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not available in all states. When

0:24

I came to this story, if

0:26

anyone ever did an article

0:29

about thalidomide, they wrote about Frances

0:31

Kelsey and they never even tried

0:34

to pick up a phone and talk to a survivor. I'm

0:39

Katie Hafner and this is Lost

0:41

Women of Science Conversations where

0:44

we talk to authors and artists

0:46

and poets and filmmakers about the

0:49

work they've done to uncover and

0:51

celebrate overlooked women in STEM. Over

0:54

the past five weeks, we've been delving

0:57

into the story of Dr. Frances Kelsey,

0:59

a medical reviewer at the US

1:01

Food and Drug Administration. In

1:04

the early 1960s, she prevented

1:06

thousands of babies from being

1:08

born with shortened limbs, hearing

1:10

loss, weakened organs, and other

1:12

horrible injuries they sustained in

1:14

the womb. If you've

1:17

listened to the whole season, you'll know

1:19

that it was Frances Kelsey who stood

1:21

her ground and would not approve thalidomide,

1:24

the drug that caused all of these

1:26

injuries. But you'll also

1:28

have heard that thalidomide was actually

1:30

available in the United States. More

1:33

than 1,200 American doctors across the

1:35

country were sent pills by the

1:37

company that wanted to manufacture and

1:40

distribute the drug. They

1:42

were part of a network of

1:44

medical professionals asked to carry out

1:46

clinical trials, such as they were,

1:48

with little oversight or guidance. So

1:51

today we've decided to put

1:53

out an episode that zeros in

1:55

on that quiet spread of thousands

1:57

of thalidomide pills across the US

1:59

and the subsequent search for

2:01

survivors. And

2:04

to do this, I'm delighted to welcome

2:06

a familiar voice to those who've been

2:08

tuning into the season, Jennifer Vanderbess. Jennifer

2:12

is the author of the book

2:14

Wonder Drug, The Hidden Victims of

2:16

America's Secret Thalidomide Scandal. The

2:19

book was published in 2023

2:21

and the paperback is out just now. In

2:24

the book, Jennifer uncovered what happened to those

2:26

pills and the people who took them here

2:28

in the US. Jennifer,

2:30

welcome to Lost Women of Science.

2:33

Hi, Katie, it's great to be here. So

2:36

I have to say, first of all, when

2:38

you embark on a nonfiction book, it

2:43

becomes like this magnificent obsession,

2:45

right? Correct. That's your decision

2:47

is, this is this thing I'm going to be

2:49

working on forever and ever. So

2:51

I wanted to ask you, when you

2:53

decided to write the book, you

2:56

knew there were already books about

2:58

Thalidomide, it had been covered a lot.

3:01

So you knew you had a lot of material to work

3:03

with. At the same

3:05

time, I wanted to ask you, how

3:08

did you want your story to differ

3:11

from those that already existed? And

3:13

also, I do have

3:16

to say, I mean, what an incredible bummer of

3:18

a subject. So

3:21

can you answer kind of both

3:23

those questions? Why decide to immerse

3:25

yourself in such a depressing topic?

3:29

It's a great question. I mean, at the

3:31

time, my entry point into this story were

3:34

the heroes, Francis Kelsey,

3:37

the primary one in the story, who

3:39

had sort of been in these glamourless,

3:42

bureaucratic posts doing

3:44

their day to day work and

3:47

rose to the occasion to prevent

3:49

this horrible tragedy from happening

3:51

in the United States. So there

3:54

was a depressing component to the

3:56

story. But I thought what

3:58

I was narrating was the heroism

4:01

of average people who heed the

4:03

call. So I was really inspired

4:05

by the story when I went into it. And

4:07

I didn't quite know the scope

4:09

of it. As you mentioned, thalidomide

4:12

and the thalidomide scandal, which actually

4:14

happened worldwide, was not an unknown

4:17

news item. I'd heard about Frances

4:19

Kelsey. What struck me first,

4:21

actually, was that most of what had

4:23

been written about her in

4:26

the past, let's say, 10 years before I started

4:28

work on the book, was pretty much exactly the

4:30

same as what had been written about her in

4:32

the 1960s. No

4:34

one had really circled back to her. No

4:36

one had done any additional digging. And that

4:38

was pretty much true of all the books

4:40

that I'd read on the subject. And there

4:43

weren't tons of them. There were a

4:45

limited number. Are you saying that her story was accepted

4:47

at face value? Or are you saying that no one

4:49

had advanced the story beyond that period of time in

4:51

history, or a little bit of both? There was a

4:53

little bit of both. There was a little bit of

4:55

case closed. The story that had been delivered was a great

4:58

one. She was a hero.

