AMERICAN NATUROPATHIC RESEARCH INSTITUTE
NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE
1250 E. Baseline Rd., Suite 205
Tempe, AZ 85283
JOINT MEETING OF THE
AMERICAN NATUROPATHIC RESEARCH INSTITUTE (ANRI)
NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE (NORI)
INTERNATIONAL NATUROPATHIC CLINICAL RESEARCH INSTITUTE
INSTITUTIONAL REVIEW BOARD (IRB)
November 14, 2014
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 21, Chapter 1, Subchapter A, Part 56, the twentieth regular quarterly meeting of the American Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) and the International Naturopathic Clinical Research Institute (INCRI) and the Institutional Review Board (IRB) was called to order at 12:00 p.m., November 14, 2014 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
(Membership is open to anyone who has attended at least once, so all of the following may designate themselves as members of ANRI / NORI if they wish.)
The following members and guests were in attendance (alphabetically by last name):
Andrew Dickens, NMD
Cheryl Hamilton, NMD
Colleen Huber, NMD
Cheryl Kollin, NMD
Kenneth Lashutka, NMD
Mary Ellen O’Brien, NMD
Glen Ozalan, NMD
Kenneth Proefrock, NMD
Deb Rogalla, NMD
Robert Waters, PhD
Bonnie Wick, NMD
We went around the room; everybody introduced themselves.
We have been invited to have our IRB listed in the AZ Biomedical Research Commission, which is a directory of Arizona IRBs. Would we like to participate? There was little discussion. Only positive interest was expressed. A motion was made and seconded. Unanimous aye votes, no nays, were for accepting the invitation to be listed. Dr. Huber will follow-up on accepting.
AMENDING THE FIRST BY-LAW
Dr. Huber proposed that the first ANRI / NORI by-law, drafted almost five years ago, was fine for its time, but unfortunately, we have to adjust to the different circumstances of government involvement now. Certain government personnel would like to see that our use of substances be explicitly covered in the IRB.
The First By-Law, reads as follows:
“Current or past practices, whether done independently, via preceptorship, externship, internship or other, have adequately demonstrated that there is no further educational or workshop requirements needed for our naturopathic physician members, other than the standard CE credits required for our profession, in order to practice in fields ranging from but not limited to: Allergy and Immunology, Anesthesiology, Cardiology, Dermatology, Emergency Medicine, Endocrinology, Family Medicine, Gastroenterology, Internal Medicine, Neurology, Obstetrics and Gynecology, Oncology, Ophthalmology, Orthopedics, Otorhinolaryngology, Pediatrics, Psychiatry, Pulmonology, Radiology, Surgery and Urology. The purpose of these organizations is not to restrict the practices of the members but rather to affirm and uphold all therapies that offer more potential benefits to patients than risk, as well as encouraging and educating patients in their options, so that they are able to make the best decisions they can. Any restriction made by the organizations to members’ practices should be rare, only if necessary and only if adopted by unanimous consent of all members.”
Dr. Huber proposed, after getting her attorney’s approval of the language, and to reflect conditions of the current legal climate, the following addition to the First By-Law:
Methods and substances to be used in our members’ practices, and considered to be under the review of our IRB when used by them, include but are not limited to the following:
- Organic and bio-inorganic, sterile, liquid substances delivered by IV, IM, SQ and other routes of delivery as necessary for optimal treatment as determined by the physician in consultation with the patient, and/or
- Non-sterile solid, liquid and/or aerosolized substances delivered PO, topically or by nebulizer to the lungs and other routes of delivery as necessary for optimal treatments as determined by the physician in consultation with the patient.
Dr. Rogalla added the following line to clarify breadth of coverage:
It is not possible to list each and all possible items, so this is not an exclusive list.
Dr. Dickens added the following line for further breadth:
Also administered intraarterially, and intratumorally as in ultrasound-guided, and transdermally.
Dr. Ozalan asked if this broad language could be seen as too broad to justify what you do. Why not make it more bulletproof? As a purpose of the IRB, what does it do? Is it punitive; does it sanction? Or is the IRB there to protect individuals who do innovative work? Is there a way to move toward the purely libertarian approach and reconcile that with procedures involving specific protocols. So what is the intentionality? Using it in the broadest way does not go far enough to create an oversight where our members create specific research projects and are protected in their performance.
