1 00:00:01,280 --> 00:00:04,320 Speaker 1: Welcome to Stuff You Missed in History Class, a production 2 00:00:04,360 --> 00:00:13,840 Speaker 1: of I Heart Radio. Hello, and welcome to the podcast. 3 00:00:13,920 --> 00:00:18,600 Speaker 1: I'm Tracy V. Wilson and I'm Holly Frying. So hopefully 4 00:00:19,200 --> 00:00:22,160 Speaker 1: what we're about to talk about will it be, if 5 00:00:22,200 --> 00:00:27,000 Speaker 1: not cleared up, at least like somewhat better understood by 6 00:00:27,000 --> 00:00:29,680 Speaker 1: the time this episode comes out. We're in one of 7 00:00:29,680 --> 00:00:32,040 Speaker 1: those situations where I'm about to talk about a thing 8 00:00:32,080 --> 00:00:35,560 Speaker 1: that may just be different by the time the episode 9 00:00:35,640 --> 00:00:40,200 Speaker 1: is audible to other people. When I research today's topic, though, 10 00:00:40,720 --> 00:00:46,400 Speaker 1: we were hearing a lot about extremely rare clotting disorders 11 00:00:46,400 --> 00:00:49,280 Speaker 1: that are potentially linked to the astra Zeneca and Johnson 12 00:00:49,280 --> 00:00:54,680 Speaker 1: and Johnson COVID vaccines, and headlines about those again extremely 13 00:00:54,760 --> 00:00:58,240 Speaker 1: rare clouding disorders have led to a lot of comparisons 14 00:00:58,280 --> 00:01:03,160 Speaker 1: between the vaccines and oral contraceptives, with the tone kind 15 00:01:03,160 --> 00:01:05,440 Speaker 1: of being like, there's a bigger risk for blood clots 16 00:01:05,520 --> 00:01:08,560 Speaker 1: or birth control and nobody cares about that, or like 17 00:01:09,120 --> 00:01:13,640 Speaker 1: and women just deal with it. Uh. It's it's a 18 00:01:13,840 --> 00:01:16,920 Speaker 1: kind of dismissive tone um in all of these contexts. 19 00:01:16,920 --> 00:01:20,840 Speaker 1: But that argument is a little bit apples to oranges, 20 00:01:20,880 --> 00:01:24,120 Speaker 1: and it also skips over a whole lot, big thing. 21 00:01:24,200 --> 00:01:25,720 Speaker 1: And we're not going to get into the weeds because 22 00:01:25,720 --> 00:01:28,800 Speaker 1: we're not doctors and this is non medical history podcast. 23 00:01:29,640 --> 00:01:32,600 Speaker 1: But the clots that are associated with oral contraceptives are 24 00:01:32,640 --> 00:01:35,720 Speaker 1: generally really different from the ones that might be connected 25 00:01:35,720 --> 00:01:39,080 Speaker 1: to the vaccines. And all of these clots can be 26 00:01:39,160 --> 00:01:42,520 Speaker 1: life threatening, but they form very differently in different parts 27 00:01:42,520 --> 00:01:46,520 Speaker 1: of the circulatory system. Also, they typically require very different 28 00:01:46,520 --> 00:01:50,000 Speaker 1: treatments because the vaccines, Uh, it's not just a clot, 29 00:01:50,160 --> 00:01:52,840 Speaker 1: it's also a low plate link count. So you just 30 00:01:52,880 --> 00:01:56,280 Speaker 1: can't give a person anticoagulants like you would with a 31 00:01:56,320 --> 00:01:59,800 Speaker 1: lot of other clots. But another big, big difference here 32 00:01:59,880 --> 00:02:04,800 Speaker 1: is information, because the connection between oral contraceptives and blood 33 00:02:04,840 --> 00:02:08,320 Speaker 1: clots has been established for decades at this point, and 34 00:02:08,360 --> 00:02:11,760 Speaker 1: in the United States, the FDA requires that every package 35 00:02:11,760 --> 00:02:15,519 Speaker 1: of birth control pills comes with patient literature that explains 36 00:02:15,600 --> 00:02:19,839 Speaker 1: this risk and all the other risks. Ideally, there would 37 00:02:19,880 --> 00:02:23,680 Speaker 1: also be a thoughtful conversation with a healthcare provider about 38 00:02:23,680 --> 00:02:26,480 Speaker 1: the risks and the benefits. Uh, there are a lot 39 00:02:26,560 --> 00:02:28,639 Speaker 1: of reasons that might not happen though, and I totally 40 00:02:28,720 --> 00:02:32,440 Speaker 1: recognize that. But like these vaccines are brand new and 41 00:02:32,480 --> 00:02:35,120 Speaker 1: the potential risk isn't fully understood yet, and you just 42 00:02:35,280 --> 00:02:39,000 Speaker 1: can't inform people of what their risk is or trying 43 00:02:39,040 --> 00:02:41,679 Speaker 1: to men to mitigate that risk if you don't really 44 00:02:41,720 --> 00:02:44,079 Speaker 1: have a handle on what's going on yet. So that's why, 45 00:02:44,160 --> 00:02:46,240 Speaker 1: as of when we're recording this, there's been a pause 46 00:02:47,000 --> 00:02:49,760 Speaker 1: to try to get a better handle on it. At 47 00:02:49,800 --> 00:02:52,880 Speaker 1: the same time, though, in the United States, this whole 48 00:02:53,040 --> 00:02:56,639 Speaker 1: idea that people should know about the risks that are 49 00:02:56,680 --> 00:03:00,919 Speaker 1: involved with the drugs that they're taking. That's tie directly 50 00:03:01,040 --> 00:03:05,200 Speaker 1: to the complicated and honestly pretty troubling sometimes history of 51 00:03:05,360 --> 00:03:08,560 Speaker 1: oral contraceptives. So that is what we're going to talk 52 00:03:08,600 --> 00:03:11,400 Speaker 1: about today, and just a level set, the social and 53 00:03:11,480 --> 00:03:15,320 Speaker 1: political impact of oral contraceptives could be its whole other thing. 54 00:03:15,440 --> 00:03:17,320 Speaker 1: We're not really going to talk about that at all 55 00:03:17,320 --> 00:03:21,280 Speaker 1: in this episode because this episode is really about safety. 56 00:03:21,760 --> 00:03:25,600 Speaker 1: So the first oral contraceptive was called a novid and 57 00:03:25,639 --> 00:03:27,560 Speaker 1: it was brought to market in the United States in 58 00:03:27,680 --> 00:03:31,440 Speaker 1: nineteen fifty seven. At first, it was only approved for 59 00:03:31,520 --> 00:03:35,720 Speaker 1: treating menstrual disorders, but researchers knew that it prevented ovulation, 60 00:03:36,480 --> 00:03:40,880 Speaker 1: thus that it prevented pregnancy, temporary infertility, was a known 61 00:03:40,960 --> 00:03:44,320 Speaker 1: side effect. It's likely that many of the roughly five 62 00:03:44,400 --> 00:03:47,560 Speaker 1: hundred thousand people who took a novid between nineteen fifty 63 00:03:47,600 --> 00:03:50,880 Speaker 1: seven and nineteen sixty we're taking it for that so 64 00:03:50,960 --> 00:03:54,600 Speaker 1: called side effect, either in addition to or instead of 65 00:03:54,640 --> 00:03:59,720 Speaker 1: treating something like irregular menstrual cycles or endometriosis. So getting 66 00:04:00,040 --> 00:04:05,120 Speaker 1: innovid approved as a contraceptive that required additional clinical trials 67 00:04:05,160 --> 00:04:09,240 Speaker 1: that were specifically for that purpose, and those trials would 68 00:04:09,240 --> 00:04:12,720 Speaker 1: not at all meet today's standards for things like ethics 69 00:04:12,760 --> 00:04:15,760 Speaker 1: and informed consent. And really this was also true of 70 00:04:15,800 --> 00:04:18,640 Speaker 1: the drugs earlier trials. Some of those had been carried 71 00:04:18,640 --> 00:04:22,360 Speaker 1: out on patients and a mental hospital. The team that 72 00:04:22,400 --> 00:04:26,000 Speaker 1: was developing the pill included guy ecologist John Rock and 73 00:04:26,120 --> 00:04:30,520 Speaker 1: reproductive physiologist Griory Pinkas, and they were in Massachusetts, and 74 00:04:30,520 --> 00:04:34,800 Speaker 1: in Massachusetts it was illegal to distribute contraceptives or information 75 00:04:34,800 --> 00:04:37,680 Speaker 1: about them. The same was true of a lot of 76 00:04:37,720 --> 00:04:41,479 Speaker 1: other states. You couldn't have a controlled trial of a 77 00:04:41,560 --> 00:04:44,359 Speaker 1: contraceptive in a place where that was illegal, So the 78 00:04:44,400 --> 00:04:46,760 Speaker 1: trials had to be carried out somewhere else. And the 79 00:04:46,839 --> 00:04:49,279 Speaker 1: location that Rock and pink has chose for some of 80 00:04:49,320 --> 00:04:52,800 Speaker 1: this work was Puerto Rico. Rock and Pink has already 81 00:04:52,839 --> 00:04:55,839 Speaker 1: had connections there through the University of Puerto Rico School 82 00:04:55,880 --> 00:04:59,479 Speaker 1: of Medicine, and contraception was legal there, and there was 83 00:04:59,520 --> 00:05:04,680 Speaker 1: already an established