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Saturday, September 6, 2014

Magnet therapy zaps depression

Magnet therapy zaps depression

Frank Gluck, (Fort Myers, Fla.) News-Press8:55 p.m. EDT September 4, 2014

depressionmagnets01.jpg

Jessica Marra, a transcranial magnetic stimulation technician for Dr. Robert Pollack, prepares patient Kimberly Depaz for a treatment. Transcranial magnetic stimulation is used to treat patients for depression by placing a magnetic coil on the scalp that targets the cortex that controls mood.(Photo: Andrew West/The News-Press )

Kimberly Depaz experienced the first signs of depression when she was 5 years old, mostly as feelings of being "really down" and different from everyone else.

Throughout her adult life, she tried every medication and anti-depressant under the sun — Prozac, Zoloft, Wellbutrin and a variety of anti-anxiety medications that provided little more than side effects.

The depression, and even detailed suicidal thoughts, never went away.

Then her Fort Myers psychiatrist offered her a seemingly novel treatment to go along with her counseling: employing high-powered magnets to stimulate the region of her brain that governs mood.

"I have noticed a difference. I would say that I feel more alive," said Depaz, 51. "I'm really happy this is happening, and I'm real optimistic. It was my last, honest to God, last resort."

The treatment — transcranial magnetic stimulation — was approved by the Food and Drug Administration in 2008 for the treatment of patients with medication-resistant depression. The FDA cleared it for use in migraines in December.

Researchers are now probing its efficacy in other disorders, such as anxiety and post-traumatic stress disorder. Other studies suggest it may help with memory.

Regulatory approval has led to a growing number of psychiatric clinics offering the treatment to patients who have otherwise found no relief.

Psychiatric Associates of Southwest Florida in south Fort Myers began offering it in August. Depaz is its first patient.

"As a process, it's probably the most magnificent aspect of the treatment of patients that I've seen in all of my, almost half century (in practice)," said Dr. Robert Pollack, CEO of the clinic and Depaz's psychiatrist. "The living proof is how many people are getting it, how many people are getting better."

Many insurers do not cover the procedure, reflecting the uncertainty the medical community still has about the procedure. And others will pay only on a case-by-case basis. For those uninsured, the price is a steep one: A seven-week course of treatment might run as high as $15,000.

Family Psychiatry, another Fort Myers psychiatric practice, has offered the treatment since April 2013. About a dozen patients have received treatment since then, said Jonathan Hart, the clinic's TMS coordinator.

"It's not a lot because, frankly, it's limited by insurance coverage," Hart said. "But we've had a lot of success stories."

Hart said clinic patients have mostly shown at least some improvement since undergoing treatment. Just under half have had their depression go into remission, he said.

Depaz said she usually feels the fog of her depression lift shortly after the treatment.

"Just clearer, is the best way I can describe," she said. "A lot clearer."

How it works

Magnets generate a directed, pulsed magnetic field — similar to an MRI in strength — to the prefrontal cortex, the front part of the brain behind the forehead. The magnetic fields induce small electrical currents, which encourage a mood-lifting chemical reaction in the brain.

The treatment is daily, for four to six weeks. If the patient improves enough, the treatment is then provided as a periodic booster.

Unlike electro-convulsive therapy, patients don't need sedation and/or anesthesia while undergoing the procedure. It also does not produce the minor memory loss that can come with the shock treatment.

depressionmagnetics02.jpg

Depaz undergoes treatment at Dr. Robert Pollack’s office in Fort Myers.She says she has felt the difference since starting the treatment. (Photo: Andrew West/The News-Press )

Patients are seated on what looks like a dental chair. A technician straps their heads in place to prevent movement, and then attaches magnets to their heads. Patients may read or watch TV while undergoing the procedure, but they may not sleep.

The room is dimly lit, and extra noise is avoided to minimize patient anxiety. Ten-pulse bursts are delivered each second, for four seconds at a time, at intervals of 26 seconds. The whole process lasts 37 minutes and 30 seconds.

Patients and technicians wear ear plugs as the machine emits a sound of rapid knocks, a sound reminiscent of a woodpecker. Depaz likened the sensation of electromagnetic pulses to a hard flicking on the same spot of her skull, over and over.

"Initially, it seemed a bit painful. But it wasn't like, 'Oh, my gosh, I can't take this!' Nothing like that," she said.

