tag:blogger.com,1999:blog-56940551844159428312024-02-07T14:59:40.703-08:00VNS Therapy (Vagus Nerve Stimulation)Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.comBlogger493125tag:blogger.com,1999:blog-5694055184415942831.post-17852543454888739512016-01-04T11:58:00.005-08:002016-01-04T12:00:36.985-08:002015-12-10 Memorial Celebration and Tribute to the Life of Joyce (Warren) SteinTo our Dear Family, Friends and Physicians,
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Our daughter Nancy and I have truly been overwhelmed by the attendance at the
Memorial Celebration and Tribute to Joyce’s life as well as the out pouring of
condolence cards, telephone calls, donations and e-mails that we both have
received from all of you honoring Joyce for which I express our sincere
gratitude and appreciation.<br />
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We are endeavoring to respond to all.
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In the midst of all this it has taken me time to edit and complete the video
recording I made of the event enabling us to share with you the vibrant, fun
loving and immensely energetic individual my beloved Joyce was.
<b><span style="color: #1e75a8;"></span></b><br />
<b><span style="color: #1e75a8;"></span></b><br />
<b><a href="https://youtu.be/pzhA-aLXAcg"><span style="color: #1e75a8;">2015-12-10 Memorial Celebration and
Tribute to the Life of Joyce (Warren) Stein</span></a></b>
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I thank you all for being in one way or another a very important and
invaluable part of our lives.
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I shall miss Joyce’s energy and fun loving spirited nature immensely.
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I wish you all wellness and all the good you’d wish for yourselves as well as
a Happy, Healthy, Prosperous and Peaceful New Year.
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<br />
With much love,
<br />
Herbherbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com3tag:blogger.com,1999:blog-5694055184415942831.post-62354373104464880972015-10-07T12:22:00.001-07:002015-10-07T12:22:01.281-07:00Noninvasive VNS Potentially Helpful for Acute Treatment of Cluster Headache<p><font size="3" face="Times New Roman">To the readers,</font> <p><font size="3" face="Times New Roman">The reason I posted this article is the fact I use to suffer for years from debilitating cluster headaches.</font> <p> <p>Clinical Pain Medicine <p>ISSUE: OCTOBER 2015 | VOLUME: 13(10) <p><font size="4">Noninvasive VNS Potentially Helpful for Acute Treatment of Cluster Headache</font> <p><a href="http://www.painmedicinenews.com/aimages/2015/PMN1015_010a_3262_300.jpg"><img alt="image" src="http://www.painmedicinenews.com/aimages/2015/PMN1015_010a_3262_300.jpg"> </a> <p>The results of the placebo-controlled ACT1 (Non-invasive Vagus Nerve Stimulation for the Acute Treatment) study, sponsored by electroCore, confirm that noninvasive vagus nerve stimulation (nVNS) may be a helpful acute intervention in selected patients with cluster headache (CH). <p>ElectroCore’s nVNS gammaCore device did not significantly increase the proportion of patients who had a pain-intensity scale score of 0 or 1 within 15 minutes of the start of therapy during their first CH attack. It also did not significantly lower average pain intensity at 15 minutes after treatment initiation, according to a presentation of the results at the American Headache Society’s 2015 Annual Scientific Meeting (abstract LBP07). Moreover, an accompanying poster indicated that true blinding was not achieved (abstract LBP08). <p>However, nVNS was associated with a higher proportion of sustained responders, defined as response at both 0.25 and one hour after treatment initiation. The respective percentages of sustained responders to nVNS or sham treatment were 26.7% and 12.3%. <p>“This is a doubling of the percentage of sustained responders, which we feel is clinically meaningful,” co-investigator Eric Liebler, BA, vice president, Scientific and Medical Affairs, electroCore, told <em>Pain Medicine News</em> in a telephone interview. “The patient wants to know whether their pain will go away or be much reduced, and they want it not only to go away, but to stay away.” <p>He said the company has conducted a similar study in Europe, and plans to submit an application that is based on data from both continents to the FDA for approval to market the device in the United States. <p>Nathaniel Schuster, MD, headache and facial pain fellow in the Department of Neurology at Montefiore Headache Center/Albert Einstein College of Medicine, in New York City, said he is looking forward to more studies of nVNS. <p><a href="http://www.painmedicinenews.com/aimages/2015/PMN1015_010c_3262_300.jpg"><img alt="image" src="http://www.painmedicinenews.com/aimages/2015/PMN1015_010c_3262_300.jpg" width="300"></a> <p>Photo: electroCore’s gammaCore device. <p>“I think that, if it proves to be effective, it will be welcomed eagerly by patients and physicians alike,” Dr. Schuster told <em>Pain Medicine News</em>. “Designing a sham control that effectively blinds trial subjects appears to be a challenge with this device, and a sham control with more effective blinding would improve the quality of the evidence.” <p>The ACT1 study initially included only people with episodic CH, but the investigators expanded it to also include those with chronic CH. <p>The sham device had an identical weight, visual and audio feedback, and user interface to the active nVNS device. However, the sham device generated a low-amplitude, low-frequency signal that did not stimulate the vagus nerve but produced a sensation by stimulating skin-touch receptors, according to Mr. Liebler. The active device produced a higher-amplitude, higher-frequency signal that stimulated the vagus nerve. <p>Seventy-three patients were randomly assigned to nVNS and another 77 to sham treatment for one month, followed by an open-label, three-month phase in which all patients received active nVNS. The two groups had similar demographic and CH characteristics. <p>There was a 26.7% response rate at 15 minutes with active nVNS and a 19.2% 15-minute response rate with sham (<em>P</em>=NS). Patients with episodic CH had a significantly higher 15-minute response rate with nVNS than those with chronic CH, at 34.2% and 13.6%, respectively (Figure). <p><a href="http://www.painmedicinenews.com/aimages/2015/PMN1015_010b_3262_600.jpg"><img alt="image" src="http://www.painmedicinenews.com/aimages/2015/PMN1015_010b_3262_600.jpg" width="600"></a> <p><strong>Figure. </strong>Response rate (ITT population). <p><strong>CH,</strong> cluster headache; <strong>ITT,</strong> intent-to-treat; <strong>nVNS,</strong> noninvasive vagus nerve stimulation <p>The rate of sustained-treatment response was significantly higher with nVNS compared with sham treatment. The bulk of the positive sustained response to nVNS was in the episodic cohort, which had a 34.2% sustained-treatment response rate versus 10.6% for sham treatment, whereas the respective rates for the chronic-CH cohort were 13.6% and 15.4%. <p>Patients with episodic CH responded in larger numbers than those with chronic CH both initially and over the first hour. Furthermore, there were no serious device-related adverse events. However, calculations of the rate of blinding at the end of the randomized phase “indicated that true blinding had not been achieved,” the authors noted in the accompanying poster. <p><em></em> <p><em></em> <p><em>—Rosemary Frei, MSc</em> <p><a title="http://www.painmedicinenews.com/ViewArticle.aspx?d=Clinical%2BPain%2BMedicine&d_id=82&i=October+2015&i_id=1234&a_id=33855" href="http://www.painmedicinenews.com/ViewArticle.aspx?d=Clinical%2BPain%2BMedicine&d_id=82&i=October+2015&i_id=1234&a_id=33855">http://www.painmedicinenews.com/ViewArticle.aspx?d=Clinical%2BPain%2BMedicine&d_id=82&i=October+2015&i_id=1234&a_id=33855</a> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-86414650778235216292015-09-24T21:53:00.001-07:002015-09-24T22:10:17.908-07:00Adverse Effects: The Perils of Deep Brain Stimulation for Depression<h3>Adverse Effects: The Perils of Deep Brain Stimulation for Depression</h3> <p> </p> <h4>Hundreds of people have been given remote control deep brain stimulation implants for psychiatric disorders such as depression, OCD and Tourette’s. Yet DBS specialists still have no clue about its mechanisms of action and research suggests its hefty health and safety risks far outweigh benefits. Two device manufacturers recently pulled the plug on experimental clinical trials, leaving DBS recipients scrambling to find ways to pay for the necessary lifelong health care, seek medical specialists to take charge of the brain clicker, replace or explant malfunctioning hardware and manage a wide range of adverse effects.</h4> <p>By <a href="http://www.madinamerica.com/author/degan/">Danielle Egan</a> <p>MIA Correspondent September 24, 2015 <h5></h5> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinKZq3TcIY9tMk5pihpfs13wBG6JvBQo-MeaAzRK3BDhIomiMjbjv4U_bZ0tIkPCD7dHng-gocGq3zLvat2PYtn-fMbBejfHDk9TafaiipS8EpyWBLQe0glH37oGo3AGEjL2HMrE2uBxA/s1600-h/image%25255B3%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqYGKBsmXdxULXVpKJBUbpQjs4ttFGeVTa235mdWJQhgy2RIttqSQ_5RREBRsEK5smXCcU2_QE59sIG1Bm66qx45o1uI6Ji69adThhhXENRUySlIvcOfaTXbcRlg4Xlt6HWKouSPdccfI/?imgmax=800" width="342" height="393"></a> <p> </p> <p>“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.” <p>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.) <p>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. <p>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. <p>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. <h5><strong><em>The Procedure</em></strong></h5> <p>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. <p><a href="http://lh3.googleusercontent.com/-nlTqLzq4TBU/VgTWWZFCXFI/AAAAAAAAA5k/9M5y1mhNKsc/s1600-h/image%25255B8%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOdq8kpz3gAf-J7KRfzXVHWwkHR4rKcqSLofqdJlYx7ypgOUSQeWxxFxuwdNeQ3n4ct7HhbL1tn2AQtLhGkWRYGBzEt6jklUrNQgMUbn4bPrSTDmufF1be-F2y4HrqGK6NiA_MVsiTxKA/?imgmax=800" width="468" height="345"></a> <p>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. <h6>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.</h6> <p>DBS surgery comes with a host of other potential surgical risks, including: <ul> <li>up to an 8% risk of bleeding in the brain that can lead to permanent deficit, or death 1.1% of the time. <li>an 8% chance of stroke or permanent neurological deficits. <li>a risk of infection of up to 15%. <li>5% risk of hemorrhage. <li>2% risk of seizure. <li>the potential for air to enter the brain, and leakage of cerebrospinal fluid or brain fluid.</li></ul> <p>‘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. <h5><strong><em>Jim’s experience</em></strong></h5> <p>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 11<sup>th</sup>. 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.” <p>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. <p>“I thought I was ‘off’ because I had no benefit,” says Jim. “I was still struggling with depression and suicidal feelings.” <p>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.” <h5><strong><em>The Theory of DBS</em></strong></h5> <p>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. <p>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. <p>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. <p>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. <p>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. <p>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. <p>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 <a href="http://www.sciencedirect.com/science/article/pii/S089662730500156X">results</a> of which were published in <em>Neuron</em>, 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. <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEig8EQVbR4gPChqJ08wphwduQpPzUqeY5qJi9nkSQzXuUE-IPxVGlyY147JN1xEh6uv2uNOirewKgkwiO7dciZrVdWUlViji1jca5AcbMRmqYQXhdtgyKRZfpAWizYFoW1YcKYdtdm-4HY/s1600-h/image%25255B31%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiz3lx9NSTARiYpm11pc37zxZIpk81AuTovBVvHJtZKH9pn-4YqL0-qLoCX-AeKSG9E184xGhJiUNs2r0zRv0NwuSkhAL_Zba-BseqHLS3CGBmObTI2UJiI-TA_K-Ctb1n-MOnI0I2YLHg/?imgmax=800" width="396" height="365"></a> <h6> </h6> <h6><strong><em>Informed Consent?</em></strong></h6> <p>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. <p>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 <em>Neurotech Reports</em>, 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. <p>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. <p>Some additional insight about the trial’s termination came six months later, in an <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4121451/">academic paper</a> published in a July 2014 issue of <em>Neurotherapeutics, </em>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%.” <h5><strong><em>Media Hype Preceded the Blackout</em></strong></h5> <p>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 <em>New York Times Magazine</em> article titled “<a href="http://(http//www.nytimes.com/2006/04/02/magazine/02depression.html?pagewanted=all">A Depression Switch</a>” 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. <p>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 <em>Times</em> 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. <h5><strong><em>Confusion in the research literature</em></strong></h5> <p>The long-term results of that initial pilot <a href="http://thejns.org/doi/pdf/10.3171/2011.10.JNS102122">study</a>, 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. <p>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 <a href="http://www.biologicalpsychiatryjournal.com/article/S0006-3223(14)00968-8/abstract">study</a> 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. <p>Two recently published study outcomes did report high efficacy rates of DBS of the Cg25 area in the brain. A Spanish <a href="http://ijnp.oxfordjournals.org/content/15/1/121.long">group</a> 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 <a href="http://www.medtronic.com/patients/obsessive-compulsive-disorder-ocd/important-safety-information/index.htm">warning</a> against that combination. <p>Helen Mayberg and her Emory University co-investigators have also reported <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4423545/">results</a> 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 <em>Neurotherapeutics</em> 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.” <p>The University of Florida group has also <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4061279/">written</a> 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.” <p>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.” <p>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.” <h5><strong><em>Financial conflicts of interest</em></strong></h5> <p>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. <h5><strong><em>Back to the Broaden Trial</em></strong></h5> <p>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. <p>Their <a href="http://investors.sjm.com/investors/financial-news/news-release-details/2008/St-Jude-Medical-Announces-First-Patient-Implants-in-Clinical-Study-Evaluating-Deep-Brain-Stimulation-for-Depression/default.aspx">press release</a> 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. <p>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.) <p>“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.” <p>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. <p>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.” <p>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.” <p>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.” <h6><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXXcLklNMA4EMOyB9OdrxyQJJB4cvLu4MwHj93m8f8Co9W5uvlcz8o3J4OWHiXvXx8WGROrs2OnOC1YktOMAmR3Ov0JfW9WOQxJXWyrxYd0jvrvo8Ia4A5qiskC7Y-a121mocGc5JHy6c/s1600-h/image%25255B18%25255D%25255B3%25255D.png"><img title="image[18]" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image[18]" src="http://lh3.googleusercontent.com/-aOvW28SMdSA/VgTWa8mBZKI/AAAAAAAAA6I/k1gj8Qe96Bg/image%25255B18%25255D_thumb%25255B1%25255D.png?imgmax=800" width="432" height="316"></a></h6> <h6> </h6> <p>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.’” <p>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.” <p>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.’” <p>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.” <p>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. <p>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.” <p>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.” <p>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.” <p>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.” <p>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 <em>Neuroethics </em>subtitled<em> “</em>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 <a href="http://www.ncbi.nlm.nih.gov/pubmed/10628886">3.4% suicide rate</a> 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. <p>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 <em>wanted</em> to kill myself, but since the DBS, when I have the suicide episodes, it’s like I <em>have</em> 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?” <p>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." <h5><em><strong>The Neurosurgeon’s Perspective</strong></em></h5> <p>According to a 2013 <a href="http://www.ncbi.nlm.nih.gov/pubmed/23797416">survey</a> 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.” <p>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.” <p>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.” <p>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.” <p>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.” <p>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.” <p>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.” <p>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.” <h5><em><strong>Left to Foot the Bill</strong></em></h5> <p>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 <strong>not</strong> 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.” <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbRwVjT_xJeRIMm-QFv5mr-JslzRhKbfRH78PhF6uH9KarPy74J95mLqEcK4YH8QpMyuW1OSQ0nbj9sdnBH8dd0w3d5wRgq88nS3k2VBOTG_CtUndT8GXdmLoMbWMBw1oX-gV02twQ9xk/s1600-h/image%25255B23%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxmvP8rlcubWJuTrDeL4tLudDOCH_f-W7KdNwyVtOcwQTyKOJMmZJzqckpcqW0Xg92Fo_2sZs8Mmkn_e6YhOtygkIMLe3r_KSy-lp6kuvSZLg9MlfCeESwI7fk81OW_w22Co80tpDrZ80/?imgmax=800" width="616" height="420"></a> <p>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. <p>“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.” <p>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.” <p>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. <p>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. <p>“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.” <p>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.” <p>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.” <p>This summer, SJM did receive FDA <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm">approval </a>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 <a href="http://annualreport.sjm.com/pdfs/2014-ar.pdf">annual report</a> “such proceedings could have a material adverse effect on consolidated results of operations, financial position and cash flows of a future period.” <p>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.” <p>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 <em>me</em> 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?” <p> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhiHTAWbuJkXZiPhBtE4f46bx4-v4gi_ptbX3BfiWRVJ8C87OyTkeQTbBxscdLPKZ4yHqJPYR4JoSLYOoRbQq6eWJ8W5ml95FqbV0Vc3NltWWGmpaCXlWJxqJu6Nz59rdNFgqY6Z5vAtKo/s1600-h/image%25255B30%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhX_-uBR97CY6_Bup6yMxPP_omKGCKfJIo7FcAgdlEYRl5M5KzNz9-p2sR0bG_LvTWCaiWfEOxRvya0-jdr36t3yUoEcCbliHAbySsbmXnEjy9VwdHxj0V6fs62TlB6yLog233CDn9tWfs/?imgmax=800" width="588" height="379"></a> <h6><em>Steve made this video last year to inform the public about the perils of DBS clinical research</em></h6> <p>* Name has been changed at his request <p>** Surname not included at his request <p>******* <p><strong><a href="http://www.danielleegan.wordpress.com/"><img alt="Danielle Egan" src="https://www.madinamerica.com/wp-content/uploads/2015/09/Danielle-Egan-119x150.jpg" width="119" height="150"></a></strong><strong>Danielle Egan</strong> is a Vancouver-based freelance journalist. Her articles about psychiatric neurosurgeries and bio-medical technologies have been published in many titles, including<em> New Scientist</em>, <em>Vancouver Magazine</em>, <em>The Tyee</em>, <em>Jane</em> and <em>The San Francisco Chronicle</em>. <p><a title="https://www.madinamerica.com/2015/09/adverse-effects-perils-deep-brain-stimulation-depression/" href="https://www.madinamerica.com/2015/09/adverse-effects-perils-deep-brain-stimulation-depression/">https://www.madinamerica.com/2015/09/adverse-effects-perils-deep-brain-stimulation-depression/</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-63230953582042600332015-09-19T08:33:00.001-07:002015-09-19T08:33:03.558-07:00Serotonin: How Psychiatry Got Over Its “High School Crush”<p> </p> <h3>Serotonin: How Psychiatry Got Over Its “High School Crush”</h3> <p>September 15, 2015 | <a href="http://www.psychiatrictimes.com/blogs/couch-crisis">Couch in Crisis</a> <p>By <a href="http://www.psychiatrictimes.com/authors/ronald-w-pies-md">Ronald W. Pies, MD</a> <p><a href="http://www.psychiatrictimes.com/sites/default/files/images/media/prom-aleisha-shutterstock.jpg"><img title="©aleisha/shutterstock.com" alt="©aleisha/shutterstock.com" src="http://www.psychiatrictimes.com/sites/default/files/styles/figures_diagrams/public/images/media/prom-aleisha-shutterstock.jpg?itok=O73p-M38" width="164" height="205"></a>©aleisha/shutterstock.com <p><em>We’ve had 6 or 7 decades with this paradigm, what I call the “high school crush” on serotonin.