5:00

The United States spared the effects of

5:02

this horrible drug that had affected babies

5:04

worldwide. JFK gives her an

5:07

award on the White House law. And it's

5:09

a fabulous story. The FDA uses it to

5:11

recruit new medical reviewers. Wonderful, wonderful. When

5:13

I came to it and I started doing my initial

5:16

research, and I was

5:18

reading what we call

5:20

secondary sources. I was reading books. I was

5:22

reading articles. What struck me is that they

5:24

were all referencing pretty much secondhand

5:28

sources from the 1960s. No

5:31

one had gone and looked at any FDA

5:33

records. No one had really done any kind

5:36

of digging into the story beyond what had

5:38

been announced in 1962 as

5:41

the end of the story. And I happened to be aware

5:43

at the time that her papers had landed at the Library

5:45

of Congress, and that some other papers

5:48

and documents relating to people peripherally

5:50

connected to the story were available. There

5:53

was a lot more that subsequently was

5:55

revealed. There were the FDA-recommended

5:57

criminal charges be pressed against the...

8:00

trying to do a deeper dive into research

8:02

was an interest in really bringing to

8:04

light the stories of these various women

8:07

who had been so essential in keeping

8:09

the drug off the market. So

8:12

you had this epiphanous moment when

8:14

you wrote to your editor and

8:16

you realized what? Yes.

8:20

So I had proposed this book

8:22

using the information that was widely circulating

8:24

for decades, which is that there were

8:27

about 17 American babies harmed

8:30

by the drug thalidomide and about

8:32

half of those were supposed to be due to

8:35

exposure from overseas thalidomide. So

8:38

it's supposed to be a very small number. And by

8:40

all accounts, most of those individuals

8:43

had not lived into adulthood.

8:46

Right. So when you say from overseas

8:48

that somebody would go overseas, find the

8:50

drug. In fact, we start the first

8:53

episode of the season with Sherry

8:55

Cheson and her husband

8:57

was in England and

9:00

came back with distival, which is how

9:02

thalidomide was branded and she took it.

9:05

And so that you're saying that that is what

9:07

it was chalked up to as people having gotten

9:09

the pill overseas. Yeah. And for

9:12

half of those FDA cases, that was

9:14

accurate. So the story was that, you

9:16

know, Francis Kelsey had not

9:18

approved thalidomide. Therefore, a very,

9:21

very small number of babies had been

9:23

exposed to it through what was suggested

9:25

to be a very small number of

9:27

clinical trials. I put that in my

9:29

proposal, you know, for Random House. That was part

9:32

of the story I thought I was telling. That there were

9:34

17. The 17. And

9:37

I don't know why,

9:39

except, you know, the

9:41

nature of working on a nonfiction book like this

9:43

that sort of always feels like it gets a

9:46

little bigger and a little stranger is that

9:48

sometimes late at night, I would just

9:50

Google things I'd already googled just to

9:53

see if I don't know something different

9:55

came up. Right. And I don't know

9:57

why or what exactly I would. into

12:00

their lives. There are survivors

12:02

that we know of who, you know, didn't

12:04

make it past their 40s. I

12:07

would say now there are probably

12:09

about 100 living in

12:12

the U.S. And it's a challenging

12:15

number to establish because

12:18

we lack, what their overseas counterparts

12:20

lack, which is a sort of

12:23

concrete proof. And the

12:25

injuries can vary widely. But I think the

12:27

numbers are on par with

12:30

the Canadian survivors. I think the drug was

12:32

so widespread here that you had about

12:35

as many injuries as the Canadians saw in

12:38

a country where it was legally distributed. Yeah,

12:41

I'm very involved with the American

12:43

thalidomide community and we still have people

12:46

emailing, you know, every few

12:48

weeks. And it's either, I think

12:50

I might be a survivor or a very

12:53

common story is we had

12:55

a sibling. I know that my mother

12:57

had a baby after me. I

12:59

was three. I remember something, something.

13:01

They didn't want to talk about it, right? I

13:03

mean, that's a pretty frequent outreach,

13:06

the surviving siblings of a thalidomide baby in

13:08

a family that didn't know what to make

13:10

of it. And is

13:12

it true that to this day,

13:14

the United States remains the world's

13:16

sole developed nation that

13:18

refuses to support a single

13:21

thalidomide victim? Is that true?

13:24

Yes, yes, absolutely. And

13:27

they're fighting it right now. They being

13:29

the thalidomide survivors. Yes, yes.

