A Letter to the FDA Concerning 3 Connecticut NDs

here, my letter to the FDA:

2015-11-01

To Whom it May Concern,

            I'm concerned about possible non-permitted clinical activity in Connecticut, for diagnosis and treatment, involving devices used by three practitioners at three different locations, in cumulatively three different states.  I am a writer who is soon to publish on this matter, and I thought I'd check these things with FDA:

I. First, there's hyperbaric oxygen chamber usage by a naturopath, for a host of conditions:

The naturopath's name is Adam Breiner

(see http://wholebodymed.com/staff/dr-adam-breiner-nd)

a licensed Connecticut naturopath

(see http://cnpaonline.org/2011/12/dr-adam-breiner-nd/).

On ND Breiner's practice bio. page, the first link above, we're told:

                        “Dr. Breiner is the first physician in the State of Connecticut to offer hyperbaric oxygen for the treatment of Lyme, Stroke, ADD, Tramua [sic.], and other neurological conditions.”

On ND Breiner's page “Hyperbaric Oxygen & Neurologic Center”

(see http://wholebodymed.com/medical/hyperbaric-oxygen-neurologic-center)

we're told:

            “At Whole-Body Medicine we offer patients access to a cutting-edge, integrative Hyperbaric & Neurologic Center. Hyperbaric Oxygen Therapy is used to help patients in their recovery from a wide range of neurological and other health challenges.”

On ND Breiner's page “Conditions Treated By HBOT”

(see http://wholebodymed.com/medical/conditions-treated-hbot)

we're told:

            “Below are some of the many conditions that can be treated by HBOT: autism, acute necrotizing fasciitis, anoxic ischemic encephalopathy, carbon monoxide intoxication, cerebral palsy, chronic fatigue, coma, cranial nerve syndrome, Crohn’s disease, decompression illness, gas gangrene, lepromatous leprosy, Lyme disease, multiple sclerosis, migraine, poor wound healing, peripheral neuropathy, post surgical repair of ligaments and tendons, radiation osteonecrosis, reflex sympathetic dystrophy (RSD), sickle cell crisis, stroke, traumatic brain injury.”

I have underlined, in the quotes above, the WIDE usage / efficacy that is claimed for HBOT by ND Breiner.

Now, FDA has a page titled “Hyperbaric Oxygen Therapy: Don't Be Misled”

(see http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm)

which states:

            “HBOT has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.  'Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies,' says Nayan Patel, a biomedical engineer in FDA's Anesthesiology Devices Branch. 'In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).' Patients may be unaware that the safety and effectiveness of HBOT has not been established for these diseases and conditions, including: AIDS/HIV, Alzheimer's disease, asthma, Bell's palsy, brain injury, cerebral palsy, depression, heart disease, hepatitis, migraine, multiple sclerosis, Parkinson's disease, spinal cord injury, sport's injury, stroke.  Patel says that FDA has received 27 complaints from consumers and health care professionals over the past three years about treatment centers promoting the hyperbaric chamber for uses not cleared by the agency […] hyperbaric chambers are medical devices that require FDA clearance. FDA clearance of a device for a specific use means FDA has reviewed valid scientific evidence supporting that use  and determined that the device is at least as safe and effective as another legally U.S.-marketed device.”

I see many things on this FDA list which the ND claims 'he treats / are treatable' with HBOT.

Along with this letter is a ZIP folder with screen captures from Facebook.

The Facebook account is for the naturopath's practice in Fairfield, CT.

Some pictures depict patients within the chamber, including a minor, and the ND is outside supervising the treatment.

Captions cast a wide net as to what the device can treat.

I'm interested in knowing if what's going on is acceptable to the FDA.

What ND Breiner is doing may very-well be approved and above-board, but I don't see posted on his practice page any kind of FDA permissions or variances for what seems to be FDA-restricted activity.

