Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Thursday, November 28, 2013

“In order to fulfill regulatory and compliance processes, we are required to remove material from the VNS Therapy Fan Page that promotes off-label information about VNS Therapy.”

To the VNS Facebook Site Administrator for Cyberonics,

I thank you for taking your valuable time in an attempt to clarify and explain to me why my comment to your webpage was removed, “promotes off-label information about VNS Therapy.”

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As often happens dialog of this nature prompts me to further research to better my understanding. I’m fascinated when I’m confronted with “legalize” such as “In order to fulfill regulatory and compliance processes.” Exactly what regulatory and compliance statues are you referring to? Is this something akin to “anti-kickback statues” to avoid doing what is morally correct? Never mind, disregard the last question.

I researched the definition of “promote” and copied and pasted the definition below:

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http://www.oxforddictionaries.com/us/definition/american_english/promote

Quite frankly I’ll have to disagree with your use of the word “promotes” as I’ve not ever promoted any therapy, treatment, company, product etc.

Through the years I’ve engaged in and attempted to share information based upon our own experiences, my readings, research and collaborations with both patients and physicians.

Unfortunately you did not elaborate as to which of my pieces of shared information “promotes off-label information about VNS Therapy.”

If anything, my comments about the lack of recognition of the “Unwanted stepchildren of Cyberonics” the depression patients should be a wakeup call to you and Cyberonics of the disgraceful omission and disregard you folks continue to exhibit.

These patients utilize the very same device that you sell for the epilepsy patients. You address topics rightfully so for the epilepsy patients but with outright total disregard for the depression patients and some of their unique issues. One of those issues is the use of ECT which I took the liberty to address and not “promotes”. It is shameful that instead of instituting valid discussions for the depression patients you address this issue by pulling out of the hat and responding to me with “regulatory and compliance processes.” Absolute non-sense on your part as through the years I’ve had discussions with some of the very same researchers you guys originally enlisted for the depression studies. Add to which here’s additional information that you folks should be posting and sharing for informational purposes and not me.

Concomitant use of vagus nerve stimulation and electroconvulsive therapy for treatment-resistant depression.

Concomitant Use of Maintenance ECT and Vagus Nerve Stimulation for More Than 10 Years in Treatment-Resistant Depression

Did you ever think of posting a discussion about the use of VNS Therapy and TMS (Transcranial Magnetic Stimulation)? Did you ever think of posting a discussion about VNS Therapy for the epilepsy patient and the use of ECT as noted in the ladder link cited above? These topics are not promoting anything off-label but are real-time life issues ignored by you folks.

I read you’re “About” section as you suggested. I have to chuckle. You speak about promoting and yet you continue to write about “treatment-resistant depression”. Maybe you missed the fact there is no formal diagnosis in the DSM IV and was similarly stated in CMS determination of May 4, 2007.

“These various indications that have been proposed for VNS illustrate that the term ”treatment resistant depression” lacks a standard definition that has been scientifically validated, and appears to be subject to various interpretations.”

Your company’s lack of acknowledgement as to the existence of the depression patient population of VNS is obscene and an abomination. While your company’s ability to generate gross profit margins of about 89 to 90% is outstanding, widely promoted in the financial community, your public relations and treatment of these your depression patients is markedly pitiful.

At the very least I’ll thank you once again for the courtesy of your responding and wish you and yours a very Happy and Peaceful Thanksgiving.

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

Wednesday, November 27, 2013

The “Unwanted stepchildren of Cyberonics” share some interesting information “pill-cam” endoscopy…

From: Kimberly Meek [mailto:k.meek@mac.com]
Sent: Wednesday, November 27, 2013 9:00 AM
To: Herbert Stein
Subject: Re: I think I hit a Cyberonics nerve today?

Hi Herb,

Glad you are hitting some nerves!  Keep it up.

