Frances Oldham Kelsey

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Miracle Cure by William Rosen

Affordable Care Act / Obamacare, availability heuristic, biofilm, cognitive bias, cognitive dissonance, conceptual framework, Copley Medal, creative destruction, demographic transition, discovery of penicillin, do well by doing good, Edward Jenner, Ernest Rutherford, experimental subject, Fellow of the Royal Society, Frances Oldham Kelsey, Frederick Winslow Taylor, friendly fire, functional fixedness, germ theory of disease, global supply chain, Haber-Bosch Process, Ignaz Semmelweis: hand washing, Isaac Newton, James Watt: steam engine, Johannes Kepler, John Snow's cholera map, Joseph Schumpeter, Louis Pasteur, medical malpractice, meta-analysis, microbiome, New Journalism, obamacare, out of africa, pattern recognition, Pepto Bismol, public intellectual, randomized controlled trial, selection bias, stem cell, the long tail, transcontinental railway, working poor

.* Despite widespread public endorsements, the support of strong majorities in both houses of Congress, and even the pharmaceutical industry itself, SB1522 seemed doomed to die the death of a thousand cuts in committee. And so it might have, but for a scandal more gruesome, and more notorious, than the Elixir Sulfanilamide and aplastic anemia scares combined. — In 1962, Frances Oldham Kelsey had been balancing the costs and benefits of the antibiotic revolution for nearly twenty-five years. In 1938, with the ink barely dry on her doctorate in pharmacology from the University of Chicago, she performed the animal studies that revealed the extent of the damage caused by Massengill’s Elixir Sulfanilamide.

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On October 10, 1962, Public Law 87-781, an “Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs,” was signed into law by President John Kennedy. Standing behind him for the traditional signing photo was Frances Oldham Kelsey. — Kefauver-Harris wasn’t the first major piece of federal legislation to recognize that the world of medicine had been utterly transformed since 1938. In 1951, Senator Hubert Humphrey of Minnesota and Representative Carl Durham of North Carolina—both, not at all coincidentally, had been pharmacists before entering political life—cosponsored another amendment that drew, for the first time, a clear distinction between prescription drugs and those sold directly to patients.

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In 1951, Senator Hubert Humphrey of Minnesota and Representative Carl Durham of North Carolina—both, not at all coincidentally, had been pharmacists before entering political life—cosponsored another amendment that drew, for the first time, a clear distinction between prescription drugs and those sold directly to patients. Credit: National Institutes of Health/National Library of Medicine Frances Oldham Kelsey (1914–2015) receiving the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy Until the 1950s, the decision to classify a drug as either a prescription drug, requiring physician authorization, or as what is now known as an over-the-counter medication, was entirely at the discretion of the drug’s manufacturer.

The Unknowers: How Strategic Ignorance Rules the World by Linsey McGoey

Alan Greenspan, An Inconvenient Truth, anti-globalists, antiwork, battle of ideas, behavioural economics, Big Tech, Black Lives Matter, Branko Milanovic, British Empire, Cambridge Analytica, carbon tax, Cass Sunstein, Clive Stafford Smith, conceptual framework, Corn Laws, corporate governance, corporate raider, Credit Default Swap, David Ricardo: comparative advantage, Donald Trump, drone strike, en.wikipedia.org, European colonialism, fake news, Frances Oldham Kelsey, hiring and firing, Howard Zinn, income inequality, it is difficult to get a man to understand something, when his salary depends on his not understanding it, joint-stock company, junk bonds, knowledge economy, market fundamentalism, mass incarceration, Michael Milken, minimum wage unemployment, Naomi Klein, new economy, Nick Leeson, p-value, Paul Samuelson, Peter Thiel, plutocrats, post-truth, public intellectual, race to the bottom, randomized controlled trial, rent-seeking, road to serfdom, Robert Mercer, Ronald Reagan, Scientific racism, selective serotonin reuptake inhibitor (SSRI), Social Justice Warrior, Steven Pinker, Suez crisis 1956, The Chicago School, The Wealth of Nations by Adam Smith, union organizing, Upton Sinclair, W. E. B. Du Bois, Washington Consensus, wealth creators

