Electro Interstitial Scans
Another Test to Avoid

Stephen Barrett, M.D.

The Electro Interstitial Scanning (EIS) System is said to provide useful information by measuring and interpreting resistance to the flow of electric current through interstitial fluid (fluid between the cells) throughout the body. Its current manufacturer is LD Technology of Sarasota, Florida. Corporate documents state that the company was incorporated in 2006 and is managed by Albert Maarek (the device's inventor/developer). The EIS is not legally marketable in the United States, but about 2,000 devices are said to be in use in other countries.

Questionable Claims Abound

LD Technology's home page states that the EIS System is:

a unique hardware/software computerized system that applies precise algorithms and proprietary formulas to generate on-screen, 3-D modeling representations of the human body's organs and organ systems; with specific intended uses:

However, many Web sites in the United States have promoted it for more. In 2008, for example, L D Teck Sales, which has offices in Florida and California, began advertising that its 3-minute Electro Interstitial Scan (EIS) System would provide data that healthcare practitioners could use for:

L D Tech Sales also claimed that the EIS System could help practitioners treat patients with many types of health problems and can verify treatment effectiveness. The company also claimed that "before reaching the U.S. marketplace, the EIS was calibrated using over 20,000 clinical study tests from individuals and subsequent tests from patients with a wide-variety of pathologies." [1]

Other literature states that the device evaluates the "bioelectromagnetic impedance" (electrical resistance) of interstitial fluid throughout the body. The EIS System is said to (a) introduce a 1.28-volt direct current through six electrodes connected through a "black box" to the practitioner's computer (b) measure the voltage drop between 22 pairs of points on the skin, and (c) interpret the results with software installed in the practitioner's computer that produces various models, graphs, and text data for the practitioner to interpret [1]. The patient sits in front of the device with bare feet on the lower electrode plates, hands resting on the desktop electrodes, and the upper electrodes applied to the forehead.

Each of the 22 electrode pairs is said to represent various organs and organ systems. The middle picture to the right illustrates the claim that current flow between the left forehead and the left hand provides information about the left sides of the ear, eye, nasal canal, sinus, tonsillar ring, upper jaw, lower jaw, and temporomandibular joint.

A video posted to YouTube during 2008 stated that the readings provide diagrammable data that represent 22 areas classified as: "cardiovascular, metabolic disorders," "acute hepatitis," "chronic respiratory disorder," "type II diabetes," "acute respiratory disorder," "neuromuscular and cardiac vascular disorder," "neuromuscular and vascular disorder," "asthenia digestive disorder" (two areas), "drugs intoxication," "metabolic disorder," "hepatic insufficiency," "hyperventilation, type I diabetes, and renal failure," "obstructive bronchitis," "acute respiratory disorder" (2 areas), "digestive risk," "cardiovascular risk, atherosclerosis," "and digestive and bone disorders." [2] In the lower picture to the right, the body image supposedly depicts the status of various organs and the "risk analysis" bar graph supposedly prioritizes the problems that need attention.

Another video on the Web site of a Canadian distributor referred to the organ images as "the money-maker page . . . the real crowd-pleaser" because it enables the practitioner and patient . . . to see quickly what's out of balance." [3]

 


Proponent Web sites also claim that in healthy subjects, the EIS system is used for a general health check, to estimate body fat percentage and to give diet and and dietary supplement suggestions. In subjects with symptoms but without treatment, the system can be programmed to to help regulate and target supplementary examinations. And in subjects under medication, EIS system is used for the therapeutic follow-up to help control dosage and monitor effectiveness and side effects [4].

L.D. Tech Sales stated that the EIS was invented in France by Albert Maarek, M.D., a French neurologist, and became available to practitioners in France in 2001; in Russia in 2002; throughout Europe in early 2003; in China and parts of Asia in 2004; in Mexico and South America in 2005; in North American in 2007; and in South Africa and Australia in early 2008. The device costs about $20,000, and practitioners are said to charge from $55 to $125 for the scan, with interpretations ranging from a flat fee of $10 to consultations at $150 per hour [1].

The LD Technology Web site has included photographs, videos, and other information from a symposium it sponsored in Cancun Mexico in December 2008. The picture to the left is part of a presentation by Maarek. The one to the right comes from a presentation by Anthony Speroni of L D Teck Sales called "Clinical Case Studies and Intended Uses" The sentence in red across the top of the pictiure states: "The only possible way to make a valid interpretation of any electro interstitial scan is in complement to the subject's clinical context. Anthony's EIS application form helps many EIS practitioners collect data easily."