Doubts remain

Despite regulatory approval and studies suggesting the treatment may help patients with depression resistant to medication, not everyone in the psychiatric community is convinced magnetic stimulation of the brain works.

They say not enough studies have proven its efficacy, and that many of those done were not done rigorously enough. And these critics worry increased marketing of this treatment could detract patients from effective medications and, in cases of particularly hard-to-treat cases, the current gold standard therapy — electro-convulsive (or "electro-shock") therapy.

Fort Myers psychiatrist and researcher Frederick Schaerf said he is a TMS skeptic and even doubts the concept of "treatment-resistant" depression. He said such patients likely have not found the right medication regimen.

"I don't see its value as a treatment," Schaerf said. "There are other ways to treat patients with pharmacology."

The National Institute of Mental Health describes the treatment as effective for some patients, but notes that studies of its efficacy have been "mixed." The American Psychiatric Association's guidelines for depression treatment states the procedure conveys "relatively small to moderate benefits."

Pollack dismissed critics of the treatment and compared TMS skeptics to those who initially questioned the benefits of anti-depressants. He said the proof is in the growing body of evidence that the treatment can help certain patients.

"There is skepticism always in anything that you do. That's just the way it is," he said. "I'll stand by anything I see data on."

http://www.usatoday.com/story/news/nation/2014/09/04/magnet-therapy-depression/15101705/

Neurostimulation for Mood Disorders

Neurostimulation for Mood Disorders

September 05, 2014 | US Psychiatric & Mental Health Congress 2014, Electroconvulsive Therapy, Mood Disorders, Transcranial Magnetic Stimulation

By Scott T. Aaronson, MD

Q&A

We have asked Dr Scott Aaronson to answer questions on neurostimulation as it relates to the treatment of mood disorders. He is speaking at this year’s PsychCongress in a presentation titled “Neurostimulation in the Treatment of Mood Disorders.” Dr Aaronson is Clinical Associate Professor in Psychiatry at the University of Maryland School of Medicine and Director of Clinical Research Programs and TMS Services at the Sheppard Pratt Health System in Baltimore, Maryland.

Q: What is neurostimulation and why do we need it?

A. Neurostimulation is a modulation of the central or peripheral nervous system by electrical or magnetic impulses. This is commonly used in neurosurgery and neurology for a variety of applications, including pain management, hearing and visual prostheses, and control of Parkinsonism. There is a long history of psychiatric use related to electroconvulsive therapy (ECT), but more recently, devices providing vagus nerve stimulation (VNS) and transcranial magnetic stimulation (TMS) have both been cleared by the Federal Drug Administration (FDA) for use in depression. Several other devices are currently in the process of review by the FDA or undergoing clinical trials.

There is a tendency to look at somatic therapies for depression being exclusively through neurochemicals, but the brain is as much electrical as it is chemical. After 4 decades of antidepressant drug development, we have not moved much beyond the monoamine hypothesis. We have drugs that can effect serotonin, norepinephrine, and—to a lesser extent—dopamine. Many other neurotransmitters are involved with mood disorders, but we have no medications yet to target them. We can alter neurochemicals by neurostimulation as well as alter aberrant neuronal activity. Neurostimulation offers a non-systemic somatic approach to depression, often with an improved side effect profile.

Q: What methods of neurostimulation are currently available and how do they work?

A. electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), and transcranial magnetic stimulation (TMS).

ECT

The oldest neurostimulation intervention, ECT has been used since 1938. It has the highest rate of response for treatment resistant depression (TRD) of any somatic intervention, up to 60%. (1)

Treatment involves inducing a generalized seizure, either through unilateral or bilateral electrical stimulation done while the patient is under general anesthesia along with a paralytic agent. The adverse effect burden is quite high and includes the effects of anesthesia, post-ictal confusion, and short term memory loss. There is a high frequency of relapse with 65% of successfully treated patients ill again within 6 months. (2) Newer techniques under investigation may reduce adverse effects—ultra brief pulse induction, magnetic seizure therapy, or more focally induced seizures. It is more acceptable as an acute treatment than a chronic one. Most insurance will support the use of ECT.

