Author: NZ Skeptics

1. INTRODUCTION

My name is Keith Garratt. I make this submission as a concerned member of the public.

In general, I applaud the intent of creating greater control and certainty regarding products referred to as “natural health products”.  However, there are some features of the Bill that are unsatisfactory or disturbing, and which have the potential to detract from achieving its objectives.

In considering this legislation and its purpose, I believe that the following points are important:

• As stated by Hon. Jonathan Coleman in introducing the Bill, the need is for a scheme “that gives the public an assurance that the natural health products they use are true to label and can provide the health benefits claimed for them.”
• By definition, the products which are the target of this legislation have not to date been shown by proper controlled scientific testing to have a proven therapeutic benefit or a medical effect. If they had, they would be defined as medicines and be subject to the Medicines Act.
• Regulation is necessary because there is no doubt that there are many companies and people who either in good faith or knowingly are marketing and supplying products that do not provide a health benefit.
• Unfortunately, there is a proportion of unscrupulous operators and suppliers within the natural health products industry who target unwell, desperate and vulnerable people with false hopes of health benefits, and who must be captured by this legislation.
• If all natural health providers were already operating in good faith and providing accurate information to consumers, the need for this legislation would not have arisen.

2. CLAUSE 5 – INTERPRETATION

The definition of “health benefit” is very puzzling. It includes “(b) nutritional support” and “(c) vitamin or mineral supplementation” as health benefits. These are not health benefits in themselves, but merely possible means to achieve a health benefit. In fact, many medical experts suggest that dietary, vitamin and mineral supplements are unnecessary to good health if a normal balanced diet is consumed.

Also, the inclusion of “nutritional support” is confusing and contradictory, given that Section 6 specifically excludes food from the ambit of the Bill, and the definition of “food” in Section 5 specifically mentions “any ingredient or nutrient” and appears to clearly include dietary supplements. It is hard to conceive how nutritional support can be offered without the use of food.

(d) lists “affecting or maintaining the structure or function of the body” as a health benefit. This seems ludicrous. If I drink a pint a day of whiskey (a natural product) for a long period, I will certainly affect the structure and function of my liver to the point where I will die.

Can I suggest that (b), (c) and (d) be deleted. Clauses (a) and (e) provide an adequate definition of “health benefit” for the purposes of the Bill.

3. CLAUSE 6 – DEFINITION OF NATURAL HEALTH PRODUCT

This is the key section of the Bill, but contains several areas of concern. In particular, I believe it needs strengthening to ensure that some of the most concerning elements of the natural health products industry are captured by the requirements of the Bill.

3.1 INTENT OR CLAIM OF HEALTH BENEFIT ?

6(1)(a)(ii) defines a natural health product as one that is intended by the sponsor to bring about a health benefit. The problem I see here is that the very people who should be the prime target of the legislation, the charlatans who knowingly tout useless quack medicines, have no intention of providing a health benefit, but only of relieving gullible and vulnerable people of hard-earned cash. The clause needs to be amended to clarify that it is a claim to provide a health benefit that is important, not an intention. It would be most unfortunate if a charlatan could escape the severe penalties in this Bill simply by admitting that there was never any intention to provide a health benefit.

3.2 HOMEOPATHY

There is some contradiction as to whether homeopathic products are to be captured by the legislation. The preamble notes to the Bill state that natural health products include homeopathic remedies. However, I note from Hansard that Sue Kedgely stated that “low-risk products like homeopathy products will be exempt“.  I believe that they must be included. While I agree that they pose a low physical risk, they do pose serious risks in other ways. Homeopathic products are displayed, marketed and often verbally promoted by staff in many pharmacies, providing them with credibility, and encouraging people to rely on them rather than conventional medicine. The website www.whatstheharm.net documents many cases worldwide where people have suffered or died through reliance on homeopathic treatments.

The definition of natural health products currently in the Bill may not capture homeopathic products. Homeopathic products are prepared by sequential 1:100 dilution of the original substance, routinely up to 30 iterations (referred to by homeopaths as potencies). In a press release on 30 January 2010, Mary Glaisyer, Media spokesperson for the New Zealand Council of Homeopaths, admitted that “In homeopathic remedies above the 12th potency no molecule of the material substance remains.” (maryglaisyer.com/2010/01/press-release-mass-overdose). Homeopaths claim that, despite this, the water used retains a “memory” of the original substance. The credibility of this claim is of course highly debatable, but for the purposes of the Bill the simple fact is that homeopathic remedies do not in fact contain the original substances in any material way. This means that homeopathic remedies contain no natural health product ingredients and are therefore not captured by the current definition. Again, this seems to leave open the possibility of a technical defence in court.

