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)
August 28, 2015
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 twenty-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 12:10 p.m., August 28, 2015 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
9 physicians and 5 non-physicians, including one attorney, were in attendance.
It was agreed to keep comprehensive, detailed minutes for review and approval of procedures, as well as the substance and outcome of all matters voted on, but to not record all of the discussion of other matters. For other matters a brief one-line summary would suffice.
ONGOING REVIEW OF CLINICAL TRIAL OF 3BP
The physician who originally presented to us the clinical study of 3-bromo pyruvate used in treatment of cancer patients gave an update, and presented the case of a pancreatic cancer patient still active and working 9 months after his diagnosis.
The physician was asked if he would write this up as a proposal to the IRB, with the consent form, so that we can know how candidates are chosen for the trial, how they are evaluated, monitored and with outcomes reported to the IRB.
The physician conducting the study agreed to present all of the above in writing to the IRB.
ONGOING REVIEW OF CASE STUDIES OF CHOLESTEROL AND CANCER
Another study that the IRB is reviewing of serum cholesterol levels in cancer patients was mentioned, with an update regarding follow-up research in this area. The association of low cholesterol with low survival in cancer seems to be more pronounced in females than in males, and is being studied.
Dr. Nelson presented his second case to the group, and received and answered questions and comments. A wide variety of treatments were discussed.
Recent visits to our IRB by the government of Jamaica has produced good impressions all around. It was announced, “This IRB is the first IRB in history to be approved for clinical trials in hospitals in Jamaica.”
COMPOUNDING PHYSICIANS TRADEMARK
“Compounded medicinal products” was suggested as a descriptor to be registered with our trademark. Other descriptors suggested were “compounded medicinal substances,” “compounded medicinal services” and “medicinal compounding services.”
This led to a discussion of the historical role of physicians in compounding, both sterile and non-sterile substances, in contrast to recent FDA re-interpretations of the physician’s role. When the FDA was asked for guidance, it pointed to USP 797.
Because that document is badly flawed, we discussed having industry standards that we establish, that are in some cases more exacting than USP 797. We discussed good practices for handling sterile and non-sterile materials, and for safeguarding the integrity of those products until consumption by the patient(s). It was agreed that our discussion and agreement with such good practices was vitally important as our profession’s defense against hypothetical egregious government over-reach. This was confirmed by unanimous vote; all ayes; no nays.
NEW MULTI-CENTER CLINICAL TRIAL
Two clinics have started a clinical trial, and others are welcome to participate. Isolation and augmentation of a patient’s lymphocytes may have beneficial outcomes in a number of health conditions. One strong advantage of this therapy is that the patient is left with nothing that did not originate in their bodies. All other materials used remain external to the patient.
Questions were asked and answered, for example if there were quality control procedures, informed consent, any side effects observed, reporting of outcomes, and if documentation of all of the above would be submitted. This documentation will be submitted prior to our next meeting. The IRB agreed to begin to review this clinical trial.
We agreed to meet in the usual place Friday, November 13, noon.
The meeting was adjourned at approximately 2:50 pm.