Frances Oldham Kelsey
Encyclopedia
Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) is 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.
on Vancouver Island
, British Columbia
, Kelsey graduated from high school at age 15, and attended Victoria College, British Columbia
(1930-1931) in Victoria, British Columbia
. 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, but Frances accepted the position rather than clarifying her gender first, 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.
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 placenta
l 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.
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 placenta
l 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." The public outcry was swift and drug testing reforms
were passed unanimously by Congress a few months later. 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.
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.
, 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.”
The Frances Kelsey Secondary School
in Mill Bay, British Columbia
is named in her honour.
Asteroid 6260 Kelsey
is named in her honour.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) who refused to authorize thalidomide
Thalidomide
Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
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 Cobble HillCobble Hill, British Columbia
Cobble Hill is a small community on Vancouver Island, British Columbia, Canada. It is located approximately north of Victoria in the Cowichan Valley Regional District, and is known for its agricultural surroundings, and for Cobble Hill itself, which gave the village its name...
on Vancouver Island
Vancouver Island
Vancouver Island is a large island in British Columbia, Canada. It is one of several North American locations named after George Vancouver, the British Royal Navy officer who explored the Pacific Northwest coast of North America between 1791 and 1794...
, British Columbia
British Columbia
British Columbia is the westernmost of Canada's provinces and is known for its natural beauty, as reflected in its Latin motto, Splendor sine occasu . Its name was chosen by Queen Victoria in 1858...
, Kelsey graduated from high school at age 15, and attended Victoria College, British Columbia
Victoria College, British Columbia
Victoria College was a two-year college in Victoria, British Columbia founded in 1903 with sponsorship from McGill University. It was one of the first post-secondary institutions in British Columbia...
(1930-1931) in Victoria, British Columbia
Victoria, British Columbia
Victoria is the capital city of British Columbia, Canada and is located on the southern tip of Vancouver Island off Canada's Pacific coast. The city has a population of about 78,000 within the metropolitan area of Greater Victoria, which has a population of 360,063, the 15th most populous Canadian...
. She then enrolled at McGill University
McGill University
Mohammed Fathy is a public research university located in Montreal, Quebec, Canada. The university bears the name of James McGill, a prominent Montreal merchant from Glasgow, Scotland, whose bequest formed the beginning of the 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
University of Chicago
The University of Chicago is a private research university in Chicago, Illinois, USA. It was founded by the American Baptist Education Society with a donation from oil magnate and philanthropist John D. Rockefeller and incorporated in 1890...
," asking for a position doing graduate work. Geiling assumed that Frances was a man, but Frances accepted the position rather than clarifying her gender first, 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
Elixir Sulfanilamide disaster
Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people...
, a sulfonamide medicine
Sulfonamide (medicine)
Sulfonamide or sulphonamide is the basis of several groups of drugs. The original antibacterial sulfonamides are synthetic antimicrobial agents that contain the sulfonamide group. Some sulfonamides are also devoid of antibacterial activity, e.g., the anticonvulsant sultiame...
. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol
Diethylene glycol
Diethylene glycol is an organic compound with the formula 2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent...
as a solvent
Solvent
A solvent is a liquid, solid, or gas that dissolves another solid, liquid, or gaseous solute, resulting in a solution that is soluble in a certain volume of solvent at a specified temperature...
. The next year, the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
passed the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
of 1938. That same year Kelsey successfully completed her studies and received a Ph.D. in pharmacology at the University of Chicago
University of Chicago
The University of Chicago is a private research university in Chicago, Illinois, USA. It was founded by the American Baptist Education Society with a donation from oil magnate and philanthropist John D. Rockefeller and incorporated in 1890...
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
Malaria
Malaria is a mosquito-borne infectious disease of humans and other animals caused by eukaryotic protists of the genus Plasmodium. The disease results from the multiplication of Plasmodium parasites within red blood cells, causing symptoms that typically include fever and headache, in severe cases...
. As a result of these studies, Kelsey learned that some drugs are able to pass through the placenta
Placenta
The placenta is an organ that connects the developing fetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply. "True" placentas are a defining characteristic of eutherian or "placental" mammals, but are also found in some snakes and...
l 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
American Medical Association
The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...
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
University of South Dakota
The University of South Dakota ', the state’s oldest university, was founded in 1862 and classes began in 1882. Located in Vermillion, South Dakota, United States, USD is home to South Dakota's only medical school and law school. USD is governed by the South Dakota Board of Regents, and its current...
