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Saturday, September 28, 2013

VNS Therapy for Depression - GOOD NEWS

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, September 28, 2013 8:48 AM
To: Amy Larrick (CMS/CM); Jonathan Blum, Deputy Administrator Director - CMS
Cc: Madam Secretary Kathleen Sebelius - HHS
Subject: VNS Therapy for Depression - GOOD NEWS

To all of Joyce’s fellow implant patients,

I’d like to share some very good news with y’all.  I am tardy in my distribution of this news.  To add to all my challenges my computer hard disk is malfunctioning so I’m limping along as best I can until I receive my new computer and get back up to speed.

In any event I wish to relate the following.  Thursday, September 26, 2013, I spoke with Ms. Amy Larrick | Senior Advisor to the Principal Deputy Administrator | Centers for Medicare & Medicaid just before she was leaving on vacation.  Our telephone conversation was “On the record” but I was asked to not record the conversation or to quote directly from what was stated.  Once again, I shall honor that request.  Therefore I shall share my understanding and interpretation of what was presented to me. 

Mr. Jonathan Blum, Ms. Amy Larrick and others members of CMS, in my opinion, are understanding and compassionate of our Catch-22 situation and wish to genuinely help our unique patient population as best they can.  Apparently there will not be any formal directive or document issued but in my opinion of more benefit is that there is an offer by CMS staff to assist directly, patients like my spouse Joyce and others, on a case by case basis to obtain Medicare/Medicaid or private health insurance coverage for the care or replacement or explanting of the prosthesis for those patients implanted on or before May 4, 2007.

I have been allowed to share the individual’s name and contact information at CMS:

Ms. Amy Larrick | Senior Advisor to the Principal Deputy Administrator | Centers for Medicare & Medicaid

202-690-5742 D.C.

410-786-2585 Balt.

amy.larrick@cms.hhs.gov

Any implanted depression patient needing assistance must be prepared to supply the following information when contacting Ms. Amy Larrick:

One’s Name

Medicare number (from one’s Medicare Card)

Email address

Telephone number

I thanked her as I knew she personally was working on expediting Joyce’s needs through the bureaucratic system.  At the same time I told her there were several others who were in dire straits and needed immediate assistance.  Amy personally told me upon completion of our conversation she would also immediately contact several of the individuals who shared publicly with us all their serious circumstances.  I must state that I did contact these individuals to see if in fact they were contacted.  I wish to report that both Ms. Larrick and Mr. Blum have lived up to their words and commitments for which I am truly grateful.

To the physicians whom I blind copy in my many messages I would encourage y’all to pass along this information to the patients you attend to and to please spread the word.

I have some other thoughts which I wish to share Jonathan and Amy but for now the computer has gotten me this far and I did want to share what I consider “Good News”.

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://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.

Tuesday, September 24, 2013

Putting a brake on depression with deep brain stimulation

Putting a brake on depression with deep brain stimulation

 

A pioneering treatment (DBS) is bringing hope to the many sufferers - like Bruce Ross - whose disorder is resistant to drugs and other common therapies

Rewired: the new treatment, known as DBS, involves either stimulating or inhibiting neural activity<br />

Rewired: the new treatment, known as DBS, involves either stimulating or inhibiting neural activity

Tom Chivers

By Tom Chivers

9:07PM BST 22 Sep 2013

Comments4 Comments

Bruce Ross was depressed for nearly 40 years. “I’d had it since early high school,” he says. “But this was the Seventies, and depression wasn’t really talked about, so I didn’t know what it was.” Mr Ross, a gentle-voiced 53-year-old Canadian credit union executive, battled alone against his unknown enemy for two decades. He even tried moving home, 1,200 miles from Nova Scotia, to Chatham, Ontario, to shake off his mystery ailment. Nothing helped: “I found that my problems followed me wherever I went.”

In the late Nineties, a doctor finally diagnosed clinical depression. Anti-depressants did not shift it, although he tried more than a dozen types; neither did psychotherapy, nor electroconvulsive therapy (ECT). By this time, he was married with a young daughter. “My psychiatrist said I was the most treatment-resistant patient he’d ever seen,” he says, “although I’m not sure that’s a badge of honour.” At one stage, Ross found himself on the fifth floor of a multi-storey car park, wondering whether it was time to end it all. “I don’t think I’d have ever gone through with it, but there were definitely times I thought about it.”

Two years ago, Mr Ross learnt about a pioneering approach to treatment-resistant depression being trialled at the University of Toronto. Called deep brain stimulation (DBS), it involves inserting tiny electrodes, attached to a battery implanted below the collarbone, to target areas deep inside the brain. The electrodes act, loosely speaking, as a brain pacemaker, transmitting high frequency, continuous electrical impulses that, depending on where they are placed, can either inhibit or stimulate neural activity. Desperate for some relief, Mr Ross agreed to take part. “I wasn’t at all nervous,” he says. “By that stage, I was pretty desperate. I just wanted it done.”

DBS is already used for intractable Parkinson’s disease and also chronic pain. For intractable depression, the research is still at an early stage – but according to Prof Andres Lozano, the Toronto neurosurgeon who operated on Mr Ross, studies show it can improve symptoms in 60 per cent of such cases.

About 10 to 20 per cent of depressed patients are resistant to conventional treatments, he points out. “These patients are severely disabled,” he says, “and at significant suicide risk.”