</em> <p><em> --Roger S. McIntyre</em> <p>I owe the cheeky title of this piece to Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto, who was interviewed at the recent American Psychiatric Association (APA) meeting in Toronto. But before providing some context for Dr McIntyre’s quip, I invite you to consider 2 claims relating to mental illness: <p>• Psychiatrists think that most mental illnesses are caused by a “chemical imbalance.” <p>• Psychiatrists think that some mood disorders are associated with abnormal serotonergic neurotransmission, among other functional or structural brain abnormalities, which may or may not be the “cause” of the disorder. <p>Since there are light years of conceptual space between these 2 claims, you might imagine, or naively hope, that psychiatry’s most strident critics would be able to distinguish claim 1 from claim 2. Alas, antipsychiatry bloggers continue to bang away at the notion that “Psychiatry” (that sinister, monolithic corporate entity) deliberately duped the public by promoting a bogus “chemical imbalance theory,” in cahoots with “Big Pharma.” Suffice it to say that this line of argumentation is itself bogus, for reasons I have reiterated at length in several venues.<sup>2,3</sup> For example, in 2005, on a publicly available website, the APA clearly stated, “The exact causes of mental disorders are unknown . . . [but] we can say that certain inherited dispositions interact with triggering environmental factors.”<sup>4</sup> At that time, the same APA website also indicated that “several factors can play a role in the onset of depression,” including “biochemistry” (abnormalities in brain chemicals or brain networks), genetics, personality, and environmental factors. To my knowledge, no professional psychiatric organization has ever publicly promoted a “chemical imbalance theory” of mental illness in general. (And, no, the original biogenic amine hypothesis was not a “theory”—the scientific distinction is important.<sup>5</sup>) That antipsychiatry bloggers assiduously comb the Internet and find a handful of “celebrity psychiatrist” quotes to the contrary neither surprises nor impresses me. <p>But there is a sense in which some of psychiatry’s critics have a point, and this brings us back to Dr McIntyre and our old friend (or “frenemy?”), serotonin. It was not hard for the general public—and, alas, some doctors—to pick up the skein of serotonin and weave an entire tapestry with it, ultimately producing the threadbare “chemical imbalance theory.” No doubt, this was abetted by drug company “illustrations” of serotonergic synapses, complete with little packets of neurotransmitters whose reuptake is inhibited by the company’s ace antidepressant.<sup>6</sup> Even today, some non-pharma websites continue to post misleading diagrams that attribute depression to a “chemical imbalance,” as Dr John Grohol recently discovered.<sup>7</sup> <p>So, to be clear: to establish, for a particular patient, a bona fide imbalance of neurotransmitters, we would need a “God’s-eye view,” in real time, of the dozens (hundreds?) of neurotransmitters in her brain; their relative concentrations in relation to well-validated norms; and their deviations from the patient’s normal baseline. Clearly, we have no such divine insight into the brain’s chemical constituents, even though we have learned a great deal about the brain’s “circuitry” and neural networks in recent years.<sup>8</sup> <p>Furthermore, all this focus on serotonin—while heuristically useful in some respects—may have delayed more fruitful inquiries into the biological bases of depression. Indeed, when asked about the role of serotonin in depression, Dr McIntyre replied: <p> "I think there’s been inertia in the field insofar as we had a paradigm based on serotonin. We’ve had 6 or 7 decades with this paradigm, what I call the 'high school crush' on serotonin, and we’ve had treatments that fit into that paradigm, such as the Prozac-type drugs, the serotonin agents, etc. Although that paradigm/treatment applies to a subset of around 10% to 20% of patients remarkably well, we need to think of ways to reach other subpopulations of patients."<sup>1</sup> <p>I agree with Dr McIntyre. And, as I recently stated: <p><strong> "</strong>There is little question that the role of serotonin in depression was over-emphasized and over-marketed in the 1990s, though most psychopharmacologists understood that the neurobiology of depression was much more complicated. Indeed, the term 'SSRI' is itself a misnomer, since some of these agents also affect other brain chemicals (eg, sertraline has mild effects on dopamine)."<sup>9</sup> <p>The neurobiology of depression is, of course, far more complicated than a simple deficiency of one or more neurotransmitters. In this regard, Dr McIntyre went on to elaborate an intriguing hypothesis that links some forms of depression to immune dysfunction, inflammation, and glucose dysregulation—what he calls the “immune inflammatory metabolic model.”<sup>1</sup> But it turns out that this model may link up with the serotonin hypothesis. Dr McIntyre notes, for example, that inflammation reduces serotonin in the brain. In principle, pharmacologic agents (eg, cytokine antagonists) that alleviate certain inflammatory conditions might amplify serotonergic function and reduce some types of depression.<sup>10</sup> All this is just to say that, while the serotonin story has been greatly overblown, there are still reasons to retain some role for serotonin in at least a subset of persons with mood disorders. <p>No, this does not necessarily mean that mood disorders are caused by an imbalance of serotonin—or any other brain chemical. Over 50 years ago, the fathers of the biogenic amine hypothesis, Drs Joseph Schildkraut and Seymour Kety, recognized the complexities of sorting out psychosocial causes from biological effects—which can in turn become new causes or predispositions. They wrote: <p> ". . . it is . . . conceivable that early experiences of the infant or child may cause enduring biochemical changes, and that these may predispose some individuals to depressions in adulthood. It is not likely that changes in the metabolism of the biogenic amines [dopamine, norepinephrine, and serotonin] alone will account for the complex phenomena of normal or pathological affect."<sup>11</sup> <p>The causal chain in the genesis of major depression is almost certainly long and complex—probably beginning with a genetic predisposition to depression, exacerbated by psychosocial stressors and losses, and worsened by dysfunctional personality traits and poor social supports. And while the “self-defeating cognitions” posited by cognitive theorists may not be a proximal cause of depression, their presence may deepen or prolong the person’s depression.<sup>12</sup> Recently, psychiatrists have also focused on socio-economic, educational, and cultural factors that contribute to the risk, and perhaps the onset, of clinical depression. In their recently released book, <em>The Social Determinants of Mental Health</em>,<sup>13</sup> psychiatrists Michael T. Compton, MD, and Ruth S. Shim, MD, cite the following risk factors for depression: racial discrimination, poverty, unemployment, lack of social skills, reduced frustration tolerance and self-regulation, and food insecurity.<sup>14</sup> <p>All this is nothing radically new—it’s really an elaboration of the biopsychosocial model that has dominated academic psychiatry since the 1980s. Clearly, this multi-level model bears little resemblance to a simplistic chemical imbalance theory. And it gives the lie to those who claim that psychiatry has become reductionistic, hostile to the role of the “mind,” or void of psychodynamic understanding. On the contrary, this expanded biopsychosocial model opens the possibility for therapeutic interventions at several links in the causal chain. Thus, antidepressants—and perhaps, someday, anti-inflammatory agents—may ameliorate the biological components of depression, while psychotherapy reduces the experiential aspects of the illness, such as pathological guilt and self-loathing. <p>In short, if serotonin was once American psychiatry’s “high school crush,” the field now appears wedded to a more mature model of biological and psychosocial understanding. <p> <h4>References</h4> <p><strong>1.</strong> LeBano L. Inflammation, mood disorders, and disease model convergence. <a href="http://www.psychcongress.com/article/depression-inflammation-connection-diabetes-and-disease-model-convergence-23649">Psych Congress Network</a> (interview with Dr Roger McIntyre). Accessed September 11, 2015. <p><strong>2.</strong> Pies R. Doctor, is my mood disorder due to a chemical imbalance? <a href="http://psychcentral.com/blog/archives/2011/08/04/doctor-is-my-mood-disorder-due-to-a-chemical-imbalance/">Psych Central</a>. Accessed September 11, 2015. <p><strong>3.</strong> Pies R. Nuances, narratives, and the “chemical imbalance” debate. <a href="http://www.psychiatrictimes.com/couch-crisis/nuances-narratives-chemical-imbalance-debate"><em>Psychiatric Times</em></a>. April 11, 2014. <p><strong>4.</strong> American Psychiatric Association. <a href="https://www.cpp.edu/~healthcounseling/Documents/mental-illness-b1.pdf">Let’s talk facts: what is mental illness?</a> 2005. Accessed September 11, 2015. <p><strong>5.</strong> <a href="http://undsci.berkeley.edu/article/howscienceworks_19">Understanding Science: How Science Really Works.</a> Accessed September 11, 2015. <p><strong>6.</strong> Healy D. Serotonin and depression. <a href="http://www.bmj.com/content/350/bmj.h1771.long"><em>BMJ</em>.</a> April 21, 2015. Accessed September 11, 2015. <p><strong>7.</strong> Grohol JM. The problem with Google’s health knowledge graphs. <a href="http://psychcentral.com/blog/archives/2015/08/21/the-problem-with-googles-health-knowledge-graphs/">Psych Central</a>. Accessed September 11, 2015. <p><strong>8.</strong> Gong Q, He Y. Depression, neuroimaging and connectomics: a selective overview. <em>Biol Psychiatry</em>. 2015;77:223-235. <p><strong>9.</strong> Borchard T. Is the link between serotonin and depression a myth? <a href="http://psychcentral.com/blog/archives/2015/09/01/is-the-link-between-serotonin-and-depression-a-myth/">Psych Central.</a> Accessed September 11, 2015. <p><strong>10.</strong> Raison CL, Miller AH. Role of inflammation in depression: implications for phenomenology, pathophysiology and treatment. <em>Mod Trends Pharmacopsychiatri</em>. 2013;28:33-48. <p><strong>11.</strong> Schildkraut JJ, Kety SS. Biogenic amines and emotion. <em>Science</em>. 1967;156:21-37. <p><strong>12.</strong> Ellis A, Harper RA. <em>A Guide to Rational Living</em>. Los Angeles: Wilshire Book Co; 1961. <p><strong>13.</strong> Compton MT, Shim RS. <em>The Social Determinants of Mental Health</em>. Washington, DC: American Psychiatric Association Publishing; 2015. <p><strong>14.</strong> Bailey RK. Book Forum. Review of <em>The Social Determinants of Mental Health</em>. <em>Am J Psychiatry</em>. 2015;172:913-914. <p><a href="http://www.psychiatrictimes.com/blogs/couch-crisis/serotonin-how-psychiatry-got-over-its-high-school-crush">http://www.psychiatrictimes.com/blogs/couch-crisis/serotonin-how-psychiatry-got-over-its-high-school-crush</a>. herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-14506218094086640962015-09-17T20:18:00.001-07:002015-09-17T20:18:04.882-07:00Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment<h4>Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment </h4> <p>Case Raises Questions of Bias Regarding Independent Review Organizations <p>By <strong><a href="http://marketwired.sys-con.com/">Marketwired .</a></strong> <p>September 9, 2015 08:00 AM EDT <p> </p> <p><img hspace="5" vspace="5" src="http://res.sys-con.com/author/5727/MW_Logo_RGB_0.PNG" align="left"> <img border="0" src="http://media.marketwire.com/attachments/201412/82451_psychappeal.jpg" align="right"> <img border="0" src="http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1216252&ProfileId=&sourceType=1" align="right"> <p>LOS ANGELES, CA -- (Marketwired) -- 09/09/15 -- A class-action lawsuit has been filed against Cigna by Psych-Appeal, Inc., in conjunction with Zuckerman Spaeder LLP, on behalf of mental health patients suffering from depression. The <a href="http://ctt.marketwire.com/?release=1216252&id=7013713&type=1&url=http%3a%2f%2fwww.psych-appeal.com%2fclass-action-filed-against-cigna-for-denying-depression-treatment%2f">federal lawsuit</a> alleges Cigna has categorically refused to cover Transcranial Magnetic Stimulation (TMS), a safe and effective treatment approved by the U.S. Food and Drug Administration. <p>"Although Medicare and numerous commercial insurers routinely cover TMS, Cigna has unjustifiably categorized this treatment as 'experimental and investigational,'" said Brian Hufford, partner at Zuckerman Spaeder LLP. "By denying coverage for TMS and restricting patients from receiving potentially lifesaving treatment, Cigna is improperly elevating its own interests above the welfare of its members." <p>The suit involves a 61-year-old woman who has tried multiple treatments for severe depression. In 2008, the FDA cleared TMS for patients who have failed to respond to psychotropic medications. TMS, unlike electroshock therapy, is performed on an outpatient basis without sedation and does not typically result in side effects such as memory loss. <p>The <a href="http://ctt.marketwire.com/?release=1216252&id=7013716&type=1&url=http%3a%2f%2fwww.psych-appeal.com%2fwp-content%2fuploads%2f2015%2f09%2fCigna-Class-Action-Complaint.pdf">complaint</a> also alleges that MCMC, LLC, an independent review organization directly contracted with Cigna to evaluate external appeals of the company's TMS denials, rubber-stamps the insurer by relying on outdated clinical research. <p>"In California alone, at least 75 external appeals to other independent review organizations have recognized TMS as a valid evidence-based treatment for depression since 2011," said Meiram Bendat, mental health attorney and founder of <a href="http://ctt.marketwire.com/?release=1216252&id=7013719&type=1&url=http%3a%2f%2fwww.psych-appeal.com%2f">Psych-Appeal, Inc.</a> "We expect this case to highlight the conflicts of interest that independent review organizations have when they are allowed to contract directly with insurers to evaluate claim denials." <p>On Sept. 3, 2015, Psych-Appeal, Inc. and Zuckerman Spaeder LLP filed a similar class action <a href="http://ctt.marketwire.com/?release=1216252&id=7013722&type=1&url=http%3a%2f%2fwww.psych-appeal.com%2fwp-content%2fuploads%2f2015%2f09%2fAetna-Class-Action-Complaint.pdf">complaint</a> against Aetna and MCMC. <p>Interested parties may contact Meiram Bendat at <a href="mailto:mbendat@psych-appeal.com">mbendat@psych-appeal.com</a> or Brian Hufford at <a href="mailto:dbhufford@zuckerman.com">dbhufford@zuckerman.com</a>. <p><em>About Psych-Appeal, Inc.<br></em>Los Angeles-based Psych-Appeal, Inc. is a law firm exclusively dedicated to mental health insurance claims, advocating on behalf of patients, clinicians and treatment facilities to overcome insurer denials of treatment. For more information, visit <a href="http://ctt.marketwire.com/?release=1216252&id=7013725&type=1&url=http%3a%2f%2fwww.psych-appeal.com%2f">www.psych-appeal.com</a>. <p><b>Contact: <br></b>Chantal Allan<br>310-598-3690 x.201 <br><a href="http://www2.marketwire.com/mw/emailprcntct?id=2C14F7B6C41DA548">Email Contact</a> <p><a title="http://news.sys-con.com/node/3447654" href="http://news.sys-con.com/node/3447654">http://news.sys-con.com/node/3447654</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-62695853701365685552015-08-21T07:37:00.001-07:002015-08-21T07:37:46.089-07:00“Your words “I am doing very well health wise” resonate loudly and clearly for me.”<p><b>From:</b> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Friday, August 21, 2015 10:29 AM<br><b>To:</b> 'Julie Ottaviani'<br><b>Cc:</b> President of the United States; Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services<br><b>Subject:</b> RE: VNS Therapy for Depression - Implementation and Enforcement of the Law. <p>Dear Julie, <p>Thank you for taking the time to share your continuing good news with us. <p>Your words “I am doing very well health wise” resonate loudly and clearly for me. If only the same can be said for Secretary Burwell and her entire organization. It is the reason I continue to remain persistent in achieving our goal of rightful medical coverage for Joyce, you and others that continue to benefit from the VNS Therapy treatment option. <p>Mental health patients for centuries have been ridiculed, discriminated against challenged and to this very day are still not quite on par for health insurance coverage as those patients having other medical challenges. This issue is exemplified by medical coverage for the epilepsy patient and the need for <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">the adjudicated decision of December 30, 2014</a> for the existing implanted depression patients and still to be told by the gatekeepers, if denied there is an available appeal process. <p>Joyce and I are reasonably well certainly not owing to the fact that the aging process sucks. We continue battling Joyce’s PSP (Progressive Supranuclear Palsy). Despite this very difficult challenge her depressive illness remains non-existent for which we are thankful and definitively attribute that remarkable result to the VNS Therapy. <p>Once again, thank you for writing and importantly allowing me to publicly share another voice in our quest to see the “Implementation and Enforcement of the Law” on behalf of our fellow implanted patients. <p>As always, I wish you continued wellness and all the good you’d wish for yourself. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> <p><b></b> <p><b></b> <p><b></b> <p><b>From:</b> Julie Ottaviani [<a href="mailto:julieottaviani@aim.com">mailto:julieottaviani@aim.com</a>] <br><b>Sent:</b> Friday, August 21, 2015 6:59 AM<br><b>To:</b> <a href="mailto:fabrik@bellsouth.net">fabrik@bellsouth.net</a><br><b>Subject:</b> Re: VNS Therapy for Depression - Implementation and Enforcement of the Law. <p>Dear Herb and Joyce, <p>I just wanted to let you know how much I appreciate all that you are doing for our cause. I am doing very well health wise and hope the same is true for you both. Herb, your tireless efforts do not go unnoticed. I read each and every email you send and save them to a file. I hope Madam Secretary Burwell does the same and more. It is unfortunate that the pace of our leaders in Government Health as well as most areas is slow and slower. But we are strong and VNS has made us so. We stand with you in this fight and we will be persistent <p>Keep the Faith <p>Julie Ottaviani <p>You may use this email in any way you deem useful.. <p>Julie Ottaviani<br><a href="mailto:julieottaviani@aim.com">julieottaviani@aim.com</a> <p>-----Original Message-----<br>From: Herbert Stein <<a href="mailto:fabrik@bellsouth.net">fabrik@bellsouth.net</a>><br>To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services <<a href="mailto:sylvia.burwell@hhs.gov">sylvia.burwell@hhs.gov</a>><br>Cc: President of the United States <<a href="mailto:president@whitehouse.gov">president@whitehouse.gov</a>><br>Sent: Thu, Aug 20, 2015 5:51 pm<br>Subject: VNS Therapy for Depression - Implementation and Enforcement of the Law. <p>Dear Madam Secretary Burwell, <p>I’m terribly sorry to have to once again bore you with the fact that either you and/or your subordinates are not carrying out the duties, obligations and/or law with which you are entrusted. <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">December 30, 2014 an appeal was adjudicated</a> rendering the <a href="https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=195&NCDId=230&ncdver=2&NcaName=Vagus+Nerve+Stimulation+for+Treatment+of+Resistant+Depression+%28TRD%29&CoverageSelection=National&KeyWord=vagus+nerve+stimulation&KeyWordLookUp=Title&KeyWordSearchType=And&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D&">NCD of May 4, 2007</a> not applicable to all the patients implanted prior to May 4, 2007. Depression patients with Vagus Nerve Stimulators, a medical device implant, are rightfully entitled, Doctrine of Continuity of Care, to medical care and replacement when necessary without having to be denied and/or responsible to appeal any denials. <p>The issue I now bring to your attention is the <b>“implementation” and “enforcement” of the law</b> and apparent lack of distribution of this law and acknowledgement by MAC, Regional agencies, State agencies, contractors etc. under your authority as evidenced by the communications I’ve received from various members of your staff and agencies that I have already shared with you and others. <p>The individual, with whom I chatted with today, a member of your agencies, confirmed “the left hand not knowing what the right hand is doing.” <p>I would finally and once and for all appreciate your getting your agencies on the same page. I would also appreciate a communication from your office that all agencies, contractors etc. on down the line acknowledge and will implement and enforce the law. <p>As always, I wish all those reading my missives good health and all the good you’d wish for yourselves. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-41381596187476618992015-08-20T17:01:00.001-07:002015-08-20T17:01:50.257-07:00VNS Therapy for Depression - Implementation and Enforcement of the Law.<p><a name="_MailOriginal"><b>From:</b></a> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Thursday, August 20, 2015 5:51 PM<br><b>To:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services<br><b>Cc:</b> President of the United States<br><b>Subject:</b> VNS Therapy for Depression - Implementation and Enforcement of the Law. <p>Dear Madam Secretary Burwell, <p>I’m terribly sorry to have to once again bore you with the fact that either you and/or your subordinates are not carrying out the duties, obligations and/or law with which you are entrusted. <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">December 30, 2014 an appeal was adjudicated</a> rendering the <a href="https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=195&NCDId=230&ncdver=2&NcaName=Vagus+Nerve+Stimulation+for+Treatment+of+Resistant+Depression+%28TRD%29&CoverageSelection=National&KeyWord=vagus+nerve+stimulation&KeyWordLookUp=Title&KeyWordSearchType=And&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D&">NCD of May 4, 2007</a> not applicable to all the patients implanted prior to May 4, 2007. Depression patients with Vagus Nerve Stimulators, a medical device implant, are rightfully entitled, Doctrine of Continuity of Care, to medical care and replacement when necessary without having to be denied and/or responsible to appeal any denials. <p>The issue I now bring to your attention is the <b>“implementation” and “enforcement” of the law</b> and apparent lack of distribution of this law and acknowledgement by MAC, Regional agencies, State agencies, contractors etc. under your authority as evidenced by the communications I’ve received from various members of your staff and agencies that I have already shared with you and others. <p>The individual, with whom I chatted with today, a member of your agencies, confirmed “the left hand not knowing what the right hand is doing.” <p>I would finally and once and for all appreciate your getting your agencies on the same page. I would also appreciate a communication from your office that all agencies, contractors etc. on down the line acknowledge and will implement and enforce the law. <p>As always, I wish all those reading my missives good health and all the good you’d wish for yourselves. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh6LdAFsa6A49vSzpKR3vKKOPZIQRg1GqL_wExVUGVW2ZXbr_ZZBvP82gzeTvUZy4Tb6QmeZOp3d1hom7iLBmBKz27LnPRGg1yd-0KvdLlGL961bcqWeCVGeKereqSGA6CuwIYat3Qn6VQ/s1600-h/clip_image002%25255B4%25255D.gif"><img title="clip_image002" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image002" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyRYAn9qoijH3XwWCVQT1391WoRk43uwvJp17wcX7zFNtWteIF8T-R6_C4sotJFcbiYlucqnvjMP5jUg4ACix2EdmCg0TRmY7iEQJLMO4u6oCYZcE5J4AcM0ZmSngZ4cWplOtXNQQZHjw/?imgmax=800" width="755" height="321"></a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-80999093146523327402015-08-20T16:53:00.001-07:002015-08-20T16:53:05.153-07:00test document 08/20/2015 7:55 PM<p>test document</p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-49125251530995956282015-08-10T12:20:00.001-07:002015-08-10T12:20:05.455-07:00"Does anyone in all of HHS/CMS understand the meaning of being "proactive"?"<p><a name="_MailOriginal"><b>From:</b></a> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Monday, August 10, 2015 2:40 PM<br><b>To:</b> Stephanie Perry, Health Insurance Special - Office of the Medicare Ombudsman - CMS<br><b>Cc:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services<br><b>Subject:</b> "Does anyone in all of HHS/CMS understand the meaning of being "proactive"?" <p>Dear Ms. Perry, <p>First I’d like to thank you for taking my telephone call the other week and for your recent letter (attached). I’d also like to apologize for my previous misspellings of your name as apparently I did not hear it clearly in our conversation. <p>In your letter you stated: <p>If you would like to request a NCD for VNS for those persons, prior to May 4, 2007, who <p>Obtained Medicare coverage for VNS to treat resistant depression and who continue to <p>Receive that treatment, please visit: <p><a href="https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.ht">https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.ht</a><u></u> <p><u>ml.</u> This will provide you information and instructions on that process. <p>Once again I wish to reiterate that when I proactively embarked some two (2) years ago on my advocacy/activism to correct the egregious and morally wrong ineptitude perpetrated against these VNS depression patients by the oversight for medical care in the May 7, 2007 decision I started out by requesting “Compassionate Use” from the former and present Secretary of Health and Human Services for these patients. As time progressed and no such document was forthcoming I learned of other decisions rendered by the judicial entity of CMS. <p><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]</a> <p><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">[Proposed Rules]</a> <p><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">[Pages 40835-40890]</a> <p><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">From the Federal Register Online via the Government Printing Office [www.gpo.gov]</a> <p><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">[FR Doc No: 2013-16107]</a> <p><a href="http://vnstherapy-herb.blogspot.com/2014/07/us-administrative-law-judge-sides-with.html">U.S. Administrative Law Judge sides with VNS Depression Patient</a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf"><b>Department of Health and Human Services</b></a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf"><b>DEPARTMENTAL APPEALS BOARD</b></a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf"><b>Appellate Division </b></a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">NCD 160.18, Vagus Nerve Stimulation </a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">Docket No. A-14-3 </a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">Decision No. 2613</a> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">December 30, 2014</a> <p>The essence of these documents is the doctrine of “Continuity of Care” and more specifically as it relates to VNS depression patients implanted prior to May 4, 2007. Therefore that decision does not apply to these VNS patients for whom I advocate. Is that too difficult for all to comprehend. <p>The point of all my communications is the obvious lack of “proactive” actions on the part of HHS/CMS with the exception of Jonathan Blum, Amy Larrick and Courtney Turner. The fact is no one discusses any of the decisions listed above and no one has indicated to me in all the communications I’ve had, including yours, that these decisions have been sent to MAC, Regional Offices, State Agencies and/or Contractors etc. to read, understand and acknowledge. If so, this would eliminate the need for any denial or question in MAC’s and/or other agencies decision making process and eliminates the need for the patient to appeal a MAC and/or other agency denial. Yes, I understand your letter all too clearly only you too continue the negativism, roadblocks and need to challenge these patients instead of really helping them. <p>Apparently what many of you folks cannot fathom or understand is the fact these patients are often physically and mentally unable to care for themselves let alone advocate for themselves especially when in the throw of severe depression. All do not have “Herb” to battle the bureaucracy’s constant Tower of Babel or what I also refer to as “Bureaucratic Speak”. <p>Does anyone in all of HHS/CMS understand the meaning of being “proactive”? The information to help these patients is on record. It is not there to challenge them or be omitted from all communications. So how about someone in authority finally getting back to me after all this time telling me that all the decision makers within your voluminous bureaucracy acknowledges the additional information pertaining to these VNS depression patients instead of rehashing that same old egregious May 4, 2007 document <b><u>which does not apply to this patient group?</u></b> <p>I’ll also take the liberty to remind you and your colleagues once again the meaning of being proactive from your own agencies mantras “especially for those who are least able to help themselves”: <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJG5635lHiOU9_VISZ1fJcfFZ0him8qA4rCA-1o4U3xng_kYbO6PAXoUfwF2h3MiJe-oUjwYrzqvLi4hk-wuDIODKBzuWKUnm2VpJwS6q-IbABzHXUA8Ka1G5gecj1kfO8swbXJTMi_I8/s1600-h/clip_image002%25255B5%25255D.gif"><img title="clip_image002" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image002" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj-NztJV-48RtCrOsgElKPU6pB5c1LpXe7U5axECCCFn1y5JPXqdMK73x49hluHSrJ9BlIuW2giW6b9bzY62bzApcZ2oteg6IJDslbFF_h66u4ytXW526oH9hN5Ze4SG-FHUh4G1ZpjgNM/?imgmax=800" width="790" height="342"></a> <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> <p><strong>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////</strong> <p><strong></strong> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg81ZLVgvHlLIS3K6s5cbjOPzsQxNq0FPTuIPDhF88Nk4q2CdcI1D_Jpb2HDyTpXYoKpNa8d-ILqn2aSdVROuSLvaTVY4jL0R6wTSlKqfM4YCgZOkP5z_8jF53NEYucCwxRW2za-1QEx9k/s1600-h/image%25255B8%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjeoENyz_CbzcruOGsVMDR0ngm9ugDrpF-6TwZpTh6RDkQNlTdAeBNmXpjihmqtKE5pkqe7Z-IOaO1wYLmSk6hC-HtjD2cZuS9Xz9j7f9V2sxZmqWrEBJ0_J_GfEgTCJzE7H-OGt1Zjyzc/?imgmax=800" width="760" height="1051"></a> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiOnjd8IHn_724kkYlXn6RJYX70oZRcYKxnswMzh7T_4u3Ucb7BF5zbw2zMpKA4qOByWp8rgEymfQRWpfw4xevaPNU5n-Yr04tvbE-sfmDtJ6JZDlMEzsZxpoG_47n9Cy6rwh6yfDG2RyM/s1600-h/image%25255B14%25255D.png"><img title="image" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="image" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnYHnXSFeaRS8WUV7FKYQSWk1oZDFuJN7kPxg6kGwGhPmubDWZImJ4S5nySN6TNx7DI_ag_WA4sILK8lcvzVqSDLiWQDPxMN-mCtnCKbZxp_nHhcVvs16X50IjG_styxkPUL5JONiLVW8/?imgmax=800" width="759" height="1024"></a> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com2tag:blogger.com,1999:blog-5694055184415942831.post-25797114694812596012015-07-29T02:28:00.001-07:002015-07-29T02:28:00.562-07:00VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”<p><b>From:</b> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Wednesday, July 29, 2015 4:48 AM<br><b>To:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services<br><b>Subject:</b> VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!” <p>Dear Madam Secretary Burwell, <p>I’d like to take a moment to commend and compliment Ms. Gaetana Marshall, M.S. Health Insurance Specialist out of your Atlanta, GA regional office for the time and effort she put into listening to my explanations and researching the document(s) you folks in D.C. recently sent to her office relating to my supposed issue(s) that I have been advocating to resolve these past two years. Ms. Marshall in turn forwarded the documents (copy and pasted below) for me to read and I in turn share for everyone’s perusal. At the same time I would also like to acknowledge the concerted efforts on the part of Ms. Courtney S. Turner, MPH - Office of Hearings and Inquiries, Medicare Ombudsman Group, Division of Medicare Ombudsman Assistance who respectfully assisted in my advocacy and has helped several of the VNS Depression patients receive medical care these past couple of years and to Ms. Stephany Terry – CMS for following up on my telephone call to Ms. Lisa Spradlin – CMS yesterday in the absence of Ms. Courtney Turner. <p>I’m sure Madam Secretary that you are familiar with these famous words, “Houston, we have a problem!” And shortly thereafter the intellectual minds at another of our government agencies, NASA, effectively, efficiently and expeditiously went to work solving a life and death crisis in a matter of days. <p>Well Madam Secretary I’ve come to the conclusion the same is not true for your agencies handling and effectiveness as it relates to the health care for the implanted VNS Depression patients. <p>In fact what I discern in this instance is “HHS/CMS we have a failure to communicate!” as well as what appears to be a classic illustration of the Tower of Babel. <p>In absolutely none of my advocacy/activism these past two (2) years have I advocated for approval of the VNS Therapy for Depression or the reversal of the May 4, 2007 denial. That is the responsibility of the sponsor, Cyberonics and yet the communications I constantly receive from your agency refer me to the CMS denial decision of May 4, 2007. Believe me I’ve carefully read that decision a number of times and I am cognizant of its contents. <p><b>What I specifically and rightfully have advocated for is care and health insurance coverage which CMS egregiously, immorally and/or unconscionably omitted or overlooked in that decision whether through ineptitude, ignorance or failure to grandfather-in-<u>care for all the study subjects and patients implanted with this medical device prior to May 4, 2007 in accordance with the doctrine of “Continuity of care” contained in several CMS documents.</u></b> <p><b></b> <p><b>Obviously not all your subordinates understand, comprehend or obtained any message that CMS recognizes and acknowledges the medical doctrine of “Continuity of Care” as was reiterated by CMS most recent <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">DBA adjudicated decision of December 30, 2014</a>. These patients are rightfully to be cared for and covered by medical insurance. The CMS decision of May 4, 2007 does not apply to these previously implanted patients. Is that too difficult for your people to read and comprehend?</b> <p><i></i> <p><i></i> <p><i></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">Page 62</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">“With respect to those</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for: (1) “the</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">interrogation and calibration of a VNS therapy device implanted and deemed to be</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">reasonable and medically necessary when implanted for TRD”; or (2) “for the</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">replacement of the implanted pulse generator device upon battery expiration, when</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">required[.]” AP Statement ¶ 43. According to the Aggrieved Parties, those omissions</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">conflict with: (1) “continuity of care” standards that are “widely accepted within the</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">medical community (i.e., a physician should not discontinue treatment that is effective for</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">unsafe for beneficiaries to have an implanted medical device that is not properly</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">wherein CMS has recognized that continuing Medicare coverage for beneficiaries who</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">received Medicare-covered durable medical equipment (DME) before it was non-covered </a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’”</a></i><i> <a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">Id. ¶¶ 40-42</a></i> <p><i><a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-08/html/2013-16107.htm">(quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).”