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Wednesday, July 29, 2015

VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 29, 2015 4:48 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

Dear Madam Secretary Burwell,

I’d like to take a moment to commend and compliment Ms. Gaetana Marshall, M.S. Health Insurance Specialist out of your Atlanta, GA regional office for the time and effort she put into listening to my explanations and researching the document(s) you folks in D.C. recently sent to her office relating to my supposed issue(s) that I have been advocating to resolve these past two years.  Ms. Marshall in turn forwarded the documents (copy and pasted below) for me to read and I in turn share for everyone’s perusal.  At the same time I would also like to acknowledge the concerted efforts on the part of Ms. Courtney S. Turner, MPH - Office of Hearings and Inquiries, Medicare Ombudsman Group, Division of Medicare Ombudsman Assistance who respectfully assisted in my advocacy and has helped several of the VNS Depression patients receive medical care these past couple of years and to Ms. Stephany Terry – CMS for following up on my telephone call to Ms. Lisa Spradlin – CMS yesterday in the absence of Ms. Courtney Turner. 

I’m sure Madam Secretary that you are familiar with these famous words, “Houston, we have a problem!”  And shortly thereafter the intellectual minds at another of our government agencies, NASA, effectively, efficiently and expeditiously went to work solving a life and death crisis in a matter of days.

Well Madam Secretary I’ve come to the conclusion the same is not true for your agencies handling and effectiveness as it relates to the health care for the implanted VNS Depression patients.

In fact what I discern in this instance is “HHS/CMS we have a failure to communicate!” as well as what appears to be a classic illustration of the Tower of Babel.

In absolutely none of my advocacy/activism these past two (2) years have I advocated for approval of the VNS Therapy for Depression or the reversal of the May 4, 2007 denial.  That is the responsibility of the sponsor, Cyberonics and yet the communications I constantly receive from your agency refer me to the CMS denial decision of May 4, 2007.  Believe me I’ve carefully read that decision a number of times and I am cognizant of its contents.

What I specifically and rightfully have advocated for is care and health insurance coverage which CMS egregiously, immorally and/or unconscionably omitted or overlooked in that decision whether through ineptitude, ignorance or failure to grandfather-in-care for all the study subjects and patients implanted with this medical device prior to May 4, 2007 in accordance with the doctrine of “Continuity of care” contained in several CMS documents.

Obviously not all your subordinates understand, comprehend or obtained any message that CMS recognizes and acknowledges the medical doctrine of “Continuity of Care” as was reiterated by CMS most recent DBA adjudicated decision of December 30, 2014. These patients are rightfully to be cared for and covered by medical insurance.  The CMS decision of May 4, 2007 does not apply to these previously implanted patients.  Is that too difficult for your people to read and comprehend?

Page 62

“With respect to those

beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for:  (1) “the

interrogation and calibration of a VNS therapy device implanted and deemed to be

reasonable and medically necessary when implanted for TRD”; or (2) “for the

replacement of the implanted pulse generator device upon battery expiration, when

required[.]”  AP Statement ¶ 43.  According to the Aggrieved Parties, those omissions

conflict with:  (1) “continuity of care” standards that are “widely accepted within the

medical community (i.e., a physician should not discontinue treatment that is effective for

a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is

unsafe for beneficiaries to have an implanted medical device that is not properly

calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements

wherein CMS has recognized that continuing Medicare coverage for beneficiaries who

received Medicare-covered durable medical equipment (DME) before it was non-covered

‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42

(quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).”

Page 63

“CMS states that it “leaves decisions

regarding the maintenance of already-implanted devices to contractor discretion” and that

such decisions “are, appropriately, made on an ad hoc basis after the local contractor’s

consideration of the applicable facts.”  Id. We understand from these representations that

CMS and its contractors do not, or will not in the future, apply NCD 160.18(C) to bar

coverage of maintenance services – including replacement of the implanted VNS device

upon battery expiration – for beneficiaries who received the VNS device prior to May 4,

2007.”

Yet I continue to receive communications from your agency citing the May 4, 2007 decision.  Obviously the proper communications from your office in the words of former President Regan are not having a “trickle down” effect.  For the umpteenth time please have your agency and your subordinates notify MAC, Regional Agencies, State Agencies, contractors etc., etc. that based upon the reaffirmation of the DBA adjudicated decision of December 30, 2014 that all VNS Depression patients implanted prior to May 4, 2007 are to be covered for medical care and health insurance coverage and there should be absolutely no need for these patients to have go through an appeals process as a result of your agencies inability to communicate this fact with one another.

Why must I continue to receive communications citing denials and reference to the May 4, 2007 as was recently illustrated in a communication dated July 17, 2015 from Kristen Dixon - Health Insurance Specialist - Atlanta Division of Financial Management & Fee for Service Operations (see below) and an earlier letter dated April 17, 2015 from Patrick Conway, MD, MSc - Acting Principal Deputy Administrator - Deputy Administrator for Innovation and Quality – CMS Chief Medical Officer (see below).

Why not a letter, directive or whatever document you issue to your MAC agencies, Regional office agencies, State Agencies, contractors etc., etc. apprising them of the doctrine of “Continuity of Care” and the DBA adjudicated decision of December 30, 2014 favorably affecting the VNS Therapy patients for depression?  Stop all this negativity, denials, oversight and appeal non-sense being referenced to the May 4, 2007 denial decision when in fact the December 30, 2014 decision clearly indicates these medical device implanted patients have rights to medical care and health insurance coverage.

