Electronic medical device proven to treat depression suddenly denied approval by FDA

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A medical device company known as Cyberonics, Inc. is outraged at a recent FDA decision to deny approval for an electromedicine device that treats depression in patients. The device stimulates the vagus nerve and had been clinically shown to effectively treat depression as well as or better than antidepressant drugs. But the device uses no drugs whatsoever -- rather, it uses electrical stimulation, which is a part of a growing trend in pioneering medicine called electromedicine.

What's interesting here is that the FDA's own panel of experts, which reviews both medical devices and drugs for either approval or denial, had initially recommended that the FDA approve this device. But in a last minute change, someone higher up in the FDA blocked the approval, going against the full recommendation of the FDA's own panel of experts. This is something that rarely happens.

Executives at Cyberonics have their theories for why this device may have been blocked for approval by the FDA, but I have my own theory: electromedicine competes with prescription drugs. If a device can stimulate the nerve of a depressed patient and give them effective treatment, then that patient very likely won't need to be taking prescription drugs like Prozac and Paxil. And there's no recurring revenue in an electrostimulating device -- a patient buys it once, and from that point forward, treatments are essentially free, because electricity is virtually without cost.

Prescription drugs, on the other hand, are very expensive and must be taken over and over again -- sometimes for a lifetime -- by patients who believe the advice of their doctors. Therefore, the FDA denied approval of this device in order to protect the profits of the pharmaceutical industry, which of course seems to be the primary mission of the FDA based on agency actions we have observed over the past several years. That's not a new idea, either -- more and more critics are speaking out against the FDA, and noting that the FDA seems far more interested in protecting the profits of Big Pharma than protecting the health of the public.

Clearly, if an electrostimulating device could safely help patients with depression, it would be in the interest of public health to approve it. It would also be a financial benefit to people if they could buy a device with a one-time payment rather than shelling out monthly payments for overpriced prescription drugs. Again, this is only my theory, but I think that is precisely why the FDA blocked the approval of this device, and I have little doubt that executives from Cyberonics, Inc. privately agree with this assessment.
About the author: Mike Adams is a holistic nutritionist with a strong interest in personal health, the environment and the power of nature to help us all heal He has authored and published thousands of articles, interviews, consumers guides, and books on topics like health and the environment, impacting the lives of millions of readers around the world who are experiencing phenomenal health benefits from reading his articles. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In 2007, Adams launched EcoLEDs, a manufacturer of mercury-free, energy-efficient LED lighting products that save electricity and help prevent global warming. He's also a successful software entrepreneur, having founded a well known email marketing software company whose technology currently powers the NaturalNews email newsletters. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and enjoys outdoor activities, nature photography, Pilates and adult gymnastics. Known on the 'net as 'the Health Ranger,' Adams shares his ethics, mission statements and personal health statistics at www.HealthRanger.org


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