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 8, 2013
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 sixteenth 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 8, 2013 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):
Colleen Huber, NMD, Secretary
Cheryl Kollin, NMD
Kenneth Lashutka, NMD
Eric Lopez, NMD
Kenneth Proefrock, NMD, President
Paul Stallone, NMD
Nanao Takaki, NMD
Phranq Tamburri, NMD
Robert Waters, PhD
Others who have attended previous meetings or wish to attend future ones are cordially invited to join us for future meetings.
MEETING CALLED TO ORDER
Dr. Huber, Secretary of ANRI / NORI, called the meeting to order.
CLINICAL TRIALS AND SAFETY STUDIES UNDER OUR IRB
Dr. Waters talked about work with a substance that he and others developed at Arizona State University. They found an extract from a plant that killed pox virus. The only drug on the market, ST246, that kills smallpox has a short shelf-life and other problems. Dr. Waters found that this substance that they developed works on HPV.
Millions of women in this country have cervical dysplasia. The gel was tested against cervical dysplasia, and adjusted and re-analyzed, and then finally the gel of various herbs worked with a different type of suspension. CIN 3 patients are back to ASCUS. No failure yet. Now they’re coming back with HPV negative. Herpes is another DNA virus that this seems to be working for. The entry point of the herpes virus is looking like the vaginal lesions. Whereas other preparations shorten the eruption time of the lesions, this preparation actually kills the virus.
Dr. Waters works with MDs and DOs on this gel, who are using it clinically with patients.
Dr. Huber talked about the human safety study, and that ANRI/NORI’s IRB has been awarded the contract. At this point, we can have that put us on the map to more recognition in the academic world.
Carol Eastman asked about the IRB proposal and registration.
Dr. Waters said the whole IRB proposal was registered when it was first done over a year ago.
There was a question about the Principal Investigator, and that the IRB has to be separate and above the clinical trial. The Principal Investigator also has to be separate and apart from the clinical trial. Dr. Lopez will fill that role. The IRB has to monitor what is happening with the trial.
Dr. Waters said a Medical Assistant can do the patient intake, and Jessica Nañez said she understood that she would have that responsibility. However, if something happens then one of the doctors would have to step in and provide a medical decision.
As an IRB we just accept, reject or modify. Dr. Waters said we will not review the data. We only have to ask if it is safe and if it is ethical.
The next study is a cold sore study.
Then there is another study that we can get involved in: This is a study with Duke University. Dr. Waters had met Barry Goldstein.
Patients come in, listen to music, answer questions about how they are feeling with the music. An example of this type of study, one that Dr. Waters had prepared in the past, is at this link: http://www.dataservicesolution.com/website/researchintro/index.html. Dr. Waters developed this online questionnaire, and it’s working. Dr. Waters encourages us to follow this link to take the 20- minute process plus questionnaire.
Duke University wants to have a partner to work with to further this kind of research, and they are considering us for it, if we will be interested. The phenomenon being studied is called decomposition. The question is if there are certain frequencies that are universally healing.
REPORT OF ANRI/NORI VISIT TO THE AZ NATUROPATHIC PHYSICIANS BOARD
Dr. Huber informed the Board of our introduction to the AZ Naturopathic Physicians Board, how we told them when we visited on October 10th that we basically started our organization to come up to the standard of the Code of Federal Regulations for patient care, and that we have an Institutional Review Board (IRB) to oversee such research, and that our IRB is now registered with the FDA and the Office of Human Research Protections (OHRP), and that we have existed for 3.5 years, and have over 30,000 consults with cancer patients among our member clinics. Dr. Tamburri then talked about our goals of protecting medical freedom and patient choice with regard to their health care. The AZ Board heard and acknowledged our introduction without further comment.
Dr. Huber noted that during the same meeting of the AZ naturopathic board, there were a number of cases that came before the board that day, including that of Carol Eastman, who is present at this ANRI/NORI meeting today.
Dr. Tamburri announced a new development. After a 6-month search, the Governor’s Office has appointed Marianne Marchese, NMD to be a member of the Board. Dr. Marchese will soon join the Board for a 5-year position.
OUR INTERNATIONAL PRESENCE
Dr. Huber read correspondence from one of the organizers of the International Congress of Naturopathic Medicine, welcoming our organization to present a lecture or workshop.
Dr. Tamburri has expressed that he would be interested in going and presenting. Dr. Huber advised him of the January deadline for submission of abstract, and that that conference is in Paris, France, July 4 to 6, 2014.
Dr. Tamburri asked if anyone else was interested in going to France also then, and no one indicated any such plans. However, Dr. Tamburri noted that he would go this year, maybe Dr. Proefrock next year, etc., and in this way, we could take turns going.
HOW OUR MEMBERS MAY REPRESENT THE ORGANIZATION PUBLICLY
Dr. Huber then raised the topic of our face to the public, speaking for the group and outreach. She said that the question had again come up as follows: If you have something to say publicly about medicine in general or on a specific medical topic, is it okay to identify yourself as an officer or a member of ANRI/NORI?
