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Author Topic: Angry Study Participant pt.3  (Read 4928 times)
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« on: January 19, 2015, 07:39:57 AM »

Given our concerns about the quality of the observational data, these results did not provide strong evidence for the effectiveness of VNS therapy. "

The insurance giant was highly critical of Cyberonics' clinical trials for their limited size and scope. The firm kept reducing the number of patients it promised to include, creating additional skepticism.

"Patient selection was a concern for all of the studies," Blue Cross asserted.

The same studies "have been published in peer-reviewed journals, almost unchanged from the documents (submitted to) the FDA," Blue Cross noted, alluding to the corruption of these journals. "New publications simply analyze the same data in various ways."

Overall, "the available scientific evidence does not demonstrate efficacy of VNS for treatment-resistant depression," Blue Cross concluded, mentioning that "results from the only double-blind trial in a multicenter European study were considered to be inconclusive."

Aetna's detailed examination of the validity of VNS for depression reached similar results, and it continues to deny reimbursement. "Comparative clinical research(on VNS) is early in its infancy, and many clinical questions about efficacy and effectiveness remain unanswered," Aetna states. "Interpretation of the data is substantially hindered by varying definitions of TRD and the paucity of relevant studies...Even for the few comparisons of treatments that are supported by some evidence, the strength of evidence is low for benefits."


In many of my blog posts, I have described the callous greed of the health-care industry. Medical-device makers fit right in with this unsavory crowd. Their well-funded lobbying efforts have secured for them a mind-boggling exemption from liability. The "doctrine of pre-emption" relieves them of any financial obligation if one of their devices injures, disables, or kills a patient (

Cyberonics, as the Public Citizen investigation dramatically revealed, is a Bad Boy among bad boys. I am absolutely disgusted that it has been able to continue hawking its fundamentally flawed product to fragile, anguished people who are desperate for relief.

Now the firm is plotting to expand the use of VNS in Alzheimer's disease, anxiety, chronic migraine headaches, and bulimia, even as its reputation is being banged around by scandals that tarnish its credibility in both the stock market and the medical world.

On Nov. 17, 2008, the House Committee on Energy and Commerce launched an investigation into whether senior managers at the Center for Devices and Radiological Health "knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation" of the law and agency regulations.

According to the National Whistleblowers Center, a substantial matter of CDRH staff dissent had been publicized in 2006 relating to the 2005 pre-marketing approval of Cyberonics' VNS device for treatment-resistant depression. In that case, a Senate Finance Committee investigation, including review of internal documents and interviews with FDA staff, found that Center Director Schultz approved Cyberonics' product after overruling more than 20 FDA staff members, mentioned previously, who had concluded that data submitted by the company did not meet reasonable standards for safety and effectiveness.

(More generally, a 2006 survey of nearly 1,000 FDA scientists found that only 47 percent felt that they could openly express concerns within the agency about public health without fear of retaliation, the Center added.)

The plot thickened as some material provided on the FDA’s website for this device was redacted.

A New Jersey federal court unsealed a complaint in 2012 alleging Cyberonics Inc. violated the False Claims Act in its campaign to convince regulators and doctors that its nerve-stimulating therapy system could treat severe depression, costing states' insurance $75 million, which was spent during the period between FDA approval and CMS rejection.

A MEDICAL COMPANY INFECTED WITH DECEIT, which "uncovers the dirty little secrets every investor needs to know," and is often quoted in the Wall Street Journal, presented an expose by Infinitalis in January 2013 containing "very serious allegations of unscrupulous and potentially fraudulent activity on the part of NASDAQ-listed Cyberonics, Inc."

In its report, TheStreetSweeper presented "the culmination of nearly two months of research into Cyberonics. The more we dug, the more we found red flags and skepticism in the scientific community as to the efficacy of VNS." It linked to 11 research papers, including one in the New England Journal of Medicine, that cast doubt on VNS, and were sourced from academia, government and private enterprise.

