“I just want the thing out,” says Jim*. “It could be harming my brain and it’s certainly doing a lot of psychological harm to me. It’s a very real presence and I can feel the wires under my skull and at my neck. After two years of this, I just want to be done with it.”
Jim is talking about a deep brain stimulator, a remote control implant that delivers chronic electricity to the brain. Jim received the implant on June 2013, at UCLA, as part of an experimental clinical trial to treat severe depression. (Jim is a pseudonym, as he asked that we not use his real name.)
Globally, at least 272 people around the globe have received experimental implants to treat psychiatric disorders, according to a recent meta-analysis of published trial data of individuals with depression, OCD and Tourette’s syndrome. The trial that Jim participated in is called The Broaden Trial, a multi-center experimental device study that began in 2008, and at its peak included 128 patients at 15 different institutions in the United States. It was called Broaden in reference to both the large number of centers and participants involved in the trial, and the area of the brain where the implant is placed, the Brodmann Area 25, an almond-sized part of the cerebral cortex thought to be implicated in depression.
The experimental trial was sponsored by St. Jude Medical, a Minneapolis-based medical device company that specializes in heart pacemakers. The company was looking to expand its product line to include a neurostimulation device called “Libra.” St. Jude’s primary competitor, Medtronic, has had an FDA-approved DBS implant to treat essential tremor since 1997, for Parkinson’s since 2002, and under a “humanitarian device exemption” for dystonia since 2003 and for OCD since 2009.
However, since the Broaden Trial began, no device companies have received FDA approval for depression, though a handful of experimental studies have been conducted in Europe and North America for depression, OCD and Tourette’s syndrome. The Broaden Trial was scheduled for a year-long follow-up, and DBS recipients were invited to participate in an additional four-year follow-up study so that the sponsors could continue to investigate efficacy and safety. Participants enrolled in the followup trial would also receive continued monitoring and medical care by trial doctors, including so-called “dosing” changes to the electrical implant, and replacement of any faulty DBS parts, particularly the battery-powered chest “pacemaker,” which can run out of power in as little as ten months, necessitating replacement surgery.
Insertion of the DBS device into Jim’s brain involved a complex day-long brain surgery at UCLA. To start, his brain was scanned with an MRI so that the specific target, also known as the subgenual cingulate gyrus (Cg25), could be anatomically located. Next, his head was shaved and a stereotactic frame was bolted into his skull to help the surgeon target the desired brain region for the implant. Then the surgeon drilled two holes through the bone in his skull, just above the hairline, and with a surgical cannula, inserted the device’s two spaghetti-sized wires–each attached to four ‘electrode contacts,’ all of which can deliver up to 10 volts of electricity–into both hemispheres of his brain until those electrode contacts, each measuring 1.5 millimeters, reached the anatomical targets. Then the two brain implants were connected to two sets of wires that were tunnelled back through the brain to the skin just beneath his scalp, and around the back of his ears and down his neck to his chest.
A second surgery in his chest was done to install an internal pulse generator under the skin, called a brain pacemaker because it serves as the electrical engine that delivers electricity via wires to the brain implant. The specific voltage for each of the eight electrode contacts are set by an external remote control computer programming device, the settings of which are controlled by a medical specialist.
A video of the DBS surgery, on a patient with Parkinson’s (Warning: graphic content)
The electrical implants aren’t turned on to provide chronic brain stimulation until two weeks after DBS surgery, which allows the brain to heal from the trauma of the surgery, which causes inflammation and brain shift of up to six millimeters. This “brain shift” results when impact to the head causes one lobe to shift beyond its midlines, pressing into the other lobe and the confines of the skull.
DBS surgery comes with a host of other potential surgical risks, including:
- up to an 8% risk of bleeding in the brain that can lead to permanent deficit, or death 1.1% of the time.
- an 8% chance of stroke or permanent neurological deficits.
- a risk of infection of up to 15%.
- 5% risk of hemorrhage.
- 2% risk of seizure.
- the potential for air to enter the brain, and leakage of cerebrospinal fluid or brain fluid.
‘Hardware-related’ complications are also possible (including breakage or migration of the implant’s wires or electrodes), all of which could necessitate additional brain or chest surgeries, including device wire fractures that make it impossible for the pacemaker to deliver electricity to the contacts in the brain.
The fact that Jim, a 48-year-old attorney, was willing to undertake such an invasive, complex and risky brain surgery illustrates just how desperate he’d become to find some method of curbing his debilitating treatment-resistant depression. “At that point I was in the midst of a severe episode of depression, the most severe I’d experienced,” says Jim. “It had all but completely shut me down. My psychiatrist is great and I had a lot of faith in him. We’d tried everything there was, over 40 different meds over the years, and nothing worked. I’ve also spent years doing cognitive behaviour therapy. I even did ECT in 2000 and I didn’t want to go through that again – the memory loss and cognitive issues were too high of a price. I had 26 ECT treatments and the result was significant memory loss; I don’t remember my wedding, September 11th. I didn’t want to do that again. So in 2013 my psychiatrist told me about the surgery. I thought, ‘Before I check out, I’ll try this – I’ve got nothing to lose. I never like to think of myself as actively suicidal but I didn’t think I’d come out of this one.”
Jim survived the surgery, and two weeks later, he returned to UCLA to have his first implant programming session. The trial was blinded for the initial six month duration, so that only one investigator involved in the trial knew whether Jim was in the active stimulation ‘on’ group or the ‘off’ control group.
“I thought I was ‘off’ because I had no benefit,” says Jim. “I was still struggling with depression and suicidal feelings.”
Jim also had a number of adverse effects that began post-implant. “I had severe mental fogginess, trouble reading, concentrating, focusing, doing my job—tasks I’d done before almost in my sleep. I had to apply for disability. I had a profound feeling of disconnection with reality, disconnection from the world around me, and anhedonia – that’s an inability to feel pleasure, motivation, anticipation, even from things you enjoy doing. I had some anhedonia before the surgery, but not to that extent. It was a lot worse after DBS. I felt very different, the changes felt internal – the innermost workings of your brain. I’d never felt like that before.”
The Theory of DBS
Proponents of DBS still have no idea about why DBS might provide a benefit, or its possible “therapeutic” mechanism of action, even though it has been researched since the ‘80s. Studies have described phenomenon that point to inhibition or enhanced neuronal activity, and excitation of brain cells. Tests have shown that stimulation at each of the four contacts, at one volt, can stimulate neurons and brain tissue two millimeters from the contact, and at a 10 volt setting, can stimulate neurons and brain tissues up to 6 millimeters away. For the Broaden trial protocol, Jim says that only the two middle contacts on each side of the brain were turned on during the trial to target the Cg 25 area as precisely as possible.
Whether Jim’s DBS was ‘off’ or ‘on’ and exciting or inhibiting his brain, he had no benefit from the depression. However, his adverse cognitive side effects—and similar adverse effects experienced by two other Broaden trial DBS recipients that I interviewed for this article—could point to an inhibiting effect, which was actually the initial rationale for DBS in depression. The effect is also reminiscent of the cognitive blunting experienced by lobotomy patients, which was introduced in the mid 1900s.
After a surge in popularity in the 1940s, lobotomy subsequently fell from grace and came to be seen as a mutilating procedure. However, psychosurgery—the destruction of brain tissue—never completely disappeared, and it went through a comeback phase in the 1990s, particularly at a handful of medical centers that have since become the primary proponents of DBS, implanting the device in the same brain regions targeted with psychosurgery. The primary objective with modern psychosurgery is to lesion the brain target by burning or cutting the brain tissue.
For depression, various parts of the brain may be targeted, including the cingulate gyrus, a part of the brain in the cerebral cortex just above the Cg25 area. DBS was assumed to be a better method for inhibiting activity than permanent lesioning, because the intervention is potentially reversible by removing the DBS device. But so-called “microlesions” from the surgery and the implant are also evident in DBS recipients. Long-term studies conducted with DBS recipients for Parkinson’s—so far more than 100,000 people, with an efficacy rate of approximately 50%—have also documented DBS-related scar formations in the brain. Numerous studies have also documented many serious adverse mood, behaviour and personality changes. These include suicide, depression, apathy, fatigue, mania and serious impulse control issues, such as hypomania, aggression, addiction (to gambling, shopping, drugs, alcohol) and hypersexuality, sometimes resulting in criminal behaviour, including pedophilia.
Moreover, the risks with DBS for psychiatric disorders are likely to be more pronounced than with Parkinson’s. With the latter disease, the brain’s movement centers are targeted with a DBS implant. But with DBS for psychiatric disorders, the targets are in the cerebral cortex, known as the brain’s CEO, because it handles a wide range of executive cognitive functions such as learning and sorting and rationalizing input from other parts of the brain and from the external world. The cerebral cortex is also known as the seat of personality, and has been linked to mood, behaviors, decision-making and impulse control.
The Broaden trial targeted a small area in the Brodmann region of the cerebral cortex, a vast network that governs sensory, visual and motor skills, along with a grocery list of cognitive, behavioral and mood-related functions. The specific target, the Cg25, has been linked to self-esteem, motivation, reward-based thoughts and behaviors and moral decision-making. It is also dense with neuropathways to other brain regions in the limbic system, a part of the brain that regulates emotions, memory and other autonomic functions (appetite, sleep, circadian rhythm), including the hypothalamus, the amydgala, the hippocampus and the insula. Clinical studies have linked tissue damage in the Cg25 with disinhibition, which is associated with frontal lobe brain damage causing poor impulse control.
Post-op PET brain scans done on the first patients involved in a pilot study investigating DBS of the Cg25 for depression (six people involved in a Canadian trial, the results of which were published in Neuron, in 2005) showed activity decreased in the Cg25, which was interpreted by these researchers as a positive inhibiting effect. Yet blood flow increased elsewhere, particularly the brain stem, where the body’s most crucial survival mechanisms are regulated, like heart rate and breathing as well as anxiety and euphoria. Other neuroscientific studies have linked these various blood flow changes to mania, dementia and serious psychiatric personality disorders including psychosis and dissociation.
St. Jude Medical promotional video of DBS
The Broaden trial consent form included some information about potential adverse effects, but these were called “rare complications” in mood and personality, described as apathy, suicide, attention deficit, anxiety, ruminativeness, hypomania, mania, panic attacks, OCD and psychosis. Monitoring of these adverse side effects is crucial, though papers published by concerned medical specialists have criticized previous clinical trials for focusing almost exclusively on efficacy and neglecting safety issues and adverse effects reporting, or dismissing these negative effects as side effects of depression, particularly suicide rates. Broaden trial participants were required to visit the study center every two weeks for two months, then monthly for the remaining blinded four month period (to discuss any complications, do mood assessments and ‘memory/cognitive function’ tests, receive device programming changes to ‘optimize’ therapy). At six months, all trial participants started receiving stimulation and had monthly followup visits for a year. But during the long-term followup phase, a time when adverse effects often emerge, the participants checked in only once every six months.
