0:01

Welcome to Stuff You Missed in History Class,

0:03

a production of I Heart Radios How Stuff

0:05

Works. Hello,

0:12

and welcome to the podcast. I'm Tracy

0:14

V. Wilson and I'm Holly Fry.

0:17

We have gotten a lot of requests

0:19

over the years to talk about the drug the litamide,

0:21

including from Ginger Cheyenne, Emily,

0:23

Brittany, Randy, Rebecca, Hannah, Tricia,

0:26

Jackie and Terrell. And we've had

0:28

some spikes in those requestsed a couple of different

0:31

points, including when this was a plot line

0:33

on the TV show called The Midwife.

0:35

We got some rite in a row over the last

0:37

couple of weeks. Uh. This has been

0:39

described as the biggest man made

0:42

medical disaster of all time. From

0:44

ninety seven to nineteen sixty two,

0:46

the litamide was marketed as being completely

0:49

safe and it was used as a treatment for morning

0:51

sickness, but it was not safe. At

0:54

least ten thousand people who were exposed

0:57

to the litamide in the womb were born

0:59

with a ring as of disabilities and medical conditions,

1:01

and about forty percent of them didn't survive

1:04

infancy, and the drug also caused

1:06

a really unknown number of miscarriages

1:09

and still births, possibly tens of

1:11

thousands more. A lot of the people

1:13

who've asked us about this episode have framed it in

1:15

the context of babies, but there

1:17

are thousands of adults living today

1:19

who were harmed by this drug many

1:22

parts of the world. They refer to themselves as

1:24

the Litta miters. As of when

1:26

we're recording this in twenty nineteen, most of these

1:28

folks are in their late fifties and early sixties,

1:30

although as we will discuss, there are

1:32

also people who are a lot younger than that. So

1:35

people who weren't personally affected

1:37

by this might imagine this story as something

1:39

that sort of is confined back in the past,

1:42

but it's really a story that's ongoing

1:44

until today, and it's also a long

1:46

enough story that we're covering it in two parts.

1:49

So today we're going to talk about what the litamide

1:51

is, the animal testing that let

1:54

its manufacturer to market it as

1:56

safe and it's released onto the market. Next

1:59

time we will be talking more about its

2:01

aftermath and how it affected everything

2:03

from drug regulations to abortion law.

2:06

Um there is some disability rights

2:09

stuff along the way that it's pretty

2:11

appalling in terms of how people were treated,

2:14

and that's going to apply really to both episodes.

2:17

Yeah, obviously not a

2:19

lighthearted rump today. Just

2:21

heads up, as if you had not gleaned

2:23

to that already from Tracy's introme. So,

2:26

the letta mine is a taradogen, which means

2:29

it's something that disrupts development, and

2:31

taradogens can affect any stage of

2:33

development, but the term is frequently

2:35

used to describe things that negatively affect

2:37

the development of an embryo or fetus,

2:39

including causing miscarriage. And

2:42

lots of things can act as taradogens,

2:44

including hyperthermia, infectious

2:46

disease, environmental pollutants,

2:48

and alcohol. Pharmaceuticals

2:51

can also have the potential to act as taradogens.

2:54

Many countries have some kind of a system

2:56

now for categorizing the level

2:58

of risk and whether the dry is recommended

3:00

for use during pregnancy. So

3:03

in the US, for example, these categories

3:05

range from A, in which the risk to

3:07

a fetus seems to be remote to

3:09

category X, in which the drugs

3:11

risks during a pregnancy outweigh any

3:14

possible benefits. Today,

3:16

drugs that fall into category X

3:19

or otherwise have serious teratgenic

3:21

effects are typically only used

3:23

with a range of safety precautions in place.

3:26

Patients who could become pregnant may need to

3:28

have a negative pregnancy test before they

3:30

start treatment, and they may also

3:32

be required to use multiple forms of birth

3:35

control and be tested for pregnancy while

3:37

they're being treated. Since f

3:40

d A, drug labeling rules in the United

3:42

States have required a section called quote

3:45

Females and Males of Reproductive Potential

3:48

and that details these recommendations

3:50

along with whether the drug has been shown to

3:52

cause infertility. Yeah, the exact rules

3:54

and laws obviously vary all over

3:56

the world, but even with these types of

3:58

precautions, it's still possible for

4:01

a drug that's known to have these kinds

4:03

of effects to harm a developing fetus.

4:05

A doctor might not communicate the risks

4:08

clearly enough for a patient might not fully

4:10

understand them, or contraceptives

4:12

could fail for a variety of reasons.

