Drugs and the FDA
Safety, Efficacy, and the Public's Trust
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Narrated by:
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Mike Lenz
About this listen
Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate United States authority on a drug's safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA's cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices.
Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member.
©2022 Mikkael A. Sekeres (P)2023 TantorListeners also enjoyed...
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On the 100th anniversary of the devastating pandemic of 1918, Jeremy Brown, a veteran ER doctor, explores the troubling, terrifying, and complex history of the flu virus, from the origins of the Great Flu that killed millions, to vexing questions such as: are we prepared for the next epidemic, should you get a flu shot, and how close are we to finding a cure?
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Important read
- By Kathryn C. on 12-21-18
By: Dr. Jeremy Brown
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Trick or Treatment
- The Undeniable Facts about Alternative Medicine
- By: Edzard Ernst, Simon Singh
- Narrated by: Dennis Kleinman
- Length: 12 hrs and 33 mins
- Unabridged
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Whether you are an ardent believer in alternative medicine, a skeptic, or are simply baffled by the range of services and opinions, this guide lays to rest doubts and contradictions with authority, integrity, and clarity. In this groundbreaking analysis, over 30 of the most popular treatments - acupuncture, homeopathy, aromatherapy, reflexology, chiropractic, and herbal medicines - are examined for their benefits and potential dangers. Questions answered include: What works and what doesn't? What are the secrets, and what are the lies?
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Well researched
- By Erik J. Rasmussen on 09-09-20
By: Edzard Ernst, and others
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State of the Heart
- Exploring the History, Science, and Future of Cardiac Disease
- By: Haider Warraich
- Narrated by: Neil Shah
- Length: 11 hrs and 8 mins
- Unabridged
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In State of the Heart, the journey to rid the world of heart disease is shown to be reflective of the journey of medical science at large. We are learning not only that women have as much heart disease as men, but that the type of heart disease women experience is diametrically different from that in men. We are learning that heart disease and cancer may have more in common than we could have imagined. And we are learning how human evolution itself may have led to the epidemic of heart disease
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Good information, bad organization
- By Conor Cox on 09-03-19
By: Haider Warraich
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Panic Attack
- Playing Politics with Science in the Fight Against COVID-19
- By: Nicole Saphier
- Narrated by: Nicole Saphier
- Length: 10 hrs and 1 min
- Unabridged
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Medical doctor and national bestselling author of Make America Healthy Again Nicole Saphier reveals how politicization of the COVID-19 pandemic has baffled the public by creating distrust, fueling conspiracy theories, and making it harder for Americans to understand the necessary path forward. The pandemic has resulted in a failure of government, much of which is unavoidable in a unique disaster scenario. However, the rampant politicization of science has hopelessly muddied the water and knee-jerk anti-Trumpism made it all worse.
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Very disappointed
- By K. Green on 07-29-21
By: Nicole Saphier
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The Emperor of All Maladies
- A Biography of Cancer
- By: Siddhartha Mukherjee
- Narrated by: Fred Sanders
- Length: 22 hrs and 18 mins
- Unabridged
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The Emperor of All Maladies reveals the many faces of an iconic, shape-shifting disease that is the defining plague of our generation. The story of cancer is a story of human ingenuity, resilience, and perseverance but also of hubris, arrogance, paternalism, and misperception, all leveraged against a disease that, just three decades ago, was thought to be easily vanquished in an all-out "war against cancer".
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Incredible
- By S.R.E. on 03-02-16
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Chronic
- The Hidden Cause of the Autoimmune Pandemic and How to Get Healthy Again
- By: Steven Phillips MD, Dana Parish, Kristin Loberg
- Narrated by: Teri Schnaubelt, Thomas Allen
- Length: 10 hrs and 42 mins
- Unabridged
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In this timely book, Steven Phillips, MD, and his former patient, Sony singer-songwriter Dana Parish, reveal striking evidence that a broad range of common infections, from COVID-19 to Lyme and many others, cause a variety of autoimmune, psychiatric, and chronic conditions. Chronic explores the science behind what makes them difficult to diagnose and treat, debunks widely held beliefs by doctors and patients alike, and provides solutions that empower sufferers to reclaim their lives.
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A must read book
- By Amazon Customer on 03-01-21
By: Steven Phillips MD, and others
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The Secret History of the War on Cancer
- By: Devra Davis Ph.D.
