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 9, 2014
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 eighteenth 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 12:30 p.m., May 9, 2014 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
(Membership is open to anyone who has attended at least once, so all of the following may designate themselves as members of ANRI / NORI if they wish.)
The following members and guests were in attendance (alphabetically by last name):
Inge Barth, ND
Colleen Huber, NMD
Cheryl Kollin, NMD
Kenneth Lashutka, NMD
Eric Lopez, NMD
Kenneth Proefrock, NMD
Deborah Rogalla, ND
Cathy Stuart, Director, AZNMA
Bob Waters, PhD
Bonnie Wick, NMD
There were 3 additional Skype attendees:
Dr. Drew Collins
Dr. Margarita Hernández-Guzmán
Dr. Alan Kadish,
REPORT OF MAY 8, 2014 AZND BOARD MEETING
Dr. Huber talked about yesterday’s AZND board meeting. There is a very different tone at the last two meetings of the Board than even only 6 – 8 months ago. Instead of needlessly berating naturopathic physicians for perfectly legitimate treatment choices, which had been so painful to witness in the past, and so humiliating and dispiriting for the doctor on the hotseat, now it seems quite different, and the Board seems willing to consider fairly the entire scope of naturopathic practice and to appreciate the individual physician’s thoughtful practice of our medicine.
Cathy Stuart announced that the AZNMA lobbyist has assured her that the restrictions in IV nutrients can be resolved with only a rule change. This would not have to go through legislation all over again. The Board is aware of this, and plans are underway to review the problem language that exists in the laws and rules as currently written.
More news from Cathy Stuart: The Arizona Interscholastic Association (AIA) for high school sports has been generally antagonistic and has been standing in the way of naturopathic physicians doing sports physicals. We had been authorized to do sports physicals. Then the AIA raised a fuss, and we just lost sports physicals only yesterday. So at this time, please be careful not to do any sports physicals for now. Because if you do, then if the clock runs out on the time period to do a physical, then someone in power throws a tantrum about the physical being done by a naturopathic physician, the kid involved may be excluded from sports for an entire year.
But AZNMA has a plan of action. The Arizona Interscholastic Association has a lot of power, and seems to be ignoring federal guidelines. So Cathy will speak at the AIA in August, and will need to take a naturopathic physician with her, in order to enlighten them on naturopathic standards of education and clinical training.
Dr. Rogalla mentioned that at yesterday’s AZND Board meeting Dr. Birdsall said, and the Board reiterated, that nobody can call themselves a specialist unless they have a specialty certificate, which he was there to collect for himself and several other members of his organization. Dr. Rogalla said and Dr. Proefrock agreed that this could allow anybody to open up certification of specialists. This is inevitably fraught with difficulty, such as power moves, and can become more divisive than solidarity moves.
Dr. Huber said that the two new “specialists” present at that meeting had received the designation by taking a test of 200 multiple choice questions that their same organization created.
Cathy Stuart says that naturopathic physicians have never been able to use the word “specialist.” And we had to change to “clinical focus.” Clinical guidelines are specific for exactly what criteria have been established. Sen Bartow’s bill had said that you cannot call yourself a specialist in any field, but it kept getting voted down.
Pepper Brydon observed that in her experience from a patient’s perspective, there are three types of naturopathic oncologists:
1) One who affiliates only with the conventional medical route;
2) One who will do naturopathic treatments, but require you to go through the conventional medical route;
3) One who treats you as a person, patient-centered, with a little or no-side-effect treatment.
Pepper said that yesterday at the AZND Board meeting the individuals that were only part of one organization ended up getting the specialist certificate She said that previously as a patient she had been quite deliberately steered to the first two of the above three types of doctor.
Pepper mentioned that she approached the Board to ask that NORI also be recognized and that we have an IRB.
Dr. Sadilek had responded to the specialist certificate seekers that you know that this opens it up to having others not affiliated with the first group getting certified as specialists as well.
Dr. Huber mentioned that Dr. Marchese had said that “any naturopathic physician can apply for this specialist certification.”