network of birth control clinics in the territory. However, 84 00:05:05,279 --> 00:05:07,719 Speaker 1: the reasons for all of that were tied to the 85 00:05:07,760 --> 00:05:11,479 Speaker 1: eugenics movement and to an effort led by US officials 86 00:05:11,520 --> 00:05:15,039 Speaker 1: to curb poverty in Puerto Rico by lowering the birth rate. 87 00:05:15,600 --> 00:05:19,000 Speaker 1: There was just a huge propaganda campaign that promoted the 88 00:05:19,040 --> 00:05:22,240 Speaker 1: idea that smaller families would mean more money and a 89 00:05:22,240 --> 00:05:25,160 Speaker 1: better quality of life. And then on top of that, 90 00:05:25,400 --> 00:05:29,159 Speaker 1: officials sent medical practitioners to Puerto Rico to carry out 91 00:05:29,160 --> 00:05:33,279 Speaker 1: a mass sterilization campaign. This was one that was often 92 00:05:33,360 --> 00:05:37,600 Speaker 1: coercive and deceptive, with women being sterilized without their knowledge 93 00:05:38,080 --> 00:05:40,640 Speaker 1: or without being told that this procedure they were about 94 00:05:40,680 --> 00:05:44,960 Speaker 1: to undergo was permanent. Another rationale for selecting Puerto Rico 95 00:05:45,080 --> 00:05:49,880 Speaker 1: for these trials was racist and paternalistic, stereotyping Puerto Ricans 96 00:05:49,960 --> 00:05:54,159 Speaker 1: as ignorant and uneducated, so basically, if they could successfully 97 00:05:54,240 --> 00:05:57,359 Speaker 1: use the pill, than anyone could. And then added to 98 00:05:57,360 --> 00:06:01,120 Speaker 1: all of that, the idea of informed can scent wasn't 99 00:06:01,200 --> 00:06:04,279 Speaker 1: really established in the world of medicine at this point. 100 00:06:04,760 --> 00:06:08,080 Speaker 1: The people who were participating in these trials weren't informed 101 00:06:08,120 --> 00:06:11,320 Speaker 1: that the drug they were taking was experimental or that 102 00:06:11,360 --> 00:06:14,799 Speaker 1: they were taking part in a clinical trial. The trials 103 00:06:14,839 --> 00:06:18,080 Speaker 1: conducted in Puerto Rico and elsewhere confirmed that anoviad was 104 00:06:18,200 --> 00:06:21,680 Speaker 1: an effective contraceptive. No one who took the drug as 105 00:06:21,720 --> 00:06:26,920 Speaker 1: directed got pregnant. However, a lot of people reported side effects. 106 00:06:26,960 --> 00:06:31,400 Speaker 1: In Puerto Rico, sevent of the trial participants reported things 107 00:06:31,440 --> 00:06:36,240 Speaker 1: like headaches, dizziness, nausea, and vomiting. Twenty five of two 108 00:06:37,160 --> 00:06:41,279 Speaker 1: participants ultimately withdrew from the study because of these issues. 109 00:06:42,080 --> 00:06:45,320 Speaker 1: Three women died, but no post mortem exams were conducted, 110 00:06:45,680 --> 00:06:48,200 Speaker 1: so it wasn't clear whether their deaths were caused by 111 00:06:48,200 --> 00:06:52,159 Speaker 1: the pill or not. Medical personnel who were monitoring these 112 00:06:52,200 --> 00:06:56,600 Speaker 1: trials were really focused on the possibility of several specific 113 00:06:57,080 --> 00:07:01,640 Speaker 1: possible issues, cancer damn us to the reproductive system, and 114 00:07:01,760 --> 00:07:05,200 Speaker 1: liver damage, so they didn't really connect all of these 115 00:07:05,279 --> 00:07:08,400 Speaker 1: other reported side effects to the pill. A lot of 116 00:07:08,400 --> 00:07:11,480 Speaker 1: the doctors just wrote them off as unrelated or as 117 00:07:11,520 --> 00:07:16,400 Speaker 1: psycho somatic. At the same time, though Dr dress Rice Ray, 118 00:07:16,440 --> 00:07:18,880 Speaker 1: who was in charge of the trial, wrote that the 119 00:07:18,920 --> 00:07:23,720 Speaker 1: pill quote causes too many side reactions to be acceptable generally. 120 00:07:24,440 --> 00:07:27,160 Speaker 1: She wrote that when she made her first report later 121 00:07:27,240 --> 00:07:29,480 Speaker 1: on though she would say quote, we could not have 122 00:07:29,680 --> 00:07:33,239 Speaker 1: been more wrong. The Puerto Rico trials are the most 123 00:07:33,280 --> 00:07:36,600 Speaker 1: widely known at this point, but trials were also conducted 124 00:07:36,640 --> 00:07:39,440 Speaker 1: in Haiti and in several cities around the US where 125 00:07:39,480 --> 00:07:42,480 Speaker 1: it was legal to do so. In the end, when 126 00:07:42,560 --> 00:07:46,320 Speaker 1: drug manufacturer G. D. Searle and Company applied for FDA 127 00:07:46,440 --> 00:07:50,200 Speaker 1: approval for an ovid as a contraceptive, it included data 128 00:07:50,320 --> 00:07:53,240 Speaker 1: on eight hundred ninety seven patients who had taken ten 129 00:07:53,320 --> 00:07:57,640 Speaker 1: milligram doses of the drug and nine who had taken 130 00:07:57,680 --> 00:08:02,520 Speaker 1: a five milligram dose. Use reports later gloamed onto the 131 00:08:02,600 --> 00:08:06,360 Speaker 1: number of a hundred and thirty two. The number had 132 00:08:06,360 --> 00:08:08,680 Speaker 1: come up in some senate hearings. That was the number 133 00:08:08,760 --> 00:08:12,280 Speaker 1: of patients who had taken the drug continuously for a 134 00:08:12,400 --> 00:08:16,960 Speaker 1: year or more. But really the documentation that Searles submitted 135 00:08:17,000 --> 00:08:19,560 Speaker 1: as part of this approval process was at the time 136 00:08:19,640 --> 00:08:23,080 Speaker 1: the largest package the f d A had ever received. 137 00:08:23,560 --> 00:08:26,760 Speaker 1: There were twenty volumes of data from trials that had 138 00:08:26,760 --> 00:08:30,600 Speaker 1: been conducted in Puerto Rico, Haiti, Los Angeles, and Massachusetts. 139 00:08:31,800 --> 00:08:35,440 Speaker 1: That was earlier research into safety. It was not the 140 00:08:35,480 --> 00:08:38,160 Speaker 1: contraceptive f x C. As part of that trial, the 141 00:08:38,280 --> 00:08:41,480 Speaker 1: FDA also pulled seventy five O, B, G, U, I, 142 00:08:41,720 --> 00:08:45,040 Speaker 1: N s about their opinions on the pills safety. At 143 00:08:45,040 --> 00:08:47,880 Speaker 1: the same time, the FDA recognized that the pill had 144 00:08:47,920 --> 00:08:50,679 Speaker 1: not existed long enough to be certain of long term 145 00:08:50,720 --> 00:08:54,000 Speaker 1: effects it might cause, so when it approved in ovid's 146 00:08:54,080 --> 00:08:57,079 Speaker 1: use as a contraceptive, the FDA required that patients be 147 00:08:57,240 --> 00:09:01,160 Speaker 1: prescribed the pill for no more than two years. The 148 00:09:01,320 --> 00:09:05,439 Speaker 1: FDA approved an ovid as a contraceptive on June twenty three, 149 00:09:05,840 --> 00:09:11,319 Speaker 1: nineteen sixty, and its popularity spread really rapidly. We'll talk 150 00:09:11,360 --> 00:09:22,199 Speaker 1: about that more after a sponsor break. As we've established, 151 00:09:22,360 --> 00:09:25,600 Speaker 1: the clinical trials on a novid would not have met 152 00:09:25,640 --> 00:09:29,760 Speaker 1: today's standards, but even if they had, they're almost certainly 153 00:09:29,800 --> 00:09:32,439 Speaker 1: would have been some side effects that were only discovered 154 00:09:32,559 --> 00:09:36,199 Speaker 1: after the drug had been approved. Today, drugs are approved 155 00:09:36,240 --> 00:09:40,560 Speaker 1: after several phases of trials that typically include thousands of participants, 156 00:09:40,600 --> 00:09:43,800 Speaker 1: but once drugs are on the market, they may be 157 00:09:43,880 --> 00:09:48,720 Speaker 1: taken by millions of people so extremely rare side effects 158 00:09:48,880 --> 00:09:51,200 Speaker 1: or side effects that only show up among groups that 159 00:09:51,240 --> 00:09:53,960 Speaker 1: were screened out of the clinical trials for some reason, 160 00:09:54,040 --> 00:09:58,120 Speaker 1: like those can show up afterward. In terms of oral contraceptives, 161 00:09:58,160 --> 00:10:01,960 Speaker 1: after a novid's approval, other drug makers soon submitted their 162 00:10:02,000 --> 00:10:06,360 Speaker 1: own new drug applications. Within five years, seven different drug 163 00:10:06,400 --> 00:10:10,000 Speaker 1: companies had an approved oral contraceptive in the US, all 164 00:10:10,040 --> 00:10:13,920 Speaker 1: of which contained estrogen and a progestin. The pill became 165 00:10:13,960 --> 00:10:16,920 Speaker 1: the most widely used contraceptive in the US, and it 166 00:10:17,000 --> 00:10:20,080 Speaker 1: made its way to other countries as well. A lot 167 00:10:20,160 --> 00:10:24,800 Speaker 1: went into this rapid and widespread, although definitely not universal, 168 00:10:25,000 --> 00:10:30,120 Speaker 1: acceptance of the pill. Drug manufacturers advertised directly to doctors, 169 00:10:30,120 --> 00:10:33,040 Speaker 1: both through in person visits from sales reps and through 170 00:10:33,080 --> 00:10:38,040 Speaker 1: advertisements in medical literature. Doctors liked that the pill was 171 00:10:38,160 --> 00:10:42,560 Speaker 1: easier to prescribe and to use than something like a diaphragm. 