October 10, 2024

The Devil in the Details: Chapter Five

The Doctor Who Said No to Thalidomide: Sixty Years Later and Thalidomide Is Still With Us.
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Episode Description

It’s September 2024 and a group of American thalidomide survivors arrive in Washington D.C. to lobby the government for support. More than 60 years have gone by since Frances Kelsey first stalled the New Drug Approval application from pharma company Merrell for thalidomide. Although she stopped the drug from going on the market in the U.S., hundreds of pregnant women still took thalidomide in Merrell’s so-called clinical trials, and many had babies with shortened limbs and other serious medical conditions. Others had miscarriages or stillborn babies. Here we look at the legacy of thalidomide, the changes in drug regulations in the wake of the scandal, and what happened to our hero, Frances Kelsey.

Frances Kelsey honored by the FDA on the 50th anniversary of her refusal to approve thalidomide. Credit: FDA
Jean Grover.
Gwen Riechmann with her service dog, Aragon.
Gwen Riechmann, Jan Garrett and Jean Grover in 2023.
Host
Katie Hafner

Katie is co-founder and co-executive producer of The Lost Women of Science Initiative. She is the author of six non-fiction books and one novel, and was a longtime reporter for The New York Times. She is at work on her second novel.

Senior Producer
Elah Feder

Elah is a journalist, audio producer, and editor. Her work has appeared on Science Friday, Undiscovered, Science Diction, Planet Money, and various Canadian Broadcasting Company radio shows.

Senior Managing Producer
Deborah Unger

Deborah started her career covering technology for Business Week magazine in New York and San Francisco. She has worked for The Guardian in London and as a freelance contributor to The New York Times in Paris.

Original Art:
Lisk Feng
Art & Design:
Lily Whear
Guests:
Jennifer Vanderbes

Jennifer Vanderbes is an award-winning novelist, journalist, and screenwriter whose work has been translated into sixteen languages. In 2023, Vanderbes returned to investigative journalism with her first nonfiction book, Wonder Drug: The Secret History of Thalidomide in America and Its Hidden Victims.

Christine Kelsey

Christine Kelsey is the daughter of Frances Oldham Kelsey.

John Swann

John Swann is a historian at the Food and Drug Administration.

Gwen Riechmann

Gwen Riechmann is a thalidomide survivor and vice president of the USA Thalidomide Survivors.

Jean Grover

Jean Grover is Communications Director of USA Thalidomide Survivors.

Jose G. Calora

Jose G. Calora is the president of USA Thalidomide Survivors.

Laura Kendall

Laura Kendall is a thalidomide survivor and author of My Prosthetic Life.

Dr. Mathew Thomas

Dr. Mathew Thomas worked with Frances Kelsey at the FDA.

Christina Jewett

Christina Jewett is a reporter at The New York Times, covering the FDA.

Original Art:
Lisk Feng
Art & Design:
Lily Whear

Further Reading:

USA Thalidomide Survivors website

Wonder Drug: The Secret History of Thalidomide in America and Its Hidden Victims, by Jennifer Vanderbes, Random House, 2023.

Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide, by Cheryl Krasnick Warsh, Oxford University Press, 2024.

Autobiographical Reflections, by Frances Oldham Kelsey, U.S. Food and Drug Administration.

My Prosthetic Life: A Memoir, by Laura Kendall, 2022.

 

Frances Kesley interviewed by Knowlton Nash on the CBC, August 13, 1962. 

Frances Kelsey obituaries in The Washington Post and The New York Times, August 7, 2015.

Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease, James H. Kim  and Anthony R. Scialli, Toxicological Sciences, 122(1), 2011.

Thalidomide: History, Withdrawal, Renaissance, and Safety Concerns, Niel Vargesson and Trent Stephens, Expert Opinion on Drug Safety, 20(12), 2021.

Episode Transcript

The Devil in the Details: Chapter Five

Katie Hafner: I’m Katie Hafner, and this is the final chapter of The Devil in the Details, a special season from “Lost Women of Science.” It’s about Frances Oldham Kelsey, the doctor who said no to the thalidomide. As we were working on this story, piecing together a complicated timeline that spanned years and oceans, there was something that kept nagging at me. It wasn’t huge, but it was something. 

You know, we’ve talked so much about time — how much time was wasted before anyone figured out there was an epidemic of injured babies, yet more time before thalidomide was pulled from the market in Europe, and even more before the American public was warned about it. 

