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Sunday, August 31, 2014

NECTAR-HF fails to demonstrate clinical benefit of vagus nerve stimulation in Heart Failure

Cardiomyopathy Trial

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Investigational study: LMNA dilated cardiomyopathy. Learn more.

 

NECTAR-HF fails to demonstrate clinical benefit of vagus nerve stimulation in Heart Failure

Saturday, August 30, 2014

 

BARCELONA, Spain – Stimulating the vagus nerve, which regulates the body’s internal organ systems including the heart, does not improve cardiac function in heart failure patients, according to results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial.


NECTAR-HF was presented as a Hot Line today at ESC Congress 2014,  with simultaneous publication in the European Heart Journal.


The trial’s failure to show a cardiac benefit of vagal nerve stimulation (VNS) was unexpected, said study investigator Faiez Zannad, MD, PhD, from l'Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, in Vandoeuvre-lès-Nancy, France.

“There is robust pre-clinical data showing the benefit of VNS, but the NECTAR-HF trial failed to demonstrate a successful clinical translation of this protocol,” he said.

 

The study is the first randomised, controlled trial designed to evaluate the safety and efficacy of right-sided VNS.


It enrolled 96 heart failure patients from 24 centres across Western Europe to assess the impact of six months of VNS on cardiac function, as well as on cardiac biomarkers, exercise capacity, and quality of life.


Patients, who were about 59 years old and receiving optimal medical therapy, had the VNS device implanted in their neck, near the right vagus nerve, and connected to a pulse generator implanted under the skin of the chest.


After baseline testing of the system, patients were then randomized to either a control group in which the devices remained switched off, or an active VNS group in which the mean stimulation amplitude was 1.24 mA at the start of the study, and 1.42 mA at the 3-month follow-up visit.


After six months, the study found no difference in objective endpoints between the groups.
Both groups had comparable changes from baseline in the primary endpoint of left ventricular end-systolic dimension (LVESD),  as well secondary echocardiographic endpoints, exercise capacity, and levels of the heart failure serum biomarker N-terminal prohormone brain natriuretic peptide (NT-proBNP).


However, there were significant differences between the groups for three subjective endpoints related to quality of life.


Analyses of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Short Form 36 Health Survey (SF-36) demonstrated statistically significant improvement in quality of life with VNS treatment compared to controls (MLHFQ p=0.049; SF-36 Physical and Mental, p=0.02 and 0.24, respectively).


Additionally, 62% of patients in the VNS group had an improvement of at least one point from baseline in their New York Heart Association (NYHA) functional classification compared to only 45% of control patients (p=0.032).

“The safety profile for this application of VNS appeared acceptable, with an overall infection rate of 7.4%, which is comparable to that in patients implanted with a VNS system for the treatment of epilepsy,” noted Professor Zannad.


Given that preliminary studies suggested a benefit of VNS, there are a number of possible explanations for NECTAR-HF’s negative findings.


First, there is still much to learn about the appropriate dosing and technique of VNS. Data from epilepsy VNS studies show that higher-amplitude dosing might be more effective, but it is often not possible because it causes patient discomfort, said Professor Zannad.


Second, patients in the NECTAR-HF trial were relatively well-managed on medical therapy alone, making them perhaps not the best candidates to show a strong benefit of VNS.

Third, the six-month study period may have been too short to detect changes in cardiac function.


Although patients were blinded to their group assignment, meaning they were not told if they were receiving active treatment, it is possible that those in the active treatment group were able to feel the sensation of stimulation. If this was the case, patients could have been vulnerable to a placebo effect, knowing that they were receiving active therapy.
For this reason, the higher quality of life scores among VNS patients compared to controls should be interpreted with caution, he said.

Authors: ESC Press Office
For background information, please contact the ESC Press Office.
For independent comment on site, please contact the ESC Spokesperson coordinator.

Notes to editor
SOURCES OF FUNDING: The study was funded by Boston Scientific Corporation.
DISCLOSURES: Professor Zannad receives honoraria from Air Liquide, Bayer, Biomérieux, Biotronik, Boston Scientific, CVCRx, Janssen, Novartis, Pfizer, Resmed, Roche Diagnostics, Sanofi, Servier, St Jude, Takeda, speaker fees from Mitsubishi and owns stocks at CVCT and CardioRenal diagnostics. Co-author Gaetano De Ferrari receives honoraria from Amgen, Boston Scientific, Menarini and Merck. Co-authors Stephen Ruble, Doug Daum, Scott Meyer, Craig Stolen, Bernd Schubert, Agnes Ramuzat, Nicholas Wold and Kenneth Stein are employees of Boston Scientific Corporation.


About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 80 000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
About ESC Congress 2014


The ESC Congress is currently the world's largest international congress in cardiovascular medicine.  The spotlight of this year's event is “innovation and the heart”.  ESC Congress 2014 takes place from 30 August to 3 September at the Fira Gran Via in Barcelona, Spain. For more information on ESC Congress 2014 contact the ESC Press Office.
To access all the scientific resources from the sessions during the congress, visit ESC Congress 365.


This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2014. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.

http://www.healthcanal.com/blood-heart-circulation/heart-disease/54662-nectar-hf-fails-to-demonstrate-clinical-benefit-of-vagus-nerve-stimulation-in-heart-failure.html

Sunday, August 24, 2014

VNS Therapy for Depression - Are we really going to break the bank?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, August 25, 2014 12:55 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression - Are we really going to break the bank?

Dear Madam Secretary Burwell,

I am always trying to piece together little tidbits of information as I collaborate with another reasonably informed patient to ascertain the enormity of my advocacy for the VNS Therapy volunteer study subjects and patients implanted for depression before the CMS denial of May 4, 2007 that seek to continue with their therapy.  I’ve never received any answer to this question from the sponsor, Cyberonics, when I posed the question to them.  So I keep on searching and recently began to re-extrapolate some figures from the information that’s come available.

This past week I received a telephone call from a representative of CMS in which I asked were they busy helping VNS patients obtain insurance coverage.  The answer was “no”.  Then I quickly listened into the recording of Cyberonics financial teleconference of August 21, 2014.  With the help from this other VNS patient I learned there were two (2) occasions in the teleconference when the depression indication was mentioned.  One mark was at 21:30 minutes into the recording and the other at 45:30 minutes.  I learned there were 28 patients implanted with VNS Therapy for Depression in Cyberonics most recent reported financial quarter and in the prior quarter only 24 patients and as I vaguely recall in the quarter before that only 16.  Furthermore it was stated in this teleconference by the CEO, Mr. Daniel Moore, that they believed most all of these were “replacements”.  This slow increase may well correlate to or be attributed to my advocacy as patients learn that CMS has made some informal accommodations for the Medicare/Medicaid subscribers.

So if I used a number on the high-side such as 40 replacements a quarter that would represent about 160 patients that were benefiting from the therapy who want to continue with their therapy.  Therefore where I previously referred to the “enormity” of my advocacy it may simply boil down to about 160 to 200 patients who have responded to the therapy and achieved a significant degree of wellness and wish to continue.

