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| A portion of the thalidomide, brand name Kevadon, seized in Chicago in 1962 (Sun-Times file) |
How many Frances Kelseys were let go from the federal government last week? Probationary workers were fired en masse, in a sham lunge at savings — really an enormous transfer of expenditure from organizations benefiting regular Americans to more tax savings for the rich.
Was there one future Dr. Kelsey? A hundred? We'll never know. One would be too many.
What? The name Frances Kelsey doesn't ring a bell? Of course not. People forget. Even though she was a hero — a local hero, too, University of Chicago Medical School, class of 1950, where she studied pharmacology.
Dr. Kelsey was a fresh hire at the Food and Drug Administration in September 1960 when a stack of three-ring binders, each the size of a phone book, landed on her desk, busywork for the new girl who joined the agency the previous month.
It was an application from William S. Merrell, an Ohio pharmaceutical company, for a drug it wanted to sell called Kevadon — a sedative introduced in Germany in 1957, and sold all over Europe. Approval was expected to be routine. The FDA had just 60 days to register an objection. Otherwise, Merrell could go ahead and sell the drug in the United States.
The company already was giving samples of Kevadon, a brand name for thalidomide, to U.S. doctors; eventually 1,200 doctors would start handing out free pills to 20,000 American patients, often to pregnant women, where it controlled the nausea of morning sickness. Without telling women the pills were unapproved. A field test conducted on the unaware, all completely legal.
But the application bothered Dr. Kelsey who, though new to the FDA, had years of experience in her field.
"There was something a little different about this one," she later remembered thinking. Before the 60-day limit ran out, Kelsey wrote to Merrell saying its studies were "incomplete," despite their bulk. She questioned the company's methodology.
Merrell cried foul. Executives hurried to Washington to complain about the "stubborn bureaucrat." They sent letters to her superiors, made phone calls, placed editorials in medical publications denouncing "dilatory tactics which certainly cause a loss to the industry of millions of dollars ... and even loss of life." Kelsey was being "unreasonable and irresponsible."
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As soon as I saw the headline, I knew that's who who were writing about.
ReplyDeleteInterestingly, thalidomide was brought back under severe restrictions about 15 years ago under the name Thalomid as an experimental treatment for Crohn's Disease & multiple myeloma.
Yup, I know someone who is on it for multiple myeloma. She has to jump through multiple hoops to prove she's not pregnant, not going to become pregnant, isn't even thinking about it... The company has managed to keep its patent by repatenting "methods of assuring patients are not pregnant" instead of the drug itself.
DeleteThanks you. The dangers of unregulated capitalism are far worse than too many regulations. Working to a happy medium is the job of a responsible government.
ReplyDeleteSee also: DES babies.
ReplyDeleteI have a friend in England whose mother was given thalidomide while she was pregnant. He has what he calls “a little hand” at his shoulder. It pains me to see how difficult the most simple things are for him although he has been struggling with this all of his life. He shouldn’t have had to. I have another friend who had polio as a child. Polio comes back to some in their later years. He is a great photographer but now he is wheel chair bound. What horrors are going to come with the decisions of this unholy administration? I don’t think we can imagine. Think we will be able to get flu shots next fall? I doubt it. Many, especially the elderly will die. This bunch of monsters couldn’t care less and yet I see post after post on Facebook congratulating them and saying they are 100% behind these decisions. Where does that leave the rest of us? Seems like we are out of options.
ReplyDeleteThe elderly, especially the poor elderly are supposed to die. I've heard that from more than one person, even insurance and medical staff. And not to end their suffering. They were serious.
DeleteYes, unfortunately "regulation" is one of many words co-opted by Republicans over the years to mean something bad or contrary to its real meaning. In the August 10, 1962, issue of Life magazine (I just googled it), thalidomide was the cover story. I was 8 years old and would look through my parents' weekly (I think) Life magazines cover-to-cover. This was a story - babies without arms! - that stuck with me through my life. I think it was prominent on the TV news at the time, too, and probably discussed and explained a bit more at home for it to have made such an impression. My takeaway, at 8 years old, was that the bad thing about this was that it was given to mommies who didn't know by doctors who didn't know that it would cause damage. It was un-tested, and that was not a good thing. Testing and understanding consquences was a good thing - then and now. Thank goodness for Frances Kelsey and all scientists and technicians in countless health and safety-related fields over the decades who have saved us from bad medicine, air, water, manufacturing, engineering, and more, by the work they have done for the greater good. And now, apparently none of those doing that fine work matter, because regulation of products and processes might cause a few rich folks to be less rich. We'll all be losers in this game foisted upon us by a cruel and clueless regime.
ReplyDeleteRemember Sherri Finkbine?
DeleteShe was a local TV personality in Phoenix. In the summer of 1962, she became nationally known when she sought an abortion, after discovering that the thalidomide she had been taking had caused serious deformities in her unborn child. When her physician asked for a court order to proceed with the abortion, Finkbine and her husband became public figures. They began receiving death threats, requiring FBI protection. She also lost her on-camera job.