Dr. Huber responded that the impetus for beginning the organizations nearly five years ago was simply libertarian: protect patients’ right to choose from the broadest possible array of treatments, and protect the physicians’ scope of practice – the widest umbrella we could express. However, as we review specific research proposals, there are numerous foci that we are reviewing, with more specific protocols and treatments.
Hazel clarified regarding the unanimous vote that we have to specify that if a person has a protocol before the IRB, then they are excluded from voting – otherwise, their one vote could be based on self-interest, and could hold up an otherwise unanimous decision.
So we discussed adding all the above comments, which resulted in the Revised First By-Law as follows:
“Current or past practices, whether done independently, via preceptorship, externship, internship or other, have adequately demonstrated that there is no further educational or workshop requirements needed for our naturopathic physician members, other than the standard CE credits required for our profession, in order to practice in fields ranging from but not limited to: Allergy and Immunology, Anesthesiology, Cardiology, Dermatology, Emergency Medicine, Endocrinology, Family Medicine, Gastroenterology, Internal Medicine, Neurology, Obstetrics and Gynecology, Oncology, Ophthalmology, Orthopedics, Otorhinolaryngology, Pediatrics, Psychiatry, Pulmonology, Radiology, Surgery and Urology. The purpose of these organizations is not to restrict the practices of the members but rather to affirm and uphold all therapies that offer more potential benefits to patients than risk, as well as encouraging and educating patients in their options, so that they are able to make the best decisions they can. Any restriction made by the organizations to members’ practices should be rare, only if necessary and only if adopted by unanimous consent of all members, excluding a person whose research is being voted on, and that person must recuse him/herself from the vote.”
Methods and substances to be used in our members’ practices, and considered to be under the review of our IRB when used by them, include but are not limited to the following. Use must be consistent with naturopathic principles, and when in question, are subject to approval by this IRB. It is not possible to list every substance or type of substance, but this is not an exclusive list:
- Organic and bio-inorganic, sterile, liquid substances delivered by IV, IM, SQ intra-arterial, intra-tumoral and other routes of delivery as necessary for optimal treatment as determined by the physician in consultation with the patient, and/or
- Non-sterile solid, liquid and/or aerosolized substances delivered PO, topically/ transdermal or by nebulizer to the lungs and other routes of delivery as necessary for optimal treatments as determined by the physician in consultation with the patient.
A motion was made to amend the First By-Law as discussed, and with the comments herein incorporated as above. The motion was seconded. Unanimous aye votes, no nays, were in favor of adding the addendum.
TREATMENT WITH SPECIFIC SUBSTANCES
There was discussion about the role of our state board in determining if a doctor could use a specific treatment. Yesterday a case came before the state board in which a patient was not hurt, yet the doctor was called to task for using a somewhat unusual substance: Ukrain. The Board’s complaint was that the substance was imported from Austria, not manufactured by a FDA-registered manufacturer in the US, and that the doctor had not drafted a new Informed Consent specific to the patient’s treatment substance.
Dr. Proefrock said that if you are a naturopathic physician, now you have to be under an IRB. All experimental medicine must now be performed under an IRB. He said that it used to be specified in the law that if two other members of your community had a particular protocol, then you had justification for using it. Unfortunately, that language has been removed. But naturopathic medicine is very often an experimental medicine process. In order for us to be most agile, most responsive to the needs of the patient in front of us, we need all the tools in our toolbox, without government overreach.
Dr. Proefrock said specific substances should be placed in the minutes for the IRB. The overriding sense is that we are going to have to discuss the materials that we use and why we use them. Is there data to substantiate a person’s use of agents? This should be done for the IV substances.
Dr. Ozalan then expressed his appreciation that Dr. Proefrock has a brain, and if the rest of us don’t have one, then we can go talk to Dr. Proefrock. (Our amusement was not fully expressed.)
Dr. Huber mentioned that her attorney said that an addendum with substances could be placed as a separate page addendum to the informed consent, and have the patient sign both. This would cover IV administration of substances, but would be impossible for substances not used by IV.
Hazel said that we should bring that addendum to the IRB for approval.
Dr. Ozalan said we should discuss a form of reasoning.
Dr. Huber asked, should we discuss mechanisms and physiology rather than substances, and that there must be a way to discuss mechanisms of action in categories, and perhaps approve those categories. [Later, after the meeting, Dr. Dickens and Dr. Huber mentioned possible inclusion of columns in the periodic table. For example, discuss the general actions of the alkali metals or of the halides, etc.]
Dr. Lashutka said: Put the written proposals in the previous minutes, as we talked about in May.