Why continue this policy of not formally recognizing and caring for this aggrieved patient group through absolutely no fault of their own?  Recognize the serious error and oversight made by CMS and rightfully correct their mistake; now. 

These very, very long-time suffering depression patients have benefited from the VNS Therapy and wish to continue as well as maintain their wellness.  In the long-term it is a significant financial savings to CMS and the health insurers.

Once again, please issue a formal document (i.e. “Compassionate Use”) to insure their medical care now and into the future.  It is the right, humane and honorable thing to do.

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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Friday, August 22, 2014

Harsh tone requires an apology

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 21, 2014 6:37 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Harsh tone requires an apology.

Dear Madam Secretary Burwell,

This past evening after emailing with Murray, a very dear and life-long friend, he had suggested I keep up my campaign to influence you and others in your administration to do the morally right thing while he also suggested toning down my rhetoric to you.

I am truly fortunate that many caring people read my missives and offer their thoughts and suggestions to help achieve our goals while at the same time emotionally sighting me on the objective.

If I’ve come off somewhat harsh in some of my words I do sincerely apologize.  

I understand that you do have a major governmental position and an enormous responsibility and that my issue and advocacy may seem minute in the scheme of things.  While our issue of VNS Therapy for the existing volunteer study subjects and patients implanted prior to CMS decision of May 4, 2007 may seem insignificant as compared to many of your other issues and challenges the fact is this group of patients has been egregiously wronged and harmed by those responsible within CMS to not have grandfathered and considered the medical needs and health insurance coverage for their care in that decision.  CMS cut off medical insurance coverage for medical devices already implanted into real-live-patients.  That decision also let the private health insurers off the hook whereas CMS has since partially made a make-shift effort to help the Medicare/Medicaid patients.

Please take a moment to think if it were your Mom or Dad, spouse or child or sibling implanted with a medical device and then you learn that the medical insurance you pay religiously will not cover your loved ones.  I’m sure you too would be agitated and fiercely advocating.

Only I’ve been at this advocacy for more than seven (7) years and prior to CMS denied coverage.  Actually my advocacy goes back half century when advocating for parity in mental health.  As my spouse Joyce was one of the earliest volunteer study subjects for VNS Therapy for depression I also recognized the potential loophole and conundrum in insurance coverage pending the denial from CMS.  At that time I conversed several times with the former CEO of Cyberonics, Mr. Skip Cummins, to share my thoughts and alert him to the predicament the study subjects were potentially facing.

As I am doggedly hounding you and advocating for these patients so too did I similarly direct my attention and efforts toward Mr. Cummins.  He assured me not to worry and then publicly issued the following corporate press release on January 18, 2006:  "Lifetime Reimbursement Guarantee for All TRD IDE Study Patients"

As it more recently evolved the current CEO, Mr. Daniel Moore, reneged on this guarantee citing federal kickback statues.

So here I am still bucking my head against all these bureaucracies trying to get department heads/bosses/CEO to act humanely and to do what is morally right. 

Joyce will need another replacement device in about 8 years.  I do not want to have to go through this same struggle to get her health insurer to cover her replacement or that of the other patients.  At the same time I want to pressure the private insurers to cover their already implanted patients and I can only do so with your help and assistance.

Again, I am asking for a moment of your time to issue a formal document (i.e. Compassionate Use) or some other instrument signed by you that will formalize and establish the rightful care for these patients, once and for all.

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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NOTICE OF CONFIDENTIALITY / Disclaimer

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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.

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.

Thursday, August 21, 2014

How to Tell If Your Health Insurance Covers Mental Health Treatment

How to Tell If Your Health Insurance Covers Mental Health Treatment

 

Pending approval Elizabeth Renter

 

8/21/14 2:00pm 41 minutes ago

 

How to Tell If Your Health Insurance Covers Mental Health TreatmentExpand

For some, the stigma associated with mental illness keeps them from seeking help, but others may be avoiding treatment simply because they are unsure of whether they can afford it or whether their health insurance covers it.

This post originally appeared on Nerdwallet.

Each year, more than 5 million American adults experience a major depressive episode and do not seek treatment, according to a recent NerdWallet study. While insurance coverage for mental health treatment is more widely available and comprehensive thanks to recent changes, some say it still doesn't go far enough.

Five Lessons I Learned From Dealing with DepressionFive Lessons I Learned From Dealing with DepressionFive Lessons I Learned From Dealing with Depressio

Depression is a hard topic to talk about. It's an even harder thing to live through. I've …Read moreRead on

If you purchased your health insurance through state exchanges set up by the Affordable Care Act, mental health care is covered. It is one of the ten benefits that must be covered on all plans under the law. If you have insurance through your employer, there's a pretty good chance you're covered, too. A Society for Human Resource Management survey of 2014 employee benefits found that 87% of employer health plans cover mental health treatment. But exactly what mental health services are covered under these plans varies and depends on what medical services are covered.

Mental Health Parity Law

Historically, mental health coverage had been treated as a less important health concern than medical coverage by the insurance industry. That has changed over the years, culminating with the passage of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act in 2008. Also referred to as the mental health parity law, the act essentially mandates mental health and substance abuse coverage to be comparable to physical health coverage.

"New efforts are underway to expand coverage to the millions of Americans who have lacked access to affordable treatment for mental and substance use disorders," said Labor Secretary Thomas Perez, upon passage of the final parity rules. "These rules will increase access to mental health and substance abuse treatment, prohibit discriminatory practices and increase health plan transparency. Ultimately, they'll provide greater opportunities for affordable, accessible, effective treatment to Americans who need it."

The parity law says that insurance policies covering mental health care must treat that care as they do other medical coverage. If you generally pay a $40 copay for doctor's appointments and treatments, for instance, an appointment with your psychologist can't carry a higher price tag.

Before the final rules of the parity law took effect, patients in need of mental health treatment would often have to seek pre-approval for coverage, and even then, they would be limited to a certain number of visits per year. That is no longer the case. Though health insurance companies can always review whether covered treatments are necessary, they can no longer put arbitrary caps on mental health visits that they wouldn't put on medical appointments.

Depending on the specifics of your policy, and whether similar medical treatments are covered, your mental health coverage can include: emergency room visits, hospital stays, individual and group therapy appointments, psychiatrist visits and coverage for mental health prescriptions.

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Dear Lifehacker, Things have been really rough for me lately, and I'm thinking about talking…Read moreRead on

Plans Still Not Required to Have Mental Health Coverage

"The parity law, on paper, certainly appears to be an improvement in health care policies", says Lisa Blackstock, a patient advocate from Soul Sherpa. "The key is whether or not your policy covers [mental] health care."

The law does increase the quality of care for those who have mental health coverage, but it does not mandate mental health coverage on all policies. Instead it requires health insurance plans that do cover mental health treatment to cover it on par with medical treatment. The American Psychological Association points out there are some programs exempt from the parity law. Some state government employee plans can opt out of parity requirements. Likewise, Medicare is not subject to the law.