 

Like all brain surgery, the operation is carried out while the patient is conscious, so that surgeons can be sure no brain damage is being inflicted. It involves drilling a half-inch hole in the skull and placing the electrodes in the target area. A battery is fitted just below the skin in a separate operation, with the lead connecting it to the electrodes running up the side of the neck to the head.

Prof Helen Mayberg, a neurologist at Emory University in Atlanta, Georgia, is one of the leading researchers in the field and carried out the first DBS on a patient with depression in 2005. In Parkinson’s, she says, researchers had identified the right target area: a motion circuit associated with structures called basal ganglia was found to be hyperactive, causing the typical symptoms of the disease, such as tremor. Blocking certain areas on this circuit with an electrical impulse was found to dampen down the circuit, and mitigate symptoms.

“We took the principle of the Parkinson’s treatment and applied it to depression,” says Prof Mayberg. Years of medical imaging, she says, have shown several parts of the brain that are involved in mood disorders. “We hypothesised that a brain region called Area 25, which is part of the cingulate region, was the problem.” Researchers experimented by using electricity to “turn down” activity in this area. “Same process as in Parkinson’s but a different spot.”

“Area 25 is connected to areas related to sleep, motivation, reward and pleasure,” adds Prof Lozano. “Think of your car. You have an accelerator but you also have a brake. Similarly, the brain has 'excitatory’ and 'inhibitory’ circuits. In depression, the sadness circuits are stuck on full throttle. We’re stimulating the inhibitory circuit, stepping on the brake.”

And stepping on the brake seems to work. Far more research is needed, but the small studies that have been published – including the trial Mr Ross took part in, published recently in the Journal of Neurosurgery – “have built up a fairly substantial body of evidence” in its favour, according to Prof Mayberg. Of the 21 patients that took part, nearly two thirds had a 40 per cent or more reduction in symptoms at 12 months.

“With treatment of Area 25, if you get better, you stay better,” says Prof Mayberg. And when it works, it’s dramatic, “like flipping a switch”, according to Prof Lozano. The “million-dollar question”, he says, is why some patients do not get better. “One possibility is that they have a different disease, that we call it depression but the basis of it is different. Another is that the brain wiring is different, that we’re not hitting the appropriate spot.”

In the UK, researchers led by Dr Andrea Malizia, a psychiatrist at the University of Bristol, are looking at whether treating brain regions other than Area 25 might work for these non-responsive patients. “It’s far too early to say,” he says, warning that the research is still unpublished, “but what we’ve found suggests that some people don’t respond to stimulation in one area and do respond to stimulation in another.”

So far, the procedure has been carried out in just a few hundred patients with depression, but researchers hope it will become more widely used. “The costs of depression to an individual, to a family, to society, are considerable. No one wants unnecessary brain surgery, but if the procedure is shown to be safe, then it should be an option,” says Prof Mayberg.

There are, of course, risks – including the possibility of the current spreading to neighbouring regions of the brain, causing side effects such as mania or panic – as have been seen in Parkinson’s patients. “If you make a hole in someone’s skull, there are risks,” says Prof Mayberg. Dr Malizia also notes that DBS may be similar to some other treatments for depression, in which people become more motivated and energetic, but are still extremely depressed, making them a higher suicide risk.

Nevertheless, DBS represents a “paradigm shift” in thinking about depression and brain disorders, says Prof Mayberg. “We used to think of depression as a weakness of character, and thank God we got rid of that,” she says. “Then we started thinking of it as a chemical imbalance. But your brain is not a bowl of soup, add salt and stir. It’s a wiring network of billions of neurons organised into units, choreographed, communicating with each other with exquisite precision. Now, we’re thinking in those terms.” DBS for other conditions, such as obsessive-compulsive disorder and epilepsy, is also being investigated.

Two years in, Bruce Ross is delighted with the result. “Before the surgery, I’d have described my life as a four out of 10,” he says. “Since then, I’d say I’m a seven. I don’t think I’ll ever be a nine or a 10, but is anybody? I sleep better, my appetite’s better. I feel more relaxed, I’m more motivated at work. Would I recommend it to others? Absolutely.”

http://www.telegraph.co.uk/health/10327129/Putting-a-brake-on-depression-with-deep-brain-stimulation.html#disqus_thread

Monday, September 16, 2013

Favorable decision and document is forthcoming...

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, September 16, 2013 1:00 PM


Subject: Favorable decision and document is forthcoming...

To all of Joyce’s fellow implant patients,

Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services is understanding and compassionate to our circumstances and cause.

While our conversation was on the record I was requested to not record the conversation.  As I have been respectful of all the conversations I have had through the years both on and off the record and where I’ve been allowed to share or not share I shall honor Jonathan’s request.

I shall paraphrase what I took from the conversation.

There will be a document of sorts issued, hopefully by the end of the week, encompassing Medicare/Medicaid coverage for the implanted VNS Therapy depression patients on/or before May 7, 2007.  This document will also be sent to the private Medicare/Medicaid carriers encouraging them to follow suit.

I did request a contact within government for those encountering any difficulty navigating the maize to accomplish our goals.  I’ll have to wait and see as there are some internal mechanics within the agency that is still being worked on.

In my opinion, I did receive a very favorable response from Jonathan for which I truly thank him not only on behalf of Joyce but all of her fellow patients in desperate need of help at this time.

