SYMHC Classics: Nelson Pill Hearings

This 2021 episode shares how in the U.S., the idea that people should know about the risks involved with the drugs that they are taking is tied directly to the complicated and often troubling history of oral contraceptives. 

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Episode Transcript

Speaker 1 (00:02):
Happy Saturday. Since the Nelson pill hearings got a brief
mention in this week's episode on iud's we are bringing
it out as Today's Saturday Classic. We recorded this episode
in twenty twenty one, wild Times after announcements that various
countries were pausing the use of COVID nineteen vaccines made
by Astrozenica and Johnson and Johnson due to concerns about

(00:25):
a clotting disorder. This disorder was real, but also very rare,
affecting roughly one out of every two hundred thousand people
who received the vaccine. Those pauses were ultimately lifted and
the vaccines were used by millions of people, although both
companies eventually stopped producing them. In February of twenty twenty six,

(00:46):
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 Adena virus as a vector, and
natural EDEENA virus infections can also cause this same reaction

(01:08):
in people who have that specific combination of factors. This
episode originally came out May fifth, twenty twenty one. Enjoy
Welcome to Stuff You Missed in History Class, a production
of iHeartRadio. Hello, and Welcome to the podcast. I'm Tracy B.

(01:34):
Wilson and I'm Holly Frye. 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, or 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.

(01:57):
When I research today's topic, though, we were hearing a
lot about extremely rare clotting disorders that are potentially linked
to the astrosenica 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,

(02:21):
with the tone kind of being like, there's a bigger
risk for blood clots from birth control and nobody cares
about that, or like, and women just deal with it.
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.

(02:43):
And we're not gonna get in the weeds because we're
not doctors and this is non 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 very differently in different parts of the circulatory system. Also,

(03:04):
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

(03:27):
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 healthcare
provider about the risks and the benefits. There are a
lot of reasons that might not happen, though, and I

(03:48):
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 real 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

(04:09):
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

(04:31):
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. So the first oral contraceptive was called a
novid and it was brought to market in the United
States in nineteen fifty seven. At first, it was only
approved for treating menstrual disorders, but researchers knew that it

(04:54):
prevented ovulation, thus that it prevented pregnancy temporary infertility as
a known side effect. It's likely that many of the
roughly five hundred thousand people who took a novid between
nineteen fifty seven and nineteen sixty were taking it for
that so called side effect, either in addition to or
instead of treating something like irregular menstrual cycles or endometriosis.

(05:18):
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

(05:41):
team that was developing the pill included gayecologist John Rock
and reproductive physiologist Grigory Pinkus, 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, So

(06:04):
the trials had to be carried out somewhere else, and
the location that Rock and Pinkus chose for some of
this work was Puerto Rico. Rock and pink has 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. However,

(06:25):
the reasons for all of that were tied to the
eugenics movement and to an effort led by US 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,

(06:45):
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 were
about to undergo was permanent. Another rationale for selecting Puerto
Rico for these trials was racist and paternalistic, stereotyping Puerto

(07:09):
Ricans as ignorant and uneducated. So basically, if they could
successfully use the pill then anyone could 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

(07:31):
they were taking part in a clinical trial. The trials
conducted in Puerto Rico and elsewhere confirmed that and novid
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, seventeen percent of the trial
participants reported things like headaches, dizziness, nausea, and vomiting. Twenty

(07:55):
five of two hundred and twenty one participants ultimately withdrew
from the study because of these issues. Three women died,
but no post mortem exams were conducted, so it wasn't
clear whether their deaths were caused by the pill or not.
Medical personnel who were monitoring these trials were really focused
on the possibility of several specific possible issues, cancer, damage

(08:19):
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,
doctor Edris Rice Ray, who was in charge of the trial,
wrote that the pill quote causes too many side reactions

(08:41):
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. 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 GD Seerle and Company

(09:04):
applied for FDA approval for a ovid as a contraceptive,
it included data on eight hundred ninety seven patients who
had taken ten milligram doses of the drug and nine
hundred ninety five who had taken a five milligram dose.
News reports later glommed onto the number of one hundred
and thirty two number had come up in some senate hearings.

