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)
January 31, 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 eighteenth 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 12:30 p.m., January 31, 2014 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
The following members and guests were in attendance (alphabetically by last name):
Drew Collins, NMD (by Skype)
Margarita Hernández Guzmán, NMD
Colleen Huber, NMD
Cheryl Kollin, NMD
Kenneth Lashutka, NMD
Eric Lopez, NMD
John Oertle, NMD
Kenneth Proefrock, NMD
Paul Stallone, NMD
Phranq Tamburri, NMD
Bob Waters, PhD
Donese Worden, NMD
Others who have attended previous meetings or wish to attend future ones are cordially invited to join us for future meetings.
We want to extend an especially warm welcome to four people attending for the first time, the naturopathic physicians Drew Collins, NMD (by Skype) and John Oertle, NMD and Donese Worden, NMD as well as Dr. Worden’s fiancé and research partner, Barry Goldstein. We are honored by the presence both of the long-time members as well as those recently joining us.
MEETING CALLED TO ORDER
Dr. Huber, Secretary of ANRI / NORI, called the meeting to order.
CLINICAL TRIALS AND SAFETY STUDIES UNDER OUR IRB
SCNM is recruiting students for the safety study for the botanical gel that we are approving under this IRB. We have about 20 total subjects of 200 minimum that we need. Any treatment using the gel for other than HSV is suspended until FDA approval. Apparently there was the idea that it might be started to be used for other purposes, which are not yet authorized.
Dr. Worden discussed a research project on music, therapeutic properties of music on brain waves. Dr. Worden reached out to our IRB in order to see if we want to evaluate her study. That particular study is morphing. A “brain wave mapping document” is something that they are looking into. Also, of great interest is pain management and other therapeutics with music. Dr. Waters said that a related study that he was working on has 15 minutes of silence, then 15 minutes of a certain frequency of sound. Then the subject answers questions, before and after music. Then Dr. Waters does a statistical analysis to see if there are differences. It is interesting to look at mood variables and anger variables.
Dr. Worden clarified that she was here, because there are medical devices that she needs an IRB to oversee. City of Hope has put together a clinical study. They are doing a double blind placebo controlled study on intake of systemic enzymes on 70 subjects. They’re looking at intracellular effects, pain management, joint and/or back pain. They are looking at both subjective and objective measures. The primary objective is pain management. That has been submitted to the ASU IRB.
If we do this IRB review, we will be competing with some academically affiliated IRBs. However, some brick wall/bureaucratic hurdles at larger institutions stand in the way of proceeding there. So Dr. Worden’s question to the IRB today is if we would like to be the reviewing IRB for her study.
Dr. Worden asks: Are we planning to be like WIRB? Are we planning to publish under our IRB? There could be other IRB work for us in the future. She would like a response from us. Our IRB would not have to re-write the study documents, simply review, critique, and give final approval.
Dr. Waters said that publications are always good. So we ought to become associated with a larger institution in the near future, and then we could do more of these. Dr. Worden said that this particular IRB review work could enable us to be associated with ASU.
Dr. Worden mentioned to write the Letter of Intent, ASU charges $1000. But she is thinking of $500 to $1200 for a budget in this case. A 3-person committee – a clinician, a technical/statistics person and a layperson, would be a team that could review data for low-risk scenarios.
Dr. Waters asked for clarification. Dr. Worden said that a smaller team could look at anything that goes through a review board. This would be a 3 month trial.
At ASU, Dr. Worden is teaching an integrative medicine course, regarding ancient healing, and stress management tools. For some of the other research that she is working on, nutraceuticals and/or medical devices that are already available are the subject of the study. Dr. Worden is PI certified.
All of the study is at Dr. Worden’s clinic. They’re doing the statistics, the subject interaction, the clinical work, such as blood draws, etc. What we would do is to read the protocol, and vote on it and approve it. This will be a 3-month study, so there is no other work than saying we approve it as an IRB. If we act in the capacity of an IRB and determine that it is a low-risk study, then we’re okay. The statistician is Bob Frankel, and Bob Waters is working with them as well. Labs are done by Spectracell, There are also CBC and CMP labs.
The City of Hope would have charged $300,000 to a million, just for this part.
OUTREACH TO OTHER ORGANIZATIONS
Regarding the upcoming OncANP conference, Dr. Huber asked what is happening. There had been talk of visiting and representing ANRI / NORI at their upcoming conference. However, it turns out that all vendors have been determined for this year, and possibly next, and that it seems that only vendors have booths there.
