The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It

by Jeanne Lenzer

Overview

Did you know...

Medical interventions have become the third leading cause of death in America.

An estimated 10 percent of Americans are implanted with medical devices — like pacemakers, artificial hips, cardiac stents, etc.

The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial.

In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment.

His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies.

In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare.

"Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated

Product Details

ISBN-13:	9780316343763
Publisher:	Little, Brown and Company
Publication date:	12/12/2017
Pages:	336
Sales rank:	732,779
Product dimensions:	6.20(w) x 9.40(h) x 1.20(d)

About the Author

Jeanne Lenzer is an award-winning medical investigative journalist and former Knight Science Journalism fellow. She is a longtime contributor to the The BMJ (formerly, the British Medical Journal), and her articles, reviews and commentary have appeared in the New York Times Magazine, Atlantic, The New Republic, Discover, Slate, Mother Jones and many other outlets.

Table of Contents

Prologue 3

1 Strange Seizures 9

2 Age of Miracles 18

3 Deadly Devices 44

4 The Man from Cyberonics 68

5 Adverse Events 91

6 No Safety Net 115

7 Regulators in Chains 127

8 The Power of Illusions 151

9 The Quest for Truth 177

10 When Money Talks 201

11 Breakdown 226

12 What Is to Be Done? 260

Resources 284

Acknowledgments 291

Notes 295

Index 317

What People are Saying About This

Marcia Angell

“In this disturbing and riveting book, the indefatigable investigative reporter Jeanne Lenzer tells the story of how millions of Americans are implanted with medical devices with almost no proof that they are safe. Lenzer exposes the web of commercial incentives governing their use, and the refusal of the manufacturers and the FDA to take responsibility when things go wrong.”

Pulitzer Prize-winning journalist and author of Th Deborah Blum

"Jeanne Lenzer's incisive investigation of one man's quest for medical justice - and the regulatory failures behind it - is a must-read for anyone wanting to understand the risks faced by all of us during routine procedures. And it should be, for all of us, a call to action."

Vinay Prasad

“One of the best books in medicine I have read. A splendid, savage story about the failings of modern device regulation that reads like a mystery, not a work of medical non-fiction: It turns out to be both.”

author of Overtreated Shannon Brownlee

“Jeanne Lenzer has pulled off a brilliant literary hat trick; she has written a page-turning tale of one patient’s odyssey, combined with hard-hitting investigative reporting and a compelling call to arms to fix America’s broken health care system. Before you get anything implanted in your body, read this book.”

Bernard Lown

“Lenzer’s gripping and carefully researched book addresses why America needs a New Deal in health care. This book enlightens, enrages, and will surely help advance that cause.”

Editorial Reviews

★ 11/27/2017
Lenzer, a former physician associate who ditched her career to become an investigative reporter, exposes a dark aspect of the “medical industrial complex:” flaws in the development, regulation, and use of high-risk implantable medical devices. Lenzer focuses on the case of Dennis Fegan, a former Texas oil rig worker and firefighter whose vagus nerve stimulator—implanted to reduce his epileptic seizures—almost killed him. Through Fegan’s story, Lenzer sketches “a complicated web of human error, corporate manipulation, and regulatory failure” while delving into the massive problems that plague healthcare: inadequate clinical testing of high-risk medical devices, the FDA’s vulnerability to political interference, and ethically questionable corporate sales pitches to doctors. Lenzer concludes that the “underlying problem is the fact that we insist upon treating health care as a commodity rather than a common good.” Her platform of solutions includes reducing unnecessary treatments and tests, insulating researchers from market forces, converting to a single-payer health insurance program, and reforming the compromised FDA. Lenzer makes an excellent, often disturbing case for “a new national attitude toward healthcare.” (Dec.)

Publishers Weekly

"One of the best books in medicine I have read. A splendid, savage story about the failings of modern device regulation that reads like a mystery, not a work of medical non-fiction: It turns out to be both."—Vinay Prasad, Assistant Professor ofMedicine, Oregon Health and Science University, and author of Ending MedicalReversal

"Jeanne Lenzer has pulled off a brilliant literary hat trick; a page-turning tale of one patient's odyssey, combined with hard-hitting investigative reporting and a compelling call to arms to fix America's broken health care system. Before you get anything implanted in your body, read this book."—Shannon Brownlee, author of Overtreated

"Lenzer's gripping and carefully researched book addresses why America needs a New Deal in health care. This book enlightens, enrages, and will surely help advance that cause."—Bernard Lown, cardiologist, Emeritus Professor,Harvard School of Public Health and Nobel Peace Prize recipient

"In this disturbing and riveting book, the indefatigable investigative reporter Jeanne Lenzer tells the story of how millions of Americans are implanted with medical devices with almost no proof that they are safe. Lenzer exposes the web of commercial incentives governing their use, and the refusal of the manufacturers and the FDA to take responsibility when things go wrong."—Marcia Angell, former editor-in-chief, the NewEngland Journal of Medicine, and author of The TruthAbout the Drug Companies

