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Page title without namespace (page_title ) | 'Frances Oldham Kelsey' |
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{{Infobox person
| name = Frances Oldham Kelsey
| image = Frances Oldham Kelsey.png
| image_size = 220px
| birth_name=Frances Kathleen Oldham
| birth_date = {{Birth date|1914|07|24}}
| birth_place = [[Cobble Hill, British Columbia|Cobble Hill]], British Columbia, Canada
| death_date = {{Death date and age|2015|8|7|1914|07|24}}
| death_place = [[London, Ontario|London]], Ontario, Canada
| alma_mater = [[Victoria College, British Columbia]]<br>[[McGill University]]<br>[[University of Chicago]]
| known_for = Preventing [[thalidomide]] from being marketed in the United States
| occupation = Pharmacologist, physician
| spouse = Fremont Ellis Kelsey (m. 1943, died 1966)
| children = 2
}}
'''Frances Kathleen Oldham Kelsey''', [[Member of the Order of Canada|CM]] (July 24, 1914 – August 7, 2015) was a Canadian-American<ref name="nyt-2015"/> [[pharmacologist]] and physician. As a reviewer for the U.S. [[Food and Drug Administration]] (FDA), she refused to authorize [[thalidomide]] for market because she had concerns about the drug's safety.<ref name="globe2014"/> Her concerns proved to be justified when it was shown that thalidomide caused serious [[birth defect]]s. Kelsey's career intersected with the passage of laws strengthening FDA oversight of [[pharmaceuticals]]. Kelsey was the second woman to be awarded the [[President's Award for Distinguished Federal Civilian Service]] by President [[John F. Kennedy]].
== Birth and education ==
Born in [[Shawnigan Lake, British Columbia]],<ref name="heirloom"/> Kelsey attended [[St. Margaret's School (Victoria, British Columbia)|St. Margaret's School]] in [[Victoria, British Columbia|the provincial capital]], graduating at age 15.<ref name="fda1"/> From 1930-1931 she attended [[Victoria College, British Columbia|Victoria College]] (now University of Victoria). She then enrolled at [[McGill University]], where she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology,.<ref name="heirloom" /> Encouraged by one of her professors, she "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".<ref name="fda1" /> Geiling, obviously 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.<ref name="name confusion"/>
During her second year, Geiling was retained by the FDA to research unusual deaths related to [[elixir sulfanilamide]], a [[sulfonamide (medicine)|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.<ref name="fda1" /> That same year she completed her studies and received a Ph.D. in pharmacology at the University of Chicago.<ref name="fda1" /> Working with Geiling led to her interest in [[teratogen]]s, drugs that cause [[birth defects|congenital malformations]] (birth defects).<ref name="nih1"/>
== Early career ==
[[Image:Frances O. Kelsey (FDA 171) (8211251003).jpg|thumb|upright|Kelsey in the 1960s]]
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, Oldham learned that some drugs are able to pass through the [[placenta]]l barrier.<ref name="JH mag" /> While at the University of Chicago, she met fellow faculty member Dr. Fremont Ellis Kelsey, whom she married in 1943.<ref name="fda1" />
While on the faculty at the University of Chicago, Kelsey was awarded her M.D. during 1950.<ref name="fda1" /> She supplemented her teaching with work as an editorial associate for the [[American Medical Association]] ''[[JAMA (journal)|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.<ref name="heirloom" />
She became a [[Multiple citizenship|dual citizen]] 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.<ref name="globe2014"/>
== Work at the FDA and thalidomide ==
[[Image:Frances Oldham Kelsey and John F. Kennedy.jpg|thumb|upright|Kelsey received the [[President's Award for Distinguished Federal Civilian Service]] from President [[John F. Kennedy]], 1962]]
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"<ref name="fda1" /> for the FDA. One of her first assignments at the FDA was to review an application by [[Marion Merrell Dow|Richardson Merrell]] for the drug [[thalidomide]] (under the tradename Kevadon) as a tranquilizer 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 more than 20 European and African countries,<ref name="acs"/> she withheld approval for the drug and requested [[clinical trial|further studies]].<ref name="heirloom" /> Despite pressure from [[Grünenthal GmbH|thalidomide's manufacturer]], Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.<ref name="fda1" />
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.<ref name="fda3"/> Researchers discovered that the thalidomide crossed the [[placenta]]l barrier and caused serious [[birth defect]]s.<ref name="JH mag" /> She was hailed on the front page of ''[[The Washington Post]]'' as a heroine<ref name="post"/> for averting a similar tragedy in the U.S.<ref name="nih2"/> [[Morton Mintz]], author of ''The Washington Post'' article, said "[Kelsey] prevented… the birth of hundreds or indeed thousands of armless and legless children."<ref name="post" /> Kelsey insisted that her assistants, Oyam Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Dr. Kelsey's persistence, however, was used to help pass rigorous drug approval regulation in 1962.<ref name="nyt-2015"/>
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.<ref name="fda3" /> 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.
