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Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of EAV are explained in an article on Quackwatch.

I’ve written about electrodermal testing before. I’ve explained how it amounts to fooling patients with a computerized Magic 8 Ball and I’ve discussed the legal and regulatory issues.

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.

Conclusion

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?

 

 

Posted in: Acupuncture, Energy Medicine, Politics and Regulation

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13 thoughts on “Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

  1. windriven says:

    It would appear at first blush that these devices are similar to Scientology’s E-Meters. It is clear to me that Dr. Hall and Stephen Barrett have missed the point of these things. They don’t diagnose disease, they measure IQ.

  2. cervantes says:

    I keep saying it. Taking people’s money under false pretenses is fraud. It is a crime. You don’t need the FDA to regulate it, the police can arrest the people and the DA can prosecute them and a jury can find them guilty and they can go to jail. That actually could happen. I have no idea why it doesn’t.

  3. Janet says:

    @cervantes

    It doesn’t happen because there are too many shruggies who feel that people can “make their own decisions about such things”. Also, prosecution is so rare that the quacks practice with impunity. Go to any “health” food store and hang around for ten minutes. You will see an employee offering an enormous range of medical advice to people (who for their part, eat it up without question) often referring to a book of quackery placed on a reading stand as though it is a holy (or at least authoritative) book of some kind. If you butt in (as old ladies sometimes can’t refrain from doing), you will only get an earful of “health freedom” or “well, that’s YOUR view”. I have found, “you can be reported for practicing medicine without a license” somewhat effective at times, but just as often results only in an eye roll.

    I’d like to say that I am only there for the produce–which is fresher than at the supermarkets. At the checkout they always ask if I am a member (it’s a co op), and I always reply that I am not, and will not be until they rid themselves of ear candles–at a minimum.

    It’s a religion, and we are so steeped in respect for that in this country (pathologically?), that it becomes difficult to ever stand up and say that the emperor is naked.

    On another note, I read that Hugo Chavez is receiving “complementary” treatment in addition to intensive chemo. It is everywhere!

  4. One of the main electrodermal devices, the MORA machine, was indeed developed by 2 Germans with Scientology connections, Windriven. I found a few abstracts about EAV, the VegaTest machine, and others when writing a post about this topic last year. Devices were found to be no better than placebo and to have poor inter-operator reproducibility. I offered a Portland acupuncturist I know $500 and the chance to split the Randi prize if he could convince me that his MORA machine could tell the difference between any two items in glass vials. Silence from him, but another bioresonance proponent showed up raving mad in the comments. http://ancientway.com/blog/?p=1594

    The FDA did recently send a warning letter to an acupuncturist for selling an unapproved Electro Meridian Imaging device: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/UCM323424

  5. KPmedic says:

    There is a joke somewhere with “Acupuncture of Zoll”

  6. BKsea says:

    I think the FDA clearance / approval distinction is a bit of splitting hairs. In either case, you are allowed to market your device within the accepted indications for use. The problem comes when you market outside the IFU. However, there are ways around that such as getting practitioners to independently promote an off-label use. I don’t think there is much that can be done about that without shutting down a lot of off-label uses of legitimate drugs/devices.

  7. PJLandis says:

    The off-label is kind of a moot point because I don’t think these devices are approved for any legitimate uses. And you can study and publish studies off-label uses, or simply prescribe/use them if they are approved for another use, but I don’t think practitioners can advertise them anymore than manufacturers.

  8. Skeptical Slug says:

    #windriven They don’t diagnose disease, they measure IQ.

    Beautiful!

  9. pmoran says:

    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.

    Making it much easier for those persons to lodge their complaints with officialdom might be one way of exerting some further control over the fraudulent use of these devices. I suspect very few of these people went so far.

    It is also the nature of the claim being made that is the problem rather than the device itself. Once you started trying to totally ban devices simply because they have the potential to be used in medical fraud there is likely to be many arguable areas and too little public support.

    For example, I would not mind seeing the sale of thermography machines controlled — they have no established medical uses that I can think of right now, but they have at least equal potential for harm when fraudulent claims are made, such as that they have value in the early detection or exclusion of breast cancer.

  10. Jan Willem Nienhuys says:

    The link to quackwatch doesn’t work because the l of html is missing.

    here is the correct link

    http://www.quackwatch.org/01QuackeryRelatedTopics/electro.html

  11. Harriet Hall says:

    @Jan Willem Nienhuys,

    Broken link fixed. Thanks for spotting it.

  12. Jan Willem Nienhuys says:

    A famous case in the Netherlands was the death of tv comedian and actress Sylvia Millecam. When she felt worried about a small (1-1.5 cm) lump in the right breast, she vistied the family practician who referred het to further diagnostic procedures which resulted in an appointment with a surgeon in a university clinic. Bur Millecam didn’t go there. She visited a physician Koonen, a friend of the family with an ‘alternative’ practice. He used electro-acupuncture to terll the famous actress that ther was nothing to worry about. About 8 months later the lump had grown to 3-4 cm and Millecam visited another clinic. A biopsy and diagnosis adeno carcinoma was established, and an appointment for surgery was proposed. But Millecam wanted a second opinion. She obtained this from a well known medium who just repeated the judgment of Koonen: no cancer. Five weeks later she went to see a fourth doctor who observed that the tumor had grown to 7-8 cm. I’ll spare you the rest of the horror story (with about 25 more doctors and quacks, and some of the doctors again using EAV or a biotensor) and in the end she died horribly on August 21, 2001, believing almost to the end that she was just suffering from a bacterial infection or a fungus that had fused with a bacterium and that she would soon be well enough to marry her lover.

    It seems clear that many people around her told her things she would like to hear, she broke off relations with anybody just whispering the c-word or the necessity of another biopsy. Especially the medium, who was quite vain and liked to have such a famous friend, stressed that Millecam did not have cancer, and when later asked why she had said that, she argued that a real doctor (i.e. Koonen had said so).

    The whole thing became a matter of investigation when some of the assistents of Koonen decided they had to speak out.

    So EAV can also serve to deny a unpleasant diagnosis in case the patient makes it clear she doesn’t want to hear unpleasant things.

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