Regulatory Actions Related to EAV Devices

Stephen Barrett, M.D.

Thousands of practitioners use "electrodiagnostic" devices to help select their recommended treatment. These devices, which are fancy galvanometers, merely measure skin resistance to the passage of electrical current. However, many are claimed to determine the cause of any disease by detecting the "energy imbalance" causing the problem. Some are also claimed to detect whether someone is allergic or sensitive to foods, deficient in vitamins, or has defective teeth. Some operators claim to tell whether a disease, such as cancer or AIDS, is not present. The diagnostic procedure is most commonly to as Electroacupuncture according to Voll (EAV) or electrodermal screening (EDS). This article summarizes the EAV-related regulatory actions that have come to my attention.

Galvanic skin resistance has no proven or logical relationship to the diagnosis or treatment of any disease. The U.S. Food and Drug Administration classifies "devices that use resistance measurements to diagnose and treat various diseases" as Class III devices, which require FDA approval prior to marketing. No such device can be legally marketed in the United States for diagnostic or treatment purposes. A few companies have obtained 510(k) clearance (not approval) by telling the FDA that their devices will be used for biofeedback or to measure skin resistance, but this does not entitle them to market the devices for other purposes.

EAV 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 to the patient's skin.)

The FDA has banned importation of EAV devices into the United States and warned or prosecuted a few marketers. Foreign and state regulatory agencies have also taken a few actions. However, no systematic effort has been made to drive them from the marketplace. As a result, these bogus devices are being used by many chiropractors, acupuncturists, dentists, "holistic" physicians, veterinarians, self-styled "nutritionists," and various unlicensed individuals. The most common use is for prescribing homeopathic products. They are also used to determine "allergies," detect "nutrient deficiencies," and locate alleged problems in teeth that contain amalgam fillings.

FDA Warnings

In 1985, the FDA notified a distributor that Vegatest devices could not be marketed as a medical devices without FDA approval (which they do not have) [1].
In 2000, the FDA ordered Phazx Systems to stop making illegal claims for its BodyScan 2010 and VLD-100 devices [2].
In 2001, the FDA warned Vega Grieshaber KG and an American distributor (BioEclectic Research, of Santa Rosa, California) that the Vega devices and several others were unapproved medical devices that could not be legally marketed in the United States [3,4]
In 2011, the FDA ordered Galloway Technologies to stop representing that its Asyra software interface allowed practitoners to evaluate their patient's parameters of health using information gathered through the device's hardware system [5].

State Attorney General Civil Actions

In 2002, the Oregon Attorney General settled a lawsuit against Monte Kline, Shirley Hancuff, and Pacific Health Center (PHC), under which the defendants agreed not to misrepresent that EDT can diagnose food allergies, "weak organs," certain viruses, lead levels in children, and various other health problems. The stipulated judgment also called for the defendants to pay $15,000 for costs and to offer refunds available to individuals whom they had tested during the previous three years [6]. State authorities in Washington subsequently charged Kline and PHC with (a) violating the state's consumer protection act by misrepresenting the significance of his credentials and the diagnostic capabilities of EDT and (b) practicing medicine, naturopathy, and acupuncture without a license. The courts ultimately ruled that Kline had violated the licensing laws but not the Consumer Protection Act. Kline announced that he would close his Washington clinic because the "unlicensed practice" ruling barred him from doing EDT, but he still operates two centers in Oregon and one in Idaho [7].
In 2006, the Washington Department of Health ordered Joyce M. Tasker of Coleville, Washington, to stop practicing medicine and veterinary medicine without a license. A motion for summary judgment stated that Tasker, who was not a licensed health-care provider, had been using EDT to diagnose a wide variety of problems in humans and animals. (In a deposition, Tasker stated that she had begun with an Orion device and later "upgraded" to an Asyra device.) Tasker appealed to her local trial court and then to the Court of Appeals, both of which upheld the Health Department's decision [8].