<ref name="CHFArticle">{{citation |title=Frances Oldham Kelsey|url=http://www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/public-and-environmental-health/food-and-drug-safety/kelsey.aspx|publisher=Chemical Heritage Foundation|accessdate=March 23, 2014 |deadurl=yes |archiveurl=https://web.archive.org/web/20160712164719/http://www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/public-and-environmental-health/food-and-drug-safety/kelsey.aspx|archivedate=July 12, 2016}}</ref> The drug testing reforms required "stricter limits on the testing and distribution of new drugs"<ref name="JH mag" /> to avoid similar problems. The amendments, for the first time, also recognized that "effectiveness [should be] required to be established prior to marketing."<ref name="fda3" /> The new laws were not without controversy.<ref>Prenatal fluoride: The most controversial use of the new 1962 law was a vigorous enforcement that took prenatal vitamins with fluoride off the market. Unlike thalidomide, fluoride was not patented or otherwise owned by anyone, so there was no one to defend it or pay for the newly required well-controlled study. The big money in fluoride is in fluoride deficiency (dental caries). Prenatal fluoride is still illegal. http://raygrogan2-ivil.tripod.com/answersforbabycenterposts/id1.html</ref>
As a result of her blocking American approval of thalidomide, Kelsey was awarded the [[President's Award for Distinguished Federal Civilian Service]] by [[John F. Kennedy]],<ref name="jfk"/> becoming the second woman so honoured.<ref name="nwhf"/> After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 amendments.<ref name="nih2" /> She also became responsible for directing the surveillance of drug testing at the FDA.<ref name="heirloom" />
Kelsey retired from the FDA in 2005, at age 90, after 45 years of service.<ref name="acs" /> In 2010 the FDA established the Kelsey Award, to be awarded annually to an employee.<ref name="post-2010"/>
== Later life and death ==
[[Image:Frances O. Kelsey 2001.png|thumb|upright|Kelsey (age 87) at the FDA Reception commemorating her induction into the National Women's Hall of Fame]]
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 in 1995 and was appointed deputy for scientific and medical affairs. In 1994, the [[Frances Kelsey Secondary School]] in [[Mill Bay, British Columbia]] was named in her honour.<ref name="schoolnamed"/> She retired in 2005.<ref name=Telegraph_obit>{{cite news|title=Frances Kelsey, scientist - obituary|url=https://www.telegraph.co.uk/news/obituaries/11794398/Frances-Kelsey-scientist-obituary.html|accessdate=11 August 2015|publisher=The Telegraph|date=August 11, 2015}}</ref>
In 2010, the FDA presented Kelsey with the first Drug Safety Excellence Award and named the annual award after her,<ref name="nyt-2010"/> announcing that it would be given to one FDA staff member annually.<ref name="FDA-award"/> In announcing the awards, Center Director [[Steven K. Galson]] 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."<ref name="fda2005"/>
Kelsey [[centenarian|turned 100]] in July 2014,<ref name="Centenary"/> and shortly thereafter, in the fall of 2014, she moved from [[Washington, D.C.]], to live with her daughter in [[London, Ontario]].<ref name="G&M-2015-07-01"/> In June 2015, when she was named to the [[Order of Canada]], [[Mercédes Benegbi]], a thalidomide victim and the head of the Thalidomide Victims Association of Canada, praised Dr. 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."<ref name="G&M-2015-07-01"/>
Kelsey died in London, Ontario, on August 7, 2015 at the age of 101,<ref name="post-2015"/> less than 24 hours after Ontario's Lieutenant-Governor, [[Elizabeth Dowdeswell]], visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide.<ref name="G&M-2015-08-07"/>
== Legacy and awards ==
[[File:Frances O. Kelsey (FDA 113) (8205474573).jpg|upright|thumb|The "Drug Detective"]]
* 1962 • [[President's Award for Distinguished Federal Civilian Service]]<ref name="acs" />
* 1963 • Gold Key Award from [[University of Chicago]], [[Pritzker School of Medicine|Medical]] and Biological Sciences Alumni Association<ref name="goldkey"/>
* 2000 • Inducted into the [[National Women's Hall of Fame]]<ref name="nwhf" />
* 2001 • Named a Virtual Mentor for the American Medical Association<ref name="ama"/>
* 2006 • Foremother Award from the [[National Center for Health Research|National Research Center for Women & Families]]<ref name="foremother"/>
* 2010 • Recipient of the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health given out by the FDA<ref>{{cite news| author =| title =FDA honors one of its own| quote =| newspaper =[[CNN]] blog| date =September 16, 2010| url =http://thechart.blogs.cnn.com/2010/09/16/fda-honors-one-of-its-own/| accessdate = August 9, 2015}}</ref>
* 2012 • Honorary doctor of science degree from [[Vancouver Island University]]<ref name="VIU"/>
* 2015 • Named to the [[Order of Canada]]<ref name="G&M-2015-07-01"/>
== See also ==
{{Portal|Pharmacy and Pharmacology|British Columbia}}
* [[European Medicines Agency]]
{{-}}
== References ==
{{Reflist|30em|refs=
<ref name="globe2014">{{citation |url=https://www.theglobeandmail.com/news/national/canadian-doctor-averted-disaster-by-keeping-thalidomide-out-of-the-us/article21721337/ |title= Canadian doctor averted disaster by keeping thalidomide out of the U.S. |first=Ingrid |last=Peritz |publisher=[[The Globe and Mail]] |date=November 24, 2014 |accessdate=August 7, 2015}}.</ref>
