Frances Oldham Kelsey
|Frances Oldham Kelsey|
July 24, 1914 |
Shawnigan Lake, British Columbia
|Occupation||Physician, FDA employee|
|Known for||preventing thalidomide from coming to market in the United States|
|Spouse(s)||Fremont Ellis Kelsey|
Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) was a pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.
Birth and education
Born Frances Kathleen Oldham in Shawnigan Lake on Vancouver Island, British Columbia, Kelsey was sent to a private boys’ school in Shawnigan Lake because her parents expected her to become as educated as her older brother, graduated from high school at age 15, and attended Victoria College, British Columbia (1930–1931) in Victoria, British Columbia (now University of Victoria). She then enrolled at McGill University to study pharmacology. At McGill she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology, and "on [a] professor's urging, wrote to EMK Geiling, M.D., a noted researcher [who] was starting up a new pharmacology department at the University of Chicago, asking for a position doing graduate work. Geiling assumed that Frances was a man and offered her the position. Frances accepted and began working for Geiling in 1936. During her second year, Geiling was retained by the FDA to research unusual deaths related to Elixir Sulfanilamide, a sulfonamide medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol as a solvent. The next year, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938. That same year Kelsey successfully completed her studies and received a Ph.D. in pharmacology at the University of Chicago in 1938. Kelsey's work for Geiling is credited with her interest in teratogens – that is, drugs that cause congenital malformations.
Early career and marriage
Upon completing her Ph.D., Kelsey joined the University of Chicago faculty. In 1942, like many other pharmacologists, Kelsey was looking for a synthetic cure for malaria. As a result of these studies, Kelsey learned that some drugs are able to pass through the placental barrier. While there she also met fellow faculty member Dr. Fremont Ellis Kelsey, whom she married in 1943.
While on the faculty at the University of Chicago, Kelsey received an M.D. She supplemented her teaching with work as an editorial associate for the American Medical Association Journal for two years. Kelsey left the University of Chicago in 1954, decided to take a position teaching pharmacology at the University of South Dakota, and moved with her husband and two daughters to Vermillion, South Dakota, where she taught until 1957.
Work at the FDA and thalidomide
In 1960, Kelsey was hired by the FDA in Washington, DC. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs" for the FDA. One of her first assignments at the FDA, was to review application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and over 20 European and African countries, she withheld approval for the drug, and requested further studies. Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.
Kelsey's insistence that the drug should be fully tested prior to approval was dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy. Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects in infants. She was hailed on the front page of The Washington Post as a heroine for averting a similar tragedy in the US. Morton Mintz, author of The Washington Post article, said "[Kelsey] prevented … the birth of hundreds or indeed thousands of armless and legless children."
After Morton Mintz broke the story in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation. Companies were required to demonstrate the effectiveness of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies. The drug testing reforms required "stricter limits on the testing and distribution of new drugs" to avoid similar problems. The amendments also, for the first time, recognized that "effectiveness [should be] required to be established prior to marketing."
As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy, becoming the second woman to receive that award. British Pathé recently released film to You Tube of Kennedy acknowledging Dr. Kelsey in a speech. 
After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 Amendments. She also became responsible for directing the surveillance of drug testing at the FDA. Kelsey finally retired from the FDA in 2005, at age 90, after 45 years of service.
In 2010, the FDA named the Kelsey Award for her, to be awarded to an FDA employee.
Legacy and awards
In 2010, the FDA honored Kelsey by naming one of their annual awards after her. In announcing the awards, Center Director Steven K. Galson, M.D., MPH, said “I am very pleased to have established the Dr. Frances O. Kelsey Drug Safety Excellence Award and to recognize the first recipients for their outstanding accomplishments in this important aspect of drug regulation.”
- 1962 • President's Award for Distinguished Federal Civilian Service
- 1963 • Gold Key Award from University of Chicago, Medical and Biological Sciences Alumni Association
- 2000 • Inducted into the National Women's Hall of Fame
- 2001 • Named a Virtual Mentor for the American Medical Association
- 2006 • Foremother Award from the NRC for Women & Families 
- 2010 • FDA Kelsey Award. Kelsey received the first Kelsey Award which will be given to one FDA staff member annually.
- Bren says, "When Kelsey read Geiling's letter offering her a research assistantship and scholarship in the PhD program at Chicago, she was delighted. But there was one slight problem — one that 'tweaked her conscience a bit.' The letter began 'Dear Mr. Oldham,' Oldham being her maiden name. Kelsey asked her professor at McGill if she should wire back and explain that Frances with an 'e' is female. 'Don't be ridiculous,' he said. 'Accept the job, sign your name, put 'Miss' in brackets afterwards, and go!' " Bren (2006).
- FDA Consumer.
- Mintz. See also Mintz's comments from 2005 on Kelsey.
- Library of Medicine biography.
- "Frances Oldham Kelsey". Chemical Heritage Foundation. Retrieved 23 March 2014.