Criminal Prosecutions

During 1990, FDA agents twice raided the Century Clinic, of Reno, Nevada (now called the Century Wellness Center) and seized Dermatron devices and the medical records of 71 patients [9]. The case was settled in 1993 with a consent agreement under which the clinic and its director, Katrina C. Tang, were prohibited from using EAV devices without either FDA approval or under an approved application for an investigational device exemption that would permit legitimate experimental use. The agreement also provided for a $200,000 penalty for violation of the consent decree. After the agreement was signed, Biosource, which was not a party to it, obtained an Investigational Device Exemption by falsely claiming that its Listen System devices would be used experimentally to see whether they could detect diabetes. According to court documents filed by the U.S. Justice Department, Tang and the clinic then used two of these devices to diagnose other serious diseases and did not collect the data necessary for the Biosource study. In 1998, a magistrate judge recommended that a $400,000 fine be imposed on Tang and the clinic [10]. A petition to overturn this ruling was denied by two federal courts and the U.S. Supreme Court [11]. In December 2002, Tang signed a stipulated agreement with the Nevada Board of Homeopathic Examiners indicating that she would retire and would not accept new nonemergency patients. The stipulation noted that between December 27, 2001, and February 4, 2002, 18 complaints had been made against her that had not been investigated by the board [12].
In 1994, Floyd E. Weston, who had been marketing EAV devices and unapproved homeopathic drugs, pleaded guilty to a misdemeanor count for introducing unapproved medical devices into interstate commerce. The plea agreement required him to agree to a permanent injunction barring him from selling the device or homeopathic remedies. He was sentenced to a year of probation and ordered to pay a $2,500 fine and complete 40 hours of community service. The injunction barred him from directly or indirectly (a) engaging in the sale, lease or distribution of any Prophyle, Biopath, Dermatron, or similar device or any other unapproved medical device, (b) engaging in the sale, advertising, or distribution of any drug not listed in the US Pharmacopeia, the Homeopathic Pharmacopeia or the National Formulary [13]
In 2000, Rebecca Y. Rogers was arrested on complaints alleging unauthorized practice of medicine involving three clients. Testimony in the case indicated that Rogers, who purported to be a naturopath, used an EAV device to falsely diagnose a woman with breast cancer, ovarian cancer, and a brain aneurysm and falsely diagnose tapeworm in the woman's son (who was sitting on her lap but not connected to the device). She also told another woman who had been medically diagnosed with multiple sclerosis that her problem was bacterial and that she also a gall stone, inflamed appendix, inflamed small intestine, and inflamed large intestine. A lower court ruled that the legal definition of "practice of medicine" was overly broad, but in 2001 the Michigan Court of Appeals reinstated the case [14]. I don't know what happened after that.

In 2003, an Australian naturopath who used a MORA device for diagnosis was convicted of manslaughter in connection with the death of an 18-day-old infant whom he had claimed to have cured of a heart defect [15].
In 2006, John E. Curran, of Exeter, Rhode Island, was sentenced to 12 1/2 years in prison for fraud and money laundering. He was also ordered to pay $1.4 million in restitution to 338 former clients he had victimized. Documents in the case indicate that pretended to be a medical doctor but had no valid health credentials. His "diagnostic" tools included "Biomeridian stress assessment." [16,17]
In 2009, Enrique Vela, and his wife, Ute Marquez, were charged with practicing medicine without a license. The couple operates the Alternative Therapy Center out of their home in Winter Haven, Florida. The charges were based on an undercover investigation by two agents of the Polk County Sheriff's Department who were tested with an Asyra System device. One was told she had hookworm larvae, bilharziasis, intestinal fluke and enzyme deficiencies in her small intestine, and bacteria and anthrax in her body. The other was diagnosed with problems of the skin, sinus, and reproductive organs [18].