<ref name="post-2015">{{citation |url=https://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine-of-thalidomide-tragedy-dies-at-101/2015/08/07/ae57335e-c5da-11df-94e1-c5afa35a9e59_story.html |title=Frances Oldham Kelsey, FDA scientist who kept thalidomide off U.S. market, dies at 101 |first1= Adam |last1=Bernstein |first2=Patricia |last2=Sullivan |date=August 7, 2015 |accessdate=August 7, 2015 |publisher=[[The Washington Post]] }}.</ref>
<ref name="heirloom">{{citation |url=http://epe.lac-bac.gc.ca/100/205/301/ic/cdc/heirloom_series/volume6/218-219.htm |title=Frances Kelsey |work=Canada Heirloom Series |year= 986 |publisher=Heirloom Publishing Inc. |accessdate=August 15, 2009 }}.</ref>
<ref name="fda1">{{citation |url=http://www.fda.gov/fdac/features/2001/201_kelsey.html|first=Linda |last=Bren |date=March–April 2001 |title=Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History |journal=FDA Consumer |accessdate = August 15, 2009 |archiveurl=https://web.archive.org/web/20061020043712/http://www.fda.gov/fdac/features/2001/201_kelsey.html |archivedate=October 20, 2006}}.</ref>
<ref name="name confusion">"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 (2001).</ref>
<ref name="nih1">{{citation |url = http://science-education.nih.gov/nihHTML/ose/snapshots/multimedia/ritn/Thalidomide/index.html |first=Rachel |last=Spiegel |title=Research in the News: Thalidomide |accessdate=August 15, 2009 |archiveurl=https://web.archive.org/web/20070822054139/http://science-education.nih.gov/nihHTML/ose/snapshots/multimedia/ritn/Thalidomide/index.html |archivedate=August 22, 2007}}.</ref>
<ref name="JH mag">{{citation |url=http://www.jhu.edu/~jhumag/0901web/pregnant.html |last=Simpson |first=Joanne Cavanaugh |date=September 2001 |title=Pregnant Pause |journal=Johns Hopkins Magazine |volume=53 |issue=4 |accessdate=April 30, 2006}}.</ref>
<ref name="acs">{{citation |url = http://pubs.acs.org/cen/coverstory/83/8325/8325thalidomide.html |first=Maureen |last=Rouhi |date=June 20, 2005 |title=Top Pharmaceuticals: Thalidomide |journal=Chemical & Engineering News |publisher=American Chemical Society |volume=83 |issue=25 |accessdate=April 30, 2006}}.</ref>
<ref name="fda3">{{citation |url = http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm |date=June 1981 |title=The Story Of The Laws Behind The Labels |journal=FDA Consumer |accessdate=August 15, 2009}}.</ref>
<ref name="post">{{citation |first=Morton |last=Mintz |title='Heroine' of FDA Keeps Bad Drug Off of Market |publisher=[[The Washington Post]] |page=Front Page |date=July 15, 1962}}. See also [http://www.niemanwatchdog.org/index.cfm?fuseaction=showcase.view&showcaseid=13 Mintz's comments from 2005] on Kelsey.</ref>
<ref name="nih2">{{citation |url=https://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.html |publisher=National Library of Medicine |title=Dr. Frances Kathleen Oldham Kelsey |accessdate=April 30, 2006}}.</ref>
<ref name="jfk">{{citation |url=http://www.presidency.ucsb.edu/ws/index.php?pid=8807 |last=Kennedy |first=John F. |authorlink=John F. Kennedy |year=1962 |title=Remarks Upon Presenting the President's Awards for Distinguished Federal Civilian Service |accessdate = May 1, 2006}}.</ref>
<ref name="nwhf">{{citation |url=http://www.greatwomen.org/women.php?action=viewone&id=93 |title=Women of the Hall – Frances Kathleen Oldham Kelsey, Ph.D., M.D. |publisher=National Women's Hall of Fame |year=2000 |accessdate=May 1, 2006 }}.</ref>
<ref name="post-2010">{{citation |url=https://www.washingtonpost.com/wp-dyn/content/article/2010/09/13/AR2010091306279.html| title=Physician to be honored for historic decision on thalidomide| work=The Washington Post| author= Lyndsey Layton| date=September 13, 2010 }}.</ref>
<ref name="goldkey">{{citation |title=Gold Key Award Recipients |url=http://bsdalumni.uchicago.edu/volunteer/goldkey.shtml |publisher=The University of Chicago The Medical & Biological Sciences Alumni Association |accessdate=August 14, 2006 }}.</ref>
<ref name="schoolnamed">{{citation |url=http://www.fkss.ca/mod/page/view.php?id=553 |archive-url=https://web.archive.org/web/20121019215202/http://www.fkss.ca/mod/page/view.php?id=553 |dead-url=yes |archive-date=October 19, 2012 |publisher=Frances Kelsey Secondary School |title=FKSS History |accessdate=December 26, 2014 }}.</ref>
<ref name="ama">{{citation |url=http://www.ama-assn.org/ama/pub/category/5335.html |last=Geraghty |first=Karen |date=July 2001 |title=Profile of a Role Model – Frances Oldham Kelsey, MD, PhD |journal=Virtual Mentor – American Medical Association Journal of Ethics |volume=7 |issue=7 |accessdate=August 15, 2009 |archiveurl=https://web.archive.org/web/20070929133432/http://www.ama-assn.org/ama/pub/category/5335.html |archivedate=September 29, 2007}}.</ref>
<ref name="foremother">{{citation |url=http://www.center4research.org/news-events/previous-foremother-awards/ |title=2006 Foremothers Awards Luncheon |accessdate=August 15, 2009 |publisher=National Research Center for Women & Families |deadurl=yes |archiveurl=https://web.archive.org/web/20110514041902/http://www.center4research.org/news-events/previous-foremother-awards/ |archivedate=May 14, 2011 |df=mdy-all }}.</ref>
