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TIL of Dr. Frances Kelsey a female Canadian/American pharmacologist working for the FDA in the 1960s who stopped authorization of Thalidomide (a drug that caused the deformation in fetuses) saving countless children and also helping reform standards in the FDA/U.S against pharmaceutical companies

132 comments
96% Upvoted
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level 1

"Kelsey insisted that her assistants, Oyam Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well."

Very noble

level 2

I'd say it was true too, simply because it was the 1960's and women weren't nearly as respected as they are today. She definitely had some men behind her to say, "no she knows what she's saying, STFU and listen." Hats off to the women brave enough to do these things, and others who were brave enough to help.

level 3

And considering the sexism of the time, it probably would not have even occurred to a male investigator to check for the possibility of causing birth defects in a pregnancy drug.

level 4
-43 points · 1 month ago(More than 24 children)
level 5
17 points · 1 month ago · edited 1 month ago

I mean, America was the only country that rejected the approval of thalidomide due to lack of data on teratology (birth defects).

For some reason.

level 6

We have gone 180° in a lot of ways since then.

level 5

Is it though?

Medicine in the 1960s and prior to evidence based medicine took women’s concerns very lightly. Hell, it took until well into the 90s and onward for medicine as a field to recognize that using a white man as the baseline for everything failed half the population.

level 6

FYI it's only this year that the medical community accepted that period cramps are as painful as heart attacks.

level 7
5 points · 1 month ago

I mean, I've met a person who walked through her heart attack but sobbed at cramps.

Different muscles. One is more lethal.

level 8

not like I'm the one making that comparison.

idk why they even go for that reach.

level 6
-55 points · 1 month ago(0 children)
level 7

Firstly, it’s “hare-brained.” If you’re going to use an idiom at least know what it is.

And no, it’s not “misandrist” to imagine that a male investigator in the 1960s wouldn’t have the schema in place to think through risk to women. The understanding of medicine as it affected women in an evidence-based manner was much, much weaker. It wasn’t until recently that medicine began observing that women undergoing heart attacks didn’t experience the same symptoms.

Put down your pitchfork for a second and imagine the era and the mindset. The statement is not really out of line.

level 8
10 points · 1 month ago

Just to point out, you're arguing with a dude who posts in men's right. I'm not evening linking that shit bc as a man myself, there are some toxic and frail people in that sub and I want no part of them.

level 9

Oh, I knew. But at the time his post hadn’t been downvoted to oblivion so it needed counterbalancing.

I also hope that maybe he reads a few of the sources and goes “oh, maybe I should rethink this.”

I’m not naive to believe that these dipshits can be turned overnight, but exposure to opposing views and data certainly helps.

level 10
6 points · 1 month ago

You're the diplomatic saint I wish we had more of.

Also, I audibly lol'd when you dragged him when pointing out it's "hare-brained".

level 8

Hell we barely have much information on women’s heart attacks (and even less for women of color), the symptoms are vastly different from men.

level 8
-33 points · 1 month ago(0 children)
level 9

The protocols for testing for contraindications in pregnant women (or women in general) weren’t really in place until after the mid-20th century: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)16308-3/fulltext

It was well-known that alcohol could affect fetuses in utero: https://www.sciencedirect.com/science/article/pii/0270309282900182?via%3Dihub

But it wasn’t seen as necessary to test drugs for contraindications in pregnancy or any teratogenic activities. Despite knowledge of risk. Hell, it wasn’t even common policy to test drugs with women until maybe the 90s or more recently. It was assumed men were suitable enough.

It’s also not crazy to imagine that the researchers were predominantly male in the 1950s and 1960s. Safe assumption GIVEN THAT WOMEN WERE LARGELY EXCLUDED FROM THAT WORK.

level 10
-20 points · 1 month ago(0 children)
level 8
-25 points · 1 month ago(0 children)
level 9

Birth defects can pose a risk to maternal health. Also many birth defects are tied to the health and well-being of the mother.

More generally, who else would you test for contraindications for teratogenic effects if not pregnant women?

