View source for Frances Oldham Kelsey

{{Infobox person
  | name        = Frances Oldham Kelsey
  | image       = Kelsey02.png
  | image_size  = 180px
  | birth_date  = {{Birth date and age|1914|07|24}}
  | birth_place = [[Cobble Hill, British Columbia]]
  | known_for   = preventing [[thalidomide]] from coming to market in the United States
  | occupation  = Physician, FDA
  | spouse      = Fremont Ellis Kelsey
}}
'''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 defect]]s. 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 Hill, British Columbia|Cobble Hill]] on [[Vancouver Island]], [[British Columbia]],<ref name="heirloom">Heirloom.</ref> Kelsey graduated from high school at age 15,<ref name="fda1">Bren.</ref> and enrolled at [[McGill University]] to study pharmacology. At McGill she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology,<ref name="heirloom" /> and "on [a] professor's urging, wrote to [[Eugene Maximilian Karl Geiling|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 assumed that Frances was a man, but Frances accepted the position rather than clarifying her gender first,<ref name="name confusion"
>Bren says, "When Kelsey read Geiling's letter offering her a research assistantship and scholarship in the PhD program at Chicago, she was delighted. But there was one slight problem--one that 'tweaked her conscience a bit.' The letter began 'Dear Mr. Oldham,' Oldham being her maiden name. Kelsey asked her professor at McGill if she should wire back and explain that Frances with an 'e' is female. 'Don't be ridiculous,' he said. 'Accept the job, sign your name, put 'Miss' in brackets afterwards, and go!' " Bren (2006).
</ref> and began working for Geiling in 1936. During her second year, Geiling was retained by the FDA to research [[Elixir Sulfanilamide disaster|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 Kelsey successfully completed her studies and received a Ph.D. in pharmacology at the [[University of Chicago]] in 1938.<ref name="fda1" /> Kelsey's work for Geiling is credited with her interest in [[teratogen]]s &mdash; that is, drugs that cause [[birth defects|congenital malformations]].<ref name="nih1">Spiegel.</ref>

== Early career and marriage ==
Upon completing her Ph.D., Kelsey joined the University of Chicago faculty. In 1942, like many other pharmacologists, Kelsey was looking for a synthetic cure for [[malaria]]. As a result of these studies, Kelsey learned that some drugs are able to pass through the [[placenta]]l barrier.<ref name="JH mag">Simpson.</ref> While there she also 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 received an M.D.<ref name="fda1" /> 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.<ref name="heirloom" />

== Work at the FDA and thalidomide ==
[[Image:Kelsey 01.jpg|thumb|1962: Frances Kathleen Oldham Kelsey receiving the President's Award for Distinguished Federal Civilian Service from President [[John F. Kennedy]]]]
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"<ref name="fda1" /> for the FDA.  One of her first assignments at the FDA, was to review application by [[Marion Merrell Dow|Richardson Merrell]] for the drug [[thalidomide]] (under the tradename Kevadon)  as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and over 20 European and African countries,<ref name="acs">Rouhi.</ref> she withheld approval for the drug, and requested [[clinical trial|further studies]].<ref name="heirloom" /> Despite pressure from 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 dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.<ref name="fda3">FDA Consumer.</ref>
Researchers discovered that the thalidomide crossed the [[placenta]]l barrier and caused serious [[birth defect]]s in infants.<ref name="JH mag" /> She was hailed on the front page of ''[[The Washington Post]]'' as a heroine<ref name="post">Mintz. See also [http://www.niemanwatchdog.org/index.cfm?fuseaction=showcase.view&showcaseid=13 Mintz's comments from 2005] on Kelsey.</ref> for averting a similar tragedy in the US.<ref name="nih2">Library of Medicine biography.</ref> [[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" /> The public outcry was swift and [[Kefauver Harris Amendment|drug testing reforms]] were passed unanimously by Congress a few months later.<ref name="fda3" /> 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 also, for the first time, 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 President [[John F. Kennedy]],<ref name="jfk">Kennedy.</ref> becoming the second woman to receive that award.<ref name="nwhf">Hall of Fame.</ref>

