The Devil in the Details: Chapter Four

The Devil in the Details: Chapter Four

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President John F. Kennedy: Recent events in this country and abroad concerning the effects of a new sedative called thalidomide emphasize again the urgency of providing additional protection to American consumers from harmful or worthless drug products…

Katie Hafner: In July, 1962, an editor at “The Washington Post” called a reporter named Morton Mintz over to his desk. The Post had gotten a tip. About an astonishing story.

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There was a drug called thalidomide that was suspected of injuring thousands of babies in Europe. And the drug had been withdrawn from the market in Germany and the U.K. eight months earlier. But somehow, by the summer of 1962, most Americans still knew nothing about this. And thousands of them were taking the drug, completely unaware of its dangers to pregnant women — that is, until July 15, the day The Washington Post put Morton Mintz’s story on the front page. The headline: “Heroine’ of FDA Keeps Bad Drug off Market.” And there, right above the fold, was a photograph of that very heroine: Frances Oldham Kelsey.

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The story was quickly picked up by newspapers across the country. And a lot of Americans reading that article over their breakfast might have thought, well, this story doesn’t have that much to do with me. Because the way Mintz told it, this was a tale of tragedy for Europe, where thousands of babies had been injured by this drug thalidomide. And it was a tale of triumph for the United States, where the drug was never approved, thanks to FDA medical reviewer Frances Kelsey.

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But that was just the beginning of the story.

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Here’s Jennifer Vanderbes, author of “Wonder Drug”:

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Jennifer Vanderbes: This hits the front page and it's the only reason why you can say the word thalidomide today in the United States and anyone of a certain generation actually knows that name because of that article. That was it. That was the pivot point. Everything sort of spins from that.

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Katie Hafner: I’m Katie Hafner, and this is the fourth chapter of “The Devil in the Details” from “Lost Women of Science.” This season is about Frances Oldham Kelsey, the doctor who said ‘no’ to thalidomide. In today’s episode: Frances Kelsey, reluctant superstar — and why it took so damn long for the thalidomide story to reach the U.S. 

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In the days after The Washington Post article came out, Frances Kelsey went from ordinary civil servant to national hero overnight, giving interviews on major networks, like this one on NBC in August 1962.

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NBC Interviewer: Well, Dr. Kelsey, uh, this is a  silly question, I suppose, but how does it feel to someone like you to suddenly become a celebrity, a heroine with your finger in the dike?

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Frances Kelsey: Well, it's not the usual, uh, situation we find ourselves in Food and Drug. 

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NBC Interviewer: Well, you seem to be doing very well.  What is your salary? I know this is a matter of public record. 

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Frances Kelsey: I'm a GS, uh, 14, top of grade, and I get 13,550 a year. 

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Katie Hafner: Her daughter Christine remembers that reporters would come to the Kelsey household to take pictures of the family… 

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Christine Kelsey: They would set us up in these strange poses that we just would not have normally been in. Stand here on either side of your mother, girls. Look lovingly. My parents refused, or mom refused, they said, each of you kiss her on the cheek. No, we're not doing that. Not gonna happen. So unlike anything that we would ever have done. And what they were trying to say was, oh, mother saves the world kind of thing. 

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Katie Hafner: Christine was a pre-teen, and her older sister, Susan, was a full-blown teenager by this point. So, obviously, they found this whole situation mortifying.

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And then there were the letters….

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Christine Kelsey: Boxes and boxes. We had boxes of letters. They came to our house like a dozen a day.

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Katie Hafner: From senators and other doctors and journalists wanting to interview her… but also from ordinary people writing to thank her… or tell her about their medical concerns. They included pictures of their families. Some people sent checks (which, by the way, she didn’t keep). And she took the time to write to as many of them as possible. Even just kids writing school reports about her. Frances tried to answer all their questions. Christine says that was just part of her upbringing. If someone writes to you, you write them back!

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But amid all this national excitement about Frances Kelsey, there was this big unanswered question: if doctors in Germany and Britain knew at least as early as November 1961 that thalidomide was suspected of causing severe injuries to embryos and if the drug had been pulled off the market over there precisely because of this danger, why were Americans only just learning about that now, in the summer of 1962?

