Stalling for Survival - A Lonely Fight Against a Deadly Medicine

Summary

Cautionary Tales with Tim Harford

Episode: "Stalling for Survival – A Lonely Fight Against a Deadly Medicine"

Release Date: September 5, 2025
Guest: Katie Hafner (Host of Lost Women of Science podcast)

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Overview

This episode of “Cautionary Tales” explores how Dr. Frances Oldham Kelsey, a little-known Canadian-American pharmacologist and FDA reviewer, quietly resisted immense pressure to approve thalidomide for the U.S. market in 1960–61. Her relentless skepticism and insistence on scientific rigor averted a catastrophe, saving thousands of American babies from birth defects linked to the drug, which had already devastated families across Europe. Alongside host Tim Harford, guest Katie Hafner (of the "Lost Women in Science" podcast) unpacks the personal, scientific, and bureaucratic drama of Kelsey's lonely crusade—and discusses its wider legacy.

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Key Discussion Points and Insights

1. Introducing Frances Oldham Kelsey and the Thalidomide Crisis

• Kelsey joined the U.S. FDA in 1960 as a medical reviewer; she was new, and pharmaceutical company William S. Merrell expected a routine approval for thalidomide (marketed as Kevidon) in time for Christmas.

• Thalidomide was already a bestselling sedative in 46 countries under names like Contergan (Germany) and Distaval (UK, Australia), with a supposed record of safety.

• Kelsey felt uneasy about the drug's clinical data, suspecting critical omissions and flaws ([03:09] Katie Hafner).

  “There was just a feeling that there was something in the data, or the absence of data, that was a cause of concern.”
  — Katie Hafner ([03:09])

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2. Kelsey’s Background and Scientific Instincts

• Kelsey was unusually qualified: an MD, the first woman in the US with a PhD in pharmacology, and an early advocate of drug safety, informed by her experience investigating the Elixir Sulfanilamide poisoning in the 1930s ([07:07] Tim Harford).

• She had researched how drugs can cross the placental barrier, making her particularly attuned to risks for pregnant women ([09:29] Katie Hafner).

  “This experience she had with the quinine work was really important because... it planted a seed in her head about the placental barrier.”
  — Katie Hafner ([09:38])

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3. Thalidomide’s Dodgy Application and Industry Pressure

• Merrell presented an avalanche of paperwork but relied on poorly translated German studies, weak evidence, and extraordinary safety claims (e.g., claiming no lethal dose) ([13:06] Katie Hafner).

• Labeling Kelsey the “new girl”, they expected her to rubber-stamp; instead, she persistently asked for more evidence and questioned the lack of animal studies.

  “She just didn't see the science, she didn't see the evidence... she just said, this just isn't working for me, guys.”
  — Katie Hafner ([12:13])

• Unable to reject the application outright without proof of harm, and facing an expiring 60-day review period, she innovatively declared the application “incomplete” to stall for time, infuriating Merrell ([14:05] Katie Hafner).

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4. Chasing Evidence: Warnings from Abroad

• In January 1961, Kelsey read a British Medical Journal letter reporting nerve damage (peripheral neuritis) linked to thalidomide in UK patients—information omitted from Merrell’s application ([18:53] Katie Hafner).

• Merrell’s representative was evasive, and their clinical “evidence” consisted largely of anecdotal, sometimes ghostwritten doctor testimonials ([35:43] Katie Hafner).

  “There is this one doctor who was a golfing buddy... and [he] allegedly writes this paper in a journal declaring the drug very safe. And it was actually written by the Merrell people. Hello?”
  — Katie Hafner ([35:43])

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5. The Human Cost: Tragedy Unfolds in Europe

• Birth defects (phocomelia, or severely shortened limbs) were being reported across continents, especially in West Germany. Pediatrician Widukind Lenz linked the devastation to thalidomide and publicly named the drug in late 1961 (story acknowledged by both Tim and Katie between [23:52] and [26:23]).
• The companies responded with hostility or denial, delaying action while damage mounted ([26:54] Katie Hafner).

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6. The Near-Miss in America

• While Kelsey stalled FDA approval, Merrell distributed thalidomide samples to U.S. doctors through so-called clinical trials, often as a freebie for morning sickness, exposing thousands of women and resulting in some U.S. birth defects ([34:17] Katie Hafner).
• Merrell did not withdraw the application until March 1962, months after thalidomide’s withdrawal in Germany ([36:50] Katie Hafner).

