Sally Helm (3:06)

Thalidomide, or controgen, as it was called in Germany, was a supposedly safe sleeping pill that ended up not being safe at all. Babies whose mothers had taken the drug were born with deformed limbs or sometimes with no arms or no legs. Many of them died. The drug harmed thousands of infants, and it also caused nerve damage in some adult patients. This trial is a criminal case to try and bring the drug company behind thalidomide to account. The defendants are five executives of that company, which is called Kemi Grunenthal. The proceedings began over two years ago. Today, the accused men watch from the front of the room as the judge announces that the trial is over and there's no verdict. It all ends in a settlement. The company will set up a fund of $27 million to help child victims of thalidomide, and these men are free to go.

Michael Magazanik (4:06)

It's frankly hard to imagine people injured in utero before they'd taken their first breath by drug companies who really were unbelievably cavalier and uncaring.

Sally Helm (4:18)

Today, how did thalidomide make it to market and become a historic medical disaster? And who are the heroes who brought that disaster to an end?

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Sally Helm (7:24)

There are an estimated 3,000 thalidomide survivors alive today. And that trial in Alsdorf, Germany, wasn't the last time they sought justice in Court.

Michael Magazanik (7:35)

About 10 years ago, a colleague and I decided we'd litigate for Australian survivors of the drug.

Sally Helm (7:41)

Michael Magazanik is a lawyer in Melbourne, Australia.

Michael Magazanik (7:45)

But it was emotional. My partner and I had our first child just before I started litigating on thalidomide. It made everything kind of very personal and very real.

Sally Helm (7:56)

The lead plaintiff in Magazanik's case was a woman named Lynn Roe, who had been born without arms and legs after her mother, Wendy, took thalidomide. In the course of his research for the trial, Magazanik spoke to Wendy's obstetrician who'd had to give her the terrible news.

Michael Magazanik (8:12)

He decided he just had to be frank and honest with Wendy. And he went up and told her that she had a healthy daughter, but that her daughter had no arms and legs. And there was a pause, and Wendy said, well, we're just going to have to take good care of her.

Michael Magazanik (8:28)

The two of them were unbelievably impressive characters. And they've stayed with me.

Sally Helm (8:33)

Magasanik's clients won a large settlement, and after the case, he decided to write a book about Lyn and about the history of the Lydomide. He'd learned a lot in the course of the trial, and he wanted to tell the story from the beginning.

Michael Magazanik (8:47)

The German company which invented or identified fledamide was called Grunenthal. And Grunenthal is the offshoot of a German perfume and soap company. And it was set up, really by the parent company to get into pharmaceuticals and to make money.

Sally Helm (9:00)

Chemie Grunenthal was set up in Germany in the wake of World War II. The economy was in ruins. Lots of German companies were looking for new ways to be profitable. And some German people were looking to escape from their recent pasts.

Michael Magazanik (9:15)

For example, Heinz Baumkotter, who was a notorious SS doctor at a concentration camp near Berlin, got a job at Grunenthal.

Sally Helm (9:22)

There were, in fact, several former Nazis working at Grunenthal, including one of the men on the scientific team that developed thalidomide. Heinrich Mukter had performed medical tests on prisoners at the Buchenwald concentration camp and at Grunenthal.

Michael Magazanik (9:36)

He'd been put in charge of their drug development program. And he'd also been promised a percentage of drugs that Grunenthal got to market. So you take a doctor with a forceful personality and a wartime history of medical experiments, and then you give him a medical laboratory. And it was he who set up a couple of other scientists to try to synthesise some new drugs. And it was they who identified a compound which they later called thalidomide.

Sally Helm (10:06)

At first, it wasn't clear that thalidomide was actually a medicine. It looked kind of like a barbiturate, but the scientists weren't sure what it could do.

Michael Magazanik (10:16)

It wasn't much of a drug at all. People have called it a drug that was in search of a disease.

