Interview: Rik Deitsch
Jake Reimer: There’s a number of people and companies involved in the marketing of Natural Cellular Defense Zeolite. The original US patent for zeolite as cancer cure is held by Harvey Kauffman, of Life Link Pharmaceuticals. As a result of an agreement between you and Kauffman in March 2004, your company, NDA Consulting, acquired the exclusive rights to that patent, and just ten days after acquiring that license, Waiora USA was incorporated in Florida. Waiora continues to be the leading, if not only marketer of zeolites as a dietary supplement in the U.S. The CEO of Waiora is your friend Stan Cherelstein, whom you know from being mutually employed at Unicity, Inc. Cherelstein is also listed as a director of your company “NutraPharma, Inc.” In a recent turn of events, Kauffman and LLP appears to be suing NDA for non-payment; you, Cherelstein, and unnamed Waiora distributors are named as defendants. Is this synopsis accurate?
Rik Deitsch: First – As a journalist you should see that your synopsis is highly one-sided and biased and makes certain negative assumptions. It is true that I licensed LifeLink’s patent through my consulting company, NDA Consulting, Inc. in March of 2004. I did so, because there was a German Company (MRI Labs) that was interested in marketing a zeolite product in Europe. The German Company began sales of some unrelated products, but never really received the funding that they expected, eventually losing momentum and failing in early 2005. During that time, Stan Cherelstein founded Waiora – an Anti-Aging company that marketed several products – not the zeolite. In fact, Waiora did not launch the zeolite until 18 months later in August of 2005.
I faithfully paid licensing fees to LifeLink as Waiora marketed the Natural Cellular Defense for over six months. At that time, LifeLink tried to breach our contract and demanded a ridiculous increase in the license payments simply because they saw the success of the product. It was a simple story of greed on their part. With these negotiations, I ceased paying the license fees as my contract clearly states that no payments were due until sales began in Germany. All payments that I made up to that point (over $220,000) were simply good-faith payments made in the course of business.
The lawsuit filed by LifeLink is for patent infringement, not for ‘non-payment’ as you suggested above. The suit fails for several reasons. First of all, my contract is still in full force and effect. How can I be infringing on a patent for which I have licensing rights? Additionally, their patent is primarily a “use patent” for a cancer therapy. Waiora markets a detoxification supplement – not a cancer drug. The patent cannot be used to support marketing efforts of the Natural Cellular Defense because that would be making an implied drug claim on a dietary supplement. Lastly, their patent specifically requires the use of a synthetic zeolite (Hydrex-R) for the manufacture of a drug. I use naturally-occurring clinoptilolite for the NCD. The process used to purify (in effect to ‘activate’) the zeolite is proprietary to myself and my manufacturer. It took several years to perfect this process and yields a completely safe and very active product.
JR: I was unable to find any information about who actually produces the substance marketed as NCD zeolite, or about where it is produced. The court documents in the above suit suggest that there may have been some reference in your original agreement with Kauffman to a “German manufacturing plant.” Can you provide any information about where the product is produced, or at least whether it is produced domestically or overseas?
RD: Both my source of zeolite and my manufacturing facility are in the United States.
JR: A clinoptilolite-based nutritional supplement that appears to be very similar to NCD was developed and marketed in Croatia under the name “Megamin”. Megamin continues to be marketed overseas, especially in Eastern Europe and in Germany. In your “Scientific Research Monograph” (see below), and elsewhere, you refer often to a small number of journal articles by Croatian authors on the potential efficacy of Megamin or, more generically, clinoptilolite in treating cancer and other disorders. This suggests that you think NCD and Megamin are at least similar enough for studies conducted with one to be relevant to the other. Aside from being “tribomechanically activated” (which I understand refers to the specific grinding process used to mill the substance to a fine powder), Megamin appears to be essentially similar to naturally occurring clinoptilolite. Are there any significant differences between NCD zeolite and Megamin, as far as you know?
