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 natural health researcher, author and award-winning journalist with a passion for teaching people how to improve their health He has authored and published thousands of articles, interviews, consumers guides, and books on topics like health and the environment, and he is well known as the creator of popular downloadable preparedness programs on financial collapse, emergency food storage, wilderness survival and home defense skills. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In 2010, Adams created TV.NaturalNews.com, a natural living video sharing site featuring thousands of user videos on foods, fitness, green living and more. 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 also serves as the executive director of the Consumer Wellness Center, a non-profit consumer protection group, and enjoys outdoor activities, nature photography, Pilates and martial arts training. He's also author a large number of health books offered by Truth Publishing and is the creator of numerous reference website including NaturalPedia.com and the free downloadable Honest Food Guide. His websites also include the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the innate healing ability of the human body. 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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Thursday, August 19, 2004
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