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« on: January 19, 2015, 08:08:40 AM »

What Happens in My Vagus Stays in My Vagus

Submitted by sylvia kronstadt on December 24, 2013 - 2:08pm

Get away from my neck, you medical-device vampires!

A highly unpleasant spotlight, which turned me into a Vagus showgirl for five years, has finally been turned off. I just completed a Cyberonics, Inc., clinical trial of the Vagus Nerve Stimulator, to assess its effectiveness in helping those who suffer from treatment-resistant depression. It was a ridiculous, scandalous experience.

I don't trust Big Pharma, and I don't trust the multibillion-dollar medical device industry. My cynicism was vindicated by the bizarre combination of incompetence and ruthlessness that characterized this study.

In trial after trial, this device has shown itself to have extremely limited value. But Cyberonics (which sounds like a sci-fi cabal that unleashes evil robots), is determined to keep trying until it wears down its opponents and qualifies for reimbursement, so it can achieve its dream: a fabulous financial windfall. This whole episode illustrates the morally compromised nature of both the FDA and the medical device industry.

I am thrilled to report that Medicare, Medicaid and the nation's insurance companies are holding their ground, finding Cyberonics' latest clinical trial to be as underwhelming as all the others. They are "flatly refusing" --in virtually every case -- to pay for the device, the surgery, and the lifetime of after-care that is required, according to the Washington Post.

The U.S. Centers for Medicare and Medicaid Services (CMS) is continuing to refuse reimbursement, despite the fact that the Food and Drug Administration (FDA) -- in its laziness, inconsistency and vulnerability to pressure -- half-heartedly approved the VNS for treatment-resistant depression nearly 10 years ago. That decision has inspired disbelief and ridicule ever since.

I have been informed that the refusal of Medicare and Medicaid to pay for an FDA-approved device is unprecedented.

And the CMS ruling that "VNS has no treatment effect," raised new concerns about the FDA's 2005 decision to approve VNS for patients with treatment-resistant depression, the Post reported.

Thus, the Cyberonics people are still conducting studies -- as if their device is going to evolve spontaneously into something worthwhile, if they just keep cutting people's necks open and putting it in. I believe this is what is known as "magical thinking."

The firm had announced that it would conduct no further trials -- which cost several millions of dollars each -- unless it could find a partner. Year after year, it could not convince anyone to get involved, but its trials continued.

"We will not rest until all eligible patients have full parity in access to VNS Therapy," George Parker, Cyberonics' then-interim chief operating officer, told the Post in 2007, after yet another round of trials failed to show that VNS is "safe or effective."

Industry analysts had been awaiting Medicare's key ruling, eyeing "the large number of potential patients who could have received the device," the Post added. Cyberonics was eyeing that large number as well, and still is.

"No one wants to touch this company with a 10-foot pole," one commenter said on an investment advisor message board.

In this article, I am going to describe my personal experience as a participant in the most recent trial, beginning in 2008. I will also address the dismal results of past studies (whose weaknesses have been replicated in subsequent studies); the outraged reaction of the scientific community to the FDA's approval of the device in 2005; and the shameless persistence of Cyberonics in pressing for reimbursement, despite the well-documented likelihood that the $30,000 to $70,000 cost per patient, just for the initial implant, would be a complete waste. I will also detail the substantial dangers and side effects of this product.


But first, I will chronicle the traumatic loss of privacy that my involvement in this clinical trial required. It was a violation that has had an ongoing effect on me. I initially refused to sign on the dotted line, because I was distressed by the "laying bare" of my mind and my life that was being demanded by Cyberonics. I eventually relented, as a favor to a friend who was involved in administering the study at one of the sites, and who was desperate to cobble together an adequate sample.

I vehemently declined, though, to have the VNS appliance implanted in me (and not just because they expected ME to pay the $30,000 cost), so I was enrolled in the control group. All of us -- two groups of severely depressed patients -- had to essentially turn everything about ourselves over to this enterprise.

It made me sick. It left me with an ongoing sense of vulnerability. I lost something that I can never retrieve. I am "out there," instead of "in here." For better or worse, this blog -- which I launched about midway through the study -- has often been perhaps overly personal. Thanks to that stupid study, I feel that I have nothing left to hide.

We should not give up the right to hide -- particularly not for the purpose of enhancing the profitability of a corporation.


Even though I didn't have my neck torn open and have a foreign object jammed into me, I was required to authorize the release of a lifetime of medical and psychiatric records, medical insurance records ( to reveal my "health-care utilization"), hospital records, records from individual doctors (including, Cyberonics specified, my gynecologist), and all of the personal insights gleaned about me during the study. The consent form acknowledged that the probing of study personnel "may upset you and worsen your depression."

"Every reasonable effort will be made to keep the information private," Cyberonics assured study participants in writing.

I was repeatedly assured that my privacy would be honored, that I would be "nothing but a number," and that none of my information would be "personally identifiable."

That was patently untrue, as the fine print in the lengthy Cyberonics consent form acknowledged:

The information we share with others may include information that directly identifies you. The Food and Drug Administration (FDA), will have access. There are other federal agencies that may need to view the data.

The study sponsor, its representatives and contractors, regulatory authorities and other supervising bodies may look at all your medical information.

Tests or examinations that you will be required to take may identify you because they may contain your name, address, telephone number, date of birth, social security number, race or ethnic origin, height, weight or other unique identifiers.

Once information is disclosed to outside groups, this information may no longer be covered by the federal privacy protections.

If your protected health information is disclosed to a recipient who is not a "covered entity," your protected health information may no longer be protected by federal or state law and may be subject to re-disclosure by the recipient.

If you revoke this authorization, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research.

Your information may be used by Cyberonics in connection with the sales and marketing of its VNS Therapy System.

This authorization does not have an expiration date.

Before the trial had even formally begun, I inadvertently discovered that a description of my "personally identifiable" sexual history, which I had mentioned to a therapist, had been shared among study personnel, including a secretary.

Input I have received from others who have been involved in Cyberonics trials indicates that study participants' personal revelations in general were handled in a cavalier fashion, which was not appropriate for any kind of patient information, particularly that which is so intimate.

My records, dating back 45 years to the present, contain vivid accounts of devastating and degrading experiences, disturbing thought processes and nightmarish phases of my life, in which my mental illness, eating disorders and substance abuse came close to killing me. In my interrogations by study personnel, I described extreme aspects of neurosis, sociopathic impulses, compulsive behavior and suicidality.

"Your responses to questions will be collected by Cyberonics and combined in a computer database with the responses of other patients," the company's consent form explained. "This information may be kept by Cyberonics long after your participation in the Registry ends and for an indefinite period of time. Cyberonics may permit physicians, researchers and depression support organizations to use this database to evaluate therapies for treatment-resistant depression."

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« Last Edit: January 19, 2015, 09:41:25 AM by dennis100 » Logged
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« Reply #1 on: January 21, 2015, 11:08:28 AM »

This lady's blog has some very interesting finds.  She did her research!

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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