I truly hope I’ve brought some hope to you all.  By nature and having the experiences and knowledge I’ve garnered all these years I do bring you this hope.  At the same time and not to discourage anyone I am also reminded of baseball’s poet laureate Yogi Berra when he said, “It ain’t over ’til it’s over.”  Or in my words, “it’s not done until it’s done” (i.e. Cyberonics reneging on their “Lifetime Reimbursement Guarantee”) I hope to see an important piece of paper in your hands shortly to help advocate for yourselves, if necessary, to obtain your replacements as soon as possible.

Once again Jonathan, I truly appreciate your understanding and compassionate efforts for this group of patients.

I would also like to acknowledge and thank all those medical professionals and others, unseen in my blind copies, who have supported, educated and encouraged my advocacy and crusade.  Thank you Vivian and Congresswoman Debbie Wasserman Schultz.

I now have to get Joyce spoofed, nails, hair etc. and I’ve got to pack.  We shall be in New York for our eldest granddaughters Bat Mitzvah and I’ll formally be back at the computer late Tuesday evening, September 24, 2013.  My phone is on 24/7 for anyone needing support.

I wish you all L’Shanah Tovah (A Good Year - Hebrew) 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://vnstherapy.wordpress.com/

Sunday, September 15, 2013

They all desperately want the same wellness now!

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, September 15, 2013 11:16 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius – HHS


Subject: They all desperately want the same wellness now!

Dear Jonathan,

It is roughly 24 hours from our scheduled 2nd conference call.  I have copied and pasted below another communication I just received.

Like Julie, Amy, Joyce and others I too am filled with major anxiety and stress.

I cannot accept anything less from you or Madam Secretary Sebelius than a favorable decision for “Compassionate use” for all these implanted patients prior to your department’s former decision of May 7, 2007.  Anything less would be immoral, unconscionable, inhumane and reeking of total outright negligence.  This issue not only directly affects the patient but so too their families and friends.

I expect you to tell me that a “Decision Memo for VAGUS NERVE STIMULATION for Treatment of Resistant Depression (TRD)” is being issued immediately and in the “Decision Summary” it will state something to the effect that:

CMS has determined through it’s initial oversight that there is sufficient evidence to conclude that vagus nerve stimulation is reasonable and necessary for treatment of resistant depression for all those implanted patients wishing to continue the therapy who have been implanted on/or before May 7, 2007. Accordingly, we are issuing the following national coverage determination and/or “Compassionate use” determination:

Vagus nerve stimulation is covered for treatment resistant depression for all implanted patients having been initially implanted on/or before May 7, 2007.

Nothing less than some document of this nature can be humanely acceptable. 

Julie, Amy and Joyce, amongst others have now known and tasted wellness for years.  They all desperately want to retain that same wellness; now!

To Julie, please understand that Joyce’s neurosurgeon fully understands the nature of this whole situation.  He too is blind copied and receives the same communications from me.  While we do have a scheduled surgery date we have not yet heard anything from our insurance carrier or the hospital whether or not she will be accepted/rejected.  In essence I am pushing the issue for Joyce and all the other implanted patients who wish to continue the therapy.  Mr. Jonathan Blum’s signature or that of Madam Secretary Kathleen Sebelius would simply and quickly resolve our issue.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trail more Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

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Julie Ottaviani

10:11 AM (September 15, 2013)

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Dear Herb,
I write to you again with my thoughts because I have not slept at all this weekend waiting for the phone call from Jonathan Blum to yourself on Monday Sept. 16th 2013.  I feel that my very life is hanging by a thread at this time.  Unlike yourself and Joyce my doctor or myself cannot even get a surgeon or hospital to schedule my surgery.  I am desperate and sinking fast.  When I think back to the day my implant was originally put in at Moses Taylor Hospital in Scranton Pa, by Dr. Michael Sunday, I become angry and sad.  Both the hospital and Dr. Sunday knew at the time there was no decision on payment and that I would try and help get payment if need be.  Before they wheeled me in for surgery I took Dr. Sunday's hand and thanked him for giving me another chance at life by doing the surgery.  Now that I need a replacement and Medicare has decided the Implant is not covered.  Dr. Sunday flat out refused to see me for the replacement and so did Moses Taylor Hospital.  The people that I thought cared about my life only cared about profit.  If they really cared they would have me on a table right now doing the surgery without a decision.  That is why Jonathan Blum's call is so important, because there is less compassion for mental health patients than any other patient.  If I had cancer would I be denied chemo, If I had diabetes would I be denied insulin, they'll even pay for a heart transplant but not a tiny little metal round disc in my chest that cost's quarter not even what a transplant costs to make me tax paying member of society again.  Pass compassionate use.  PLEASE
Julie Ottaviani
11 Alexandria Drive
Blakely, Pa 18447
570-604-3043
You have my permission to use this email and all it's contents in any way you choose if it will help our cause.

Julie Ottaviani
julieottaviani@aim.com

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

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.

Friday, September 13, 2013

Oh Herb do I dare have hope?


From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 1:48 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: Oh Herb do I dare have hope?