</a></i> <p><i></i> <p><i></i> <p><i></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">Page 63</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">“CMS states that it “leaves decisions</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">regarding the maintenance of already-implanted devices to contractor discretion” and that</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">such decisions “are, appropriately, made on an ad hoc basis after the local contractor’s</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">consideration of the applicable facts.” Id. We understand from these representations that</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">CMS and its contractors do not, or will not in the future, apply NCD 160.18(C) to bar</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">coverage of maintenance services – including replacement of the implanted VNS device</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">upon battery expiration – for beneficiaries who received the VNS device prior to May 4,</a></i> <p><i><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">2007.”</a></i> <p><i></i> <p>Yet I continue to receive communications from your agency citing the May 4, 2007 decision. Obviously the proper communications from your office in the words of former President Regan are not having a “trickle down” effect. For the umpteenth time please have your agency and your subordinates notify MAC, Regional Agencies, State Agencies, contractors etc., etc. that based upon the reaffirmation of the <b><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">DBA adjudicated decision of December 30, 2014</a></b> that all VNS Depression patients implanted prior to May 4, 2007 are to be covered for medical care and health insurance coverage and there should be absolutely no need for these patients to have go through an appeals process as a result of your agencies inability to communicate this fact with one another. <p>Why must I continue to receive communications citing denials and reference to the May 4, 2007 as was recently illustrated in a communication dated July 17, 2015 from Kristen Dixon - Health Insurance Specialist - Atlanta Division of Financial Management & Fee for Service Operations (see below) and an earlier letter dated April 17, 2015 from Patrick Conway, MD, MSc - Acting Principal Deputy Administrator - Deputy Administrator for Innovation and Quality – CMS Chief Medical Officer (see below). <p>Why not a letter, directive or whatever document you issue to your MAC agencies, Regional office agencies, State Agencies, contractors etc., etc. apprising them of the doctrine of “Continuity of Care” and the <b><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">DBA adjudicated decision of December 30, 2014</a></b> favorably affecting the VNS Therapy patients for depression? Stop all this negativity, denials, oversight and appeal non-sense being referenced to the May 4, 2007 denial decision when in fact the December 30, 2014 decision clearly indicates these medical device implanted patients have rights to medical care and health insurance coverage. <p>And to those private health insurance CEO’s I have also addressed and hounded you too have unjustly denied care and medical insurance coverage to these patients and similarly you should be issuing directives to your staff that these patients should be properly cared for and rightly insured. <p>Take a positive approach to wellness. Advise all your agencies and health insurance carriers that the previously implanted VNS patients for depression are rightfully entitled to medical care and coverage without need for any denials or subsequent appeals! <p>Lastly, I’ll also take the liberty to remind you and all those agency staffers who read this communication: <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFiM7KD7mAkIai43y7CGiWRKn_o_MgedEe3Q7oxpG-dyQCN11z55xFSUyC7hyJfwIu3J-FXuJTXRPvZvNvvoRXqEGXLAnfDihJZwNhpn_Czf0uYpNUeP4fsbwG2zLhxpfMjunyVQ5hkgE/s1600-h/clip_image001%25255B4%25255D.jpg"><img title="clip_image001" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image001" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi4OTB8DrYsytg7LWxtB4oDDF48z8-RlWZnL2Z8NX_DqFobhzZsQoYw6sVSqCGULLICy8LgdVhmQ_caX0h9Yy0Dqwy5wsBf-3Z6E68JN0H0Z115f_BfN6qCWxPWsE0WBQ0QpWxvQDUhZ4I/?imgmax=800" width="730" height="316"></a> <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p><b>From:</b> Marshall, Gaetana (CMS/CMHPO) [<a href="mailto:Gaetana.Marshall@cms.hhs.gov">mailto:Gaetana.Marshall@cms.hhs.gov</a>] <br><b>Sent:</b> Tuesday, July 21, 2015 7:59 AM<br><b>To:</b> Herbert Stein (<a href="mailto:fabrik@bellsouth.net">fabrik@bellsouth.net</a>)<br><b>Subject:</b> C1502484607 Re. Mr. H. Stein <p>Good morning Mr. Stein, <p>Since our telephone conversation on Friday I have had an opportunity to follow up from discussions we had and to speak with a few of my CMS colleagues who have responsibility for standard Medicare A/B policy decisions. Notably, I have spoken to Courtney Turner who works with the CMS Ombudsman team and the management team for Medicare A/B policy decisions. <p>They have provided me with the following items for your records and information: <p>A. A Beneficiary Casework Call (August 2014) presentation regarding VNS coverage. <p>B. A Sept. 24, 2013 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to the Honorable Debbie Wasserman Schultz on behalf of your wife regarding health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression. <p>C. The CMS Ombudsman’s response from January 2015 regarding the Division of Appeal Board’s (DAB) decision. <p>D. The April 17, 2015 letter from the CMS Center for Clinical Standards and Quality formally responding to you (on behalf of Secretary of Health and Human Services) regarding the DAB decision. <p>E. A July 17, 2015 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to you regarding the health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression. <p>The documents above are official CMS responses to your questions regarding Medicare Advantage plan coverage for VNS treatment for depression since MA coverage is established by standard A/B policy. Additionally, the 2014/2015 DAB appeal decision attached upheld CMS’ policy. As such, the attached CMS letters are considered comprehensive and fully respond to questions regarding health insurance coverage of VNS for treatment of depression. <p>I would like to thank your patience and for the opportunity to speak with you and thank you for your advocacy regarding those suffering with depression and VNS therapy. <p>It was my pleasure to assist you. <p>Very truly, <p>Gaetana Marshall <p>Ms. Gaetana Marshall, M.S. <p>Health Insurance Specialist <p>US Department of Health and Human Services <p>Centers for Medicare and Medicaid Services <p>Division of Medicare Health Plans Operations <p>61 Forsyth Street, Suite 4T20 <p>Atlanta, Georgia 30303 <p>Ofc: 404-562-3562 <p>Fax: 443-380-5963 <p>Email: <a href="mailto:gaetana.marshall@cms.hhs.gov">gaetana.marshall@cms.hhs.gov</a> <p><b></b> <p><b></b> <p><b></b> <p>Please consider the environment before printing this email. <br><b><i>INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:</i></b> <p>This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 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display: inline; padding-right: 0px" border="0" alt="clip_image026" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBWwqEjooG_SmlSU44IPT8gIVUpCvNW8z5LJQIZ8x4_5dNoYhegFdJnsIj7KM3U9t5YPHdvw5mwKGW6FOLVf82AlH8xaQwGxNvQ55xXPN_HbOQzyMbkqDOI668NOnEYFsQYngjpBFkCqE/?imgmax=800" width="502" height="566"></a> <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix3HxeGaUsh4J43pIBJo682YtRsVohY-lE2eBWJJhQX9mpTMuHqQ8Ziaei0CRkozRqQLse6bcSaUzsQ9Hpeifv3HOLT9obyC1UrsgzRA_UkRJ3TgAU1s0_ZOXOxSiJAYlhuna7YPOIwtQ/s1600-h/clip_image027%25255B4%25255D.jpg"><img title="clip_image027" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image027" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzufyuYxmn_oOE43O44B_fUKo9JuAZebsCFILUn33sa6qh4PcKBtMY7-wEyGJvBJJO-zDarvUDQtaup_dyhj519FVj4linMFvTC6QpTdjR-pKBK3A9cO6zHTodA9m-Z-Cp4Vq36L-KzLg/?imgmax=800" width="501" height="673"></a> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgwEnDgI5OuRUU0f4d_qGn-AiNZl8ETB-_aYtfEhibVbXpW5mWW8OI2qLcjFAce9gHqOMeWMz13hPcaPPBqxFTI2J8sqUf7v2O2rvdRc9OGPMxU5QLlpemvxPRTiMg5l3D14HmouxVwLp4/s1600-h/clip_image028%25255B4%25255D.jpg"><img title="clip_image028" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image028" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9EDV2r3ErYyqw_cHTCBmlpGJox7BEbQevaF6ziq_j1FqMJn9txA76SyGkcKZVBEK3hQ8yZCLgUl7ivh_vrE2L06vbL7Dud3qt9sVE9CNeuqiTKnhlWOhq9Tfi6O0b7eMHPpJltKuzGsc/?imgmax=800" width="509" height="391"></a> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-58307378942237631032015-07-19T11:59:00.001-07:002015-07-19T12:09:47.051-07:00Stolen equipment and the expeditious resolution…<p>To Joyce’s fellow VNS patients et al, <p>Just recently we ran into an unusual problem(s). We made an appointment with Joyce’s attending physician to interrogate her VNS prosthesis. The appointment was made for Monday, June 22, 2015. As we were about to leave our home for our scheduled appointment we received a call cancelling the appointment as the doctor could not find his handheld computer to interrogate the device. <p>We rescheduled the appointment for the following Monday, June 29, 2015 and I advised his office I would send a reminder to the doctor on Sunday prior to our office visit to bring the equipment. I e-mailed the doctor as a reminder early Sunday and later that evening I received a return correspondence that the interrogating equipment had apparently been stolen from his office. Late that same evening I sent an e-mail to Dan Moore, CEO – Cyberonics and his associates asking for help. Much to my surprise even later that Sunday evening I received a reply. <p>I have been allowed to share the correspondence and events that have unfolded and acknowledge the coordinated efforts of the Cyberonics staff. . I wish to extend my appreciation and gratitude publicly for the expeditious handling and resolution of the problem(s) and help I received. I rightly feel it proper to exhibit all sides of the coin unbiasedly as possible in view of the fact that I have at times respectfully expressed harsh critical opinions of the company as it related to several other issues. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p><a name="_MailOriginal">From:</a> Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Sunday, June 28, 2015 11:25 AM<br>To: Dr. Ely Pelta<br>Subject: Reminder... <p>Hi Doc, <p>Just a friendly reminder to please bring the wand with you to interrogate Joyce’s prosthesis tomorrow! <p>I hope all is well with you and yours. <p>Herb <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Ely Pelta [Redacted] <br>Sent: Sunday, June 28, 2015 1:50 PM<br>To: Herbert Stein<br>Subject: Re: Reminder... <p>Herb. The wand went missing, can you provide me with a contact to get a replacement wand? It most likely was stolen. I looked everywhere <br>Sent from my iPhone <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Sunday, June 28, 2015 6:14 PM<br>To: 'Ely Pelta'<br>Subject: RE: Reminder... <p>Doc, <p>Is the wand all that is missing or are you missing the handheld computer too? <p>Please let me know promptly and I’ll try to contact Dan Moore, CEO of Cyberonics to help us out. I’ll cancel our appointment for tomorrow until you’re once again equipped. <p>Thanks, <p>Herb <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Att [mailto:(Redacted)] <br>Sent: Sunday, June 28, 2015 8:53 PM<br>To: Herbert Stein<br>Subject: Re: Reminder... <p>Herb, missing it all , thanks for understanding <br>Sent from my iPad <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Sunday, June 28, 2015 9:38 PM<br>To: Daniel Moore, CEO - Cyberonics<br>Cc: Dr. Ely Pelta; Jackie J. Baumgartner; Dr. Mark Bunker; Bryan Olin, Ph.d<br>Subject: Stolen equipment... <p>Dear Dan, <p>I hope this note finds you and yours all doing well. <p>I need your assistance. Apparently someone has stolen Dr. Ely Pelta’s handheld computer and wand and I shall have to cancel Joyce’s appointment for tomorrow to have her prosthesis interrogated. <p>I would sincerely appreciate if you could have one of your staff immediately contact Dr. Pelta to arrange for a replacement of the equipment. <p>Dr. Ely Pelta <p>Miami Beach Community Health Center <p>11645 Biscayne Boulevard <p>Miami Beach, FL 33141 <p>305-538-8835 x1670 for Dr. Pelta <p>(Redacted) <p>Bianca F., nurse for Dr. Pelta <p>Carla is Dr. Pelta’s secretary at 305-538-8835 ext. 1670 <p>As always, I thank you for your prompt attention to my concerns as I wish you all well. <p>Dr. Pelta, <p>Please have your office notify me promptly once you’ve obtained the replacement equipment so that we may reschedule Joyce’s appointment. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com] <br>Sent: Sunday, June 28, 2015 10:40 PM<br>To: Herbert Stein<br>Cc: Dan Moore; Dr. Ely Pelta; Jackie J Baumgartner; Mark Bunker<br>Subject: Re: Stolen equipment... <p>Dear Herb,<br>I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.<br>Best regards,<br>Bryan<br>Sent from my iPhone <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Sunday, June 28, 2015 10:59 PM<br>To: 'Bryan Olin'<br>Cc: 'Dan Moore'; 'Dr. Ely Pelta'; 'Jackie J Baumgartner'; 'Mark Bunker'<br>Subject: RE: Stolen equipment... <p>Dear Bryan, <p>Thank you for your very speedy reply. It is most appreciated. <p>We’ll at worst have to reschedule for next week but it is your cooperation and that of your company’s personnel that is most impressive and outstanding to me. <p>I may have some respectful differences on certain issues with you folks but I cannot deny the fact they y’all have gone to bat through the years to help me care for Joyce for which I truly thank you. <p>Once again, thanks Bryan. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Ely Pelta [mailto:(Redacted)] <br>Sent: Sunday, June 28, 2015 11:16 PM<br>To: Herbert Stein<br>Subject: Re: Stolen equipment... <p>Great job Herb ! <br>Sent from my iPhone <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com] <br>Sent: Monday, June 29, 2015 10:06 AM<br>To: fabrik@bellsouth.net<br>Cc: (Redacted)</p> <p>Subject: RE: Stolen equipment...</p> <p>Mr. Stein, <p>I am the Nurse Case Manager at Cyberonics who works with the Depression patients and their Psychiatrists. I was asked to communicate with you about replacing Dr. Pelta’s programming equipment. We will be overnighting the new equipment to Dr. Pelta’s office in Miami today and he should have it tomorrow morning. I will reach out to both Carla and Bianca to let them know the replacement equipment has been ordered and to ecxpect arrival tomorrow morning. <p>If you need assistance with anything else, please let me know. <p>Take care, <p>Susan <p><i><u>Susan Dotson, L.V.N., Sr. Manager</u></i> <p><i>Case Management Department</i> <p><i>Manager for the Carolinas, Lone Star and Southeast Regions</i> <p><i>Depression Case Manager</i> <p><i>Toll Free: 1-800-332-1375, ext. 7363</i> <p><i>Direct Number: 281-228-7363</i> <p><i>Direct Fax: 281-853-1315</i> <p><i>E-mail: <a href="mailto:susan.dotson@cyberonics.com">susan.dotson@cyberonics.com</a></i> <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Monday, June 29, 2015 10:44 AM<br>To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics<br>Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Jackie J. Baumgartner<br>Subject: RE: Stolen equipment... <p>Dear Susan, <p>Thank you for reaching out and quickly coming to our assistance. By copy of this e-mail I am alerting Dr. Pelta to expect the replacement equipment tomorrow and to also alert his staff. <p>Your prompt help and that of your fellow staff members have proven invaluable to maintaining Joyce’s depression free-state these many years. <p>Once again, thank you. <p>Dr. Pelta, <p>Please have Bianca call me as soon as the replacement programming equipment is received so that we may promptly schedule a new appointment for Joyce. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com] <br>Sent: Monday, June 29, 2015 10:47 AM<br>To: Herbert Stein<br>Cc: Dr. Ely Pelta; Dan Moore; Bryan Olin; Mark Bunker; Jackie J Baumgartner<br>Subject: RE: Stolen equipment... <p>Dear Mr. Stein, <p>You are welcome…always happy to assist. <p>Take care, <p>Susan <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Ely Pelta [mailto:(Redacted)] <br>Sent: Monday, June 29, 2015 1:03 PM<br>To: Herbert Stein<br>Subject: Re: Stolen equipment... <p>I will be looking for it tomorrow <br>Sent from my iPhone <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Wednesday, July 01, 2015 1:43 PM<br>To: Dr. Ely Pelta<br>Subject: Replacement equipment and rescheduling appointment... <p>Doc, <p>I haven’t heard from anyone in your office whether or not you received the replacement equipment so that we can reschedule an appointment for Joyce. <p>Please advise me. <p>Herb <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Ely Pelta [mailto;(Redacted)] <br>Sent: Thursday, July 02, 2015 8:27 AM<br>To: Herbert Stein<br>Subject: Re: Stolen equipment... <p>Came today <br>Sent from my iPhone <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Thursday, July 02, 2015 8:46 AM<br>To: 'Ely Pelta'<br>Cc: Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Bryan Olin, Ph.d; Daniel Moore, CEO - Cyberonics; Jackie J. Baumgartner; Dr. Mark Bunker<br>Subject: RE: Stolen equipment... <p>Doc, <p>Thanks. I’ll schedule a new appointment for Joyce. <p>Susan, Brian et al, <p>Thank you too for your prompt help and assistance. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com] <br>Sent: Thursday, July 02, 2015 9:00 AM<br>To: Herbert Stein; 'Ely Pelta'<br>Cc: Bryan Olin; Dan Moore; Jackie J Baumgartner; Mark Bunker<br>Subject: RE: Stolen equipment... <p>Mr. Stein, <p>I am glad to hear that the equipment was delivered. Please let me know if you need assistance again. <p>Take care and have a nice 4<sup>th</sup> of July! <p>Susan <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Thursday, July 02, 2015 9:21 AM<br>To: 'Susan Dotson'; 'Ely Pelta'<br>Cc: 'Bryan Olin'; 'Dan Moore'; 'Jackie J Baumgartner'; 'Mark Bunker'<br>Subject: RE: Stolen equipment... <p>Susan, <p>Thanks again and you too have a happy and safe 4<sup>th</sup> of July. And if you don’t mind, family, friends and business associates all call me Herb. <p>Herb <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com] <br>Sent: Thursday, July 02, 2015 10:20 AM<br>To: Herbert Stein<br>Subject: RE: Stolen equipment... <p><a href="http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCM2Zvrfv58YCFcMTkgodDk4OEA&url=http%3A%2F%2Fwww.geckorecruitment.com%2Fblog%2Fis-the-smiley-face-king-of-email-land%2F&ei=oPKrVc3JFsOnyASOnLmAAQ&bvm=bv.98197061,d.cGU&psig=AFQjCNGCqNkwSa4-R0mcjY9vOZ3iqVGuHQ&ust=1437418520458157"><img 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width="19" height="20"></a> <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Wednesday, July 15, 2015 8:53 AM<br>To: Dr. Ely Pelta<br>Subject: Reminder... <p>Doc, <p>Joyce has an appointment with you tomorrow. Please remember to have the interrogation device available. <p>Thanks, <p>Herb <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: EDP [mailto:(Redacted)] <br>Sent: Wednesday, July 15, 2015 1:02 PM<br>To: Herbert Stein<br>Subject: Re: Reminder... <p>It's fired up and ready <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Friday, July 17, 2015 10:45 AM<br>To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics<br>Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker<br>Subject: VNS Technical Question <p>Dear Susan, <p>Once again I’d like to take this opportunity to thank all you guys for speedily coming to our assistance. <p>Yesterday we finally got to see Dr. Pelta who interrogated Joyce’s prosthesis (Model 104). All settings for Joyce were normal with one exception as Joyce continues with her depression free state. Dr. Pelta’s newest handheld computer did not indicate the battery life as we previously were able to view (Please see photo below). Is there something wrong with the programming or hardware of the handheld device or whatever? <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilPZUoAkWajL42bhOj58TOVNhDHWhys_B49N2nZSLsJafMcwYPF_Q8iahLlwU7CcctMP-7XCu4ddjqQEsVUm7k4UL3HtJG8CR0eRxRAtchI73zER0COTlzQO5SkgrdYzmqvR5zhyphenhyphenpwV_g/s1600-h/clip_image001%25255B5%25255D.jpg"><img title="clip_image001" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image001" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhY2NwH5sLFlKTvNCrKtMCNFQgfJGrZanJpexTuKZoII6l_XzfN1zPNZ_i_A8qDWY6F7INGkbcut9aRjbOl-z-OL-aBVxMiuZ7Y9vfc4ozPqvDedLFXpz3jinWpZM5NaQk6upgvJY_QE_E/?imgmax=800" width="440" height="551"></a> <p>Would you please advise a solution to this problem? <p>Thank you as always. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com] <br>Sent: Friday, July 17, 2015 10:51 AM<br>To: Herbert Stein<br>Cc: Susan Dotson; Dr. Ely Pelta; Dan Moore; Mark Bunker<br>Subject: Re: VNS Technical Question <p>Dear Herb,<br>I contacted our Clinical Technical Support team and asked them to contact you and Dr. Pelta to answer your question.<br>Best regards,<br>Bryan<br>Sent from my iPhone <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Friday, July 17, 2015 11:02 AM<br>To: 'Bryan Olin'<br>Cc: 'Susan Dotson'; 'Dr. Ely Pelta'; 'Dan Moore'; 'Mark Bunker'<br>Subject: RE: VNS Technical Question <p>Brian, <p>As always your exceptionally prompt responses I greatly appreciate. <p>Have a wonderful weekend. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Dylan Adams [mailto:Dylan.Adams@cyberonics.com] <br>Sent: Friday, July 17, 2015 3:47 PM<br>To: fabrik@bellsouth.net<br>Subject: Joyce's VNS Device <p>Hi Herb, <p>Thank you again for talking with me today. While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571. <p>Best regards, <p>Dylan Adams <p>Clinical Engineer <p>Cyberonics, Inc <p>100 Cyberonics Blvd. <p>Houston, Texas 77058 <p>Tel: 1.800.332.1375 <p>Direct: 281.727.2571 <p>Fax: 281.853.2735 <p><a href="http://www.cyberonics.com/">www.cyberonics.com</a> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFrUSx6UtpIrf4SmhrrmR9nklWDq1tTbde0PhmeE0H1rs5WcJUcLBw2gPLB8C9Cw2MIyg3EIFqQ7V3HX3O3eqcxW8MAmKDRoJ5qVVmK_ZpeyneEbJzdqIPT4G_ZTLjpgBzTEt5IhSiyxQ/s1600-h/clip_image002%25255B3%25255D.png"><img title="clip_image002" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image002" src="http://lh3.googleusercontent.com/-PeiymvrHJBc/Vavzm8NsLTI/AAAAAAAAAyI/xkJyC46FhRI/clip_image002_thumb.png?imgmax=800" width="137" height="28"></a> <p>This e-mail message may contain confidential or privileged information, including sensitive patient-related information protected by state and federal laws. If you are not the intended recipient of this message, or an authorized representative of the intended recipient, you are prohibited from reviewing, copying, or distributing this message, its attachments, or any information contained in this message. If you received this message in error, please notify the sender immediately by replying to the message and delete this message from your system. <hr align="center" size="3" width="100%"> <p>This email has been scanned for email related threats and delivered safely by Mimecast.<br>For more information please visit <a href="http://www.mimecast.com">http://www.mimecast.com</a> <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Saturday, July 18, 2015 2:40 AM<br>To: 'Dylan Adams'<br>Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics<br>Subject: RE: Joyce's VNS Device <p>Hi Dylan, <p>Thank you for the telephone call and email yesterday clarifying the battery status Joyce’s model 104 implant. At the time of your call I was driving to my doctor as I’ve been under the weather and couldn’t take any notes and therefore I was unable to respond to you until now. Your prompt response and that of your fellow associates is greatly appreciated in resolving several recent issues expeditiously. <p>By copy of this communication to Joyce’s attending physician, Dr. Ely Pelta, I shall similarly update him as to your company’s updated programming of his newest handheld computer as it relates to the battery status as you explained it to me and the fact Dr. Pelta has other patient(s) who will similarly need their prosthesis interrogated. <p><i></i> <p><i><font color="#ff0000" size="3">“While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.”</font></i> <p>Joyce’s previous model 102R at the same settings was in use closing in on 9 years and because of certain health insurance issues at the time we did not want to take any chances that her battery would deplete. We previously experimented deactivating her device and within 2 weeks she rapidly declined into a severe depression. Within about 2 days of reactivation of the prosthesis she was depression free once again and we have not looked back. Her more recent model 104 was implanted October 2013 so it will be unnecessary to trouble you at this time for a “battery life calculation” but I shall record that terminology and process in my records when I feel the time becomes necessary for replacement. So thank you for that piece of information too. <p>Once again, I cannot fully express my appreciation to all you folks for the very prompt and expeditious handling and assistance you all have shared and executed on our behalf. Most importantly despite Joyce’s other advancing neurological challenge PSP (Progressive Supranuclear Palsy) which would be cause for severe depression Joyce continues in a depression free state for which I am eternally grateful to all who have assisted us in one way or another to give her a reasonable quality of life. Thank you, thank you and thank you… <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: EDP [mailto:(Redacted)] <br>Sent: Saturday, July 18, 2015 7:15 AM<br>To: Herbert Stein<br>Subject: Re: Joyce's VNS Device <p>Thank you herb ! <br>Sent from my iPhone <p>////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Saturday, July 18, 2015 3:11 AM<br>To: Daniel Moore, CEO - Cyberonics<br>Cc: Dr. Ely Pelta; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Dylan Adams - Clinical Engineer - Cyberonics<br>Subject: Publicly sharing recent correspondence... <p>Dear Dan et al, <p>As you are aware from my recent correspondence with your associates we ran into a couple of issues which were expeditiously resolved by your staff. <p>I would like your permission to share the correspondence I have recently had between Bryan, Susan and Dylan publicly in what I consider a truly favorable light as to how your organization has functioned expeditiously to help one of its patients and physician. <p>Putting our differences aside as to the legal issues of the Guarantee and the anti-kickback statutes which I blogged previously I do try to maintain a balanced perspective regarding the VNS Therapy as well as all treatments and I think this is an opportunity for me to favorably blog the good your organization has demonstrated. <p>Please let me know if this is acceptable to you and your staff. <p>As always, I wish you all wellness and all the good you’d wish for yourselves. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com] <br>Sent: Saturday, July 18, 2015 3:56 PM<br>To: Herbert Stein; Dan Moore<br>Cc: Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams<br>Subject: RE: Publicly sharing recent correspondence... <p>Dear Herb, <p>Thank you for the kind words. We always appreciate the feedback on the level of service we provide-it is great to see Dylan and Susan’s work recognized. However, please don’t feel any obligation to include this in your blog. Our perspective is that this is simply the level of service that we owe our patients, caregivers and physicians as a medical device company. <p>As always, don’t hesitate to contact us with any further questions. <p>Best regards, <p>Bryan <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Herbert Stein [mailto:fabrik@bellsouth.net] <br>Sent: Saturday, July 18, 2015 11:20 PM<br>To: 'Bryan Olin'; 'Dan Moore'<br>Cc: 'Dr. Ely Pelta'; 'Mark Bunker'; 'Susan Dotson'; 'Dylan Adams'<br>Subject: RE: Publicly sharing recent correspondence... <p>Hi Bryan, <p>I don’t feel any obligation but when I undertook some 15 years ago sharing our experiences, my research and collaborations with many of the patients and professionals as it related to VNS Therapy for Depression I did so because Joyce and I were intimately involved with the therapy. While doing so I felt by sharing with others my accumulated knowledge from the viewpoint of a support person as well as a long-time mental health advocate/activist that it might benefit someone else. I also endeavored to share both pro and con as well as the good or bad as unbiasedly as possible and where I felt it appropriate to inject my personal opinion(s). <p>I have also been given permission in many instances through the years to publicly share personal correspondence both from patients and professionals to emphasize both sides of the coin and to establish creditability of the website(s) I established. Then too, I have also been requested to not publicly share many communications which I have also complied with. I share Joyce and my personal address information, as you will note, along with my correspondence to help establish our creditability and the fact we have nothing to hide and are real people unlike some other sites, participants and webmasters I have encountered through the years. <p>Certainly I have been assertive and outspoken while trying to be respectful about several issues not favorable to Cyberonics while on other matters I have expressed my gratitude and admiration. I am well aware of patients who have been extremely dissatisfied with both your company and therapy and I have freely shared that information too. I now have experienced another instance which is both pro and good, in my opinion, and I would like to share that information by presenting the quick action on your part, late on a Sunday evening, and the prompt follow up by your other associates to overcome these two (2) recent issues and I can think of no better way to illustrate those facts than by sharing our various recent communications. <p>I do appreciate and thankfully acknowledge your taking your valuable time and consideration to address this matter too. <p>Once again, may I be allowed to publish the recent correspondence I’ve had with you, Susan and Dylan? <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p>From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com] <br>Sent: Sunday, July 19, 2015 11:33 AM<br>To: Herbert Stein<br>Cc: Dan Moore; Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams<br>Subject: Re: Publicly sharing recent correspondence... <p>Dear Herb,<br>It would be fine if you would like to share the experience in your blog.<br>Best regards,<br>Bryan<br>Sent from my iPhone <p>/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// <p><font size="3">And in the words of the late Paul Harvey and now you have “The Rest of the Story”. </font> <p><font size="3">Herb</font></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-45966794619027532132015-07-13T07:58:00.001-07:002015-07-13T07:58:01.905-07:00TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial<p>July 13, 2015 <h3>TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial</h3> <p>Posted: Wednesday, July 8, 2015 4:25 pm <p><a href="http://fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html">TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial</a> <p>TIRR Memorial Hermann is taking part in a clinical trial aimed at assessing Vagus Nerve Stimulation (VNS) during rehabilitation for improved upper limb motor function following a stroke. According to the American Heart Association, someone in the United States has a stroke every 40 seconds and stroke is a leading cause of disability in the United States. <p>The goal of this research is to improve and maximize arm and hand function in stroke survivors. The current study is an extension of a clinical trial conducted last year in Europe. Following the European clinical trial, some patients were able to resume daily activities like driving, cooking, and taking care of young children. <p>TIRR Memorial Hermann is one of only three sites in the United States participating in this trial. Dr. Gerard E. Francisco, chief medical officer at TIRR Memorial Hermann and Professor and Chairman of Physical Medicine and Rehabilitation Department (PM&R) at UT-Health and Dr. Nuray Yozabitran, researcher in the UTHealth Neuromodulation and Neural Interfaces Laboratory at TIRR Memorial Hermann’s NeuroRecovery Research Center are coordinating the Houston trial. <p>“At TIRR Memorial Hermann we’re known around the world for our rehabilitation services. But the cutting edge research we are doing is important so that we can continue to rehabilitate even better,” says Dr. Francisco. “The results from the European clinical trial were very promising and we’re excited to get our research underway.” <p>The trial requires an outpatient surgical procedure to place an electrical device in the patient’s chest area. The device is then connected to the vagus nerve in the neck using thin wires that are also implanted. <p>The vagus nerve directly connects to the brain and sends important signals to tell the brain what to learn. The patient will do a series of therapeutic tasks aimed at rebuilding the neural circuits in the brain that are responsible for upper limb movement. Each time the patient completes a correct movement, the therapist pushes a button and the patient receives a small burst of neurostimulation, which activate the vagus nerve. VNS aims to encourage the growth of new neural connections in the brain that may have been damaged by a stroke. <p>The treatment uses the Vivistim System developed by Texas based medical device firm MicroTransponder. <p>To participate in the trial you must be between the ages of 30 and 80 and have had a stroke at least four months ago but not more than five years ago. You must also experience some arm and hand movement difficulties. <p>To learn more about the trial go to <a href="http://www.vnsstroketrial.com/">http://www.vnsstroketrial.com/</a> or call (713) 797-5282. <p><a title="http://www.fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html" href="http://www.fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html">http://www.fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com1tag:blogger.com,1999:blog-5694055184415942831.post-17176769879886086792015-06-29T04:42:00.001-07:002015-06-29T04:42:37.858-07:00“…there also may be secondary benefits Joyce and you are also accruing…”<p><b>From:</b> Herbert Stein [<a href="mailto:fabrik@bellsouth.net">mailto:fabrik@bellsouth.net</a>] <br><b>Sent:</b> Saturday, June 20, 2015 12:32 PM<br><b>Subject:</b> Hacking the nervous system <p>To Joyce’s fellow VNS depression patients et al, <p>I truly hope this note finds you all doing well. <p>As you well know I have advocated fervently trying to help all those who have benefited and wish to continue with this depression therapy obtain health insurance coverage while also continuing my reading, research, collaborating and advocacy/activism. I am aware VNS Therapy is still being studied for other medical illnesses as well. Just today a very dear and long, long, long-time friend Murray shared with me an article that I’d also like to share with you. <p>While you may be benefiting for purposes of depression there also may be secondary benefits Joyce and you are also accruing unbeknownst to you. Please take a moment to read the below listed link: <p><b><a href="http://www.vnstherapy-herb.blogspot.com/2015/06/hacking-nervous-system.html">Hacking the nervous system</a></b> <p><b></b> <p>As always, I wish you all wellness and all the good you’d wish for yourselves. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><font size="1">---------------------------------------------------------------</font> <p><font size="1">NOTICE OF CONFIDENTIALITY / Disclaimer</font> <p><font size="1">---------------------------------------------------------------</font> <p><font size="1">Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</font> <p><font size="1"></font> <p><font size="1">CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</font></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-19868432689012735652015-06-28T20:52:00.001-07:002015-06-28T20:52:41.321-07:00In all fairness and balanced reporting...<p><b>From:</b> Herbert Stein [<a href="mailto:fabrik@bellsouth.net">mailto:fabrik@bellsouth.net</a>] <br><b>Sent:</b> Sunday, June 28, 2015 11:46 PM<br><b>Subject:</b> In all fairness and balanced reporting... <p>To Joyce’s fellow depression patients’ et al.: <p>As you know I have had through the year’s respectful differences of opinion on several important issues with the executive management of Cyberonics. At the same time and in all fairness to the management they have always responded promptly to my calls for assistance in helping to achieve wellness for Joyce. <p>Joyce had a scheduled appointment to see her attending psychiatrist to interrogate her VNS prosthesis tomorrow Monday, June 29, 2015. I sent an e-mail earlier today (Sunday) to her doctor to remind him to please have the computer equipment available to interrogate Joyce’s implant. When we returned home later in the evening after dinner his e-mail advised me that apparently the equipment had been stolen and could I assist in obtaining a replacement. <p>“Sun 6/28/2015 9:38 PM” I sent an e-mail to several executives at Cyberonics enlisting their help. <p>“Sun 6/28/2015 10:40 PM” I received the following reply from one of Cyberonics executives: <p><i>Dear Herb,<br>I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.</i> <p>While I may tend to be assertive in my advocacy/activism toward achieving my goals for both Joyce and her fellow patients I also try my best to be reasonably fair and balanced in my blog reporting. <p>Cyberonics thank you for your attention and speedy response to my request. More specifically, thank you Bryan. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p> <p><b><font size="1">---------------------------------------------------------------</font></b> <p><b><font size="1">NOTICE OF CONFIDENTIALITY / Disclaimer</font></b> <p><b><font size="1">---------------------------------------------------------------</font></b> <p><b><font size="1">Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</font></b> <p><b><font size="1"></font></b> <p><b><font size="1">CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</font></b></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-39062506541493337672015-06-20T09:02:00.001-07:002015-06-20T09:02:13.860-07:00Hacking the nervous system<p><img alt="" src="http://mosaicscience.com/sites/default/files/styles/mosaic_large/public/Vagus-Nerve-01v2__%28c%29-Job-Boot.jpg?itok=EQ10IYRi"> <p>© Job Boot <h3>Hacking the nervous system</h3> <p>One nerve connects your vital organs, sensing and shaping your health. If we learn to control it, the future of medicine will be electric. By Gaia Vince. <p>26 May 2015 <p>When Maria Vrind, a former gymnast from Volendam in the Netherlands, found that the only way she could put her socks on in the morning was to lie on her back with her feet in the air, she had to accept that things had reached a crisis point. “I had become so stiff I couldn’t stand up,” she says. “It was a great shock because I’m such an active person.” <p>It was 1993. Vrind was in her late 40s and working two jobs, athletics coach and a carer for disabled people, but her condition now began taking over her life. “I had to stop my jobs and look for another one as I became increasingly disabled myself.” By the time she was diagnosed, seven years later, she was in severe pain and couldn’t walk any more. Her knees, ankles, wrists, elbows and shoulder joints were hot and inflamed. It was rheumatoid arthritis, a common but incurable autoimmune disorder in which the body attacks its own cells, in this case the lining of the joints, producing chronic inflammation and bone deformity. <p>Waiting rooms outside rheumatoid arthritis clinics used to be full of people in wheelchairs. That doesn’t happen as much now because of a new wave of drugs called biopharmaceuticals – such as highly targeted, genetically engineered proteins – which can really help. Not everyone feels better, however: even in countries with the best healthcare, at least 50 per cent of patients continue to suffer symptoms. <p>Like many patients, Vrind was given several different medications, including painkillers, a cancer drug called methotrexate to dampen her entire immune system, and biopharmaceuticals to block the production of specific inflammatory proteins. The drugs did their job well enough – at least, they did until one day in 2011, when they stopped working. <p>“I was on holiday with my family and my arthritis suddenly became terrible and I couldn’t walk – my daughter-in-law had to wash me.” Vrind was rushed to hospital, where she was hooked up to an intravenous drip and given another cancer drug, one that targeted her white blood cells. “It helped,” she admits, but she was nervous about relying on such a drug long-term. <p>Luckily, she would not have to. As she was resigning herself to a life of disability and monthly chemotherapy, a new treatment was being developed that would profoundly challenge our understanding of how the brain and body interact to control the immune system. It would open up a whole new approach to treating rheumatoid arthritis and other autoimmune diseases, using the nervous system to modify inflammation. It would even lead to research into how we might use our minds to stave off disease. <p>And, like many good ideas, it came from an unexpected source. <h4> </h4> <p><img alt="" src="http://mosaicscience.com/sites/default/files/styles/mosaic_landscape/public/Vagus-Nerve-02_%28c%29-Job-Boot.jpg?itok=a_9eGcst" width="666" height="315"> <p>© Job Boot <h5>The nerve hunter</h5> <p>Kevin Tracey, a neurosurgeon based in New York, is a man haunted by personal events – a man with a mission. “My mother died from a brain tumour when I was five years old. It was very sudden and unexpected,” he says. “And I learned from that experience that the brain – nerves – are responsible for health.” This drove his decision to become a brain surgeon. Then, during his hospital training, he was looking after a patient with serious burns who suddenly suffered severe inflammation. “She was an 11-month-old baby girl called Janice who died in my arms.” <p>These traumatic moments made him a neurosurgeon who thinks a lot about inflammation. He believes it was this perspective that enabled him to interpret the results of an accidental experiment in a new way. <p>In the late 1990s, Tracey was experimenting with a rat’s brain. “We’d injected an anti-inflammatory drug into the brain because we were studying the beneficial effect of blocking inflammation during a stroke,” he recalls. “We were surprised to find that when the drug was present in the brain, it also blocked inflammation in the spleen and in other organs in the rest of the body. Yet the amount of drug we’d injected was far too small to have got into the bloodstream and travelled to the rest of the body.” <p>After months puzzling over this, he finally hit upon the idea that the brain might be using the nervous system – specifically the vagus nerve – to tell the spleen to switch off inflammation everywhere. <p>It was an extraordinary idea – if Tracey was right, inflammation in body tissues was being directly regulated by the brain. Communication between the immune system’s specialist cells in our organs and bloodstream and the electrical connections of the nervous system had been considered impossible. Now Tracey was apparently discovering that the two systems were intricately linked. <p>The first critical test of this exciting hypothesis was to cut the vagus nerve. When Tracey and his team did, injecting the anti-inflammatory drug into the brain no longer had an effect on the rest of the body. The second test was to stimulate the nerve without any drug in the system. “Because the vagus nerve, like all nerves, communicates information through electrical signals, it meant that we should be able to replicate the experiment by putting a nerve stimulator on the vagus nerve in the brainstem to block inflammation in the spleen,” he explains. “That’s what we did and that was the breakthrough experiment.” <h4> </h4> <p><img alt="" src="http://mosaicscience.com/sites/default/files/styles/mosaic_landscape/public/Vagus-Nerve-03_%28c%29-Job-Boot.jpg?itok=BMwTraKp" width="666" height="315"> <p>© Job Boot <h5>The wandering nerve</h5> <p><a href="http://mosaicscience.com/story/hacking-nervous-system#">Ups and downs in the nervous system</a>The vagus nerve starts in the brainstem, just behind the ears. It travels down each side of the neck, across the chest and down through the abdomen. ‘Vagus’ is Latin for ‘wandering’ and indeed this bundle of nerve fibres roves through the body, networking the brain with the stomach and digestive tract, the lungs, heart, spleen, intestines, liver and kidneys, not to mention a range of other nerves that are involved in speech, eye contact, facial expressions and even your ability to tune in to other people’s voices. It is made of thousands and thousands of fibres and 80 per cent of them are sensory, meaning that the vagus nerve reports back to your brain what is going on in your organs. <h5><font size="1"><font style="font-weight: normal">Operating far below the level of our conscious minds, the vagus nerve is vital for keeping our bodies healthy. It is an essential part of the parasympathetic nervous system, which is responsible for calming organs after the stressed ‘fight-or-flight’ adrenaline response to danger. Not all vagus nerves are the same, however: some people have stronger vagus activity, which means their bodies can relax faster after a stress.</font></font></h5> <p>The strength of your vagus response is known as your vagal tone and it can be determined by using an electrocardiogram to measure heart rate. Every time you breathe in, your heart beats faster in order to speed the flow of oxygenated blood around your body. Breathe out and your heart rate slows. This variability is one of many things regulated by the vagus nerve, which is active when you breathe out but suppressed when you breathe in, so the bigger your difference in heart rate when breathing in and out, the higher your vagal tone. <p>Research shows that a high vagal tone makes your body better at regulating blood glucose levels, reducing the likelihood of diabetes, stroke and cardiovascular disease. Low vagal tone, however, has been associated with chronic inflammation. As part of the immune system, inflammation has a useful role helping the body to heal after an injury, for example, but it can damage organs and blood vessels if it persists when it is not needed. One of the vagus nerve’s jobs is to reset the immune system and switch off production of proteins that fuel inflammation. Low vagal tone means this regulation is less effective and inflammation can become excessive, such as in Maria Vrind’s rheumatoid arthritis or in toxic shock syndrome, which Kevin Tracey believes killed little Janice. <p>Having found evidence of a role for the vagus in a range of chronic inflammatory diseases, including rheumatoid arthritis, Tracey and his colleagues wanted to see if it could become a possible route for treatment. The vagus nerve works as a two-way messenger, passing electrochemical signals between the organs and the brain. In chronic inflammatory disease, Tracey figured, messages from the brain telling the spleen to switch off production of a particular inflammatory protein, tumour necrosis factor (TNF), weren’t being sent. Perhaps the signals could be boosted? <p>He spent the next decade meticulously mapping all the neural pathways involved in regulating TNF, from the brainstem to the mitochondria inside all our cells. Eventually, with a robust understanding of how the vagus nerve controlled inflammation, Tracey was ready to test whether it was possible to intervene in human disease. <h4> </h4> <p><img alt="" src="http://mosaicscience.com/sites/default/files/styles/mosaic_landscape/public/Vagus-Nerve-04_%28c%29-Job-Boot.jpg?itok=jTXA0Jf_" width="666" height="315"> <p>© Job Boot <h5>Stimulating trial</h5> <p>In the summer of 2011, Maria Vrind saw a newspaper advertisement calling for people with severe rheumatoid arthritis to volunteer for a clinical trial. Taking part would involve being fitted with an electrical implant directly connected to the vagus nerve. “I called them immediately,” she says. “I didn’t want to be on anticancer drugs my whole life; it’s bad for your organs and not good long-term.” <p>Tracey had designed the trial with his collaborator, Paul-Peter Tak, professor of rheumatology at the University of Amsterdam. Tak had long been searching for an alternative to strong drugs that suppress the immune system to treat rheumatoid arthritis. “The body’s immune response only becomes a problem when it attacks your own body rather than alien cells, or when it is chronic,” he reasoned. “So the question becomes: how can we enhance the body’s switch-off mechanism? How can we drive resolution?” <p>When Tracey called him to suggest stimulating the vagus nerve might be the answer by switching off production of TNF, Tak quickly saw the potential and was enthusiastic to see if it would work. Vagal nerve stimulation had already been approved in humans for epilepsy, so getting approval for an arthritis trial would be relatively straightforward. A more serious potential hurdle was whether people used to taking drugs for their condition would be willing to undergo an operation to implant a device inside their body: “There was a big question mark about whether patients would accept a neuroelectric device like a pacemaker,” Tak says. <p>He needn’t have worried. More than a thousand people expressed interest in the procedure, far more than were needed for the trial. In November 2011, Vrind was the first of 20 Dutch patients to be operated on. <p>“They put the pacemaker on the left-hand side of my chest, with wires that go up and attach to the vagus nerve in my throat,” she says. “I waited two weeks while the area healed, and then the doctors switched it on and adjusted the settings for me.” <p>She was given a magnet to swipe across her throat six times a day, activating the implant and stimulating her vagus nerve for 30 seconds at a time. The hope was that this would reduce the inflammatory response in her spleen. As Vrind and the other trial participants were sent home, it became a waiting game for Tracey, Tak and the team to see if the theory, lab studies and animal trials would bear fruit in real patients. “We hoped that for some, there would be an easing of their symptoms – perhaps their joints would become a little less painful,” Tak says. <p>At first, Vrind was a bit too eager for a miracle cure. She immediately stopped taking her pills, but her symptoms came back so badly that she was bedridden and in terrible pain. She went back on the drugs and they were gradually reduced over a week instead. <p>And then the extraordinary happened: Vrind experienced a recovery more remarkable than she or the scientists had dared hope for. <p>“Within a few weeks, I was in a great condition,” she says. “I could walk again and cycle, I started ice-skating again and got back to my gymnastics. I feel so much better.” She is still taking methotrexate, which she will need at a low dose for the rest of her life, but at 68, semi-retired Vrind now plays and teaches seniors’ volleyball a couple of hours a week, cycles for at least an hour every day, does gymnastics, and plays with her eight grandchildren. <p>Other patients on the trial had similar transformative experiences. The results are still being prepared for publication but Tak says more than half of the patients showed significant improvement and around one-third are in remission – in effect cured of their rheumatoid arthritis. Sixteen of the 20 patients on the trial not only felt better, but measures of inflammation in their blood also went down. Some are now entirely drug-free. Even those who have not experienced clinically significant improvements with the implant insist it helps them; nobody wants it removed. <p>“We have shown very clear trends with stimulation of three minutes a day,” Tak says. “When we discontinued stimulation, you could see disease came back again and levels of TNF in the blood went up. We restarted stimulation, and it normalised again.” <p>Tak suspects that patients will continue to need vagal nerve stimulation for life. But unlike the drugs, which work by preventing production of immune cells and proteins such as TNF, vagal nerve stimulation seems to restore the body’s natural balance. It reduces the over-production of TNF that causes chronic inflammation but does not affect healthy immune function, so the body can respond normally to infection. <p>“I’m really glad I got into the trial,” says Vrind. “It’s been more than three years now since the implant and my symptoms haven’t returned. At first I felt a pain in my head and throat when I used it, but within a couple of days, it stopped. Now I don’t feel anything except a tightness in my throat and my voice trembles while it’s working. <p>“I have occasional stiffness or a little pain in my knee sometimes but it’s gone in a couple of hours. I don’t have any side-effects from the implant, like I had with the drugs, and the effect is not wearing off, like it did with the drugs.” <h4> </h4> <p><img alt="" src="http://mosaicscience.com/sites/default/files/styles/mosaic_landscape/public/Vagus-Nerve-05_%28c%29-Job-Boot.jpg?itok=5uSRaGnB" width="666" height="315"> <p>© Job Boot <h5>Raising the tone</h5> <p><a href="http://mosaicscience.com/story/hacking-nervous-system#">A nervy way to lose weight</a>Having an electrical device surgically implanted into your neck for the rest of your life is a serious procedure. But the technique has proved so successful – and so appealing to patients – that other researchers are now looking into using vagal nerve stimulation for a range of other chronic debilitating conditions, including inflammatory bowel disease, asthma, diabetes, chronic fatigue syndrome and obesity. <p>Gaia Vince describes a device that deals directly with the nervous system to help control obesity. <p>But what about people who just have low vagal tone, whose physical and mental health could benefit from giving it a boost? Low vagal tone is associated with a range of health risks, whereas people with high vagal tone are not just healthier, they’re also socially and psychologically stronger – better able to concentrate and remember things, happier and less likely to be depressed, more empathetic and more likely to have close friendships. <p>Twin studies show that to a certain extent, vagal tone is genetically predetermined – some people are born luckier than others. But low vagal tone is more prevalent in those with certain lifestyles – people who do little exercise, for example. This led psychologists at the University of North Carolina at Chapel Hill to wonder if the relationship between vagal tone and wellbeing could be harnessed without the need for implants. <p>In 2010, Barbara Fredrickson and Bethany Kok recruited around 70 university staff members for an experiment. Each volunteer was asked to record the strength of emotions they felt every day. Vagal tone was measured at the beginning of the experiment and at the end, nine weeks later. As part of the experiment, half of the participants were taught a meditation technique to promote feelings of goodwill towards themselves and others. <p>Those who meditated showed a significant rise in vagal tone, which was associated with reported increases in positive emotions. “That was the first experimental evidence that if you increased positive emotions and that led to increased social closeness, then vagal tone changed,” Kok says. <p>Now at the Max Planck Institute in Germany, Kok is conducting a much larger trial to see if the results they found can be replicated. If so, vagal tone could one day be used as a diagnostic tool. In a way, it already is. “Hospitals already track heart-rate variability – vagal tone – in patients that have had a heart attack,” she says, “because it is known that having low variability is a risk factor.” <p>The implications of being able to simply and cheaply improve vagal tone, and so relieve major public health burdens such as cardiovascular conditions and diabetes, are enormous. It has the potential to completely change how we view disease. If visiting your GP involved a check on your vagal tone as easily as we test blood pressure, for example, you could be prescribed therapies to improve it. But this is still a long way off: “We don’t even know yet what a healthy vagal tone looks like,” cautions Kok. “We’re just looking at ranges, we don’t have precise measurements like we do for blood pressure.” <p><a href="http://mosaicscience.com/story/hacking-nervous-system#">Bioelectric dreams</a>What seems more likely in the shorter term is that devices will be implanted for many diseases that today are treated by drugs: “As the technology improves and these devices get smaller and more precise,” says Kevin Tracey, “I envisage a time where devices to control neural circuits for bioelectronic medicine will be injected – they will be placed either under local anaesthesia or under mild sedation.” <p>Treating disease could become far more precise by using bioelectronics rather than drugs. <p>However the technology develops, our understanding of how the body manages disease has changed for ever. “It’s become increasingly clear that we can’t see organ systems in isolation, like we did in the past,” says Paul-Peter Tak. “We just looked at the immune system and therefore we have medicines that target the immune system. <p>“But it’s very clear that the human is one entity: mind and body are one. It sounds logical but it’s not how we looked at it before. We didn’t have the science to agree with what may seem intuitive. Now we have new data and new insights.” <p>And Maria Vrind, who despite severe rheumatoid arthritis can now cycle pain-free around Volendam, has a new lease of life: “It’s not a miracle – they told me how it works through electrical impulses – but it feels magical. I don’t want them to remove it ever. I have my life back!” <ul> <li> <p>Author: <a href="http://mosaicscience.com/people/gaiavince">Gaia Vince</a></p> <li> <p>Editor: <a href="http://mosaicscience.com/people/michaelregnier">Michael Regnier</a></p> <li> <p>Fact checker: Laura Dawes</p> <li> <p>Copyeditor: <a href="http://mosaicscience.com/people/tomfreeman">Tom Freeman</a></p> <li> <p>Illustrator: Job Boot</p> <li> <p>Art director: <a href="http://mosaicscience.com/people/petabell">Peta Bell</a></p></li></ul> <p><a title="http://mosaicscience.com/story/hacking-nervous-system" href="http://mosaicscience.com/story/hacking-nervous-system">http://mosaicscience.com/story/hacking-nervous-system</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-27460718492627922312015-05-20T09:02:00.001-07:002015-05-20T09:02:42.355-07:00"I don't understand...please explain it to me?" VNS Therapy for depression.