Just so you know, I recently had a small "pill-cam" endoscopy -- where the patient swallows a "pill" that is about the size of a large vitamin and it has a camera and lights in it.  It takes about 40,000 photos of your entire intestinal tract as it makes its way through.  Because the images are transmitted wirelessly to a belt I had to wear, I asked my doctor to check with Cyberonics.  He was able to get through to them (surprise!) and they said that the VNS should be "zero-ed out."  I guess that means turned off.  

So I went to my psychiatrist to have it zero-ed out the day before my pill-cam procedure, and that is when we discovered that my battery was near the end of service.

Anyway, just in case anyone ever asks you, the VNS should be turned off for "pill-cam" endoscopies.

Have a Happy Thanksgiving.  I am most thankful for you & Joyce.

--Kim

 

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, November 27, 2013 11:08 AM
To: 'Kimberly Meek'
Subject: RE: I think I hit a Cyberonics nerve today?

Dear Kim,

Thank you for the information.  That is an interesting piece of news.

May I be allowed to share your email to me in its entirety?

Sincerely,

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: Kimberly Meek [mailto:k.meek@mac.com]
Sent: Wednesday, November 27, 2013 12:19 PM
To: Herbert Stein
Subject: Re: I think I hit a Cyberonics nerve today?

Sure, no problem!
Sent from my iPhone

 

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, November 27, 2013 12:29 PM
To: 'Kimberly Meek'
Subject: RE: I think I hit a Cyberonics nerve today?

Kim,

Thanks for contributing to our combined knowledge.

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.

Tuesday, November 26, 2013

I think I hit a Cyberonics nerve today?

image

 

I think I hit a Cyberonics nerve today?  I responded earlier in the day to the above topic on Cyberonics Facebook page.  They removed my comment.

As best I could remember I posted:

This is a very good topic and one which should also be read by the “Unwanted stepchildren of Cyberonics” the depression patients.  Although the swiping of the magnet does not really apply to the depression patients the fact the magnet placed over the prosthesis and held in place will deactivate the device applies to both epilepsy and depression patients.

What Cyberonics also does not address and that which I recently learned from another depression patient was the fact that Cyberonics would not answer the patient’s doctor when asked about deactivating the device for ECT.  What I can share from my own knowledge and experiences as a long-time support person for Joyce is that ECT is a reasonably safe adjunctive treatment for a VNS patient provided the attending physician tapes the magnet in place directly over the prosthesis prior to administering ECT.  Once the ECT procedure is completed the magnet could then be removed and the device should immediately reactivate and resume its normal 24/7/365 cycle.

Cyberonics also does not address the issue of a lost, stolen or broken magnet.  At one time Cyberonics did replace the magnets free of charge.  I do not know Cyberonics current policy.  I think the site administrator is better qualified to answer that question.  I also know that both the epilepsy and depression patients could Google “cow magnets” which from my readings work just as well and are relatively inexpensive.

From my readings the subject of cardiac arrest and the use of the magnet should also have been addressed.  What I’ve learned is that “SAVING A LIFE COMES FIRST” and if defibrillation of the patient is necessary “SAVE A LIFE” and do not worry about the magnet and deactivating the prosthesis.  If the VNS is fried so be it.  The VNS can be replaced; the individual cannot.

I would also like to suggest to the Cyberonics Facebook site administrator discussing the topic of “Warnings and Precautions”.  Too often patients and/or their support persons do not carefully read the manuals.  This is a topic that both epilepsy and depression patients should be reasonably knowledgeable about for safety purposes.

That’s the extent of my transgression(s).

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

Monday, November 25, 2013

Cyberonics stepchildren are speaking up…

From: Eric Eisinger [mailto:erhalt1@aol.com]
Sent: Monday, November 25, 2013 9:27 PM
To: Herbert Stein
Subject: Re: An “Unwanted stepchild of Cyberonics” speaks up.

What's amazing is that Cyberonics doesn't want to be a spokesperson for their IMPLANTED patients.  They were advocating while we were being implanted. 