For almost five years, women were taking this drug, thinking it was the safest thing in the world.

Well, there’s another little stretch of time that got me to wondering about that something I just mentioned. It starts in April 1962, when Helen Taussig alerts Frances Kelsey to just how bad the situation was in Europe, and it ends three months later in July 1962, when Americans finally get the message about thalidomide. 

What was Frances Kelsey doing during those months? Did she just decide to trust that the drug company, William S. Merrell, had it covered? Of course not. 

Jennifer Vanderbes: She starts just going to big hospitals that she has relationships with and asking, have you seen a spike in babies born with phocomelia?

Katie Hafner: Jennifer Vanderbes, the author of “Wonder Drug.”

Jennifer Vanderbes: The answer is yes, but we don't think they're connected to thalidomide.  And that's pretty much the answer she gets along the way. She gets really ticked off. There's another hospital in Cincinnati, that she writes a memo, she says, you know, this is ridiculous, there's reported five phocomelic births at this hospital, and they're saying it's not thalidomide. 

Katie Hafner: But there was only so much she could do. Because don’t forget– Frances Kelsey reviewed drug applications; she didn’t run national investigations. 

It was only when the FDA launched its official investigation that the agency finally dug into how far thalidomide had spread. And at first, it seemed like the U.S. really had dodged a bullet. On August 7, 1962, the Secretary of Health, Education, and Welfare sent out a press release. A pretty optimistic one. It said that the FDA had already interviewed more than a thousand doctors who’d participated in the “clinical trials” and had determined that more than 15,000 people across the country had received thalidomide. 

Katie Hafner: Of those, about one in five were women of childbearing age. But according to this press release, quote “no abnormalities were observed in the offspring of these patients.”

Frances herself offered a similar message when she was interviewed by the CBC a few days later.

Interviewer: In the experimental use of thalidomide in the United States, about how many people did take the drug? 

Frances Kelsey: Uh, in the neighborhood of 15,000, I believe. 

Interviewer: Have there been any reports at all of, uh, thalidomide babies here? 

Frances Kelsey: Not that I know of, no.

Katie Hafner: But 10 days later, the FDA sent out its own press release with some troubling updates.

The estimated number of patients found to have taken thalidomide had risen to nearly 20,000. 3760 of those were women of childbearing age. And 624 had been pregnant when they took the drug. 

Worse, the FDA had now learned of three cases of abnormal births. In one case, the FDA didn’t think thalidomide was responsible because the mother had taken the drug late in pregnancy. They were investigating the other two.

In the end, the FDA’s official count was this: 17. Seventeen babies born in the U.S., who were hurt by thalidomide.  In half these cases, the drug came from overseas. Two were stillborn. One died shortly after birth. Leaving just six recognized, living thalidomide survivors in the country. Six. But the FDA was wrong.

Gwen Riechmann: Don’t run off. We are going to do presentations later…in a little bit.

Katie Hafner: On a Thursday evening in mid-September, a group of about 25 thalidomide survivors and their family members gather at the Embassy Suites by Dulles Airport near Washington, D.C.. The event has been organized by the USA Thalidomide Survivors, and they’ve spent the better part of a week lobbying legislators for support as they age. Evenings, they regroup at the hotel, reviewing the day’s events, giving presentations, and just catching up with each other.

Katie Hafner: There’s a lot of laughter and giddiness at the event, but this isn’t just a social gathering. This group wants justice, and for that, they’ve turned to the government.

Laura Kendall: We want them to pay us back for using our bodies for science.  And not ever making it right. And not ever recognizing the fact that we are here. And just because it was not FDA approved here, doesn't mean we, we don't exist.

Katie Hafner: Laura Kendall came from California for the event. She put out a memoir in 2022 called “My Prosthetic Life.” And like a lot of the survivors we spoke to, she’s never been able to prove her mother took thalidomide. In fact, she says,

Laura Kendall: My mother always said it wasn't thalidomide because it wasn't in this country.  She obviously was unaware that there was a clinical trial. But was given the same pill with me and my sister, who was born 17 months after me and only lived an hour. 

