Stalling for Survival - A Lonely Fight Against a Deadly Medicine

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In a neat Washington, D.C.

office with peeling green walls, time is running out for softly spoken, incredibly thorough Dr.

Francis Oldham Kelsey.

It's November 1960.

Two months earlier, a thick bundle of papers, several phone books worth, arrived on her desk at the Food and Drug Administration.

It was an application for a new drug to be approved for the American market.

Frances and her small team had been given 60 days to approve or refuse a drug, and this application was expected to sail through.

The drug has been given the name Kevidon and is reportedly a side-effect-free sedative that can ease anxiety, insomnia and morning sickness.

For years it's been used by millions of people in Europe, Africa and Australia.

Manufacturer William S.

Merrill is so confident of a swift approval in the States, it's already printed promotional material for the Wanda drug and gathered the ingredients to make 15 million pills.

But something isn't sitting right with Frances Oldham Kelsey.

She would later say,

Here was a drug that looked like it should be no problem, but at the same time, there was just a feeling that

there was something in the data or the absence of data that was a cause of concern.

The trouble is, Frances doesn't have any hard proof that there is a problem with Kevadon, and the end of her 60-day review period is fast approaching.

If she doesn't approve it or reject it by then, the company can sell it regardless.

What can she do to buy herself more time to determine the drug's safety?

William S.

Merrill is pressing Francis hard.

An approval for the mild sedative in time for Christmas would be very lucrative.

After all, it's hugely popular in West Germany, where it goes by the name of Contagan.

In Britain, New Zealand and Australia, where it's called Distaval,

and in South Africa, where people take enterocediv.

So many names for the same drug, thalidomide.

I'm Tim Harford, and you're listening to Cautionary Tales.

Today, thalidomide is synonymous with babies born with terrible injuries suffered during pregnancy.

But in the 1960s, no one appreciates the danger.

It's a very mild sedative, after all.

Freely available in 46 countries, only Frances Oldham Kelsey stands in the way of thalidomide entering the American market.

Here to tell us all about this incredible woman is Katie Hafner of the Lost Women of Science podcast.

Katie, welcome to Cautionary Tales.

Tim, thank you so much for having me.

It's a pleasure.

Now, A Lost Women of Science is a remarkable podcast.

Just give us the quick explanation of what it is that you do.

Well, our mantra is, we're not mad, we're curious.

Okay, we're a little mad.

So we started the podcast a few years ago with the idea that for every Marie Curie or Rosalind Franklin out there whose story

has been told,

There are hundreds, if not thousands, of women whose stories deserve to be told.

And we have a growing database of something like 350 women, all of whom did remarkable work in science.

And we are just chipping away at it and telling their stories.

Well, we're going to tell Frances Oldham Kelsey's story today with your help.

So just tell me a little bit more about this woman.

Well, she was, as you say in your introduction, soft-spoken, a very serious scientist.

She was an MD and a pharmacologist.

And she wanted to be a scientist from a very early age, which was at that time fairly unusual for a woman.

And this woman, by the way, was Canadian.

She was also a very wonderful mother.

We talked to one of her daughters.

And in her spare time, and I just love this, for a good time, she would read medical journals with her husband, who was also a pharmacologist.

After dinner, the kids remember, oh yeah, mom and dad would do their romantic thing and discuss what they just read in the BMJ or

curl up on the sofa and discuss the latest pharmacological trials.

Yeah, I love that.

Frances had a PhD in pharmacology.

I believe she was the first woman in the United States to earn a PhD in pharmacology.

And

she had early dealings with the FDA

because her mentor, EMK Geiling,

had been asked by the FDA to look into

a medicine called Elixir sulfanilamide, which was this cherry-flavoured cold medicine that was suspected of having killed over 100 people, many of them children.

So in the late 1930s, he was asked to look into that.

Was Frances Oldham Kelsey involved in that investigation or just hear about it secondhand?

She was involved, and I think it planted a seed in her head about the need for strict, rigorous requirements for FDA approval for drugs.

It was really kind of a free-for-all before them, which is how this crazy antifreeze thing happened.

Aaron Trevor Burrus, yeah, so this drug had an antifreeze diethylene glycol, which is potentially deadly and killed people.