<ref name="FDA-award">{{citation |url=http://www.fda.gov/NewsEvents/Speeches/ucm226349.htm |title=Margaret A. Hamburg, M.D., Commissioner of Food and Drugs – Remarks at the Award Ceremony for Dr. Frances Kelsey}}.</ref>
<ref name="fda2005">{{citation |url=http://www.fda.gov/cder/pike/Nov2005awards.htm |last=Barber |first=Jackie |title=Center ceremony honors 107 individuals, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award |journal=News Along the Pike |publisher=FDA/Center for Drug Evaluation and Research |date=November 10, 2005 |accessdate=August 15, 2009 |archiveurl = https://web.archive.org/web/20070615102054/http://www.fda.gov/cder/pike/Nov2005awards.htm |archivedate=June 15, 2007}}.</ref>
<ref name="nyt-2010">{{citation |url=https://www.nytimes.com/2010/09/14/health/14kelsey.html?_r=1 |title=The Public's Quiet Savior From Harmful Medicines |first=Gardiner |last=Harris |newspaper=[[The New York Times]] |date=September 13, 2010 |accessdate=January 4, 2011}}.</ref>
<ref name="VIU">{{citation |url=http://www.nanaimobulletin.com/news/157349815.html |title=Honorary doctor of science degree from Vancouver Island University |work=Nanaimo News Bulletin |publisher=Black Press, Inc. }}.</ref>
<ref name="Centenary">{{citation |url = http://globalnews.ca/news/1470760/canadian-scientist-frances-kelsey-who-spurred-fda-reforms-turns-100/ |last=McElroy |first=Justin |title=Canadian scientist Frances Kelsey, who spurred FDA reforms, turns 100 |publisher=[[Global News]] |date=July 24, 2014 |accessdate=July 24, 2014}}.</ref>
<ref name="G&M-2015-07-01">{{citation |url=https://www.theglobeandmail.com/news/national/doctor-who-opposed-thalidomide-in-us-named-to-order-of-canada/article25213185/ |title=Doctor who opposed thalidomide in U.S. named to Order of Canada |newspaper=[[The Globe and Mail]] |author=Ingrid Peritz |date=July 1, 2015 |accessdate=July 1, 2015}}.</ref>
<ref name="G&M-2015-08-07">{{citation |url=https://www.theglobeandmail.com/news/national/canadian-doctor-who-kept-thalidomide-out-of-us-dies/article25873611/ |title=Canadian doctor who kept thalidomide out of U.S. dies |newspaper=[[The Globe and Mail]] |author=Ingrid Peritz |date=August 7, 2015 |accessdate=August 7, 2015}}.</ref>
<ref name="nyt-2015">{{citation |last=McFadden |first=Robert |title=Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101 |publisher=[[The New York Times]] |url=https://www.nytimes.com/2015/08/08/science/frances-oldham-kelsey-fda-doctor-who-exposed-danger-of-thalidomide-dies-at-101.html?_r=0 |date=August 7, 2015 }}.</ref>
}}
== Further reading ==
{{commons category|Frances Oldham Kelsey}}
* {{citation |last=Bren |first=Linda |url=http://www.fda.gov/fdac/features/2001/201_kelsey.html |date=March–April 2001 |title=Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History |journal=FDA Consumer |accessdate = August 15, 2009 |archiveurl=https://web.archive.org/web/20061020043712/http://www.fda.gov/fdac/features/2001/201_kelsey.html |archivedate=October 20, 2006}}
* {{citation |last=Harris |first=Gardiner |url=https://www.nytimes.com/2010/09/14/health/14kelsey.html?_r=1 |title=The Public's Quiet Savior From Harmful Medicines |publisher=[[The New York Times]] |date=September 13, 2010 }}.
* {{citation |last=Harris |first=Steven B. |date=1992 |url=http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html |archive-url=https://web.archive.org/web/20010420025145/http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html |dead-url=yes |archive-date=2001-04-20 |title=The Right Lesson to Learn from Thalidomide }}.
* {{citation |last=Kelsey |first=Frances O. |date=1993 |url=http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/OralHistories/SelectedOralHistoryTranscripts/UCM406132.pdf |title=Autobiographical Reflections }}. 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.
* {{citation |last=Mintz |first=Morton |date=1965 |title=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. |location=Boston |publisher=Houghton Mifflin |lccn=65015156 }}. [http://catalog2.loc.gov/cgi-bin/Pwebrecon.cgi?v1=1&hd=1,1&CallBrowse=1&SEQ=20150807185722&PID=XSnYgHfncowAhApfdhreYim5&SID=3 Library of Congress catalog entry].
* {{citation |last=McFadyen |first=R. E. |date=1976 |title=Thalidomide in America: A Brush With Tragedy |journal=Clio Medica |volume=11 |issue=2 |pages=79–93}}.
* {{citation |last=Mulliken |first=J. |date=August 10, 1962 |title=A Woman Doctor Who Would Not be Hurried |journal=[[Life Magazine]] |volume=53 |pages=28–9 |lccn=37008367}}.
* {{citation |last=Perri III |first=Anthony J. |author2=Hsu MD, Sylvia |title=A review of thalidomide's history and current dermatological applications |url=http://dermatology.cdlib.org/93/reviews/thalidomide/hsu.html |journal=Dermatology Online Journal |pages=5 |accessdate=August 14, 2006 |volume=9| issue = 3}}.
* {{citation |last=Seidman |first=Lisa A. |author2=Warren, Noreen |title=Frances Kelsey & Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations |journal=The American Biology Teacher |date=September 2002 |doi=10.1662/0002-7685(2002)064[0495:FKTITU]2.0.CO;2 |volume=64 |pages=495 |id=7 |issue=7 }}.
* {{citation |last=Stamato |first=Linda |work=NJ Voices |url=http://blog.nj.com/njv_linda_stamato/2012/12/thalidomide_after_fifty_years.html |title=Thalidomide, after fifty years: A tribute to Frances Oldham Kelsey and a call for thorough, responsible federal drug regulation and oversight |publisher=NJ.com |date=December 17, 2012}}.
