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Author Topic: Angry Study Participant pt.4  (Read 4179 times)
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« on: January 19, 2015, 07:34:59 AM »

My online outreach to those who have had experiences with Cyberonics' clinical trials was very rewarding.

Several people who had been crippled and tortured by depression for many years -- and who had tried everything, including electroconvulsive therapy (ECT) to find relief -- responded in a "miraculous" way to vagus nerve stimulation. It had put them in complete remission, giving them the gift of pleasurable and productive lives.

Mental health activist Herb Stein has sent me several emails from those who have been "saved" by VNS after decades of despair, drugs, job loss, suicide attempts, shock treatments and an inability to function as a parent, spouse or friend. Their stories provide a compelling counterpoint to the hard data, which indicate that VNS is a clinical failure. Here is an example:

"I have suffered from depression for almost 20 years. I have attempted suicide many times. On my best days, I did not care if I lived or died. Depression has cost me a career as an accountant, almost destroyed my relationship with my only child, and may still take my life. I lost 5 years with my daughter because I could not care for her and I let my ex-husband have custody of her. He told her that I did not love or want her and I did not get to see her for 5 years. I was first hospitalized in 1998, then again six more times before October 2006. I have spent over 83 days in various psychiatric hospitals and have had over 18 ECTs. None of which helped for more than a month at a time. In October 2006 I was at the very end of my ability to go on. I think God every day that my doctor told me about VNS therapy. After all I had tried that failed, I had no hope that VNS therapy would be any different. To my surprise, after just a few months, I started to feel the crushing weight of my depression slowly lift. I felt as if my life had been saved. I have no doubt that I would have been dead within a year if I had not been lucky enough to get the VNS during the window of opportunity between the FDA approval and CMS national decision to decline coverage." .


Even many of those who had gotten some relief from VNS had been dismayed, though, at the way in which the studies were conducted. "Unprofessional" is a word that was used a number of times. One man, who worked in administering a trial, described the process as "improvisational," admitting that, "We were flying by the seat of our pants. The whole thing was always on the verge of falling apart. Cyberonics had a slapdash approach."

There were frantic efforts being made, apparently, to find and retain enough patients to constitute a scientifically valid study. The turnover during the trials detracted significantly from their credibility. It was as if Cyberonics had never conducted a clinical trial, and had no idea what it was doing, I was told.

A woman who, like me, was in a control group, said, "I didn't know half the time if it was still being done. No one (at the clinic) seemed to even know if Cyberonics was serious about keeping it going."

I felt the same way. The process seemed haphazard and half-hearted.


Given the dire warnings enumerated below, it's easy to see why it was hard to find study participants, despite the fact that there are millions of people in the U.S. with treatment-resistant depression.

The whole thing seemed like a pain in the neck.

All of us who take medications realize that we aren't likely to experience all -- or even most -- of the possible side effects that are listed on drug handouts. But if a drug's effects are too problematic, all we have to do is stop taking it.

The vagus nerve stimulator will alter your body forever. And instead of paying out $20 or $40 dollars to try a drug, you must pay tens of thousands of dollars to have a vagus nerve stimulator implanted. If the device is helping you, and you choose to keep it turned on, you must have it checked regularly, which can cost up to $1,400 per visit. And the device must be surgically replaced every five to seven years, at full price, including costs for doctors, anesthesiologists and surgical center fees. Moreover, VNS is explicitly an "adjunctive" therapy, which means the patient is expected to continue taking pharmaceuticals. This inevitably means side effects on top of side effects.

