June 18, 2004 -- The Neurological Devices Panel of FDA's Medical Devices Advisory Committee has voted "5 to 2 to recommend approval with conditions of Cyberonics' VNS Therapy™ System 'as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to four or more adequate antidepressant treatments.'" [ref1
"FDA's Division of General and Restorative Neurological Devices will consider the deliberations, vote and recommendation of the Advisory Panel and make the final decision on approval of the VNS Therapy System for the proposed indication for use." [ref1
We urge the Psychiatric community and the 'FDA's Division of General and Restorative Neurological Devices' to reject the panel's recommendation. We urge the Psychiatric community to put their hands on the wheel and start driving.
Setting aside, for the moment, the company's appeal for those who suffer from chronic depression, which is actually a veiled excuse for pleading the ability to recover investments, the approval of the device "Vagus Nerve Stimulation (VNS Therapy)" [ref1 stands in the face of logic and science and threatens the very future of Psychiatry as well as the lives of those it purports to help.
In an age when Psychiatric treatment has finally escaped the barbarism of blood-letting, the overkill of electric shock treatments and the absurdity of lobotomy, the FDA is seeking to approve the return to barbarism under the excuse of technology, expecting a magic bullet for the cause of a condition the FDA itself cannot define.
The study is peddled by Cyberonics, Inc. (NASDAQ:CYBX) as its proof of effectiveness.
"Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood." [ref2
"The decision by an expert advisory panel of the Food and Drug Administration came after a day of clashing scientific opinions about whether the data submitted by the manufacturer were adequate for approval. Proponents of the device prevailed, citing the desperate need of patients with chronic depression that does not respond to existing treatments." [ref2
"Cyberonics' central study was a randomized trial involving 221 patients. All received implants, but the power was turned on for only half the group." [ref2
"Of 111 patients getting stimulation, 17 showed an improvement of at least 50 percent on a psychiatric scale of depression after 12 weeks. Of 110 patients getting "sham" treatment, only 10 showed similar improvement. The difference between the groups was not statistically significant, however." [ref2
Placebo trials make for one sided and ignorant assumptions. In this study, as with all other placebo trails, the company makes conclusions about the placebo participants as if the knowledge the researchers have of who used the placebo and who did not is somehow imposed upon the group of patients, who in reality, all assume they may or may not have the placebo.
With 111 patients resulting in 17 showing improvement of 'at least' 50%, that alone is a paltry 15% success rate. Of 110 patients receiving the placebo (interesting that it is referred to as the 'sham' treatment) and 10 showed 'similar improvement', a 9 percent success rate without the device: that would logically mean that the device itself contributed to only a 6% success rate. Failing to apply the placebo effect to the actual working device patients is a fatal flaw of all such studies. People participating in such trials are aware they either do or do not have the real treatment. Failing to take into account that assumption by those who actually have the treatment is to ignore the placebo effect altogether.
Cyberonics is resting its case on a 6% success rate but they do not address the rate of regression if the device fails to work or is removed. They do not address the long or short term consequences of the implant's effect on the patient. They do not address the most logical extension of this treatment.
If the FDA approves the device and a state or condition, based on "two or more adequate antidepressant treatments at appropriate dose and duration" [ref1 or even four or more such treatments is established, where surgery to implant a device is evident then the procedure becomes medical and not psychiatric and the science of Psychiatry will pass the legal ability to treat a patient with such state of condition to medical science after a specific number of chemical attempts.
That is forcing the science of Psychiatry back to the dark ages. It is passing the responsibility of mental condition to a tool instead of the trained professional. It is placing the determination of treatment options upon the use of previous treatment options and opening up a legal question of mal-practice against Psychiatrists who attempt to urge the removal of the device (only 6% were effective in trial) in order to 'try' other treatment options.
While Cyberonics' press release goes to great lengths to justify its mission "to improve the lives of people touched by epilepsy, depression and other chronic illnesses that prove to be treatable with our patented therapy, VNS" [ref1 it does so without one concern of consequence.