Cyberonics has turned their back on their depression patients by not fulfilling it's promise to it's IMPLANTED patient's.  Thanks Herb for being our patient advocate!
Eric Eisinger

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, November 25, 2013 9:35 PM
To: 'Eric Eisinger'
Subject: RE: An “Unwanted stepchild of Cyberonics” speaks up.

Eric,

May I be allowed to share your email publicly?

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: Eric Eisinger [mailto:erhalt1@aol.com]
Sent: Monday, November 25, 2013 9:38 PM
To: Herbert Stein
Subject: Re: An “Unwanted stepchild of Cyberonics” speaks up.

Anytime Herb!
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, November 25, 2013 9:39 PM
To: 'Eric Eisinger'
Subject: RE: An “Unwanted stepchild of Cyberonics” speaks up.

Thank you.

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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.

An unwanted stepchild of Cyberonics speaks up…

From: Julie Ottaviani [mailto:julieottaviani@aim.com]
Sent: Monday, November 25, 2013 8:32 PM
To: fabrik@bellsouth.net
Subject: Re: "Unwanted stepchildren of Cyberonics"

Thank you for giving us a name Herb.  At least now we can be recognized as a unique and individual group associated with Cyberonic's.  Shame on Cyberonic's for not acknowledging it's children who are promoting their product by continued good health.  I for one am proud to be called an Unwanted stepchild of Cyberonics for at least our group now has a name.
Contunued Good Health to All,
Julie Ottaviani
You have my permission to use this email in anyway you choose.

Julie Ottaviani
julieottaviani@aim.com

"Unwanted stepchildren of Cyberonics"

I might as well join in.

Thanks to Dr. Paul Goodnick (formerly with the University Of Miami School Of Medicine) for sending Joyce and me to Dr. Mark George at MUSC (Medical University of South Carolina) and for his allowing Joyce into the initial depression (D-01) study even though we were residents of Florida.

Thanks to the former CEO, Robert (Skip) Cummins for reaching out and training Joyce’s current attending psychiatrist Dr. Ely Pelta before the depression indication was approved by the FDA so a trained physician could attend to her needs. Thanks to Dr. Pelta for working with us and helping to maintain Joyce’s wellness. And thanks again to Skip for pushing for the FDA approval.

I extend a special thank you to Dr. Daniel Schultz for overriding his underlings at the FDA and for his practical hands-on patient care and medical knowledge and understanding of these patient’s desperate needs and for his approving the therapy for depression despite all the pressures against him.

I also extend a special thank you to Mr. Jonathan Blum, Deputy Administrator and Director for CMS and Ms. Amy Larrick, Senior Advisor to the Principal Deputy Administrator and their staff for also understanding the desperate needs of this small group of implanted patients and assisting these patients in obtaining medical coverage.

Lastly, I certainly am thankful for Cyberonics having developed this therapy as it has truly been remarkable in maintaining Joyce’s wellness. Other than developing the therapy and also significantly benefiting the epilepsy patient population I am extremely disappointed in Cyberonics current and total lack of acknowledgement of the existing depression patients by mere fact there is no significant mention of their existence either on their corporate website or this Facebook website and so I refer to these patients as the “Unwanted stepchildren of Cyberonics”.

Sad as it may be a number of these "Unwanted stepchildren of Cyberonics" also publicly represented Cyberonics at lectures and other events and when called upon for help Cyberonics turned their backs on these very same people with what I consider a very lame excuse. Tsk, tsk, tsk!

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

Thursday, November 21, 2013

A communication recently received from one of the stepchildren…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, November 21, 2013 2:00 PM
Subject: Another illustration of Cyberonics disgraceful approach to their depression patients...

I just recently received an email from one of Cyberonics depression patients with whom I collaborate, amongst a number of patients.  I’d like to share with you the below communication after having received permission to do so.  In this instance I have redacted certain personal information but the context of the communication is self-explanatory.