Katie Hafner: Laura Kendall isn’t the only one who hasn’t been recognized as a survivor by the U.S. government. As we mentioned earlier, the FDA only ever recognized that 17 babies had been born in the U.S. with thalidomide injuries, but Jennifer Vanderbes has found there are about 100 survivors still living today - and that doesn’t include all of the babies that were stillborn or died a couple of years into their lives. So many just weren’t counted. We heard this story over and over - that for a long time, many U.S.-born survivors themselves didn’t think thalidomide had anything to do with their disabilities.

Jean Grover: I didn't know. So powerful was the misinformation that was fed to the American public that thalidomide had never made it to the U.S. and Frances Kelsey had saved us all that I did not find out the truth until I was in my fifties, which is crazy.

Katie Hafner: Jean Grover was born in August 1962 at Jewish Hospital in Cincinnati… not far from Merrell, the very company that made the drug that caused her severely shortened arms and legs. As soon as Jean was born, she was separated from her mother, in the belief that for Jean’s mother to see her newborn would be too emotionally painful. 

Jean Grover: And the doctor came into her hospital room and asked her, did you go to Canada or Europe and get thalidomide? 

Katie Hafner: Jean’s mother said no. She hadn’t taken drugs from Canada or Europe. In fact, the only pills she could remember taking were ones he had given her. She was under the impression they were vitamins.  And now here he was, asking her about thalidomide. 

Jean Grover: He really, really did ask her that. The guy that handed it to her asked her that, I think to cover his, I'm sure to cover his butt. 

Katie Hafner: The question implied she’d left the country to get her hands on a drug that wasn’t approved in the U.S…. Jean’s mother was offended.

Jean Grover: Because it implied she was somehow drug seeking 

Katie Hafner: So no, Jean’s mother didn’t think she’d taken thalidomide. And growing up, Jean was told thalidomide had nothing to do with her. And she believed it for decades. But then, around 2018, she joined a Facebook group for thalidomide survivors. She thought, okay, she might not be one of them, but physically, she had so much in common with them she might still learn something useful. And then one day, a writer named Jennifer Vanderbes contacted the group, looking for members who’d been born in Cincinnati. So Jean invited Jennifer over to her house one evening for an interview.

Jean Grover: And Jennifer asked me, did I know Gwen and Lori, two other thalidomide survivors from Cincinnati?

Katie Hafner: Gwen Riechmann, the survivor we met in an earlier episode.

Jean Grover: And I'm like no and she said they both as a matter of fact were born in exactly the same hospital as you exactly the same year. That was a like holy crap moment that I couldn't believe. I didn't know them. I didn't know anybody else was born at Jewish hospital that year in 1962 with limbs affected like mine. And there are actually about five of us that were born that year at Jewish Hospital. Uh, we call ourselves the Cincinnati Sisters.

Katie Hafner: The chances that Jean and four other babies just happened to be born with this incredibly rare condition in the same hospital in Cincinnati all in the same year… the chances of that being a coincidence are about as close to zero as you can get.

Katie Hafner: And obstetricians who delivered babies at that hospital just happened to be giving out thalidomide samples to their pregnant patients at around that time? From these threads, what truth might we weave?

But could Jean prove her mother had taken thalidomide? No. Her doctor and the drug company hadn’t kept the kinds of records that would allow her to prove it. The kind of records they should have kept. 

As long as we’re on the subject of record keeping, one of the things the FDA discovered in its investigations is just how wildly sloppy these doctors were. We’ve talked about Merrell’s so-called clinical trials before.  Remember Ray Nulsen, the doctor who relayed his so-called study results to his buddy at Merrell over rounds of golf?

Katie Hafner: Well, if that sounds bad to you, listen to this. In August 1962, when the FDA started interviewing doctors, the agency found that more than a third of the doctors they talked to hadn’t bothered to go back and contact the patients they’d given thalidomide to. Why was that? Well, the FDA reported, many felt it wasn’t necessary because, I don’t know, some time had passed, and also they didn’t even know who they’d given it to. 

So Jean can’t prove she’s a survivor of thalidomide. And she hasn’t received any compensation to speak of. Gwen Riechmann has had more luck. 

Gwen Riechmann: I was one of the few that have received compensation in the U.S. 

Katie Hafner: From Merrell. In 1964, Gwen’s parents sued the company, and four years later, Merrell offered her family a settlement. But the settlement contained a gag clause. The parents agreed not to talk about the case. To anybody.  