Even if mental health coverage is available, some providers may not accept your insurance. Blackstock told NerdWallet that mental health providers are often reluctant to accept these policies because reimbursement rates are so low.

If you are unclear about your coverage, consult your description of plan benefits or contact your insurance carrier directly.

Deductibles and Copays Still Apply

The parity law, along with requirements under the ACA, may mean mental health care is more accessible than ever. But that doesn't mean there aren't costs. Just like your medical care, mental health care is subject to copays, coinsurance, deductibles and other out-of-pocket costs. It is likewise still subject to coverage denials from insurance companies.

You can prepare for these costs by becoming familiar with your plan's coverage specifics before you seek mental health treatment. If you receive an unexpected denial or higher-than-anticipated bills after treatment, you may find help through a medical bill advocate.

Blackstock says patients with mental health questions shouldn't be afraid to get help.

"My advice to all persons regarding emotional well-being and mental health is to maintain a strong support group, be open when stress gets to be too much, and don't be hesitant to appoint an agent for you in your advance health care directive who you can trust to help navigate your care when the going gets tough," Blackstock says. "If you incur a big bill for mental health treatment that isn't covered by insurance, find a patient advocate with a proven track record in bill negotiation […] Someone needs to pick it apart and aggressively advocate on your behalf, not unlike an attorney or realtor doing their job in their respective fields."

Does My Health Insurance Cover Mental Health Treatment? | Nerdwallet

http://www.nerdwallet.com/blog/health/2014/08/18/health-insurance-cover-mental-health-treatment/


Nerdwallet offers data-driven tools and impartial information to help you make solid decisions about the money you work hard to earn. In short, we do the homework so you don't have to.

Image adapted from Lightspring (Shutterstock).

Want to see your work on Lifehacker? Email Andy.

Wednesday, August 20, 2014

Message About Tragic Passing of Robin Williams

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 20, 2014 3:38 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Message About Tragic Passing of Robin Williams

Dear Madam Secretary Burwell,

“Unfortunately, every day over 100 Americans die as a result of suicide.” --- Jeffrey Borenstein, M.D., President & CEO, Brain & Behavior Research Foundation

Just what does it take for you and your cadre of subordinates to understand that there are a number of VNS Therapy volunteer study subjects and patients who have finally achieved a degree of wellness and wish to continue doing so if not for the obstacles your organization and the health insurance industry has put before them.

I have previously laid out before you that the CMS decision of May 4, 2007 was careless, ignorant, stupid, egregious, unconscionable and criminal by overlooking care for the existing patients and especially for those having benefited from the VNS Therapy and wishing to continue with the therapy.  Judge John Smith’s decision further justifies this position.

How many more individuals have to be added to Dr. Borenstein’s list of “Americans die as result of suicide”?  Does the buck not stop at your desk?  Are you not the “boss”?

Again, I am asking you for a formal document be signed to protect this patient population to insure that they have access to and obtain medical health insurance coverage.  I am also asking for your office to influence the private health insurance companies to similarly follow suit.

This issue has drawn on since May 4, 2007.  These patients have been seriously wronged like no other by the short-sightedness of CMS.  Is it not time to right this harmful wrong?  Please act now. 

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

---------- Forwarded message ----------
From: The Brain & Behavior Research Foundation <enews@bbrfoundation.org>
Date: Wed, Aug 13, 2014 at 1:03 PM
Subject: Message About Tragic Passing of Robin Williams
To: Herbert <vnsdepression@gmail.com>

 

View this email in your browser

clip_image002

Dear Foundation Supporters,I am saddened by the very tragic passing of Robin Williams. Unfortunately, every day over 100 Americans die as a result of suicide. The national conversation in the media about Robin Williams will hopefully encourage people to seek treatment and not suffer in silence. I also hope that the media attention will reduce stigma and encourage increased support for research to develop new methods of treatment of brain disorders. I had the privilege of representing our Foundation and joining the national conversation about suicide and suicide prevention. Please see the links to the CBS Evening News, WPIX News, and Bloomberg article.
Thank you for your ongoing commitment to the Brain & Behavior Research Foundation. Please help the families of today and tomorrow by SUPPORTING brain research.
Better treatments and breakthroughs come from scientific discovery.
With warmest regards and appreciation,
Jeffrey Borenstein, M.D.
President & CEO
Brain & Behavior Research Foundation


Read an article from Bloomberg.com.

bbrfoundation.org

 

Copyright © 2014 Brain & Behavior Research Foundation, All rights reserved.
You are receiving this email because you joined our eNews mailing list.
Our mailing address is:

Brain & Behavior Research Foundation

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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.

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.

Saturday, August 16, 2014

The re-organization of functional brain networks in pharmaco-resistant epileptic patients who respond to VNS.

Neurosci Lett. 2014 Aug 11. pii: S0304-3940(14)00651-X. doi: 10.1016/j.neulet.2014.08.010. [Epub ahead of print]

The re-organization of functional brain networks in pharmaco-resistant epileptic patients who respond to VNS.

Fraschini M1, Demuru M2, Puligheddu M3, Floridia S2, Polizzi L4, Maleci A3, Bortolato M5, Hillebrand A6, Marrosu F7.

Author information
  • 1Dipartimento di Ingegneria Elettrica ed Elettronica, Università di Cagliari, Italia. Electronic address: fraschin@unica.it.
  • 2Dipartimento di Ingegneria Elettrica ed Elettronica, Università di Cagliari, Italia.
  • 3Dipartimento di Sanità Pubblica, Medicina Clinica e Molecolare, Università di Cagliari, Italia.
  • 4Azienda Ospedaliero Universitaria di Cagliari, Italia.
  • 5Department of Pharmacology and Toxicology, School of Pharmacy, University of Kansas, Lawrence (KS), USA.
  • 6Department of Clinical Neurophysiology and Magnetoencephalography Center, Neuroscience Campus Amsterdam, VU University Medical Centre, Amsterdam, The Netherlands.
  • 7Dipartimento di Sanità Pubblica, Medicina Clinica e Molecolare, Università di Cagliari, Italia; Azienda Ospedaliero Universitaria di Cagliari, Italia.
Abstract

Vagal nerve stimulation (VNS) is a therapeutic add-on treatment for patients with pharmaco-resistant epilepsy. The mechanism of action is still largely unknown. Previous studies have shown that brain network topology during the inter-ictal period in epileptic patients deviates from normal configuration. In the present paper, we investigate the relationship between clinical improvement induced by VNS and alterations in brain network topology. We hypothesize that, as a consequence of the VNS add-on treatment, functional brain network architecture shifts back towards a more efficient configuration in patients responding to VNS. Electroencephalographic (EEG) recordings from ten patients affected by pharmaco-resistant epilepsy were analyzed in the classical EEG frequency bands. The phase lag index (PLI) was used to estimate functional connectivity between EEG channels and the minimum spanning tree (MST) was computed in order to characterize VNS-induced alterations in network topology in a bias-free way. Our results revealed a clear network re-organization, in terms of MST modification, towards a more integrated architecture in patients responding to the VNS. In particular, the results show a significant interaction effect between benefit from VNS (responders/non-responders) and condition (pre/post VNS implantation) in the theta band. This finding suggests that the positive effect induced by VNS add-on treatment in epileptic patients is related to a clear network re-organization and that this network modification can reveal the long debated mechanism of action of VNS. Therefore, MST analysis could be useful in evaluating and monitoring the efficacy of VNS add-on treatment potentially in both epilepsy and psychiatric diseases.

