Speaker 1: Welcome to Stuff You Missed in History Class, a production
Speaker 1: of I Heart Radios How Stuff Works. Hello, and welcome
Speaker 1: to the podcast. I'm Tracy V. Wilson and I'm Holly Fry.
Speaker 1: We have gotten a lot of requests over the years
Speaker 1: to talk about the drug the litamide, including from Ginger Cheyenne, Emily, Brittany, Randy, Rebecca, Hannah, Tricia,
Speaker 1: Jackie and Terrell. And we've had some spikes in those
Speaker 1: requestsed a couple of different points, including when this was
Speaker 1: a plot line on the TV show called The Midwife.
Speaker 1: We got some rite in a row over the last
Speaker 1: couple of weeks. Uh. This has been described as the
Speaker 1: biggest man made medical disaster of all time. From ninety
Speaker 1: seven to nineteen sixty two, the litamide was marketed as
Speaker 1: being completely safe and it was used as a treatment
Speaker 1: for morning sickness, but it was not safe. At least
Speaker 1: ten thousand people who were exposed to the litamide in
Speaker 1: the womb were born with a ring as of disabilities
Speaker 1: and medical conditions, and about forty percent of them didn't
Speaker 1: survive infancy, and the drug also caused a really unknown
Speaker 1: number of miscarriages and still births, possibly tens of thousands more.
Speaker 1: A lot of the people who've asked us about this
Speaker 1: episode have framed it in the context of babies, but
Speaker 1: there are thousands of adults living today who were harmed
Speaker 1: by this drug many parts of the world. They refer
Speaker 1: to themselves as the Litta miters. As of when we're
Speaker 1: recording this in twenty nineteen, most of these folks are
Speaker 1: in their late fifties and early sixties, although as we
Speaker 1: will discuss, there are also people who are a lot
Speaker 1: younger than that. So people who weren't personally affected by
Speaker 1: this might imagine this story as something that sort of
Speaker 1: is confined back in the past, but it's really a
Speaker 1: story that's ongoing until today, and it's also a long
Speaker 1: enough story that we're covering it in two parts. So
Speaker 1: today we're going to talk about what the litamide is,
Speaker 1: the animal testing that let its manufacturer to market it
Speaker 1: as safe and it's released onto the market. Next time
Speaker 1: we will be talking more about its aftermath and how
Speaker 1: it affected everything from drug regulations to abortion law. Um
Speaker 1: there is some disability rights stuff along the way that
Speaker 1: it's pretty appalling in terms of how people were treated,
Speaker 1: and that's going to apply really to both episodes. Yeah,
Speaker 1: obviously not a lighthearted rump today. Just heads up, as
Speaker 1: if you had not gleaned to that already from Tracy's introme. So,
Speaker 1: the letta mine is a taradogen, which means it's something
Speaker 1: that disrupts development, and taradogens can affect any stage of development,
Speaker 1: but the term is frequently used to describe things that
Speaker 1: negatively affect the development of an embryo or fetus, including
Speaker 1: causing miscarriage. And lots of things can act as taradogens,
Speaker 1: including hyperthermia, infectious disease, environmental pollutants, and alcohol. Pharmaceuticals can
Speaker 1: also have the potential to act as taradogens. Many countries
Speaker 1: have some kind of a system now for categorizing the
Speaker 1: level of risk and whether the dry is recommended for
Speaker 1: use during pregnancy. So in the US, for example, these
Speaker 1: categories range from A, in which the risk to a
Speaker 1: fetus seems to be remote to category X, in which
Speaker 1: the drugs risks during a pregnancy outweigh any possible benefits. Today,
Speaker 1: drugs that fall into category X or otherwise have serious
Speaker 1: teratgenic effects are typically only used with a range of
Speaker 1: safety precautions in place. Patients who could become pregnant may
Speaker 1: need to have a negative pregnancy test before they start treatment,
Speaker 1: and they may also be required to use multiple forms
Speaker 1: of birth control and be tested for pregnancy while they're
Speaker 1: being treated. Since f d A, drug labeling rules in
Speaker 1: the United States have required a section called quote Females
Speaker 1: and Males of Reproductive Potential and that details these recommendations
Speaker 1: along with whether the drug has been shown to cause infertility. Yeah,
Speaker 1: the exact rules and laws obviously vary all over the world,
Speaker 1: but even with these types of precautions, it's still possible
Speaker 1: for a drug that's known to have these kinds of
Speaker 1: effects to harm a developing fetus. A doctor might not
Speaker 1: communicate the risks clearly enough for a patient might not
Speaker 1: fully understand them, or contraceptives could fail for a variety
Speaker 1: of reasons. Especially in places that don't have a robust
Speaker 1: medical system, patients might share their medications with each other
Speaker 1: without fully understanding the risks involved, and especially because these
Speaker 1: same places don't often have the resources to really follow
Speaker 1: up and monitor patients, it's possible that babies may be
Speaker 1: born with disabilities or health effects that aren't ever reported
Speaker 1: or connected back to the drug. Even in places that
Speaker 1: do have really robust medical systems. The level of monitoring
Speaker 1: and compliance involved with this can really be a lot.