Jim had no clue that six months into his trial participation, St. Jude Medical, the trial sponsor and maker of the DBS implant, terminated the trial after it failed to reach its benchmark of a 50% response rate according to the Hamilton Depression Scale. St. Jude released no public information about the trial’s termination (and still hasn’t), but the news was first reported by the editor of Neurotech Reports, in December, 2013, saying that St. Jude had made the an unofficial announcement about the trial’s termination at the annual meeting of the North American Neuromodulation Society. This is an organization of doctors and manufacturers of DBS devices, and also of business investors with an eye on the neuromodulation market, which is estimated to be $3.6 billion this year, and forecasted to grow by at least 11% by 2020.
When the blog “Neurocritic” posted a piece about the trial’s end, in January, 2014, a handful of Broaden trial participants posted their comments and concerns on the blog. Some had benefited from the DBS, while others reported serious adverse effects, but regardless of outcomes, all commenters expressed deep concern that they would be orphaned by the trial sponsors and by the medical specialists charged with their followup care.
Some additional insight about the trial’s termination came six months later, in an academic paper published in a July 2014 issue of Neurotherapeutics, authored by University of Florida College Of Medicine specialists in DBS. According to a letter from St. Jude’s clinical study team, a statistical futility analysis done after 75 patients reached the six-month post-op followup, predicted “the probability of a successful study outcome to be no greater than 17.2%.”
Media Hype Preceded the Blackout
The lack of public information provided by St. Jude is in stark contrast to the publicity that DBS for depression began generating in 2006, soon after the initial results of the Canadian pilot trial, which by that point included twelve patients, were released. A New York Times Magazine article titled “A Depression Switch” included amazing stories of recovery for eight of the 12 patients, along with quotes from the two primary investigators. Neurosurgeon Dr. Andres Lozano called the targeting procedure “quite easy,” and neurologist Dr. Helen Mayberg said that the surgery was “fixing the circuit” related to depression.
Doctors unaffiliated with the study were also quoted as praising the study results. “This just makes so much sense… the weight of the results is so sizable,” said Dr. Antonio Damasio, a University of Southern California neurologist. Meanwhile, Thomas Insel, director of the National Institute or Mental Health, suggested that a breakthrough in depression treatment might be at hand. “Here we know enough to say this is something significant. I really do believe this is the beginning of a new way of understanding depression.” The Times reporter also noted that “the treatment so far seems remarkably free of side effects,” citing only the potential for slight adverse reactions related to high dosages. DBS was hailed as an alternative to antidepressants for people that were so-called “treatment-resistant,” meaning that medications didn’t benefit them.
Confusion in the research literature
The long-term results of that initial pilot study, published in 2012, including 21 patients, saw the response rates plummet to 29 percent, and included “a large number of adverse events” including one suicide and one suicide attempt. Nine individuals had gastrointestinal issues like nausea, vomiting and diarrhea, six had headaches long-term, six had persistent pain, four had muscular issues like tremors, spasms and stiffness. Yet the researchers claimed that “none” were “thought to be the result of the stimulation per se,” but instead “likely related to the patient population.” They blamed the “disease,” rather then their treatment.
Results from several other long-term trials (of more than six months followup), and from randomized, controlled trials of DBS for depression, which were conducted in a number of countries and sometimes targeted other parts of the brain, have also yielded less than favorable results,, including a recent Massachusetts General/Harvard study that found DBS had no better efficacy than sham treatment, the surgery-specific method of testing placebo effect. That multicenter study sponsored by Medtronic, the biggest player in the DBS device market, was also terminated after it failed to reach the 50% improvement benchmark.
Two recently published study outcomes did report high efficacy rates of DBS of the Cg25 area in the brain. A Spanish group had response and remission rates of 62% and 50% respectively in eight patients (with a Medtronic implant) including one non-responder who became a remitter after being given post-implant ECT, even though the implant has never been tested in combination with ECT and Medtronic has a warning against that combination.
Helen Mayberg and her Emory University co-investigators have also reported results for their St. Jude sponsored trial. After one year, and a total of 14 patients, five patients were responders and another five patients were remitters. After two years of DBS, all 11 of 12 patients were considered responders, and 7 of those patients were remitters. The Neurotherapeutics paper by the University of Florida specialists called these reported outcomes “exceptionally good, adding that, “It is noteworthy that the currents delivered in this study [up to 10 volts, the maximum voltage] were typically higher than those in other reported studies.”
The University of Florida group has also written about the risks of high-voltage stimulation with OCD, which has been linked to adverse behavioral and mood changes including euphoria, hypomania, fear and panic. According to the Florida authors, “There is an urgent need for some expert consensus on the best approach to acute and long-term programming of OCD DBS devices…. the effects of electrical stimulation are much more complex than can be explained by simply stating they are excitatory or inhibitory; they also involve astrocytes, a propagating calcium wave, neurotransmitter release, and changes in blood flow… There is some concern that high voltage stimulation may result in the tissue damage though there is a lack of data on this point, and clinical outcomes to date have been positive. More research and perhaps post-mortem data may be helpful in clarifying this issue.”
DBS trial sponsors have also been criticized for substandard reporting methods. One 2013 meta-analysis of DBS for psychiatric disorders excluded 25 of 49 published medical articles, in part because the data didn’t include “standardized outcome scales” or had a “lack of statistical support that shows that DBS is an efficacious therapy for treatment-refractory patients.”Another 2010 paper published in JAMA, co-written by a neurosurgeon who performs DBS surgeries in Europe, stated the ethical issues quite bluntly. The authors wrote: “In 2004 the international committee of medical journal editors put forward a fundamental truth: ‘The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice.’ There is perhaps no arena in medical research where the threat of selective reporting is greater than in the emerging field of deep brain stimulation and neuromodulation… this area is particularly vulnerable to bias because of an excessive reliance on single-patient case reports. Until cohort studies are routinely performed, the possibility will remain that only positive results will be published at the expense of negative data that might also have important implications.”
Another paper by neurologist Erwin Montgomery discussed many flaws in DBS research including confirmation bias and “the fallacy of confirming the consequence,” which Montgomery called “particularly problematic as it is the essence of the Scientific Method where hypotheses are tested and then modified if the experiments are inconsistent . . . . The resolution of the paradox often is “majority vote” when the contrary evidence is not ignored outright. This has the perverse consequence that a flawed experiment replicated a thousand times trumps a valid experiment done once . . . In terms of DBS science, the error is in studying one structure to the exclusion of others and then attributing the therapeutic mechanisms to the single structure studied. Even a cursory survey of the literature will demonstrate that the overwhelming majority of studies have been confined to the study of a single structure…. To date, hypotheses as to the mechanisms of action have been derivative from prevailing implicit presuppositions and explicit theories of pathophysiology, most of which are incorrect.”
Financial conflicts of interest
Given the problems with DBS research, and with growing evidence of bias in much clinical trial research conducted, it’s perhaps no surprise that many of the doctors and specialists involved in these DBS trials were paid by device manufacturers and/or provided with research funding. For instance, among the investigators involved in the initial Canadian trial, Dr. Helen Mayberg holds patent and licensing rights for the treatment of depression through DBS of the Cg25. Neurosurgeon Dr. Andres Lozano is a consultant for Medtronic and holds intellectual property rights in DBS; in 2010, he founded of a DBS investigational company called Functional Neuromodulation, a partner company of Medtronic.
Back to the Broaden Trial
That initial Canadian pilot trial, which began in Toronto, based partly on brain scan research done by Mayberg in which she posited that the Cg 25 was linked to sadness in depression, expanded in 2006 to include Vancouver and Montreal centers, but the trial was then sponsored by ANS, a DBS manufacturer in the United States that has since been purchased by St. Jude Medical. In February, 2008, evidence from the initial Canadian pilot study (including the initial six patients implanted with the Medtronic device and 14 additional patients with the St. Jude device) seemed so promising that St. Jude Medical announced the kick-off of the multi-center Broaden trial, with three U.S. sites, in Chicago (at Alexian Brothers Behavioral Health Hospital), Dallas, and New York City.
Their press release boasted that their pilot study in Canada had a remarkable 78 percent response rate among the 20 patients, eight of whom “have re-engaged in life activities such as work, school, travel and relationships.” While a handful of other DBS-for-depression trials had already been conducted over the past decade around the globe, with various DBS device manufacturers, the Broaden trial was to be the first U.S. multi-center, controlled, double-blind trial. It was conducted under an FDA investigational device exemption, which allows sponsors to skip the standard phase 1 and phase 11 safety and efficacy trials, and has been criticized for putting patients at risk while facilitating corporate development (saving device sponsors millions of dollars). As the U.S. trial kicked off, St. Jude was also granted a U.S. patent to treat depression in the Cg25 with their “Libra” implant; the company president called the patent “a cornerstone in developing our approach to DBS for depression.” At that time, St Jude had no FDA-approved neurostimulation devices on the U.S. market to treat any diseases or conditions.
Jim was oblivious to all of these corporate influences and regulatory shortcuts. He was just trying to stay alive. Aside from the cognitive issues, he had extreme sleep problems that began about 6 months post-implant, a time when all trial participants started receiving electricity. “I’d have night terrors and catatonic sleep, like narcolepsy; it would just come over me in the middle of the day and I’d have 20 minutes to get somewhere safe before it took over and knocked me out; my wife couldn’t even wake me up. That happened four or five times per week.” Eventually Jim sought out a sleep disorder specialist who conducted a sleep study and diagnosed him with REM Behaviour Disorder, a condition in which the brain functions as it does during consciousness, and without the normal muscle paralysis that comes with REM sleep. The theory is that sleep and waking states invade each other and neurological barriers between states is dysfunctional. (Animal studies have found it’s caused by lesions in the brain stem where locomotion is inhibited.)
“The doctor discovered that for four to six hours a night I have no REM sleep, and the other half of the night I have three to four hours of solid REM sleep – the doctor said he’d never seen anything like that,” Jim says. “Who knows if it’s implant-related, or due to stimulation. I know it’s not related to medications because I wasn’t on any medications during the first year of the trial.”
