Two recent SBM posts have used the “Wild West” metaphor for poor health care regulation. Arizona may be the wildest: a worst-case scenario of a state licensing pseudoscience as medicine, under the cover of so-called naturopathy “research.” (Photo courtesy of the Orange County Archives, some rights reserved).

Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.

Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.

In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.

Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.

Arizona’s unusually broad scope of practice for naturopathy

In Arizona, licensed naturopaths benefit from the broadest naturopathic scope of practice in the United States. Arizona law treats naturopaths like primary care physicians qualified to diagnose and treat diseases, administer vaccinations, and perform sports physicals (also chiropractors too) on young athletes. They are legally permitted to:

  • write prescription medications including some schedule II drugs
  • certify patients for medical marijuana
  • perform minor surgery
  • administer substances intravenously
  • dispense natural medicines such as desiccated animal organs, nutritional supplements, herbs, and homeopathic preparations

In the United States, naturopathic scopes of practice vary wildly across 16 states and jurisdictions. In some states, like Alaska, licensed naturopaths have very narrow scopes: they cannot diagnose disease, prescribe pharmaceuticals, or call themselves “physicians.” (Oddly, insurance reimbursement is mandated for their services.)

In California, naturopaths appear more like physician assistants: naturopaths require supervision by a physician (MD/DO) to prescribe from a limited formulary, but they can independently perform physical exams (including gynecological exams), order labs and imaging, and propose diagnoses. They can call themselves “doctors” but not “physicians,” and insurance coverage is not guaranteed. For more information see Dr. Stephen Barrett’s page on naturopathic regulation from 2005, useful even if somewhat outdated.

But the scope of practice is broadest of all in Arizona. This would be a problem even if it was regulated properly. But it’s not.

Arizona’s sketchy regulation of naturopathy

Like other states with naturopathic licensure, Arizona has a naturopathic board of physicians tasked with licensing and regulating the practice of naturopathy. In my opinion, this board has done an unusually poor job of regulating naturopathic medicine to protect the public. A quick look at its disciplinary actions shows a chronic pattern of weak regulation and inadequate sanctions for what appear to be serious instances of professional misconduct. The Arizona naturopathic board also has a history of scandals:

The Arizona Auditor General’s office condemned the board in 2000 for severe shortcomings in how licensees are examined, how quickly complaints are resolved, and how the board is managed. Most appalling, the naturopathic board was found to have inflated exam scores so every applicant would pass.

Fourteen years later, things hadn’t improved much.

In 2014, the Auditor General reported that the naturopathic board still needed to strengthen examination and licensing requirements, improve complaint processing, develop consistent policies for serving disciplinary actions, and provide timely and accurate licensing and complaint information to the public.

As I explained last month in my first post for SBM, the education and practice of naturopathic medicine is so uncritically diverse that nearly any kind of treatment of patients is considered acceptable. Thus, it follows that naturopathic regulation must be weak for such practices to be lawful. In a state with a scope of practice as broad as Arizona’s, patients face considerable risks as naturopaths are permitted to treat patients however they like without regard for evidence or science.

This regulatory environment also creates a strange opportunity for hijacking the system.

Photograph of artifacts at America's Largest Antique and Collectible Show by liquidnight, some rights reserved.

Almost any kind of treatment of patients is acceptable in naturopathy. (Photograph of artifacts at America’s Largest Antique and Collectible Show by liquidnight, some rights reserved.)

A naturopathic ethics committee?

A group of Arizona naturopaths established an Institutional Review Board and research group to direct, approve and monitor “naturopathic research” conducted by its members and other naturopaths in private practice. In my opinion, they are not conducting any legitimate medical research. Rather, they are using the group to establish flimsy standards of care and conduct dangerous experiments on patients.

A real IRB is an ethics committee designated to scrutinize research involving human subjects. An IRB ensures that research on people meets reasonable ethical standards for patient privacy, informed consent, and (most importantly) protection from physical and psychological harm. IRBs are crucial components of enforcing ethical standards in human research. Any medical IRB in the United States must be registered with the Food and Drug Administration.

The Arizona naturopathic IRB was founded in 2010 by licensed and practicing naturopaths and has three names:

  • Arizona Naturopathic Clinical Research Group (ANRI)
  • Naturopathic Oncology Research Institute (NORI)
  • Institutional Review Board (IRB)

ANRI/NORI/IRB states on NaturopathicStandards.org that the group strives to protect Arizona’s naturopaths against regulatory and malpractice insurance liability that could “erode and restrict the scope of naturopathic practice.” I think it’s striking that an ostensible ethics committee takes an adversarial stance against institutions that serve to protect patients, which is what an IRB is meant to do — not protect the naturopathic profession. I am concerned that the ANRI/NORI/IRB defines valid treatments for study and practice as anything taught in naturopathy school or done by two or more naturopaths. So, it seems, anything goes.

