Report to the Maryland Board of Physicians Naturopathic Advisory Committee: Recommendations for Naturopathic Regulation
About the Society for Science-Based Medicine
The Society is a community of like-minded individuals, both in and out of health care, who believe that people should not suffer, die and lose hope, time and money due to pseudo- medicine. We support a single, science-based standard of care for all health care and believe that effective, reliable care can only be delivered within a consistent framework of scientific knowledge and standards.
Our mission is to educate consumers, professionals, and policymakers about science-based medicine. We support sound consumer health care laws and oppose legislation that undermines science-based medicine.
The Society has members all across the U.S., including Maryland, and in other countries. Formed in 2013, the Society is a 501(c)(3) tax-exempt charitable organization. All of our work is done by volunteers.
The Society maintains a website providing resources and information free to the public, including a beta version of a wiki that will eventually include a vast library of information about pseudo-scientific practices that are detrimental to the health, safety and welfare of the public. Additional information about the topics addressed in this Report can be accessed there. www.sfsbm.org.
Volunteer Board of Directors and Officers
David A. Gorski, M.D., Ph.D. Detroit, MI
Mark A. Crislip, M.D. Portland, OR President
Steven Novella, M.D. New Haven, CT
Jann J. Bellamy, J.D. Tallahassee, FL Secretary
Harriet Hall, M.D. Puyallup, WA Treasurer
The Maryland Legislature passed a naturopathic doctor licensing act in 2014 in order to “protect the health, safety, and welfare of the public, and specifically protect individuals who are the direct recipients of services regulated [by the law].” As public protection is the constitutional basis of the state’s authority to regulate health care practitioners, via the state’s police power, all other legislative goals are by necessity subservient to this goal.1The law is also intended to maintain standards in the delivery of naturopathic services, ensure naturopathic care by qualified naturopathic doctors is available and provide a means for identifying qualified naturopathic doctors.
The act defines “naturopathic medicine” as
“The prevention, diagnosis, and treatment of human health conditions, injury, and disease using only patient education and naturopathic therapies and therapeutic substances recognized by the Council of [sic]Naturopathic Medical Education.”
However, the Council on Naturopathic Medical Education, the accrediting agency for four- year naturopathic schools, does not officially “recognize” any particular “therapies and therapeutic substances,” and the meaning of this language is unclear. 2
The Legislature specifically rejected the broader scope of practice and self-regulation naturopaths lobbied for in favor of a more limited scope of practice, regulation by the State Board of Physicians, notice to patients of the limitations of naturopathic practice, and a required collaboration/consultation agreement with an MD or DO physician. The Legislature did agree to give naturopaths a voice in their regulation by specifying that two members of a five-member Naturopathic Medicine Advisory Committee, appointed by the Board, would be naturopaths. Other members include two MD or DO physicians and a consumer member.
The Committee is to “develop and recommend to the Board regulations to carry out” the licensing act and can “provide any service and perform any function necessary” to do so. Specific tasks include evaluating the content of clinical, practical or residency requirements for licensure, as well as developing procedures for issuing licenses by reciprocity, examination standards, a code of ethics and continuing education.
In its role as a consumer protection organization and advocate for science-based medicine, the Society has researched naturopathic education, training and practice. The Society feels it can be of service to the Committee in fulfilling its role by presenting the results of this research as well as recommending specific regulations that will assist the Committee in fulfilling its statutory duties.
This Report is divided into three sections:
Section I provides background information on naturopathic education, training and practice.
Section II presents the results of the Society’s survey of Maryland naturopaths. Appendix A contains additional materials relevant to the survey. Appendix B is a list of conditions and diseases Maryland naturopaths claim they treat. Appendix C is a list of diagnostic methods used by Maryland naturopaths.
Section III addresses specific subjects of regulation and provides the Society’s recommendations for regulations which we feel should be adopted as Committee recommendations to the Board of Physicians. Appendix D contains further information relevant to the Society’s recommendations.
An exhaustive discussion of naturopathic education, training and practices is beyond the scope of this brief. However, the Society submits that the information contained herein is an honest representation of naturopathy as practiced in Maryland and will be of invaluable assistance in the Committee’s work.
