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 consumer health advocate and award-winning journalist with a passion for sharing empowering information to help improve personal and planetary health He has authored and published thousands of articles, interviews, consumers guides, and books on topics like health and the environment, reaching millions of readers with information that is saving lives and improving personal health around the world. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In mid 2010, Adams produced NaturalNews.TV, a natural health video sharing website offering user-generated videos on nutrition, green living, fitness and more. He also founded an environmentally-friendly online retailer called BetterLifeGoods.com that uses retail profits to help support consumer advocacy programs. He's also the CEO of a highly successful email newsletter software company that develops software used to send permission email campaigns to subscribers. 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 martial arts training. He's also author of numerous health books published by Truth Publishing and is the creator of several consumer-oriented grassroots campaigns, including the Spam. Don't Buy It! campaign, and the free downloadable Honest Food Guide. He also created the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the ending of corporate control over medicines, genes and seeds. Known as the 'Health Ranger,' Adams' personal health statistics and mission statements are located at www.HealthRanger.org
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Thursday, August 19, 2004
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