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Author Topic: Angry Study Participant pt.2  (Read 5633 times)
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« on: January 19, 2015, 08:07:15 AM »

Depression support organizations? Don't they host "fun runs" and have web sites that provide message boards and lists of resources? They don't have a right to my life story!

My information would also be made available to personnel at the university from which I graduated.

And I don't want Cyberonics using me to fuel its propaganda machine, spreading the word at all levels of the Depression Industry that its device should be sold to vulnerable patients. But of course, that's exactly what it's doing.

And it's doing a masterful job of generating favorable coverage on many web sites, in medical journals and in the mass media, based upon study data that informed experts find "astonishingly weak."

My secrets, kept forever, in a vault that has a big welcome mat.

So they were collecting my very personal history, not just to be used for one study and destroyed, but to be kept in perpetuity for others to use. I picture a big vault, in which my nightmares repose, ready to be serve the purposes of whomever might come along, to achieve a goal I can't even imagine.


Instead of its pathetically weak reassurance that, "Every reasonable effort will be made to keep the information private," why didn't the company make a forceful guarantee: "Cyberonics pledges that your privacy will be fully protected, and it has in place a protocol that makes it impossible for any personally identifiable information about you to be accessed by its own personnel, or by anyone else. Cyberonics agrees to be legally and financially liable for any breach. Any injured party will be eligible for both punitive and compensatory damages."

(Just kidding)

The firm offers no such guarantee, and in fact it guarantees quite the opposite, as its consent form made disgracefully clear.

No wonder Cyberonics has so much trouble finding anyone to participate in its clinical trials. This is ridiculous! Does the firm always rely on study administrators using their personal friends, like me, who grudgingly agree to be involved in such a debacle?

I haven't trusted the United States government to respect my privacy since the 1960s. Now I know not to expect a faceless corporation with no accountability, no loyalty and no evident integrity to do so.

I jokingly told clinician that a laptop containing all of our information would probably be stolen during the study, and that is exactly what happened, about two years into the process.

In order to sustain my commitment to participate, I had to repress my humiliation, even more after the theft. It was hard on me.

Every few months, for five years, I had to answer very personal questions, on detailed forms, and in separate interviews with a psychiatrist and a psychologist. By personal, I mean everything from "feelings of worthlessness" and "obsessive thoughts" to detailed inquires about my sexuality, including the amount of lubrication I was producing. These latter questions I refused to answer on the forms we had to fill out regularly, and a study assistant said, "Don't worry -- we'll fill those in for you."

Oh great! I wonder what sort of answers about lust and responsiveness have been attributed to me. Maybe it's so lurid, someone will make a movie about it: "Lilith: The Nympho Resurfaces."

All of this, and all my other records, are now -- and forever will be -- the property of Cyberonics, Inc., that ever-so well-lubricated machine.


I lost an aspect of precious autonomy and discretion for the benefit of a piece-of-crap device made by a haughty, hapless profiteer.

Even the FDA, which inexplicably approved the VNS device, was so lukewarm in its announcement, it could reasonably be regarded as a repudiation of Cyberonics. It began by referring to the initial, and best-designed, round of trials, in which VNS therapy was shown to be no better than a placebo. The federal regulator stated:

Based on the results of a clinical study of over 200 patients conducted in the United States, during the first 3 months of therapy, patients who had the device implanted and turned on did not show any significant advantage in response compared to patients in whom the "sham" device was implanted but not turned on. At 1 year, approximately 2 or 3 out of every 10 subjects had a clinically significant improvement in symptoms of depression.....and continued to have a similar degree of response through 2 years.

The remainder of the patients, however, had no improvement in symptoms, and some actually got worse. This therapy is intended to be given along with other traditional therapies, such as medications and ECT, and patients should not expect to discontinue these other treatments, even with the device in place. Patients will require regular visits to their physicians for adjustments to their device and other treatments.

By "clinically significant," the FDA meant at least a 50 percent improvement in patients' severe, debilitating depressive symptoms. And 70-80 percent did not even get that.

Just prior to granting its approval, the FDA sent a 3,256-word warning letter to Cyberonics noting that its devices were "adulterated." The letter went on to enumerate a wide-ranging list of serious violations following an inspection of its facilities.

These violations included:

"Failure to completely investigate and evaluate the cause of each medical adverse event; Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include design testing under actual or simulated use conditions; Failure to investigate the cause of nonconformities relating to product, processes, and the quality system; Failure to analyze processes, work operations, and other sources of quality data to identify existing and potential causes of non-conforming product; Failure to implement and record changes in methods and procedures needed to prevent and correct identified quality problems; Failure to establish and maintain procedures for implementing corrective and preventive action; Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints."