"What we found was troubling," TheStreetSweeper reported. "The efficacy of VNS therapy as measured scientifically in randomized trials was very weak, and its approval as a treatment was met with unusual controversy."

The article went on to quote award-winning mental health journalist John Mcmanamy's views of the clinical trials. Mcmanamy noted that Cyberonics' president had said that VNS was used on "hopeless, desperate, suicidal patients, not expected to respond."

"Unfortunately, the patients lived up to expectations," Mcmanamy wrote. "Ordinarily, a study with this design and these results never would have made it past the FDA doorman."

The most recent clinical trials didn't change things, except for Cyberonics' stock price.


A Reuters dispatch on May 28, 2013 reported, "The decision by the U.S. Centers for Medicare and Medicaid Services (CMS) not to provide reimbursement coverage for Cyberonics' Vagus Nerve Stimulation (VNS) therapy sparked a selloff in the company's shares, and dimmed hopes of wider sales of its most important product. Cyberonics stock price plunged 10 percent in extended trade." (Even so, the firm's domestic-product revenues "reached a record high in the last quarter on the back of new patients and higher replacement activity," according to a company press release.)

On the back, indeed. No wonder we have so much back pain in this country. We are hauling around the health-care industry's unconscionable costs, and they just keep going up.


As if Cyberonics' bad faith weren't already obvious enough, it flamboyantly announced in 2006 an "unprecedented" lifetime reimbursement guarantee "to honor" hundreds of patients who had participated in its FDA clinical trials and required ongoing care, maintenance and regular replacement of the battery-powered device. By this time, their devices needed to be replaced, and surgeons needed to be paid. Since reimbursement had been denied, these patients -- who had expected that they would be taken care of after volunteering to participate in Cyberonics' studies -- were left holding the bag.

The company promptly got itself a new CEO and reneged on this offer, enraging those who were left with a lifetime of medical bills -- up to hundreds of thousands of dollars for some patients -- that they would have to pay out of pocket. What percentage could not find a way to finance the replacement procedure? No one is saying. I know that second mortgages have been taken out and 401-ks have been ransacked, thanks to Cyberonics' indifference.

When I agreed to participate in the clinical trial, the issue of ongoing care for those who had the device implanted never occurred to me. I guess we all implicitly assumed that study volunteers would be respected -- that they wouldn't just be "thrown under the bus."

Cyberonics volunteers became corporate roadkill.

In an August 13, 2013, email to Herbert Stein, whose wife was a volunteer in the earliest trials, Cyberonics president Dan Moore blamed a federal anti-kickback statute for the company's reversal on reimbursement -- a claim that is absurd to anyone who has read the statute, the FDA's protocols and Cyberonics own literature. Moore added that the firm never thought it would have to pay the entire cost of the volunteers' medical bills -- it had expected federal assistance.

His flaccid protestations about the weighty problem of helping these patients are appalling, particularly given that Cyberonics is a very profitable firm.

Stein -- a heroically persistent, articulate, forceful and well-informed mental-health advocate -- says his wife and the other study subjects are the victims of a "very stressful and immoral Catch-22."

"We have implanted devices that are therapeutic, with no one willing to care, pay or giving a damn for these patients," Stein told Brown in their email exchange.

Stein's wife, and all the others who responded well to the implant, face a desperate situation: Come up with lots of money every several years, or be plunged back into a life of mental anguish.

One woman wrote to Stein that her VNS battery has died, and she has been in a deeply hopeless state ever since.

She had her device implanted in the "window" between when VNS was approved by the FDA and CMS determined that it would not provide coverage. Like many of those who have benefited from VNS therapy, she had been so miserable before the implant that she had attempted suicide several times.

