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)
February 10, 2017
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-ninth 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., February 10, 2017 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
17 members and guests were in attendance. This included 13 physicians and 4 non-physicians.
NEWS: VICTORY FOR NATUROPATHIC MEDICINE IN MASSACHUSETTS
We had wonderful news since we last met, this time from the State of Massachusetts: Both houses of their legislature passed a bill, with bipartisan support, to license and regulate naturopathic medicine. Since then, Governor Charlie Baker then signed it into law, making Mass the 19th state to license naturopathic medicine (as well as the District of Columbia, Puerto Rico and the Virgin Islands.) More information on the Massachusetts news is available here:
That should mean only 31 states (and most of the world) to go!
NATUROPATHIC PHYSICIANS AS EXPERT MEDICAL WITNESSES IN COURT
One of the physicians present described having been asked by a patient’s attorney to be an expert witness in a case involving a question related to the patient’s health. Without going into much detail, the judge admitted the testimony as such, and related documentation, signed by the naturopathic physician, was filed as an Exhibit to the case. So there is now precedent of a medical documents written by a naturopathic physician admitted by a judge in a court of law.
However, our legal counsel advised us that a trial court, such as the venue of this particular case, only imposes what the law says, and only has persuasive authority. An appellate court on the other hand, actually says what the law is. That is, the present case does have some value as persuasive authority in legal precedent to be viewed in future cases, and the current case, if resolved without future appeal, would then never proceed to appellate court.
Another doctor said that other naturopathic physicians have served as expert witnesses in Arizona courts in medical matters. These should be referred to when such precedent is required to be cited in future cases.
It was noted that legislative committees at the state level should not be comprised primarily of those with a vested interest. Some of those who perceive themselves as in competition with naturopathic physicians would vote to restrict every aspect of our scope of practice if they could.
One doctor noted that when you go to the ER, and the doctor pops his head in and says, “Whazzup?” the bill for that word alone is $600. Then a ten-minute procedure of placing 4 stitches and 3 staples in a laceration turned out to be a $1,600 line item. No wonder insurance premiums are going through the roof.
It was mentioned that the return to Pharma for the cost of each lobbyist is 21 times that cost.
Two doctors commented on medical conferences that they had recently attended.
WHEN PATIENT INTERESTS ARE PRIORITIZED IN A LEGALLY NEBULOUS ENVIRONMENT
A doctor said the #1 goal is to work in the best interests of the patients. If a particular substance is in a gray area of the law – not entirely established if legal or illegal – but if it’s helping a patient, and the patient was fully informed and signed the informed consent, then the doctor has a stronger basis for using it, and then having the use of the substance under this IRB makes a still stronger case for its use, if the topic ever comes up in a regulatory arena.
It was noted that such fire in the belly for asserting the rights of our patients to make choices in treatment, and to assert our rights to treat them as both doctor and patient agree, is what keeps our scope as broad as it is ultimately in the long run.
Our attorney reminded us that if there is no law out there that says ‘You cannot do this or that,’ then legally we are in a gray area, and there is no guarantee that the outcome of a dispute would turn out favorably or not.
The use of various substances was discussed.
One of the researchers said, “You have to have case studies a priori (which could be from outside, as reported in published research). Only then do you submit to the IRB.
He also said that this IRB was especially helpful, because we never had a complaint by a study subject. Also, we never had a complaint by other researchers. But always go the extra mile to stay squeaky clean: Make sure of the pedigreed sources of the materials that you use.
He also commented that there are very few IRBs to do alternative medical evaluations. And when they do, they always take too long and they don’t understand protocols. Stay steadfast, he advised the rest of us. And, “You guys help patients wonderfully.”
He mentioned that there is a lot of breast cancer in the Caribbean, even in young women. And now there are massive $$$ chasing down a genetic cause, which is a tragedy, because five to ten years will be lost going down the wrong road, allowing the true cause, which has to be environmental, to go unnoticed and unchecked.
One of the doctors made a motion to amend his initially proposed research to include all physicians that were here in the initial training of use of a particular substance as covered in his study as presented and approved by this IRB.