Professional Board Actions

In 1986, the California Board of Dental Examiners suspended the license of Ralph A. Landerman, D.D.S. after concluding that he had mistreated two patients. The accusation stated that he used a Dermatron to diagnose "energy" problems with many of their teeth that he purported to treat with homeopathic injections followed by extraction of the teeth. The board concluded that removal of the teeth—11 from one patient and 3 from the other—was unnecessary, caused the patients to become "dental cripples," and constituted "gross ignorance and/or inefficiency . . . incompetence and/or gross negligence." [19] The case was settled with a stipulated order under which Landerman's dental license was suspended for five months and he was placed on five years' probation during which he was required to (a) take remedial education courses, (b) arrange for monitoring when he resumed practice, and (c) refrain from further ues of the Dermatron device [20].
In 1990, the New Zealand Medical Journal described how a homeopathic physician had used a Vega device to diagnose allergies in three infants. In each case, the device was applied to the mother with the child on the mother's lap or roaming about the examining room. The doctor also diagnosed "miasms," which, if not removed, would prove fatal later in life. The Medical Practitioners Disciplinary Committee ordered that he be censured, pay a penalty of NZ$900 plus NZ$25,000 for costs and expenses, and follow certain standards of care for three years [21].
In 1992, the Wisconsin Medical Examining Board obtained a stipulated order barring Timoteo Galvez further use of an Interro device for diagnosing or treating patients [22].
In 1994, the Oregon Medical Board revoked the license of John E. Gmbee, M.D., after noting that his use of unscientific practices—including EAV and ozone therapy—justified revocation of his license [23]. (He was permitted to resume practice in 1994 but got into trouble repeatedly and had his license revoked in 2011.)
In 1995, after reviewing her care of 36 patients, the College of Physicians and Surgeons of Ontario (Canada) concluded that Carolyn Dean, M.D. was unfit to practice and revoked her registration certificate. The questionable practices that concerned the regulators included Vega and Interro testing [24].
In 1996, the New Jersey Attorney General obtained a consent agreement in which William Holder, M.D., was ordered to (a) properly code insurance claim forms; (b) obtain informed consent when using unconventional methods; (c) stop using an "Acuscope," device; (d) stop selling dietary supplements, homeopathic remedies, and herbal products; and (e) pay $5,319.92 to cover the cost of the state medical board's investigation of him [25].
In 1996, a hearing officer concluded that Dr. Richard Plagenhoef had provided substandard care to a patient and recommended that his license be suspended until he can demonstrate to the licensing board that he can practice medicine with skill and safety. The hearing officer's report said that Plagenhoef had (a) diagnosed chemical toxicity based on no medical tests or physical examination, (b) used a worthless device (an Interro) to confirm that "diagnosis," and (c) improperly treated the patient with "detox drops." The board adopted the hearing officer's recommendations. The Florida Department of Health's Web site states that Plagenhoef's license was revoked in 1997 but does not indicate why [26].
In 1998, the Missouri licensing board charged a chiropractor (Gary Edwards) with falsely telling a patient his HIV (AIDS virus) infection had been cured, leading to infection of the man's wife and daughter with the virus. According to reports in the Kansas City Star, the patient, who had hemophilia, consulted Edwards after learning that he was infected with the virus. According to the board's complaint, Edwards said that he could treat the disease with help from an Interro device and prescribed various supplements and herbs. Six months later, he allegedly said that the virus had been eradicated, and the patient and his wife decided to have a child. The child was born in 1992. The patient died a few months later of complications triggered by AIDS, and tests subsequently showed that both mother and daughter were infected [27]. In February 2000, a Missouri judge agreed that the chiropractic board could discipline Edwards for "fraud deception and misrepresentation." [28] In May, the board suspended him for two years followed by five years of probation [29]. In April 2002, the Missouri Court of Appeals ruled that the Board's fact-finding body erred by not allowing Edwards to have access to certain evidence [30]. The board subsequently withdrew its complaint. Edwards sued the board members and an investigator for malicious prosecution [31], but the Missouri Court of Appeals reversed the decison and permitted the case to continue to trial and the jury awarded $6.2 million to Edwards [32].
In 1998, the Discipline Committee of the College of Physicians and Surgeons of Ontario (Canada) found Jozef Krop, a Canadian physician, guilty of professional misconduct in that he failed to maintain the standard of practice in the care of six patients whose cases the committee had reviewed. The misconduct included use of a Vegatest device to "screen" and/or to determine how to treat the patients. Krop appealed the decision, but the divisional court ruled against him and his petition to appeal to the Ontario Court of Appeal was denied in 2003 [33].
In 1998, the Nevada Medical Board entered into a stipulation for settlement with Donald Soli, M.D., under which he was reprimanded, placed on probation for five years, and barred from using a Dermatron or any similar machine.
In 1998, an Australian dentist received a 6-month suspension for performing jaw surgery based on readings of a Dermatron device [34].
In 2003, Anthony G. Roeder, D.D.S., of Paoli, Pennsylvania, permanently surrendered his dental license to settle charges of unprofessional conduct. The settlement agreement indicates that the dental board was concerned with his substandard treatment of two women [35]. One case concerned a woman who suffered severe pain after he unnecessarily removed amalgam fillings in 11 other teeth. At his direction, the woman also underwent EDS. In the other case, he injected homeopathic "remedies" into the patient's gums.
In 2003, the Maryland State Board of Physician Quality Assurance revoked the license of Barbara A. Solomon, M.D. for refusing to cooperate with an investigation of her use of a Computron device. In 1998, after a patient complained, the board warned her about failure to adequately disclose the risks involved and said that in six months it would review her practice. When the board subsequently asked to see patient records, Solomon stalled and ultimately filed suit to block the board's request [36]. The court upheld the board's actions [37].
In 2004, the Washington Department of Health Medical Quality Assurance Commission concluded that Geoffrey S. Ames, M.D., who practices in Richland, Washington, had committed unprofessional conduct by using a LISTEN device to (incorrectly) diagnose a patient as having an "egg allergy." The Commission issued a 5-year license suspension that would be stayed provided that Ames (a) stopped using the device, (b) undergoes quarterly practice reviews, and (c) pays a $5,000 fine [38]. In 2007, the Washington Court of Appeals agreed that use of the device had created an "unreasonable risk of harm." [39] In 2009, the Washington Supreme Court agreed, stating that Ames had "led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither." [40]
In 2005, the Connecticut Department of Health accepted a consent agreement under which Warren M. Levin, M.D., waived his right to a hearing about allegations that, if proven, would have been grounds for disciplinary action. The agreement included routine electrodermal screening in a list of eight diagnostic and treatment methods that were "outside the standard of care." The investigator's report alleged that Levin had engaged in various illegitimate medical practices, falsely told patients he was doing research, and had staff members perform procedures for which they were not properly credentialed and licensed. Levin relocated to Arizona at about that time and let his Connecticut license lapse in August 2004. However, the Department took steps to ensure that if he reapplied for licensure in Connecticut, it could deny the application unless he could demonstrate that his practice would be legal, safe, and effective [41].
In 2005, the Wisconsin Dentistry Examining Board revoked the license of Richard Vander Heyden, D.D.S., of Green Bay, Wisconsin, for unprofessional conduct related to the use of two EAV devices (Dermatron and Interro). The heart of the Board's decision was that Vander Heyden's diagnostic use of EAV devices and prescription of homeopathic products for non-dental conditions were beyond the legitimate scope of dental practice. In one case the board investigated, Vander Heyden used his Dermatron at various times to falsely diagnose botulism; pneumonia; meningitis; hepatitis; coxsackie virus; Epstein-Barr virus; E. coli and klebsiella (bacterial infections); whooping cough; and gallbladder and colon inflammation, most of which he then treated with homeopathic products. Although he claimed to have used the devices for research purposes, he refused to provide the board with any experimental thesis, protocol, data, or patient records [42].
In 2005, Dorothy Merritt, M.D., who operates chelation clinics in Texas, signed a consent agreement with the Texas Board of Medical Examiners under which she was assessed $3,000 and ordered to retract a misleading promotional statement that the BioMeridian device was "the medical tool of the millennium." [43]
In 2010, the Connecticut Board of Health charged Jarir Nakouzi, M.D. with deviating from the standard of care in caring for a late-stage cancer patient {44]. The treatment centered around the use of a bioresonance device for diagnosis and treatment. Newsweek has published a vivid account of what happened [45]. The case was settled in 2011 with a consent order under which Nakouzi agreed to (a) pay $5,000, (b) stop using devices that measure skin resistance for diagnostic or treatment purposes, (c) stop making unsubstantiated claims that refrain from recommending, prescribing, or administering any alleged cancer treatment that lacks FDA approval or scientific support, and (d) serve probation for two years, during which at least 20 of his patient charts should be subject to random review by a supervisor acceptable to the Connecticut Department of Health [46].