4:15

Especially in places that don't have a

4:17

robust medical system, patients

4:19

might share their medications with each other without

4:21

fully understanding the risks involved, and

4:24

especially because these same places don't

4:26

often have the resources to really

4:29

follow up and monitor patients, it's

4:31

possible that babies may be born with disabilities

4:34

or health effects that aren't ever reported

4:36

or connected back to the drug. Even

4:39

in places that do have really robust medical

4:41

systems. The level of monitoring

4:43

and compliance involved with this can really

4:45

be a lot. Sometimes it is just

4:47

not sustainable in real world conditions.

4:50

But none of these steps were in place

4:52

when the lita mine was developed, and

4:55

no one knew about its teratogenic effects

4:57

when it was first put on the market. So

4:59

we're going to get into why that was in a moment,

5:02

but first we're going to have an overview

5:04

of the conditions and disabilities that the litamide

5:06

causes in a developing fetus.

5:09

So the condition that's most associated

5:11

with the litamide is folk amelia, and

5:14

that's when the bones and a person's limbs

5:16

are shortened or missing. This

5:18

usually affects the long bones and the

5:20

arms and the legs, so sometimes it results

5:23

in the hands or the feet being connected

5:25

to the trunk of the body without a limb in

5:27

between. Most of the

5:29

time these effects are symmetrical, with

5:31

both legs or both arms or

5:33

all four limbs affected, and the arms

5:36

are affected the most often with the litamide.

5:39

The litamide can also cause a similar

5:41

condition called amelia, or the total

5:44

absence of the limb. The litamide

5:46

can also affect a person's digits, including

5:48

having extra or missing fingers or toes.

5:51

Sometimes the size and shape of the bones

5:54

can also cause the hands or feet to

5:56

have a different size or shape than a

5:58

typical hand or foot. The eyes

6:00

and the ears can be affected as well. They

6:02

might be missing completely or missing parts

6:04

of their structures, and that can cause problems

6:07

with a vision or hearing, as well as blindness

6:09

and deafness. These are the most

6:12

outwardly visible effects of the litamide

6:14

exposure in utero, but the drug

6:16

can also cause internal organ damage,

6:18

including heart, kidney, nervous

6:21

system, and g I problems, as well

6:23

as damage to the reproductive organs, and

6:25

sometimes this is not immediately apparent at

6:27

birth, even after a medical examination,

6:30

so these conditions are then discovered later

6:32

in life. People who are exposed

6:34

to the litamide before birth also have higher

6:37

rates of cognitive disabilities and epilepsy.

6:40

Altogether, these and other effects

6:43

of the litamite exposure in the womb are known

6:45

as the litamide embryopathy or fetal

6:47

the litamide syndrome. Most

6:49

of the research into the litamides effects

6:51

was conducted on infants in the nineteen

6:54

sixties, and there hasn't been nearly as

6:56

much follow up from the medical

6:58

community as people have grown own and aged,

7:01

so it's really possible that there are other delayed

7:03

effects that haven't been widely studied

7:06

or traced back to the litamide. One

7:08

exception is whether the litamides effects can

7:10

be passed down to a person's children,

7:13

and the litamized effects don't appear

7:15

to be inheritable. These are a

7:17

lot of different effects for one drug to cause,

7:20

and many people have several of them,

7:22

and that's largely tied to exactly when

7:24

during the pregnancy that the litamite exposure

7:27

happened and what was developing within the embryo

7:29

or fetus at that time. The

7:31

litamides effects tend to be the most severe

7:33

between twenty and thirty six days after

7:36

conception. At this point

7:38

in pregnancy, things are moving very quickly,

7:40

with lots of growing and development happening

7:42

in multiple body systems all at

7:44

once. Just one dose

7:46

of the lidamide can disrupt all of this,

7:48

causing multiple negative health effects

7:51

or disabilities in at least fifty of

7:53

pregnancies, and some studies

7:55

suggest at that rate is actually even higher

7:57

than that, and this is why the litamite

8:00

it's use as a morning sickness treatment

8:02

affected so many people. So dramatically.

8:05

Morning sickness occurs in about sevent pregnancies,

8:08

and it can happen at any time of the day and

8:10

at any point during the pregnancy, but it's

8:12

really the most common in the first trimester.

8:15

It's usually the worst from four to

8:18

seven weeks after conception, and that

8:20

largely overlaps with the window

8:22

when the lidamides effects are also the

8:24

most severe and affect the most

8:26

parts of the body. So we're going to talk about

8:29

how Solida Mine made it to market without

8:31

anyone discovering any of this after

8:33

we first pause for a sponsor break.

