“…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

https://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

https://vnstherapy.wordpress.com/

—————————————————————

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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

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About vnstherapy

I'm a very, very long-time support person and health care and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.
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