Jim is an exception on that count. Post-implant, the significant majority of DBS recipients continue to take baseline medications, or start taking new meds, and while some published study results include detailed data on pre- and post-implant drug usage, no studies have been done looking at the potential adverse interactions with the combination of DBS and medications.
When the trial started, Jim was in the midst of a washout period in an attempt to try a new medication, but post-op, he was told that protocol dictated no change in meds for the one-year duration. “I found out later that other people were allowed to have their meds changed or tweaked, so I don’t think the study sponsors represented things accurately,” he says. His wife, a registered nurse, says, “It’s been so awful. He was so depressed during the blinded year. It was hard, just trying to keep him alive, painful for both of us, thinking this is our last hope and it’s not working. In fact everything’s become unbelievably worse. No [stimulation] setting worked.”
A short while ago, Jim returned to his study center and had the device turned off. “Now my thinking is clearing up a bit,” he says. “The fog is clearing a bit. The sleep problems have virtually disappeared. But I want this thing out.”
Soon, Jim will return to the neurosurgeon to discuss the removal of the device, but he’s worried about potential complications. “When I signed up for this trial, the consent form said that DBS is reversible because you can remove the implant,” he says. “But when I signed up for the followup study, the form had a different insert than the original consent form: ‘In some cases the device is not removable’ – where’s the evidence around that? I’ve read about the intracranial hemmorhage rates and that’s scary. There are so many nerve pathways just in that one region that connect to so many regions in the frontal cortex and the other parts of the brain. The surgeon said that the leads might be too tense and they might have to leave them there. When I enrolled in this trial, I was so desperate. But now that I’ve done more research and read all the extensive DBS literature, I feel I can’t believe anything I read. So much of it is vague and biased. And I found out that the Broaden trial is hiding behind an IDE [investigational device exemption] so it’s hard to get any info on what’s going on with the trial. The UCLA doctors have been great, especially since the trial was unblinded. But I feel as if there’s multiple levels of heresay when it comes to this technology.”
A short video of Rich’s DBS surgery
Back in 2008, Rich** had only read the glowing media reports about DBS. He was the second patient implanted in the Broaden trial that February 2008, in Chicago. “When I came out of anesthesia I was in complete remission from the depression,” says the 49-year-old who was working as a computer programmer for a large corporation at that time. “People at work were like, ‘That surgery did wonders.’”
That immediate post-op effect is called “the stun effect” and it’s linked to post-op trauma and oedema that decreases as the brain heals from surgery. “Gradually over the next six months, little bits of depression started coming in,” he says. “At six months everyone’s device got turned on. That’s when all hell broke loose with me. It hit me like a Mack truck. I was working from home doing a conference call and the rage just popped. Somebody said something stupid and I felt like I was going to murder someone. I called the [study] doctor saying, ‘I’m out of my mind.’ For the next 6 months that cycle repeated. I’d go in for programming, they’d change the [DBS device] settings to who knows what, they never said what they were doing, but within 24 hours, a new Richard emerged—apathetic Richard, manic Richard, suicidal Richard, homicidal Richard, who knows what kind of Richard would appear after these sessions.”
Rich says that when he reported side effects to the trial doctor, they would simply jot down a note and “throw a different drug at the symptom. Every month it was a new drug regime. I was on no drugs before the implant, but after the stimulation started, I was on a minimum of three drugs on average including antipsychotics. They didn’t say anything about side effects, just, ‘See you in a month.’ They’d also say things like, ‘You’re bipolar now.’ They’re telling me that, after four months of careful screening [pre-trial] and putting me in a treatment-resistant depression study? They didn’t even report side effects verbatim. I looked at my file and many things weren’t copied down. When I was in a homicidal rage, they wrote down ‘mild mania and anger issues.’”
Luckily for Rich and his sphere of friends, family and contacts, he only had three homicidal episodes, but they scared the hell out of him. These DBS-linked adverse changes had already been documented in Parkinson’s patients, and published in medical journals, but, Rich says, the study team “acted as if they had no clue why this was happening to me.” He describes these mood and personality changes as “emotional seizures” that would come out of nowhere and last up to three days. “It would be a single emotion, like rage, extreme anxiety, paranoia or self-harm. Between these episodes I was just a robot with no emotions, no feelings.”
Rich had to quit his job and go on disability. He signed up for the four-year followup study, which required visits with the study doctors once every six months. Rich will never forget what happened in August, 2009, a year and a half post-implant, and the day before his summer followup visit with the trial doctors. “I tried to lie down and sleep, but I couldn’t. I wasn’t thinking about suicide. I wasn’t thinking about anything. But then I got up, grabbed a sharp knife and started hacking at my arm. There was no thought behind my actions, no mental negotiation, no thought of consequences, no premeditation. It felt like an involuntary action, like my brain ordering my heart to beat. I remember being fascinated by the blood and understanding that since I was alone, I had all the time in the world. That’s when I got a call from the person at the [Broaden] study center, wanting to make sure I had the time and location of my appointment. I gave no indication of what I was doing until he asked me if I was safe. I just started laughing hysterically and couldn’t stop. I eventually said something about being in a pool of my own blood. I guess the phone was handed off to another member of the study staff who kept asking me what I had done, what [part of my body] I had cut. Whenever she mentioned a spot, I’d cut that particular spot. Then she asked if I had taken any pills, so I started downing the bottle of Geodon [antipsychotics]. This went on until the police showed up at my door. I started to joke around with them. But that’s not like me to be disrespecting the police. I went for my bag where I had the wand [provided to DBS recipients to turn the device on or off by waving it over the chest pacemaker] and told them I had this brain implant, I just needed to get it turned off. But who’d believe that story? They carted me off to the hospital and then I was shipped to Alexian,” he says, referring to Alexian Brothers, the center conducting the trial in Chicago. The lead psychiatrist ,Dr. Anthony D’Agostino, was on vacation at the time. When he returned a week later, he signed Rich’s release forms and sent him on his way.
Soon after, Richard waved the wand over his chest and turned off the device. “At my next six month appointment I informed the study personnel that I had no intention of turning it back on until something was done to determine what was happening to me,” says Rich. He also tried to get the device settings changed, since a DBS device can be custom-programmed; each contact can be turned on or off and there are literally thousands of settings available. “They said, ‘We can’t change the settings. Only the voltage. We’ll just take out the implant.’ But I didn’t want that. This thing was the only hope I had left. I felt like they just wanted me out of their hair, that they just wanted to cast me aside.”
The following summer, Rich agreed to have the device turned back on, but only at its lowest voltage of 1 volt. “My reasoning was that since I was obviously hypersensitive to the device and it was magnifying, not suppressing, the activity in Cg25,” says Rich. “They argued that a low setting would be ‘useless’ but they agreed. The next morning I woke up in a state of total apathy, a total lack of emotion. My family and friends noticed it.” Rich was driving one night and was nearly involved in a serious car accident as a result of a dangerous driver, yet he had none of the typical physiological or psychological responses, such as increased pulse and blood pressure, sweating, fear or panic. That apathy lasted for four months and then Rich started experiencing what he calls “sadness bubbles” which he compares to carbonated bubbles rising to the surface and popping, but involving an intense feeling of sadness—“the saddest moment in your life suddenly pops into your mind and then disappears almost immediately,” he says. The apathy got worse over Christmas. While his family visited, he sat alone in the basement, feeling no guilt that he was avoiding everyone, or any emotion whatsoever. “I was devoid of empathy,” he says. “If the whole family had died, I would have just kept sitting there watching TV.”
Rich reported his side effects to the study center, but the only option they gave him was to have the device removed. That happened in February, 2011, three years after implant. But while the cognitive effects diminished slightly, he continued to experience bizarre episodes. “At that point I assumed the damage to my brain was permanent and it was. One night I was just sitting there watching TV. I got up, boiled a pot of water, poured it on myself, and went back to watching TV. It was like taking out the trash, just something you do almost automatically, without thought.” Eventually Rich went to the hospital to get the burns treated. “I see the scars every day, and I remember exactly what happened that day. But I don’t understand how or why it happened.”
After the device was removed, Rich says that the trial doctors had promised that they would help him find psychiatric care, and they did, but after the self-harm episode, the psychiatrist refused to see him, saying he was treatment-resistant and there were no options left for him. “I’d give anything from a diagnostic look at what’s going on in my brain,” says Rich. “It would be so much relief to get a brain scan, even if there was nothing they can do about it. But I’d need a referral and I don’t even have a GP right now. I wrote an email to [Helen] Mayberg, saying, ‘You’re involved in studies of DBS effects. So, study me. There are people falling off the boat and you’re not circling back to rescue them. Circle back and see what’s going wrong.’ I didn’t hear back from her.”
Rich did correspond with a neuroethicist named Frederic Gilbert, who studies DBS at the University of Tasmania and has papers related to DBS side effects. Gilbert ultimately published a paper about DBS for depression in a 2013 issue of Neuroethics subtitled “Postoperative Feelings of Self-Estrangement, Suicide Attempt and Impulsive–Aggressive Behaviours.” He analyzed data from four North American DBS-for-depression trials that had published data (including two targeting the Cg25, one targeting the ventral capsule and one the nucleus accumbens), and he found that 9% to 11.7% of trial participants ultimately attempted suicide and the same percentage of patients committed suicide. That’s three to four times higher than the best estimates of a 3.4% suicide rate among people with severe depression. Rich’s grizzly suicide attempt was included in the paper as a case report of post-op suicide and “self-estrangement.” Rich has also communicated with other DBS trial participants, including an Amsterdam man who eventually committed suicide. He says that during a follow-up visit to his study center, he met another Chicago patient and he says that she had a negative outcome, too. “Where’s everybody else?” he wonders.
Rich is still dealing with severe depressive episodes, but it feels like an autonomic response, like an automatic gear shift on a car, except that his foot is never on the gas. “Before DBS I was the protagonist,” he says. “I’d ruminate and play the role of my [abusive] grandfather and tear myself down. I don’t do that anymore. I went from having an environmental depression related to my life experiences, to this state where my brain dictates how I feel. Now my whole mental health status is built on the biology of my brain. I can’t make myself depressed, but I can wake up tomorrow and be manic or suicidal as hell, for no reason. When the depression used to get bad, I wanted to kill myself, but since the DBS, when I have the suicide episodes, it’s like I have to kill myself. It’s as if I don’t have a mind anymore, I’m just a brain. My brain now controls itself. I work with every fiber of my being, to still be here. Otherwise I’d kill someone or myself, but it’s exhausting. I’d go back to my old severe depression in a heartbeat. Now I look at myself in the mirror and I wonder, ‘Who are you?”