Sally Helm (10:21)

Nevertheless, they patent it in 1954 and start testing it by 1955. They test it first on rodents, and it seems that no matter how much thalidomide the animals take, the drug isn't lethal. The rodents don't die. Thalidomide is deemed safe enough to test on humans in clinical trials. They test it on patients with everything from influenza to liver disease. And they notice that a few of their test subjects are falling asleep. Grunenthal realizes they might have something very marketable on their hands.

Michael Magazanik (10:57)

The barbiturates, which dominated the sleeping pill and sedative market had a really big problem with overdoses. They led to accidental deaths and were used frequently in suicides. So there was a bit of a hunt on for a safe sleeping pill and sedative.

Sally Helm (11:11)

And it seems like you can't overdose on thalidomide. The drug gets approved for sale in Germany.

Michael Magazanik (11:19)

In a higher dose it was a sleeping pill and in a lower dose it was a sedative or anti insective medication.

Sally Helm (11:26)

It's marketed as a bit of a cure all. It might treat everything from stage fright to insomnia to irritability. Soon it gets approved for sale outside of Germany too. It wasn't so hard to get drugs approved back then. Many countries didn't even have a central regulatory agency like the US's Food and Drug Administration.

Michael Magazanik (11:45)

Even though the FDA was flawed, it was at least something other countries didn't have a regulatory authority like that. For example, in Australia, the drug company is just allowed to sell the drug. They didn't have to go get approval anywhere.

Sally Helm (11:58)

By 1960, thalidomide is being marketed in 46 countries. It's selling nearly as much as aspirin. But one place it's not yet being sold, the United States, that is Grunenthal's white whale.

Michael Magazanik (12:14)

They were just champing at the bid to get sales approval because they thought there were rivers of gold gonna come to them from flutimide in the United States. And they desperately wanted approval.

Sally Helm (12:24)

But in the us there is an fda. And at the fda, a new employee has just started.

Michael Magazanik (12:31)

A woman called Frances Kelsey. She had just arrived with the fda. It was her first new drug approval for consideration.

Sally Helm (12:39)

Kelsey had gotten her Ph.D. in pharmacology before World War II. During the war, she and her husband had been involved in the search for antimalarial drugs. At one point, they'd solicited ideas from the public.

Michael Magazanik (12:52)

She recalled years later that a vet in Texas sent in a proposed malarial cure, which he tested on his secretary. And he said he was now planning to test it on his cattle. Kelsey's setup shows the relative value placed on women and cattle in Texas.

Sally Helm (13:09)

Kelsey is tough, no nonsense, independent. And when this drug application gets to her desk, at the fda, she was.

Michael Magazanik (13:16)

Concerned about the health of the fetus, a concern that didn't trouble some of the men in charge of the drug companies at the time.

Sally Helm (13:24)

Kelsey starts asking questions.

Sally Helm (13:28)

It was known at this point that drugs taken by pregnant women could affect the fetus. But no one had tested those possible effects before bringing thalidomide to market.

Michael Magazanik (13:38)

And yet sales pitch for thalidomide worldwide was that it was an ultra safe drug. The iconic advertisement for thalidomide was a picture of a child standing on a stool, reaching into a medicine cabinet, holding a jar, which one is supposed to assume is thalidomide. And the caption says, this child's life may depend on the safety of thalidomide.

Sally Helm (14:00)

Which was based on those studies first done in rodents, showing that it's very hard to overdose on thalidomide. But what if a mom takes it while she's pregnant? What about the fetus's safety?

Michael Magazanik (14:12)

Kelsey was just disturbed by the crazy safety claims that were being made for the drug. And she said, no way. Go back and do some more testing.

Sally Helm (14:22)

The drug company execs in Germany and the US distributors, they are not happy.

Michael Magazanik (14:27)

They hated Kelsey. They vilified her. They went behind her back to her bosses. At one stage, they threatened defamation. They asked her to be shifted off the application.