{{National Women's Hall of Fame}}
{{Authority control}}
{{Good article}}
{{DEFAULTSORT:Kelsey, Frances Oldham}}
[[Category:1914 births]]
[[Category:2015 deaths]]
[[Category:American civil servants]]
[[Category:American centenarians]]
[[Category:American pharmacologists]]
[[Category:Canadian centenarians]]
[[Category:Canadian emigrants to the United States]]
[[Category:Canadian pharmacologists]]
[[Category:Women pharmacologists]]
[[Category:20th-century Canadian physicians]]
[[Category:20th-century American physicians]]
[[Category:American women physicians]]
[[Category:Canadian women physicians]]
[[Category:Food and Drug Administration people]]
[[Category:McGill University alumni]]
[[Category:Members of the Order of Canada]]
[[Category:People from the Cowichan Valley Regional District]]
[[Category:University of Chicago alumni]]
[[Category:University of Chicago faculty]]
[[Category:University of South Dakota faculty]]
[[Category:Victoria College, British Columbia alumni]]
[[Category:20th-century women physicians]]
[[Category:Women centenarians]]' |
New page wikitext, after the edit (new_wikitext ) | '{{Use mdy dates|date=August 2015}}
{{Infobox person
| name = Frances Oldham Kelsey
| image = Frances Oldham Kelsey.png
| image_size = 220px
| birth_name=Frances Kathleen Oldham
| birth_date = {{Birth date|1914|07|24}}
| birth_place = [[Cobble Hill, British Columbia|Cobble Hill]], British Columbia, Canada
| death_date = {{Death date and age|2015|8|7|1914|07|24}}
| death_place = [[London, Ontario|London]], Ontario, Canada
| alma_mater = [[Victoria College, British Columbia]]<br>[[McGill University]]<br>[[University of Chicago]]
| known_for = Preventing [[thalidomide]] from being marketed in the United States
| occupation = Pharmacologist, physician
| spouse = Fremont Ellis Kelsey (m. 1943, died 1966)
| children = 2
}}
'''Frances Kathleen Oldham Kelsey''', [[Member of the Order of Canada|CM]] (July 24, 1914 – August 7, 2015) was a Canadian-American<ref name="nyt-2015"/> [[pharmacologist]] and physician. As a reviewer for the U.S. [[Food and Drug Administration]] (FDA), she refused to authorize [[thalidomide]] for market because she had concerns about the drug's safety.<ref name="globe2014"/> Her concerns proved to be justified when it was shown that thalidomide caused serious [[birth defect]]s. Kelsey's career intersected with the passage of laws strengthening FDA oversight of [[pharmaceuticals]]. Kelsey was the second woman to be awarded the [[President's Award for Distinguished Federal Civilian Service]] by President [[John F. Kennedy]].
== Birth and education ==
Born in [[Shawnigan Lake, British Columbia]],<ref name="heirloom"/> Kelsey attended [[St. Margaret's School (Victoria, British Columbia)|St. Margaret's School]] in [[Victoria, British Columbia|the provincial capital]], graduating at age 15.<ref name="fda1"/> From 1930-1931 she attended [[Victoria College, British Columbia|Victoria College]] (now University of Victoria). She then enrolled at [[McGill University]], where she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology,.<ref name="heirloom" /> Encouraged by one of her professors, she "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".<ref name="fda1" /> Geiling, obviously 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.<ref name="name confusion"/>
During her second year, Geiling was retained by the FDA to research unusual deaths related to [[elixir sulfanilamide]], a [[sulfonamide (medicine)|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.<ref name="fda1" /> That same year she completed her studies and received a Ph.D. in pharmacology at the University of Chicago.<ref name="fda1" /> Working with Geiling led to her interest in [[teratogen]]s, drugs that cause [[birth defects|congenital malformations]] (birth defects).<ref name="nih1"/>
== Early career ==
[[Image:Frances O. Kelsey (FDA 171) (8211251003).jpg|thumb|upright|Kelsey in the 1960s]]
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, Oldham learned that some drugs are able to pass through the [[placenta]]l barrier.<ref name="JH mag" /> While at the University of Chicago, she met fellow faculty member Dr. Fremont Ellis Kelsey, whom she married in 1943.<ref name="fda1" />
While on the faculty at the University of Chicago, Kelsey was awarded her M.D. during 1950.<ref name="fda1" /> She supplemented her teaching with work as an editorial associate for the [[American Medical Association]] ''[[JAMA (journal)|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.<ref name="heirloom" />
She became a [[Multiple citizenship|dual citizen]] 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.<ref name="globe2014"/>
== Work at the FDA and thalidomide ==
[[Image:Frances Oldham Kelsey and John F. Kennedy.jpg|thumb|upright|Kelsey received the [[President's Award for Distinguished Federal Civilian Service]] from President [[John F. Kennedy]], 1962]]
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"<ref name="fda1" /> for the FDA. One of her first assignments at the FDA was to review an application by [[Marion Merrell Dow|Richardson Merrell]] for the drug [[thalidomide]] (under the tradename Kevadon) as a tranquilizer 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 more than 20 European and African countries,<ref name="acs"/> she withheld approval for the drug and requested [[clinical trial|further studies]].<ref name="heirloom" /> Despite pressure from [[Grünenthal GmbH|thalidomide's manufacturer]], Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.<ref name="fda1" />
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.<ref name="fda3"/> Researchers discovered that the thalidomide crossed the [[placenta]]l barrier and caused serious [[birth defect]]s.<ref name="JH mag" /> She was hailed on the front page of ''[[The Washington Post]]'' as a heroine<ref name="post"/> for averting a similar tragedy in the U.S.<ref name="nih2"/> [[Morton Mintz]], author of ''The Washington Post'' article, said "[Kelsey] prevented… the birth of hundreds or indeed thousands of armless and legless children."<ref name="post" /> Kelsey insisted that her assistants, Oyam Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Dr. Kelsey's persistence, however, was used to help pass rigorous drug approval regulation in 1962.<ref name="nyt-2015"/>
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.<ref name="fda3" /> 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.