Dr. Rogalla said that hospitals use standardized informed consent forms, and just fill in the blanks for you, depending on what type of surgery they are going to do. So can you put in fill in the blank in the informed consents?
Dr. Waters said that you can’t do that, because you are being held to a stricter standard in a clinical trial under an IRB.
Dr. Proefrock said: We are trying to find a way to approach patient care in such a way that it is the objective that is important. If we want to go back in and establish some kind of precedent in this way, or reduce that to the common denominator that we are talking about, then we can move toward a discussion of reasoning out strategies for approaching kinds of illnesses. If somebody presents a case, then let’s have a conversation about it.
Dr. Huber said, and that’s how we will reaffirm our scope of practice from a place of some legal vulnerability to a somewhat stronger position.
Dr. Proefrock said that the IRB is not a get out of jail free card. It is a means by which we can ask: have we addressed the concerns by presenting everything to be considered in a particular area of patient care? Also substantiating literature: this is why I would use it, to show that there is precedent for a particular type of thinking in medicine.
Dr. Proefrock, Dr. Ozalan and Dr. Huber emphasized the rationale being more important than the substance, and that we have to look at those categories.
Dr. Huber and Dr. Dickens wanted to talk about practicalities however.
Dr. Lashutka said, didn’t we specifically talk about cesium chloride? I was getting grilled on it about a while ago by another ANRI / NORI member. [Secretary’s notes: that was in the May 2013 ANRI / NORI meeting; the minutes are at this link: http://naturopathicstandards.org/2013/05/03/minutes-14/]
Dr. Proefrock said that ultimately you are a doctor, and you are liable for anything you put in to your patient.
Dr. Dickens said: Let’s get practical: what about the specific use of Ukrain, for example?
Dr. Proefrock responded that there have got to be measures here. Some of the best things come from outside of the United States. You have to make sure that the quality is good. For example, pyrogen testing and UV light is necessary. This has become an issue. What happened was that the FDA-approved pyrogen test kits were taken off the market. And they do not approve of anything that is currently out there. So no pyrogen test is available that is FDA-approved.
Dr. Huber asked if the ones that are available are adequate to do the job.
Dr. Proefrock responded that they are fine. He said, we keep certificates on file of doing the pyrogen tests, but that is as good as it gets right now. As a physician, you have to do your due diligence to make sure that you do not introduce contaminants or pathogens. The Board really should not be interfering in this.
Dr. Waters expressed dismay that the Arizona Board would be actually trying to limit the scope of practice. If anything, they should be broadening the scope of practice.
Dr. Proefrock responded: My certificate to dispense allows me to produce anything.
Dr. Dickens asked, Does UV light denature vitamins?
Dr. Waters responded: We have to use it in the labs for sanitization of containers and other such non-consumible materials. The vitamins can be brought in after use of the UV light.
Dr. Ozalan said: I just want to go before the board and say these people are doing their due-diligence, and everything was considered in an intelligent way.
Dr. Proefrock said that the Certificate to Dispense makes everything fair game.
DR. WATERS’ PRESENTATION OF THE HEPASSURE STUDY FOR IRB REVIEW
Dr. Waters said that there is a known problem with liver biopsies. So we developed this process of light penetration of the liver, which is actually comparable to, and was developed on looking at the density of cheese, by shining a light through it.
But first let’s talk about payment. Normally there is a charge for the complexity of the IRB’s work involved here. This is actually a clinical trial. This will be published and referred to anywhere in the world. So the company is willing to pay. We’ve been to local university, and they charge a lot of money for this. This clinical trial will be done in a psychiatrist’s office because he treats a lot of people with liver disease, due to alcohol use, history of recreational substances in general, etc.
Dr. Huber said, Bob can I please not charge you money? Because I don’t want to charge naturopaths, and therefore, I don’t want to unfairly charge you.
Dr. Waters said, go ahead and charge me. This money is coming from a corporation. They have an interest in this, and like I say, they would have to spend this money elsewhere, and likely even quite a bit more.
Dr. Rogalla said let’s make a new by–law, for the standard of charging a corporation but not a naturopath.
Dr. Huber agreed that that was a good idea if everybody approved.
Dr. Rogalla and Dr. Waters submitted the following language for the By-Law: Regarding fees, for preview approval feeds, and private naturopathic physicians and practices seeking IRB approval for their work in their clinic, there’s no fee. On the other hand, corporations, hospitals or similar entities seeking approvals pay $1,000 to $2000, depending on the complexity of the approval. There may or may not be any other special fees to cover other expenses, or for other reasons as determined by the IRB, depending on the circumstances.
