America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It
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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.

Pub Date: Dec. 12th, 2017
ISBN: 978-0-316-34376-3
Page count: 336pp
Publisher: Little, Brown
Review Posted Online:
Kirkus Reviews Issue: Nov. 1st, 2017


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