Frances Kathleen Kelsey ( Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American
pharmacologist
Pharmacology is a branch of medicine, biology and pharmaceutical sciences concerned with drug or medication action, where a drug may be defined as any artificial, natural, or endogenous (from within the body) molecule which exerts a biochemica ...
and physician. As a reviewer for the U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), she refused to authorize
thalidomide
Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of ...
for market because she had concerns about the lack of evidence regarding the drug's safety.
Her concerns proved to be justified when it was shown that thalidomide caused serious
birth defect
A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can ...
s. Kelsey's career intersected with the passage of laws strengthening FDA oversight of
pharmaceuticals
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...
. Kelsey was the second woman to receive the
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 ...
, awarded to her by
John F. Kennedy
John Fitzgerald Kennedy (May 29, 1917 – November 22, 1963), often referred to by his initials JFK and the nickname Jack, was an American politician who served as the 35th president of the United States from 1961 until his assassination ...
in 1962.
Birth and education
Born in
Cobble Hill, British Columbia
Cobble Hill is a small community on Vancouver Island, British Columbia, Canada. It is located approximately north of Victoria, British Columbia, Victoria on Highway 1 in the Cowichan Valley Regional District, and is known for its agricultural sur ...
,
Kelsey attended
St. Margaret's School from 1928–1931 in
the provincial capital, graduating at age 15.
From 1930–1931, she attended
Victoria College (now University of Victoria). She then enrolled at
McGill University
McGill University (french: link=no, Université McGill) is an English-language public research university located in Montreal, Quebec, Canada. Founded in 1821 by royal charter granted by King George IV,Frost, Stanley Brice. ''McGill Universit ...
, where she received both a B.Sc. (1934) and an M.Sc. (1935) in pharmacology.
Encouraged by one of her professors, she "wrote to EMK Geiling, M.D., a noted researcher
howas starting up a new pharmacology department at the
University of Chicago
The University of Chicago (UChicago, Chicago, U of C, or UChi) is a private research university in Chicago, Illinois. Its main campus is located in Chicago's Hyde Park neighborhood. The University of Chicago is consistently ranked among the b ...
, asking for a position doing graduate work".
Geiling, unaware of spelling conventions with respect to Francis and Frances, presumed that Frances was a man and offered her the position, which she accepted, starting work in 1936.
During Kelsey's second year, Geiling was retained by the FDA to research unusual deaths related to
elixir sulfanilamide
Elixir sulfanilamide was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disast ...
, a
sulfonamide
In organic chemistry, the sulfonamide functional group (also spelled sulphonamide) is an organosulfur group with the structure . It consists of a sulfonyl group () connected to an amine group (). Relatively speaking this group is unreactive. ...
medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of
diethylene glycol
Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, and hygroscopic liquid with a sweetish taste. It is a four carbon dimer of ethylene glycol. It is miscible in water, alcohol, ...
as a
solvent
A solvent (s) (from the Latin '' solvō'', "loosen, untie, solve") is a substance that dissolves a solute, resulting in a solution. A solvent is usually a liquid but can also be a solid, a gas, or a supercritical fluid. Water is a solvent for ...
. The next year, the
United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washing ...
passed the
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
of 1938.
That same year she completed her studies and received a Ph.D. in pharmacology at the University of Chicago.
Working with Geiling led to her interest in
teratogens, drugs that cause
congenital malformations
A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can r ...
(birth defects).
Early career
Upon completing her Ph.D., Oldham joined the University of Chicago faculty. In 1942, like many other pharmacologists, Oldham was looking for a synthetic cure for
malaria
Malaria is a mosquito-borne infectious disease that affects humans and other animals. Malaria causes symptoms that typically include fever, tiredness, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death. S ...
. As a result of these studies, Oldham learned that some drugs are able to pass through the
placenta
The placenta is a temporary embryonic and later fetal organ that begins developing from the blastocyst shortly after implantation. It plays critical roles in facilitating nutrient, gas and waste exchange between the physically separate mater ...
l barrier.
During her work, she also met fellow faculty member Fremont Ellis Kelsey, whom she married in 1943.
While on the faculty at the University of Chicago, Kelsey was awarded her M.D. in 1950.
She supplemented her teaching with work as an editorial associate for the
American Medical Association
The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016.
The AMA's state ...
''
Journal
A journal, from the Old French ''journal'' (meaning "daily"), may refer to:
*Bullet journal, a method of personal organization
*Diary, a record of what happened over the course of a day or other period
*Daybook, also known as a general journal, a ...
'' for two years. Kelsey left the University of Chicago in 1954, decided to take a position teaching pharmacology at the
University of South Dakota
The University of South Dakota (USD) is a public research university in Vermillion, South Dakota. Established by the Dakota Territory legislature in 1862, 27 years before the establishment of the state of South Dakota, USD is the flagship univ ...