(09:27):
That was the number of patients who had taken the
drug continuously for a year or more. But really the
documentation that Searles submitted as part of this approval process
was at the time, the largest package the FDA had
ever received. There were twenty volumes of data from trials
that had been conducted in Puerto Rico, Haiti, Los Angeles,

(09:49):
and Massachusetts that was earlier research into safety. It was
not the contraceptive ficc is part of that trial. The
FDA also polled seventy obgyns about their opinions on the
pill's safety. At the same time, the FDA recognized that
the pill had not existed long enough to be certain

(10:09):
of long term effects it might cause, so when it
approved anovid's use as a contraceptive, the FDA required that
patients be prescribed the pill for no more than two years.
The FDA approved innovid as a contraceptive on June twenty third,
nineteen sixty, and its popularity spread really rapidly. We will

(10:30):
talk about that more after a sponsor break. As we've established,
the clinical trials on enovid would not have met today's standards,
but even if they had, there almost certainly would have

(10:52):
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

(11:13):
screened out of the clinical trials for some reason, like
those can show up afterward. In terms of oral contraceptives,
after a novid'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

(11:36):
the most widely used contraceptive in the US, and it
made its way to other countries as well. A lot
went into this rapid and widespread, although definitely not universal,
acceptance of the pill. 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

(12:00):
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

(12:20):
or switching brands. There were advertisements aimed at consumers as well,
and newspapers and magazines covered the pills debut with a
lot of generally positive fanfare, And of course, a lot
of people were just really eager for a convenient, effective,
discrete way to prevent pregnancy for all kinds of reasons.
Planned Parenthood had been operating birth control clinics and advocating

(12:44):
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 nineteen sixty one, almost ninety percent of Planned
Parenthood clinics were offering the pill. But it didn't take

(13:07):
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, and by nineteen sixty one,
Doctors were also starting to report serious and even life

(13:30):
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 nineteen sixty one, but it
wasn't completely clear whether those clots had actually been caused
by the pill. As other reports of clotting issues and

(13:53):
other serious side effects started to come in, gd Serling
Company arranged a one day conference in nineteen six to
review all the evidence. At that point, an estimated one
million people were taking in NOVID and there had been
twenty eight documented cases of blood clots, six of which
had been fatal. The assembled group at this conference unanimously

(14:15):
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 one point three out of one
hundred thousand users, and that was a lot lower than

(14:38):
the rate of deaths from pregnancy related complications at the time.
That was almost thirty seven out of one hundred thousand. However,
after this conference and its results were publicized, there were
one hundred and thirty two more cases of blood clotting
issues that were reported in just amount of month. These
were probably not clots that happened just then, but people

(15:00):
hadn't realized there might be a connection, so after it
was reported, they started realizing that there might be. As
this was happening, news broke that the sedative solidamide, 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 twenty nineteen. The news about solidimide

(15:25):
temporarily overshadowed the growing safety concerns about the pill, but
it also led to much tighter restrictions on drug testing
and safety afterward. 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,

(15:49):
which included a chapter on things like pesticide poisonings and
a connection between pesticides and cancer that came out in
nineteen sixty two. That book is when we've had a
lot of request to cover. It's a tricky one because
it covers a lot of different territory. Yeah. Yeah, the
potential health connections is just one chapter of a longer book. Yeah.

(16:11):
Through the early to mid sixties, 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 nineteen sixty three, which ultimately found no increased
risks for issues like blood clots. In other studies, findings

(16:32):
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.
In November of nineteen sixty five, a report came out

(16:53):
that advised further study into whether the pill was causing
neurooptimologic issues. 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.
The FDA's Advisory Committee on Obstetrics and Gynecology formed four

(17:15):
task forces to do more research into the pill, one
on thrombo embolic disease, one on carcinogenic potential, one on
endocrine and metabolic effects, and one on efficacy. But the
report it issued in nineteen sixty six once again mostly
called for more research, describing a lot of results as
quote inconclusive, and acknowledging that it was simply too soon

(17:39):
to know whether contraceptives taken now would have an impact
on someone's body thirty years down the road. There were
also lots of unanswered questions about whether demographic groups that
were more likely to be on the pill were predisposed
to various potential side effects or not. Compounding all of
this was the fact that the medical community as a

(17:59):
whole was debating exactly how to weigh the pills 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 safe enough were also
connected to how serious that condition was and what it

(18:21):
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

(18:43):
pregnancy For years or even decades. 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. In April of nineteen sixty seven,