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7. Recognition, Reform, and Lasting Impact

• Kelsey’s vigilance became public in July 1962 via a Washington Post front-page story: "Heroine of FDA Keeps Bad Drug Off Market" ([37:24] Katie Hafner).
• She was honored with the nation's highest civilian award by President John F. Kennedy.
• Her actions prompted major FDA regulatory reform, ushering in modern, rigorous drug approval standards ([38:53] Katie Hafner).
• Thalidomide is now used, with extreme caution, for cancer and leprosy—an example of how drugs can have both disastrous and beneficial effects when properly studied ([40:11] Katie Hafner).

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Notable Quotes & Memorable Moments

• On the broken FDA regulatory landscape pre-Kelsey:

  “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.”
  — Tim Harford ([08:23])

• On the power and peril of “gut feeling” in science:

  “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?”
  — Katie Hafner ([29:41])

• On company conduct:

  “They did nothing ... Grunenthal was extremely hostile to Widikind Lenz and threatened legal action, but did agree to a warning label ... and then finally after years of tragedy, removed it from the market.”
  — Katie Hafner ([26:54])

• On the real-world cost of lack of rigor:

  “There is this one doctor who was a golfing buddy... And [he] allegedly writes this paper in a journal declaring the drug very safe. And it was actually written by the Merrell people. Hello?”
  — Katie Hafner ([35:43])

---

Important Segment Timestamps

• Kelsey's unease with thalidomide data (early suspicions): [03:09]
• Her early experience with drug dangers and the FDA: [07:07]–[09:56]
• FDA’s powerlessness before 1938, law changes: [08:23]
• Merrell’s push and Kelsey’s stalling tactics: [12:13]–[14:49]
• Discovery of UK warning signs, obfuscation by Merrell: [18:53]–[21:24]
• European tragedies, Lenz exposes thalidomide: [22:37]–[26:54]
• Merrell’s reckless U.S. drug distribution: [34:17]–[36:47]
• Kelsey’s recognition and subsequent FDA reforms: [37:24]–[38:53]
• Discussion of thalidomide’s later uses: [40:11]
• Misinterpretations of Kelsey’s legacy (RFK Jr. anecdote): [41:47]–[42:36]
• Kelsey’s later career and quiet heroism: [42:55]–[43:41]

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Final Thoughts & Tone

The episode weaves a suspenseful, intimate story, blending admiration for Kelsey’s dogged, data-driven caution with frustration and horror at pharmaceutical and regulatory failures. There’s gentle humor (“Nothing says Christmas like a sleeping pill” — Tim), deep empathy for victims, and a clear-eyed analysis of system-level change. Both Tim Harford and Katie Hafner’s tone is inquisitive and respectful, celebrating persistence, scientific integrity, and a critical balance between safety and innovation.

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For Further Listening

• Lost Women of Science podcast by Katie Hafner, for more unsung stories of groundbreaking women in science.

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Summary prepared for those who may have missed the episode, as an in-depth, chronological guide to Frances Oldham Kelsey’s fight—a cautionary tale of science, skepticism, and stewardship.

Transcript

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[Manny (No Such Thing Podcast)]

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[Katie Hafner]

You got a hoodie on.

[Tim Harford]

Take it all.

[Manny (No Such Thing Podcast)]

I'm Manny. I'm Noah. This is Devin. And we're best friends and journalists with a new podcast called no Such Thing, where we get to the bottom of questions like that. Why are you screaming at me? I can't expect what to do now? If the rule was the same, go off on me. I deserve it, you know, Lock him up. Listen to no Such thing on the iHeartRadio app, Apple Podcasts, or wherever you get your podcasts. No Such Thing.

[Tim Harford]

Pushkin.

[Narrator (Cautionary Tales Host - Tim Harford)]

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 wonder 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.

[Katie Hafner]

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.