I mean, can we just stop for a second and say, how crazy is that?

Okay.

Yeah.

It is.

I mean, one of the points that Lost Women of Science mentioned, which I just thought was fascinating and horrifying, is that that the FDA wasn't actually in charge of making sure that that sort of thing was safe.

It wasn't the FDA's job to make sure that the cough medicine wouldn't kill you.

It was the FDA's job to make sure that the cough medicine had what the manufacturers said it had in it.

So they said it had antifreeze in it, and it did have antifreeze in it, so there's no problem.

The law changed after that, understandably.

Right.

And we're going to see later on how the law changes even more thanks to her.

Aaron Powell, and the other thing that she did that I think would later become important as a young scientist was to investigate quinine,

which is a drug used for malaria medication.

And one of the things that she and her colleagues discovered was that that drug could pass the placental barrier.

So it would get into the fetuses of pregnant animals who were given quinine.

Yes, in fact, this is how how she met her husband.

I love it, you say quinine, we say quinine.

It's okay, I'll allow it.

So, yes,

this experience she had with the quinine work was really important because, again, it planted a seed in her head about the placental barrier, which then plays a very important role in her concerns later about thalidomide.

Okay.

So,

she's seen that drugs can pass into a fetus.

She's seen that the work of the FDA is incredibly important, and if things go wrong, people die.

So these are two parts of her life story.

And in 1960, she begins a new job as a medical reviewer at

the New Drug Application Division of the FDA, working in Washington, D.C.

And just a few weeks later, in September 1960, this application from the drug company William S.

Merrill lands on her desk.

So just tell me a little bit more about the company and about the drug they were trying to get approved.

The drug thalidomide had been developed by the Germans not long after World War II.

This company, Chemie Grunenthal, and Merrill was the American company that was hoping to take this thing to market.

It was hugely successful.

in Europe and elsewhere.

Thalidomide was considered this wonder drug, a sedative substitute for barbituric.

In other words, it had none of these hangover qualities.

It wasn't addictive.

There were no side effects that could be determined.

And it was taken for anxiety and for insomnia.

And later it was prescribed for morning sickness.

And people were taking this drug, just popping them like gumdrops.

And there was a very cozy relationship between the pharmaceutical industry and the FDA.

And a lot of these drugs were just basically rubber stamped.

And she was new.

Frances Kelsey was brand new

to the agency.

And everyone thought, well, you know, the new girl, we'll just stamp it and this thing will be on the market by Christmas and we're good to go.

Yeah, the new girl who's, we should say, I think is in her 40s at this point, but yeah, sure, the new girl.

Yes, the new girl.

I think they actually said the new girl.

Absolutely.

I've no doubt that they did.

The claim for this drug is that it's completely safe.

You literally cannot overdose on it.

It's risk-free.

But Frances Kelsey wasn't so sure.

What was it that made her doubt this?

Of course, there was a deluge of paperwork, and she was going through all of this.

She said something like several phone books worth of paperwork.

And she just didn't see the science.

She didn't see the evidence.

She didn't see what have come to be known as clinical trials done in any kind of rigorous way.

And she just said, this just isn't working for me, guys.

And she did not rubber stamp it.

She wanted more evidence

that it was safe.

Yeah, and she took her work home with her and she showed it to her husband because he's another pharmacologist.

So she's getting a second opinion.

And he picked up on this weird claim that there is no lethal dose.

You can overdose on water, but apparently thalidomide, you cannot overdose on thalidomide.

So, yeah.

So exactly.

So that's a red flag.

There had been no animal testing.

And also others in the office who could read the German because Meryl had included all of these so-called studies that the Germans had done.

And apparently the translations weren't done properly.

And, you know, there were all kinds of things to him that made her just say, well, wait a minute.

I mean, this was a woman who crossed her T's and dotted her I's and it wasn't working for her.

So she looks at this and she goes, well, it seems strange that they haven't done really good studies.

It seems strange that they've botched the translation.

It seems strange that they've made this

extraordinary claim that it's absolutely non-toxic.

But there's no actual evidence that it does any damage.

And she's only got 60 days to approve it or reject it.

And she can't reject it because there's no evidence that there's a problem.