172 00:10:42,720 --> 00:10:46,640 Speaker 1: Doctors also saw a financial benefit, since patients were supposed 173 00:10:46,679 --> 00:10:49,120 Speaker 1: to have an office visit every six months to get 174 00:10:49,160 --> 00:10:53,319 Speaker 1: their prescriptions renewed. People also got around that whole requirement 175 00:10:53,440 --> 00:10:55,240 Speaker 1: that they were only supposed to be on the pill 176 00:10:55,360 --> 00:10:58,760 Speaker 1: for a maximum of two years by either switching doctors 177 00:10:58,880 --> 00:11:03,679 Speaker 1: or switching brands. There were advertisements aimed at consumers as well, 178 00:11:03,920 --> 00:11:07,440 Speaker 1: and newspapers and magazines covered the pills debut with a 179 00:11:07,480 --> 00:11:11,040 Speaker 1: lot of generally positive fanfare, and of course, a lot 180 00:11:11,080 --> 00:11:14,359 Speaker 1: of people were just really eager for a convenient, effective, 181 00:11:14,400 --> 00:11:17,640 Speaker 1: discrete way to prevent pregnancy for all kinds of reasons. 182 00:11:18,400 --> 00:11:22,479 Speaker 1: Planned Parenthood had been operating birth control clinics and advocating 183 00:11:22,480 --> 00:11:25,880 Speaker 1: for birth control to be legalized for decades. At this point, 184 00:11:26,480 --> 00:11:29,240 Speaker 1: they worked out a deal with Searle to purchase pills 185 00:11:29,280 --> 00:11:32,760 Speaker 1: directly from the company, rather than having to go through distributors. 186 00:11:32,800 --> 00:11:34,920 Speaker 1: They did this to cut costs and to make the 187 00:11:34,960 --> 00:11:38,520 Speaker 1: pill more affordable for people with lower incomes. By the 188 00:11:38,600 --> 00:11:42,880 Speaker 1: end of nineteen sixty one, almost of Planned Parenthood clinics 189 00:11:42,920 --> 00:11:45,959 Speaker 1: were offering the pill, but it didn't take long before 190 00:11:45,960 --> 00:11:48,959 Speaker 1: people started reporting a lot of side effects like new 191 00:11:49,120 --> 00:11:55,360 Speaker 1: or worsening migraines, nausea, depression, water retention, weight gain, spotting, 192 00:11:55,360 --> 00:12:00,400 Speaker 1: and breakthrough bleeding, breast tenderness, reduced sex drive, and reduced 193 00:12:00,400 --> 00:12:04,480 Speaker 1: fertility after stopping the pill, and by nineteen sixty one, 194 00:12:04,760 --> 00:12:08,439 Speaker 1: doctors were also starting to report serious and even life 195 00:12:08,440 --> 00:12:13,720 Speaker 1: threatening potential issues, including blood clots, heart attacks, and strokes 196 00:12:13,760 --> 00:12:16,920 Speaker 1: that were brought on by both clots and by high 197 00:12:16,920 --> 00:12:20,800 Speaker 1: blood pressure. A report on fatal clots in Britain was 198 00:12:20,840 --> 00:12:24,120 Speaker 1: published in The Lancet in nineteen sixty one, but it 199 00:12:24,200 --> 00:12:27,959 Speaker 1: wasn't completely clear whether those clots had actually been caused 200 00:12:28,000 --> 00:12:31,360 Speaker 1: by the pill. As other reports of clotting issues and 201 00:12:31,440 --> 00:12:34,559 Speaker 1: other serious side effects started to come in, G D. 202 00:12:34,720 --> 00:12:38,160 Speaker 1: Sterling Company arranged a one day conference in nineteen sixty 203 00:12:38,200 --> 00:12:41,640 Speaker 1: two to review all the evidence. At that point, an 204 00:12:41,760 --> 00:12:44,760 Speaker 1: estimated one million people were taking an ovid and there 205 00:12:44,760 --> 00:12:48,440 Speaker 1: had been twenty eight documented cases of blood clots, six 206 00:12:48,440 --> 00:12:51,680 Speaker 1: of which had been fatal. The assembled group at this 207 00:12:51,800 --> 00:12:56,400 Speaker 1: conference unanimously approved a resolution that called for more research 208 00:12:56,520 --> 00:13:00,480 Speaker 1: into this issue, but the vast majority also felt that 209 00:13:00,480 --> 00:13:04,720 Speaker 1: the available data didn't indicate a causal relationship between the 210 00:13:04,760 --> 00:13:08,000 Speaker 1: pill and the clots, and the FDA maintained that the 211 00:13:08,080 --> 00:13:12,160 Speaker 1: rate of serious adverse reactions translated to about one point 212 00:13:12,280 --> 00:13:15,680 Speaker 1: three out of a hundred thousand users, and that was 213 00:13:15,720 --> 00:13:18,760 Speaker 1: a lot lower than the rate of deaths from pregnancy 214 00:13:18,800 --> 00:13:22,760 Speaker 1: related complications at the time that was almost thirty seven 215 00:13:22,840 --> 00:13:27,240 Speaker 1: out of a hundred thousand. However, after this conference and 216 00:13:27,280 --> 00:13:30,600 Speaker 1: its results were publicized. There were a hundred and thirty 217 00:13:30,640 --> 00:13:33,520 Speaker 1: two more cases of blood clotting issues that were reported 218 00:13:33,559 --> 00:13:36,480 Speaker 1: in just amount of months. These were probably not clots 219 00:13:36,520 --> 00:13:39,679 Speaker 1: that happened just then, but people hadn't realized there might 220 00:13:39,679 --> 00:13:42,920 Speaker 1: be an connection, so after it was reported, they started 221 00:13:43,120 --> 00:13:46,440 Speaker 1: realizing that there might be. As this was happening, news 222 00:13:46,520 --> 00:13:49,320 Speaker 1: broke that the sedative the Lidamne, which had been prescribed 223 00:13:49,360 --> 00:13:52,400 Speaker 1: as a treatment for morning sickness, had caused a range 224 00:13:52,400 --> 00:13:55,400 Speaker 1: of illnesses and disabilities and babies who were exposed to 225 00:13:55,440 --> 00:13:59,600 Speaker 1: it in utero. We covered this medical disaster in August 226 00:13:59,600 --> 00:14:04,480 Speaker 1: of twenty nineteen. The news about the litamine temporarily overshadowed 227 00:14:04,520 --> 00:14:07,360 Speaker 1: the growing safety concerns about the pill, but it also 228 00:14:07,440 --> 00:14:11,199 Speaker 1: led to much tighter restrictions on drug testing and safety afterward. 229 00:14:11,920 --> 00:14:14,120 Speaker 1: This was also happening at the same time as a 230 00:14:14,240 --> 00:14:19,480 Speaker 1: generally increased scrutiny into chemicals and environmental pollutants and other 231 00:14:19,560 --> 00:14:23,800 Speaker 1: issues and what effect they might have on the human body. 232 00:14:23,920 --> 00:14:28,440 Speaker 1: For example, Rachel Carson's Silent Spring, which included a chapter 233 00:14:28,600 --> 00:14:32,280 Speaker 1: on things like pesticide poisonings and a connection between pesticides 234 00:14:32,320 --> 00:14:36,040 Speaker 1: and cancer that came out in nineteen sixty two. That 235 00:14:36,080 --> 00:14:38,240 Speaker 1: book is when we've had a lot of request to cover. 