Gwen Riechmann: And they took that to heart, including, don't talk to your daughter. Don't go through anything. And so, most of what I know about thalidomide in my background, and in their background, has come bits and pieces over the years.

Katie Hafner: Gwen is one of the 17 people recognized by the U.S. government as a victim of thalidomide, but the government hasn’t compensated her.  In fact, the U.S. remains one of the only developed nations affected by thalidomide that has not compensated its survivors. 

And yet, this is a group of people who don’t give up easily. And seeing them in action in D.C. only reinforces that impression. 

Laura Kendall: There’s three items we want. We want recognition, uh, we want assessment to make sure who is and who isn't.

Katie Hafner: A.K.A who’s truly been injured by thalidomide

Laura Kendall: And we want a support package to help us live our lives with dignity and independence.

Jose G. Calora: We are at our advanced age. 

Katie Hafner: Jose Martynov Galvez Calora is the president of the USA Thalidomide Survivors.

Jose G. Calora: We are in our late 50s, 60s, and early 70s. And our bodies seems to be breaking down more faster and we need this assistance as soon as we can. 

Katie Hafner: That means financial and medical assistance to cover things like specialized surgeries, vehicle modifications for accessibility, and attendant care. 

Take Jean Grover, whom we heard earlier—she actually had to miss the DC conference because she recently fell and broke her arm and needed surgery. And this isn’t the first time she’s had a serious break. Her femur is more fragile than most people’s. And she’s broken her femur FIVE times.

These are the kinds of issues thalidomide survivors are dealing with.

A lot of people my age remember those images of thalidomide babies in newspapers and magazines. Over time, those images have faded from our collective memory, but the thalidomide survivors are still here. They’re no longer babies, they’re getting older, and living with serious disabilities and unknown prognoses. Here’s Jennifer Vanderbes again:

Jennifer Vanderbes:  As a community, as a society, we owe them the right to just live out their lives, you know, with as much health and happiness and comfort as we can, because we sure got a lot out of them.

As we’re about to see, it’s thanks to the thalidomide crisis and its living reminders that drug safety in the United States today looks very different than it did in the 1960s… 

Knowlton Nash: Well, uh, could such a thing as this thalidomide scare happen again in the United States? 

Frances Kelsey: Well, uh, I suppose, uh, that drugs just are very complicated and it's very difficult to be absolutely sure. but I think with thorough testing in advance, one can eliminate a great deal of the hazards.

Katie Hafner: That was Frances Kelsey in an interview with the CBC’s Knowlton Nash on August 13, 1962. She’s the same reliably matter-of-fact Frances we’ve come to know and love throughout this season. And she’s honest. Her answer here isn’t completely reassuring. She can’t promise this won’t happen again.

Which is understandable. Because the system for vetting drug safety in the United States back then was shockingly loose by today’s standards.

Even some legislators at the time couldn’t believe their country was operating like this. Two week before Frances gave that interview to the CBC, she and the FDA’s Commissioner, George Larrick testified before a Senate committee about drug research and regulation. 

And if you read the transcript, you can tell that some of these senators Frances and her boss are talking to are absolutely gobsmacked by what they’re hearing.

Katie Hafner: At one point, the question of patient consent comes up. Something we take for granted: you know, that patients in clinical trials should agree to what’s happening to them. They’re being questioned by a Republican Senator from New York named Jacob Javits. So the senator asks—and I’m paraphrasing here—if patients know when they’re given experimental drugs? Do doctors have to tell them? 

Larrick tells the senator, that’s the state’s business. The federal government doesn’t get involved with the practice of medicine.

So Javits asks this: would patients see the drug label that says it’s an experimental drug?

Larrick says no, probably not.

So just to be sure about what he’s just heard, the senator reiterates: the patient might get a highly experimental drug without giving consent? 

And Larrick says - and here I’ll quote - “That is up to the doctor, what he does with his patient.”

Katie Hafner: A few months later, Congress passed legislation that tightened drug safety and gave the FDA more power, and the next year, new regulations were introduced governing investigational drugs.  

And together, these addressed some of the biggest problems that came up in these hearings. Some really important, let me add, shockingly obvious rules, rules that, had they been in place in 1960, the cascade of collateral damage from thalidomide could have been avoided. 

The new rules required basic things like informed consent from clinical trial participants. And that any claims pharmaceutical companies made in their advertising be based on scientific evidence.