- Hall of Fame.
- "President Kennedy Calls For Stronger Drug Laws". British Pathe News. 1962.
- Lyndsey Layton (September 13, 2010). "Physician to be honored for historic decision on thalidomide". The Washington Post.
- "Gold Key Award Recipients". The University of Chicago The Medical & Biological Sciences Alumni Association. Retrieved 2006-08-14.
- "2006 Foremothers Awards Luncheon". National Research Center for Women & Families. Retrieved 2009-08-15.
- "Margaret A. Hamburg, M.D., Commissioner of Food and Drugs – Remarks at the Award Ceremony for Dr. Frances Kelsey".
- Harris, Gardiner (13 September 2010). "The Public’s Quiet Savior From Harmful Medicines". The New York Times. Retrieved 4 January 2011.
- Bren, Linda. "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". Frances Kelsey Secondary School. Retrieved 2009-08-15.
- "Asteroids with Canadian Connections". Royal Astronomical Society of Canada. Retrieved 2010-04-27.
- Honorary doctor of science degree from Vancouver Island University, NanaimoBulletin.com
- Barber, Jackie (2005-11-10). "Center ceremony honors 107 individuals, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award". News Along the Pike (FDA/Center for Drug Evaluation and Research). Archived from the original on 2007-06-15. Retrieved 2009-08-15.
- Bren, Linda (March–April 2001). "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". FDA Consumer. Archived from the original on 2006-10-20. Retrieved 2009-08-15.
- ---. "Dr. Frances Kathleen Oldham Kelsey". National Library of Medicine. Retrieved 2006-04-30. Cited as "Library of Medicine biography".
- --- (1986). "Frances Kelsey". Canada Heirloom Series. Heirloom Publishing Inc. Retrieved 2009-08-15. Cited as "Heirloom".
- Geraghty, Karen (July 2001). "Profile of a Role Model – Frances Oldham Kelsey, MD, PhD". Virtual Mentor – American Medical Association Journal of Ethics 7 (7). Archived from the original on 2007-09-29. Retrieved 2009-08-15.
- Kennedy, John F. (1962). "Remarks Upon Presenting the President's Awards for Distinguished Federal Civilian Service". Retrieved 2006-05-01.
- Mintz, Morton (1962-07-15). "'Heroine' of FDA Keeps Bad Drug Off of Market". The Washington Post. p. Front Page.
- Rouhi, Maureen (2005-06-20). "Top Pharmaceuticals: Thalidomide". Chemical & Engineering News (American Chemical Society) 83 (25). Retrieved 2006-04-30.
- Simpson, Joanne Cavanaugh (September 2001). "Pregnant Pause". Johns Hopkins Magazine 53 (4). Retrieved 2006-04-30.
- Spiegel, Rachel. "Research in the News: Thalidomide". Archived from the original on 2007-08-22. Retrieved 2009-08-15.
- --- (June 1981). "The Story Of The Laws Behind The Labels". FDA Consumer. Retrieved 2009-08-15. Cited as "FDA Consumer".
- --- (2000). "Women of the Hall – Frances Kathleen Oldham Kelsey, Ph.D., M.D.". National Women’s Hall of Fame. Retrieved 2006-05-01. Cited as "Hall of Fame".
- Harris, Steven B. 1992. The Right Lesson to Learn from Thalidomide.
- Mintz, Morton (1965) The therapeutic nightmare; a report on the roles of the United States Food and Drug Administration, the American Medical Association, pharmaceutical manufacturers, and others in connection with the irrational and massive use of prescription drugs that may be worthless, injurious, or even lethal. Boston, Houghton Mifflin. LOC HD9666.6 .M55, Dewey 338.4761519.Library of Congress catalog entry
- McFadyen, R.E. (1976). Thalidomide in America: A Brush With Tragedy. Clio Medica, 11, (2), 79–93.
- Mulliken, J. (August 10, 1962). A Woman Doctor Who Would Not be Hurried. Life Magazine, 53, 28–9. Call# AP2 .L547
- Perri III, Anthony J; Hsu MD, Sylvia. "A review of thalidomide's history and current dermatological applications". Dermatology Online Journal 9 (=3): 5. Retrieved 2006-08-14.
- Seidman, Lisa A.; Warren, Noreen (September 2002). "Frances Kelsey & Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations". The American Biology Teacher 64 (7): 495. doi:10.1662/0002-7685(2002)064[0495:FKTITU]2.0.CO;2. 7.
- "Dr. Frances Kathleen Oldham Kelsey". National Library of Medicine. Retrieved September 14, 2010.
- The Public’s Quiet Savior From Harmful Medicines, by Gardiner Harris, New York Times, September 13, 2010
- Thalidomide, after fifty years: A tribute to Frances Oldham Kelsey and a call for thorough, responsible federal drug regulation and oversight NJ.com December 17, 2012