HEFFNER: I am Alexander Heffner, your host on The Open Mind, and I'm delighted to welcome the author of Wonder Drug, Jennifer Vanderbes, to our broadcast today.

Jennifer is a celebrated and accomplished novelist and author of this important nonfiction work.

Jennifer, a pleasure to see you today.

VANDERBES: Hi, Alexander.

It's great to be here.

HEFFNER: Jennifer, I know you had come from a culture of the novel and had written a lot of novels, and I wondered how you stumbled upon the Wonder Drug and chronicling the history of an important and difficult story in our nation's history of pharmaceuticals.

VANDERBES: Yeah.

This was a big turn for me, project-wise.

I've written and published three novels.

Some of them had veered into the space of science and women in the sciences in, you know, mid 20th century.

So I came to this story initially because I was very interested in one of the key characters, Dr. Francis Kelsey, the woman who is historically credited with sparing the United States a Thalidomide catastrophe.

And, you know, thus, being the only country in the world that was supposed to have escaped the drug.

So I was interested in writing about her.

I didn't really know if it was going to be fiction, if it was going to be short or long.

And essentially what happened was I had a background in journalism from college in my early years after college, when I started doing this initial research, I very quickly realized that this story about Thalidomide in the United States was much bigger than just Francis Kelsey.

That so much of it had been untold.

And my storytelling instincts realized that it was just a great story.

I mean it had so many different villains and heroes and high stakes and a ticking clock.

And I very quickly saw that there was a way to write a nonfiction book that would feel like a novel.

HEFFNER: And as you were working on this over the course these past years, and especially since the pandemic struck, I'm sure your knowledge of FDA practice and Dr. Kelsey's trials and tribulations, that it had even more resonance.

Take us to the outset of this.

This is a person who, would you call her a whistleblower?

She was very public in advising the country about the danger and risk associated with a drug that I believe was birthed in Europe or outside of the U.S. VANDERBES: Yeah.

The drug was created in Germany.

And Francis Kelsey was an FDA medical reviewer who arrived to work at the FDA in 1960.

And, you know, as the story goes, the Thalidomide application was the first to land on her desk.

And it was supposed to be very simple and very straightforward because the drug was already on sale in about 46 countries around the world.

She is a very interesting character.

She was a medical reviewer of the FDA but she held a PhD in pharmacology, which was a pretty new field at the time.

She had a medical degree and she was known to be a real stickler when it came to research.

So she gets this application, it's a few phone books worth of paperwork, and she immediately senses that something is wrong.

She has been credited and she's on lists of whistleblowers.

What she effectively does, though, she's not in a position to blow the whistle at first, she has to stop this application.

She essentially is the one person at the FDA who has to keep this drug off the market.

So before she can make anything public, because she doesn't quite know what's going on, except that the paperwork is a mess.

It smells, it's shifty, it's missing all sorts of important patient data.

So she gets into this sort of year and a half long battle with the American drug firm that was trying to get Thalidomide in the market and just stalls this application through some bureaucratic loopholes.

HEFFNER: And to be clear, this is a medication, most Americans, at least, who were born since 1980 likely haven't heard of this medicine, but it was designed to treat a number of things, but cancer specifically was the hope that it would help with some cancer patients.

VANDERBES: Well, that's its sort of current incarnation.

When the drug was first invented and patented in Germany in the 1950s, it was part of a wave of new pharmaceuticals kind of coming out of World War II that were essentially chill pills, right?

There's this new market like World War II had really bolstered the pharmaceutical, um, industry.

They had all these, you know, infrastructure that had come out of trying to sort of fast-track penicillin during the war.

So you find the public sort of suddenly very interested in all these new chemicals that can be sold in bottles and have multiple applications.

Thalidomide, like the story of Thalidomide is really interesting because I refer to it in the book as sort of like, it was, was supposed to be like the Titanic of pharmaceuticals, this unsinkable ship.

It was a sedative and hypnotic and its selling point.

And the reason so many firms around the world were interested in selling it is it was supposed to be completely non-toxic, completely safe.

You could not overdose.

Right?

And so they listed tons of applications that they could sell this drug for, you know, anxiety, headaches, menstrual cramps, you know, ran the gamut.

The one that it kind of goes down in history for is its use in treating morning sickness in pregnant women.

The arc of this story is this super safe drug that's being pumped out in the millions around the world and quite secretively in the United States, and is reaching pregnant women.

And then suddenly in around 1961, after this drug has been on the market for a while, doctors start to realize that babies are being born with very distinctive limb abnormalities referred to as phocomelia or seal limbs.