Speaker 1: Sometimes it is just not sustainable in real world conditions.
Speaker 1: But none of these steps were in place when the
Speaker 1: lita mine was developed, and no one knew about its
Speaker 1: teratogenic effects when it was first put on the market.
Speaker 1: So we're going to get into why that was in
Speaker 1: a moment, but first we're going to have an overview
Speaker 1: of the conditions and disabilities that the litamide causes in
Speaker 1: a developing fetus. So the condition that's most associated with
Speaker 1: the litamide is folk amelia, and that's when the bones
Speaker 1: and a person's limbs are shortened or missing. This usually
Speaker 1: affects the long bones and the arms and the legs,
Speaker 1: so sometimes it results in the hands or the feet
Speaker 1: being connected to the trunk of the body without a
Speaker 1: limb in between. Most of the time these effects are symmetrical,
Speaker 1: with both legs or both arms or all four limbs affected,
Speaker 1: and the arms are affected the most often with the litamide.
Speaker 1: The litamide can also cause a similar condition called amelia,
Speaker 1: or the total absence of the limb. The litamide can
Speaker 1: also affect a person's digits, including having extra or missing
Speaker 1: fingers or toes. Sometimes the size and shape of the
Speaker 1: bones can also cause the hands or feet to have
Speaker 1: a different size or shape than a typical hand or foot.
Speaker 1: The eyes and the ears can be affected as well.
Speaker 1: They might be missing completely or missing parts of their structures,
Speaker 1: and that can cause problems with a vision or hearing,
Speaker 1: as well as blindness and deafness. These are the most
Speaker 1: outwardly visible effects of the litamide exposure in utero, but
Speaker 1: the drug can also cause internal organ damage, including heart, kidney,
Speaker 1: nervous system, and g I problems, as well as damage
Speaker 1: to the reproductive organs, and sometimes this is not immediately
Speaker 1: apparent at birth, even after a medical examination, so these
Speaker 1: conditions are then discovered later in life. People who are
Speaker 1: exposed to the litamide before birth also have higher rates
Speaker 1: of cognitive disabilities and epilepsy. Altogether, these and other effects
Speaker 1: of the litamite exposure in the womb are known as
Speaker 1: the litamide embryopathy or fetal the litamide syndrome. Most of
Speaker 1: the research into the litamides effects was conducted on infants
Speaker 1: in the nineteen sixties, and there hasn't been nearly as
Speaker 1: much follow up from the medical community as people have
Speaker 1: grown own and aged, so it's really possible that there
Speaker 1: are other delayed effects that haven't been widely studied or
Speaker 1: traced back to the litamide. One exception is whether the
Speaker 1: litamides effects can be passed down to a person's children,
Speaker 1: and the litamized effects don't appear to be inheritable. These
Speaker 1: are a lot of different effects for one drug to cause,
Speaker 1: and many people have several of them, and that's largely
Speaker 1: tied to exactly when during the pregnancy that the litamite
Speaker 1: exposure happened and what was developing within the embryo or
Speaker 1: fetus at that time. The litamides effects tend to be
Speaker 1: the most severe between twenty and thirty six days after conception.
Speaker 1: At this point in pregnancy, things are moving very quickly,
Speaker 1: with lots of growing and development happening in multiple body
Speaker 1: systems all at once. Just one dose of the lidamide
Speaker 1: can disrupt all of this, causing multiple negative health effects
Speaker 1: or disabilities in at least fifty of pregnancies, and some
Speaker 1: studies suggest at that rate is actually even higher than that,
Speaker 1: and this is why the litamite it's use as a
Speaker 1: morning sickness treatment affected so many people. So dramatically. Morning
Speaker 1: sickness occurs in about sevent pregnancies, and it can happen
Speaker 1: at any time of the day and at any point
Speaker 1: during the pregnancy, but it's really the most common in
Speaker 1: the first trimester. It's usually the worst from four to
Speaker 1: seven weeks after conception, and that largely overlaps with the
Speaker 1: window when the lidamides effects are also the most severe
Speaker 1: and affect the most parts of the body. So we're
Speaker 1: going to talk about how Solida Mine made it to
Speaker 1: market without anyone discovering any of this after we first
Speaker 1: pause for a sponsor break. Internationally, the pharmaceutical industry really
Speaker 1: expanded dramatically after the end of World War two. People
Speaker 1: needed treatments for illnesses and injuries that had resulted from
Speaker 1: the war. Multiple countries had started establishing national health care
Speaker 1: systems in the decades that we're leading up to the
Speaker 1: war and then afterward, and that led to more demand
Speaker 1: for medicines overall. There were also breakthroughs and various types
Speaker 1: of medicines, including antibiotics and anti anxiety medications, and those
Speaker 1: had also led pharmaceutical companies to develop new drugs very
Speaker 1: aggressively to try to compete sedatives in particular, became incredibly
Speaker 1: popular as a newly developed class of drugs. The sedative
Speaker 1: known as Milltown was launched in nineteen fifty five, and
Speaker 1: it quickly became the best selling drug in the United States.