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Well, to answer that, we need to go back to these key couple of days in the fall of 1961. On November 29, Grünenthal – that’s the German company that developed thalidomide and was licensing it for sale all over the world – alerts Merrell – that’s the American company that wants to sell it in the U.S— that it’s pulling the drug from the market in Germany. The next day, November 30th, Merrell's FDA liaison, Joseph Murray, calls Frances Kelsey at the FDA to pass on the news. 

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Murray tells Frances they’ve heard from the German manufacturer that thalidomide causes birth malformations and that the company is withdrawing it from the German market. He adds that he hopes this is all just an unfortunate coincidence, but that Merrell is sending a representative to Germany to find out more.  But – and here’s the odd thing – Merrell does not withdraw its  application for Kevadon, its thalidomide drug. 

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Jennifer Vanderbes: It's interesting, I mean, of the many irresponsible things done along the way. The sort of concrete facts that the inventor and licensor of the drug in Germany removes it completely from the market because of documented concerns that it's causing birth defects. And Merrell in the U. S. does not withdraw their application.

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Katie Hafner: Over the next few days (now we’re in December 1961), Merrell sends letters to Canadian and American doctors telling them not to give this drug to pregnant women, or those still in their child-bearing years.

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Jennifer Vanderbes: They send a few, I'll call them light letters basically saying that they're not alarmed, you know, this is what's happened, you know, maybe proceed cautiously. But they don't send it to all their investigators, and they don't seem to be concerned with the fact that these investigators gave it to other doctors. 

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Katie Hafner: In the U.S., the letter went out to 37 doctors. You heard it. Of the 1200 plus doctors Merrell had given the drug to, the company wrote letters to thirty-seven. Those were the only doctors listed in Merrell’s Kevadon application, and therefore the only ones the FDA knew about. 

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Jennifer Vanderbes: So yes, you have months and months and months go by where this drug is still freely circulating. The public has no idea. Most doctors have no idea. This story has been resolved by all accounts in Europe, but in the United States this drug is still, you know, zipping around from doctor's office to doctor's office and being handed to women and it's absolutely bonkers to think how many months that went on. It wasn't a matter of weeks. It was months.

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Katie Hafner: But as far as Frances Kelsey knew, Merrell had done what it was supposed to do. The company learned its drug might be harmful. The company immediately notified the FDA. And Merrell said it had also notified the doctors it had sent the drug to. (Of course, Frances had no way of knowing that this wasn’t true.) And Merrell couldn’t go one step further and withdraw the drug from the market because it wasn’t on the market. The FDA had never approved it in the first place. 

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So, in early 1962, Merrell and the FDA were still in this weird, familiar holding pattern: waiting for clinical evidence, data that would either exonerate or further implicate thalidomide.

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Three months passed. Nothing. But then, in early March, Merrell suddenly withdrew its application for Kevadon, and it also withdrew the drug from the Canadian market, where Merrell had already been selling Kevadon for almost a year.

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In a letter to the German manufacturer, a Merrell executive described this decision to pull the drug from the Canadian market as stemming from an abundance of caution, you know, a temporary pause while they sorted this out and figured out whether this link to birth abnormalities was real. It makes it sound like Merrell had, of its own volition, finally done the responsible thing. When in fact, the Canadian Food and Drug Directorate had asked Merrell to withdraw the drug. In any case, Merrell did take action at that point, putting everything on hold in both Canada and the US until it had more information. 

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And that was fine by Frances Kelsey. Again, as far as she knew, there was nothing more that needed to be done.

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She was about to learn just how wrong that was. Just a few weeks later, in April 1962, the FDA received a disturbing phone call. It was from a renowned cardiologist named Helen Taussig. 

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Here’s historian Cheryl Warsh:

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Cheryl Warsh: She was working at Johns Hopkins, the head of the pediatric cardiac clinic.

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Katie Hafner: Dr. Taussig was a pioneer in the field of pediatric cardiology. So when a former student of Taussig’s learned about this epidemic affecting babies in Europe - an epidemic that hurt their hearts, he told Dr. Taussig about it.  That was a few months earlier, in January of 1962.  

And he told her about how doctors suspected a drug called thalidomide was to blame. 

