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)
INVESTIGATIONAL REVIEW BOARD (IRB)
May 3, 2013
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 fourteenth regular quarterly meeting of the American Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) and the Institutional Review Board(IRB) was called to order at 1:11 p.m., May 3, 2013 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
The following members were in attendance (alphabetically by last name):
Dr. Thomas Jemison
Dr. Cheryl Kollin
Dr. Kenneth Lashutka
Dr. Eric Lopez
Dr. Kenneth Proefrock, presiding over meeting
Dr. Paul Stallone,
Dr. Nanao Takaki
Dr. Phranq Tamburri (by Skype)
CLINICAL APPLICATIONS OF CANCER STRATEGIES CONFERENCE
We began the meeting by discussing the recent Healthy Medicine Academy conference,
April 26-29, 2013: Integrative Cancer Medicine, Clinical Applications of Cancer Strategies, DoubleTree Resort by Hilton, Paradise Valley – Scottsdale, AZ
Dr. Proefrock was a speaker on Lung Cancer, as well as on a panel discussion regarding general approaches to patients with cancer. Drs. Huber, Kollin, Lopez and Takaki were attendees.
The conference was well-attended and informative. Some of the more interesting discussions revolved around long-term prevention, as well as short-term, acute interventions for fulminant cancerous processes.
Of note, and discussed at this meeting:
The use of tetrathiomolybdate, a copper chelator, in preventing metastatic processes. Dr. Proefrock has used this modality extensively in the past. Some clinical pearls: 100 mg/day is a usual dose—desired goal is a ceruloplasmin level of 8-12. Check the baseline and adjust dosage according to need. Most people can get to the desired goal and then go off the prescription; recheck after 2-3 months and resume therapy as needed.
The meeting turned then to a discussion of particular modalities, including ozone.
Regarding ozone, per Dr. Kollin from Dr. Psenka: ozone is not always good for cancer; there are many variables that have to be accounted for.
Dr. Stallone described calibration of ozone generators: gamma measurements are used. 78-83 gamma creates more cytokines. This is the German approach. Italians are more at 60 gamma and find less cytokine response.
Prolozone in joints is different. There is plenty of research to show that certain concentrations work for different problems. Shallenberger likes 20 gamma for joints. 20-38 is what Dr. Stalllone uses to good effect with minimal degeneration and decent effect at shortening ligamentous structures. If bacterial encroachment into the joint is suspected, consider increasing gamma.
The discussion turned to PRP and the importance of reevaluating tried and true methods. In this instance there are now FDA approved centrifuges with kits ($200 plus per kit).
FDA requirements were discussed. There are variable speed centrifuges. The C5-variable speed is the one that Drs. Proefrock, Lopez and Takaki use at their clinic.
The question arose of how to reconcile a methodology/procedure that was born out of an essential trial and error clinical process that still allows benefit for individuals when the physician can make subtle changes in the technique, vs. relying on a piece of equipment that is considered, in some circles, superior to other methods because it has been FDA approved. Dr. Proefrock’s clinic has been doing platelet counts and considering some growth factor assays on selected samples to determine effectiveness of different centrifugation strategies.
Regarding old business, nothing was brought to the floor.
IRB FULFILLMENT AND INFORMATION SHARING
The meeting then turned to a discussion on considerations for how to share protocols/strategies, how to protect proprietary information, and yet find ourselves complying with IRB requirements. The IRB should have general protocols available from practitioners for whom the IRB is supposed to be a point of accountability. The primary intentions behind creating the IRB was: 1) to provide an avenue of FDA compliance for those of us practicing in the realm of ‘experimental medicine’ 2) to provide a forum for the sharing of information and a place where the other practitioners involved can review strategy and make comments regarding safety and efficacy and scope of practice.
1 and 2 are not mutually exclusive as the one derives from the other.
Dr. Lashutka brought up the example that cesium is considered by some sources as a heavy metal with potential toxicity, whereas we have seen it used safely and to beneficial effect in the clinical setting, which seems to beg for some clarification of what represents chemotherapy vs food based items. We recognize that it does not serve us to create such a demarcation, but we need something more than the current Board definitions which are very vague. Being vague allows for selective enforcement and forces precedent. If we allow specialty boards the luxury of determining standards of care, then those of us in practice prior to the specialty boards or those of us who desire to offer patients interventions outside of specialty recommendations may well have to go before the board with some precedent that a given intervention is safe and efficacious.
It was suggested that there be some sort of a forum to share strategies and protocols, so that the IRB is seen to do its job and to be maintained. Our case presentations are how we go about this. But beyond that, we need an experimental medicine database, in order to ensure safety for new practitioners as well as for enforcement/investigative purposes. This should be accessible only to ANRI/NORI members.
Dr. Jemison asked about any rubidium toxicity. The response was that up to 2 mg doses are generally safe.
Dr. Stallone discussed heavy metal profiles and our approach possibly causing those tests to be off.
