The Danger Within Us

November 1, 2017
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 expose that uncovers a significant danger within the contemporary health care industry.

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Starred review from November 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.”

Starred review from December 1, 2017
Beware the medical-industrial complex. Lenzer, a medical investigative journalist, powerfully details some alarming reasons hospital CEOs, insurance executives, and doctors become millionaires. The U.S. ranks number one in healthcare spending but number 43 in life expectancy, below Costa Rica and Cuba and just ahead of Lebanon. Why? Lenzer points to the explosion of high-priced medical technology; the 1965 passage of Medicare without caps on payments and the increase in private health insurers; and the Bayh-Dole Act of 1980, which rewarded commercial research at universities. Lenzer is a master of the show, don't tell rule of writing. To demonstrate how pricey implanted devices can cause life-threatening problems, she tells the story of Texas firefighter Dennis Fegan, who, at 42, got a vagus nerve stimulator meant to help with his seizures. Instead, it nearly killed him. A 2011 review found that 6.7-million people were implanted each year with the top 11 implanted devices. 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. (Reprinted with permission of Booklist, copyright 2017, American Library Association.)

Starred review from December 1, 2017

This engrossing and terrifying new book from award-winning medical investigative journalist and former Knight Science Journalism fellow 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. The details of the heavy influence of large corporations on the approval of medical devices and the inadequate oversight by the FDA are disturbing. The author intends this book to be an eye-opening warning to the public regarding the dangerously lax and industry-influenced approval process for medical devices, and she succeeds admirably. Lenzer manages to keep the reader engaged even when describing FDA approval processes in detail. While many textbooks about medical device safety and approval exist, no similar books written for the general public were found. Suitable for adult and teen readers. VERDICT Highly recommended for readers with an interest in the safety and efficacy of medical devices. [See Prepub Alert, 6/26/17.]--Stacey S. Hathaway-Bell, Lorenzo de Zavala State Archives and Lib. Bldg., Austin, TX

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