 

Julie Ottaviani
10:49 PM (September 12, 2013)
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Oh Herb do I dare have hope?  I listened to your conversation with Jonathan and all I heard was the same old nonsense. I'll get back to you. I received my denial letter from my insurance company Humana Advantage stating the CMS policy on coverage of patients implanted after May 2007 which doesn't apply to me, I was implanted Jan. 12, 2006. And they also said I was denied because it was being used to diagnose which again does not apply to me because I am already implanted with 100% success for the last 7 years.  When I called and questioned them they had no answer for me except that my doctor would have to call in and make a verbal appeal for medical necessity.  I explained that they should be talking to me because my doctor was dead and the doctor making the request did not treat my illness for the past 15 years.  Fell on deaf ears.  The psychiatrist who is the partner of my doctor that passed away is Dr. Mathew Berger and quit frankly knows nothing about me. Just to fill you in Joyce's history is severe and no one should suffer with this black cloud my suicide attempts totaled 12 and a few times my oldest son who was about 12 at the time was the person calling 911.  Do you know that to this day even though I would not attempt suicide again because after being well for so long I realize the pain that it caused my family and my children, I still instinctively keep a full bottle of klonapin just in case I don't get the battery.  I swore I would never go back into the black hole of depression I would rather be dead.   I mentioned my decline to Dr. Berger at my appointment on Sept. 12th and also about my conversation with you and your working with other doctor to convince CMS to pass the compassionate care issue.  He did not seem to know anything about it.  I feel more alone than ever.  I mentioned to you in our conversation that I was going to consult my lawyer about the very issues you brought up in your telephone conversation with Blum and he told me it was pointless to file a suit against CMS it's like banging your head against a brick wall.  As I was listening to you tell Joyce's story it was all so familiar to me, the endless medications

the ECT treatments that did more harm than good, but medicare will pay for them.  It is because of too much shock therapy that I am on disability and costing the system money although a  lot less since the VNS was put in.  ECT wiped out most of my long term memory and damaged my short term memory.  So much gone my whole lifetime.  My talent and what earned me a living.  I was somewhat of a child prodigy on the guitar classical.  By the age of 12 my teachers told my parents they couldn't teach me any more that I had learned everything they knew and more.  So I began teaching.  I planned on music being my life's work.  After the treatments I could not remember how to read a note.  It was gone all gone.  All I could remember were a few basic chords.  I have never picked it up since that day.   Hospital bills eventually ran us into bankruptcy.  And when I finally got the implant in 2006 my improvement was just as quick as Joyce's and very similar. I did get a little manic for a while but not bad it was a kind over happy manic and my very much missed Dr deSoto put it " Your way too happy girl, we have to turn you down a notch".  Loved that man.  So I'm going to be waiting to hear from you on Monday after you speak to Blum and I will be praying for a positive answer for Joyce, myself and all of us fighting this battle.  Thank you for being our knight in shining armor.

Julie Ottaviani
11 Alexandria Drive   
Blakely, Pa  18447       
570-604-3043

You have my permission to use any or all of this email in anyway you think will be useful in our fight.
Julie Ottaviani

 

 

 

Dear Jonathan,

 

What does it take to get through to all you folks that your department’s negligence and further delays are seriously harming the very folks that you should be caring for and that the multi-year wellness they’ve derived from VNS Therapy are also reducing health care costs.

 

After speaking with Dr. Daniel Schultz earlier in the day I’ve come to the conclusion it may well be both your “medical team” and his former so called “experts” appear to be out of touch with reality.

 

Today I was also reminded of my immediate thoughts and response after reading the contents of the May 4, 2007 national coverage denial document.  I certainly was not happy to read the final determination.  But what truly appalled me was some of the contents of which I read.  Whoever composed the document, in my opinion, denigrated the physicians who practice psychiatry and the Art and Science of Psychiatry.  If I were a Psychiatrist, I certainly would be appalled.  There is no doubt in my mind that the authors of that document have no understanding of the difficult challenges these physicians face day in and day tending to this unique and seriously ill population of patients with whom conventional therapies are ineffective and very costly.  How can these people who penned that document really have an understanding when amongst other statements they issue the below listed statement?

 

D02 RCT

The well-designed, randomized controlled trial (D02) of 10 weeks (standard trial length for efficacy determination of an antidepressant medication)

failed to demonstrate statistically significantly superior outcomes greater than sham treatment (15% versus 10%, p = 0.31 (Fisher’s exact)).

 

“The well-designed, randomized controlled trial (D02) of 10 weeks…” sums up what little they knew and understood and what appears to continue to this very moment.  Dr. Schultz in my conversation with him today cited that a study of such a short duration was a mistake from the start and doomed to failure.  Amongst this and other points he, unlike his underlings, saw beyond their computer screens and as a practicing physicians he understood the need for the therapy.  The study needed more time but why discuss this matter now as any reasonable minded individual knows it was a mistake.  These patients for whom I advocate have not only responded but obtained long-term efficacy as you’ve read.  Yet your department issued the absurd statement amongst other abominating statements. 

 

The point being that it seems to me y’all still can’t comprehend what is being exhibited before your very eyes.  Once again, 100% of these implanted patients wanting to continue this therapy are responders obtaining long-term efficacy.  What can’t your “medical team” or any of you folks not comprehend or compute?

 

Your department issued the non-coverage statement on May 4, 2007.  Now do the morally right and just thing and issue a favorable “Compassionate use” decision for all those patients implanted on or before May 4, 2007.  At the same time it should put a smile on Dan Moore’s face as it will relieve Cyberonics of any responsibility or legal worry of violating “kickback statues” (joke).

 

Sincerely,

Herb

 

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




 

 

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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.

"I write this I am preparing for another hospitalization."

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 9:43 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: "I write this I am preparing for another hospitalization."

Dear Jonathan,

I have copied and pasted another email below that I just received.  It too is self-explanatory.

I shall not give up.  I owe it to my spouse Joyce and Amy, Julie, Tami and all the other patients wanting a chance to live out their lives in peace, wellness and with dignity.