Dr. Huber asked if anybody wants us to be represented at AANP, considering it will meet in Phoenix this year. Dr. Tamburri liked the idea and lamented that our last attempt at outreach to that conference a few years ago had the poor timing of coming during the date and time of the memorial to the late Dr. Konrad Kail. Dr. Tamburri suggested that we have a presence again in the future at AANP. He said that maybe we could think of planning something for the next conference.
Dr. Tamburri also mentioned that there is an upcoming textbook on the foundations of naturopathic medicine, which will become a part of core naturopathic curriculum. He asked, will it be practical as a textbook? It will cover a lot of philosophy. Dr. Tamburri is collaborating on and writing the men’s health chapter. The title is Foundations of Naturopathic Medicine.
Dr. Waters asked if other professions, specifically medical doctors and osteopaths of his acquaintance, would be allowed to be a part of this group, and to attend our meetings. Dr. Proefrock and Dr. Huber said yes.
WORLD HEALTH ORGANIZATION, AND OTHER INTERNATIONAL OUTREACH
Dr. Hernández Guzmán mentioned her friend Andrei, who is a SCNM student. He discussed with her that if you get 1,000 people to petition for something, then the World Health Organization (WHO) would open a motion, and vote on it. So they had discussed creating an international naturopathic medicine coalition. So then we could get our curriculum compared with that of other countries, and we could work with the health ministers of the different countries. The idea is to put together everybody under one umbrella. So under a master table of very loosely defined “naturopaths” put together a list of the credentials (the credentialed organizations and individuals) that exist. Then ideally, you have a table of say physicians – NMDs or NDs. Then you have others who don’t have such credentials. See if you can get coalitions among various countries, and even among different echelons of those interested.
We can start to interact with people on the research angle, because they are also interested in being acknowledged for their interest in naturopathic medicine. So we are the ones who have the most education, but that doesn’t mean we can’t interact with others around the world who have an interest in naturopathic medicine.
Dr. Huber followed this comment by saying that she will be presenting her study of her clinic’s data on glycemic restriction in cancer patients, in Paris this July, at the 2nd International Congress of Naturopathic Medicine, with the following goal: Because it is an international audience, with a great variety of actual medical training and licensure, and lack thereof, some of whom will be simply interested laypeople, she wants to give them all something they can use. So trying to find a common basis that way, instead of talking about for example intravenous therapies or labs, or other things inaccessible to such an audience, she plans to talk about the kind of foods that benefit or harm the cancer patients who have come to her clinic. That way, everyone at the conference could conceivably take away some information that would be relevant to someone else with whom they would interact in the future, and would be able to point to a study done at a naturopathic clinic in the U.S., in order to plant the seed cognitively in themselves and their acquaintances, that it is possible for naturopaths to actually achieve these kinds of standards: comparable medical education, standardization of the same, credentialing and licensing, professional associations and clinical work, research and publication.
Dr. Huber also mentioned that although people in other countries are qualitatively different from us in that they don’t have our training or licensing, we all started out in a common place: an interest in Vis medicatrix naturae, and a desire to help others from this basis. So we are much further along in our history in North America, but with empathy, we can perhaps help them to start along a similar path. We probably should especially think about this in light of the fact that in 2013 the unprecedented step of a national regulation of naturopathic medicine took place. The country was Portugal. Yet still without a naturopathic medical school that even comes close to the standards of the West means that they will need a lot of mentoring from the North American naturopathic community, in order to make best use of that new national licensing that the Portuguese now have.
Dr. Proefrock brought up the situation with reciprocity between Canada and France. The Canadian government is looking at what are the parameters for recognizing naturopathic medicine internationally. He said that naturopathic medicine is a phenomenon that is uniquely North American, and as such the ability to create a curriculum with broad appreciation and applicability across cultures is tricky. Whether or not Europe is able to come up to the standards of North American naturopathic medicine, or those countries are willing to, there are control issues over how to do this, and how to make it win-win for all involved. The question is ultimately: how do you handle this difference? So and so went to a correspondence school, whereas so and so went to a school where they dissected a cadaver.
Dr. Tamburri said we should be an example for others, both in US or abroad.
Dr. Huber agreed that our best role toward those abroad is as mentors.
Dr. Proefrock said the question is who owns the title “Naturopathic Doctor” or “Naturopathic Medical Doctor”? The reality is that that is our title. We own it. So where are concessions okay to be made? And where is control as to how it progresses? So each of the nations and Canadian provinces has acted as if they were totally sovereign. The Canadian government said we have to have reciprocity across different provinces. Then to what extent does that happen with France? So if someone is a French and Canadian dual citizen, can they expect a level of reciprocity that Canada has developed? There is a lot of difference among different countries. Lithuania allows almost anything. Germany restricts almost everything. However, there is an economic incentive for both the countries and the schools to attract people to bring them up to the standards. Then on top of all these considerations, translating all of those board exams into many different languages would be an amazingly difficult task.
