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On August 7, 1962, Frances Oldham Kelsey received the President's Award for Distinguished Federal Civilian Service.
Frances Oldham Kelsey
Frances Oldham Kelsey
Born: Frances Kathleen Oldham; July 24, 1914
Cobble Hill, British Columbia, Canada
Died: August 7, 2015 (aged 101); London, Ontario, Canada
Citizenship:
Canada
United States (from 1950s)
Alma mater:
Victoria College, British Columbia
McGill University (BSc, MSc)
University of Chicago (PhD, MD)
Occupation: Pharmacologist
Known for: Preventing thalidomide from being marketed in the United States
Medical career
Field: Physician
Awards: President's Award for Distinguished Federal Civilian Service (1962)
Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American 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 lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.
{snip}
Work at the FDA and thalidomide
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" for the FDA. One of her first assignments at the FDA was to review an application by 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. Although it had been previously approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested to see clinical trial information. At the time, the FDA could only withhold approval for 60 days at a time, so she continually requested further information from the company every 60 days for over a year. Her initial reason for doing this was that the testimonials supplied by Richardson-Merrell contained no scientific methodology, and she recognized their authors as having published suspicious articles in the past.
In December 1960, Leslie Florence published a letter in the British Medical Journal connecting thalidomide to neurological symptoms. Kelsey saw this letter and added Florence's observed symptoms to her ongoing data requests. The unexpected neurological effects caused her to recall her earlier work on the mechanism of birth defects, so she also requested animal studies to demonstrate that the drug would not be harmful to the fetus. In fact, Richardson-Merrell had reportedly discovered birth defects when the drug was tested on rats but did not report this finding; Kelsey was instead sent misleading partial data suggesting the product was safe for pregnant women. Despite the fact that thalidomide was already widely used in Europe and elsewhere, Kelsey remained suspicious and scrutinized this data with concern and skepticism, sometimes asking her husband to check her conclusions. As 1960 turned to 1961, Kelsey's continual requests for more information incurred the ire of her contact at Richardson-Merrell, who insisted on speeding up the approval process and attempted to escalate the application, but Kelsey's superiors at the FDA stood by her.
Kelsey's insistence that the drug should be fully tested prior to approval was vindicated in November 1961 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 placental barrier and caused serious birth defects. In March 1962, after distributing "experimental" tablets to tens of thousands of patients without approval (causing 17 malformed births), Richardson-Merrell at last withdrew their FDA application. Kelsey was hailed on the front page of The Washington Post as a heroine for averting a large-scale tragedy in the U.S. Morton Mintz, author of The Washington Post article, said "[Kelsey] 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 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. 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 [should be] required to be established prior to marketing."
As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy 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 was named Director of the Investigational Drug Branch.
{snip}
Further career
In 1966, Lyndon B. Johnson appointed James L. Goddard as Commissioner of Food and Drugs. Goddard resented the public attention Kelsey continued to receive and believed widespread rumors spread by pharmaceutical industry executives that Kelsey had delayed the thalidomide application through pure laziness. This was precisely the opposite of the truth: most applications were automatically approved by reviewers ignoring the 60 day deadline, while Kelsey had carefully sent out data requests for over a year. Regardless, Kelsey was demoted from Director of the Investigational Drug Branch to Chief of the Division of Oncology and Radiopharmaceutical Drug Products, where she was given little work.
After Goddard's departure, Kelsey was again appointed Director of Scientific Investigations, and continued in this position for many decades. She was involved in the contentious regulation of diethylstilbestrol, which also caused birth defects, and dimethyl sulfoxide. 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. She attended the opening ceremony despite having suffered broken ribs and a vertebral compression fracture on the way to the ceremony. In 1995, when she was eighty-one, the FDA created a special position for her, Deputy for Scientific and Medical Affairs in the Office of Compliance.
{snip}
Later life and death
{snip}
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, visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide.
{snip}
Frances Oldham Kelsey
Born: Frances Kathleen Oldham; July 24, 1914
Cobble Hill, British Columbia, Canada
Died: August 7, 2015 (aged 101); London, Ontario, Canada
Citizenship:
Canada
United States (from 1950s)
Alma mater:
Victoria College, British Columbia
McGill University (BSc, MSc)
University of Chicago (PhD, MD)
Occupation: Pharmacologist
Known for: Preventing thalidomide from being marketed in the United States
Medical career
Field: Physician
Awards: President's Award for Distinguished Federal Civilian Service (1962)
Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American 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 lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.
{snip}
Work at the FDA and thalidomide
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" for the FDA. One of her first assignments at the FDA was to review an application by 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. Although it had been previously approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested to see clinical trial information. At the time, the FDA could only withhold approval for 60 days at a time, so she continually requested further information from the company every 60 days for over a year. Her initial reason for doing this was that the testimonials supplied by Richardson-Merrell contained no scientific methodology, and she recognized their authors as having published suspicious articles in the past.
In December 1960, Leslie Florence published a letter in the British Medical Journal connecting thalidomide to neurological symptoms. Kelsey saw this letter and added Florence's observed symptoms to her ongoing data requests. The unexpected neurological effects caused her to recall her earlier work on the mechanism of birth defects, so she also requested animal studies to demonstrate that the drug would not be harmful to the fetus. In fact, Richardson-Merrell had reportedly discovered birth defects when the drug was tested on rats but did not report this finding; Kelsey was instead sent misleading partial data suggesting the product was safe for pregnant women. Despite the fact that thalidomide was already widely used in Europe and elsewhere, Kelsey remained suspicious and scrutinized this data with concern and skepticism, sometimes asking her husband to check her conclusions. As 1960 turned to 1961, Kelsey's continual requests for more information incurred the ire of her contact at Richardson-Merrell, who insisted on speeding up the approval process and attempted to escalate the application, but Kelsey's superiors at the FDA stood by her.
Kelsey's insistence that the drug should be fully tested prior to approval was vindicated in November 1961 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 placental barrier and caused serious birth defects. In March 1962, after distributing "experimental" tablets to tens of thousands of patients without approval (causing 17 malformed births), Richardson-Merrell at last withdrew their FDA application. Kelsey was hailed on the front page of The Washington Post as a heroine for averting a large-scale tragedy in the U.S. Morton Mintz, author of The Washington Post article, said "[Kelsey] 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 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. 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 [should be] required to be established prior to marketing."
As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy 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 was named Director of the Investigational Drug Branch.
{snip}
Further career
In 1966, Lyndon B. Johnson appointed James L. Goddard as Commissioner of Food and Drugs. Goddard resented the public attention Kelsey continued to receive and believed widespread rumors spread by pharmaceutical industry executives that Kelsey had delayed the thalidomide application through pure laziness. This was precisely the opposite of the truth: most applications were automatically approved by reviewers ignoring the 60 day deadline, while Kelsey had carefully sent out data requests for over a year. Regardless, Kelsey was demoted from Director of the Investigational Drug Branch to Chief of the Division of Oncology and Radiopharmaceutical Drug Products, where she was given little work.
After Goddard's departure, Kelsey was again appointed Director of Scientific Investigations, and continued in this position for many decades. She was involved in the contentious regulation of diethylstilbestrol, which also caused birth defects, and dimethyl sulfoxide. 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. She attended the opening ceremony despite having suffered broken ribs and a vertebral compression fracture on the way to the ceremony. In 1995, when she was eighty-one, the FDA created a special position for her, Deputy for Scientific and Medical Affairs in the Office of Compliance.
{snip}
Later life and death
{snip}
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, visited her home to present her with the insignia of Member of the Order of Canada for her role against thalidomide.
{snip}