AMERICAN NATUROPATHIC RESEARCH INSTITUTE

NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE

Interim address:

1250 E. Baseline Rd., Suite 205

Tempe, AZ 85283

Tel: 480-839-2800

JOINT MEETING OF THE

AMERICAN NATUROPATHIC RESEARCH INSTITUTE (ANRI)

AND THE

NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE (NORI)

AND THE

INTERNATIONAL NATUROPATHIC CLINICAL RESEARCH INSTITUTE

AND THE

INSTITUTIONAL REVIEW BOARD (IRB)

February 9, 2018

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 thirty-third 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., February 9, 2018 at 1250 E. Baseline Rd., Tempe, AZ 85283.

MEMBERS AND GUESTS

14 members and guests were in attendance. This included 10 physicians and 4 non-physicians, The meeting was called to order at 12:00 pm.

REMINDER ABOUT NATUROPATHIC CANCER SOCIETY

Dr. Huber reminded the group about Naturopathic Cancer Society (NCS), and that the only requirement for physician membership is to be licensed in one’s state, and not to coerce or threaten patients to either have or not have conventional treatments. Many, many cancer patients are now seeking natural treatments for their cancer.
Please peruse www.NatOnco.org, and if you agree with what you see, please let Dr. Huber know, to be added to the list of doctors, in order for our clinics to be able to refer to you during extra busy times.

RESEARCH IN ELIMINATING OPIOID ADDICTION

This is a proprietary natural formula. Patients to be enrolled in this study have been diagnosed with opioid withdrawal disorder. If they get better, we will look at how this compares to methadone and naloxone, etc. This is single-blind, rather than double-blind. 54 patients have been selected for treatment and 25 for control. Physicians have gone through the list of ingredients to rule out allergies. This is the first time in history that we know of herbs for opioid withdrawal being studied under an IRB.

Lack of compliance and lack of attendance, and non-follow through has been a big problem with the target population, as observed among various clinical settings. This portends a potential problem when the end of the clinical trial comes, and there could be no data or the wrong data. SF36 Version 2 is a short-form health survey, which include “generic, coherent, and easily administered quality of life measures.” It was developed for the Rand Corporation by Harvard University for assessment regarding medical outcomes. Our member biostatistician is in that role for this study.
He reminded us that some form of statistics should be agreed upon before a vote is taken, and he described the multi-variate analysis that he will use. Our member biostatistician’s statistics have never been rejected by universities and research institutes.

Q: Any alcohol consumption is prohibited by the study. However, that is difficult to enforce. Would Ant-abuse be appropriate to prescribe to the subjects?

A: That is a poorly tolerated drug, and may skew outcomes.

Q: Is there something in the formula that is incompatible with alcohol?

A: We don’t yet know, but we will find out.

Q:Should we suggest that alcohol consumption not be a disqualifying factor? Or on the Informed Consent, should they agree not to drink alcohol? Or should they report if they do have alcohol consumption?

Q: Are the subjects on prescription opioid-based medications? Or are they on street drugs?

A: There are both, so the study could separate these into various data points, for both recent history and current medical history.

Q: Are these subjects all local?

A: Participants are from various venues all over the country.
A 1st and 2nd motion to approve research review was made, and it was voted unanimously to approve this research for review under the IRB.
Kratom is now being attacked by FDA. However, it has a 2,000 history of use, including for this particular use, in SE Asia!

DR. HUBER’S NEW RESEARCH

Dr. Huber presented a proposal for new research regarding an old treatment protocol.
Dr. Huber discussed mechanism of action, synergistic role with various classes of chemotherapy and radiation, goals of treatment and protocols and logistics for use, as well as indications normally used in the US and Europe and contraindications against use.
Questions were addressed and discussed.
Dr. Huber suggested, among a long list of contraindications, that brain tumors would not be addressed, and as always, they do not treat cancer in children at that clinic, due to intense political crushing in our time of natural therapeutics used with child cancer patients.
A 1st and 2nd motion to approve research review was made, and it was voted unanimously to approve this research for review under the IRB.

DR. HUBER’S UPDATE ON INTRAVENOUS NUTRIENT RESEARCH

Dr. Huber reminded the group of the parameters of the research that we do on intravenous nutrients, updating the group on the extent of clinical use, and the time since first approval.
Numerous questions were asked and answered, and the vote to approve continued IRB review was unanimous.

PURPOSE OF IRB

The purpose of the IRB on some level is to establish safe and efficacious ways to use nutrients, and when comparing notes on how we are using these nutrients, in order that we may learn from each other about successes or to avoid problems or failures of therapy.

DR. ROGALLA’S PRESENTED RESEARCH ON AN HERBAL EXTRACT

Dr. Rogalla is interested in exploring an avenue of research on various ways of preparing an herbal extract as well as its therapeutic use. Discussion involved indications, history of use and possible side effects and contraindications. We then discussed its preparation.
Questions were addressed and discussed.
A 1st and 2nd motion to approve research review was made, and it was voted unanimously to approve this research for review under the IRB.

FURTHER FDA VIOLATIONS OF THE US ANTI-TRUST LAW

We are in a time where FDA is taking more and more items out of 503A and 503B. Appallingly, curcumin and aloe vera were just removed recently, and this even covers aloe plants growing in Arizona that someone takes a leaf from to treat a skin burn.
The FDA has issued a draconian new document that blatantly violates anti-trust law, by forbidding more and more compounding, boasting of criminal charges against some compounders, often on flimsy pretext.
Public notice on change of rules must be 90 days. EPA just violated this 90-day rule, and now so did the FDA.
We discussed how to deal with this dilemma, and legal protections against these problems.

NEXT MEETING

The next meeting will be held on Friday, May 4, 2018 at noon, the usual place.