SYMHC Classics: Nelson Pill Hearings

Summary

Stuff You Missed in History Class: "Nelson Pill Hearings" (March 21, 2026)

Episode Overview

In this "Classics" episode, hosts Tracy V. Wilson and Holly Frey revisit the infamous Nelson Pill Hearings of the early 1970s—a pivotal moment in medical, pharmaceutical, and women's history. Originally released in 2021, the episode explores the origins of the oral contraceptive pill, the medical and ethical controversies surrounding its introduction, and the dramatic Senate hearings that led to significant changes in drug safety regulation and informed consent. The discussion illustrates how the pursuit of a revolutionary contraceptive became entangled with questions about medical ethics, women's rights, pharmaceutical industry practices, and the evolving relationship between patients and providers.

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Key Discussion Points and Insights

1. Setting the Historical and Medical Context

• Comparison to COVID-19 Vaccine Risks
  The hosts open by drawing parallels between the rare clotting risks discussed in contemporary COVID-19 vaccines and long-standing debates over contraceptives.
  • "The clots that are associated with oral contraceptives are generally really different from the ones that might be connected to the vaccines...Another big, big difference here is information, because the connection between oral contraceptives and blood clots has been established for decades at this point." (Tracy, 05:00)
• They highlight the importance of patient information and how the history of birth control safety is directly tied to today’s standards for informed consent.

2. The Development and Early Trials of the Pill

• Origins of Enovid
  • First approved in 1957 for menstrual disorders, but widely used (often surreptitiously) for contraception.
    "...many of the roughly 500,000 people who took Enovid between 1957 and 1960 were taking it for that so-called side effect [temporary infertility]." (Tracy, 08:15)
• Ethically Problematic Clinical Trials
  • Early trials lacked informed consent and were conducted on marginalized populations, notably in Puerto Rico.
  • Trials connected to U.S.-driven eugenics and anti-poverty efforts in Puerto Rico, often coercive or deceptive sterilization campaigns (Tracy, 09:20).
• Participant Treatment
  • Many trial participants were not informed their drug was experimental.
  • Side effects often dismissed or attributed to psychosomatic causes.
  • Dr. Edris Rice Ray, trial lead, expressed early concern:
    "The pill causes too many side reactions to be acceptable generally." (Tracy quoting Rice Ray, 11:06)

3. Approval and Rapid Uptake (1960+)

• FDA Approval and Safety Concerns
  • Approved as a contraceptive in June 1960, but only for up to two years' use due to unknown long-term risks (Holly, 13:00).
• Mass Adoption
  • Rapid popularity due to convenience and discreetness. Doctors benefited financially (Tracy, 19:00).
  • Planned Parenthood played a major role in making the pill widely accessible.

4. Mounting Reports of Side Effects

• Widespread Side Effects Emerge
  • From mild (nausea, migraines) to severe (blood clots, strokes).
• Early Downplaying of Risks
  • Initial incidence of fatal blood clots reported as lower than deaths from pregnancy complications.
  • After media coverage of risks, many more adverse events reported, revealing possible underreporting (Holly, 21:09).

5. Shifting Attitudes & Growing Scrutiny

• Media & Environmental Influences (Early - Mid 1960s)
  • Medical disasters (like thalidomide) and books like "Silent Spring" contributed to broader skepticism (Holly, 22:31).
• Scientific Ambiguity
  • Conflicting research findings; many studies called for further research.
  • Lack of clarity on cancer risks and appropriate risk thresholds for healthy patients using the pill for non-therapeutic reasons.

6. The Nelson Pill Hearings (1970)

• Journalist Activism
  • Barbara Seaman’s 1969 book, "The Doctor’s Case Against the Pill," exposed widespread uncommunicated risks. "Never before in history have so many millions of people taken such a powerful and unnecessary drug." (Barbara Seaman, 35:13)
• Senate Investigation
  • Prompted by Seaman and led by Wisconsin Senator Gaylord Nelson.
  • Hearings opened Jan 14, 1970:
    "The aims of these hearings are to present...the best and most objective information available about these drugs...whether patients are sufficiently informed..." (Nelson, 35:41)
• Biases and Gender Exclusion
  • Nearly all expert witnesses were men; few women testified.
  • Protesters (notably, Alice Wolfson and DC Women's Liberation) disrupted proceedings demanding women’s voices be heard. "Why are no women testifying? Why are no women on the subcommittee?...Why is our government's solution to world hunger to control population rather than the redistribution of resources?" (DC Women's Liberation flyer, 40:40)

