An article from Quackwatch on alternative therapies~ A site worth visiting if you are interested in what will be regulated and prosecuted next

Date:   8/14/2005 10:14:35 AM ( 19 y ago)

Dubious Claims for the Molecular Magnetic Energizer
Stephen Barrett, M.D.
Several years ago, Florsheim Shoes marketed magnetic shoes with preposterous claims that some of us suffer from magnetic deficiency that their shoes could correct [1]. The claims came to an abrupt halt when the company was sued for false advertising. But today, similar claims are being used to market Magnetic Molecular Energizer (MME) treatment for a wide range of diseases. In an apparent attempt to ward off regulatory action, the promoters represent the treatment as research "conducted under the auspices of an Institutional Review Board (IRB) as outlined in FDA regulations." However, there is good reason to suspect that the whole set-up is a scam.

The most elaborate information about MME is on the Advanced Magnetic Research Institute of Washington (AMRI-WA) Web site, which claims:


The Magnetic Molecular Energizer (MME) is a device made up of two strong electromagnets which applies a strong direct current electromagnetic field. (Although the magnetic field is strong at 3,000 to 5,000 "gauss", it's quite safe. MRI scanners operate at up to 20,000 "gauss".) . . . . If you're being treated, you lie on an open bed which moves you into the correct position between the two magnets.

While you're in the electromagnetic field, there's a temporary increase in the magnetic field affecting every atom in every cell. Some of the electrons on these atoms start moving faster, which leads to an acceleration of normal chemical reactions, including oxygen carrying capacity, nutrient assimilation, metabolic waste removal, enzyme synthesis, reduction of free radicals, tissue regeneration, and healing [2].

According to the AMRI-WA Web site, the conditions treatable by MME include Alzheimer's disease, arrhythmias, autism, avascular necrosis (hip), bone fractures, bursitis/tendonitis, carpal tunnel syndrome, cerebral palsy, chronic obstructive pulmonary disease (COPD), chronic pain, closed head injuries, congenital liver fibrosis, congestive heart failure, coronary artery plague, degenerative arthritis (knee/hip), diabetic peripheral neuropathy, fibromyalgia/chronic fatigue syndrome, herniated discs, hypertension, migraine, multiple sclerosis, muscle necrosis, muscular dystrophy, neuro-degenerative, organ dysfunction/blindness, Parkinson's disease, plantar fasciitis, ruptured disc, seizures, spinal bifida, spinal cord damage, sprains/strains, stroke, and torn ligaments/tendons [3]. The average number of treatment hours, which cost $50 per hour, are said to range from 20 for carpal tunnel syndrome to 350 for brain tumor pain; and the results are claimed to be permanent in most cases [4].

I don't believe that magnetic fields accelerate normal chemical reactions or influence oxygen carrying capacity, nutrient assimilation, metabolic waste removal, enzyme synthesis, or reduction of free radicals, or generaally cause tissues to regenerate or heal. If they could do any of these things, thousands of scientists would be studying these phenomena and reports would be making headlines everywhere. Even if MME treatment were helpful—which I also doubt—I don't believe that the MME device has been used long enough to determine that results are usually permanent.

Background History
The MME was invented by Dean R. Bonlie, D.D.S., of Calgary, Canada and was patented in the United States in 2001. The patent document states:

A method of treating a patient who lives in a relatively weak magnetic field such as is naturally present by using an oriented, unidirectional, DC magnetic field. The magnetic field is aligned to pass through the patient's body in substantially the same direction that the Earth's magnetic field did during the majority of recent cell division within the patient's body. The first step of the present invention is to determine what the orientation of the Earth's magnetic field has been with respect to the patient's body during cell division in the recent past. The next step is to position the patient's body within a treating magnetic field. The magnetic field is oriented to correspond to some extent to the direction of the Earth's magnetic field determined in the first step. The magnetic field is constrained to prevent fringing magnetic fields from passing through any part of the patient's body in an obtuse direction with respect to the direction of the Earth's magnetic field determined in the first step. The treating magnetic field has zero frequency and is at least 500 gauss in intensity at its weakest point within the portion of the patient's body to be treated [5].

A biographical sketch of Bonlie states that AMRI facilities are located in Calgary, Canada; Seattle, Washington; Sterling Heights, Michigan; Hanover, Pennsylvania; Mocksville, North Carolina; Toledo, Ohio; Laguna Niguel, California; and Tucson, Arizona [6]. Bonlie and three physicians who direct AMRI facilities have co-authored a paper describing what happed with 14 people with Parkinson's disease who they say improved with MME treatment [7]. The report is meaningless, however, because there was no control group and the data lack detail. The authors acknowledged that "statistical analysis of the results was not possible" and said that they were planning to launch a more definitive study in 2003.