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 finally retired from the FDA in 2005, at age 90, after 45 years of service.<ref name="acs" />

In 2010, the FDA named the Kelsey Award for her, to be awarded to an FDA employee.<ref>{{cite news| url=http://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>

== Legacy and awards ==
[[Image:Frances O. Kelsey 2005.PNG|200px|thumb|left|Dr. Kelsey (age 87) at the FDA Reception commemorating her induction into the National Women's Hall of Fame]]
In 2005, the FDA honored Kelsey by naming one of their annual awards after her. In announcing the awards, Center Director [[Steven K. Galson]], M.D., MPH, said “I am very pleased to have established the Dr. Frances O. Kelsey Drug Safety Excellence Award and to recognize the first recipients for their outstanding accomplishments in this important aspect of drug regulation.”<ref name=fda2005>Barber.</ref>

*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>{{cite web |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=2006-08-14 }}</ref>
*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">Geraghty.</ref>
*2006 • Foremother Award from the NRC for Women & Families <ref>{{cite web|url=http://www.center4research.org/news-events/previous-foremother-awards/|title=2006 Foremothers Awards Luncheon|accessdate=2009-08-15|publisher=National Research Center for Women & Families}}</ref>

The [[Frances Kelsey Secondary School]] in [[Mill Bay, British Columbia]] is named in her honour.<ref>{{cite web|url=http://www.fkss.ca/Dr_Kelsey/KelseyArt.html|publisher=Frances Kelsey Secondary School|title=Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History|accessdate=2009-08-15|first=Linda|last=Bren}}</ref>

Asteroid [[6260 Kelsey]] is named in her honour.<ref>{{cite web|url=http://www.rasc.ca/education/asteroids.shtml
|publisher=Royal Astronomical Society of Canada|title=Asteroids with Canadian Connections|accessdate=2010-04-27}}</ref>

<br clear="all"/>

==See also==
{{Portal|Pharmacy and Pharmacology}}
* [[European Medicines Agency]]
* [[Kefauver Harris Amendment]]

