This year, July 24 marked Dr. Frances Oldham Kelsey’s 98th birthday. Dr. Kelsey is a true medical hero from North America (‘North America’ is more befitting as I consider her a true Canadian hero and an inspiration while my American colleagues refer to her as an American hero since she moved to the US and currently resides in the suburbs of Washington).
Organizations/regulatory bodies such as Health Canada and the US Food and Drug Administration (FDA) exist for a reason. They are there to safeguard the public through regulations and measures overseeing food, medications, health products and devices. Researchers and industry may at times be too eager to market a drug that has shown potential and/or may find it too tiring to continuously go over regulations ensuring all t’s are crossed and i’s are dotted. However, experiences of Dr. Kelsey are there to remind us that these regulations exist for a reason.
Dr. Kelsey was born in Vancouver Island, British Columbia. She completed her undergraduate and master’s degree in pharmacology from McGill University. She later obtained a Ph.D. in Pharmacology from the University of Chicago and her M.D. from Chicago Medical School. Dr. Kelsey then joined the FDA in 1960. Within her first month of service at the FDA, she was asked to review the application for a drug called Kevadon which was manufactured in West Germany and known there by its more popular and generic name, thalidomide. This appeared to be a quick task of approving a drug, which was popularly prescribed in Europe and Canada for insomnia and was hailed as a wonder drug, providing a ‘safe and sound sleep’. It had already been approved in over a dozen countries. However, Dr. Kelsey was alarmed by the evidence supporting the drug’s safety claims and rejected approval until further clinical evidence was provided. She was particularly concerned about what harmful effects such a drug might have during pregnancy. The manufacturer grew frustrated and began to pressure Kelsey and her superiors for approval, but Kelsey stuck to her principles and stood her ground. Around that time physicians in Europe began to notice an increase in birth defects and in November 1961, Dr. Lenz, a German pediatrician determined that thalidomide was the cause. It was estimated that around 10,000-12,000 children worldwide were born with deformities associated with thalidomide. However, thanks to the efforts of Dr. Kelsey, America was spared such a disaster with only 17 documented cases of thalidomide related birth defects. These US documented exposures to thalidomide had occurred because the manufacturer had already distributed more than 2.5 million tablets to more than a thousand doctors across the US on an ‘investigational basis.’ These tablets in turn were given out to more than 20,000 patients, several hundred of whom were pregnant women (this would make us think twice before freely handing out samples to our patients). By 1962, thalidomide was withdrawn from the world market, including Canada. In more recent times, thalidomide has been studied and approved in certain countries for the treatment of leprosy and multiple myeloma but under strict control due to its teratogenic effects.
On July 15, 1962 the front page of The Washington Post noted “‘Heroine’ of FDA keeps Bad Drug Off of Market” recognizing and honoring Dr. Kelsey’s efforts in saving thousands. As a result of Dr. Kelsey’s commendable act of not bowing to pressure, steps were taken toward stricter measures and amendments of drug regulations. The thalidomide incident as a whole also made women and physicians become more aware and cautious about various medications taken during pregnancy. In today’s time, organizations such as the world renowned Motherisk Program at the Hospital for Sick Children in Toronto founded by Dr. Gideon Koren, serve as a valuable resource and reservoir of information providing evidence-based information and guidance about the safety or risks to the developing fetus/infant of maternal exposure to various drugs, diseases and agents.
Dr. Kelsey has received several awards and honors which includes the President’s Award for Distinguished Federal Civilian Service awarded in 1962 by President John F. Kennedy; she has had a school named after her in British Columbia (Canada); and in 2010, the FDA named an award after her called the ‘Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health.’ The FDA also announced the first recipient of this award was none other than Dr. Frances Kelsey herself at the age of 96.
— Dr. Farhan M. Asrar is the chief resident medical doctor in the Dual Public Health and Preventive Medicine and Family Medicine Program at McMaster University, Canada. He is passionate about the history of medicine and is a keen collector of original art, antiques and collectibles pertaining to the same.
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