From: Joyce and Herbert Stein [mailto:email@example.com]
Sent: Friday, June 07, 2013 12:04 PM
To: Daniel Moore
Cc: Dr. Paul Goodnick; Dr. Ely Pelta; Dr. Charles Conway; Dr. Mark George; Dr. Ziad Nahas; Dr. Yvette Sheline; Dr. Harold Sackeim; Dr. Steve Balt; Craig Malisow; Margaret Sullivan; Howard Finkelstein; Dr. John Rush; Dr. Werner Doyle; Dr. Istvan Takacs; Dr. John M. Nardo; Dr. Jeffrey Paley
I’d like to congratulate you on your outstanding and record breaking profitable quarter. There is no doubt I would believe in anyone’s mind that your stewardship has brought Cyberonics from the brink of disaster to a remarkable financial recovery and profitability.
At the same time I have been patient as I awaited CMS response to your most recent request for depression approval. CMS having declined this recent request I cannot wait any longer. I have just embarked upon a campaign covered in the petition I’ve pasted below. I am making my best efforts to put my campaign in the front of as many governmental officials, President of the United States, Senators, Congress people, FDA, CMS and other governmental agencies, news media including newspapers, magazines and television, the APA and various medical associations, as well as the general public for support to get you and your company to honor the previous public commitments of the former CEO and to standup and be morally responsible and adherent to the desperate needs of these former study subjects hung-out-to-dry.
Please also understand I still remain very supportive of VNS Therapy for Depression as a viable treatment option to be considered by patients in collaboration with one’s attending healthcare practitioner.
I strongly feel at this point in time although the FDA had approved the therapy for depression the only way the therapy will overcome CMS denial is to re-institute a new properly prepared double-blind study and not one following a drug protocol. A study more suited for a neuro-modulation device requiring considerably more time to demonstrate efficacy. But then again, I’m sure you already know that and based upon Dr. Conway’s demonstrated favorable results you would have someone very capable of structuring the new study and protocol and someone already compassionate to the plight of the current study subjects. Although, I cannot wait any longer.
Joyce has done remarkably well over these past 13 years in terms of no depression. Joyce was last re-implanted in January 2005. This coming January will be 8 years of service on her 2nd and current prosthesis, if it lasts that long, You have put us and others former study subjects in a very precarious, tenuous and extremely stressful situation.
I have inquired and been told I cannot undertake any legal action at this time against Cyberonics based upon a future event. That is until Joyce’s battery is depleted and our insurance carrier (United Healthcare) and your company formally denies covering Joyce’s pulse generator replacement surgery.
Please understand my position and rest assured that unless something can be favorable accomplished for these former study subjects and Joyce as well whereby you reconsider your position before Joyce’s need for replacement that I shall continue my campaign to make an all-out effort to make Cyberonics both legally and financially responsible for breaking and reneging on its previous publicly stated commitments (“Lifetime Reimbursement Guarantee for All TRD IDE Study Patients…”) while also making sure the news media and general public stays informed as best I can.
As always I wish you continued success and wellness for you and yours.
Cc: Benedict Carey, New York Times
Barnaby J. Feder, New York Times
P.S. Doc Mickey and Doc Steve I would hope that you take this matter seriously under consideration by sharing our petition and campaign on your respective blog sites and encouraging your respective readership to sign on with us.
Caution: Do not volunteer for any medical research until you read this petition.
VNS THERAPY FOR DEPRESSION (VAGUS NERVE STIMULATION)
The purpose of this petition is quite simple and straight forward, that is to obtain health insurance coverage for a group of volunteer medical study subjects for an FDA (Food and Drug Administration) approved therapy and to warn all medical volunteer study subjects to obtain in writing who is responsible for their medical care if CMS (Centers for Medicare and Medicaid Services) and/or one’s insurance company denies coverage. FDA approval does not mean or insure health insurance coverage.
On or about 1997 Cyberonics, Inc. received FDA approval for VNS Therapy for Epilepsy. On or about 1998 Cyberonics additionally got the go ahead to institute an open pilot study (D-01) for the same VNS Therapy for Depression. The D-01 was instituted as a result of Epilepsy studies and patients not only reporting decreases in number and severity of their seizure activity but also diminishing depression episodes.
Through the assistance and caring of my spouse’s then attending psychiatrist, Dr. Paul Goodnick, Joyce was enrolled in the D-01 open study as study subject #46 at MUSC (Medical University of South Carolina) under the directorship of Dr. Mark George and Dr. Ziad Nahas. She was implanted with the device on December 13, 1999.
