RIP Frances O. Kelsey, Ph.D., M.D.
August 7, 2015 9:29 AM   Subscribe

Frances Oldham Kelsey, the doctor who kept thalidomide from becoming available in the United States, has died at age 101.

In 1960, Kelsey became a reviewer for the FDA, and made a decision that would have a profound impact:
A month after assuming her position [with the FDA] she was assigned the review of a new drug application for thalidomide, a sedative that had been used by expectant mothers and many others in dozens of countries since the late 1950s. U.S. law at the time required a firm to provide evidence of a drug’s safety as a requirement for sale. Despite the global popularity of this drug, and despite a constant and increasing pressure from the firm to approve the application, Dr. Kelsey refused to do that without adequate evidence that the drug was safe, a decision that was supported by her colleagues and superiors.
Her "autobiographical reflections," an oral history of her work, is available here (pdf).

In a 2010 interview with the New York Times, she said:
“When a woman took a job in those days, she was made to feel as if she was depriving a man of the ability to support his wife and child,” [...] “But my professor said: ‘Don’t be stupid. Accept the job, sign your name and put “Miss” in brackets afterward.’ ”
posted by mandolin conspiracy (49 comments total) 32 users marked this as a favorite
 
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posted by Blue Jello Elf at 9:30 AM on August 7, 2015


. Frances Kelsey was one of my heroes as a kid. We're worse off without her.
posted by sciatrix at 9:37 AM on August 7, 2015 [1 favorite]


Reading through her bio, it sounds like thalidomide probably could have squeezed through the approvals process that was present at the time, had a different scientist reviewed the application.

Dr. Kelsey singlehandedly demonstrated that increased levels of scientific scrutiny could (and did!) avert a public health crisis, which led to the passage of legislation that significantly raised the bar that drug manufacturers needed to pass before the FDA would approve their products.

Frances Kelsey was a hero. We are better off for having her.

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posted by schmod at 9:50 AM on August 7, 2015 [31 favorites]


How lucky are many of us to have only learned about thalidomide from a Billy Joel song?

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posted by everybody had matching towels at 9:52 AM on August 7, 2015 [12 favorites]


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How ridiculous is it that she was not given the Order of Canada until May of this year?
posted by Poldo at 9:57 AM on August 7, 2015 [2 favorites]


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posted by mrdaneri at 9:57 AM on August 7, 2015


I'm glad to learn about her now, even if she has left us.

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posted by harrietthespy at 9:58 AM on August 7, 2015 [1 favorite]


I've read about Kelsey before, in a book of short essays on the accomplishments of little known Canadians. All she had to do was rubber stamp the application and thalidomide would have been on the U.S. market. She was professional and thorough in her review, and refused to approve the drug. The company pushed back, and then went over her head to complain to her boss. Fortunately he backed her up. It was such a close shave.

And libertarians/right wingers would dismantle or defund the FDA if they got their way. So many people take safety regulations totally for granted.
posted by orange swan at 9:58 AM on August 7, 2015 [25 favorites]


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posted by Going To Maine at 10:04 AM on August 7, 2015


Her Autobiographical Recollections are terrific -- one bit about her post-doc research:
I did my Ph.D. on the adult armadillo, receiving my degree in 1938, and then a year's post-graduate study on why these two lobes [of the pituitary] were separate. That meant studying the embryos. Armadillos have a very weird cycle and there is no way they can be bred in the laboratory. We had to get our supplies from Texas at that time. Possibly that is still done. There was an armadillo farm in Texas, very close to the Lyndon Baines Johnson ranch. They used to ship the armadillos up to us. On one occasion when I wanted to study embryo armadillos, I had to go down to the armadillo farm in Texas to hunt and catch a few to get my embryonic armadillos.
posted by pie ninja at 10:05 AM on August 7, 2015 [5 favorites]


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posted by brecc at 10:08 AM on August 7, 2015


How ridiculous is it that she was not given the Order of Canada until May of this year?

This isn't all that surprising. She is a Canadian whose heroism was primarily for the benefit of another country. Thalidomide was legal in Canada at the time she did this and for several years after and the Canadian government's treatment of those affected was (and still is ) pretty horrible. So awkward....
posted by srboisvert at 10:09 AM on August 7, 2015


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posted by Lynsey at 10:11 AM on August 7, 2015


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posted by Pendragon at 10:11 AM on August 7, 2015


Apparently thalidomide was available to a few women during US testing. My mother claims she had the opportunity to take it but declined. Whether or not that's true, I'm grateful to Dr. Kelsey for possibly saving my life.
posted by Araucaria at 10:11 AM on August 7, 2015 [4 favorites]


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posted by Cash4Lead at 10:13 AM on August 7, 2015


This is what makes me so angry about libertarians and their like. They would say we don't need the FDA, just let thalidomide be sold on the free market and those harmed or killed (or their estates) could sue the manufacturer, who could stay in business as long as it could afford to.

And this is their ideal world.