Background: Naturopathic Education, Training and Practice
Naturopathic Education and Training
Little is known outside of naturopathic circles about naturopathic education and training. While the American Association of Naturopathic Physicians (AANP) claims that naturopaths are “primary care” physicians who “treat all medical conditions and can provide both individual and family health care,” their actual ability to do so safely and effectively remains unproven. In fact, as discussed further below, the medical literature casts doubt on the AANP’s assertion. 3
The U.S. Department of Education, which permits the Council on Naturopathic Medical Education (CNME) to accredit naturopathic schools, has not itself investigated, nor does it make any determination of, the appropriate naturopathic scope of practice. More specifically, the Department does not determine the scientific validity of what is taught in naturopathic schools nor does it determine whether any particular diagnosis or treatment students learn is evidence-based, or even scientifically plausible. The Department’s main concerns in granting accrediting authority are the ability of the accrediting agency to ensure financial stability, adequate staffing, honesty in determining credit hours, due process-type protections for students and transparency.4
Likewise, while the law requires that a candidate for licensure pass Parts I and II of a licensing exam administered by the North American Board of Naturopathic Examiners (currently, the “NPLEX” exam), no authority independent of naturopaths has ever investigated this exam to determine if it adequately assesses whether a naturopath can safely and effectively diagnose and treat patients.
Probably the most troubling deficiency in naturopathic preparation for practice is the extremely limited clinical training naturopaths undergo in comparison to that of MDs or DOs. This difference is illustrated by a chart from the American Association of Family Physicians. 5
Even though naturopaths will not be allowed to practice as primary care physicians, the practicing naturopath will often see the undifferentiated patient in his or her office and may be the first contact that patient has with the health care system. Thus, the naturopath will be required to evaluate the patient, perform or order appropriate diagnostic testing, and reach an accurate diagnosis before either treating the patient or referring him or her to another health care professional. With their limited clinical experience, patients can be at risk of misdiagnosis and inappropriate treatment. In addition, it is not known how, or whether, naturopaths keep abreast of the medical literature regarding patient evaluation, proper diagnosis or when to refer.
The Society feels this lack of information about naturopathic education and training will hamper the Committee in its ability to perform its statutory duties in two ways. First, as noted above, the Committee is charged with the responsibility of recommending procedures for issuing licenses to those who apply for license by reciprocity, developing the content of clinical and practical requirements for licensure, and developing and recommending examination standards and continuing education requirements.
Second, the Committee is charged, more generally, with developing and recommending regulations to carry out the licensing law. Yet, the entire scope of naturopathic practice is defined by one important limitation imposed by the Legislature: any diagnostic method or treatment employed by a naturopath must be “consistent with naturopathic education and training and competence demonstrated by passing the [NPLEX].”
It will be extremely difficult for the Committee to appropriately advise the Board on naturopathic regulation without fully understanding exactly what the content of that education and training is or what level of competence the NPLEX in fact demonstrates. Both
the U. S. Medical Licensing Examination 6and the National Board of Osteopathic Medical Examiners 7offer a plethora of information to the public about the medical and osteopathic licensing exams. In contrast, there is virtually no publicly available information about the NPLEX on the website of the North American Board of Naturopathic Examiners. 8
To remedy this, the Society recommends that the Committee investigate naturopathic education and training so it can adequately determine the scope and content of the regulations it will recommend to the Board. The Society respectfully suggests that, while the naturopathic members of the Committee can provide some of this information, they should not be the sole source nor should conclusory assertions, as opposed to actual factual information, be accepted as the final word.
The Society suggests, at a minimum, that the Committee review the curricula, syllabi of courses, and textbooks used (including which portions of those texts are actually taught if not the entire textbook), as well as the content of the NPLEX exams. Most importantly, the Committee should determine the exact content of clinical training: the number of patients naturopathic students see and the conditions presented by the patients, what diagnostic methods and therapies they use, how the students are evaluated, patient outcomes, and the like. MD or DO Committee members will be aware of, and have access to further information regarding, the education and training of MDs and DOs and can use this as a point of comparison. This groundwork will be invaluable to both the Committee and the the Board of Physicians as without it neither the Committee nor the Board can adequately fulfill their statutory duty to protect the public health, safety and welfare via regulation.
Naturopaths claim that they find and treat the underlying “”cause” of disease, while medical doctors treat only the “symptoms” of disease. As well, they diagnose patients with diseases and conditions which will be unfamiliar to physicians. 9 Typical of these is candidiasis, which is diagnosed based on vague symptoms and without any clinical symptoms or laboratory evidence of candidemia. 10Naturopaths also diagnose subclinical food “sensitivities.”
“Adrenal fatigue” is another common diagnosis, again based on vague symptoms like fatigue. Other treatments include severely restrictive diets, such as those which require the elimination of all products containing gluten in the absence of any objective evidence of celiac disease or gluten intolerance. 11Prescription of dietary supplements and herbs, often sold to the patient by the naturopath, is a mainstay of naturopathic practice despite the dearth of evidence that they are safe or effective for any disease or condition. 12
Naturopaths are traditionally anti-vaccination, although this ideology is sometimes obfuscated by terms like parental “informed choices” and promotion of “vaccination safety.” 13This opposition is well documented in the medical literature.