<ref name="CHFArticle">{{citation |title=Frances Oldham Kelsey|url=http://www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/public-and-environmental-health/food-and-drug-safety/kelsey.aspx|publisher=Chemical Heritage Foundation|accessdate=March 23, 2014 |deadurl=yes |archiveurl=https://web.archive.org/web/20160712164719/http://www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/public-and-environmental-health/food-and-drug-safety/kelsey.aspx|archivedate=July 12, 2016}}</ref> The drug testing reforms required "stricter limits on the testing and distribution of new drugs"<ref name="JH mag" /> to avoid similar problems. The amendments, for the first time, also recognized that "effectiveness [should be] required to be established prior to marketing."<ref name="fda3" />
As a result of her blocking American approval of thalidomide, Kelsey was awarded the [[President's Award for Distinguished Federal Civilian Service]] by [[John F. Kennedy]],<ref name="jfk"/> becoming the second woman so honoured.<ref name="nwhf"/> After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 amendments.<ref name="nih2" /> She also became responsible for directing the surveillance of drug testing at the FDA.<ref name="heirloom" />
Kelsey retired from the FDA in 2005, at age 90, after 45 years of service.<ref name="acs" /> In 2010 the FDA established the Kelsey Award, to be awarded annually to an employee.<ref name="post-2010"/>
== Later life and death ==
[[Image:Frances O. Kelsey 2001.png|thumb|upright|Kelsey (age 87) at the FDA Reception commemorating her induction into the National Women's Hall of Fame]]
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 in 1995 and was appointed deputy for scientific and medical affairs. In 1994, the [[Frances Kelsey Secondary School]] in [[Mill Bay, British Columbia]] was named in her honour.<ref name="schoolnamed"/> She retired in 2005.<ref name=Telegraph_obit>{{cite news|title=Frances Kelsey, scientist - obituary|url=https://www.telegraph.co.uk/news/obituaries/11794398/Frances-Kelsey-scientist-obituary.html|accessdate=11 August 2015|publisher=The Telegraph|date=August 11, 2015}}</ref>
In 2010, the FDA presented Kelsey with the first Drug Safety Excellence Award and named the annual award after her,<ref name="nyt-2010"/> announcing that it would be given to one FDA staff member annually.<ref name="FDA-award"/> In announcing the awards, Center Director [[Steven K. Galson]] 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."<ref name="fda2005"/>
Kelsey [[centenarian|turned 100]] in July 2014,<ref name="Centenary"/> and shortly thereafter, in the fall of 2014, she moved from [[Washington, D.C.]], to live with her daughter in [[London, Ontario]].<ref name="G&M-2015-07-01"/> In June 2015, when she was named to the [[Order of Canada]], [[Mercédes Benegbi]], a thalidomide victim and the head of the Thalidomide Victims Association of Canada, praised Dr. 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."<ref name="G&M-2015-07-01"/>
Kelsey died in London, Ontario, on August 7, 2015 at the age of 101,<ref name="post-2015"/> less than 24 hours after Ontario's Lieutenant-Governor, [[Elizabeth Dowdeswell]], visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide.<ref name="G&M-2015-08-07"/>
== Legacy and awards ==
[[File:Frances O. Kelsey (FDA 113) (8205474573).jpg|upright|thumb|The "Drug Detective"]]
* 1962 • [[President's Award for Distinguished Federal Civilian Service]]<ref name="acs" />
* 1963 • Gold Key Award from [[University of Chicago]], [[Pritzker School of Medicine|Medical]] and Biological Sciences Alumni Association<ref name="goldkey"/>
* 2000 • Inducted into the [[National Women's Hall of Fame]]<ref name="nwhf" />
* 2001 • Named a Virtual Mentor for the American Medical Association<ref name="ama"/>
* 2006 • Foremother Award from the [[National Center for Health Research|National Research Center for Women & Families]]<ref name="foremother"/>
* 2010 • Recipient of the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health given out by the FDA<ref>{{cite news| author =| title =FDA honors one of its own| quote =| newspaper =[[CNN]] blog| date =September 16, 2010| url =http://thechart.blogs.cnn.com/2010/09/16/fda-honors-one-of-its-own/| accessdate = August 9, 2015}}</ref>
* 2012 • Honorary doctor of science degree from [[Vancouver Island University]]<ref name="VIU"/>
* 2015 • Named to the [[Order of Canada]]<ref name="G&M-2015-07-01"/>
== See also ==
{{Portal|Pharmacy and Pharmacology|British Columbia}}
* [[European Medicines Agency]]
{{-}}
== References ==
{{Reflist|30em|refs=
<ref name="globe2014">{{citation |url=https://www.theglobeandmail.com/news/national/canadian-doctor-averted-disaster-by-keeping-thalidomide-out-of-the-us/article21721337/ |title= Canadian doctor averted disaster by keeping thalidomide out of the U.S. |first=Ingrid |last=Peritz |publisher=[[The Globe and Mail]] |date=November 24, 2014 |accessdate=August 7, 2015}}.</ref>
<ref name="post-2015">{{citation |url=https://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine-of-thalidomide-tragedy-dies-at-101/2015/08/07/ae57335e-c5da-11df-94e1-c5afa35a9e59_story.html |title=Frances Oldham Kelsey, FDA scientist who kept thalidomide off U.S. market, dies at 101 |first1= Adam |last1=Bernstein |first2=Patricia |last2=Sullivan |date=August 7, 2015 |accessdate=August 7, 2015 |publisher=[[The Washington Post]] }}.</ref>
<ref name="heirloom">{{citation |url=http://epe.lac-bac.gc.ca/100/205/301/ic/cdc/heirloom_series/volume6/218-219.htm |title=Frances Kelsey |work=Canada Heirloom Series |year= 986 |publisher=Heirloom Publishing Inc. |accessdate=August 15, 2009 }}.</ref>