8:43

Internationally, the pharmaceutical industry

8:46

really expanded dramatically after the end

8:48

of World War two. People needed treatments

8:50

for illnesses and injuries that had resulted

8:52

from the war. Multiple countries

8:55

had started establishing national health

8:57

care systems in the decades that we're leading

8:59

up to the war and then afterward, and that

9:01

led to more demand for medicines overall.

9:04

There were also breakthroughs and various

9:06

types of medicines, including antibiotics

9:09

and anti anxiety medications, and

9:11

those had also led pharmaceutical companies

9:13

to develop new drugs very aggressively

9:16

to try to compete sedatives

9:18

in particular, became incredibly popular

9:20

as a newly developed class of drugs.

9:23

The sedative known as Milltown was launched

9:25

in nineteen fifty five, and it quickly became

9:28

the best selling drug in the United

9:30

States. Drug manufacturers

9:32

around the world we're trying to break into this fast

9:34

growing segment of the drug market, hoping

9:36

for a similar success of their own. West

9:39

German pharmaceutical company Shami grunenthalogy

9:42

mbH was founded in nineteen forty

9:44

six and was one of the companies trying to

9:46

rapidly develop new drugs and bring

9:49

them to market. In nineteen fifty

9:51

four, they synthesized the drug that would come

9:53

to be known as the litamided for the first time

9:55

and they applied for a patent. A

9:57

paper describing the drugs pharmacological

10:00

effects, including its sedative effects,

10:02

was published in nineteen fifty six, and

10:04

that paper, it was referred to as K seventeen,

10:08

was also when Grunenthal conducted some safety

10:10

tests on this new drug, and one

10:12

of the tests that was conducted is called the

10:14

median lethal dose or LD fifty

10:17

test, and this test is conducted

10:19

on lab animals and it's used to determine

10:22

how much of a substance it takes for it

10:24

to become deadly. The l D fifty

10:26

is the amount of the substance that it takes to

10:28

kill fifty of the test subjects.

10:31

The LD fifty tests for the litamide

10:33

were conducted on mice and they suggested

10:36

that there was no dose, no matter

10:38

how high, that would be lethal and fifty

10:40

percent of the subjects. Everyone thought

10:42

this was amazing in terms of the folks developing

10:44

it. It's set the litamide apart from

10:46

other sedatives and sleep aids, which could

10:48

be lethal at high doses, like an

10:51

overdose could cause someone to die. Based

10:54

on these results, Grudenthal started marketing

10:56

this drug as safe and non toxic.

10:59

In November of eighteen fifty six, Grunenthal

11:01

began marketing a flu remedy called grip

11:04

X, which combines solidamined with other

11:06

substances like quinine and vitamin

11:08

C. In ninety seven,

11:10

it launched several versions of a drug called

11:13

coundragone, which was solidimized

11:15

for use as a daytime sedative or

11:17

a nintime sleep aid. Grip

11:20

X and coundragone were available without

11:22

a prescription. The idea that you could

11:24

just go to a pharmacy in nineteen fifty seven

11:26

and get a sedative over the counter

11:29

marketed as a sedative blows

11:32

my mind just a little bit. Yeah, same, I

11:35

don't I don't know what to add to there.

11:37

There are plenty of drugs that have sleepiness

11:39

or drowsiness as a side effect, but like, if

11:41

that's in the US at least, you can't

11:44

just walk up to a counter and say

11:46

I would like a sedative please and get one. In

11:49

many parts of the world, in the nineteen fifties, it

11:51

was common for doctors to prescribe

11:53

or recommend a variety of medicines of pregnant

11:55

patients for the sake of their physical comfort

11:57

and mental health, and this included sedatives

12:00

and stimulants and other medications. The

12:03

prevailing attitudes about both prescription

12:05

and over the counter medicines during pregnancy

12:07

was pretty cavalier compared to how

12:09

it is today, and soon after

12:12

Contragone hit the market, patients and

12:14

doctors started reporting that it wasn't just

12:16

providing RESTful sleep or a calmer

12:18

mood during pregnancy, it was also

12:21

treating mourning sickness. Soon

12:23

doctors were recommending contragone for

12:25

the off label use of mourning sickness

12:28

treatment and prevention. Patients

12:30

who had taken it were also recommending it

12:32

to their pregnant friends and family members.

12:34

I mean, people who took this drug described

12:37

as being miraculous in terms

12:40

of the difference that it made in the

12:42

morning sickness level. But none of the

12:44

tests that had been performed on solidamide

12:46

before it was released were conducted

12:48

on pregnant animals, and even

12:50

if they had been, it turns out that mice

12:53

and rats aren't susceptible to solidamide

12:55

in the same way that humans and many other mammals

12:58

are. Although there had been and some

13:00

clinical trials, no one in

13:02

them had been pregnant. Also, the

13:04

clinical trials themselves were very small

13:07

and not very thorough. Testing

13:09

on some other sedatives at this time had involved

13:12

things like examining the urine

13:14

to analyze how the drug had been

13:16

broken down inside the body and

13:18

how much of the drug was being excreted

13:20

without being broken down at all. Nothing

13:23

like this was performed for the litamide.

