Research was so different at that time. From the conception of the idea at Rochester to the time the first patient was implanted was six weeks. Now it would probably take six years going through committees and through all sorts of hurdles. Anyway, it helped. It was an excellent way for patients to turn the stimulator on themselves.
In a gutsy experiment in 1967, Braunwald became the first doctor to implant humans with a medical device—a prototype of the VNS—to treat angina.
Within months of his visit to the Schwartz lab, Braunwald published an article in the New England Journal of Medicine describing the “striking relief” experienced by two men in their fifties, an artist and a drug salesman, after he implanted them with a stimulator device. The very next year, in 1968, one of his patients with a stimulator came to the clinical center at the National Institutes of Health with severe chest pain. Worried that the man was in the throes of an impending heart attack, Braunwald cautioned him not to activate his stimulator. He worried that turning the device on during an actual heart attack—as opposed to when he was experiencing uncomplicated chest pain—could increase the likelihood of dangerous heart rhythms. To Braunwald’s chagrin, despite “evidence of an ongoing heart attack,” his patient “didn’t listen” to his advice. He recalls:
When I came to see him in the coronary care unit I found he had it on, and I turned it off. I came back to see him about every twenty minutes, and several times I found that he turned the stimulator on, and I would turn it off. Finally I took the stimulator away from him. I said, “This isn’t helping you.”
That evening, Braunwald was reviewing his patient’s EKGs when he noticed something strange. When the stimulator was off, the patient had signs of severe ischemia, or impending heart attack, but when the patient turned it on—against Braunwald’s explicit instructions—the EKG became “almost normal.” “So he was right and I was wrong!” he mused. Braunwald compares a heart attack to a light switch. Until that time, in his analogy, doctors viewed a heart attack as causing immediate and permanent damage that could be neither limited nor reversed—much like a light switch that is flipped off. But what he learned from his wayward patient, and the fact that his EKG improved when the stimulator was turned on, was that ongoing damage from a heart attack could be limited. He concluded that maybe a heart attack was more “like a dimmer switch” that offered a window of time during which doctors could “resurrect” the heart.
Although Braunwald’s electrical device would ultimately fail as a treatment for angina, it provided the conceptual basis for the VNS device that was implanted in Dennis Fegan to control his seizures. Cyberonics, the company that won a patent for this device, cited Braunwald’s work in dozens of patent applications. The company wanted to use the device to treat not only seizures but also everything from depression and obesity to drug addiction, anxiety, hypertension, and hiccups.77
Once the device was on the market, many patients with seizures and their neurologists would praise it as miraculous. One caretaker of a patient implanted with a VNS device reported that any time the patient began to have a seizure, all he had to do was turn the device on, and the seizure would stop immediately. He said, “It works really well; it’s like magic!”
Braunwald’s discovery of the therapeutic power of vagus nerve stimulation—and the ability of a company like Cyberonics to harness that power in the form of a patented device—is a classic example of the innovative capabilities of the medical-industrial complex. Brilliant scientific insight, well-honed medical instincts, groundbreaking research, and the entrepreneurial quest for profit came together to produce a technological breakthrough that appeared to benefit many thousands of patients with a host of varied conditions.
Unfortunately, for many people like Dennis Fegan, the story doesn’t end there.
Chapter Three
Deadly Devices
FOR THE FIRST FEW months after Dennis Fegan had the VNS device implanted in his neck in 2000, he thought it was working well—a typical “honeymoon period,” as he would later describe it. He was having somewhat fewer seizures, without any apparent side effects from the device. But slowly the seizures resumed, and soon they were just as frequent and as bad as ever. Even worse, he began to develop new symptoms. The first thing he noticed was a change in his “aura”—the visual, auditory, and tactile sensations that can herald the onset of seizures. In the past his auras had varied, in keeping with the variety of temporal seizures. Sometimes the aura would feel like a grain of sand flicking over his face. At other times he couldn’t describe how he knew a fit was coming except to say that a certain feeling would come over him.
