Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

These machines are being used to practice medicine without a license, but they think they can get around the law by offering a disclaimer and by espousing the fiction that they are not diagnosing or treating diseases but only detecting energy imbalances and advising patients about how to restore balance.

Here are some typical protestations:

  • I can only find imbalances that may be causing problems. It would be up to a medical doctor to determine if what I am finding IS the cause.
  • I wouldn’t call EAV biofeedback “treatment”. You don’t treat anything with EAV. Creating a vial of treated water for a client to take may help balance their energy. Balancing energy is not medical treatment. It is perfectly legal to own one for home usage.
  • And the reason all these people are spending money on this equipment is what??? Would they continue to invest in something that is “bogus”?
  • EAV is not anything like the medical tests that we are used to. It works by quantum physics not biology.
  • Yes, there are a bunch of enforcement actions. I assume that what is listed is about the entire list. Do you also want to list the claims made against regular M.D.s?
  • Something that shows up energetically does not necessarily mean that it is a physical condition!
  • We are only just now getting the scientific ability to test these [homeopathic] remedies by quantum physics.

In the training videos I mentioned in my previous article, the demonstrator answers questions from the audience that reveal more about the way they operate:

Q: I’m not a doctor. I have to send patients to an MD for IV infusions. What do you say when the doctor questions how you determined the patient needs it?

A: Tell him you determined it by electrodermal testing, similar to muscle testing [applied kinesiology] and ask him if what he does is any better. At least we have some monitoring device.

Q: One remedy you recommended is acid, but she has an acid problem.

A: That seems contradictory but we need it for her circulation, and the body can sort out what it needs.

Q: Is the circulation due to blockage in her superior vena cava?

A: No.

Q: Should she stop other medications or products?

A: Bring in the products and put them on the test tray. Medicine is a legal issue, so we can only show her what it does to her pancreas, we can’t tell her to stop using it. You might be liable if you told them to go off their meds.

Q: Will other medications interfere with our treatment?

A: Our treatment will not be as effective if they stay on their meds. Cancer treatments like chemo and radiation will usually interfere with our efforts.  If the patient needs to stay on medication, we can give more products to balance out the effect of prescription meds on liver and to reduce med side effects.

Q: [Something about] cancer showed up on the readings. Does that mean she has cancer?

A: I don’t think she has cancer, but if she doesn’t correct the problems in her body, I can guarantee you down the road she will have problems like that. Cancer loves miasms, acidosis, poor circulation, emotional issues, and immune dysfunction. She’s got ‘em all. It’s just a matter of time. You can’t tell a person they have cancer — just that that matches the picture. Biopsy is needed for medical diagnosis. You can treat it before it gets to the biopsiable stage.

Q: What if the patient says “Every time I come in you give me something different.”

A: Well duh, do you want to be on the same thing all your life if it’s not working? If it’s fixed, why keep taking it? The body prioritizes all the time, so what it needs today will not be what it needs tomorrow.

Regulatory Actions

The FDA, state attorney generals, professional licensing boards, and foreign regulatory agencies have all taken action to stop electrodermal testers.  Details of many of these cases can be found on Quackwatch.

An examination of 3 cases from my own state, Washington, highlights some of the problems with regulation.

The Ames Case

A licensed physician was using a LISTEN device to diagnose allergies. The findings of fact are interesting:

  • After he used the LISTEN machine, he wrapped the probe in tissue paper and had the patient hold the probe with tissue paper wrapped around it. When the patient asked why, he answered that he has done this so long, that he could do what the machine could do, and that he did not need the machine anymore.
  • He used the machine not only to diagnose, but to treat allergies.
  • He also used applied kinesiology, a phoney muscle testing procedure.
  • He used dubious hair and urine tests to determine that the patient had a mineral imbalance, and told him he needed treatment for metal poisoning.
  • He used what sounds like a chiropractic “activator” device on acupressure points.
  • He prescribed the Metabolic Type Diet, a diet with no scientific justification.

The Washington State Department of Health Medical Quality Assurance Commission suspended his license for 5 years. Only they didn’t, because the suspension was stayed as long as he (a) stops using the device, (b) undergoes quarterly practice reviews, and (c) pays a $5,000 fine. The MQAC’s decision was appealed but the state Supreme Court upheld the decision, saying that Ames had “led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither.”  Note that the board and the courts only considered his use of the device and did not even address any of his other questionable practices or his basic competence to practice medicine.

The Trasker Case

Joyce Trasker was convicted of practicing medicine and veterinary medicine without a license. She used the Orion and the Asyra devices to determine a patient’s “energy signature” and to prescribe homeopathic remedies. She offered testing on saliva and blood samples sent to her by mail. Eventually she began taking these samples and the machine onto an Indian reservation to do the testing, claiming that the State had no jurisdiction there. She claimed she was not practicing medicine. She even claimed that the right to free speech protected what she was doing. Her case went all the way to the state Supreme Court. She was ordered to cease and desist and to pay a fine of $10,000.

No problem: she simply moved a short distance across the state line to Idaho where she is still offering the same electrodermal testing for $295 per test. You can mail in saliva samples, even from Washington State: her website says “Washington may not prohibit its residents from patronizing an Oregon or Idaho business.” She is also involved in a long term campaign for the freedom to choose safe unregulated health care.

A Dropped Complaint

A few years ago I found a website for a local clinic offering electrodermal testing. After I filed a complaint with the medical board, all references to electrodermal testing mysteriously vanished from the website. The doctor and his lawyers threatened the medical board with legal action if they tried to act on the complaint. The complaint was dropped.

Confusing Terminology

The variety of devices and the many variants of terminology make it difficult to identify the magnitude of the problem. These devices are illegal and cannot be sold or imported, but they are still available. On E-bay I found 6 Biomeridian systems for sale. They seem to be going for around $5000 compared to an original price of $12,000 to $17,000.

If these systems do use some kind of frequency analyzer to capture EMF and then use a frequency generator to re-introduce that same signal back into the human body for “testing”, now they have produced what the FDA considers a radiation emitting device and not a galvanic skin response meter. The QXCI, EPFX, or SCIO falls into that category. The FDA banned importation of this device after an embarrassing exposé by investigative reporters in The Seattle Times featuring patients who died because they relied on the device to treat cancer.

What Can We Do?

In his exposé, Quackwatch’s Stephen Barrett says:

The devices described in this article are used to diagnose nonexistent health problems, select inappropriate treatment, and defraud insurance companies. The practitioners who use them are either delusional, dishonest, or both. These devices should be confiscated and the practitioners who use them should be prosecuted. If you encounter any such device, please report it to the state attorney general, any relevant licensing board, the FDA, the FTC, the FBI, the Better Business Bureau, and any insurance company to which the practitioner submits claims that involve use of the device.

I echo his plea. There is an online directory of practitioners that could be helpful in identifying some of the offenders, but there are undoubtedly many more who are avoiding publicity for fear of legal consequences. We have the tools to stop most of these offenders, but first we need to identify the offenders and then we need to actually use the tools.

This article was originally published in the Science-Based Medicine Blog

Dr. Hall is a contributing editor to both Skeptic magazine and the Skeptical Inquirer. She is a weekly contributor to the Science-Based Medicine Blog and is one of its editors. She has also contributed to Quackwatch and to a number of other respected journals and publications. She is the author of Women Aren’t Supposed to Fly: The Memoirs of a Female Flight Surgeon and co-author of the textbook, Consumer Health: A Guide to Intelligent Decisions.

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