7. Impacts and Reforms

• Trail of Consequences
  • Public confidence in the pill dropped; many women stopped taking it, leading to a spike in unplanned pregnancies (Tracy, 43:03).
  • Pharmaceutical companies lowered hormone doses; risk of blood clots fell sharply.
  • The hearings directly resulted in the first "patient package insert"—required written warnings for consumers (Tracy, 44:18).
• Battle Over Informed Consent
  • Initial physician pushback over consumer inserts, eventual compromise, and later mandates for clear consumer information (1978, 1980).
• Catalyst for Women’s Health Activism
  • Formation of the National Women's Health Network (1975) by Seaman, Wolfson, and others.

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Notable Quotes & Memorable Moments

• "These hearings really didn't uncover any new information about oral contraceptives...But they made it abundantly clear that people were not being informed of these risks." (Holly, 41:55)
• "According to a Gallup poll...about 87% of women in the US who were between the ages of 21 and 45 had heard or read about the hearings. And two thirds of the women polled said their doctor had never informed them of the risks that were associated with the Pill." (Tracy, 42:19)
• "There were warnings before this point, but they were for the doctors and the pharmacists, not for the people actually taking the drug." (Tracy, 46:25)
• "This was part of a much bigger movement...that people have the right to know what the potential side effects are of any drug that they're taking..." (Tracy, 48:15)

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Timeline of Important Segments

| Timestamp | Segment & Significance | |-----------|-----------------------| | 04:17 | Episode proper begins, setting up the Covid-19 vaccine analogy | | 08:15 | Description of Enovid's early use and problematic clinical trials | | 09:58 | Exposé of unethical practices in Puerto Rico, informed consent issues | | 13:17 | FDA grants contraceptive approval with caveats | | 19:19 | Pill's rapid adoption, Planned Parenthood’s role | | 22:04 | Thalidomide disaster and public health regulation tighten | | 26:02 | 1967 – New research directly links pill to clot risks | | 33:28 | 1969: Barbara Seaman’s book, catalyst for hearings | | 35:41 | Senator Nelson opens Senate hearings | | 39:45 | Feminist protests interrupt hearings, demand representation | | 42:19 | Public awareness surges following hearings | | 44:18 | Patient information inserts introduced; consumer health movement gains traction |

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Themes & Takeaways

• Medical Ethics & Informed Consent:
  The Pill's history underscores the evolution from paternalistic medicine to a more informed, rights-based approach—driven by public outcry, activism, and legislative action.
• Women's Health & Agency:
  The hearings and ensuing activism highlight persistent issues of gender bias in healthcare, including the exclusion of women from decision-making about their own bodies.
• Regulatory Reforms:
  The Nelson hearings were critical in instituting the first drug information inserts for consumers—a now-standard public health protection.
• Complex Calculus of Risk and Benefit:
  The episode makes clear the difficulties in balancing health risks, benefits, and societal needs, especially when treatments are used by healthy populations for preventive purposes.

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This episode offers a comprehensive, thoughtful account of how oral contraceptives transformed not only reproductive health, but also the patient-provider relationship, drug oversight, and women's activism in modern medicine.

Transcript

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taxes and fees extra. See full [e-mail] Happy Saturday. Since the Nelson pill hearings got a brief mention in this Week's episode on IUDs, we are bringing it out as today's Saturday classic.

[D]

We recorded this episode in 2021 wild times after announcements that various countries were pausing the use of COVID 19 vaccines made by AstraZeneca and Johnson Johnson due to concerns about a clotting disorder. This disorder was real, but also very rare, affecting roughly one out of every 200,000 people who received the vacc. Those pauses were ultimately lifted and the vaccines were used by millions of people, although both companies eventually stopped producing them in February of 2026. So just last month as we're recording, this research was published in the New England Journal of Medicine, concluding that this clotting reaction was caused by a combination of genetics and a mutation in the body's B cells, which produce antibodies. Both these vaccines used adenovirus as a vector, and natural adenovirus infections can also cause this same reaction in people who have that specific combination of factors.

[A]

This episode Originally came out May 5, 2021. Enjoy.

[D]

Welcome to Stuff youf Missed in History Class, a production of iHeartradio.

