Thalidomide and the FDA
Frances Kathleen Oldham Kelsey receiving the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy, in 1962
National Institutes of Health
Fifty years ago, a newly appointed medical officer at the FDA stood up to corporate pressure and refused to approve thalidomide, the drug already used for morning sickness in other parts of the world. The case transformed how Americans think about medicine and the FDA's drug-testing policy. Diane and guests explore how thalidomide is being used today and discuss how Frances Kathleen Oldham Kelsey saved thousands of babies from the perils of thalidomide.
Guests
science reporter for "The New York Times" and author of the mystery novel 'Hazard.'
a developmental biologist and a lecturer Lecturer at the School of Medical Sciences of University of Aberdeen, in Scotland, studies thalidomide-induced limb malformations.
Historian at the Food and Drug Administration
Head of Molecular Pharmacology Section and Senior Scientist at the National Cancer Institute, studies the use of thalidomide in prostate cancer patients.

Comments
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I'm waiting with bated breath for someone from the Cato Institute to pop up and describe Dr Kelsey as a villain who furthered the restriction of our freedom to bear children with deformed limbs and organs. Even more damnably, she stood in the way of the basic freedom of persons, especially artificial ones, to make money by selling things to people who wish to buy them, regardless of how ill-informed the former helped the latter remain.
My mother claimed that she had had terrible morning sickness whilst carrying me in 1961, and was well-acquainted with numerous forward-thinking doctors at the time, so I'm very glad this freedom was denied her...making me a typical Statist, I guess.
I suffered from morning sickness for MOST of my pregnancy. I was perscribed 3 different drugs and was hospitalized for dehydration. I was never a marijuana user, but after loosing so much weight and being dehydrated I tried marijuana, and with the smallest amount I could drink a glass of water and eat something. Now I have a healthy little girl.
Scary. If they loosen the regulations as much as they have for the financial industry we could have the case occur again.
Dianne, your guest Mam'ed you! LOL.
What happened to Dr. Kelsy's standards when E-Ferol entered the market in 1983? E-Ferol was another significant FDA event (Class I Recall April 11/12, 1984)... hundreds of babies died because of this drug. The company's principals served prison terms because of this drug... many families devastated because of E-Ferol. Continues to be litigated today! Thank God for Dr. Kelsey and her impact at the time.
I was born is 1960 so I grew up hearing about this drug. As a teenager I saw someone who I believe was a "flipper" baby. (A term used for children effected by Thalidomide.) Because of this, when I was pregnant with my son, I wouldn't take any medications except aspirin and then I only took 1 regular dose aspirin for my migraine headaches. I had a healthy baby boy.
This situation brings up another important point. With the economy concerns of the general public and the efforts of the general public to "cut government spending" I don't think that people realize that oversight of this type of problem will likely be one of the first things to be cut.
Then with less oversight these types of problems will only grow.
I grew up in West Germany in the 1960's. I can only second to the comment I just heard. 'Kontergan children', as they were known to the public, had high visibility and enjoyed extensive outreach. Quite a few with disabled arms learned how to use their feet with great dexterity. A number achieved careers as acclaimed painters. People can be profoundly resilient with a little help from the rest of us.
could Gardiner Harris please comment on the sunshine act that requires doctors to disclose payments from drug companies
I remember growing up in the 1970s in England and seeing children with no arms, and it was common knowledge for us that their malformations were caused by thalidomide. What chilled me was when I saw that people with AIDS in Brazil in the 1990s were being prescribed the drug and their pregnant wives took a pill or two and the new generation of thalidomide children were born. For those birth defects to occur in different generations in different countries is a real tragedy.
Thank you Diane Rehm for your show topic today, very informative and eye-opening and yes, anger provoking. Those people who run the FDA should all be shot - they are nothing more than Liars, Murderers, and Thieves.
For Christ's sake, they are sociopathic/psychopathic, unscrupulous sell outs to the biggest crooks and murderers of all time, Big Pharma. Drugs kill and they make sure of it.
I'm so sick and tired of constantly hearing tv commercials/advertisements promoting these useless drugs that kill with all these far worse side-effects at the same time that lawyers are compiling class action lawsuits on the same drugs being pushed by our healthcare providers.
Doctors are also big sell-outs - completely unconscienable - it's the reason that I have no doctor at present. The one who is currently holding my "chart/records" is a total loon and nitwit. You've got to pack a lunch to go to his office - he takes his sweet damn time. Talk about being disrespected! I believe he has some variation of Alzheimer's and forgets where he is and his equally stupid staff patronize him and allow him to wander around aimlessly. One can literally sit and sit for hours ... one time I had to remind him that I was waiting for a slip to get a blood test.
It's insane, what's happened to this country's healthcare system. Big Pharma controls everyone. And then I hear this incredibly dumb statement from someone on the show about the FDA working on a fake marijuana drug. Those effing morons. Why not use the real thing? Dumbasses. It's always about the Money$$$$.
dcmorin1: You must have read the August 30th New Yorker article by Jane Mayer, "Covert Operations" about the extreme ideology of the John Birch derived Libertarians, focusing on David and Charles Koch. They not only astro-turf activism and lobby-bribe Congress, but also fund think tanks and Institutes that commentate through media. My own suspicion is that Bill Moyers Journal and NOW were canceled on the power of donations to public media by David Koch. You see and hear his name on PBS and NPR more and more. What William F. Buckley (a legitimate conservative theorist) called Anarchist Totalitarianism wishes to eradicate all public assistance and entitlements as well as all industrial and product regulation. Consumers have no power to research or investigate and would then have to take the word of big business on safety and effectiveness issues. Pregnant barefoot women should never have to visit Ron Paul with a chicken under each arm. It will require intense planning, non-partisan public education and careful regulation to preserve humanity in this crowded and depleted world. Anyone who denies this is nobody's friend.
Grady Lee Howard, 'sounds right to me. That William F. Buckley has a good head on his shoulders. Money doesn't sway his thinking, thus he's able to think independently and critically - on his own. A real rarity in this world today where everyone agrees with whomever is paying. Most people have no integrity or courage to have principles.
I am a user of meridia and I lost 26 #'s in combination with a new low calorie diet.
Prozac and meridia have a chemical ingredient that helps with weight loss and consequently cannot be taken together.
When I first started taking prozac I lost about 20 #'s.
Ray from Pasco Wa.
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uthrillme007 wrote:
I am a user of meridia and I lost 26 #'s in combination with a new low calorie diet.
Prozac and meridia have a chemical ingredient that helps with weight loss and consequently cannot be taken together.
When I first started taking prozac I lost about 20 #'s.
Ray from Pasco Wa.
You are very unusual, most people gain weight on "psych drugs"