"Jeanne Lenzer's incisive investigation of one man's quest for medical justice - and the regulatory failures behind it - is a must-read for anyone wanting to understand the risks faced by all of us during routine procedures. And it should be, for all of us, a call to action."—DeborahBlum, Pulitzer Prize-winning journalist and author of The Poisoner'sHandbook

"Lenzer, a medical investigative journalist, powerfully details some alarming reasons hospital CEOs, insurance executives, and doctors become millionaires... Readers will be impressed with Lenzer's profiles of doctors who decry unnecessary treatments and tests, decline to take money for drug company sponsored talks, advocate disentangling money and medicine, and promote 'doing as little as possible to patients and as much as possible for patients.'"—Booklist (Starred Review)

"More than a decade ago, longtime BMJ contributor Lenzer abandoned her career as an emergency room physician associate to become an investigative medical journalist. Her debut book, an inspired inquiry into the politics of the industry, is startling and provocative . . . Reading like a cross between a riveting medical thriller and 'a Kafka novel', the book is a powerful cautionary tale . . . An impassioned exposé that uncovers a significant danger within the contemporary health care industry."—Kirkus

"Lenzer makes an excellent, often disturbing case for 'a new national attitude toward healthcare.'"—Publishers Weekly (Starred Review)

"Engrossing and terrifying...Lenzer takes readers deep into the processes by which medical devices are approved by the Food and Drug Administration (FDA). Thorough research is skillfully interwoven with the story of Dennis Fegan, whose struggle to expose the dangers of an implanted device that nearly killed him is both gripping and emotionally affecting... Highly recommended."—Library Journal (Starred Review)

"Blazing a new trail in medical research, Lenzer examines these medical devices and the industry surrounding them...These well-researched findings show how medical devices and implants may do more harm than good."—Shelf Awareness

From the Publisher

2017-10-11
Intensive reporting on the downsides of the high-risk medical device industry.More than a decade ago, longtime BMJ contributor Lenzer abandoned her career as an emergency room physician associate to become an investigative medical journalist. Her debut book, an inspired inquiry into the politics of the industry, is startling and provocative. Once she established herself as a journalist, the author was contacted by patients and physicians who were eager to blow the whistle on their harrowing experiences with drugs and medical devices that were falsely touted as safe. She effectively focuses on Dennis Fegan, a middle-aged former firefighter with epilepsy who battled increasing episodes of seizures. Through his story and those of others, the author shows how even cutting-edge clinical technology can fail patients. Ultimately culminating in a "complicated web of human error, corporate manipulation, and regulatory failure," Fegan's ordeal began with the head trauma he'd endured as a child after a car accident. Suffering seizures decades later, he agreed to the implantation of an FDA-approved, newly developed nerve-stimulating device; though initially hopeful, he experienced pain and further seizures almost immediately. The story unravels further to incorporate the "questionable tactics" of the device's blame-shifting, unscrupulous manufacturer and its representatives, nervous reshufflings of neurologists who treated Fegan, and his resultant near-death experience. As Lenzer paints this distressing picture through Fegan's tragic mishap and heroic crusade for justice, she also incorporates statistical data, a historic, representative sampling of medical drug and device disasters, and varied medical and patient perspectives on implantable devices. Reading like a cross between a riveting medical thriller and "a Kafka novel," the book is a powerful cautionary tale that reveals the problem as one of profiteering, regulatory negligence, and the marriage of medicine and technology that can spur both miraculous modern breakthroughs and nightmarish consequences for patients. The author closes with a series of reform action points.An impassioned exposé that uncovers a significant danger within the contemporary health care industry.

Kirkus Reviews

Oil worker Dennis Fagan's war against health industry practices began with deadly seizures linked, ironically, to the device implanted to ease his epilepsy. Journalist Jeanne Lenzer traces all the obstacles he encountered in trying to correct this problem, in the process revealing the lack of oversight in the medical device industry. Lenzer reads her investigation with passion, making it a call for reform of the health-care system. She voices contempt for revolving-door regulatory agencies with close ties to industry and praise for independent researchers. Lenzer's compassion for Fagan and others affected is clear in her voice. She stresses that medical devices, such as those intended for hip or eye lens replacement, can be necessary but shows the need to weigh the dangers and benefits carefully. J.A.S. © AudioFile 2017, Portland, Maine

DECEMBER 2017 - AudioFile

Oil worker Dennis Fagan's war against health industry practices began with deadly seizures linked, ironically, to the device implanted to ease his epilepsy. Journalist Jeanne Lenzer traces all the obstacles he encountered in trying to correct this problem, in the process revealing the lack of oversight in the medical device industry. Lenzer reads her investigation with passion, making it a call for reform of the health-care system. She voices contempt for revolving-door regulatory agencies with close ties to industry and praise for independent researchers. Lenzer's compassion for Fagan and others affected is clear in her voice. She stresses that medical devices, such as those intended for hip or eye lens replacement, can be necessary but shows the need to weigh the dangers and benefits carefully. J.A.S. © AudioFile 2017, Portland, Maine

DECEMBER 2017 - AudioFile