Here is a partial list of other NDs using HBOT in various states:

            NDs Dick-Kronenberg and Potenza

http://www.windroseclinic.com/Hyper.html

            NMDs Ramsey and Brouwer

http://www.drramsey.com/hyperbaric-oxygen-therapy/

            ND Ruhland

http://www.drruhland.com/16.html

            NDs Bankole and Preston

http://www.inlandnaturalmedicine.com/Hyperbaric_Oxygen.html

            ND Cavaiola

http://www.phoenixantiagingclinic.com/treatments/hyperbaric-oxygen-therapy/

            ND Shohet

http://www.boisenaturalmedicine.com/services/hyperbaric-oxygen-therapy/

            NDs Abfall and Borden

http://www.foxvalleywellness.com/services-hyperbarics.php

            ND Sarvestani

http://coronanaturalhealth.com/services---techniques/mild-hyperbaric-oxygen-therapy.html

II. Second, there's the use of an electrodermal screening device and darkfield microscope for diagnostic purposes by ND Zampieron at his practice in Connecticut:

ND Zampieron is a CT licensed naturopath

(see http://cnpaonline.org/2015/04/eugene-r-zampieron-nd-mh-rh/)

who has been in continuous practice for the past couple of decades.

His web site is drznaturally.com, where there is no mention of EDS or electrodermal, or darkfield.

But, there is a 2006 book he co-authored, “Arthritis: An Alternative Medicine Definitive Guide”

(see http://www.amazon.com/Alternative-Medicine-Definitive-Guide-Arthritis/dp/1587612585 ).

Describing in the book what he does at his practice, with co-author RN Kamhi, we're told such things as:

            “alternative medicine diagnostic tests: electrodermal […] electrodermal screening (EDS): we use electrodermal screening to determine where to start the protocol of intervention for the arthritis patient […] arthritis is a multifaceted illness […] instead, we use EDS testing to prioritize which system in the patient's body needs attention first. By quickly pinpointing problems, EDS can indicate the degree of stress that is affecting an organ and prevent unnecessary guesswork testing. As a cross-reference, specific blood, urine, and stool analyses can then be ordered to confirm electrodermal results [p.056...] if EDS indicates that a person has a specific type of parasite [...] EDS can also help to select an individualized treatment protocol  for each person based on their sensitivities to certain natural medicines or supplements. In EDS, a blunt, noninvasive electric probe is placed at specific points on the patient hands, face, or feet, corresponding to acupuncture points at the beginning or end of energy meridians. Minute electrical discharges from these points serve as information signals about the condition of the body's organs and systems. The key idea with EDS is that it is a 'data acquisition process' in which the trained practitioner conducts an 'interview' with the patient's organs and tissues [...] electrodermal screening probes specific points on the hands (see black dots above) to gather information about the health, function, or possible toxicity of organs and body systems. These points are part of acupuncture meridians [p.057...] gathering information about the basic functional status of those systems and their energy pathways. As such, EDS is an investigational, not diagnostic, device because it requires the practitioner's knowledge of acupuncture, physiology, and therapeutic substances to interpret the energy imbalances, establish their precise focus, and select the most appropriate therapeutic response. EDS uses a scale of zero to 100, with 45-55 being 'normal' or 'balanced.' Readings above 55 are interpreted as indicating an inflammation of the organ associated with the meridian tested, while readings below 45-50 suggest organ stagnation and degeneration. The practitioners task is to find a single substance or combination of substances that will bring the EDS reading back close to 50. When  working with arthritis patients, we measure painful joints. These areas of sensitivity typically score around 85 or higher on the test. Then we try different substances, such as glucosamine sulfate and other nutrients, to balance the reading to 50. The nutrients that are successful at lowering the reading are then used in future supplementation for the patient [...a photo of the process is captioned] Ellen Kamhi, Ph.D., R.N., H.N.C., performs electrodermal screening on a patient [p.058...other effective and more convenient tests for identifying allergens, or allergy-causing substances, include applied kinesiology, electrodermal screening, the IgG ELISA test, blood typing, and skin testing [p.069...]electrodermal screening (EDS): electrodermal screening  is widely used by holistic practitioners in Europe and the United States to screen for a wide range of allergens, including food and environmental substances. It determines what remedies to use to properly neutralize allergic reactions as well as monitors the success of prescribed remedies [p.070... ] additional alternative medicine screening tools to diagnose the presence of parasites include electrodermal screening (EDS), applied kinesiology, and darkfield microscopic blood analysis [p.158...] electrodermal screening (EDS) is a form of computerized information gathering which is based on physics, not chemistry. A blunt, noninvasive electric probe is placed at specific points on the patient's hands, face, or feet, corresponding to acupuncture points at the beginning or end of energy meridians. Minute electrical discharges from these points serve as information signals about the condition of the body's organs and systems, useful for the physician in evaluation and developing a treatment plan. EDS can indicate the degree of stress that is affecting an organ and can monitor the progress of therapy, avoiding trial and error and general guesswork. EDS can use a computerized list or vials containing specimens of various parasites to test the meridians of the patient; if parasites are a factor, there will be a   corresponding weakened EDS reading [p.159]."