We need your help now…no more kicking the can down the road.  We need another individual with the compassion and understanding as exhibited by Dr. Daniel Schultz to do the right thing.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trail more Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

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Tami

8:29 PM (September 13, 2013)

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Herb,

I listened to your phone call with Jonathan Blum of CMS.  Me and my family are waiting on pins and needles to find out if the "Compassionate Use" document will be signed .  It is all I can do to follow your blog, but it has given me a glimmer of hope.   As I write this I am preparing for another hospitalization.  It will not help me other than to keep me safe for a few weeks.  Mr. Blum and the other "powers that be" need to understand the cost to so called treat my depression will continue to increase until it is greater than the cost of VNS.  I had not been hospitalized or had ECT for the five years my VNS worked.  

My battery died two years ago.  Since then I have been hospitalized once and am home bound and practically bed bound.   My very life depends on getting my VNS replaced soon.  VNS saved my life!  I just wish Mr. Blum and the others would see that I am a human being and I am pleading and begging for my life.  

Bless you for your advocacy.   As always, you have my permission to publish or use this email in anyway that will help.

Tami Gee

8913 Fresno St

Fort Smith, AR

firetlg@aol.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.

"...treating severe unresponsive depressive disorder is exactly the reason that I approved the device..."

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 2:37 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: "...treating severe unresponsive depressive disorder is exactly the reason that I approved the device..."

Dear Jonathan,

I just received an email which I have copied and pasted below from Dr. Daniel Schultz (please read from the bottom of this page on up) as it is self-explanatory.  It also satisfied my 9 year need to know and understand this courageous and compassionate man’s thinking despite all the controversy surrounding this therapy option.

While Dr. Schultz also had medical experience and wisdom to understand the nature of the illness and challenges, you and Madam Secretary Sebelius certainly have far more information available at this time than Dr. Schultz.   At the very minimum you both by now should understand health benefits being obtained by these existing implanted patients.  This is no longer experimental for these patients.  This therapy has demonstrated for these patients 100% efficacy which cannot be denied nor in the annuals of psychiatric treatments has there been an efficacy demonstrated anywhere near to what I am presenting to you for these patients.

Again, correct the negligence perpetrated against these study subjects and patients.  Do what is morally right.  Issue a favorable “Compassionate use” decision now so that Joyce, Amy and the other patients can return to a reasonable quality of life.  The byproduct of their wellness is a cost savings to our economy.  Take care of the problem now or continue to pay higher and higher ineffective maintenance costs year after year.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 2:05 PM
To: 'Daniel Schultz'
Subject: RE: VNS Therapy for depression...

Dear Dan,

Thank you ever so much for taking the time to talk with me the other day and for sharing your thoughts in this email.

I am making every effort humanly possible to get the powers that be to understand and issue a favorable “Compassionate use” decision for all those implanted patients prior to the national denial.  While I do believe like you that it is important to have newer treatment options available for these difficult to treat patients my immediate and urgent goal is care for those who have for multiple years responded and obtained efficacy.

L’Shanah Tovah as I also wish you and yours wellness and all the good you’d wish for yourselves.

Once again, thank you.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://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.

From: Daniel Schultz [mailto:daniel.schultz@greenleafhealthllc.com]
Sent: Friday, September 13, 2013 1:55 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy for depression...

Hi Herb,

It was very nice talking to you yesterday and hearing how well your wife Joyce is doing with her VNS therapy. Providing patients with like Joyce with another option for treating severe unresponsive depressive disorder is exactly the reason that I approved the device and your story and others like it confirm my belief that despite the controversy associated with that decision, it was the right thing to do. 

I hope that Joyce and other patients who have benefited will continue to have access to the therapy and whatever reimbursement issues exist can be resolved to everyone's satisfaction.

Best regards,

Dan   

Daniel Schultz, M.D.

Senior Vice President, Medical Devices & Combination Products

Greenleaf Health LLC

202-609-8996 x2 w

240-401-2382 m

www.greenleafhealthllc.com

Greenleaf Health's NEW main number is 202.609.8996

Thursday, September 12, 2013

I’ve finally made contact with Dr. Daniel Schultz…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 12, 2013 2:55 PM
Subject: VNS Therapy for depression...

To all of Joyce’s fellow implant patients,

This morning after some searching I was finally able to make contact with Dr. Daniel Schultz.  For many of you his name may not be familiar but from my vantage point as a long, long time support person and health care advocate for Joyce and my knowledge of VNS Therapy for depression his decision for us was monumental.  Dr. Schultz was the former Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004 to 2009.  It was Dr. Schultz’s compassionate, caring, medical knowledge and understanding as a practicing physician whose decision on July 15, 2005 (document attached) has brought us to this point in time. 

I also share with you a link so that many of you would have a better understanding of the challenges and thought climate at that time.

I spoke with Dr. Schultz by telephone this morning.  His reply to my questions has finally satisfied my long-time desire to understand one man’s thinking.  I share the below listed email with you.  I’ve asked Dr. Schultz’s aid to please share with me, on-the-record, so that all of you will also understand his thinking on the subject of VNS Therapy for depression.  I do so in the further hope that we may obtain a favorable “Compassionate use” response from Mr. Jonathan Blum – CMS or Madam Secretary Kathleen Sebelius – HHS so that they too may understand our desperate and immediate need for health care coverage.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 12, 2013 12:01 PM
To: Dr. Daniel G. Schultz
Subject: VNS Therapy for depression...

