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