VNS

Treatment involves the implantation of a small battery driven device in the upper chest with electrical leads that are tunneled under the skin and wrapped around the left vagus nerve in the neck. Stimulation is delivered continuously throughout the day for 30 seconds every 5 minutes. This stimulation is carried through the vagus nerve into the brain and has an effect on neurotransmitter synthesis and release. Response to this intervention takes up to 6 months to build and continued improvement has been shown over 5 years.

While having FDA approval since 2005, the use of VNS has been severely limited because of the reluctance of insurance carriers, including Medicare, to provide support, claiming that the evidence for its use has not justified the expense. A recent study looked at dosing of VNS and even low doses show efficacy over time. (3) It is hoped that the coming release of new data looking at the efficacy of VNS over 5 years of treatment might encourage a re-evaluation of its use in patients with chronic severe unipolar and bipolar depression.

TMS

The use of TMS has experienced significant growth in its use since its FDA clearance in 2009. TMS involves the use of a rapidly moving magnetic field to induce a small electric current in the left dorsolateral prefrontal cortex of the brain, an area that has decreased activity when patients are depressed. There are now 2 devices cleared by the FDA—the Neuronetics device (since 2009) and a device from Brainsway (since 2013). The latter uses a different magnetic configuration and purports to offer deeper stimulation.

Outcomes studies on the Neuronetics device demonstrate a 58% response rate in normal clinical practice in a population with moderately treatment resistant depression (patients failed an average of 2.5 antidepressants prior to treatment). (4) The Brainsway study has yet to be published, so comparisons are difficult, but the treatment paradigm uses 5 treatments a week for 5 weeks, rather than 6 with TMS and 20 minutes rather than 37.5 minutes of treatment during every session.

Insurers are slowly increasing their support of this intervention, and many companies now have coverage policies. Issues about treatment of bipolar depression and the use of maintenance treatment have yet to be clarified from research studies. Several other devices are in the process of either FDA review or in clinical trials.

Q. Who are the right patients for neurostimulation?

A. ECT candidates are patients who require quick responses due to severity, suicide risk, or psychosis and are usually fully disabled by their depressions. They have often failed several other interventions, including medications and psychotherapy.

Should VNS become a more reliably covered intervention, one of the best populations would be patients with severe illness that has been chronic. In my experience, ECT responders who require maintenance ECT are ideal candidates. Often they can be maintained with VNS and no longer require ECT. As well, VNS has demonstrated efficacy and has FDA approval for use with bipolar depression, often a population that has limited options for treatment.

TMS, in its current format, is likely not as reliable with severe depression as ECT. It probably will work best with moderate to marked depressions. My experience suggests a better response when used in addition to antidepressant medication but it may also be useful in patients who have been intolerant of multiple antidepressant medications given the lack of systemic side effects. TMS is very well tolerated with only a small incidence of mild to moderate headache during the time of stimulation which is usually for only 4 seconds during each 30 seconds of treatment. The main barriers to use are insurance coverage, time commitment (45 minutes, 5 days a week for up to 6 weeks), and availability of equipment which varies by location.

Q. What does the future hold for neurostimulation?

A.Neurostimulation will likely occupy a greater piece of the psychiatric treatment paradigm. It offers effective interventions for people with severe illness and a non-pharmacologic intervention for patients with moderate to marked presentations. New devices in development may permit shorter courses of treatment and even the possibility of home use.

Suggested reading: Cusin C, Doherty DD. Somatic therapies for treatment-resistant depression: ECT, TMS, VNS, DBS. Biol Mood Anxiety Disord. 2012;2:14.

Disclosures

Dr Aaronson reports that he is a consultant for Neuronetics; an investigator for Neuronetics, Cervel Neurotech, and Neosync; and received a research grant from Stanley Medical Research Institute for Transcranial Direct Current Stimulation.

References

1. Kellner CH, Knapp RG, Petrides G, et al. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006;63:1337-1344.

2. Sackheim HA, Haskett RF, Mulsant BH, et al. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: A randomized controlled trial. JAMA. 2001;285:1299-1307.

3. Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: acute and chronic effects. Brain Stimul. 2013;6:631-640.