REPORT OF SAFETY STUDY OF TOPICAL HERBAL GEL
Dr. Lopez then reported on the study of topical herbal gel that is being observed for its safety on human skin. There are now 89 people out of 144 planned who have completed the study. 29 controls have completed it, and 60 regulars have completed it. CBC and CMP blood labs have come back as normal, except in the following circumstances:
3 people have increased ALT. It turns out the 2nd blood draw was taken after final exams and after celebrations after final exams. So an increase would be explainable by that event. Another person had higher eosinophils. It turns out that was higher after swimming, which was a plausible cause.
The group expressed general approval of the ongoing work of the Safety Study.
Cathy Stuart said that in AZNMA’s Scientific Affairs Committee – a resident named Dr. Amanda Roberson wrote a study about polycystic ovarian syndrome (PCOS). She said to our group, please put your articles on the website, those of you who are AZNMA members, in order to help populate the AZNMA website with Arizona naturopathic research.
REPORT OF DR. PROEFROCK’S STEM CELL PROCEDURE FOR IRB OVERSIGHT
Dr. Proefrock gave a summary overview for cursory review of the pending oversight of the documents related to his stem cell procedure.
Dr. Proefrock introduced his stem cell research. He started this in 2008. At that time there were not a lot of rules. Dr. Proefrock then described his work with autologous stem cell therapy in considerable detail.
It turns out that in people who have been exposed to Agent Orange there is very little viability of stem cells. At 40 – 50 years later, after exposure in the Vietnam War, there were no stem cells found at all.
Dr. Waters commented that 2,4D (2,4 Dichlorophenoxyacetic acid) herbicide is a very similar molecule to Agent Orange that many in the US are exposed to in agriculture. [It is one of the most widely used herbicides in the world, the 3rd most common in North America.-CH]
Dr. Proefrock commented that the heavier a person is, the more dilute their stem cells are in the fat tissue. Conversely, slender people seem to have a higher concentration of stem cells in their adipose tissue.
Dr. Proefrock then described his stem cell treatment in considerable detail for the IRB.
Say you want a joint reconstruction sort of effect – There is usually a pretty good response. This was what the Brno University in the Czech Republic and Dr. Proefrock cooperated on. Imaging is done before and after.
Results of the study: 1400 joints treated. Dr. Proefrock has seen a 96% success rate – improvement in cartilage beds and ligament strength. They try to contain it to the site.
Stem cells can also be done with a nasal insertion – good at getting into the turbinates. Also there is site-specific delivery to most affected parts of the body. Stem cell researchers abroad have generally been more honest to work with than some in the U.S., and Dr. Proefrock has found those interactions to be generally more valuable.
Sometimes other chronic conditions and neurological conditions respond very well, such as a woman with complete blindness who now is beginning to see lights and at times colors, and is partially sighted now. No other procedure that she had previously tried had ever restored any of her sight.
At this time, fewer and fewer items that the patient didn’t bring with them are going into the process. So as irritating as the FDA is in requiring that as little as possible be added, their restrictions have actually led to a better process, in a necessity being the mother of invention sort of route.
Dr. Lashutka asked about hyaluronic acid. Dr. Proefrock responded it was a bacterial source. The FDA considers hyaluronic acid to be a device, not a drug. So because it comes under a different category, there is a different sort of scrutiny.
Dr. Lashutka said that in an IRB, questions are as important as the description of the research, and that we should really ask a lot of questions.
Dr. Eastman said that in any research there has to be a concern about the ethics, such as how you code material gathered from subjects to protect subjects’ confidentiality.
Dr. Proefrock said he had to do that with so many different clinics, since multiple clinics were involved in the reporting of this study.
Dr. Eastman asked to clarify that there were other clinics.
Dr. Proefrock said yes, some in Europe.
Dr. Eastman reminded us that generally an IRB has to be informed within 10 days of any adverse events.
Dr. Waters said yes, and any event that arises such as that has to be put as an addendum.
Dr. Proefrock commented that for naturopathic physicians, research is funded by patients. In patient-funded research, then we gear it to patient needs, and because we are addressing an individual’s particular needs, we have many fewer adverse events, because we don’t strictly adhere to a one-size-fits-all sort of strict protocol.