The definition therefore needs amendment to clarify that homeopathic products are captured.

3.3 PRESENTATION AND MARKETING

A feature of the natural healing sector is that products are often presented or marketed in a manner that skirts around the requirements of fair trading and truth in advertising requirements by vague and misleading implications of efficacy. Also, as mentioned above regarding homeopathy, natural health products are widely displayed and marketed in pharmacies without specific or actionable claims of therapeutic properties, but in a manner that in many cases gives a false credibility and a false impression of efficacy.

3.4 SUGGESTED AMENDMENTS TO CLAUSE 6

To address these three issues, I propose that Clause 6 be amended along the following lines:

• Amend (1)(a) to “that is claimed by the sponsor of the product to bring about a health benefit to the person to whom the product is administered.”
• Delete (1)(a)(ii) and renumber the remainder of (a) as (b), with subsequent amendments to the numbering of later clauses (b), (c) and (d).
• In the present (b), insert after “contains only natural health product ingredients” “or is prepared by dilution of one or more natural health product ingredients”.
• Add a new clause (1)(f): “that is presented, promoted, located or displayed in such a manner that any person might reasonably infer that it is intended to provide a health benefit.”

4. SECTION 10 – NATURAL HEALTH PRODUCTS ADVISORY COMMITTEE

The implication of 10(4) is that the members of the advisory committee will be natural health products practitioners or producers. This is somewhat akin to having an advisory committee on drug abuse made up of drug producers and sellers. Given that we are dealing here with public health, it would seem important that the committee includes people with the scientific and medical skills required to objectively assess the efficacy of products and the accuracy of any claims for their health benefits.

It would appear that an effective and efficient solution that would reduce duplication and achieve greater consistency would be to extend the functions of the Medicines Classification Committee established under Clause 9 of the Medicines Act.

5. SECTION 13 – PRODUCT NOTIFICATION and evidence

13(3)(b)(ii) requires the sponsor to hold evidence to support the health benefit claims made for the product. This is good, but 13(8)(b) provides that this can be “evidence based on traditional use of a substance or product”. This is very concerning, and brief consideration demonstrates that it is in fact ridiculous. If we look only in Western culture, we can find many examples of traditional uses that have been discarded in the light of modern knowledge. In my own childhood, the traditional treatment for burns was butter, and traditional treatments for wounds were mercurochrome or pure iodine.  These are all now recognized as ineffective and potentially harmful.

Up until about 100 years ago, laudanum was the traditional treatment for many ailments, and available without prescription. This was a tincture of opium equivalent to high doses of morphine, and was addictive. As the active ingredient was produced from poppies, laudanum would qualify as a natural health product under the provisions of this Bill.

There would be a major problem in defining what is meant by “traditional use”. A brief glance at an Oxford Dictionary reveals that “tradition” has various shades of meaning.

Evidence based on traditional use is clearly inappropriate, and I urge that section 13(8)(b) is deleted, and that the Bill should specify that the only acceptable evidence for efficacy is double-blinded placebo-controlled scientific research.

I should note also that alternative health providers frequently provide anecdotal accounts as supposed evidence of efficacy. This is also unacceptable. The body is a self-healing mechanism, so there will always be examples of apparent cures that are in fact not a result of treatment, whether alternative or conventional.

6. CLAUSE 6(1) AND 6(3)

Taken together, these clauses appear to have the effect of excluding substances to be administered intravenously or to eyes or ears from the definition of “natural health product”. This is presumably in recognition that such administration of unproven substances in these ways is dangerous. However, I fear that these clauses as worded could be interpreted to exempt such substances from registration and regulation rather than to provide greater restriction on their use. If those clauses are removed, they would need to prove effectiveness and safety in the same manner as any other substances. Alternatively, a clause such as follow may be appropriate:

“Nothing in this Act or its administration is to be construed to permit the manufacture, sale or administration of substances to be administered by injection or parenteral infusion or to the eyes and ears.”

7. CLAUSE 13

Clause 13(6)(a) exempts from notification a product that is prepared by a practitioner for a particular person. This seems illogical. I believe such products are less likely to be prepared under controlled conditions and less likely to be of proven effectiveness. As an example, I have a friend who some years ago acquired a severe auto-immune disorder. She recovered under conventional medical treatment, but now spends many hundreds of dollars a year on a herbal concoction prepared by a backyard practitioner, with no evidence that it has any beneficial effect.

