Lessons Learned in the Lifetime of Dr. Frances O. Kelsey : Building a Sense of Mission and Responsibility from Early to Mid-Life

Abstract

Frances Oldham was born on July 24, 1914 in the town of Cobble Hill on Vancouver Island, British Columbia, Canada. She passed away on August 7, 2015 at the age of 101. 　Frances attended Leinster Preparatory School in Shawnigan Lake and graduated at the age of 15. She then attended Victoria College and McGill University in Montreal, Canada, earning a Master's Degree in Science in 1935. In March 1936, Dr. Geiling opened a new laboratory of in the Pharmacology Department at the University of Chicago, USA, and Frances was fortunately accepted, creating her path to PhD studies. In September 1937, the sulfanilamide elixir tragedy involving the excipient diethylene glycol (DEG) occurred in the US, leading to 105 deaths. Dr. Geiling’s laboratory participated in the safety animal study, which involved the use of rats given DEG. Frances thought that, if by carefully work such animal studies, future tragedies could be avoided. In 1938, Frances earned a PhD with a thesis featuring the anatomy and pharmacology of the posterior pituitary gland of the nine-banded armadillo. In 1941, she started a new project entitled, The influence of pregnancy on the quinine oxidase of rabbit liver, which was carried out jointly with Dr. Fremont Ellis Kelsey. In 1943, the study was published in the Journal of Pharmacology and Experimental Therapeutics, and Frances married Fremont the same year. In 1946, Frances entered a medical school at the University of Chicago and graduated in 1950.She moved to South Dakota with her husband with two daughters in 1952, and started her internship in early 1953 at the Sacred Heart Hospital at Yankton. In August 1960, De. Frances Kelsey was appointed the newest medical officer of the US Food and Drug Administration (FDA). On September 12 of the same year, William S. Merrel Company submitted a new drug application (NDA) for thalidomide to the US FDA. As a medical officer, Frances had the primary responsibility for evaluating the clinical reports submitted with the NDA, with particular emphasis on safety. Her steadfast refusal to approve the application saved the lives of thousands of US babies. In 1962, President John F. Kennedy presented Dr. Frances Kelsey with an award for Distinguished Federal Civilian Service for preventing thalidomide from being marketed in the US. In September 2010, the FDA honored her with an award named for her, and a promise from FDA Commissioner Margaret A. Hamburg, MD, that the agency will carry on Kelsey’s commitment to science and integrity. Beginning in 2010, some ethics education of training materials began being used to build a sense of mission and responsibility among Japanese pharmacy and medical students. Lessons learned from the lifetime of Dr. Frances Kelsey have received strong feedback from freshmen and sophomores taking related courses.