[Narrator (Cautionary Tales Host - Tim Harford)]

The trouble is, Frances doesn't have any hard proof that there is a problem with Kevidon. 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 Kontagan, in Britain, New Zealand and Australia where it's called Disteval, and in South Africa, where people take Entero Sedive. 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 Francis Oldham Kelsey stands in the way of thalidomide entering the American market. Here to tell us all about this incredible woman is Katie Haffner of the Lost Women of Science podcast. Katie, welcome to Cautionary Tales.

[Katie Hafner]

Tim, thank you so much for having me. It's a pleasure.

[Tim Harford]

Now, Lost Women of Science is a remarkable podcast. Just give us the quick explanation of what it is that you do.

[Katie Hafner]

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, or all of whom did remarkable work in science. And we are just chipping away at it and telling their stories.

[Tim Harford]

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.

[Katie Hafner]

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.

[Tim Harford]

Yeah, yeah. Curl up on the sofa and discuss the latest pharmacological trial.

[Katie Hafner]

Yeah, I love that.

[Tim Harford]

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?

[Katie Hafner]

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.

[Tim Harford]

Yeah. So this drug had an antifreeze diethylene glycol, which is potentially deadly and kill people.

[Katie Hafner]

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

[Tim Harford]

Yeah.

[Katie Hafner]

All right.

[Tim Harford]

It is. I mean, one of the points that Lost Women of Science mentioned, which I just thought was fascinating and horrifying, is 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.

[Katie Hafner]

Right. And we're going to see later on how the law change even more. Thanks to her.

[Tim Harford]

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.

[Katie Hafner]

Yes. In fact, this is how she met her husband. I love it. You say quinine, we say quinine.

[Tim Harford]

It's okay. I'll allow It.

[Katie Hafner]

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. In her concerns later about thalidomide.

[Tim Harford]

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.

[Katie Hafner]

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. Hugely successful in Europe and elsewhere. Yeah, thalidomide was considered this wonder drug, a sedative substitute for barbiturates. 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 will just stamp it and this thing will be on the market by Christmas and we're good to go.

[Tim Harford]

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

[Katie Hafner]

Yes, the new girl in her. I think they actually said the new girl.

[Tim Harford]

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?

[Katie Hafner]

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.

[Tim Harford]

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.

[Katie Hafner]

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, Tim, that made her just say, well, wait a minute, I mean, this was a woman who crossed her T's and dotted her I. And it wasn't working for her.

[Tim Harford]

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. 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?

[Katie Hafner]

Frances had a mentor at the FDA named Barbara Moulton, who actually left in a very high profile way. And Moulton was very outspoken.

[Tim Harford]

Another difficult woman.

[Katie Hafner]

Yes, another difficult one. 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.

[Tim Harford]

Yeah. Because they want to sell this drug in time for Christmas, which is.

[Katie Hafner]

Can we just say for Christmas, like, because everyone needs sedatives at Christmas.

[Tim Harford]

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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[Manny (No Such Thing Podcast)]

Imagine that you're on an airplane and all of a sudden you hear this.

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Attention passengers. The pilot is having an emergency and.

[Katie Hafner]

We need someone, anyone, to land this plane.

[Manny (No Such Thing Podcast)]

Think you could do it? It turns out that nearly 50% of men think that they could land the plane with the help of air traffic control. And they're saying like, okay, pull this until this, pull that, turn this. It's just I can do my eyes closed. I'm Manny. I'm Noah. This is Devin. And on our new show, no Such Thing, we get to the bottom of questions like these. Join us as we talk to the leading expert on overconfidence.

[Tim Harford]

Those who lack expertise lack the expertise they need to recognize that they lack expertise.

[Manny (No Such Thing Podcast)]

And then as we try the whole thing out for real. Wait, what? Oh, that's the Runway. I'm looking at this thing.

[Katie Hafner]

See?

[Manny (No Such Thing Podcast)]

Listen to no Such thing on the iHeartRadio app, Apple Podcasts, or wherever you get your podcasts.

[Tim Harford]

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, Kevidon, AKA thalidomide, is dangerous. She just has this gut instinct that something's not right. So what does she do next?

[Katie Hafner]

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

[Tim Harford]

On the sofa with her husband.

[Katie Hafner]

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 Merrell even submitted its application to the fda.

[Tim Harford]

Did Merrill's application mention.

[Katie Hafner]

No.

[Tim Harford]

These concerns or the warning labels?

[Katie Hafner]

No.

[Tim Harford]

Okay.