Copyright © 2014. Published by Elsevier Ireland Ltd.

KEYWORDS:

EEG; Epilepsy; Functional Network; Minimum spanning tree; PLI; Theta Band; Vagal Nerve Stimulation

PMID:
25123446
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/25123446

Thursday, August 14, 2014

"Parkinson's and depression can go hand in hand"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 14, 2014 7:30 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: "Parkinson's and depression can go hand in hand"

Dear Madam Secretary Burwell,

Early on in a number of my messages to your predecessor Kathleen Sebelius, Jonathan Blum - CMS, medical professionals and Joyce’s fellow patients I shared my interesting and unique observations that despite worsening of Joyce’s Parkinson’s type illness, PSP (Progressive Supranuclear Palsy), she continues to remain depression free.  In Joyce’s case history there is no doubt in my mind that I attribute this unique and amazing benefit to her VNS Therapy. 

The point being Madam Secretary that information of this nature does not appear in the data contained in the computers that your medical experts ruminate as to safety and efficacy of VNS Therapy for Depression.  In my spouse’s case 14 years of therapy have exhibited no safety issues and efficacy has been nothing short of remarkable.  The fact is there is a group of volunteer study subjects and patients implanted with this medical device similarly benefiting from the therapy despite whatever incorrect conclusions your staff may have arrived at.  The reality is their facts are skewed and/or misinterpreted and do not match real world results.  And even if the percentage obtaining efficacy are not up to your medical staffs criteria the most important point your people are missing is that these are the worst of the worst patients, like Robin Williams experiencing suicidal ideations, who have found a treatment that finally works for them.

Robin Williams’s death is a tragedy from my perspective as is the suicide of others who lack information and awareness of many newer treatment options.  The fact is no one can guarantee the efficacy of any therapy for severe depression patients but to deny a VNS Therapy patient a treatment option that is already beneficial and working for the patient is truly inhumane and criminal.  And that is exactly what CMS has done through their blatant ignorance and/or professional arrogance and so too the private health insurers that followed CMS lead.  Whether through oversight or stupidity you have left this group of patients without medical coverage for therapy that has remarkably benefited their lives like no other.

Again I am asking you to abort this lunacy.  Issue a formal document (i.e. “Compassionate Use”) to insure medical care for the existing patients and help put similar pressure on the private health insurers to follow suit and abort their arrogance too.

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

Robin Williams suffered from early Parkinson's at death: widow

By Piya Sinha-Roy and Eric Kelsey

LOS ANGELES Thu Aug 14, 2014 5:54pm EDT

3 Comments

·

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A woman takes a picture of a mural depicting late actor Robin Williams in Belgrade, August 13, 2014.

Credit: Reuters/Marko Djurica

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· Entertainment »

· People »

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LOS ANGELES (Reuters) - Robin Williams was sober but suffering from the early stages of Parkinson's disease as well as severe depression and anxiety at the time of his apparent suicide, the actor's widow said in a statement on Thursday.

Susan Schneider said Williams "was not yet ready to share publicly" his struggles with Parkinson's, an incurable and debilitating nervous system disorder that causes tremors and slowness of movement.

"It is our hope in the wake of Robin's tragic passing, that others will find the strength to seek the care and support they need to treat whatever battles they are facing so they may feel less afraid," Schneider said in the statement.

The 63-year-old Oscar-winning comedic virtuoso, whose madcap style and dramatic versatility made him one of film and television's top stars, was found hanged at his Tiburon, California, home north of San Francisco on Monday.

The news that the comedian also suffered Parkinson's disease has drawn attention to the correlation between the disorder and depression.

"While a diagnosis of any serious disease can be overwhelming, Parkinson's and depression can go hand in hand," the National Parkinson Foundation said in a statement following Schneider's announcement.

"Depression affects quality of life more than the motor impairments of the disease," the foundation said, adding that more than half of those who suffer from Parkinson's also experience clinical depression as part of the disease.

Actor Michael J. Fox, boxer Muhammad Ali and singer Linda Ronstadt have all be diagnosed with Parkinson's. Ronstadt said last year that the disease had robbed her of her singing voice.

Between 50,000 and 60,000 people are diagnosed with Parkinson's each year in the United States. It typically affects people over 50 years old.

Williams, whose starring roles included "Mrs. Doubtfire" and "Good Will Hunting," had been open about his struggles with alcohol and had gone to a Minnesota rehabilitation center this summer to "fine-tune" his sobriety, his publicist said in July.

Friends of the comedian, who first shot to prominence as a friendly alien in late 1970s TV series "Mork & Mindy," described Williams as a man who masked his depression and thrived from performing for a crowd.

Williams' death, which has touched off a national conversation about suicide and depression, shook Hollywood and generations of fans.

U.S. President Barack Obama called him a "one of a kind" actor while directors and colleagues noted his humble nature, generosity and talent as one the most inventive comedians of his era.

"Since his passing, all of us who loved Robin have found some solace in the tremendous outpouring of affection and admiration for him from the millions of people whose lives he touched," Schneider said.

"His greatest legacy, besides his three children, is the joy and happiness he offered to others, particularly to those fighting personal battles," she added in the statement.

Funeral arrangements are pending, and a full toxicology report will take two to six weeks, local officials said.

(Editing by Jonathan Oatis)

http://www.reuters.com/article/2014/08/14/us-people-robinwilliams-idUSKBN0GE1YQ20140814

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Robin Williams Death Inspires 'Coming Out' About Depression

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 14, 2014 1:15 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Robin Williams Death Inspires 'Coming Out' About Depression

Dear Madam Secretary Burwell,

So the death of actor/comedian Robin Williams sparks discussion about depression

I think it’s extremely sad that such a brilliant talent is lost to us and it takes his death to evoke discussion as to the seriousness of severe depression and mental health issues.  On the other hand I’ve been at it for some 50 years.  Worse is the fact I’m still at it and can you believe even worse yet, VNS Therapy for Depression, an FDA approved therapy is being denied medical insurance coverage to a group of volunteer study subjects and patients who are and have benefited from this therapy like no other.

What does it take to make you understand and your symphony of subordinates who can’t seem to hit the right notes to right the criminal wrong and injustice you folks have perpetrated against this group of patients?  How much effort does it really take for you to sign a “Compassionate Use” document to see that this group of patients is able to maintain their wellness?  Does it take another suicide of a lesser known individual whose attention you’d probably never notice to die because you lack understanding of what CMS has done to these volunteer study subjects and patients?

This is not an issue of politics or number crunching bureaucratic medical experts sitting at their computer screens without ever having examined a patient.  It is an issue of maintaining life of giving these implanted patients the ability to continue with a therapy that has proven to be beneficial to them as acknowledged by the patients as well as their attending physicians and to remove them from the precipice of death.