When I was approached and asked to participate in the trial, the medical problems listed below were the possible complications I was told I must agree in writing to accept. The most common side effects reported during VNS Therapy are voice alteration (often described as hoarseness), discomfort in the neck (typically mild pain or a tingling sensation), cough, shortness of breath, difficulty swallowing, and a feeling of tightness in the throat. These effects are particularly aversive to me. I'm afraid I'd have a panic response, especially if my swallowing was impaired. Other possible side effects are:

Possible Surgery or Treatment-Related Problems
Abnormal dreams
Abnormal thinking
Belching (eructation)
Chest pain
Difficulty sleeping
Difficulty swallowing
Dry mouth
Emotional lability
Eye pain
Fainting (syncope)
Fast heart beat (tachycardia)
Flu syndrome/viral infection
Flushing (vasodilatation)
Heart palpitations
High blood pressure (hypertension)
Inability to pass urine
Incision pain (36 percent)
Incision site reaction
Increased appetite
Increased cough (24 percent)
Increased tension of the muscles
Infection at the surgical site
Inflammation of colon (colitis)
Inflammation of lining in nose (rhinitis)
Inflammation of the throat (pharyngitis)
Joint pain (arthralgia)
Laryngeal inflammation
Loss of memory (amnesia)
Low blood pressure (hypotension)
Low blood pressure upon standing (postural hypotension)
Muscle ache (myalgia)
Muscle weakness (myasthenia)
Neck pain
Other reactions around the device generator or leads
Pain around the device generator or leads (29 percent)
Shortness of breath (14 percent)
Skin rash
Stoppage of menstrual periods (Amenorrhea)
Tightness in throat
Weight gain/loss
Tingling (paresthesia)
Vibrating sound heard during respiration (stridor)
Vocal cord paralysis
Voice alteration (59 percent)

Voice alteration was particularly likely to persist for longer than 90 days. Implantation of the Lead may cause nerve constriction (squeezing of the nerve).

Vagus nerve damage, if it occurs, can cause vocal cord paralysis. It can also cause Horner's syndrome. Horner's syndrome has symptoms that involve the eye and eyelid, and an absence of sweating on one side of the face. Nerve damage during surgery may also occur. It could result in permanent hoarseness, difficulty in swallowing, or gastrointestinal problems.

Possible Depression-Related Problems
Appetite change
Concentration problems
Emergence of mania
Fatigue, loss of energy, heavy feeling
Feeling helpless or hopeless or worthless
Feelings of guilt
Feelings of unreality
Sensitivity to how others treat you
Sleep problems
Suicide or thoughts of suicide
Weight change
Mechanical Problems
The following problems could occur:
The Pulse Generator could malfunction and not deliver stimulation or deliver too
much stimulation.
The Pulse Generator or Bipolar Lead could move or push through the skin.
The battery in the Pulse Generator could become depleted, (reach its end-of-life).
The Bipolar Lead could break or become corroded, disconnected, or dislodged.

Any mechanical problems could require surgery. Surgery could cause the nerve to swell because of the lead placement around your vagus nerve. If the Pulse Generator and Lead are removed, it is possible the nerve may swell due to the handling of the nerve. Moving the VNS Therapy ™ System could cause damage to the vagus nerve or other parts of your body. You should not move or twist the Pulse Generator or Bipolar Lead.

A malfunction of the Pulse Generator could damage the vagus nerve. This malfunction could lead to permanent hoarseness or other complications. Stimulation may become painful, irregular, or continuous. Call your doctor immediately.


I wasn't about to subject myself to the dangers of this unproven device. My role as part of the control group was basically to remain depressed (which Cyberonics could realistically assume I would, after all these years and all those medications). My ongoing depression would magnify any beneficial effects that occurred within the treatment group -- it would skew the data in Cyberonics' favor.

"I despise these companies," I told a study employee.

"All you have to do is get better, if you want to screw things up," he said.

(It's not going to happen.)

I didn't get better. I should have faked it, as a way of expressing my Rage Against the Machine.