I suspect a lot of EDS diagnostic activity at ND Zampieron's practice, by way of these accounts.

Additionally, in terms of darkfield microscopy, we're told such things as:

            "we also performed a darkfield microscopic analysis of Vanessa's blood. We could see in the projected image of her blood many long, unidentified tubules, which we have found to correlate with the presence of parasites [p.23]."

Darkfield as a term actually occurs in the book at least 28 times.

I think the title of the post “Electrodermal Testing Part I: Fooling Patients with a Computerized Magic Eight Ball” at sciencebasedmedicine.org

(see https://www.sciencebasedmedicine.org/13926/)

says it all, concerning EDS.

As for darkfield microscopy, we're told in “The Pseudoscience of Live Blood Cell Analysis”

(see http://www.csicop.org/si/show/the_pseudoscience_of_live_blood_cell_analysis/)

by the Committee for Skeptical inquiry:

            “take a simple scientific fact or term, build an elaborate fantasy on top of it, promote it, and you have pseudoscience. Live blood cell analysis by darkfield microscopy is an example. It sounds like a legitimate and valuable evidence-based diagnostic procedure; it is not.”

Again, I suspect these two devices are being used for diagnostic purposes while, apparently, not approved for such activity due to their inherent lack of a basis in reality.

I will return to ND Zampieron's practice in IV. in this letter, because I suspect something even more disturbing than EDS and darkfield pseudodiagnostics has occurred / could regularly occur there.

III. Third, there's the use of an electrodermal screening device for diagnostic purposes by ND Ingels in Southport, CT, New York State, and California:

ND Ingels is a Connecticut licensed naturopath

(see http://cnpaonline.org/2011/12/dr-darin-ingels/).

His practice is ingelsfamilyhealth.com, with practice sites in the states of CT, NY, and CA

(see http://www.ingelsfamilyhealth.com/services-locations/).

ND Ingels explains, in all three states

(see http://www.ingelsfamilyhealth.com/services-locations/southport-ct/)

he does:

            “non-invasive allergy assessment […] Dr. Ingels utilizes the Orion®, a non-invasive computer- based electrodermal screening instrument which measures changes in skin conductance. The Orion® is a computer-based method of evaluating sensitivities to many different substances including foods, inhalants (pollens, molds, animal danders) and chemicals. It was first developed by a German physician more than 50 years ago, but currently utilizes state-of-the-art technology combining the principles of computer engineering and quantum physics. The  Orion® measures skin conductance along the surface of the skin using a specific non-invasive probe. Unlike scratch testing, the Orion® allows multiple items to be tested in a short period of time, which is particularly appropriate for young patients. The information gathered is then used in conjunction with standard tests to determine which allergens or substances are underlying one’s illness. This pain-free method does not pose any risk of serious allergic reaction, which is a potential risk with traditional scratch testing. This method is also safe to use with children and   infants and is preferable for those with a fear of needles.  Food and environmental allergies / sensitivities have been shown to be an underlying component of many conditions […] the Orion® is an investigational medical device only and the performance characteristics of this product have not been established by the FDA.”

Now, in that sciencebasedmedicine.org article on EDS, MD Hall tells us:

            “It is illegal to use the devices for anything other than biofeedback.”

Perhaps?

IV. Forth, and I don't know how to categorize these two items, but I'll append it to the already listed concerns above, are what appears to be:

a. injection of novel or ad hoc, physician-compounded, peculiar and implausible remedies – as recounted by ND Zampieron in that Arthritis book and as having happened at his practice in Connecticut -- with the patient being a minor.