Sally Helm (14:38)

None of it works. Kelsey stays steadfast. She rejects their application for over a year. She says the safety testing just isn't sufficient. Even aside from the possible effect on fetuses, it's starting to come out that adult patients who take thalidomide might be experiencing harmful effects.

Michael Magazanik (14:56)

They started getting reports of peripheral neuritis, which is damage to the nervous system. It was horrible. Itching and burning at the ends of the nerves and the fingers and toes, unsteadiness when walking. Some people were so tormented, ended up in psychiatric hospitals.

Sally Helm (15:14)

Despite these concerning reports, thalidomide is soon all over the world. One of the doctors trialing the drug is named William McBride. He's an OB GYN in Australia, and in 1960, he accepts a request from the drug company Distillers. They're the British licenser of thalidomide to try out this new drug. He agrees, and sometime after, he's working with one of his patients, a pregnant.

Michael Magazanik (15:39)

Woman suffering severe morning sickness. He couldn't alleviate her symptoms, and in desperation he gave her some distaval tablets, which was the Australian name for thalidomide, and it quelled her morning sickness. And so McBride became convinced he'd found the answer to morning sickness. And he started handing it out as someone later served, like lollipops.

Sally Helm (15:58)

Then very soon, McBride starts to see some really concerning things.

Michael Magazanik (16:04)

His patients start delivering malformed babies and there's three in quick succession, all of whom have severe limb malformations and all of whom die quickly after birth.

Sally Helm (16:14)

McBride is distressed by this. He wonders what could possibly be causing it. One weekend In June of 1961, he's home studying medical journals and he says he. He has a eureka moment. The Distival. It must be the distival. He immediately notifies the Australian drug company Distillers, which has licensed the drug from Grunental.

Michael Magazanik (16:38)

The great tragedy of this whole episode is that Distillers sits on that information.

Sally Helm (16:44)

The Australian branch of Distillers is really just a sales arm of the company.

Michael Magazanik (16:49)

About 50 years later, I found a couple of those, but by then elderly men who had worked at Stillers. These two men were very junior at the time, and they told me the story, which is that, yes, they got that report from McBride and that their bosses sat on that information desperately hoping it wasn't true. And even while knowing about this report, they kept selling the drug, promoting it, pushing it out there.

Sally Helm (17:12)

By November, McBride still hasn't heard anything. So he takes matters into his own hands. He writes a letter to the Distiller's headquarters in the uk, hoping that they might respond better than the Australian office did, or just respond at all. He puts the letter in the mail and waits.

Sally Helm (17:33)

Meanwhile, back in Germany, another doctor is also on the case, Wittekind Lenz.

Michael Magazanik (17:40)

In many ways, Videkund Lenz is sort of with Kelsey, the cohero of this story in terms of the doctors.

Sally Helm (17:47)

Thalidomide is at this point very popular in Germany. It's in medicine cabinets across the country. And in early 1961, right around the time that McBride starts noticing the terrible problems with his patients in Australia, a mother and father in Germany come to see Dr. Lenz.

Michael Magazanik (18:04)

He was consulted by a family about their baby with very unusual limb malformations. And Lenz at that point thought that the probable cause was a gene mutation.

Sally Helm (18:13)

Lenz is a celebrated pediatrician not working specifically with thalidomide. And it's not clear to him that there's a pattern here. This looks like an isolated case.

Michael Magazanik (18:23)

But then in June 1961 came the visit that really changed Lenz's life. And it was a lawyer called Carl Schulter Hillen who came to him because Schulter Hillen's wife Linda had given birth to a child. With thalidomide malformations. And almost at the same time, Schulter Hillen's own sister gave birth to a child with similar malformations.

Sally Helm (18:44)

Lenz promises to look into it.

