770 Speaker 3: Yes, the new girl and her they could I think 151 00:10:31,810 --> 00:10:34,050 Speaker 3: they actually said the new girl. 152 00:10:33,930 --> 00:10:37,210 Speaker 1: Absolutely, I've no doubt that they did. The claim for 153 00:10:37,290 --> 00:10:40,810 Speaker 1: this drug is that it's completely safe. You literally cannot 154 00:10:40,850 --> 00:10:44,530 Speaker 1: overdose on it. It's risk free. But Francis Kelsey wasn't 155 00:10:44,530 --> 00:10:47,130 Speaker 1: so sure. What was it that made her doubt this? 156 00:10:47,690 --> 00:10:51,610 Speaker 3: Of course, there was a deluge of paperwork and she 157 00:10:51,690 --> 00:10:54,130 Speaker 3: was going through all of this. She said, something like 158 00:10:54,930 --> 00:10:59,410 Speaker 3: several phone books worth of paperwork, and she just didn't 159 00:10:59,490 --> 00:11:02,890 Speaker 3: see the science. She didn't see the evidence. She didn't 160 00:11:02,970 --> 00:11:07,170 Speaker 3: see what have come to be known as clinical trials 161 00:11:07,850 --> 00:11:10,890 Speaker 3: done in any kind of rigor. And she just said, 162 00:11:11,090 --> 00:11:15,530 Speaker 3: this just isn't working for me, guys, And she did 163 00:11:15,570 --> 00:11:19,930 Speaker 3: not rubber stamp it. She wanted more evidence that it 164 00:11:19,970 --> 00:11:20,410 Speaker 3: was safe. 165 00:11:20,930 --> 00:11:24,370 Speaker 1: Yeah, And she took her work home with her and 166 00:11:24,410 --> 00:11:27,490 Speaker 1: she showed it to her husband because he's another pharmacologist. 167 00:11:27,490 --> 00:11:29,970 Speaker 1: So she's getting a second opinion, and he picked up 168 00:11:30,010 --> 00:11:34,810 Speaker 1: on this this weird claim that there is no lethal dose. 169 00:11:35,250 --> 00:11:39,090 Speaker 1: You can overdose on water, but apparently plidamide you cannot 170 00:11:39,130 --> 00:11:40,370 Speaker 1: overdose on plidamide. 171 00:11:40,850 --> 00:11:45,010 Speaker 3: So yeah, so exactly, so that's a red flag. There 172 00:11:45,010 --> 00:11:48,890 Speaker 3: had been no animal testing, and also others in the 173 00:11:48,930 --> 00:11:52,610 Speaker 3: office who could read the German because Merril had included 174 00:11:52,650 --> 00:11:56,930 Speaker 3: all of these so called studies that the Germans had done, 175 00:11:57,610 --> 00:12:03,250 Speaker 3: and apparently the translations weren't done properly, and you know, 176 00:12:03,290 --> 00:12:05,690 Speaker 3: there were all kinds of things to him that made 177 00:12:05,730 --> 00:12:07,930 Speaker 3: her just say, well, wait a minute. I mean, this 178 00:12:08,050 --> 00:12:10,970 Speaker 3: was a woman who critis and dotted her eyes and 179 00:12:11,810 --> 00:12:13,930 Speaker 3: it wasn't working for her. 180 00:12:14,450 --> 00:12:16,810 Speaker 1: So she looks at this and she goes, well, it 181 00:12:16,850 --> 00:12:19,250 Speaker 1: seems strange that they haven't done really good studies. It 182 00:12:19,290 --> 00:12:22,450 Speaker 1: seems strange that they've watched the translation. It seems strange 183 00:12:22,450 --> 00:12:27,770 Speaker 1: that they've made this extraordinary claim that it's absolutely non toxic. 184 00:12:29,370 --> 00:12:31,650 Speaker 1: There's no actual evidence that it does any damage. And 185 00:12:31,690 --> 00:12:34,690 Speaker 1: she's only got sixty days to approve it or reject it, 186 00:12:34,850 --> 00:12:37,730 Speaker 1: and she can't reject it because there's no evidence that 187 00:12:37,730 --> 00:12:39,050 Speaker 1: there's a problem. So what does she do. 188 00:12:40,010 --> 00:12:44,730 Speaker 3: Francis had a mentor at the FDA named Barbara Malton, 189 00:12:45,770 --> 00:12:49,210 Speaker 3: who actually left in a very high profile way. And 190 00:12:49,610 --> 00:12:50,930 Speaker 3: Malton was very outspoken. 191 00:12:51,570 --> 00:12:55,050 Speaker 1: Another difficult woman, Yes, another dog. 192 00:12:55,970 --> 00:12:58,730 Speaker 3: And Malton said to her, you know, here's what you 193 00:12:58,770 --> 00:13:03,810 Speaker 3: could do. You could just declare the application, regardless of 194 00:13:03,810 --> 00:13:08,570 Speaker 3: how many phone books it's taken up, as incomplete. And 195 00:13:08,850 --> 00:13:11,650 Speaker 3: so that's what she did in order to buy herself time. 196 00:13:12,850 --> 00:13:16,770 Speaker 3: So this thing came onto her desk in September. In November, 197 00:13:17,410 --> 00:13:22,970 Speaker 3: she declares it incomplete and infuriates infuriates the people at Meryl. 198 00:13:23,690 --> 00:13:25,810 Speaker 1: Yeah, because they want to sell this drug in time 199 00:13:25,810 --> 00:13:27,090 Speaker 1: for Christmas. 200 00:13:27,250 --> 00:13:31,130 Speaker 3: Which is Confuciuscy for Christmas, Like, because everyone needs sedatives 201 00:13:31,130 --> 00:13:31,970 Speaker 3: at Christmas. 