Please tell me; just what it takes for you or anyone in your bureaucracy to understand the dire need for a treatment that finally works for these patients.  The fact is that the trillions of dollars our country has spent on conventional treatments for these patients that don’t work is not the answer.  But when patients come forward and tell their physicians who observe, monitor and agree that they’ve finally found a treatment such as VNS Therapy that works and you and your organization and the health insurance industry deny medical coverage; to me it is an example of absolute unadulterated and sheer stupidity despite your educations and advanced degrees.

Just ask the patients, their families, loved ones and their attending physicians.  No advanced degrees neither high speed number crunching computer systems required to evaluate the difference in the lives of those patients who have benefited from the VNS Therapy for Depression.  Nor or month, 6 month or year of efficacy.  These patients have benefited 5 years, 10 years or in the case of my spouse approaching 15 years this December.

Wake up!  The reality Madam Secretary is we need you to sign a formal document.  Whether it is a “Compassionate Use” document or some other bureaucratic form, we need it now!

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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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.

Wednesday, August 13, 2014

VNS Therapy for Depression

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 13, 2014 12:00 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression...

Dear Madam Secretary Burwell,

Once again I write to you addressing the current news regarding the spread of Ebola and the World Health Organizations position to fast tract an experimental drug and the death of Robin Williams and the fact that severe depression kills tens of thousands Americans each year brings me back to my position and advocacy that CMS is simply not doing enough for depression patients and worse yet their decision to deny medical coverage to implanted volunteer study subjects and patients already benefiting from VNS Therapy is not only unconscionable, egregious and immoral but criminal in my opinion.

While I am aware that efforts within CMS are being made to informally address and care for those Medicare/Medicaid patients who were implanted prior to the May 4, 2007 national determination to deny coverage I ask that a written document to this effect be issued to formalize their care.  I also advocate for those patients covered by private health insurance carriers such as United Healthcare that continue to deny care and coverage for the same patient population.  The private health insurers jumped on the May 4, 2007 decision to deny but seem to have ignored CMS recent events and the U.S. Administrative Law Judge Troy Smith’s decision.

I’ve been informed that CMS has no authority over the private health insurers but that should not preclude the fact that CEO’s of these companies should be made aware as to CMS informally providing care for the Medicare/Medicaid study subjects and patients and the recent ruling by Judge Troy Smith.  Maybe an informal letter from you addressing this issue might influence Mr. Stephen J. Hemsley - CEO, United Healthcare and other insurers to change their positions as it relates to the existing VNS Therapy patients.

In my opinion that is the least you can do to share your concern for these patients trying to maintain their wellness.  Do we need more individuals dying like Robin Williams?  Here we have patients that have and are benefiting from a therapy only to be denied insurance coverage by their carriers.  Can you not see the irony and sadness of all this bureaucratic crap?

Please, do something constructive and beneficial.  Issue a “Compassionate Use” letter for the exiting patients and write an informal letter to these CEO’s.  Ten minutes of your letter writing time should suffice to right these wrongs.

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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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.

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.

Monday, August 11, 2014

Under Surveillance

Under Surveillance

Shock therapy: Cyberonics link to deaths and injuries

by Sonya Colberg, Senior Investigative Reporter - 4/16/2014 1:28:01 PM

Judy Bowling could easily complete the night shift at a New York medical clinic, drive the 20-mile commute back home, yank off her favorite green scrubs and grab a few hours of sleep. After school, the single mom and her young daughter would often jump in the car so the child could spend the night with Ms. Bowling’s parents, giving the two some cherished “girl time” during the drive.  

But life changed radically after Ms. Bowling had a “VNS” device by Houston, Texas-based Cyberonics (Nasdaq: CYBX) implanted inches above her heart to try to control her epileptic seizures with tiny electric shocks transmitted to the brain.

She is one of thousands of patients who have been implanted with the device that Dr. Peter Barglow terms, “completely worthless.”

“I’d never dream of subjecting anyone to that sort of nonsense,” said Dr. Barglow, an MD with more than five decades in the psychiatry field, now handling a busy practice in Berkeley, Calif. After extensive examination of the issue and VNS studies, he said he considers any association with VNS irrational.

In Ms. Bowling’s case, the seizures became worse, and she quickly spiraled downward both physically and mentally.

Ms. Bowling’s experience is one of more than 9,000 Cyberonics-linked injury reports submitted to the US Food and Drug Administration from 1998 to this month. It is the manufacturer's responsibility to determine whether these are linked to its medical device used to treat difficult epilepsy and depression cases.

In fact, more than 1,980 Cyberonics-linked death reports were uncovered in our investigation.

These “adverse events” resulted from the device made and touted by a company staggering beneath two extensive FDA warning letters and targeted by a US Senate investigation regarding effectiveness and safety concerns examined during its controversial FDA approval process. And the heat’s still on in the form of a false claims lawsuit that we believe the government should move forward.  

Losing it: In the institution

Ms. Bowling had to fold up her scrubs and place her 10-year-old daughter under the temporary care of her parents. With that pocket watch-sized VNS device still pulsing in her body, Ms. Bowling then found herself shuffled from psychiatric hospital to psychiatric hospital. Often she arrived as a screaming, writhing ball of fury, bound in a five-point restraint from which she says she learned to escape.

“It was a nightmare,” she said with a nervous laugh. “Like something you see on TV.”

By then, her mother had already told Judy’s big sister, Nancy Bowling, that she felt certain the personality changes were caused by the VNS (vagus nerve stimulation) device. She investigated and became convinced the problem was indeed that device shooting tiny electric shocks into her sister’s brain.

Judy Bowling settled into what would become her final, five-month stay at a psychiatric hospital. In New York’s Rockland Psychiatric Center – an institution she now remembers fondly - the normally mild, disciplined then-45-year-old woman manipulated and fought for her place in the inmate pecking order.

One day, an 18-year-old inmate made fun of the way she looked in the throes of a seizure. Ms. Bowling stood up to her and the teenager threw a punch. Ms. Bowling flew into the toughie who had been known to enjoy a good street fight now and then. Fists flew. Feet kicked. Hands grabbed.

The street fighter grabbed a chunk of Ms. Bowling’s glossy blond locks. And another. And, while keeping her own hair out of Ms. Bowling’s reach, yet another handful.

“She pulled out half my hair!” said Ms. Bowling, now 50.

Nancy Bowling insisted that the neurologist (who has not responded to TheStreetSweeper’s request for comment) authorize removal of the VNS device the family suspected caused such uncharacteristic behavior in Judy Bowling.

But he was reluctant. In fact, February 2009 documentation shows it took a congressman’s interest to convince the neurologist to authorize removal of the device.

At that point, Judy Bowling’s surgeon immediately removed the VNS device.

Beating “the devil”: Medical literature describes VNS link to psychotic behavior

Medical literature contains cases that point toward a link between VNS and the onset or worsening of psychosis.