<ref name="fda1">{{citation |url=http://www.fda.gov/fdac/features/2001/201_kelsey.html|first=Linda |last=Bren |date=March–April 2001 |title=Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History |journal=FDA Consumer |accessdate = August 15, 2009 |archiveurl=https://web.archive.org/web/20061020043712/http://www.fda.gov/fdac/features/2001/201_kelsey.html |archivedate=October 20, 2006}}.</ref>
<ref name="name confusion">"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 (2001).</ref>
<ref name="nih1">{{citation |url = http://science-education.nih.gov/nihHTML/ose/snapshots/multimedia/ritn/Thalidomide/index.html |first=Rachel |last=Spiegel |title=Research in the News: Thalidomide |accessdate=August 15, 2009 |archiveurl=https://web.archive.org/web/20070822054139/http://science-education.nih.gov/nihHTML/ose/snapshots/multimedia/ritn/Thalidomide/index.html |archivedate=August 22, 2007}}.</ref>
<ref name="JH mag">{{citation |url=http://www.jhu.edu/~jhumag/0901web/pregnant.html |last=Simpson |first=Joanne Cavanaugh |date=September 2001 |title=Pregnant Pause |journal=Johns Hopkins Magazine |volume=53 |issue=4 |accessdate=April 30, 2006}}.</ref>
<ref name="acs">{{citation |url = http://pubs.acs.org/cen/coverstory/83/8325/8325thalidomide.html |first=Maureen |last=Rouhi |date=June 20, 2005 |title=Top Pharmaceuticals: Thalidomide |journal=Chemical & Engineering News |publisher=American Chemical Society |volume=83 |issue=25 |accessdate=April 30, 2006}}.</ref>
<ref name="fda3">{{citation |url = http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm |date=June 1981 |title=The Story Of The Laws Behind The Labels |journal=FDA Consumer |accessdate=August 15, 2009}}.</ref>
<ref name="post">{{citation |first=Morton |last=Mintz |title='Heroine' of FDA Keeps Bad Drug Off of Market |publisher=[[The Washington Post]] |page=Front Page |date=July 15, 1962}}. See also [http://www.niemanwatchdog.org/index.cfm?fuseaction=showcase.view&showcaseid=13 Mintz's comments from 2005] on Kelsey.</ref>
<ref name="nih2">{{citation |url=https://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.html |publisher=National Library of Medicine |title=Dr. Frances Kathleen Oldham Kelsey |accessdate=April 30, 2006}}.</ref>
<ref name="jfk">{{citation |url=http://www.presidency.ucsb.edu/ws/index.php?pid=8807 |last=Kennedy |first=John F. |authorlink=John F. Kennedy |year=1962 |title=Remarks Upon Presenting the President's Awards for Distinguished Federal Civilian Service |accessdate = May 1, 2006}}.</ref>
<ref name="nwhf">{{citation |url=http://www.greatwomen.org/women.php?action=viewone&id=93 |title=Women of the Hall – Frances Kathleen Oldham Kelsey, Ph.D., M.D. |publisher=National Women's Hall of Fame |year=2000 |accessdate=May 1, 2006 }}.</ref>
<ref name="post-2010">{{citation |url=https://www.washingtonpost.com/wp-dyn/content/article/2010/09/13/AR2010091306279.html| title=Physician to be honored for historic decision on thalidomide| work=The Washington Post| author= Lyndsey Layton| date=September 13, 2010 }}.</ref>
<ref name="goldkey">{{citation |title=Gold Key Award Recipients |url=http://bsdalumni.uchicago.edu/volunteer/goldkey.shtml |publisher=The University of Chicago The Medical & Biological Sciences Alumni Association |accessdate=August 14, 2006 }}.</ref>
<ref name="schoolnamed">{{citation |url=http://www.fkss.ca/mod/page/view.php?id=553 |archive-url=https://web.archive.org/web/20121019215202/http://www.fkss.ca/mod/page/view.php?id=553 |dead-url=yes |archive-date=October 19, 2012 |publisher=Frances Kelsey Secondary School |title=FKSS History |accessdate=December 26, 2014 }}.</ref>
<ref name="ama">{{citation |url=http://www.ama-assn.org/ama/pub/category/5335.html |last=Geraghty |first=Karen |date=July 2001 |title=Profile of a Role Model – Frances Oldham Kelsey, MD, PhD |journal=Virtual Mentor – American Medical Association Journal of Ethics |volume=7 |issue=7 |accessdate=August 15, 2009 |archiveurl=https://web.archive.org/web/20070929133432/http://www.ama-assn.org/ama/pub/category/5335.html |archivedate=September 29, 2007}}.</ref>
<ref name="foremother">{{citation |url=http://www.center4research.org/news-events/previous-foremother-awards/ |title=2006 Foremothers Awards Luncheon |accessdate=August 15, 2009 |publisher=National Research Center for Women & Families |deadurl=yes |archiveurl=https://web.archive.org/web/20110514041902/http://www.center4research.org/news-events/previous-foremother-awards/ |archivedate=May 14, 2011 |df=mdy-all }}.</ref>
<ref name="FDA-award">{{citation |url=http://www.fda.gov/NewsEvents/Speeches/ucm226349.htm |title=Margaret A. Hamburg, M.D., Commissioner of Food and Drugs – Remarks at the Award Ceremony for Dr. Frances Kelsey}}.</ref>
<ref name="fda2005">{{citation |url=http://www.fda.gov/cder/pike/Nov2005awards.htm |last=Barber |first=Jackie |title=Center ceremony honors 107 individuals, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award |journal=News Along the Pike |publisher=FDA/Center for Drug Evaluation and Research |date=November 10, 2005 |accessdate=August 15, 2009 |archiveurl = https://web.archive.org/web/20070615102054/http://www.fda.gov/cder/pike/Nov2005awards.htm |archivedate=June 15, 2007}}.</ref>
<ref name="nyt-2010">{{citation |url=https://www.nytimes.com/2010/09/14/health/14kelsey.html?_r=1 |title=The Public's Quiet Savior From Harmful Medicines |first=Gardiner |last=Harris |newspaper=[[The New York Times]] |date=September 13, 2010 |accessdate=January 4, 2011}}.</ref>