And possibly the most important change, from Frances Kelsey’s perspective: before a company could even start testing a drug in humans, it had to show the FDA evidence that led the company’s investigators to believe it was safe to do so. 

Oh, and here’s another big one - in the course of clinical trials, if there were serious side effects, the FDA must be alerted immediately

John Swann: That change in the law was incredibly important to help provide citizens with the understanding that the drugs they take are safe and effective. 

Katie Hafner: John Swann is a historian at the FDA.

 

John Swann: We didn't have anything like that before. Not really. And it set the standard for the global regulation of drugs, too.

Katie Hafner: The early 1960s was a revolutionary moment for drug safety in the United States and for the FDA. And the FDA had been given some important new responsibilities. So the agency created a whole new branch, this one tasked with reviewing proposals for human clinical trials and monitoring them. And Dr. Frances Kelsey was put in charge of it.  So, what had started off as a simple medical reviewer job—a job that many before her had done part time or for short stints –turned into a decades-long career at the FDA for Frances Kelsey.

Dr. Mathew Thomas worked under Frances Kelsey at the FDA later on in her career. 

Dr. Mather Thomas: I think she was in her 80s. Perhaps early 80s when I started working directly for her. My recall is that, you know, although she was that age, you wouldn't mess with her because she was very sharp.

Katie Hafner: So sharp in fact that she continued to work at the FDA until she was 90. Her daughter Christine says that was very much by choice.

Christine Kelsdy:  She just loved it.  She loved the work and I don't think she ever wanted to retire. 

Margaret Hamburg: Good morning and welcome to this very special event for our agency and for one of our agency's greatest heroines, Dr. Frances Kelsey…

Katie Hafner: In 2010, the FDA held an event at its Silver Spring, Maryland campus, commemorating the 50th anniversary of Frances Kelsey’s refusal to approve thalidomide, and presented the inaugural Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health to the woman herself: 96-year-old Frances O. Kelsey. Historian John Swann again.

John Swan: I guess the thing that stands out for me is here she was, and her daughters were there. And I remember when her daughters, Suzanne and Christine, roll out the wheelchair that she's in out onto the stage, I mean, it's just, just such a like an explosion of applause. 

[Applause]

John Swann: Just an overwhelming, um, a response of love for Dr. Kelsey and what she represents from everyone in the audience. I know she had a few comments that I remember as being, I don't know, for lack of a better word, kind of spunky at the end. 

Frances Kelsey: I hope you can hear me… Can you hear me? This is very exciting.

Katie Hafner: It’s a bit hard to understand what Frances is saying in this old videotape, but she starts by talking about the old days when she was working out of that little prefab building downtown, one of just 8 or 10 medical officers… But it’s not all sweet nostalgia. Because she throws this in this little barb: that back in the day, drug firms used to have free access to the medical reviewers.

Frances Kelsey: You could always count-before I joined- you could always count on being taken out to lunch. And not to the corner drug store, but to an elegant restaurant.

Katie Hafner: If you didn’t catch that, she said the drug reps would invite the FDA medical reviewers out for lunch, and they weren’t sittin’ at the soda fountain on the corner… they were at the fancy places. 

Margaret Hamburg (FDA Commissioner): I think this is a day we will all remember for a very long time. And a woman that we will never forget and history will never forget. So thank you so very much. I think one last round of applause and we will end program. 

Katier Hafner: Obviously, we haven’t solved all the problems that existed in Frances Kelsey’s day. We have profit-driven companies pushing hard to get their products approved. We’ve had a full-blown opioid crisis that continues to this day. 

But to get a better sense of how far we have—or haven’t come—since the 1960s, we contacted Christina Jewett, a New York Times reporter, who covers the FDA. And Christina says there are people doing some really important work at the FDA to make sure drugs really are as safe as possible. It’s not like Frances Kelsey was the last good one.

Christina Jewett: The FDA people I've sort of gotten to know, and former FDA people, I mean, they are all in for the  public service mission. But then, you put on top of that, this layer of just incredible pressure from the companies that want to pull strings in Congress, from companies that are going to hire top tier law firms to have regulatory counsel go in and meet with the FDA and sort of press their case. There is just an incredible amount of pressure, an incredible amount of money, riding on the decisions.

Katier Hafner: Still, given that a lot of Christina’s job involves reporting on the screw-ups, her view of the FDA was rosier than I expected.