13:25

It also doesn't appear that these clinical trials

13:28

were double blind or involved any kind

13:30

of comparison between the drug anniple

13:32

cebo. On top of that, the papers

13:35

that were published to support the litamide safety

13:37

and efficacy read more like doctors

13:39

testimonials than research that was actually

13:42

backed up by data. Vitikin

13:44

Lens, who was one of the doctors who made the connection

13:47

between the litamide and its teratogenic

13:49

effects, later said quote the papers

13:51

published in nineteen fifty six by Kun's

13:54

at All on animal experiments and by

13:56

Young on clinical experiences with

13:58

the linamide have so little scientific

14:01

value that, in my opinion, they should

14:03

not have been accepted for print. In

14:05

other words, all this testing was not very

14:07

thorough or rigorous or well documented.

14:11

Just one example of how it all fell

14:13

short is that it later turned out that the

14:15

reason that they could not find a lethal

14:18

dose of the litamide and mice wasn't

14:21

because the drug was inherently safe.

14:23

It was because the mice weren't

14:25

actually absorbing most of it.

14:28

Different preparations of the drug that were tested

14:30

later on and were more easily absorbed

14:33

turned out to be highly toxic. Based

14:35

on the litamide success in West Germany,

14:37

Grunenthal began working on distributing it

14:39

to other parts of the world. It was

14:42

ultimately marketed and distributed through various

14:44

other pharmaceutical companies in forty

14:46

six different countries under a range

14:48

of brand names, including dist of All

14:51

in the UK and Australia and

14:53

soften On in parts of Europe. As

14:55

all of that was happening, doctors

14:57

in places where the litamide was being used

15:00

to treat morning sickness, we're starting to encounter

15:02

babies who had a collection of health problems

15:04

and disabilities that they'd never really seen

15:07

before. In nineteen fifty nine,

15:09

a gynecologist in Munich reported

15:11

a baby born with folk amelia. There

15:13

wasn't a clear connection at that time, but

15:16

later on the doctor learned that the baby's

15:18

mother had taken gripp X while pregnant.

15:20

This wasn't actually the earliest documented

15:23

case of solidamide having a teratogenic

15:25

effect, That had happened back in

15:27

December of nineteen fifty six, before the

15:29

drug was even on the market. This

15:31

case was a baby born to a Grunenthal

15:33

employee and his wife, and he

15:35

had been given free samples at work and

15:38

their child was born without ears. That

15:40

connection was not uncovered until much later.

15:43

So at first doctors were reporting

15:45

what they described as this strange

15:48

epidemic of folk amelia, but they

15:50

weren't really sure what was causing it, as

15:53

that was happening, though, doctors were noticing

15:55

a different pattern and adults who

15:57

were taking the lidamide. As ly

16:00

as April of nineteen fifty nine, pharmacists

16:02

were reporting that patients were experiencing

16:05

things like tingling hands and feet,

16:07

or cold hands and feet, or a

16:09

sense of giddiness after taking the litamide.

16:12

In October of nineteen fifty nine, a doctor

16:14

named Ralph Voss reported neuritis

16:17

or nerve inflammation and people who had

16:19

taken contragne for a year. Voss

16:22

contacted Grunenthal, who told him

16:24

quote, no such side effects have come

16:26

to our notice. Another doctor

16:28

named Horse Frankel was also working

16:31

with patients that were experiencing nearitis

16:33

after taking the litamine. He

16:35

wrote a paper detailing twenty cases,

16:37

but for unclear reasons, it wasn't printed

16:40

until nineteen sixty one. Meanwhile,

16:43

Voss delivered a presentation on the naritis

16:45

issue on April nineteen sixty

16:48

In December of that year, a letter

16:50

titled is the litamide to blame

16:52

was printed in the British Medical Journal. It

16:55

was written by A Leslie Florence

16:57

of Aberdeenshire, and it described

17:00

four cases of tingling, cold

17:02

extremities, leg cramps, and other

17:04

side effects, and adult patients taking

17:06

the lidamide, these improved,

17:09

but they didn't really go away when the patients

17:11

stopped taking the drug. The letter

17:13

included the line quote it would appear

17:16

that these symptoms could possibly be

17:18

a toxic effect of the lidamide.