Rich has many issues with the way the trial was conducted, particularly the lack of follow-up medical care, but he has no bitterness towards the neurosurgeon who performed the DBS surgery. “Trailblazing can be an exciting and noble endeavor,” he says. “But only if you’re the blazer, and not so much if you’re the trail.”
The Neurosurgeon’s Perspective
According to a 2013 survey of 106 North American functional neurosurgeons, 82% said their primary patients are those with movement disorders, while 34% said that the majority of their patients had psychiatric conditions primarily with OCD and depression. Ninety percent of these surgeons felt “optimistic about the future of neurosurgery for psychiatric disorders.”
Dr. Konstantin Slavin, who implanted Rich and all of the 20 Chicago trial participants, is one of the enthusiastic ones. “This is a very exciting time to be doing research,” he says. “The Toronto studies were very impressive and it’s why I bought into DBS of the Cg25 as a viable treatment for depression.”
The majority of Slavin’s patients have Parkinson’s, and that surgery involves intraoperative stimulation while the patient is awake, to test for specific targets that help curb the debilitating tics. Neurosurgeons have also done this with depressed patients and found that they can elicit intense positive and negative emotions, specific memories, cravings for food or sex—you name it—by test-stimulating parts of the brain. “But the Broaden trial was blinded, and because of that, our patients were unconscious and we didn’t test stimulate for emotional effects,” says Slavin. He also acknowledges that precise targeting is a challenge. “The Brodmann areas are not even visible on imaging studies and the Cg25 isn’t a well-defined area; it’s a pretty large area and every patient is slightly different. Also the brain is asymmetric in many ways, so the anatomy of cortical surface varies from the left to the right.” During surgery, Slavin targeted the Cg25 via other better-defined landmarks, particularly the ventricles. “The Cg25 target is so new for us and we didn’t know what to expect,” he says. “But in principle, the surgery is very straightforward. There will be micro-lesions from us sticking the device in the brain and manipulating it. And when you open the head, spinal fluid leaks out. Brain shift from the drilling process is also a concern, so we do intraoperative brain scans. But I didn’t see any surgery-related adverse effects—we were lucky.”
When I turn the talk to past trailblazers, such as Walter Freeman, the icepick lobotomist (who was a neurologist, not a surgeon), he says, “Freeman is still a great example of a doctor who had good intentions and wanted to cure humanity of a terrible disease.”
Electrical brain stimulation (EBS) also has a checkered past. Tulane University researchers, backed by CIA and military funding, did deep-brain EBS experiments on psychiatric patients and prisoners from the 50s until the 70s and reported that some patients “brightened” and experienced “warm and pleasant” sensations; others were driven to suicide. Their most infamous experiment involved trying to change a homosexual man’s orientation by rigging him up to electrodes and stimulating areas implicated with pleasure while he had sex with a prostitute. Jose Delgado was probably the technology’s most famous proponent. He famously stopped a bull from charging by stimulating its brain and he performed Clockwork Orange-style experiments on humans at Yale in the 1940s to cure aggression and schizophrenia, stating that “man does not have the right to develop his own mind,” and suggesting that EBS would “conquer the mind” and create “a less cruel, happier, and better man.” “Delgado did some crazy things,” acknowledges Slavin. “Nowadays, we’re careful not to repeat history and we’re better at the ethical protocols and patient selection.”
Slavin admits that depression is a condition that he knows little about, both in his life and in training. “We didn’t get that kind of training in school. What causes depression? That’s a deep question and something I can’t answer. Until I started doing these procedures, I didn’t realize that depression can be so severe. These people have tried hundreds of treatments. But I can say that about 20% of our patients got better. And all of them would get worse without DBS. Even if one person gets better, that’s worth it. The adverse effects profile is really benign—just turn it off if it doesn’t help. I don’t recommend explant. It’s an outpatient procedure but there are still risks, such as lesions, infection and bleeding. We’ve done a few explants, but I recommend to leave it in there.”
In terms of the mechanism of DBS, whether it inhibits or excites neurons, Slavin says, “I think it’s a bit of both, but in general, it’s a normalization.” While other neurosurgeons are trying DBS experimentally for Alzheimer’s, addiction, obesity, anorexia, bipolar disorder and aggression (and it’s even been suggested to treat criminal behaviour), he’s not worried that DBS will be misused for financial motivations or for off-label conditions. “There are so many surgical candidates for DBS,” he says. “My job security is pretty high. You can spin this story in so many ways. You should make it optimistic, so that it doesn’t make people depressed.”
Dr. Anthony D’Agostino is the lead Chicago psychiatrist in the trial. He says that of their 20 patients, perhaps five to seven people plan to keep their devices turned on post-trial. “Several people got worse and three or four were explanted,” he says, but for any additional information about the trial data, he directs me to speak to St. Jude Medical. I contacted Justin Paquette in its media department, who asked me to send a list of questions, and while waiting for a response, I contacted Dr. Mustafa Husain, the lead trial psychiatrist in Dallas. “Some of my patients could be poster children for DBS,” he says. “They’ve had remarkable life changes. One ob/gyn had quit his practice and moved to Mexico. Since the DBS, he’s back in practice. Of course there are non-responders, too. I’ll put you in touch with both.” When I contact him again in mid-June to be put in touch with patients, he tells me I have to go through St. Jude, but adds that some patients are still receiving follow-up care in Dallas. “We don’t leave them without any follow-up. Our center still has the programming devices and a few patients have been in to change their settings. When the follow-up wraps up, which should be within a month or two, we’ll send the programmers to the patients’ local doctors, ideally neurologists. They’ll get TAU (treatment as usual) and bill it to their insurance companies.”
Left to Foot the Bill
Steve Ogburn’s insurance company, like many insurers, doesn’t cover DBS for experimental, non-FDA approved conditions. But the 60-year-old California architect believed what was written in the informed consent document, which stipulated that all DBS-related care would be provided by St. Jude Medical, along with all “services, supplies, procedures and care associated with the study” that “are not part of routine medical care” including all “medical complications,” and “an injury or illness that is directly caused by your participation in this study, care will be provided to you. You will not be responsible for any of these costs.” The document also stated that medical care would “continue until the DBS system is approved by the FDA for the treatment of major depressive disorder, ANS [now St. Jude] discontinues this study or the FDA denies approval of the DBS system, whichever occurs first.”
Steve had the surgery at Stanford, in November, 2012. After the surgery, he had “severe cognitive decline” and a slew of physiological adversities. “The leads [wires] were 18 inches longer than they needed to be, so they coiled it up in the chest and at the top of the head; I could feel them externally,” he says. “And the leads were too tight. I could move my ear and my chest would move, too,” he says of a condition called “bowstringing,” whereby scar tissue encapsulates the wires (partly from the body’s natural response to foreign material), which has been documented in DBS cases and can cause permanent complications. Steve also had many symptoms that were ultimately diagnosed as shoulder and jaw muscle atrophy, spinal accessory nerve palsy and occipital nerve palsy. He reported all adverse effects immediately and continuously throughout the first year of the study, but the trial doctors continually told him that they’d never heard of such symptoms with DBS, even though nerve damage and DBS wire-related “hardware” complications were among the potential risks listed on the informed consent document.
“Even when there’s scientific literature published about these adverse effects, you’re constantly being told, ‘This is all in your head,’” says Steve, who didn’t want to give up hope that the DBS might provide therapeutic benefit, but he wanted to find out the root cause of his overwhelming pain. Instead, he was referred to Stanford’s pain clinic and provided numerous painkillers, but he didn’t receive the official diagnoses listed above until the following October, almost 11 months after implant. “The neurosurgeon, Dr. Henderson would only agree to a partial explant of the leads,” says Steve. “And then, if my pain had resolved adequately, he’d do another surgery to tunnel the leads down the [other] side of my head and neck, install a new IPG [chest pacemaker] in that side of my chest and reconnect them to the electrodes in my brain.”
Steve was very disheartened by the thought of at least two additional surgeries that might not provide any benefit, and could make his pain worse, so he chose the only other option available and had the entire DBS device explanted in December 2013, the day after he was told that the Broaden Study had been terminated. “The pain was even worse after the explant. At my eight week follow-up, Henderson said, ‘I’ve never seen this with over 1,000 DBS procedures—congratulations, you’re one in 1,000.’” That day, Henderson acknowledged that his many adverse effects may have been from the DBS wires pressing on the nerves, or that a nerve may have been “nicked” during the initial implant surgery. “After that, Stanford cut the ties with me,” says Steve. “But it was much worse than that. I was stonewalled by Stanford, St. Jude and the FDA. I participated in this trial in good faith that Stanford would cover all medical costs and that the FDA had oversight of the study.”
Steve sought help from a number of neurology specialists, but few would agree to take him on because his medical file included a notation that said he was “under risk management” as part of a research study. To pay for his six digit medical bills, he’s had to use his retirement funds, and after speaking with dozens of lawyers that wouldn’t touch his case, he found a lawyer through the Alliance for Human Research Protection. With his lawyer Alan Milstein, Steve is pursuing a lawsuit against St. Jude Medical, Stanford, Stanford’s IRB, and the neurosurgeon Dr. Henderson, alleging medical and professional negligence.
I contacted St. Jude and Stanford for their comments on the suit, but neither would provide comment “on pending litigation.” Steve sent me Stanford’s legal response, a “motion to dismiss” the case, stating that that the Stanford doctors provided appropriate care to trial participants under the FDA requirements for informed consent and medical care, which are regulated by federal courts—“matters that rest within the enforcement authority of the FDA, not this [state] court.” Regarding the IRB, the motion stated that “Stanford’s IRB is immune from liability under California’s Peer Review Statute Civil Code.” Also, under state law, Steve was required to begin legal action within a year of injury. That happened within two weeks of the surgery, and he reported the side effects, not just to the Stanford trial doctors, but also to other DBS specialists, including email exchanges with Dr. Helen Mayberg (the neurologist with the patent on DBS for depression). But Steve wasn’t given an official diagnosis and treatment options until a month before the statutory period lapsed and not long before the trial was terminated.
“In the three plus years I have been dealing with the effects of this clinical trial, only one doctor, Jeffrey Tanji, at UC Davis would see me,” says Steve. He ultimately had some benefit from scar revision surgery and orthopedic rehab. But the combination of chronic pain, chronic cognitive issues and what he describes as implant-related “depression on steroids,” makes it hard to simply put one foot in front of the other every day. Steve finds the legal battle exhausting, particularly “revisiting the deep, dark periods of despair” throughout the trial period, but he hangs to hopes that at his next court date, scheduled for October, a judge will reject Stanford’s motion to dismiss so that the discovery process might shed some light on the mechanisms of FDA-sponsored experimental trials. “My primary goal is better protection for humans in trials,” says Steve. “There’s no PETA for human lab rats. There’s more activism for death row inmates. I feel like I’ve been left twisting on a hook for two years. It’s like all of us Broaden trial participants have gone down a rabbit hole and all we can do is fingernail scratch on the walls.”