Another wrote to Stein: "On Jan 12, 2006 I was implanted with the VNS implant for depression. It was a desperate attempt by my doctor to save my life, which I had tried to end many times. After the implant was turned on and adjustments were made, the improvement was almost instantaneous. I will never forget the day I woke up after the last adjustment and for the first time since I could remember I thought something is different. Then I knew, I felt happy, I felt alive, I felt like laughing. My girls came running into the bedroom because they heard me and we all jumped on the bed wrestling. Ashley who was 3 said Mommy's back, Mommy's back. And Sara went running to get her brothers yelling Mommy's all better, look she's all better. The tears of joy were running down my face and it felt good. Now it is time for a new generator and I feel the sadness descending. Ashley is 18 and a senior in high school. She is terrified of losing me again. Sara says I can see it happening Mom. I come home and you're sleeping just like when I was little. It's not fair to give children their Mother back for 7 years and then tell them that's all you get it's over, we're taking her away again."

Yet another of Stein's correspondents whose entire outlook on life had become loving and joyful, added: "I never thought that I would have to plead for my life when I signed up for this study. I thought all my problems were over." These people, who regard a return to their former states as a sort of death, are incredulous that

Cyberonics implanted a device in them that it has no intention of maintaining.

"I have lived in some of the blackest days of my life since my VNS stopped working. The only reason that I have not been hospitalized more is that I no longer believe that it will do any good. I cannot care for my self or even leave my house. My life is very much at stake," another patient told Stein.

One former trial participant poignantly expressed similar anguish: "It's so frustrating, because the stress of the $64,000+ hanging over my head tends to threaten my health and well-being...also the knowledge that I've spent over 18 months jumping thru the hoops required by my insurance company and still have no promise they will pay the bills or cover me in the future for my VNS related services."

Stein has drafted an online petition, which I gladly signed, that would require ongoing care for all study patients in FDA clinical trials. He is expecting a decision soon from CMS on a "compassionate use" exception that would provide funding for those who were implanted with the VNS device and obtained substantial benefit.

Since we obviously can't rely upon corporate America to treat clinical-trial subjects with dignity and fairness, the FDA should impose stringent rules for the protection of patients, who are being grossly exploited under the current regime.

I certainly felt exploited by the process as well, although the cost to me was psychological rather than financial. We who participated were mere cogs in Cyberonics' self-serving machine. We were as dispensable and disposable as Kleenex. It is disgraceful.

Given how few people respond to this extremely expensive treatment, it's not surprising that the scientific community is baffled by FDA approval, and it's certainly not surprising that private and public insurers are refusing reimbursement.

Cyberonics isn't giving up. Company officials seem convinced that if they sustain their lobbying long enough, they will win. If they do, they will have insinuated themselves into one of the most lucrative device markets in the world -- a world filled with very sad people -- and Cyberonics will be very happy. Maybe all the company's Top Dogs will go to Vegas and get their minds blown, no implanted gadget required. Martinis are delicious, especially when they have blondes sitting in them:


The Cyberonics trials have attempted to prove that the VNS device is effective against refractory, or treatment-resistant, depression.

According to the company's web site, Cyberonics received FDA approval in 1997 "to market VNS therapy for the treatment of epilepsy. Since that time, more than 32,000 patients worldwide have been implanted with the device. The remarkable success of VNS therapy in the treatment of epilepsy has served as a platform for continued innovation."

This is a typical example of the company's deceptive tactics, for which it has repeatedly been criticized. VNS therapy was actually approved for use in a subset of refractory patients, not as a general treatment for epilepsy, and it has not been "a remarkable success."

Patients must continue taking their anti-seizure medications. even after receiving an implant.

The National Institute of Neurological Disorders and Stroke estimates that VNS therapy reduces the frequency of seizures by an average of only 20 to 40 percent in the "small subset" of patients who respond to it.

According to a 2011 meta-analysis in the Journal of Neurosurgery, "disagreement regarding the utility of VNS in epilepsy continues because of the variability in benefit reported across clinical studies. (At best), seizures were reduced by 50 percent or more in approximately 50 percent of the patients. A quarter of patients do not receive any benefit from therapy."