And to those private health insurance CEO’s I have also addressed and hounded you too have unjustly denied care and medical insurance coverage to these patients and similarly you should be issuing directives to your staff that these patients should be properly cared for and rightly insured.    

Take a positive approach to wellness.  Advise all your agencies and health insurance carriers that the previously implanted VNS patients for depression are rightfully entitled to medical care and coverage without need for any denials or subsequent appeals!

Lastly, I’ll also take the liberty to remind you and all those agency staffers who read this communication:

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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.

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From: Marshall, Gaetana (CMS/CMHPO) [mailto:Gaetana.Marshall@cms.hhs.gov]
Sent: Tuesday, July 21, 2015 7:59 AM
To: Herbert Stein (fabrik@bellsouth.net)
Subject: C1502484607 Re. Mr. H. Stein

Good morning Mr. Stein,

Since our telephone conversation on Friday I have had an opportunity to follow up from discussions we had and to speak with a few of my CMS colleagues who have responsibility for standard Medicare A/B policy decisions.  Notably, I have spoken to Courtney Turner who works with the CMS Ombudsman team and the management team for Medicare A/B policy decisions.

They have provided me with the following items for your records and information:

A. A Beneficiary Casework Call (August 2014) presentation regarding VNS coverage.

B. A Sept. 24, 2013 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to the Honorable Debbie Wasserman Schultz on behalf of your wife regarding health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

C. The CMS Ombudsman’s response from January 2015 regarding the Division of Appeal Board’s (DAB) decision.

D. The April 17, 2015 letter from the CMS Center for Clinical Standards and Quality formally responding to you (on behalf of Secretary of Health and Human Services) regarding the DAB decision.

E. A July 17, 2015 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to you regarding the health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

The documents above are official CMS responses to your questions regarding Medicare Advantage plan coverage for VNS treatment for depression since MA coverage is established by standard A/B policy.  Additionally, the 2014/2015 DAB appeal decision attached upheld CMS’ policy. As such, the attached CMS letters are considered comprehensive and fully respond to questions regarding health insurance coverage of VNS for treatment of depression.

I would like to thank your patience and for the opportunity to speak with you and thank you for your advocacy regarding those suffering with depression and VNS therapy.

It was my pleasure to assist you.

Very truly,

Gaetana Marshall

Ms. Gaetana Marshall, M.S.

Health Insurance Specialist

US Department of Health and Human Services

Centers for Medicare and Medicaid Services

Division of Medicare Health Plans Operations

61 Forsyth Street, Suite 4T20

Atlanta,  Georgia  30303

Ofc:  404-562-3562

Fax: 443-380-5963

Email: gaetana.marshall@cms.hhs.gov

Please consider the environment before printing this email.
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:

This information has not been publicly disclosed and may be privileged and confidential.  It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information.  Unauthorized disclosure may result in prosecution to the full extent of the law.  If you are the unintended recipient of this information please notify the sender.

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Sunday, July 19, 2015

Stolen equipment and the expeditious resolution…

To Joyce’s fellow VNS patients et al,

Just recently we ran into an unusual problem(s). We made an appointment with Joyce’s attending physician to interrogate her VNS prosthesis. The appointment was made for Monday, June 22, 2015. As we were about to leave our home for our scheduled appointment we received a call cancelling the appointment as the doctor could not find his handheld computer to interrogate the device.

We rescheduled the appointment for the following Monday, June 29, 2015 and I advised his office I would send a reminder to the doctor on Sunday prior to our office visit to bring the equipment. I e-mailed the doctor as a reminder early Sunday and later that evening I received a return correspondence that the interrogating equipment had apparently been stolen from his office. Late that same evening I sent an e-mail to Dan Moore, CEO – Cyberonics and his associates asking for help. Much to my surprise even later that Sunday evening I received a reply.

I have been allowed to share the correspondence and events that have unfolded and acknowledge the coordinated efforts of the Cyberonics staff. . I wish to extend my appreciation and gratitude publicly for the expeditious handling and resolution of the problem(s) and help I received. I rightly feel it proper to exhibit all sides of the coin unbiasedly as possible in view of the fact that I have at times respectfully expressed harsh critical opinions of the company as it related to several other issues.

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 11:25 AM
To: Dr. Ely Pelta
Subject: Reminder...

Hi Doc,

Just a friendly reminder to please bring the wand with you to interrogate Joyce’s prosthesis tomorrow!

I hope all is well with you and yours.

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Ely Pelta [Redacted]
Sent: Sunday, June 28, 2015 1:50 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb. The wand went missing, can you provide me with a contact to get a replacement wand?   It most likely was stolen.  I looked everywhere
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 6:14 PM
To: 'Ely Pelta'
Subject: RE: Reminder...

Doc,

Is the wand all that is missing or are you missing the handheld computer too?

Please let me know promptly and I’ll try to contact Dan Moore, CEO of Cyberonics to help us out.  I’ll cancel our appointment for tomorrow until you’re once again equipped.

Thanks,

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Att [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 8:53 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb, missing it all , thanks for understanding
Sent from my iPad

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 9:38 PM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Jackie J. Baumgartner; Dr. Mark Bunker; Bryan Olin, Ph.d
Subject: Stolen equipment...

Dear Dan,

I hope this note finds you and yours all doing well.

I need your assistance.  Apparently someone has stolen Dr. Ely Pelta’s handheld computer and wand and I shall have to cancel Joyce’s appointment for tomorrow to have her prosthesis interrogated.