8. CONCLUSION

The basic objectives of the Bill are commendable. However, I believe that there are some concerning anomalies, contradictions, weaknesses and potential loopholes that need to be rectified if it is to properly meet its objectives. The amendments that I have proposed are designed to achieve that.

Keith Garratt
9 February 2012

Submission to the Ministry of Health on the matter of the proposal that Traditional Chinese Medicine (TCM) become a regulated profession under the Health Practitioners Competency Assurance Act (HPCAA) 2003.

1. Is TCM a health service, as defined by the HPCA Act?

In the proposal, the applicants have defined TCM:

as an occupation with a clear professional identity and an established body of knowledge with standards of practice, and as a system of primary health care, encompassing a range of therapeutic interventions, including but not limited to, acupuncture and moxibustion, Chinese herbal medicine, remedial massage, diet and exercise, as well as contemporary practice developments….

Statistics New Zealand defines TCM as:

the treatment of imbalances of energy flows through the body by assessing the whole person, and using techniques and methods such as acupuncture, Chinese herbal medicine, massage (tuina), diet, exercise and breathing therapy (quigong).

We consider that Statistics New Zealand provides a better descriptive definition of TCM, as the applicants’ definition focuses on the interventions that are part of TCM rather than defining TCM as a whole. The former definition also tends to be overly broad, with the term “including but not limited to” allowing the definition to be arbitrarily added to and any products and services appended. The alternative health industry is well known for taking a scatter-gun approach to include a vast range of modalities based, it seems, on marketing and consumer wishes, rather than on evidence of efficacy.

As well, some interventions are defined as unique to TCM but are in fact used by many other health practices, such as diet, exercise and massage in providing health care services. In the case of dietary approaches, there already is a health profession adequately covered by the HPCAA of Dieticians, and based on evidence and independent verification.

In many respects either of these definitions appears to meet Primary Criteria, as the practice of TCM does appear to involve the process of assessing and treating the physical or mental health of individuals or groups of individuals. Whether the assessment or treatment is acceptable health practice is another matter, and we maintain that it should not be accepted as such based on current evidence.

Measures to protect the public such as regulation and other applicable consumer protection legislation, particularly in the context of health care, need to be robust and have the trust of the public. It is particularly important to support the process of regulation of health care practice and delivery where appropriate to ensure that people seeking care can be confident that the person they seek care from is qualified and competent to practice safely and that, should they fail to meet identified standards, there is a system in place to deal with this.

There is, however, significant risk in granting the legitimacy of official regulation ahead of adequate evidence of efficacy and a plausible method of action (Secondary criteria: Criterion 2). Such presumption can lead to regulation being ineffective in protecting the public.

An example is where the ability for informed consent is diminished as the person seeking care must make an assessment based on the beliefs of the provider rather than proper assessment of their clinical condition and choice of evidence-based therapies. It is also possible that such a person can receive treatment that is not only ineffective for their condition, but which also has the potential to cause harm.

This has been demonstrated in many of the core practices of TCM such as acupuncture, energy medicines, cupping/moxibustion and the like (example case studies from the media are monitored by WhatsTheHarm.net; others are available via professional medical groups and monitoring organisations).

In such cases, regulation may fail in its aims by creating the situation where it is difficult for a health care consumer to determine the best health care provider to treat them and provide apparent support for situations where care can be inappropriate or even harmful but where the provider is not deemed to be acting outside the regulations that cover their practice. This also tends to go against a growing number of legislative developments worldwide where jurisdictions have determined that it is illegal to make claims about treatments where no evidence exists to support that claim.

TCM uses two major concepts – that of Yin-Yang and Five Elements. Diagnosis involves looking, listening, smelling, asking and touching. It includes acupuncture, which is based the idea that health relates to the flow of the claimed Chi/Qi (life force) through pathways in the body. The goal of needling is to rebalance and unblock Chi, under the belief that such imbalance and blockages cause illness. TCM also involves dietary management by categorising foods into set characteristics of “hot” or “cold” (NB: not actually based on temperature, but on esoteric qualities) and by flavour. Imbalances in such characteristics are believed to be a root cause of illness. As an example, the stomach and spleen are conceptualised as a cauldron, with internal fire transforming the food into energy and blood. Herbal medicine in TCM again involves categorising by temperature and flavour that is considered to influence Yin-Yang energy patterns.