Steve keeps in touch with other DBS for depression recipients, in a private Facebook group of approximately 15 people, mostly participants in the Canadian trial and the Broaden trial. He believes that only one Broaden trial participant in the group has had some positive effects; the rest have had many adversities, including a person who recently attempted suicide. Since clinical trial sponsors aren’t required to publish study results, and even when they do, they rarely provide information about so-called “non-responders,” Steve has this profound question: “Who’s going to know the results of this trial? Who’s going to know our stories? The bigger story here is the need for protection of human participants in medical trials and real, transparent oversight from the FDA. It is so morally, ethically and legally wrong to not treat human participants with the respect and dignity we are owed. Our participation in this clinical trial has to have meant something.”
A few weeks after sending my questions to St. Jude Medical, I received a written response to some of my queries about the Broaden trial, via Paquette in the public relations department, providing the basic information about the total number of patients implanted (128), along with a statement about why the trial was terminated: “based on a low probability for future success.” Paquette wouldn’t provide any other trial data information, but he said that a paper was currently being drafted so that the details could be “disclosed in a future publication,” but that “this study was not terminated based on safety. There were no unanticipated adverse events recorded.” Regarding details on whether patients would be provided medical follow-up care for a specific duration, he would only say, “SJM has been continuing to support all implanted patients through a long term follow up protocol.” To the question of whether SJM was currently involved in sponsoring any other DBS trials for psychiatric conditions, he said, “SJM currently has one ongoing study in Canada for the treatment of depression. We support independent grants that are investigating DBS for depression [by providing] research grants to support physician-initiated trials investigating DBS for depression.”
This summer, SJM did receive FDA approval of their DBS device for Parkinson’s and dystonia, based on two clinical trials involving 136 patients and 127 patients respectively. That should give a big boost to their net sales, which climbed 4% in a year, to $5.622 billion ($437 million of which came from sales of their neurostimulation products), and their operating profit increased to $1.15 billion. Their legal costs have also increased from $16 million in 2012 to $31 million last year; according to their annual report “such proceedings could have a material adverse effect on consolidated results of operations, financial position and cash flows of a future period.”
The day after Jim’s explant surgery, he is in bed, recovering from a four-hour surgery that was scheduled as a routine one-and-a-half hour outpatient procedure. “I guess the surgeon had to do a bit of prying,” he says. “After he took off the burr caps that cover the holes in my skull, the second piece that fits into the skull gave him trouble because the bone and tissue had knitted around it. My head is throbbing around the burr holes and so is the skin around the [chest pacemaker] box. Hopefully it’ll all heal. I can’t go back and unring the bell. I feel like the DBS broke my brain; it broke something in me. I think the UCLA investigators did what they could for me, but I think that the way these studies are conducted, peoples’ health and safety is often secondary to the goals of the corporate sponsors. But I need to put what happened behind me. I’m just relieved it’s out.”
I don’t want to tax Jim’s head with too much future-gazing, but every time I try to get off the phone, telling him he needs to rest his head (mind, brain and all) from the operation, the conversation drifts into new territory, such as finding better methods to deal with depression, both medically (with better preventative measures and non-invasive treatments) and with greater cultural acceptance that depression happens in life, just like broken bones. Jim’s so smart and well-read and has such a great sense of humor that he cheers me up many times, until the conversation drifts into doctor-assisted suicide. “Let’s not go there today,” I say and then I tell him I’ll call back in a few weeks. He says, “If I’m not around next time you call, don’t be upset, OK?”
Steve made this video last year to inform the public about the perils of DBS clinical research
* Name has been changed at his request
** Surname not included at his request
Dang, that was DEPRESSING! No joke intended. I am always amazed at people saying “My psychiatrist is great” despite trying 30+ drugs and ECT without any improvement. I can’t even imagine being in a state where allowing the surgical insertion of such a device in my brain would even enter in as a possibility I’d ever consider.
Another psychiatric success story!
Of course, it also says much about individuals inability to obtain depression treatment that makes a difference. Depression really hurts …. and I can understand how someone suffering so much for so long will try virtually anything in an attempt to obtain relief.
I can understand that, too. What I can’t understand is how someone can praise or compliment a system or approach that has failed to have any positive impact. At what point do you say, “Hey, these people don’t seem to really know what they’re doing. Maybe I need to look somewhere else for a solution.”
Holy crap those pictures are scary.
This “treatment” sounds like the basis for a new Hostel horror movie or a new entry in the Saw series, or a modern version of a Franz Kafka novel.
How far from the reality of individual distress can psychiatry get… there is no limit.
Check out my report on How “transcranial magnetic stimulation” works I did in the forums. You will be like ” WTF really ? ”
You had no idea did ya ?
Drilling holes in peoples skulls and running wires into brains and through their bodies…
Meanwhile doctors are prohibited from doing research with Psilocybin , lysergic acid diethylamide and other ‘psychedelic’ substances that HAVE been shown to help people suffering depression.
Guess maybe there is no money in wild mushrooms or no way to patent old drugs. Its all money and politics that I know.
Google search: Grow Magic Mushrooms
Google search: Psychocibe mushroom depression
Seems odd, doesn’t it? Although, to be accurate, it should be noted that increasing numbers of clinical trials are investigating psilocybin, LSD, ketamine, MDMA and other “mind-altering” substances for efficacy in treating a variety of mental illnesses, including major depression.
As for “patent” issues, you would be surprised at what can be done to protect and monetize specific formulations or treatment methods.
No they are not. Recently, there have been many article’s, peer review journals stating science is doing exactly this. Studying LSD, psilocybin and ketamine to treat mental disorders. So back in the 70’s when I was popping my hit of window pane or my mescaline, remember back when they said we were destroying brain cells by this, so it turns out what I was really doing was ‘taking my medicine’! Thank god, I was something right.
I took these drugs back then to alleviate severe [PTSD] symptoms of a traumatic rape when I was 13, and it worked quite well. I was able to laugh again and feel human. But I am concerned with that it seems to me since we now know the current psychiatric drugs are really ineffective that big pharma is turning here for profit reasons only. How about psychiatry stop turning trauma symptoms, as they did in my case years later into Bipolar thus being heavily drugged for the next 35 years. And with devastating results to my physical and mental health. I’m actually very lucky to be alive from taking those drugs for decades.
I wanted to compliment you on a very encompassing article on DBS.
Some 50 years ago I coined a phrase, “The Trial and Error Approach to Wellness.” Obviously this phrase is still applicable today.
As a mental health advocate/activist and support person to my spouse I know what it means to be desperate and the willingness to try any therapy option in the hope of alleviating one’s chronic and severe depression.
I am truly sorry that DBS did not show better results but there is an interesting point which I am acutely aware of. Like similar poor initial results and findings from VNS Therapy the fact is 17 or so percent of the DBS study subjects did respond and for those individuals the therapy may prove remarkable as nothing else worked for these patients.
Unlike DBS, VNS Therapy was approved by the FDA but declined by CMS.
My spouse, an original study subject for VNS Therapy for Depression, has been remarkably depression free for almost 16 years as a result of her VNS Therapy.
There simply is no way of knowing who will or will not respond to any given therapy without trying.
Lastly, for any study subjects who have favorably responded to DBS and wish to maintain their therapy should they run into problems with health care coverage be apprised there is a doctrine of “Continuity of Care” which Medicare/Medicaid has on their books and is a lawful policy.
I have battled HHS/CMS to maintain care for the study subjects and patients implanted with the VNS who wish to continue their therapy. Information that may be beneficial to the DBS patient’s medical coverage may be found on my blogsite(s) listed below.
I wish good luck and wellness to all those who struggle with MDD.
(vnstherapy) Herb, I’m glad you commented on the importance of a treatment’s benefit — even if that benefit is to a minority of study subjects. VNS went through a convoluted path to FDA approval, with the FDA even going against its own report recommendation.
When a treatment provides benefit to a small percentage of subjects, it often signifies an inadequate understanding of the condition, the treatment, or both.
DBS seems to be far more effective in open-label case studies. When subjected to the rigors of double-blinded study, the response rates were not significantly different that sham stimulation.
Please note that the ~17-18% response rate is just that… a “response.” “Response” to a treatment describes an acute effect, rather than a continuous state. It is also important to note that a “response” does not equate to a patient achieving “remission” or “recovery” or “normalcy.”
VNS Therapy for depression is a Wharton text book case in what not to do. This study was steeped in controversy from the get-go.
I caught up with the former FDA director Dr. Daniel Schultz (Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004 to 2009) some 9 years later and finally was able to ask him despite all the controversy surrounding the therapy what reasons did he have to override the decisions of his underlings and approve the therapy.
“…treating severe unresponsive depressive disorder is exactly the reason that I approved the device…”
“When a treatment provides benefit to a small percentage of subjects, it often signifies an inadequate understanding of the condition, the treatment, or both.” — InfiniteJest
Actually there is a third which is most applicable to the VNS study. That is a poorly designed study. The VNS study was based upon a drug protocol of 12 weeks. Knowing that which we know today Medtronics and St. Jude learned from the VNS fiasco that the study should have been based upon a minimum of 6 months to a year’s study. You are correct that the study results were poor and “not significantly different that sham stimulation.” What you may not be aware of is the fact that one study site had not only a 50% response rate as well as long-term efficacy. What you also might not be aware of those early responders as well as late responders have maintained long-term efficacy as well as recovery unlike anything experienced with medications. From my experiences and knowledge medications often exhibit initial response and efficacy and then refractory results surface over the longer haul for this unique group of patients. On the other hand those that did respond to VNS improved and have maintained long-term efficacy which is unheard of in this group of patients.
Drs. Wolfe and Laurie of Public Citizen denounced the therapy as nothing more than a placebo effect. That prompted me to request my spouse’s physician to deactivate her prosthesis. He thought I was crazy. Incidentally, I have collaborated through the years with many of the leading KOLs who have been instrumental and helpful with information and suggestions which have helped me to maintain my spouse’s depression free state. I explained to her attending physician that we shall experiment and see whether or not the VNS for my spouse is a placebo. He asked me again, “Are you sure you want to do this?” I explained that it is the only way to know for sure whether this therapy is truly efficacious. Besides, we can easily re-activate her prosthesis. In my spouse’s case she lapsed back into a severe depressive state within a week’s time. The pulse generator was re-activated and within days she was out of her depression and we have not looked back. That experiment was about 14 years ago.