I would sincerely appreciate if you could have one of your staff immediately contact Dr. Pelta to arrange for a replacement of the equipment.

Dr. Ely Pelta

Miami Beach Community Health Center

11645 Biscayne Boulevard

Miami Beach, FL 33141

305-538-8835 x1670 for Dr. Pelta

(Redacted)

Bianca F., nurse for Dr. Pelta

Carla is Dr. Pelta’s secretary at 305-538-8835 ext. 1670

As always, I thank you for your prompt attention to my concerns as I wish you all well.

Dr. Pelta,

Please have your office notify me promptly once you’ve obtained the replacement equipment so that we may reschedule Joyce’s appointment.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, June 28, 2015 10:40 PM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Jackie J Baumgartner; Mark Bunker
Subject: Re: Stolen equipment...

Dear Herb,
I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.
Best regards,
Bryan
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 10:59 PM
To: 'Bryan Olin'
Cc: 'Dan Moore'; 'Dr. Ely Pelta'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Dear Bryan,

Thank you for your very speedy reply.  It is most appreciated.

We’ll at worst have to reschedule for next week but it is your cooperation and that of your company’s personnel that is most impressive and outstanding to me.

I may have some respectful differences on certain issues with you folks but I cannot deny the fact they y’all have gone to bat through the years to help me care for Joyce for which I truly thank you.

Once again, thanks Bryan.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Ely Pelta [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 11:16 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

Great job Herb !
Sent from my iPhone

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:06 AM
To: fabrik@bellsouth.net
Cc: (Redacted)

Subject: RE: Stolen equipment...

Mr. Stein,

I am the Nurse Case Manager at Cyberonics who works with the Depression patients and their Psychiatrists.  I was asked to communicate with you about replacing Dr. Pelta’s programming equipment.  We will be overnighting the new equipment to Dr. Pelta’s office in Miami today and he should have it tomorrow morning.  I will reach out to both Carla and Bianca to let them know the replacement equipment has been ordered and to ecxpect arrival tomorrow morning.

If you need assistance with anything else, please let me know.

Take care,

Susan

Susan Dotson, L.V.N., Sr. Manager

Case Management Department

Manager for the Carolinas, Lone Star and Southeast Regions

Depression Case Manager

Toll Free:  1-800-332-1375, ext. 7363

Direct Number:  281-228-7363

Direct Fax:  281-853-1315

E-mail:  susan.dotson@cyberonics.com

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, June 29, 2015 10:44 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Jackie J. Baumgartner
Subject: RE: Stolen equipment...

Dear Susan,

Thank you for reaching out and quickly coming to our assistance.  By copy of this e-mail I am alerting Dr. Pelta to expect the replacement equipment tomorrow and to also alert his staff.

Your prompt help and that of your fellow staff members have proven invaluable to maintaining Joyce’s depression free-state these many years.

Once again, thank you.

Dr. Pelta,

Please have Bianca call me as soon as the replacement programming equipment is received so that we may promptly schedule a new appointment for Joyce.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:47 AM
To: Herbert Stein
Cc: Dr. Ely Pelta; Dan Moore; Bryan Olin; Mark Bunker; Jackie J Baumgartner
Subject: RE: Stolen equipment...

Dear Mr. Stein,

You are welcome…always happy to assist.

Take care,

Susan

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From: Ely Pelta [mailto:(Redacted)]
Sent: Monday, June 29, 2015 1:03 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

I will be looking for it tomorrow
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 01, 2015 1:43 PM
To: Dr. Ely Pelta
Subject: Replacement equipment and rescheduling appointment...

Doc,

I haven’t heard from anyone in your office whether or not you received the replacement equipment so that we can reschedule an appointment for Joyce.

Please advise me.

Herb

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Ely Pelta [mailto;(Redacted)]
Sent: Thursday, July 02, 2015 8:27 AM
To: Herbert Stein
Subject: Re: Stolen equipment...

Came today
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 8:46 AM
To: 'Ely Pelta'
Cc: Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Bryan Olin, Ph.d; Daniel Moore, CEO - Cyberonics; Jackie J. Baumgartner; Dr. Mark Bunker
Subject: RE: Stolen equipment...

Doc,

Thanks.  I’ll schedule a new appointment for Joyce.

Susan, Brian et al,

Thank you too for your prompt help and assistance.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 9:00 AM
To: Herbert Stein; 'Ely Pelta'
Cc: Bryan Olin; Dan Moore; Jackie J Baumgartner; Mark Bunker
Subject: RE: Stolen equipment...

Mr. Stein,

I am glad to hear that the equipment was delivered.  Please let me know if you need assistance again.

Take care and have a nice 4th of July!

Susan

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 9:21 AM
To: 'Susan Dotson'; 'Ely Pelta'
Cc: 'Bryan Olin'; 'Dan Moore'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Susan,

Thanks again and you too have a happy and safe 4th of July.  And if you don’t mind, family, friends and business associates all call me Herb.

Herb

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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.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 10:20 AM
To: Herbert Stein
Subject: RE: Stolen equipment...

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 15, 2015 8:53 AM
To: Dr. Ely Pelta
Subject: Reminder...

Doc,

Joyce has an appointment with you tomorrow.  Please remember to have the interrogation device available.

Thanks,

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: EDP [mailto:(Redacted)]
Sent: Wednesday, July 15, 2015 1:02 PM
To: Herbert Stein
Subject: Re: Reminder...