17:20

By May of nineteen sixty one, Grudenthal

17:23

had received reports of more than one thousand

17:25

cases of neuritis that were connected

17:27

to thelidamide. The company

17:29

was forced to make the drug available only by

17:32

prescription. Before that point,

17:34

it had been responsible for more than half of the

17:36

company's gross revenues, and it was West

17:38

Germany's most popular over the

17:40

counter sedative, with more than twenty

17:43

million tablets sold each month.

17:46

Even after these reports of neurological

17:48

side effects and after it became available

17:50

only by prescription, Grunenthal

17:52

continued to market solidamide as completely

17:55

safe, even during pregnancy.

17:57

So we should note that even today, it

17:59

is very common for a drug's side

18:01

effects, including some very serious

18:04

side effects, to be discovered after the

18:06

drug is approved and out on the market, even

18:08

when they're meticulously controlled and carefully

18:11

planned out. Clinical trials are very

18:13

small compared to the general population,

18:16

and the real world has a lot of factors that

18:18

might not be present in the context

18:20

of a controlled study. But it's clear

18:22

that Grunenthal's original testing on

18:25

the litamide was not very thorough,

18:27

and the company does not appear to have looked

18:29

into whether all these reports of near rytis

18:32

pointed to a greater problem with the drug.

18:34

And in nineteen sixty one doctors started

18:36

making connections between the litamide as

18:38

used for morning sickness and the drugs teratogenic

18:41

effects. One was the German doctor

18:43

vitikin Lens who we mentioned earlier, and

18:46

he had noticed the unusual increase in

18:48

phok melia and other conditions that we

18:50

now know as part of fetal the litamide syndrome.

18:53

He went back through medical records and he

18:55

found that this pattern had started very suddenly.

18:58

He didn't initially know what the exact cause

19:00

was, but he was confident that there was one, and

19:03

that it might be some kind of chemical exposure,

19:05

like an undisclosed chemical spill, or

19:07

perhaps a new household product. Thousands

19:10

of miles away. Dr William McBride

19:12

was working at a hospital in Australia

19:15

and on May fourth, nineteen sixty one, a

19:17

baby was born there with both folk Amelia

19:20

and bowel atresia, which is a condition

19:22

in which part of the bowel is blocked

19:24

are absent. Thousands

19:26

of babies were born every year at the hospital,

19:28

but this was the first time in its history

19:30

that a baby had been born with that combination

19:33

of conditions. Two more babies

19:35

with folk amelia and bowel atricia

19:37

were born between May fourth and June

19:39

eight. McBride realized

19:41

all three had been exposed to the lidamide,

19:44

which had been on the market in Australia since June

19:46

of nineteen sixty. On June

19:49

he convinced the hospital to withdraw the litamide

19:51

from use and informed the drug company

19:54

Distillers, which was distributing the litamide

19:56

in Australia. This was the first published

19:59

letter specif typically linking the litamide

20:01

to its teratogenic effects. McBride

20:04

later told The New York Times that he also

20:06

wrote to the company headquarters in London,

20:08

but quote the reply from the medical

20:10

director of the London office implied

20:13

that I was utterly wrong. His

20:15

high handed letter implying that I was just

20:17

a colonial annoyed me. I

20:19

was determined to prove I was right. The

20:21

following month, Dr Hans Vicker documented

20:24

twenty babies with folk amelia, five

20:26

of which were known to have been exposed to the

20:28

lidamide in the womb. But Viker

20:31

had been told in error that the litamide

20:33

was being used very widely in the US,

20:35

but that the US was not experiencing

20:38

the folk amelia epidemic that other countries

20:40

were. He learned from Dr Lens

20:42

that this was not true, and when he went back

20:44

through his records specifically

20:46

looking for the litamide, he confirmed

20:48

its use in even more cases. After

20:51

his communication with Viker, Lens

20:54

called Grunenthal and was told to expect

20:56

a visit from somebody in a few days. He

20:59

told them that the needed attention immediately,

21:01

that in a few days hundreds more people could

21:04

be taking this drug for the first time. Lens

21:07

also sent a registered letter to the company

21:09

on November sixteenth, nineteen sixty

21:11

one, detailing his concerns. Meanwhile,

21:14

in Australia, drug company distillers

21:16

removed the litamide from the market on November

21:18

twenty one. It was only after

21:20

all this that Grudenthal finally took action,

21:23

pulling the litamide off the German market

21:25

on November nineteen sixty

21:27

one. As words spread, it

21:29

was taken off the market in the UK on December

21:32

two. On December sixteenth, Solidamide

21:35

and Congenital Abnormalities was published

21:37

in The Lancet. The lidamide was taken

21:39

off the market in more countries in the weeks that

21:42

followed. It was banned worldwide

21:44

in nineteen sixty two, although in some places

21:47

it was not formally made illegal until

21:49

much later. It was only after

21:51

all of this that there was any kind of formal

21:54

study of the litamide and pregnant animals.