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Cheryl Warsh: But it wasn't public knowledge in the States what happened. That's where Dr. Taussig comes in.

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Katie Hafner: After she heard about what was happening in Europe, Taussig immediately went there to investigate the situation, and when she returned home six weeks later, it was with a profound sense of urgency. What was happening in Europe was a disaster. And people in the United States needed to know about it, to make sure it didn’t happen here too. So Dr. Taussig called up a different former student of hers (that’s the thing about these academic physicians…they have got former students all over the place), and this student worked at the FDA now and she invited him and Frances Kelsey to come visit her at home. 

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Cheryl Warsh: She told them the story of what she saw, and she said it was a very good idea that you didn't let this drug into the U.S. because this is what's happening in Europe.

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Katie Hafner: Up until this point, all Merrell had told Frances Kelsey about the link between thalidomide and the congenital malformations was that the data was inconclusive. And the information Frances had received indicated that the drug had been sold for several years in Europe before any issue with babies arose. But Helen Taussig told her that wasn’t true. 

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Taussig knew of an affected baby born at least as early as 1959, and had seen data showing a rapid rise in cases every year after that. Several factors pointed to thalidomide. Painstaking histories of the mothers in these cases usually revealed they’d taken the drug, and there appeared to be a higher incidence among the children of Grünenthal’s employees. Meanwhile, Taussig reported that the children of American servicemen appeared to be unaffected - US army hospitals didn’t use the drug.

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Katie Hafner: Helen Taussig estimated that as many as 6,000 babies had been affected in Germany. And more than a thousand in other countries. But the true number wouldn’t be known until the summer of 1962, because remember, there were women who had taken thalidomide before it was taken off the market and had yet to give birth.

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For Frances Kelsey, thalidomide was no longer just a shoddy drug application with unanswered questions. And it wasn’t an abstract threat. What Helen Taussig had shown her convinced her that thalidomide was dangerous. And if any of this drug was floating around somewhere in the U.S., Merrell had better make sure it didn’t reach pregnant patients.

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One thing that has struck me working on this story is just how much it takes – or took, back then – to get a nation’s attention. The article in The Washington Post that told Americans about thalidomide - that came out in July of 1962. And people were understandably shocked and upset. Americans like Sherri Chessen, the kids’ TV presenter we met in the first episode, who had taken thalidomide, learned for the very first time that it might be harming their babies.

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But “The Washington Post” article wasn’t actually the first to share the story of thalidomide with Americans. There were several articles in American publications before that. One came out in December 1961, just a few weeks after Grünenthal withdrew the drug. That one was in a medical periodical, so it’s understandable if that article didn’t reach a wider public. 

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But the next articles weren’t in obscure publications. In February 1962, the thalidomide crisis made the pages of TIME magazine.  And the article could not have been clearer. The headline was this: “Sleeping Pill Nightmare.” The article said this sleeping pill, thalidomide, was quote,  “accused of causing many hideous malformations in babies.” It listed the brand names of the drug in Germany, the UK and the U.S. I repeat – AND THE U.S. But…this article didn’t seem to register with many people. TIME mentioned thalidomide yet again in an article in March. 

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And then, just a few weeks after that, on April 12, 1962, yet another article came out, this one in The New York Times, reporting on Dr. Helen Taussig’s findings in Europe. 

Cheryl Warsh: Helen Taussig, after she speaks to the FDA people, she decides that she has to make sure that every physician in America and the government knows about this drug and avoids it. And make sure that it never happens again.

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Katie Hafner: Dr. Taussig argued that the United States could have met the same fate as Europe because this drug could have passed the country’s drug laws at the time. She urged for better regulations, ones that ensured drugs were tested on pregnant animals.

Cheryl Warsh: So she's definitely on a mission. And she makes speeches to the American Medical Association. She makes speeches to all kinds of agencies, to schools, universities.

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The New York Times article was on page 37 of the paper. And it seems like a lot of people missed it. So after several articles in the popular press, months after the crisis became public knowledge in Europe, people in the U.S., by and large, still didn’t know what thalidomide was. Much less that they should be looking out for it. It would be another few months before Morton Mintz’s article in the Post finally broke through.