202 00:13:32,570 --> 00:13:36,810 Speaker 1: Yeah, yeah, nothing says Christmas like a sleeping pill. Right. Okay, 203 00:13:37,050 --> 00:13:42,970 Speaker 1: so the clock resets, but it's still ticking. Francis Kelsey's 204 00:13:43,050 --> 00:13:47,370 Speaker 1: no closer to finding any actual proof that there is 205 00:13:47,410 --> 00:13:51,530 Speaker 1: a problem. So where should she look for answers? How 206 00:13:51,570 --> 00:13:54,410 Speaker 1: does the son of a Nazi geneticist come into the picture. 207 00:13:54,730 --> 00:13:58,290 Speaker 1: We will find out the answers to these questions. After 208 00:13:58,290 --> 00:14:13,770 Speaker 1: the break, we're back and I am joined by Katie Hafner, 209 00:14:13,970 --> 00:14:18,170 Speaker 1: the host of Lost Women of Science. So Katie we 210 00:14:18,330 --> 00:14:22,290 Speaker 1: left Francis Oldham Kelsey having brought herself a little bit 211 00:14:22,330 --> 00:14:25,290 Speaker 1: more time. But she still doesn't have any proof that 212 00:14:25,370 --> 00:14:30,210 Speaker 1: this new drug Kevidon aka solidamide is dangerous. She just 213 00:14:30,250 --> 00:14:33,930 Speaker 1: has this gut instinct that something's not right. So what 214 00:14:33,970 --> 00:14:34,690 Speaker 1: does she do next? 215 00:14:35,610 --> 00:14:40,050 Speaker 3: Well, what she does next thanks to her avid interest 216 00:14:40,170 --> 00:14:42,490 Speaker 3: in reading medical journals on. 217 00:14:42,530 --> 00:14:44,490 Speaker 1: The sofa with hausband yeah on the. 218 00:14:44,490 --> 00:14:48,050 Speaker 3: Song with her husband. Is that in late January nineteen 219 00:14:48,050 --> 00:14:51,850 Speaker 3: sixty one. So now we're several months into this and 220 00:14:51,890 --> 00:14:56,530 Speaker 3: we have missed the Christmas window. She reads a letter 221 00:14:57,170 --> 00:15:00,730 Speaker 3: from a Scottish doctor in an old copy of the 222 00:15:00,770 --> 00:15:05,610 Speaker 3: British Medical Journal BMJ, and the title absolutely gets her attention. 223 00:15:05,810 --> 00:15:10,610 Speaker 3: It's is solidamide to blame? And what he notes in 224 00:15:10,650 --> 00:15:15,570 Speaker 3: this letter is that four patients have peripheral neuritis, which 225 00:15:15,610 --> 00:15:18,530 Speaker 3: is this painful tingling in the arms and feet and 226 00:15:19,290 --> 00:15:24,210 Speaker 3: loss of sensation. And this happened for all four of 227 00:15:24,250 --> 00:15:29,650 Speaker 3: these people after taking pholidamide for a year. So he 228 00:15:30,370 --> 00:15:36,170 Speaker 3: alerts the UK distributor of polidamide, which is called distillers, 229 00:15:36,970 --> 00:15:41,050 Speaker 3: and they put warnings on their labels in August of 230 00:15:41,290 --> 00:15:45,810 Speaker 3: nineteen sixty, which is a full month before Meryl even 231 00:15:45,890 --> 00:15:48,090 Speaker 3: submitted its application to the FDA. 232 00:15:48,450 --> 00:15:53,610 Speaker 1: Did Merrill's application mention no these concerns or the warning nabeles, No, 233 00:15:54,850 --> 00:15:55,330 Speaker 1: it did not. 234 00:15:56,370 --> 00:16:01,170 Speaker 3: The Meryl representative Joseph Murray, the one who's been communicating 235 00:16:01,210 --> 00:16:05,650 Speaker 3: principally with Francis and has been harassing her to no end. 236 00:16:06,490 --> 00:16:10,010 Speaker 3: He never even mentions this until he is pressed to 237 00:16:10,090 --> 00:16:12,410 Speaker 3: do so, and when she brings it up with him, 238 00:16:12,490 --> 00:16:15,050 Speaker 3: he says, oh, well, no, it's it's all okay. 239 00:16:15,250 --> 00:16:17,530 Speaker 1: Right, Well, he says that to her, but then he 240 00:16:17,530 --> 00:16:19,650 Speaker 1: calls her boss and complains. 241 00:16:19,450 --> 00:16:21,890 Speaker 3: Right, And then he calls her boss and complains because 242 00:16:21,930 --> 00:16:26,330 Speaker 3: this woman is just making his life a misery. 243 00:16:26,970 --> 00:16:29,690 Speaker 1: What did her boss do when? Because I understand that 244 00:16:29,730 --> 00:16:33,210 Speaker 1: he basically accused her of Lionel. He's like, the FDA, 245 00:16:33,650 --> 00:16:38,410 Speaker 1: your inspector, Francis Oldham Kelsey, she is libeling us, which 246 00:16:38,450 --> 00:16:41,410 Speaker 1: is a pretty heavy claim. 247 00:16:41,010 --> 00:16:41,410 Speaker 2: It is. 248 00:16:41,810 --> 00:16:46,890 Speaker 3: But her boss backed her up, which was also infuriating 249 00:16:47,450 --> 00:16:51,130 Speaker 3: to Merrill. They have so much on the line here 250 00:16:51,810 --> 00:16:56,930 Speaker 3: and they're getting absolutely nowhere. And in the spring of 251 00:16:57,010 --> 00:17:00,250 Speaker 3: nineteen sixty one, Francis went so far as to write 252 00:17:00,250 --> 00:17:03,730 Speaker 3: a letter to Murray and say that the burden of 253 00:17:03,810 --> 00:17:07,090 Speaker 3: proof that the drug is safe lay with the applicant. 254 00:17:07,570 --> 00:17:11,170 Speaker 1: You want me to approve this drug, you prove it safe. Yes, 255 00:17:11,810 --> 00:17:13,810 Speaker 1: they don't expect me to prove it's dangerous. I want 256 00:17:13,850 --> 00:17:14,930 Speaker 1: you to prove it safe. 257 00:17:15,090 --> 00:17:15,770 Speaker 3: That's correct. 