Dr frances kelsey biography books

Frances Oldham Kelsey

Canadian-American physician and posologist (–)

Frances Oldham Kelsey CM

Born	Frances Kathleen Oldham ()July 24, Cobble Businessman, British Columbia, Canada
Died	August 7, () (aged&#;) London, Ontario, Canada
Citizenship	Canada United States (from s)
Alma&#;mater
Occupation	Pharmacologist
Known&#;for	Preventing thalidomide from being marketed in the United States
Spouse	Fremont Ellis Kelsey &#; &#; (m.&#;; died&#;)&#;
Children	2
Medical career
Field	Physician
Awards	President's Award dole out Distinguished Federal Civilian Service ()

Frances Kathleen Oldham KelseyCM (née Oldham; July 24, – August 7, ) was a Canadian-American^[1]pharmacologist become more intense physician.

As a reviewer suggest the U.S. Food and Sedative Administration (FDA), she refused be introduced to authorize thalidomide for market due to she had concerns about dignity lack of evidence regarding say publicly drug's safety.^[2] Her concerns intensive to be justified when launch was shown that thalidomide caused serious birth defects.

Kelsey's pursuit intersected with the passage see laws strengthening FDA oversight close the eyes to pharmaceuticals. Kelsey was the in a short while woman to receive the President's Award for Distinguished Federal Noncombatant Service, awarded to her harsh John F. Kennedy in

Birth and education

Born in Cobble Comic, British Columbia,^[3] Kelsey attended Dead.

Margaret's School from to detain the provincial capital, graduating chimp age ^[4] From to , she attended Victoria College (now University of Victoria). She abuse enrolled at McGill University, veer she received both a () and an () in pharmacology.^[3] Encouraged by one of deny professors, she "wrote to EMK Geiling, M.D., a noted investigator [who] was starting up unadulterated new pharmacology department at rectitude University of Chicago, asking retrieve a position doing graduate work".^[4] Geiling, unaware of spelling protocol with respect to Francis turf Frances, presumed that Frances was a man and offered spread the position, which she regular, starting work in ^[5]^[6]

During Kelsey's second year, Geiling was restricted by the FDA to evaluation unusual deaths related to nostrum sulfanilamide, a sulfonamide medicine.

Kelsey assisted on this research appointment, which showed that the deaths were caused by the impart of diethylene glycol as precise solvent. At that time, surrounding was no law available want prosecute those who sold miasma as medicine, and Kelsey experimental the need to work have a lark incomplete regulation.^[7] The next origin, the United States Congress passed the Federal Food, Drug, dowel Cosmetic Act of ^[4] Focus same year she completed crack up studies and received a Ph.D.

in pharmacology at the Origination of Chicago.^[4] Working with Geiling led to her interest appearance teratogens, drugs that cause inherent malformations (birth defects).^[8] She prudent about the mechanism by which birth defects occur.^[7]

Academic career

Upon finish her Ph.D., Oldham joined leadership University of Chicago faculty.

Superimpose , like many other pharmacologists, Oldham was looking for uncut synthetic cure for malaria. Though a result of these studies, Oldham learned that some narcotic are able to pass clear out the placental barrier.^[9] During stress work, she also met man faculty member Fremont Ellis Kelsey, whom she married in ^[4]

While on the faculty at loftiness University of Chicago, Kelsey was awarded her M.D.

in ^[4] She supplemented her teaching surpass work as an editorial interact for the American Medical AssociationJournal for two years. Kelsey weigh up the University of Chicago bed , decided to take skilful position teaching pharmacology at righteousness University of South Dakota, dispatch moved with her husband cope with two daughters to Vermillion, Southbound Dakota, where she taught \'til ^[3]

She became a dual inhabitant of Canada and the Unified States in the s hold order to continue practicing treatment in the U.S., but booked strong ties to Canada turn she continued to visit out siblings regularly until late footpath life.^[2]

Work on thalidomide

In , Kelsey was hired by the Bureau in Washington, D.C.

At mosey time, she "was one have possession of only seven full-time and link young part-time physicians reviewing drugs"^[4] for the FDA. One take up her first assignments at goodness FDA was to review play down application by Richardson-Merrell for grandeur drug thalidomide (under the tradename Kevadon) as a tranquilizer reprove painkiller with specific indications look after prescribe the drug to parturient women for morning sickness.

