Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Thursday, November 28, 2013

“In order to fulfill regulatory and compliance processes, we are required to remove material from the VNS Therapy Fan Page that promotes off-label information about VNS Therapy.”

To the VNS Facebook Site Administrator for Cyberonics,

I thank you for taking your valuable time in an attempt to clarify and explain to me why my comment to your webpage was removed, “promotes off-label information about VNS Therapy.”

clip_image002

As often happens dialog of this nature prompts me to further research to better my understanding. I’m fascinated when I’m confronted with “legalize” such as “In order to fulfill regulatory and compliance processes.” Exactly what regulatory and compliance statues are you referring to? Is this something akin to “anti-kickback statues” to avoid doing what is morally correct? Never mind, disregard the last question.

I researched the definition of “promote” and copied and pasted the definition below:

clip_image004

http://www.oxforddictionaries.com/us/definition/american_english/promote

Quite frankly I’ll have to disagree with your use of the word “promotes” as I’ve not ever promoted any therapy, treatment, company, product etc.

Through the years I’ve engaged in and attempted to share information based upon our own experiences, my readings, research and collaborations with both patients and physicians.

Unfortunately you did not elaborate as to which of my pieces of shared information “promotes off-label information about VNS Therapy.”

If anything, my comments about the lack of recognition of the “Unwanted stepchildren of Cyberonics” the depression patients should be a wakeup call to you and Cyberonics of the disgraceful omission and disregard you folks continue to exhibit.

These patients utilize the very same device that you sell for the epilepsy patients. You address topics rightfully so for the epilepsy patients but with outright total disregard for the depression patients and some of their unique issues. One of those issues is the use of ECT which I took the liberty to address and not “promotes”. It is shameful that instead of instituting valid discussions for the depression patients you address this issue by pulling out of the hat and responding to me with “regulatory and compliance processes.” Absolute non-sense on your part as through the years I’ve had discussions with some of the very same researchers you guys originally enlisted for the depression studies. Add to which here’s additional information that you folks should be posting and sharing for informational purposes and not me.

Concomitant use of vagus nerve stimulation and electroconvulsive therapy for treatment-resistant depression.

Concomitant Use of Maintenance ECT and Vagus Nerve Stimulation for More Than 10 Years in Treatment-Resistant Depression

Did you ever think of posting a discussion about the use of VNS Therapy and TMS (Transcranial Magnetic Stimulation)? Did you ever think of posting a discussion about VNS Therapy for the epilepsy patient and the use of ECT as noted in the ladder link cited above? These topics are not promoting anything off-label but are real-time life issues ignored by you folks.

I read you’re “About” section as you suggested. I have to chuckle. You speak about promoting and yet you continue to write about “treatment-resistant depression”. Maybe you missed the fact there is no formal diagnosis in the DSM IV and was similarly stated in CMS determination of May 4, 2007.

“These various indications that have been proposed for VNS illustrate that the term ”treatment resistant depression” lacks a standard definition that has been scientifically validated, and appears to be subject to various interpretations.”

Your company’s lack of acknowledgement as to the existence of the depression patient population of VNS is obscene and an abomination. While your company’s ability to generate gross profit margins of about 89 to 90% is outstanding, widely promoted in the financial community, your public relations and treatment of these your depression patients is markedly pitiful.

At the very least I’ll thank you once again for the courtesy of your responding and wish you and yours a very Happy and Peaceful Thanksgiving.

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://www.vnstherapy.wordpress.com

No comments:

Post a Comment