<p><a name="_MailOriginal"><b>From:</b></a> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Wednesday, May 20, 2015 5:01 AM<br><b>Subject:</b> "I don't understand...please explain it to me?" VNS Therapy for depression. <p><b>From:</b> Herbert Stein [<a href="mailto:fabrik@bellsouth.net">mailto:fabrik@bellsouth.net</a>] <br><b>Sent:</b> Wednesday, May 20, 2015 4:53 AM<br><b>To:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director; Dr. Patrick Conway - Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer<br><b>Subject:</b> "I don't understand...please explain it to me?" VNS Therapy for depression. <p>Dear Madam Secretary Burwell, <p><a href="http://www.lifenews.com/2015/05/12/obama-admin-makes-insurance-companies-obey-hhs-mandate-offer-abortion-drugs-for-free/">Obama Admin Makes Insurance Companies Obey HHS Mandate, Offer Abortion Drugs for Free</a> <p>"I don't understand...please explain it to me?" Why is it that the President and Federal Government can mandate and tell the health insurers they “must” follow suit and offer abortion drugs for free and yet you and your CMS agency, for the two (2) years I’ve been writing to your predecessor and you advocating for the VNS Therapy depression patients, can’t tell all your Medicare contractors in writing to rightfully cover the care once and for all for these study subjects and patients? <p>While we’re on the subject of “must” how is it that the Government can tell the private health insurers what they must do when CMS tells me they have no control over private health insurers when it comes to the care of these very same VNS Therapy patients? <p>I constantly stand in wonderment how anything in our convoluted and bloated government bureaucracy ever gets accomplished. <p>Once again, please read the slogans listed below taken from your own home pages. Is there not anyone with authority and common sense within your agencies to notify all CMS contractors and private health insurance carriers of the doctrine of “Continuity of care” and the fact this doctrine was reaffirmed for these patients in your agency’s <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">December 30, 2014 decision</a>? <p><b>Just what does it take to get through to you people to take effective action?</b> <p><b></b> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgArs0dlfumsFLKNqdJDEWCPZXVvCMeBe7fthIb0BDohF0pkOJmkjrirs9kFcJjgmSZeadPSuaMuuSk87-MPppLXISFnT6Sj2xIMZuNjdHKSkIShWyCFH0kYmq-oaewcR_voYm_cE2tMaU/s1600-h/clip_image001%25255B4%25255D.jpg"><img title="clip_image001" style="border-left-width: 0px; border-right-width: 0px; background-image: none; border-bottom-width: 0px; padding-top: 0px; padding-left: 0px; display: inline; padding-right: 0px; border-top-width: 0px" border="0" alt="clip_image001" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4G4eb99Tm3qINiO16IJOrFqeyQ2qH6sBmhfXboIwyWkWHyikvx2_UokAbPMbXO9NP5CzNyxfcc1H7rPEHJAqjW1t9KroYPG-iWOgI3hjpe36xQtU80swKABlv-YPPgFSkpA3sYO6-qhQ/?imgmax=800" width="609" height="249"></a> <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p>--------------------------------------------------------------- <p>NOTICE OF CONFIDENTIALITY / Disclaimer <p>--------------------------------------------------------------- <p>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person. <p> <p>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately. herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-61184119406720633942015-05-11T11:32:00.001-07:002015-05-11T11:33:32.674-07:00Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007.<p><a name="_MailOriginal"><b>From:</b></a> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Monday, May 11, 2015 2:14 PM<br><b>To:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director; Dr. Patrick Conway - Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer; Courtney Turner; Nancy Conn - DMOA Acting Deputy Director <br><b>Subject:</b> Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007. <p>Dear Madam Secretary Burwell, <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_3B33RWnvD8l1sEpUcYiwArLo_tZ23ebM77OqBdcf2cYBi65cMQHu_PpU3hiV-ebEpA1oFjZn2NqWxaMlh8m6RiKrduuDwpBYHfHwTDpZ0Q1OiptwQFeb6jd-kMAvdZeT3Hf9HEq0ZAk/s1600-h/clip_image001%25255B5%25255D.jpg"><img title="clip_image001" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image001" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgW603S-l8qmbo-xHy8ej8ad_3SHSV8Zigrb0h18-NvUlepjmduhFCy5QmwHm12hbIG3vgbKNJrSf9UzalH3MJnp6Ml8Wr6-juZoizwbHzhH83VrXX-Hl9WxFBR2lfMI5FKERc3bi_xPN0/?imgmax=800" width="778" height="343"></a> <p><a href="http://www.hhs.gov/about/">http://www.hhs.gov/about/</a> <p>So exactly when does your agency/bureaucracy actually do something helpful and effective “for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves”? <p>It has been two (2) years now that I’ve been on this project advocating and writing to former Secretary Kathleen Sebelius and you. My original pleas were for “Compassionate Use” only to learn all along your CMS agency incorporates the doctrine of “Continuity of care” which rightfully should have insured medical coverage for this unique population of patients implanted with a medical device being denied care and/or replacement by your various contractors. <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">The decision of December 30, 2014</a> reiterates this fact of “Continuity of care”. <p>What does it take to get any of you people to understand that it is rightfully your responsibility to care for these patients (read you’re agencies statement at the beginning of this communication) and you folks are failing? Why can’t you add an addendum to <a href="http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=195&NCDId=230&ncdver=2&NcaName=Vagus+Nerve+Stimulation+for+Treatment+of+Resistant+Depression+%28TRD%29&CoverageSelection=National&KeyWord=vagus+nerve+stimulation&KeyWordLookUp=Title&KeyWordSearchType=And&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D&">the NCD of May 4, 2007</a> noting the fact that all VNS Therapy depression patients implanted prior to that date are rightfully to be covered? Why can’t any formal message, document or piece of paper be sent to all your Medicare/Medicaid contractors to inform them what should have properly been included in the original decision but was egregiously or negligently and/or intentionally overlooked and/or omitted? <p>Why can’t anyone in the multitude of your agencies personnel get the message out to all your contractors? Why must the patient, “least able to help themselves” be forced to appeal? <p><a href="http://www.vnstherapy-herb.blogspot.com/2015/04/vns-therapy-for-depression-hang-on.html">“Please note, that if a particular Medicare claim is not paid, the Medicare beneficiary has the right to appeal.”</a> --- Dr. Patrick Conway, CMS Chief Medical Officer. <p>Why it is your own people don’t understand the true realities of life/procedures from the patient viewpoint? <a href="http://vnstherapy-herb.blogspot.com/2013/11/expediting-vns-replacement-surgery-for.html">The hospitals will not proceed unless they get the okay from MAC.</a> The hospitals will not perform surgery for replacement of the prosthesis for a depression patient although they will perform the exact same surgery for an epilepsy patient. Obviously your own people don’t know it is not a question of appealing non-payment but first obtaining approval for the surgery and/or care in the first place. <p>It is truly, truly sad and maddening situation as I sit here writing to you for the umpteenth time to tell you, in my opinion, of the ineptness and what I consider the incredible incompetence within your agency based upon some of the answers and/or communications that I receive based upon patient pleas asking for my assistance to overcome your contractor’s denials. <p>Why can’t you in writing or one of your subordinates inform all your Medicare/Medicaid contractors in one document submission that these VNS Therapy depression patients are to be covered and treated exactly the same as the VNS Therapy epilepsy patient? Is that too difficult for anyone to comprehend? <p>I no longer have to beg for “Compassionate use”. I now ask that you only do what are rightfully your job and that of all your subordinates and that which has been adjudicated within your own agency. <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf"><b>Medicare/Medicaid coverage is rightfully to be covered for all VNS Therapy depression patients implanted prior to May 4, 2007.</b></a><b></b> <p>The next letter I would truly hope to receive from either you or any of your subordinates is one informing me that all the Medicare/Medicaid contractors have rightfully been informed and acknowledge that all VNS Therapy depression patients implanted prior to May 4, 2007 are to be covered for both care and replacement of their medical devices without any further need or discussion for any appeals. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-57592209763935752082015-05-09T12:31:00.001-07:002015-05-09T12:31:50.875-07:00UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke<h3>UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke</h3> <p>Published on May 8, 2015 <p><img alt="ut" src="http://cdn.ptproductsonline.com/ptproduc/2015/05/ut.jpg" width="464" height="271"> <p>A recent university news release from <a href="http://www.utsouthwestern.edu/">UT Southwestern Medical Center</a> reports that the center will be one of three national sites to pioneer US testing for an implant device designed to stimulate the vagus nerve in stroke patients; the aim is to determine whether the technology can help restore lost arm function. <p>The release states that the device, known as the <a href="http://www.vnsstroketrial.com/?page_id=14">Vivistim System</a>, was developed by Dallas-based company MicroTransponder Inc with a license from UT Dallas. The technology is engineered to stimulate the neck’s vagus nerve. It is implanted under the collarbone and is about the size of a pacemaker. According to the release, it sends painless, half-second electrical pulses up the vagus nerve, causing neruomodulators to be released in various parts of the brain. There are also alternate forms of vagus nerve stimulation therapy already approved for use by the FDA for treating other illnesses, such as depression and epilepsy, the release adds. <p>The neuromodulators “appear to facilitate the creation of new neuron pathways in the brain, which play a key role in restoring muscle movement,” says <a href="http://profiles.utsouthwestern.edu/profile/137563/ty-shang.html">Ty Shang, MD, PhD</a>, in the release. <p>Shang is an assistant professor of Neurology and Neurotherapeutics, UT Southwestern, and is heading the UT Southwestern arm of the trial. <p>A stroke deprives brain cells of oxygen, and without oxygen, brain cells die and can no longer perform the function for which they were intended, Shang points out. <p>“There has been no known way to regenerate new brain cells to replace them, but in early tests with this device, the brain appears to ‘rewire’ other cells to perform the function,” he adds. <p>The Vivistim System is built to improve motor function in the more involved arm of a patient post-stroke. The technology was studied beginning in 2013 for efficacy and safety in a small study in Glasgow, Scotland, the release says. Individuals in the Glasgow study reportedly experienced meaningful, functional improvements in their more involved arm. <p>Shang theorizes that VNS therapy may serve as the stimulus for motor relearning with the more involved arm for individuals post-stroke. While gaining functional improvement in the impaired arm can be a challenge, Shang says, “VNS therapy might make achieving functional gains easier.” <p>The release notes that currently, UT Southwestern researchers are seeking individuals in the Dallas-Fort Worth metroplex who sustained a stroke 4 months to 5 years ago to participate in the trial. <p>Once participants have undergone outpatient surgery to implant the device, the release says they will be scheduled for 18, 90-minute sessions of intensive, task-specific therapy during a 6-week period, with quarterly follow-up evaluations for the next year. <p>Interested participants can visit <a href="http://www.vnsstroketrial.com/">www.vnsstroketrial.com</a> or contact the Department of Physical Therapy at (214) 648-1533. <p>[Photo Credit: UT Southwestern Medical Center] <p>[Source(s): Newswise, UT Southwestern Medical Center] <p><a href="http://www.ptproductsonline.com/2015/05/ut-southwestern-one-sites-test-implant-device-designed-restore-arm-function-post-stroke/#sthash.flR5WI14.dpuf">http://www.ptproductsonline.com/2015/05/ut-southwestern-one-sites-test-implant-device-designed-restore-arm-function-post-stroke/#sthash.flR5WI14.dpuf</a> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-29484271796673291712015-04-24T00:08:00.001-07:002015-04-24T00:08:40.500-07:00VNS Therapy for Depression - "to hang on their individual desks and walls so that they finally get the message"<p><b>From:</b> Herbert Stein [<a href="mailto:fabrik@bellsouth.net">mailto:fabrik@bellsouth.net</a>] <br><b>Sent:</b> Friday, April 24, 2015 2:56 AM<br><b>To:</b> Dr. Patrick Conway - Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer<br><b>Cc:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director<br><b>Subject:</b> VNS Therapy for Depression - "to hang on their individual desks and walls so that they finally get the message" <p>Dear Dr. Conway, <p>On the Internet about page of HHS.gov you’ll find the following quotations: <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnSgJet9WJvlMZsd8hMoAYfye8uCcV6VGIGwELbnkuIfWKS4uKTyd6R7tPZoYHQwiS4ptQWxnOfRY4H2BNfPp7Bxzv_4rSNkSYrzUa5-2BCb4zsX2HtjZPol6KraslIHUg6PjrDTa-HEo/s1600-h/clip_image002%25255B6%25255D.jpg"><img title="clip_image002" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image002" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdWri7AkLogu3iM2DawDMUvVBxIAIsPxJWhl6Y9av_YQM04_6Kc-75OGqd-Bdlo5H5BbI2f__jZI3N90HNXHFkojKTTmL_a2MYY8DiUD9EdQiYTZgNj_c94MDBnxQYPeD7R9KT_g_V7gE/?imgmax=800" width="798" height="359"></a> <p>First, thank you for taking your valuable time to respond to my recent email to Madam Secretary Sylvia Burwell. For purposes of this response I shall not at the moment address “Medicare has no jurisdiction over coverage decisions of a private insurance company.” What I would like to address is that I have been cited and admonished in my two (2) years of advocacy and correspondence for this unique VNS Therapy depression patient population for my sometime harsh rhetoric in addressing/responding to those who work for the bureaucracy of HHS/CMS. I therefore wish to point out that which follows may be harsh and is not a personal indictment of you. <p>I have spent two (2) years advocating and battling with HHS/CMS only to find out that your own agency acknowledges the doctrine of “Continuity of care” and these patients should have rightfully been attended to and cared for from the onset. And yet, there are still obstacles being thrown in our way as evidenced by your letter whether through lack of knowledge, incompetence or bureaucratic sludge. <p>Please read those quotations listed above real carefully once again and then tell me the contents of your letter to me adhere to those principles. My father-in-law, may he rest in peace, used to use spoonerisms at times to raise attention and/or get his point across. One such spoonerism is the fact that you’ve got this matter “backasswards”. I’m well aware of NCD of May 4, 2007, which incidentally only applies to depression patients, but you totally omit addressing your own agencies recent <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">decision of December 30, 2014</a> and the doctrine of “Continuity of case as I quote: <p><b>VII. <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">The AGGRIEVED PARTIES’ CONTENTIONS REGARDING MEDICARE BENEFITS WHO WERE IMPLANTED WITH THE VNS DEVICE PRIOR TO MAY 4, 2007 PROVIDE NO BASIS FOR INVALIDATING NCD 160.18(C). </a></b> <p><a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">The Aggrieved Parties suggest that NCD 160.18(C) is invalid because it does not address the needs of Medicare beneficiaries with TRD who were implanted with the VNS device and received Medicare coverage for VNS prior to the issuance of NCD 160.18(C) on May 4, 2007. Statement ¶¶ 38-43; Complaint ¶¶ 90-95. With respect to those beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for: (1) “the interrogation and calibration of a VNS therapy device implanted and deemed to be reasonable and medically necessary when implanted for TRD”; or (2) “for the replacement of the implanted pulse generator device upon battery expiration, when required[.]” AP Statement ¶ 43. According to the Aggrieved Parties, those omissions conflict with: (1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” <i>Id. </i>¶¶ 40-42 (<i>quoting </i>78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).</a><b></b> <p>Why any of these seriously ill depression patients must be challenged by your bureaucracy to have to file an appeal is anything but effective management in my opinion or in line with “Continuity of care” as cited in the above quotation from the <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">December 30, 2014 decision</a>. Is there no one in all of your agencies with the authority or capability to issue a formal document of notification to any and all of your “local Medicare Administrative Contractors” to hang on their individual desks and walls so that they finally get the message? These patients are to be covered by Medicare/Medicaid period. <p>With all due respect to you and the fact I’ve been a mental health advocate/activist and support person over a half century, your letter to me is one which I refer to as “bureaucratic speak”. It sounds good but effectively accomplishes nothing. How’s about also getting the message out to MAC (Medicare Appeals Council)? So when the hospital applies for patient coverage for replacement surgery MAC can expeditiously approve the request because they would already have the “Continuity of care” decision of December 30, 2014 to guide them thereby significantly lessening the stress and anxiety on an already ill patient in line with the precepts noted early on in this message? How’s about finally producing some effective and productive document to put these issues to bed? <p>The former Deputy Administrator Director, Jonathan Blum, put in place a contact individual within your organization to expedite and lessen the stress on the patient in order to obtain their replacement prosthesis. In view of the fact that CMS acknowledges the doctrine of “Continuity of care” and the rightful medical coverage for these patients why is it seemingly so difficult to get the damn message out to your bureaucracy and get them all on the same page at the same time? Send me a new letter telling me these issues have been resolved and then I can feel you and your agency have finally accomplished something and become effective. Until that time I’ll consider these various replies as the normal “bureaucratic speak” that comes from DC. <p>Once again, thank you for taking the time to respond to my advocacy for the VNS Depression patients. <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFw7w2OEskUAPANGZVnMobEclFX3K4G4zHzr5YTgB-m2WVYPid1WhchRxnUT5_TG9J-d-YDxg6unCnegf889GtDHSj1Occi6cCOB0njSfoQfbKbY4SfQp8ZmEfCTXrc6eaPPsVmwZU2ZY/s1600-h/clip_image003%25255B8%25255D.jpg"><img title="clip_image003" style="border-top: 0px; border-right: 0px; background-image: none; border-bottom: 0px; padding-top: 0px; padding-left: 0px; border-left: 0px; display: inline; padding-right: 0px" border="0" alt="clip_image003" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEio40BqcuKCl1G9oYWDzX4PDFswJMQUKe5XTwl-4tXlJwlj1Oe6il4CnN76v_1ExSeq3h0-eQ1f4YsMszcBuZ2q4-e9BJ9Kr6u8n6K2K0g_IwJJXMa2xNxBO52rHhafZhEe-DLWA5Ja-jQ/?imgmax=800" width="836" height="1133"></a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-8716062364284632772015-04-22T09:10:00.001-07:002015-04-22T09:10:35.691-07:00Device-based autonomic modulation in arrhythmia patients: the role of vagal nerve stimulation.