Speaker 1: Drug manufacturers around the world we're trying to break into
Speaker 1: this fast growing segment of the drug market, hoping for
Speaker 1: a similar success of their own. West German pharmaceutical company
Speaker 1: Shami grunenthalogy mbH was founded in nineteen forty six and
Speaker 1: was one of the companies trying to rapidly develop new
Speaker 1: drugs and bring them to market. In nineteen fifty four,
Speaker 1: they synthesized the drug that would come to be known
Speaker 1: as the litamided for the first time and they applied
Speaker 1: for a patent. A paper describing the drugs pharmacological effects,
Speaker 1: including its sedative effects, was published in nineteen fifty six,
Speaker 1: and that paper, it was referred to as K seventeen,
Speaker 1: was also when Grunenthal conducted some safety tests on this
Speaker 1: new drug, and one of the tests that was conducted
Speaker 1: is called the median lethal dose or LD fifty test,
Speaker 1: and this test is conducted on lab animals and it's
Speaker 1: used to determine how much of a substance it takes
Speaker 1: for it to become deadly. The l D fifty is
Speaker 1: the amount of the substance that it takes to kill
Speaker 1: fifty of the test subjects. The LD fifty tests for
Speaker 1: the litamide were conducted on mice and they suggested that
Speaker 1: there was no dose, no matter how high, that would
Speaker 1: be lethal and fifty percent of the subjects. Everyone thought
Speaker 1: this was amazing in terms of the folks developing it.
Speaker 1: It's set the litamide apart from other sedatives and sleep aids,
Speaker 1: which could be lethal at high doses, like an overdose
Speaker 1: could cause someone to die. Based on these results, Grudenthal
Speaker 1: started marketing this drug as safe and non toxic. In
Speaker 1: November of eighteen fifty six, Grunenthal began marketing a flu
Speaker 1: remedy called grip X, which combines solidamined with other substances
Speaker 1: like quinine and vitamin C. In ninety seven, it launched
Speaker 1: several versions of a drug called coundragone, which was solidimized
Speaker 1: for use as a daytime sedative or a nintime sleep aid.
Speaker 1: Grip X and coundragone were available without a prescription. The
Speaker 1: idea that you could just go to a pharmacy in
Speaker 1: nineteen fifty seven and get a sedative over the counter
Speaker 1: marketed as a sedative blows my mind just a little bit. Yeah, same,
Speaker 1: I don't I don't know what to add to there.
Speaker 1: There are plenty of drugs that have sleepiness or drowsiness
Speaker 1: as a side effect, but like, if that's in the
Speaker 1: US at least, you can't just walk up to a
Speaker 1: counter and say I would like a sedative please and
Speaker 1: get one. In many parts of the world, in the
Speaker 1: nineteen fifties, it was common for doctors to prescribe or
Speaker 1: recommend a variety of medicines of pregnant patients for the
Speaker 1: sake of their physical comfort and mental health, and this
Speaker 1: included sedatives and stimulants and other medications. The prevailing attitudes
Speaker 1: about both prescription and over the counter medicines during pregnancy
Speaker 1: was pretty cavalier compared to how it is today, and
Speaker 1: soon after Contragone hit the market, patients and doctors started
Speaker 1: reporting that it wasn't just providing RESTful sleep or a
Speaker 1: calmer mood during pregnancy, it was also treating mourning sickness.
Speaker 1: Soon doctors were recommending contragone for the off label use
Speaker 1: of mourning sickness treatment and prevention. Patients who had taken
Speaker 1: it were also recommending it to their pregnant friends and
Speaker 1: family members. I mean, people who took this drug described
Speaker 1: as being miraculous in terms of the difference that it
Speaker 1: made in the morning sickness level. But none of the
Speaker 1: tests that had been performed on solidamide before it was
Speaker 1: released were conducted on pregnant animals, and even if they
Speaker 1: had been, it turns out that mice and rats aren't
Speaker 1: susceptible to solidamide in the same way that humans and
Speaker 1: many other mammals are. Although there had been and some
Speaker 1: clinical trials, no one in them had been pregnant. Also,
Speaker 1: the clinical trials themselves were very small and not very thorough.
Speaker 1: Testing on some other sedatives at this time had involved
Speaker 1: things like examining the urine to analyze how the drug
Speaker 1: had been broken down inside the body and how much
Speaker 1: of the drug was being excreted without being broken down
Speaker 1: at all. Nothing like this was performed for the litamide.