236 00:14:39,160 --> 00:14:41,040 Speaker 1: It's a tricky one because it covers a lot of 237 00:14:41,080 --> 00:14:45,200 Speaker 1: different territory. Yeah. Yeah, the potential health connections is just 238 00:14:45,280 --> 00:14:50,120 Speaker 1: one chapter of the longer book. Yeah. Through the early 239 00:14:50,160 --> 00:14:52,680 Speaker 1: to mid sixties, there was more research into whether the 240 00:14:52,680 --> 00:14:56,359 Speaker 1: pill was causing blood clots and other serious health problems, 241 00:14:56,400 --> 00:14:59,720 Speaker 1: but a lot of it was really contradictory. The f 242 00:14:59,840 --> 00:15:02,600 Speaker 1: d A formed an ad hoc committee to investigate the 243 00:15:02,600 --> 00:15:06,640 Speaker 1: pill in nineteen sixty three, which ultimately found no increased 244 00:15:06,720 --> 00:15:10,640 Speaker 1: risks for issues like blood clots. In other studies, findings 245 00:15:10,680 --> 00:15:14,600 Speaker 1: disagreed with one another, and published research often concluded mostly 246 00:15:15,080 --> 00:15:18,360 Speaker 1: the more research was needed. There were also a lot 247 00:15:18,520 --> 00:15:21,560 Speaker 1: of questions about whether the pill could increase the risk 248 00:15:21,640 --> 00:15:24,520 Speaker 1: of cancer, but because cancers can take a long time 249 00:15:24,560 --> 00:15:28,120 Speaker 1: to develop, it wasn't possible to even really study that yet. 250 00:15:28,600 --> 00:15:32,600 Speaker 1: In November of nineteen a report came out that advised 251 00:15:32,640 --> 00:15:36,200 Speaker 1: further study into whether the pill was causing neuro optimal 252 00:15:36,240 --> 00:15:40,480 Speaker 1: logic issues, and the FDA advised drug manufacturers to add 253 00:15:40,560 --> 00:15:44,200 Speaker 1: eye problems to the list of contraindications that was provided 254 00:15:44,240 --> 00:15:47,600 Speaker 1: to doctors and pharmacists when they were prescribing and dispensing 255 00:15:47,600 --> 00:15:52,520 Speaker 1: the pill. The FDA's Advisory Committee on Obstetrics and Gynecology 256 00:15:52,560 --> 00:15:56,080 Speaker 1: formed four task forces to do more research into the pill, 257 00:15:56,920 --> 00:16:01,760 Speaker 1: one on thromboembolic disease, one on car synergenic potential, one 258 00:16:01,800 --> 00:16:05,960 Speaker 1: on endocrine and metabolic effects, and one on efficacy. But 259 00:16:06,040 --> 00:16:09,880 Speaker 1: the report it issued in nine once again mostly called 260 00:16:09,920 --> 00:16:14,280 Speaker 1: for more research, describing a lot of results as quote inconclusive, 261 00:16:14,840 --> 00:16:17,400 Speaker 1: and acknowledging that it was simply too soon to know 262 00:16:17,440 --> 00:16:21,080 Speaker 1: whether contraceptives taken now would have an impact on someone's 263 00:16:21,120 --> 00:16:24,760 Speaker 1: body thirty years down the road. There were also lots 264 00:16:24,760 --> 00:16:28,200 Speaker 1: of unanswered questions about whether demographic groups that were more 265 00:16:28,240 --> 00:16:31,160 Speaker 1: likely to be on the pill we're predisposed to various 266 00:16:31,200 --> 00:16:35,680 Speaker 1: potential side effects or not. Compounding all of this was 267 00:16:35,720 --> 00:16:38,480 Speaker 1: the fact that the medical community as a whole was 268 00:16:38,640 --> 00:16:42,520 Speaker 1: debating exactly how to weigh the pills risks and benefits. 269 00:16:43,240 --> 00:16:46,960 Speaker 1: All drugs have side effects, but before the pill was introduced, 270 00:16:47,040 --> 00:16:49,680 Speaker 1: virtually all the prescription drug is on the market were 271 00:16:49,680 --> 00:16:54,280 Speaker 1: meant to treat a specific illness or condition. Questions of 272 00:16:54,320 --> 00:16:57,440 Speaker 1: whether a drug was safe enough we're also connected to 273 00:16:57,480 --> 00:17:00,280 Speaker 1: how serious that condition was and what it would to 274 00:17:00,320 --> 00:17:04,320 Speaker 1: treat it. Although birth control was sometimes being prescribed to 275 00:17:04,359 --> 00:17:07,760 Speaker 1: treat things like painful or irregular periods, in a lot 276 00:17:07,760 --> 00:17:11,080 Speaker 1: of cases the patient was young and healthy and just 277 00:17:11,240 --> 00:17:14,680 Speaker 1: wanted to prevent pregnancy. So it just left this big 278 00:17:14,800 --> 00:17:19,000 Speaker 1: question what was an appropriate level of risk for a young, 279 00:17:19,119 --> 00:17:22,520 Speaker 1: healthy person who wanted to prevent pregnancy For years or 280 00:17:22,560 --> 00:17:28,000 Speaker 1: even decades. Meanwhile, the news media was generally interpreting no 281 00:17:28,200 --> 00:17:31,720 Speaker 1: conclusive evidence to mean that there's not a problem. So, 282 00:17:31,840 --> 00:17:34,680 Speaker 1: even though doctors and researchers had been reporting at least 283 00:17:34,680 --> 00:17:38,560 Speaker 1: the possibility of serious issues for six years, reporting on 284 00:17:38,600 --> 00:17:41,760 Speaker 1: the pill in the mainstream press continued to be pretty positive. 285 00:17:42,760 --> 00:17:46,160 Speaker 1: In April of nineteen sixty seven, the tone of all 286 00:17:46,200 --> 00:17:50,679 Speaker 1: this started to shift. More reports started to suggest a 287 00:17:50,760 --> 00:17:54,680 Speaker 1: definitive link between the pill and blood clots. In May 288 00:17:54,720 --> 00:17:57,800 Speaker 1: of nineteen sixty seven, the British Medical Journal printed the 289 00:17:57,840 --> 00:18:01,520 Speaker 1: results of a study that found that fifty out of 290 00:18:01,560 --> 00:18:05,760 Speaker 1: a hundred thousand oral contraceptive users would be hospitalized for 291 00:18:05,880 --> 00:18:10,360 Speaker 1: thrombo embolism every year. That was ten times higher than 292 00:18:10,359 --> 00:18:13,080 Speaker 1: the rate of hospitalizations among people who were not on 293 00:18:13,119 --> 00:18:17,159 Speaker 1: the pill. This report showed a similar dramatic disparity in 294 00:18:17,280 --> 00:18:20,359 Speaker 1: death rates. For people between the ages of twenty and 295 00:18:20,400 --> 00:18:24,120 Speaker 1: thirty four, one point five per one hundred thousand pill 296 00:18:24,200 --> 00:18:28,560 Speaker 1: users would die of complications from a thrombo embolism. Among 297 00:18:28,600 --> 00:18:32,359 Speaker 1: non users, that number was only zero point two, and 298 00:18:32,400 --> 00:18:35,000 Speaker 1: for pill users between the ages of thirty five and 299 00:18:35,040 --> 00:18:38,120 Speaker 1: forty four, the death rate was three point nine per 300 00:18:38,160 --> 00:18:41,320 Speaker 1: one hundred thousand users, but it was only zero point 301 00:18:41,400 --> 00:18:45,760 Speaker 1: five per one hundred thousand non users, So this seemed 302 00:18:46,080 --> 00:18:49,720 Speaker 1: pretty clear. But this report only led some more debate, 303 00:18:50,119 --> 00:18:54,280 Speaker 1: with doctors and pharmaceutical companies arguing about whether the study 304 00:18:54,400 --> 00:18:58,080 Speaker 1: was accurate or whether it had been correctly designed. But 305 00:18:58,280 --> 00:19:01,160 Speaker 1: news reporting on the pill started to become a lot 306 00:19:01,200 --> 00:19:05,000 Speaker 1: more critical. There's a lot more first person testimony from 307 00:19:05,000 --> 00:19:08,560 Speaker 1: people who had been harmed, like patients who had experienced 308 00:19:08,560 --> 00:19:11,960 Speaker 1: blood clots or family members whose loved one had died. 309 00:19:12,560 --> 00:19:14,879 Speaker 1: There was also just a lot more reporting on the 310 00:19:14,960 --> 00:19:18,680 Speaker 1: more vague and inconvenient problems that were associated with the pill, 311 00:19:18,840 --> 00:19:23,400 Speaker 1: like breast tenderness, spotting, and nausea. By nineteen sixty nine, 312 00:19:23,440 --> 00:19:27,679 Speaker 1: the medical community was increasingly recognizing a clear connection between 313 00:19:27,720 --> 00:19:30,560 Speaker 1: the pill and blood clots. It was also clear that 314 00:19:30,600 --> 00:19:33,719 Speaker 1: the pill was causing some kind of metabolic effects, although 315 00:19:34,119 --> 00:19:37,480 Speaker 1: it really wasn't yet clear what those were, and they 316 00:19:37,480 --> 00:19:40,440 Speaker 1: still really didn't know whether the pill increased the risk 317 00:19:40,520 --> 00:19:45,560 Speaker 1: of various cancers. But then individual doctors were all over 318 00:19:45,600 --> 00:19:48,399 Speaker 1: the place and how much they knew about this and 319 00:19:48,440 --> 00:19:52,080 Speaker 1: how it affected their work with their patients. Communication about 320 00:19:52,080 --> 00:19:55,480 Speaker 1: these issues within the medical community was just not very robust. 