, and moved with her husband and two daughters to
Vermillion, South Dakota
Vermillion ( lkt, Waséoyuze; "The Place Where Vermilion is Obtained") is a city in and the county seat of Clay County. It is in the southeastern corner of South Dakota, United States, and is the state's 12th-largest city. According to the 2020 ...
, where she taught until 1957.
She became a
dual citizen
Dual or Duals may refer to:
Paired/two things
* Dual (mathematics), a notion of paired concepts that mirror one another
** Dual (category theory), a formalization of mathematical duality
*** see more cases in :Duality theories
* Dual (grammatical ...
of Canada and the United States in the 1950s in order to continue practicing medicine in the U.S., but retained strong ties to Canada where she continued to visit her siblings regularly until late in life.
Work at the FDA and thalidomide
In 1960, Kelsey was hired by the FDA in Washington, D.C. 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 an application by
Richardson-Merrell
Marion Merrell Dow and its predecessor Marion Laboratories was a U.S. pharmaceutical company based in Kansas City, Missouri from 1950 until 1996.
The company specialized in bringing to market drugs that had been discovered but unmarketed by other ...
for the drug
thalidomide
Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of ...
(under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for
morning sickness
Morning sickness, also called nausea and vomiting of pregnancy (NVP), is a symptom of pregnancy that involves nausea or vomiting. Despite the name, nausea or vomiting can occur at any time during the day. Typically the symptoms occur between th ...
. Although it had been previously approved in Canada and more than 20 European and African countries,
she withheld approval for the drug and requested
further studies.
Despite pressure from thalidomide's manufacturer
Grünenthal
Grünenthal is a pharmaceutical company headquartered in Aachen in Germany. It was founded in 1946 as Chemie Grünenthal and has been continuously family-owned. The company was the first to introduce penicillin into the German market in the po ...
, Kelsey persisted in requesting additional information to explain an English study that documented
peripheral neuritis
Peripheral neuropathy, often shortened to neuropathy, is a general term describing disease affecting the peripheral nerves, meaning nerves beyond the brain and spinal cord. Damage to peripheral nerves may impair sensation, movement, gland, or o ...
,
a nervous system side effect.
She also requested data showing the drug was not harmful to the fetus.
Kelsey's insistence that the drug should be fully tested prior to approval was 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
The placenta is a temporary embryonic and later fetal organ that begins developing from the blastocyst shortly after implantation. It plays critical roles in facilitating nutrient, gas and waste exchange between the physically separate mater ...
l barrier and caused serious
birth defect
A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can ...
s.
She was hailed on the front page of ''
The Washington Post
''The Washington Post'' (also known as the ''Post'' and, informally, ''WaPo'') is an American daily newspaper published in Washington, D.C. It is the most widely circulated newspaper within the Washington metropolitan area and has a large nati ...
'' as a heroine
for averting a similar tragedy in the U.S.
Morton Mintz, author of ''The Washington Post'' article, said prevented ... the birth of hundreds or indeed thousands of armless and legless children."
Kelsey insisted that her assistants, Oyama Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Kelsey's persistence was used to help pass rigorous drug approval regulation in 1962.
After Morton Mintz broke the story in July 1962, there was a substantial public outcry. The
Kefauver Harris Amendment
Carey Estes Kefauver (;
July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S. House of Representatives from 1939 to 1949 and in the Senate from 1949 until his de ...
was passed unanimously by Congress in October 1962 to strengthen drug regulation.
Companies were required to demonstrate the efficacy 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, for the first time, also recognized that "effectiveness
hould berequired 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
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 ...
by
John F. Kennedy
John Fitzgerald Kennedy (May 29, 1917 – November 22, 1963), often referred to by his initials JFK and the nickname Jack, was an American politician who served as the 35th president of the United States from 1961 until his assassination ...
on August 7, 1962,
becoming the second woman so honoured.
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 retired from the FDA in 2005, at age 90, after 45 years of service.
Later life and death
Kelsey continued to work for the FDA while being recognised for her earlier work. She was still working at the FDA's
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...
in 1995 and was appointed deputy for scientific and medical affairs. In 1994, the
Frances Kelsey Secondary School
Frances Kelsey Secondary School (FKSS) 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 on ...
in
Mill Bay, British Columbia
Mill Bay is a commuter town of about 7,200 people located on Vancouver Island, British Columbia, Canada about north of Victoria, the capital. It is part of the Cowichan Valley Regional District.
Mill Bay was founded in the 1860s with lumber an ...
, was named in her honour.