Foreign Regulatory Agency Actions

In 1999, the British Advertising Standards Authority (ASA) reviewed a pamphlet which alleged that a Bio Resonance Therapy device could help people suffering from headaches, overweight, tiredness, bloating, irritable bowel syndrome, skin rashes, arthritis, and premenstrual tension. In May 1999, after reviewing a manual and other information about the device, the Authority concluded that the claims were unsubstantiated [47].
In 2000, the Australian Competition and Consumer Commission secured an agreement under which Listen Systems Pty Ltd and its director, Stephen John Alexander, would stop falsely advertising that their "EQ4 Quick Check" and the '"EQ4 Computerised Electrodermal Screening" devices can: (a) test particular energy points and find an appropriate remedial strategy by scanning over 40,000 items stored in their "virtual inventory"; measure allergic reactions to samples of specific food, pollens and other substances; and imprint appropriate frequencies to create individually designed isopathic remedies [48].
In 2002, Health Canada suspended the licenses for the Vegasom (License No.13264), Vega Audiocolor (License No. 13267), Vegaselect (License No.13270) and Vegatest Expert (License No. 14736), which prohibits the sale or importation of these devices.
In 2002, the ASA concluded that a leaflet offering Vega testing as a "complete test for hidden problems" was misleading and advised the advertiser to withdraw it [49].
In 2011, the ASA concluded that a leaflet for "food sensitivity testing" with a Vegatest device was misleading and must be discontinued because validity of the device was not backed by sufficiently robust evidence [50].

For Additional Information

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This article was revised on September 8, 2013.