Patients that have come to me to advocate for their replacement generators have similarly shared stories with me of their lapsing into depression as the batteries in their generators depleted and once able to obtain their replacement they are back to a reasonably good mental state. When I wrote to Drs. Wolfe and Laurie asking them if there is such a thing as a “continuous multiple year placebo effect” I received no response.
The point being doctors are not deities. There are doctors, good doctors and better doctors. I have been fortunate in obtaining the respect of many of the physicians attending to my spouse as well as those who I have collaborated with through the years that have helped educate, encourage and direct me to help my spouse as well as others.
Another point I’d also like to make. At the time of the write-in period advocating for CMS to approve the VNS Therapy for the depression indication some 200 psychiatric physicians expressed their reasons the therapy should be approved. One in particular noted that although the response rate was significantly poor one of his patients, the son of a doctor, was one of the worst cases he attended to. Nothing worked. This therapy turned the life of this young man totally around. The point being, the therapy was 100% efficacious for this individual. I repeat 100% efficacious is certainly far better than 17 to 18% response rate. It all depends upon one’s perspective and interpretation of the study results.
The same holds true for DBS. If the patient is fortunate to respond and obtain efficacy when nothing else has worked a low response rate from a double-blind study is meaningless to that individual. The low response rates are meaningful to the number crunchers sitting behind the computer spreadsheet as well as the health care bureaucracy from the standpoint of money, power and politics.
Lastly and I really needn’t discuss the fact that I am aware of the controversy surrounding numerous pharmaceutical studies with outstanding results that have been a total sham and yet they have been FDA and CMS approved. Who can one really trust?
Thank you for sharing your experience with VNS. I don’t doubt that treatments like VNS and DBS may be effective in some patients. And for those fortunate patients, the treatment can be a lifesaver.
The problem is when the percent of “successful” outcomes is low, e.g. <20%, and the costs and risks of the treatment are considerable, how does one decide? And should insurance be required to cover the treatments?
You mentioned a study site with a 50% response rate. That sounds great. But numbers can be deceiving. How many subjects were in the study? Was it a randomized double-blind trial? If is was, and if the number of subjects was significant then the sponsors should carefully evaluate what was done differently. In a clinical trial there shouldn't be opportunities for different sites to vary the study protocols. And sometimes there are data outliers. That's the nature of a study.
I'm glad that VNS has been beneficial for some and believe similarly that some benefit from DBS. However, data from open label trials is notably unreliable, as the placebo effect can be quite amazing. The field of hospice is loaded with cases of placebo effect achieving what medicine could not. I don't believe that every successful treatment is due to placebo effect, however it is a powerful influence that is hard to separate from an open label study. Perhaps these recent, large scale failed clinical trials of DBS for refratory depression will afford valuable lessons in study design and improved standards for patient rights and treatment.
Whist I don’t want to trivialise your loved one’s experience, I have to point out that the return of her depression a week after the VNS was de-activated and its disappearance shortly after re-activation does not mean that her response was not a placebo response. Placebo involves hope, expectation and belief. People can climb mountains without oxygen if they believe they have it – a medical condition can clear up and stay better even after the person KNOWS their pills are only placebo. (In one case the illness returned only after the sugar pills were used up long after she knew that’s what they were). if a person believes that their condition will return if they don’t have the treatment, in a placebo response, it will, and when the treatment is resumed, it will go away again – that IS a placebo response. But does it really matter, in your spouse’s case, since the device is already present, so long as she has relief. My problem is that for others an invasive potentially very damaging procedure might be avoided if it is known that the major effect is that of placebo.
When you consider that there are so many natural methods of stimulating the vagus nerve, invasion by surgery seems excessive. Singing is the best, vibrates the entire vagus nerve from head to root. Walking is another. Acupuncture. Breathing techniques. So many non-invasive ways of stimulating the vagus nerve without surgery. There are tales of natural Vagal Nerve toning here: https://www.survivingantidepressants.org/topic/3173-vagus-nerve-stimulation/
Only with Parkinson symptoms being severe ( too shaky to function), would I consider DBS as a viable treatment.
The author is to be commended for capturing the extreme futility, despair and hopelessness that brings these severely depressed patients to try this treatment of last resort. If asked, most patients would tell you that without the hope for success of the DBS treatment, they were facing death.
It is easy to see how such patients are enticed into being human lab rats for unproven experimentation. There exists a compelling need for greater protections of such patients, as multi-billion dollar corporations are quick to slough off these patients’ needs, all in the name of improving stock value and shareholder profits. Meanwhile, very real people, these patients are left to endure and pay for the lasting adverse effects they received during the study.
The author writes with a depth of insight that evidences extensive research and thorough interviewing of subjects. The intertwining of the story’ various threads is captivating. I hope that she may consider following up with a companion piece in the future and I look forward to reading more articles by her. Kudos!
The very term “treatment resistant depression” usually means: Drug didn’t work and made things worse and more intractable. So the people considered for the study are ones who have already been damaged by multiple drugs.
I always loved that one. It’s NOT that we failed the client, their DEPRESSION resisted us! It’s not our fault, not even the CLIENT’S fault, it’s DEPRESSION’S fault! As if it is a separate entity with an ability to resist despite everyone’s best efforts. Why not just say, “We haven’t been able to find a way to help her so far.” But that would mean admitting that their wonderful “treatments” may not be quite so wonderful! We can’t have THAT, so let’s “blame the disorder!” It’s a win-win! Oh, except for the client, who remains depressed and looses all hope, but hey, it’s not OUR fault that Depression is so mean to her!
Thanks for this story! – it is a very important issue to investigate. I myself almost started the DBS procedure a year ago, out of a desperate hope to alleviate worsening, co-morbid OCD and anorexia. However as a freelance and former newspaper journalist I must comment on the significant need for editing in this story — I found it very hard to wade through and could only skim parts of it due to its poor flow, grammatical errors & run-on sentences, poor organization, and excessive length. I think the author is a great writer and reporter — but even the best writers need editors. I know I sure do. I only point this out because the writing problems may prevent this story from garnering a more mainstream audience – and I think that should be an aim of Mad in America. If the issues raised here only circulate among those of us who share the same views toward the incredibly flawed treatment and perception of “mental illness” which reigns in the U.S. today – then the writing here will never really help spur change. And isn’t that a primary goal of the Mad in America community? That aside — thank you nonetheless for all your thorough research and for bringing out into the open the problems with DBS treatment – problems I had not been informed of when I was considering the procedure a year ago. I also want to agree with a previous commenter’s post about the need for greater attention being paid to psilocybin research — I too agree this holds a lot of hope. I actually had a psychiatrist indirectly recommend (since he couldn’t say it outright) I try magic mushrooms myself; there are psychiatrists who are trying to legitimize/legalize the use of things like psilocybin, MDMA, etcetera in academic settings. There is also the Santa Cruz research center (I think it’s MAPS?) doing FDA approved studies. It would be great if we could help advocate that more funding go toward those studies. I understand the existential/ego separation effects of drugs like these play a big role in helping alleviate our “problems in living.” If I had the means to try something like psilocybin, I would do it in a New York minute…..
Thank you so much for this. Finding information on side-effects and personal experiences is so very difficult. Of course, “no one” wants you to know. This, DBS, was my last resort; now it’s not even close to being a possibility. And TMS does not fit the bill: too many unanswered questions concerning what happens to the grey matter between the skull and the site of focus. So, what the hell am I to do? Cognitive Therapy is nice, as in nice to know, nice to have an intellectual experience of what’s going on; but when it comes to being in the middle of an event CBT is useless. Now? I think I will move to a town out in the middle of nowhere with no social pressures, no “infrastructure” and few people. This would also benefit my writing, which has taken a dive over the past 5 yrs, half of it spent not writing at all.
Have a look at this person’s experience. He went from needing hospitalization to feeling fine in two days.
If you want to try the same thing, see that thread or these notes http://egg.bu.edu/~youssef/SNAP_CLUB/BA.pdf
It’s safe, easy and fun to try. – Saul
Incidentally, the game in those notes is a simple fun way to train yourself by making lots of tiny fun decisions as a way of healing depression overall.
Now, the part of the brain most associated with deciding things (i.e. intention formation, goal-directed action, attention control (among other things)) is the dorsolateral prefrontal cortex.
And guess what area of the brain they try to stimulate with TMS? The dorsolateral prefrontal cortex. – Saul
Your game may be of help to some people who are experiencing a depressed mood. However, the individuals that qualify for experimental intra-cerebral neurosurgery in efforts to treat their refractory depressive disorder are suffering something altogether different.
Severely refractory major depressive disorder, sometimes referred to as malignant or insidious depression, is not easily or effectively treated by playing a game.
It is a progressive, neurodegenerative disease that causes increasing cognitive dysfunction, impaired memory and executive functioning, and these impairments not only persist if the depressive episode remits but these cognitive deficits persist and accrue with subsequent depressive episodes.
These toxic effects of major depressive disorder can be observed in the reduced volume of the hippocampus, reduced volumes of cortical grey matter, and a number of other gray matter abnormalities that progressively worsen with each subsequent episode.
If you have scientific evidence that demonstrates how your simple game can effectively treat these gravely suffering patients and halt or reverse the damage to their brains and cognitive functioning, that would be wonderful. So far, my brief search for such evidence did not produce any such results.
What evidence is there that “severe refractory depressive disorder” is a valid reliable condition? In other words, how can one reliably separate moderate, severe, severe refractory, etc. depression, give the many individual presentations people have, the fact that many different environmental experiences might cause severe depression? I.e. given the lack of any biomarkers / genetic or biological causes for this supposed condition, how can we be sure that psychiatrists can reliably identify or treat it?
It’s nice to say things like this, but there’s no evidence for severe refractory depressive disorder being a separable, discrete illness separate from other more or less severe experiences of depression.
I don’t know if you had a chance, but look at this link carefully.
This is someone who was actually hospitalized for depression with severe symptoms including psychomotor retardation. Someone who “obviously has a real medical problem.” And yet, playing a simple fun game, his problems were gone after only two days. It is hard to imagine a better outcome or a more promising thing to try for a depressed person. If this were in pill form, it would be known to all as a miracle cure.
You say that depression is a progressive, neurodegenerative disease. Changes in the brains of depressed people have indeed been discovered, but notice that no underlying disease process has been discovered. I think that this is because there actually is no underlying disease process other than a habitual ingrained unconscious reaction to stress. It is controversial whether brain changes in depressives are fully reversible, but people do recover from depression and that’s surely the best thing to do if you are depressed.
