How one scientist averted a national health crisis – Andrea Tone


In the fall of 1960,
Frances Oldham Kelsey was one of the Food
and Drug Administration’s newest recruits. Before the year was out, she would begin a fight that would
save thousands of lives, though no one knew it at the time. Although she was new to the FDA,
Kelsey was no novice as a scientist. After graduating
from high school at age 15, she enrolled
at McGill University in Montreal and earned both undergraduate
and master’s degrees in pharmacology. From there, she applied
for a research post at the University of Chicago’s
pharmacology department. Her acceptance letter was addressed
to Mr. Oldham. Kelsey later joked that had her name
been Elizabeth or Mary Jane, her career might have ended there. Fortunately, it didn’t. She earned her doctorate
in pharmacology and accepted Chicago’s invitation
to stay as faculty, where she undertook pioneering
research on drugs and fetal safety. In 1950, she earned an MD,
her fourth and final degree. By the time she joined the FDA, Frances Kelsey was one of the most
educated, experienced scientists around. Yet, as the newest member
of the team, Kelsey was assigned what everyone
thought would be an easy review: an application from the
US drug company Merrell to sell a drug called thalidomide. Thalidomide was a sedative
developed in Germany that was already being widely used
in dozens of countries to treat insomnia and workplace stress. Thalidomide’s anti-nausea properties also made it a popular remedy for pregnant
women with morning sickness. Reviewing Merrell’s application, Kelsey found its data on thalidomide’s
absorption and toxicity inadequate. Today, the FDA classifies drugs based
on their safety for a fetus. But in 1960, many experts believed
that the placental barrier shielded a fetus from harm. Kelsey’s earlier animal-based research demonstrated the opposite: drugs could pass from mother
to fetus through the placenta. Like other drug companies at this time, Merrell had not tested its drug
on pregnant animals. Kelsey later said Merrell’s evidence
for thalidomide’s safety seemed “more like testimonials than
the results of well-designed studies.” Kelsey rejected Merrell’s application and asked them to submit a second
backed by better evidence. Her FDA colleagues
supported this decision. Merrell had expected a quick,
affirmative reply so it could launch thalidomide
for the holiday season, when sedative sales soar. Instead of supplying Kelsey
with the data she requested they first tried to convince her
to approve the drug over a series of calls and visits. When these failed to sway her, Merrell executives complained that stubborn and nit-picking
Kelsey was the problem, not thalidomide. The FDA backed Kelsey, forcing Merrell to file
another application, and another, and another. As Kelsey reviewed
and rejected each new application, news of thalidomide’s adverse
side effects began to surface. Doctors reported cases of nerve damage
in early 1961, and by fall,
they’d unmasked a more horrible truth. Thalidomide, widely used by pregnant
women, caused severe birth defects. Thousands of babies died in utero, and tens of thousands more
were born with extra appendages, shorter limbs, or no limbs at all. In November 1961, thalidomide
was pulled from the German market. Nonetheless, Merrell continued trying
to get it approved in the US for several months before withdrawing
their sixth and final application. While Kelsey wasn’t the only scientist
to identify the risks of thalidomide, she sounded the alarm that kept it off the multi-billion-dollar
American drug market. As public awareness
of the thalidomide tragedy grew, the quiet scientist
became a media sensation. Headlines in newspapers
and magazines heralded her heroism while a smiling President John F. Kennedy presented her an award
on the White House lawn. After the thalidomide scare, Congress passed laws that expanded
the FDA’s authority and toughened requirements
for new drug applications. Kelsey was tapped to head
the agency’s drug investigation branch. Working at the FDA in
different capacities into her 90s, Kelsey was able to witness the changes
her actions helped inspire. Her visibility may have dimmed since,
but her legacy endures. Privileging facts over opinions,
and patience over shortcuts, she made evidence-based medicine
the foundation of reforms that continue to protect people today.

100 Replies to “How one scientist averted a national health crisis – Andrea Tone”

  1. If you're a student with a passion for science, share your ideas, discoveries and hopes with the world through TED's student idea platform: http://bit.ly/2M7hd87. If your passions lie elsewhere, we want to hear from you, too! TED-Ed is creating a space to celebrate and amplify student ideas on a wide range of topics — from human rights to staying organized in school — and we want you to be a part of it! Check it out!

  2. We love you Dr. Kelsey. Without you, I could have never been born. I thank you so much for your unwavering bravery and courage because it could have easily have given me life, or at least a life without any disparages. Thank you.

  3. And we don't know she is …. Had there been a crisis and she then saved the day she would be remembered by everyone

  4. Someone forward this to today's White House: They don't read, but perhaps they'll watch a cartoon.

  5. Someone doing their job instead of being a moron, and she didn't expect the praise. This should have been, and still should be, the way things work. To remember a time when people used to be competent, so crazy.