Take Thalidomide, a drug marketed by its German manufacturer, Grünenthal, as a mild sleeping pill and approved for over-the-counter use in many European countries over the 1950s and 1960s. Thalidomide was heavily marketed by Grünenthal and its UK licensee even after early signs of birth defects were apparent.5 In the United States, an FDA drug examiner named Frances Oldham Kelsey grew concerned by reports of birth defects in Europe and Australia. Supported by many of her colleagues and superiors, she refused to approve the drug. Her actions helped to avert American parents and their children from experiencing the tragedy unfolding in Europe, and also vindicated British health activists who had long campaigned for the UK to establish a system on par to the FDA in the US, a system that owed its existence to the influence of progressive American reformers at the turn of the 20th century.

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‘Frances Kelsey, drug regulator who barred Thalidomide, 1914–2015’ (Financial Times, August 14). 8 Leila McNeill, 2017. ‘The woman who stood between America and a generation of “Thalidomide babies”’ (Smithsonian.com, May 8). 9 Quoted in Ward, ‘Frances Kelsey.’ 10 Robert McFadden, 2015. ‘Frances Oldham Kelsey, who saved U.S. babies from Thalidomide, dies at 101’ (The New York Times, August 7). 11 Benjamin Kentish, 2016. ‘Donald Trump could be like John F Kennedy, says Bill Gates’ (Independent, December 14). 12 J. Avorn, 2006. ‘Dangerous deception: Hiding the evidence of adverse drug effects.’ New England Journal of Medicine 355 (November 23): 2169–2171, 2169. 13 H.

Suggestible You: The Curious Science of Your Brain's Ability to Deceive, Transform, and Heal by Erik Vance

classic study, fixed income, Frances Oldham Kelsey, hive mind, impulse control, Isaac Newton, meta-analysis, nocebo, personalized medicine, placebo effect, randomized controlled trial, Ronald Reagan, side project, stem cell, Steve Jobs, sugar pill, Yogi Berra

Many thousands of babies died in the womb. Another 10,000 suffered a range of maladies, including shocking deformities. The hysteria that followed forever changed the public image of the pharmaceutical industry. The drug was never available in the United States (thanks largely to the heroically skeptical FDA doctor Frances Oldham Kelsey), but by 1962 the U.S. public was deeply shaken and demanded safeguards against the possibility that such a dangerous drug could be available here. In a gesture of bipartisan panic, the House and Senate grabbed Kefauver’s bill and added it to the Drug Efficacy Amendment to the Federal Food, Drug, and Cosmetic Act.

Irreversible Damage: The Transgender Craze Seducing Our Daughters by Abigail Shrier

Affordable Care Act / Obamacare, autism spectrum disorder, deplatforming, en.wikipedia.org, false memory syndrome, Frances Oldham Kelsey, glass ceiling, helicopter parent, Jeff Bezos, opioid epidemic / opioid crisis, scientific mainstream, Skype, social contagion, Steve Jobs, TED Talk, TikTok, unpaid internship

Even the medical advice Katherine found online seemed to support Maddie’s new identity and the urgency of medical transition. “She has everybody on her side. I mean, I don’t have a leg to stand on.” Katherine eventually founded the Kelsey Coalition, an organization devoted to opposing transgender ideology; it’s named for Dr. Frances Oldham Kelsey who, back in 1960, had warned the world of the dangers of thalidomide. Katherine has also drafted legislation that would make it illegal for adults to consent to eliminating the future fertility of their children, and has even managed to get some lawmakers to sponsor it. But like most of the mothers of suddenly trans-identified adolescents, she continues to work under a pseudonym, and her sense of isolation is keen.