4. Carpenter LL1, Janicak PG, Aaronson ST, et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012;29:587-596. - See more at: http://www.psychiatrictimes.com/uspc2014/neurostimulation-mood-disorders#sthash.q22xAP3P.dpuf

http://www.psychiatrictimes.com/uspc2014/neurostimulation-mood-disorders

Tuesday, September 23 • 10:15am - 11:45am

Neurostimulation in the Treatment of Mood Disorders

Neurostimulation will continue to provide a novel, nonpharmacologic, somatic treatment for mood disorders and eventually other psychiatric illnesses, including obsessive-compulsive disorder, anxiety disorders, and addictive behaviors. This session will provide an up-to-date overview of developments in the use of transcranial magnetic stimulation, direct current stimulation, and electroconvulsive therapy. Relevant data pertaining to patient selection, treatment outcomes, and possible mechanisms of action will be discussed along with a look at the future of neurostimulation with regard to expanding patient populations and insurance support.

Faculty

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Scott T. Aaronson, MD

Director, Clinical Research Programs, Sheppard Pratt Health System, Baltimore, Maryland; Director, TMS Services, Sheppard Pratt Health System, Baltimore, Maryland | | Scott T. Aaronson, MD, is Director of Clinical Research Programs at Sheppard Pratt Health System in Baltimore, Maryland, where he has been responsible for developing a research program dedicated to the development of medications, devices, and genetic tests for the treatment of illnesses across the spectrum of psychiatric...
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Tuesday September 23, 2014 10:15am - 11:45am
Room 2 - TBA (Rosen Shingle Creek Hotel)

Thursday, September 4, 2014

TMS NeuroHealth Centers Now Accepting Medicare and Reaches Treatment Milestone

TMS NeuroHealth Centers Now Accepting Medicare and Reaches Treatment Milestone

Medicare’s coverage of TMS therapy offers assistance to clients needing depression treatments. TMS NeuroHealth surpasses 10,000 treatments.

 

We are excited to provide Medicare and Blue Cross members with the opportunity to utilize TMS therapy for their battle against Major Depressive Disorder

(PRWEB) September 04, 2014

TMS NeuroHealth Centers, a leading provider of TMS Therapy to patients located in the Washington DC Metro Area, Virginia, and Maryland, is pleased to announce that it is now accepting Medicare in order to make this groundbreaking treatment available to a broader range of patients suffering from Major Depressive Disorder. TMS NeuroHealth Centers, which has been in operation since 2011, has also reached a proud milestone; 10,000 TMS Therapy treatments have been administered since opening.

TMS Therapy is a non-drug, non-invasive, and FDA-cleared medical treatment for patients suffering from depression. It uses highly focused magnetic pulses to gently stimulate the area of the brain that controls mood. This specific area in the prefrontal cortex of the brain is stimulated to release chemical neurotransmitters, relieving the symptoms of depression. Each treatment is approximately a 45 minute outpatient procedure; typically administered five days a week for 4-6 weeks in its acute phase. TMS Therapy is a proven form of treating depression when patients are suffering from side effects of medication and/or have not benefited from antidepressant medication.

Medicare offers competitive coverage for TMS Therapy and we are thrilled that our list of insurance providers is expanding for this depression treatment which also includes Blue Cross and Blue Shield. As part of TMS NeuroHealth Centers’ ongoing dedication to provide top quality care to our patients, we are committed to helping our patients manage the process for reimbursement and discuss options for financing of their TMS therapy.

"We are excited to provide Medicare and Blue Cross members with the opportunity to utilize TMS therapy for their battle against Major Depressive Disorder,” said Bill Leonard, President of TMS NeuroHealth Centers. “TMS is a proven therapy that has benefited thousands and thousands of patients suffering from depression."

TMS NeuroHealth Centers is also very proud that we have now administered over 10,000 treatments to our patients since opening in 2012. "It’s fantastic that we have hit this milestone,” commented Dr. Singh, Medical Director of TMS NeuroHealth Centers in Tysons Corner, VA. “This is an indication that TMS therapy is becoming more accepted as a treatment by the community. We can also see this from the increase in referrals from local psychiatrists”. A contributing factor to reaching this milestone is the fact that 3 out of every 4 patients have had success in reducing or relieving depression symptoms at TMS NeuroHealth Centers and they are sharing their experiences.

As of July, it is easier to get to TMS NeuroHealth Centers Tysons Corner location with the opening of the new Silverline Metro. Spring Hill Station is less than 1 block from the center. By offering a convenient alternative to driving, the Silver Line is expected to transform Tysons, previously an automobile-centric area into a more walkable, bikeable, and livable community. The opening gives more people much easier access to our location and this depression treatment.

