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The Danger Within Us
America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It
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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
WHEN I WAS STUDYING to be a physician associate (PA) at Duke University, I was taught to diagnose and treat common and not-so-common illnesses. As a practicing PA, I wrote prescriptions, performed minor surgical procedures, and made referrals to specialists. I thought that if I stayed on top of new developments in medicine, and was caring and conscientious enough, I could help people. I wouldn't harm patients. Certainly I wouldn't kill them.
I was wrong.
For years, I worked in rural emergency rooms, serving as the sole on-site medical provider for patients with everything from sprained ankles to heart attacks and major trauma.
When I saw patients with chest pain, I routinely ordered several drugs, including one called lidocaine, given to prevent or stop extra heartbeats known as premature ventricular contractions (PVCs). Although PVCs can occur occasionally in healthy individuals and aren't dangerous in themselves, they tend to occur more frequently in heart attack patients, and they have the potential to touch off deadly heart rhythms.
Lidocaine was widely seen as a lifesaving drug. Professional organizations such as the American College of Emergency Physicians and the American Heart Association (AHA) had issued guidelines recommending lidocaine for routine use in patients with acute chest pain.1 And like doctors across the nation, I had faith in the drug, not just because it was recommended but because I'd seen it save the life of a man too young to die.
Mr. R. was in his early forties when he was wheeled into the small rural ER where I was working as the medical provider along with two nurses. One of the nurses recognized him as a local firefighter. He had crushing chest pain and was sweating profusely. I saw the look of terror in his eyes and knew he was wondering, Am I going to die? Within minutes I had ordered oxygen, aspirin, nitroglycerin, and morphine for Mr. R. and was just about to add lidocaine when the alarm on his heart monitor suddenly emitted its high-pitched squeal. I looked up to see the fluorescent green tracing revealing a run of PVCs. I ordered the lidocaine, which the nurse injected into an intravenous line.
The first few minutes after a heart attack are always tense. If one of those PVCs touched off the deadly rhythm known as ventricular fibrillation, Mr. R. was likely to be dead within minutes. The nurse completed the injection. The PVCs persisted. As the alarm continued to screech, I felt beads of sweat collect on my upper lip. Finally the lidocaine took hold. The electrical storm was over. Mr. R.'s heart was beating normally. The alarm fell silent, and I exhaled.
The ability of lidocaine to magically erase these abnormal beats made me secure in the belief that I'd helped a patient cheat death. Over the years, I repeated this process for patients with chest pain many times. It felt good to save lives.
Until I found out I wasn't saving lives at all.
In the early 1990s, more than a decade after the AHA had recommended lidocaine for chest-pain patients, studies with disturbing results began to emerge. In 1993, one author wrote in the Journal of Emergency Medicine that although the drug could reduce PVCs, "overall mortality may be increased."2 A study sponsored by the National Institutes of Health called the Cardiac Arrhythmia Suppression Trial (CAST) found that, although oral drugs related to lidocaine, such as flecainide and propafenone, could suppress PVCs, if they did occur despite the medication, the PVCs were more likely to trigger deadly rhythms.3 Researchers found that the patients who'd been medicated were actually 3.6 times more likely to die.3 Thus lidocaine and related drugs could fix the PVCs but kill more patients than they saved in the process. To put it in the vernacular: the operation was a success, but the patient died.
When I learned about the lidocaine study, I was devastated. I was also fascinated. Could it be true that we were killing patients when we were eyewitnesses to so many cures? And if so, if we were really killing patients, why didn't we see the carnage we'd caused?
I began to search for answers. I stayed up late at night reading about clinical trials and statistics. I attended as many medical conferences as the dollars in my pocket allowed. The more I learned, the more obsessed I became. I wanted to know how and why it was possible for patients and doctors alike to become involved in this massive folie à deux, a dance in which everyone was convinced that the march of medical progress was saving lives even when it wasn't. How had the best and the brightest doctors, including the guideline writers at the American Heart Association, been fooled? And if we could be fooled by this class of drugs, how many other mirages were we chasing? How many more patients were we harming?