RD: The Megamin product is simply powdered clinoptilolite that has been encapsulated. The manufacturers process the material through “tribomechanical activation”. This process is supposed to help micronize the zeolite and separate out the more toxic components. The problem is that powdered zeolite products tend to have a substantial amount of contamination. We know that the natural, powdered zeolite derived from mined sources contains toxins and heavy metals. We also know that the cage is mostly full and cannot absorb many of the toxins an empty cage could.
Please see the link to the powdered zeolite’s application for approval in the UK. You can clearly see that there is an abundance of heavy metals that they list as ‘acceptable.’
Our proprietary activation process removes all extraneous metals and empties out the zeolite cage - therefore removing any toxins that were found with the zeolite and 'activating' the molecule to be at its most effective. Understand that the zeolite molecule is, for all practical purposes, indestructible. Heat up to 900 degrees Fahrenheit will not crack the molecule and it can be frozen in solution and defrosted without any change in activity. It is also amphoteric – meaning that it exists just as well in an acidic or a basic environment. We heat the powdered zeolite at temperatures approaching boiling point in a slightly acidic environment. The slightly acidic condition allows for easy cationic exchange and allows any absorbed material to ‘fall out’ of the zeolite. This material precipitates out of solution and is removed from the product. The only thing left in solution is the micronized zeolite and some extraneous cations that help balance the negative charge. These are: calcium, sodium, magnesium, potassium and phosphorus. These lighter metals migrate back into the zeolite and help stabilize the molecule. After ingestion, they easily undergo cationic exchange with metals that are higher in the affinity scale of the zeolite (i.e. Mercury, Lead, Cadmium, etc..). Once the zeolite is ‘cleaned out’, the surface area is maximized. This allows for greater adsorption of higher-affinity compounds (mercury, lead, arsenic, etc..) Each gram of the activated zeolite has approximately ninety square feet of surface area.
There are now several colloidal suspensions of zeolite (liquid zeolites) on the market that are, again, simply powdered clinoptilolite from mined sources. In these products, the manufacturers just mix the zeolite in water – sometimes including other minerals to aid in the suspension. These products all contain some amount of metals and VOCs. They also lack the usable surface area that we’ve created in the NCD.
JR: You produced what you refer to as a “white paper” on research supporting the potential efficacy of NCD zeolite that is available on a number of websites. (Although you mentioned in an email that the FTC has prohibited you from directly disseminating the paper because of the claims it made for NCD.) The title page of this document says: “Scientific Research Monograph by Rik J . Deitsch.” On the third page of the document, after your biographical information, the following text appears: “Copyright © 2005 All rights reserved. No part of this publication may be reproduced in any form without permission from the author.” Clearly, the implication is that you are the author of this article. However, significant portions of the text are taken wholesale, and without quotation marks or attribution, from a variety of other sources. What’s your response to this allegation of plagiarism?
RD: The piece in question “Scientific Research Monograph for Natural Cellular Defense” was for the internal use and education of Waiora staff. It was also intended as an introduction of the technology for medical professionals. It was never sold or distributed commercially in any way. The piece specifically states that:
“The information presented in this monograph is intended for professional education and is obtained from published research, articles, and books.”
All of the references were included in the text – proper credit was given. There was no plagiarism – it was a ‘cut & paste’ review with my commentary (which is why the copyright was issued) for internal use. Some copies had been shared by distributors (not sold commercially) which brought the piece to the attention of federal regulators. The FTC stated that the article may be making implied drug claims on a dietary supplement. Because of their comments, the Monograph has been completely removed from circulation.
JR: There are a number of mentions on websites and discussion groups about “an upcoming study coming out of Duke” regarding the efficacy of NCD. Several of these reports occurring as early as March of 2006 suggest that this research was due to be published less than a month later. Can you provide a list of any ongoing studies on NCD zeolite?
