Never Take Candy from Strangers ... or Free Drug Samples from Doctors
(This is a story from a memoir I am writing about life in West Germany during the Cold War. My husband was drafted into the US Army in 1968.
Instead of going to Vietnam, as we expected, he was assigned to duty at a base in Darmstat, West Germany. I lived there with him for 14 months.)
While obviously pregnant women were out of sight in West Germany, children and babies were not.
We spent our weekends sightseeing during the summer of 1969. On our excursions, we noticed a number of families pushing strollers and wheelchairs with children who had striking deformities. Splayed feet, and legs bowed so badly that it was obvious the child would never walk. Many had preshortened arms. Sometimes no arms at all - just little hands attached to their shoulders, like flippers.
These children weren’t infants. The ones I remember were pre-schoolers. Some may have been older.
I heard about birth defects like these in nurse’s training. They were caused by a drug called Thalidomide, which was prescribed for pregnant women to relieve morning sickness.
Even though I knew about these birth defects and had seen photos, I wasn’t prepared for the shock of actually seeing children afflicted in that way. It was heartbreaking.
Image credit: Judith Johnson PhD
I never saw a Thalidomide baby in the US. I only knew about them from photos and what I learned in school. I was told that the drug was never approved in our country and so the tragedy was averted for us. I felt very fortunate that I was an American.
But it turns out that there is more to the story.
It is true that Thalidomide was never approved for use in the US, thanks to Dr. Frances Oldham Kelsey at the FDA (Food And Drug Administration). She wouldn’t approve the drug because proper testing had not been done, and she was concerned by early reports of serious side effects experienced by patients in Europe. She was steadfast in her refusal, despite pressure from FDA colleagues and Richardson-Merrell, the US manufacturer of the drug.
What Dr. Kelsey did not know, however, was that “pre-approval” samples of the drug were being distributed in the US.
In her book, Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims, author Jennifer Vanderbes explains that behind the scenes, Richardson-Merrell was distributing Thalidomide in the US for use in a so-called “clinical trial.”
Richardson-Merrell gave free samples of Thalidomide to 1,200 doctors, and told them that the drug was going to be approved soon. They gave the impression that it was safe for them to begin giving it to their patients.
Trials like that were permissible then because of lax regulations. Merrell intended to use the “trial” as a marketing tool. If women used Thalidomide and liked it, their testimonials would help Merrell sell the drug once it received final approval.
The number of American women who received the drug is estimated at 20,000. The number of victims is impossible to know.
Many women didn’t realize they had taken that particular drug. They recalled later that they took “something” their doctor gave them. It is likely that none of them were told that the drug was not approved by the FDA. Nor were they told that they were part of a “clinical trial.” Doctors later said they didn’t remember who they gave the drug to.
Shortly after Dr. Kelsey refused to approve the drug, a wave of devastating reports came from Europe revealing the extent of the Thalidomide disaster. She was hailed as a hero in the US, and rightly so.
In 1962, President John F Kennedy awarded Dr. Kelsey the Award for Distinguished Federal Civilian Service for what he described:
"Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people."
Of course, Merrell’s clinical trial was abandoned, but the damage was done.
Where are the US thalidomide babies today? They are still with us. Visit the USA Thalidomide Survivors website and learn about these remarkable people.
This article in Scientific American, published in 2024, tells more of their story and profiles Dr. Kelsey in an installment of “Lost Women in Science.”
You might wonder why doctors weren’t more skeptical about Merrell’s trial. They knew the drug hadn’t been approved yet. My best guess is that they weren’t prepared to challenge drug companies - they simply didn’t know enough to ask the right questions.
Pharmacology studies were hit or miss in medical schools during the 1960s. Some schools had pharmacology classes, other schools combined drug information with specific course work, but there weren’t general requirements that applied to all students in all medical schools.
At the school where I took nurse’s training, we were required to take a full semester of pharmacology classes. We didn’t understand why. We weren’t going to be prescribing drugs. It seemed like a good overview of frequently prescribed medications should have been enough.
Some of my classmates, the wives and girlfriends of medical students, compared notes with their partners. It seemed to them that our studies were a lot more rigorous. My classmates asked our instructors why we had to take these classes, and their partners didn’t.
We were told that we needed that information because “nurses are there to catch doctor’s mistakes.”
The tragedy and scandal in Europe
Thalidomide was initially prescribed in Europe for relief from anxiety and as a sleep aid. When Chemie Grunenthal, a German pharmaceutical company, took over production of the drug in 1954, they marketed it for those purposes and also to treat morning sickness for pregnant women.
Chemie Grunenthal was founded in 1946 by Hermann Wirtz Sr., a former Nazi. Wirtz hired men for key positions in his company who had been involved in Nazi medical experiments during World War II.
One of them was Heinrich Mückter, a chemist who escaped prosecution for war crimes for his experiments on prisoners in concentration camps because of his experience in research and development of an anti-typhus vaccine during the war. Apparently, the life saving implications of his research excused him from being accountable for his methods.
Other hires included, according to Wikipedia, “...Martin Staemmler, a medical doctor and leading proponent of the Nazi eugenics programme, as head of pathology, as well as Heinz Baumkötter, the chief medical officer at the Sachsenhausen concentration camp, and Otto Ambros, a chemist and Nazi war criminal.”
Sadly, but perhaps not surprisingly, given the backgrounds of the men involved, the drug was never tested before it was prescribed for morning sickness. By “tested,” I don’t mean testing on pregnant women. That wasn’t necessary. Testing could be done in a lab.
Medical professionals in other countries did exactly that. In Turkey, for example, tests involving tissue cultures led doctors to conclude that the drug was unsafe in 1960. They would not approve the drug.
East German officials also refused to approve Thalidomide based on the information supplied in the patent. They noted that, due to the structure of the molecule, an “embryo-toxic effect” was possible.
In addition to birth defects, many miscarriages and still births were caused by Thalidomide. The full extent of the damage will never be known.
“Nine Things You Didn’t Know About the ‘Poisonous Pill’,” is an article written by medical researcher, Judith Johnson. Her father was the Director of the UK Thalidomide Trust between 2000 and 2014. She summarizes the Thalidomide catastrophe that The Guardian describes as “war apart, it remains the greatest manmade global disaster.”
Image credit: Wikipedia
What became of the children in Europe who survived? The 2008 documentary, “Nobody’s Perfect,” by Niko Von Glasow tells the stories of 12 “Thalidomides,” as those afflicted call themselves. They talk about their lives quite candidly, describing how they deal with the challenges of functioning in the world, finding love (or not), and making peace in some way with their circumstances.
Each of them agreed to pose nude for a calendar to bring awareness to their condition and ask for the German government to provide justice for them.
Nico’s film won the German Film Award in 2009. It also led to a 2.7 billion Euro compensation benefit from the German government to Thalidomide survivors.
Glasow, who is himself a Thalidomide, and his cohorts are now well into their 60s and 70s. Their lives have been a remarkable testament to the ability of humans to adapt. But the sad truth is that none of them should ever have had to.
***
When I became pregnant in 1969, I didn’t know the full Thalidomide story. But what little I knew caused me to be wary of medication for morning sickness. When my doctors prescribed Bendectin, I asked a lot of questions.
I was reassured to learn that the drug had been approved by the FDA and had been used for a long time without incident. Still, to be on the safe side, I took it only when I felt I had to.
It wasn’t a perfect drug. I still spent a lot of time feeling queasy and throwing up. But it allowed me to function when I needed to. I am grateful that it was available to me and that my son was born healthy.
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