13:32

Speaking of which, there's a famous very

13:34

messy case, Hagens Berman.

13:37

Yes. Can you tell me about

13:39

that? So there's

13:41

a law firm in Seattle that

13:44

has mounted a lot of very

13:46

famous successful class action suits against

13:48

large wrongdoers. They

13:52

heard about the thalidomide story after

13:55

a very successful case in Australia

13:57

in which some adult survivors who

13:59

hadn't previously... been recognized, were able

14:01

to get compensation. This

14:03

American firm became interested, and

14:06

they started placing ads

14:08

and trying to find whatever American survivors

14:10

they could. They gathered, I think it

14:13

was about 50 or so

14:15

in their first filing, and they

14:17

brought it to a court.

14:19

Now, we have a thing in the United

14:22

States called the Statute of Limitations, which makes

14:24

it incredibly hard to bring a suit

14:27

decades later. And this

14:29

has been sitting, I mean,

14:32

boy, I mean, well over a

14:34

decade in a Philadelphia court as

14:37

a judge and some other

14:39

people involved try to untangle whether

14:42

or not this case can

14:44

really even be heard, and

14:47

whether or not the survivors

14:49

can establish that

14:52

there's a reason they didn't know

14:54

until recently that they were thalidomide

14:56

survivors. My hope in the book,

14:58

and I did something I

15:00

never thought I would do, but I sort of insert myself as

15:02

a character at the end because it became

15:04

impossible to tell the story truthfully

15:06

without acknowledging that my role as

15:09

an author, meeting people in this community, doing

15:11

research that was very pertinent to their lives,

15:14

their legal cases, their story, there was simply

15:16

no way to pretend that the writing of

15:18

this book and the research wasn't actually impacting

15:20

the story. Right. It

15:23

emboldened people. I think

15:25

that was a very smart decision on your part. Yeah.

15:28

And it was the most honest way to go

15:30

about it. And they are still

15:32

trying to see if there

15:34

is a universe in which this court case can

15:36

be heard. What I thought could be helpful in

15:39

what I discovered in the book. So

15:41

when Hoggins-Burman brought this case, the

15:43

defense, these pharmaceutical companies now, they've

15:46

been gobbled up by larger firms and

15:48

go by different names. But their argument

15:50

was, hey, like here's an article by Morton

15:53

Mince from 1962. See,

15:55

everybody knew that thalidomide was round

15:57

and about. This made it all

15:59

clear. Everybody should have known

16:01

in the 1960s that they might have been exposed to it,

16:04

brought these lawsuits ages ago, end of story.

16:07

What I, and they submitted to the court

16:09

a list, it probably was 40 or 50

16:12

articles that had appeared in the 1960s about

16:14

the litemite. What I tried

16:17

to clarify in the book is

16:19

that in the real of it, you know, if

16:21

you live in Mississippi and

16:23

are not reading the Washington Post, you

16:26

know, this is not the age of Google, where

16:28

you have a baby with shortened arms and you

16:31

just type it into your computer and it comes

16:33

up like, oh, maybe this is related to the

16:35

litemite, to really establish how completely in

16:37

the dark these families were.