RD: The following are the clinical studies that we have conducted:
- NCD therapy in healthy individuals without chronic exposure to heavy metal toxins: A Short-term (7-day) trial in five individuals to evaluate changes in urinary excretion of heavy metals. Urinary excretion was measured with Atomic Absorption Spectroscopy (AAS).
- NCD therapy in healthy individuals without chronic exposure to heavy metal toxins – An Intermediate-term (30-day) trial in twenty individuals to evaluate changes in urinary excretion of heavy metals. Urinary excretion was measure with Atomic Absorption Spectroscopy (AAS).
- NCD therapy in otherwise healthy individuals with chronic, employment-related exposure to heavy metal toxins (West Virginia Coal Miners) – A Long-term (84-day) blinded clinical trial in fifty individuals to evaluate changes in urinary excretion of heavy metals and determine longevity of the effect. Urinary excretion was measure with Atomic Absorption Spectroscopy (AAS). Additionally, hair and saliva was collected at the beginning and the end of the trial and measured for heavy metal content.
- Electrolyte levels with the use of NCD – A trial to evaluate changes in vital serum electrolytes in healthy individuals following 30-day NCD therapy.
- Exercise recovery with NCD – A trial to evaluate the effect of NCD therapy on post-workout recovery-time in competitive athletes vs. non-competitive participants. Our largest trial to-date included 300 individuals.
- pH balancing with NCD – A trial to evaluate the effect of short- vs long-term NCD therapy on serum and salivary pH in healthy and compromised individuals.
The following in-vitro analyses have been performed to provide rationale for further human trials:
- An in vitro analysis was conducted to measure the affinity of NCD for volatile-organic-compounds (VOCs). Sixty compounds were tested to provide information to support a future trial in humans focusing on benzene and dioxin derivatives.
- An in vitro analysis was conducted to measure the affinity of NCD for uranium. This provides a rationale to study urinary excretion in patients using the NCD that have been exposed to depleted uranium sources.
Most of these studies have been written and submitted for publication. As you must know, the peer-review process can take many months until an article is published. I cannot know with any certainty when these will be made available. I have presented many of the above studies in scientific meetings, which allows for the limited distribution of data.
JR: Quite a few of the sites advertising NCD zeolite refer to an “informal” study conducted in Ohio with 70 or so stage 4 cancer patients in which a large number of patients experienced partial or complete remission. There appear to be no even unpublished data about this study, beyond these anecdotal reports. Can you provide any information about the accuracy of these reports, and about the nature or outcome of that study?
RD: No. This ‘study’ was presented by Harve Kaufman at a meeting of Wairoa distributors and has been widely quoted since that time. I did not participate in it and have no direct knowledge of it. I have asked distributors to stop quoting these sources as they are unverifiable.
JR: NCD has garnered a new following among the parents of autistic children. I understand there is currently at least one study underway regarding the efficacy of zeolites in autism. Can you say anything about how and why NCD started to be used for autism? Beyond anecdotal reports, is there any evidence that NCD is efficacious with regard to autism?
RD: Much work has recently been done on the accumulation of mercury in children and the possible link to such problems as ADD, ADHD, and autism. There are enough data to conclude that mercury accumulation may potentiate these problems and there are some data that show that reducing the burden of mercury in nervous tissue restores the ability to concentrate and modifies behavior abnormalities. Reports in the literature, both substantiated and unsubstantiated, have linked mercury exposure in children to toxic reactions in brain cells. In some instances this has resulted in the creation of the classic features of autism, including speech loss and loss of social and communication skills. We have not taken a stand in this issue, but we do feel that mercury chelation has benefits and may prove useful in the amelioration of the symptoms of autism spectral disorders. Several parents of autistic children utilized the NCD with their children. Their positive results provided a rationale for a clinical study. I am not part of the study – it is being conducted by a third-party group of researchers, headed by Dr. James Adams of Arizona State University. The study is on-going with completion expected by the end of the year.
Accompanying “The Zeolistas” by Jake Reimer-