321 00:19:56,000 --> 00:19:59,320 Speaker 1: A lot of the studies that suggested the strongest connection 322 00:19:59,400 --> 00:20:02,520 Speaker 1: between the hill in a specific problem, a lot of 323 00:20:02,520 --> 00:20:06,760 Speaker 1: those were printed in specialist journals, so, for example, papers 324 00:20:06,800 --> 00:20:09,639 Speaker 1: about blood clots in the eye were being printed in 325 00:20:09,760 --> 00:20:14,960 Speaker 1: journals of optimology. General practitioners and gynecologists who were likely 326 00:20:15,000 --> 00:20:18,480 Speaker 1: to be prescribing the pill to their patients weren't necessarily 327 00:20:18,560 --> 00:20:23,359 Speaker 1: reading these particular journals. GPS often found about really concerning 328 00:20:23,400 --> 00:20:26,360 Speaker 1: studies only after they were picked up and reported on 329 00:20:26,400 --> 00:20:30,719 Speaker 1: by mainstream news outlets, and as a trend, doctors often 330 00:20:30,760 --> 00:20:34,320 Speaker 1: weren't talking to their patients about risks at all. If 331 00:20:34,359 --> 00:20:37,160 Speaker 1: you wanted oral contraceptives, you went to your doctor and 332 00:20:37,280 --> 00:20:38,800 Speaker 1: asked for them, and a lot of the time you 333 00:20:38,880 --> 00:20:42,399 Speaker 1: just got a prescription with no discussion about the pills 334 00:20:42,440 --> 00:20:45,359 Speaker 1: potential side effects, or whether you had any kind of 335 00:20:45,400 --> 00:20:48,080 Speaker 1: illness or condition that might make you more prone to 336 00:20:48,119 --> 00:20:50,840 Speaker 1: those side effects. All of this came to a head 337 00:20:50,880 --> 00:20:53,359 Speaker 1: in nineteen sixty nine, which we will get to you 338 00:20:53,560 --> 00:21:04,840 Speaker 1: after a sponsor break. In nineteen sixty nine, journalist Barbara 339 00:21:04,880 --> 00:21:09,400 Speaker 1: Semen published The Doctor's Case Against the Pill. It documented 340 00:21:09,520 --> 00:21:13,440 Speaker 1: numerous accounts of serious problems that were associated with the pill, 341 00:21:14,080 --> 00:21:17,920 Speaker 1: although some of these connections were anecdotal and were later disproven. 342 00:21:18,200 --> 00:21:21,120 Speaker 1: A lot of the book documented side effects that were 343 00:21:21,160 --> 00:21:24,719 Speaker 1: well known but which patients were not being informed of 344 00:21:24,920 --> 00:21:29,080 Speaker 1: before taking the pill. Siemen was particularly driven by the 345 00:21:29,119 --> 00:21:32,280 Speaker 1: idea that patients had a right to be informed of 346 00:21:32,320 --> 00:21:35,240 Speaker 1: the risks that were involved in any drug or other 347 00:21:35,320 --> 00:21:38,639 Speaker 1: medical treatment that they took. Her aunt had actually died 348 00:21:38,720 --> 00:21:42,360 Speaker 1: of a uterine cancer that was connected to high estrogen 349 00:21:42,480 --> 00:21:45,439 Speaker 1: levels in a hormone replacement therapy that she was taking, 350 00:21:45,920 --> 00:21:48,800 Speaker 1: and then her son had also nearly died as a 351 00:21:48,840 --> 00:21:52,320 Speaker 1: baby because she had been prescribed a laxative that was 352 00:21:52,400 --> 00:21:55,720 Speaker 1: passed to him through her breast milk. On September twenty 353 00:21:55,760 --> 00:21:59,520 Speaker 1: three nine, Siemen wrote to U S. Senator gay Lord 354 00:21:59,600 --> 00:22:03,119 Speaker 1: Nelson of Wisconsin. Her letter read, in part, quote, I 355 00:22:03,160 --> 00:22:06,439 Speaker 1: wish you would seek out ten randomly selected women who 356 00:22:06,520 --> 00:22:08,960 Speaker 1: have been on the pill for any length of time 357 00:22:09,359 --> 00:22:12,280 Speaker 1: and ask them whether they have had any other medications 358 00:22:12,320 --> 00:22:15,840 Speaker 1: to control pill side effects. You may be amazed, as 359 00:22:15,880 --> 00:22:18,480 Speaker 1: I was, to find that a high proportion six or 360 00:22:18,520 --> 00:22:21,359 Speaker 1: seven out of ten have had to take other powerful 361 00:22:21,400 --> 00:22:26,000 Speaker 1: medications to counteract pill side effects. These include diuretics to 362 00:22:26,040 --> 00:22:31,200 Speaker 1: control bloating, pain killers for headaches, et cetera, anti nausea preparations, 363 00:22:31,640 --> 00:22:38,520 Speaker 1: tranquilizers for nerves, pep pills for lethargy, and perhaps most alarmingly, anticoagulants. 364 00:22:39,359 --> 00:22:41,680 Speaker 1: Some doctors appear to be handing these out for any 365 00:22:41,760 --> 00:22:46,080 Speaker 1: suspicious swelling and a pill user, not just for established clots. 366 00:22:46,960 --> 00:22:50,639 Speaker 1: She also wrote, quote, never before in history have so 367 00:22:50,840 --> 00:22:55,200 Speaker 1: many millions of people taken such a powerful and unnecessary drug. 368 00:22:55,760 --> 00:22:59,119 Speaker 1: Nelson read Siemens book. He was on the Senate Subcommittee 369 00:22:59,160 --> 00:23:03,000 Speaker 1: on Monopoly, which was under the Select Committee on Small Business, 370 00:23:03,040 --> 00:23:06,919 Speaker 1: and he was conducting hearings into the pharmaceutical industry. On 371 00:23:06,960 --> 00:23:09,879 Speaker 1: December twenty second, nineteen sixty nine, he announced that the 372 00:23:09,880 --> 00:23:13,800 Speaker 1: committee would hold hearings into the safety of oral contraceptives. 373 00:23:14,600 --> 00:23:18,040 Speaker 1: These hearings started on January fourteenth, nineteen seventy, and they 374 00:23:18,119 --> 00:23:21,800 Speaker 1: lasted into March. On the first day, Nelson gave a 375 00:23:21,840 --> 00:23:24,560 Speaker 1: statement that said, in part quote, the aims of these 376 00:23:24,600 --> 00:23:27,919 Speaker 1: hearings are to present, for the general public's benefit, the 377 00:23:27,960 --> 00:23:32,919 Speaker 1: best and most objective information available about these drugs. First 378 00:23:32,960 --> 00:23:36,240 Speaker 1: whether they are dangerous for the human body, and second, 379 00:23:36,320 --> 00:23:40,520 Speaker 1: whether patients taking them have sufficient information about the possible 380 00:23:40,600 --> 00:23:43,840 Speaker 1: dangers in order to make an intelligent judgment whether they 381 00:23:43,840 --> 00:23:47,119 Speaker 1: wished to assume the risks. Many of the people who 382 00:23:47,200 --> 00:23:49,920 Speaker 1: were invited to testify were people who had been featured 383 00:23:49,960 --> 00:23:55,520 Speaker 1: in Siemens book. Most were doctors, biologists, physiologists, professors of medicine, 384 00:23:55,520 --> 00:23:59,920 Speaker 1: and other experts of the pills original co developers dot 385 00:24:00,080 --> 00:24:02,880 Speaker 1: or John Rock was still living but was not invited 386 00:24:02,920 --> 00:24:05,840 Speaker 1: to testify, and many of the people who did speak 387 00:24:05,880 --> 00:24:09,119 Speaker 1: were deeply critical of the pill, enough that Senator Bob 388 00:24:09,119 --> 00:24:14,040 Speaker 1: Dole of Kansas criticized the hearings as unbalanced. In general, 389 00:24:14,320 --> 00:24:18,520 Speaker 1: the criticisms made at these hearings were about purported problems 390 00:24:18,560 --> 00:24:21,919 Speaker 1: being caused by the pill itself, not about the FDA 391 00:24:22,040 --> 00:24:25,000 Speaker 1: approval process that had led to its being made available 392 00:24:25,560 --> 00:24:28,840 Speaker 1: because of the Theldomide disaster. The process for that in 393 00:24:28,960 --> 00:24:32,080 Speaker 1: nineteen seventy was much different than it had been ten 394 00:24:32,160 --> 00:24:35,560 Speaker 1: years earlier, so picking apart the pills development and testing 395 00:24:35,600 --> 00:24:39,440 Speaker 1: process did not seem quite as relevant. A key figure 396 00:24:39,640 --> 00:24:43,240 Speaker 1: and the first person to testify, was Dr Hugh J. Davis, 397 00:24:43,520 --> 00:24:48,280 Speaker 1: who taught obstetrics and gynecology at Johns Hopkins. Davis described 398 00:24:48,400 --> 00:24:51,960 Speaker 1: oral contraceptives as an experiment that was being carried out 399 00:24:52,040 --> 00:24:55,760 Speaker 1: on millions of healthy women. He argued that the synthetic 400 00:24:55,760 --> 00:25:00,240 Speaker 1: hormones being used in contraceptives were carcinogens in various animals, 401 00:25:00,280 --> 00:25:02,879 Speaker 1: and that he was certain that would also be true 402 00:25:02,880 --> 00:25:06,920 Speaker 1: of humans. He also described them as causing metabolic problems 403 00:25:06,960 --> 00:25:10,399 Speaker 1: and criticized the pharmaceutical industry for trying to protect their 404 00:25:10,440 --> 00:25:15,800 Speaker 1: own profits instead of finding safer options. However, Davis had 405 00:25:15,840 --> 00:25:20,320 Speaker 1: an enormous conflict of interest here. He was developing an 406 00:25:20,320 --> 00:25:23,199 Speaker 1: intra uterine device that would, in his opinion, be a 407 00:25:23,280 --> 00:25:27,119 Speaker 1: much safer option than oral hormones were. He thought this 408 00:25:27,160 --> 00:25:30,360 Speaker 1: was going to be a completely effective method of contraception 409 00:25:30,440 --> 00:25:34,080 Speaker 1: that had no side effects. So even though he said 410 00:25:34,119 --> 00:25:36,280 Speaker 1: he didn't have any conflicts of interests. It was in 411 00:25:36,359 --> 00:25:40,480 Speaker 1: his personal and financial interest if people stopped trusting the 412 00:25:40,520 --> 00:25:43,400 Speaker 1: pill and started looking for other forms of birth control. 