One thing was consistent, though: his auras had never been painful. But several years after he was implanted with the VNS device, he began to have a painful sensation in his throat right before his seizures hit. When the pain started, he knew he had only fifteen seconds before he’d lose consciousness. “I’d feel like I was choking. Then I’d cough, and the next thing I knew I’d pass out and wake up on the ground.”
Along with the change in his aura, the period after his seizures changed. Normally, if he lost consciousness, he would have a typical after-seizure syndrome known as a postictal state, the hallmark of grand mal seizures. During the postictal state, he’d be profoundly tired, groggy, and confused. The symptoms would clear gradually over an hour or two. Now he was finding himself suddenly sprawled on the floor but wide awake, with no grogginess or confusion.
From his reading about epilepsy, he knew that a certain rare type of seizure, known as a drop or atonic seizure, could cause people to abruptly drop to the ground and recover almost immediately.78 Such seizures are caused by a sudden break in the electrical impulses from brain to muscle, impulses that are necessary not only to spark muscles to contract but also to give them their tone, even at rest. Without these impulses, muscles abruptly stop working, and the affected individual simply goes limp, like a human rag doll, and drops to the floor, sometimes causing serious injuries. Occasionally, the only muscles affected might be in the head and neck, causing the eyelids to droop and the head to flop forward on the chest. Typically the episodes last from mere seconds to a minute or two, and the individual remains conscious.
Fegan told Bahamon about his new aura, the throat pain, and the drop seizures. He wasn’t overly concerned when Bahamon didn’t provide any insight or specific new treatment for his symptoms. As Fegan says, “I had lots of different types of seizures. That’s what temporal lobe epilepsy is like. So I just figured I was having a new type of seizure.”
But there was a puzzling aspect to his new seizures. Drop seizures are generally abrupt and give no warning. There is no aura, so the fact that Fegan was having what seemed to be a new type of aura consisting of throat pain and a cough before his seizures was mysterious. Another unusual development was that he was losing consciousness, which isn’t common with drop seizures. These odd symptoms were pointing to something else entirely, but at the time, neither Fegan nor his neurologist had any idea what.
Finally, in late 2004 or early 2005, he’d had enough. Although Fegan could turn off the device temporarily with his magnet, he asked his neurologist to permanently disable the VNS with the programming wand. It wasn’t preventing his seizures, he was still on a boatload of medicines, and he just wanted the damned thing turned off. Even though the VNS had been implanted more than four years earlier, his neurologist suggested that he give it more time. The manufacturer, Cyberonics, claimed it could take a year or two for the device to help. Maybe Fegan’s was just taking longer to kick in.
In June of 2006, six years after the device was implanted, he had one of his new “drop attacks,” taking a hard fall that crushed the bones in his left wrist. The surgeon said he’d have to wait for the swelling to go down before he could have surgery to insert a metal plate to hold the bones together.
About six weeks before the fall, he’d been started on Inderal, a medicine to treat tremors caused by his seizure meds. Inderal can slow the he
art rate and lower blood pressure, especially at high doses. If the pulse or blood pressure drops far enough, it can cause light-headedness or fainting. But there was no evidence that the Inderal, which Fegan was taking in low doses, was causing his heart to slow or his blood pressure, which had been a bit high, to drop. And his drop attacks had started before he was placed on Inderal. So with nothing to suggest that the drug was causing a problem, his doctor continued Fegan on the medicine.
It was then, less than two weeks after his fall, and before his wrist surgery was scheduled, that Fegan’s parents went to his house to drop off his egg-and-potato taquitos and found him, as we saw, in very bad shape, repeatedly losing consciousness, at which point he was taken by ambulance to Corpus Christi Medical Center.
Dr. Larry Johnson, the doctor on duty at the Corpus Christi Medical Center ER on Sunday morning, July 2, 2006, says he remembers Dennis Fegan more clearly than any other patient he has treated during his thirty years as an ER doctor.79 When he first saw Fegan, he thought he was in status epilepticus—a state of continuous seizures. He had powerful drugs he could administer to stop the seizures, and the first-line drug for status is diazepam (Valium), which the paramedics had already given him intravenously. Despite the medicine, Fegan kept passing out. The outlook was not good.