Michael Magazanik (18:47)

He rang a couple of friends. He was told that there were many more babies around with these malformations. And soon Lenz had whipped into action, determined to find what he called one single connection for all of these cases. And it was really something of a detective, private investigator search rather than that of a doctor. He's literally traveling around and looking at medicine cabinets, talking to mums, giving them a questionnaire. And initially Lens wondered whether it was a new lipstick or a face cream.

Sally Helm (19:15)

Macasanik told us today it would probably be obvious sooner that a drug was to blame. But back then it wasn't so clear. Lentz did ask about drugs, though, and he couldn't seem to find one that connected these babies.

Michael Magazanik (19:29)

Nest. Cazo's mothers thought of the sleeping pill they'd been taken as so innocuous that many of them didn't mention it because they'd been sure it was so super safe.

Sally Helm (19:38)

Lenz keeps looking. And then In November of 1961, he talks to the mother of a baby girl who'd been born without arms, and she says she'd taken chondrogen, which is the German name for thalidomide.

Michael Magazanik (19:53)

Then the next day, the father of another baby told Lens that he blamed Contradan.

Sally Helm (19:58)

Lenz thinks this is a lead.

Michael Magazanik (20:01)

He visited more families. By 15 November 1961, he'd gathered about 14 cases. So by now, Lenz was sure. And that's when he confronted Grunenthal.

Sally Helm (20:13)

Lenz calls the company. He tells them what he thinks the drug is doing. He says the company must take it off the market. Then he goes in for a meeting.

Michael Magazanik (20:22)

And as he says, the Grunentile representatives just showed no interest in the facts, what he said. And they concluded the meeting by refusing to withdraw Fluttermide from sale. What's astonishing is that on that day, the 20th of November 1961, after Lenz has warned them that he believes it's maiming and killing babies, Grunenthal sends out almost 70,000 copies of a pamphlet addressed to doctors describing Ethelimide as a safe medicine.

Sally Helm (20:49)

So Now Lenz and McBride, thousands of miles apart, have raised the same alarm. And they're not really good comparing notes.

Michael Magazanik (20:58)

This is pre Internet, pre fax machines, pre email. In those days, doctors communicated by letter and they met occasionally at conferences.

Sally Helm (21:07)

But even though they're not coordinating, these two doctors have uncovered the same thing and their efforts are about to combine to finally take thalidomide down.

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Sally Helm (22:56)

Mobile.Com Just as Lenz is making his case in Germany In November of 1961, McBride in Australia is getting tired of waiting. He goes back to Distillers, says I.

Michael Magazanik (23:08)

Told you about this months ago. What have you done? Why are you still selling it?

Sally Helm (23:13)

And so finally Distillers writes to their headquarters in the UK and says we've gotten this report from an obstetrician about this drug possibly harming babies.

Michael Magazanik (23:23)

And it's that report in November 1961, which distillers forwards to Grunital and arrives at Gruner just in the midst of the fuss that Lenz is creating.

Sally Helm (23:33)

McBride's report cites six infant mortalities where the mothers took Thalidomide. That's on top of Lenz's already concerning evidence.

Michael Magazanik (23:43)

But unbelievably, that's still not enough for Grunenthal to agree to withdraw the drug. What really seals the drug's fate is the next morning, a very popular German newspaper carries an article about Lenz's fears.

Sally Helm (23:59)

The writing is on the wall. In rapid succession, thalidomide gets withdrawn from markets all over the world. West Germany, then the UK and Australia, then Canada months later.

Sally Helm (24:11)

Meanwhile, a team of lawyers has gathered in Germany to investigate Grunenthal's alleged negligence. The case will take years to put together, in part because of the sheer scale of the damage.

Michael Magazanik (24:23)

They gathered thousands and thousands and thousands of documents. And in 1967, the state authorities in Germany confirmed that it would pursue serious criminal charges, in fact, negligent manslaughter against nine Grunenthal executives.