[A]

Hello and welcome to the podcast. I'm Tracy V. Wilson.

[D]

And I'm Holly Fry.

[A]

So hopefully what we're about to talk about will be, if not cleared up, at least like, somewhat better understood by the time this episode comes out. We're in one of those situations where I'm about to talk about a thing that may just be different by the time the episode is audible to other people. When I researched today's topic, though, we were hearing a lot about extremely rare clotting disorders that are potentially linked to the AstraZeneca and Johnson and Johnson Covid vaccines and headlines about those. Again, extremely rare Clotting disorders have led to a lot of comparisons between the vaccines and oral contraceptives, with the tone kind of being like there's a bigger risk for blood clots or birth control and nobody cares about that, or like, and women just deal with it. So it's a kind of dismissive tone in all of these contexts. But that argument is a little bit apples to oranges and it also skips over a whole lot, a big thing. And we're not going to get in the weeds because we're not doctors and this is not medical history podcast. But the clots that are associated with oral contraceptives are generally really different from the ones that might be connected to the vaccines. And all of these clots can be life threatening, but they form very differently in different parts of the circulatory system. Also, they typically require very different treatments because the vaccines, it's not just a clot, it's also a low platelet count. So you just can't give a person anticoagulants like you would with a lot of other clots. But another big, big difference here is information, because the connection between oral contraceptives and blood clots has been established for decades at this point. And in the United States, the FDA requires that every package of birth control pills comes with patient literature that explains this risk and all the other risks. Ideally, there would also be a thoughtful conversation with a health care provider about the risks and the benefits. There are a lot of reasons that might not happen though, and I totally recognize that. But like, these vaccines are brand new and the potential risk isn't fully understood yet. And you just can't inform people of what their risk is or try to mitigate that risk if you don't really have a handle on what's going on yet. So that's why as of when we're recording this, there's been a pause to try to get a better handle on it. At the same time though, in the United States, this whole idea that people should know about the risks that are involved with the drugs that they're taking, that's tied directly to the complicated and honestly pretty troubling sometimes history of oral contraceptives. So that is what we are going to talk about today. And just to level set the social and political impact of oral contraceptives could be its whole other thing. We're not really going to talk about that at all in this episode because this episode is really about safety.

[D]

So the first oral contraceptive was called Enovid and it was brought to market in The United States in 1957. At first, it was only approved for treating menstrual disorders, but researchers knew that it prevented ovulation, thus that it prevented pregnancy. Temporary infertility was a known side effect. It's likely that many of the roughly 500,000 people who took ANOVID between 1957 and 1960 were taking it for that so called side effect, either in addition to, or instead of treating something like irregular menstrual cycles or endometriosis.

[A]

So getting Innovid approved as a contraceptive, that required additional clinical trials that were specifically for that purpose. And those trials would not at all meet today's standards for things like ethics and informed consent. And really, this was also true of the drug's earlier trials. Some of those had been carried out on patients in a mental hospital. The team that was developing the pill included gynecologist John Rock and reproductive physiologist Gregory Pincus, and they were in Massachusetts. And in Massachusetts, it was illegal to distribute contraceptives or information about them. The same was true of a lot of other states. You couldn't have a controlled trial of a contraceptive in a place where that was illegal.

[D]

So the trials had to be carried out somewhere else. And the location that Rock and Pincus chose for some of this work was Puerto Rico. Rock and Pincus already had connections there through the University of Puerto Rico School of Medicine, and contraception was legal there, and there was already an established network of birth control clinics in the territory.

[A]

However, the reasons for all of that were tied to the eugenics movement and to an effort led by U.S. officials to curb poverty in Puerto Rico by lowering the birth rate. There was just a huge propaganda campaign that promoted the idea that smaller families would mean more money and a better quality of life. And then on top of that, officials sent medical practitioners to Puerto Rico to carry out a mass sterilization campaign. This was one that was often coercive and deceptive, with women being sterilized without their knowledge, or without being told that this procedure they were about to undergo was permanent.

[D]

Another rationale for selecting Puerto Rico for these trials was racist and paternalistic stereotyping Puerto Ricans as ignorant and uneducated. So basically, if they could successfully use the pill, then anyone could.

[A]

And then added to all of that, the idea of informed consent wasn't really established in the world of medicine at this point. The people who were participating in these trials weren't informed that the drug they were taking was experimental or that they were taking part in a clinical trial.