  

Speroni's form included more than 500 boxes that the patient can check about symptoms, illnesses diet, and other lifestyle factors [5,6]. The checked items are then recorded into the practitioner's computer. The resultant 8-page Electro Interstitial Scan Status Reports—which are generated by the EIS System software—include long lists of speculations about possible problems with organs, organ systems, and body functions, as well as "supplementary exams" that it recommends. At the end, the computer can print diagrams and reports to give to the patient. The reports state that "the software proposes some possibilities of diseases or dysfunction with a specificity and a sensitivity." However, they add that "these possibilities are not diagnostic but help for [sic] regulate more specific and supplementary examinations." [7] The reports I have seen include:

Re-examination in a month or two is commonly recommended.

What Does the Device Actually Do?

David A. Bender, a Senior Lecturer in the Department of Biochemistry and Molecular Biology at University College London, has written an easy-to-understand report about the EIS device. report. After examining literature provided by a British distributor, he concluded:

The underlying principle of the scanner is that it measures the electrical conductivity of the body. This is well-established as a means of measuring body fat. Electrolytes (sodium, potassium, chloride, bicarbonate and phosphate, etc) in lean tissues conduct an electric current, fat does not. For body fat determination a low voltage high frequency (typically 50 kHz) alternating current is used, and the impedance (equivalent to resistance) between the hands and feet is measured. The greater the impedance, the more fat is present. Such devices are widely used in nutrition research, and have begun to appear in gyms for people to use themselves. A high frequency alternating current penetrates all body water compartments: the bloodstream, intracellular water and water between cells (the interstitial fluid). The EIS, by contrast, uses a low voltage direct current, which the manufacturers state only measures interstitial fluid electrolytes and the volume of interstitial fluid. Unfortunately they do not cite a reference for this so it is not clear whether research supports this use of direct rather than alternating current in this application. . . .

The manufacturer's booklet and website suggest that sophisticated mathematical analysis of the results permits estimation of the volume and contents of the interstitial fluid in discrete organs and tissues. I cannot follow the mathematical arguments in the paper cited, but I doubt that you could differentiate between say the liver, pancreas and gall bladder, or indeed between the large and small intestines, with only six electrodes—even in 21 different combinations [8].

Research Status

Proponents claim that electro interstitial scanning has been validated by many studies. However, most of the studies cited on their Web sites did not involve their device and those that did were poorly designed, skimpily reported, and/or lacking in meaningful data. In March 2007, the Institutional Review Board at McLean Hospital (Belmont, Massachusetts) approved a proposal to examine whether the EIS could distinguish patients with mood disorders can distinguish patients with mood disorders from non-ill control subjects, and whether this technique can differentiate the patients with unipolar major depression from those with bipolar disorder." [9] However, a few months later, the IRB administratively withdrew the proposal because the study was not carried out.

Regulatory Status

The EIS device is registered with the FDA, which merely means that the agency has been notified that it exists. It is not listed in the agency's 510(k) database, which means that it has not been cleared for marketing and is not legal to market in interstate commerce in the United States. The FDA has cleared \some "impedence plethsmograph" devices that determine regional blood flow or body fat composition by measuring the resistance of interstitial fluid. However, a device intended to diagnose a wide range of health problems would require premarket approval (not just clearance) that includes its software [10,11]. The lack of legal and scientific standing may explain why Speroni's application form states:

I, the undersigned, hereby authorize ______ to assess my health concerns and perform an ElectroScanGram (ESG) study. . . .

I understand the EIS is a programmable electro medical system (PEMS) that generates an ESG used to: study body composition; compute various physiologic parameters in certain organs; explore probabilities of the functional risks of the various body systems; scrutinize effectiveness of treatments used to cure or attenuate an organic dysfunction or a disease. . . .

I understand only licensed medical doctors diagnose or treat a patient, using medical devices designed specifically for diagnosis and/or with pharmaceutical products approved by the U. S. Food and Drug Administration (FDA); and the practice is not a medical doctor or allopathic practitioner; and the ESG is not a diagnosis. This practice and the PEMS are not designed to and do not diagnose, prevent, treat, cure, mitigate, or prevent anything (including, but not limited to, diseases, ailments, disorders, and medical conditions). It also does not replace a medical examination but is, rather, considered a complementary tool for an exam. Furthermore, I understand a result of the EIS showing no abnormal values does not mean that I am healthy; it only indicates that there are no physiological tissue parameter or interstitial biochemical value disorders.

