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)
February 8, 2013
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the thirteenth 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 12:20 p.m., February 8, 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):
Margarita Hernández-Guzmán, NMD
Colleen Huber, NMD
Cheryl Kollin, naturopathic candidate
Kenneth Lashutka, NMD
Eric López, NMD
María Martínez, medical assistant
Kenneth Proefrock, NMD
Paul Stallone, NMD
Nanao Takaki, NMD
Phranq Tamburri, NMD
Others who have attended previous meetings or wish to attend future ones are cordially invited to join us for future meetings.
MEETING CALLED TO ORDER
Dr. Huber, Secretary of ANRI / NORI, called the meeting to order. She mentioned that this quarterly board meeting has met regularly without fail every three months for the last 3 years, beginning in February 2010, and that we have had a quorum each time, as established in the minutes for each meeting, which are available online for public review.
INFORMED CONSENT FORMS FOR THE CZECH REPUBLIC RESEARCHERS
Dr. Proefrock has asked this Board to review the informed consent forms drafted for use with research subjects in the Czech Republic, at the University of Masaryk, as a favor to the researchers there, and with input as to what considerations we use when drafting informed consent forms.
Dr. Proefrock described his visit to the Czech Republic, the University of Masaryk, and told us about his recent experience exchanging information with researchers there on work done by each on dendritic stem cells. This exchange was mutually helpful and led to new collaboration on the kind of stem cell treatments that each is doing for cancer patients and other patients.
Dr. Lashutka asked questions regarding the role of Dr. Proefrock in relation to the University there and their researchers. Dr. Proefrock talked about the naturopathic role in compounding of natural substances, here in the United States, and how it is helpful to compound for individual patients at the level of the naturopathic clinic, because needs vary so widely from one patient to the next, and it is here where we can most flexibly devise helpful substances. Fortunately, the naturopathic Certificate to Dispense allows the compounding and dispensing of natural substances at the level of the clinic.
Dr. Proefrock described autologous stem cell therapy as the ultimate nosode, the source of the disease containing its cure, in the Hegelian dialectic or Taoist understanding that everything contains its own opposite.
Dr. Proefrock said that the Czech researchers set up the format for how they wanted to receive the data from Dr. Proefrock, and his patients’ data are available to the Czech researchers to incorporate into larger studies on outcomes in dendritic stem cell treatments. Dr. Proefrock also extended the invitation from the Czech researchers to the ANRI / NORI doctors, to welcome any of our patients there in the Czech Republic for autologous stem cell therapies.
Dr. Hernandez thought the Informed Consent forms looked good.
Dr. Proefrock clarified that because stem cells are likely to not be long-lived in deciduous teeth, the cells are harvested from a deciduous tooth very quickly after it is shed. Dr. Proefrock explained that all the stem cells in this research are autologous, as it is in the U.S. at his clinic for example. He described the isolation process and harvesting of the stem cells.
It was generally agreed that the Informed Consent forms were good for the intended purpose.
THE ROLE OF SPECIALTY BOARDS IN NATUROPATHIC MEDICINE
Dr. Tamburri asked if we had read his e-mail, and we all said we had. He said that we are on the cusp of letting the naturopathic profession know that we exist, but also that there are other naturopaths who are interested in what he’s about to discuss, and ready to join us in this purpose.
Dr. Tamburri aims to propose the following to the American Association of Naturopathic Physicians, in the spirit of “Freedom’s the answer; what’s the question?”
1) Specialty boards are respected. However, . . .
2) Their role is to provide guidance to the profession, and their value is to expand the profession, rather than to restrict or limit the scope of practice, particularly regarding naturopathic physicians who are not on those specialty boards.
Dr. Proefrock responded that freedom is not only the answer, but that freedom is never a static answer. N+1 freedoms exist whenever we only think we have n freedoms. That is, one of the biggest problems with restrictions placed on a scope of practice is that it can stifle or pre-empt new and different therapies which have never even been heretofore considered.
Dr. Tamburri reminded us of our Patient Bill of Rights. [Dr. Huber notes here that we actually do not have a Patient Bill of Rights exclusive to ANRI / NORI. Rather, back in the May, 2010 meeting and again in the August 2010 meeting, we voted to adopt the Patient Bill of Rights from the American Association of Physicians and Surgeons, which reads as follows:]
All patients should be guaranteed the following freedoms:
- To seek consultation with the physician(s) of their choice;
- To contract with their physician(s) on mutually agreeable terms;
- To be treated confidentially, with access to their records limited to those involved in their care or designated by the patient;
- To use their own resources to purchase the care of their choice;
- To refuse medical treatment even if it is recommended by their physician(s);
- To be informed about their medical condition, the risks and benefits of treatment and appropriate alternatives;
- To refuse third-party interference in their medical care, and to be confident that their actions in seeking or declining medical care will not result in third-party-imposed penalties for patients or physicians.