== Footnotes ==
{{Reflist|2}}

==References==
*{{cite journal
 | last = Barber
 | first = Jackie
 | title = Center ceremony honors 107 individuals, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award
 | url = http://web.archive.org/web/20070615102054/http://www.fda.gov/cder/pike/Nov2005awards.htm
 | journal = News Along the Pike
 | publisher = FDA/Center for Drug Evaluation and Research
 | date = 2005-11-10
 | accessdate = 2009-08-15
}}
*{{cite journal
 | first = Linda
 | last = Bren
 | year = 2001
 | month = March/April
 | title = '''Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History'''
 | journal = FDA Consumer
 | url = http://web.archive.org/web/20061020043712/http://www.fda.gov/fdac/features/2001/201_kelsey.html
 | accessdate = 2009-08-15
}}
*{{cite web
 | last = ---
 | url = http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.html
 | publisher = National Library of Medicine
 | title = Dr. Frances Kathleen Oldham Kelsey
 | accessdate = 2006-04-30
}} ''Cited as "Library of Medicine biography".
*{{cite web
 | last = ---
 | title = Frances Kelsey
 | work = Canada Heirloom Series
 | year = 1986
 | url = http://epe.lac-bac.gc.ca/100/205/301/ic/cdc/heirloom_series/volume6/218-219.htm
 | publisher = Heirloom Publishing Inc.
 | accessdate = 2009-08-15
}} ''Cited as "Heirloom".
*{{cite journal
 | last = Geraghty
 | first = Karen
 | year = 2001
 | month = July
 | title = '''Profile of a Role Model - Frances Oldham Kelsey, MD, PhD'''
 | journal = Virtual Mentor - American Medical Association Journal of Ethics
 | volume = 7
 | issue = 7
 | url = http://web.archive.org/web/20070929133432/http://www.ama-assn.org/ama/pub/category/5335.html
 | accessdate = 2009-08-15
 }}
*{{cite web
 | last = Kennedy
 | first = John F.
 | authorlink = John F. Kennedy
 | year = 1962
 | url = http://www.presidency.ucsb.edu/ws/index.php?pid=8807
 | title = Remarks Upon Presenting the President's Awards for Distinguished Federal Civilian Service
 | accessdate = 2006-05-01
}}
*{{cite news
 |first= Morton
 |last= Mintz
 |title= 'Heroine' of FDA Keeps Bad Drug Off of Market
 |publisher= The Washington Post
 |page= Front Page
 |date= 1962-07-15
}}
*{{cite journal
 | first = Maureen
 | last = Rouhi
 | date = 2005-06-20
 | title = '''Top Pharmaceuticals: Thalidomide'''
 | journal = Chemical & Engineering News
 | publisher = American Chemical Society
 | volume = 83
 | issue = 25
 | url = http://pubs.acs.org/cen/coverstory/83/8325/8325thalidomide.html
 | accessdate = 2006-04-30
}}
*{{cite journal
 | last = Simpson
 | first = Joanne Cavanaugh
 | year = 2001
 | month = September
 | title = '''Pregnant Pause'''
 | journal = Johns Hopkins Magazine
 | volume = 53
 | issue = 4
 | url = http://www.jhu.edu/~jhumag/0901web/pregnant.html
 | accessdate = 2006-04-30
}}
*{{cite web
 | first = Rachel
 | last = Spiegel
 | url = http://web.archive.org/web/20070822054139/http://science-education.nih.gov/nihHTML/ose/snapshots/multimedia/ritn/Thalidomide/index.html
 | title = Research in the News: Thalidomide
 | accessdate = 2009-08-15
}}
*{{cite journal
 | last = ---
 | year = 1981
 | month = June
 | title = '''The Story Of The Laws Behind The Labels'''
 | journal = FDA Consumer
 | url = http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm
 | accessdate = 2009-08-15
}} ''Cited as "FDA Consumer".
*{{cite web
 | last = ---
 | year = 2000
 | 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
 | accessdate = 2006-05-01
}} ''Cited as "Hall of Fame".

== Further reading ==
* Harris, Steven B. 1992. [http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html 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.[http://catalog.loc.gov/cgi-bin/Pwebrecon.cgi?Search_Arg=HD9666.6+.M55&Search_Code=CALL_&PID=3698 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
* {{cite journal |last=Perri III |first=Anthony J |coauthor=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 |pp=5 |accessdate=2006-08-14 |volume=9| issue = =3}}
* {{cite journal |last=Seidman |first=Lisa A. |coauthor=Warren, Noreen |title=Frances Kelsey & Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations |journal=The American Biology Teacher |vol=64 |date=September 2002 |doi=10.1662/0002-7685(2002)064[0495:FKTITU]2.0.CO;2 |pp495=500 |volume=64 |pages=495 |year=2002 |ID=7 }}
*{{cite web| url=http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.html| title=Dr. Frances Kathleen Oldham Kelsey| publisher=National Library of Medicine| accessdate=September 14, 2010 }}

{{Good article}}

{{persondata
 | NAME              = Kelsey, Frances Oldham
 | ALTERNATIVE NAMES = Oldham, Frances
 | SHORT DESCRIPTION = FDA examiner who prevented [[thalidomide]] from coming to market in the United States
 | DATE OF BIRTH     = 1914-06-24
 | PLACE OF BIRTH    = [[Cobble Hill, British Columbia|Cobble Hill]], [[British Columbia]], [[Canada]]
 | DATE OF DEATH     =
 | PLACE OF DEATH    =
}}
{{DEFAULTSORT:Kelsey, Frances Oldham}}
[[Category:1914 births]]
[[Category:Food and Drug Administration]]
[[Category:Living people]]
[[Category:McGill University alumni]]
[[Category:People from the Cowichan Valley Regional District]]
[[Category:Canadian pharmacologists]]
[[Category:University of Chicago alumni]]

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