Dr. Eastman says individual protocol is less important than ethics. And are Dr. Proefrock’s patients given the option to be part of a clinical trial or to decline? Dr. Proefrock said yes, they are given that option.
Dr. Eastman asked if a Project Review form had been turned in, and Dr. Proefrock had mentioned that we had been informal till now, and had not used those yet in ANRI / NORI.
Another word about selection criteria, Dr. Proefrock said that there are a lot of people searching for some kind of an answer to their health conditions. He said, we try to never misrepresent our findings or likelihood for success. Often naturopathic management can be more helpful than stem cells per se. Some conditions are still very difficult to treat successfully. ALS for example is a challenging condition that won’t always find success strictly with stem cell treatment.
So far the best success with this stem cell treatment has been observed with joint reconstruction, auto-immune conditions, cerebral palsy and seizure disorders.
The group agreed to proceed with review of the pending oversight of the documents related to Dr. Proefrock’s stem cell procedure, following his summary overview.
REPORT OF DR. HUBER’S DIETARY AND IV NUTRIENT TREATMENT OF CANCER PATIENTS STUDY, FOR IRB OVERSIGHT
Dr. Huber then distributed and read aloud the abstract of her ongoing study of the cancer patients who come to her clinic. No cancer patient was excluded from the study, except those who had stayed less than two weeks in the care of the clinic. Every cancer patient was asked to follow a diet which excluded sweetened foods, unless sweetened with Stevia rebaudiana. With the practical consideration that almost all processed food and restaurant food has some HFCS or cane sugar, Dr. Huber asked that patients exclude desserts, sweetened sauces, fruit juice and alcohol, in order to try to keep the blood sugar on the lower side of the normal range. No other dietary recommendation was made, although when asked for help with other dietary choices, the clinic’s doctors would all try to be helpful. The other request was that patients take 2 to 3 IV nutrient infusions per week, with the goals of opposing cancer growth and of interfering with cancer cell metabolism. Patients were considered steadfast if they were able to avoid sweetened foods and if they took IV nutrient infusions 2 to 3 times per week for 12 weeks.
The results for patients who were steadfast with IV treatments, regardless of diet, was 83% of patients who went into remission. The result for patients who were steadfast with IV treatments but continued to eat sweetened foods was only 36% who went into remission.
Dr. Eastman asked if there were a control group. Dr. Huber responded that patients self-selected as far as compliance. Most chose to follow the recommended diet, but some chose not to, or were spontaneously tempted away from it. So there was no blinding in the study.
Dr. Eastman and Dr. Proefrock said that therefore those were not proper controls. There were simply compliant patients and non-compliant patients. If at end of the study you evaluated who complied with you and who did not, that’s not a control group. They then agreed with Dr. Huber that it would be unethical to create a control group from cancer patients, already having the prior knowledge that those in the control group would very likely fare worse in the long-term.
Dr. Huber said there were non-quantifiable, intangible factors in the success of the treatments. For example, the same room in which we were then sitting usually serves as an IV room. While patients get IV nutrient treatments for their cancer, they are also having interactions with other patients that are therapeutic in several ways: Both listening and expressing oneself to another cancer patient is very helpful and healing in itself. It is also encouraging to see others getting better as you are also beginning to feel better.
Hazel said that even if some of that is placebo effect, it is powerful and healing.
So there are ways to have a qualitative study, said Pepper, that you can get information and data that are unique and viable. A psychometric scale such as the Likert Scale is a way to ask someone to agree, somewhat agree, somewhat disagree, etc. with various statements. Questionnaires such as this could be given to the patients.
Pepper said it would be a good idea to modify the research that way. Do a more specific group doing a diet that is more exact – that may have some benefits. Dr. Huber said she did not want to do that, because it would take focus away from the more essential dietary focus, namely, to avoid sweetened foods. However, it can be done with more motivated patients, as long as they are able to not lose sight of the main dietary focus.