It's fired up and ready 

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 10:45 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker
Subject: VNS Technical Question

Dear Susan,

Once again I’d like to take this opportunity to thank all you guys for speedily coming to our assistance.

Yesterday we finally got to see Dr. Pelta who interrogated Joyce’s prosthesis (Model 104).  All settings for Joyce were normal with one exception as Joyce continues with her depression free state.  Dr. Pelta’s newest handheld computer did not indicate the battery life as we previously were able to view (Please see photo below).  Is there something wrong with the programming or hardware of the handheld device or whatever?

clip_image001

Would you please advise a solution to this problem?

Thank you as always.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Friday, July 17, 2015 10:51 AM
To: Herbert Stein
Cc: Susan Dotson; Dr. Ely Pelta; Dan Moore; Mark Bunker
Subject: Re: VNS Technical Question

Dear Herb,
I contacted our Clinical Technical Support team and asked them to contact you and Dr. Pelta to answer your question.
Best regards,
Bryan
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 11:02 AM
To: 'Bryan Olin'
Cc: 'Susan Dotson'; 'Dr. Ely Pelta'; 'Dan Moore'; 'Mark Bunker'
Subject: RE: VNS Technical Question

Brian,

As always your exceptionally prompt responses I greatly appreciate.

Have a wonderful weekend.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Dylan Adams [mailto:Dylan.Adams@cyberonics.com]
Sent: Friday, July 17, 2015 3:47 PM
To: fabrik@bellsouth.net
Subject: Joyce's VNS Device

Hi Herb,

Thank you again for talking with me today. While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.

Best regards,

Dylan Adams

Clinical Engineer

Cyberonics, Inc

100 Cyberonics Blvd.

Houston, Texas 77058

Tel: 1.800.332.1375

Direct: 281.727.2571

Fax: 281.853.2735

www.cyberonics.com

clip_image002

This e-mail message may contain confidential or privileged information, including sensitive patient-related information protected by state and federal laws. If you are not the intended recipient of this message, or an authorized representative of the intended recipient, you are prohibited from reviewing, copying, or distributing this message, its attachments, or any information contained in this message. If you received this message in error, please notify the sender immediately by replying to the message and delete this message from your system.


This email has been scanned for email related threats and delivered safely by Mimecast.
For more information please visit http://www.mimecast.com

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 2:40 AM
To: 'Dylan Adams'
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Subject: RE: Joyce's VNS Device

Hi Dylan,

Thank you for the telephone call and email yesterday clarifying the battery status Joyce’s model 104 implant.  At the time of your call I was driving to my doctor as I’ve been under the weather and couldn’t take any notes and therefore I was unable to respond to you until now.  Your prompt response and that of your fellow associates is greatly appreciated in resolving several recent issues expeditiously.

By copy of this communication to Joyce’s attending physician, Dr. Ely Pelta, I shall similarly update him as to your company’s updated programming of his newest handheld computer as it relates to the battery status as you explained it to me and the fact Dr. Pelta has other patient(s) who will similarly need their prosthesis interrogated.

“While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.”

Joyce’s previous model 102R at the same settings was in use closing in on 9 years and because of certain health insurance issues at the time we did not want to take any chances that her battery would deplete.  We previously experimented deactivating her device and within 2 weeks she rapidly declined into a severe depression.  Within about 2 days of reactivation of the prosthesis she was depression free once again and we have not looked back.  Her more recent model 104 was implanted October 2013 so it will be unnecessary to trouble you at this time for a “battery life calculation” but I shall record that terminology and process in my records when I feel the time becomes necessary for replacement.  So thank you for that piece of information too.

Once again, I cannot fully express my appreciation to all you folks for the very prompt and expeditious handling and assistance you all have shared and executed on our behalf.  Most importantly despite Joyce’s other advancing neurological challenge PSP (Progressive Supranuclear Palsy) which would be cause for severe depression Joyce continues in a depression free state for which I am eternally grateful to all who have assisted us in one way or another to give her a reasonable quality of life.  Thank you, thank you and thank you…

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

---------------------------------------------------------------

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.

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From: EDP [mailto:(Redacted)]
Sent: Saturday, July 18, 2015 7:15 AM
To: Herbert Stein
Subject: Re: Joyce's VNS Device

Thank you herb !
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 3:11 AM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Dylan Adams - Clinical Engineer - Cyberonics
Subject: Publicly sharing recent correspondence...

Dear Dan et al,

As you are aware from my recent correspondence with your associates we ran into a couple of issues which were expeditiously resolved by your staff.

I would like your permission to share the correspondence I have recently had between Bryan, Susan and Dylan publicly in what I consider a truly favorable light as to how your organization has functioned expeditiously to help one of its patients and physician.

Putting our differences aside as to the legal issues of the Guarantee and the anti-kickback statutes which I blogged previously I do try to maintain a balanced perspective regarding the VNS Therapy as well as all treatments and I think this is an opportunity for me to favorably blog the good your organization has demonstrated.

Please let me know if this is acceptable to you and your staff.

As always, I wish you all wellness and all the good you’d wish for yourselves.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Saturday, July 18, 2015 3:56 PM
To: Herbert Stein; Dan Moore
Cc: Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: RE: Publicly sharing recent correspondence...

Dear Herb,

Thank you for the kind words.  We always appreciate the feedback on the level of service we provide-it is great to see Dylan and Susan’s work recognized.  However, please don’t feel any obligation to include this in your blog.  Our perspective is that this is simply the level of service that we owe our patients, caregivers and physicians as a medical device company.