About TMS NeuroHealth Centers
TMS NeuroHealth Centers are medical centers dedicated to helping those affected by neurological disorders live better lives. TMS NeuroHealth Centers provide access to the best medical expertise and the latest medical technology in the field of neurology and mental health. The first TMS NeuroHealth Center opened in Tysons Corner (McLean, Virginia) in November, 2011. To find out more, visit http://www.tmsneuro.com.

http://www.prweb.com/releases/2014/09/prweb12141814.htm

Genetics or Environment? Why Two New Landmark Studies May Change Your Mind

Genetics or Environment? Why Two New Landmark Studies May Change Your Mind

by Charles Raison, MD

My close friend and fellow Psych Congress Steering Committee member Rakesh Jain, MD, has been riding high lately. He and I have an ongoing friendly, but intense, debate about the relative importance of genetic versus environmental factors in the etiology of psychiatric disease. He is a hardcore genetic determinist, convinced that eventually all mental illness will be shown to derive from our genes. While I certainly recognize the power of genes, I maintain that environmental factors play a far larger role in the pathogenesis of mental illness than the good Dr. Jain would ever allow.

Lately science appears to have been favoring Dr. Jain’s position, something he has noted in repeated gleeful emails to me over last month. In particular, two landmark studies have shown conclusively that genes play a definite role in the risk for major mental illness, in this case schizophrenia and autism. Using very large sample sizes and complex, high-tech analytic methods, one of these studies reports that approximately 60% of the risk for autism comes from our genes and the other finds that 108 single nucleotide polymorphisms (SNPs) contribute significantly to the risk for schizophrenia.[1,2]

I say these studies appear to favor Dr. Jain’s position because they establish definitively that genes play a major, and perhaps the major, role in risk for two of our most serious mental illnesses. But as an “environmentalist” I could not have been more thrilled by the study results.

I want to suggest that these two recent studies are game changers for psychiatry not because they demonstrate the primacy of genes, but because of what kind of genetic changes they find to be most important for disease risk. Specifically, the genes that most powerfully increase the risk for schizophrenia and autism point straight back to the environment.

To understand how this can be the case, we have to step back a bit from the details and quickly visit what I think is the primary debate within psychiatric genetics. The crux of this debate boils down to the question of whether serious mental illnesses are more likely to be caused by rare mutations that have large effects or very common forms of genes that individually have very small effects but that together add up to produce disease. [3]

The results from the recent studies in autism and schizophrenia are unequivocal: these diseases are mostly caused by the combination of many common SNPs, any one of which has only a minor effect. Although rare mutations may have huge effects in any given individual (say someone born with a new deleterious mutation), their overall contribution to disease burden is small, for example 2.6% of the genetic risk for autism.

It is apparent both from data and common sense observations that both schizophrenia and autism reduce Darwinian fitness, meaning that afflicted individuals are less likely to leave viable offspring to pass along the genes that promote these disorders. It turns out this simple fact has huge implications, because it immediately raises the question of why genes that contribute to these catastrophic conditions should have been retained in the human gene pool.

There are only two possible answers to this question. One is that although autism and schizophrenia are common, the genes that cause them are not. In this scenario, these diseases result from any of a large number of different rare, and highly deleterious, mutations. These mutations occur, cause the disease, and then vanish when the afflicted individual fails to reproduce, only to reappear “de novo” in other individuals where they suffer the same fate. However, although many subtly different rare mutations exist and cause the disease states we now recognize as schizophrenia or autism, any one of these “killer” mutations must be rare—in general never existing in more than 1% of the population.

But this possibility is essentially dismissed by the recent studies. Rather than being caused by rare but very powerful mutations, schizophrenia and autism are far more often caused by the summed total effects of many different very common forms of genes. And here is where the environment comes roaring back in.

Any given form of a gene (i.e. a SNP) can only be common if it is interacting with the environment (or did so in the past) in ways that had a survival and/or reproductive benefit. Genes that are wholly deleterious never exist at rates higher than about 1% of the population because they are quickly culled by natural selection from the gene pool.