258 00:17:16,130 --> 00:17:19,050 Speaker 1: And she was I think possibly influenced by her work 259 00:17:19,090 --> 00:17:23,730 Speaker 1: on quinine. Yes, she was particularly concerned to prove it 260 00:17:23,850 --> 00:17:25,490 Speaker 1: safe for use during pregnancy. 261 00:17:25,610 --> 00:17:29,490 Speaker 3: That's absolutely right, because of this whole idea of crossing 262 00:17:29,570 --> 00:17:33,450 Speaker 3: the placental barrier. And that was something that she asked 263 00:17:33,490 --> 00:17:39,250 Speaker 3: about time and again. And also what's very important is 264 00:17:39,290 --> 00:17:45,410 Speaker 3: that Meryll had only looked at late pregnancy and what 265 00:17:45,530 --> 00:17:48,650 Speaker 3: about the entire term? And Francis wanted to know about 266 00:17:48,690 --> 00:17:49,290 Speaker 3: that as well. 267 00:17:50,090 --> 00:17:54,170 Speaker 1: So this dance goes back and forth between the FDA 268 00:17:54,370 --> 00:17:59,450 Speaker 1: and Meryl. Francis Oldham Kelsey keeps storing the process. This 269 00:17:59,530 --> 00:18:03,250 Speaker 1: takes eighteen months. Merrill keep coming to the FDA office. 270 00:18:03,250 --> 00:18:07,330 Speaker 1: I think they come about fifty times. But over in 271 00:18:07,370 --> 00:18:13,410 Speaker 1: West Germany there are miscarriages and children being born dead, 272 00:18:13,650 --> 00:18:16,570 Speaker 1: but those who were born alive are born with these 273 00:18:16,610 --> 00:18:17,570 Speaker 1: really serious. 274 00:18:17,250 --> 00:18:23,010 Speaker 3: Injuries, including at Grunental itself, Gruntel that the company that 275 00:18:23,130 --> 00:18:23,850 Speaker 3: makes the drug. 276 00:18:24,010 --> 00:18:26,810 Speaker 1: So in fact, this is where some of the earliest injuries. 277 00:18:26,530 --> 00:18:29,930 Speaker 3: Yes could Yes, employees were taking this home to their 278 00:18:29,970 --> 00:18:35,490 Speaker 3: pregnant wives. The very first case was a baby born 279 00:18:35,570 --> 00:18:37,810 Speaker 3: with no ears in the late nineteen. 280 00:18:37,490 --> 00:18:43,810 Speaker 1: Fifties, which is several years before Franst starts stalling the process. 281 00:18:43,810 --> 00:18:46,090 Speaker 1: In America, there's a. 282 00:18:46,010 --> 00:18:49,450 Speaker 3: Lot of suppression of information. There's just a lot of 283 00:18:49,450 --> 00:18:53,010 Speaker 3: information that isn't getting out. And let's not forget tim 284 00:18:53,130 --> 00:18:58,130 Speaker 3: as this is happening, babies are being born on many 285 00:18:58,170 --> 00:19:04,850 Speaker 3: different continents, born with this severe, severe set of injuries, 286 00:19:05,530 --> 00:19:10,650 Speaker 3: the most harrowing of which is folk which literally means 287 00:19:10,810 --> 00:19:16,130 Speaker 3: sort of seal limbs, and babies born with very, very 288 00:19:16,130 --> 00:19:23,530 Speaker 3: truncated arms and legs. And this was actually happening while 289 00:19:24,170 --> 00:19:29,450 Speaker 3: this whole thrash between Meryl and the FDA was going on. 290 00:19:30,010 --> 00:19:34,370 Speaker 1: Okay, so babies are being born with these injuries, but 291 00:19:34,730 --> 00:19:39,090 Speaker 1: what's the connection to fldamite. How is the connection to 292 00:19:39,210 --> 00:19:40,850 Speaker 1: this drug first suspected? 293 00:19:42,130 --> 00:19:46,650 Speaker 3: So in West Germany, in Hamburg, in April of nineteen 294 00:19:46,730 --> 00:19:51,690 Speaker 3: sixty one, a couple, Carl and Linda Schultehillen, had a 295 00:19:51,730 --> 00:19:57,130 Speaker 3: son born with shortened arms and three fingers on each hand. 296 00:19:57,530 --> 00:20:00,730 Speaker 3: And obviously it was tragic and it was shocking, but 297 00:20:01,130 --> 00:20:07,130 Speaker 3: Carl's sister had recently given birth to a baby with 298 00:20:07,170 --> 00:20:12,170 Speaker 3: similar problems, and Carl decides that he needs to find 299 00:20:12,170 --> 00:20:15,210 Speaker 3: out what's really happening. And Carl went to talk to 300 00:20:15,250 --> 00:20:22,210 Speaker 3: a pediatrician and the pediatrician was named Viticant Lens and 301 00:20:22,570 --> 00:20:26,530 Speaker 3: he is, I must say, very much one of the 302 00:20:26,570 --> 00:20:31,490 Speaker 3: main heroes of our story. But what's very ironic is 303 00:20:31,530 --> 00:20:34,730 Speaker 3: that he was the son of a Nazi geneticist, a 304 00:20:34,850 --> 00:20:39,370 Speaker 3: very very high level, really heinous human being named Fritz Lens, 305 00:20:40,330 --> 00:20:48,330 Speaker 3: and the son Viticant recognized this folkomelia seal limbs in 306 00:20:48,450 --> 00:20:52,010 Speaker 3: the baby. What's very important to remember is that focomeilia 307 00:20:52,050 --> 00:20:54,970 Speaker 3: is extremely rare. I think it's one in one hundred 308 00:20:55,130 --> 00:21:00,570 Speaker 3: thousand births or something like that. He and the father, 309 00:21:01,530 --> 00:21:05,730 Speaker 3: Carl Schultz Hillen, go off in this VW beetle across 310 00:21:05,770 --> 00:21:10,210 Speaker 3: Germany and they basically they do this road trip looking 311 00:21:10,330 --> 00:21:15,490 Speaker 3: for more babies who had been born with these injuries. 