(19:07):
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 nineteen sixty seven, the British
Medical Journal printed the results of a study that found
that fifty out of one hundred thousand oral contraceptive users
would be hospitalized for thrombo embolism every year. That was

(19:31):
ten times higher than the rate of hospitalizations among people
who were not on the pill. This report showed a
similar dramatic disparity in death rates. For people between the
ages of twenty and thirty four, one point five per
one hundred thousand pill users would die of complications from
a thrombo embolism. Among non users, that number was only

(19:52):
zero point two, and for pill users between the ages
of thirty five and forty four, the death rate was
three point nine per one hundred thousand users, but it
was only zero point five per one hundred thousand non users,
So this seemed pretty clear, But this report only led
to more debate, with doctors and pharmaceutical companies arguing about

(20:15):
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 was 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

(20:35):
more reporting on the more vague and inconvenient problems that
were associated with the pill, like breast tenderness, spotting, and nausea.
By nineteen sixty nine, 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

(20:58):
those were, and they still really didn't know whether the
pill increased the risk of various cancers. 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

(21:19):
that suggested the strongest connection between the pill and 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

(21:44):
about really concerning studies only after they were picked up
and reported on by mainstream news outlets, 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

(22:07):
of illness or condition that might make you more prone
to those side effects. All of this came to a
head in nineteen sixty nine, which we will get to
after a sponsor break. In nineteen sixty nine, journalist Barbara

(22:28):
Seman 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 that were
well known but which patients were not being informed of

(22:48):
before taking the pill. Semen 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,

(23:09):
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. On September twenty third,
nineteen sixty nine, Seaman wrote to US Senator gay Lord
Nelson of Wisconsin. Her letter read, in part, quote, I
wish you would seek out ten randomly selected women who

(23:29):
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 six or
seven out of ten have had to take other powerful
medications to counteract pill side effects. These include diuretics to
control bloating, painkillers for headaches, et cetera, anti nausea preparations,

(23:54):
tranquilizers for nerves, pep pills for lethargy, and perhaps most
of armingly anticoagulants. Some doctors appear to be handing these
out for any suspicious swelling in a pill user, not
just for established clots. She also wrote, quote, never before
in history have so many millions of people taken such

(24:16):
a powerful and unnecessary drug. Nelson read Seamen's 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 twenty second, nineteen
sixty nine, he announced that the Committee would hold hearings
into the safety of oral contraceptives. These hearings started on

(24:39):
January fourteenth, nineteen seventy, and they lasted into March. On
the first day, Nelson gave a statement that said, in
part quote, 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, weather patients taking them

(25:01):
have sufficient information about the possible dangers in order to
make an intelligent judgment whether they wished to assume the risks.
Many of the people who were invited to testify were
people who had been featured in Siemen's book. Most were doctors, biologists, physiologists,
professors of medicine, and other experts of the pills original

(25:22):
co developers. Doctor 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.
In general, the criticisms made at these hearings were about
purported problems being caused by the pill itself, not about

(25:44):
the FDA approval process that had led to its being
made available. Because of the thlidemide disaster, the process for
that in nineteen seventy was much different than it had
been ten years earlier, so picking apart the pills development
and testing process not seem quite as relevant. A key
figure and the first person to testify, was doctor Hugh J. Davis,

(26:06):
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

(26:30):
and criticized the pharmaceutical industry for trying to protect their
own profits instead of finding safer options. 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

(26:50):
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. And
we should also note that IUD was the Dalkon shield,

(27:10):
which hit the market in nineteen seventy one. The Dalkon
shield was associated with at least eighteen deaths and more
than two hundred thousand infections, miscarriages, and other serious problems
because its multi filament string could draw bacteria into the uterus.
Ah Robins sold two point eight million of them before
it stopped making them in nineteen seventy four, although it

(27:33):
didn't actually recall them for another decade and covered up
what was going on. More than three hundred thousand lawsuits
were filed against ah Robin's company, which ultimately filed for
bankruptcy in nineteen eighty five. 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

(27:55):
me to remember seeing news reports about it when I
was a kid, saying 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,

(28:16):
though only four of the people who testified at these
hearings were women. The first woman to testify was doctor
Elizabeth Connell. That was on February twenty fourth, which was
well into the hearings themselves. The only woman to testify
that she personally had used the pill was doctor Mary E. Laine,

(28:37):
who was clinical director of the contraception service at Margaret
Sanger Research Bureau. 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 twenty third, protesters interrupted the testimony of Philip Krph,

