By: Jean Johnson for Medtech1
It’s been up, down, and around for technology aimed at treating severely depressed patients. The company Cyberonics, Inc. has manufactured an implantable device that stimulates areas of the brain affecting mood. Cyberonics’ stated goal is to offer new hope to thousands of patients so severely depressed that they have difficulty carrying out the activities of daily living and are often moved to try and take their own lives.
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The National Institute of Mental Health (NIMH) points out that depression and mania can often go together. Below is a list of symptoms adapted from NIMH.
Depression
Persistent sad, anxious, or empty mood
Feelings of hopelessness and pessimism
Feelings of guilt, worthlessness, helplessness
Loss of interest or pleasure in hobbies and activities that were once enjoyed, including sex
Decreased energy, fatigue, a feeling of being slowed down
Difficulty concentrating, remembering, making decisions
Insomnia or oversleeping
Appetite fluctuations that can lead to weight gain or loss
Thoughts of death or suicide, and attempts to take one’s own life
Restlessness, irritability
Persistent physical symptoms that do not respond to treatment, such as headaches, digestive disorders, and chronic pain
Mania
Abnormal or excessive elation
Unusual irritability
Decreased need for sleep
Grandiose notions
Increased talking
Racing thoughts
Increased sexual desire
Markedly increased energy
Poor judgment
Inappropriate social behavior |
Backgrounder
Advances in the field of implantable nerve stimulators for depression came about after the fact. Cyberonics was incorporated in 1987 to develop a device implanted in the chests of patients designed to control epileptic seizures. What the company found after 1997 when the US Food and Drug Administration (FDA) approved the stimulators for epileptics was that the implants that delivered frequent electrical impulses to the nervous system, particularly the vagus nerve, also improved mood in some patients.
The reports were not too surprising since earlier research has showed that stimulating the vagus nerve the way the Cyberonics implant for epilepsy does can help minimize severe depression. Indeed, the neurophysiologist who invented the stimulator during his tenure at Temple University in the 1980s, Jacob Zabara, PhD, was one of many to explore how implants capable of delivering jolts of electricity to the nerves can influence a range of emotional and physical attributes. Enter the brave new world of neurotechnology.
After epileptic patients reported mood elevation, Cyberonics started animal testing and began accumulating documents from patients attesting to the benefits of the implant on mood. Before long, Cyberonics was at the door of the FDA again, this time applying for use of the stimulator in patients with depression.
Cyberonics was successful to some degree, although it seemed for every two steps forward, there was the proverbial step back. In June 2004, the FDA’s advisory panel gave thumbs up to the device – but two months later, the agency took the unusual step of going against the panel’s recommendation. That sent a big enough flap through Congress so that by February 2005, the FDA rescinded its initial refusal, with several caveats related to follow-up studies. Cyberonics has finally worked with those parameters and is now moving forward. To date, 1,810 patients have had the vagus nerve stimulator implanted in their chests.
The only problem, according to some, is the company’s CEO, Robert Cummings. With his shaved head, black-rimmed glasses, and standard-issue shirt and tie, you’d never know the man was a line-backer at Dartmouth in his college days. You might also not realize at first glance that Cummings has been investigated by the Securities and Exchange Commission for stock options he was granted by the Cyberonics board of directors just before news of various breakthroughs became public knowledge. Indeed, Cummings’ questionable shares have earned him well over ten million dollars.
More, Cummings has adopted a strident attitude toward those who have been skeptical about the stimulator’s ability to successfully treat serious depression. In an email to the New York Times Cummings first branded those he disagreed with as “shrill,” and then issued the following dictum: “I look forward to the day when T.R.D. [treatment resistant depression] patients and fully qualified psychiatrists have the right to make treatment decisions regarding the ONLY treatment ever studied, proven safe and effective and F.D.A. approved for the long-term treatment of T.R.D.!”
Perhaps some of Cummings’ passion comes from his own history. His mother was severely depressed and succumbed to bouts of alcohol and drug addiction throughout his childhood. Thus, the man at currently at the helm at Cyberonics has experienced debilitating depression first-hand and knows how profoundly the disease can affect not only those who suffer, but family and friends as well.
How It Works
According to Cyberonics, severely depressed TRD patients who have not responded to more common therapies who have had the implants placed in their chests (since the FDA approved the device) are benefiting in varying degrees. Thousands more, according to Cummings, are in the queue – and frustrated by lack of insurance coverage.
For those who have had the stimulators placed in their chests, however, it’s still a long haul between hope and results. Even getting the system up and running is a job. First, there is the $10,000 surgery to place the $15,000 implant. A month later there is the trip into the office to activate the device. Once that happens, there’s the wait to see if the patient is among the 50 percent of those whose depression is lifted in some way from the stimulator.
Patients with Depression Are Cautiously Optimistic
For those who suffer, the gamble is more than worth the trouble. As forty-nine year old Joe Marhefka of Colchester, Connecticut, told the NYT, “When I had the implant last month, I was hoping I wouldn’t wake up.”
He added that, “I don’t have any hopes that this is going to work. I’m doing this because my wife deserves a husband and my two daughters deserve a Dad. They have hope. I’m just going along with the doctors.”
For her part, Ellen Thwaite of Los Angeles is watching the developments carefully. Thwaite has battled depression on and off throughout her life, and although she was suicidal fifteen years ago, she thinks she has come through the worst of it now.
“With a history like mine, you can’t help but be interested in this new technology even if it is a bit frightening to have something implanted in your body. I remember what it was like to go through those dark, dark days…all that business about depressed people not being able to keep up with their houses and grooming. That’s what I experienced at one point. I mean it was horrible. I was so sluggish and so sleepy and fatigued. And my mood, there was nothing that I found inspiring, even mildly so. Life was just this horrible, dull dream that I walked through day after day. I felt like a zombie and all I wanted to do was sleep so I could have relief.”
Thwaite explains that in her estimation, the world does not look kindly on victims of depression. “In many ways depression is one of the worst diseases there is out there. It carries such a stigma. It’s as bad as being fat, because it’s very difficult for people to have much compassion because the person suffering does not appear very lovable.
“I remember at some of my worst points, only longtime friends stood beside me – and even with them, they kept their distance,” she said. “Mainly I had to walk a long, lonely road pretty much alone.”
Thwaite says the depression she experienced probably wouldn’t be grouped with implant candidates, but that she can understand how desperately those patients need help. “That was the problem for me – my depression tended to get passed off as just me being bitchy or in a ‘bad mood,’” Thwaite said. “I only had a few severe episodes that lasted a few months each. Other than that it was more a low grade anguish that I lived with year in and year out – a level of depression that left me without much confidence or belief in myself.
“I was tongue-tied around people. I lost opportunity after opportunity for good careers. I made a mess of my family relationships. I never went on a vacation because what was the point – I’d have to take myself along and I’d ruin everything. But I was still able to carry on after some fashion. Still it was totally miserable, and if anyone had offered me an implant and even a shred of hope back then I would have grabbed at it.
“I guess what I’m saying is that I’m glad there is a chance that the implants might help those who have the worst depression, but that the rest of us who have been diagnosed would probably not turn down the chance to take advantage of this area of medicine if it ever comes our way. You know what I mean? Patients that are so bad they try to kill themselves do need help, I’m not denying it. But those others who limp along year after year are serious emotional cripples as well.
“Perhaps once they work all the kinks out of this, one day there will be more hope for everyone with depression. I certainly hope so and take my hat off to those who are trying to make some headway on this living nightmare.”