413 00:25:43,960 --> 00:25:46,480 Speaker 1: And we should also note that I U D was 414 00:25:46,520 --> 00:25:49,840 Speaker 1: the Dalkon Shield, which hit the market in nineteen seventy one. 415 00:25:50,400 --> 00:25:53,560 Speaker 1: The Dalkon shield was associated with at least eighteen deaths 416 00:25:53,600 --> 00:25:57,320 Speaker 1: and more than two hundred thousand infections, miscarriages, and other 417 00:25:57,440 --> 00:26:01,480 Speaker 1: serious problems because it's multi filam string could draw bacteria 418 00:26:01,600 --> 00:26:05,600 Speaker 1: into the uterus. A H. Robbins sold two point eight 419 00:26:05,640 --> 00:26:08,080 Speaker 1: million of them before it stopped making them in nineteen 420 00:26:08,080 --> 00:26:11,800 Speaker 1: seventy four, although it didn't actually recall them for another 421 00:26:11,920 --> 00:26:15,200 Speaker 1: decade and covered up what was going on. More than 422 00:26:15,359 --> 00:26:19,560 Speaker 1: three hundred thousand lawsuits were filed against A. H. Robbin's company, 423 00:26:19,880 --> 00:26:24,719 Speaker 1: which ultimately filed for bankruptcy in nine five. Yeah, they 424 00:26:24,720 --> 00:26:27,520 Speaker 1: were still telling people who had these inserted that they 425 00:26:27,600 --> 00:26:30,320 Speaker 1: needed to go to the doctor to have them removed, 426 00:26:31,359 --> 00:26:35,000 Speaker 1: recently enough for me to remember seeing news reports about 427 00:26:35,040 --> 00:26:38,280 Speaker 1: it when I was a kid. Same. Yeah. In addition 428 00:26:38,320 --> 00:26:41,200 Speaker 1: to that, like I, a member of my extended family 429 00:26:41,240 --> 00:26:44,000 Speaker 1: actually had a stroke from her birth control pills before 430 00:26:44,040 --> 00:26:48,240 Speaker 1: I was born, So it's like multiple overlapping aspects of 431 00:26:48,320 --> 00:26:52,200 Speaker 1: this episode have like a personal connection for me. Back 432 00:26:52,240 --> 00:26:55,800 Speaker 1: to the Senate hearings. Though only four of the people 433 00:26:55,880 --> 00:26:59,840 Speaker 1: who testified at these hearings were women. The first woman 434 00:26:59,880 --> 00:27:04,040 Speaker 1: to testify was Dr Elizabeth Connell. That was on February, 435 00:27:04,400 --> 00:27:08,200 Speaker 1: which was well into the hearings themselves. The only woman 436 00:27:08,240 --> 00:27:12,119 Speaker 1: to testify that she personally had used the pill was 437 00:27:12,280 --> 00:27:15,320 Speaker 1: Dr Mary E. Laine, who was clinical director of the 438 00:27:15,359 --> 00:27:19,720 Speaker 1: contraception service at Margaret Sanger Research Bureau. Of course, the 439 00:27:19,800 --> 00:27:22,960 Speaker 1: fact that an all male Senate committee was holding hearings 440 00:27:22,960 --> 00:27:26,880 Speaker 1: into birth control without involving many women, and without inviting 441 00:27:26,920 --> 00:27:30,320 Speaker 1: women who were directly affected by the pill to testify, 442 00:27:30,520 --> 00:27:35,159 Speaker 1: made people angry. On January twenty three, protesters interrupted the 443 00:27:35,200 --> 00:27:38,879 Speaker 1: testimony of Philip Corfman, director of the Center for Population 444 00:27:38,960 --> 00:27:42,679 Speaker 1: Research at the National Institutes of Health. They were members 445 00:27:42,720 --> 00:27:45,600 Speaker 1: of the feminist group d C Women's Liberation, led by 446 00:27:45,600 --> 00:27:49,640 Speaker 1: Alice Wolfson and General Wilson and the other women agreed 447 00:27:49,680 --> 00:27:52,439 Speaker 1: with the basics of what Korfman was saying, which was 448 00:27:52,480 --> 00:27:56,159 Speaker 1: that oral contraceptives caused all kinds of effects throughout the body, 449 00:27:56,560 --> 00:27:59,840 Speaker 1: and that these effects were poorly understood, that women were 450 00:27:59,840 --> 00:28:02,919 Speaker 1: not being told about them, but they objected to the 451 00:28:02,960 --> 00:28:06,000 Speaker 1: fact that everyone who had testified at that point was 452 00:28:06,080 --> 00:28:09,520 Speaker 1: a man, and that women whose experiences had been covered 453 00:28:09,520 --> 00:28:13,560 Speaker 1: in Siemen's book semen herself, none of them were being included. 454 00:28:14,000 --> 00:28:17,960 Speaker 1: DC Women's Collective also distributed flyers to the hearings attendees 455 00:28:17,960 --> 00:28:21,680 Speaker 1: with questions that echoed what they shouted during the proceedings. 456 00:28:21,720 --> 00:28:25,560 Speaker 1: These flyers read, why are no women testifying? Why are 457 00:28:25,560 --> 00:28:29,400 Speaker 1: no women on the subcommittee? Why is the profitable relationship 458 00:28:29,440 --> 00:28:32,760 Speaker 1: between doctors and drug companies whitewashed by the press and 459 00:28:32,920 --> 00:28:36,720 Speaker 1: in these hearings. Why isn't there a mail pill? Why 460 00:28:36,760 --> 00:28:40,640 Speaker 1: are contraception and medicine profit making industries rather than free 461 00:28:40,680 --> 00:28:46,000 Speaker 1: public services. Why are drug companies deliberately withholding available information 462 00:28:46,040 --> 00:28:49,520 Speaker 1: on side effects. Why is our government's solution to world 463 00:28:49,600 --> 00:28:54,040 Speaker 1: hunger to control population rather than the redistribution of resources. 464 00:28:54,600 --> 00:28:57,560 Speaker 1: Why are these hearings not discussing the issue of abortion 465 00:28:57,600 --> 00:29:00,959 Speaker 1: on demand. What kind of reparation will be made by 466 00:29:01,000 --> 00:29:04,080 Speaker 1: the white male medical establishment to women who have been 467 00:29:04,160 --> 00:29:08,680 Speaker 1: used as guinea pigs in this mass experiment. Nelson cleared 468 00:29:08,720 --> 00:29:12,200 Speaker 1: the room after this disruption and then only allowed the 469 00:29:12,280 --> 00:29:16,560 Speaker 1: press back in when the committee reconvened. His treatment of 470 00:29:16,640 --> 00:29:19,840 Speaker 1: these women and his discussions of them during the hearings 471 00:29:19,920 --> 00:29:24,400 Speaker 1: and afterwards that was pretty dismissive and patronizing, including calling 472 00:29:24,440 --> 00:29:30,160 Speaker 1: them girls and lecturing them about appropriate behavior. These hearings 473 00:29:30,200 --> 00:29:35,040 Speaker 1: really didn't uncover any new information about oral contraceptives. Most 474 00:29:35,080 --> 00:29:38,480 Speaker 1: of the testimony repeated details that had already been published 475 00:29:38,520 --> 00:29:41,600 Speaker 1: in journals or in Siemens book, And they didn't really 476 00:29:41,640 --> 00:29:44,360 Speaker 1: answer the questions of whether the risks of blood clots 477 00:29:44,360 --> 00:29:48,200 Speaker 1: and other potential health issues outweighed the pills benefits. But 478 00:29:48,240 --> 00:29:51,280 Speaker 1: they made it abundantly clear that people were not being 479 00:29:51,320 --> 00:29:54,480 Speaker 1: informed of these risks now, like a lot of this 480 00:29:54,600 --> 00:29:58,520 Speaker 1: had been documented that people didn't know until they heard 481 00:29:58,560 --> 00:30:01,320 Speaker 1: about it in these hearings, and and this had a 482 00:30:01,440 --> 00:30:06,840 Speaker 1: dramatic impact on the pill itself and on its acceptance. Initially, 483 00:30:06,880 --> 00:30:10,240 Speaker 1: these hearings were expected to take place over five days. 484 00:30:10,480 --> 00:30:14,560 Speaker 1: All three major American TV networks covered at least four 485 00:30:14,600 --> 00:30:17,720 Speaker 1: of those