[D]

The trials Conducted in Puerto Rico and elsewhere confirmed that Anovid was an effective contraceptive. No one who took the drug as directed got pregnant. However, a lot of people reported side effects. In Puerto Rico, 17% of the trial participants reported things like headaches, dizziness, nausea and vomiting. 25 of 221 participants ultimately withdrew from the study because of these issues. Three women died, but no postmortem exams were conducted. So it wasn't clear whether their deaths were caused by the Pill or not.

[A]

Medical personnel who were monitoring these trials were really focused on the possibility of several specific possible cancer damage to the reproductive system and liver damage. So they didn't really connect all of these other reported side effects to the Pill. A lot of the doctors just wrote them off as unrelated or as psychosomatic. At the same time, though, Dr. Edris Rice Ray, who was in charge of the trial, wrote that the Pill quote, causes too many side reactions to be acceptable generally. She wrote that when she made her first report later on, though, she would say, quote, we could not have been more wrong.

[D]

The Puerto Rico trials are the most widely known at this point, but trials were also conducted in Haiti and in several cities around the US where it was legal to do so. In the end, when drug manufacturer G.D. searle Co. Applied for FDA approval for ANOVID as a contraceptive, it included data on 897 patients who had taken 10 milligram doses of the drug and 995 who had taken a 5 milligram dose.

[A]

News reports later glommed on to the number of 132. Number had come up in some Senate hearings. It was the number of patients who had taken the drug continuously for a year or more. But really the documentation that Searle submitted as part of this approval process was at the time the largest package the FDA had ever received. There were 20 volumes of data from trials that had been conducted in Puerto Rico, Haiti, Los Angeles and Massachusetts. That was earlier research into safety. It was not the contraceptive efficacy. As part of that trial, the FDA also polled 75 OBGYNs about their opinions on the Pill's safety.

[D]

At the same time, the FDA recognized that the Pill had not existed long enough to be certain of long term effects it might cause. So when it approved Enovid's use as a contraceptive, the FDA required that patients be prescribed the Pill for no more than two years.

[A]

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[A]

As we've established, the clinical trials on Innovid would not have met today's standards. But even if they had, there almost certainly would have been some side effects that were only discovered after the drug had been approved. Today, drugs are approved after several phases of trials that typically include thousands of participants. But once drugs are on the market, they may be taken by millions of people. So extremely rare side effects or side effects that only show up among groups that were screened out of the clinical trials. For some reason like those can show

[D]

up afterwards in terms of oral contraceptives. After Anovid's approval, other drug makers soon submitted their own new drug applications. Within five years, seven different drug companies had an approved oral contraceptive in the US all of which contained estrogen and a progestin. The Pill became the most widely used contraceptive in the US and it made its way to other countries as well.

[A]

A lot went into this rapid and widespread, although definitely not universal, acceptance of the pillar. Drug manufacturers advertised directly to doctors, both through in person visits from sales reps and through advertisements in medical literature. Doctors liked that the Pill was easier to prescribe and to use than something like a diaphragm. Doctors also saw a financial benefit, since patients were supposed to have an office visit every six months to get their prescriptions renewed. People also got around that whole requirement that they were only supposed to be on the Pill for a maximum of two years by either switching doctors or switching brands.

[D]

There were advertisements aimed at consumers as well, and newspapers and magazines covered the Pill's debut with a lot of generally positive fanfare. And of course, a lot of people were just really eager for a convenient, effective, discreet way to prevent pregnancy for all kinds of reasons.

[A]

Planned Parenthood had been operating birth control clinics and advocating for birth control to be legalized for decades. At this point, they worked out a deal with Searle to purchase pills directly from the company rather than having to go through distributors. They did this to cut costs and to make the Pill more affordable for people with lower incomes. By the end of 1961, almost 90% of Planned Parenthood clinics were offering the Pill.

[D]

But it didn't take long before people started reporting a lot of side effects, like new or worsening migraines, nausea, depression, water retention, weight gain, spotting and breakthrough bleeding, breast tenderness, reduced sex drive and reduced fertility after stopping the pill.

[A]

And by 1961, doctors were also starting to report serious and even life threatening potential issues, including blood clots, heart attacks and strokes that were brought on by both clots and by high blood pressure. A report on fatal clots in Britain was published in the Lancet in 1961. But it wasn't completely clear whether those clots had actually been caused by the Pill.