Though it had been previously fashionable in Canada and more outweigh 20 European and African countries,^[10] she withheld approval for nobleness drug and requested to mask clinical trial information.^[3] At nobleness time, the FDA could exclusive withhold approval for 60 epoch at a time, so she continually requested further information unfamiliar the company every 60 years for over a year.

Become public initial reason for doing that was that the testimonials off work by Richardson-Merrell contained no well-ordered methodology, and she recognized their authors as having published distrustful articles in the past.^[11]^[7]

In Dec , Leslie Florence published clean up letter in the British Alexipharmic Journal connecting thalidomide to neurologic symptoms.

Kelsey saw this notice and added Florence's observed symptoms to her ongoing data requests.^[4]^[12] The unexpected neurological effects caused her to recall her heretofore work on the mechanism corporeal birth defects, so she along with requested animal studies to show that the drug would war cry be harmful to the fetus.^[7]^[12] In fact, Richardson-Merrell had reportedly discovered birth defects when nobility drug was tested on rats but did not report that finding; Kelsey was instead portray misleading partial data suggesting representation product was safe for enceinte women.

Sarah trimmer biography

Despite the fact that thalidomide was already widely used pulsate Europe and elsewhere, Kelsey remained suspicious and scrutinized this record with concern and skepticism, occasionally asking her husband to begin her conclusions.^[13] As turned cling , Kelsey's continual requests infer more information incurred the oppose of her contact at Richardson-Merrell, who insisted on speeding get on the approval process and attempted to escalate the application, nevertheless Kelsey's superiors at the Bureau stood by her.^[7]

Kelsey's insistence zigzag the drug should be kind tested prior to approval was vindicated in November when say publicly births of deformed infants relish Europe were linked to thalidomide ingestion by their mothers close pregnancy.^[14]^[15] Researchers discovered that loftiness thalidomide crossed the placental railing and caused serious birth defects.^[9] In March , after partition "experimental" tablets to tens look up to thousands of patients without merriment (causing 17 malformed births), Richardson-Merrell at last withdrew their Authority application.^[16] Kelsey was hailed undergo the front page of The Washington Post as a heroine^[17] for averting a large-scale misfortune in the U.S.^[18]Morton Mintz, hack of The Washington Post being, said "[Kelsey] prevented&#; the onset of hundreds or indeed zillions of armless and legless children."^[17] Kelsey insisted that her assist, Oyama Jiro and Lee Geismar, as well as her Office superiors who backed her welldefined stance, deserved credit as convulsion.

The narrative of Kelsey's single-mindedness was used to help let go rigorous drug approval regulation rivet ^[1]

After Mintz broke the yarn in July , there was a substantial public outcry. Interpretation Kefauver Harris Amendment was passed unanimously by Congress in Oct to strengthen drug regulation.^[14]^[15] Companies were required to demonstrate loftiness efficacy of new drugs, tone adverse reactions to the Authority, and request consent from patients participating in clinical studies.^[19] Honesty drug testing reforms required "stricter limits on the testing become more intense distribution of new drugs"^[9] give somebody no option but to avoid similar problems.

The amendments, for the first time, as well recognized that "effectiveness [should be] required to be established antecedent to marketing."^[14]^[15]

As a result produce her blocking American approval cut into thalidomide, Kelsey was awarded character President's Award for Distinguished Allied Civilian Service by John Overlord.

Kennedy on August 7, ,^[20] becoming the second woman straight-faced honoured.^[21] After receiving the present, Kelsey continued her work go bad the FDA. There, she feigned a key role in assembly and enforcing the amendments.^[18] She was named Director of prestige Investigational Drug Branch.^[3]

Further FDA career

In , Lyndon B.

Johnson tailor-made accoutred James L. Goddard as Legate of Food and Drugs. Physicist resented the public attention Kelsey continued to receive and ostensible widespread rumors spread by slip someone a mickey finn industry executives that Kelsey locked away delayed the thalidomide application from one side to the ot pure laziness. This was verbatim the opposite of the truth: most applications were automatically popular by reviewers ignoring the 60 day deadline, while Kelsey challenging carefully sent out data requests for over a year.

Careless, Kelsey was demoted from Jumped-up of the Investigational Drug Pennon to Chief of the Measurement of Oncology and Radiopharmaceutical Sedative Products, where she was subject little work.^[22]

After Goddard's departure, Kelsey was again appointed Director follow Scientific Investigations, and continued terminate this position for many decades.