As always, don’t hesitate to contact us with any further questions.

Best regards,

Bryan

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 11:20 PM
To: 'Bryan Olin'; 'Dan Moore'
Cc: 'Dr. Ely Pelta'; 'Mark Bunker'; 'Susan Dotson'; 'Dylan Adams'
Subject: RE: Publicly sharing recent correspondence...

Hi Bryan,

I don’t feel any obligation but when I undertook some 15 years ago sharing our experiences, my research and collaborations with many of the patients and professionals as it related to VNS Therapy for Depression I did so because Joyce and I were intimately involved with the therapy.  While doing so I felt by sharing with others my accumulated knowledge from the viewpoint of a support person as well as a long-time mental health advocate/activist that it might benefit someone else.  I also endeavored to share both pro and con as well as the good or bad as unbiasedly as possible and where I felt it appropriate to inject my personal opinion(s).

I have also been given permission in many instances through the years to publicly share personal correspondence both from patients and professionals to emphasize both sides of the coin and to establish creditability of the website(s) I established.  Then too, I have also been requested to not publicly share many communications which I have also complied with.  I share Joyce and my personal address information, as you will note, along with my correspondence to help establish our creditability and the fact we have nothing to hide and are real people unlike some other sites, participants and webmasters I have encountered through the years.   

Certainly I have been assertive and outspoken while trying to be respectful about several issues not favorable to Cyberonics while on other matters I have expressed my gratitude and admiration.  I am well aware of patients who have been extremely dissatisfied with both your company and therapy and I have freely shared that information too.  I now have experienced another instance which is both pro and good, in my opinion, and I would like to share that information by presenting the quick action on your part, late on a Sunday evening, and the prompt follow up by your other associates to overcome these two (2) recent issues and I can think of no better way to illustrate those facts than by sharing our various recent communications.

I do appreciate and thankfully acknowledge your taking your valuable time and consideration to address this matter too.

Once again, may I be allowed to publish the recent correspondence I’ve had with you, Susan and Dylan?

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, July 19, 2015 11:33 AM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: Re: Publicly sharing recent correspondence...

Dear Herb,
It would be fine if you would like to share the experience in your blog.
Best regards,
Bryan
Sent from my iPhone

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And in the words of the late Paul Harvey and now you have “The Rest of the Story”.

Herb

Monday, July 13, 2015

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

July 13, 2015

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

Posted: Wednesday, July 8, 2015 4:25 pm

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

TIRR Memorial Hermann is taking part in a clinical trial aimed at assessing Vagus Nerve Stimulation (VNS) during rehabilitation for improved upper limb motor function following a stroke. According to the American Heart Association, someone in the United States has a stroke every 40 seconds and stroke is a leading cause of disability in the United States.

The goal of this research is to improve and maximize arm and hand function in stroke survivors. The current study is an extension of a clinical trial conducted last year in Europe. Following the European clinical trial, some patients were able to resume daily activities like driving, cooking, and taking care of young children.

TIRR Memorial Hermann is one of only three sites in the United States participating in this trial. Dr. Gerard E. Francisco, chief medical officer at TIRR Memorial Hermann and Professor and Chairman of Physical Medicine and Rehabilitation Department (PM&R) at UT-Health and Dr. Nuray Yozabitran, researcher in the UTHealth Neuromodulation and Neural Interfaces Laboratory at TIRR Memorial Hermann’s NeuroRecovery Research Center are coordinating the Houston trial.

“At TIRR Memorial Hermann we’re known around the world for our rehabilitation services. But the cutting edge research we are doing is important so that we can continue to rehabilitate even better,” says Dr. Francisco. “The results from the European clinical trial were very promising and we’re excited to get our research underway.”

The trial requires an outpatient surgical procedure to place an electrical device in the patient’s chest area. The device is then connected to the vagus nerve in the neck using thin wires that are also implanted.

The vagus nerve directly connects to the brain and sends important signals to tell the brain what to learn. The patient will do a series of therapeutic tasks aimed at rebuilding the neural circuits in the brain that are responsible for upper limb movement. Each time the patient completes a correct movement, the therapist pushes a button and the patient receives a small burst of neurostimulation, which activate the vagus nerve. VNS aims to encourage the growth of new neural connections in the brain that may have been damaged by a stroke.

The treatment uses the Vivistim System developed by Texas based medical device firm MicroTransponder.

To participate in the trial you must be between the ages of 30 and 80 and have had a stroke at least four months ago but not more than five years ago. You must also experience some arm and hand movement difficulties.

To learn more about the trial go to http://www.vnsstroketrial.com/ or call (713) 797-5282.

http://www.fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html

Monday, June 29, 2015

“…there also may be secondary benefits Joyce and you are also accruing…”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, June 20, 2015 12:32 PM
Subject: Hacking the nervous system

To Joyce’s fellow VNS depression patients et al,

I truly hope this note finds you all doing well.

As you well know I have advocated fervently trying to help all those who have benefited and wish to continue with this depression therapy obtain health insurance coverage while also continuing my reading, research, collaborating and advocacy/activism.  I am aware VNS Therapy is still being studied for other medical illnesses as well.  Just today a very dear and long, long, long-time friend Murray shared with me an article that I’d also like to share with you.

While you may be benefiting for purposes of depression there also may be secondary benefits Joyce and you are also accruing unbeknownst to you.  Please take a moment to read the below listed link:

Hacking the nervous system

As always, I wish you all wellness and all the good you’d wish for yourselves.

