Dr. Frances Oldham Kelsey died recently at the age of 101. Her name, most likely, is unknown to the generation of American babies born in the sixties. Many owe their having been born healthy to Dr. Kelsey.
Back in the fifties, control, supervision and approval of new drugs was almost a perfunctory process not only in USA but also in Canada, Europe and the rest of the world. In the USA the newly formed agency, the FDA, approved the application of new drugs based on whatever information was provided by the manufacturer. The same was true of the rest of the world, where similar agencies existed and when not, new drugs were simply imported into the various countries without much control, if any.
In the late fifties, a new drug was introduced into West German market and shortly thereafter into most of Europe, Canada and into other parts of the world. It was promoted as a drug with multiple applications. It was a sedative and hypnotic, it was useful for the treatment of gastritis as well as morning sickness and nausea of pregnancy. In some countries it was sold over the counter being considered a mild sedative with no complications.
The name of the drug: Thalidomide.
The application for selling the drug in the US was filed with the FDA in September of 1960. The application was assigned to Dr.Kelsey, recently employed by the agency as a reviewer of new applications. In her review she was unsatisfied with the safety data provided by the company. She asked for more data. Thus started a long administrative process. More data was provided to Dr.Kelsey which did not satisfy or did not answer her questions. This back and forth continued. Eventually the manufacturer complained to the FDA about Dr. Kelsey’s bureaucratic delays, but Dr. Kelsey stood her ground.
In the meantime, strange things were happening to babies born in West Germany, England, Canada and elsewhere. Too many babies were being born with a rare anomaly known as phocomelia, where arms and legs do not develop normally or do not develop at all. Other anomalies were also noted: heart, gastrointestinal system, urinary tract, blindness and deafness.
At first manufacturers, including in the US, claimed data was “inconsistent”.
Independently, an Australian obstetrician Dr. W. McBride and the German pediatrician Dr. W. Lenz, as well as others, were beginning to correlate the rise of these rare malformations to the drug thalidomide.
Eventually, when data coming in could not be ignored anymore or considered “insufficient”, the manufacturer withdrew the application from the FDA. It is estimated that over 10,000 babies, with some estimates going as high as 20,000 babies, in 46 countries worldwide, were born with such malformations, and less than 50% actually survived. In the US only a handful of babies were born with phocomelia, as a result of the manufacturer having given samples of the yet unapproved drug to some doctors presumably for “clinical trial”.
In the aftermath of this tragedy, millions and millions of dollars were paid by the German manufacturer without admitting any guilt. It was only recently, in 2013, that the CEO apologized for what happened.
As a result of this tragedy which was avoided in the US thanks to Dr.Kelsey, in 1962 Congress passed new laws which require drug companies to present to the FDA proof of safety and effectiveness of the new drug for which they apply.
As for Dr.Kelsey, she was considered and recognized as a hero. She received the President’s Award for Distinguished Services presented by President Kennedy in 1962. Many more awards and recognitions were bestowed upon her during her lifetime, including being inducted in the National Women Hall of Fame joining the likes of Eleanor Roosevelt, Hellen Keller and other wonderful women.
If you did not know or heard about Dr. Kesley before, and if you were born in the sixties, you should remember and cherish her memory. You were born healthy in part due to her.
SILVIO ALADJEM MD, an obstetrician/gynecologist and Maternal Fetal Medicine (high risk obstetrics) specialist, is Professor Emeritus in obstetrics and gynecology at Michigan State University, College of Human Medicine, in Lansing, MI. He is the author of “10,000 babies: my life in the delivery room” now available on Amazon, Barnes and Noble and other book stores. Dr. Aladjem published extensively in Scientific Medical Journals and wrote several textbooks in the specialty. Should you wish to contact him, you may do so by email at: dr.aladjem@gmail.com
You can read more of Dr. Aladjem’s posts on Imperfect Women by clicking here. Dr Aladjem also answers questions of medical interest related to pregnancy in a recurring post here at Imperfect Women. You can read more details about this feature and ask a question by filling out the form here.