five days, and according to a Gallop poll 486 00:30:17,840 --> 00:30:21,640 Speaker 1: that was released shortly after that, about eighty seven percent 487 00:30:21,840 --> 00:30:24,240 Speaker 1: of women in the US who were between the ages 488 00:30:24,280 --> 00:30:27,400 Speaker 1: of twenty one and forty five had heard or read 489 00:30:27,440 --> 00:30:31,120 Speaker 1: about the hearings, and two thirds of the women polled 490 00:30:31,200 --> 00:30:34,640 Speaker 1: said their doctor had never informed them of the risks 491 00:30:34,640 --> 00:30:38,120 Speaker 1: that were associated with the pill. After these hearings, the 492 00:30:38,200 --> 00:30:41,400 Speaker 1: number of people taking the pill dropped sharply, with about 493 00:30:41,440 --> 00:30:44,080 Speaker 1: eighteen percent of people who had been taking them stopping 494 00:30:44,480 --> 00:30:49,440 Speaker 1: and another roughly considering it. In the months after the hearings, 495 00:30:49,520 --> 00:30:54,320 Speaker 1: Doctors reported an uptick in unexpected pregnancies. In the wake 496 00:30:54,400 --> 00:30:58,160 Speaker 1: of these hearings and this growing body of information about 497 00:30:58,160 --> 00:31:02,240 Speaker 1: the dangers that were associated with the pill, pharmaceutical companies 498 00:31:02,440 --> 00:31:08,480 Speaker 1: lowered the amount of hormones in their contraceptives dramatically. The 499 00:31:08,560 --> 00:31:13,680 Speaker 1: first formulation of a novid contained ten thousand micrograms of 500 00:31:13,760 --> 00:31:18,680 Speaker 1: progestine and a hundred and fifty micrograms of estrogen. Today, 501 00:31:19,120 --> 00:31:22,680 Speaker 1: a low dose contraceptive pill is more like between fifty 502 00:31:22,720 --> 00:31:25,760 Speaker 1: and a hundred and fifty micrograms of protestine and between 503 00:31:25,800 --> 00:31:30,360 Speaker 1: twenty and fifty micrograms of estrogen. A lot of different formulations. 504 00:31:30,400 --> 00:31:34,160 Speaker 1: They can vary pretty significantly and exactly what dosages of 505 00:31:34,200 --> 00:31:36,920 Speaker 1: what are in there, but that is a lot less. 506 00:31:37,920 --> 00:31:41,240 Speaker 1: This decrease also led to a reduction in the occurrence 507 00:31:41,240 --> 00:31:44,640 Speaker 1: of blood clots. Today, the FDA estimates that for every 508 00:31:44,720 --> 00:31:49,440 Speaker 1: ten thousand people on oral contraceptives, between three and nine 509 00:31:49,560 --> 00:31:53,160 Speaker 1: will develop a blood clot every year. These hearings also 510 00:31:53,240 --> 00:31:56,160 Speaker 1: led to the inclusion of the patient package insert that 511 00:31:56,240 --> 00:31:59,600 Speaker 1: is required in birth control pills and other medications in 512 00:31:59,600 --> 00:32:03,320 Speaker 1: the US today. The first proposed draft of this insert 513 00:32:03,440 --> 00:32:06,320 Speaker 1: was a six hundred word piece called what You Should 514 00:32:06,320 --> 00:32:09,560 Speaker 1: Know about Birth Control Pills. It went over the risk 515 00:32:09,600 --> 00:32:11,920 Speaker 1: of blood clots and noted that anyone who had a 516 00:32:12,000 --> 00:32:17,360 Speaker 1: history of clots, serious liver disease, breast cancer, certain other cancers, 517 00:32:17,480 --> 00:32:21,320 Speaker 1: or unexplained vaginal bleeding should not take the pill. It 518 00:32:21,400 --> 00:32:26,800 Speaker 1: also noted that anyone with kidney disease, asthma, high blood pressure, diabetes, epilepsy, 519 00:32:26,920 --> 00:32:30,600 Speaker 1: uterine fibroids, and migraines should take it only with special 520 00:32:30,640 --> 00:32:35,400 Speaker 1: medical supervision. It listed possible reactions and noted that while 521 00:32:35,440 --> 00:32:38,720 Speaker 1: these hormones had caused cancer in animals, there was no 522 00:32:38,800 --> 00:32:42,240 Speaker 1: proof that they did in humans. It then read quote, 523 00:32:42,480 --> 00:32:45,360 Speaker 1: because your doctor knows this, he will want to examine 524 00:32:45,360 --> 00:32:51,200 Speaker 1: you regularly. Okay that last sentence. That's one of many 525 00:32:51,320 --> 00:32:55,680 Speaker 1: assumptions that this pamphlet made about the doctor patient relationship. 526 00:32:56,320 --> 00:32:59,440 Speaker 1: It assumed that the doctor was male, and it said 527 00:32:59,480 --> 00:33:02,320 Speaker 1: things like your doctor has taken your medical history and 528 00:33:02,360 --> 00:33:06,400 Speaker 1: has given you a careful physical examination. He has discussed 529 00:33:06,440 --> 00:33:09,520 Speaker 1: with you the risks of oral contraceptives, and has decided 530 00:33:09,560 --> 00:33:12,720 Speaker 1: that you can take this drug safely. Of course, that 531 00:33:12,840 --> 00:33:17,080 Speaker 1: is something a pre printed piece of paper had no 532 00:33:17,200 --> 00:33:22,080 Speaker 1: way of actually knowing. The American Medical Association opposed this insert, 533 00:33:22,160 --> 00:33:26,640 Speaker 1: saying it would undermine relationships between doctors and patients. Drug 534 00:33:26,680 --> 00:33:31,640 Speaker 1: companies were also opposed, and the Pharmaceutical Manufacturers Association submitted 535 00:33:31,640 --> 00:33:35,400 Speaker 1: a list of objections in June of nineteen seventy. The 536 00:33:35,520 --> 00:33:38,920 Speaker 1: f d A ultimately decided on a much shorter information 537 00:33:38,960 --> 00:33:42,120 Speaker 1: card that described the risk of blood clots as quote 538 00:33:42,120 --> 00:33:45,760 Speaker 1: the most serious known side effect. It was only seven 539 00:33:45,800 --> 00:33:49,680 Speaker 1: sentences long, about half of which explained that patients could 540 00:33:49,680 --> 00:33:52,200 Speaker 1: get a copy of the longer piece from their doctor. 541 00:33:53,080 --> 00:33:56,200 Speaker 1: This made oral contraceptives the first drug in the US 542 00:33:56,280 --> 00:33:59,239 Speaker 1: to come with a warning meant for consumers. Yeah, they 543 00:33:59,280 --> 00:34:02,320 Speaker 1: were warning before this point, but they were for the 544 00:34:02,360 --> 00:34:05,880 Speaker 1: doctors and the pharmacists, not for the people actually taking 545 00:34:06,200 --> 00:34:12,200 Speaker 1: the drug. DC Women's Liberation and other feminist groups protested 546 00:34:12,239 --> 00:34:15,200 Speaker 1: the watering down of this statement, which, to be clear, 547 00:34:15,320 --> 00:34:17,280 Speaker 1: was kind of a mixed bag in the first place. 548 00:34:18,000 --> 00:34:20,440 Speaker 1: They sat in at the Office of Health, Education, and 549 00:34:20,480 --> 00:34:24,560 Speaker 1: Welfare Secretary Robert Finch. They met with officials. They petitioned 550 00:34:24,640 --> 00:34:28,000 Speaker 1: to reinstate the longer and stronger version of that warning, 551 00:34:28,960 --> 00:34:32,280 Speaker 1: but that nothing changed at that point. Between nineteen seventy 552 00:34:32,440 --> 00:34:36,640 Speaker 1: and nineteen seventy five, there were about ten million prescriptions 553 00:34:36,640 --> 00:34:40,360 Speaker 1: written for the pill, but only about four million copies 554 00:34:40,400 --> 00:34:45,040 Speaker 1: of that longer informational statement were distributed. A more thorough 555 00:34:45,320 --> 00:34:49,040 Speaker 1: pill insert with all the information actually on it, became 556 00:34:49,120 --> 00:34:52,400 Speaker 1: mandatory and birth control pills in nineteen seventy eight, and 557 00:34:52,440 --> 00:34:55,279 Speaker 1: in nineteen eighty the FDA mandated that this had to 558 00:34:55,320 --> 00:35:00,120 Speaker 1: be understandable to the average consumer. I don't know if 559 00:35:00,160 --> 00:35:03,920 Speaker 1: it's a understandable to average consumers now, because I know 560 00:35:04,040 --> 00:35:06,480 Speaker 1: every time I've gotten a package of birth control pills, 561 00:35:06,520 --> 00:35:10,040 Speaker 1: it's been like very thin paper with tiny, tiny type 562 00:35:10,040 --> 00:35:12,399 Speaker 1: on it and a whole lot on there. Yeah, it's 563 00:35:12,400 --> 00:35:16,000 Speaker 1: like a small novelette. Um, yeah, I agree. I mean 564 00:35:16,080 --> 00:35:17,919 Speaker 1: I haven't I haven't seen one in a long time, 565 00:35:17,960 --> 00:35:20,480 Speaker 1: but last time I did. Yeah, we we might talk 