[Katie Hafner]

It did not. The MERYL 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.

[Tim Harford]

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

[Katie Hafner]

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

[Tim Harford]

What did her boss do when. Because I understand, he basically accused her of libel. He's like the fda. Your inspector, Frances Oldham Kelsey, she is libeling us, which is a pretty heavy claim.

[Katie Hafner]

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, Francis 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.

[Tim Harford]

You want me to approve this drug? You prove it's safe?

[Katie Hafner]

Yes.

[Tim Harford]

Don't expect me to prove it's dangerous. I want you to prove it's safe.

[Katie Hafner]

That's correct.

[Tim Harford]

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

[Katie Hafner]

Yes.

[Tim Harford]

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

[Katie Hafner]

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. And also what's very important is that Meryl had only looked at late pregnancy and what about the entire term? And Frances wanted to know about that as well.

[Tim Harford]

So this dance goes back and forth between the FDA and Merrill. Frances 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. Being born dead. But those who are 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.

[Katie Hafner]

Yes, employees were taking this home to their pregnant wives. The very first case was a baby born with no ears in the late.

[Tim Harford]

1950S, which is several years before Frances starts stalling the process.

[Katie Hafner]

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, this babies are being born on many different continents, born with this severe, severe set of injuries, the most harrowing of which is phocomelia, which literally means sort of seal limbs. And babies born with very, very truncated arms and legs. And this was actually happening while this whole thrash between Merrell and the FDA was going on.

[Tim Harford]

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?

[Katie Hafner]

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 Widukind 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, Wiederkind, recognized this folkomelia seal limbs in the baby. What's very important to remember is that folkomelia is extremely rare. I think it's 1 in 100,000 births or 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, Widokind 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, 1, and it caused all this injury to their baby. And Wiedekind Lenz, 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.

[Tim Harford]

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?

[Katie Hafner]

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 Widikind 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. 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 Ministry of Health in West Germany put out an urgent warning.

[Tim Harford]

Yeah. So years of tragedy in West Germany. The drug has only been on Francis kelce's desk for 14 months.

[Katie Hafner]

Correct.

[Tim Harford]

And when I say only 14 months, that seems like a very long time to Mel. So Merrell are told what's happening in Germany. What do they do?

[Katie Hafner]

They do not believe it or not withdraw their application. Can you believe that? I mean, just. Right.

[Tim Harford]

It's a bold move.

[Katie Hafner]

Yes.

[Tim Harford]

What do they tell Francis Kelsey? What does Joseph Murray, this. This man who who has been complaining about Francis Kelsey to Francis Kelsey's boss. What does he say?

[Katie Hafner]

He calls her and he says that they're not withdrawing their application for lights licensing this drug.

[Tim Harford]

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?

[Katie Hafner]

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.

[Tim Harford]

Incredible. It seems that Francis Oldham 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.

[Katie Hafner]

Right. And what's interesting is that she didn't know specifically what was happening and how, what the actual mechanism of the drug was to injure the fetus, but she just knew it did, didn't sit right with her. So there's a lot to be said for going with one's gut. Right.

[Tim Harford]

In this case for sure. Frances Oldham Kelsey clearly had a very well developed gut based on all of her training, all of her reading and all of her experience.

[Katie Hafner]

A golden gut. Exactly.

[Tim Harford]

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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[Manny (No Such Thing Podcast)]

Imagine that you're on an airplane and all of a sudden you hear this.

[Katie Hafner]

Attention passengers.

[iHeart Radio Announcer]

The pilot is having an emergency sea and we need someone, anyone, to land this plane.

[Manny (No Such Thing Podcast)]

Think you could do it? It turns out that nearly 50% of men think that they could land the plane with the help of air traffic control. And they're saying like, okay, pull this until this, pull that, Turn this. It's just I do my eyes closed. I'm Manny. I'm Noah. This is Devin. And on our new show, no Such Thing, we get to the bottom of questions like these. Join us as we talk to the leading expert on overconfidence.

[Tim Harford]

Those who lack expertise lack the expertise they need to recognize that they lack expertise.

[Manny (No Such Thing Podcast)]

And then as we try the whole thing out for real. Wait, what? Oh, that's the Runway. I'm looking at this thing. See, listen to no Such thing on the iHeartRadio app, Apple Podcasts, or wherever you get your podcasts.