- Children were significantly less likely to receive each of the four recommended vaccinations if they saw a naturopathic physician. Children aged 1–17 years were significantly more likely to be diagnosed with a vaccine preventable disease if they received naturopathic care.14
- Consultation with a naturopath was associated with anti-vaccination attitudes among mothers of pediatric patients.17
- Consultation with a naturopath was found to have an independent inverse association with annual flu shots among women in contact with young children. 18
This ideology appears to originate with the naturopathic schools themselves, which should be taken into account in determining the educational and clinical requirements for practice in Maryland.19
Surveys of students attending the CNME-accredited Canadian College of Naturopathic Medicine found that only 12.8% of the respondents would advise parents that their children receive all recommended vaccinations and that anti-vaccination attitudes increased in the last two years of school.20
- A survey of the CNME-accredited National College of Natural Medicine students found that only 26% planned on regularly advising vaccinations for their patients and 96% would recommend a schedule different from the standard CDC-ACIP schedule.21
Positive studies of naturopathic care often cited by naturopaths are of limited value. First, in each instance, the naturopaths were providing only adjunctive care to patients that had been diagnosed by, and were being managed by, physicians. Nothing in Maryland’s licensing law requires that naturopaths limit themselves in this manner. Second, because naturopathy does not generally follow evidence-based standardized protocols, there is no assurance that this care is typical of practicing naturopaths.
Specific naturopathic diagnostic methods and treatments described below. In Section II, you will see at least one example of each employed by an MDNA-member naturopath.
Naturopaths are required to study homeopathy in naturopathic school. Homeopathy is a 200 year-old, pre-scientific set of beliefs about medicine known to be at odds with basic laws of chemistry, physics, and biology. It is based mainly on two tenets: like cures like, which holds that the correct remedy for a patient is a substance that, when given to a healthy individual, produces “symptoms” similar to those of the patient; and potentization, which holds that serial dilutions and succussions (shakings) render a remedy increasingly potent, even well past the point at which any of the original substance exists in the preparation.27
Despite its implausibility, hundreds of clinical trials of homeopathy have been conducted. In 2013, the Australian government conducted an exhaustive review of the evidence and concluded “the available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.”28This is accord with earlier reviews of the evidence.29 30
A mélange of homeopathic remedies designed to eliminate “toxins” from the body.31According to one naturopathic source, a biotherapeutic product line, called UNDA numbers, includes different homeopathic formulae containing a combination of certain plants and/or minerals. Plant sources are alleged to have a specific effect on particular organs or tissues.
Mineral sources supposedly “catalyze the detoxification process within cells.”32“Biotherapeutic drainage” is wholly implausible and, not surprisingly, there is no evidence that it is effective for anything.
Many naturopaths maintain that patient health is adversely affected by ubiquitous, often unidentified, “toxins” and that these “toxins” can be removed from the body through a process called “detoxification,” which can take various forms. There does not seem to be a standardized method for determining what is, or is not, a “toxin.” Nor is there a standard protocol for determining the purported location of the “toxins” in the patient’s body, when any particular “toxin” reaches a level that requires removal, or a validated method for determining removal has been successful. Diagnosis is apparently based on the patient’s exhibiting vague symptoms like fatigue or gastrointestinal upset. Methods of alleged “detoxification” include colonic hydrotherapy, which is specifically excluded from naturopathic practice by the licensing act, taking dietary supplements, which naturopaths are allowed to prescribe and which they often sell to patients, and special diets. 33
This “therapy” is based on the anatomically impossible concept that the therapist can detect a “craniosacral rhythm” in the cranium, sacrum, cerebrospinal fluid and membranes enveloping the craniosacral system. Therapists claim that maintaining proper “rhythm” is essential to good health and that they can measure this “rhythm” with their hands. The therapist purports to manipulate the cranium and sacrum to restore proper functioning, which is purported to relieve pain and address other ailments. While the treatments can be relaxing, there is no evidence that craniosacral therapy has any effect beyond placebo.34
“Bio-identical hormone” is a marketing, not a medical, term. The FDA has evaluated claims that bio-identical hormones are safer and more effective than pharmaceutical hormone replacement therapies and claims that they can prevent or cure certain diseases. It also evaluated claims that bio-identical hormones can be individualized based on saliva testing. The FDA found no evidence to support these claims.35The Medical Letter on Drugs and Therapeutics warns that patients should be discouraged from taking them.36