While examining Fegan, Johnson looked up at the sound of an alarm and was startled by what he saw on Fegan’s heart monitor: the steady blip-blip-blip of heartbeats scrolling across the monitor was followed by a long flat line, which had triggered the monitor’s high-pitched wail. It was the sort of flat line shown on television dramas that signals that a patient has just died. Fegan was going into asystole (pronounced “a-SIS-toh-lee”), meaning that all the electrical activity of his heart was stopping. And it was stopping for so long that Fegan was passing out—not from seizures but from lack of oxygen to the brain.
Johnson recalls, “He would seem to be trying to clear his throat by coughing. Then he would become pale and unresponsive to any stimuli.…He was in complete asystole. I remember striking him on the chest to attempt to jolt his heart into beating again.”
In television shows, patients are dramatically saved with a jolt to the chest, but in real life, even immediate emergency care by doctors rarely saves a patient whose heart has flatlined. And Fegan kept going back into asystole. Johnson recalls his fear that he was not going to be able to save this seemingly healthy man who was too young to die. Individuals with epilepsy are two to three times more likely than individuals in the general population to die early. Seizure-related deaths can result from status epilepticus or from a disorder known as sudden unexpected death in epilepsy (SUDEP), which tends to occur in the aftermath of a grand mal seizure, particularly in individuals whose seizures are poorly controlled.80–83 Estimates of the rate of SUDEP vary widely, depending on a person’s age and other factors, and the exact cause of SUDEP is uncertain. Experts theorize that it could be caused by sudden cessation of breathing or heartbeat caused by deranged brain function. Had Fegan died that day, as it seemed likely he would, Johnson might very well have cited SUDEP as the probable cause, not knowing how else to explain the heart stoppages. Luckily, as Johnson watched Fegan’s heart monitor, he noticed a curious thing: Fegan was lapsing into asystole at precise three-minute intervals. Johnson didn’t know anything about Fegan, his history, or about the VNS device implanted in his chest. Emergency doctors don’t have the privilege of learning about patients in critical condition before they treat them. Serious injuries from car crashes, gunshot wounds, and knife wounds have to be treated. Hemorrhages have to be stopped. And hearts that aren’t beating must be restarted.
Johnson called in a cardiologist who came to the ER. Fegan’s neurologist, alerted by his family, was on his way as well. All three doctors stood watching the monitor, and all witnessed the strange phenomenon: every three minutes, Fegan’s heart flatlined. As the doctors conferred, something Bahamon told them made the diagnosis clear: Fegan’s VNS device was set to fire at three-minute intervals.
The doctors came to a sudden, startling conclusion. What had looked like seizures was actually a side effect of Fegan’s VNS device.
One of the main functions of the vagus nerve is to slow the heart rate. Now the device was doing its job with deadly efficiency: each time the VNS fired, it was not just slowing Fegan’s heart rate, it was also causing his heart to stop altogether. The VNS had to be turned off—and fast. It was impossible to tell how much longer Fegan could withstand the episodes of asystole.
Bahamon was unprepared for this new diagnosis. When Fegan’s parents called him, he was told Fegan was having seizures. He didn’t suspect a problem with the device and didn’t bring the programming wand to turn it off. Wanting to stay with his patient, he turned to Fegan’s mother, who’d arrived minutes earlier. Could she run to her son’s home to get Fegan’s magnet? The magnet, used to activate the VNS, couldn’t turn the device off permanently, but it could disable it temporarily. Irene raced out of the ER and headed back to her son’s house.
When Fegan was brought in by the ambulance crew, Johnson had immediately ordered blood tests, drug levels, and a twelve-lead EKG. The tests would tell him if Fegan had suffered a heart attack or had liver, kidney, or thyroid dysfunction. Now the results were coming back. Fegan’s complete blood count and electrolytes were normal. The level of valproic acid (a medicine to treat seizures) in his blood was in the therapeutic (correct) range. His blood oxygen level was normal. With no underlying problem to treat, there was nothing else to do.