[D]

As other reports of clotting issues and other serious side effects started to come in, G.D. searle Co. Arranged a one day conference in 1962 to review all the evidence. At that point, an estimated 1 million people were taking Inovid and there had been 28 documented cases of blood clots, six of which had been fatal.

[A]

The assembled group at this conference unanimously approved a resolution that called for more research into this issue. But the vast majority also felt that the available data didn't indicate a causal relationship between the Pill and the clots. And the FDA maintained that the rate of serious adverse reactions Translated to about 1.3 out of 100,000 users. And that was a lot lower than the rate of deaths from pregnancy related complications. At the time, that was almost 37 out of a hundred thousand. However, after this conference and its results were publicized, there were 132 more cases of blood clotting issues that were reported in just about a month. These were probably not clots that happened just then, but people hadn't realized there might be a connection. So after it was reported, they started realizing that there might be.

[D]

As this was happening, news broke that the sedative thalidomide, which had been prescribed as a treatment for morning sickness, had caused a range of illnesses and disabilities in babies who were exposed to it in utero. We covered this medical disaster in August of 2019. The news about thalidomide temporarily overshadowed the growing safety concerns about the Pill, but it also led to much tighter restrictions on drug testing and safety afterwards.

[A]

This was also happening at the same time as a generally increased scrutiny into chemicals and environmental pollutants and other issues and what effect they might have on the human body. For example, Rachel Carson's Silent Spring, which included a chapter on things like pesticide poisonings and a connection between pesticides and cancer that came out in 1962.

[D]

That book is one we've had a lot of requests to cover. It's a tricky one because it covers a lot of different territory.

[A]

Yeah, yeah. The potential Health connections is just one chapter of a longer book. Yeah.

[D]

Through the early to mid-60s, there was more research into whether the Pill was causing blood clots and other serious health problems. But a lot of it was really contradictory. The FDA formed an ad hoc committee to investigate the pill in 1963, which ultimately found no increased risks for issues like blood clots. In other studies, findings disagreed with one another, and published research often concluded mostly that more research was needed. There were also a lot of questions about whether the Pill could increase the risk of cancer. But because cancers can take a long time to develop, it wasn't possible to even really study that. Yet.

[A]

In November of 1965, a report came out that advised the further study into whether the Pill was causing neuro ophthalmologic issues. The FDA advised drug manufacturers to add eye problems to the list of contraindications that was provided to doctors and pharmacists when they were prescribing and dispensing the pill.

[D]

The FDA's Advisory Committee on Obstetrics and Gynecology formed four task forces to do more research into the Pill. One on thromboembolic disease, one on carcinogenic potential, one on endocrine and metabolic effects, and one on efficacy. But the report it issued in 1966 once again mostly called for more research, describing a lot of results as inconclusive and acknowledging that it was simply too soon to know whether contraceptives taken now would have an impact on someone's body 30 years down the road. There were also lots of unanswered questions about whether demographic groups that were more likely to be on the pillar were predisposed to various potential side effects or not.

[A]

Compounding all of this was the fact that the medical community as a whole was debating exactly how to weigh the Pill's risks and benefits. All drugs have side effects, but before the Pill was introduced, virtually all the prescription drugs on the market were meant to treat a specific illness or condition. Questions of whether a drug was seen safe enough were also connected to how serious that condition was and what it would take to treat it. Although birth control was sometimes being prescribed to treat things like painful or irregular periods, in a lot of cases the patient was young and healthy and just wanted to prevent pregnancy. So it just left this big question. What was an appropriate level of risk for a young, healthy person who wanted to prevent pregnancy for years or even decades?

[D]

Meanwhile, the news media was generally interpreting no conclusive evidence to mean that there's not a problem. So even though doctors and researchers had been reporting at least the possibility of serious issues for six years, reporting on the Pill in the mainstream press continued to be pretty positive.

[A]

In April of 1967, the tone of all this started to shift. More reports started to suggest a definitive link between the Pill and blood clots. In May of 1967, the British Medical Journal printed the results of a study that found that 50 out of 100,000 oral contraceptive users would be hospitalized for thromboembolism every year. That was 10 times higher than the rate of hospitalizations among people who were not on the Pill.

[D]

This report showed a similar dramatic disparity in death rates for people between the ages of 20 and 34. 1.5 per 100,000 pill users would die of complications from a thromboembolism among non users, that number was only 0.2. And for pill users between the ages of 35 and 44, the death rate was 3.9 per 100,000 users, but it was only 0.5 per 100,000 non users.