16:40

And, you know, to me,

16:43

one of the biggest horror stories of this

16:45

story is not the drug itself, it's

16:48

the complicity of the doctors along the

16:50

way. Well, yes, let's get

16:52

into that. The complicity of the doctors

16:54

along the way, because what we need

16:56

to explain is how it

16:58

is that those pills were distributed in

17:01

the United States. So why don't you

17:03

tell me about that? Yeah, so there

17:05

was, you know, we had an FDA

17:07

when thalidomide was invented and we

17:09

had a process, which was you're a drug

17:11

firm, you want to sell a drug, okay,

17:13

you need to submit to the FDA an

17:16

application explaining what this drug is, how it

17:18

works, and you should submit

17:20

to them some human research, and

17:22

we call those clinical trials, right? And

17:24

nowadays, if you're part of a clinical

17:27

trial, my guess is you've probably signed

17:29

some extensive paperwork, you know, acknowledging

17:31

that you're in a clinical trial, understanding the terms,

17:33

the risks, or whatever. Well, in 1959, if you

17:35

were in a clinical trial, like

17:40

maybe your doctor knew, but

17:42

you didn't necessarily know, and

17:44

further, with thalidomide

17:46

specifically, because the drug

17:48

had been sold overseas for a few

17:50

years and was so successful, the approach

17:52

of Merrill, the American drug firm, when

17:55

they wanted to put it on the

17:57

American market, was like, this

17:59

is a slam dunk. This is

18:01

like aspirin. Like, it's been circulating, it's

18:03

fine, clinical trial, schminical

18:05

trial. So Meryl decides

18:07

that for thalidomide, they're going

18:10

to get the sales force engaged before

18:12

FDA approval. So they essentially

18:14

send their entire sales force around

18:16

the country to knock on doors

18:18

in hospitals. They want doctors

18:21

with the most access to

18:23

the most patients. And they say, FDA

18:26

approval is like around the corner. This is the

18:28

greatest drug ever. Go ahead. We'll

18:31

ship you a few thousand pills. And

18:34

that's how they start. By 1960,

18:36

there's sort of two things going

18:38

on simultaneously in the story. One is that this

18:41

massive stack of papers sitting on Francis

18:43

Kelsey's desk, and at the same time,

18:46

there are like a few hundred salesmen

18:48

hobnobbing in a hotel in Cincinnati, getting

18:50

their marching orders about their new sales

18:52

mission, which is to basically sweep the

18:55

country, go hospital to hospital, doctor

18:57

to doctor, and try to get these doctors

18:59

as excited as possible about

19:02

handing out thalidomide before FDA

19:04

approval. And the reason that Meryl was so

19:06

hot to trot on this drug is that

19:09

Meryl saw that the German company

19:11

that had first developed and

19:13

sold the drug Grunenthal was

19:16

making money hand over fist. Sedatives

19:19

in the 1960s were a goldmine. It

19:22

was an era where people believed

19:25

that every discomfort, anxiety could

19:27

be solved, remedied

19:31

by a pill. These were drugs

19:33

that were not designed to treat an

19:35

illness for a week. They were going

19:37

to be taken like everyday drugs a few

19:39

times a day, hopefully into perpetuity. This

19:42

was the most lucrative kind of pharmaceutical you

19:44

could put on the market in 1960. And

19:48

they were guns blazing, ready to go.

19:51

And all they had to do was

19:53

get FDA approval and get Francis Kelsey to say,

19:55

OK, go. She

19:57

wouldn't do that. But they kept

19:59

deciding. distributing it to doctors under

20:02

the guise of clinical trials. And it's really

20:04

important to really explain that

20:06

though they called them clinical trials,

20:09

when the FDA finally investigated these

20:11

were completely sloppy, undocumented,

20:13

no records of patients' age, dosages,

20:15

you know, it was a hot

20:18

mess. And because they

20:20

had been so ambitious

20:23

and overzealous in representing

20:25

this to doctors, the

20:27

key part of what went wrong in the

20:29

American story is that when they

20:32

finally realized that over 1200 doctors had

20:34

officially been given the drug, they

20:36

also discovered that those doctors had

20:39

handed it to their friends. So

20:41

the number starts to double, triple,

20:43

quadruple really quickly. And

20:46

the reason why it became hard

20:48

to impossible for the American survivors

20:51

to ever concretely prove that they were

20:53

given the drug is that their

20:55

mothers were not seeing a doctor that was on

20:57

that list of 1200 official doctors. Their

21:01

mothers were seeing doctors that were

21:03

friends with those doctors working in

21:05

the same hospital, golf buddies. That's

21:08

how it's spread so perniciously and in

21:10

this completely undocumented way. Unbelievable.

21:14

That is, it's

21:16

shocking. I mean, and also, you

21:18

know, these women were just being told, oh, this

21:20

will help you sleep. Oh, this will help with

21:22

morning sickness. Were they given the morning sickness line

21:25

at that point as well? The

21:27

drug was distributed for everything

21:29

from morning sickness to headaches,

21:31

to menstrual cramps, to anxiety.

21:33

A lot of doctors actually believe that morning

21:35

sickness was not a real medical condition. Excuse

21:37

me? Right. They

21:40

just believed that it was anxiety about

21:42

potentially an unwanted pregnancy. Right. That

21:45

was a medical theory in circulation amongst male

21:47

doctors. The reason

21:49

that it made sense to them to give

21:51

an anti-anxiety pill was that they thought that

21:53

that's what was actually at the root of

21:55

what was causing a woman

21:58

to feel nauseated. so

22:00

they were handing it out for everything. More

22:04

after the break. Hey

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23:07

right, so there's Kelsey. Let's circle

23:09

back to her for a minute.