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

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

Sunday, June 28, 2015

In all fairness and balanced reporting...

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 11:46 PM
Subject: In all fairness and balanced reporting...

To Joyce’s fellow depression patients’ et al.:

As you know I have had through the year’s respectful differences of opinion on several important issues with the executive management of Cyberonics.  At the same time and in all fairness to the management they have always responded promptly to my calls for assistance in helping to achieve wellness for Joyce.

Joyce had a scheduled appointment to see her attending psychiatrist to interrogate her VNS prosthesis tomorrow Monday, June 29, 2015.  I sent an e-mail earlier today (Sunday) to her doctor to remind him to please have the computer equipment available to interrogate Joyce’s implant.  When we returned home later in the evening after dinner his e-mail advised me that apparently the equipment had been stolen and could I assist in obtaining a replacement.

“Sun 6/28/2015 9:38 PM” I sent an e-mail to several executives at Cyberonics enlisting their help.

“Sun 6/28/2015 10:40 PM” I received the following reply from one of Cyberonics executives:

Dear Herb,
I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.

While I may tend to be assertive in my advocacy/activism toward achieving my goals for both Joyce and her fellow patients I also try my best to be reasonably fair and balanced in my blog reporting.

Cyberonics thank you for your attention and speedy response to my request.  More specifically, thank you Bryan.

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

 

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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, June 20, 2015

Hacking the nervous system

© Job Boot

Hacking the nervous system

One nerve connects your vital organs, sensing and shaping your health. If we learn to control it, the future of medicine will be electric. By Gaia Vince.

26 May 2015

When Maria Vrind, a former gymnast from Volendam in the Netherlands, found that the only way she could put her socks on in the morning was to lie on her back with her feet in the air, she had to accept that things had reached a crisis point. “I had become so stiff I couldn’t stand up,” she says. “It was a great shock because I’m such an active person.”

It was 1993. Vrind was in her late 40s and working two jobs, athletics coach and a carer for disabled people, but her condition now began taking over her life. “I had to stop my jobs and look for another one as I became increasingly disabled myself.” By the time she was diagnosed, seven years later, she was in severe pain and couldn’t walk any more. Her knees, ankles, wrists, elbows and shoulder joints were hot and inflamed. It was rheumatoid arthritis, a common but incurable autoimmune disorder in which the body attacks its own cells, in this case the lining of the joints, producing chronic inflammation and bone deformity.

Waiting rooms outside rheumatoid arthritis clinics used to be full of people in wheelchairs. That doesn’t happen as much now because of a new wave of drugs called biopharmaceuticals – such as highly targeted, genetically engineered proteins – which can really help. Not everyone feels better, however: even in countries with the best healthcare, at least 50 per cent of patients continue to suffer symptoms.

Like many patients, Vrind was given several different medications, including painkillers, a cancer drug called methotrexate to dampen her entire immune system, and biopharmaceuticals to block the production of specific inflammatory proteins. The drugs did their job well enough – at least, they did until one day in 2011, when they stopped working.

“I was on holiday with my family and my arthritis suddenly became terrible and I couldn’t walk – my daughter-in-law had to wash me.” Vrind was rushed to hospital, where she was hooked up to an intravenous drip and given another cancer drug, one that targeted her white blood cells. “It helped,” she admits, but she was nervous about relying on such a drug long-term.

Luckily, she would not have to. As she was resigning herself to a life of disability and monthly chemotherapy, a new treatment was being developed that would profoundly challenge our understanding of how the brain and body interact to control the immune system. It would open up a whole new approach to treating rheumatoid arthritis and other autoimmune diseases, using the nervous system to modify inflammation. It would even lead to research into how we might use our minds to stave off disease.

And, like many good ideas, it came from an unexpected source.

 

© Job Boot

The nerve hunter

Kevin Tracey, a neurosurgeon based in New York, is a man haunted by personal events – a man with a mission. “My mother died from a brain tumour when I was five years old. It was very sudden and unexpected,” he says. “And I learned from that experience that the brain – nerves – are responsible for health.” This drove his decision to become a brain surgeon. Then, during his hospital training, he was looking after a patient with serious burns who suddenly suffered severe inflammation. “She was an 11-month-old baby girl called Janice who died in my arms.” 

These traumatic moments made him a neurosurgeon who thinks a lot about inflammation. He believes it was this perspective that enabled him to interpret the results of an accidental experiment in a new way.

In the late 1990s, Tracey was experimenting with a rat’s brain. “We’d injected an anti-inflammatory drug into the brain because we were studying the beneficial effect of blocking inflammation during a stroke,” he recalls. “We were surprised to find that when the drug was present in the brain, it also blocked inflammation in the spleen and in other organs in the rest of the body. Yet the amount of drug we’d injected was far too small to have got into the bloodstream and travelled to the rest of the body.” 

After months puzzling over this, he finally hit upon the idea that the brain might be using the nervous system – specifically the vagus nerve – to tell the spleen to switch off inflammation everywhere.

It was an extraordinary idea – if Tracey was right, inflammation in body tissues was being directly regulated by the brain. Communication between the immune system’s specialist cells in our organs and bloodstream and the electrical connections of the nervous system had been considered impossible. Now Tracey was apparently discovering that the two systems were intricately linked.

The first critical test of this exciting hypothesis was to cut the vagus nerve. When Tracey and his team did, injecting the anti-inflammatory drug into the brain no longer had an effect on the rest of the body. The second test was to stimulate the nerve without any drug in the system. “Because the vagus nerve, like all nerves, communicates information through electrical signals, it meant that we should be able to replicate the experiment by putting a nerve stimulator on the vagus nerve in the brainstem to block inflammation in the spleen,” he explains. “That’s what we did and that was the breakthrough experiment.”