312 00:21:16,370 --> 00:21:22,370 Speaker 3: And in November, Vita Kent met parents who blamed contragan 313 00:21:22,530 --> 00:21:29,090 Speaker 3: aka thlenamide for their child's injuries. The father says it 314 00:21:29,530 --> 00:21:33,690 Speaker 3: was this pill, contragan. He's sure of it. He points 315 00:21:33,690 --> 00:21:39,250 Speaker 3: the finger directly at the pill, after which Linda Schulta 316 00:21:39,330 --> 00:21:44,690 Speaker 3: Hillen remembers that she has taken one and I repeat 317 00:21:44,930 --> 00:21:49,370 Speaker 3: one pill that was given to her, which was Contragan 318 00:21:49,770 --> 00:21:55,290 Speaker 3: aka thlenamide one, and it caused all this injury to 319 00:21:55,410 --> 00:22:01,250 Speaker 3: their baby. And Viticant lends then at a pediatric's conference 320 00:22:02,490 --> 00:22:08,770 Speaker 3: very boldly names Grunental, names the drug as the culprit 321 00:22:08,850 --> 00:22:13,090 Speaker 3: for the epidemic, and that then gets into the papers. 322 00:22:14,050 --> 00:22:17,010 Speaker 1: I mean they push back. He's quite robust about this 323 00:22:17,090 --> 00:22:22,250 Speaker 1: because there are various potential legal threats, but he's very brave. 324 00:22:22,290 --> 00:22:27,570 Speaker 1: He stands his ground. And at the same time, in Australia, 325 00:22:27,890 --> 00:22:31,290 Speaker 1: a pediatrician is spotting the same thing that babies seem 326 00:22:31,370 --> 00:22:34,330 Speaker 1: to be suffering these injuries in the womb when their 327 00:22:34,370 --> 00:22:37,970 Speaker 1: mothers are taking the lidamite. How are the drug companies 328 00:22:38,010 --> 00:22:42,170 Speaker 1: responding as these patterns are starting to be observed and 329 00:22:42,210 --> 00:22:43,410 Speaker 1: the concerns are being raised. 330 00:22:44,570 --> 00:22:48,250 Speaker 3: How did they respond? They did nothing. So distillers in 331 00:22:48,290 --> 00:22:52,690 Speaker 3: the UK, which also had the license in Australia, did nothing. 332 00:22:53,610 --> 00:22:57,890 Speaker 3: And then in Germany in West Germany. Grunenthal was extremely 333 00:22:58,050 --> 00:23:03,290 Speaker 3: hostile to viticant lens and threatened legal action, but did 334 00:23:03,370 --> 00:23:08,050 Speaker 3: agree to a warning label advising against the use of 335 00:23:08,090 --> 00:23:12,170 Speaker 3: the drug during pregni and see, so it's all beginning 336 00:23:12,490 --> 00:23:16,930 Speaker 3: to unravel for them, Grunental and so then and this 337 00:23:17,010 --> 00:23:20,530 Speaker 3: is when things get truly dramatic. A story leaked to 338 00:23:20,530 --> 00:23:25,410 Speaker 3: the press in late November, around Thanksgiving of nineteen sixty one, 339 00:23:26,090 --> 00:23:30,530 Speaker 3: and the headline of this story was birth defects due 340 00:23:30,570 --> 00:23:36,530 Speaker 3: to pills question Mark. And so that's when the company finally, finally, 341 00:23:37,290 --> 00:23:43,930 Speaker 3: after years of tragedy, removed it from the market. And 342 00:23:43,970 --> 00:23:47,290 Speaker 3: then the Ministry of Health in West Germany put out 343 00:23:47,290 --> 00:23:48,250 Speaker 3: an urgent warning. 344 00:23:49,170 --> 00:23:53,930 Speaker 1: Yeah, so years of tragedy in West Germany. The drug 345 00:23:53,970 --> 00:23:59,130 Speaker 1: has only been on Francis Kelsey's desk for fourteen months, correct, 346 00:23:59,410 --> 00:24:01,610 Speaker 1: I mean, I say only fourteen months. That seems like 347 00:24:01,650 --> 00:24:06,530 Speaker 1: a very long time to Merril. So Merril are told 348 00:24:07,850 --> 00:24:10,930 Speaker 1: what's happening in Germany? What do they do? 349 00:24:12,010 --> 00:24:15,770 Speaker 3: They do not believe it or not withdraw their application? 350 00:24:16,090 --> 00:24:18,250 Speaker 3: Can you believe that? 351 00:24:18,850 --> 00:24:20,250 Speaker 2: I mean just right? 352 00:24:21,050 --> 00:24:24,810 Speaker 1: It's a bold move. Yes, What do they tell Francis Kelsey? 353 00:24:24,850 --> 00:24:28,010 Speaker 1: What is Joseph Murray, this man who who has been 354 00:24:28,130 --> 00:24:32,090 Speaker 1: complaining about Francis Kelsey to Francis Kelsey's boss, what does 355 00:24:32,130 --> 00:24:32,570 Speaker 1: he say? 356 00:24:33,170 --> 00:24:36,210 Speaker 3: He calls her and he says that they're not withdrawing 357 00:24:36,250 --> 00:24:41,090 Speaker 3: their application for licensing this drug, and. 358 00:24:41,050 --> 00:24:43,250 Speaker 1: Does he have any explanation as to what's going on 359 00:24:43,250 --> 00:24:44,810 Speaker 1: in Germany? Does he think the Germans have just made 360 00:24:44,810 --> 00:24:46,490 Speaker 1: a mistake, They're making a fuss about nothing. 