Speaker 1: It also doesn't appear that these clinical trials were double
Speaker 1: blind or involved any kind of comparison between the drug
Speaker 1: anniple cebo. On top of that, the papers that were
Speaker 1: published to support the litamide safety and efficacy read more
Speaker 1: like doctors testimonials than research that was actually backed up
Speaker 1: by data. Vitikin Lens, who was one of the doctors
Speaker 1: who made the connection between the litamide and its teratogenic effects,
Speaker 1: later said quote the papers published in nineteen fifty six
Speaker 1: by Kun's at All on animal experiments and by Young
Speaker 1: on clinical experiences with the linamide have so little scientific
Speaker 1: value that, in my opinion, they should not have been
Speaker 1: accepted for print. In other words, all this testing was
Speaker 1: not very thorough or rigorous or well documented. Just one
Speaker 1: example of how it all fell short is that it
Speaker 1: later turned out that the reason that they could not
Speaker 1: find a lethal dose of the litamide and mice wasn't
Speaker 1: because the drug was inherently safe. It was because the
Speaker 1: mice weren't actually absorbing most of it. Different preparations of
Speaker 1: the drug that were tested later on and were more
Speaker 1: easily absorbed turned out to be highly toxic. Based on
Speaker 1: the litamide success in West Germany, Grunenthal began working on
Speaker 1: distributing it to other parts of the world. It was
Speaker 1: ultimately marketed and distributed through various other pharmaceutical companies in
Speaker 1: forty six different countries under a range of brand names,
Speaker 1: including dist of All in the UK and Australia and
Speaker 1: soften On in parts of Europe. As all of that
Speaker 1: was happening, doctors in places where the litamide was being
Speaker 1: used to treat morning sickness, we're starting to encounter babies
Speaker 1: who had a collection of health problems and disabilities that
Speaker 1: they'd never really seen before. In nineteen fifty nine, a
Speaker 1: gynecologist in Munich reported a baby born with folk amelia.
Speaker 1: There wasn't a clear connection at that time, but later
Speaker 1: on the doctor learned that the baby's mother had taken
Speaker 1: gripp X while pregnant. This wasn't actually the earliest documented
Speaker 1: case of solidamide having a teratogenic effect, That had happened
Speaker 1: back in December of nineteen fifty six, before the drug
Speaker 1: was even on the market. This case was a baby
Speaker 1: born to a Grunenthal employee and his wife, and he
Speaker 1: had been given free samples at work and their child
Speaker 1: was born without ears. That connection was not uncovered until
Speaker 1: much later. So at first doctors were reporting what they
Speaker 1: described as this strange epidemic of folk amelia, but they
Speaker 1: weren't really sure what was causing it, as that was happening, though,
Speaker 1: doctors were noticing a different pattern and adults who were
Speaker 1: taking the lidamide. As ly as April of nineteen fifty nine,
Speaker 1: pharmacists were reporting that patients were experiencing things like tingling
Speaker 1: hands and feet, or cold hands and feet, or a
Speaker 1: sense of giddiness after taking the litamide. In October of
Speaker 1: nineteen fifty nine, a doctor named Ralph Voss reported neuritis
Speaker 1: or nerve inflammation and people who had taken contragne for
Speaker 1: a year. Voss contacted Grunenthal, who told him quote, no
Speaker 1: such side effects have come to our notice. Another doctor
Speaker 1: named Horse Frankel was also working with patients that were
Speaker 1: experiencing nearitis after taking the litamine. He wrote a paper
Speaker 1: detailing twenty cases, but for unclear reasons, it wasn't printed
Speaker 1: until nineteen sixty one. Meanwhile, Voss delivered a presentation on
Speaker 1: the naritis issue on April nineteen sixty In December of
Speaker 1: that year, a letter titled is the litamide to blame
Speaker 1: was printed in the British Medical Journal. It was written
Speaker 1: by A Leslie Florence of Aberdeenshire, and it described four
Speaker 1: cases of tingling, cold extremities, leg cramps, and other side effects,
Speaker 1: and adult patients taking the lidamide, these improved, but they
Speaker 1: didn't really go away when the patients stopped taking the drug.
Speaker 1: The letter included the line quote it would appear that
Speaker 1: these symptoms could possibly be a toxic effect of the lidamide.