This means that while schizophrenia and autism are manifestly not good for survival or reproduction, the genes that cause the illnesses are, or were, of some benefit across most of human history. Indeed the genetic risk factors for schizophrenia and autism are common because they must confer benefit, but are not ubiquitous because these benefits come at a cost, a phenomenon known as balancing selection. [4]

The key point is that the genes for schizophrenia and autism are not “bad”. They are not errors like the ones that cause rare genetic diseases. They are genes that the environment has actively selected as being of value. In this way these genes can be seen as the residues of our species’ long history of interactions with past environments. In a way, these genes are past environments, crystalized now within the structure of our DNA.

So what benefits could possibly explain how common each of these risk SNPs (or alleles) is in modern populations?

Again, the answer boils down to two general, non-exclusive possibilities. One possibility is that the symptoms of the diseases themselves are of some survival or reproductive benefit. Or, more likely, that conditions such as schizophrenia and autism represent the extreme end of continuous traits that enhance fitness when present to a lesser degree. This is the most common argument advanced by those seeking to account for the high prevalence of risk alleles, and much evidence supports this possibility. To take just one example among many, a recent study found that children with autistic spectrum disorders had substantially better motion perception (something of potential survival relevance in ancestral environments) when compared to normal children. [5]

A second possibility that might account for the high prevalence of risk alleles for psychiatric conditions goes by the technical name of pleiotropy, which means that the same gene can have a multitude of different biological/behavioral effects, some of which—like promoting schizophrenia and autism—may be deleterious to survival, while having other effects that might promote fitness. The prevalence of any given SNP in human populations then reflects to a large degree the balance of these costs and benefits.

This is the tack my research group has taken in most of our work exploring evolutionary factors that drive the development and maintenance of genes for psychiatric disorders. In particular, we have argued that genes that promote depression in particular may have evolved because they enhanced our ability to survive infections in the long eons before modern sanitation, refrigeration, public health education, and medicine did much of this job for us. [6]

Interestingly, the evidence for a link between immune function and disease is even stronger for schizophrenia and autism than for depression. For example, of the 108 SNPs associated with schizophrenia, most of them fall into two main camps. Many are linked to signaling in the central nervous system. Many of the others are, remarkably, found in genes that regulate the immune system.

So how would an “environmentalist” summarize the recent findings in autism and schizophrenia?

First and most importantly, the genetic alleles most relevant to these disorders are not “bad genes”. They exist because of their benefit in prior environments. This complicates any simple ideas that gene therapy will ever be a simple cure for disorders such as schizophrenia or autism (and even less so for depression). In the first place, for most individuals with the disorders, any specific SNP will only contribute a miniscule amount of the risk. Second, if the genetic variation that increases the risk for mental illness is stripped from the human genome we will likely be leaving ourselves less adapted as a species to the world in which we live.

The second point an environmentalist would take from the recent findings is that genes and environment are like the yin and yang of traditional Chinese thinking—really separate sides of the same complex coin.

Genes only exist as responses that have worked to prior environments or as genuine worthless flubs. Some cases of autism and schizophrenia result from flubs, from simple mistakes. The majority result from forms of genes that have been endorsed by the environment to various degrees as winning strategies for what it means to be human.

References

1. Gaugler T, Klei L, Sanders SJ, et al. Most genetic risk for autism resides with common variation. Nat Genet. Aug 2014;46(8):881-885.

2. Schizophrenia Working Group of the Psychiatric Genomics C. Biological insights from 108 schizophrenia-associated genetic loci. Nature. Jul 24 2014;511(7510):421-427.

3. International HapMap C, Altshuler DM, Gibbs RA, et al. Integrating common and rare genetic variation in diverse human populations. Nature. Sep 2 2010;467(7311):52-58.

4. Turelli M, Barton NH. Polygenic variation maintained by balancing selection: pleiotropy, sex-dependent allelic effects and G x E interactions. Genetics. Feb 2004;166(2):1053-1079.

5. Foss-Feig JH, Tadin D, Schauder KB, Cascio CJ. A substantial and unexpected enhancement of motion perception in autism. J Neurosci. May 8 2013;33(19):8243-8249.

6. Raison CL, Miller AH. The evolutionary significance of depression in pathogen host defense (PATHOS-D). Molecular Psychiatry. 2012;Epub.