My Nana had a thalidomide baby named Leslie. It was so bad that they couldn’t even tell if it was a male or female, so they named it a neutral name. The baby only lived for a day or two.
This was a very informative article, Thanks for researching and sharing this content. We still have drugs today that hit the market and then later we find out how bad they really are for us. Advil and Aleve are two they claimed were safe. Now the warning label will tell you it WILL increase your chance for heart attack or stroke. My friend at advil like candy – one a day. Had a massive stroke in Feb. Coincidence?
This is a great information. I was born in the sixties, but I haven’t heard of Dr. Kelsey. I’d like to read more about her.
I’ve never heard of her before. She surely lived to be ripe old age. Would love to live as long as she did.
I have to admit I haven’t heard of her, but what an amazing woman, great article. x
It’s great that she was willing to hold her ground and prevent the drug for being easily approved. She really prevented a lot of potential complications.
What a remarkable woman! We do owe her much. Thanks for pointing her out to us
Wow. She sounds like a true hero. Thanks for introducing her.
She definitely made some important contributions to this country. I’m sure she had a long and wonderful life.
What great information. I can’t even imagine all the great history this woman lived through.
It sounds like she really accomplished a lot in life. I’m to see she lived a long life as well.
How wonderful that she was able to link everything together and was able to get it so this drug was not administered. So sad that so many families lost little ones due to the issues.
Thank you for sharing this bit of history! I did not even know about thalidomide & now I’m glad I learned about it. Kudos to Dr. Kelsey for knowing her stuff 🙂
I heard of the epidemic before and it was so horrific and sad that children had to suffer. I have to give many thanks to Dr. Frances Oldham Kelsey for the countless lives she saved.
I have read about this drug before. I cannot believe the horrible effects it had on the unborn child! Dr. Kelsey did a remarkable job in preventing the use of Thalidomide in the United States. My her good soul rest in peace.
I’ve never heard of her before. Glad she stood her ground and helped to prevent the drugs approval in the US.
I haven’t heard of her before but this is some great information. I think it’s great she helped keep the drug from being approved.
Very interesting article. I was just watching the last season of Call the Midwife which is set in England during 1960. In one episode, a character with severe morning sickness was helped with the new miracle drug. I had to wonder how many people watching even know what it was or the side effects it had.
I bet a lot of people had no idea. I only knew because of my family’s personal experience with the drug.
I love to reading this article sounds interesting. I haven’t heard her yet but it seems she accomplished lot in her life. and it is a great information
I have heard of thalidomide before. I did not know about her. This is a great post.
This is one incredible lady. Thank you for this great post. I love when i learn something new.
What an amazing contribution she made to society. Thanks for celebrating her here and raising awareness of this very important woman.
Wow! I had never heard of Dr. Kelsey! She is truly a hero! I am going to do some more research on her!
Wow, this gave me chills. I have an uncle who never came home from the hospital after being born in the 60s. My grandma was given ALOT of anti-nausea medication during his pregnancy. The whole time i was pregnant she cautioned me never to take any drug, because ‘safe’ today may turn out to be deadly after more research.
This was an interesting post. I have never heard of Dr. Kelsey or Thalidomide.
Gosh. I am so glad she stood up and did all she could to block this. So many babies were saved from this outcome.
It took a lot of courage for Dr. Kelsey to challenge the big drug companies by naming possible birth defects caused by thalidomide. Thanks for bringing attention to her contribution to the world.
Interesting story of a lady I never heard of until now. Amazing that she lived to be over 100.
My mom took either this or something similar while she was pregnant with me. I was born with a club foot as a result. It took years to fix it and I still have an odd gait because of it.
Ah, it’s nice to hear the history behind things that seem so common. I enjoyed the learning here today.
Thank you for a great post, I enjoy reading about people that have done great things. Raising kids they give me hope that our two can go on to great things as well.
I never heard of her. I love learning about history.
I’ve heard about this but didn’t know the story behind it. There are so many scary things that can happen to your unborn baby
I had never heard of her before, wow. What a long life for a great woman!
I remember back then when you seen picture of thalidomide babies . Thank God someone did what they could to help them. Gee whiz living to be 101 years old yet at that .