So what does she do?

Frances had a mentor at the FTA named Barbara Moulton who actually left in a very high-profile way.

And Moulton was very outspoken.

Another difficult woman.

Yes, another difficult woman.

And Moulton said to her, you know, here's what you could do.

You could just declare the application, regardless of how many phone books it's taking up, as incomplete and so that's what she did in order to buy herself time

so this thing came onto her desk in September in November she declares it incomplete and infuriates infuriates the people at Merrill yeah because they want to sell this drug in time for Christmas which is can we just say for Christmas like because everyone needs sedatives at Christmas yeah yeah nothing says Christmas like a sleeping pill right

Okay,

so

the clock resets, but it's still ticking.

Frances Kelsey is no closer to finding any actual proof that there is a problem.

So, where should she look for answers?

How does the son of a Nazi geneticist come into the picture?

We will find out the answers to these questions after the break.

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As Amika says, empathy is our best policy.

That's why they'll go above and beyond to tailor your insurance coverage to best fit your needs.

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We're back and I am joined by Katie Hafner, the host of Lost Women of Science.

So Katie, we left Frances Oldham Kelsey having brought herself a little bit more time, but she still doesn't have any proof that this new drug Kevadon, aka thalidomide, is dangerous.

She just has this gut instinct that something's not right.

So what does she do next?

Well, what she does next, thanks to her avid interest in reading medical journals.

On the sofa with her husband, yeah.

On the sofa with her husband, is that in late January 1961,

so now we're several months into this and we have missed the Christmas window,

she reads a letter from a Scottish doctor in an old copy of the British medical journal BMJ, and the title absolutely gets her attention.

It's, is thalidomide to blame?

And what he notes in this letter is that four patients have peripheral neuritis, which is this painful tingling in the arms and feet and loss of sensation.

And this happened for all four of these people after taking thalidomide for a year.

So he alerts the UK

distributor of thalidomide, which is called Distillers,

and they put warnings on their labels in August of 1960, which is a full month before Merrill even submitted its application to the FDA.

Did Merrill's application mention

these concerns or the warning labels?

No!

It did not.

The Merrill representative, Joseph Murray, the one who's been communicating principally with Frances and has been harassing her to no end, he never even mentions this until he is pressed to do so.

And when she brings it up with him, he says, oh, well, no, it's all okay.

Right.

Well, he says that to her, but then he calls her boss and complains.

Right.

And then he calls her boss and complains because this woman is just making his life a misery.

What did her boss do?

Because I understand he basically accused her of libel.

It's like the FDA, your inspector, Frances Olden Kelsey, she is libeling us, which is a pretty heavy claim.

It is, but her boss backed her up, which was also infuriating to Merrill.

They have so much on the line here.

And they're getting absolutely nowhere.

And in the spring of 1961, Frances went so far as to write a letter to Murray and say that the burden of proof that the drug is safe lay with the applicant.

You want me to approve this drug.

You prove it's safe.

Yes.

Don't expect me to prove it's dangerous.

I want you to prove it's safe.

That's correct.

And she was, I think, possibly influenced by her work on quinine.

Yes.

She was particularly concerned to prove it safe for use during pregnancy.

That's absolutely right, because of this whole idea of crossing the placental barrier.

And that was something that she asked about time and again.

And also, what's very important is that Merrill had only looked at late pregnancy.

And

what about the entire term?

And Frances wanted to know about that as well.

So

This dance goes back and forth between the FDA and Merrill.

Francis Oldham Kelsey keeps stalling the process.

This takes 18 months.

Merrill keep coming to the FDA office.

I think they come about 50 times.

But over in West Germany,

there are miscarriages and children being born dead.

But those who were born alive are born with these really serious injuries.

Including at Grunenthal itself.

Grunenthal, the company that makes the drug.

So in fact, this is where some of the earliest injuries occurred.

Yes, employees were taking this home to their pregnant wives.

The very first case was a baby born with no ears in the late 1950s.

Which is several years before France starts stalling the process in America.

There's a lot of suppression of information.

There's just a lot of information that isn't getting out.