In 2010, the FDA presented Kelsey with the first Drug Safety Excellence Award and named the annual award after her,
announcing that it would be given to one FDA staff member annually.
In announcing the awards, Center Director
Steven K. Galson
Steven Kenneth Galson (born 1956) is an American public health physician. He is currently Senior Vice President for Global Regulatory Affairs & Strategy at Amgen, the California-based biopharmaceutical company. He is also Professor-at-Large at the ...
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."
Kelsey
turned 100 in July 2014,
and shortly thereafter, in the fall of 2014, she moved from Washington, D.C., to live with her daughter in
London, Ontario
London (pronounced ) is a city in southwestern Ontario, Canada, along the Quebec City–Windsor Corridor. The city had a population of 422,324 according to the 2021 Canadian census. London is at the confluence of the Thames River, approximate ...
.
In June 2015, when she was named to the
Order of Canada
The Order of Canada (french: Ordre du Canada; abbreviated as OC) is a Canadian state order and the second-highest honour for merit in the system of orders, decorations, and medals of Canada, after the Order of Merit.
To coincide with the ...
,
Mercédes Benegbi, a thalidomide victim and the head of the Thalidomide Victims Association of Canada, praised Kelsey for showing strength and courage by refusing to bend to pressure from drug company officials, and said "To us, she was always our heroine, even if what she did was in another country."
Kelsey died in London, Ontario, on August 7, 2015, at the age of 101,
less than 24 hours after Ontario's Lieutenant-Governor,
Elizabeth Dowdeswell
Violet Elizabeth Dowdeswell (née Patton; born November 9, 1944) is a Canadian public servant who currently serves as the lieutenant governor of Ontario, the 29th since Canadian Confederation. She is the viceregal representative of the King ...
, visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide.
Legacy and awards
![Frances O](https://upload.wikimedia.org/wikipedia/commons/2/26/Frances_O._Kelsey_%28FDA_113%29_%288205474573%29.jpg)
* 1962 •
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 ...
* 1963 • Gold Key Award from
University of Chicago
The University of Chicago (UChicago, Chicago, U of C, or UChi) is a private research university in Chicago, Illinois. Its main campus is located in Chicago's Hyde Park neighborhood. The University of Chicago is consistently ranked among the b ...
,
Medical
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practic ...
and Biological Sciences Alumni Association
* 1994 • Chosen as the namesake for Frances Kelsey Secondary School which opened in 1995.
* 2000 • Inducted into the
National Women's Hall of Fame
The National Women's Hall of Fame (NWHF) is an American institution incorporated in 1969 by a group of men and women in Seneca Falls, New York, although it did not induct its first enshrinees until 1973. As of 2021, it had 303 inductees.
Induc ...
* 2001 • Named a Virtual Mentor for the American Medical Association
* 2006 • Foremother Award from the
National Center for Health Research
The National Center for Health Research (formerly known as the National Research Center for Women & Families) is a Washington, D.C.-based non-profit organization founded in 1999, providing health-related services such as providing free informatio ...
* 2010 • Recipient of the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health given out by the FDA
* 2012 • Honorary doctor of science degree from
Vancouver Island University
Vancouver Island University (abbreviated as VIU, formerly known as Malaspina University-College and earlier as Malaspina College) is a Canadian public university serving Vancouver Island and coastal British Columbia. Malaspina College began in 196 ...
* 2015 • Named to the
Order of Canada
The Order of Canada (french: Ordre du Canada; abbreviated as OC) is a Canadian state order and the second-highest honour for merit in the system of orders, decorations, and medals of Canada, after the Order of Merit.
To coincide with the ...
See also
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
References
Further reading
*
* .
* .
* . This was drawn from oral history interviews conducted in 1974, 1991, and 1992; presentation, Founder's Day, St. Margaret's School, Duncan, B. C., 1987; and presentation, groundbreaking, Frances Kelsey School, Mill Bay, B. C., 1993.
* .
*
Library of Congress catalog entry
* .
* .
* .
* .
* .
{{DEFAULTSORT:Kelsey, Frances Oldham
1914 births
2015 deaths
American civil servants
American centenarians
American pharmacologists
Canadian centenarians
Canadian emigrants to the United States
Canadian pharmacologists
Women pharmacologists
20th-century Canadian physicians
20th-century American physicians
Canadian women physicians
Food and Drug Administration people
McGill University Faculty of Science alumni
Members of the Order of Canada
People from the Cowichan Valley Regional District
University of Chicago alumni
University of Chicago faculty
University of South Dakota faculty
Victoria College, British Columbia alumni
20th-century American women physicians
Women centenarians
Members of the Society of Woman Geographers
Recipients of the President's Award for Distinguished Federal Civilian Service
American women academics
20th-century Canadian women scientists
21st-century American women