"'The Panel's recommendation represents a major step forward toward U.S. availability of the first FDA-approved, safe, tolerable and effective long-term treatment for patients with treatment-resistant depression,' commented Robert P. ('Skip') Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. 'Millions of Americans today suffer from treatment-resistant depression (TRD), a devastating, lifelong and life-threatening illness. According to published studies, 15% of previously hospitalized patients commit suicide and annual depression treatment costs in the United States exceed billion including .7 billion for drugs alone.'" [ref1
"Major Depressive Disorder (MDD) is one of the most prevalent and serious illnesses in the world, affecting nearly 19 million Americans over the age of 18 in any given year. MDD is the fourth most disabling condition worldwide and the second most disabling condition in the U.S. Total annual costs of depression in the U.S. exceed billion including billion of annual direct treatment costs. Twenty percent of depressed Americans or approximately 4 million people suffer from treatment-resistant depression (TRD) defined as a depressive episode that has failed to respond to at least two antidepressant treatments of adequate dose and duration. Patients with TRD are often isolated, hopeless, desperate, and unemployed. Studies show that annual healthcare costs for patients with TRD exceed ,000 per patient per year. A person with depression is 35 times more likely to commit suicide than a person not experiencing depression and 15 percent of previously hospitalized depressed patients commit suicide. Although there are many safe and effective acute antidepressants including medications, psychotherapy and electro-convulsive therapy (ECT), there are no FDA-approved, informed-use, safe and effective long-term treatments for TRD. Multiple medication combinations are used to treat TRD without evidence of long-term safety and efficacy. ECT, the most effective acute antidepressant, is often declined, and is of limited long-term value due to cognitive side effects and high relapse/recurrence rates within six months of treatment." [ref1
While Cyberonics identifies its target market and the vast potential for revenue it mentions how other treatments are "without evidence of long-term safety and efficacy", but fails to test its own treatment for the same consequence while admitting the business is full-steam ahead with "Pilot studies are underway evaluating VNS Therapy as a potential treatment for anxiety disorders, Alzheimer's disease and chronic headache/migraine."
Cyberonics has not one clue what causes any of those conditions, let alone depression. The Cyberonics treatment is like a cancer patient accepting a doctor's recommended surgery to open them up and wrap the tumor in a Band-Aid. Not one study is offered as to what the results will be, long term, to a patient who's treatment consists of masking a cause so it can be rushed to market so it can start making money without regard to if it does any good in the process. With only 6% success in the study offered to the FDA the claim is ridiculous.
The actual consequences are enormous.
A point in this issue is near the opening of the Washington Post's article: "Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood." [ref2
Notice the term 'believed to regulate mood'.
There is no 'location' that 'regulates' anything. Brain science has turned into where, instead of how, thanks to the fMRI and the false readings of blood flow through use. It is de-evolution of science to return to a modern and now accepted version of head-bumps and Franz Josef Gall's Phrenology.
Benjamin Rush was one of the leaders in 'Moral Treatment' which, "challenged the demonic explanations for insanity and emphasized the role of environment in determining character" [ref3 "Essential to this theory was a physiological basis for mental disorder: insanity was caused by brain damage." [ref3
Today's chemotherapy treatments employ that attitude in treating synapse response. The present Cyberonics device extends it to the Vagus nerve.
"Promoted in the United States by Orson S. Fowler, the [phrenology movement claimed a person's character was made up of 37 faculties which could be "read" on the cranium at the site where each was located. The size of the brain in these locations would reveal the strength of that particular faculty. As Fowler stated, there were "connexions and relations which exist between the conditions and developments of the BRAIN and the manifestations of the MIND." Phrenology was even applied to art as sculptors and painters did phrenological profiles of their subjects to insure their art would reflect the traits of the subject."
Now, science has switched from 'size' to 'location' but the quackery still persists.
In reality, the Cyberonics device and therapy is a patented return to the electropathy of the 19th century. "If electricity was applied to the areas where these charges were out of balance, the patient would be cured. Electricity was particularly useful in treating "nervous diseases" (mental illness) since there were no known scientific cures. Resourceful entrepreneurs soon began producing electrical garments and products, including corsets, belts, and hairbrushes (advertised as a cure for hair loss)." [ref3
Cyberonics has produced a device that does the same thing and is no different in intent. It is created to make money, regardless of the noble attempt, "'to accomplish our mission in epilepsy in fiscal 2005 ... and the plan to properly scale our organization to accomplish our mission in depression will be implemented as soon as we are confident of depression approval.'" [ref1
To place that commerce driven noble gesture ahead of the safety of the use of a device that has been shown by its own salesmen as capable of just 6% effectiveness is no less snake-oil than the electropathy it is based in and the phrenology that gives it credence.
In the Washington Post article, "'It's possible this is a viable treatment; it is also possible it is not a treatment,' said Richard P. Malone, a psychiatrist at Philadelphia's MCP Hahnemann University. 'I'm not sure it is ethical to give a treatment for which there is not substantial evidence.'" [ref2
"Malone and another panel member, statistician Jonas Ellenberg, nearly convinced other panelists that the company should conduct another trial, but the proposal was shot down after a tense vote, with one panelist changing her mind. The chairwoman of the panel, Kyra Becker, a neurologist at the University of Washington, School of Medicine in Seattle, cast the deciding vote." [ref2
No, it is not ethical and the excuses provided by Cyberonics to push through approval of the device border on the insane.