What I learned eventually led me to a very unusual doctor who was able to explain how and why medical illusions like the belief in lidocaine as a lifesaver arise: Dr. Jerome R. Hoffman, then a professor of medicine and emergency medicine at UCLA. Hoffman helped me understand how easy it is for healthcare professionals to make deadly errors despite their best intentions and advanced training, and I'll share a number of his insights later in this book. These revelations also led me to leave my career in medicine more than a decade ago to become an investigative medical journalist.
Since that time, and especially while writing this book, I've been stunned to learn how frequently complications produced by a medical treatment are mistaken for symptoms of the underlying condition—a phenomenon I refer to as cure as cause. The failure to consider a treatment or cure as the cause of a bad outcome means that when a patient dies following a heart attack, we assume that the death was due to the heart attack and not to the medicine we gave. Examples can be found in virtually every specialty, from emergency medicine to psychiatry, cancer care, infectious diseases, and more. Mistaking the ill effects of a treatment as symptoms of the condition being treated is an illusion that is both natural and understandable—and it's an illusion that the healthcare industry repeatedly exploits to reap enormous profits.
But I was in for yet another shock when I learned the untold story of medical devices and how they, too, can cause the very symptoms they are intended to cure. I began to delve into the rise of the medical device industry and its disturbing role in the healthcare business. Although many concerned citizens have grown distrustful of the pharmaceuticals industry, thanks to the high-profile exposés of dangerous drugs such as Vioxx and Avandia, the same skepticism is largely lacking about implantable devices—from simple devices such as the surgical mesh used for hernias and urinary incontinence to an array of more complex devices such as deep-brain stimulators; spine implants with biologically active bone stimulators; Wi-Fi-enabled pacemakers and defibrillators; breast implants; brain-fluid shunts; intrauterine devices; filters that catch blood clots on their way to the heart; lens implants for cataracts; cadaver bone used for dental surgery; artificial heart valves; gastric bands; artificial hips, knees, and elbows; hormonal implants; cochlear implants; radium seeds; stents to hold coronary, carotid, and renal arteries open; stents that release drugs; and more.4–11 The public and doctors often perceive these devices as advanced products of cutting-edge technology that are inert and so, unlike drugs, don't have serious side effects.
Nothing could be further from the truth.
The reality is that the Food and Drug Administration (FDA) does not require manufacturers to submit even a single clinical trial for the overwhelming majority of high-risk implanted devices it approves.12–14 * Whereas the standard for approval of a new medicine usually calls for two randomized controlled clinical trials, only 5 percent of high-risk implanted cardiac devices have even partially met that standard.13, 15 It's no wonder that many of the millions of patients who have been fitted with implanted medical devices have experienced little or no health benefit as a result—and that others have suffered serious, often fatal, complications from the implants themselves.
It wasn't long after I became known as a journalist that doctors and patients around the world began to contact me to share their experiences with unsafe drugs and dangerous devices. One story stood out—the story of a Texas man named Dennis Fegan who has spent years battling the after effects of a near-death experience linked to the supposedly safe medical device implanted in him by a well-intentioned doctor. I tell his story in this book not because it is the worst I've heard (it isn't) but rather because it reveals so much about what ails the medical device industry and, more broadly, the healthcare system in the US.
As Fegan's story weaves throughout The Danger Within Us, powerful doctors at the epicenter of modern medicine appear, offering profoundly conflicting views that go to the heart of the way healthcare is organized and our perception of what is science and what is illusion in medicine. One of these doctors, Eugene Braunwald, the father of modern cardiology and emeritus professor of medicine at Harvard, has made discoveries that affect millions of people around the world.16, 17 His career is emblematic of the changing face of healthcare and the emergence of what many call the medical-industrial complex, a network of wealthy and powerful institutions that has dramatically reshaped American healthcare over the past half century. Others, including Dr. Bernard Lown, a Nobel Peace Prize recipient and Harvard cardiologist,18–22 and Hoffman, emeritus professor of medicine at UCLA,23–28 have called for radical changes in our deeply flawed healthcare system. Their differing perspectives represent alternative future paths that policy makers, healthcare consumers, and concerned citizens urgently need to understand.