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But one important group of Americans did read Helen Taussig’s plea for stricter drug regulation. Senator Estes Kefauver had been investigating pharmaceutical companies for price fixing and for years had been trying to pass a drug reform bill. Unsuccessfully.

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Thalidomide could change that. Jennifer Vanderbes again:

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Jennifer Vanderbes: They hear the Thalidomide story, they realize, oh my gosh, you know, this is, this is literally sensational, right? We have, this is a huge story. This is going to terrify people. They're going to finally pay attention after several years of everybody, the media, the public, tuning out the drug bill hearings. And suddenly this will get them.

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Katie Hafner: But to really get people paying attention to this, they needed a good hook. A character who could push this issue into the public consciousness.

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Frances Kelsey, the public servant who saved the American people from a dangerous drug.

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Cheryl Warsh: And they leak the story to The Washington Post. 

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Cheryl Warsh again.

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Cheryl Warsh: They say, here's the story of what happened last year and how we had- thalidomide could have come in. And there was a reporter at The Washington Post who was the science reporter. But the editors saw this could be an explosive story and he's a really boring writer. So they got another one by the name of Morton Mintz. 

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Katie Hafner: Morton Mintz was not a science reporter, he was a general assignment reporter. And he didn’t cover the drug industry. But his editor at the Post knew that he was the kind of guy who could kick up a righteous fury. And that’s exactly the energy the paper wanted on the Frances Kelsey story.

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Jennifer Vanderbes: Morton Mintz is this great kind of like old school, loves going after everybody kind of reporter, doesn't get scared, loves to learn about a new subject.

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Katie Hafner: Jennifer Vanderbes spoke with Mintz while working on her book.

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Jennifer Vanderbes: So he gets put on to the story. He runs right over to the FDA, speaks with Frances Kelsey. He knows a good story of when he's got one. 

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Katie Hafner: Mintz, who by the way is still alive as of this recording and is 102 years old, had started his journalism career in St. Louis, where, among other things, he published a series of investigations into the treatment of people with intellectual disabilities. One of his own daughters had been born with Down syndrome, and he became a passionate advocate for families of disabled children.

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When Mintz sat down in Kelsey’s FDA office for their interview, he started their conversation by telling Kelsey about his daughter. The two of them connected. And when his article was published in the Post a few days later, it painted Kelsey in terms befitting a hero. The opening lines were everything Estes Kefauver’s office could have hoped for:

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“This is the story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy, the birth of hundreds or indeed thousands of armless and legless children.”

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“She saw her duty in sternly simple terms, and she carried it out, living the while with insinuations that she was a bureaucratic nitpicker, unreasonable – even, she said, stupid.”

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Christine Kelsey: And it went on the front page, and it was, it just couldn't be ignored. The way he wrote it, it could not be ignored.

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Katie Hafner: Christine Kelsey, Frances Kelsey’s daughter again:

Christine Kelsey: The whole thing tumbled, right? His article came out and then it became clear that the public wasn't going to let this go and the Kefauver hearings needed to be sped up a bit. So it all tumbled from that one article.

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President John F. Kennedy: Good afternoon. I have several announcements.

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Katie Hafner: On August 1,1962,  President John F. Kennedy held a press conference.

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President John F. Kennedy: Recent events in this country and abroad concerning the effects of a new sedative called thalidomide emphasize again the urgency of providing additional protection to American consumers from harmful or worthless drug products.

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Katie Hafner: A week later on the White House Lawn, President Kennedy presented Dr. Frances Kelsey with the President’s Award for Distinguished Federal Civilian Service, the highest award the federal government can give a career civil servant. 

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Christine Kelsey: She only heard that she was getting this medal about less than a week before. 

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Katie Hafner: Frances’s family was there. And Barbara Moulton too—remember the FDA whistleblower and Frances’s good friend. It was important to Frances that the woman who had tried to reform the FDA and who supported Frances through all this be there. This was a big moment for all of them. Though, on brand, Frances’s two daughters found the whole event…embarrassing.

Christine Kelsey: I think she'd already gotten the award, and some guy in a suit came and said, Oh, the President would like to meet you. To my sister and I, we were so shy, we said, Oh no, no, no. So we didn't. So, I, I lay claim to fame as probably one of the few people that said no to meeting President Kennedy.