21:57

Dr McBride had actually tried to do this in Australia,

21:59

but he didn't really have any experience in

22:01

how to perform this kind of trial or access

22:04

to the lab animals that he would need to do

22:06

it. The results of this study were

22:08

published in a letter to The Lancet on April

22:11

nineteen sixty two, showing that the litamide

22:13

had similar to ratogenic effects and

22:15

rabbits as it was now clear to be having

22:18

in humans. We're going to talk about the aftermath

22:20

of all of this, and about why the US isn't

22:22

one of the countries that we have talked about so far.

22:25

After we first paused for another sponsor break

22:35

between nineteen fifty seven and nineteen sixty

22:38

two, The litamide was sold in forty six

22:40

different countries around the world, but

22:42

it was never officially introduced in the United

22:44

States. Richardson Meryl,

22:47

the drug company, had planned to distribute

22:49

the litamide in the US under the trade

22:51

named Kevi Don Meryl submitted

22:54

an application to the Food and Drug Administration.

22:56

At that time, the US did have some laws

22:59

that we're governing the drug approval process.

23:01

That application was given to Dr Francis

23:04

Oldham Kelsey to review. Kelsey

23:06

was born on Vancouver Island in British Columbia,

23:08

Canada, and she had first started studying

23:11

unsafe pharmaceuticals while she was a graduate

23:13

student at the University of Chicago,

23:15

and there she earned both her PhD and

23:18

her medical degree. At the university,

23:20

Dr Eugene Galing was trying to figure out

23:22

what had caused the deaths of more than one d

23:24

people who had taken a drug called Elixir

23:26

of Sulfonilla mine, and Kelsey

23:29

was one of the graduate students who helped pinpoint

23:31

the cause as a solvent that had been

23:33

used to add a raspberry flavor

23:35

to make the drug less bitter. Kelsey

23:38

was really new to the job as a drug application

23:40

reviewer at the f d A. The kevin

23:42

On application was only the second one

23:44

that she had been given, and in her account,

23:47

it was given to her because she was new and it was

23:49

supposed to be an easy one. The

23:51

littamide was already being used in countries

23:53

all over the world. It was regarded as completely

23:56

safe, so really this process seemed like

23:58

a formality. But when

24:00

Kelsey started reviewing the application,

24:02

sheep had some concerns about the litamne

24:04

safety testing, a lot of those

24:06

same problems that we talked about before, and

24:09

after some back and forth with Meryl, she rejected

24:11

the application on November tenth, nineteen

24:14

sixty. Meryl reapplied in

24:16

December. Kelsey read the letter in the British

24:18

Medical Journal about neuropathy and people

24:21

that had taken the lidomide, which he talked about before

24:23

the break. She pushed back on

24:25

Meryl, noting that a simple sleep

24:27

age shouldn't be causing neuropathy and that

24:29

a drug that was causing neuropathy could

24:31

not be as safe and non toxic

24:33

as the company was claiming. This

24:36

went back and forth for weeks. At

24:38

one point Kelsey met with executives from

24:40

the company and, in her words,

24:42

quote, I had the feeling throughout the

24:44

day that they were at no time being wholly

24:46

frank with me. As Kelsey continued

24:49

to refuse to approve the kevidan application,

24:51

more and more information was coming out

24:54

about the effects that the litamide was having

24:56

on the nervous systems of adults and on prenatal

24:59

development. Merrill finally

25:01

withdrew its application in April of nineteen

25:03

sixty two, as countries were banning the

25:05

litamide. President John F. Kennedy

25:08

later awarded Dr Kelsey the President's

25:10

Award for Distinguished Federal Civilian

25:12

Service, and she was awarded numerous other

25:15

honors for her work in drug safety. During

25:17

her lifetime. She died,

25:19

and I think so

25:21

that was pretty recently. For her part, Kelsey

25:24

insisted that this was a team effort

25:26

and that her colleagues and supervisors should

25:28

also get the credit. Even though thelidamide

25:31

did not receive FDA approval for distribution

25:34

in the US, the US did

25:36

have cases of fetal palidamide syndrome.

25:39

Richardson. Merrill had distributed more than

25:41

two million doses of the drug two doctors

25:43

as samples, and those have been given

25:45

to patients either as sedatives or

25:48

to treat mourning sickness. At

25:50

least seventeen people in the United

25:52

States were born with fetal palidamide syndrome.