Charles L. Raison, MD, is an associate professor in the Department of Psychiatry, College of Medicine and the Barry and Janet Lang Associate Professor of Integrative Mental Health in the Norton School of Family and Consumer Sciences, College of Agriculture and Life Sciences, University of Arizona, Tucson, AZ. He is also the behavioral health expert for CNN.com, and he is a Psych Congress Steering Committee member.

The views expressed on this blog are solely those of the blog post author and do not necessarily reflect the views of Psych Congress Network or other Psych Congress Network authors.

http://www.psychcongress.com/blogs/charles-raison-md/genetics-or-environment-why-two-new-landmark-studies-may-change-your-mind

World suicide prevention day on September 10, 2014

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 04, 2014 11:59 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: World suicide prevention day on September 10, 2014

Dear Madam Secretary Burwell,

I bring to your attention that Wednesday, September 10, 2014 is world suicide prevention day.

“More than 800,000 people each year worldwide commit suicide – around one person every 40 seconds - with many using poisoning, hanging or shooting to end their own lives, the World Health Organization (WHO) said on Thursday.”

“In the 15 to 29-year age group, suicide is the second leading cause of death globally.”

In each of my emails to you I have tried to convey to the best of my ability the seriousness of severe depression and now I also add the enormity of the problem.

The facts are we have for decades offered conventional therapies that for many of these patients have proven ineffective and costly to our families and economy.  This being one of several reasons we as a nation have need for newer treatment options. 

As I’ve already explained to you, one of those treatment options, VNS (Vagus Nerve Stimulation), which the FDA approved and two (2) years later CMS (Centers for Medicare and Medicaid Services) denied coverage has helped benefit patients who have for decades been unresponsive to conventional therapies.  In that ill-fated decision and for the first time ever CMS denied coverage for an FDA approved medical device.  We are also now learning not only with the suicide of Robin Williams, the enormity of severe depression and the suicide challenge.  Worse yet CMS left a group of volunteer study subjects and patients without medical care and coverage.  CMS through their ineptitude, ignorance, deity syndrome and/or criminality either overlooked or ignored grandfathering care and medical coverage for our fellow citizens and patients.  Bless our convoluted and bureaucratic health care system and agencies.

I also take this opportunity to inform you and others that today is “NAMI's National Day of Action”:

“Join with thousands of others on September 4th, to bring national attention to the need for comprehensive mental health legislation. Mental illness affects everyone and it’s time that we spoke up.”

Madam Secretary, I encourage you and all who read this message to please sign on and share this initiative with others while at the same time I once again implore you to sign a “Compassionate Use” document to formally cover these aggrieved VNS patients to insure proper care and to encourage the private health insurers to follow suit.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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Tuesday, September 2, 2014

ESC: Left or Right Nerve Stimulation Feasible in HF

ESC: Left or Right Nerve Stimulation Feasible in HF

Published: Sep 1, 2014

By Ed Susman , Contributing Writer, MedPage Today

 

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

BARCELONA -- Stimulation of either the right or left vagus nerve appeared to improve cardiac function in patients with heart failure, researchers said here.

In the ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) trial, left ventricular ejection fraction (LVEF) increased from 32.4% to 37.2% with the stimulation device (VNS Therapy System) after 6 months, a statistically significant and clinically meaningful change (P<0.0001), reported Inder Anand, MD, DPhil, from the University of Minnesota in Minneapolis, and colleagues.

"We pooled the results of the left and right side vagus nerve stimulation because there were no major differences in outcomes based on which nerve is stimulated," Anand said at a press conference at the European Society of Cardiology meeting. The study results will also be published in the Journal of Cardiac Failure.

In addition to the improvement in left ventricular function, about 70% of the patients in the ANTHEM-HF study improved their NYHA heart failure class by at least one class, Anand reported, and those changes were also statistically significant (P<0.0001).

"No patients' conditions worsened," he told MedPage Today.

Anand also reported that the patients significantly bolstered their distance in the 6-Minute Walk Test, improving by 56 m from baseline (P<0.0001) and saw their heart rates slowed by 3.9 beats per minute (P<0.005). Also, patients recorded an 18-point reduction in the Minnesota Living with Heart Failure Questionnaire (P<0.0001).

"We saw both improvements in objective measures of heart failure and in subjective measures," he said.

The results of the ANTHEM-HF trial differed from another trial of vagal stimulation presented at ESC -- NECTAR-HF showed no benefit was observed.