All of these concepts developed long before modern medicine, biology, chemistry and physics, which are evidence-based, cross-cultural bodies of knowledge that exist independently of a practitioner’s or client’s beliefs, supported by independent verification and monitored practice. With TCM, there is no evidence for the existence of concepts such as Yin-Yang or its role in health care.

The highly fluid nature of such beliefs means that there is little correlation between practitioners when diagnosing and treating patients and no correlation with relevant physiological processes in the body. Where the diagnosis may be cited as something like “kidney Qi deficiency”, this has no relationship to any conventional medical diagnosis. Thus while TCM practitioners may appear to be undertaking assessments, diagnosis and treatment using similar-sounding terms and practices to evidence- based medicine, there is no accepted medical body of knowledge or health practice at work.

TCM does not fulfill the criteria of being a health service, but is more in the nature of an applied cultural practice or belief system. Much of its current system, in fact, owes a great deal to the political and social context of China in the 1950s and 60s rather than to the claimed long-established traditional practices. The same can be said for a great deal of its apparent pharmacopoeia, where materials have been added, often on an ad hoc basis, over the past 50 years. There are many reports of the problems that this lack of consistency and independent oversight has caused, ranging from animal welfare issues (eg the use of bear bile or tiger parts) to negative health outcomes from unmonitored and unacceptable production process (eg heavy metal poisoning or inclusion of drugs such as Viagra).

As such, to provide TCM with apparent legitimacy of health regulation would be misleading to those seeking such services, doing a disservice to the general public, particularly if this were used to justify the expenditure of public monies for the provision thereof. The only way in which this could be accepted would be if there were to be established an independent assessment and monitoring body prepared to:

• Examine all current and proposed practices for both safety and efficacy.
• Check claims relating to practices, services and products.
• Provide in-depth, freely accessible advice to allow informed consent on the part of the general public with regard to the relative claims, successes and appropriate applicability of such practices, services and products.

2. Are practitioners of TCM generally agreed on the qualifications required to deliver the health services they provide?

It is typical of such cultural practices that there is a wide, divergent range of beliefs and applications throughout those operating within such a system. This has proved a major problem for much in the way of complementary and alternative health practices where very little agreement has been possible in defining such practices, the nature, role or extent of qualifications required; the responsibilities of those involved etc (New Zealand’s MACCAH group serves as one example of the industry’s lack of capability in this regard).

In the proposal it is noted that currently there are two institutions offering bachelor degrees and diploma and certificate courses in TCM which are the New Zealand School of Acupuncture and Traditional Chinese Medicine and the New Zealand College of Chinese Medicine. These courses are approved by NZQA. The proposal notes not all groups agree on hours required to achieve both theoretical and clinical competence, and that courses need to be a combination of both to define minimum standards for practice and to determine a practitioners fitness to practice.

On checking information provided by these institutions, it is extremely difficult to determine whether there is any agreement between the courses and what teaching they deliver. In addition, while there is some agreement, there are significant differences in schools of thought within TCM with, for example, some acupuncturists working on the basis of 14 meridians, while many support the idea of 12 and with additional concepts such as Yin-Yang some schools may divide this into 2 subcategories while others may divide into 4. This does not provide any confidence that there is any recognised basis for acceptable health care practice or meaningful education related to these practices. Rather than suggesting that these practices are acceptable health care, such disparity indicates that they are based on highly variable cultural beliefs with significant variation from practitioner to practitioner.

The currently provided courses may have some science-based material within the qualification they offer, but it is well known that NZQA determinations are more about processes and quality of delivery than actual content of courses. Mere acceptance in to the NZQA framework says little to nothing about the validity, scholarship, research, safety and the like of approved courses.

This does not engender any confidence in the ability of the industry to define, monitor or regulate its practices. This is exacerbated by those practices being fully embedded in a culturally determined context, rather than in any evidence-based, cross-cultural body of knowledge.

An example may help indicate the problems that this approach causes for any attempt to provide industry-wide regulation for such a non-defined culturally based approach to health.

The New Zealand School of Acupuncture provides the following information on TCM core teaching areas:

Core Teaching Areas in TCM: Traditional Chinese Medicine is a vast area of study with many and varied concepts concerning sickness and health. Of that body of information there are certain core concepts that underpin this system of medicine. Listed below are those concepts that can be taken as the ‘core teachings’ of TCM.