  6. brilliant story, right untill you went off the reservation and turned it into a gender topic, it may have been an issue back in the 1960's but today it is just an insult to those early equalists. Rede Vatro Satanas, Mene mene tekel ufarsin!

  7. I personally, love the fact that I'm going against my gender norm and taking a stem field. Of course, I hate the fact that women aren't as represented, but just doing my part to fix that, while doing what I love, is great

  8. Want more women in STEMs? Stop subsidizing women's' studies, gender studies and other bogus degrees. I would be a much happier guy knowing that women were bigger on evidence based scientific fields

  9. We can start by stop buying Barbie dolls in bikinis for our daughters and instead force manufacturers to make female dolls are scientists, warriors and women who will change the world.

  10. This is interesting and great and all, but praising women and saying they’re not equal is ridiculous. First of all, nothing will change if you keep believing that’s true, and keep saying it is.

    Second, it’s not. And women are treated like gods compared to how Men treat their own gender and even themselves. Men are beautiful, but those blind to Male beauty praise women and obsess over them and treat them better than other Men.

  11. women are underrepresented in STEM because women generally don't like STEM as much as men. everyone should have equal opportunities and any discrimination is bad but quotas are even worse,

  12. Frances: I wanna be a female doctor!

    Males: Imma bout to end this whole girl's career

    lol sorry if that sounded sexist idk

  13. I thought this is was a great video until the the end where they started talking about gEnDer EqUAliTy

  14. All people born from 1960 and beyond should be grateful for this scientist’s discovery. She saved us all from possible birth defects from a medicine we thought was safe

  15. Why are women underrepresented in Stem? Mostly because they aren’t interested. Although partly due to social pressure to adopt gender conforming roles most women opt to enroll into other fields, like the popular gender studies majors who complain about women not being represented despite the obvious answer.

  16. Frick frack, don't you think there are just more men interested and skilled in STEM? Friggin feminism, you gotta learn to be more realistic. I understand if it were back then, but there's a lot of equality now, and I think we should stick to being decent human beings. Where you need to help is in the Middle East.

  17. Le me, only half-paying attention – Oh, that name sounds familiar…
    At 1:21 – le gasp

    Humor aside, people like Dr. Frances Oldham Kelsey are in short supply. It's part of why STEM (or, perhaps, STREAMM – Science, Technology, Reading, Engineering, Arts, Math, and Musicphew! that's a mouthful!) is so important. Increasing the relevancy of education in our daily lives, for each and every profession to build on, is the core of what STEM is, whether you become an artist, as the animator of this lovely educational short did, or a scientist, as the subject of said short video did.

  18. How one scientist averted a national health crisis – Frances Kelsey… not Andrea Tone. I ve not found any other more narcisistic writer puting their name up there instead of the person they are talking about.

  19. STEM: is underrepresentative of women
    Women: Research why instead of researching STEM so they can go into STEM

  20. The reason why there's more men than women in STEN fields is because men have a higher interest in those fields of work then women.

  21. The reason there are less women in the stem field is because they are mostly either not smart enough, or don’t work as hard as men. That is not to say that there aren’t some brilliant female scientists, but it is pure, scientific, mathematically correct statistics and studies that gives us evidence of this case.

  22. I dont get why its bad if theres not as much women in stem. All I care is that they have the equal ability, and are seen as equal to men. When hiring, one should not pay Any attention to gender, especially in Stem careers.

  23. Simply brilliant.
    I can only hope there are more people like her on their way to help put good science forward and keep people safe.

  24. It seems there are no Dr. Oldhams left. She was in the vanguard of actual EBM. Increasingly, what we have now is a sham. "Gold-standard" does not exactly glitter these days. This is especially true with regards to vaccines, where placebos are not used. The FDA of today is a Gollum like shadow of its former self – it has fallen for the "Precious".

  25. There are still many meds that need to be pulled from market, such as ciprofloxacin to name one. Unfortunately money rules over most other things and it will be the usual battle over and over. Will there ever be true order and balance? We will just cause our own demise and be remembered as Stone Age, Bronze Age, we are the Plastic Age.

  26. This is why other parents don't like vaccine and medicine because members in FDA or pharmaceutical company is bought by greedy business minded people.

  27. It's weird how popular culture is constantly trying to sully the reputation of government agencies. I wonder why. 🤔🤔

  28. this video popped up after i submitted my college essay i wrote about her. so happy i did. absolutely adore frances and all she's done, as well as the fda's support.

  29. 4:32 부터 한글자막 작업 안되어있네요 여성차별 이슈에 대한 내용이라 자막을 안 입힌거임? 그렇다면 진짜 실망스러움

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