Pepper asked if a comparison had been made with chemotherapy patients who ate sweetened foods with those who abstained. Collect data on whether a no sugar diet has done better for chemo patients who avoid it or eat it. Dr. Huber said that the data is available to make that comparison, but that numbers for that had not yet been crunched.
Pepper advocated considering a qualitative study with a quantitative study with triangulation.
Dr. Huber wishes to continue the ongoing study with the guidance of the IRB, and the group will continue its review and oversight of the documents related to Dr. Huber’s study of sugar intake and naturopathic treatments of cancer patients, following her summary overview, and on an ongoing basis, as further information is reported by Dr. Huber.
MODIFYING THE NATUROPATHIC STANDARDS WEBSITE TO ACCOMMODATE THE RESEARCH PAPERS AND ABSTRACTS THAT ARE UNDER IRB REVIEW
Both Dr. Proefrock and Dr. Huber agreed to post their research abstracts online on ANRI / NORI’s website, www.NaturopathicStandards.org, when we have a forum in place. We then asked the webmasters for Dr. Huber’s clinic, to upgrade the Naturopathic Standards website to have a forum open to ANRI / NORI members for this purpose.
INCORPORATING AS A 501C3
Pepper has been studying this issue and addressed the group. Pepper urged the ANRI / NORI members not to delay any longer in getting a 501c3 up and running. Because she perceived an urgency to this, Pepper wrote and submitted a qualifying Letter of Intent for establishing a relationship with an umbrella organization. We passed with flying colors to be able to apply for a grant. Pepper than takes us to the next conversation with consideration of 501c3 criteria.
In the last 4 grants that Pepper wrote applications for, she had 3 grants approved and funded. She is involved with a partner, a lawyer, in a business. Because there are people who want naturopathic oncology treatments, but just have no financial resources, there is some urgency in being able to help them. So Pepper vets non-profits and people who want to be non-profits. There are a lot of people who would like to donate to a group. But Pepper can only get this to happen with a 501c3.
Harvest for Humanity is a 5-acre site at Rural and Guadalupe in Tempe that was all zucchini and turnips decades ago. 5-6 years ago Denise Phillips joined and directed this organization. It has focused on growing produce for cancer patients and single parents. A great variety of produce is being grown. This is the organization that has offered to have an umbrella relationship with us.
Pepper listed 6 reasons we should be a 501 c3:
1) We can be exempt from federal income taxes.
2) All donations are tax-deductible for donors.
3) It would qualify us to receive both public and private money
4) We would have lower corporate rates on mail
5) 501c3 organizations get out press releases better
6) It would help to build credibility in the non-profit community.
Eligibility: – there are many ways to be eligible: We could have a general purpose that benefits the public. Don’t be a professional organization of 501c6, because nobody donates to them. Professionals are assumed to be able to take care of themselves.
Organizations can devote themselves to many different things: For example, professional development of the arts, or relief of poverty, or other.
Even if we get an umbrella organization helping us out first, it’s really urgent that we become a 501c3, because it is an untenable position for a 501c3 to have an umbrella relationship with an organization that is not a 501c3 or at least applying to become one.
Dr. Kollin asked if there would be a conflict of interest for patients to receive money from the 501c3, then possibly choose to come to a clinic to spend that same money, if that clinic is owned by a member of the IRB?
Pepper answered that if the money is distributed without bias or strings attached, and if it is distributed to the clinic of the patient’s choice, that would be one way to go about that.
Hazel said if other cancer support organizations are doing this, we could partner with them.
Dr. Lashutka said if an existing group were willing to umbrella us first, let’s go with it.
Dr. Huber asked the members if we should incorporate as a 501c3. The ayes were unanimous. There were no nay votes.
Pepper told us that the IRS doesn’t want to get a new 501c3 started unless it’s been doing work in the community for 3 years. We responded that we were over 4 years active in the naturopathic community. She said yet another organization has expressed interest in ANRI / NORI. A grant application and Letter of Intent should be submitted to them.