• Yin-Yang / The Five Phases
• Zang-fu organ theory
• Qi-Blood-Body Fluid Inter-relationships
• Channel Theory
• Acupoint Classification/Nomenclature
• Therapeutic Properties the Points
• Etiology and Pathogenesis
• The Four Diagnostic Methods
• Eight Principles Syndromes
• Qi-Blood-fluids Syndromes
• Differential Diagnosis
• Principles of Treatment
• Treatment Methods
• Basic Prescription Principles
• Selection of Points
• Selection of Herbs and Formulas

While it is not possible here to comment on detailed content, it is clear students are being taught pre-scientific concepts that bear no relationship to the current understanding of the human body, anatomy, physiology, the germ theory of disease etc, etc.

It may be that they would be the first to admit that – and perhaps even claim it as a strong point of differentiation for their practices – but it does mean that there are definite vulnerabilities for their target client market who may not be aware of the lack of evidence for the practices, the cultural context for TCM and the variability of training in potential practitioners.

In another example, which raises concerns regarding the nature of research and teaching within the TCM industry, a University of Salford examination paper (2009) included questions such as:

Q1: Which of the following explain(s) the physiological relationships between qi and blood/xue:

1. Qi is the source of all material in the body and blood carries the energy.
2. Blood is the source of all material in the body including Qi.
3. Qi drives blood moving and blood carries Qi.
4. Qi flows in the channels and blood is stored in the organs.
5. Qi produce blood and blood is the mother of Qi.

Q24: In Chinese Medicine, anger is associated with liver and the suppression of of anger causes Liver Qi stagnation. Explain your understanding of the statement in 100 words.

As with other alternative health approaches, proponents of TCM do not question the underlying assumptions of their industry, treating their authorities as having perfect knowledge that does not need testing. In many cases, any external calls for such testing is met with resistance, if not outright hostility. Providing a faux legitimisation of such a authoritarian approach will make the would-be consumer much more vulnerable to negative health outcomes, and with very little in the way of any avenue for protection or redress.

3. Is there a risk of harm to the public from the practice of TCM?

Yes.

There is the risk of physical harm from:

• The use of unnecessary and inappropriate invasive practices (such as acupuncture).
• The distribution of unmonitored substances which may contain harmful substances that are not disclosed to the consumer (or even the practitioner if they are supplied by a third party, as is common practice).
• The tendency for this type of industry to discourage (whether actively or passively) their clientele from seeking conventional medical treatment.

There is the risk of financial harm from:

• the long-term reliance encouraged by this industry on its products and services; dependency relationships are a common factor in alternative health practices, which raise both financial and ethical issues.
• the diversion of public monies (whether ACC payments, insurance coverage or outright funding support) into a health industry based on cultural beliefs.

There are many examples of specific examples of actual and potential harm related to core TCM practices. The alternative health industry is well-known for poor record- keeping and a lack of patient redress, but many cases and concerns can be found in publications such as The Journal of Alternative and Complementary Medicine; websites such as Quackwatch.com; health analytics such as the Cochrane Collaboration and so on.

1. Acupuncture Risks:

For a core practice such as acupuncture, there are risks of:

• Infection due to not using sterile techniques, including not using single use needles and incorrect disposal of used sharps.
• Tissue damage from bruising and bleeding, forgotten or broken needles and perforation of vital organs such as the lung or heart. The proposal states that “the evidence of risk of harm is largely based on practitioners that are inadequately trained or who have inadequate clinical experience”. While this may be the case for such areas as prevention of infection, this tends to ignore risks inherent in the insertion of needles. The “Code of Safe Practice for Acupuncturists” from the New Zealand Acupuncture Standards Authority (NZASA) states that there are vulnerable points that require skill and care including Zhongfu LU1, Jiangjing GB21 and Dazhu BL11 which are points over lung tissue unprotected by bone or cartilage. This indicates that acupuncturists may insert needles in areas with an increased risk to the patient if it is deemed necessary for treatment. In addition, in case decision 07HDC12714 of the Health and Disability Commissioner, pneumothorax was experienced as a complication of using acupuncture to treat asthma. The acupuncturist was not deemed to have breached the standard of care with the opinion of another acupuncturist being “The following points were selected by [Mr B] in the treatment: BL12, BL13, BL23, BL43, DU4, EX-B1, K13, ST36 and SP6. These points are used to treat Asthma or reinforce body energy…[Mr B’s] acupuncture treatments comply with these standards.” despite the complication occurring.