566 00:35:20,480 --> 00:35:24,960 Speaker 1: about that more on the means. In addition to the 567 00:35:25,000 --> 00:35:28,480 Speaker 1: patient packet insert, the pill hearings and the overall debate 568 00:35:28,520 --> 00:35:32,280 Speaker 1: over oral contraceptives had a huge impact on the consumer 569 00:35:32,320 --> 00:35:36,120 Speaker 1: health movement, especially as it related to women. In nineteen 570 00:35:36,960 --> 00:35:41,200 Speaker 1: Seamen Wolfson and three other activists founded the National Women's 571 00:35:41,200 --> 00:35:44,279 Speaker 1: Health Network. You'll see that listed as n w h N, 572 00:35:44,360 --> 00:35:48,000 Speaker 1: and that still exists today and it combines lobbying, activism, 573 00:35:48,040 --> 00:35:50,880 Speaker 1: and education. Yeah, this was it was part of a 574 00:35:50,960 --> 00:35:54,279 Speaker 1: much bigger movement that was about like consumer education and 575 00:35:54,360 --> 00:35:58,200 Speaker 1: informed consent and people having the right to know what 576 00:35:58,239 --> 00:36:02,360 Speaker 1: the potential side effects are of any rug that they're taking. Uh. Today, 577 00:36:02,480 --> 00:36:06,200 Speaker 1: to just circle back to Gaylord Nelson for a minute, Um, 578 00:36:06,239 --> 00:36:09,359 Speaker 1: he is not best known for these pill hearings. He's 579 00:36:09,440 --> 00:36:11,920 Speaker 1: best known as the founder of earth Day, which he 580 00:36:11,960 --> 00:36:15,880 Speaker 1: also did in nineteen seventy. So that's that's kind of 581 00:36:15,920 --> 00:36:18,880 Speaker 1: the story of how we got to this point that 582 00:36:18,920 --> 00:36:21,560 Speaker 1: you're supposed to be informed of the risks of things, 583 00:36:21,600 --> 00:36:25,560 Speaker 1: of drugs that you take before you actually take them, 584 00:36:25,600 --> 00:36:29,040 Speaker 1: which hopefully we will understand better whether these like what 585 00:36:29,160 --> 00:36:32,600 Speaker 1: exactly these very rare risks with the vaccines maybe, and 586 00:36:32,600 --> 00:36:37,680 Speaker 1: and how best to tell people about them. What's going 587 00:36:37,719 --> 00:36:40,840 Speaker 1: on with listener mail for you? Wow? I have listener 588 00:36:40,840 --> 00:36:43,600 Speaker 1: mail from Ian. Ian is the person who had suggested 589 00:36:43,640 --> 00:36:48,800 Speaker 1: the rum rebellion episode and uh, and wrote in again 590 00:36:49,320 --> 00:36:51,520 Speaker 1: to say thanks for doing that suggestion, and to thank 591 00:36:51,560 --> 00:36:55,000 Speaker 1: the person who wrote in about the gum nut baby 592 00:36:55,239 --> 00:37:00,200 Speaker 1: and and Cookabara illustration that we talked about in listener mail. Um, 593 00:37:00,239 --> 00:37:03,319 Speaker 1: and then to just skip ahead. Ian has sent some 594 00:37:03,480 --> 00:37:09,080 Speaker 1: interesting information related to cardboard boxes and a Christmas story. Uh. 595 00:37:09,120 --> 00:37:10,759 Speaker 1: And so I'm going to read just that part of 596 00:37:10,760 --> 00:37:14,360 Speaker 1: this email. Ian says, quote, I too think a wooden 597 00:37:14,400 --> 00:37:17,560 Speaker 1: box was used for dramatic effect. However, I did also 598 00:37:17,600 --> 00:37:21,360 Speaker 1: think about intermodal containers as they became popular in the 599 00:37:21,440 --> 00:37:25,839 Speaker 1: nineteen seventies. Before containers, just about everything being shipped, from 600 00:37:25,920 --> 00:37:28,800 Speaker 1: lamps to pianos to sacks of flour to car parts 601 00:37:28,840 --> 00:37:32,719 Speaker 1: and so on had to be manually loaded and onloaded 602 00:37:32,760 --> 00:37:35,920 Speaker 1: onto every form of transport it traveled on, from ship 603 00:37:35,960 --> 00:37:38,759 Speaker 1: to truck to train car. This resulted in a lot 604 00:37:38,800 --> 00:37:42,800 Speaker 1: of breakage and also theft when containers came along. Something 605 00:37:42,840 --> 00:37:46,160 Speaker 1: like say, a leg lamp could be loaded onto a 606 00:37:46,200 --> 00:37:48,719 Speaker 1: container and a factory in China and then not be 607 00:37:48,920 --> 00:37:51,719 Speaker 1: touched until it got to a distribution center in Atlanta. 608 00:37:52,200 --> 00:37:54,880 Speaker 1: The reduction in damage meant it could now be shipped 609 00:37:54,880 --> 00:37:57,960 Speaker 1: in a cheaper, lighter, cardboard box rather than a heavy 610 00:37:58,000 --> 00:38:01,799 Speaker 1: wooden box. I will not suggests an episode on intermodal 611 00:38:01,800 --> 00:38:04,600 Speaker 1: containers because I think that might be too geeky for 612 00:38:04,680 --> 00:38:09,640 Speaker 1: listeners who are not railroaders or similar like me. For instance, 613 00:38:09,719 --> 00:38:13,200 Speaker 1: before containers, ships were often limited in size because if 614 00:38:13,200 --> 00:38:15,920 Speaker 1: they got any bigger, they would spend more time in 615 00:38:16,080 --> 00:38:19,680 Speaker 1: port than at sea. For instance, the Liberty ships which 616 00:38:19,680 --> 00:38:22,760 Speaker 1: were mass produced during World War Two, we're ten thousand 617 00:38:22,760 --> 00:38:25,279 Speaker 1: tons in size, but the ever given the ship that 618 00:38:25,320 --> 00:38:28,360 Speaker 1: recently made headlines by getting stuck in the Suez Canal 619 00:38:28,640 --> 00:38:34,120 Speaker 1: is two hundred thousand tons. Also, waterfronts of many cities 620 00:38:34,239 --> 00:38:37,440 Speaker 1: of the world, from London, England, to Wellington, New Zealand, 621 00:38:37,440 --> 00:38:40,239 Speaker 1: to Sydney, Australia to Baltimore, USA, have been changed by 622 00:38:40,239 --> 00:38:43,840 Speaker 1: container shipping. Container ships needed new types of cranes and 623 00:38:43,960 --> 00:38:47,839 Speaker 1: open spaces next to the wharfs store containers instead of warehouses. 624 00:38:48,360 --> 00:38:52,400 Speaker 1: This often meant new purpose built ports had to be 625 00:38:52,440 --> 00:38:55,440 Speaker 1: built for them. This left the old wharves and warehouses 626 00:38:55,480 --> 00:38:59,000 Speaker 1: free to be redeveloped into everything from waterfront apartments to 627 00:38:59,000 --> 00:39:03,120 Speaker 1: tourist areas to new business centers, and that there's a 628 00:39:03,120 --> 00:39:05,359 Speaker 1: little further detail on there, but I'm gonna wrap this 629 00:39:05,520 --> 00:39:09,520 Speaker 1: email at this point. Thank you Ian for writing this. UM, 630 00:39:09,600 --> 00:39:12,920 Speaker 1: the setting of Christmas story is a little earlier than 631 00:39:13,040 --> 00:39:16,040 Speaker 1: was described in the listener mail that we originally read. UM, 632 00:39:16,080 --> 00:39:19,439 Speaker 1: but it doesn't change the bulk of my answer, which 633 00:39:19,480 --> 00:39:23,680 Speaker 1: was that, Um, the cardboard boxes existed early enough that 634 00:39:23,680 --> 00:39:26,799 Speaker 1: there's like, there are pictures of things like World War 635 00:39:26,880 --> 00:39:31,000 Speaker 1: One gas masks being distributed in cardboard boxes. UM. So 636 00:39:31,040 --> 00:39:32,879 Speaker 1: that would not have changed the answer. But I felt 637 00:39:32,920 --> 00:39:36,239 Speaker 1: like this information about shipping containers was a really interesting 638 00:39:36,280 --> 00:39:40,080 Speaker 1: add on to the whole specific conversation. So thank you 639 00:39:40,120 --> 00:39:43,640 Speaker 1: Ian number one for suggesting the Rum Rebellion episode, but 640 00:39:43,680 --> 00:39:47,880 Speaker 1: and also number two for writing in with this additional information. UH, 641 00:39:47,920 --> 00:39:49,399 Speaker 1: if you would like to write to us about this 642 00:39:49,520 --> 00:39:51,920 Speaker 1: or any other podcasts were at history podcast that I 643 00:39:51,960 --> 00:39:55,040 Speaker 1: Heart radio dot com. And we're also all over social 644 00:39:55,040 --> 00:39:57,640 Speaker 1: media at Myston History That's Real Hunter, Facebook and Twitter 645 00:39:57,760 --> 00:40:01,000 Speaker 1: and Pinterest in Instagram, and you can subscribe to our 646 00:40:01,040 --> 00:40:03,759 Speaker 1: show on the I Heart Radio app and Apple podcasts, 647 00:40:03,920 --> 00:40:11,400 Speaker 1: and anywhere else that you get your podcasts. 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