And they basically reverse engineer and realize that it's caused by Thalidomide.

HEFFNER: And just a crippling discovery, just the horror of that.

I have so many questions.

One of which comes to mind first from the perspective of the good doctor who is the principal heroine, right?

You refer to heroes and villains.

I think of it from the context of the Sacklers and what's happened with the opioid crisis today and the fact that that was unleashed despite the fact that there were whistleblowers.

What was the culture that this doctor, Dr. Kelsey, was dealing with, in what must have been the 60s and, and then the 70s, that that enabled her to stand strong and be effective?

Was it just a fluke and whistleblowers are always going to be alienated in whatever culture they are in and whatever entities they're in, or is there something to be said for the culture of the FDA and America then that was more responsive to her?

VANDERBES: Yeah, it's a really great question.

I mean, I will say one of the things that interested me about the story is there, there's sort of a few whistleblowers on the American side when it comes to Thalidomide.

The chief one we talked about is Dr. Francis Kelsey.

Another one is a woman who worked before her at the FDA, who was a medical reviewer, whose name was Dr. Barbara Moulton, who had started to tell Congress.

In around 1959, Congress gets interested in looking into the drug industry, like it's making tons of money, and they're hearing reports that some of these drugs aren't safe.

And you get this woman, Barbara Molten, who actually goes and testifies before Congress and has this sort of laundry list of problems going on with the FDA.

She airs the agency's dirty laundry.

And I would argue because of what she does, she sets the stage, she effectively resigns in protest and then can't get a job in federal government to save her life for a while.

Right?

She's blacklisted.

Francis Kelsey comes to the agency, takes on that job.

Barbara Moten becomes her secret confidant in sort of advising her how she can keep this drug application off the market.

But what's interesting in the story is that because of what Barbara Moulton said about the agency, she accused there was way too much friendliness between the drug industry and FDA reviewers.

Things were being fast-tracked without proper safety testing.

Because of that Francis Kelsey, when she's at the FDA, gets a little more space and support to resist this drug than she would have had there not already been people looking into how the FDA operated.

I would also say it's interesting.

Barbara Moulton, Francis Kelsey, and then a third doctor, Helen Taussig also appears before Congress after she's traveled to Germany to investigate the harm that the drug is doing.

It's interesting in terms of the culture of whistleblowing.

At that time, all of these women had come up against so many blockades just trying to get medical degrees.

If you look back at the history of what they faced just trying to properly train themselves.

They were used to being in adversarial positions.

So I don't think whistleblowing.

They were not part of the boys club.

They didn't have anything to lose.

And I think they probably also knew one of the problems with the FDA in the 1960s and the FDA today is that you have people working at these agencies and they're simply not paid well enough.

So there's always a more lucrative position waiting on the other side of the glass door in the private sector.

I don't think a lot of these women were going to be offered the same opportunities.

No matter what they did, they were not going to be invited in by those drug firms to join those boys clubs.

So, you know, why not tell the truth?

Why not keep everybody safe?

Why not make a little bit of noise and make your mark that way?

HEFFNER: One of the points you made from the outset, Jennifer, is that these three doctors prevented, a more significant ordeal, a more massive scandal and harm to livelihoods, basically we're able to set up some guardrail to prevent that.

And unlike in Europe, is that accurate, where there weren't were these early voices, and it was already disseminated pretty prolifically so that while there was harm done to America.

These doctors prevented a lot of potential harm that could have been done further.

VANDERBES: Yeah, absolutely.

So at the time that, um, Thalidomide hits the German market where it hits first, the Germany doesn't have anything like an FDA, it simply doesn't exist.

They decide after the Thalidomide scandal that they need one, so that they can vet, you know, medicines and drugs coming onto the market.

Canada does have something comparable.

England has something comparable.

Interestingly, it passes those boards, probably for the same reasons it would've.

I mean, but for Frances Kelsey, most people would say Thalidomide would've been on the American market.

It was really just sort of lucky for us that she happened to be the person who got that paperwork.

So you do have when this drug is already widespread around the rest of the world, you have this one American doctor sitting, looking at all this data and saying, something's not right here.

Something's not right here.

We can't put it on the market.

In Germany and the UK or in Australia in particular, nobody notices that the paperwork is sloppy.

Nobody notices that the drug firm doesn't actually understand how the drug works.

In those countries because it was on sale sooner, news finally breaks of the drug's dangers, because you have doctors and parents who are starting to put together the pieces that there's in Germany an outbreak of phocomelia, and the physical damage traditionally attributed to Thalidomide, which is again, is seal limbs.