361 00:24:46,770 --> 00:24:50,930 Speaker 3: Joseph Murray, the Meryl rep, calls Francis and he says, oh, yeah, 362 00:24:51,010 --> 00:24:54,890 Speaker 3: not to worry. This is probably just an unfortunate coincidence, 363 00:24:55,130 --> 00:24:57,890 Speaker 3: and we're going to send a rep to Germany to 364 00:24:58,290 --> 00:25:01,090 Speaker 3: sort this all out. But they do not, I repeat, 365 00:25:01,170 --> 00:25:03,090 Speaker 3: they do not withdraw their application. 366 00:25:04,370 --> 00:25:10,170 Speaker 1: Incredible. It seems that Francis Olden Kelsey is is vindicated. 367 00:25:10,690 --> 00:25:15,690 Speaker 1: At this point. The evidence is starting to grow that 368 00:25:15,770 --> 00:25:19,490 Speaker 1: this is a very dangerous drug for pregnant women. Her 369 00:25:19,570 --> 00:25:22,690 Speaker 1: rather bold move of saying I want to see more information, 370 00:25:22,730 --> 00:25:25,010 Speaker 1: I want to see more evidence that it's safe. I 371 00:25:25,050 --> 00:25:27,290 Speaker 1: want to see more evidence that it's safe during pregnancy 372 00:25:28,330 --> 00:25:31,210 Speaker 1: has been I think, utterly vindicated by events in Germany. 373 00:25:31,850 --> 00:25:35,890 Speaker 3: Right, And what's interesting is that she didn't know specifically 374 00:25:36,050 --> 00:25:40,410 Speaker 3: what was happening and how what the actual mechanism of 375 00:25:40,490 --> 00:25:44,490 Speaker 3: the drug was to injure the fetus. But she just 376 00:25:44,650 --> 00:25:47,530 Speaker 3: knew it didn't sit right with her. So there's a 377 00:25:47,570 --> 00:25:52,330 Speaker 3: lot to be said for going with one's gut right in. 378 00:25:52,210 --> 00:25:54,850 Speaker 1: This case, for sure, Francis Oldham Kelsey clearly had a 379 00:25:54,970 --> 00:25:58,610 Speaker 1: very well developed gut based on all of her training, 380 00:25:58,610 --> 00:26:01,090 Speaker 1: all of her reading, and all of her experience. 381 00:26:00,770 --> 00:26:02,690 Speaker 3: A golden gut exactly. 382 00:26:04,290 --> 00:26:06,970 Speaker 1: You would think that the story ends there, job done. 383 00:26:07,250 --> 00:26:12,610 Speaker 1: Validamide not approved in the United States. However, Francis Kelsey 384 00:26:12,650 --> 00:26:16,210 Speaker 1: is about to learn that actually pregnant women have been 385 00:26:16,250 --> 00:26:21,570 Speaker 1: taking this dangerous drug all across the United States. Caution 386 00:26:21,650 --> 00:26:36,530 Speaker 1: retales will be back after the break. We're back. I 387 00:26:36,570 --> 00:26:39,610 Speaker 1: am with Katie Hafner, the host of the Lost Women 388 00:26:39,650 --> 00:26:43,290 Speaker 1: of Science podcast, and she is telling the story of 389 00:26:43,330 --> 00:26:47,730 Speaker 1: Francis Oldham Kelsey. So, Katie, by now it's December nineteen 390 00:26:47,770 --> 00:26:52,570 Speaker 1: sixty one. Terrible things have emerged in Germany, but in America, 391 00:26:53,010 --> 00:26:59,290 Speaker 1: the merial application for kevdon akahldamide is still active. Francis 392 00:26:59,290 --> 00:27:03,050 Speaker 1: Olden Kelcey, the dogged data detective, has been vindicated in 393 00:27:03,130 --> 00:27:08,170 Speaker 1: repeatedly deferring the approval of this drug, and as a 394 00:27:08,210 --> 00:27:13,050 Speaker 1: result that she saved thousands of Americans from being born 395 00:27:13,130 --> 00:27:19,690 Speaker 1: with severe injuries caused by thlidamide. So a happy story 396 00:27:20,010 --> 00:27:22,130 Speaker 1: at least the United States. No. 397 00:27:23,610 --> 00:27:29,490 Speaker 3: Merrill was getting this drug to doctors all over the 398 00:27:29,650 --> 00:27:33,210 Speaker 3: United States who were then giving it to patients in 399 00:27:33,410 --> 00:27:38,050 Speaker 3: little envelopes and patting pregnant women on the head and saying, here, 400 00:27:38,570 --> 00:27:41,050 Speaker 3: this will easier morning sickness. Take this. This is a 401 00:27:41,090 --> 00:27:43,850 Speaker 3: new drug that's just coming down the pike. And aren't 402 00:27:43,890 --> 00:27:46,730 Speaker 3: we lucky that we happen to have samples? And these 403 00:27:46,770 --> 00:27:51,090 Speaker 3: samples were given by the thousands to American women. 