Speaker 1: By May of nineteen sixty one, Grudenthal had received reports
Speaker 1: of more than one thousand cases of neuritis that were
Speaker 1: connected to thelidamide. The company was forced to make the
Speaker 1: drug available only by prescription. Before that point, it had
Speaker 1: been responsible for more than half of the company's gross revenues,
Speaker 1: and it was West Germany's most popular over the counter sedative,
Speaker 1: with more than twenty million tablets sold each month. Even
Speaker 1: after these reports of neurological side effects and after it
Speaker 1: became available only by prescription, Grunenthal continued to market solidamide
Speaker 1: as completely safe, even during pregnancy. So we should note
Speaker 1: that even today, it is very common for a drug's
Speaker 1: side effects, including some very serious side effects, to be
Speaker 1: discovered after the drug is approved and out on the market,
Speaker 1: even when they're meticulously controlled and carefully planned out. Clinical
Speaker 1: trials are very small compared to the general population, and
Speaker 1: the real world has a lot of factors that might
Speaker 1: not be present in the context of a controlled study.
Speaker 1: But it's clear that Grunenthal's original testing on the litamide
Speaker 1: was not very thorough, and the company does not appear
Speaker 1: to have looked into whether all these reports of near
Speaker 1: rytis pointed to a greater problem with the drug. And
Speaker 1: in nineteen sixty one doctors started making connections between the
Speaker 1: litamide as used for morning sickness and the drugs teratogenic effects.
Speaker 1: One was the German doctor vitikin Lens who we mentioned earlier,
Speaker 1: and he had noticed the unusual increase in phok melia
Speaker 1: and other conditions that we now know as part of
Speaker 1: fetal the litamide syndrome. He went back through medical records
Speaker 1: and he found that this pattern had started very suddenly.
Speaker 1: He didn't initially know what the exact cause was, but
Speaker 1: he was confident that there was one, and that it
Speaker 1: might be some kind of chemical exposure, like an undisclosed
Speaker 1: chemical spill, or perhaps a new household product. Thousands of
Speaker 1: miles away. Dr William McBride was working at a hospital
Speaker 1: in Australia and on May fourth, nineteen sixty one, a
Speaker 1: baby was born there with both folk Amelia and bowel atresia,
Speaker 1: which is a condition in which part of the bowel
Speaker 1: is blocked are absent. Thousands of babies were born every
Speaker 1: year at the hospital, but this was the first time
Speaker 1: in its history that a baby had been born with
Speaker 1: that combination of conditions. Two more babies with folk amelia
Speaker 1: and bowel atricia were born between May fourth and June eight.
Speaker 1: McBride realized all three had been exposed to the lidamide,
Speaker 1: which had been on the market in Australia since June
Speaker 1: of nineteen sixty. On June he convinced the hospital to
Speaker 1: withdraw the litamide from use and informed the drug company Distillers,
Speaker 1: which was distributing the litamide in Australia. This was the
Speaker 1: first published letter specif typically linking the litamide to its
Speaker 1: teratogenic effects. McBride later told The New York Times that
Speaker 1: he also wrote to the company headquarters in London, but
Speaker 1: quote the reply from the medical director of the London
Speaker 1: office implied that I was utterly wrong. His high handed
Speaker 1: letter implying that I was just a colonial annoyed me.
Speaker 1: I was determined to prove I was right. The following month,
Speaker 1: Dr Hans Vicker documented twenty babies with folk amelia, five
Speaker 1: of which were known to have been exposed to the
Speaker 1: lidamide in the womb. But Viker had been told in
Speaker 1: error that the litamide was being used very widely in
Speaker 1: the US, but that the US was not experiencing the
Speaker 1: folk amelia epidemic that other countries were. He learned from
Speaker 1: Dr Lens that this was not true, and when he
Speaker 1: went back through his records specifically looking for the litamide,
Speaker 1: he confirmed its use in even more cases. After his
Speaker 1: communication with Viker, Lens called Grunenthal and was told to
Speaker 1: expect a visit from somebody in a few days. He
Speaker 1: told them that the needed attention immediately, that in a
Speaker 1: few days hundreds more people could be taking this drug
Speaker 1: for the first time. Lens also sent a registered letter
Speaker 1: to the company on November sixteenth, nineteen sixty one, detailing
Speaker 1: his concerns. Meanwhile, in Australia, drug company distillers removed the
Speaker 1: litamide from the market on November twenty one. It was
Speaker 1: only after all this that Grudenthal finally took action, pulling
Speaker 1: the litamide off the German market on November nineteen sixty one.
Speaker 1: As words spread, it was taken off the market in
Speaker 1: the UK on December two. On December sixteenth, Solidamide and
Speaker 1: Congenital Abnormalities was published in The Lancet. The lidamide was
Speaker 1: taken off the market in more countries in the weeks
Speaker 1: that followed. It was banned worldwide in nineteen sixty two,
Speaker 1: although in some places it was not formally made illegal
Speaker 1: until much later. It was only after all of this
Speaker 1: that there was any kind of formal study of the
Speaker 1: litamide and pregnant animals. Dr McBride had actually tried to
Speaker 1: do this in Australia, but he didn't really have any
Speaker 1: experience in how to perform this kind of trial or
Speaker 1: access to the lab animals that he would need to
Speaker 1: do it. The results of this study were published in
Speaker 1: a letter to The Lancet on April nineteen sixty two,
Speaker 1: showing that the litamide had similar to ratogenic effects and
Speaker 1: rabbits as it was now clear to be having in humans.