In my opinion, I believe Cyberonics continues to disgracefully not acknowledge or address publicly the existence of this small population of depression patients implanted prior to CMS decision on or before May 4, 2007.  Worse yet I personally feel that Cyberonics also does a piss poor job of staying in touch with these patients as well as inadequately informing and answering questions from their attending physicians.

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: (redacted) (redacted) [mailto:(redacted)]
Sent: Thursday, November 21, 2013 10:25 AM
To: Herbert Stein
Subject: Re: CYBX

Get them herb!!

This (redacted) started ect yesterday, 1 treatment kind of rough!  11 more to go.  The attending dr called cyberonics for an opinion on weather to keep vns on or off while being treated.  Guess what no answer.  Nice to know they aren't just communicating with their clients, but even their dr are not getting answers.

As always thanks for your help, you are a champion to the ones crippled by this terrible disease.

Sincerely 

(redacted) (redacted)
Sent from my iPhone

On Nov 21, 2013, at 10:17 AM, "Herbert Stein" <fabrik@bellsouth.net> wrote:

Dear Dan,

Congratulations on another outstanding financial quarter.  Your stewardship of Cyberonics is to be highly commended.

On today’s financial teleconference a sole analyst asked a brief question about the depression indication.  It is amazing to me to hear how little informed or aware the financial community is as it relates to the depression indication.  This fact doesn’t surprise me as your company seemingly makes no effort or mention of the recent informal change of position by CMS toward those depression patients implanted on or before May 4, 2007 on either your corporate website or Facebook and as I’m finding so too are many attending physicians uninformed.

As a side note I also find it interesting that I am recently denied participation on your teleconferences especially knowing the fact that the therapy has been remarkably beneficial for my spouse and that in the past I was also allowed to participate and to pose questions to management.

As always, I wish you and yours wellness and continued success at your endeavor.

Sincerely,

Herb

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.

The stepchild doesn’t exist in some minds…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, November 21, 2013 10:17 AM
To: Daniel Moore, CEO - Cyberonics
Subject: CYBX

Dear Dan,

Congratulations on another outstanding financial quarter.  Your stewardship of Cyberonics is to be highly commended.

On today’s financial teleconference a sole analyst asked a brief question about the depression indication.  It is amazing to me to hear how little informed or aware the financial community is as it relates to the depression indication.  This fact doesn’t surprise me as your company seemingly makes no effort or mention of the recent informal change of position by CMS toward those depression patients implanted on or before May 4, 2007 on either your corporate website or Facebook and as I’m finding so too are many attending physicians uninformed.

As a side note I also find it interesting that I am recently denied participation on your teleconferences especially knowing the fact that the therapy has been remarkably beneficial for my spouse and that in the past I was also allowed to participate and to pose questions to management.

As always, I wish you and yours wellness and continued success at your endeavor.

Sincerely,

Herb

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

Saturday, November 16, 2013

Caring physician helping to educate and expedite VNS replacement for depression patients.

Through the years Joyce and I have been extremely fortunate to have collaborated with some truly compassionate, caring KOL’s (Knowledgeable Opinion Leaders) both in the field of Psychiatry as well as other related practices. During that time I have shared what I’ve learned both on and off the record and where I’ve been allowed I’ve also publicly shared correspondence and/or quotes.

I’ve recently been corresponding with and received a reply (see below) from another distinguished medical professional in response to my recent posting “Expediting the VNS replacement surgery for the depression patient” that I would like to share.

I do so in the hope that other professionals reading my messages and advocacy share with their respective colleagues and that Cyberonics management understands and conveys this important message throughout their organization to help the depression patients who continue utilizing their device and therapy and they too quickly get the message cited above into the hands of all the physicians and depression patients they attend to.