404 00:27:52,170 --> 00:27:54,410 Speaker 1: And I mean, the extraordinary thing about this is this 405 00:27:54,570 --> 00:27:58,330 Speaker 1: wasn't for profit, at least not directly. They weren't selling 406 00:27:58,570 --> 00:28:02,170 Speaker 1: these drugs. They were distributing them because it was part 407 00:28:02,250 --> 00:28:05,290 Speaker 1: of what I think we might very loosely call a 408 00:28:05,330 --> 00:28:08,770 Speaker 1: clinical trial. But there's no clinical trial I've ever heard of. 409 00:28:09,210 --> 00:28:12,490 Speaker 3: I think they were priming the market for this drug, 410 00:28:13,130 --> 00:28:16,330 Speaker 3: and by the time it was approved, people would already 411 00:28:16,810 --> 00:28:20,610 Speaker 3: be taking it. It's an anchoring bias. Oh, I'm anchored 412 00:28:21,130 --> 00:28:25,090 Speaker 3: in this particular drug. And what happens with doctors is 413 00:28:25,490 --> 00:28:29,890 Speaker 3: that they get anchored in prescribing a particular drug, and 414 00:28:29,970 --> 00:28:33,570 Speaker 3: that kind of seeding is very very common to this day. 415 00:28:34,250 --> 00:28:37,050 Speaker 1: We know that Francis has been suspicious about some of 416 00:28:37,050 --> 00:28:39,450 Speaker 1: these sloppy doctor's reports that she read as part of 417 00:28:39,490 --> 00:28:43,290 Speaker 1: the Meryal application. They hadn't recorded doses or length of 418 00:28:43,330 --> 00:28:45,610 Speaker 1: time on the drug, or the reason for prescribing anything 419 00:28:45,650 --> 00:28:48,570 Speaker 1: like that, But was there anything more untoward? 420 00:28:49,530 --> 00:28:52,450 Speaker 3: This is just horrible even just telling you this, Tim, 421 00:28:52,730 --> 00:28:56,770 Speaker 3: just I'm so ashamed of my fellow humans. There is 422 00:28:56,850 --> 00:29:01,290 Speaker 3: this one doctor who was a golfing buddy of one 423 00:29:01,330 --> 00:29:05,970 Speaker 3: of the guys from Merrill, and on the golf course, 424 00:29:06,090 --> 00:29:10,010 Speaker 3: you know, while they're you know, teeing off, they're kind 425 00:29:10,050 --> 00:29:14,450 Speaker 3: of talking about the drug. And then this doctor allegedly 426 00:29:15,170 --> 00:29:20,330 Speaker 3: writes this paper in a journal declaring the drug very 427 00:29:20,370 --> 00:29:23,090 Speaker 3: safe and it was actually written by the Meryl people. 428 00:29:24,290 --> 00:29:28,930 Speaker 1: Hello, yeah, all basically he signed his name to it, 429 00:29:29,410 --> 00:29:31,210 Speaker 1: but Merril wrote it. 430 00:29:31,010 --> 00:29:31,730 Speaker 3: Right I. 431 00:29:31,770 --> 00:29:35,050 Speaker 1: Meanwhile, he's giving these pills to his patients who are 432 00:29:35,090 --> 00:29:38,610 Speaker 1: pregnant women whose babies may well be being harmed by it. 433 00:29:38,810 --> 00:29:44,690 Speaker 3: Who are being harmed by it, Yes, yes, that's all happening. 434 00:29:45,330 --> 00:29:47,890 Speaker 1: Please tell me that Merril at some stage with through 435 00:29:47,930 --> 00:29:48,530 Speaker 1: the application. 436 00:29:50,450 --> 00:29:54,090 Speaker 3: Merril at some stage withdrew the application, thank you. How 437 00:29:54,090 --> 00:30:00,330 Speaker 3: long did it take Meryl withdrew the application? Not days 438 00:30:00,810 --> 00:30:04,250 Speaker 3: after it was taken off the market in Germany, not 439 00:30:04,490 --> 00:30:10,810 Speaker 3: weeks months. In March nineteen sixty two, Barrel finally with 440 00:30:10,970 --> 00:30:11,890 Speaker 3: Drewett's application. 441 00:30:14,050 --> 00:30:17,090 Speaker 1: Yes, not before time, at least at least it was 442 00:30:17,090 --> 00:30:21,090 Speaker 1: never approved, even if it was widely distributed, and it 443 00:30:21,130 --> 00:30:27,330 Speaker 1: was never approved thanks to Francis Oldham Kelsey. Was she 444 00:30:27,450 --> 00:30:30,050 Speaker 1: recognized for this work at the time. 445 00:30:30,730 --> 00:30:34,490 Speaker 3: Yes, she became a total national hero. In July of 446 00:30:34,570 --> 00:30:39,090 Speaker 3: nineteen sixty two, word of her work made its way 447 00:30:39,170 --> 00:30:42,130 Speaker 3: to the Washington Post and there was a front page 448 00:30:42,170 --> 00:30:46,330 Speaker 3: story with the headline heroine of FDA keeps bad drug 449 00:30:46,330 --> 00:30:51,690 Speaker 3: off market, with a wonderful photograph of her above the fold. 450 00:30:52,410 --> 00:30:56,610 Speaker 3: Just great. Even though many, many, many babies were born 451 00:30:56,650 --> 00:31:02,010 Speaker 3: with focomelia in the United States, she prevented thousands more. 452 00:31:03,210 --> 00:31:07,450 Speaker 3: In nineteen sixty three, she was given the highest possible 453 00:31:07,530 --> 00:31:12,130 Speaker 3: award by the President for civilian service. And there's a 454 00:31:12,410 --> 00:31:18,570 Speaker 3: lovely photograph of her clearly beaming as JFK. John F. 455 00:31:18,690 --> 00:31:22,010 Speaker 3: Kennedy is presenting this to her. It was a shining moment, 456 00:31:22,090 --> 00:31:24,970 Speaker 3: not just for her individually, but for the United States. 457 00:31:25,010 --> 00:31:28,810 Speaker 3: And this woman, by the way, was Canadian. Let's not 458 00:31:28,890 --> 00:31:33,770 Speaker 3: forget that. So what was more important was that this 459 00:31:33,890 --> 00:31:37,490 Speaker 3: led to really the modern FDA as we know it, 460 00:31:37,650 --> 00:31:44,690 Speaker 3: which is very very rigorous trials and studies done before. 461 00:31:45,490 --> 00:31:48,810 Speaker 3: Now it's become what some people do think is a 462 00:31:48,930 --> 00:31:52,010 Speaker 3: very cumbersome process. But to get a drug approved in 463 00:31:52,050 --> 00:31:56,730 Speaker 3: the United States, many people trace it back to the 464 00:31:56,810 --> 00:31:58,610 Speaker 3: whole polidomide tragedy. 