25:55

Richardson Merrill was also the company that marketed

25:57

the lidamite in Canada, where it stayed

26:00

down the market until March second, nineteen

26:02

sixty two. It's possible that there

26:04

were a lot more than seventeen people, because

26:06

only about half of those folks

26:09

parents had gotten the litamite in the US.

26:11

The rest of them had gotten it while traveling, So

26:14

it's totally possible that there are a lot

26:16

more people that just aren't recorded in that

26:18

that official list. Babies

26:21

continued to be born with feetle with the litamite

26:23

syndrome after the drug was banned around

26:25

the world, including babies that were

26:27

conceived after the bands. People

26:30

who had bought or been given the medicine

26:33

before it was pulled from the shelves still

26:35

had it in their medicine cabinets. People

26:38

who had not heard about the drug's effects

26:40

continued to take it or to share it with other

26:42

people. Some people had also just

26:44

been given a sample of a few pills in

26:46

an envelope that was maybe labeled with

26:49

dosage instructions, but not with the name

26:51

of the drugs, so they might not have even known

26:53

that it was the litamide that they were taking.

26:55

In some countries, governments and medical

26:58

associations tried to warn the public lick

27:00

about the dangers of the litamide and urged

27:02

them to go through their medicine cabinets to

27:04

make sure they did not have the litamide

27:07

or any unlabeled pills. One

27:09

person who was a big part of this outreach was Dr

27:11

Helen Brook Tausig, along

27:14

with surgical technician Vivian Thomas and

27:16

surgeon Alfred Blaylock. Tausig

27:18

was one of the people who developed a surgical treatment

27:20

for the tetrology of fellow, which

27:23

caused what was then known as blue Baby

27:25

syndrome. That is on the list for another episode,

27:28

especially Dr Tausig and Vivian Thomas

27:30

um in particular. In January

27:33

of nineteen sixty two, Tausig learned

27:35

about what was happening in Europe, and she flew

27:38

overseas to examine babies who had been

27:40

harmed by the litamide. When she got

27:42

back to the US, she undertook an extensive

27:44

campaign to try to raise awareness

27:46

about the drug's effects, including speaking

27:49

before the American College of physicians and

27:51

writing numerous articles meant for a general

27:54

audience to try to warn people about

27:56

the drug, but this didn't happen everywhere.

27:59

In austra Alia, for example, distillers

28:01

pulled the drug off the market in nineteen sixty

28:03

one and warned the Australian government of

28:06

the drugs teratogenic effects, but there

28:08

was not a wide scale effort to

28:10

notify pharmacies, hospitals, doctors

28:12

offices, or the public about what

28:14

was happening. As many as a quarter

28:17

of the thelidamide survivors born in Australia

28:19

were conceived after December nineteen

28:21

sixty one. In Spain,

28:24

it took years for the government to formally

28:26

outlost solidamide or to remove it from

28:28

the official Register of Drugs, and

28:30

sometimes warnings used the term the liidamide

28:33

while the drug was being sold under other brand

28:36

names. There were seven different brands

28:38

of the litamide sold in Japan alone.

28:41

Even in places with more coordinated efforts

28:43

to warn people about the dangers of the drug, the

28:45

first generation of the litamide survivors

28:48

included people born as late as nineteen sixty

28:50

four and possibly even later.