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Katie Hafner: But everyone else was pretty pleased. Jennifer Vanderbes says it wasn’t just a personal victory for Frances Kelsey. It was a huge win for the FDA—the agency looked totally heroic for blocking this drug that other countries had carelessly approved. It was a big win for Kennedy, whose administration came off looking tough on big pharma. And it was a big win for Senator Estes Kefauver, who might finally get some stricter drug laws passed.

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Jennifer Vanderbes again.

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Jennifer Vanderbes: Frances Kelsey became this poster child of the hero fighting bad pharma at a moment when the United States government. Congress wanted to pass a bill that was going to rein in big pharma. 

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Katie Hafner: And here we have thousands, maybe tens of thousands of pregnant American women who’ve dodged a bullet, right?  Yes. And also no.

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Because while the media celebrated Frances Kelsey, they missed something. Something important. Many women did take thalidomide in the United States. And hundreds of them were pregnant at the time.

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Kristin Atwell: Sherri became pregnant in early May. 

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Katie Hafner: That’s Kristin Atwell, Sherri Chessen’s youngest daughter. We spoke with Kristi and Sherri a few months ago. As you might recall from our first episode, Sherri Chessen was in her first trimester of pregnancy in July 1962, when she saw an article in her local paper about thalidomide. This was just a day after The Washington Post story ran. Here’s Kristin:

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Kristin Atwell: Sherri saw that article and her heart wept for mothers and their families who would be faced with that decision of having a child so deeply injured that it couldn't sustain life.

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Sherri Chessen: Poisoned.

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Katie Hafner: That’s Sherri popping in.

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Sherri Chessen: Poisoned.

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Kristin Atwell: From a drug that they took in good conscience.

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Sherri Chessen: Yeah.

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Katie Hafner: Sherri was moved by this story. She loved kids—she already had four of her own—and when she wasn’t taking care of them, she hosted a kids’ TV program. “Romper Room.” She could relate to the parents in the story. She was pregnant with a baby she desperately wanted. She’d taken a sedative during her pregnancy. It was awful to think about what had happened to those other parents. 

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Here’s Sherri, now 92:

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Sherri Chessen: And I said, well, first of all, the drug I took came from England. My husband brought it down. Back from a, uh, trip with high school students and it was called Distaval. So I thought, I wonder if Distaval has thalidomide in it.

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Kristin Atwell: And that's what sent Sherri to her doctor with the Distaval that my father had brought back from London.

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Katie Hafner: So she called her doctor, and he told her…

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Sherri Chessen: I want you and your husband, not good news when they say that, to come in to see me. And he says, Sherri, come Saturday. Use my back door. Don't Let anyone see you.

So we went down there and, um,  he showed me the telegram that the thing was, I remember the last words, Distaval was thalidomide. It didn't have thalidomide, it was thalidomide 

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Katie Hafner: Sherri’s doctor, didn’t know much about thalidomide, but he knew that Sherri had been taking it regularly, throughout the early stages of her pregnancy. And based on the news coming out of Europe, the baby’s prognosis did not look good.

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And where did he turn?

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Kristin Atwell: He wrote Frances Kelsey immediately. 

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Katie Hafner: Specifically, Sherri’s doctor sent Frances Kelsey a telegram.

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Kristin Atwell: Asking what the odds were since Sherri had been taking it regularly through the sensitive weeks.

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Katie Hafner: Of course, Frances responded, taking time out of what were her clearly VERY busy days, with a thorough and thoughtful letter. 

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Kristin Atwell: Frances Kelsey wouldn't really say that she recommended a termination because it wasn't her place.

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Katie Hafner: Frances suggested they get in touch with Dr. Helen Taussig to get more information. She also passed along what information she had–that yes, according to Taussig, even a single dose of thalidomide could cause severe phocomelia, but you could also take more thalidomide with only mild damage. So there was really no telling.

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And just as she had handled the Merrell application, Frances Kelsey was cautious in her response. She didn’t want to say more or less than she had evidence for. So the doctor got in touch with Helen Taussig, whose response was a lot more definitive than Frances Kelsey’s had been. She told him there was a high probability that the baby had been injured. And given all this, Sherri’s doctor advised her.