It’s plausible and easy to think that this is a just silly game and can’t have any big effect, but I really think that this is a mistake. You can compare it with meditation. Meditation is also easy to underestimate or mock “sitting and doing nothing is supposed to help??”, but it is now widely accepted that meditation does cause real biological benefits to meditators.
Regards, – Saul
re: “If you have scientific evidence that demonstrates how your simple game can effectively treat these gravely suffering patients and halt or reverse the damage to their brains and cognitive functioning, that would be wonderful. So far, my brief search for such evidence did not produce any such results.”
The game is new and there is no literature on it yet, although it’s probably in the category of “behavioral activation,” which has been studied. It has been used for about 20 depression patients at the Brigham and Women’s hospital in Boston and has been successfully used by quite a few people on-line. It is a promising area for scientific study, I believe, but this is a little different than DBS. There is clearly no risk to trying this. It is and fast acting and even fun to do. If you are a depressed person, you might as well just try it and see if it works. There is nothing to lose by trying.
You seem to “blame” the victim for experiencing rumination by thinking without deciding. My understanding of rumination, both from published scientific journals and personal experience, is as follows:
Ruminative responding in major depressive disorder (MDD) is defined as a recurrent,
self-reflective, and uncontrollable focus on depressed mood and its causes and consequences (1-3). Higher levels of rumination have been found to predict both more severe depressive
symptoms in depressed individuals (4) and the onset of depressive symptomatology in nondepressed people (5). Although ruminative responding is not considered a criterion symptom of depression in DSM-5 or ICD-10, measures of rumination nonetheless consistently (and often, perfectly, e.g., 6) differentiate depressed from never-depressed individuals. Indeed, theorists have posited that rumination is a central aspect of the phenomenology of MDD (7).
If you wish to review the cited references, and I encourage you to do so, they are:
1. Morrow J, Nolen‐Hoeksema S (1990): Effects of responses to depression on the
remediation of depressive affect. Journal of Personality and Social Psychology. 58:519‐527.
2. Nolenhoeksema S (1991): RESPONSES TO DEPRESSION AND THEIR EFFECTS ON
THE DURATION OF DEPRESSIVE EPISODES. Journal of Abnormal Psychology. 100:569‐582.
3. Whitmer AJ, Gotlib IH (in press): An Attentional Scope Model of Rumination.
4. Kuehner C, Weber I (1999): Responses to depression in unipolar depressed
patients: an investigation of Nolen‐Hoeksema’s response styles theory. Psychological
5. Nolen‐Hoeksema S, Wisco BE, Lyubomirsky S (2008): Rethinking Rumination.
Perspectives on Psychological Science. 3:400‐424.
6. Hamilton JP, Furman DJ, Chang C, Thomason ME, Dennis E, Gotlib IH (2011):
Default‐mode and task‐positive network activity in Major Depressive Disorder:
Implications for adaptive and maladaptive rumination. Biological Psychiatry. 70:327‐733.
7. Lyubomirsky S, Tucker KL, Caldwell ND, Berg K (1999): Why ruminators are poor
problem solvers: Clues from the phenomenology of dysphoric rumination. Journal of
Personality and Social Psychology. 77:1041‐1060.
Turning now to your “SNAP CLUB” game, am I correct in understanding the rules as:
1. Do anything you want, any time you want.
2. When you decide to do something, at the moment when you decide, SNAP YOUR FINGERS.
As you may be aware, anhedonia is recognized as a hallmark symptom of depression. Anhedonia, the inability to experience pleasure, is included as a primary symptom in the diagnostic criteria for clinical depression in both the Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV; American Psychiatric Association, 2000) and the International Statistical Classification of Diseases and Related Health Problems (World Health Organization, 1992).
Along with other symptoms used to clinically diagnose Major Depressive Disorder, are lack of interest, lack of enthusiasm, reduced attention span, reduced concentration, loss of energy, and excessive fatigue.
While some people experiencing depressed mood may benefit from games and other diversionary activities, patients with Major Depressive Disorder or refractory depressive disorder may likely find the first rule overwhelming and implausible. Of course, I am referring to patients who suffer from severely treatment-resistant depressive disorder, as determined by one or more accepted assessment tools, i.e. the Antidepressant Treatment History Form (ATHF), the Thase and Rush Staging Model (TRSM), the European Staging Model (ESM), the Massachusetts General Hospital Staging Model (MGH-s), or the Maudsley Staging Model (MSM).
If you doubt that treatment-resistant depression is somehow different from feeling depressed, I recommend you read some research on the subject. May I suggest:
Treatment-resistant Depression: A Separate Disorder, Hans-Jürgen Möller, Florian Seemüller, Rebecca Schennach and Ramesh K. Gupta (2013), also Definitions and Predictors of Treatment-Resistant Depression, Daniel Souery and William Pitchot (2013).
Lastly, you might find it informative to review:
Toxic Effects of Depression on Brain Function: Impairment of Delayed Recall and the Cumulative Length of Depressive Disorder in a Large Sample of Depressed Outpatients, P. Gorwood, et al, Am J. Psych. 2008; 165:731-739. This article has been widely cited for its finding, gathered from over 8,000 patients, that “There is a current tendency to demean the
significance of depressive symptoms as evidence of distress rather than illness. We would not seek to dispute the distress, but our data support the hypothesis that recurrent or prolonged depression has effects on the brain that make it a significant and disabling illness.”
Also, “Atrophy of the hippocampus is one of the most consistent imaging findings in major depressive disorder. This has highlighted the potential role of physiological stress as a core mediating factor (often assuming a neurotoxic effect of cortisol on the hippocampus) and has
emphasized the need for antidepressant treatments that might prevent or even reverse hippocampal atrophy.
re: Adverse Effects: The Perils of Deep Brain Stimulation for Depression
A warning from a decade ago, from an article about mind invasive technology: “He also said that in this century, human nature is no longer a fixed commodity, that perhaps we should contemplate the possibility that humans would even have implants in the brain.” http://www.globalresearch.ca/on-the-need-for-new-criteria-of-diagnosis-of-psychosis-in-the-light-of-mind-invasive-technology/7123
No need to contemplate the possibility. It’s time to acknowledge history and today’s reality.
The brain tinkerers won’t be satisfied until they’ve ruined and destroyed everything and everyone, so they can fix ‘er up and create their own fantastical ideas in select, willing human beings and in non-consenting, unsuspecting human beings.
This is the reality of today,
Jennifer Doudna is the co-inventor of an extremely alarming and concerning technology, and has called for a global conversation to consider all of the ethical and societal implications of a technology like this: ” …that we realized that we could harness its function as a genetic engineering technology, a way for scientists to delete or insert specific bits of DNA into cells with incredible precision that would offer opportunities to do things that really haven’t been possible in the past.”
Pause at 2:39 and take a good look at her face, and read the message on her face. https://youtu.be/e9CdeLJCFRw
When I look at that face, I see somebody who IS AWARE of the danger of what she and they are doing.
A woman named Sheila Cook was claimed to have had successful DBS, but in the long term it did not work. She willingly received a precise Lobotomy /Anterior Cingulotomy . http://www.telegraph.co.uk/news/health/news/8279576/British-woman-cured-of-deep-depression-by-pioneering-surgery.html
Thanks, Youssef, but I find this rather simplistic and momentary. I can go out and function; I do. I meet with group of writers and I’m a member of the local NFB, though not blind, and I work out. But it’s all momentary. None of this touches the underlying genetic “cause.” This article was interesting but it was damning the process despite its working for some. As DBS for TRD Bipolar I is not approved by the FDA, it is not covered by any insurance at all. Where do I go for the $50,000+? TRMS is out not only because of unanswered questions, including from NAPA and CAPA, but also because I live in Brownbackistan (Kansas) where privatization is kind and so many doctors get to “opt out.” VNS? Just because it works with MDD does not mean it is viable for TRD Bipolar I–but it certainly would help the migraines. But all of this is only one side of the equation, the causative, scientific side; there is no thought to the socio-cultural side. There is a poem of mine at http://www.thewriteroomblog.com for 4 July that captures the dilemma. So, I am, to satisfy this need, which seems to have precipitated the last 5 yrs of grief, seriously thinking of returning overseas and staying. So, no, Youseff. SNAP is just games to me; I can do all of those things. I do do all of those things. It is the infrastructure that irritates the hell out of me and makes life difficult. And my poor attitude that I did not have before RX; that I did not have before returning to the US; that is deeper than just being depressed. Thank you anyway for your kind thoughts.
The problem with the likes of DBS for TRD is that it is really unregulated. Yes the FDA provides initial approval but when the trial is cancelled by the FDA they will not and cannot disclose the exact reasons due to it being a “clinical trial” and as such, the information from the likes of SJM is legally and commercially privileged and not able to be disclosed.
The way in which this trial was run in my opinion borders on medical malpractice. I would love to hear from everyone who went through the trial and had adverse side effects.
The article written by Danielle Egan is excellent but only the tip of the iceberg. Medical companies such as SJM and Medtronic need to be held accountable for the misinformation and damage caused ongoing to people who are not able to provide informed consent.
“…only the tip of the iceberg”. That’s for sure.
The questionable pharmaceutical studies and the fudged results that have gone on for years, in my opinion, borders on criminality. It’s all about money and profits.
Thanks to all of you for commenting. markps2, you mentioned a person who had a cingulotomy, and I wanted to point out that I have written about these psychiatric neurosurgeries as well. As I mentioned in this article, the rationale and choice of DBS brain targets was based on these psychiatric neurosurgeries. Many of the early adapters to DBS were performing these surgeries and looking for a “reversible” method of psychosurgery. These surgeries may be marketed as precision targeting, but they target brain regions in exactly the same way as they do with DBS, with all the same challenges. And typically, it doesn’t work and individuals are given additional surgeries, which destroys more brain tissue. If you’re interested in reading more about that subject, I’ve written many articles on psychosurgeries: https://danielleegan.wordpress.com/5-2/neuroscience/
I recommend starting with the article “Vicky’s Brain.” It’s a short article, but I’d like as many people as possible to bear witness to Vicky’s life. She died at the age of 22, and so she can no longer speak out against this surgery.
Vicky’s story is horrifying. So, from 17 drug trials that not only did not help, but probably made her worse to ECT to THREE cingulotomies?? And “Dr.” Lorne said why not a fourth?? And her “mother” agreed?? That poor child. This kind of lunacy and butchery is what psychiatry offers and is allowed to do to living, breathing human beings?