And let's not forget, Tim, as this is happening, babies are being born on many different

continents born with this severe severe set of injuries the most harrowing of which is focomelia which literally means sort of seal limbs and babies born with very very truncated arms and legs

and and this was actually happening while this whole thrash between Merrill and the FDA was going on.

Okay, so babies are being born with these injuries, but what's the connection to thalidomide?

How is the connection to this drug first suspected?

So in West Germany, in Hamburg, in April of 1961, a couple, Carl and Linda Schultehillen, had a son born with shortened arms and three fingers on each hand.

And obviously it was tragic and it was shocking.

But Carl's sister had recently given birth to a baby with similar problems.

And Carl decides that he needs to find out what's really happening.

And Carl went to talk to a pediatrician.

And the pediatrician was named Vitokint Lenz.

And he is, I must say, very much one of the main heroes of our story.

But what's very ironic is that he was the son of a Nazi geneticist, a very, very high-level, really heinous human being named Fritz Lenz.

And the son, Vitokunt, recognized this Focomelia,

sealed limbs, in the baby.

What's very important to remember is that Phocomelia is extremely rare.

I think it's one in 100,000 births something like that.

He and the father, Carl Schulte-Hillen, go off in this VW Beetle across Germany, and they basically do they do this road trip looking for more

babies who had been born with these injuries.

And in November, Vitokent

met parents who blamed Contragan, aka thalidomide, for their child's injuries.

The father says it was this pill, contragan.

He's sure of it.

He points the finger directly at the pill.

After which,

Linda Schultehillen remembers that she has taken one, and I repeat, one pill that was given to her, which was contragan, aka thalidomide, one, and it caused all this injury to their baby.

And Vitakund Lens then, at a pediatrics conference, very boldly names, Grunenthal names, the drug as the culprit for this epidemic.

And that then gets into the papers.

I mean, they push back.

He's quite robust about this because there are various potential legal threats, but he's very brave.

He stands his ground.

And at the same time, in Australia, a pediatrician is spotting the same thing, that babies seem to be suffering these injuries in the womb when their mothers are taking thalidomide.

How are the drug companies responding as these patterns are starting to be observed and the concerns are being raised?

How did they respond?

They did nothing.

So distillers in the UK,

which also had the license in Australia, did nothing.

And then in Germany, in West Germany, Grunenthal was extremely hostile to Videkant Lenz and threatened legal action, but did agree to a warning label advising against the use of the drug during pregnancy.

So it's all beginning to unravel for them, Grunenthal.

And so then,

and this is when things get truly dramatic, a story leaked to the press.

in late November around Thanksgiving of 1961.

And the headline of this story was birth defects due to pills question mark and so that's when the company finally finally after years

of tragedy removed it from the market and then the the Ministry of Health in West Germany put out an urgent warning

yeah so years of tragedy in West Germany.

The drug has only been on Francis Kelsey's desk for 14 months.

Correct.

I mean when I say only 14 months, that seems like a very long time to Merrill.

So Merrill are told

what's happening in Germany.

What do they do?

They do not, believe it or not, withdraw their application.

Can you believe that?

I mean, just right?

It's a bold move.

Yes.

What do they tell Francis Kelsey?

What does Joseph Murray, this man who has been complaining about Francis Kelsey to Francis Kelsey's boss, what does he say?

He calls her and he says that they're not withdrawing their application for

licensing this drug.

And does he have any explanation as to what's going on in Germany?

Does he think the Germans have just made a mistake?

They're making a fuss about nothing.

Joseph Murray, the Merrill rep, calls Francis and he says, oh, yeah, not to worry.

This is probably just an unfortunate coincidence.

And we're going to send a rep to Germany to sort this all out.

But they do not, I repeat, they do not withdraw their application.

Incredible.

It seems that Frances Olden Kelsey is vindicated at this point.

The evidence is starting

to grow that this is a very dangerous drug for pregnant women.

Her rather bold move of saying, I want to see more information.

I want to see more evidence that it's safe.

I want to see more evidence that it's safe during pregnancy, has been, I think, utterly vindicated by events in Germany.

Right.

And what's interesting is that she didn't know specifically what was happening and what the actual mechanism of the drug was to injure the fetus, but she just knew it didn't sit right with her.

So there's a lot to be said for going with one's gut, right?

In this case, for sure.