Dear Dr. Schultz,

About 9 years ago I wrote to you thanking you for what I considered a very courageous decision in spite of all the circumstances and turmoil surrounding the VNS indication for depression.  I will also add despite the subsequent inept investigation by Senator Grassley’s people, in my opinion.

I thought your decision courageous because of the enormous pressures being exerted but I can tell you from my knowledge then and that which I better know today, it was a correct and humanist decision for a number of patients who were considered the “worst of the worst” which included my spouse Joyce.

My spouse Joyce was one of the earliest study subjects.  She was implanted December 13, 1999.  This December 2013 will be her 14th anniversary of the therapy.  She has been almost continuously depression free these 14 years.  She is on no antidepressant medications and we haven’t discussed the illness of depression in our home for years.  As far as CMS is concerned there is no doubt in my mind we’ve also saved them untold costs.  We no longer have yearly multiple hospitalizations consisting of 2 to 3 week stays.  No ECT.  Joyce is off all antidepressant medications, no longer do we have weekly visits for psychotherapy and medication checks as she now sees her psychiatrist quarterly to interrogate her prosthesis and the quality of life for both of us improved 180 degrees.

So, exactly what prompts me to contact you after all these years.  First, anything I do discuss with you is off-the-record and confidential other than what you would allow me to share publicly.

I am in a major battle with Madam Secretary Kathleen Sebelius – HHS and Mr. Jonathan Blum – CMS pleading with either of these 2 bureaucrats to sign a favorable “Compassionate use” document for all the VNS depression patients implanted on or before CMS National decision on May 4, 2007.  As I’m sure you are aware and to the best of my knowledge, this was the first time an FDA device was declined coverage by CMS.  In doing so, they have caused an egregious injustice, morally, ethically and through their negligence to have not at least grandfathered the care for the study subjects and the other implanted patients who obtained the therapy through Medicare/Medicaid, private health insurance and other means before the national coverage decision.

I am doing everything in my power to humanize this issue as I strongly sense these department heads and their underlings are number pushers and lack any true understanding or hands on medical experiences about these real life struggles.  I’ve even attempted sharing my yearly VNS video of Joyce to further humanize her and the issue.

At the same time I am battling Cyberonics to honor their “Lifetime Reimbursement Guarantee” to the study subjects.  Cyberonics has reneged on the guarantee as Dan Moore, CEO of Cyberonics throws smoke screens at the subject citing “kickback statues” to which I politely replied in my own mind, “He’s full of shit,” but in actual writing this was my response to Dan.

I maintain and advocacy blog site at: http://www.vnstherapy-herb.blogspot.com which should give you a good feel about the previous correspondence and my advocacy.  I do converse and collaborate with a number of the leading psychiatric KOL’s both on and off the record.

Second and most importantly I am asking for your help.  After all these years I am asking you once again, what is it that you saw, understood, knew or believed to prompt you to override the so called knowledgeable opinions of your “expert” subordinates to approve VNS for the depression indication?   

If you choose to answer that question or lend any kind of assistance to our cause would you please advise me what part or parts of your response might I be allowed to share publicly or if not at all?

My wife and the other VNS patients are truly desperate.  They do not want to return to the hell they once endured and most patients cannot afford to pay out-of-pocket for the replacement surgery.

Please consider helping us.  I am at this advocacy 24/7/365 until we achieve our goal of health insurance coverage.  I would welcome your response in any manner day or night.

Jonathan Blum – CMS has scheduled with me a second telephone conference this Monday, September 16, 2013, 12:00pm as they continue to kick the can further down the road.  My first conference call can be heard at this link:  http://www.vnstherapy-herb.blogspot.com/2013/09/vns-therapyconversation-with-mr.html

I truly do not have the slightest idea of the internal workings and mechanics of these various governmental departments.  I ran, at the time before my retirement, a successful small multi-million dollar company and I knew when there were decisions to be made I sat down with my partners, we reviewed the facts, discussed the issues and made a decision.  Hopefully the correct decision most of the time but all done within an hour or two at the most.  From my vantage point and of now having to deal with government agencies it is incredulous to me to see how in the world our government gets anything effectively accomplished if at all.

I seek your aid, knowledge and understanding to better help advocate our cause during this second conference call if you would take a few moments to lend us a hand.

I would also like to wish you and yours L’Shanah Tovah, 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

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

vnsdepression@gmail.com

http://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.

Wednesday, September 11, 2013

VNS Therapy – Conversation with Mr. Jonathan Blum – CMS

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, September 11, 2013 2:41 PM
Subject: VNS Therapy "Compassionate use" for depression patients...

To all of Joyce’s fellow implant depression patients,

In trying to keep you all informed to the best of my ability and to which I am allowed to publicly share information as it relates to my efforts to obtain a favorable “Compassionate use” determination for all the patients implanted for depression on/or before May 4, 2007 I would like to share some information.  While I have not yet achieved my goal you should know the following as I continue advocating for you all.

I would first and most importantly like to thank Mr. Jonathan Blum - CMS for taking his valuable time to speak with me personally to better understand Joyce’s and your very serious medical issues requiring immediate attention.  Quite frankly, I expected to be listening to Jonathan but he threw me a curve ball and I awkwardly did most of the speaking.  By the way, please also forgive my southern drawl if y’all don’t understand my speech.  I grew up in the deep South; that is South Brooklyn (joke).

My telephone conversation with Mr. Jonathan Blum – CMS

Joyce and I shall be leaving on Tuesday, September 17th to New York to attend our eldest granddaughter’s Bat Mitzvah.  We shall return on Tuesday, September 24th so I’ll be less available by computer for the week but my phone is on 24/7 if you folks need support.