A hospital admitted a 38-year-old epileptic patient claiming he was the devil. He had tried to cut his own throat because he believed he heard the voice of God urging him to kill himself.

The VNS inside him pumped out a few seconds’ electrical charges every five minutes, according to his doctors’ medical report.

Just three months earlier, doctors had surgically implanted the device. He’d had mental issues previously that he’d overcome but after surgery his mental state hit the boiling point. Psych ward doctors tried anti-psychotic drugs over five months to try to break his psychotic state. To no avail.

Desperate doctors combed the medical literature and found 11 published cases of VNS inducing or aggravating psychosis. On their suggestion, the neurologist repeatedly reduced the VNS pulse rate, a simple procedure using a computer.

“The improvement in his condition following each reduction in VNS pulse intensity was swift and dramatic,” doctors wrote.

“Only adjusting the VNS pulse intensity brought relief,” they reported.

His improvement was so startling, doctors signed papers authorizing the patient to move to a halfway house to begin his transition back into society.

FDA’s bizarre approval sets device free in the marketplace

We’ve found Cyberonics reports describe more than 10,000 deaths, injuries and equipment malfunctions. These are “adverse event reports” filed in the FDA’s “MAUDE” online reporting system. These reports represent events that may be linked to VNS as well as some that occurred in VNS patients with other medical issues that make establishing a VNS link more difficult. Anyone knowledgeable about an adverse event, from doctors and medical facilities to patients and family members, may anonymously file a report here.

FDA spokeswoman Jennifer Rodriquez said in an email that the medical device reports are just one of several post-market data sources.

“As such, the FDA evaluates each situation on a case-by-case basis, considering a variety of factors to determine whether additional analysis or action may be needed for a particular device,” she said.

So how did the device get FDA approval?

The VNS first got approval in 1997 for use in difficult cases of epilepsy. Then the FDA went into a bizarre – and secretive – application process to approve the use of VNS for treatment-resistant depression or TRD.

The FDA’s head honcho then responsible for approvals, Dr. Daniel Shultz, made an astonishing decision to override an entire FDA panel and sign the company’s application - personally.

He approved the application despite objections of more than 20 FDA scientists, doctors and managers, according to a report filed in the Congressional Record. He acknowledged to staffers that the public would be unaware of this.

Reports of death after death and injury after injury among VNS epileptic patients poured in, TheStreetSweeper found, even as the company sought the depression-use application.

Death reports reached 115. Injury reports hit 181 and malfunction reports reached 458 during that time.

During that time, the FDA also socked the company with an official warning letter in December 2004 that listed 30-odd serious allegations – including failure to fully investigate adverse events - uncovered during the agency’s two-month inspection of Cyberonics. The company took months to address the issues to get the FDA to close the file just three months before Dr. Schultz stunned the FDA team with his decision.

FDA reviewers: Like an “experimental project;” “disturbed”

The FDA panel reviewed Cyberonics’ application materials for 15 long months. They focused on Cyberonics’ clinical studies on depression (TRD) and determined they did not show the device was safe or effective.

One reviewer said in an email: “I am disturbed that VNS might actually get an approval for ‘‘TRD’’. In my opinion, they do not have adequate data and I don’t understand how this can move forward.”

Another wrote: “As an MD interested in science, it seems to me that such an approval would be akin to approving an experimental product.”

Cyberonics increased its lobbying effort, in the midst of all this, to mount the company’s record high in 2005 of nearly half-a-million-dollars.

Meanwhile, the FDA rumblings reached the ears of Sen. Charles Grassley and Sen. Max Baucus, who commanded an investigation into the FDA’s decision.

Though the FDA team recommended again and again that the device not be approved for treating depression, the Senate staff report states that “at every stage of the review, the team was instructed by the FDA official, who ultimately made the decision to approve the device, to proceed with the next stage of pre-market review.”

Patients and doctors were kept in the dark about the scientific dissension or that Cyberonics’ short-term study “failed to reach, or even come close to reaching, statistical significance with respect to its primary endpoint (of efficacy).”

The FDA team requested that the company strengthen its weak study results by conducting a new randomized, controlled study prior to approval, according to the report. Cyberonics refused to conduct that study pre-approval.

The investigative report and the senators harshly criticized the whole mess. On Aug. 10, 2005, Dr. Schultz resigned by “mutual consent” with the FDA commissioner. He later found a job with a consulting firm serving companies regulated by the FDA.

But Cyberonics already had what it wanted. On July 15, 2005, the company walked away with FDA’s approval letter in its back pocket.

Another risk: Medicare/Medicaid approval fails - again

Insurance giant Blue Cross Blue Shield hit the warning bell shortly after the FDA approval with an ominous comment that “overall, the evidence supporting efficacy of VNS is not strong.” Over the years, insurers tended to pay in some depression cases but generally refused because of the safety and effectiveness questions.

Insurance often isn’t covering VNS treatment now, according to Dr. Robert Dolgoff, director of the Berkeley Therapy Institute in California.

Cyberonics chief executive Daniel Moore mentioned this very issue during the last earnings call. Mr. Moore, who replaced the embattled CEO in charge during the application fiasco, partially blamed weakness in the last month of the quarter on “an unusually large number of changes in insurance coverage.”

Cyberonics has tried numerous times to get the ever-important Medicare/Medicaid reimbursement for VNS for depression.

But time and again, Medicare/Medicaid has said, “No,” and it seems doubtful Cyberonics will secure coverage for depression use, effectively shutting itself out of its most promising market. After the May 2007 Medicare denial, Cyberonics filings say it ceased marketing VNS for depression in all markets.

The stock price crumpled by 10 percent last May on the most recent news that federal administrators once again said, “No,” to Medicare reimbursement costs for depression.

The Centers for Medicare and Medicaid Services (CMS) pays for about 25 percent of the implants, the company’s filings state. The cost for implant surgery and programming the device runs about $25,000.

The company didn’t respond to TheStreetSweeper’s request for comment. Investors may find other viewpoints on Cyberonics here.

Risk: Options, options and more options for difficult epilepsy and depression cases

“Write this down, ‘TMS,’” said Dr. Dolgoff.

TMS or transcranial magnetic stimulation is probably the hottest, new FDA-approved treatment for depression. Dr. Oz featured this nerve-stimulating therapy on his show, showing a doctor using a painless magnet inside a helmet-like device on an audience member. The magnet – pinging like a subdued woodpecker - stimulates the part of the brain responsible for depression. Therapy takes about 35 minutes, five days a week for three to six weeks until depression disappears.

Results have been so encouraging that Dr. Dolgoff said his clinic now recommends TMS first for patients with depression.

This private company’s non-invasive therapy - a far cry from Cyberonics’ surgical implant - is among the potential risks listed in the company’s Securities and Exchange Commission filings.

Cyberonics also faces stiff competition from $58-billion Medtronic (NYSE: MDT), the giant that parlayed its Deep Brain Stimulation therapy beyond the Parkinson’s field into the refractory epilepsy field with FDA approval.