Dr. Proefrock said that it really is all about choice.
Dr. Tamburri likened this to the libertarian viewpoint that people should have the liberty to choose any form of treatment they like. Perhaps the uniform consent form that we came up with is a good one for other naturopathic physicians to use. He said that
“it all comes down to the consent.”
Dr. Tamburri expressed concern that he is hearing that naturopathic students are being told that if you’re not a member of a specialty board then you are not allowed to go into the areas of medicine over which those boards lay claim. Dr. Tamburri has been talking to a lot of doctors who are concerned about overreach by these boards. Dr. Tamburri says that the more we explore how other doctors feel about this, the more we’re going to be able to figure out who agrees and who is opposed. You could turn on the lights and see the cockroaches scurry. If anyone says “no, no, no,” (in defense of specialty board hegemony), then we have to ask why. This naturopathic profession has often seemed to be like a younger brother looking to the older brother (the conventional medical profession) wanting to have and do what they have. Yet this is defeating. If we look at history, we see the D.O.’s wanting so desperately to be like M.D.’s, that they gave up the very thing that made them most valuable and unique, namely osteopathic manipulative medicine. Arguably, chiropractic is going this way, as chiropractors have fought hard, with some success, to get insurance reimbursement. Dr. Tamburri said the old timers have seen other professions fragmented and compromised by a desire to be subsumed in the major medical profession.
Dr. Proefrock agreed that the quest for insurance reimbursement can be so self-defeating as to compromise those who take it. [Dr. Huber would like to note that in her experience of having a cash practice that submits claims to insurance, such as her clinic has done for the last couple of years, she has never had to, nor tried to, conform to any demands by insurance companies. Dr. Huber’s clinic operates according to the best medical judgment of the three doctors there, and if insurance reimburses for this, that is fortunate, but insurance reimbursement has never been a determining factor in deciding how to proceed with any patient, or regarding how much time to spend, or what kind of imaging or labs to order, or what treatments to pursue. Just sayin’.]
Dr. Proefrock reminded us that as naturopathic physicians, the standard of care is still that if two or more of our profession are doing something therapeutically, then a third physician has grounds for using that same therapy. If something is taught in an accredited school, that also creates a precedent to help justify use of that therapy.
Dr. Hernández said that we have to choose our words wisely in drafting this proposal, because it is going to be dissected.
Dr. Huber suggested that we begin as follows: “As naturopathic physicians, in recognition of the breadth of our training, the unparalleled breadth of our medical education, encompassing both the widest feasible range of natural medicine, and all of primary care in conventional medicine. Therefore in recognition of this, we re-assert that no specialty board shall pre-empt the basic tenets of core naturopathic principles and especially patient choice in treatments offered to the fullest extent of individual state licensure law.” However, that was rejected for being too wordy.
Dr. Tamburri and Dr. Proefrock both said practically simultaneously: “Specialty boards should only increase our scope and the educational basis for that increase, not restrict it.
The safety of the public is already protected by the State boards, and therefore there is no need and no legal basis for specialty boards to serve that function.”
And as long as there is a proper consent there is no reason for a naturopathic physician to be restricted in any way from the extent of the scope of their training.
We then agreed that the body of the proposal would be as follows:
|“No specialty board shall suppress the basic tenets of core naturopathic principles or especially patient choice in treatments offered to the fullest extent of individual state licensure law, specifically:Specialty boards should promote patient choice, not restrictions.Specialty boards should provide medical options, not limitations.
Specialty boards should provide advice and referrals, not regulations.
Specialty boards exist as private nurturing organizations, not governing bodies.
Specialty boards should lead by example, not by force.
Specialty boards should only increase, not restrict, the naturopathic scope and the educational basis for that increased scope of practice. The safety of the public is already protected by the State boards, and therefore there is no need and no legal basis for specialty boards to serve that function.
Specialty boards have no jurisdiction.
Specialty boards must not fragment the integrity, the wholeness of the naturopathic profession.
Dr. Hernández contributed the last sentence of the above, which Dr. Proefrock agreed with. Dr. Hernández went on to say that our medicine is art and science combined, and our ability to optimally practice medicine is much worsened by unnecessary, unwarranted restrictions. Dr. Huber contributed the next to last sentence about jurisdiction.