These are very shortened limbs where sometimes hands are coming directly out of shoulders, and feet are coming out of kind of like the upper leg.

This is a condition that most obstetricians would never see in their entire practicing career.

So when you have hospitals in Australia and Germany, one after another after another, babies are being born for this condition, those doctors and parents who have neighbors with similar children do their own investigating.

HEFFNER: To your point the lobby, the infrastructure for this drug was not formidable yet.

And there was a foundation of skepticism laid by the predecessor to Dr. Kelsey, who you mentioned.

So it wasn't a case of the FDA culture being different, I suppose, is a fair point.

And my question may have been rather na ïve, in a pessimistic and cynical era, judging by the fact that of course, we had tobacco and the insipid reality of tobacco and cigarettes for many decades.

It wasn't until truly the 90s that that was definitively exposed.

But was there any way in which her skepticism, her curiosity, her soundness of mind, her discerning review of the sloppy documents informed other people at the FDA who were involved in cases like tobacco or nicotine or whatever.

There were a myriad of crises, and she averted this one.

Was there anything that you discovered about her impact on the culture or other doctors there?

VANDERBES: Yeah, absolutely.

It's such a great question.

Thalidomide is really the origin story of what we think of as modern drug safety, the origin story of modern suspicion of medicine and doctors.

So she fights the Merrill Company refuses to put the drug officially on the American market.

And what's really interesting about when she's doing this is, as I mentioned, Congress and in particular, Tennessee Senator Estes Kefauver was at that moment initiating this probe into the drug industry.

He's about two years into this daily rigmarole of charts showing the markups, and he's got doctors testifying and every bit of about, the pharmaceutical in industry and its misdeeds have been brought to the surface, but there's nothing really captivating.

It's a lot of numbers and charts.

And what he finds is that after he does this incredible multi-year expose, the press has lost interest.

The public has lost interest.

Congress has lost interest.

They know that they need something sensational to get this drug bill passed, and Thalidomide becomes it.

So this is 1962, Senator Kefauver hears about what's been going on with Francis Kelsey at the FDA and decides that she will be the posterchild, and the Thalidomide will be the sort of the test case that he wants to show before his colleagues to say, this is why we need drug reform and it works.

And Frances Kelsey herself ends up going into congressional subcommittees and saying, well, if we're going to have a new drug law, you know, it should have this, this, this, and this.

What we think of now as standard protections, right, for clinical trials or, you know, any conversation we've been having recently about the idea that a drug should be effective before 1962, you, you didn't have to have an effective drug.

It was a non-issue.

If you wanted to market something, the FDA wasn't even going to ask the question, really.

It was not, does this actually work for what you say it does.

Um, that becomes part of the 1962 drug bill.

So she really changes the landscape as we know it.

Another interesting thing, because you bring up tobacco, the Merrill company ultimately, the FDA does this deep dive, once they discover how messy the paperwork was, how many Thalidomide pills were sent around the country without telling the FDA.

And at the same time, the Merrill company has been marketing a cholesterol pillcalled MER 29.

The FDA tries to get the Justice Department eventually to bring criminal charges against Merrill.

They don't, and part of the theory is that they're busy doing it on behalf of this other drug, this cholesterol pill.

This is the first time executives as at a drug firm are held accountable for wrongdoing and misleading the public and doctors about their product.

And it lays the groundwork.

They plead nolo contendere and then you have this wave of civil suits against the drug firm because of this cholesterol drug.

And if you ask sort of historians of tort law like that lays the groundwork for everything that comes after with big tobacco.

The world had never seen cases like that where you have masses of people saying your product caused this damage.

HEFFNER: Did folks in Europe per capita, and you also men mentioned Australia, who were more plagued by the disease, did they have legal recourse and did they achieve any settlement outcomes for their loved ones and families?

VANDERBES: Yeah, so that's a great question.

So the story of Thalidomide overseas plays out very differently than the story of Thalidomide in the United States, right?

Overseas, the drug was either on prescription or was cleared by a medical board, or sold in some way whereby women who had taken it or been given it eventually had pill bottles, prescription notes, allowing them to prove to some degree that they had taken Thalidomide during the first trimester of pregnancy.

And, and that was the reason why their child was born with these injuries.

So you have court cases, both civil and criminal, really around the world.

Um, there is compensation that's granted, but there's never a finding of criminal wrongdoing on the part of this pharmaceutical firms.

