Now Stephen Barrett (founder of Quackwatch and Vice-President of the Institute for Science in Medicine) has written an article in FACT (Focus on Alternative and Complementary Therapies) entitled “Bogus electrodermal testing devices: where are the regulators?” He points out that existing regulations are sufficient to ban these devices, but that regulators have failed to take appropriate action.
Claims of FDA approval are false. The people who promote these devices claim that they are FDA approved. They are not. Dr. Barrett explains:
[The FDA] classifies ‘devices that use resistance measurements to diagnose and treat various diseases’ as Class III devices that require FDA approval prior to marketing. No EAV device has ever been FDA-approved. A few companies have obtained 510(k) clearance (not approval) by telling the FDA that their devices are substantially similar to devices previously cleared for biofeedback or skin-resistance measurement. Their FDA applications fail to reveal that the device would be bundled with software intended to diagnose and/or prescribe, which would make them ineligible for 510(k) clearance.
Electroacupuncture devices are not biofeedback devices. Biofeedback is a relaxation technique that uses an electronic device that continuously signals pulse rate, muscle tension or other body function by tone or visual signal. In biofeedback, the signal originates and is influenced by the patient. In EAV, the signal is influenced by how hard the operator presses the probe against the patient’s skin. (Pressure makes the electric current flow more easily between the device and the patient’s skin.) The 510(k) clearance enables manufacturers to market these devices for biofeedback of skin-resistance measurement but not for diagnosis or treatment.
Inadequate action by regulators. There have been a few actions against users for practicing medicine without a license, and medical boards have looked at their use by licensed practitioners but have rarely acted against them. Sporadic enforcement efforts have banned importation of these devices into the US and have prosecuted or warned individual marketers. But there has been no systematic effort to eliminate them. As a result:
these bogus devices are being used throughout the world by many chiropractors, acupuncturists, dentists, holistic physicians, veterinarians, self-styled nutritionists and various unlicensed individuals. The most common use is for prescribing homeopathic products, dietary supplements and herbal products. The devices are also used to determine allergies, detect nutrient deficiencies and locate alleged problems in teeth that contain amalgam fillings. Some operators claim to tell whether a disease, such as cancer or acquired immunodeficiency syndrome, is absent. Some devices are claimed to treat the patient with electromagnetic impulses transmitted into the body or are used to energise products.
These devices are widely promoted through the Internet, and it would be easy to identify offenders for prosecution, but regulatory agencies don’t seem to care.
What’s the Harm? False health information and false beliefs can lead to unwise health decisions. Over the last 10 years, Dr. Barrett has personally heard from over 200 victims who were unnecessarily frightened about bogus findings and who were bilked of hundreds or thousands of dollars.
Electrodermal testing is clearly bogus and illegal. Inaction on the part of regulators has allowed it to persist and to defraud patients. Dr. Barrett’s article is a call to action. Will regulators answer that call?
This article was originally published in the Science-Based Medicine blog.