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://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.

Tuesday, September 10, 2013

The New Science of Mind

The New York Times


September 6, 2013

The New Science of Mind

By ERIC R. KANDEL

THESE days it is easy to get irritated with the exaggerated interpretations of brain imaging — for example, that a single fMRI scan can reveal our innermost feelings — and with inflated claims about our understanding of the biological basis of our higher mental processes.

Such irritation has led a number of thoughtful people to declare that we can never achieve a truly sophisticated understanding of the biological foundation of complex mental activity.

In fact, recent newspaper articles have argued that psychiatry is a “semi-science” whose practitioners cannot base their treatment of mental disorders on the same empirical evidence as physicians who treat disorders of the body can. The problem for many people is that we cannot point to the underlying biological bases of most psychiatric disorders. In fact, we are nowhere near understanding them as well as we understand disorders of the liver or the heart.

But this is starting to change.

Consider the biology of depression. We are beginning to discern the outlines of a complex neural circuit that becomes disordered in depressive illnesses. Helen Mayberg, at Emory University, and other scientists used brain-scanning techniques to identify several components of this circuit, two of which are particularly important.

One is Area 25 (the subcallosal cingulate region), which mediates our unconscious and motor responses to emotional stress; the other is the right anterior insula, a region where self-awareness and interpersonal experience come together.

These two regions connect to the hypothalamus, which plays a role in basic functions like sleep, appetite and libido, and to three other important regions of the brain: the amygdala, which evaluates emotional salience; the hippocampus, which is concerned with memory; and the prefrontal cortex, which is the seat of executive function and self-esteem. All of these regions can be disturbed in depressive illnesses.

In a recent study of people with depression, Professor Mayberg gave each person one of two types of treatment: cognitive behavioral therapy, a form of psychotherapy that trains people to view their feelings in more positive terms, or an antidepressant medication. She found that people who started with below-average baseline activity in the right anterior insula responded well to cognitive behavioral therapy, but not to the antidepressant. People with above-average activity responded to the antidepressant, but not to cognitive behavioral therapy. Thus, Professor Mayberg found that she could predict a depressed person’s response to specific treatments from the baseline activity in the right anterior insula.

These results show us four very important things about the biology of mental disorders. First, the neural circuits disturbed by psychiatric disorders are likely to be very complex.

Second, we can identify specific, measurable markers of a mental disorder, and those biomarkers can predict the outcome of two different treatments: psychotherapy and medication.

Third, psychotherapy is a biological treatment, a brain therapy. It produces lasting, detectable physical changes in our brain, much as learning does.

And fourth, the effects of psychotherapy can be studied empirically. Aaron Beck, who pioneered the use of cognitive behavioral therapy, long insisted that psychotherapy has an empirical basis, that it is a science. Other forms of psychotherapy have been slower to move in this direction, in part because a number of psychotherapists believed that human behavior is too difficult to study in scientific terms.

ANY discussion of the biological basis of psychiatric disorders must include genetics. And, indeed, we are beginning to fit new pieces into the puzzle of how genetic mutations influence brain development.

Most mutations produce small differences in our genes, but scientists have recently discovered that some mutations give rise to structural differences in our chromosomes. Such differences are known as copy number variations.

People with copy number variations may be missing a small piece of DNA from a chromosome, or they may have an extra piece of that DNA.

Matthew State, at the University of California, San Francisco, has discovered a remarkable copy number variation involving chromosome 7. An extra copy of a particular segment of this chromosome greatly increases the risk of autism, which is characterized by social isolation. Yet the loss of that same segment results in Williams syndrome, a disorder characterized by intense sociability.

This single segment of chromosome 7 contains about 25 of the 21,000 or so genes in our genome, yet an extra copy or a missing copy has profound, and radically different, effects on social behavior.

The second finding is de novo point mutations, which arise spontaneously in the sperm of adult men. Sperm divide every 15 days. This continuous division and copying of DNA leads to errors, and the rate of error increases significantly with age: a 20-year-old will have an average of 25 de novo point mutations in his sperm, whereas a 40-year-old will have 65. These mutations are one reason older fathers are more likely to have children with autism and schizophrenia.

Our understanding of the biology of mental disorders has been slow in coming, but recent advances like these have shown us that mental disorders are biological in nature, that people are not responsible for having schizophrenia or depression, and that individual biology and genetics make significant contributions.

The result of such work is a new, unified science of mind that uses the combined power of cognitive psychology and neuroscience to examine the great remaining mysteries of mind: how we think, feel and experience ourselves as conscious human beings.

This new science of mind is based on the principle that our mind and our brain are inseparable. The brain is a complex biological organ possessing immense computational capability: it constructs our sensory experience, regulates our thoughts and emotions, and controls our actions. It is responsible not only for relatively simple motor behaviors like running and eating, but also for complex acts that we consider quintessentially human, like thinking, speaking and creating works of art. Looked at from this perspective, our mind is a set of operations carried out by our brain. The same principle of unity applies to mental disorders.

In years to come, this increased understanding of the physical workings of our brain will provide us with important insight into brain disorders, whether psychiatric or neurological. But if we persevere, it will do even more: it will give us new insights into who we are as human beings.