Speaker 1: We're going to talk about the aftermath of all of this,
Speaker 1: and about why the US isn't one of the countries
Speaker 1: that we have talked about so far. After we first
Speaker 1: paused for another sponsor break between nineteen fifty seven and
Speaker 1: nineteen sixty two, The litamide was sold in forty six
Speaker 1: different countries around the world, but it was never officially
Speaker 1: introduced in the United States. Richardson Meryl, the drug company,
Speaker 1: had planned to distribute the litamide in the US under
Speaker 1: the trade named Kevi Don Meryl submitted an application to
Speaker 1: the Food and Drug Administration. At that time, the US
Speaker 1: did have some laws that we're governing the drug approval process.
Speaker 1: That application was given to Dr Francis Oldham Kelsey to review.
Speaker 1: Kelsey was born on Vancouver Island in British Columbia, Canada,
Speaker 1: and she had first started studying unsafe pharmaceuticals while she
Speaker 1: was a graduate student at the University of Chicago, and
Speaker 1: there she earned both her PhD and her medical degree.
Speaker 1: At the university, Dr Eugene Galing was trying to figure
Speaker 1: out what had caused the deaths of more than one
Speaker 1: d people who had taken a drug called Elixir of
Speaker 1: Sulfonilla mine, and Kelsey was one of the graduate students
Speaker 1: who helped pinpoint the cause as a solvent that had
Speaker 1: been used to add a raspberry flavor to make the
Speaker 1: drug less bitter. Kelsey was really new to the job
Speaker 1: as a drug application reviewer at the f d A.
Speaker 1: The kevin On application was only the second one that
Speaker 1: she had been given, and in her account, it was
Speaker 1: given to her because she was new and it was
Speaker 1: supposed to be an easy one. The littamide was already
Speaker 1: being used in countries all over the world. It was
Speaker 1: regarded as completely safe, so really this process seemed like
Speaker 1: a formality. But when Kelsey started reviewing the application, sheep
Speaker 1: had some concerns about the litamne safety testing, a lot
Speaker 1: of those same problems that we talked about before, and
Speaker 1: after some back and forth with Meryl, she rejected the
Speaker 1: application on November tenth, nineteen sixty. Meryl reapplied in December.
Speaker 1: Kelsey read the letter in the British Medical Journal about
Speaker 1: neuropathy and people that had taken the lidomide, which he
Speaker 1: talked about before the break. She pushed back on Meryl,
Speaker 1: noting that a simple sleep age shouldn't be causing neuropathy
Speaker 1: and that a drug that was causing neuropathy could not
Speaker 1: be as safe and non toxic as the company was claiming.
Speaker 1: This went back and forth for weeks. At one point
Speaker 1: Kelsey met with executives from the company and, in her words, quote,
Speaker 1: I had the feeling throughout the day that they were
Speaker 1: at no time being wholly frank with me. As Kelsey
Speaker 1: continued to refuse to approve the kevidan application, more and
Speaker 1: more information was coming out about the effects that the
Speaker 1: litamide was having on the nervous systems of adults and
Speaker 1: on prenatal development. Merrill finally withdrew its application in April
Speaker 1: of nineteen sixty two, as countries were banning the litamide.
Speaker 1: President John F. Kennedy later awarded Dr Kelsey the President's
Speaker 1: Award for Distinguished Federal Civilian Service, and she was awarded
Speaker 1: numerous other honors for her work in drug safety. During
Speaker 1: her lifetime. She died, and I think so that was
Speaker 1: pretty recently. For her part, Kelsey insisted that this was
Speaker 1: a team effort and that her colleagues and supervisors should
Speaker 1: also get the credit. Even though thelidamide did not receive
Speaker 1: FDA approval for distribution in the US, the US did
Speaker 1: have cases of fetal palidamide syndrome. Richardson. Merrill had distributed
Speaker 1: more than two million doses of the drug two doctors
Speaker 1: as samples, and those have been given to patients either
Speaker 1: as sedatives or to treat mourning sickness. At least seventeen
Speaker 1: people in the United States were born with fetal palidamide syndrome.