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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From: Fernandez, Francisco [mailto:ffernand@health.usf.edu]
Sent: Saturday, November 16, 2013 4:54 AM
To: Herbert Stein
Subject: RE: Expediting the VNS replacement surgery for the depression patient.

Outstanding … I have forwarded to all the neurosurgeons and vascular surgeons I work with. Keep up the  GREAT work! Frank

Francisco Fernandez, M.D. 

Professor and Chair

Department of Psychiatry and Behavioral Neurosciences

USF Health - Morsani College of Medicine

Professor, Department of Community and Family Health

USF Health - College of Public Health

Tampa, Florida 

P:  (813) 974-1437

F:  (813) 974-3236

Friday, November 15, 2013

Expediting the VNS replacement surgery for the depression patient.

To all VNS depression patients and their attending physicians,

Word trickles back to me by way of my collaborations with both patients and physicians and I’d like to share the following information in order to help expedite the replacement process and lessen the stress and anxiety on the patients.

The patient should first make arrangements for replacement of the VNS prosthesis through his/her attending surgeon and/or hospital facility. Should there be any initial question as to whether or not the patient’s health insurance covers the procedure the patient should direct the surgeon and/or hospital facility to contact:

MAC (Medicare Administrative Contractor) in the local region and have the physician and/or hospital ask MAC if the particular patient’s procedure would be coverable.

This from my understanding would be a normal procedure. The hospitals and doctors I am told are very familiar with this process and they should receive a reasonably quick response.

At that time should there be any questions or issues obtaining coverage I would then recommend calling Ms. Amy Larrick with all the pertinent information as stated in my earlier posting.

It is my understanding that CMS has been reaching out to MAC (Medicare Administrative Contractor) in the local regions so that these regional offices are covering Medicare/Medicaid and Medicare Advantage insured subscribers. I’ve also learned that CMS has no control over private health insurance carriers although they generally follow the guidance of CMS. CMS will help go to bat for those patients with private insurance who encounter similar coverage difficulties. I learned of a patient whose husband had insurance coverage through his workplace and CMS did assist that patient.

I’ve also learned from several patients that CMS has been honoring their word and when necessary have assisted the VNS depression patients. A number of patients have informed me that they have already undergone surgery and received their replacement prosthesis.

Once again, see your surgeon and/or hospital facility first to schedule the replacement procedure. They should contact MAC for patient coverage acknowledgement. If there remains any coverage issues then contact Ms. Larrick.

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

Thursday, November 14, 2013

An interesting surgical question and professional response…

Through the years that I have been involved with VNS Therapy for depression I have been extremely fortunate to have the aid of many expert and knowledgeable medical professionals who have taken of their valuable time to answer my questions, further educate me in my support and advocacy for Joyce and other patients, and depending upon the circumstances have allowed me to share their responses publicly or otherwise.

Once again, I would like to thank Dr. Werner Doyle for his prompt response to a question asked of me just recently by another VNS depression patient. I was unable to share any of my knowledge on the subject. Dr. Doyle has now shared his expertise and thoughts and I in turn share with you the readers in the following email communications.

Sincerely,

Herb

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, November 13, 2013 4:09 PM
To: Dr. Badih Afif Adada; Dr. Werner Doyle; Dr. Istvan Takacs
Subject: VNS Surgical Question...

Dear Drs. Adada, Doyle and Takacs,

I was recently questioned by a VNS patient for depression.  One of the very few times I was not qualified or knowledgeable and therefore unable to answer the question factually so I am turning to you fellows for assistance.

I would appreciate if any of you outstanding surgeons could answer my question and if at the same time you would allow me to publicly share your respective response(s) and information?

The patient is coming due for a replacement generator.  The patient was originally implanted with a single incision just below the left collarbone.  At the time of replacement for this particular patient would the operating surgeon handling the replacement surgery re-enter through the exact same incision to remove and replace the existing pulse generator or would the surgeon have need to create a new entry point?

Your knowledgeable responses would be gratefully appreciated.