Branding is something that happens in our profession, both domestically and internationally. We should not be snobs, but we must also be aware of who we are, said Dr. Tamburri.
POLITICS and HEALTH INSURANCE
Dr. Tamburri mentioned the Freedom Summit, here in Phoenix soon. Dr. Tamburri met with a politician recently, and he speculated that the main issue of the next presidential election will be health insurance.
[Secretary’s note: ANRI / NORI and INCRI are completely non-partisan, and these organizations encompass individual members from different sides of the political spectrum. Therefore, this organization has no relationship with any politician or political party.]
Dr. Tamburri continued: Suppose medical doctors who don’t want to participate in the insurance treadmill called themselves something different, such as CMD – “cash medical doctor.” That way they can avoid all the red tape and aggravation of both the new law and the insurance companies. Why don’t naturopaths want to do that?
Dr. Tamburri summarized the non-discrimination clause of Section 2706 of the ACA –that he thought that it doesn’t really prevent discrimination against naturopaths.
WORKING TOWARD THE DESIGNATION OF NATUROPATHIC ONCOLOGIST
Dr. Huber presented a paper on cholesterol, diet and cancer that Dr. Waters and she had collaborated on. (Cholesterol and diet in cancer survivors: a double-blind, retrospective case series of 255 cancer patients in a naturopathic clinic). Dr. Waters had used Artificial Intelligence to analyze the data. Dr. Huber summarized the paper, pointing out the data in the various tables, to which each person was able to refer in their photocopies. Dr. Tamburri motioned that Dr. Huber be recognized as “Naturopathic Oncologist” for having just now completed the last of all the pre-requisites for that designation. Dr. Proefrock seconded the motion. Nobody was opposed, so the motion passed.
ACQUIRING HOSPITAL PRIVILEGES
Dr. Huber mentioned that Dr. Lopez and she had recently been credentialed by a small local hospital, and that both now had admitting privileges there. Also, she mentioned that she has been able to do anything she wants with the patient who she is following there, including acupuncture, herbal medicine, parenteral nutrition discussion, participation and compromise, Rx prescription, PICC line placement order, IV nutrients, and referral. Dr. Huber said this to the group because her and Dr. Lopez’s goal is to open that door farther, for him to also look to a hospital closer to him and for her to also look for a hospital closer to her, in order to try to extend those privileges to other institutions, and to then try to bring in at least one other naturopath at those places to also be credentialed, and then to also let our patients know by way of form letter that if they know anyone who has the misfortune of needing hospitalization, that they can have at least part of their care be naturopathic on demand, at these particular institutions. To thus stimulate patient demand, and create a competitive advantage for those particular hospitals, should be able to create a win-win situation for both our profession and the institutions involved, as well as the patients wanting naturopathic care.
If any of you are especially interested in pursuing this yourselves, please contact Dr. Lopez or Dr. Huber to strategize.
RECENT AZND BOARD MEETING
Dr. Lopez summarized the most recent AZND Board meeting as not quite as judgmental and prosecutorial as the previous board meeting that he had attended. Some of the membership of that Board had changed, and the tone seems to be somewhat more fair, balanced and just. Dr. Huber volunteered to represent ANRI / NORI at the March 2014 AZND Board meeting.
OUR NEXT BOARD MEETING
The next ANRI / NORI board meeting is Friday, May 9.
Dr. Stallone presented a case (his fifth case to this Board) of a 52 y.o. male hepatitis C patient, with chronic fatigue. Normal weight, well nourished. HR, respiration, BP all normal. Some icterus. When labs came in, there was a very high ALT and AST, as well as elevated lymphocytes. The ALT was especially high. Dr. Stallone ordered labs for EBV, Hepatitis A and Hepatitis B. All of these were also positive co-infections. There was no history of blood transfusions. He had gotten sick 13 years earlier at the time of a root canal. Dr. Stallone gave phosphatidyl choline IV. The patient had a strict diet, no alcohol. The labs showed low protein levels. Dr. Stallone does electrodermal screening. So he tested Sanum remedies, and used some of those. Dr. Stallone described electrodermal screening, such as a Voll machine, which is a sort of mechanical muscle testing. Dr. Stallone used a variety of nutrients, both oral and IV, homeopathic remedies, glycyrrhizic acid, colonics, juicing beets. He counseled the patient to change his diet to a vegetarian + fish diet. With the treatment plan, symptoms originally got worse. After the Rx of Nux vomica, symptoms started to get better. Most labs came back toward normal. Viral titers got back toward normal. Dr. Stallone had originally considered ozone treatment, then postponed that, then went back to looking at ozone. However, in the end, the homeopathic and dietary treatments worked the best for this patient.