Frances Olden Kelsey clearly had a very well-developed gut based on

all of her training, all of her reading, and all of her experience.

A golden gut, exactly.

You would think that the story ends there.

Job done, thalidomide, not approved in the United States.

However, Frances Kelsey is about to learn that actually pregnant women have been taking this dangerous drug all across the United States.

Cautionary Tales will be back after the break.

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And with seamless coverage from the world's largest satellite-to-mobile constellation, your whole team can text and stay updated even when they're off the grid.

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Learn more at supermobile.com.

Seamless coverage with compatible devices in most outdoor areas in the US where you can see the sky.

Best network based on analysis by UCLA of Speed Test Intelligence Data 1H 2025.

Cautionary Tales is proudly sponsored by Amika Insurance.

As Amika says, empathy is our best policy.

That's why they'll go above and beyond to tailor your insurance coverage to best fit your needs.

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We're back.

I am with Katie Hafner, the host of the Lost Women of Science podcast, and she is telling the story of Frances Oldham Kelsey.

So Katie, by now, it's December 1961.

Terrible things have emerged in Germany, but in America, the Merrill application for Kevadon, aka thalidomide, is still active.

Frances Oldham Kelsey, the dogged data detective, has been vindicated in repeatedly deferring the approval of this drug.

And as a result, that she saved thousands of Americans from being born with severe injuries caused by thalidomide.

So

a happy story, at least for the United States, no?

Merrill was getting this drug to doctors

all over the United States, who were then giving it to patients in little envelopes and patting pregnant women on the head and saying, Here, this will ease your morning sickness.

Take this.

This is a new drug that's just coming down the pike, and aren't we lucky that we happen to have samples?

And these samples were given by the thousands to American women.

And I mean, the extraordinary thing about this is this wasn't for profit, or at least not directly.

They weren't selling these drugs.

They were distributing them because it was part of what I think we might very loosely call a clinical trial, but there's no clinical trial I've ever heard of.

I think they were priming the market for this drug.

And by the time it was approved, people would already be taking it.

It's an anchoring bias.

Oh, I'm anchored in this particular drug.

And what happens with doctors is that they get anchored in prescribing a particular drug.

And that kind of seeding is very, very common to this day.

We know that Frances has been suspicious about some of these sloppy doctors' reports that she read as part of the Merrill application.

They hadn't recorded doses or length of time on the drug or the reason for prescribing, anything like that.

But was there anything more untoward?

This is just horrible, even just telling you this, Tim.

I'm so ashamed of my fellow humans.

There is this one doctor who was a golfing buddy of one of the guys from Merrill.

And

on the golf course, you know, while they're

teeing off, they're kind of talking about the drug.

And then this doctor allegedly writes this paper in a journal declaring the drug very safe, and it was actually written by the Merrill people.

Hello.

Yeah, all basically he signed his name to it, but Merrill wrote it.

Right.

And meanwhile, he's giving these pills to his patients who are pregnant women

whose babies may well be being harmed by it.

Who are being harmed by it.

Yes.

Yes, that's all happening.

Please tell me that Merrill at some stage withdrew the application.

Merrill at some stage withdrew the application.

Thank you.

How long did it take?

Merrill withdrew the application

not days after it was taken off the market in Germany, not weeks, months.

In March 1962, Merrill finally withdrew its application.

Yes, not before time.

At least it was never approved, even if it was widely distributed.

And it was never approved thanks to Frances Holdham Kelsey.

Was she recognised for this work at the time?

Yes, she became a total national hero.

In July of 1962, word of her work made its way to the Washington Post, and there was a front-page story with the headline, Heroine of FDA Keeps Bad Drug Off Market, with a wonderful photograph of her above the fold.

Just great.

Even though many, many, many babies were born with Phocomelia in the United States, she prevented thousands more.

In 1963, she was given the highest possible award by the President for civilian service.

And there's a lovely photograph of her clearly beaming as JFK.

John F.

Kennedy is presenting this to her.

It was a shining moment, not just for her individually, but for the United States.

And this woman, by the way, was Canadian.

Let's not forget that.

So

what was more important was that this led to really the modern FDA as we know it, which is very, very rigorous.

trials and studies

done before now it's become what some people do think is a very cumbersome process.