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: Werner Doyle [mailto:wkd1@nyu.edu]
Sent: Thursday, November 14, 2013 6:48 AM
To: Herbert Stein
Subject: Re: VNS Surgical Question...

Dear Mr. Stein,

Generally revisions (replacements, etc.) are performed through the same incision. I never favored the single incision procedure since it is located  in a cosmetically unacceptable location, requires that the incision be much larger than the alternative approaches, and one can not if appropriate place the generator subpectorally. The single incision is just not cosmetically good nor is it surgically efficient. It is not possible to be completely sure about how to approach this issue unless I see the incision and the specific anatomical circumstance. Most likely replacing the generator is an easy task by using the old incision line.

Best,

Werner Doyle

Thursday, November 7, 2013

Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity.

PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221.

Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity.

Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD.

Source

Department of Human Biology, School for Nutrition, Toxicology and Metabolism - NUTRIM, Maastricht University Medical Center, Maastricht, The Netherlands ; Department of General Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.

Abstract
BACKGROUND:

Human brown adipose tissue (BAT) activity is inversely related to obesity and positively related to energy expenditure. BAT is highly innervated and it is suggested the vagus nerve mediates peripheral signals to the central nervous system, there connecting to sympathetic nerves that innervate BAT. Vagus nerve stimulation (VNS) is used for refractory epilepsy, but is also reported to generate weight loss. We hypothesize VNS increases energy expenditure by activating BAT.

METHODS AND FINDINGS:

FIFTEEN PATIENTS WITH STABLE VNS THERAPY (AGE: 45±10yrs; body mass index; 25.2±3.5 kg/m(2)) were included between January 2011 and June 2012. Ten subjects were measured twice, once with active and once with inactivated VNS. Five other subjects were measured twice, once with active VNS at room temperature and once with active VNS under cold exposure in order to determine maximal cold-induced BAT activity. BAT activity was assessed by 18-Fluoro-Deoxy-Glucose-Positron-Emission-Tomography-and-Computed-Tomography. Basal metabolic rate (BMR) was significantly higher when VNS was turned on (mean change; +2.2%). Mean BAT activity was not significantly different between active VNS and inactive VNS (BAT SUV(Mean); 0.55±0.25 versus 0.67±0.46, P = 0.619). However, the change in energy expenditure upon VNS intervention (On-Off) was significantly correlated to the change in BAT activity (r = 0.935, P<0.001).

CONCLUSIONS:

VNS significantly increases energy expenditure. The observed change in energy expenditure was significantly related to the change in BAT activity. This suggests a role for BAT in the VNS increase in energy expenditure. Chronic VNS may have a beneficial effect on the human energy balance that has potential application for weight management therapy.

TRIAL REGISTRATION:

The study was registered in the Clinical Trial Register under the ClinicalTrials.gov Identifier NCT01491282.

PMID:
24194874
[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/24194874

Sunday, November 3, 2013

Moral responsibility belongs to all parties...

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, November 03, 2013 4:29 PM
To: Daniel Moore, CEO - Cyberonics
Subject: Moral responsibility belongs to all parties...

Dear Dan,

Now that things have calmed down I’ve had a chance to also think about and reflect on the lack of morals and the egregious nature that your company has demonstrated toward the depression patients implanted with your company’s medical device.

CMS has recognized and acted appropriately to correct their lack of grandfathering care to these very same patients as evidenced by Mr. Jonathan Blum’s decision to help insure medical coverage and care for all the implanted patients on or prior to the May 4, 2007 national decision to deny.  Yet and in my opinion your company and you as CEO have exhibited no such appropriate morals or humanist concerns.  In my opinion, you’ve treated the depression patients more as pariahs than patients and/or consumers utilizing your FDA approved medical device.