Many in the healing professions undoubtedly regret that their service to patients has become so enmeshed with the politics of healthcare and the ideological and partisan clashes it evokes. Yet from a broader perspective, such entanglement is all but inevitable. In the words of Rudolf Virchow, the brilliant nineteenth-century physician credited with bringing scientific rigor to medicine, "Medicine is a social science, and politics [is] nothing more than medicine on a grand scale."29
I hope the stories you'll read in this book will illustrate Virchow's insights, which suggest that we cannot achieve a healthy society solely through the application of medical and scientific knowledge and that we will need to address challenging questions about the organization of society, the distribution of resources, and access to information. The answers to these questions have profound implications about who we are as a people and what kind of society we want. Ultimately we have to decide whether healthcare should be treated as a commodity—or a common good.
Kingston, New York
DENNIS FEGAN WOKE UP with a start. He rolled over, pulling some covers with him as he scanned the darkness for his clock radio. Slowly his eyes focused on the tiny fluorescent lights telling him it was just a few minutes after 2:00 a.m. He flicked on a light, went to the laundry room, where he kept a calendar and a pen, and made a vertical mark under the date. It was July 2, 2006.
Fegan had trained himself to mark each seizure on his calendar to help his doctors manage his medicines. This night would prove unusually bad. He was awakened repeatedly by a pain in his throat. In a fog of fatigue and darkness, he eventually lost count of just how many seizures he had—but by morning there were a dozen marks on July 2, 2006.
Every Sunday for the previous fourteen years, Fegan, an imposing 48-year-old veteran of the hardscrabble Texas oil industry, had had brunch with his parents at the Town & Country Café in a small strip mall not far from Fegan's home, in Corpus Christi, Texas. This custom was his parents' way of keeping tabs on him ever since he'd been diagnosed with epilepsy. But that morning when his parents called, Fegan told them to go along without him. He wasn't feeling well. Nothing serious. He just needed to get some sleep. He didn't mention that he was having a bad run of seizures.
As they finished brunch at the Town & Country Café, his parents, seated in a booth and served by their favorite waitress, Colleen, decided to bring some food to their son. They ordered the breakfast Fegan loved—egg-and-potato taquitos—to go, then drove over to the working-class section of town where he lived.
Fegan's parents, George and Irene, had been born and raised in Texas. Like most of their neighbors, they were "good Republicans," no-nonsense people who raised their children in a strict Catholic household. George was a geologist with the sprawling Texas oil industry. He was proud of his work and grateful for the stable income it provided. He and Irene liked both Presidents Bush, and they didn't hold much truck with people who were always harping about excessive corporate profits and the need for social welfare. Fegan had followed in his parents' footsteps. The last president he liked or paid any attention to at all was Ronald Reagan.
Irene knocked on the front door of Fegan's small, neat ranch house. When she got no response, George banged on the door. Finally they dug up a spare key they had and cautiously let themselves in. As they reached the small dining room, Fegan staggered out of his bedroom looking dazed. He peered at his parents, sat down at the dining-room table, and abruptly lost consciousness. Unable to reach him in time, George and Irene watched helplessly as Fegan fell sideways off his chair, slamming his head hard onto the uncarpeted floor.
Within a few minutes, Fegan roused, got up, and sat back down in the dining-room chair. Then, as if in a movie set to run in a sickening continuous loop, his parents watched the same scene all over again: Fegan fell off the chair, this time slamming face-first onto the floor. Within a span of minutes, he awakened. Now fearful of another fall, he wiggled across the floor and propped himself up in a sitting position with his back against a wall and his legs splayed in front of him. His jeans were wet with urine. He looked half dead. And then he fell over again.