465 00:31:59,610 --> 00:32:03,530 Speaker 1: I mean, as a professional statistics nerd, I think it's 466 00:32:03,570 --> 00:32:09,890 Speaker 1: probably worth distinguishing the insistence on caution and with the 467 00:32:09,930 --> 00:32:12,050 Speaker 1: insistence on rigor. 468 00:32:12,530 --> 00:32:13,770 Speaker 3: Yes, it's a balance. 469 00:32:14,050 --> 00:32:18,570 Speaker 1: Yes, there definitely is a risk of having bureaucrats who say, oh, 470 00:32:18,650 --> 00:32:21,610 Speaker 1: I'm not sure, I'm not going to approve this. I 471 00:32:21,650 --> 00:32:23,450 Speaker 1: want to see more, I want to wait and see, 472 00:32:23,530 --> 00:32:27,970 Speaker 1: I'll see it. Because some drugs save lives, and if 473 00:32:27,970 --> 00:32:30,570 Speaker 1: you make it incredibly expensive to get approval and you 474 00:32:30,690 --> 00:32:34,010 Speaker 1: delay approval, then that can cost lives just as much 475 00:32:34,010 --> 00:32:37,610 Speaker 1: as approving the wrong drug can. But I think it's 476 00:32:37,970 --> 00:32:43,490 Speaker 1: absolutely essential to demand rigor and to say, you know, 477 00:32:43,530 --> 00:32:46,170 Speaker 1: you need to do the proper clinical trials, you need 478 00:32:46,210 --> 00:32:50,810 Speaker 1: to disclose the appropriate information. It's not okay just to 479 00:32:51,570 --> 00:32:54,690 Speaker 1: include some letters from some doctors, which by the way, 480 00:32:54,730 --> 00:32:56,650 Speaker 1: the doctors didn't even write. 481 00:32:56,410 --> 00:32:58,610 Speaker 3: Who were on the golf course when they thought about it. 482 00:32:58,730 --> 00:33:01,930 Speaker 1: Yeah, yeah, and bury the information from the British Medical 483 00:33:02,010 --> 00:33:06,290 Speaker 1: Journal kind of cough and divert attention from what's going 484 00:33:06,290 --> 00:33:08,610 Speaker 1: on in Germany and basically say, well, look, we really 485 00:33:08,650 --> 00:33:11,690 Speaker 1: want the drug available by Christmas. Why do you hate capitalism? 486 00:33:11,930 --> 00:33:14,770 Speaker 1: Rigor is important, even if we don't just want to 487 00:33:14,810 --> 00:33:17,570 Speaker 1: turn down every drug on principle exactly. 488 00:33:17,810 --> 00:33:19,610 Speaker 3: Well, let's talk about this for a second. There are 489 00:33:19,650 --> 00:33:21,970 Speaker 3: two things that come to mind for me. One is 490 00:33:22,010 --> 00:33:25,130 Speaker 3: that there's a very interesting coda to the whole story, 491 00:33:25,170 --> 00:33:29,770 Speaker 3: which is polidomide actually has proven to be quite efficacious, 492 00:33:29,890 --> 00:33:36,170 Speaker 3: quite effective for treating leprosy and multiple myeloma. Isn't that interesting? 493 00:33:36,210 --> 00:33:37,530 Speaker 1: Which is a cancer, isn't it? 494 00:33:37,770 --> 00:33:41,450 Speaker 3: Yes, So it's having kind of a you know, a renaissance, 495 00:33:42,050 --> 00:33:45,930 Speaker 3: and so that's interesting. But the other thing, on a 496 00:33:46,010 --> 00:33:51,130 Speaker 3: kind of darker note, is ugh, so our new Secretary 497 00:33:51,130 --> 00:33:53,010 Speaker 3: of Health and Human Services. 498 00:33:52,690 --> 00:33:54,490 Speaker 1: The nephew of President Kendy. 499 00:33:54,730 --> 00:33:58,610 Speaker 3: Yes, yes, the nephew of the very man who bestowed 500 00:33:58,650 --> 00:34:03,930 Speaker 3: this honor upon Francis Kelcey our FK. Junior. During his 501 00:34:04,090 --> 00:34:11,090 Speaker 3: confirmation hearings, he invoked Francis Kelcey to the horror of 502 00:34:11,490 --> 00:34:15,850 Speaker 3: us that lost women of science, and he said, my 503 00:34:16,570 --> 00:34:21,370 Speaker 3: uncle gave this medal to this woman, Francis Oldham Kelsey 504 00:34:21,450 --> 00:34:25,250 Speaker 3: in nineteen sixty three, which is when the medal was given. 505 00:34:25,850 --> 00:34:27,450 Speaker 3: So he was right about that, but he was wrong 506 00:34:27,490 --> 00:34:29,330 Speaker 3: about a few other things. He said she worked at 507 00:34:29,330 --> 00:34:31,210 Speaker 3: the NIH. He said she was young. 508 00:34:31,290 --> 00:34:31,690 Speaker 1: She was not. 509 00:34:31,730 --> 00:34:34,450 Speaker 3: She was in her forties. And he said that there 510 00:34:34,490 --> 00:34:38,090 Speaker 3: was like a panel of people who had approved the drug. 511 00:34:38,170 --> 00:34:41,490 Speaker 3: And then he said, and she was screaming. She never screamed, 512 00:34:41,890 --> 00:34:45,370 Speaker 3: and she prevented all of this horror and tragedy from 513 00:34:45,370 --> 00:34:49,290 Speaker 3: coming into the United States. But then he said something 514 00:34:49,570 --> 00:34:54,450 Speaker 3: very interesting. He said, she stood up to science. 