Some alternative practitioners claim that when the body is too acidic the risk of disease is increased. They therefore advocate a diet purported to alter the body’s pH to make it more alkaline. In fact, because the body’s natural mechanisms strive to maintain its pH in a normal range, if the pH shifts outside this range and becomes too acidic or too alkaline, the body automatically corrects itself to bring things back to normal. Thus, it is almost impossible to maintain a high alkaline pH for very long. There are no human studies supporting the notion that a high alkaline pH will prevent or cure any disease.37
This unvalidated diagnostic method involves the use of a galvanometer to measure the electrical resistance on the skin's surface. The galvanometer is usually hooked up to software programs that purportedly diagnose conditions such as allergies and recommend treatments, such as dietary supplements.38
There is evidence that this test can detect sensitivity to certain metals. However, naturopaths may be employing it beyond its validated purposes and the Committee should further investigate this.39
Autonomic Response Testing (ART)
An unvalidated and implausible diagnostic method positing that when a substance is placed over an area of the patient’s body that contains this identical substance, a stress signal is elicited, which makes a strong indicator muscle go weak. ART purports to diagnose allergies to foods and other substances.40It is apparently a mechanized version of an equally implausible and invalidated diagnostic method called “applied kinesiology.”41
These devices use light to produce heat instead and warm the body42and can have side effects if used improperly.43Naturopaths claim they are useful for “detoxification” and weight loss. As with any sauna, weight loss is due to water loss and is temporary.
Chelation therapy is a proven treatment for heavy metal poisoning and it is rarely necessary for any legitimate medical purpose. However, it is often used by alternative practitioners who diagnose chronic metal poisoning based on a poorly documented environmental exposure, vague clinical findings, and inappropriate diagnostic testing. (See, “DMSA Challenge Protocol,” below.) The results are incorrectly presented to the patient as evidence of metal “toxicity,” leading to expensive chelation treatments. In 2009, the American College of Medical Toxicologists issued a statement condemning this practice and saying that it should be abandoned.44
Dietary supplements are also marketed for the purpose of chelation. The FDA has sent warning letters to several marketers telling them to stop advertising these supplements as treatment for serious diseases. The FDA warned consumers that all of the approved chelation agents require a prescription and can’t be purchased without one. The FDA also found that some of the chelation supplements sold without prescriptions actually contain dangerous prescription drugs.45
DMSA Challenge Protocol
"Urine mobilization test," "challenge test," and "provoked urine test" are all terms used to describe the administration of a chelating agent to a person prior to collection of urine to test for metals. The American College of Medical Toxicology has issued a position statement that “post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.”46Other professional and government organizations recommend against the use of provoked urine testing as well. Current evidence does not support the use of DMPS, DMSA (dimercaptosuccinic acid), or other chelation challenge tests for the diagnosis of metal toxicity. Since there are no established reference ranges for provoked urine samples in healthy subjects, no reliable evidence to support a diagnostic value for the tests, and potential harm, these tests should not be utilized.47
Salivary Hormone Testing
According to the FDA, “some compounding pharmacies and other promoters of ‘bioidentical hormone replacement therapy’ claim that estrogen levels in a person’s saliva can be tested by practitioners to estimate the amount of hormone a person needs. This is used to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels.”48
Blood Nutrition Analysis
There are several different names and methods for this unvalidated lab analysis. All claim to reveal deficiencies not apparent in standard lab analysis of blood and are used as a rationale for prescribing dietary supplements. 4
Survey of Maryland Naturopathic Doctors
During the month of September, 2014, the Society conducted an informal survey of Maryland naturopaths. The survey reviewed the website of each member of the Maryland Naturopathic Doctors Association who listed a website on the MDNA’s “Find a Doctor” page, as well as the MNDA itself. We found that all members surveyed, save one practicing under physician supervision, offered diagnoses and treatments on their websites that are not supported by adequate evidence of safety and effectiveness and should not be considered an acceptable part of standard patient care. The MNDA offers continuing education courses that endorse such practices. As noted earlier, these findings are in accord with similar reports in the literature. 50 51 52 A list of these naturopaths and a sample of the claims made appears below.
All of the surveyed MNDA members graduated from an accredited naturopathic school and are presumably eligible for licensing in Maryland. (One practices in Delaware, where naturopaths are not licensed, and would be eligible if she established a residence in Maryland.)