The main goal of ANRI/NORI/IRB is to “explore and conduct research” using naturopathic treatments that embrace “diverse practice modalities in a non-judgemental way” that will hopefully lead to “the greatest possible [number of] treatment choices” for patients with serious health conditions, like cancer and autoimmune diseases. (I spliced up the summary and quotations to provide an accurate gist, but you can read their whole mission statement, which actually seems more damning than my abridged version.)

The ANRI/NORI/IRB’s priorities are suspicious.

IRB shenanigans

Let’s review an example of how ANRI/NORI/IRB’s board members consider approving naturopathic research from their board meeting minutes dated February 13, 2015.

Cast of characters:

Kenneth Proefrock, NMD, President of ANRI/ NORI/ IRB, vice-president of the North American Board of Naturopathic Examiners and founder of the Arizona Stem Cell Center.

Debbie Rogalla, NMD at Simply Ageless Nation.

Mary Ellen O’Brien, NMD with her own private practice.

Andrew Dickens, NMD at Healing Pathways Medical Clinic.

Cheryl Hamilton, NMD at the Women’s Health and Healing Center.

Bob Waters, PhD, professor at the Southwest College of Naturopathic Medicine; board member of the Aviratek Biomedical Solutions which develops botanical medicines; board member of Relief Blue which develops botanical cold sore treatments; a researcher at LiquidCMO which makes botanical medicines for fibromyalgia and osteoarthritis patients; he is also a former adjunct professor at Arizona State University’s Biodesign Institute.

This is the full text of the IRB minutes discussing Dr. Rogalla’s “research”:

Dr. Rogalla said: I want to start a brain center, and I want to compete with the largest neurological centers and distinguish myself for offering integrative-type therapies. I feel working under an IRB would give me some credibility. I feel it would help me protect myself from those who say it would be crazy to give fish oil, for example, to a patient with a neurological condition. Also if I work with others in my office, I would want them to be protected under my IRB umbrella.

Dr. Proefrock asked: Do you have a protocol for how to interview patients and how treatments would be chosen?

Dr. Rogalla said that there are many categories of patients: MS, ALS, Alzheimers [sic], sleep problems.

Dr. Proefrock asked: Do you provide the diagnosis, or do they come in with that?

Dr. Rogalla said: They’ve already been diagnosed. I feel like I don’t want to put a powerful label on a person. Also, I don’t want to do invasive procedures. Those should already have been done in the conventional medical community prior to coming in. Now there are wellness programs for various conditions and optimizing programs – like for kids who want to do better in school, or seniors who want to prevent cognitive deterioration.

Dr. Hamilton asked: Is this like doctors who do brain scans?

Dr. Rogalla responded: I want to stay away from SPECT scans, because of all the radiation. I would like to do QEEGs, etc. There are gentle and non-invasive ways to diagnose and to treat people. But I would require the labs and imaging to back up the diagnosis.

Dr. O’Brien asked: Do you have an evaluation plan, so that every few months you can reassess?

Dr. Rogalla responded: So if they’re coming in for the wellness side or the optimizing side, I want to track that, based on condition and the therapies.

Dr. Proefrock asked: Can you bring us case studies as this unfolds, so that we can know what happened after this remedy or that?

Dr. Rogalla agreed to do so.

Dr. Hamilton asked, so if you work with other doctors, who are giving other prescriptions, are you coordinating?

Dr. Rogalla replied: In my HIPAA form I ask permission to share. If a patient chooses not to, I would honor that. Most of the patients will be on hard-core drugs. So I would be heavily invested in homeopathics and frequency specific micro-current.

Dr. Dickens asked: Would you do any testing, such as Neuroscience or something like that?

Dr. Rogalla responded: I may order baseline organic acids or neurotransmitters, depending on their condition. But a lot of what they do would be based on their existing treatment programs. I would like them to work with a PCP, neurologist and other team members.

I added low dose naltrexone (LDN) on the list, because it’s a controversial area, technically off-label. But I’d like to err on the side of caution, have it on the IRB. In Europe, research has shown LDN can be compatible with a lot of the Rx’s out there. It can be compatible to wean them off their current Rx’s.

Dr. Proefrock said: I think it’s exciting; I think you have a good idea. From an IRB perspective, it’s broad, but that’s okay. In principle, I have no disagreement with it.

Dr. Dickens said: I make a motion to accept Dr. Rogalla’s research for review by the IRB. Dr. Huber said: I second it.

Dr. Proefrock said: All in favor aye; opposed nay.

[The motion was approved unanimously.]

I missed it: what is the research project under review?

Dr. Rogalla tells the board that she wants to setup a private clinic for patients with severe neurological diseases and have “IRB credibility” so she will be “protected.” She seems to anticipate that her naturopathic clinic would treat patients in a way that regulatory or consumer groups might find inappropriate or illegal. One wonders if her motivation is to protect herself, not her research subjects, particularly since she doesn’t say anything about research subjects. She identifies no research population other than her own patients, and doesn’t present any information about her research design. Her methodology seems to be to treat neurology patients in her naturopathic clinic with fish oil, low-dose naltrexone, homeopathy, and frequency-specific microcurrent (also a mystery to me).