TCM is claimed to treat many disorders, from acne to vertigo, but with little to no actual proof beyond placebo and marketing testimonials for many such claims. It is a common attribute of the alternative health industry to maximise its clientele and profits by keeping its alleged coverage as broad as possible.

The fact that acupuncture is accepted by ACC is already used to legitimise use of the practice far beyond any clinically accepted areas, with a consequent risk to patient care and waste of public funds.

As an example, acupuncture has been shown to have minimal use in almost all its applications, with only some success in a very limited context (i.e. it may provide some pain relief). Its effects have been replicated using sham acupuncture and other non-invasive techniques, which makes its use ethically questionable, particularly given the cases of infection and other negative outcomes associated with its use.

Acupuncture is widely used for conditions for which there is no evidence that it has any efficacy. Acupuncture additionally may not compare well in outcomes or cost-effectiveness for the patient in comparison with other comparable treatments. Even if there appears to be some efficacy, it can be difficult to assess benefit/risk for the patient. Non-specific effects may apply for pain-related conditions and there may be some benefit to needling in those cases. However, for conditions such as lower back pain simple and cheap interventions like regular pain relief and advice to keep active can achieve the same benefit for the person seeking care without the risks of needling being incurred. Using Chinese diagnosis may also mean a medical condition is not properly diagnosed or treated.

That many studies are of poor quality can make it difficult to determine whether any evidence is reliable. According to Edzard Ernst and Simon Singh (citing the Cochrane Collaboration in “S Singh, E Ernst (2008) Trick or treatment?”” Bantam Books. ISBN 0593061292, 9780593061299), there is no significant benefit from acupuncture for the following conditions: smoking, cocaine dependence, induction of labour, Bell’s palsy, chronic asthma, stroke, breech presentation, depression, carpal tunnel syndrome, irritable bowel, schizophrenia, Rheumatoid Arthritis, insomnia, back pain, lateral elbow pain, shoulder pain, soft tissue shoulder injury, morning sickness, egg collection, glaucoma, vascular dementia, period pain, whiplash. Any perceived benefit appears to be from the placebo effect. Some other conditions have been more optimistically reported, but not stated to be convincing, such as pelvic and back pain in pregnancy, low back pain, headaches, post- operative and chemotherapy induced nausea and vomiting. Later well-designed trials for conditions such as chronic tension headache, migraine prevention, nausea under chemotherapy and post-operative nausea and vomiting using sham acupuncture provide no convincing evidence that real acupuncture is much more effective than sham acupuncture. These finding apply also to any variations of acupuncture, such as laser acupuncture or acupressure.

2. Chinese Herbal Medicine risks:

• Interactions between herb and drugs, or herb-herb interactions.
• Failure to assess contraindications of herbs for patients i.e. liquorice root (Glychrriza species) may cause problems for those with high blood pressure, exacerbating the condition.
• Safety issues such as the possibility of toxicity and liver or kidney damage or allergic reactions. Some herbs may require specific preparation such as boiling before use, which may fail to be communicated and therefore increase the risk of toxicity. It may also fail to be communicated to the patient that they may have an adverse event, and what to do if they have any possible reaction to a herbal medicine they are taking.
• Contamination or adulteration of products which may cause poisoning or if adulterated with pharmaceuticals, adverse effects or interactions with other medications that may be being taken.
• Labelling or identification issues that mean an herb may be misidentified.
• The use of several types of herbs in a mix as made by TCM practitioners can mean dosage varies and increasing numbers of herbs taken in the mixture gives a greater chance of adverse effects.
• TCM may use rare or threatened species of plants or animal products in preparations.
• Inappropriate use such as the use of herbal preparations where there is a safer and more effective pharmaceutical option can be risky where evidence is lacking for the safety and efficacy of an herb or herbal preparation. Using Chinese diagnosis may mean a medical condition is not properly diagnosed or treated. Patients may also fail to inform their doctor or abandon current treatment which may lead indirect harm from their condition not being treated properly or at all. It can be very difficult to determine if any particular preparation is safe to use and there may be a lack of information as to whether many herbs are safe for use while pregnant or breastfeeding, in children or with current medication being taken.
• TCM herbal preparations are used to treat many disorders and while there is a plausible mechanism of action due to active ingredients, the evidence for efficacy may be variable and many trials are poor and have methodological problems. This means that these may be used for conditions for which there is no evidence it may be effective which can be considered an indirect harm as it may delay uptake of effective treatment, interfere with other treatments being used by the patient or make it difficult to assess benefit/risk in using the treatment. This may also not compare well in outcomes or cost-effectivenessfor the patient in comparison with other comparable treatments due to the lack of evidence of efficacy and safety issues. The Cochrane Library in New Zealand has assessed Chinese herbal medicines in conjunction with lifestyle modification for impaired Glucose tolerance or impaired fasting blood glucose (D72D15553B7D8719E901E.d01t04), finding that “The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.” and for idiopathic chronic fatigue and chronic fatigue syndrome finding that “Although studies examining the use of TCM herbal products for chronic fatigue were located, methodologic limitations resulted in the exclusion of all studies. Of note, many of the studies labelled as RCTs and conducted in China did not utilize rigorous randomization procedures. Improvements in methodology in future studies is required for meaningful synthesis of data.” Other Cochrane reviews are in their database and it would be relevant to consider that if regulating, that this is limited to preparations where evidence of efficacy and safety for a condition are present.

