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It’s September 2024, and a group of American thalidomide survivors and their family members arrive in Washington, D.C., to lobby the government for support. More than 60 years have gone by since Food and Drug Administration medical examiner Frances Oldham Kelsey first stalled the new drug application for thalidomide from the pharmaceutical company Richardson-Merrell.

Although she stopped the drug from going on the market in the U.S., thousands of pregnant people 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.

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.

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