As noted, the licensing law will permit naturopaths to treat any patient will any condition or disease. The Society found that Maryland naturopaths claim they treat a vast array of diseases and conditions that appear to be beyond their limited education and training. In medicine, many of these diseases and conditions require specialty training before the physician is considered competent to manage them. Yet the individual naturopath will claim he or she treats conditions that would subsume several medical specialties. Some of these diseases are not recognized in medicine at all. Other medical conditions are never mentioned. The diseases and conditions which MDNA members claim they treat are listed in Appendix B.
Naturopaths will also be permitted to
Appendix C contains a list of diagnostic methods utilized by MDNA-member naturopaths, according to their websites. Some of these are standard lab tests, but others are unvalidated diagnostic methods and standard tests which appear to be employed in a non-standard manner.
Order and perform physical and laboratory examinations for diagnostic purposes, including phlebotomy, clinical laboratory tests, orificial examinations, electrocardiograms with overread by a cardiologist, and physiological function tests;
Order diagnostic imaging studies and interpret the reports of diagnostic imaging studies.
“The Top Five Homeopathic Remedies in the Treatment of Depression featuring Drs. Amy Rothenberg and Paul Herscu
Date: July 22, 2014: Drs. Herscu and Rothenberg are 1986 graduates of the National College of Naturopathic Medicine, and each have nearly 3 decades of clinical and classroom experience. They are the founders of the New England School of Homeopathy, and have developed the Cycles and Segments style of homeopathy.”
“Eric Yarnell, ND ‘Naturopathic Treatment of Chronic Kidney Disease’ For 2 CEUs Oct. 6, 2014”53
Recommendations for depression: raw vegetable juicing, gluten-free diet, various dietary supplements, herbs, detoxification, drinking only fluoride-free water, using fluoride-free toothpaste, reducing or eliminating sugar.54
A copy of Acree’s “Nutritional Assessment Questionnaire” is included in Appendix A.
“The basic idea of a detox is to reduce the amount of toxins in your body so that your body can function at its best.”
Claims detoxification will benefit “most people;” benefits include improving organ function, immune function, sleep, and digestion, and increased energy, natural weight loss, better stress management, and a “sexier you.” Offers numerous detoxification regimens.
Paul Faust, ND
Sells herbal and other dietary supplements to patients, including herbal remedies for children.
Allergy Elimination Program: “With a combination of Electrodermal screening, blood testing for food allergies and environmental allergens, and MELISA testing for metals, the patient’s allergic response can be identified while a unique blend of antigenic serums are prepared to desensitize the patients.”
FAR Infrared sauna: “A powerful detoxification and weight loss tool. It penetrates deeper into the tissues than a stream sauna and 20 minutes in it will detoxify as well as I hour of exercise.”
Please see Appendix A for an example of her "Instructions for Homeopathic Intake Form” downloaded from her website.
Offers “Fatigue-Proof Body Blend,” an herbal concoction described as “natural energy boosters and adaptogenic herbs . . . designed to work with your body to build real, sustainable and balanced energy.”
Claims that “when the body is more acidic than alkaline it can lead to a progression of chronic diseases, decreased immunity and in general poor health.” Advises that one should “consume 20% of your diet with acidic foods, 80% with alkalizing foods.”
Describes symptoms of, and diagnostic methods for, “heavy metals toxicity,” which is addressed with “detoxification.” Alleged sources of heavy metals include dental fillings, aluminum from antacids, and non-organic produce and meat.
Advises use of, among other things, for PMS: eliminating refined sugars, coffee and alcohol, using glandular products “like ovary and anterior pituitary,” and “uterine tonic to balance the hormones.”
Describes homeopathy as “an effective and scientific system of healing which assists the natural tendency of the body to heal itself. It recognizes that all symptoms of ill health are expressions of disharmony within the whole person and that it is the patient who needs treatment, not the disease. . . . the homeopathic remedy acts as a stimulus to the curative powers of the body. . . If you develop a runny cold, rash or some form of discharge, this is
probably the remedy cleansing the body. . . they are an important part of the healing process.”
Employs “blood nutrition analysis,” which purports to “adequately assess your own physiology.”
“Homeopathy is a system of natural medicine [that] is used to treat a range of illnesses, from simple coughs to chronic conditions. It is known for . . . being able to alleviate symptoms where other treatments have been ineffective.”
“Natural treatment of hypothyroidism” includes “herbal therapy, vitamin/nutrient therapy, homeopathy and prescriptive thyroid hormones including natural glandular extracts and compounded thyroid hormone.” Criticizes standard medical diagnosis and treatment of thyroid disease.
Prescribes “bio-identical hormones” and claims that they do not have the same risks as prescription-only HRT and that their use can “reduce risk related to certain conditions including bone loss and even certain forms of cancer.”
