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: firstname.lastname@example.org
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