Or do you find it hard to believe that the medical field didn’t think to include maternal health as a drug indication?

level 10

Considering that this was only several years after doctors stopped prescribing cigarettes, yeah I really think there were some major oversights in the medical community that didn't have to do with sexism.

level 7

I bet you think white males are totally discriminated against, too.

level 7

People having this critical inability to interpret information accurately that you suffer from is the logical consequence of how much our society pisses all over the humanities. It turns out that there's actually significant upsides to taking thought seriously as a goal in itself, whodathunkit? Every fucking civilization up until now would have thunk it is who.

level 5

But totally true

level 1
151 points · 1 month ago

She also worked on the elixir sulfanilamide incident when she was in grad school. She was part of the team that discovered that diethylene glycol was the component of the drug that was making children ill. It’s interesting that she was a part of two of the the most important watershed moments in American public health.

level 2

People back then needed to be told that antifreeze kills people?

level 3

Yes, because prior to this the FDA didn't exist and a business could literally sell you poison and tell you it's medicine.

level 4

The FDA existed, but it only had the power to do something after the fact. Now all drugs go through an approval process and if you fail inspections you can’t sell the drugs.

level 4

Also known as the Good Ol' Days! MAGA!

level 5

Eat your checkers? Overboard reference?

level 6

I don't know who I am, but I'm sure I have a lawyer.

level 3
11 points · 1 month ago

Sort of. The problem was that sulfanilamide worked, but it didn’t dissolve well in water. They wanted to make a formulation that kids would take, so they found a solution that would dissolve lots of the drug and tasted sweet (diethylene glycol). They added fruit flavor, called it an elixir and sold if for kids. They didn’t do safety testing because they didn’t have to. The only legal recourse they got was misbranding (elixir means an ethanol solution), and they were never really penalized for the kids that died because the safety regs for drugs were almost non-existent.

It’s worth finding the letter one of the parents wrote to the president describing how their child dies. It’s heartbreaking.The company’s chemist felt so bad he later killed himself. It’s a sad story but it helped create the regulation that requires safety testing for drugs.

level 3

Not exactly. Diethylene glycol (C4H10O2) is not the same chemical compound as ethylene glycol (C2H6O2), the main component in antifreeze (aside from water). While both are sweet, the metabolic pathways for toxicity are distinct (though they both share renal failure as a common symptom). I’m not sure when ethylene glycol based antifreeze became common, but it was not the initial choice and may not have been common in 1937.

level 1

They tried to give her a simple case because she was just starting out. Approval for Thalidomide was considered by most people a mere formality.

level 2
Original Poster46 points · 1 month ago · edited 1 month ago

This is the most important part of this case I wish I could put it in the title.

level 1

We still use thalidomide, it’s just heavily restricted.

level 2

Just not on women of child baring age

level 3
4 points · 1 month ago

Too bad, I hear it's great for morning sickness.

level 4
Original Poster6 points · 1 month ago

I hear cyanide can get rid of all your pains.

level 5

Works for me!

level 2

thalidomide is safe for adults, it's just not safe for fetuses, so if someone is pregnant, or planning to become pregnant you can't take it. the problem is because thalidomide inhibits the growth of blood vessels. which as you can imagine is crucially important to children.

the problem is that it's really good at treating morning sickness, which is tied to pregnancy so it's main effect is kind of negated by the horrible downsides. now a days thalidomide is used for other things.

level 3

The teratogenic effects are tied to one specific enantiomer (non-superimposable mirror images) of the racemic (equal mixture of 2 enantiomers) substance. Asymmetric synthesis (or synthesis from a chiral starting material) to produce a single enantiomer or chiral separation of the racemic mixture affords the desired compound responsible for the anti-nausea characteristics. Unfortunately, this compound can racemize in vivo (ie. the pure material converts back to the mixture of 2 enantiomers), so still not safe for fetuses. It was also originally a hypnotic/ sedative.

Edit: looks like I didn’t read far enough and this was already discussed.

level 1

My organic chemistry professor could never stop talking about this. Companies were using the wrong enantiomer of the compound which caused the developmental problems

level 2

It was more that they tested one of them, and that was safe - but the other one really, really wasn't. And you couldn't separate the good ones and the bad ones, meaning the entire drug was unsafe.

level 3

It also didn't help that the good enantiomer racemized once consumed so you could never prevent exposure to the bad one

level 3
12 points · 1 month ago

Separation of both forms was not the problem. Both forms transform into each other inside the body in like 2-6 hours (and back and so forth etc).

level 2
11 points · 1 month ago

Did your prof also tell you that using the "right" enantiomer of it would have yielded the same result because both enantiomers transform into the other one (and back) inside the human body?

level 3

Mine did!

level 2

Wait, did companies sell this thing knowing it could cause birth defects? Or was everyone just grossly incompetent?

level 3

people at the time did not understand that thalidomide, which occurred into mirror image optical isomers, would racemise (swap over to other optical isomer/enantiomer) in the body. They thought they were using the optical isomer that had benefits, and did not know it would convert to the dangerous optical isomer

you could call it incompetence but it was hard to test as it only occurred in the body, which is hard to test

level 3

It was cause by a lack of understand of organic chemistry at the time. It wasn't deliberate.