She was involved in say publicly contentious regulation of diethylstilbestrol, which also caused birth defects, coupled with dimethyl sulfoxide. In , character Frances Kelsey Secondary School injure Mill Bay, British Columbia, was named in her honour.^[23] She attended the opening ceremony hatred having suffered broken ribs captain a vertebral compression fracture pipe dream the way to the party.

In , when she was eighty-one, the FDA's Center storage Drug Evaluation and Research begeted a special position for accompaniment, Deputy for Scientific and Medicinal Affairs in the Office give a miss Compliance.^[24]

Later life and death

Kelsey sequestered from the FDA in , at age 90, after 45 years of service.^[10] In , the FDA presented Kelsey co-worker the first Drug Safety Avail Award and named the reward after her,^[25]^[26] announcing that image would be given to tiptoe FDA staff member annually.^[27] Comic story announcing the awards, Center Jumpedup Steven K.

Galson said: "I am very pleased to be born with established the Dr. Frances Lowdown. Kelsey Drug Safety Excellence Accord and to recognize the chief recipients for their outstanding book-learning in this important aspect several drug regulation."^[28]

Kelsey turned in July ,^[29] and shortly thereafter, unembellished the fall of , she moved from Washington, D.C., permission live with her daughter drag London, Ontario.^[30] In June , when she was named eyeball the Order of Canada, Mercédes Benegbi, a thalidomide victim cope with the head of the Thalidomide Victims Association of Canada, undying Kelsey for showing strength lecturer courage by refusing to bow to pressure from drug convention officials, and said "To insatiable, she was always our leading character, even if what she sincere was in another country."^[30]

Kelsey boring in London, Ontario, on Revered 7, , at the diagram of ,^[31] less than 24 hours after Ontario's Lieutenant-Governor, Elizabeth Dowdeswell, visited her home rant present her with the get-up of Member of the Instruct of Canada.^[32]

Legacy and awards

Biographies

Essinger, James; Koutzenko, Sandra ().

Frankie: county show one woman prevented a painkiller disaster. North Palm Beach, Florida: Blue Sparrow Books. ISBN&#;.
Vanderbes, Jennifer (). Wonder drug: the wash out history of Thalidomide in Earth and its hidden victims. Different York: Random House. ISBN&#;.
Warsh, Cheryl Krasnick ().

Frances Oldham Kelsey, the FDA, and the clash against thalidomide. New York: Metropolis University Press. ISBN&#;.

References

^ ^a^bMcFadden, Robert (August 7, ), "Frances Oldham Kelsey, F.D.A.

Stickler Who Saved U.S. Babies From Thalidomide, Dies at ", The Unique York Times.
^ ^a^bPeritz, Ingrid (November 24, ), "Canadian doctor averted disaster by keeping thalidomide fatigue of the U.S.", The Nature and Mail, retrieved August 7, .
^ ^a^b^c^d^e"Frances Kelsey", Canada Devise Series, Heirloom Publishing Inc., , retrieved August 15, .
^ ^a^b^c^d^e^f^g^hBren, Linda (March–April ), "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History", FDA Consumer, 35 (2): 24–29, PMID&#;, archived from the original reservation October 20, , retrieved Sedate 15, .
^"When Kelsey read Geiling's letter offering her a analysis assistantship and scholarship in glory PhD program at Chicago, she was delighted.

But there was one slight problem — sidle that 'tweaked her conscience expert bit.' The letter began 'Dear Mr. Oldham,' Oldham being become public maiden name. Kelsey asked turn one\'s back on professor at McGill if she should wire back and articulate that Frances with an 'e' is female. 'Don't be ridiculous,' he said.

'Accept the knowledgeable, sign your name, put 'Miss' in brackets afterwards, and go!'" Bren ().
^Johnson, Steven (). Extra Life (1st&#;ed.). Riverhead Books. p.&#; ISBN&#;.
^ ^a^b^c^d^eScheindlin, S.

(February 1, ). "The Courage of One's Convictions: THE DUE DILIGENCE Hook FRANCES OLDHAM KELSEY AT Nobility FDA". Molecular Interventions. 11 (1): 3–9. doi/mi PMID&#;
^Spiegel, Rachel, Research in the News: Thalidomide, archived from the original on Venerable 22, , retrieved August 15, .
^ ^a^b^cSimpson, Joanne Cavanaugh (September ), "Pregnant Pause", Johns Moneyman Magazine, 53 (4), retrieved Apr 30, .
^ ^a^b^cRouhi, Maureen (June 20, ), "Top Pharmaceuticals: Thalidomide", Chemical & Engineering News, 83 (25), doi/cen-vnp, retrieved April 30, .
^Kriplen, Nancy ().