But to get a drug approved in the United States, many people trace it back to the whole thalidomide tragedy.

I mean as a professional statistics nerd, I think it's probably worth distinguishing the insistence on caution with the insistence on rigor.

Yes, it's a balance, yes.

There definitely is a risk of having bureaucrats who say, oh, oh, I'm not sure.

I'm not going to approve this.

I want to see more.

I want to wait and see.

I'll see.

Because some drugs save lives.

And if you make it incredibly expensive to get approval and you delay approval, then that can cost lives just as much as approving the wrong drug can.

But I think it's absolutely essential to demand rigor.

and to say, you know, you need to do the proper clinical trials, you need to disclose the appropriate information.

It's not okay just to include some letters from some doctors, which, by the way, the doctors didn't even write.

Who were on the golf course when they thought about it.

Yeah, and bury the information from the British Medical Journal,

kind of cough and divert attention from what's going on in Germany and basically say, well, look, we really want the drug available by Christmas.

Why do you hate capitalism?

Rigor is important, even if we don't just want to turn down every drug on principle.

Exactly.

Well, let's talk about this for a sec.

There are two things that come to mind for me.

One is that there's a very interesting coda to the whole story, which is thalidomide actually has proven to be quite efficacious, quite effective for treating leprosy and multiple myeloma.

Isn't that interesting?

Because cancer, isn't it?

Yes.

So it's having kind of a

renaissance.

And so that's interesting.

But the other thing, on a kind of darker note, is

so our new Secretary of Health and Human Services The nephew of President Kennedy, yes.

Yes, the nephew of the very man who bestowed this honor upon Francis Kelsey, our F.K.

Jr.,

during his confirmation hearings, he invoked Frances Kelsey.

to the horror of us at Lost Women of Science,

and he said, my uncle gave this medal to this woman, Frances Oldham Kelsey, in 1963, which is when the medal was given.

So he was right about that, but he was wrong about a few other things.

He said she worked at the NIH.

He said she was young.

She was not.

She was in her 40s.

And he said that there was like a panel of people who had approved the drug.

And then he said, and she was screaming.

She never screamed.

And she prevented all of this horror and tragedy from coming into the United States.

But then he said something very interesting.

He said, She stood up to science.

And

yes.

Stood up to or stood up for?

Two.

Yeah.

Two.

Those were his words.

It's funny you say that because I went back and listened to it three times.

And he said, she stood up to science.

And in other words,

she took a stand against science.

You know, this is

the whole anti-vaccine movement is, you know, we don't believe these scientists, but she was just, she was reacting to bad science or non-existent science.

Yeah, no science at all in many cases.

Yes, exactly.

And so he has twisted this

history

really to align with

his agenda, which was really unfortunate.

Yeah.

If the lesson is you need to stand up to science, I think that's,

well, that's certainly not what Frances Kelsey would have said, or indeed what she did.

Oh, she would be horrified to see her name used that way.

Well, let's end on a slightly cheerier note.

What did she do the rest of her career?

She stayed at the FDA.

And, you know, she maintained a surprisingly low profile.

And later, she helped spearhead this new division at the FDA called the Division of Scientific Investigations.

They were known informally as Kelsey's COPS, and they were tasked with inspecting clinical sites to test the integrity of data.

And she never wavered, and she lived well into her 90s.

But, you know, her name eventually sort of disappeared to the point where very few people recognize it.

Yeah.

Well, she retired at the age of 90 in 2005.

She actually lived to the age of 101,

which is quite incredible.

And she was in Canada in her final years and she

received the Order of Canada medallion and she was too sick to leave her house, so the medal came to her.

I love that.

Yeah.

Thank you so much, Katie.

I've been talking to Katie Hafner, who is the host of Lost Women of Science.

Wonderful podcast.

You can get it in all the usual pod places.

This has been fascinating.

Katie, thank you so much.

Thank you, Tim.

Thank you.

For everyone else, I will be back next week with another Cautionary Tale.

Cautionary Tales is written by me, Tim Harford, with Andrew Wright, Alice Fiennes, and Ryan Dilley.

It's produced by Georgia Mills and Marilyn Rust.

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