"ANTHEM showed a very significant effect on beneficial remodeling as a result of vagus nerve stimulation," Mariell Jessup, MD, professor of medicine at the University of Pennsylvania in Philadelphia told MedPage Today. "They compared right sided vagus nerve stimulation to left sided stimulation and both were effective. This is in contrast to NECTAR-HF which showed absolutely no signal, but was done primarily on the right side."

"So we are kind of confused," she added. "We will really have to understand, in a better way, what the differences were in the techniques and how they used the stimulation. There is still a possibility that this is going to offer a new avenue of therapy."

The researchers set out to test whether stimulating the right vagus nerve or the left vagus nerve would better improve outcomes, but Anand said that stimulation of either nerve appeared to help patients achieve changes in cardiac function. There were 60 patients -- all with chronic symptomatic heart failure with LVEF ≤40% -- enrolled, and outcomes were studied at 6 months. Patients were on optimal medical therapy including beta-blockers. There was no control group.

The experimental autonomic regulation therapy system delivered chronic intermittent stimulation to the vagus (10 Hz natural frequency, 250-microsecond pulse width). The stimulation intensity titrated over 10 weeks to maximum tolerable current. The average stimulation current was 2.0 mA.

There were three deaths in the study, including one that involved implantation of the device (postsurgical embolic stroke). The other two deaths were adjudicated as due to worsening heart failure and sudden death. Other serious adverse events were equally distributed among patients with either right or left implantation. The most common nonserious adverse events included voice alternation and hoarseness, cough, and oropharyngeal pain.

There were no instances of system malfunction, the authors reported.

"There is attractiveness to using the left side because that is where we put most of our devices," explained Jessup, who is immediate past president of the American Heart Association. "In theory, if you were implanting a device, you could be implanting the vagal nerve stimulator and, I suppose, you could put the generators in one single pocket."

Kenneth Dickstein, MD, professor of medicine at the University of Bergen, Norway, said the use of the right vagus nerve has been targeted because it was believed that method provided more of a baroreceptor impact than the left side vagus nerve. He said that ANTHEM-HF indicated that the left vagus nerve is at least as effective as the right side and may be easier to access.

The study was sponsored by Cyberonics.

Anand disclosed relevant relationships with Amgen, Critical Diagnostics, Cyberonics, Novartis, and Zensun.

Jessup disclosed no relevant relationships with industry.


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Primary source: European Society of Cardiology
Source reference: Premchand R, et al "Autonomic regulation therapy for the improvement of left ventricular function and heart failure symptoms: The ANTHEM-HF Study" ESC 2014.

http://www.medpagetoday.com/MeetingCoverage/ESC/47450

Monday, September 1, 2014

Cyberonics device improves heart function after Boston flop

Cyberonics device improves heart function after Boston flop

Monday, September 01, 2014 2:35 a.m. CDT

By Ben Hirschler

BARCELONA (Reuters) - A nerve stimulation device from Cyberonics improved cardiac function in heart failure patients in a small clinical trial, in contrast to an unsuccessful study backed by Boston Scientific.

However, the Cyberonics trial reported on Monday did not contain a control arm - unlike the one using the Boston device in which some patients received sham treatment - and experts said further research was now needed.

Both companies are trying to improve outcomes for patients with heart failure, in which the heart fails to pump blood efficiently, by stimulating the vagus nerve – a superhighway connecting the brain to the rest of the body.

Vagus nerve stimulation (VNS), which involves delivering mild electrical pulses to the nerve in the neck, is already used successfully to treat severe epilepsy and treatment-resistant depression.

Cyberonics is the leading proponent of such therapy and the six-month heart failure trial, involving 60 patients, used its system to stimulate both the left and right-sided vagus nerve.

Patients, on average, showed a 4.5 percent improvement in left ventricular ejection fraction, a key measure of heart function, the study found, and there was no difference in the results between the left and right sides.

"I think, at six months, that (4.5 percent improvement) is a very impressive achievement," study leader Inder Anand from the University of Minnesota told reporters at the European Society of Cardiology annual meeting.

The fact that the device worked equally well on both sides is important because the system could be combined with cardiac devices such as implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, the vast majority of which are implanted on the left side.

http://wtaq.com/news/articles/2014/sep/01/cyberonics-device-improves-heart-function-after-boston-flop/