Dr Frances Oldham Kelsey : 20th-century American heroine for her role in the Thalidomide case
In 1960, Frances Kelsey was one of the Food and Drug Administration’s newest recruits. Before the year was out, she would begin a fight that would save thousands of lives — though no one knew it at the time.
Andrea Tone explains how Kelsey was able to prevent a massive national public health tragedy by privileging facts over opinions, and patience over shortcuts.
After 60 years, scientists uncover how thalidomide produced birth defects
More than 60 years after the drug thalidomide caused birth defects in thousands of children whose mothers took the drug while pregnant, scientists at Dana-Farber Cancer Institute have solved a mystery that has lingered ever since the dangers of the drug first became apparent: how did the drug produce such severe fetal harm?
ScienceAlert reports, 2 AUG 2018.
Frequently used to treat morning sickness, the drug thalidomide led to the birth of thousands of children with severe birth defects. Despite their teratogenicity, thalidomide and related IMiD drugs are now a mainstay of cancer treatment, however, the molecular basis underlying the pleiotropic biology and characteristic birth defects remains unknown.
Here we show that IMiDs disrupt a broad transcriptional network through induced degradation of several C2H2 zinc finger transcription factors, including SALL4, a member of the spalt-like family of developmental transcription factors.
Strikingly, heterozygous loss of function mutations in SALL4 result in a human developmental condition that phenocopies thalidomide induced birth defects such as absence of thumbs, phocomelia, defects in ear and eye development, and congenital heart disease.
We find that thalidomide induces degradation of SALL4 exclusively in humans, primates and rabbits, but not in rodents or fish, providing a mechanistic link for the species-specific pathogenesis of thalidomide syndrome.
Decades years after Thalidomide was launched, with devastating results, it was being hailed once again as a wonder drug.
Thalidomide is prescribed in Brazil, where there are a large number of leprosy patients, but children are still being born today in South America with limb defects because of its terrible effects in pregnancy.
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2011 – Thalidomide returns: scandal-hit drug is now used across NHSIndependent.
Because Some People See Things the Rest of Us Miss
The thalidomide tragedy was averted in the United States because Dr. Kelsey, alone and in the face of fierce opposition, did her job. Her perspective was educated, fresh and unique. If there had been no thalidomide crisis, the United States, with the rest of the world following, would still at some time have brought pharmaceutical regulation into the 20th century. But thalidomide created one of those moments when something had to be done. It could not be ignored in 1961-62, and it led immediately to a better and stronger regulatory system. Maybe someone else would have stopped thalidomide in the United States had Dr. Kelsey not been assigned the NDA, but, interestingly, no one else stopped it anywhere else until it was too late. Dr. Kelsey was the only person in the entire world who said no. She said no to a bad drug application, she said no to an overbearing pharmaceutical company and she said no to vested interests who put profits first. She was one brave dissenter. In the end, the question is not what made Frances Kelsey, but why aren’t there more like her?
The nature writer Rachel Carson identified an emerging environmental disaster and pulled the fire alarm. Public protests, individual dissenters, judges, and juries can change the world – and they do.
A wide-ranging and provocative work on controversial subjects, Why Dissent Matters tells a story of dissent and dissenters – people who have been attacked, bullied, ostracized, jailed, and, sometimes when it is all over, celebrated.
William Kaplan shows that dissent is noisy, messy, inconvenient, and almost always time-consuming, but that suppressing it is usually a mistake – it’s bad for the dissenter but worse for the rest of us. Drawing attention to the voices behind international protests such as Occupy Wall Street and Boycott, Divest, and Sanction, he contends that we don’t have to do what dissenters want, but we should listen to what they say. Our problems are not going away. There will always be abuses of power to confront, wrongs to right, and new opportunities for dissenting voices to say, “Stop, listen to me.” Why Dissent Matters may well lead to a different and more just future.
A collection of 57 papers and commentaries, arranged in eight sections, discuss the historical aspects, epidemiology, mechanisms, genetics, etiology, prenatal diagnosis, management, and social aspects of birth defects.
Paperback: 399 pages
Publisher: University Park Press (1977).
Beliefs, Mythology, Magic and Superstition.
Congenital malformations in the past.
A brief history of teratology to the early 20th century.
Epidemiology of Birth Defects.
Classification and nomenclature of morphological defects.
Epidemiologic aspects of the problem of congenital malformations.
Congenital malformations. A report of a study of series of consecutive births in 24 centres. (Extracts).
The incidence of developmental and other genetic abnormalities.
Interrelation of the common congenital malformations. Some aetiological implications.
Frances Oldham Kelsey, F.D.A. stickler who saved U.S. babies from Thalidomide, dies at 101
A Londoner who’s kept the scourge of thalidomide out of the United States has died, leaving behind a legacy of achievement that made her a heroine south of the border.
In 1962, President John F. Kennedy awarded Kelsey the highest honour given to a civilian in the U.S., the President’s Award for Distinguished Federal Civilian Service. Kelsey was only the second woman to receive the award. The new laws would pass and Kelsey would play a leading role giving them force.
Dr Frances Kelsey spent her final years here with family after a trail-blazing career that once led the Baltimore Post-Examiner to call her America’s greatest living heroine.
Sources and more information
Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide,
Dies at 101, NYtimes, AUG. 7, 2015.
Documents raise fresh questions about thalidomide criminal trial
” The dark shadow of thalidomide is still with us. The original catastrophe maimed 20,000 babies and killed 80,000… …Now evidence has been uncovered that the pharmaceutical outrage was compounded by a judicial scandal that has suppurated all these years.
Documents recently unearthed by the UK’s Thalidomide Trust will surely stoke fresh controversy about how and why the criminal trial against the drug’s makers ended without a verdict in December 1970.
And more than half a century since the pill’s threat to an embryo was proven, the company that produced the first disaster has continued to sell the drug in parts of Latin America. ”