Fegan's cycles of passing out, waking up, and passing out again repeated like clockwork. His parents frantically dialed Fegan's neurologist, Dr. Juan Bahamon. Even though it was a Sunday morning, the doctor answered promptly and told them to dial 911 for an ambulance. He'd meet the family at the hospital. While they were waiting for the ambulance, Fegan told his parents he'd been having seizures since two that morning. Now, some ten hours later, Fegan's parents privately wondered how long he could last. They later learned their fears were not unwarranted.
By the time the ambulance arrived at Fegan's home, Irene and George Fegan had watched their son lose and regain consciousness at least eight times. The lead paramedic, believing Fegan was having seizures, injected diazepam, a drug commonly used to stop the life-threatening continuous seizures known as status epilepticus, directly into an intravenous line they'd placed in Fegan's arm. Surprisingly, the diazepam had no effect at all. Fegan continued to pass out and rouse at regular intervals. By then an ugly series of bruises was forming on Fegan's forehead from his falls. But the crew was too distracted by something else to pay attention to the bruises: when they hooked him up to a heart monitor, what they saw stopped them dead in their tracks.
Although he didn't yet know it, Dennis Fegan was already fatefully entangled in a complicated web of human error, corporate manipulation, and regulatory failure that would turn his life into a Kafkaesque nightmare—and that would encapsulate much of what is worst about the American way of healthcare.
* * *
The troubles of the US healthcare system are widely recognized. They have been the subject of countless articles, books, and television news stories. Politicians have debated their causes and possible cures for decades. Yet the seriousness of those problems, and the enormous price we pay in wealth, resources, and lives, are still not fully understood by most Americans. Consider a few of the appalling facts.
According to the Institute of Medicine (IOM), Americans today not only live shorter lives, they're also sicker than the people of virtually all other well-off nations.30 And according to the United Nations, the US ranks number 43 in life expectancy, below Costa Rica and Cuba and just ahead of Lebanon.31, 32 Life span has declined over the past two decades in the US for the first time since World War II.33 Now, in 43 percent of US counties, women are no longer living as long as their mothers.34–36
Personal habits such as smoking and drinking are part of the cause of our shorter, sicker lives, but only a small part: Americans smoke and drink less than people in a number of peer countries.37, 38 What the US does have compared to other wealthy nations are higher rates of violence, obesity, and drug use.30 Only three nations included in the IOM report have higher homicide rates than the US: Mexico, Turkey, and Estonia.30 But even these issues account for only a fraction of the excessive mortality in the US.
One huge problem is our squandering of resources on ill-advised treatments. The US spends trillions of dollars on healthcare each year, and 20 to 30 percent of that care is considered unnecessary.39–41 Many treatments do significant harm beyond wasting resources: medical interventions (including implantation of medical devices) are now the third leading cause of death in the US, killing an estimated 225,000 to 440,000 Americans each year.42 That's more deaths than from diabetes, murder, car accidents, and AIDS combined. By 2012, prescribed medicines, such as blood thinners and drugs for diabetes, were causing so many deaths that the nonprofit group Institute for Safe Medication Practices conducted a study to quantify the number of deaths and concluded that prescribed medicines are "one of the most significant perils to human health resulting from human activity."43 Although the precise number of deaths from medical error, drug and device complications, and overtreatment is subject to debate, even if the numbers were cut in half they would still comprise the third leading cause of death in the US.
We also have a problem unheard of in other wealthy nations: a large uninsured and underinsured population, which is associated with an estimated 45,000 avoidable deaths per year.44 Despite the promise of the Affordable Care Act of 2010 (often called Obamacare), unpayable medical bills continue to be the leading cause of bankruptcy in the US.45–47 As we spend more and more each year on healthcare, we threaten not only patients' lives but also their personal finances and the nation's economy.
The causes of these devastating statistics are numerous and complex, with roots in politics, economics, and social and cultural forces. But at the heart of the problem is the growing wealth gap, which has a profound effect on life span, and a massive healthcare industry that is sapping our economy.48–51 Healthcare is now the single biggest sector of the US economy. It is bigger than big oil, bigger than big banking, and bigger even than the famous military-industrial complex that President Dwight Eisenhower warned about in his farewell speech. In 2013, the most generous estimate pegged the price of the military-industrial complex at $1.3 trillion, while healthcare expenditures in 2015 were $3.2 trillion, consuming nearly one of every five dollars spent in the US.52, 53
We may be less healthy and long-lived than the people of dozens of other nations, but in one respect America comes first: we are number 1 in healthcare spending, far surpassing all other countries.