Dr. Proefrock commented that this was a nicely comprehensive approach. Dr. Stallone commented that the patient just came in the other day, and is still looking good, feeling good.
Dr. Waters asked about pleomorphic transformations in the body.
In response, Dr. Stallone talked about how the milieu in the body will change the form of the microbe.
Dr. Proefrock referred to Beauchamp’s study of the milieu, and how pathogenic microbes can be more or less pathogenic or even benign depending on the environment.
Dr, Kollin presented a case (her first to this Board) of a 64 y.o. woman, Stage 4 breast cancer – with liver, lung, brain metastases. Labs show high calcium, high liver enzymes. Dr. Kollin is treating her with high dose vitamin C, and with cesium. She is also doing systemic ozone, as well as rectal insufflation of ozone (to try to get to the liver). She is now doing Pleo Sanuvis, Pleo Muc, and a number of other Pleo products. She has not done electrodermal screening. The patient is ER plus, PR plus. She smoked years ago. Dr. Kollin Rx’ed Zofran for nausea. The patient got her br ca dx in 2007. Dr. Kollin mentioned that many labs were at extreme values, such as the CD 15-3 being over 9000. Dr. Kollin said she has some substernal pain.
Dr. Kollin asked for help from the group in order to be able to help this patient.
Dr. Proefrock asked if there is a baseline hormonal output. That has not been tested yet. Dr. Proefrock talked about the buildup of toxic intermediates, through the glucuronidation pathway. This creates a biological white noise, in that what has gone through phase I is now more water soluble, and therefore now more problematic, more absorbable. He suggested adding gluronolactone for this patient. He said that you might want to induce menopause, if it hasn’t already happened, that is, to take down the source of some of the problematic hormones.
Dr. Proefrock suggested considering for this patient a scopolamine patch – It acts for 3 days, and can give her enough relief to at least eat and get a break from the worst of her condition. He mentioned the adhesive on it can be difficult. Dr. Lopez said she could have dry mouth. Other than this, the scopolamine patch seems to usually be well-tolerated.
Dr. Proefrock also commented that in this patient there are so many metastases, that angiogenesis has already happened. Molybdenum methionate could be helpful to slow further progression of angiogenesis. Dr. Proefrock would use colchicine, Catharanthus, Cephalotaxus with such patients. But also the tropane alkaloids of the scopolamine can have an effect on the cancer.
Dr. Proefrock cautioned that you have to be careful in a situation like this, because something that is a cytotoxic therapy, because of the huge tumor mass, is likely to create a huge burden of toxins that she has to deal with on top of the cancer. And that in itself can induce much morbidity.
Dr. Kollin commented that the patient cannot keep anything down orally. The patient had tried the ketogenic diet at some point. Dr. Proefrock described how he has a pancreatic cancer patient who is thriving on a ketogenic diet and calorie restriction.
Hyperthermia, Dr. Proefrock said, could be helpful. Simple wet sheet packs.
Dr. Proefrock talked about using chemosensitivity testing, such as Dr. Nagourney uses.
Dr. Kollin wondered if the SOT – single — nucleotide polymerase is a subject for upcoming research.
INTRODUCTION OF VISITING NATUROPATHIC PHYSICIAN
John Oertle NMD is a local naturopathic physician, who works with cancer patients and others, using IV therapies and other modalities.
We welcomed him to our group and to please join us in the future.
NEXT BOARD MEETING: Friday, May 9, 2014 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.
Please mark your calendars now, to keep that afternoon 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.
Dr. Huber continues to offer for her clinic to provide lunch for the meetings at no cost to the membership, in order to save up the usual $10 dues per quarter per person to pay the $400 fee for the eventual incorporation of the non-profit.
POSSIBLE AGENDA ITEMS FOR MAY 9, 2014 BOARD MEETING
Report on the progress of the human safety study currently under review by the IRB.
Discussion of Dr. Worden’s study, and consideration of future relationship between this board and ASU and or other large institutions.
These meetings are the opportunity to present anything that you think important or interesting. Of course, agenda items may even be added at the last minute. But please remember that we should probably curtail political/philosophical discussions after a certain point in order to have time to get to the case presentations.
Also, should we take a maximum of say 45 minutes for miscellaneous issues and politics, so that we can then hear a lot of cases before people have to leave? Or shall we start with case presentations?
Colleen Huber, NMD
Secretary, ANRI / NORI
January 31, 2014