<ref name="VIU">{{citation |url=http://www.nanaimobulletin.com/news/157349815.html |title=Honorary doctor of science degree from Vancouver Island University |work=Nanaimo News Bulletin |publisher=Black Press, Inc. }}.</ref>
<ref name="Centenary">{{citation |url = http://globalnews.ca/news/1470760/canadian-scientist-frances-kelsey-who-spurred-fda-reforms-turns-100/ |last=McElroy |first=Justin |title=Canadian scientist Frances Kelsey, who spurred FDA reforms, turns 100 |publisher=[[Global News]] |date=July 24, 2014 |accessdate=July 24, 2014}}.</ref>
<ref name="G&M-2015-07-01">{{citation |url=https://www.theglobeandmail.com/news/national/doctor-who-opposed-thalidomide-in-us-named-to-order-of-canada/article25213185/ |title=Doctor who opposed thalidomide in U.S. named to Order of Canada |newspaper=[[The Globe and Mail]] |author=Ingrid Peritz |date=July 1, 2015 |accessdate=July 1, 2015}}.</ref>
<ref name="G&M-2015-08-07">{{citation |url=https://www.theglobeandmail.com/news/national/canadian-doctor-who-kept-thalidomide-out-of-us-dies/article25873611/ |title=Canadian doctor who kept thalidomide out of U.S. dies |newspaper=[[The Globe and Mail]] |author=Ingrid Peritz |date=August 7, 2015 |accessdate=August 7, 2015}}.</ref>
<ref name="nyt-2015">{{citation |last=McFadden |first=Robert |title=Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101 |publisher=[[The New York Times]] |url=https://www.nytimes.com/2015/08/08/science/frances-oldham-kelsey-fda-doctor-who-exposed-danger-of-thalidomide-dies-at-101.html?_r=0 |date=August 7, 2015 }}.</ref>
}}
== Further reading ==
{{commons category|Frances Oldham Kelsey}}
* {{citation |last=Bren |first=Linda |url=http://www.fda.gov/fdac/features/2001/201_kelsey.html |date=March–April 2001 |title=Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History |journal=FDA Consumer |accessdate = August 15, 2009 |archiveurl=https://web.archive.org/web/20061020043712/http://www.fda.gov/fdac/features/2001/201_kelsey.html |archivedate=October 20, 2006}}
* {{citation |last=Harris |first=Gardiner |url=https://www.nytimes.com/2010/09/14/health/14kelsey.html?_r=1 |title=The Public's Quiet Savior From Harmful Medicines |publisher=[[The New York Times]] |date=September 13, 2010 }}.
* {{citation |last=Harris |first=Steven B. |date=1992 |url=http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html |archive-url=https://web.archive.org/web/20010420025145/http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html |dead-url=yes |archive-date=2001-04-20 |title=The Right Lesson to Learn from Thalidomide }}.
* {{citation |last=Kelsey |first=Frances O. |date=1993 |url=http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/OralHistories/SelectedOralHistoryTranscripts/UCM406132.pdf |title=Autobiographical Reflections }}. 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.
* {{citation |last=Mintz |first=Morton |date=1965 |title=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. |location=Boston |publisher=Houghton Mifflin |lccn=65015156 }}. [http://catalog2.loc.gov/cgi-bin/Pwebrecon.cgi?v1=1&hd=1,1&CallBrowse=1&SEQ=20150807185722&PID=XSnYgHfncowAhApfdhreYim5&SID=3 Library of Congress catalog entry].
* {{citation |last=McFadyen |first=R. E. |date=1976 |title=Thalidomide in America: A Brush With Tragedy |journal=Clio Medica |volume=11 |issue=2 |pages=79–93}}.
* {{citation |last=Mulliken |first=J. |date=August 10, 1962 |title=A Woman Doctor Who Would Not be Hurried |journal=[[Life Magazine]] |volume=53 |pages=28–9 |lccn=37008367}}.
* {{citation |last=Perri III |first=Anthony J. |author2=Hsu MD, Sylvia |title=A review of thalidomide's history and current dermatological applications |url=http://dermatology.cdlib.org/93/reviews/thalidomide/hsu.html |journal=Dermatology Online Journal |pages=5 |accessdate=August 14, 2006 |volume=9| issue = 3}}.
* {{citation |last=Seidman |first=Lisa A. |author2=Warren, Noreen |title=Frances Kelsey & Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations |journal=The American Biology Teacher |date=September 2002 |doi=10.1662/0002-7685(2002)064[0495:FKTITU]2.0.CO;2 |volume=64 |pages=495 |id=7 |issue=7 }}.
* {{citation |last=Stamato |first=Linda |work=NJ Voices |url=http://blog.nj.com/njv_linda_stamato/2012/12/thalidomide_after_fifty_years.html |title=Thalidomide, after fifty years: A tribute to Frances Oldham Kelsey and a call for thorough, responsible federal drug regulation and oversight |publisher=NJ.com |date=December 17, 2012}}.
{{National Women's Hall of Fame}}
{{Authority control}}
{{Good article}}
{{DEFAULTSORT:Kelsey, Frances Oldham}}
[[Category:1914 births]]
[[Category:2015 deaths]]
[[Category:American civil servants]]
[[Category:American centenarians]]
[[Category:American pharmacologists]]
[[Category:Canadian centenarians]]
[[Category:Canadian emigrants to the United States]]
[[Category:Canadian pharmacologists]]
[[Category:Women pharmacologists]]
[[Category:20th-century Canadian physicians]]
[[Category:20th-century American physicians]]
[[Category:American women physicians]]
[[Category:Canadian women physicians]]
[[Category:Food and Drug Administration people]]
[[Category:McGill University alumni]]
[[Category:Members of the Order of Canada]]
[[Category:People from the Cowichan Valley Regional District]]
[[Category:University of Chicago alumni]]
[[Category:University of Chicago faculty]]
[[Category:University of South Dakota faculty]]
[[Category:Victoria College, British Columbia alumni]]
[[Category:20th-century women physicians]]
[[Category:Women centenarians]]' |
Whether or not the change was made through a Tor exit node (tor_exit_node ) | false |
Unix timestamp of change (timestamp ) | 1548541032 |