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)
May 13, 2016
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-sixth 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 13, 2016 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
20 members and guests were in attendance. This included 16 physicians and 4 non-physicians.
SUMMARY OF PREVIOUS MEETING
Dr. Huber briefly summarized the previous ANRI / NORI meeting of February 2016.
HAZEL CHANDLER’S BOOK DESCRIBING HER CANCER JOURNEY
This book has been several drafts in the making. In it, Hazel describes challenges that she faced in seeking treatments of her choice, and the confrontations regarding those choices that ensued both in the oncology world and even within her own family. It should be ready to go up on Amazon in about 48 hours. Hazel has offered to donate a sizeable portion of the proceeds from the sales to Naturopathic Cancer Society, which is a 501c3 non-profit that is dedicated to honoring patient choices in cancer treatment.
PRODUCT COMPOUNDING AND REGULATORY MATTERS
Dr. Huber summarized recent events regarding instructions to the FDA regarding compounding coming from both Congress and Health and Human Services (HHS) over the last several months.
- MARK DAVIS AND FMT
Dr. Davis flew down from Portland today in order to attend our meeting and to present his research, for the consideration of our IRB, to possibly approve for review.
Dr. Davis graduated from NCNM in 2011 He does work with fecal microbiota transport (FMT).
Stool is 2/3 microbes by dry weight. 4th century Chinese medical doctor Ge Hong seems to have been the first to document using stool donation by healthy donors.
Dr. Ben Eiseman of Denver in 1958 began treating patients with Clostridium difficile (C diff) and Pseudomembranitis. After his treatment, all patients were asymptomatic by retention enema.
At the turn of the last century, case studies began to be recorded.
For patients, there are very few exclusion criteria. Anybody of any age seems eligible for fecal transplant.
Donors, however, are screened very thoroughly. Exclusion criteria include HIV, viral hepatitis, syphilis.
Thomas Louie, MD of Calgary came up with the idea of encapsulated fecal microbiota. ½ million people per year get C. diff., and 29,000 die of it. Likely 90% of those lives can be saved using fecal transplant. Louie had a 95% cure rate with enemas and colonoscopies, but many were not able to tolerate this regimen.
So Louie prepared a fecal slurry of 1 ml fluid to 1 g of stool, blend for 30 to 60 seconds, then filter. For capsules, centrifuge a few times, spin at 5000g, take bacterial population, get rid of supernatant. Agitate in HCl for a stomach-similar amount of time. Then triple encapsulation, and the capsules are breaking open in the distal small bowel or proximal large bowel.
FMT was unregulated by the FDA. Then they decided to classify it as a drug. Dr. Davis gave a TEDX talk, in which he said, well, it is treating disease, so it is a drug. Davis argued, “You classify fecal transplant as a drug. However, you have to prove that every batch is the same. And we cannot.” It was proposed to re-classify it as a tissue, but that wasn’t appropriate either, because human tissue includes human cells, and this generally does not.
Because of this, the FDA said you have to stop now. Of course, there was then a public outcry. So the FDA said, we are not going to approve it, but we are going to use discretionary enforcement, so we are going to give you a pass to break our rules, and it’s okay.
Dr. Davis works with people with inflammatory bowel disease (IBD), such as ulcerative colitis (UC), Crohn’s and microscopic colitis. He uses all naturopathic modalities with such patients; however FMT is the most powerful, and seems to keep people in remission for at least years.
There seem to be no know risks at yet. No SIBO has been detected in patients.
Dr. Davis’ study, which he brings here today for our consideration for IRB review, will specifically look for risk. It will look at the lactulose breath test, which is the standard test for SIBO.
The Board thanked Dr. Davis for a very informative and interesting overview of his work. Many questions were asked:
How does probiotic therapy compare with Dr. Davis’ work? How do anaerobes in FMT compare with aerobes? How are treatments given and with what frequency? Is there a viral microbiome taken into consideration, and how is that handled? Does prebiotic treatment enhance the patient response? Are donor and recipient matched in any way? Is there a separate screening for cancer among donors? Where does the last capsule open in the GI tract? If the capsules were to open earlier, say in the stomach, would there be any problem? Is there a risk of creating SIBO? Is this a commercially available product? Is there a financial interest with the company making the capsules? Will there be compensation for the study? Will there be a crossover in this study? What is the procedure to monitor current donors to ensure they remain healthy? Is there any interference by antibiotics in donors, and what are those exclusion criteria? How about antibiotic use by patients? When you finish your study, how quickly will that affect protocols?
Dr. Davis thoroughly answered the above questions to the Board’s satisfaction.
A vote was then taken, and the Board unanimously voted to approve IRB review of Dr. Davis study. Dr. Huber asked Dr. Davis’ permission to register the study and Dr. Davis agreed. Dr. Davis agreed to return to us within a year for follow-up review.
We moved on to a case history, a patient with stage IV bladder cancer. Some discussion ensued.
A case of osteosarcoma was presented.
Dr. Rogalla reminded the doctors to begin to get their work published. Dr. Huber mentioned that it may be easier to begin to get published in Open Access online journals. Researchers at major universities also publish in these journals, and because the author pays some for the publication, there is not the obvious influence of drug ads, as seen in some of the mainstream medical journals.
Dr. Huber mentioned a new website, for which we would like content to be generated by physicians, and for them to reap the benefit of public interest in that content. Dr. Huber invited doctors to write articles for www.PrimaryDoctor.org. Please see Dr. Huber if you are interested in contributing an article.
Dr. Huber also invited ANRI / NORI members to submit an abstract to speak at 2nd World Congress on Breast Cancer, Phoenix, September 2016.
We agreed to meet again next time on Friday, August 12, 2016 – usual time and place. Please mark your calendars.
Meeting adjourned at 2:45 p.m.