This has become an interesting part of the narrative because these early criminal charges were brought in about the 1960s, and since those charges were dismissed, a lot of other information has come to light that would probably change the course of those findings about wrongdoing.

But the Thalidomide survivors in the rest of the world mostly have had some access to financial compensation or support because these injuries can be so extreme that these are people who cannot leave their homes on their own, they need full-time care, they can't write, feed themselves, a range of physical injuries.

But the United States is very different.

So the United States, because the drug was never officially approved in 1962, it looked like, oh my God, this is great, you know, thousands of babies around the world injured by this drug, but we kept it off the market.

God bless Francis Kelsey.

And that part of the story is true, right?

Francis Kelsey gets an award from Kennedy on the White House launch.

She's in Life Magazine.

People are celebrating this great American victory.

It's a great kind of national rah rah moment.

However, what the FDA finds in the sort of six months to a year after this great celebration of Francis Kelsey for keeping the drug off the market is they ultimately learn that the pharmaceutical firm was dispensing this drug widely, to the tune of millions of tablets across the country under the guise of what they called clinical trials, which are nothing like what we would consider clinical trial today.

As a result, American women who took Thalidomide had a very different experience than let's say their German counterparts.

They had no bottle that said Thalidomide.

They had no piece of paper from their doctor.

And by and large, because it was given out in this reckless to violation of the law way, the doctors who had given it to women in the United States completely denied and gaslit those women.

So the American babies affected by Thalidomide mostly grew up in this country with the same injuries as their international counterparts, without any proof and sometimes any awareness that Thalidomide has had caused their birth injuries.

To this day, Alexander, they are still fighting.

I was just with them in September, we went down to the Senate to present, you know, a lot of the new findings from the book.

And talk about the fact that the United States is the only developed nation in the world that has not supported its Thalidomide survivors.

There is a court case sitting in Philadelphia, with dozens of American survivors that were not recognized in the 60s, all hinging on whether or not this wild story of misinformation can help them clear the hurdle of the standard statute of limitations.

So they have not by and large received a cent.

HEFFNER: So this was directly attributed to the lack of transparent trial practices at that point in American history?

VANDERBES: Right.

HEFFNER: It seems like that's the direct result of not having an FDA or not having governing bodies establishing what is legal.

VANDERBES: Absolutely.

There was a loophole, which was a drug firms were allowed to start clinical trials, which means testing in humans before getting approval, with the idea that you bring that data from the human experience to the FDA as part of your application.

Francis Kelsey gets the Thalidomide application.

She's told 37 doctors around the U.S. are testing the drug in clinical trials.

That is fair, standard, appropriate.

Nothing in that was disturbing.

By 1962 when they know that the drug causes this massive damage, she discovers that they've been giving it to over 1200 doctors around the United States.

Then the FDA discovers that those doctors were handing it out to their colleagues, you know, like, you know, like peppermints.

HEFFNER: Yeah, it's like setting up a lemonade stand.

It's hard to believe.

But then of course we had our parents and grandparents and many others on tobacco products without any skepticism, willy-nilly.

But yeah, it's interesting to think that as late as the 1960s, there were no standardized trials.

You could basically set it up like you were promoting your candidate for mayor on the street.

One final question.

Did she have any intuition that this was going to be the result because she knew that the practices were so lax when it came to trials that even though she was trying to prevent official authorization and approval.

Was there an awareness that this was going on and therefore we were going to have a silent bout of this even if not as severe as where the drug was already authorized?

VANDERBES: She was suspicious of the paperwork and the drug.

In her wildest dreams, neither she nor anyone could have imagined the physical damage to the unborn that this drug did.

When she realizes in 1962 that Merrill the drug firm has been handing this out widely, she's really concerned and alarmed.

And, you know, you started and you asked about whistleblower, I would say from looking at her archives, she was very aggressive in making sure that the FDA pushed to bring criminal charges against the Merrill company.

She was very active in trying to track down these babies.

She was met with a lot of red tape.

She was convinced that there were many out there, but she was also met with a wide wave of denials and lies on the part of doctors.

I mean, hospitals would say, oh, yes, we had six babies with phocomelia born within the past year.

And yes, we did end up putting Thalidomide in the pharmacy, but no, it didn't get to any pregnant women.

And you know what, what do you do?

You can't prove it.

It's smoking gun.

HEFFNER: Jennifer, thank you for writing this amazing book and unearthing this unparalleled research on this subject, author of Wonder Drug, Jennifer Vanderbes, a pleasure to meet you and chat with you about this book today.

VANDERBES: Thanks so much for having me, Alexander.

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