I hereby attest and affirm that I am now and at all future times meeting with the practice solely as a client, on my first and all, if any, subsequent visits (in person, through e-mail communications, or by telephone consultation), and solely on my own behalf; and not as an agent of any agency, people, or other parties. I also attest that any person or persons present with me at any time while meeting with the practice, either in person, through e-mail communications, or via telephone consultation, are strictly present at my request to accompany me and not as an agent of any agency, people, or other parties. Finally, I understand the practice will not advise me regarding the use of any pharmaceutical agents as relates directly to me [5].

A device claimed to provide information about hundreds of diseases and conditions could not be approved without a mountain of evidence substantiating usefulness and reliability. X-ray equipment is approved, for example, because the relationships between x-ray findings and physical findings have been studied in countless millions of cases. Electro Interstitial Scans have no proven practical value and could cause large amounts of time and money to be wasted by people who believe the speculations.

Maarek Responds

In September 2008, I summarized what I had found on about a dozen Web sites that had represented themselves as distributors of the device. In February 2009, I exchanged e-mails with Albert Maarek, who described himself as designer and patent owner of the EIS system [12]. His messages stated:

Some of the incriminating information that Maarek disclaimed are no longer posted, but some sites still have it. Maarek told me that the December 2008 LD Technology Symposium was for European and South American distributors. Since the original version of this report was posted, nearly all of the EIS-related pages to which I have linked have been removed from the Internet. I assume that Maarek engineered their removal by contacting the site owners.

In April 2009, I received an e-mail from Ryan Williams, who asked me to remove the LD-Tech Sales press release from this site. He said had written it without the manufacturer's approval and that the information was "no longer valid" and did not comply with their registration guidelines. When I asked whether any of the information I posted was false, he replied "Most of it," but he did not identify specific statements. He also said that his company no longer distributed the EIS System. If the FDA concludes that the EIS System is intended for diagnosing or treating diseases in the United States, it will require premarket approval, which it could never get. I assume that Maarek wants me to remove my observations so that he can persuade the FDA that the system is not intended for disease management in the United States—even though it is actually used for that purpose both here and elsewhere.

Regardless of what Maarek "officially" claims, if the FDA clears the EIS System for marketing, it will not be able to control how practitioners use it.

References

  1. The EIS: a new medical device aims to improve healthcare experience through safe, noninvasive electro interstitial scans. Press release, L D Tech Sales, Inc., March 15, 2008. Note: On Feb 22, 2009, Albert Maarek e-mailed me this comment about the press release: "Come from a Californian distributor and not from . . . LD TECHNOLOGY. All the claims are incorrect. We stop it immediately and we are in lawsuits against this distributor. He make a copyright of our logo with some changes. . . . This Press release was made by illegal way and no approved by the manufacturer."
  2. E.I.S. Electro Interstitial Scan: Non invasive screening technique designed to measure organ function and monitor therapeutic control. Video, accessed Aug 29, 2008, and Feb 2, 2009.
  3. Main body image. Video demo. Electro Interstitial Company (Canada) Web site, accessed Sept 2, 2008 and Feb 23, 2009.
  4. Use of EIS. Cenzitek Web site, accessed 8/31/08.
  5. Speroni A. EIS intake form. C.A.M. Options Inc. Web site, accessed Aug 29, 2008 and Feb 20, 2009.
  6. Manufacturer and developer information, LD Technology Power Point presentation, accessed Sept 1, 2008.
  7. Electro interstitial scan status reports, acquired Aug 2008.
  8. Bender DA. The Electro-Interstitial Scanner: Can it do what I think it claims to do? Healthwatch Newsletter 72:7-8, Jan 2009.
  9. Stoll AL. Application for an Investigational Device Exemption, bioelectric impedance device.
  10. Rollings J. Letter to Stephen Barrett, M.D., Nov 28, 1986.
  11. Yellin AK. What are 510(k) clearance and premarket approval? Device Watch, Jan 9, 2009.
  12. Maarek A. E-mail messages to Stephen Barrett, M.D., Feb 21-26, 2009.

This article was revised on April 5, 2009.

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