28:53

Because all of this traced back

28:55

to a drug that they had believed was

28:57

safe. This whole crisis

28:59

led to just an incredible and crushing

29:02

sense of shame, grief, depression,

29:04

and anger for everyone involved,

29:07

whether they had prescribed the drug or

29:09

taken it or given it to a friend or family

29:11

member. Many babies born with

29:13

solidamide embryopathy died

29:15

in their first year of life. Those

29:17

who survived usually had multiple disabilities

29:20

that have seriously affected the rest of their lives,

29:23

which means that this whole crisis was exacerbated

29:25

by attitudes about disability and the state

29:28

of disability rights. The various

29:30

countries where solidamide was sold all

29:32

had their own nuances, but in general,

29:35

disability was more heavily stigmatized

29:37

than it is now, and doctors approached

29:39

the subject very differently than

29:41

they do today. So if you read

29:43

articles written about this crisis as

29:46

it was unfolding, a lot of them don't

29:48

even sound like they're describing human

29:50

beings worthy of life. The

29:52

default response, even among medical

29:54

professionals, was often to see these

29:56

newborns as a hopeless and even

29:59

monstrous track agedy, rather than as a person

30:01

who could live and thrive with the right

30:03

care and accessibility. There were

30:06

even cases and suspected cases

30:08

of infanticide. In one documented

30:10

example, a Belgian woman named Suzanne

30:12

Vanderputt admitted to killing her daughter with

30:14

barbiturous dissolved in milk. She

30:16

was acquitted in nineteen sixty two, and

30:19

many countries, doctors recommended

30:21

that babies with folk amelia or other

30:23

disabilities be placed in institutions

30:26

rather than being sent home with their families, regardless

30:29

of the level of care that the baby actually

30:31

needed. My mom worked

30:33

in long term care for kids with multiple

30:35

disabilities for years and years,

30:38

and she definitely worked with kids who needed

30:40

some kind of twenty four hour medical

30:42

assistance. This was not the case

30:45

with a lot of children who were born after

30:47

being exposed to the linamide. Sometimes

30:50

medical staff took newborns

30:52

away from the delivery room before their

30:54

parents had held them or even seen

30:56

them, and a lot of places,

30:58

parents who took their baby home did

31:00

so against medical advice and

31:03

after being strongly discouraged

31:05

from doing so by their doctors.

31:08

And whether a child was growing up in an institution

31:10

or at home, most communities were

31:12

far less accessible than they are today, and

31:15

today there is still a long way to go. In

31:17

most of the world, schools and

31:19

other public buildings were not accessible for

31:21

wheelchairs. Parents, teachers,

31:23

and administrators had little to no education

31:25

or experience in how to make a home or a

31:27

school accessible to children with

31:30

these types of disabilities. Prosthetics

31:32

and adaptive devices had not really been

31:34

developed for children. So, in other words,

31:37

there were barriers everywhere, physical

31:39

barriers to being able to access facilities,

31:42

and societal barriers due to prevailing

31:44

attitudes about disability. US

31:46

includes the litamied survivors who

31:48

have described being bullied and harassed

31:51

by peers and by adults

31:53

because of their disabilities. The ones

31:55

who grew up in care have often described

31:57

feeling like strangers every time they visited

31:59

their family, least once they got older. But

32:01

really this is us as

32:04

full of information and heartbreaking as

32:06

this is simply the beginning of the story.

32:09

The Solido mine crisis led to totally

32:11

revised drug standards around the world, a

32:14

criminal investigation, and decades

32:16

of lawsuits and ongoing efforts

32:18

to get access to necessary support

32:20

and services. And we're going to talk about

32:22

all of that next time. I

32:25

also have a little bit of listener

32:27

mail to close us out, all

32:30

right, This is from Rachel. Rachel

32:32

says, Hello, ladies, I listened to your episode

32:34

on the women of the Civil War and loved

32:36

it, especially learning about Elizabeth

32:39

Thorne. So fantastic, but it made me think

32:41

about how other women have played a part in

32:43

military service. I've listened to your

32:45

episodes on the Night Witches and the six

32:47

Triple eight, Central Postal Directory

32:49

Battalion and others, but I really wanted

32:51

to look into more Canadian history,

32:54

seeing as that's where I am from, and I

32:56

stumbled across the Nursing Sisters.

32:58

The Nursing Sisters started out as volunteers

33:01

during the South African War, but eventually

33:03

gained a relative rank

33:05

as lieutenants and then officers. By World

33:08

War One, they were nicknamed the Bluebirds

33:10

because of their blue dresses and white veils, which

33:12

I just love, and by the end

33:14

of World War Two they had been renamed as

33:16

the Royal Canadian Army Medical Corps.

33:19

Another interesting fact, two of the Nursing

33:21

Sisters, Meta Hodge and Eleanor Thompson,

33:23

in World War One, became the first women to be

33:26

awarded a wartime Medal of Valor

33:28

in Canada. There's a great heritage

33:30

minute on this story which I'll link below,

33:33

and then moving on to a

33:35

more personal note. Also, I'm

33:37

not sure if you remember Momo the historian

33:40

hound, but that's my dog, and I wanted to thank

33:42

you again for getting us through so many awful

33:44

bats. I don't know if I could do it without you,

33:47

guys, so I've added pictures of her into

33:49

Thanks again, and have a great day, ladies. I

33:51

was from Rachel. Thank you so much. Rachel. Of

33:53

course we even remember Momo this story

33:56

and hound Mo Mo such

33:59

a good dog. Thank you so much for

34:01

this um this email and for sharing

34:03

this information about the nursing sisters.

34:05

I don't know if they will make it into a full episode

34:08

at some point, but in case they do not, there's

34:10

a little tidbit about it about them for our

34:12

listeners. If you would like to write to us

34:14

about this or any other podcast, where at History

34:17

podcast at how stuff Works dot com. And then we're

34:19

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34:21

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34:23

and Instagram. You can come to

34:25

our website, which is missed in History dot com,

34:27

and you'll find show notes for all the episodes Holly

34:29

and I have never done together in a searchable archive

34:32

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34:34

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34:36

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34:43

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