The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable--And How We Can Get There by Vincent T. Devita, Jr., M. D., Elizabeth Devita-Raeburn

Affordable Care Act / Obamacare, Albert Einstein, double helix, Frances Oldham Kelsey, mouse model, personalized medicine, RAND corporation, randomized controlled trial, Ronald Reagan, stem cell, three-martini lunch

., “An Analysis of Predictor Variables for Adjuvant Treatment of Breast Cancer,” Cancer Chemotherapy and Pharmacology 2, no. 3 (1979): 147–58, www.rand.org/pubs/external_publications/EP19790001.html.   3. Peter Greenwald and Edward Sondik, eds., Cancer Control Objectives for the Nation: 1985–2000, National Cancer Institute Monographs 2 (Bethesda, Md.: National Cancer Institute, 1986). 8. Frances Kelsey Syndrome   1. Frances Oldham Kelsey, Chemical Heritage Foundation, www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/public-and-environmental-health/food-and-drug-safety/kelsey.aspx.   2. Morton Mintz, “‘Heroine’ of FDA Keeps Bad Drug off Market,” Washington Post, July 15, 1962.   3. Attard et al., “Phase I Clinical Trial of a Selective Inhibitor of CYP17, Abiraterone Acetate, Confirms That Castration-Resistant Prostate Cancer Commonly Remains Hormone Driven.”   4.

Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban

Affordable Care Act / Obamacare, Bernie Madoff, Frances Oldham Kelsey, global pandemic, Mahatma Gandhi, Nelson Mandela, offshore financial centre, old-boy network, Ponzi scheme, rolodex, Ronald Reagan, Skype, Upton Sinclair, urban planning

what a good control system should be: Dale E. Cooper, “Adequate Controls for New Drugs,” Pharmacy in History 44, no. 1 (2002); John P. Swann, “The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices,” Pharmacy in History 40, no. 1 (1999). to sell a drug called Kevadon: Linda Bren, “Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History,” U.S. Food and Drug Administration, FDA Consumer (March/April 2001), http://web.archive.org/web/20061020043712/http:/www.fda.gov/fdac/features/2001/201_kelsey.html (accessed December 28, 2017). known as the Kefauver-Harris Amendment: Cornelius D.

The Alignment Problem: Machine Learning and Human Values by Brian Christian

Albert Einstein, algorithmic bias, Alignment Problem, AlphaGo, Amazon Mechanical Turk, artificial general intelligence, augmented reality, autonomous vehicles, backpropagation, butterfly effect, Cambridge Analytica, Cass Sunstein, Claude Shannon: information theory, computer vision, Computing Machinery and Intelligence, data science, deep learning, DeepMind, Donald Knuth, Douglas Hofstadter, effective altruism, Elaine Herzberg, Elon Musk, Frances Oldham Kelsey, game design, gamification, Geoffrey Hinton, Goodhart's law, Google Chrome, Google Glasses, Google X / Alphabet X, Gödel, Escher, Bach, Hans Moravec, hedonic treadmill, ImageNet competition, industrial robot, Internet Archive, John von Neumann, Joi Ito, Kenneth Arrow, language acquisition, longitudinal study, machine translation, mandatory minimum, mass incarceration, multi-armed bandit, natural language processing, Nick Bostrom, Norbert Wiener, Northpointe / Correctional Offender Management Profiling for Alternative Sanctions, OpenAI, Panopticon Jeremy Bentham, pattern recognition, Peter Singer: altruism, Peter Thiel, precautionary principle, premature optimization, RAND corporation, recommendation engine, Richard Feynman, Rodney Brooks, Saturday Night Live, selection bias, self-driving car, seminal paper, side project, Silicon Valley, Skinner box, sparse data, speech recognition, Stanislav Petrov, statistical model, Steve Jobs, strong AI, the map is not the territory, theory of mind, Tim Cook: Apple, W. E. B. Du Bois, Wayback Machine, zero-sum game

The drug thalidomide was marketed as “completely safe” because the drugmaker “could not find a dose high enough to kill a rat.” But it caused tens of thousands of horrible deformities in human fetuses before the drug was taken off the market.8 (Americans were largely spared, as a result of a skeptical Food and Drug Administration employee, Dr. Frances Oldham Kelsey.) In the case of “supervised learning,” where the training data is “labeled” in some fashion, we need to consider critically, too, not only where we get our training data but where we get the labels that will function in the system as a stand-in for ground truth. Often the ground truth is not the ground truth.