 

© Job Boot

The wandering nerve

Ups and downs in the nervous systemThe vagus nerve starts in the brainstem, just behind the ears. It travels down each side of the neck, across the chest and down through the abdomen. ‘Vagus’ is Latin for ‘wandering’ and indeed this bundle of nerve fibres roves through the body, networking the brain with the stomach and digestive tract, the lungs, heart, spleen, intestines, liver and kidneys, not to mention a range of other nerves that are involved in speech, eye contact, facial expressions and even your ability to tune in to other people’s voices. It is made of thousands and thousands of fibres and 80 per cent of them are sensory, meaning that the vagus nerve reports back to your brain what is going on in your organs.

Operating far below the level of our conscious minds, the vagus nerve is vital for keeping our bodies healthy. It is an essential part of the parasympathetic nervous system, which is responsible for calming organs after the stressed ‘fight-or-flight’ adrenaline response to danger. Not all vagus nerves are the same, however: some people have stronger vagus activity, which means their bodies can relax faster after a stress.

The strength of your vagus response is known as your vagal tone and it can be determined by using an electrocardiogram to measure heart rate. Every time you breathe in, your heart beats faster in order to speed the flow of oxygenated blood around your body. Breathe out and your heart rate slows. This variability is one of many things regulated by the vagus nerve, which is active when you breathe out but suppressed when you breathe in, so the bigger your difference in heart rate when breathing in and out, the higher your vagal tone.

Research shows that a high vagal tone makes your body better at regulating blood glucose levels, reducing the likelihood of diabetes, stroke and cardiovascular disease. Low vagal tone, however, has been associated with chronic inflammation. As part of the immune system, inflammation has a useful role helping the body to heal after an injury, for example, but it can damage organs and blood vessels if it persists when it is not needed. One of the vagus nerve’s jobs is to reset the immune system and switch off production of proteins that fuel inflammation. Low vagal tone means this regulation is less effective and inflammation can become excessive, such as in Maria Vrind’s rheumatoid arthritis or in toxic shock syndrome, which Kevin Tracey believes killed little Janice.

Having found evidence of a role for the vagus in a range of chronic inflammatory diseases, including rheumatoid arthritis, Tracey and his colleagues wanted to see if it could become a possible route for treatment. The vagus nerve works as a two-way messenger, passing electrochemical signals between the organs and the brain. In chronic inflammatory disease, Tracey figured, messages from the brain telling the spleen to switch off production of a particular inflammatory protein, tumour necrosis factor (TNF), weren’t being sent. Perhaps the signals could be boosted?

He spent the next decade meticulously mapping all the neural pathways involved in regulating TNF, from the brainstem to the mitochondria inside all our cells. Eventually, with a robust understanding of how the vagus nerve controlled inflammation, Tracey was ready to test whether it was possible to intervene in human disease.

 

© Job Boot

Stimulating trial

In the summer of 2011, Maria Vrind saw a newspaper advertisement calling for people with severe rheumatoid arthritis to volunteer for a clinical trial. Taking part would involve being fitted with an electrical implant directly connected to the vagus nerve. “I called them immediately,” she says. “I didn’t want to be on anticancer drugs my whole life; it’s bad for your organs and not good long-term.”

Tracey had designed the trial with his collaborator, Paul-Peter Tak, professor of rheumatology at the University of Amsterdam. Tak had long been searching for an alternative to strong drugs that suppress the immune system to treat rheumatoid arthritis. “The body’s immune response only becomes a problem when it attacks your own body rather than alien cells, or when it is chronic,” he reasoned. “So the question becomes: how can we enhance the body’s switch-off mechanism? How can we drive resolution?”

When Tracey called him to suggest stimulating the vagus nerve might be the answer by switching off production of TNF, Tak quickly saw the potential and was enthusiastic to see if it would work. Vagal nerve stimulation had already been approved in humans for epilepsy, so getting approval for an arthritis trial would be relatively straightforward. A more serious potential hurdle was whether people used to taking drugs for their condition would be willing to undergo an operation to implant a device inside their body: “There was a big question mark about whether patients would accept a neuroelectric device like a pacemaker,” Tak says.

He needn’t have worried. More than a thousand people expressed interest in the procedure, far more than were needed for the trial. In November 2011, Vrind was the first of 20 Dutch patients to be operated on.

“They put the pacemaker on the left-hand side of my chest, with wires that go up and attach to the vagus nerve in my throat,” she says. “I waited two weeks while the area healed, and then the doctors switched it on and adjusted the settings for me.”

She was given a magnet to swipe across her throat six times a day, activating the implant and stimulating her vagus nerve for 30 seconds at a time. The hope was that this would reduce the inflammatory response in her spleen. As Vrind and the other trial participants were sent home, it became a waiting game for Tracey, Tak and the team to see if the theory, lab studies and animal trials would bear fruit in real patients. “We hoped that for some, there would be an easing of their symptoms – perhaps their joints would become a little less painful,” Tak says.

At first, Vrind was a bit too eager for a miracle cure. She immediately stopped taking her pills, but her symptoms came back so badly that she was bedridden and in terrible pain. She went back on the drugs and they were gradually reduced over a week instead.

And then the extraordinary happened: Vrind experienced a recovery more remarkable than she or the scientists had dared hope for.