As recently as last month, the American Academy of Neurology referred to ambiguities, evidence gaps and unmet research needs in the use of VNS for refractory epilepsy.

The FDA really makes a mess of things.

Now VNS is being investigated as a possible treatment for heart failure.

On the upside, an August 28, 2013, article in Neurology noted that "a small subset" of patients being treated for epilepsy with VNS experienced an improvement in mood "as an additional benefit."

No wonder Cyberonics confidently plunged into the depression market, which has 10 times as many potential customers.

On July 15, 2005 , after seven years of "extensive study and clinical trials," VNS therapy was approved by the FDA as a long-term adjunctive treatment for treatment-resistant depression.

Cyberonics' trials have been characterized from the start as being too small, poorly designed, sloppily managed and ultimately misleading.

As usual, the most recent trial was guilty of enrolling people who either hadn't met the standards for "treatment resistance" (having failed to get sustained relief from at least four drugs) (it used to be six) (but sometimes it was two), or they were so hopelessly ill that one consultant said, "They are simply lost. Nothing we have can help them."

I don't see how people who are that impaired could even have provided informed consent to participate in this trial, and I am horrified that they were put through it.

One mental-health professional told me that this trial was the most stressful experience of his career. "We were not prepared for the eviscerating impact of coping with such deeply disturbed and inconsolable people," he said. "I never thought I'd say this, but I'm ready to retire."

But this is the extremely depressed population for which VNS claimed to provide a solution.

I was asked to submit to the surgery, even though I suffer from three conditions that should have excluded me, according to Cyberonics' own patient manual.

As I have described, the trial required participants to "bare all" in its intense scrutiny of our psyches, but we were not people in this context -- we were data. Our years of responses to hundreds of questions were merely paperwork, which would form a stack that Cyberonics would point to as "documentation." It was a charade of going through the motions -- from the executive Cyberonics level down to the local clinical trial level -- to amass unwieldy stacks of information that could be tweaked somehow to seduce CMS into changing its mind.

Having suffered from depression and related psychiatric issues for my entire adult life, I was an ideal candidate from Cyberonics' perspective.

But I had a different perspective. Why did I reject the opportunity to try a medical technology that I was told could bestow upon me a whole new life of joy and functionality?


The VNS appliance is very invasive. The pacemaker-like implant in the chest didn't bother me particularly, but the wire lead, which is firmly attached along the vagus nerve, up the neck, generally can't be removed, no matter what side effects it is producing. The tissues surrounding it become so enmeshed in the lead that it would be life-threatening to extract it, I was told. I couldn't tolerate this.

The thought of having a major component of my central nervous system in the grips of that coil made me feel ill and strangely claustrophobic. I told the study coordinator, "I can imagine freaking out, and trying to rip it out of my neck with my fingernails."

He responded, "That's happened."

Moreover, I was told that I would have to pay $30,000 of my own money to have this controversial, unproven device implanted.

What kind of fool do you think I am?


Are you kidding me? People don't pay to be a part of clinical trials -- if anything, they are paid. Cyberonics was conducting the trial for its own financial benefit, yet it expected me to pay for taking a major health risk, and devoting a lot of time subjecting myself to its repeated, probing scrutiny.

Even if data from previous studies had indicated that I had a good chance of experiencing substantial benefit from the implantation of the VNS, I would not have paid. It was their trial, and it was their financial responsibility. But the data were not impressive. Simply put: I was not likely to benefit. No one was -- or is -- likely to, which is why Cyberonics has not been able to get reimbursement status.

The overall failure of VNS to treat refractory depression can overshadow the fact that, for a minority of patients, the device can be "transformative," according to one study coordinator. "In a few cases, it has been quite unbelievable," he said.

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« Last Edit: January 19, 2015, 09:43:14 AM by dennis100 » Logged
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