(29:00):
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 and General. Wolfson
and the other women agreed with the basics of what
Kaufman was saying, which was that oral contraceptives caused all
kinds of effects throughout the body, and that these effects

(29:20):
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 Seamen's book semen herself,
none of them were being included. DC Women's Collective also
distributed flyers to the hearings attendees with questions that echoed

(29:42):
what they shouted during the proceedings. These flyers read, why
are no women testifying? Why are no women on the
sub committee? Why is the profitable relationship between doctors and
drug companies whitewashed by the press and in these hearings.
Why isn't there a male pill? Why higher contraception and
medicine profit making industries rather than free public services. Why

(30:06):
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

(30:28):
pigs in this mass experiment. 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
was pretty dismissive and patronizing, including calling them girls and

(30:49):
lecturing them about appropriate behavior. These hearings really didn't uncover
any new information about oral contraceptives. Most of the testimony
repeated to tis that had already been published in journals
or in Semen'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

(31:11):
it abundantly clear that people were not being informed of
these risks now like a lot of those 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

(31:35):
American TV networks covered at least four of those five days,
and according to a Gallup poll that was released shortly
after that, about eighty seven percent of women in the
US who were between the ages of twenty one and
forty five had heard or read about the hearings, and
two thirds of the women polled said their doctor had

(31:55):
never informed them of the risks that were associated with
the pill. After these hearings, the number of people taking
the pill dropped sharply, with about eighteen percent of people
who had been taking them stopping and another roughly twenty
three percent considering it In the months after the hearings,
Doctors reported an uptick in unexpected pregnancies. In the wake

(32:17):
of these hearings and this growing body of information about
the dangers that were associated with the pill, pharmaceutical companies
lowered the amount of hormones in their contraceptives dramatically. The
first formulation of enovid contained ten thousand micrograms of progestine

(32:38):
and one hundred and fifty micrograms of estrogen. Today, a
low dose contraceptive pill is more like between fifty and
one hundred and fifty micrograms of progestine and between twenty
and fifty micrograms of estrogen. To a lot of different formulations,
they can vary pretty significantly, and exactly what dosages of
what are in there, but that is a lot less yes.

(33:01):
This decrease also led to a reduction in the occurrence
of blood clots. Today, the FDA estimates that for every
ten thousand people on oral contraceptives, between three and nine
will develop a blood clot every year. These hearings also
led to the inclusion of the patient Package insert that
is required in birth control pills and other medications in

(33:22):
the US today. The first proposed draft of this insert
was a six hundred 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

(33:44):
also noted that anyone with kidney disease, asthma, high blood pressure, diabetes, epilepsy,
uterine fibroids, and migraines should take it 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,

(34:05):
because your doctor knows this, he will want to examine
you regularly 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

(34:29):
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. The American Medical Association opposed this insert,
saying it would undermine relationships between doctors and patients. Drug

(34:50):
companies were also opposed, and the Pharmaceutical Manufacturers Association submitted
a list of objections in June of nineteen seventy. The
FDA ultimately sided on a much shorter information card that
described the risk of blood clots as quote the most
serious known side effect. It was only seven sentences long,

(35:10):
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. Yeah, there were warnings
before this point, but they were for the doctors and
the pharmacists, not for the people actually taking the drug.

(35:31):
DC 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

(35:52):
nothing changed at that point. Between nineteen seventy and nineteen
seventy five, there were about ten million prescriptions written for
the pill, but only about four million copies of that
longer informational statement were distributed. A more thorough pill insert
with all the information actually on it, became mandatory in

(36:13):
birth control pills in nineteen seventy eight, and in nineteen
eighty the FDA mandated that this had to be understandable
to the average consumer. I don't know if it's one
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

(36:33):
on it and a whole lot on there. 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. Yeah, we we might talk about that
more behind the scenes. 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

(36:57):
as it related to women. In nineteen seventy five, i've
Seamen Wolfson and three other activists founded the National Women's
Health Network. You'll see that listed as nw HN, and
that still exists today and it combines lobbying, activism, and education. Yeah,
this was it was part of a much bigger movement
that was about like consumer education and informed consent and

(37:19):
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 nineteen seventy. So that's that's kind of the

(37:39):
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

(38:04):
for joining us on this Saturday. If you'd like to
send us a note, our email addresses History Podcast at
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