[Tim Harford]

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 Merrell application for Kevidon, AKA thalidomide, is still active. Frances Holden Kelsey, the dogged data detective, has been vindicated in repeatedly deferring the approval of this drug. And as a result, 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?

[Katie Hafner]

Meryl 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.

[Tim Harford]

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 it's not. There's no clinical trial I've ever heard of.

[Katie Hafner]

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.

[Tim Harford]

We know that Frances has been suspicious about some of these sloppy doctors reports that she read as part of the Merrell 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?

[Katie Hafner]

This is just horrible, even just telling you this, Tim. Just. 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, you know, 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?

[Tim Harford]

Yeah, all. Basically, he signed his name to it, but Meryl wrote it.

[Katie Hafner]

Right.

[Tim Harford]

And meanwhile, he's giving these pills to his patients who are pregnant women whose babies may well be being harmed by it.

[Katie Hafner]

Who are being harmed by it. Yes. Yes, that's all happening.

[Tim Harford]

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

[Katie Hafner]

Meryl at some stage withdrew the application.

[Tim Harford]

Thank you. How long did it take?

[Katie Hafner]

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.

[Tim Harford]

Yes. Not before time, at least. It was never approved, even if it was widely distributed. And it was never approved. Thanks to Frances Oldham. Kelsey. Was she recognized for this work at the time?

[Katie Hafner]

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 folkomelia 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.

[Tim Harford]

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

[Katie Hafner]

Yes, it's a balance. Yes.

[Tim Harford]

There definitely is a risk of having bureaucrats who say, 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.

[Katie Hafner]

Were on the golf course when they thought about it.

[Tim Harford]

Yeah, 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.

[Katie Hafner]

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?

[Tim Harford]

Which is a cancer, isn't it?

[Katie Hafner]

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.

[Tim Harford]

Nephew of President Kennedy.

[Katie Hafner]

Yes, yes, the nephew of the very man who bestowed this honor upon Francis Kelsey, RFK Jr. During his confirmation hearings, he invoked Francis 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.

[Tim Harford]

Stood up 2. Or stood up 4.

[Katie Hafner]

2.

[Tim Harford]

2.

[Katie Hafner]

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

[Tim Harford]

Yeah, no science at all. In many cases.

[Katie Hafner]

Yes. Exactly. And so he has twisted this history really, to align with his agenda, which was really unfortunate.

[Tim Harford]

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.

[Katie Hafner]

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

[Tim Harford]

Well, let's end on a slightly cheerier note. What did she do the rest of her career?

[Katie Hafner]

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.

[Tim Harford]

Yeah, well, she was. She retired at the age of 90 in 2005. She actually lived to the age of 101, which is quite, quite incredible.

[Katie Hafner]

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.

[Tim Harford]

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.

[Katie Hafner]

Thank you Tim.

[Tim Harford]

Thank you for everyone else. I will be back next week with another Cautionary tale.

[Narrator (Cautionary Tales Host - Tim Harford)]

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. The sound design and original music are the work of Pascal Wise. Additional sound design is by Carlos San Juan at Brain Audio. Ben Nadaff Haffrey edited the scripts. The show also wouldn't have been possible without the work of Jacob Weisberg, Greta Cohn, Sarah Nix, Eric Sandler, Christina Sullivan, Keira Posey and Owen Miller. Cautionary Tales is a production of Pushkin Industries. If you like the show, please remember to share, rate and review. It really makes a difference to us. And if you want to hear the show ad free, sign up to Pushkin plus on the show page on Apple Pay Podcasts or@Pushkin FM Plus.

[Manny (No Such Thing Podcast)]

Why are TSA rules so confusing?

[Katie Hafner]

You got a hoodie on?

[Tim Harford]

Take it off.

[Manny (No Such Thing Podcast)]

I'm Manny. I'm Noah, this is Devin and we're best friends and journalists with a new podcast called no Such Thing where we get to the bottom of questions like that. Why are you screaming at me? I can't expect what to do now if the rule was the same, go off on me. I deserve it, you know. Lock him up. Listen. No such thing on the iHeartRadio app, Apple Podcasts or wherever you get your podcasts. No Such thing.

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