Christina Jewett:I honestly would critique myself as not doing a better job in telling the sort of more, you know, the, it's harder to write the stories about the, you know,the boring bureaucrat, the boring careful, methodical, thoughtful, bureaucrat who just wrote a 30 page single space report on, on concern, you know, benefits and risks of a drug and that that's going to be there for posterity for people to look at for years. But that's there as well. 

Katie Hafner: I love what she just said because those are the stories of the Frances Kelseys! In other words without the thalidomide disaster, we probably never would have heard about the good work Frances did day in and day out. 

She would just be there, plodding her way through voluminous drug applications, writing reports, quietly protecting us behind the scenes. 

It’s been sixty-eight years since an employee of Chemie Grünenthal, the German company that developed thalidomide, took some samples of the drug home to his pregnant wife. And she had a baby born on Christmas Day 1956 without ears. That’s nearly a lifetime ago. And what has happened in the intervening decades to the protagonists of this story? 

Let’s start with Sherri Chessen, the “Romper Room” host we opened this series with. Sherri is 92 today, living in Southern California. After her abortion in 1962, she went on to have two more kids, for a grand total of six and to write children’s books. And to this day, she’s asked to weigh in on abortion rights in this country.

Widukind Lenz continued to work on behalf of survivors and died in 1995, respected as both a physician and a humanitarian.

Katie Hafner: And what about the corporate entities of this saga? Let’s start with the company that set all these events in motion: Chemie Grünenthal. In 1968, seven Grünenthal executives were put on trial. The charges were serious: intent to commit bodily harm as well as involuntary manslaughter.  

The trial dragged on for two years and seven months, then it ended abruptly a few months after  Grunenthal agreed to pay a settlement to survivors. About $30 million dollars—that would be more than $200 million today. The company has since contributed additional funds through both a federal foundation for survivors, and its own foundation. And in 2012, the company did something that it had failed to do for five decades: it offered survivors an apology. In its statement directed at the survivors themselves, the company themself said they’d been silent for so many years because of “the shock that your fate caused in us.” Many survivors were unimpressed.

So the company is still very much around. In an email to us, a spokesperson wrote:

The thalidomide tragedy will always remain a part of our company’s history. We will never forget what happened, and we deeply regret the severe consequences for those affected and their families. 

It goes on. I won’t read the whole thing, but you get the point. 

Katie Hafner: As for Merrell, the American company, back in 1964, the justice department concluded that “criminal prosecution is neither warranted nor desirable” and that was that.

The company did, however, face several lawsuits, including the one from Gwen Riechmann’s parents, and paid out some settlements.

Today, Merrell no longer exists, but it didn’t exactly die either. Over the years it’s been swallowed up by other pharma companies and the ghost of Merrell lives on inside pharmaceutical giant Sanofi, which is facing a class action suit brought by thalidomide survivors—though that case has been tied up in the courts for years.

And what about the survivors themselves? Well, as we know, many of them are around today. Most are in their early 60s now, and they want justice, they want recognition, and they want to be seen. 

Gwen Riechmann: One of the things that survivors have been told to do in their whole life, and I wasn't raised like this, so it blew my mind, was when you're in a family photo, like a group shot, hide your bad arm. Turn, so your bad side is away from the film. Or you stand behind so-and-so, so that your arms can't be seen.

Katier Hafner: Gwen remembers that at the first USA Thalidomide Survivors conference she attended, they took a group photo. 

Gwen Riechmann: We did the first one and I said, okay, this one, just raise your arms, raise them up in the air as high as you can get them. And everybody did it. They didn't question why I was telling them to do it. And then I said, one thing I’ve heard over and over this week was people being told to hide their arms. And we’re not hiding them anymore. We're not hiding our bad side. We're here. We're who we are.


Katner Hafner: And what of the inanimate villain of our story? Well, thalidomide is still with us. It’s actually turned out to be a remarkably useful drug for some conditions, like leprosy, which is still a global scourge and multiple myeloma, a historically intractable cancer. Though there have been reports from Brazil, where leprosy is still a big problem, that some thalidomide is still getting into the hands of pregnant women, and babies are sometimes born with phocomelia.

That’s the thing about drugs - they’re not inherently good or bad. There’s always a risk and often a benefit.  

In fact, someone who’s been listening to this season posted this on Facebook just last week:. 