I am deeply troubled that she discusses her plans to experiment with weaning patients off of “hard-core drugs” — and I don’t think she means heroin or crystal meth. Her attitude towards prescription medications indicates she might not understand or respect the medical treatments she hopes to usurp.

She fails to mention how she will do anything ethical for her patients in her study, except to “honor” their preference for privacy. There is no mention of informed consent, how the data will be disseminated and published, or how the research is funded. She will not even be confirming the diagnoses of her patients! (Perhaps she doesn’t know how.) Most troubling, the IRB board members ask her irrelevant questions and simply encourage Dr. Rogalla’s extremely insufficient research design. The board members do not scrutinize any aspect of her proposal, as a proper IRB would certainly do.

Read the whole text: there’s a lot more questionable content and interesting dialog that paints a dark picture of this group of naturopaths.

Naturopathic “research” versus ethics

The purpose of a medical IRB is to ensure the safety and protection of research subjects. In the above exchange, there appears to be a complete lack of concern shown for the welfare of Dr. Rogalla’s patients. Instead, it seems like the other naturopaths on the board are rubber stamping a naturopathic business plan and passing it off as medical research, to deflect outside scrutiny.

Here’s another important excerpt from the meeting:

Dr. Proefrock: I’m not painting the picture that we are saving the profession by having an IRB, but rather, it is a way to strengthen the breadth of our scope of practice.

Dr. Waters said: I use this IRB for a different purpose. We use is commercially, and we brought in a 92-page IRB, and we got it approved very quickly. If we went through big bureaucracies, it would take months. I don’t want this IRB to go away any time [sic] soon. It is a Godsend.

Dr. Hamilton said, so then we should mentor and help newer graduates and people in other states, and we should join the big leagues and stop hiding in our offices and pretend nothing is going on.

I get the impression they have an agenda. They admit to using the IRB to protect and expand their scope of practice, make money, and teach their methods across the country. It seems to me like this naturopathic IRB does not have the purpose or ethical standards of a real IRB.

Dr. Waters goes on to voice concern that this naturopathic IRB may get shut down if outsiders are allowed to partake: “If you go out and invite scrutiny, you can get hammered.”

Ironically, Waters then goes on to say: “We have contacts that have a lot of weight in the governor’s office. So we have friends in high places.”

He’s got some true grit.

Indeed, the ANRI/NORI/IRB is registered by the FDA. Follow this link to the FDA and search “naturopathic” to find its records. The ANRI/NORI/IRB posts their meeting minutes online per FDA rules. I encourage you to take a look.

The Arizona naturopathic board gets involved

In early 2015, the ANRI/NORI/IRB successfully petitioned the Arizona Naturopathic Physicians Board to expand the naturopathic intravenous formulary to include previously banned substances. The board then issued a request for an emergency rule change to the Secretary of State to permit naturopaths to administer “silver protein, or any substance that contains silver, Cesium chloride, Hydrazine sulfate, and Lipid replacement as used in total parenteral nutrition.” In the rule change, the ANRI/NORI/IRB is cited as “currently conducting an IRB (ID # IORG0007953), in which one or more of the excluded nutrients had been used.”

The rule change document clearly states that the board did not review or rely upon any study in its decision. The board solely relied on the word of the naturopaths wielding their dubious IRB.

The order of events indicate that naturopaths were administering these substances to their patients despite Arizona law having explicitly banned them. Then they scrambled to get the law changed.

The brazen attitudes of these naturopaths makes me fearful for the safety of Arizona residents. They could be misled into seeking bogus medical care as if it was part of legitimate research or a proven clinical regimen. When I practiced in Arizona, I witnessed patients being duped, but prior to finding this naturopathic IRB I had no idea that the deceit runs so deep in the profession. I am disgusted.

Pulling back the curtain on naturopathic

On NaturopathicDiaries.com, I plan to write a series of posts about the malfeasance found in the IRB’s minutes, in the claims made by its participants, and in publicly-available documents at the FDA. I hope that these tales of a naturopathic IRB will communicate the real threat that is the practice of naturopathy in Arizona. I feel terrible for the patients who are at the hands of these naturopathic “doctors” and “physicians.” Those titles should always be reserved for the best-educated medical practitioners.

Arizona may not be the only problem jurisdiction. There may be more examples in the US and around the world of dangerously blurred lines between patient safety and the headstrong naturopathic ideology. Please be vigilant. If you suspect any wrongdoing, please report the activity to the relevant, non-naturopathic authorities.

For now, it appears, Arizona is the Wild, Wild West of naturopathic medicine.

 


Britt Marie Deegan

Britt Marie Hermes is a naturopathy apostate: she practiced as a licensed naturopathic doctor in the United States for about three years, but then left the profession to pursue a science-based career. She is now a Master’s of Science student in Medical Life Sciences at the University of Kiel. Her research interests include inflammatory and genetic diseases, like psoriasis and Crohn’s. She lives in Kiel, Germany, with her husband, who is a doctoral candidate in archaeology, and their two dogs. She recently started the blog Naturopathic Diaries: Confessions of a Former Naturopath.

 

 

Posted by Britt Hermes

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