Deborah Unger, ‘Lost Women in Science’: Thalidomide

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/11/08

Deborah Unger talks about thalidomide and its tragic impact on pregnancy, the FDA’s history, and Lost Women of Science. Unger discusses thalidomide’s return for cancer treatment, Frances Kelsey’s role, and their podcast’s mission to highlight forgotten female scientists.

Scott Douglas Jacobsen: Today, we are here with Deborah Unger to discuss thalidomide and a podcast on lost women in science. So, what was thalidomide?

Deborah Unger: Thalidomide was first marketed as a sedative. It was developed in West Germany in the 1950s by the pharmaceutical company Chemie Grünenthal. It was initially thought to be a completely non-toxic sedative. It succeeded in the German market and was licensed by many countries, but not the United States. As a sedative, it was considered non-addictive, unlike barbiturates, and it was believed to be impossible to overdose on. It was thought to be a good medicine for expectant mothers to calm them down and help them sleep, and it was even claimed to help with morning sickness. It was sold under different brand names. In Germany, it was called Contergan. In the United States, it was branded as Kevadon. However, it never gained approval from the FDA and was never widely marketed there. It was sold as Distaval in the UK and available in Australia under the same name.

Jacobsen: What were the health effects for pregnant individuals and those who were not?

Unger: It didn’t seem to affect most people who were not pregnant. The first adverse effects were related to nerve damage—people reported numbness in their fingers and toes, but this feedback was slow to reach the company. However, for pregnant women, especially those who took it during the early stages of pregnancy, the effects were devastating. Some experienced stillbirths and miscarriages, while babies that were born often had severe limb deformities and other serious internal malformations.

Thousands of babies across Europe were born with shortened or missing limbs, a condition called phocomelia. Phocomelia can be genetic, but it is extremely rare. Doctors were seeing an unprecedented number of babies born with shortened arms, legs, or both. This was a shocking event across Europe, Australia, Canada, and, to a lesser extent, the United States.

Jacobsen: What was the correlation between thalidomide and phocomelia, and is that pathway fully understood now?

Unger: The correlation is somewhat understood, but the exact mechanism remains unclear. Thalidomide interferes with the development of blood vessels, which affects the growth of limbs and other organs during early pregnancy. This is a simplified explanation, but essentially, the drug disrupts normal development, leading to the tragic outcomes we saw. Because of these effects, thalidomide cannot be used during pregnancy, as it will cause severe congenital disabilities like phocomelia.

Jacobsen: What happened to the children who survived birth with phocomelia?

Unger: Many of them are still alive today. They are now in their sixties, and there are thalidomide survivors around the world. They have had to adapt to their disabilities, and many have led successful lives, with some becoming doctors or artists. However, as they age, they face increasing health problems because their bodies have had to compensate for the lack of properly developed limbs. Many suffer from secondary health conditions, such as joint problems, due to the long-term strain on their bodies. There are still several hundred survivors worldwide who were affected by thalidomide in the 1960s.

Jacobsen: What was the size of the staffing and the budget for the FDA in those days, and what is it now? What does that tell you about some lessons learned from the history of thalidomide and other events?

Unger: We interviewed a historian, John Swann, at the FDA for our podcast, The Devil in the Details. He told us that in the 1960s, the FDA had 1,860 full-time staff and a budget of about $13.8 million. If you look up the latest data sheet on the FDA’s website, it now says there are around 18,600 employees, with a budget of about $6.7 billion. They oversee the safety of products worth approximately $3.6 trillion. You can see a massive increase in what the FDA does and how it operates.

Jacobsen: What do these numbers tell you? Were there other interesting insights about the FDA’s growth from this expert?

Unger: Yes, we were mainly asking him about this. What it indicates is that the FDA does far more now than it did in the 1960s. When the thalidomide application hit the desk of Dr. Frances Oldham Kelsey, who was reviewing it, there were no clinical trial requirements as we know them today. She couldn’t demand data from properly conducted clinical trials because they didn’t exist then. Instead, she had to use her intuition and judgment to realize the company hadn’t provided enough evidence of safety. The application needed to be completed.

When the thalidomide tragedy became widely known, Congress acted quickly to pass new laws that strengthened drug regulations, making clinical trials and safety reviews much more rigorous. As a result, the FDA had to expand its staff and budget to handle the increased regulatory burden.

Jacobsen: What are some similarly bad circumstances in U.S. history where looser regulations led to negative consequences?

Unger: There have been other scandals. One example was an elixir in the 1930s that used diethylene glycol—a poison—as a solvent. It killed over 100 people. That incident led to the first round of tougher drug regulations in the UU.S. But thalidomide was the case that truly reshaped the way the government oversees the pharmaceutical industry. Before the 1962 Kefauver-Harris Amendments, clinical trials didn’t even require informed consent, meaning patients often didn’t know they were part of a trial.