Eric R. Kandel, a professor at the Mortimer B. Zuckerman Mind Brain Behavior Institute at Columbia, a senior investigator at the Howard Hughes Medical Institute and a recipient of the 2000 Nobel Prize in Physiology or Medicine, is the author of “The Age of Insight: The Quest to Understand the Unconscious in Art, Mind and Brain, From Vienna 1900 to the Present.”

http://www.nytimes.com/2013/09/08/opinion/sunday/the-new-science-of-mind.html?smid=pl-share&_r=0

Monday, September 9, 2013

Time is running out for these patients…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, September 10, 2013 12:26 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...

Dear Mr. Blum,

I had some computer problems and was just able to retrieve my emails from yesterday. 

I have copied and pasted below another email that I just read.  I several minutes ago got off the telephone with the young woman who sent the email giving me verbal permission to share her correspondence publicly.

Need I say more to you or Madam Secretary Sebelius.  Joyce, this young woman Amy and the other patients are running out time.  They do not want to return to a living hell.

We are all pleading for a favorable “Compassionate use” decision from you or the Madam Secretary, now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

From: Amy [mailto:keyanote@gmail.com]
Sent: Monday, September 09, 2013 3:00 AM
To: Joyce and Herbert Stein
Subject: Re: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...

Herb,

I really hope you receive an answer soon. Things are getting worse here...I started a new drug called Latuda and increased the Lamictal but I am feeling so bad tonight.  I'm am crying uncontrollably and feeling hopeless.  Life is getting back to what my "normal" used to be back before I had the VNS.   If they want a real live experiment of what happens when the battery dies...here I am.  Thank you for all your work and letters. 

~ Amy

Friday, September 6, 2013

The pleas for help are slowly trickling in…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 06, 2013 3:50 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius – HHS

Subject: How many appeals and pleadings will it take to make you folks see the light?

Dear Mr. Blum and Madam Secretary Sebelius,

I’ve moments ago received another very compelling email correspondence from another VNS depression patient which I’ve copied and pasted below.  These real-life experiences are slowly trickling into me.  I have asked those patients, allowing me to share their personal life experiences, to also list their full names, addresses, telephone numbers etc. so that your “Medical team” can validate this data should they have nothing else better to do.  In doing so I am once again supplying facts/data that I would believe do not register in your computers or records of any kind.  I also ask these patients to share this information in the hope that maybe you or your people can comprehend the devastating effect your continued negligence and immoral position is having upon these patients.

How long will it take for you and your staff and Madam Secretary Sebelius and her staff to correct the wrong you’ve perpetrated and the negligence you’ve created by not caring for these patients?

Either of you two department heads have the ability through the stoke of your pens to cease this ongoing agony, suffering and forcing these patient back into hell.

I would only hope that some attorney with compassion and understanding for helping others might come across our pleas and find a legal issue to address your outright negligence, in my opinion.  I’ll have to look up the name of the attorney and the judge that ruled in the case for that 11-year old youngster in obtaining adult lungs for the young girl.  Maybe then we can get you folks moving in a favorable direction.

I hope you all have a wonderful weekend filled with the thoughts and remembrances of what you are reading from these real-live citizens whose anguish you can easily and morally end.

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://vnstherapy.wordpress.com/

From: ssagi@aol.com [mailto:ssagi@aol.com]
Sent: Friday, September 06, 2013 3:00 PM
To: fabrik@bellsouth.net
Subject: My VNS Story

My name is Sharon Strugnell and I am 66 years old.  I have suffered with depression since I was 16 years old when I had my first episode.  It is a horrible out of body experience, the worst ever.  You do not even feel human.  All you want to do is die and disappear.  I had a wonderful caring psychiatrist who was the most positive person in my life.  I believe he was at the end of his rope trying to help me but he never gave up and he found an article in some paperwork he received that advertised for people to volunteer to be study subjects for VNS.  He immediately called me and of course I said yes.  He set me up and filed all the paperwork with Cyberonics for me to participate in their research for their Vegas Nerve Stimulator.  He worked so fast that I was number one study subject.  I, too, tried every antidepressant made to man, psychiatrist after psychiatrist, 15 shock treatments, hospitalized for four weeks and nothing came close to helping at all. This illness effects everyone of your friends and family.  Somehow I came out with two beautiful daughters and five grandchildren. My husband stuck by my side though it all and was with me throughout the ordeal. Most of the time people want to run away from people like me as we cannot do anything but bring people down.  What kind of a life is that?

My stimulator was implanted on August 14, 2006.  It took a while to work but what wonderful results happened.  I am a new person now and honestly would love to help other people with this problem.  You cannot fully understand what it is like until you experience it and believe me, you wouldn't want to. I did my clinical study at FAU in Florida.  I never missed an appointment for five years as we sign that we will follow through with this program so with the hope that it would help other people as well. My doctor that headed the program was Dr.Peter Holland, a wonderful man.  My battery life had the expectancy of 5 years and I have been so lucky that it is still functioning, but I live in fear of the day the battery dies. I do not think I could ever go through that torture of the Black Hole again. It is truly a killer.

I am pleading with you to help myself and all other VNS receipients that want to continue their therapy.  It is such a shame that people have to commit suicide because they have nothing left to try.  What if it was your mother, father, husband or child that suffered so?  What would you do?  I never thought that I would have to plead for my life when I signed up for this study.  I thought all my problems were over.  So did everyone else I am sure. We appreciate everything Herb is trying to do to help us and his wife.  Thank you for reading this and for your time.

Sincerely

Sharon Strugnell

1365 SW 151st Way

Sunrise, FL 33326-1932

e-mail ssagi@aol.com

Phone:  954-801-9468

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

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.