“Within a few weeks, I was in a great condition,” she says. “I could walk again and cycle, I started ice-skating again and got back to my gymnastics. I feel so much better.” She is still taking methotrexate, which she will need at a low dose for the rest of her life, but at 68, semi-retired Vrind now plays and teaches seniors’ volleyball a couple of hours a week, cycles for at least an hour every day, does gymnastics, and plays with her eight grandchildren.

Other patients on the trial had similar transformative experiences. The results are still being prepared for publication but Tak says more than half of the patients showed significant improvement and around one-third are in remission – in effect cured of their rheumatoid arthritis. Sixteen of the 20 patients on the trial not only felt better, but measures of inflammation in their blood also went down. Some are now entirely drug-free. Even those who have not experienced clinically significant improvements with the implant insist it helps them; nobody wants it removed.

“We have shown very clear trends with stimulation of three minutes a day,” Tak says. “When we discontinued stimulation, you could see disease came back again and levels of TNF in the blood went up. We restarted stimulation, and it normalised again.”

Tak suspects that patients will continue to need vagal nerve stimulation for life. But unlike the drugs, which work by preventing production of immune cells and proteins such as TNF, vagal nerve stimulation seems to restore the body’s natural balance. It reduces the over-production of TNF that causes chronic inflammation but does not affect healthy immune function, so the body can respond normally to infection.

“I’m really glad I got into the trial,” says Vrind. “It’s been more than three years now since the implant and my symptoms haven’t returned. At first I felt a pain in my head and throat when I used it, but within a couple of days, it stopped. Now I don’t feel anything except a tightness in my throat and my voice trembles while it’s working.

“I have occasional stiffness or a little pain in my knee sometimes but it’s gone in a couple of hours. I don’t have any side-effects from the implant, like I had with the drugs, and the effect is not wearing off, like it did with the drugs.”

 

© Job Boot

Raising the tone

A nervy way to lose weightHaving an electrical device surgically implanted into your neck for the rest of your life is a serious procedure. But the technique has proved so successful – and so appealing to patients – that other researchers are now looking into using vagal nerve stimulation for a range of other chronic debilitating conditions, including inflammatory bowel disease, asthma, diabetes, chronic fatigue syndrome and obesity.

Gaia Vince describes a device that deals directly with the nervous system to help control obesity.

But what about people who just have low vagal tone, whose physical and mental health could benefit from giving it a boost? Low vagal tone is associated with a range of health risks, whereas people with high vagal tone are not just healthier, they’re also socially and psychologically stronger – better able to concentrate and remember things, happier and less likely to be depressed, more empathetic and more likely to have close friendships.

Twin studies show that to a certain extent, vagal tone is genetically predetermined – some people are born luckier than others. But low vagal tone is more prevalent in those with certain lifestyles – people who do little exercise, for example. This led psychologists at the University of North Carolina at Chapel Hill to wonder if the relationship between vagal tone and wellbeing could be harnessed without the need for implants.

In 2010, Barbara Fredrickson and Bethany Kok recruited around 70 university staff members for an experiment. Each volunteer was asked to record the strength of emotions they felt every day. Vagal tone was measured at the beginning of the experiment and at the end, nine weeks later. As part of the experiment, half of the participants were taught a meditation technique to promote feelings of goodwill towards themselves and others. 

Those who meditated showed a significant rise in vagal tone, which was associated with reported increases in positive emotions. “That was the first experimental evidence that if you increased positive emotions and that led to increased social closeness, then vagal tone changed,” Kok says.

Now at the Max Planck Institute in Germany, Kok is conducting a much larger trial to see if the results they found can be replicated. If so, vagal tone could one day be used as a diagnostic tool. In a way, it already is. “Hospitals already track heart-rate variability – vagal tone – in patients that have had a heart attack,” she says, “because it is known that having low variability is a risk factor.”

The implications of being able to simply and cheaply improve vagal tone, and so relieve major public health burdens such as cardiovascular conditions and diabetes, are enormous. It has the potential to completely change how we view disease. If visiting your GP involved a check on your vagal tone as easily as we test blood pressure, for example, you could be prescribed therapies to improve it. But this is still a long way off: “We don’t even know yet what a healthy vagal tone looks like,” cautions Kok. “We’re just looking at ranges, we don’t have precise measurements like we do for blood pressure.” 

Bioelectric dreamsWhat seems more likely in the shorter term is that devices will be implanted for many diseases that today are treated by drugs: “As the technology improves and these devices get smaller and more precise,” says Kevin Tracey, “I envisage a time where devices to control neural circuits for bioelectronic medicine will be injected – they will be placed either under local anaesthesia or under mild sedation.”

Treating disease could become far more precise by using bioelectronics rather than drugs.

However the technology develops, our understanding of how the body manages disease has changed for ever. “It’s become increasingly clear that we can’t see organ systems in isolation, like we did in the past,” says Paul-Peter Tak. “We just looked at the immune system and therefore we have medicines that target the immune system.

“But it’s very clear that the human is one entity: mind and body are one. It sounds logical but it’s not how we looked at it before. We didn’t have the science to agree with what may seem intuitive. Now we have new data and new insights.”

And Maria Vrind, who despite severe rheumatoid arthritis can now cycle pain-free around Volendam, has a new lease of life: “It’s not a miracle – they told me how it works through electrical impulses – but it feels magical. I don’t want them to remove it ever. I have my life back!”

http://mosaicscience.com/story/hacking-nervous-system