, and moved with her husband and two daughters to Vermillion, South Dakota
Vermillion, South Dakota
Vermillion is a city in and the county seat of Clay County, in the southeastern corner of the U.S. state of South Dakota, and the tenth largest city in the state. According to the 2010 Census, the population was 10,571. Vermillion lies atop a bluff near the Missouri River.The area has been home to...
, 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 MerrellMarion Merrell Dow
Marion Merrell Dow and its predecessor Marion Laboratories was a U.S. pharmaceutical company based in Kansas City, Missouri from 1950 until 1996....
for the drug thalidomide
Thalidomide
Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
(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
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
. 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 placenta
Placenta
The placenta is an organ that connects the developing fetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply. "True" placentas are a defining characteristic of eutherian or "placental" mammals, but are also found in some snakes and...
l barrier and caused serious birth defects in infants. She was hailed on the front page of The Washington Post
The Washington Post
The Washington Post is Washington, D.C.'s largest newspaper and its oldest still-existing paper, founded in 1877. Located in the capital of the United States, The Post has a particular emphasis on national politics. D.C., Maryland, and Virginia editions are printed for daily circulation...
as a heroine for averting a similar tragedy in the US. Morton Mintz
Morton Mintz
Morton Mintz is an investigative journalist who in his early years reported for two St. Louis, Missouri newspapers, the Star-Times and the Globe-Democrat; and then, most notably The Washington Post . He exposed such scandals as thalidomide and the Dalkon Shield...
, author of The Washington Post article, said "[Kelsey] prevented ... the birth of hundreds or indeed thousands of armless and legless children." The public outcry was swift and drug testing reforms
Kefauver Harris Amendment
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval...
were passed unanimously by Congress a few months later. 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
President's Award for Distinguished Federal Civilian Service
Established by President Dwight D. Eisenhower on 27 June 1957 by , the President's Award for Distinguished Federal Civilian Service was created to allow the President to recognize civilian officers or employees of the federal government who have made contributions "so outstanding that the officer...
by President John F. Kennedy
John F. Kennedy
John Fitzgerald "Jack" Kennedy , often referred to by his initials JFK, was the 35th President of the United States, serving from 1961 until his assassination in 1963....
, becoming the second woman to receive that award.
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 2005, the FDA honored Kelsey by naming one of their annual awards after her. In announcing the awards, Center Director Steven K. GalsonSteven K. Galson
Steven Kenneth Galson is an American public health physician. He is a retired rear admiral in the United States Public Health Service Commissioned Corps and public health administrator who served as the acting Surgeon General of the United States from October 1, 2007 – October 1, 2009...
, 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 ServicePresident's Award for Distinguished Federal Civilian ServiceEstablished by President Dwight D. Eisenhower on 27 June 1957 by , the President's Award for Distinguished Federal Civilian Service was created to allow the President to recognize civilian officers or employees of the federal government who have made contributions "so outstanding that the officer...
- 1963 • Gold Key Award from University of ChicagoUniversity of ChicagoThe University of Chicago is a private research university in Chicago, Illinois, USA. It was founded by the American Baptist Education Society with a donation from oil magnate and philanthropist John D. Rockefeller and incorporated in 1890...
, MedicalPritzker School of MedicineThe Pritzker School of Medicine is the M.D. granting unit of the Biological Sciences Division of the University of Chicago. It is located on the University's main campus in the Hyde Park neighborhood of Chicago, and matriculated its first class in 1927...
and Biological Sciences Alumni Association - 2000 • Inducted into the National Women's Hall of FameNational Women's Hall of FameThe National Women's Hall of Fame is an American institution. It was created in 1969 by a group of people in Seneca Falls, New York, the location of the 1848 Women's Rights Convention...
- 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.
The Frances Kelsey Secondary School
Frances Kelsey Secondary School
Frances Kelsey Secondary School is a high school located in Mill Bay, British Columbia, Canada, named after Dr. Frances Oldham Kelsey. The school, under founding Principal Allan MacLeod, adopted a self-directed learning system. FKSS is one of School District 79 Cowichan Valley's four main-stream...
in Mill Bay, British Columbia
Mill Bay, British Columbia
Mill Bay is a commuter town of about 3,200 people located on Vancouver Island, British Columbia, Canada about north of Victoria, the capital.Mill Bay was founded in the 1860s with lumber and milling as its primary industries, done at the mill on the bay...
is named in her honour.
Asteroid 6260 Kelsey
6260 Kelsey
6260 Kelsey is a main-belt asteroid discovered on August 2, 1949 by K. Reinmuth at Heidelberg.- External links :*...
is named in her honour.
See also
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- Kefauver Harris AmendmentKefauver Harris AmendmentThe U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval...
Further reading
- 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