Dr. Tamburri summarized the ANRI / NORI position this way: My agenda is I want to keep my freedom, and I want to keep my patients’ freedom of choice. Ultimately it’s about the patient’s right of choice. This is the ultimate way to heal and to give patients options. And the specialty boards may certainly exist, only they should never dictate what can or cannot be performed by naturopaths.
Throughout Dr. Tamburri’s presentation of these ideas and this proposal, it must be acknowledged that the ANRI / NORI members in attendance offered frequent comments of approval and enthusiastic agreement with Dr. Tamburri’s motion, and it was met with unanimous encouragement, and admiration of his initiative.
Dr. Tamburri reminded us that the next AANP meeting is in April, and that we should be able to present this to them by then.
Dr. Huber said that if it is presented as a “petition” but has fewer than 100 signatures, it will look like a weak petition. However, if it is a “letter” signed by multiple naturopaths, it will look more substantial.
Dr. Tamburri said that the AANP by-laws say now that Onc-ANP is the highest standard of cancer care in our profession, so although a dominant role for the specialty boards is not the law, the potential for erosion of our rights has already been set in motion. He then asked, “have you recent grads been told you have to be in OncANP in order to treat cancer patients?”
Cheryl Kollin is a recent graduate, and had not had this experience; however Dr. Tamburri’s understanding is that students are now being told that it is medically unethical to treat cancer patients. Dr. Lashutka said that the naturopath who taught his oncology course in 2008-2009 had said this, that it is medically unethical unless there is also conventional treatment.
Dr. Proefrock summarized some of the political considerations of regulation: Libertarians tend to eschew government and therefore are under-represented on regulatory bodies, leaving those less committed to individual liberties to be in charge, and capable of either upholding or destroying those liberties. Therefore, a proposal such as ours will have an uphill battle to get adopted.
Furthermore, malpractice companies have incentive to regulate, because they are afraid that a doctor may be somewhat of a wild card, which would risk future payouts, unless that doctor is uber-regulated.
Dr. Tamburri speculated that the universal insurance reimbursement aspect of Obamacare would either kill off cash practices, or itself implode from being unworkable. Dr. Huber argued that non-discrimination against licensed healthcare practitioners / universal reimbursement is already the case in Washington state, which seems to be a sustainable system. Dr. Tamburri countered that Washington state is not necessarily representative of what would happen on a nation-wide scale. It was then agreed that such political debate was too much of a detour from the business of this meeting.
In the ANRI / NORI meeting of May 2012, we discussed qualification for the awarding of an ANRI fellowship or a NORI fellowship to ANRI / NORI members. We had agreed back then that each doctor should present 5 case studies in order to qualify for this designation, and the membership agreed. We look at those 5 cases, and we ask questions, such as what is happening with the patient now, and questions based on seeking further clarification of what happened during treatment. We also give treatment suggestions for unresolved cases. We had decided that during each meeting a certain number of cases could be presented, perhaps one from each doctor each time, until each doctor arrives at 5 cases presented.
It was generally agreed that case studies would be the requirement of a Fellowship for ANRI or NORI, depending on the nature of the cases presented, ANRI for general cases, NORI for cancer cases, as each physician prefers for himself or herself.
We had agreed back in May that next time we would begin to all bring case studies and begin with these, and that as time goes on more and more of our meetings would be about this. So that is how we spent the remainder of today’s meeting.
Today Dr. Proefrock presented his fifth case to the Board, that of a patient with a brain tumor. The patient had considered going to get anti-neoplaston therapy at a famous clinic in Texas. At that clinic, the use of phenyl acetone and phenyl acetyl glutamate is a ketogenic approach to brain tumors. Once you get a person into ketosis with a brain tumor, you can very likely shrink the tumor. You can get differentiation of tumor tissue to become more normal tissue. So what happens is a massive amount of ketones is given orally as well as by IV. Now, medicine is a superstitious field, said Dr. Proefrock, and when people get fixated on a treatment, there may be an unjustified amount of faith placed on the treatment. Then, worsening the decision-making ability of the patient, the quality of decisions gets compromised by the cognitive effects of the brain tumor.
When we are in the mode of giving patients choices, you are not always going to be able to talk them and their families out of bad decisions. So for example in this case, Dr. Proefrock said, he had been feeding a lot of phenyl butyrate to the patient. When this happens, you generally see a slowing of the growth, and when you see shrinkage, it’s because ketosis is a dehydrating process, and the reduction of fluid is very helpful because of tight volume restrictions in the skull.