Advertises “Fall Detox . . . adapted from Thorne’s MediClear Detox Plan.” According to the Thorne MediClear Detox website, “The MediClear Plus program is designed to do two things: first, to decrease your exposure to toxins and allergens, and second, to help your body cleanse.” It is a “formula that blends a combination of rice and pea protein with a full complement of vitamins, minerals, amino acids, botanicals, probiotics, and other nutrients for the enhancement of detoxification.”55
“Detox add-on kits” are also offered on Telfair’s website, which are “additional supplements to further enhance your detox experience.” These include
“Belly Boost: To help aide digestion for those with sensitive stomachs. “Liver Love: To help clear toxins while protecting the liver.
Detox Reviver: To help reduce fatigue & headache while eliminating caffeine, sugar and alcohol.”
Section III Recommendations for Regulations
Sections I and II demonstrate that this Committee must recommend, and the Maryland Board of Physicians must enact, stringent regulations to ensure that the public is not subjected to unvalidated diagnostic methods, treatments that do not have sufficient evidence of safety and effectiveness or practitioners whose education and training do not allow them to safely practice. Many regulations are already set forth in the licensing law, but the Committee has the authority to recommend others. The Society further recommends that Maryland regulations governing physicians be used as a guide. In particular, Sec. 10.32.01.12, Code of Maryland Regulations, governing advertising, should be adopted in full.
Naturopathic Education and Training
While the Legislature set graduation from a school accredited by the CNME and passing the NPLEX as a minimum requirement, the fact that a naturopath has fulfilled these requirements is of limited significance in determining whether patients will be protected from financial or physical harm due to a lack of appropriate education and training.
Importantly, there is nothing in the licensing law to indicate that graduating from school and passing the NPLEX was intended to grant carte blanche to naturopaths, prevent further inquiry into the content of that education and training, or set more specific requirements. Indeed, legislative purposes mentioned in the act include maintaining standards in the delivery of naturopathic services to the public and providing a means of identifying qualified naturopathic doctors. The Legislature clearly granted the Board, and by logical extension, the Committee, the authority to look beyond this minimal requirement in regulating naturopaths and to establish (or, in the Committee’s case, recommend) regulations that go beyond those requirements.
Although it will be better able to formulate specific regulations after further study of their education and training, the Society believes that sufficient information is already available to support the following:
A two-year probationary period for all naturopaths who will begin practice in Maryland directly from naturopathic school. Continuing education beyond that normally required, testing and more direct supervision from a collaborating physician (a subject addressed below) should be required during this period.
Consideration of additional testing beyond NPLEX on specific subjects such as evidence-based diagnostic methods and treatments.
It is unfortunately obvious from information already presented that naturopaths require additional education and training in order to practice effectively and that current offerings from the MNDA are insufficient for the task. Fortunately, the Committee is specifically empowered to recommend regulations regarding continuing education.
No fewer than 30 hours of continuing education should be required annually, or 60 hours biennially, as is required in California.56All continuing education courses should be conducted by the Board of Physicians, or, if provided by an outside source, approved by the Board. They should meet the same standards as those required by the Board for physicians.
CE subjects should include public health and vaccination, evidence-based medicine, appropriate diagnostic testing, pharmacognosy, and evidence-based courses on homeopathy, “detoxification,” and ethics, including informed consent.
As is the case with naturopathic education, there is no indication that the Maryland Legislature intended to grant carte blanche to naturopaths to continue with their current practices. Indeed, doing so would defeat the very purpose of this legislation, which is to protect the public health, safety and welfare. Significantly, the Legislature granted the Board of Physicians the authority to regulate naturopaths and amended the original licensing bill to reject self-regulation. The licensing statute itself explicitly rejects naturopathic standards as the sole arbiter of the appropriateness of patient care. A naturopath is subject to discipline if he or she
“Engages in an act or omission that does not meet generally accepted standards of practice of naturopathic medicine or of the safe care of patients, whether or not actual injury to a patient is established.”
It is imperative that the Committee recommend regulations that will prevent the use of discredited diagnostic methods, and diagnoses and treatments, such as chronic candidiasis, adrenal fatigue and “detoxification” unless and until naturopaths can come forth with convincing evidence of their validity. Some of these prohibited methods suggest themselves in the excerpts from Maryland naturopathic websites.