Speaker 1: Richardson Merrill was also the company that marketed the lidamite
Speaker 1: in Canada, where it stayed down the market until March second,
Speaker 1: nineteen sixty two. It's possible that there were a lot
Speaker 1: more than seventeen people, because only about half of those
Speaker 1: folks parents had gotten the litamite in the US. The
Speaker 1: rest of them had gotten it while traveling, So it's
Speaker 1: totally possible that there are a lot more people that
Speaker 1: just aren't recorded in that that official list. Babies continued
Speaker 1: to be born with feetle with the litamite syndrome after
Speaker 1: the drug was banned around the world, including babies that
Speaker 1: were conceived after the bands. People who had bought or
Speaker 1: been given the medicine before it was pulled from the
Speaker 1: shelves still had it in their medicine cabinets. People who
Speaker 1: had not heard about the drug's effects continued to take
Speaker 1: it or to share it with other people. Some people
Speaker 1: had also just been given a sample of a few
Speaker 1: pills in an envelope that was maybe labeled with dosage instructions,
Speaker 1: but not with the name of the drugs, so they
Speaker 1: might not have even known that it was the litamide
Speaker 1: that they were taking. In some countries, governments and medical
Speaker 1: associations tried to warn the public lick about the dangers
Speaker 1: of the litamide and urged them to go through their
Speaker 1: medicine cabinets to make sure they did not have the
Speaker 1: litamide or any unlabeled pills. One person who was a
Speaker 1: big part of this outreach was Dr Helen Brook Tausig,
Speaker 1: along with surgical technician Vivian Thomas and surgeon Alfred Blaylock.
Speaker 1: Tausig was one of the people who developed a surgical
Speaker 1: treatment for the tetrology of fellow, which caused what was
Speaker 1: then known as blue Baby syndrome. That is on the
Speaker 1: list for another episode, especially Dr Tausig and Vivian Thomas
Speaker 1: um in particular. In January of nineteen sixty two, Tausig
Speaker 1: learned about what was happening in Europe, and she flew
Speaker 1: overseas to examine babies who had been harmed by the litamide.
Speaker 1: When she got back to the US, she undertook an
Speaker 1: extensive campaign to try to raise awareness about the drug's effects,
Speaker 1: including speaking before the American College of physicians and writing
Speaker 1: numerous articles meant for a general audience to try to
Speaker 1: warn people about the drug, but this didn't happen everywhere.
Speaker 1: In austra Alia, for example, distillers pulled the drug off
Speaker 1: the market in nineteen sixty one and warned the Australian
Speaker 1: government of the drugs teratogenic effects, but there was not
Speaker 1: a wide scale effort to notify pharmacies, hospitals, doctors offices,
Speaker 1: or the public about what was happening. As many as
Speaker 1: a quarter of the thelidamide survivors born in Australia were
Speaker 1: conceived after December nineteen sixty one. In Spain, it took
Speaker 1: years for the government to formally outlost solidamide or to
Speaker 1: remove it from the official Register of Drugs, and sometimes
Speaker 1: warnings used the term the liidamide while the drug was
Speaker 1: being sold under other brand names. There were seven different
Speaker 1: brands of the litamide sold in Japan alone. Even in
Speaker 1: places with more coordinated efforts to warn people about the
Speaker 1: dangers of the drug, the first generation of the litamide
Speaker 1: survivors included people born as late as nineteen sixty four
Speaker 1: and possibly even later. Because all of this traced back
Speaker 1: to a drug that they had believed was safe. This
Speaker 1: whole crisis led to just an incredible and crushing sense
Speaker 1: of shame, grief, depression, and anger for everyone involved, whether
Speaker 1: they had prescribed the drug or taken it or given
Speaker 1: it to a friend or family member. Many babies born
Speaker 1: with solidamide embryopathy died in their first year of life.
Speaker 1: Those who survived usually had multiple disabilities that have seriously
Speaker 1: affected the rest of their lives, which means that this
Speaker 1: whole crisis was exacerbated by attitudes about disability and the
Speaker 1: state of disability rights. The various countries where solidamide was
Speaker 1: sold all had their own nuances, but in general, disability
Speaker 1: was more heavily stigmatized than it is now, and doctors
Speaker 1: approached the subject very differently than they do today. So
Speaker 1: if you read articles written about this crisis as it
Speaker 1: was unfolding, a lot of them don't even sound like
Speaker 1: they're describing human beings worthy of life. The default response,
Speaker 1: even among medical professionals, was often to see these newborns
Speaker 1: as a hopeless and even monstrous track agedy, rather than
Speaker 1: as a person who could live and thrive with the
Speaker 1: right care and accessibility. There were even cases and suspected
Speaker 1: cases of infanticide. In one documented example, a Belgian woman
Speaker 1: named Suzanne Vanderputt admitted to killing her daughter with barbiturous
Speaker 1: dissolved in milk. She was acquitted in nineteen sixty two,
Speaker 1: and many countries, doctors recommended that babies with folk amelia
Speaker 1: or other disabilities be placed in institutions rather than being
Speaker 1: sent home with their families, regardless of the level of
Speaker 1: care that the baby actually needed. My mom worked in
Speaker 1: long term care for kids with multiple disabilities for years
Speaker 1: and years, and she definitely worked with kids who needed
Speaker 1: some kind of twenty four hour medical assistance. This was
Speaker 1: not the case with a lot of children who were
Speaker 1: born after being exposed to the linamide. Sometimes medical staff
Speaker 1: took newborns away from the delivery room before their parents
Speaker 1: had held them or even seen them, and a lot
Speaker 1: of places, parents who took their baby home did so
Speaker 1: against medical advice and after being strongly discouraged from doing
Speaker 1: so by their doctors. And whether a child was growing
Speaker 1: up in an institution or at home, most communities were
Speaker 1: far less accessible than they are today, and today there
Speaker 1: is still a long way to go. In most of
Speaker 1: the world, schools and other public buildings were not accessible
Speaker 1: for wheelchairs. Parents, teachers, and administrators had little to no
Speaker 1: education or experience in how to make a home or
Speaker 1: a school accessible to children with these types of disabilities.