3. Tui na:

• Tui na is a form of massage and can be generally regarded as being safe, however spinal manipulation may cause harm particularly when a practitioner is inadequately trained.
• There appears to be little evidence for effectiveness in treating any condition, and one study which was a systematic review and meta-analysis of the efficacy of tuina for cervical spondylosis (Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM systematic review and meta-analysis of the efficacy of tuina for cervical spondylosis J Clin Nurs. 2008 Oct;17(19):2531-8.) found that “based on the results of this systematic review, a definitive conclusion regarding the effects of tuina on cervical spondylosis remains to be determined” with the clinical relevance being that “The efficacy of tuina is not supported by parallel-group comparison studies.”

4. Diet:

• Dietary interventions can be considered generally low risk, however there may be some risk that a proposed diet and restrictions of certain foods could cause harm or inconvenience to the patient. The advice given as it does not follow current human nutritional rationales may conflict with other advice given by health professionals, such as diet recommendations for diabetics.

5. General:

• Traditional Chinese Medicine may be used inappropriately, as in treating very young children, pregnant or lactating women or the elderly who may have different health needs to the rest of the population and/or for conditions it is not effective for. It is not difficult to find websites that promote its use for children for conditions such as colic, cerebral palsy, new born jaundice, myopia, eczema and epilepsy which have material on them such as “children may avoid disease altogether if introduced to acupuncture at an early age.” This also may indicate that treatments such as acupuncture may be recommended where there is no evidence of needing treatment, increasing risk without benefit to the person. It is important for these groups to be properly assessed, as they may not display symptoms of illness the same or have specific health care needs and it is important that they have appropriate assessment and treatment with minimal delay.
• Failure to refer on to medical or other care or inform other health professionals appropriately may occur as the practitioner may not recognise the limits of their expertise or may incorrectly think they can treat a diagnosed condition.
• TCM practitioners may make claims that outstrip the evidence and give advice contrary to other health practitioners such as displaying or giving anti-vaccination advice or giving information that otherwise may deter people from medical care. Many may make an artificial division between so-called “Western” and “Eastern” medicine which does not in fact exist. In one case, an immune system package is offered along with information stating acupuncture is effective for colds and flu and an article stating “The flu shot does not work for babies … the flu shot does not work in children with asthma … adults are also not protected by flu vaccine … for elderly living in nursing homes, flu shots were non-significant for preventing the flu … for elderly living in the community, vaccines were not significantly effective…”. This may discourage people seeking appropriate interventions, particularly in groups vaccines are recommended for.
• General contraindications such as need for caution or not using acupuncture and other therapies with those with bleeding disorders, pacemakers (use of electroacupuncture), high blood pressure, diabetes and unstable epilepsy.

(Note: with unstable epilepsy the NZASA Code of Safe Practice for Acupuncturists states “care should be taken with needling. If a seizure is triggered then appropriate resuscitation techniques apply including the use of Rhenzong CV26 or/and Yongquan KI 1.” It could be suggested that basic first aid, including keeping the person safe, would be the most appropriate intervention rather than needling a seizuring person.)

4. If so, what are the nature, frequency, severity and potential impact of risks to the public? What is the likelihood of the harm occurring?