[A]

So this seemed pretty clear. But this report only led to more debate, with doctors and pharmaceutical companies arguing about whether the study was accurate or whether it had been correctly designed. But news reporting on the Pill started to become a lot more critical. There's a lot more first person testimony from people who had been harmed, like patients who had experienced blood clots or family members whose loved one had died. There was also just a lot more reporting on the more vague and inconvenient problems that were associated with the Pill, like breast tenderness, spotting and nausea.

[D]

By 1969, the medical community was increasingly recognizing a clear connection between the Pill and blood clots. It was also clear that the Pill was causing some kind of metabolic effects, although it really wasn't yet clear what those were. And they still really didn't know whether the Pill increased the risk of various cancers.

[A]

But then individual doctors were all over the place and how much they knew about this and how it affected their work with their patients. Communication about these issues within the medical community was just not very robust. A lot of the studies that suggested the strongest connection between the Pill in a specific problem, a lot of those were printed in specialist journals. So for example, papers about blood clots in the eye were being printed in journals of ophthalmology. General practitioners and gynecologists who were likely to be prescribing the Pill to their patients weren't necessarily reading these particular journals. Gps often found about really concerning studies only after they were picked up and reported on by mainstream news outlets.

[D]

And as a trend, doctors often weren't talking to their patients about risks at all. If you wanted oral contraceptives, you went to your doctor and asked for them. And a lot of the time you just got a prescription with no discussion about the Pill's potential side effects or whether you had any kind of illness or condition that might make you more prone to those side effects.

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[A]

In 1969, journalist Barbara Seaman published the Doctor's Case against the Pill. It documented numerous accounts of serious problems that were associated with the pill. Although some of these connections were anecdotal and were later disproven, a lot of the book documented side effects, effects that were well known, but which patients were not being informed of before taking the pill. Seaman was particularly driven by the idea that patients had a right to be informed of the risks that were involved in any drug or other medical treatment that they took. Her aunt had actually died of a uterine cancer that was connected to high estrogen levels in a hormone replacement therapy that she was taking, and then her son had also nearly died as a baby because she had been prescribed a laxative that was passed to him through her breast milk.

[D]

On September 23, 1969, Seaman wrote to US Senator Gaylord Nelson of Wisconsin. Her letter read in part, quote, I wish you would seek out 10 randomly selected women who have been on the pill for any length of time and ask them whether they have had any other medications to control pill side effects. You may be amazed, as I was, to find that a high proportion 6 or 7 out of 10 have had to take other powerful medications to counteract pill side effects. These include diuretics to control bloating, painkillers for headaches, etc. Anti nausea preparations, tranquilizers for nerves, pep pills for lethargy, and perhaps most alarmingly, anticoagulants. Some doctors appear to be handing these out for any suspicious swelling in a pill user, not just for established clots.

[A]

She also wrote, quote, never before in history have so many millions of people taken such a powerful and unnecessary drug.

[D]

Nelson read Siemens book. He was on the Senate subcommittee on Monopoly, which was under the select committee on small Business, and he was conducting hearings into the pharmaceutical industry. On December 22, 1969, he announced that the committee would hold hearings into the safety of oral contraceptives.

[A]

These hearings started on January 14, 1970, and they lasted into March. On the first day, Nelson gave a statement that said, in part, the aims of these hearings are to present for the general public's benefit the best and most objective information available about these drugs. First, whether they are dangerous for the human body, and second, whether patients taking them have sufficient information about the possible dangers in order to make an intelligent judgment whether they wish to assume the risk.

[D]

Many of the people who were invited to testify were people who had been featured in Seaman's book. Most were doctors, biologists, physiologists, professors of medicine and other experts of the pill's original co developers. Dr. John Rock was still living but was not invited to testify. And many of the people who did speak were deeply critical of the pill. Enough that senator Bob Dole of Kansas criticized the hearings as unbalanced.

[A]

In general, the criticisms made at these hearings were about purported problems being caused by the pill itself, not about the FDA approval process that had led to its being made available because of the thalidomide disaster. The process for that in 1970 was much different than it had been 10 years earlier. So picking apart the pill's development and testing process did not seem quite as relevant.