The FDA added that Cyberonics' responses to previous warnings "have not satisfactorily addressed the underlying issues," and "did not provide any supporting information or evidence."

And then the FDA gave its blessing to Cyberonics and its product. What a country!

Cyberonics had been forced to acknowledge that, "less than one in three or one in four patients (depending on the rating scale used) appeared to respond to VNS therapy," but that didn't seem to hurt its case.

In Phase II trials, the device performed even more poorly, with a 90 percent failure rate. I learned this not from Cyberonics, which continues enthusiastically to market VNS for depression, but from a clinician who had seen the most recent data in documents that are not publicly available.

Severely depressed patients who are pressed to try VNS treatment are not informed that it is very unlikely to help them, that it will cost them tens of thousands of dollars for the initial implant and at least tens of thousands of dollars in lifetime after-care.

Much has been reported in recent years about the unsatisfactory performance of antidepressant medications. But even they were required to reach a higher benchmark of proof before gaining FDA approval.

Cyberonics' marketing materials claim that "VNS therapy delivers long-term benefits that improve over time to patients who have not responded well to other treatment options." They should say "to a small minority of patients," but of course that would require integrity, which is not often seen in this industry. And the two-year data that it and the FDA cite do not constitute a long-term benefit, in my opinion.

To make the whole thing even less appealing, Cyberonics admits, "At present, doctors have no way to predict which patients will respond to VNS therapy."

So just put the device in everyone with difficult-to-treat depression, and have the American public pay hundreds of millions of dollars for it: That's what Cyberonics is seeking. For the time being, patients desperate for help are footing the bill.

The company shouldn't expect doctors to "predict which patients will respond." That's its job.


After extensive investigation, Public Citizen Inc., a nonprofit watchdog group created by Ralph Nader in 1971, submitted testimony to the FDA, characterizing the federal agency's approval of VNS for treatment-resistant depression as "scientifically meritless."

In fact a Senate subcommittee found that one official had overruled all 20 FDA staff members, who had asserted that data submitted by the company did not meet reasonable standards for safety and effectiveness.

"The post-approval data on VNS ... are largely irrelevant to the basic issue surrounding VNS: Does the device actually work?" Public Citzen said. "The history of the approval of this device remains an embarrassment to the FDA."

Public Citizen added that an official involved in the approval process had described it as “very unusual, emotional, not data-driven.”

Public Citizen continued, with rousing conviction: "Even the full-court press of misleading advertising, misleading training sessions in its use for physicians, misleading presentations at the American Psychiatric Association annual meeting, misuse of case managers to help secure reimbursement for individual patients, abuse of FDA employees, misleading clinical trial write-ups, ghost-written review articles and company-generated favorable local media coverage cannot disguise what is lacking and what insurers are increasingly realizing: There are no convincing data of the device’s effectiveness, let alone that it is 'reasonable and necessary'."

(One of the ghost-written journal articles, secretly bought and paid for by Cyberonics, resulted in the forced resignation of its editor, Charles Nemeroff, the chair of Emory University’s Department of Psychiatry and Behavioral Sciences.)


I have kept tabs on the FDA's controversial, chaotic approval process since my work as a New York consumer advocate in the 1970s. It has given the green light to countless drugs and devices that have turned out to be neither safe nor effective, but these products have always been granted reimbursement status.

Medical devices are held to a significantly lower standard than are pharmaceuticals for reasons I don't understand, particularly since they are appliances that are usually surgically implanted, creating additional risks and costs.

A statement supporting Medicare's denial, published in Current Opinions in Psychiatry, said, "...given the invasive nature of vagal nerve stimulation and potential side effects, further research is urgently required. The scientific evidence is considered to be insufficient to permit conclusions concerning the effect of this technology on major depression."

The insurance industry's position can be summed up thusly: "There is no compelling evidence to support the efficacy of this device or to define the patient population that might be helped by it."

Blue Cross echoed the opinions of many health-care analysts in its refusal to provide reimbursement. Vagus nerve stimulation for treatment-resistant depression met only one of the five assessment criteria established by Blue Cross's highly regarded Technology Evaluation Center (TEC).


TEC determined, “"Studies examining VNS for the treatment of depression are limited, and all data concerning clinical outcomes come from company-sponsored clinical studies....

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« Last Edit: January 19, 2015, 09:42:20 AM by dennis100 » Logged
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