Do we still have forum access? Remember the informed consent letters.
Dr. Lashutka feels that their clinic has such a broad spectrum approach to cancer patients that a single agent type of informative process would not jeopardize anyone’s proprietary information.
Dr. Lopez asked how an organization like ours could help new practitioners. Some groups are obviously more inclined towards a complementary approach, and few are interested in a primary approach to alternative cancer care.
GRAND ROUNDS: CASE PRESENTATIONS
Dr. Nanao presented the case of a patient, a 50 year old female, referred by her dentist. She had bad reactions to titanium implantation, which destroyed her mucous membranes throughout her entire GI tract. The patient was very difficult to understand, unable to talk well, had several obstructions in small intestine, severe achalasia, was RF+, suffered from arthritis. The patient, smoking 1.5 packs per day, taking in no solid foods, no pills, arrived at Dr. Nanao.
Dr. Nanao’s strategy was to heal the gut: She used glycine, glutamine, glycyrrhizinate and cromolyn sodium in powder. The patient is at times compliant. Dr. Nanao prescribed medical marijuana for the patient’s persistent nausea. She also recommended focus smoking—1 or 2 cigarettes per hour, asking, why am I smoking?
Dr. Nanao feels that her efforts to establish rapport and hear the patient really established a strong relationship. That was important as the patient had recommendations from four other physicians that she was not comfortable with. She is comfortable with Dr. Nanao. Now she is considering a nebulizer approach to cleanse her lungs, improve her diet and possibly some IV nutrients.
Dr. Nanao considers that the patient has a toxicity issue. She is considering some botanical tinctures and IV detoxification. She is considering Phytolacca and Iris and soothing things.
The patient is excited about the fact that she can heal herself.
A relatively long discussion ensued regarding the legalities and ethics of medical marijuana.
Dr. Jemison presented a case of a 52 yo female with hairy cell leukemia a few years ago. She was among the 15% for whom navelbine and fludarabine were ineffective. She was prescribed Pentostatin. The patient then came to find other therapies. She is currently having IVs twice a week, supportive treatments. The patient owns a juice bar, does Herbalife. Her biggest complaint was that she had splenomegaly 20 cm across. Surgery was not an option. The goal was to bring the spleen down. The goal has been achieved. Now U/S shows 12-13 cm spleen, chronically anemic but asymptomatic. She had a transfusion and it helped none. The symptoms did not improve with transfusion.
Dr. Jemison wanted to present the case to the board in order to find things that will reduce size of the spleen.
Dr. Stallone suggests Pleo Pin for splenomegaly. Dr. Proefrock discussed botanicals like Ceanothus, Celastrus, Alpinia, and antiviral agents.
Dr. Kollin was a clinical laboratory technician for Dr. Robert Nagourney for nine years—she would work on the biopsied specimens from cancer pts and find the most appropriate cancer interventions from a chemotherapy perspective. She found that leukemias and lymphomas are the easiest to deal with in that approach, working with blood samples.
Dr.Tamburri made his appearance by internet, and addressed ANRI / NORI. The AANP meeting had just ended. They were shuttled to the bylaws committee. Dr. Marchese was unable to make that meeting. For our proposal, the AANP wanted letterhead and signatures. The final version has been emailed. That letter has the intention of introducing this proposal regarding the role of specialty boards. It is now in the hands of AANP delegates. Dr. Marchese couldn’t meet, and Dr. Tamburri became her proxy. There had been about 40 people on the line—it was a phone meeting—the vote regarding the standards of care bill—defining what the standards are for naturopathic doctors.
It was debated and put up for viewing and public discussion, but no discussion happened. The State of WA hired an attorney to stop it. The vote today was barely passed; there were too many abstentions.
Regarding our proposal, we were at the end. Dr. Cronin was presiding and gave Dr. Tamburri five mintues to describe the proposal. Dr. Cronin stopped him and said that this is a bylaws group, but that ours is a position paper. If it is to be a bylaw it needs to be more technically legal. Dr. Tamburri described the people involved and the fact that this meeting was the place to start. The number of signatures attracted attention but they felt the movement was not pertinent to that committee. They want a specialty board task force.
This issue was brought up ten years ago, and killed due to misunderstanding. Dr. Tamburri would like us to define specialty rather than specialty organizations defining us. The vote was unanimous for our proposal. Dr. Tamburri is facilitating the next step of cooperative effort with some other doctors from that meeting. A task force is expected to be created. Two other issues regarding specialty boards: AANP members debating merits of Obamacare and specialty groups. The arguments are similar: specialty groups are a good thing if we go with Obamacare. The reason is that when this medical system goes into play, there will be limited money and competition will ensue. They will have to reevaluate the efficacy of treatment interventions.
What we do is difficult to quantify for Obamacare. Specialty groups have a protocol orientation, which is what government wants to see. In Colorado this year, at the AANP conference, the hot topic agenda item will be specialty organizations! This was decided before our proposal even came up.