The poor performance of US healthcare strongly suggests that we are not getting what we should in exchange for this massive investment. And the wealth and power of the healthcare industry helps to explain why this is so. Over the past two generations—since the late 1960s—American healthcare has gradually been transformed from a relatively modest professional endeavor ruled mainly by traditional ethical norms governing independent doctors into a vast network of institutions dominated by for-profit corporations whose chief loyalty is to their shareholders and nonprofit organizations that function much as for-profit entities do.
While universities, government agencies, and some not-for-profit organizations such as certain hospitals and clinics continue to play an important role in developing, regulating, and administering healthcare treatments, they have been increasingly forced to follow the dictates of for-profit medical groups, hospital chains, insurance companies, drug manufacturers, and medical device makers, whose huge economic footprint translates into enormous political clout. Taken together, this interlocking network of organizations makes up the medical-industrial complex. In October 1980, Arnold Relman, then editor of the New England Journal of Medicine, described "The New Medical-Industrial Complex," comparing it to the military-industrial complex, and said it posed "troubling implications."
The birth of the medical-industrial complex can be traced in part to the explosion of new healthcare technologies beginning in the 1950s and '60s, an era of healthcare innovation marked by the development of the first vaccines against polio, measles, and mumps.54 The cardiopulmonary bypass machine first came into use in the early 1950s. Pacemakers, hip replacements, organ transplants, polymerase chain reaction, DNA fingerprinting, gel electrophoresis, stents for heart disease, and stem-cell therapy were all developed after 1960. CAT scans and MRIs were first performed on humans in 1971.55 Commonly prescribed drugs exploded from a mere handful to many thousands, aimed at treating everything from high cholesterol to infections, restless leg syndrome, balding, overeating, and cancer.
Some of these innovations offer amazing benefits to the victims of age-old afflictions. Certain childhood forms of leukemia are now curable.56 Infections that were previously life-threatening have been transformed into minor inconveniences. Diseased and worn-out human hearts, livers, and lungs can be replaced or transplanted. The discovery of stem cells, the primordial cell type that gives rise to every other cell type—from hair to brain to liver and nerve—has brought researchers around the world close to developing lab-grown organs of every sort. Doctors have successfully implanted lab-grown skin, corneas, and bladders into human patients.
Some of the most recent breakthroughs have been so dazzling that they strain credulity. When an Internet image of a mouse growing a human ear on its back went viral, some viewers said it must have been digitally altered. It wasn't. The hairless laboratory mice running around in cages with ears on their backs were developed by Robert Langer, an MIT researcher, and Dr. Joseph Vacanti, director of the Laboratory for Tissue Engineering and Organ Fabrication at the Massachusetts General Hospital, in Boston.57 The human-size ears, which take up almost the entire back of a mouse from neck to tail, begin life as a biodegradable ear-shaped scaffold, which the researchers seed with bits of cow cartilage. The structure is surgically implanted under the skin of "nude mice." The ears can be made to order for shape and size to match the needs of the human recipient.
The growth of complex body parts took a giant step forward in early 2008, when Doris Taylor created the first beating lab-grown heart.58 Like Vacanti, she created a scaffold by dissolving the cellular material of a rat heart, then placing a mix of heart stem cells on the matrix. With careful environmental controls, the cells not only began to beat, they also even grew their own blood supply. "It's gorgeous," Taylor said of her creation. "You can see the whole vascular tree, from arteries to the tiny veins that supply blood to every single heart cell." By coupling lab-grown hearts with pacemakers, she hopes to create a supply of made-to-order, rejection-free human heart implants—a salvation for thousands of people who die each year while awaiting traditional transplants.
- "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
- On Sale
- Dec 12, 2017
- Page Count
- 336 pages
- Little, Brown and Company