As if all the failures, side-effects and irreversibility of the implant weren't enough, there are quite a few somewhat scary precautions for those who had the device implanted. For example:

"Being close to certain types of equipment can affect the Pulse Generator. Move away from or avoid equipment such as transmitting antennas. Move at least 1.8 meters (6 feet) away from any equipment that interferes with your device. The Cyberonics Magnets are very strong. They can damage televisions, computer disks, credit cards. Move through antitheft devices and medical detectors at a steady pace; do not linger in the area and stay at least 40 centimeters (16 inches) away from such equipment. Electrical or electromechanical devices with a strong static or pulsing magnetic field can cause the Pulse Generator to start suddenly. Such devices may include strong magnets, tablet computers and their covers, hair clippers, vibrators, antitheft tag deactivators, and loudspeakers.

Ah, the lucrative beauty of neuromodulation.

"Keep this type of equipment at least 20 centimeters (8 inches) away from your chest. Treatment with radiation, cobalt machines, and linear accelerators may damage the Pulse Generator.

Note that no testing has been done to date. The effect of radiation on the device is not known. External cardiac defibrillation (an emergency, life-saving procedure) and other procedures for heart problems, as well as extracorporeal shockwave lithotripsy, diathermy, and electrocautery, may damage the Pulse Generator.

"While the Pulse Generator is stimulating or being set or tested, it may briefly interfere with nearby equipment. If this happens, move at least 1.8 meters (6 feet) away from such equipment. The Pulse Generator can interfere with devices that operate in the 30 kHz to 100 kHz range. Hearing aids and transistor radios operate in this range. The Pulse Generator may affect other implanted medical devices, such as cardiac pacemakers and implantable defibrillators. Possible effects include sensing problems. These could lead to inappropriate responses from the Pulse Generator.


Cyberonics' own clinical trial data are unimpressive when regarded through the eyes of one who needs effective treatment of depression rather than through the eyes of a corporate executive who is fantasizing about an exploding global market. Caveat emptor.


Vagus nerve stimulation is being tested by several device makers for possible treatment of a wide array of conditions. But Cyberonics' implanted device may become obsolete before it ever gains a significant foothold in the depression market: Several firms are already developing noninvasive, handheld devices to deliver the electric pulses.

Cyberonics, whose invasive, problematic VNS system has undoubtedly deterred many potential customers -- has seen the light, and has developed an alliance with CerboMed, a private company based in Erlangen, Germany. Its NEMOS t-VNS system, which includes an earplug-like device, is designed to stimulate a branch of the vagus nerve in the outer ear by sending a pulse through the skin.

CerboMed’s device has received clearance for marketing in Europe for patients with epilepsy, depression, and pain, but is not yet approved in the U.S. In early September 2013, Cyberonics said it had made an initial investment of about $2.6 million in Cerbomed and gained an exclusive option to market the NEMOS device worldwide as an epilepsy treatment.

In a clinical trial in Germany, "Five of the seven patients who applied t-VNS for nine months showed a reduction in seizure frequency." This information is obviously not adequate to enable a prospective patient to make an informed decision. How much reduction? How severe was the disease in those studied?

The transcutaneous therapy is also being tested in migraine patients.

Cyberonics’ VNS system already dominates the market in devices for epilepsy. Some 100,000 people worldwide have received its relatively primitive and permanent implant. Think how they must feel, knowing that the wire that is gripping a nerve deep in their necks is unnecessary?

At the 86th congress of the German Society of Neurology in Dresden, CerboMed will present "first-hand information about transcutaneous Vagus Nerve Stimulation (t-VNS)" between September 18 and 21.

COMING NEXT: Neuromodulation is a burgeoning field in the medical-device industry. Profound effects on the brain and body may soon be delivered by high-tech products that are already being tested worldwide. The ambitious medical device firms are already making grandiose problems and hiding mediocre clinical-trial results. They are raising tens of millions of dollars in venture capital. The biggest companies are getting bigger, and the little startups are hoping to attract their attention. Everyone's eyes are on the prize: The pot of gold. Who is watching out for us?

« Last Edit: January 19, 2015, 09:20:46 AM by dennis100 » Logged
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