Homeopathy is specifically permitted by the licensing law. However, a patient’s right to informed consent, as defined by Maryland law and discussed below, requires that all patients be informed of the lack of evidence of effectiveness for all homeopathic remedies. Thus, a regulation stating that “Naturopaths should not prescribe, dispense or administer homeopathic remedies without informing the patient that there is no reliable evidence that homeopathy is effective for any disease or condition” should be adopted. If naturopaths wish to revise the regulation to permit the use of homeopathic remedies in certain situations, they should be required to present substantial competent evidence that it is safe and effective for the intended purpose.
The Declaration of Helsinki requires that “Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information . . .” No human diagnostic method or treatment should fall below this standard. At the very least, the Committee should recommend a regulation stating that all naturopathic diagnoses and treatments “conform to generally accepted scientific principles.”
All must have an “assistant physician collaborative practice arrangement” with a fully licensed physician, who can oversee no more than 3 assistant physicians. These arrangements must be written agreements, jointly agreed-upon protocols or standing orders. The assistant physician must practice in the same physical location as the physician for 30 days. After that, they must be within “geographic proximity” of one another. The assistant physician must submit at least 10% of his charts to the collaborating physician every 14 days for review. The collaborating physician “is responsible at all times for the oversight of the activities and accepts responsibility for primary services rendered by the assistant physician.” However, as long as the licensed physicians follow the procedures set forth in the law, they won’t be held vicariously liable.
While not entirely applicable to Maryland’s situation, we believe the Committee should recommend similar provisions for naturopath/physician collaboration and consultation, including chart review, geographic proximity, identification requirements, and written agreements, jointly agreed-upon protocols or standing orders. We suggest the Committee contact the Missouri Board of Registration for the Healing Arts for further information, as the Board is charged with developing regulations to implement the assistant physician licensing law.
“[I]nformed consent is predicated on the notion that a patient has a right to exercise control over her own body. Because a patient, however, generally does not possess the expertise necessary to understand the consequences of submitting to a particular medical treatment, she, necessarily, relies on the physician for such information. Accordingly, the doctrine of informed consent imposes on a physician a duty to disclose material information that ‘a physician knows or ought to know would be significant to a reasonable person in the patient's position in deciding whether or not to submit to a particular medical treatment or procedure,’ including ‘the nature of the ailment, the nature of the proposed treatment, the probability of
success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment.’”
Of course, legally and ethically, naturopaths will be required to employ informed consent even if there is no regulation requiring that they do so. However, given the apparently widespread use of methods without a sufficient basis in evidence, the Society believes a specific regulation setting forth the elements of informed consent required in Maryland is appropriate. In addition, the consent should be in writing and applied to each and every diagnostic method and treatment for every patient. Blanket consents signed before the patient is examined should not be allowed.
One of the most disturbing aspects of naturopathic care is the anti-vaccination ideology of naturopathy. Vaccination is excluded from the naturopathic scope of practice in Maryland. To insure that patients receive evidence-based advice regarding immunization, the Society recommends a regulation stating that naturopaths must tell patients that vaccination is outside their scope of practice and must refer any inquiries regarding vaccination to the patient’s primary care physician. Nor should they be allowed to give advice contrary to other evidence-based public health practices, like fluoridation of public water supplies and supplemental fluoride, as in toothpaste.
The licensing law requires that naturopathic patients sign a consent form stating that the naturopath’s practice of naturopathic medicine is limited to the scope of practice identified in the law. The Society believes that additional disclosures are required to ensure that patients fully understand the limitations of naturopathic practice, including the following:
Maryland does not license naturopaths as primary care providers and the naturopath is not responsible for the overall medical care of any patients. Naturopathic care is intended only as an adjunct to, and not a substitute for, medical care from a physician or allied health practitioner practicing under the supervision of a physician. Patients are urged to have a primary care MD or DO physician and to have all specialty care provided by a properly credentialed MD or DO specialist.
Naturopaths are not permitted to practice chiropractic, acupuncture or psychology without a maintaining a separate license as such.
Information about the collaboration/consultation agreement between the naturopath and an MD/DO physician, including his or her contact information and the right of the patient to have any naturopathic advice reviewed by the consulting physician or the patient’s primary care or specialty physician. Patients should be advised to keep their physicians informed of all naturopathic diagnoses and treatments.
The U.S. Food and Drug Administration has not evaluated or approved any dietary supplements or herbal and homeopathic remedies, for safety or effectiveness.
Naturopaths are regulated by the Maryland Board of Physicians and instructions on how to file a complaint against a naturopath.
The right to informed consent as to each and every diagnostic procedure and treatment employed and that blanket consents are not appropriate.
