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Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide
- Narrado por: Andrea Gallo
- Duración: 16 h y 41 m
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Resumen del Editor
In the early 1960s, Dr. Frances Oldham Kelsey of the U.S. Food and Drug Administration became one of the most celebrated women in America when she prevented a deadly sedative from entering the U.S. market. A Canadian-born pharmacologist and physician, Kelsey saved countless Americans from the devastating side effects of thalidomide, routinely given to pregnant women to prevent morning sickness.
As the FDA medical officer charged with reviewing Merrell Pharmaceutical’s application for approval in 1960–1961, Kelsey was unconvinced that there was sufficient evidence of the drug’s efficacy and safety. Despite substantial pressure, she held her ground for nineteen months while the extent of the drug’s worldwide damage became known—thousands of stillborn babies, as well as at least 10,000 children across forty-six countries born with severe deformities such as missing limbs, arms, and legs that resembled flippers, and improperly developed eyes, ears, and other organs.
As a result of Kelsey’s efforts, thalidomide was never sold in the United States.
The incident led Congress to pass the 1962 Drug Amendment, which fundamentally changed drug regulation in America. Those regulations, still in force today, required pharmaceutical companies to conduct phased clinical trials, obtain informed consent from participants in drug testing, and warn the FDA of adverse effects, and it granted the FDA important controls over prescription-drug advertising.
One of a small minority of women to earn an advanced degree in science in the 1930s, Kelsey faced challenges that resonate with women scientists to this day.
Revered by the public as a “good mother of science,” she went on to act as a formidable gatekeeper against other suspect drugs, such as diesthylstilbestrol (DES) and laetrile. As part of the team that tested anti-malarial drugs on prisoner volunteers during World War II, she later was instrumental in the formulation of ethical protocols for drug testing on prisoners and the vulnerable, including the elderly and children. Yet behind the public adulation, she faced professional jealousies and glass ceilings, political interference with FDA’s actions, and ongoing hostility from pharmaceutical industry officials. She was sustained and supported by family and friends, co-workers and mentors, and a lifetime commitment to good science.
Based upon FDA archival records, private family papers, and interviews with family and colleagues, this biography highlights the efforts and legacy of a pioneering woman of science whose contributions are still influential today.
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Historia
A Great Disorder is a bold, urgent work that helps us make sense of today's culture wars through a brilliant reconsideration of America's foundational myths and their use in contemporary politics. Richard Slotkin identifies five myths, born of different eras, that have shaped our conception of what it means to be American: the myths of the Frontier, the Founding, the Civil War (which he breaks into two opposing camps, Emancipation and the Lost Cause), and the Good War, embodied by the multiethnic platoon fighting for freedom.
De: Richard Slotkin
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Playing with Reality
- How Games Have Shaped Our World
- De: Kelly Clancy
- Narrado por: Patty Nieman
- Duración: 11 h y 39 m
- Versión completa
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Historia
We play games to learn about the world, to understand our minds and the minds of others, and to make predictions about the future. Games are an essential aspect of humanity and a powerful tool for modeling reality. They’re also a lot of fun. But games can be dangerous, especially when we mistake the model worlds of games for reality itself and let gamification co-opt human decision making. Playing with Reality explores the riveting history of games since the Enlightenment.
De: Kelly Clancy
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Do Something
- Coming of Age Amid the Glitter and Doom of '70s New York
- De: Guy Trebay
- Narrado por: Edoardo Ballerini
- Duración: 6 h y 29 m
- Versión completa
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Born in the Bronx, Guy Trebay was raised in an atmosphere of privilege on Long Island’s North Shore after his entrepreneurial father struck business gold with Hawaiian Surf, a wildly successful cologne company that capitalized on the optimism of the 1960s as marketed to “an adventurous new breed of men.’’ But behind the facade of material prosperity lay the emotional disarray of a household dominated by a charismatic, con artist father, a glamorous yet lost and careless mother, a family haunted by tragedy.
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Heartache and heartbreak and the will to survive.
- De Polly B. en 07-05-24
De: Guy Trebay
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Night Flyer
- Harriet Tubman and the Faith Dreams of a Free People
- De: Tiya Miles, Henry Louis Gates Jr.
- Narrado por: Janina Edwards
- Duración: 6 h y 5 m
- Versión completa
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Harriet Tubman is among the most famous Americans ever born and soon to be the face of the twenty-dollar bill. Yet often she’s a figure more out of myth than history, almost a comic-book superhero. You could almost say she’s America’s Robin Hood, a miraculous vision, often rightly celebrated but seldom understood. Tiya Miles’s extraordinary Night Flyer changes all that.
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academic tripe
- De Amazon Customer en 07-27-24
De: Tiya Miles, y otros
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The Great River
- The Making and Unmaking of the Mississippi
- De: Boyce Upholt
- Narrado por: Gabriel Vaughan
- Duración: 10 h y 18 m
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Over thousands of years, the Mississippi watershed was home to millions of Indigenous people who regarded "the great river" with awe and respect, adorning its banks with astonishing spiritual earthworks. But European settlers and American pioneers had a different vision: the river was a foe to conquer. In this landmark work of natural history, Boyce Upholt tells the epic story of human attempts to own and contain the Mississippi River, from Thomas Jefferson's expansionist land hunger through today's era of environmental concern
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a great summation of the Great River
- De Michael H. Link en 07-27-24
De: Boyce Upholt
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At the Edge of Empire
- A Family's Reckoning with China
- De: Edward Wong
- Narrado por: Edward Wong, Will Dao
- Duración: 16 h y 49 m
- Versión completa
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The son of Chinese immigrants in Washington, DC, Edward Wong grew up among family secrets. His father toiled in Chinese restaurants and rarely spoke of his native land or his years in the People’s Liberation Army under Mao. Yook Kearn Wong came of age during the Japanese occupation in World War II and the Communist revolution, when he fell under the spell of Mao’s promise of a powerful China. His astonishing journey as a soldier took him from Manchuria during the Korean War to Xinjiang on the Central Asian frontier.
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China’s Social and Economic Evolution Under Communism: Progress, Errors, and Implications of
- De Deborah en 09-09-24
De: Edward Wong