Our podcast episodes, The Devil in the Details, discuss Dr. Frances Oldham Kelsey’s role. Richardson-Merrell company was distributing thalidomide to doctors, saying, “This has been sold in Europe for four years with no known problems. Can you test it with your patients?” However, many doctors didn’t keep detailed records about which patients received it, how much was given, or the outcomes. There was a serious lack of rigour in drug testing at that time, which has changed significantly since then.

The drug companies didn’t have to provide scientific evidence that a drug did what it claimed, at least not to the extent required today. That was another major change in the law after the thalidomide crisis. The most relevant change in this case is that they must notify the FDA immediately when side effects are reported to a drug company. But during the thalidomide scandal, it took months—absolutely months, not weeks or days—for people to begin realizing and tracing the side effects of thalidomide.

People kept taking the drug because it wasn’t immediately pulled from the market or distribution stopped. It wasn’t until November 1961, after an investigation by a German pediatrician who linked the large number of phocomelia births to thalidomide, that it was finally taken off the market in Germany. However, the drug application in the U.S. remained active until March of the following year, which seems excessive to me.

Dr. Frances Kelsey at the FDA wasn’t even aware of these side effects that should have been reported. So, while we are in a better place now, there are still several things that could make us even safer as consumers of new drugs.

Jacobsen: Do you think consumers are now more alert and cautious about experimental drug use?

Unger: Well, if they take an experimental treatment today, they must give informed consent, which is a big difference. So, if someone has a very serious illness and nothing else is working, they might choose to try experimental drugs. However, thalidomide wasn’t marketed as a treatment for a life-threatening condition. It was marketed as a sleeping pill and for anxiety—drugs that were becoming more popular in the 1950s and 1960s but hadn’t been on the market before.

It had a very different marketing approach. One thing that always surprises me—and you can probably tell by my accent that I’m British—is that when you go to the UU.S., the TT.V.adverts for new drugs have these long disclaimers at the end, which are read at 100 miles an hour, listing all the contraindications. It sounds like no one would ever take those drugs, but that’s legally required now. It wasn’t like that in the 1960s.

So, today’s regulations are designed to help people stay safe. In the past, safety was almost a side issue when new drugs came to market.

Jacobsen: For those who have listened to the episodes of your podcast, has there been any feedback about how you describe the 64-year history of drug development and regulation, particularly with thalidomide, and the FDA’s growth into the regulatory body it is today?

Unger: Some people will see something as big and bureaucratic and assume it’s bad. When things aren’t talked about much and are running relatively uneventfully, that can be a sign that they’re functioning well. What this tells me about the FDA is that despite being a large and sometimes criticized organization, it plays a crucial role in ensuring drugs are as effective, safe, and useful as possible.

The podcast didn’t five deeply into the inner workings of the FDA. Still, we did touch on the discussions today about overregulation. At least in the current political climate, leading up to the US election, we’ve seen calls for entire government departments to be shut down, and the FDA has faced accusations of internal conspiracies. However, despite such criticisms, we must remember that the FDA’s role is to protect public health by ensuring that drugs are properly vetted before reaching consumers.

How can we be sure that drugs are safe without an independent regulator? The FDA missed the opioid crisis, where a drug was put on the market that was said to be non-addictive. Still, it turned out to be highly addictive, and the dosage levels were very high. People did become addicted, and we’ve all seen the devastating outcomes of that.

What we felt about the FDA when we looked into this is that the bureaucrats like Dr. Frances Oldham Kelsey, who sit in their cubicles, receive piles of documentation and go through them carefully. To me, as a consumer, that’s a comfort. Drug companies may want to get their products out quickly. They might not appreciate a nitpicking bureaucrat—trained as a doctor or pharmacologist—going through all the paperwork. Still, as a consumer, I’m grateful. Please look at all the details and make sure the drug is safe.

The FDA’s development has paralleled the expansion of both big and small pharmaceutical companies and the overall growth of the pharmaceutical market. They now oversee the safety of $3.6 trillion products in the U.S. market alone. That’s a vast amount. My perspective, and the one we came to after doing the series, is that you want knowledgeable, expert people who know what they’re doing to prevent scandals and crises like the thalidomide disaster.

Jacobsen: What other stories are being pursued through the Lost Women of Science podcast?

Unger: The Lost Women of Science podcast launched in 2021, and we explore a mix of different stories. We’ve done several seasons, including the Frances Kelsey season, a five-part series about her life, work, and impact. That was our fifth season. Our first series was about Dr. Dorothy Anderson, probably unknown to most of our listeners. She worked in a New York hospital and discovered that cystic fibrosis is a genetic disease. She dedicated her work to helping those suffering from cystic fibrosis.

We’ve also done a series on Dr. Marie Nyswander, who developed methadone as a treatment for heroin addiction, which we called The Doctor and the Fix. We’ve covered Klari von Neumann, one of the first computer programmers, who worked on the instructions for computers used in developing the atomic bomb and beyond.