In our desperation at the time and after some 36 years of Joyce’s continuing severe depressive episodes and suicidal attempts and failed therapy trials as well as numerous ineffective medications and refractory treatments, she signed the papers for this newest neuro-modulation study.
We carefully noted that death was a possible outcome. We also noted once FDA approved, Cyberonics would no longer be responsible for her medical care.
What we didn’t know or realize at the time of signing nor did any of the study volunteers and worse yet the fact that all the other affiliated parties and medical professionals didn’t take into consideration when structuring any of these depression studies that with FDA approval it ended Cyberonics responsibility for medical care but it did not insure Medicare/Medicaid and/or health insurance coverage for the study subjects. Nor did anyone know despite FDA approval that CMS denying coverage for this medical device (historically the first time such an event took place) left these volunteer patients in a Catch-22 with an implanted medical device and some with paid health insurance but still denied coverage for this particular therapy.
VNS Therapy, VNS depression studies, Cyberonics, the former CEO Robert P. (“Skip”) Cummins and the FDA have all been steeped in controversy and maligned as well. Yet and at the time, when I brought this loophole to the attention of Mr. Cummins he assured me “not to worry.”
Mr. Cummins honored his words and to his credit, took action and made a responsible and morally correct pronouncement. He acted and assured the depression study subjects would have health coverage for the VNS Therapy if their own health insurance and/or Medicare/Medicaid carriers denied to cover the therapy by publicly announcing on January 18, 2006:
“Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15
Million TRD Indigent Care Program…Cyberonics has taken the unprecedented steps with its lifetime reimbursement guarantee for study patients and its $15 million TRD Indigent Access Program, to ensure that study patients and indigent Americans with TRD have fully informed access to VNS Therapy.”
Similar information was also entered into the Cyberonics corporate 8-K SEC filings.
Mr. Skip Cummins is no longer with Cyberonics and the current management has reneged upon their oral and published contract, commitments and statements. The company has refused to pay for the servicing, care and replacement of their implantable devices for those volunteer study subjects (patients) wanting to continue the therapy.
A number of these volunteers, who were devastatingly ill, are benefiting long-term and living reasonable quality of lives as a result of VNS Therapy. These patients are being denied health insurance coverage by their own paid for carriers as well as Medicare/Medicaid despite the fact the therapy works for them and was FDA approved.
Adding to the illogic of this conundrum is the fact the very same therapy is covered by Medicare/Medicaid and health insurance carriers for epilepsy and that some 200 leading psychiatric professionals had commented during the write-in period to CMS that the therapy should be approved for coverage based upon their personal patient treatment experiences and that conventional therapies are ineffective for this unique population of seriously ill patients.
In the infinite “lack” of wisdom on the part of our government’s convoluted working agencies to protect us the FDA, CMS as well as the sponsor and the oath taken by all the medical researchers (to do no harm) no one thought to ask or provide for health care and replacement coverage for these medical volunteers. Thereby leaving these study subjects (my spouse included) with a costly implanted medical device and therapy that no study subject rightfully or morally should be paying for out-of-pocket especially since we have health insurance.
CMS in their denial of coverage should have rightfully grandfathered in the existing study subjects. They did not.
One last and most important point; Joyce and I still remain advocates for VNS Therapy for Depression as a potentially viable treatment option to be considered by a reasonably informed patient.
As a result of this therapy my spouse has been depression free approaching 14 years. We no longer discuss depression. She takes no antidepressants. Our major concern is to continue maintaining her past 14 year wellness utilizing the same VNS Therapy and to have our paid for health insurance carrier, Cyberonics and/or any other responsible party honor their commitments to cover Joyce’s medical expenses and that of the other study subjects as they do for epilepsy.
At the same time to once again caution and make aware to other volunteer medical study subjects in any other kind of study to not get caught up in a very stressful similar and costly situation and negligent oversight.
Please sign and join this petition to correct this medical injustice:
I am requesting The United States President, Senate, Congress, CMS, state and local governmental officials, Health Insurance Industry, Cyberonics and all medical professionals especially those having anything to do with VNS Therapy for Depression to do the responsible and morally correct thing by exerting pressure upon any of the responsible parties to correct this oversight and injustice by helping these volunteer study subjects (patients) to obtain medical coverage and to insure future medical study volunteers are not faced with a similar predicament.
Thank you all for your consideration in reading this petition and joining in to obtain health care for all medical research study volunteers.
Herbert Stein, caregiver and long-time support person to my spouse, Joyce Stein
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