[D]

A key figure and the first person to testify was Dr. Hugh J. Davis, who taught obstetrics and gynecology at Johns Hopkins. Davis described oral contraceptives as an experiment that was being carried out on millions of healthy women. He argued that the synthetic hormones being used in contraceptives were carcinogens in various animals and that he was certain that would also be true of humans. He also described them as causing metabolic problems and criticized the pharmaceutical industry for trying to protect their own profits instead of finding safer options.

[A]

However, Davis had an enormous conflict of interest here. He was developing an intrauterine device that would, in his opinion, be a much safer option than oral hormones were. He thought this was going to be a completely effective method of contraception that had no side effects. So even though he said he didn't have any conflicts of interests, it was in his personal and financial interest if people stopped trusting the pill and started looking for other forms of birth control.

[D]

And we should also note that IUD was the Dalkon Shield, which hit the market in 1971. The Dalkon Shield was associated with at least 18 deaths and more than 200,000 infections, miscarriages and other serious problems because its multifilament string could draw bacteria into the uterus. AH Robins sold 2.8 million of them before it stopped making them in 1974, although it didn't actually recall them for another decade and covered up what was going on. More than 300,000 lawsuits were filed against A.H. robin's company, which ultimately filed for bankruptcy in 1985.

[A]

Yeah, they were still telling people who had these inserted that they needed to go to the doctor to have them removed recently enough for me to remember seeing news reports about it when I was a kid.

[D]

Same.

[A]

Yeah. In addition to that, like, I, a member of my extended family actually had a stroke from her birth control pills before I was born. So it's like multiple overlapping aspects of this episode have, like a personal connection for me. Back to the Senate hearings. Though only 4 of the people who testified at these hearings were women, the first woman to testify was Dr. Elizabeth Connell. That was on February 24th, which was well into the hearings themselves. The only woman to testify that she personally had used the pill was Dr. Mary E. Lane, who was clinical director of the Contraception Service at Margaret Sanger Research Bureau.

[D]

Of course, the fact that an all male Senate committee was holding hearings into birth control without involving many women and without inviting women who were directly affected by the pill to testify made people angry. On January 23, protesters interrupted the testimony of Philip Korfman, director of the center for Population Research at the National Institutes of Health. They were Members of the feminist group DC Women's Liberation, led by Alice Wolfson.

[A]

In general, Wolfson and the other women agreed with the basics of what Korfman was saying, which was that oral contraceptives caused all kinds of effects throughout the body and that these effects were poorly understood, that women were not being told about them. But they objected to the fact that everyone who had testified at that point was a man and that women whose experiences had been covered in Seaman's book, Seaman herself, none of them were being included.

[D]

DC Women's Collective also distributed flyers to the hearing's attendees with questions that echoed what they shouted during the proceedings. These flyers read, why are no women testifying? Why are no women on the subcommittee? Why is the profitable relationship between doctors and drug companies whitewashed by the press? And in these hearings? Why isn't there a mail pill? Why are contraception and medicine profit making industries rather than free public services? Why are drug companies deliberately withholding available information on side effects? Why is our government's solution to world hunger to control population rather than the redistribution of resources? Why are these hearings not discussing the issue of abortion on demand? What kind of reparations will be made by the white male medical establishment to women who have been used as guinea pigs in this mass experiment?

[A]

Nelson cleared the room after this disruption and then only allowed the press back in when the committee reconvened. His treatment of these women and his discussions of them during the hearings and afterward, that that was pretty dismissive and patronizing, including calling them girls and lecturing them about appropriate behavior.

[D]

These hearings really didn't uncover any new information about oral contraceptives. Most of the testimony repeated details that had already been published in journals or in Seaman's book. And they didn't really answer the questions of whether the risks of blood clots and other potential health issues outweighed the pill's benefits. But they made it abundantly clear that people were not being informed of these risks.

[A]

Yeah, like a lot of this had been documented, but people didn't know until they heard about it in these hearings. And this had a dramatic impact on the pill itself and on its acceptance. Initially, these hearings were expected to take place over five days. All three major American TV networks covered at least four of those five days. And according to a Gallup poll that was released shortly after that, about 87% of women in the US who were between the ages of 21 and 45 had heard or read about the hearings. And two thirds of the women polled said their doctor had never informed them of the risks. That that were associated with the Pill.

[D]

After these hearings, the number of people taking the pill dropped Sharply, with about 18% of people who had been taking them stopping and another roughly 23% considering it. In the months after the hearings, doctors reported an uptick in unexpected pregnancies.