Pepper said that the non-profit should be a different organization than ANRI / NORI. Dr. Huber said that if it is alright to use an existing organization that has only existed for one year, she suggested International Naturopathic Clinical Research Institute (INCRI), because it’s an organization that’s existed for a year, and is pretty much the same thing as ANRI / NORI, only includes our international contacts as well.
Pepper suggests that the type of non-profit that we form should be a public charity. This is for cancer patients who are unemployed, underemployed or otherwise disadvantaged. Pepper is also liaison for organic produce from Harvest for Humanity for the cancer patients. Pepper has been doing all of this for the IRB pro-bono. Dr. Proefrock and the rest of the membership thanked her.
Dr. Huber asked how much it would all cost.
Hazel also has experience in grant writing. It will be $60 to file state corporation papers. The total cost will probably be $2,000 to file for a 501c3, although it was only $150 a few years ago. It looks like it costs $400 at the state level. So then you have to get it approved federally. We might be able to get the whole thing done for $695. Get the 501c3 done within the state. Get the state and federal done at the same time. It will be about 90 days, but could possibly, with luck, take only one month.
SHOULD WE AGAIN SPONSOR THE INTERNATIONAL CONGRESS OF NATUROPATHIC MEDICINE (ICNM) ?
Dr. Huber mentioned that we had sponsored the ICNM last year, its first year of existence, and that our motive for going there was to plant a flag of medical freedom / patient choice, to be able to form the initial impression of U.S. naturopathic physicians as those who practice and serve their patients best when they are able to have unrestricted access to all laboratory procedures, and all medical treatments. This would give those in other countries a group to look to for inspiration and if they choose, mentoring regarding the establishment of such an organization in their countries.
Some options discussed were whether to get a quarter page ad or a full page ad as we did last year in the Proceedings Manual.
Dr. Huber said she would look into those options, and what was still available in that regard and the cost. Dr. Lopez volunteered to help with some of the cost.
Everybody introduced themselves.
Hazel Chandler has worked in non-profits, NGOs and government-related work for most of her career.
Dr. Eric Lopez works with Dr. Proefrock at his clinic during the week and works with Dr. Huber on Saturdays. He is the Principal Investigator of the Safety Study for the topical herbal gel that we are studying.
Cathy Stuart is Director of the Arizona Naturopathic Medical Association (AZNMA).
Dr. Inge Barth is active in pain relief, and has studied the properties of medical marijuana.
Dr. Kenneth Proefrock is President of ANRI / NORI and has a private practice focusing on all areas of human health.
Dr. Colleen Huber is Secretary of ANRI / NORI and is in private practice focusing on cancer patients.
Dr. Deborah Rogalla is not currently practicing, but is on sabbatical and is doing research.
Dr. Carol Eastman is research coordinator for the American College of Homeopathy. They are developing training for research subjects. Dr. Eastman has years of IRB experience.
Dr. Cheryl Kollin works with Dr. Huber and Dr. Lashutka, and has previous experience working in genomics related to cancer.
Dr. Kenneth Lashutka is the Treasurer of ANRI / NORI. He practices primary care naturopathic medicine. He works with Dr. Huber and Dr. Kollin.
Pepper Brydon is a writer, videographer and editor. She has years of experience as a multimedia and resource consultant.
The social media consultant for Dr. Huber’s clinic.
The webmaster for Dr. Huber’s clinic and website, natureworksbest.com.
Dr. Bob Waters is a biochemist and statistician at Arizona State University. He has served as Principal Investigator on many IRBs
NEXT BOARD MEETING: Friday, August 22, 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.
Don’t forget $10 dues per quarter per person, payable to Dr. Lashutka in cash.
Please mark your calendars now, to keep that afternoon August 22 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 explained to the membership the reason for bringing in their cases. Bringing in cases and discussing them and letting the IRB review them is probably the strongest thing that you can do, not only to protect your own practice – if ever scrutinized for the non-conventional treatments that you employ (treatments considered to be experimental by the FDA) – but also to protect the breadth of scope that we Arizona naturopathic physicians use!
Of course, agenda items may even be added at the last minute. Meeting adjourned 3:40 p.m.
Colleen Huber, NMD
Secretary, ANRI / NORI
May 9, 2014