Dr. Stallone then presented his fourth case to the Board of a breast cancer patient, with invasive ductal carcinoma, who had had Gerson clinic treatments. She then met with Dr. Stallone and began IV treatments with him. Somehow she had gotten the advice, prior to ever meeting with Dr. Stallone, that she could address a breast tumor with black salve, and that would be preferable to surgery. Only too late did she find out that it destroyed a large amount of breast tissue, and ended up with a worse outcome than an early surgical lumpectomy would have created.
Dr. Huber commented that she has seen a fair number of these cases of ill-advised desire “not to be cut on,” where black salve had been used at home instead of surgery and mangled the breast far worse than surgery would have done. Dr. Huber said that black salve is more appropriate for some skin cancers, in consultation with a patient’s doctor, than for deeper tumors under intact epidermis. However, Dr. Huber expressed empathy for a disgruntled patient, having received unsatisfactory treatment from the medical community, wanting to take matters into her own hands, and trying to re-assert her control over her own body and outcome with the use of black salve.
Dr. Lopez presented a case of a patient who waited so long with a breast cancer before seeking any medical help at all, then finally came to him once it had metastasized so widely that it was now very challenging to treat. We talked about the need to move forward with a patient from that day on, and not dwell on what should have happened, no matter how glaring the patient’s mistake had been.
Dr. Huber then presented her fourth case to the Board, of a hepatocellular carcinoma patient who had a successful liver transplant. With the drug Prograf, the patient is doing well with the new liver, and from the imaging it appears to be cancer-free. Then there were lung metastases, but these were also successfully resected with clear margins. Now there appears to be in this patient only one remaining body burden of cancer, and that is in the hilar lymph nodes. The challenge is to fight the cancer, while being careful not to stimulate the immune system in the wrong way.
Dr. Proefrock responded that Prograf seems to work on the major histocompatibility complex, and that this antigen is the most common cause of organ transplant rejection. So a treatment strategy then would be to stimulate the immune system only in such a way that would not interfere with Prograf’s suppression of the HLA antigen, and would not stimulate production of interleukin-2 (IL-2). Dr. Huber wondered if Vitamin A’s role in cell differentiation and making cancer cells more apparent to the immune system as “non-self” may mean that Vitamin A would not be a feasible therapy for a transplant patient. (Here is a link to an abstract discussing this role of Vitamin A in the immune system: http://www.ncbi.nlm.nih.gov/pubmed/21471300
Clin Vaccine Immunol. 2011 Jun;18(6):1015-20. doi: 10.1128/CVI.00004-11. Epub 2011 Apr 6.
Retinoic acid and α-galactosylceramide differentially regulate B cell activation in vitro and augment antibody production in vivo.
Department of Nutritional Sciences, Pennsylvania State University, University Park, Pennsylvania 16802, USA.
CONGRATULATIONS ARE IN ORDER
Cheryl Kollin, our naturopathic medical graduate and licensing candidate, accomplished the nearly superhuman feat today of attending our Board meeting directly following the final morning of the Naturopathic Clinical Licensing Board Exams. We are in amazement at her stamina for even staying awake immediately after such an ordeal, let alone doing us the honor of attending the ANRI / NORI board meeting!
INTERIM CONFERENCE CALL
We seem to need another meeting before the next board meeting to be sure that we have the language that we want in order to submit to AANP. Dr. Hernández-Guzmán offered to organize a conference call for us, and we agreed that a weekday evening would be best. Shall we plan on 7:00 p.m., and Dr. Huber requests that it be a Wednesday or a Friday due to late work hours the other days.
NEXT BOARD MEETING: Friday, May 3, 2013 at noon, at the usual place, the clinic of Drs. Huber, Lashutka and Jemison, in Tempe. Food from Chipotle’s will be served, unless objections surface before then. Dr. Huber apologizes for the Carnivores R Us lunch today. The platter order has now been messed up 2 or 3 times by this one place, so Chipotle’s is probably a more reliable option. That way, we can get individual orders next time also.
Please mark your calendars now, to keep this afternoon 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 continues to offer for her clinic to provide lunch for the meetings at no cost to the membership, in order to save up the usual $10 dues per quarter per person to pay the $400 fee for the eventual incorporation of the non-profit.
POSSIBLE AGENDA ITEMS FOR MAY 3, 2012 BOARD MEETING
These meetings are the opportunity to present anything that you think important or interesting. Of course, agenda items may even be added at the last minute.
Colleen Huber, NMD
Secretary, ANRI / NORI
February 8, 2013