Vicky was better off washing her hands twenty times a day or obsessing on whatever she was compelled to obsess about. No one thought about using love or kindness or empathy or trauma informed therapy? They just poisoned and electrocuted and butchered her brain and decimated her intellect and sense of self. Yes, standard psychiatric care.
I need to ask. How did Vicky die?
I’m not sure what caused Vicky’s death. I was unable to keep in touch with Vicky after the article was published, because her parents were very upset about it. They were upset with her for saying negative things about the surgeries, and they were upset that I published information from people that were critical of the surgery. So, I kept in touch with her psychiatrist and periodically emailed him. About two years after I wrote about Vicky, I emailed to check in and he said that she had died, but that he couldn’t remember whether she had died by suicide, or from some other cause.
Regarding other comments:
– People with bipolar disorder have been among the recipients of experimental DBS.
– I have not researched the specific game mentioned, but games can be very effective with various diseases and disorders, including video games and other games for PTSD, chronic pain (including from body burns, which I’ve heard are some of the most severe types of pain), methods to curb Alzheimer’s, methods to curb anxiety, methods to help with autism and Asberger’s. Games are key to various neuroplasticity-focused therapies, which are used for everything from stroke recovery to phantom limb syndrome to addiction. They certainly aren’t magic cures, but with continued use, games can improve cognitive and neurological function, much like physical rehab therapies can help people gain back lost function, whether it’s learning to walk, button a coat, or other cognitive functions. In fact, games are part of that critical rehab. But, yes, in many cases, they have to be ‘played’ repeatedly, for weeks, months and perhaps years.
I can’t imagine how tough the process of recovery must be for anyone facing any difficult and painful situation. I consider myself very lucky that I haven’t had to climb that kind of mountain at the very same time that I was at my weakest and most vulnerable. That’s one of the many reasons I find Rich, Jim and Steve’s stories incredibly hopeful and inspiring.
It is better to be an alcoholic (to dull ones pain) than to get some of your brain removed/burnt out.
Yes. Danielle. But you cannot discount those for whom DBS has been effective. There are similar drawbacks to cardiac surgery, pacemaker surgery, mastectomy, nasal surgery, cholecystectomy, gastric bypass and, so, we should not do these surgeries and should rant against them? Are you bipolar? Do you suffer from TRD? Is there some other condition that has ruined your life, is continuing to ruin your life that you would do anything to “cure”? Desperation is a major motive for taking big steps, like DBS, and to tell someone that, no, you cannot have this hope is ludicrous. Yes. We should be aware of the downside of DBS or any surgery. . .like my abdominal surgery: if we can’t find the place of hemorrhage of fresh arterial blood, you will die. Not may or might; will. I’m left with a life of almost constant infection in my gut–and I’m already immunologically compromised. But I’m alive. Every time you cut into a body, you open the gates to problems, you kill or distort cells and growth, you infect. I, in fact, find surgery to be barbaric, but continued dysfunction and/or death is preferable? You cannot damn it outright. That is an untenable stance. I find it objectionable. I gave up on DBS because I can’t afford $50,000. Not because of these horrors. Desperation. Individual choice.
I appreciate the fact for someone who has TRD, there is no light at the end of the tunnel and DBS would be seen as appealing. Problem is that the device manufacturers are attempting to go to market far too soon and at the cost of hundreds of sufferers who become their guinea pigs and with limited rights. Additionally, the lack of support when something does go wrong is what differs that from the proceedures you mentioned in your post.
The fact is that DBS for TRD is plagued with problems and has been for many years. SJM continue to “hide” around the facts of their clinical trials which they have been supporting. Why not share the results openly…and now…..rather then simply saying that they are coming.
Informed consent is a wonderful thing; when you are fully informed. Unfortunately medical companies fail to fully inform potential patients about what can go wrong. Medical ethics would dictate that a patient has all the facts prior to agreeing to a proceedure which is not proven and is still very much in the experimental phase. I agree it is down to individual choice, and appreciate the aspect of there being the element of desperation. Full disclosure however and honesty is required from the manufacturers and medical professionals who continue to “push” certain options.
I don’t know anyone who’s pushing DBS for TRD in Bipolar I people. They push it for MDD and Parkinson’s, Tourette’s, OCD, etc. The profession is pushing electrocution therapy (ECT). But you’ve completely side-stepped my comment, more or less replying to yourself. And I don’t think you understand desperation at all.
I can identify with your frustration. There’s little doubt that medical advances for treatment of mental illness have a very long way to go and have not progressed anywhere near what the public believes.
However, from reading your posts one gets the impression that you are functioning fairly well. Maybe not where you want to be but you are able to get out, meet with other writers, and more. In patients enrolled for DBS for severely refractory major depressive disorder, such functioning was not possible. The patients viewed DBS as their last chance to get out from under the crushing weight of depression, even if it meant allowing someone to drill into their skull and experiment directly on their brain.
I say this, not to glorify those who were DBS Guinea pigs, but rather to encourage you to locate the most qualified and most experienced psychiatrist that has proven expertise in working with patients with your diagnoses.
Perhaps this sounds trite and dismissive. I assure you it is not. It is my sincere recommendation, based on 30+ years of wrangling with serious depressive disorder. Cultivating a mutually respectful Doctor-patient relationship with the right psychiatrist can be the most successful treatment possible.
I don’t care if they aren’t covered by your insurance. If you really want to get better, start prioritizing where you spend your money. Also, be willing to travel to see them. It may be necessary to find the experienced pdoc you need.
The biggest mistake you can make is thinking that you know what treatment is best for you and then trying to find a doctor who will prescribe it. You will soon find that doctors view such patients as noncompliant and undesirable. Basically you alienate the person you are paying to help you! Not a recipe for success.
If you are truly suffering, not merely wanting to feel better than you do, do yourself a favor and locate a true ally in you battle. Don’t try to go it alone.
I truly hope you find what you’re looking for.
Any doctor who is alienated because I want to make my own decisions is a doctor I want to avoid at all costs. And any doctor who even THINKS the word “noncompliant” when considering his patient’s decisions should not longer be a doctor. A doctor is not a jailer or schoolteacher or general – s/he is a professional adviser, and his/her client is entitled to listen or not listen to his advice. That’s what “informed consent” is about.
I would bet that James trusted his psychiatrist and paid the price. It’s kind of arrogant to suggest that he should trust them again. I don’t trust any treatment I haven’t personally researched. With doctors having been shown by the JAMA itself to be the third leading cause of death in the USA, such caution is very well warranted, and any doctor who can’t understand that is not going to have me for a patient.
As an FYI, I am dealing with another medical issue (not psychiatric) in which I have gotten pretty desperate at times. So I do relate to what you are saying as yes, there were times, I would have done anything to alleviate the situation.
I wish you all the luck in the world in resolving your problems. My heart really does go out to you.
Happened across another news article of a FAILURE, first sold as a success.
Chantal Remeny alive in 2006
Chantal Remeny dead in 2009
I found it very interesting that `Jim’ preferred the enormous risks of this extreme procedure rather than try ECT again. “I didn’t want to go through that again – the memory loss and cognitive issues were too high of a price. I had 26 ECT treatments and the result was significant memory loss; I don’t remember my wedding.”
This in spite of the insistence of many psychiatrists in the current and ongoing PR campaign that ECT is benign and the `Gold Standard’, optimal treatment for `treatment resistant depression which includes applying to the FDA to grant a reduction of its `danger’ status in 2016. and THIS treatment adversely affects over 100,000 people a year in the US alone, many against their will.
Another point, as a retired mental health professional I worked with people with very severe depression for many years – I never met ONE who did NOT have some reason in their lives to suffer from it. There is plenty of evidence that the experience of trauma, and abuse of ALL kinds alters brain function so it is currently impossible to claim that the changes where there are any that can be seen in the brains of depressed (or any mental `illness’) are the CAUSES of anything at all. But we certainly know that interference by substance or assault with radiation, knives, electrodes, electrical currents, WILL cause serious and permanent `changes’ to brain structure and therefore FUNCTION. Given the current miniscule understanding of how the brain actually works perhaps we really are better off talking people through their pain, those changes are probably reversible.
Lying to the public about research results and thus building a hype for investors to prey on through means of capitalizing on human suffering seems to be the new BLACK in biomedical science. A forerunner to the forthcoming free hunt on lesser human beings that will hit the entertainment industry in the future. Oh! Wait a minute… isn’t that already h…?
“While other neurosurgeons are trying DBS experimentally for Alzheimer’s, addiction, obesity, anorexia, bipolar disorder and aggression (and it’s even been suggested to treat criminal behaviour)…”
So… Soon ‘God’ help you if you are a criminal inmate serving three strikes… ‘Cause these people have their eyes turned on you… and they mean you no well.
A new study on the effects on the patients thoughts and feelings. http://www.tandfonline.com/doi/full/10.1080/21507740.2017.1320319
Patient 09 stated: “I felt I was 15 years younger after the operation … I felt so strong and confident … I could do anything … I felt so good I tried to move the pool table and I ruptured the disc in my back … I blame DBS for that because I felt so good, I did something that I couldn’t have done when I was 21 and I don’t know why I thought I could do it when I was 54 … I was in a wheel chair for 2 months.”
Which goes to show that emotions are important survival entities, even “negative” ones, and generally speaking, screwing with them does not improve our survival.
I heard a news magazine report on NPR about a guy diagnosed with autism that got this process done on an experimental basis. It did make him more sensitive to others’ emotions, in fact, dramatically so. This unfortunately was overwhelming for him and altered his relationship with his wife, who felt he was withdrawing and didn’t need her any more. It ultimately led to them getting divorced. And when the experiment was done, they left him on his own and the effects faded. He said he would do it again because it helped in his relationship with his son, but reported it created tremendous chaos in his life. Again, we humans are arrogant when we believe we can mess with someone’s emotions and not have serious adverse effects occur!
Hello to all. I just wrote another article about the topic, with an update on the DBS recipients interviewed in this article. It’s on the home page this morning.
I too want it out of my head. Since having the DBS surgery at Augusta University hospita approximately 3 months ago I experience nothing but severe front right lobe headaches. Never experienced a headache in my lfe. Just this weekend lost full control of right side of body Augusrta attending physician advice me to visit local hospital for possible stroke but stated conditions could not have been in anyway tied to the DBS. Remained in hospital for 4 days and was sent home and due to DBS being relatively new they have no way of testing. Augusta University was contacted so Lexington County never received any advice. So I personally want this time bomb out of my head.