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.
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
From: Joyce and Herbert Stein [mailto:firstname.lastname@example.org]
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.
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
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.