- Narrated by: Pam Ward
- Length: 19 hrs and 11 mins
- Unabridged
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The War on Cancer was run by leaders of industries that made cancer-causing products and sometimes also profited from drugs and technologies for finding and treating the disease. Filled with compelling personalities and never-before-revealed information, The Secret History of the War on Cancer shows how we began fighting the wrong war, with the wrong weapons, against the wrong enemies, a legacy that persists to this day.
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Silly Book
- By Adam Smith on 12-24-14
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The Problem of Alzheimer's
- How Science, Culture, and Politics Turned a Rare Disease into a Crisis and What We Can Do About It
- By: Jason Karlawish
- Narrated by: Jason Karlawish, Jonathan Todd Ross
- Length: 13 hrs and 41 mins
- Unabridged
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In 2020, an estimated 5.8 million Americans had Alzheimer’s, and more than half a million died because of the disease and its devastating complications. Sixteen million caregivers are responsible for paying as much as half of the $226 billion annual costs of their care. As more people live beyond their 70s and 80s, the number of patients will rise to an estimated 13.8 million by 2025. Part case studies, part meditation on the past, present and future of the disease, The Problem of Alzheimer's traces Alzheimer’s from its beginnings to its recognition as a crisis.
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A must read
- By kara kuntz on 05-20-21
By: Jason Karlawish
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A Nation in Pain
- Healing Our Biggest Health Problem
- By: Judy Foreman
- Narrated by: Karen White
- Length: 14 hrs and 57 mins
- Unabridged
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Published in partnership with the International Association for the Study of Pain, A Nation in Pain offers a sweeping, deeply researched account of the chronic pain crisis, from neurobiology to public policy, and presents practical solutions that are within our grasp today. Drawing on both her personal experience with chronic pain and her background as an award-winning health journalist, she guides us through recent scientific discoveries, including genetic susceptibility to pain.
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Broad but superficial.
- By J. P. Murphy on 07-03-15
By: Judy Foreman
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How Doctors Think
- By: Jerome Groopman M.D.
- Narrated by: Michael Prichard
- Length: 10 hrs and 27 mins
- Unabridged
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On average, a physician will interrupt a patient describing her symptoms within 12 seconds. In that short time, many doctors decide on the likely diagnosis and best treatment. Often, decisions made this way are correct, but at crucial moments they can also be wrong: with catastrophic consequences. In this myth-shattering book, Jerome Groopman pinpoints the forces and thought processes behind the decisions doctors make.
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Disappointing
- By Audiophile on 05-13-07
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The Truth About Cancer
- By: Ty M. Bollinger
- Narrated by: Ty M. Bollinger
- Length: 9 hrs and 11 mins
- Unabridged
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One out of three women alive today, and one out of two men, will face a cancer diagnosis, according to the World Health Organization. Ty Bollinger takes this personally: in the course of a decade, he says, "I lost my entire family to cancer. I don't believe I had to lose them." The Truth about Cancer has been written for one simple reason: to share the knowledge we need to protect ourselves, treat ourselves, and in some cases save our lives or the lives of those we love.
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save a life with this valuable information.
- By edwin matias on 12-30-16
By: Ty M. Bollinger
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The Panic Virus
- A True Story of Medicine, Science, and Fear
- By: Seth Mnookin
- Narrated by: Dan John Miller
- Length: 10 hrs and 44 mins
- Unabridged
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The Panic Virus is a gripping scientific detective story about how grassroots radicals, snake-oil salesmen, and cynical journalists have perpetrated the biggest health-scare hoax of all time. It explores what happens when the media treats all viewpoints as equally valid, regardless of facts, from parents who are convinced that vaccines caused their children's autism to right-wing radicals who believe that climate change is a myth
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Incredible thorough journey
- By Rachel Dewald on 03-22-11
By: Seth Mnookin
What listeners say about Drugs and the FDA
Average customer ratingsReviews - Please select the tabs below to change the source of reviews.
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- Anne E. Sharman
- 05-07-23
Metastic
As a cancer doc interested in drug development the book has good content and narrative. Why can’t the reader pronounce METASTATIC in a book like this and keep saying METASTIC
Good lord - where is the editing on something so simple and central to the book
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- Anthony W. Shallin
- 11-12-23
What is “metastic”?
Very good overview of fda drug approval, but the reader says “metastic” instead of metastatic. Metastic is not a word.
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- Ji Li
- 09-28-24
Great book but reading of professional word needs improve
It is a Great book but reading of professional word needs improvement such as ‘metastatic’.
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