Sally Helm (24:38)

By the end of the case, it's just five executives. And throughout the trial, Grunenthal's lawyers are sharp and aggressive.

Michael Magazanik (24:46)

Amazingly, Grunental managed to find witnesses to assert that thalidomide did not cause nerve damage or malformations. They got people along to say it was pure speculation that there was any connection between the two, which was completely bizarre. Brunetail even tried to promote a theory that thalidomide might have actually been foetus saving rather than foetus naming. That theory asserted that somehow thalidomide did not damage the foetus. That, on the contrary, somehow allowed otherwise really badly damaged foetuses to survive until birth.

Sally Helm (25:19)

Dr. Lenz testifies for the prosecution and gives devastating evidence about the victims and the families he'd seen. But ultimately Grunenthal manages to get his testimony thrown out as biased. The case goes on for two and a half grueling years, and finally both sides agree to settle.

Michael Magazanik (25:37)

The lawyer at the trial, representing the Trojan's interests, one of those children was his. And even he agreed to the suspension of the trial. He said, we can't afford to spend time on legal problems at this stage. We've got much, much bigger problems in terms of health and education.

Sally Helm (25:50)

German child Victims receive a $27 million settlement, which works out to about $19,000 per child. Adult victims with nerve damage receive about $1.1 million in total, and there is no formal verdict. So Grunenthal never admits guilt.

Michael Magazanik (26:08)

The trial was over with a massive silver lining for Grunenthal, which was that at 200 million million mark fund was set up for the survivors. But Grinentaal, courtesy of the gift of the German government got a law preventing any more civil or criminal claims against the company.

Sally Helm (26:25)

No more civil or criminal belidomide trials in Germany, though Grunenthal and its licensors would go on to pay another large settlement to victims in Australia and New Zealand. That's Lynn's case that Magazanuck litigated. And in 2012, Grunenthal finally does issue an apology, but they stop short of admitting liability.

Sally Helm (26:45)

Translated from German to English, part of the statement reads, quote, we ask that you regard our long silence as a sign of the shock that your fate caused in us.

Michael Magazanik (26:55)

It just enraged the survivors, the idea that the company was so shocked by what had happened that it couldn't apologise when the people really suffering the shock were the survivors and the mothers and the fathers and the family members.

Sally Helm (27:14)

The company is still around today. They specialize in producing medications for pain. As for the various heroes of the thalidomide story, Dr. Lenz became the director of the Institute of Human genetics in Munster. Dr. McBride's legacy was tarnished in later years by accusations of scientific fraud. And Frances Kelsey got a commendation from President John F. Kennedy and went on to have a stellar career at the fda. Articles she wrote helped pave the way for modern day drug testing procedures.

Sally Helm (27:46)

In large part in response to the thalidomide scandal. Drug approval procedures got much tougher around the world. Drugs intended for human use could no longer rely solely on animal testing to prove safety, and drug trials for drugs that could be taken by pregnant women had to provide evidence of safety for the fetus.

Michael Magazanik (28:05)

The silver lining, I suppose, from this unmitigated catastrophe was that it made drug regulation much more effective around the world and it also focused attention on the need for care when giving untested drugs to pregnant women.

Sally Helm (28:20)

New drugs are always risky, but as we understand all too well in the age of COVID they're also hugely important. Sometimes we want them fast, but science isn't always fast. And the thalidomide disaster serves as an important reminder of why the safeguards we have now are so important.

Sally Helm (28:49)

Thanks for listening to history this week. For more moments throughout history that are also worth watching, check your local TV list listings to find out what's on the History Channel today. This episode was produced by McCamey Lynn. History this week is also produced by Julie McGruder, Ben Dickstein and me, Sally Helm. Our editor and sound designer is Dan Rosado and our researcher is Emma Fredericks. Our executive producers are Jesse Katz and Ted Butler. Don't forget to subscribe, rate and review history this week, wherever you get your podcasts and we will see you next week.