Mountain View, Calif.-area private company NeuroPace’s therapy just last November got FDA approval for difficult-to-treat epilepsy and is in early commercialization. This newcomer’s RNS device sends an electric pulse through thin wires precisely located at the one or two spots in the brain where seizures start.

“We don’t look at VNS from a competitive perspective. We really look at the need to grow the overall field,” said NeuroPace chief executive Frank Fischer.

A NeuroPace study found seizures dropped 37.9 percent in patients implanted with live RNS wires. For comparison, a Cyberonics’ study found seizures dropped just 28 percent with the highest level of VNS. The low stimulation VNS group saw 15 percent – or 2 percent less relief - than RNS subjects who received absolutely no stimulation from their RNS wires.

“Both of us, ourselves and Cyberonics, are going to benefit by virtue of the therapy becoming available. Because it gives the community something to think about, to discuss, to get excited about and then doctors refer their patients. That’s what’s not been going on in recent years,” said Mr. Fischer.

Since the therapy addresses difficult or refractory epilepsy, this poses some issues. Cyberonics claims about 70,000 patients in this comparatively small category of about 400,000 that seems unlikely to suddenly grow. In fact, only six more US units were sold last quarter than the same quarter the year before.

So replacement units would be especially important to sales growth. Unfortunately, Cyberonics’ is seeing a decline in replacement devices. They fell by 9 percent last quarter compared with prior year, or 1,047.

Cyberonics’ SEC filings also include Neurotech, CerebralRX and St. Jude Medical among the arm’s-length list of companies aiming for depression and epilepsy patients.

Signals? Insiders selling

Cyberonics insiders tip their hands about the level of confidence they have in their own company when they sell its stock like crazy. That’s all they’ve done in the past year.

In the last month alone, CEO Moore has sold more than his peers, peeling off over 11,000 of his direct and indirectly owned shares. He now owns little more than 191,000 shares of his company. Under his automatic trading plan over the last two months, he’s cut down his direct and indirect ownership by nearly 11 percent – not a good sign for investors.

Conclusion

Judy Bowling, now free of the VNS device, still struggles with some memory problems and depression, along with lost confidence.

“I lost my life over this. I lost it,” she said, her voice quivering. “I’ve been so traumatized that I won’t be able to go back to work as a nurse.”

Like other families, the Bowling family is not suing Cyberonics because a 2008 US Supreme Court decision allows manufacturers to avoid being sued in state court if their medical devices have been approved by the FDA.

Ms. Bowling and her daughter now get more girl time together, and Ms. Bowling is making plans to become a counselor. She wants to go back to the New York state psychiatric hospital, Rockland. But this time, she hopes to gain respect for her counseling. Instead of her left hook.

The company behind the VNS device, we believe, faces its own challenges.

*Considering more than 10,000 death and injury reports, are the FDA and Cyberonics acting responsibly? Only the iciest heart could ignore reports like the one from a parent who believes the VNS stopped her daughter’s heart: “She meant everything to me …”

*Plagued by Medicare’s decision to deny coverage of its anti-depression device multiple times, the door to the depression space has slammed shut on Cyberonics.

*Difficult-to-treat epilepsy patient base is small. Demand for VNS replacement units is declining.

*Exciting, new treatments – even non-invasive ones - threaten the VNS position.

*One of the most ominous red flags surrounds a false claims complaint filed Feb. 4, 2013. Filed as United States of America, et al v. Cyberonics, Inc., this is separate from the complaint filed and dismissed by a former employee. The lawsuit obviously poses risks to the company if the government chooses to pick this up, as we believe it should.

TheStreetSweeper would love to see better treatments for epilepsy and depression patients. But not this device. And not this company.

* Important Disclosure: The owners of TheStreetSweeper hold a short position in CYBX and stand to profit on any future declines in the stock price.

  • Editor's Note: As a matter of policy, TheStreetSweeper prohibits members of its editorial team from taking financial positions in the companies that they cover. To contact Sonya Colberg, the author of this story, please send an email to scolberg@thestreetsweeper.org.

http://www.thestreetsweeper.org/undersurveillance/Shock_therapy__Cyberonics_link_to_deaths_and_injuries

 

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, August 11, 2014 4:56 PM
To: 'scolberg@thestreetsweeper.org'
Subject: Under Surveillance by Sonya Colberg, Senior Investigative Reporter - 4/16/2014 1:28:01 PM

Dear Ms. Colberg,

I just happened upon your article “Under Surveillance” and read it with much interest.

As I’ve come to learn from much news reporting’s that they tend to come from a sensationalistic biased viewpoint often lacking an in-depth investigation into all sides of the picture.  I do take issue with your presentation from my perspective as a very, very long-time support person and health care advocate/activist for my spouse.

What you omit is a balanced perspective whether intentionally or otherwise.  You did not indicate that many of the psychotropic medications normally prescribed for these patients have serious potential side-effects and can readily induce psychosis of the nature you described in your article.  While I do admit and acknowledge that VNS Therapy too has the potential to induce psychosis as was experienced by my spouse.  Except in my spouse’s case history we were knowledgeable of this potential side-effect and addressed and overcame the issue promptly.  You also didn’t mention amongst other points that antidepressants can potentially induce suicidal ideations and in a number of cases that these drugs have a high correlation with death.  Nor did you detail Dr. Peter Barglow’s experience and knowledge of VNS Therapy.  Were his comments related to Epilepsy and/or Depression as there are also many epilepsy patients and their physicians who would take serious issue with his comments?

Worse yet, you never interviewed or discussed the VNS Therapy for depression with any of the patients benefiting from the therapy or with any of the physicians who have attended to these patients and observed remarkable improvements.  You never bothered to interview Dr. Daniel Schultz did you?  Yet your writings paint a very negative presentation.  On the other hand and unlike you I did question him and his thoughts.  In response to my questions I share with you Dr. Schultz’s public reply.  You also ran with the Senators Grassley’s investigation without really having an understanding.  Grassley’s investigators never interviewed any of the treating physicians for their opinions nor did you note the comments from many of the physicians who wrote into CMS during the open comment period and their reasons for wanting the therapy approved.

You also are obviously not aware of my battle with CMS to obtain medical insurance coverage and care for the study subjects and patients implanted prior to their May 4, 2007 national determination or the fact that there are depression patients having benefited from the therapy desperately battling to obtain replacement pulse generators because the VNS Therapy has given life back to them.

I’m not here to do your job although I personally will opine I think it was inadequately researched and/or a “hack job”.  I’m somewhat familiar with Ms. Judy Bowling’s case by way of her sister Nancy.  What was never addressed or discussed in any of the information I read what was being immediately done to alleviate the psychiatric symptoms.  Remember too, she was implanted for epilepsy.

I’ll also point out to you that VNS Therapy is not “shock therapy”.

Maybe it’s time for you to go back to the subject matter with a more opened mind and better understanding to share a more balanced perspective.

I’m available to share my thoughts and I’m sure there are others with their experiences that’d be willing to help balance you’re reporting.

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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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.