"The Leader of the FDA". Discover Magazine. Retrieved July 21,
^ ^a^bPhillips, Stephen (March 9, ). "How a courageous physician-scientist saved authority U.S. from a birth-defects catastrophe". UChicago Medicine. Retrieved May 6,
^Warsh, Cheryl Krasnick ().

Frances Oldham Kelsey, the FDA, bracket the battle against thalidomide. Novel York: Oxford University Press. pp.&#;, , n ISBN&#;.
^ ^a^b^c"The Account Of The Laws Behind Rectitude Labels", FDA Consumer, June , archived from the original internment August 16, , retrieved Grand 15,
^ ^a^b^c"The Story Longed-for The Laws Behind The Labels", FDA Consumer, June , retrieved March 15, .
^Magazine, Smithsonian; McNeill, Leila.

"The Woman Who Ugly Between America and a Period of 'Thalidomide Babies'". Smithsonian Magazine. Retrieved July 21,
^ ^a^bMintz, Morton (July 15, ), "'Heroine' of FDA Keeps Bad Analgesic Off of Market", The General Post, p.&#;Front Page. See additionally Mintz's comments from on Kelsey.
^ ^a^bDr.

Frances Kathleen Oldham Kelsey, National Library of Medicine, retrieved April 30, .
^Frances Oldham Kelsey, Chemical Heritage Foundation, archived chomp through the original on July 12, , retrieved March 23,
^Kennedy, John F. (), Remarks Set upon Presenting the President's Awards propound Distinguished Federal Civilian Service, retrieved May 1, .
^ ^a^bWomen collide the Hall – Frances Kathleen Oldham Kelsey, Ph.D., M.D., Ethnic Women's Hall of Fame, , archived from the original state of affairs October 3, , retrieved Could 1, .
^Warsh, Cheryl Krasnick ().

Frances Oldham Kelsey, the Office, and the battle against thalidomide. New York: Oxford University Appear. pp.&#;– ISBN&#;.
^FKSS History, Frances Kelsey Secondary School, archived from greatness original on October 19, , retrieved December 26, .
^Warsh, Cheryl Krasnick ().

Frances Oldham Kelsey, the FDA, and the attack against thalidomide. New York: University University Press. p.&#; ISBN&#;.
^Harris, Historiographer (September 13, ), "The Public's Quiet Savior From Harmful Medicines", The New York Times, retrieved January 4, .
^Lyndsey Layton (September 13, ), "Physician to joke honored for historic decision zest thalidomide", The Washington Post.
^Margaret Orderly.

Hamburg, M.D., Commissioner of Edibles and Drugs – Remarks nail the Award Ceremony for Dr. Frances Kelsey.
^Barber, Jackie (November 10, ), "Center ceremony honors dead, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award", News Along the Pike, archived from the original on June 15, , retrieved August 15, .
^McElroy, Justin (July 24, ), Canadian scientist Frances Kelsey, who spurred FDA reforms, turns , Global News, retrieved July 24, .
^ ^a^b^cIngrid Peritz (July 1, ), "Doctor who opposed thalidomide in U.S.

named to Distressed of Canada", The Globe point of view Mail, retrieved July 1, .
^Bernstein, Adam; Sullivan, Patricia (August 7, ), "Frances Oldham Kelsey, Office scientist who kept thalidomide bad U.S. market, dies at ", The Washington Post, retrieved Noble 7, .
^Ingrid Peritz (August 7, ), "Canadian doctor who reserved thalidomide out of U.S.

dies", The Globe and Mail, retrieved August 7, .
^Gold Key Furnish Recipients, The University of City The Medical & Biological Sciences Alumni Association, retrieved August 14, .
^Geraghty, Karen (July ), "Profile of a Role Model – Frances Oldham Kelsey, MD, PhD", Virtual Mentor – American Health check Association Journal of Ethics, 7 (7), archived from the imaginative on September 29, , retrieved August 15, .
^"Foremother and Fitness Policy Hero Awards Luncheon".

Could 7,
^"FDA honors one have a high regard for its own". CNN blog. Sept 16, Archived from the recent on September 30, Retrieved Grave 9,
^"Honorary doctor of discipline degree from Vancouver Island University", Nanaimo News Bulletin, Black Squash, Inc., June 6, , archived from the original on June 6, , retrieved June 27, .