From: Joyce and Herbert Stein [mailto:firstname.lastname@example.org]
Sent: Thursday, September 05, 2013 4:30 PM
To: Jonathan Blum, Deputy Administrator Director - CMS
Cc: Madam Secretary Kathleen Sebelius
Subject: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...
Dear Mr. Blum
Not being a religious person although it is an auspicious time of year for some, I would like to wish you and your family and all those reading my correspondence, L’Shanah Tovah.
I can’t help but to continue reflecting back upon your statement to me that “Patient perspectives are invaluable to our review process” with much agitation.
Now that I’ve had some time to calm down I wanted you to know the statement had infuriated me at the time. Just as I acknowledge that you’re not an M.D. and in all likelihood your “medical team” has little to no experience in tending to psychiatric patients or this implanted patient population I wanted you to know that I am not a patient but a support person and caregiver. Nor am I just any ordinary support person and caregiver.
In fact, I am an expert. I am an expert far more knowledgeable than any of your medical team reviewing this issue for “Compassionate use” as it relates to my spouse Joyce and for all these implanted VNS patients for depression. I am an expert far more knowledgeable than any of the physicians who have attended to my spouse all these years. Now that you’ve finished scratching your head and wondering whether I’m a kook or something else I’ll elaborate.
I am an expert to my spouse Joyce as it relates to her major depressive illness. There is absolutely no one who knows more about my spouse, her illness, her medications, her treatments, her responses, her side-effects and what has and has not worked for her all these years. There is no one who has kept more detailed records and has observed her reactions 24/7/365 than I.
Neither you nor your medical team has carefully and astutely observed and maintained empirical data as I have through 50 years of marriage. So when you speak of “perspectives” it grinded upon me. You may have perspectives but when it applies to my spouse Joyce I have careful observations, empirical data and record keeping and detailed facts.
You folks have no knowledge of her responses, efficacy or reactions to her Zoloft (sertraline HCl), Lamictal (Lamotrigine) or for that matter the pharmacopeia of drugs she’s trialed over decades. You folks have no knowledge of her responses, efficacy or reactions to ECT (Electroconvulsive shock therapy) trials over decades, do you? Your department and staff quite honestly and frankly don’t know “shit from Shinola” as to what has and has not worked for my spouse and yet you talk about perspectives and reviews.
We have been fortunate through these years to have very knowledgeable, capable and compassionate physicians attend to Joyce. And in doing so we retained those who also had the ability to listen attentively to what we know and thought. Those who exhibited the deity syndrome were quickly dismissed.
I responded twice to CMS during the comment period for VNS Therapy for depression. I was reminded by someone from CMS that the information I supplied was anecdotal. If that be the case while my knowledge and information may be considered anecdotal then as an expert tending to my spouse all that your medical review board, in my opinion, could possibly offer up is valueless information or perspectives as they truly no nothing about my spouse.
I am also reminded about the Chinese physician, a number of years ago, who attended to cancer patients in the hinterlands of his country. Through listening to patients and then through careful observations and detailed record keeping he was able to achieve remarkable success rates using arsenic for his cancer patients. That Chinese physician faced ridicule and scoffing on the part of Western physicians just as I’ve similarly have read (i.e. Peter Laurie formerly of Public Citizens and I believe now with the FDA) as it pertains to VNS Therapy for depression. The point being; the Chinese physician as I later read was eventually awarded a Noble prize for his observations, findings and newer effective treatment. I am not a physician but I find I am facing similar circumstances in dealing with HHS and CMS.
What does this all have to do with Joyce? You can’t close your eyes or shut your ears to what you are reading and being told. I am telling you as her expert support person that after 50 years of my observations and record keeping that VNS Therapy has worked favorably for my spouse like no other therapy with absolutely no side-effects or safety issues. Not only is she a responder she is in remission for almost 14 years. I know with certainty there are other attending psychiatrists who can attest to similar observations and findings with their patients. As an expert to my spouse how in good conscience can you or Madam Secretary Sebelius continue to delay issuing a favorable “Compassionate use” decision to all the patients similarly responding to that of Joyce and wishing to continue with the therapy? How can you both in good conscience allow anyone to be implanted with a foreign object and simply turn your backs and walk away from their care?
This doesn’t require a medical team to review. This is a matter of medical ethics, morals and humanism and doing what is right and just. I’ll also add in the long-run money will be saved.
If a physician inadvertently during surgery left an instrument or object in a patient he or she might face charges for negligence. Don’t you think that your department has intentionally committed the very same or similar negligence? Your department through its oversight or ignorance or lack of concern has since May 4, 2007 not addressed this serious medical negligence.
Today I received an email petition for an individual appealing and seeking to obtain a trial medication for a cancer drug. While I can empathize with the individual doing all one can to maintain hope and life I am again pointing out to you we are not talking about a trial and an uncertain outcome in our pleas. 100% of the implanted patients wanting to continue with this therapy are responders and obtaining efficacy. I shall also point out to you again; these patients are responding for multiple years a fact which in and of itself is truly remarkable and won’t show up in your medical teams review statistics. I’ll also point out to you these individuals are willing to undergo continued surgeries to maintain their wellness another fact that won’t show up before your medical review team.
At this point in time, knowing that which I do, isn’t it time that both you and Madam Secretary Sebelius acknowledge the oversight and correct this egregious negligence and injustice? More importantly wouldn’t it suit you both better to know and allow these patients to enjoy the sweet nectar of their wellness rather than condemning them back to Hell?
Something else I’d like to share with you that does not show up in any of your data or statistics. I am truly not an arrogant, pretentious or mean spirited individual. In fact I was brought up to respectful and caring of others while at the same time I am assertive and most importantly, persistent. Above my desk hangs a note with several precepts by which I try to live my life and which I’d like to share with you.
The first and most important of which that has served me well is:
“Nothing in this world can take the place of persistence.
Talent will not; nothing is more common than unsuccessful people with talent.
Genius will not; unrewarded genius is almost a proverb…” – Calvin Coolidge
“Happiness isn’t what you have…
It’s the ability to enjoy
What you have!” – Author unknown
“What we have done for
ourselves alone dies with us;
what we have done for
others and the world remains
and is immortal” – Albert Pike
“This is my simple religion. There is no
need for temples; no need for
complicated philosophy. Our own brain
our own heart is our temple; the
philosophy is kindness.” – Dalai Lama
Once again, I ask, I plead for you or Madam Secretary Sebelius to please pen your signature to a favorable “Compassionate use” document for the VNS implanted patients wanting to continue the therapy for depression.
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
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