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 2, 2019
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-eighth 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., May 10, 2019 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
14 members and guests were in attendance. This included 10 physicians, representing 8 different clinics, and 4 non-physicians.
The meeting was called to order at 12:05 pm.
RESEARCH ON SAFETY OF A MYCELIAL EXTRACT
So far, 53 cancer patients were observed. Of those, 51 have no more tumor burden. Of the remaining 2, one decided to also have chemotherapy, and then died. For the other, the patient left and data was no longer obtainable. Almost all of the cases were breast cancer cases.
Some of the most striking effect of this mycelium is alleviation of chemotherapy side effects.
Gathering of data and verification will be determined by health care providers involved with the patients. Such labs would be for example the PSA value reducing in prostate cancer patients.
A possible study of use of this mycelium may involve repeat imaging before and after to assess tumor burden and cancer activity. This would likely practically involve patient-funded research.
Extensive discussion ensued.
Motion: It is proposed that the protocol be used as a template for establishing a multi-center research project, along with Informed Consent in order to look for initial efficacy and to further monitor safety and efficacy. Our IRB specifies ultrasound and/or other imaging as relevant, for the physician to choose the most appropriate imaging.
The motion was seconded. It was unanimously approved by this IRB.
RESEARCH ON INDIVIDUALIZED PROTEOMICS AND GENOMICS
The cancer patients who received individualized cell analysis and protein analysis started getting better. Over 350 patients have benefitted from this at this point, some surviving cancer over a decade. All of them were late stage cancer patients, of various types of cancer. Greater than 35% efficacy was found at the time with urinary proteomics to plot the affinities.
However, now there is higher precision, with higher specificity. No serious adverse effects have been observed. Also, it yields information on what therapies may be most appropriate for an individual, and which may not be so useful.
It is feasible for the average person to get their genetic data, and with this updated technology, it is so much improved and advanced over what was used 6 years ago.
One goal is to make this economical for patients.
Question: What adverse effects have you seen?
Answer: Fever, malaise, rash, all self-limiting within 3 days, followed by improvement in quality of life.
Question: Who are the manufacturers and suppliers of the immunopeptides that you are using?
Answer: Only CGMP materials are used.
Extensive discussion ensued.
Proposal: To approve Initial Phase I Safety Portion of a Study, that this kind of consulting service is safe for patients to access.
This was the motion, and then it was seconded. Unanimous approval is that the Safety Portion of the Study may proceed under the review of this IRB.
ANNUAL UPDATE OF IV NUTRIENTS RESEARCH
One year after last presenting annual updates of ongoing use of intravenous nutrient treatments with cancer patients, not only by naturopathic physicians, but also all licensed physicians, and not only in that clinical practice, but in all that use it, an update was presented.
The update consisted of compilation and analysis of data gathered from a questionnaire distributed to patients at a clinic during 2018. In 2018, quality of life questions were asked, and the responses were compiled and analyzed.
Motion: Continue review of use of IV nutrients under this IRB. Seconded. Passed unanimously.
FECAL TRANSPLANT CLINICAL TRIALS HALTED BY FDA
We looked at a NYT article discussing the allegation that two patients died after fecal transplant. Then the FDA prohibited further clinical trials. Discussion ensued.
Rasmussen’s encephalitis case update: Patient ended up in the ICU twice. There had been some bad seizure bouts. Patient received slow-drip IV vitamin C 25 grams over 8 hours. Excellent recuperation. Could walk without stopping or falling. Patient was more alert and focused. Then worse in April and May, partial seizures beginning with eye movement. Then more grand mal seizures. Ativan, Lorazepam, Phenobarbital, Keppra. No improvement. Then another slow-drip 10 g vitamin C. The patient tolerates that well. Conventional doctors and hospitals are slow to agree to and appreciate use of high-dose vitamin C.
The next meeting will be held on Friday, November 8, 2019 at noon, the usual place.