Bonlie also patented a magnetic mattress pad, which he markets under the name Magnetico Sleep Pads. Magnetico's Web site contains testimonials from people who reported benefits in cases of arthritis, asthma, attention deficit/hyperactivity disorder, autism, chronic fatigue, diabetes, epilepsy, fibromyalgia, heart problems, poor circulation, sleep disorders, thyroid problems, multiple sclerosis [8]. The company's Web site states that (a) magnetic fields accomplish magnetic resonance, which dramatically enhances chemical reactions in the body; (b) magnetic resonance occurs when when the brain’s pulsed magnetic frequency matches the frequencies of the various tissues and organs.; (c) a decline in the earth's geomagnetic field has left the atoms in our bodies in a lower energy state, making it more difficult for magnetic resonance to occur; and (d) these deficiency states can be overcome by providing an enhanced steady-state magnetic field to the body during sleep [9]. These statements are scientific-sounding nonsense. Tissues and organs do not resonate; humans are not suffering from magnetic deficiency; and magnets have almost no effect on the body.

Research Improprieties
Several of the AMRI Web sites state that the Institutes were set up to offer MME treatment under the guidelines of an Institutional Review Board (IRB), consistent with FDA regulations, and that the IRB reviews the records of all cases treated. The above-mentioned Parkinson's disease report says:

The Independent Institutional Review Board for Magnetic Molecular Energizer consists of all Advanced Magnetic Research Institute investigators, a medical university professor and registered nurse, a clinical psychologist, and two board certified medical physicians (neurology and family practice) who are experts in magnetic therapy and are not affiliated with AMRI. All minutes from meetings are on file with the FDA [9].

I believe that that this description violates FDA guidelines on IRB membership, which which prohibit investigators and co-investigators from approving studies in which they are participating. They are obligated to recuse themselves, and once they do so, the required quorum fails and the IRB cannot approve anything. If "investigators" also own the machine used in the alleged study, they violate regulations on financial conflict of interest. The FDA is aware that something is wrong. In February 2005, it notified AMRI-PA that it was not following the rules because:

Its "informed consent" form did not properly explain benefits or risks.
There was no documentation that the consent forms were reviewed or approved by the IRB.
Preliminary tests described in the experimental protocol were not performed.
There was no documentation that three subjects were seen by the facility's doctor.
The time to which patients were exposed to the device was not documented.
The investigator participated in IRB votes about his own study and other matters in which he had a conflict of interest [10].
I believe that the violations throughout the AMRI network are much more extensive and serious. FDA regulations also state that sponsors and investigators shall not: (a) promote or test market an investigational device, until after FDA has approved the device for commercial distribution; (b) commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling; or (c) represent that an investigational device is safe or effective for the purposes for which it is being investigated [11,12]. It appears to me that Bonlie and his associates are violating these rules.

References
Barrett S. Florsheim's MagneForce Shoes: Should we worry about "magnetic deficiency"? Quackwatch, Aug 8, 2000.
Wright JV. Introduction to MME by Dr. Jonathan V. Wright, M.D. Advanced Magnetic Research Institute of Washington Web site, accessed March 11, 2005.
Conditions treatable by MME. Advanced Magnetic Research Institute of Washington Web site, accessed March 11, 2005.
Estimated MME treatment hours per disease. Advanced Magnetic Research Institute of Washington Web site, accessed March 11, 2005.
Treatment using oriented unidirectional DC magnetic field. U.S. Patent #6,210,317, April 3, 2001.
Meet the Inventor of MME. Advanced Magnetic Research Institute of Washington Web site, accessed March 11, 2005.
Testimonials. MagnetiCo Web site, accessed March 11, 2005.
Biomagnetic theory. MagnetiCo Web site, accessed March 11, 2005.
Nichols TW and others. Clinical Observations on Magnetic Molecular Energizer in Parkinson's Disease: A pilot study. Undated, circa 2002.
Ulatowski TA. Warning letter to Trent Nichols, M.D. Feb 24, 2005.
Prohibition of promotion and other practices. Title 21, Code of Federal Regulations § 812.7, revised April 1, 2004.
Brown J. Summary of FDA requirements for investigators who are also considered sponsors of new devices. Sept 15, 2005.


 

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