My mom was an Army wife in Germany and had a deformed, stillborn thalidomide baby. Decades later, I remember watching the news with her when the FDA approved thalidomide with restrictions to fight a rare cancer. Two years ago, I was diagnosed with that cancer, multiple myeloma. Such an irony that the drug class that killed a brother before he was born is now saving my life.

Katie Hafner: And what about Frances Kelsey?

In 2014, at age 100, Frances moved back to Canada, the country of her birth, to live with her daughter, Christine. Her husband had died in 1966 and she’d been on her own for years. 

A few months later, Frances got word that she had received the Order of Canada, the second highest honor given by the Canadian government. But she was too frail to travel to the ceremony to receive the medal. So the medal came to her.  

Christine Kelsey: So the Lieutenant Governor of Ontario, who's delightful, um, came to the house and presented her with her medal, and she was lying in bed there. Mom was thrilled. She wasn't able to speak at that point, but you could tell, you know, she was totally animated when this whole thing happened. 

And, um, and she, she died sometime during the night. 

Katie Hafner: On August 7, 2015, the day Frances Kelsey died, her obituary ran on the front page of both “The New York Times” and “The Washington Post.” By the way, if you’re not Henry Kissinger, say, or Katharine Hepburn, a front-page obit is pretty unusual. So hats off to the editors at the Times and the Post who got it.

So here she was, with a presidential medal, an Order of Canada, an award in her name, half a dozen books about thalidomide and the role she played, can we really claim Frances Kelsey as a lost woman of science?

Katie Hafner: Yes, for a couple of reasons. First, there is the obvious one for us. She was a scientist who did important work and now, nearly a decade on, with the exception of a few doctors of a certain age, almost no one I asked recognized the name Frances Kelsey. Then again, that would probably be true if she’d been a man. 

But she also deserves this multi-episode shout-out, we think, because she represents another group of people who are, if not forgotten these days, often reviled: public servants. 

Our era of bitterly divisive politics has cast a spotlight on the role of government and civil servants. There’s talk of doing away with entire federal agencies and eviscerating others and replacing people who possess true expertise with partisan hacks. Which is…a scary prospect.  While in office, former president Donald Trump frequently lashed out at the quote “deep state over at the FDA” for one thing or another.

BUT over at the FDA it’s really just bureaucrats sitting in their cubicles reviewing drug applications, day in and day out. And yes, they still have to contend with the pressures of a profit-driven industry.  But in the main, they’re doing their best to protect an unsuspecting public from harm.  

And sometimes they get it wrong. Really wrong.

Katie Hafner: The opioid crisis has made me wonder about what might have happened if, in 1995, the desk that the application for the painkiller OxyContin landed on had been Frances Kelsey’s. What if diligent, stubborn, no-nonsense nit-picky do-not-rush-me, Frances Kelsey, then 80 years old and still at the FDA, had been the medical reviewer dealing with the big guns at Purdue Pharma. What if?

The example she set is one that needs to remain sharp in our collective memory, even if the woman herself has blurred. Remember when I said, back in episode one, that I can’t imagine many kids saying they want to be an FDA medical reviewer when they grow up. But you know what? Maybe they should.

Katie Hafner: Elah Feder was senior producer for this episode, and Deborah Unger was senior managing producer. Our associate producer is Mila Rahim. Sophia Levin and Eva McCullough provided research support. Sarah Wyman wrote an early draft.

Our music was composed by Lizzy Younan. 

We had fact checking help from Lexi Atiya. Alexa Lim edited the audio. And Morgane Fouse mastered this episode. Lisk Feng created the incredible art for the season and Lily Whear did the art design.

Thank you, as always, to my co-executive producer, Amy Scharf, and to Eowyn Burtner, our program manager. Thanks also to Jeff DelViscio at our publishing partner, Scientific American. We're distributed by PRX.

Funding for Lost Women of Science comes in part from the Alfred P. Sloan Foundation and the Anne Wojcicki Foundation. 

Next week on Lost Women of Science Conversations we are talking to Jennifer Vanderbes, author of Wonder Drug, and a voice you will recognize from this season. In the course of writing her book, she went on  a personal crusade to find and give voice to the U.S. thalidomide survivors.

For a transcript of this episode or to learn more about Frances Kelsey, please go to our website, lostwomenofscience.org and don’t forget to hit that all-important omnipresent donate button.

See you next week!

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