level 1

I attended a highschool named in her honour. It's in Mill Bay, B.C. which is close to where she was born. Had a display case of some of her personal belongings and our teachers would sometimes visit her during their summers.

level 2

Same here!

level 2
Original Poster3 points · 1 month ago

I believe she whent to that high school I live in Portland and go up there on road trips.

level 2

Me too!

level 2

I also went to Frances Kelsey High School! Vancouver Island is beautiful

level 1
[deleted]
19 points · 1 month ago

I've actually met a few people who were born afflicted by this stuff. They all had some pretty detailed stories from their mothers.

level 2

The actor (an musician) Mat Fraser in American Horror Story: Freak Show was harmed by Thalidomide.

level 2

The NICU doctor that treated my premature son was affected; one of his legs never formed from the knee down. He's an absolutely amazing doctor who I'm sure was drawn to his profession by his condition.

level 1

If on the off-chance you’ve ever wondered what that particular line in Billy Joel’s “We didn’t start the Fire” was referring to, now you know!

level 2

The more I learn about American history in the 20th century, the more I like that song.

level 1

You weren’t just watching the same rerun of Call the Midwife as I was, were you?

level 2
Original Poster6 points · 1 month ago

No sorry lol I’ve been meaning to to get into that show I’m a sucker for bbc.

level 2

I no shit was JUST watching this episode! So it was ironic that I found this today as well.

level 3
Original Poster1 point · 1 month ago

How is it? I love Poldark and Downton Abbey so if it has the same tone I’m sure I’ll love it.

level 4

I like it a lot! But mostly because I'm a history junkie.

level 2

That show is my jam. Love it. I have to fast forward through all of the birth scenes, though.

level 3

I still close my eyes when the baby squirts out but I’ve become inured to the rest...

level 1

Whoa there, that sounds like government regulations to me. Are you sure we shouldn't allow teeming hordes of libertarians and conservatives to just undo that? We have to respect business ability to profit after all!

level 2
13 points · 1 month ago

Hey. The Free Market would have eventually sorted everything out. People would have just stopped buying thalidomide after having a few terribly deformed children.

(I wish this was just too ludicrous an argument for anyone to ever make, but I've spoken with an otherwise reasonable and intelligent libertarian who seriously thought this way)

level 2

The problem with capitalism is that it doesn't go far enough. If you don't want to regulate the rich, fine stop regulating the poor too. If I was allowed to spend my hard earned dollars paying someone to murder the people who gave my child birth defects, believe me the market would correct itself

level 2
-4 points · 1 month ago

Um, I don't think you understand the NAP if you think Libertarians would say this is a bad move by government.

level 3

Non-Aggression Pact?

level 4
12 points · 1 month ago

Non-agression principle. Basically, there shouldn't be any laws that prevent people from doing things if the action doesn't hurt another person.

There are many problems with this, but the clearest is stuff like drunk driving or randomly shooting into a crowd of people. If no one was hurt, it technically doesn't violate the principle.

It's a lot like everything else libertarian. It's an incredibly simple "solution" to a complex problem. Only it doesn't actually solve the problem.

level 3

It's just making light of people who cry about regulations, rather than a nuanced censure of real political stances.

level 1
Original Poster3 points · 1 month ago

If you guys want more information I found this doc on youtube I don’t know if it breaks any rules posting it but here it is: https://youtu.be/41n3mDoVbvk

level 1
5 points · 1 month ago · edited 7 days ago

https://www.youtube.com/watch?v=4wIBCoxuOJ0

Ted-ed made this interesting video on her a few months ago.

level 2
Original Poster3 points · 1 month ago

Thanks for this!

level 1

As a person born in 1963, I have to thank Dr. Kelsey for potentially saving me, just in the nick of time, from an armless and legless life.

level 1

Thalidomide, ironically, was found in 1999, to help extend the lives of Mutiple myeloma patients under the trade name revlimid--Many other drugs are available for MM today, but revlimid is still used and is being credited for helping to extend MM patients from 2 year survival to 5 to 7 year survival rates--Roy Scheider and Peter Boyle both died from it, Tom brokaw is battling it now

level 2

Wrong wrong wrong. Celgene actually developed second generation immunomodulatory drugs (IMiD) based on thalidomide, which was really never used clinically. Those drugs are Revlimid (lenidomide) and Pomalyst (pomalidomide). Nobody re-patented thalidomide for the treatment of MM. These were wholly new drugs

level 3

I work in a hospital pharmacy and whilst we more often use lenalidomide we do use thalidomide a fair amount, almost always paired up with cyclophosphamide

level 4

Christ, where???