Speaker 1: Prosthetics and adaptive devices had not really been developed for children. So,
Speaker 1: in other words, there were barriers everywhere, physical barriers to
Speaker 1: being able to access facilities, and societal barriers due to
Speaker 1: prevailing attitudes about disability. US includes the litamied survivors who
Speaker 1: have described being bullied and harassed by peers and by
Speaker 1: adults because of their disabilities. The ones who grew up
Speaker 1: in care have often described feeling like strangers every time
Speaker 1: they visited their family, least once they got older. But
Speaker 1: really this is us as full of information and heartbreaking
Speaker 1: as this is simply the beginning of the story. The
Speaker 1: Solido mine crisis led to totally revised drug standards around
Speaker 1: the world, a criminal investigation, and decades of lawsuits and
Speaker 1: ongoing efforts to get access to necessary support and services.
Speaker 1: And we're going to talk about all of that next time.
Speaker 1: I also have a little bit of listener mail to
Speaker 1: close us out, all right, This is from Rachel. Rachel says, Hello, ladies,
Speaker 1: I listened to your episode on the women of the
Speaker 1: Civil War and loved it, especially learning about Elizabeth Thorne.
Speaker 1: So fantastic, but it made me think about how other
Speaker 1: women have played a part in military service. I've listened
Speaker 1: to your episodes on the Night Witches and the six
Speaker 1: Triple eight, Central Postal Directory Battalion and others, but I
Speaker 1: really wanted to look into more Canadian history, seeing as
Speaker 1: that's where I am from, and I stumbled across the
Speaker 1: Nursing Sisters. The Nursing Sisters started out as volunteers during
Speaker 1: the South African War, but eventually gained a relative rank
Speaker 1: as lieutenants and then officers. By World War One, they
Speaker 1: were nicknamed the Bluebirds because of their blue dresses and
Speaker 1: white veils, which I just love, and by the end
Speaker 1: of World War Two they had been renamed as the
Speaker 1: Royal Canadian Army Medical Corps. Another interesting fact, two of
Speaker 1: the Nursing Sisters, Meta Hodge and Eleanor Thompson, in World
Speaker 1: War One, became the first women to be awarded a
Speaker 1: wartime Medal of Valor in Canada. There's a great heritage
Speaker 1: minute on this story which I'll link below, and then
Speaker 1: moving on to a more personal note. Also, I'm not
Speaker 1: sure if you remember Momo the historian hound, but that's
Speaker 1: my dog, and I wanted to thank you again for
Speaker 1: getting us through so many awful bats. I don't know
Speaker 1: if I could do it without you, guys, so I've
Speaker 1: added pictures of her into Thanks again, and have a
Speaker 1: great day, ladies. I was from Rachel. Thank you so much. Rachel.
Speaker 1: Of course we even remember Momo this story and hound
Speaker 1: Mo Mo such a good dog. Thank you so much
Speaker 1: for this um this email and for sharing this information
Speaker 1: about the nursing sisters. I don't know if they will
Speaker 1: make it into a full episode at some point, but
Speaker 1: in case they do not, there's a little tidbit about
Speaker 1: it about them for our listeners. If you would like
Speaker 1: to write to us about this or any other podcast,
Speaker 1: where at History podcast at how stuff Works dot com.
Speaker 1: And then we're all over social media at miss in History,
Speaker 1: and that's where you'll find our Facebook, Twitter, Pinterest, and Instagram.
Speaker 1: You can come to our website, which is missed in
Speaker 1: History dot com, and you'll find show notes for all
Speaker 1: the episodes Holly and I have never done together in
Speaker 1: a searchable archive of every episode ever. And you can
Speaker 1: subscribe to the show on Apple podcast. I heart Radio app,
Speaker 1: and wherever else to get your podcasts. Stuff you Missed
Speaker 1: in History Class is a production of I heart Radio's
Speaker 1: How Stuff Works. For more podcasts for my heart Radio,
Speaker 1: visit the iHeart radio app, Apple Podcasts, or wherever you
Speaker 1: listen to your favorite shows.