Our mission is to tell the stories of forgotten female scientists so they can receive the recognition they deserve. We also produce 30-minute episodes about various scientists, including astronomers, engineers, and others.

Jacobsen: Which episode received the most reaction from listeners?

Unger: The episode that received the most response was about Yvonne Clark, a Black engineer who worked at NASA. The reaction was partly influenced by the popularity of Hidden Figures, which also highlighted Black engineers and mathematicians at NASA. We received a lot of positive feedback on that episode. Interestingly, in reaction to the Kelsey season, not the Clark season, one listener shared a very personal story on our Facebook page. He mentioned that his mother had taken thalidomide as part of a so-called clinical trial in the U.S., and his brother, who was born stillborn, didn’t survive long after birth. That was a particularly poignant response.

And thalidomide was the cause of that. But thalidomide has returned to the market. It is now used as a very effective treatment for certain kinds of cancer and for leprosy. Of course, it’s indicated not to be taken during pregnancy. The person who wrote in said he had recently been diagnosed with one of these types of cancers and was now being prescribed thalidomide to help treat his cancer.

It was the same drug that had taken his brother away many years before. 

Jacobsen: Did you interview any survivors of these pregnancies?

Unger: Yes, we did. That forms part of our final episode, as we tried to bring the story up to date. There is a U.S. Thalidomide Survivors Group, and many of them didn’t even know others existed until much later in life. They found each other through social media, often in their 50s and 60s, because thalidomide wasn’t discussed much after the early 1960s.

The U.S. remains one of the only developed countries that has never financially supported thalidomide survivors. This stems from the fact that the drug was never officially approved in the U.S. Those affected were taking it in these so-called clinical trials with virtually no records kept. When the FDA investigated, they estimated that only 17 people were born with phocomelia, which was a wild underestimate given how widely the drug was distributed. Today, it’s estimated that there are about 100 thalidomide survivors in the U.S., and they’ve come together.

In early September, they went to Washington to lobby the government for support. Jennifer Vanderbes, whom we interviewed for the podcast, wrote a great book called Wonder Drug. She tracked down many of these survivors, who had been largely forgotten—just like Dr. Frances Kelsey.

Jacobsen: Do you have a particular favourite episode?

Unger: Of our series? No, you should listen to all of them, from episodes 1 through 5, to get the full story.

Jacobsen: You might be biased.

Unger: I’m biased, but start with episode 1 and see how it grabs you. However, I have a favourite Lost Women of Scienceepisode outside the Frances Kelsey series. We did a 30-minute episode on a woman from the 1930s to 1950s, a chemistry teacher named Mary Louisa Willard. She was one of the first forensic scientists, and she teamed up with the police department in State College, Pennsylvania, where she was based, to help solve crimes using chemistry.

Jacobsen: And that sounds like a great episode. How did you team up with Scientific American for this project?

Unger: Scientific American is our publisher because they host our podcast on their website and help promote it. We do all the work, and they assist us in reaching more people. They might also help with marketing and advertising, which is always helpful.

Jacobsen: Marketing and advertising is always helpful.

Unger: Yes, it definitely is. We’d love to reach as many people as we can. 

Jacobsen: I’ve covered everything I wanted to convey and explored all the creative angles I can think of. 

Unger: At Lost Women of Science, we have a tip line.

We also have a database with over 300 female scientists we may cover in future episodes. Often, people know of forgotten women scientists who did great work but have yet to receive recognition. We encourage them to call us, leave a message or email us. You can find the tip line at lostwomenofscience.org. We also create shorter programs about the scientists people tell us about, in a segment called “From Our Inbox.”

We interviewed the person who had left the tip and then researched the scientist to create a story.

Jacobsen: What about your upcoming episode for Breast Cancer Awareness Month?

Unger: Sure! For Breast Cancer Awareness Month, we’re doing a two-part episode on a very overlooked figure—Dora Richardson. She was the chemist in England who synthesized the compound that became tamoxifen, one of the most revolutionary treatments for breast cancer. It’s a drug therapy that went on the market in the 1970s and has saved thousands of lives. Katie Couric, who is a breast cancer survivor herself, is introducing our episodes on Dora Richardson because, frankly, I don’t think many people realize it was a woman chemist who developed the compound that became tamoxifen.

That series will be released at the end of October. We have much more coming up in November, but I’ll leave it at that for now.

Jacobsen: Thanks so much, Deborah. 

Jacobsen: Any final thoughts based on our conversation today?

Unger: My final thought is that unless we purposefully tell these stories, they’ll continue to be forgotten. We want to inspire people—especially women and girls—to pursue careers in STEM. While many do today, knowing that others have faced obstacles before them and still made a difference can be incredibly motivating. By sharing these stories, we hope to prevent more women from becoming “lost women of science” and instead inspire them to make their marks in the field.

Jacobsen: Excellent, Deborah. Thank you so much for your time today. I appreciate it.

Unger: Thank you, Scott.

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