There was a motion to adopt this as a new By-Law. The motion passed. Unanimous ayes and no nays confirmed this text as a new By-Law, which will appear soon on our website.
Dr. Waters said, getting back to this particular study, please vote to accept, reject or modify.
Dr. Dickens asked who the principal investigator is.
Dr. Waters responded that the Principal Investigator is Tam Spat, NMD. Kristine Nguyen, NMD is also an investigator. Dr. Waters has been certified with the FDA.
Dr. Huber asked: Do we accept this study for review by our IRB?
A motion was made to accept the study, and it was seconded. Unanimous ayes and no nays confirmed that we have accepted this study for review by our IRB.
Dr. Waters thanked us, and talked a little about other studies that he has. He said, we have also a topical herbal blend for the shrinking of tumors. We are having good results for the shrinking of HPV-caused oral tumors. Then there is another study after that.
Dr. Waters asked: Would we be in favor of working with hospitals? We were all in favor, on a case by case basis.
DR. DICKENS’ PROPOSED RESEARCH
Dr. Dickens said, I would like to present my research on 3-bromo pyruvate. It is out of Israel in a non-FDA approved facility. A Johns Hopkins researcher is working with Na phenyl butyrate. A lot of research is done in Canada. A side effect of treatment is a tumor-lysis problem; a lot of ammonia is being released. 3-bromo pyruvate (3bp) is a small molecule, an alkylating agent, that will adhere to hexokinase. It has aerobic glycolysis. 3bp inhibits hexokinase-2, and binds pyruvate. Pyruvate dehydrogenase kinase phosphorylates pyruvate dehydrogenase; they need to be in combination for pyruvate to function. These are blocking that function, and therefore are opening movement into the mitochondria. Cancer cells produce 3 ATP, not the 38 ATP that we get with oxidative phosphorylation. This product comes irradiated – the method of sterilization used. I will be getting this from the east coast US.
[Secretary’s note: 3bp is an analog of lactic acid and pyruvate. “Appearing” as lactic acid to a cancer cell, 3bp strongly inhibits ATP production in cancer cells, because cancer cells, unlike normal cells, have a much higher number of lactic acid transporters. Researcher Stephanie Seneff PhD has proposed that a tumor is actually a machine with a function: convert poorly tolerated glucose into better-tolerated lactic acid. Glucose in, lactic acid out is the tumor’s only proposed function. So piling up extra lactic acid, or its look-alike, 3bp, should stop the lactic acid producing machinery, and should bring the metabolism of the cancer cell to a standstill.]
Dr. Waters asked, has someone checked pyruvate levels in the blood after 3bp? Because you’ve got lactate.
Dr. Dickens responded that when mitochondria start to degrade in the cancer cells, more glucose comes in, but cannot come into the mitochondria. So 3bp inhibits pyruvate to lactate, but it is getting deflected into the bloodstream instead.
Dr. Dickens said that the Johns Hopkins researchers are finding that it’s pushing more toward apoptosis. When a cancer cell’s cytochrome C is released, then you have degradation of the cancer cell through apoptosis.
Dr. Waters said: and you also have hypercalcemia, which is leading to cancer cell death. The phosphatases got stimulated taking phosphorus, so calcium is gathered as a result.
Dr. Dickens agreed and noted that we are looking for phosphorylation.
Dr. Waters said: Good.
Dr. Proefrock said that Dr. Burzynski’s anti-neoplastons included phenyl butyrate, phenyl acetone, phenyl acetylglutamine, some peptides, etc. Dr. Burzynski’s theories behind that are that the ketone bodies promote more ketosis, you can replace some carbohydrate use with the consumption of fat reserves. His approach was valid, basically using ketone bodies. Unfortunately, due to problems on both sides, Dr. Burzynski gave up working in the US and is now going to Tokyo. Again, politics and law squashed promising medicine.
Dr. Waters agreed that people are often the major problem, and said that the people who had firmly rejected the herbal formula that he had worked on, now want it as their own.
Dr. Kollin asked Dr. Dickens: Did you start this research yet? Are there any other side effects?
Dr. Dickens responded: There are tumor lysis effects; controlling hyperammonemia; those are the main side effects. So I want to propose that this IRB review 3bp and di-chloro acetic acid (DCA) and sodium phenyl butyrate.