Finkbine sought an abortion in Japan, but was denied a visa. She then obtained a successful and legal abortion in Sweden, citing mental health issues. The fetus had no legs and only one arm, would not have survived, and was too badly deformed to determine its gender.
Sherri Finkbine's story became the basis for a TV-movie in 1992.
“A Private Matter” starred Sissy Spacek.
The trouble with Trump's brand of governing is that he wants to operate at a level so low that he's flying under the radar. There's no room for mistakes. A stifled yawn, a sneeze, one little hiccup, and the ground is coming up fast.
ReplyDeleteI'm thinking (hoping) that Musk and Trump have misread their audience by assuming that half of America is just as mean and foolish as they are, that they too can ignore the plight of farmers with tons of grain and beans going to waste that could be feeding millions without food, that they too can spit on ordinary Americans robbed of their livelihoods without notice or apology. If not, if Musk's and Trump's assumptions are true, bring on the machines; they can't be more hardhearted and merciless than America the great.
ReplyDeletejohn
Great column, Mr. S.
ReplyDeleteThank you for this article. Unfortunately, many people rarely think about how they’ve been helped by regulations. The health agencies need to speak loudly about all the lives saved because of regulations. Improving public health education is important so that more people understand.
ReplyDeleteExcellent and timely column, Mr S! I especially liked the final paragraph.
ReplyDeleteAfter reading your work on Pg 2, I turned the page to read about the gutting of federal agencies in the Chicago area, highlighting the VA, Consumer Financial Protection Bureau, and the EPA -Great Lakes regional office. Pg 5: Dangerous and ill-advised cuts to the Nat'l Nuclear Security Administration and the FDA (ahem.) Further into the paper, on Pg 8, an obituary for a public service 'good guy', Peter Bensinger, who led the DEA 1976-1981. And finally, Pg 11, a column about the death of a local bald eagle, likely from Avian Flu. That column, written by R Herguth, notes the excellent work of the US Fish and Wildlife Service and Environmental Protection Agency, to help Bald Eagles recover as a species, though ongoing work remains due to lead poisoning and Avian Flu. A different column also mentioned the need for water testing after the watermain break in Skokie.
So the Sun Times was full of news that emphasized the value of Federal regulatory agencies and public service employees today. Well done!
Bird watchers would set up behind Meijer's on Algonquin where they could see the eagle nest across the tollway. I walk the bike paths through those woods and probably saw that eagle on the hunt. There are also numerous hawks in the preserve that runs east of 53/290, between Golf and Biesterfield, who are also at risk from the bird flu.
DeleteAn A-plus column!
ReplyDeleteOne of my aunts took this drug for morning sickness; fortunately my cousin was born with two fused fingers on one hand.
ReplyDeletePerhaps Frances Kelsey was underestimated when she became a new hire at the FDA in the summer of 1960. She was no kid. Born in 1914, Dr. Kelsey was 46, and had already had a distinguished academic career at the University of Chicago. She received her doctorate in pharmacology in 1938, and continued on as a faculty member. At the relatively advanced age of 36, she was awarded her medical degree from the U. of. C. in 1950, while investigating cures for malaria.
ReplyDeleteIn addition to her award from JFK in 1962, Dr. Kelsey also received the insignia of Member of the Order of Canada, was inducted into the National Women’s Hall of Fame in 2000, and was honored in 2010 by the FDA as the first recipient of an annual award that continues to be given in her name. She died in the summer of 2015, at the age of 101. Dr. Kelsey was the champion of modern ethical and evidence-based drug approval.
Brilliiant column, Neil. Thank you. Dr. Kelsey ought to be on a stamp.
ReplyDeleteShe died at 101, 9 & a half years ago, so she is definitely eligible for a US stamp.
DeleteGrowing up in the late 60s, one of the neighbor kids in my apartment building, Tommy, had flipper-like limbs instead of normal arms and legs. His mother was Irish and had been given thalidomide. He sat in a little contraption that he could scoot around in. I remember lowering a model of the Apollo Lunar Lander on a string from an upper story and landing it on his head. It delighted both of us, but it broke my eight-year-old heart to see how limited he was in his ability to play. I cannot fathom how this Musk-Trump regime relishes demolishing the regulatory system that protected me, but not Tommy. It's as they've gone through life blind to everything except their own reflection in a mirror.
ReplyDeleteThe quisling Republicans going along with it just as dangerous and offensive, but their cowardice is the least understandable.
And the cowardly Democrats? Especially the well off ones cowering in a corner
Deleteethical and evidence based drug approval? im all for that. it wouldn't be right to rush a drug into use .
ReplyDeleteThanks for this column. My youngest daughter was a probationary employee at the EPA until last week. She was researching the “forever chemicals” that are in our drinking water and causing cancer. She’s an absolutely stellar person, graduated with highest honors, and was working on her Masters with her research at the EPA.
ReplyDeleteAnn, was your daughter terminated? A friend of mine, long time DoD employee, received an email requesting his resignation. The last line was a snarky suggestion that he quit and do something worthwhile with his life. Insult heaped on injury. I hope your daughter finds work that makes us a better People, and fulfills your lofty description of her abilities. We need people like her.
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