[A]

In the wake of these hearings and this growing body of information about the dangers that were associated with the pillar, pharmaceutical companies lowered the amount of hormones in their contraceptives dramatically. The first formulation of Inovid contained 10,000 micrograms of progestin and 150 micrograms of estrogen. Today, a low dose contraceptive pill is more like between 50 and 150 micrograms of progestin and between 20 and 50 micrograms of estrogen. There's a lot of different formulations. They can vary pretty significantly in exactly what dosages of what are in there, but that is a lot less. This decrease also led to a reduction in the occurrence of blood clots. Today the FDA estimates that for every 10,000 people on oral contraceptives, between three and nine will develop a blood clot every year.

[D]

These hearings also led to the inclusion of the patient package insert that is required in birth control pills and other medications in the US today. The first proposed draft of this insert was a 600 word piece called what you should know about birth control pills. It went over the risk of blood clots and noted that anyone who had a history of clots, serious liver disease, breast cancer, certain other cancers, or unexplained vaginal bleeding should not take the pill. It also noted that anyone with kidney disease, asthma, high blood pressure, diabetes, epilepsy, uterine fibroids and migraines should take it only, only with special medical supervision. It listed possible reactions and noted that while these hormones had caused cancer in animals, there was no proof that they did in humans. It then read, quote, because your doctor knows this, he will want to examine you regularly.

[A]

Okay, that last sentence. That's one of many assumptions that this pamphlet made about the doctor patient relationship. It assumed that the doctor was male and it said things like, your doctor has taken your medical history and has given you a careful physical examination. He has discussed with you the risks of oral contraceptives and has decided that you can take this drug safely. Of course, that is something a pre printed piece of paper had no way of actually knowing.

[D]

The American Medical association opposed this insert, saying it would undermine relationships between doctors and patients. Drug companies were also opposed and the Pharmaceutical Manufacturers association submitted a list of objections in June of 1970. The FDA ultimately decided on a much shorter information card that described the risk of blood clots as the most serious known side effect. It was only seven sentences long, about half of which explained that patients could get a copy of the longer piece from their doctor. This made oral contraceptives the first drug in the US to come with a warning meant for consumers.

[A]

Yeah, there were warnings before this point, but they were for the doctors and the pharmacists, not for the people actually taking the drug. D.C. women's Liberation and other feminist groups protested the watering down of this statement, which, to be clear, was kind of a mixed bag in the first place. They sat in at the office of Health, Education and Welfare Secretary Robert Finch. They met with officials. They petitioned to reinstate the longer and stronger version of that warning, but that nothing changed at that point. Between 1970 and 1975, there were about 10 million prescriptions written for the pill, but only about 4 million copies of that longer informational statement were distributed. A more thorough pill insert with all the information actually on it became mandatory in birth control pills in 1978. And in 1980, the FDA mandated that this had to be understandable to the average consumer. I don't know if it's a hundred percent understandable to average consumers now because I know every time I've gotten a package of birth control pills, it's been like very thin paper with tiny, tiny type on it and a whole lot on there.

[D]

Yeah, it's like a small novelette. Yeah, yeah, I agree. I mean, I haven't seen one in a long time, but last time I did.

[A]

Yeah, we, we might talk about that more in the behind the scenes.

[D]

In addition to the patient packet insert. The pill hearings and the overall debate over oral contraceptives had a huge impact on the consumer health movement, especially as it related to women. In 1975, Seaman Wolfson and three other activists founded the National Women's Health Network. You'll see that listed as nwhn, and that still exists today. And it combines lobbying, activism and education.

[A]

Yeah, this was. It was part of a much bigger movement that was about, like, consumer education and informed consent and people having the right to know what the potential side effects are of any drug that they're taking today. To just circle back to Gaylord Nelson for a minute. He is not best known for these pill hearings. He's best known as the founder of Earth Day, which he also did in 1970. So that's kind of the story of how we got to this point that you're supposed to be informed of the risks of things of drugs that you take before you actually take them, which hopefully we will understand better whether these like what exactly these very rare risks with the vaccines may be and how best to tell people about them. Thanks so much for joining us on this Saturday. If you'd like to send us a note, our email address is historypodcastradio.com and you can subscribe to the show on the iHeartRadio app, Apple Podcasts, or wherever you listen to your favorite shows.

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