"'We lost four of these individuals in the last 2 1/2 hours,' said A. John Rush, a psychiatrist at the University of Texas Southwestern Medical Center at Dallas, basing that figure on the high suicide rate among patients with resistant depression." [ref2
"Karmen McGuffee of Garland, Tex., told the panel she had tried virtually every antidepressant drug on the market before getting the device. Improvement came within weeks, she said." [ref2
"'My mother said she wasn't looking into the eyes of a dead person anymore,' she said. When people asked why she was willing to get an implant, she replied, 'I had nothing to lose.' [ref2
Citing a desperate patient as proof of the reason to approve a literally untested and suspect device is an affront to the scientific community and the patients the device prays to assist. But she was not just a desperate patient.
"McGuffee was paid by Cyberonics to testify. Rush (not Benjamin), who was paid to conduct some of the clinical trials, said there are 30,000 suicides a year in America, about 80 percent of them attributable to depression. Half of those are among patients with treatment-resistant depression who had tried multiple therapies and were still not better, he said." [ref2
"In response to suggestions by some panel members that the company conduct another trial, Rush warned, 'In the time to do another trial, we will lose another 1,000 patients a month, 36,000 if the trial takes three years.' [ref2
And there is the threat of 'act now so we can save them', as if the device is the only hope to desperate people. If that was the case for any chemical therapy the safety of drugs entering the market could never be assured or even pretended, but this is a mechanical device: a technological interference in brain function, a scary thought in and of itself.
"The company conducted a separate analysis with patients in another study. This group involved 124 patients who were similarly ill but were not getting vagus nerve stimulation. The company showed trend data that over 12 months, patients with the device were significantly better compared with those getting drugs or electro-convulsive therapy." [ref2
"Malone, Ellenberg and the FDA's statisticians expressed worry that the two groups of patients were not comparable and the apparent benefit might be statistically spurious. Cyberonics officials argued that conducting a new trial would be problematic because of the special needs of this patient group." [ref2
Not only is a new trial mandatory, but it is absurd not to be forced.
In the U.S. alone, over 400,000 people die each year from cigarette smoking-related causes. Using Rush's logic in the time to do another trial, we will lose another 1288 patients a month, 46,368 if the trial takes three years. Dare we compare losses without effective treatment over losses with ineffective and perhaps (most logically) damaging, treatment?
By Cyberonics' own flawed study, Rush's patients' deaths might be reduced by 6%. 60 people to benefit per thousand from the rush to market for a product that treats a condition the makers of the product have no idea of how is caused and the therapy that offers alternatives to barbaric intrusion surgery has never seen the light of day.
Depression, chronic or not, as long as it is not caused by a malfunction of tissue (which is almost never the case) is like the driver of a car who never touches the wheel.
Why is the car going there? Why did I hit that tree? I didn't turn that way. Slow down before I hit something else. Stay slow. Why is everything else so chaotic? Don't tell me I don't have control of my car. I have the gas pedal.
The problem with depression is, it is misunderstood. Depression is treated by increasing synapse transmission, but the synapse does not do the thinking. It sends the thinking on to the next neuron and keeps it from going the wrong direction.
Perhaps the most viable excuse for approving the Cyberonics device is its best hope to stop it from starting the ruin of a science who's only intention is to help others. Psychiatry cannot treat what the science of the medical doctor has assumed.
"The panelists mostly agreed that the data presented by Cyberonics had problems but were swayed by the lack of alternative treatments and the evidence that the device is generally safe, based on its widespread use to reduce epileptic seizures." [ref2
The cause of seizures and the cause of depression are not at all the same. And there are alternative treatments. The problem with alternative treatment is simple. It is not normal. It is not accepted. It is not understood. And in most cases it is completely unknown.
The only treatment for any condition should be based on how the condition is caused and how the total system is affected by it.
To learn how depression is caused, what it is, how to treat it and why Psychiatry should never, ever give away the responsibility to fight depression, even after a million attempts, read 'The Brain Is A Wonderful Thing' and 'Modern Mysticism' available at The Enticy Institute. The books are free.
But in the mean time, do not let the presentation of a different approach get in the way of stopping a horrible one.
References:
[ref1 FDA ADVISORY PANEL RECOMMENDS APPROVAL OF CYBERONICS’ DEPRESSION DEVICE Cyberonics Press Release 6/15/2004 http://www.cyberonics.com/PressRelease_detail.asp?id={3FEFBC64-A01B-44BF-909F-9150D2D9CF89}
[ref2 'FDA Panel Backs Implant To Counter Depression But Questions Linger About Manufacturer Data' By Shankar Vedantam Washington Post Staff Writer, Wednesday, June 16, 2004; Page A03 http://www.washingtonpost.com/wp-dyn/articles/A44636-2004Jun15.html?nav=rss_health
[ref3 University of Toledo Libraries, Mental Health, http://www.cl.utoledo.edu/canaday/quackery/quack5.html
[ref4 Cigarette Smoking-Related Mortality Centers For Disease Control http://www.cdc.gov/tobacco/research_data/health_consequences/mortali.htm
For information about antidepressants and vertigo, visit
http://yourdepressioninfo.com/antidepressanttreatmentinvertigo/
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