Thank God we have what little protection we do, and people like Kelsey, looking out for us.
posted by Sangermaine at 10:18 AM on August 7, 2015 [19 favorites]


Welp now I'm off to Wikipedia about armadillo reproduction.... Thanks Doc!
posted by sio42 at 10:24 AM on August 7, 2015 [5 favorites]


Metafilter: Now I'm off to Wikipedia about armadillo reproduction.

Oh, and

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posted by Cookiebastard at 10:38 AM on August 7, 2015 [5 favorites]


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posted by ignignokt at 10:41 AM on August 7, 2015


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posted by Flood at 10:42 AM on August 7, 2015


Another highlight from her recollections, about working on a WW II project to find a replacement for quinine -- they had asked people to send in promising compounds to investigate:
Another came from a veterinarian in Texas. It looked like ink and was shipped in what looked like an ink bottle. He said he was hoping to use it to treat a plasmodium-like parasite in cattle. He also said that he had just tried it on his secretary without ill effects, and he planned next to try it on cattle.
posted by pie ninja at 10:45 AM on August 7, 2015 [11 favorites]


Her age made me wonder... According to Wikipedia we still have two people left alive who were born in the 1899 and four more from the last year of the 19th century (1900).
posted by dances_with_sneetches at 10:47 AM on August 7, 2015


It is so weird to think of America being a place where corporate interests were told to suck it in the name of science. HERO.
posted by a fiendish thingy at 11:09 AM on August 7, 2015 [2 favorites]


Apparently thalidomide was available to a few women during US testing. My mother claims she had the opportunity to take it but declined. Whether or not that's true, I'm grateful to Dr. Kelsey for possibly saving my life.

Could be true. Wiki says: Although thalidomide was never approved for sale in the United States at the time, millions of tablets had been distributed to physicians during a clinical testing program. It was impossible to know how many pregnant women had been given the drug to help alleviate morning sickness or as a sedative.
posted by daninnj at 11:18 AM on August 7, 2015


orange swan: And libertarians/right wingers would dismantle or defund the FDA if they got their way. So many people take safety regulations totally for granted.

And interfere with the Invisible Flipper of the Free Market? Perish the thought!

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posted by dr_dank at 11:22 AM on August 7, 2015 [4 favorites]


How lucky are many of us to have only learned about thalidomide from a Billy Joel song?

I well remember watching this 60 Minutes story about thalidomide back in the late 1980s, not too long before Billy Joel name-checked it in his song. I think a lot of us born in the late 1950s and early 1960s are very grateful indeed to Dr. Kelsey.
posted by briank at 11:26 AM on August 7, 2015 [1 favorite]


This is what makes me so angry about libertarians and their like. They would say we don't need the FDA, just let thalidomide be sold on the free market and those harmed or killed (or their estates) could sue the manufacturer, who could stay in business as long as it could afford to.

While at the same time complaining about "activist judges" and pushing for tort reform to limit jury awards.
posted by dances with hamsters at 11:27 AM on August 7, 2015 [4 favorites]


Of note is that thalidomide, in an analog form (lenalidomide) actually is a FDA approved drug today, though for multiple myeloma. It's also distributed under an FDA risk evaluation management system (REMS), which requires specific verification of a negative pregnancy test and providing/counseling on birth control. The REMS also put limits on how much can be disbursed to patients at a time, and this can only be done through certified providers and pharmacies.
posted by Panjandrum at 12:01 PM on August 7, 2015 [1 favorite]


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posted by riverlife at 12:21 PM on August 7, 2015


Of note is that thalidomide, in an analog form (lenalidomide) actually is a FDA approved drug today, though for multiple myeloma. It's also distributed under an FDA risk evaluation management system (REMS), which requires specific verification of a negative pregnancy test and providing/counseling on birth control. The REMS also put limits on how much can be disbursed to patients at a time, and this can only be done through certified providers and pharmacies.

Thalidomide derivatives have proved useful in a number of conditions - for its effect on the immune system rather than as a sedative. It's just very incompatible with pregnancy.
posted by atoxyl at 12:23 PM on August 7, 2015 [2 favorites]


Good point - and also for leprosy.
posted by mandolin conspiracy at 12:24 PM on August 7, 2015


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posted by crush-onastick at 1:15 PM on August 7, 2015


Thalidomide was available in many countries for quite a long time. In some countries, like Brazil, the symbol for "Do not take while pregnant" was a pictogram of a pregnant woman with the red circle and slash...this led to people taking it to prevent pregnancy, and even to attempt a drug induced abortion. The same symbol is also being used for the anti-acne drug Accutane... a drug also linked to birth defects.
posted by Gungho at 1:29 PM on August 7, 2015 [2 favorites]


Reading through her autobiographical reflections, the more or less non existing ethical concerns regarding experiments on prisoners seem quite cavalier. She mentions that the Germans were opposed to such practices after the war, without acknowledging there being any ethical ramifications. She deserves accolades for preventing the thalidomide catastrophe reaching the U.S., of course. I find it interesting however the way that her generation instituted IRB oversight purely to ensure scientific validity of studies, while to my understanding medical ethics is a defining concern for such boards today. Since I'm not American nor in the medical field, my understanding might be flawed in that ethical concerns are supposed to be addressed solely by other institutions?