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Sherri Chessen: Sherri, if you really want to have a fifth child, we'll terminate this pregnancy and start again under better odds. 

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Katie Hafner: Sherri’s doctor arranged for her to have an abortion at a local hospital. Now remember, abortion was illegal in Arizona, as it was everywhere else in the U.S., because this was all a decade before Roe v. Wade. Abortion was only allowed only when the mother’s life was at risk, but abortions for medical reasons were sometimes performed if they were approved by a panel of doctors. 

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But just  before her scheduled abortion, Sherri made another, very brave choice. She went to the press.

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Sherri Chessen: I am very impulsive. And my first thought was, as soon as we got home, I said, I have to call the newspaper. 

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Katie Hafner: Sherri wanted to make sure that other American mothers knew about thalidomide. She wanted to say to other parents what she wished someone had said to her. Keep an eye out. This could happen to you too. 

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The following Monday, July 23, 1962, Sherri’s story was on the front page of The Arizona Republic.

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Sherri Chessen: …“Baby Deforming Drug May Cost A Woman Her Child Here.” It did not name me, of course. 

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Katie Hafner: The article referred to her as a housewife and mother, not a beloved television host. But apparently, just the revelation that someone in Arizona was having an abortion that wasn’t required to save the mother’s life—that was enough to put a target on her back. Because the next day, her doctor came to her with some bad news.

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Sherri Chessen: My doctor said, the abortion has been canceled. They don't know who it is, but the county attorney knows that someone here in Arizona is going to have an abortion and they will do a citizen's arrest.

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Katie Hafner: Sherri fought to get a legal abortion in Arizona, but ultimately, she was forced to go to Sweden for it. Abortions were also restricted there at the time, but she was granted one on the grounds that it was necessary to protect her mental health. Still, it was a terrible time for Sherri. She lost her job hosting “Romper Room” - the station didn’t think she should be on TV working with little kids. And she lost her anonymity. All of the painful twists and turns of her journey were covered in the press.

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Sherri Chessen: Everyone said that I would be vilified. One of my attorney friends said I  circumvented Arizona law so I should serve jail time.

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Katie Hafner: Sherri Chessen became one of the faces of the American thalidomide story, seen on newsstands across the country alongside Frances Kelsey. And thanks to the pair of them —a stoic FDA researcher and a brave childrens’ TV host—thalidomide began to feel personal to Americans. For many, Sherri’s story underscored the danger and the tragedy. Which, in turn, made Frances Kelsey seem even more heroic. 

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And so that’s how in the summer of 1962,  Americans finally learned about the dangers of thalidomide. Almost five years after a German company first started selling a drug called Contergan, and a full eight months after that same company finally withdrew the drug from the market. But how many families would have been spared if the news about thalidomide had reached them sooner?

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Jennifer Vanderbes: There's another version of the story where, for example, the moment it's recalled in Germany, it's recalled worldwide. Right? and doctors are very well and fully informed as to the drugs risks.

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Katie Hafner: But that’s not what happened. The American company, Merrell, left the pills out to circulate… well after the drug had been pulled in Europe. American women like Sherri Chessen continued to take those pills, trusting them to be safe. And the American government didn’t issue warnings to the public until AFTER the story broke in the Washington Post. 

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Which leads me to something that’s been nagging at me as I’ve gone over this whole insane, unforgivable timeline of events. The Germans pulled thalidomide off the market in November 1961. Frances Kelsey was informed of this turn of events, and what she learned from Helen 

Taussig alarmed her. But what did she do in those months before the dangers of thalidomide became known to the American public? Did she know about the pills already circulating in the U.S.? Was it even her job to know? And what was she thinking, specifically about whether any thalidomide babies were out there in her own backyard?

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Next time on the “Devil in the Details”: 

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

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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.

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Our music was composed by Lizzy Younan. We had fact checking help from Lexi Atiya. Alexa Lim edited the audio, and Hansdale Hsu mastered this episode. Lisk Feng created the art for the season and Lily Whear did the art design.

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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.

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

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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.

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See you next week!