<ul> <li><a href="http://www.ncbi.nlm.nih.gov/pubmed/25894588#" name="EntrezSystem2.PEntrez.PubMed.Pubmed_ResultsPanel.Pubmed_DisplayBar.Display">Abstract</a><a href="http://www.ncbi.nlm.nih.gov/pubmed/25894588#">Curr Treat Options Cardiovasc Med.</a> 2015 May;17(5):379. doi: 10.1007/s11936-015-0379-9.</li></ul> <h3>Device-based autonomic modulation in arrhythmia patients: the role of vagal nerve stimulation.</h3> <p><a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Huang%20WA%5BAuthor%5D&cauthor=true&cauthor_uid=25894588">Huang WA</a><sup>1</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Shivkumar%20K%5BAuthor%5D&cauthor=true&cauthor_uid=25894588">Shivkumar K</a>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Vaseghi%20M%5BAuthor%5D&cauthor=true&cauthor_uid=25894588">Vaseghi M</a>. <h5><a href="http://www.ncbi.nlm.nih.gov/pubmed/25894588#">Author information</a></h5> <ul> <li><sup>1</sup>UCLA Cardiac Arrhythmia Center, University of California, 100 Medical Plaza, Suite 660, Los Angeles, CA, 90095, USA.</li></ul> <h5>Abstract</h5> <h6>OPINION STATEMENT: </h6> <p>Vagal nerve stimulation (VNS) has shown promise as an adjunctive therapy for management of cardiac arrhythmias by targeting the cardiac parasympathetic nervous system. VNS has been evaluated in the setting of ischemia-driven ventricular arrhythmias and atrial arrhythmias, as well as a treatment option for heart failure. As better understanding of the complexities of the cardiac autonomic nervous system is obtained, vagal nerve stimulation will likely become a powerful tool in the current cardiovascular therapeutic armamentarium. <dl> <dt>PMID: <dd>25894588 <dd>[PubMed] <a title="http://www.ncbi.nlm.nih.gov/pubmed/25894588" href="http://www.ncbi.nlm.nih.gov/pubmed/25894588">http://www.ncbi.nlm.nih.gov/pubmed/25894588</a></dd></dl> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-73864957054330620072015-04-22T09:00:00.001-07:002015-04-22T09:00:54.194-07:00Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.<p><a href="http://www.ncbi.nlm.nih.gov/pubmed/25526267#">J Neurosurg.</a> 2015 Mar;122(3):532-5. doi: 10.3171/2014.10.JNS14640. Epub 2014 Dec 19. <h3>Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.</h3> <p><a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Robinson%20LC%5BAuthor%5D&cauthor=true&cauthor_uid=25526267">Robinson LC</a><sup>1</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Winston%20KR%5BAuthor%5D&cauthor=true&cauthor_uid=25526267">Winston KR</a>. <h5><a href="http://www.ncbi.nlm.nih.gov/pubmed/25526267#">Author information</a></h5> <ul> <li><sup>1</sup>Department of Neurosurgery, University of Colorado School of Medicine, Aurora;</li></ul> <h5>Abstract</h5> <h6>OBJECT: </h6> <p>This investigation was done to examine, following implantation of vagus nerve stimulators, the relationship of vocal cord paralysis to the inner diameter of the coils used to attach the stimulator lead to the nerve. <h6>METHODS: </h6> <p>All data in this investigation were collected, as mandated by the FDA, by the manufacturer of vagus nerve stimulators and were made available without restrictions for analysis by the authors. The data reflect all initial device implantations in the United States for the period from 1997 through 2012. <h6>RESULTS: </h6> <p>Vocal cord paralysis was reported in 193 of 51,882 implantations. In patients aged 18 years and older, the incidence of paralysis was 0.26% when the stimulator leads had coil diameters of 3 mm and 0.51% when the leads had 2-mm-diameter coils (p < 0.05). Across all age groups, the incidence of vocal cord paralysis increased with age at implantation for leads having 2-mm-diameter coils. <h6>CONCLUSIONS: </h6> <p>In patients aged 18 years and older, vocal cord paralysis occurred at almost twice the rate with the implantation of vagus nerve stimulator leads having 2-mm-diameter coils than with leads having 3-mm-diameter coils. The incidence of vocal cord paralysis increases with patient age at implantation. <h6>KEYWORDS: </h6> <p>VNS = vagus nerve stimulation; complications; epilepsy; vagus nerve injury; vagus nerve stimulator lead; vocal cord paralysis <dl> <dt>PMID: <dd>25526267 <dd>[PubMed - indexed for MEDLINE]</dd></dl> <p><a title="http://www.ncbi.nlm.nih.gov/pubmed/25526267" href="http://www.ncbi.nlm.nih.gov/pubmed/25526267">http://www.ncbi.nlm.nih.gov/pubmed/25526267</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-31577222676716332942015-04-21T10:02:00.001-07:002015-04-21T10:02:47.854-07:00VNS Therapy for Depression - Another taste of governmental bureaucracy and its ineptitude...<p><a name="_MailOriginal"><b>From:</b></a> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Tuesday, April 21, 2015 11:02 AM<br><b>To:</b> Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director; Courtney Turner; Davonda Roberts - Nurse Consultant, HHS/CMS<br><b>Subject:</b> VNS Therapy for Depression - Another taste of governmental bureaucracy and its ineptitude... <p>Dear Madam Secretary Burwell et al, <p>This early morning I received a lovely and caring telephone call from Ms. Davonda Roberts, Nurse Consultant out of your Atlanta, Ga Medicare office following up on an <a href="http://www.vnstherapy-herb.blogspot.com/2015/01/and-its-contractors-will-allow.html">email I sent you and others on January 8, 2015.</a> I expressed my appreciation for her telephone call and for seeking to assist me this morning. The fact is and the reality is someone in the executive offices of HHS/CMS in the Washington DC bureaucracy took my email message and simply shoved the message on down the line to this lovely woman who had no idea of my struggles and advocacy these past two years or the events surrounding the VNS Therapy for Depression and the issues. <p>A simple analysis from my viewpoint after some two (2) years of advocacy to obtain medical coverage for VNS Depression Patients implanted prior to the <a href="http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=195&NCDId=230&ncdver=2&NcaName=Vagus+Nerve+Stimulation+for+Treatment+of+Resistant+Depression+%28TRD%29&CoverageSelection=National&KeyWord=vagus+nerve+stimulation&KeyWordLookUp=Title&KeyWordSearchType=And&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D&">CMS determination of May 4, 2007</a> is that our health care bureaucracy is so voluminous that literally “One hand does not know what the other hand is doing” and that no one and I do mean no one is really knowledgeable how to promptly and effectively assist our citizen patients. <p>Almost two (2) years into this struggle I learn about <a href="http://www.hhs.gov/dab/decisions/dabdecisions/dab2613.pdf">the doctrine of “Continuity of Care.” </a>Yet no one but no one in all of HHS/CMS acknowledged or cited the doctrine of “Continuity of Care” to insure the medical coverage for these patients. I have appealed to you and your predecessor Kathleen Sebelius numerous times for “Compassionate Use” of this therapy for these patients when all this time the doctrine of “Continuity of Care” existed in your records which should have promptly insured coverage and care for these patients. <p>I am truly embarrassed for you and for all the agencies you direct. <p>Worse yet is the fact I received another communication recently from a woman having Medicare coverage and difficulty obtaining replacement surgery for her depleted device. She called Courtney Turner without receiving a return call. <p>Doesn’t anyone within the bureaucracy comprehend the urgency of these health care matters? <p>Lastly, I am also truly flabbergasted by the fact that another individual also contacted me that he was covered by Florida Blue, a private health insurance carrier. and they too have continued to deny him replacement therapy. I realize and have heard it numerous times that CMS has no control over private health insurance companies. What about “Continuity of Care”? Is there not anyone in all of the HHS bureaucracy with enough authority, intelligence and moxie to call Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) to inform him of “Continuity of Care” to assist this patient in rightfully obtaining replacement prosthesis? <p>How much longer do these ineptitude, immoral and egregious acts have to continue? <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-4950605508518577292015-04-18T06:58:00.001-07:002015-04-18T06:58:38.969-07:00Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.<p><a href="http://www.ncbi.nlm.nih.gov/pubmed/25884606#">BMC Psychiatry.</a> 2015 Mar 31;15(1):64. <h3>Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.</h3> <p><a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Albert%20U%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Albert U</a><sup>1</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Maina%20G%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Maina G</a><sup>2</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Aguglia%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Aguglia A</a><sup>3</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Vitalucci%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Vitalucci A</a><sup>4</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Bogetto%20F%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Bogetto F</a><sup>5</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Fronda%20C%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Fronda C</a><sup>6</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Ducati%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Ducati A</a><sup>7</sup>, <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Lanotte%20M%5BAuthor%5D&cauthor=true&cauthor_uid=25884606">Lanotte M</a><sup>8</sup>. <h5><a href="http://www.ncbi.nlm.nih.gov/pubmed/25884606#">Author information</a></h5> <ul> <li><sup>1</sup>Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. umberto.albert@unito.it. <li><sup>2</sup>Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. giuseppe.maina@unito.it. <li><sup>3</sup>Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. andrea_aguglia@yahoo.it. <li><sup>4</sup>Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alberto.vitalucci@unito.it. <li><sup>5</sup>Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. filippo.bogetto@unito.it. <li><sup>6</sup>Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. chiara.fronda@unito.it. <li><sup>7</sup>Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alessandro.ducati@unito.it. <li><sup>8</sup>Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. michele.lanotte@unito.it.</li></ul> <h5>Abstract</h5> <h6>BACKGROUND: </h6> <p>Limited therapeutic options are available for patients with treatment-refractory major depression who do not respond to routinely available therapies. Vagus nerve stimulation showed adjunctive antidepressant effect in chronic treatment resistant depression, even though available studies rarely exceed 2-year follow up. We report a naturalistic 5-year follow up of five patients who received VNS implant for resistant depression (3 patients with major depressive disorder and 2 with bipolar disorder). <h6>METHODS: </h6> <p>Response was defined as a reduction of the 17-item HDRS total score ≥50% with respect to baseline, remission as a score ≤7. <h6>RESULTS: </h6> <p>Response and remission rates were both 40% (2/5) after 1 year, and 60% (3/5) at 5 years. Two patients withdrew from the study because of side effects or inefficacy of stimulation. <h6>CONCLUSIONS: </h6> <p>Our case series showed that long-term VNS may be effective in reducing severity of depression in a small but significant minority of patients, although two patients had stimulation terminated because of adverse effects and/or refusal to continue the study. <dl> <dt>PMID: <dd>25884606 <dd>[PubMed - as supplied by publisher] </dd></dl> <p><a title="http://www.ncbi.nlm.nih.gov/pubmed/25884606" href="http://www.ncbi.nlm.nih.gov/pubmed/25884606">http://www.ncbi.nlm.nih.gov/pubmed/25884606</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-39010895569716326872015-03-10T20:10:00.001-07:002015-03-10T20:10:30.034-07:00Treatment for stroke victims shows ‘promising’ results<p><a href="http://www.scotsman.com/"><img alt="" src="http://www.scotsman.com/webimage/7.14068.1374460454!/image/2203368453.png_gen/derivatives/default/2203368453.png"> </a> <ul> <ul> <ul> <ul> <li>Wednesday 11th March 2015 </li></ul></ul></ul></ul> <h3>Treatment for stroke victims shows ‘promising’ results</h3> <p><img title="Them trial recruited 20 patients in Glasgow and Newcastle. Picture: John Devlin" alt="Them trial recruited 20 patients in Glasgow and Newcastle. Picture: John Devlin" src="http://www.scotsman.com/webimage/1.3715350.1426028307!/image/2342523744.jpg_gen/derivatives/landscape_620/2342523744.jpg"> <h6>Them trial recruited 20 patients in Glasgow and Newcastle. Picture: John Devlin </h6> <p> </p> <h6>TIM BUGLER</h6> <p>22:58 Tuesday 10 March 2015 00:00 Wednesday 11 March 2015 <h5><strong> <p>A GROUND-BREAKING new treatment to help stroke patients regain the use of their arms has shown “promising” ­results. <p></strong></h5> <p>Vagus nerve stimulation (VNS) uses small doses of electricity to encourage the growth of new neural connections in the brain. <p>It has now been shown to help patients improve arm function by a greater degree than standard physiotherapy alone. <p>A stroke happens as a result of a loss of blood supply to a part of the brain, leading to tissue death and loss of functions controlled by the affected brain area. Around 85 per cent of stroke victims seen at the stroke clinic at Glasgow’s Western Infirmary have arm weakness, which persists to a significant degree in half of these. <p>The two-year trial, which recruited 20 patients in Glasgow and Newcastle-upon-Tyne with long-term arm weakness after their stroke, involved the implantation of a small electrical device into the body. <p>The device is similar to a pacemaker and is implanted in the chest. It is then connected to the vagus nerve in the neck using thin wires that are also implanted. Scientists decided to stimulate the vagus nerve as it connects to structures in the brain involved in recovery from injury. The idea was to take ­advantage of neuroplasticity – the natural ability of the brain to form new neural connections. <p>Pairing the vagus nerve stimulation with traditional rehabilitation encourages the brain to form new, stronger neural connections. The researchers in this study hoped this process would significantly improve arm function during the recovery process following the stroke. <p>The study recruited volunteers who had suffered ischaemic stroke at least six months earlier with moderately severe arm problems. The patients were split into two groups, one receiving intensive physiotherapy alone, the other receiving physiotherapy paired with VNS. <p>When patients followed the study protocol in full, there was a significantly greater improvement in a measure of arm function called the upper extremity Fugl-Meyer score. <p>The scores of VNS treated patients were six points higher than those who did not receive VNS in addition to their physiotherapy. When patients have such a large change in their score, noticeable improvements in arm related tasks can be ­observed on a daily basis. <p>Dr Jesse Dawson, of the Institute of Cardiovascular and Medical Sciences at Glasgow University, who led the trial, said: “Our initial study demonstrates that VNS paired therapy holds promise. Greater improvements in arm function were observed in patients using VNS paired therapy compared to participants using traditional rehabilitation alone. <p>“We need to do larger trials to confirm our findings and determine if the widespread adoption of this technique could benefit post-stroke patients with upper limb deficits. These initial results are certainly encouraging and warrant further investigation.” <p>The trial was run with Texas-based biomedical company MicroTransponder, which developed the “Vivistim” device. <p><a title="http://www.scotsman.com/news/health/treatment-for-stroke-victims-shows-promising-results-1-3715354" href="http://www.scotsman.com/news/health/treatment-for-stroke-victims-shows-promising-results-1-3715354">http://www.scotsman.com/news/health/treatment-for-stroke-victims-shows-promising-results-1-3715354</a></p> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0tag:blogger.com,1999:blog-5694055184415942831.post-1416700011727487432015-02-28T12:43:00.001-08:002015-02-28T12:43:11.979-08:00Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue)<p><b>From:</b> Herbert Stein [mailto:fabrik@bellsouth.net] <br><b>Sent:</b> Saturday, February 28, 2015 3:18 PM<br><b>To:</b> Chet Burrell, President & CEO CareFirst BlueCross BlueShield<br><b>Subject:</b> Battling Florida Blue... <p>To Joyce’s fellow patients et al, <p>I need your help. If anyone out there reading this message knows the direct email address for Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) I would gratefully appreciate your assistance by sending me the address. <p>I am trying to advocate for <a href="http://www.vnstherapy-herb.blogspot.com/2015/02/still-battling-florida-blue.html">a fellow VNS Depression patient being denied coverage</a> for the replacement of his/her prosthesis as a private pay subscriber. <p>Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield, <p>I would appreciate if you could give me Mr. Geraghty’s direct email address. I am aware and thank you for the assistance you previously gave to one of your VNS Depression patients by paying for her replacement and based upon what she had told me you did so stating, “continuity of care”. At the time I did not fully understand the significance of the term as I now know it establishes a medical precedence and practice which Medicare/Medicaid and the private insurance carriers should have been adhering to. I would also ask, if possible, if you would contact your fellow CEO and apprise him of the patient that his company has been denying medical coverage. If necessary I’m sure the patient would supply you with personal information so that Mr. Geraghty would see to the expediting of this case. Just let me know. <p>It is truly shameful and anxiety ridden that these implanted patients with a medical device and I have to shamefully fight tooth and nail with our last once of strength for that which already exists in medical doctrine and practice buried somewhere in the vestiges of HHS and no one knowledgeable enough throughout these bureaucracies to come forth to rightfully help these patients and rectify the situation by stating, “continuity of care”. <p>Shameful, shameful, shameful on all you bureaucrats who sit back, spout platitudes, collect your checks and really make no effort to reach out and truly help with a few exceptions, that’s unfortunately the way I see things based upon my lengthy advocacy for these patients. <p>Shame on you all for not comprehending what it is like to help keep someone alive! <p>Sincerely, <p>Herb <p>Joyce and Herbert Stein <p>1008 Trailmore Lane <p>Weston, FL 33326-2816 <p>(954) 349-8733 <p><a href="mailto:vnsdepression@gmail.com">vnsdepression@gmail.com</a> <p><a href="http://www.vnstherapy-herb.blogspot.com">http://www.vnstherapy-herb.blogspot.com</a> <p><a href="http://www.vnstherapy.wordpress.com">http://www.vnstherapy.wordpress.com</a> <p><b>---------------------------------------------------------------</b> <p><b>NOTICE OF CONFIDENTIALITY / Disclaimer</b> <p><b>---------------------------------------------------------------</b> <p><b>Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.</b> <p><b></b> <p><b>CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.</b> herbhttp://www.blogger.com/profile/08968393732209782959noreply@blogger.com0