Nevertheless, .
posted by delegeferenda at 2:09 PM on August 7, 2015


And interfere with the Invisible Flipper of the Free Market? Perish the thought!


dr_dank is the unambiguous winner of today's Metafilter Bad Taste Award
posted by hwestiii at 5:36 PM on August 7, 2015 [3 favorites]


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posted by Mitheral at 7:22 PM on August 7, 2015


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posted by Quietgal at 7:35 PM on August 7, 2015


delegeferenda, a lot of the science in that era was somewhat cavalier with regards to patient ethics. We knew about the Germans and their WWII experiments but it took a while for the US to come to terms with that (the rest of the world, too, I would guess).

The Belmont Report, which is regarded as one of the cornerstones of the US IRB program and which put ethics front and center of IRB, didn't come out until 1978. She's talking in that oral history about experiments which happened in the '40s and '50s for the most part.

Now you cannot do the kinds of experiments on prisoners and mental patients and children that she describes. I will joke forever that the worst experiment ever to get through IRB would be juvenile prisoners who are terminally ill who you will coercively reward by giving them pennies per experiment and with a protocol that calls for deceptive techniques. But her generation predates a lot of that.

Despite that, she did amazing science and her insistence on thorough documentation prevented a lot of deaths and infirmities in the US--in the case of thalidomide for certain and other drugs likely as well. As someone who's been administered a drug under the REMS system, I am personally grateful both for her and for a system that allows the use of these drugs under regulated care.
posted by librarylis at 8:47 PM on August 7, 2015


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posted by cotton dress sock at 12:19 AM on August 8, 2015


I went through elementary school with a girl, Colleen, whose arms were badly affected by thalidomide. She sat on her desk and wrote her notes with her feet on her chair. Looking back it seems remarkable how well integrated she was despite essentially no accommodation made for her and the cruelty of children generally. Of course there were four or five kids affected by polio at the school, a girl, Agatha, with an almost unrepaired hare lip, and on and on. So many medical advances in my lifetime and I like to think I'm not even that old.
posted by Rumple at 1:16 AM on August 8, 2015 [1 favorite]


One of the doctors who discovered the link between thalidomide and birth defects was William McBride, who is (was?) something of an Australian hero. The drug was sold in Australia by a firm called Distillers, who reportedly knew about its effects for months before taking it off the market. As for the development of the drug itself,
Dr Heinrich Muckter, the chemist doctor in charge of the company’s postwar development of thalidomide research, was a Nazi medical officer in typhus research in occupied Poland, which involved experiments on inmates at Auschwitz and also at Buchenwald. Otto Ambros, a research director at Grunenthal in the 1950s, was a chemist at IG Farben, which manufactured Zyklon B pesticide for the gas chambers and was one of Farben’s managers at its Auschwitz plant. Ambros was jailed in 1948 for mass murder and slavery at Auschwitz yet in the 1970s was the chair of Grunenthal’s advisory board.
posted by Joe in Australia at 4:55 AM on August 8, 2015 [1 favorite]


Like Rumple, I went to school with a kid affected by thalidomide: fortunately his legs were normal, but he was basically missing half his arms --- imagine your hands connected directly where your elbow is, with no joint in the middle of your arm. Ditto going to school with kids permanently on crutches because of polio, deaf because of measles, and on and on.

All you young folks who have only read about the horrors of thalidomide and polio and all the other things: thank your lucky stars you have only read about them.
posted by easily confused at 7:02 AM on August 8, 2015 [2 favorites]


How ridiculous is it that she was not given the Order of Canada until May of this year?

Well, the thing is, thalidomide did make it into the Canadian market, and affected a lot of people (Canada was especially slow to remove it from the market), so there's probably some lingering embarrassment slash liability issues about that.

*glances at Related Posts*

Well, would you look at that. Compensation was announced three months ago.
posted by Sys Rq at 8:09 AM on August 8, 2015


or five or whatever
posted by Sys Rq at 8:15 AM on August 8, 2015


All you young folks who have only read about the horrors of thalidomide and polio and all the other things: thank your lucky stars you have only read about them.

This is a derail: “Practices of Enfreakment”, the ninth episode of Everything Is Stories, is a long interview with actor Mat Fraser, who played Paul The Illustrated Seal on American Horror Story. His condition is due to his mother’s use of thalidomide.
posted by Going To Maine at 9:03 AM on August 8, 2015 [1 favorite]


About thalidomide being available in the U.S. Around 1982ish I had a friend who's Mom had taken the drug. He got money from the government and had his own place.
posted by marxchivist at 9:11 AM on August 8, 2015


Going to Maine: I was first acquainted with Mat Fraser when he was co-hosting the (very excellent) BBC Ouch disability podcast. Archive here.
posted by mandolin conspiracy at 2:35 PM on August 8, 2015 [1 favorite]


Well, would you look at that. Compensation was announced three months ago.

The thing was, the government caught the people who would be receiving it off guard - rather than, you know, asking them what they needed.

But that shitty handling by the Conservatives doesn't let previous governments off the hook for sitting on it for decades and doing nothing either.
posted by mandolin conspiracy at 2:46 PM on August 8, 2015


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