Dr. Huber pointed to Dr. Tamburri’s recent article on the cover of the Naturopathic Doctor News and Review (NDNR) and to Dr. Proefrock’s recent article in the Cancer Strategies Journal, and said that she was impressed with and grateful for each article, and would have liked the NDNR article to have identified the author as a member of ANRI/NORI. It was an enormous success that the two articles on cancer were written not by independent doctors, because then we establish that there exists knowledge and experience and expertise in naturopathic oncology outside of a specific specialty organization. Dr. Huber mentioned her own presence on Natchat in the last few months, giving bland general information-type answers to oncology questions posted there, signing as Co-Founder and Secretary of ANRI/NORI.
Dr. Tamburri said that he doesn’t like to broadcast too much of himself, or give too much information to the public. His concern is no matter what we put online, you are forever branded with it online. So the question is: what does ANRI/NORI mean if we brand ourselves with that title? What we are representing is the rights of doctors to practice in many ways. So let’s take as an example, other specialty organizations: When you are a member of those you take a back seat to the leadership’s positions on issues. If you go on Natchat for example, and you want to say that I think krispy kreme donuts cure cancer, you might write that. But if you put down your membership status with that, then the leadership of that organization would come down very hard on you. So the thing with our group is that we don’t have a rigid dogma. So then we could have somebody come back to us and say, so that’s what you all think? That krispy kreme donuts cure cancer?
So how do we do that? So if people knew that we are a libertarian group that allows diversity of thought and practice, then they would understand that we may have a lot of different views. But if they don’t know that about us, then they may assume that we always agree with each other on everything.
Dr. Waters said that he in the past has used a disclaimer to make the distinction between his views, and those of the larger group.
Dr. Huber said that that would probably be the best way to resolve the Tamburri-Huber debate: that is, to have members feel free to speak publicly, but to have a disclaimer saying, “The views expressed herein may or may not reflect the views of other members of ANRI/NORI.”
Dr. Waters said to make it an informative disclaimer, ending with: “For more information on ANRI/NORI, please visit www.naturopathic.org.”
Dr. Tamburri said that we should vote on using that.
Dr. Huber offered a motion to identify ourselves publicly, but to use the disclaimer. Dr. Proefrock seconded the motion. Then there was a vote, with the membership unanimously in favor of the proposal.
QUALIFICATIONS AND CERTIFICATION OF NATUROPATHIC ONCOLOGIST, AND/OR “FANRI,” AND/OR “FNORI”
Dr. Huber brought up the fact that Dr. Proefrock has presented well over the five required cases to the Board, and has produced many papers suitable for publication, and has therefore earned the title of Naturopathic Oncologist.
Dr. Proefrock expressed that he is not interested in being called a naturopathic oncologist, and does not need or want any more initials after his name.
Dr. Huber protested that there are others in line for that title behind Dr. Proefrock, and that he has earned it first, before any of the rest of us, so that he should not be cheated of it if he wants it, but that she understood that he did not want it.
Dr. Tamburri raised the issue that there is an organization that is agitated by the fact of our very existence, and that if we use the designation naturopathic oncologist at all, then they will not like it.
Dr. Stallone agreed with Dr. Tamburri and said that if we use the designation “naturopathic oncologist,” then there is another organization that is going to go berserk. So therefore, we should not.
Dr. Huber asked why we need permission from another group for this.
Dr. Tamburri agreed with Dr. Stallone, and explained it in terms of the Italian-American culture of South Philadelphia, that you have to be decent at all times, and use the “Popeye Defense” and not let a fight escalate.
[Later, Dr. Huber’s husband, who is also of Italian-American descent, and also from the Philadelphia area, observed that in the Rocky movie, Rocky never was a doormat for Apollo. However, Dr. Huber acknowledges that boxers and naturopaths have different roles in the world.]
Dr. Huber said that there is a difference between being assertive and aggressive, that if another group is offended for no good reason, just by one’s very existence, then you don’t have to accommodate that; in other words, that feeling of being offended for no good reason is a lack of maturity, and should not dictate which way we go with our organization. You certainly don’t have to go poke them in the eye, but neither do you have to become their doormat.
Dr. Stallone said that “naturopathic oncologist” is a protected title.
Dr. Proefrock contradicted this, and said that it is a generic expression, and should not be of one organization or specialty board. He said that when we first came together, we wanted to say that it’s possible to practice with cancer patients without being part of one specific specialty organization.
Dr. Huber agreed that we need to take back this title to its generic origin.
Dr. Waters noted that the MDs he works with don’t like the designation of oncologist.
Dr. Proefrock observed that we all have holes in our psychology and these initials are there to fill that, but otherwise, what good are they?
Dr. Stallone said that from the beginning of this group he was glad that we were trying to broaden the scope again of what we do.
NEXT BOARD MEETING: Friday, January 31, 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 this 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 JANUARY 31, 2014 BOARD MEETING
Preparation for having a booth at conferences, beginning with the OncANP conference mid-February.
Report on the progress of the human safety study currently under review by the IRB.
Discussion of the Duke University study.
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
November 8, 2013