Yes, I’ve had conversation with your executives as well as patients and have learned that your representatives are now beginning to make calls on the physicians alerting them and that your nurse case managers are also aware of Mr. Blum’s – CMS recent decision benefiting the depression patients.  The fact still remains in all this time there is absent any information about the depression patients (pariahs) on both your Cyberonics Corporate website and social media site on Facebook.

The fact your company obtained FDA approval and was denied national coverage by CMS, in my opinion, was no reason to ignore your company’s moral and humanist responsibility to these patients.  The fact that your company reneged on its published statement of January 18, 2006 to promise “Lifetime Reimbursement Guarantee” to the depression study subjects is further evidence of the egregious lack of responsibility and moral character of your company not only to the study subjects but all the depression patients as well.  To add fuel to this subject of lack of moral judgment and responsibility you never replied to my retort to you that “kickback statues” which was truly a lame and irresponsible justification to not care for the study subjects, in my opinion.  As it turned out your actions or properly lack of effective action and failed second attempt at approval in May 2013 was the impetuous to start my campaign and advocacy to obtain coverage for the study subjects which then continued to grow as I received patient emails questioning “what about me”.  Finally I was able to obtain medical coverage for all the implanted patients prior to the cut-off date simply because it was a moral wrong and egregious negligent oversight not only on the part of CMS, but all those individuals at the FDA, Cyberonics etc. who established the study protocol and allowed for this egregious loophole.

I shall continue to advocate and make study subjects aware to not volunteer for any study unless they are guaranteed medical care by the sponsor up and until CMS approval.

I have a niece who works for Genentech who indicated to me this fiasco would never have been allowed by her company.  They care for their study subjects throughout and encourage patient and citizen advocacy groups.  I am aware of a couple of depression patients who advocated and were spokespersons on behalf of your company for the depression therapy and once the denial was issued by CMS not only were they dropped like a scolding iron in hand, Cyberonics did little or nothing to aid these advocates when they requested replacement surgery.  Need I say more as to the deplorable way your company has addressed this depression patient population; consumers of your product.  I have much respect for Dr. Daniel Schultz, Mr. Skip Cummins and Mr. Jonathan Blum for their understanding and moral responsibilities to do the right thing for these patients.

I have expressed numerous times my sincere admiration of your financial stewardship of Cyberonics to rescue the corporation from disaster but you, in my opinion, have failed miserably as it relates to social responsibility, humanism, morals and truly understanding the challenges of this severely ill depression population and the users of your product.  Your offering a free prosthesis to these patients so long as they put the rest of the package together for free, in my eyes, is sadly laughable and demonstrates your truly lacking understanding of the patient population your addressing.  I strongly believe CMS change of position was not so much governed by statistics and crunching numbers in a computer but moral responsibility to do the right thing.  On the other hand I also feel strongly that Cyberonics remains focused, with tunnel vision and a corporate mentality, solely about money and has failed miserably to understand the human equation and true suffering of these patients.  Your corporation could have done a lot better than it has.

I think it time to change the corporate mindset at Cyberonics and that these existing patients should be acknowledged with the same understanding and PR as you place toward the Epilepsy community.  The fact that your sales may not be significant for the depression indication as a result of the May 4, 2007 determination should not have diminished your responsibility to the existing patients.  You’ve now obtained an unforeseen and unexpected bonus in that you won’t have to offer free devices to those depression patients benefiting from the therapy as their costs will be covered by medical insurance and in turn you’ll profit.

I mentioned it previously when I responded to your email about citing “kickback issues” that the depression indication would never had made it to the FDA had not the study subject patients themselves presented a compelling and humanistic advocacy in terms of response, efficacy and improved quality of life to the FDA panel of experts who agreed with the patients and then voted favorably.

I think it time you acknowledged the fact these patients exist and should finally be included on your corporate and social media websites.  I also think, in the future, as I have recently learned the importance, strength and impact that can be exerted by citizenry advocacy groups that your company might better learn how to utilize this asset.

As always, I wish you and yours wellness and continued success.

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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