Friday, August 1, 2014

Stimulation Device Shows 'Immediate' Impact on Depression

Stimulation Device Shows 'Immediate' Impact on Depression

Pauline Anderson

July 31, 2014

Stimulation with a low-strength electromagnetic field device immediately improves mood in patients with major depressive disorder (MDD) and bipolar disorder (BPD), new research shows.

Results from a randomized, double-blind, sham-controlled study are exciting, especially because the effects were so rapid, lead author Michael L. Rohan, PhD, a physicist at McLean Hospital and Harvard Medical School, Belmont, Massachusetts, told Medscape Medical News.

"I think we have something that is working on the depressed state in either major depressive disorder or bipolar disorder," said Dr. Rohan. "Whether it's more effective in either one of them, we don't know, but it seems to have an immediate effect on the depressed state."

The device holds "great potential" as a clinical tool for psychiatrists, Dr. Rohan added.

The study was published in the August 1 issue of Biological Psychiatry.

Serendipity

The ability of the rapidly oscillating electromagnetic field, called low-field magnetic stimulation (LFMS), to improve mood was discovered "serendipitously" about a decade ago. Researchers who were carrying out experimental MRI scans to assess brain chemistry noticed changes in depressed bipolar patients.

"The subjects started coming out of the baseline scan with improved mood," said Dr. Rohan.

After further research, Dr. Rohan designed and built the portable tabletop device that is now being studied. It consists of a magnetic coil, an amplifier, a waveform generator, and a computer.

The US Food and Drug Administration (FDA) has determined that the device carries a nonsignificant risk.

Dr. Rohan described the LFMS device as being similar in size and shape to "an old-fashioned mailbox." Patients lie on a bed with a padded headrest. The top of their head fits into the device, leaving the rest of their head, including their eyes, exposed.

Compared with transcranial magnetic stimulation (TMS), which uses electromagnetic pulses to stimulate nerve cells, and electroconvulsive therapy (ECT), which induces "small self-repairing seizures," LFMS uses fields that are "at least 100 times weaker," said Dr. Rohan.

Although ECT is "the most successful treatment for depression," it carries a cost, he said. "Patients come in regularly and they get sedated; the treatments are invasive."

High Hopes

The new study included 63 patients aged 18 to 65 years with BPD or MDD who were stably medicated but still symptomatically depressed and who scored 17 or more on the observer-rated 17-item Hamilton Depression Rating Scale (HDRS-17). Most patients took multiple medications throughout the study.

Patients were randomly assigned to receive 20 minutes of active (n = 34) or sham (n = 29) treatment. The inactive device resembled the real one in every way, down to the faint beeping noise it emitted. Neither the patients nor the operators could tell the difference.

"Because the placebo effect is so high in antidepressant studies, we had to be very careful about that sham," stressed Dr. Rohan. "When you have an exciting new device like this, people have high expectations."

Directly before and after the treatment, the mood of the patients was determined with the HDRS-17 and the self-rated visual analogue scale (VAS), which is designed to be responsive to an immediate change in mood.

The study showed that the mean improvements in VAS score were greater for active compared to sham treatment by 0.8 points for BPD (95% confidence interval [CI], -.6 to 2.1; P = .60), 1.6 points for MDD (95% CI, -.4 to 3.6; P = .17), and 1.1 points for the combined sample (95% CI, .2 to 1.9; P = .01).

Mean improvements in HDRS-17 score were greater for LFMS than for sham by 2.5 points for BPD (95% CI, -1.2 to 6.2; P = .34), 3.2 points for MDD (95% CI, -3.3 to 9.6; P = .74), and 3.1 points for the combined sample (95% CI, .5 to 5.8; P = .02).

Dr. Rohan believes that the differences between active and sham treatments were not significant in the individual diagnostic groups because these groups did not have enough participants. He pointed out that the differences did reach significance when the data were combined across groups.

Mood was also assessed with the self-rated Positive and Negative Affect Schedule (PANAS). There was greater improvement in scores among both BPD and MDD patients receiving the active treatment. In this case, the difference was statistically significant not only for the combined sample but also for BPD patients alone, although not for MDD patients alone.

No adverse effects linked to the device were reported.

Potential Mechanisms

There is evidence that rapidly fluctuating magnetic fields that are below the threshold for depolarization can still influence neuronal activity. This, noted the authors, suggests potential cellular mechanisms of action.

Although this is still speculative, Dr. Rohan suggests the device may interact with the nerves in the area of the dendrites where synapses are located.

"The synapses have an electrical function as well as a chemical function, and I suspect that we are interacting with the electrical function in the dendrites."

Because the device seems to provide immediate relief, it might prove useful as a treatment "bridge" in the emergency department, where psychiatric patients may end up in crisis, although the psychiatric community will eventually determine the best application, said Dr. Rohan.

He pointed out that antidepressant medications take several weeks to exert a clinically meaningful improvement in mood and that even ECT requires 2 to 3 treatments per week during a period of up to 4 weeks.

Researchers are now studying the properties of LFMS to determine the optimal frequency, spatial distribution, and timing of the electromagnetic field needed to produce an antidepressant effect.

Dr. Rohan is doing further investigation of the potential mechanisms of the device. He is also participating in a study of 72 patients that is looking at the effect and duration of multiple treatments, the results of which he estimated would be available by the end of next year.

Elsewhere, a multisite study funded by the National Institutes of Health is comparing the device with antidepressant interventions, said Dr. Rohan.

Encouraging Results

Commenting on the study for Medscape Medical News, Paul E. Holtzheimer, MD, associate professor of psychiatry and surgery, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, said the study was "great," the results "encouraging," the design "reasonably straightforward," and that he had "no major criticisms" of the research.

"There does seem to be an antidepressant effect; it's not a huge effect, but that's also true for transcranial magnetic stimulation and other approved treatments," said Dr. Holtzheimer. "It warrants further investigation, but in terms of trying to figure out how much of a splash this is going to make, it's too early to say."

The "exciting" aspect of LFMS, said Dr. Holtzheimer, is that it is mechanistically different from TMS in that it is less focal and could be affecting a broader area of the brain involved in mood regulation.

"Mechanistically, it's probably doing something different: it's a similar brain region and a similar idea in terms of altering electrical activity in the brain, but it's different in terms of how focal it is and how much it's altering that activity."

Dr. Holtzheimer warned against being overly enthusiastic about rapid results after using LFMS. He noted that when TMS and deep brain stimulation were first being studied, there were also reports of immediate effects. "Now, we have learned that it's not necessarily related to whether patients get better longer term."

He noted that some patients have an immediate response to drug therapies. "Even though we say that it takes 8 to 12 weeks to have a full effect, some patients get better very quickly."

The same is true for ECT, he added. "We say it takes 9 treatments, but some patients are well within the first 1 or 2 treatments."

McLean Hospital has been awarded patents for the low-field magnetic stimulation treatment and device. Dr. Rohan is listed as an inventor of these patents. He has received consulting fees from Taj Medical, which McLean Hospital approves and limits. Dr. Holtzheimer reports no relevant financial relationships.

Biol Psychiatry. 2014;76:186-193. Full text

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