Another doctor seconded the motion.
The motion passed with unanimous Ayes, and no Nays.
A question arose regarding immunotherapy and its use against cancer. One doctor mentioned that in the limited experience that she had with it clinically that it had not seemed to be as effective as other measures used naturopathically in cancer treatment.
It was noted that Keytruda brings massive amounts of revenue to conventional oncology, and has horrendous adverse effects including highly fatal pneumonitis. So immunotherapy is another cash cow apparently for its vendors (Merck).
We got our projector and screen up and running, which is why the meeting was conducted in the dark, and we hope nobody minded too much. Then we spent some time with that.
We first went to the www.NaturopathicStandards.org, which is ANRI / NORI’s website:
Ideas are welcome for editing the site, which members may want to think about over time, and contribute suggestions.
We read aloud Dr. Proefrock’s description of ANRI / NORI that we used for the US directory of IRBs:
Who We Are
The American Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) are co-dependent, non-profit, research institutes focused on studying, understanding, and developing Naturopathically-oriented solutions for persistent problems in healthcare. ANRI/NORI have jointly formed this IRB in order to provide oversight of basic and clinical research related to therapeutic interventions and strategies that are based upon the historical imperatives that have shaped the evolution of modern Naturopathic medical practice. Our research oversight includes, but is not limited to, safety and efficacy studies for novel, natural therapeutics as well as study design for use within the clinical setting of independent practitioners to validate safety and efficacy of complex, multi-component therapeutic interventions. This IRB serves an international community with oversight over a number of small, clinician run, independent clinical studies being conducted worldwide as well as several large university–based, federally grant-funded, investigational studies being conducted in the US, Canada and Europe.
Another doctor said, and the rest of us agreed, that this was a really awesome description, and the group was quite pleased with it.
We then looked at Dr. Benjamin Rush’s advice to fellow signers of the Declaration of Independence, that Americans would rue the day if not writing medical freedom into the Constitution. We agreed and lamented that Dr. Rush’s peers should have listened to him.
We had discussed using today’s meeting to discuss practice-building techniques. One doctor discussed implementing certain practice-building tools.
One doctor presented a case of a 63 year old female patient post-hysterectomy, with a biopsy-proven diffuse Non-Hodgkins Lymphoma (NHL) diagnosed in May 2016. She had been treated with chemotherapy, and then was told that chemo did not work for her anymore, and that the side effects were too threatening to her, and that she had to discontinue it, and to put her affairs in order, and go to hospice.
6 weeks after her last chemotherapy, entering in a wheelchair, she met with the naturopathic physician. He found that her Vitamin D was critically low, at only 6.9. She had lots of signs and symptoms of low Vitamin D. Her calcium was very low. Her GFR was 39. Her hemoglobin was quite low. She was extremely hypothyroid. She had painful nodules, lesions throughout her abdomen. She had peripheral neuropathy. She was jaundiced.
The doctor started her on various naturopathic treatments, which were described for the group.
Then her energy and demeanor improved greatly over the next 4 months. She got out of the wheelchair, and went for long daily walks. Her neuropathy improved. On the first imaging, it was found that the tumors stopped growing. The 2nd imaging, an abdominal MRI with contrast, it was found that the tumors no longer demonstrated any metabolic activity. Then the CT showed the lesions had decreased in size by 75%.
That doctor also addressed questions of testing in his patients.
Another doctor then presented a case of a Stage IV breast cancer patient, and the naturopathic treatments used, as described for the group. The patient is now walking better with less pain.
PROBLEM WITH AZ PMP DATABASE
Another doctor mentioned a new problem with the prescriber database:
Apparently the software/website has been changed, and the new version no longer lists naturopathic physicians in the drop-down box from the choices of type of provider.
Our attorney commented on this matter..
Another doctor mentioned that there is a representative, a liaison between the AZNMA and the Pharmacy Board that manages that database, and perhaps she would be the person to get the AZPMP to fix the problem.
We agreed to meet again next time on Friday, May 12, 2017– usual time and place.
Meeting adjourned at 2:45 p.m.