Dr. Waters said that in a clinical trial, we have to define exactly what is going to happen. However, in a private clinic, with individualized treatment, that’s different.
A motion was made, and then got seconded, to review Dr. Dickens’ research. The ayes were unanimous; there were no nays.
Dr. Hamilton presented the case of a 39-yo clinically obese male patient with a chief complaint of low blood testosterone but high exogenous testosterone use and leukemia. He had a white blood cell count that grew to 50,000. He came in on an already prescribed high dose of testosterone.
Dr. Waters said that in testicular tissue a statin interferes with testosterone production.
Dr. Dickens said he is convinced that a high cholesterol is from a low functioning thyroid, and that measuring thyroid levels in the blood is as useless as appraising a car by the amount of gas in the tank. In other words, blood levels of thyroid hormones are simply residual left over from organ uptake. So thyroid is perhaps low. Also, this patient does seem to have burned out adrenals, and I would check his cortisol.
Dr. Proefrock said please switch the vitamin D2 out to D3. Check his prolactin. The more testosterone that gets pushed into him, the more his liver is going to process it. Plus due to previous breast reduction, he must have been aromatizing a lot of the testosterone. Consider switching him to a ketogenic diet.
Dr. Proefrock said that for treating leukemia it is a situation of watch and wait. Here is a guy who’s always vigilant. No wonder he has such a high WBC count, when you consider that the immune system is the vigilant police force of the body. If he could get somebody to help him work through all of his emotional issues, he may be able to undergo a profound enough transformation to break through his current state.
Dr. Ozalan agreed. He got into this because he is in red alert. Get him over to a Brain State therapy, to help get him out of a sympathetic state over to a parasympathetic state. So he’s gotten into an addictive cycle in the sympathetic state and the adrenal overdrive. In the long run, over 35 years of practice, I have seen the pattern of everything outside of work on transformational levels as only a band aid.
Dr. Dickens said that EMF and EMDR all work in such a way to unhook the neurological loops that are self-sustaining.
Dr. Proefrock said that Robert Sapolsky wrote a very good essay, “The Trouble with Testosterone.” It’s about the psychological problems with excess testosterone. The patient being considered seems to be having this problem. Blood testosterone levels are also a poor indicator of actual testosterone use in the body, a left over residual.
Dr. Dickens said that a big problem with police forces is sometimes underground steroids.
Dr. Proefrock said, I’m seeing the testosterone as the biggest problem.
Dr. Kollin said, I would look at environmental stuff. Some lead toxicity.
Dr. Proefrock said yes, I have seen high lead in people who are long-term shooters.
Dr. Huber said that she thinks CLL is one of the more challenging cancers to actually have some effect on; often there seems to be a well-entrenched, chronic, latent pathogen involved. His shingles, the zoster virus; this could be something addressed.
Dr. Waters said, Sometimes stem cells are absent with Agent Orange, to which this patient has been exposed. Most of the people with that have neurodegenerative conditions. In many cases this is the case, even with no dioxin left in them. We do a fat biopsy to see what is going on.
Dr. Proefrock mentioned that food poisoning can lead to off the wall blood counts.
The meeting adjourned at 2:50 p.m.
NEXT BOARD MEETING: Friday, February 13, 2015 at noon, at the usual place, the Nature Works Best Medical Clinic in Tempe. Food from Chipotle’s will be served, unless objections surface before then. We will ask you a few days in advance to choose something from that menu.
Don’t forget $10 dues per quarter per person, payable to Dr. Lashutka in cash.
Please mark your calendars now, to keep that afternoon February 13 open for ANRI / NORI.
Please remember to bring your case studies in to present, at least one. We may have time for two each, for those of you feeling ambitious. And we should allow extra time for those who have not presented many cases yet.
Please remember the reason for having started this organization and bringing in your cases. Bringing in cases or your research, and discussing them and letting the IRB review them is probably the strongest thing that you can do, not only to protect your own practice – if ever scrutinized for the non-conventional treatments that you employ (treatments considered to be experimental by the FDA) – but also to protect the breadth of scope that we Arizona naturopathic physicians use!
In fact, the FDA now requires that all experimental medicine be under the oversight of an IRB. So the participation of naturopathic physicians is more crucial for their own practices than ever.
Of course, agenda items may even be added at the last minute. Meeting adjourned 2:50 p.m.
Colleen Huber, NMD
Secretary, ANRI / NORI
November 14, 2014