We're told in that aforementioned book:
            “Success Story: Auto-Sanguis Therapy Calms the Autoimmune Reaction: Yvonne, 13, developed symptoms of juvenile rheumatoid arthritis shortly after a visit to the dentist […] in order to reverse Yvonne's arthritis, we had to eradicate her strep infection and modify her autoimmune response. This was achieved through two autoimmune therapies: auto-sanguis oral nosode therapy and injectible auto-sanguis dilution therapy.  First, we prescribed the homeopathic remedy Streptococcinum 200C at three sublingual pellets, once a day between meals, for one month.  We also prepared an oral auto-sanguis nosode through the following method: an extraction of a small amount of Yvonne's blood was placed in a centrifuge for 20 minutes; then, one part serum was mixed with nine parts Willard's Water; the mixture was shaken vigorously 100 times. This process produces a homeopathic nosode at 1X potency. To  increase the potency of the nosode, the process was repeated six times, rendering the remedy at a potency of 6X; we added 15% ethyl alcohol to stabilize the solution. We instructed Yvonne to place ten drops of this solution under her tongue three times a day. Upon her second visit, we   increased the potency of the original nosode to 12X potency; her third visit to 30X potency; and finally to 60X potency. In addition, she was treated with an auto-sanguis injectible dilution by extracting 3 cc (cubic centimeters) of her blood and emptying the syringe until only a microscopic film of blood remained in the cartridge. We then mixed into the same syringe 1 cc of the homeopathic nosodes Streptococcus viridans-injeel and Streptococcus haemolyticus-  injeel, and 1 cc of the homeopathic remedies Traumeel and ZEEL (indicated for inflammation and degenerative processes). The mixture was agitated 20 times rendering a solution at 1X   potency and was injected into her buttock. The process was repeated to produce a remedy of 2X  potency and injected as well. Yvonne returned for treatment once a week for one month. During  this time, injections reached a potency of 4X.Two weeks after Yvonne's last treatment, we repeated all initial blood tests and found that her body was no longer producing Streptococcus antibodies. She also no longer had positive blood factors (RF and ANA) for autoimmune reactions and she experienced com[p.218]plete relief of her arthritis symptoms. We suspected that Yvonne's recent visit to the dentist may explain how she was infected by the strep bacteria. During the routine dental cleaning, strep cell fragments in the teeth or gums translocated to other regions of the body, prompting an immune response, leading to autoimmunity. We suggested that, in the future, Yvonne should receive preventive homeopathic treatment with Streptococcinum 200C before visiting the dentist […] Auto-sanguis (oral or injectible) dilution therapy can be administered only by a licensed physician. Practitioners can contact Eugene Zampieron at 203-263-2970.”

This sounds exceptionally implausible and invasive, so therein it carries risk without benefit.

Here is a link from one of the ingredients makers which details the procedure

(see http://www.traumeel.com/upload/Journal_BT_Fall_2000_7531.pdf ).

It sounds exceptionally experimental, and I'm wondering if an ND practice in Connecticut has statutory permission to compound and inject ad hoc mixtures.

Also, homeoprophylaxis, aka homeopathy preventative treatment along the lines of vaccination, is considered bogus.

And, as a reminder, the patient is 13 years old, in this account, being injected with weird substances the ND and staff have blended together.

b. pharmaceutical trails / human experimentation at his practice that I don't see authorization for:

Now, also in the book, ND Zampieron states:

            “clinical trials are under way at the Naturopathic Medical Center of Middlebury, Connecticut, to evaluate Lignum vitae and sarsaparilla extracts to treat Lyme disease, which can cause debilitation of the nervous system and severe arthritis [p.298...] Eugene R. Zampieron, ND., A.H.G., Naturopathic Medical Center, Middlebury, CT [p.370].”

I suspect that there are a whole bunch of permissions missing, which need to be granted by FDA, to actually engage in such human experimentation, in both instances.

I thank you for your time, patience, and consideration of these matters,

Rob Cullen

Author and Publisher,

The Naturocrit Blog and Podcast.