515 00:34:55,570 --> 00:35:01,210 Speaker 1: And yes, stood up two, stood up four two. 516 00:35:00,970 --> 00:35:03,210 Speaker 3: Two those were his words. It's funny you say that, 517 00:35:03,210 --> 00:35:05,250 Speaker 3: because I went back and listened to it three times. 518 00:35:05,770 --> 00:35:08,650 Speaker 3: And he said she stood up to science, and in 519 00:35:08,730 --> 00:35:14,610 Speaker 3: others words, she took a stand against science. You know, 520 00:35:14,690 --> 00:35:19,890 Speaker 3: this is the whole anti vaccine movement is. You know, 521 00:35:19,970 --> 00:35:24,010 Speaker 3: we don't believe these scientists. But she was just she 522 00:35:24,130 --> 00:35:28,090 Speaker 3: was reacting to bad science or nonexistent science. 523 00:35:28,330 --> 00:35:30,410 Speaker 1: No science at all in many cases. 524 00:35:30,330 --> 00:35:34,450 Speaker 3: Yes, exactly, And so he has twisted this this history 525 00:35:35,610 --> 00:35:41,730 Speaker 3: really to align with with his agenda, which was really unfortunate. 526 00:35:42,090 --> 00:35:44,530 Speaker 1: Yeah, if the lesson is you need to stand up 527 00:35:44,570 --> 00:35:48,250 Speaker 1: to science, I think that's well, that's certainly not what 528 00:35:48,290 --> 00:35:50,890 Speaker 1: Francis Kelsey would have said or indeed what she did. 529 00:35:51,050 --> 00:35:54,370 Speaker 3: Oh, she would be horrified to see her name used 530 00:35:54,410 --> 00:35:54,810 Speaker 3: that way. 531 00:35:55,330 --> 00:35:58,210 Speaker 1: Well, let's let's end on a slightly cheerier note. What 532 00:35:58,250 --> 00:36:00,170 Speaker 1: did she? What did she? What did she do? The 533 00:36:00,170 --> 00:36:01,890 Speaker 1: rest of her career, she. 534 00:36:01,930 --> 00:36:06,370 Speaker 3: Stayed at the FDA, and you know, she maintained a 535 00:36:06,410 --> 00:36:12,450 Speaker 3: surprisingly low profile, and later she helped spearhead this new 536 00:36:12,490 --> 00:36:16,530 Speaker 3: division at the FDA called the Division of Scientific Investigations. 537 00:36:16,610 --> 00:36:19,770 Speaker 3: They were known informally as Kelsey's cops, and they were 538 00:36:19,810 --> 00:36:24,530 Speaker 3: tasked with inspecting clinical sites to test the integrity of data. 539 00:36:25,170 --> 00:36:29,450 Speaker 3: And she never wavered, and she lived well into her nineties. 540 00:36:30,090 --> 00:36:34,170 Speaker 3: But you know, her name eventually sort of disappeared to 541 00:36:34,210 --> 00:36:36,890 Speaker 3: the point where very few people recognize it. 542 00:36:38,090 --> 00:36:41,490 Speaker 1: Yeah. Was she retired at the age of ninety in 543 00:36:41,730 --> 00:36:43,570 Speaker 1: two thousand and five. She lived at the age of 544 00:36:43,570 --> 00:36:47,090 Speaker 1: one hundred and one, which is quite quite incredible. 545 00:36:47,490 --> 00:36:51,530 Speaker 3: And she was in Canada in her final years and 546 00:36:50,610 --> 00:36:54,970 Speaker 3: she received the Order of Canada medallion and she was 547 00:36:55,010 --> 00:37:00,410 Speaker 3: too sick to leave her house, so the medal came 548 00:37:00,450 --> 00:37:02,090 Speaker 3: to her. I love that. 549 00:37:02,410 --> 00:37:06,130 Speaker 1: Yeah, thank you so much, Katie. I've been talking to 550 00:37:06,210 --> 00:37:09,930 Speaker 1: Katie Haffner, who was the host of Lost Women of Science. 551 00:37:09,970 --> 00:37:12,290 Speaker 1: Wonderful podcast. You can get it in all the usual 552 00:37:12,370 --> 00:37:16,170 Speaker 1: pod places. This has been fascinating, Katie. Thank you so much. 553 00:37:16,290 --> 00:37:19,810 Speaker 1: Thank you Tim, thank you for everyone else. I will 554 00:37:19,810 --> 00:37:26,890 Speaker 1: be back next week with another cautionary tale. Cautionary Tales 555 00:37:26,970 --> 00:37:30,450 Speaker 1: is written by me Tim Harford with Andrew Wright, Alice Fines, 556 00:37:30,650 --> 00:37:34,730 Speaker 1: and Ryan Dilly. It's produced by Georgia Mills and Marilyn Rust. 557 00:37:35,330 --> 00:37:38,050 Speaker 1: The sound design and original music are the work of 558 00:37:38,130 --> 00:37:42,250 Speaker 1: Pascal Wise. Additional sound design is by Carlos San Juan 559 00:37:42,490 --> 00:37:47,650 Speaker 1: at Brain Audio. Bend Daf Haffrey edited the scripts. The 560 00:37:47,690 --> 00:37:50,490 Speaker 1: show also wouldn't have been possible without the work of 561 00:37:50,610 --> 00:37:55,530 Speaker 1: Jacob Weisberg, Greta Cohne, Sarah Nix, Eric Sandler, Christina Sullivan, 562 00:37:55,850 --> 00:38:00,250 Speaker 1: Kira Posey, and Owen Miller. Cautionary Tales is a production 563 00:38:00,410 --> 00:38:04,210 Speaker 1: of Pushkin Industries. If you like the show, please remember 564 00:38:04,250 --> 00:38:07,090 Speaker 1: to share, rate, and review. It really makes a difference 565 00:38:07,130 --> 00:38:08,650 Speaker 1: to us. And if you want to hear the show 566 00:38:08,810 --> 00:38:12,010 Speaker 1: ad free, sign up to Pushkin Plus on the show 567 00:38:12,090 --> 00:38:16,010 Speaker 1: page on Apple Podcasts or at pushkin dot fm, slash 568 00:38:16,250 --> 00:38:16,690 Speaker 1: plus