23:12

She doesn't know any of this. All

23:15

she really knows is that she's unhappy with

23:17

the application. She sees

23:19

holes in it. It's quote, incomplete,

23:21

incomplete, incomplete. And she keeps throwing it back

23:23

at them. And the Meryl people are, especially

23:27

this one guy, Joseph Murray, he's

23:30

like going out of his mind because he's

23:32

promised his bosses that this thing was gonna

23:34

get rubber stamped. Okay, so

23:36

it all comes out just

23:40

very quickly to make a

23:42

very long story shorter. The Germans

23:44

withdraw it after a

23:47

lot of pressure after having denied it for a

23:49

long time. In November of 1961,

23:53

but can I tell you, Jennifer, that

23:55

what I, through this entire

23:58

season, what... galls

24:00

me more than anything. And I know what you

24:02

mean about how we aren't in the age of

24:04

Google, but the time lapse

24:07

between when, for instance,

24:10

the Germans withdraw the drug from

24:12

the market in Germany and others

24:15

withdraw it in other places. Word

24:18

doesn't get out in the United States.

24:21

My main kind of

24:24

rant in the season is why

24:27

was there this delay? It's

24:30

interesting. I mean, of the many

24:32

irresponsible things done along the way,

24:34

the sort of concrete facts that

24:36

the inventor and licenser

24:39

of the drug in Germany removes

24:41

it completely from the market because

24:43

of documented concerns that

24:45

it's causing birth defects. And

24:48

Maryland, the U.S. does not

24:50

withdraw their application from the FDA. But

24:52

they knew it. They obviously they knew

24:54

it. And I'll circle back to this

24:56

amazing sales force that they have. Let's

24:58

just say you find out that a

25:00

drug you've sent around the country is

25:03

wreaking havoc. You

25:05

don't need to mail letters. You've got

25:07

all these guys in their suits with

25:09

their briefcases who can drive up and

25:11

tell doctors right away, stop giving it

25:13

out. And they don't do that. The

25:15

detailmen were never even told that the

25:17

drug was no longer safe. So

25:21

Merrill takes this sort of,

25:23

you know, reckless, optimistic, idiotic,

25:27

you know, criminal,

25:29

like so many adjectives

25:31

you could throw at it. But

25:33

essentially they choose not to withdraw

25:36

the application. They

25:38

send a few, I'll call

25:40

them light letters to a

25:42

few clinical investigators basically saying

25:44

that they're not alarmed. You

25:46

know, this is what's happened.

25:49

You know, maybe proceed cautiously.

25:52

So yes, you have months and months and

25:54

months go by where this drug

25:56

is still freely circulating. The public

25:58

has no idea. Most doctors. no idea.

26:00

This story has been resolved

26:02

by all accounts in Europe, but in

26:05

the United States, this drug is still

26:07

zipping around from doctor's office to doctor's

26:09

office and being handed to women. And

26:12

it's absolutely bonkers to think how many months that

26:14

went on. It wasn't a matter of weeks, it

26:16

was months. And then the

26:18

other big question. Once Frances Kelsey

26:21

knew how harmful it was and all those

26:23

dots had been connected, did

26:25

she know about all those detail

26:27

men, Meryl's sales guys, and

26:30

how many pills had been distributed around the

26:32

US? And what did she

26:34

do in order to investigate how many

26:36

American survivors there were? So

26:39

as soon as this news hits the FDA, some

26:42

portion of it is sort of removed

26:44

from her purview, right? Like she understands,

26:47

oh my God, this drug is harmful.

26:49

She starts making phone calls. And what

26:51

she starts hearing, which is basically what

26:54

the FDA encounters is, oh

26:56

yes, we do have a few babies

26:58

at this hospital born with folkamelia,

27:00

but no, they weren't given the drug.

27:03

At this same hospital, this incredibly rare

27:05

condition. Right, exactly. Where you

27:07

should only see one case every 30

27:09

years. Oh yes, we had five in the

27:11

last two years. Oh yes, it was in

27:13

the hospital pharmacy, but no, all

27:16

the doctors are saying that that wasn't exposure.

27:18

It's interesting to talk about sort of pharmaceutical

27:20

greed, which I think everybody would sort of

27:22

nod their heads nowadays and say, oh yeah,

27:24

yeah, yeah, we get. For me,

27:27

the really shocking component of this

27:29

story was realizing how many

27:31

physicians after the fact knew

27:34

what they had given these women, knew

27:36

that they had contributed and participated, you

27:38

know, not their fault, but they had

27:40

information that was very essential to share

27:42

and they chose not to. One of

27:44

the early rare court cases, which is

27:46

a case of David Diamond,

27:49

whose mother had been visiting the Cleveland

27:51

Clinic, her husband I think was suffering

27:53

a heart attack. She kind of is

27:55

in the hospital corridors, having

27:57

an anxiety attack and someone hands her an envelope.

38:00

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38:12

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