The Danger Within Us

by Jeanne Lenzer

  Copyright © 2017 by Jeanne Lenzer

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  First Edition: December 2017

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  ISBN 978-0-316-34378-7

  E3-20171114-DA-NF

  Contents

  Cover

  Title Page

  Copyright

  Prologue

  Chapter One: Strange Seizures

  Chapter Two: Age of Miracles

  Chapter Three: Deadly Devices

  Chapter Four: The Man from Cyberonics

  Chapter Five: Adverse Events

  Chapter Six: No Safety Net

  Chapter Seven: Regulators in Chains

  Chapter Eight: The Power of Illusions

  Chapter Nine: The Quest for Truth

  Chapter Ten: When Money Talks

  Chapter Eleven: Breakdown

  Chapter Twelve: What Is to Be Done?

  Industry-Independent Organizations, Publications, and Patient Advocacy and Support Groups

  Acknowledgments

  Notes

  About the Author

  Newsletters

  Prologue

  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 m
edicine 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.

  Jeanne Lenzer

  Kingston, New York

  May 2017

  Chapter One

  Strange Seizures

  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 hal
f 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.