Johnson recalls the tense vigil as the doctors waited for Fegan’s mother to return with the magnet. The minutes ticked by. They watched helplessly as Fegan continued to lose consciousness and Johnson continued to attempt resuscitation, knowing that with each new episode of asystole, Fegan’s chance of survival was becoming vanishingly small. Finally the wait grew to be too much for Bahamon. He decided to risk leaving his patient’s bedside and raced back to his office to retrieve his own wand. When he returned to the ER, Johnson was still doing everything in his power to keep Fegan alive. Bahamon took out the wand, pressed it against Fegan’s chest, and within a minute, the device was off. Fegan’s “seizures” and asystole immediately stopped. Once the doctors realized that his heart was beating normally and their patient was safe, Johnson had him moved to the hospital’s intensive care unit to recover. All three doctors documented the link between Fegan’s asystole and the VNS device, indicating that his “seizures” stopped as soon as the device was deactivated. Fegan would have no further episodes of asystole.
Fegan doesn’t recall much about the day he was brought to the ER. Nor does he remember Johnson striking his chest in an attempt to get his heart restarted. But he does recall waking up in the intensive care unit and learning something that left him puzzled. “I saw someone standing at my bedside staring at my heart monitor,” he says. “I didn’t know who I was talking to, but I knew he was a doctor. I asked if I had a seizure, and he said no. So I asked what happened, and he said I had ‘heart stoppages.’ I didn’t know if I heard him right. I said, ‘Heart seizures?’ And he said, ‘No. Heart stoppages.’ Then he introduced himself and told me he was a cardiologist. I was surprised because I knew I’d never had heart problems.”
Fegan didn’t learn why he’d had the “heart stoppages” until a day later, when Bahamon came to see him. “He told me that he had to go to his office to get the equipment to disable the vagus nerve stimulator, and once he did that [the “seizures”] stopped. He told me he just got off the phone with Cyberonics. He said he told them he was going to report what happened to the FDA.” The FDA is the US government agency charged with regulating the manufacture and sale of medical devices.
When Fegan realized that the device in his chest had nearly killed him, he was confused. He thought back to his earlier seizures. They had started to change between six months to a year earlier, and he had told Bahamon about his new symptoms. How many times had he thought he was having seizures when
it was really the device making his heart stop? How long had his “cure” been putting his life in danger?
Unbeknownst to Fegan or his doctors, his hospitalization for asystole would prove to be just the beginning of a downward spiral that would culminate in a horrifying and very public event.
* * *
Dr. Eugene Braunwald’s 1967 experiment with electrical stimulation of the vagus nerve was the scientific breakthrough that would lead decades later to the implantation of Cyberonics’ VNS device in Dennis Fegan’s neck. But that connection would never have occurred without the complex web of scientific, economic, social, and political trends that, taken together, tell the story of the rise of the medical-industrial complex in the post–World War II US. Those interlocking interests would continue to ensnare Fegan again and again, long after he was hospitalized with “heart stoppages” in 2006. And it was that same web that would ultimately lead to Fegan’s unraveling years later.
Three historical developments lie at the center of the rise of the medical-industrial complex: the explosion of medical technology beginning in the 1960s; the passage of Medicare in 1965, along with the proliferation of private health insurance; and the Bayh-Dole Act of 1980. Together these three developments drove the corporatization of medicine, with profound implications for the way healthcare is promoted, practiced, and regulated in the US.
The first development in this triad was the availability of new technologies that began to pour onto the market, such as bone-marrow transplants and cardiopulmonary bypass machines. But with new technologies came medical price tags beyond the reach of the average citizen. Prior to the mid-twentieth century, few US citizens had health insurance. Nor did they need it, in most instances. In the early 1900s, patients paid their doctors with a few dollars or by barter, with gifts of, say, chickens, or occasionally by performing a chore.84 Hospital care was cheap, since hospitals had little to offer besides beds to rest in, nurses who could watch over patients following a heart attack, and maybe cheap antibiotics for the treatment of pneumonia. The primary expense of being sick wasn’t medical care, it was loss of income.85 A 1919 state of Illinois study found that lost wages cost workers four times as much as their medical expenses did.86
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