Naturopaths are not licensed to prescribe drugs or to advise patients regarding prescription drugs beyond possible dietary supplement/herb – prescription drug interactions. All questions regarding prescription medications should be directed to the prescribing physicians or to the patient’s primary care physician.
Naturopaths are not authorized to advise patients to alter or amend advice from the patient’s physician or to advise patients regarding health matters that are outside the scope of naturopathic medical practice, including immunization. All questions regarding such matters should be referred to the patient’s physician.
Patients should be advised of their right to copies of all naturopathic medical records and to request that copies be sent to their physicians, subject to the payment of reasonable copying costs.
Patients should be told of their right to purchase any product from sources other than the naturopath prescribing them. They should also be given information on the USP Dietary Supplement Verification Program 57so that patients can identify dietary supplements meeting the USP’s requirements when shopping.
The licensing law requires naturopaths to “keep written medical records justifying the course of treatment of a patient.” In Colorado, where a naturopathic registration (not licensing) act was passed last year, regulations spell out what those medical records must include. The regulations also cover retention of records after retirement and destruction of records. A copy of the regulation is attached as a part of Appendix D. The Society recommends that a similar regulation be enacted in Maryland covering these subjects, adjusted, if necessary, to this state’s requirements for physician retention and destruction of records.
Colorado’s naturopathic registration act requires naturopaths to maintain liability insurance in an amount not less than one million dollars. 58It also states that each naturopath is liable for his or her acts or omissions in the performance of naturopathic medicine. The Society believes' such insurance is absolutely necessary to ensure that the burden of any adverse consequences of naturopathic practice does not fall on the patient or the State of Maryland.
Reciprocity should not be granted based simply on the fact that a naturopath has a license from another state. Unlike physician scope of practice, naturopathic scope of practice and licensing requirements vary greatly from state to state. Unless each licensing state’s requirements are independently reviewed for concordance with Maryland’s licensing law and regulations, it would be unwise to assume that another state’s licensing law is the same as, or even similar to, Maryland’s. It would also be unwise to license naturopaths who do not meet Maryland’s standards for licensing.
Although actual figures are hard to come by, it appears that many naturopaths are not practicing or are underemployed (e.g., working in health food stores) due to the oversupply of naturopaths in relation to demand. There are about 4,750 licensees in the U.S. While some practice in Canada, that number exceeds the number of graduates from naturopathic schools, apparently by a large factor. Although the figure cannot be confirmed, the naturopathic schools are graduating 500 naturopaths per year. Naturopathic members of the Committee will be able to provide more accurate figures.
Independent surveys show that the demand for naturopathic services is extremely limited. In Washington State, two studies demonstrated less than 2% of insured patients made a health insurance claim for naturopathic services even though coverage of their services is mandated by state law. 59 60 Maryland does not want to encourage an influx of un- or underemployed naturopaths licensed in other states by enacting low standards for reciprocity.
The American Association of Naturopathic Physicians has adopted a Code of Ethics but it consists of a little over two pages and provides only bare bones guidance.61
While not ignoring the AANP Code, the Society urges the Committee to review the American Medical Association’s Code of Medical Ethics62as a template for naturopathic regulation.Many of the subjects the Committee will address, such as the sale of health care products to patients, are covered there. We believe it can serve as an excellent model upon which to
base its recommended regulations and prevent the Committee’s having to “reinvent the wheel.”
Current naturopathic practices in Maryland reveal the need for adequate regulation to ensure the health, safety and welfare of Maryland citizens who chose to see a licensed naturopath.
This should include the prohibition of those practices for which there is lack of sufficient evidence of safety or effectiveness to warrant their use, including diagnostic methods that have not been scientifically validated and do not have any diagnostic value. As well, naturopaths should not be allowed to practice in areas for which they are not adequately educated or trained or are outside their scope of practice. Effective collaboration and consultation agreements with physicians, continuing education requirements, stringent ethical rules, disclosure to patients, informed consent in accordance with Maryland law, and professional liability insurance will all serve to ensure the goals of the licensing act.
1Hawker v. N.Y., 170 U.S. 189, 18 S.Ct. 573, (1898)
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23Leaver CA, et al., Naturopathic management of females with cervical atypia: a Delphi process to explore current practice. Integr Med Insights 2013; 8: 9-17.
59Bellas A, et al., Frequency, predictors, and expenditures for pediatric insurance claims for complementary and alternative medical professionals in Washington State. Arch Pediatr Adolesc Med, 2005 Apr; 159(4):367-72.
60Lafferty WE, et al., Insurance coverage and subsequent utilization of complementary and alternative medicine providers. Am J Manag Care, 2006 Jul; 12(7):397-404.
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