level 5

In the UK, it helps prolong life but it isn't really a first line treatment. Some of the stuff used in chemotherapy is horrific, my husband was treated with isfosfamide which is derived from mustard gas

level 6

Ya, but NICE is so stingy that your patients are not getting access to some of the most exciting new therapies. Out of curiosity, you administer venclexta (venetoclax)?

level 2

TIL Roy Scheider is dead.

level 1

Thank you

level 2

HAPPY CAKE DAY

level 3

Thank you

level 4
Original Poster6 points · 1 month ago

HAPPY CAKE DAY

level 5

Thank you

level 6
2 points · 1 month ago

HAPPY CAKE DAY

level 7

Thank you

level 1
5 points · 1 month ago

She would be pretty disappointed with our current practice of hiring former Pharma bigwigs as new FDA bigwigs.

level 2

Every sane person is disappointed in that

level 1
2 points · 1 month ago

So the FDA used to help people?!

level 1
2 points · 1 month ago

Asshole. We needed those scanners.

level 2
Original Poster1 point · 1 month ago

I’m guessing this is a reference to something

level 3
3 points · 1 month ago

Yeah, a little movie where a dude's head explodes.

level 4
Original Poster1 point · 1 month ago

Kings man?

level 5
2 points · 1 month ago

SCANNERS

level 1

How times have changed...

level 1
Original Poster2 points · 1 month ago

Wow 4K likes guys my highest rated post ever glad it’s this one thanks guys!

level 1

I actually took thalidomide as part of a study for neurofibromatosis. For about 3 years from around 1995-1998 or 99

level 1

Ben Shapiro & co. have no good answer to such an inevitably.

level 1

It seems to have now gone the other way.

level 2

After many years without I recently started watching US ota tv and the number of ads I see that are canvassing for drug issue sufferers is kinda shocking. So many drugs I remember being advertised are now known to cause a shitton of side effects. Not just cancers but behavioral stuff like compulsive gambling! Yeah doc my hearts ok but now my liver is fucked.

level 3

Yeah or "increased risk of suicide".

level 3
1 point · 1 month ago

Well to be fair no one really knew the issues caused by these drugs back then. It's actually a lot more work/expense to get a drug approved in the US than it is in most of europe.

level 1

They still sell that today

level 1

I too watched Breaking Bad last night.

level 2
Original Poster1 point · 1 month ago

Never watched it sorry.

level 1

I don't mean to be disrespectful, but wasn't that literally her job? Isn't it what an FDA reviewer is supposed to do, reject products that aren't safe?

level 2

It’s incredible how many people just doing their “jobs” end up fighting tooth and nail to do so. Especially in large organizations with lots of internal and external stakeholders.

level 2

It was the first product she tested in her new job - they gave her an 'easily and obviously safe' drug to test.

It was already out in Germany, and since the FDA thought it was already safe, they just needed to go through the motions.

level 3

Thank you for the information.

level 2

The thing is that at the time everyone thought it was safe. However she believed that the testing on pregnant women was inadequate, and since this was a drug heavily marketed towards pregnant women, she denied the request for it to be sold in the US (it was extremely popular abroad). And it was later discovered that it was causing severe birth defects and high rates of stillbirth.

level 3

My mom lived in Germany and was actually part of the testing of it there. They did the testing on guinea pigs, some that were pregnant. She stated the guinea pigs would kill or bury their babies. (since they were not healthy) She thought it was funny that nobody was concerned about it or even paid much attention to it until all the baby birth defects showed up.

level 2

Just doing what your supposed to puts you ahead of moist people

level 3

the moist are the worst

level 2
Original Poster6 points · 1 month ago · edited 1 month ago

Here this should explain more why she was so important: https://youtu.be/41n3mDoVbvk

level 2
5 points · 1 month ago

From what I remember reading, she was under enormous pressure to just 'rubber stamp' the approval. She was ridiculed and even threatened for not doing so. She was beset by all sides - her colleagues, the pharmaceutical companies, and the public who had heard of the 'amazing benefits' of the 'wonder' drug and were clamoring for its release.

level 1

Let's not forget the Aussies who were first to raise the alarm https://en.m.wikipedia.org/wiki/Thalidomide

level 1
-8 points · 1 month ago(0 children)
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