According to the 2000 paper by Bensoussan, Myers and Carlton “Risks Associated With the Practice of Traditional Chinese Medicine: An Australian Study” (Bensoussan A, Myers SP, Arch Fam Med. 2000;9:1071-1078) it is extremely difficult to estimate the rate of adverse events for Chinese Herbal Medicines (CHM) as the total exposure to any particular substance is unknown and there is likely to be significant under-reporting.

The study stated:

the most common adverse events reported were severe gastrointestinal symptoms (n=124), fainting and dizziness (n=119), and significant skin reactions (n=110). Serious adverse events reported included central nervous system effects (n=37), hepatotoxicity (n=29), renal toxicity (n=28), and death (n=19). The number of deaths reported is consistent with literature reviews, which cite deaths associated with specific Chinese herbal preparations, notably those containing aconite…

For acupuncture the paper stated:

Medical practitioners used predominantly acupuncture, while non medical practitioners frequently combined acupuncture and CHM…Mean length of full-time TCM practice was 7.7 years. Practitioners reported that more than 3000 adverse events occurred duringtheir practice lifetimes. The most common adverse events reported were fainting during treatment (n=1169), increased pain (n=1069), and nausea/vomiting (n=534). Serious adverse events reported included pneumothorax (n = 64) and convulsions (n=80).” In addition the authors noted “Instances of local and systemic infections have been reported in the literature such as endocarditis, septicemia,hepatitis B, human immunodeficiency virus infection, osteomyelitis,myositis, peritonitis, and pleural empyema, allegedly contractedas a result of acupuncture. Causality had not been confirmed in many of these cases. Numerous reports of trauma-related injuries from acupuncture have been published in the last 15 years, including pneumothorax, spinal cord injuries, auricular chondritis, fatal and nonfatal cardiac tamponade, pseudoaneurysm, deep- vein thrombosis,nerve damage, burns (from moxa), and severe bruising (from cupping). Published reports have also referred to psychiatric changes(such as depression), insomnia, convulsions, hypotension, menstrual disturbance, increased pain, and allergies to certain needle compositions.

The majority of acupuncture practitioners stated that they always used single-use disposable needles (93%) and adhered to government skin penetration guidelines (83%). Of the small number (n=69) who did not always use disposable needles, autoclaving was the preferred method of sterilization (68%). A variety of treatment techniques, many of which fell under the umbrella of acupuncture, were administered to patients. Some of the more traditional techniques such as bleeding, scarring moxibustion, and scraping were used only by non medical practitioners,and carried their own distinct risks. It is unknown how many of the adverse events reported by practitioners could be accounted for by any one technique….Adverse events due to acupuncture accounted for 79% of all adverse events reported. This reflects the substantially larger cohort of practitioners who principally use acupuncture…

The paper stated:

We determined that each practitioner had encountered an average of 1.38 adverse events during each year of equivalent full-timeTCM practice. Hence, approximately 1 adverse event occurred every 8 to 9 months of full-time practice, or for every 633 consultations.

Practitioners were also identified as having prescribed a number of scheduled or restricted substances.

Another paper by White, Hayhoe, Hart and Ernst (White A, Hayhoe S, Hart A and Ernst E, Adverse events following acupuncture: prospective survey of 32000 consultations with doctors and physiotherapists BMJ 323 : 485 doi: 10.1136/bmj.323.7311.485 (Published 1 September 2001)) attempted to ascertain the incidence related to acupuncture treatment finding that:

a total of 2135 minor events was reported, giving an incidence of 671 per 10 000 (42/10 000 to 1013/10 000) consultations. The most common events were bleeding (310 (160 to 590) per 10 000 consultations) and needling pain (110 (49-247) per 10 000 consultations). Aggravation of symptoms occurred in 96 (43-178) per 10 000 consultations; in 70% of these cases, there was a subsequent improvement in the presenting complaint. The highest rates reported by individual acupuncturists, expressed as a percentage of consultations, were 53% for bleeding, 24% for pain, and 11% for aggravation of symptoms. … Doctors and physiotherapists who performed acupuncture reported no serious adverse events and 671 minor adverse events per 10 000 acupuncture consultations. These rates are classified as minimal; however, 14 per 10 000 of these minor events were reported as significant. These event rates are per consultation, and they do not give the risk per individual patient.

The researchers noted that some avoidable adverse events occurred.

Ernst (Ernst E, Acupuncture – a critical analysis Journal of Internal Medicine 2006; 259: 125-137) has also published safety data in an 2005 paper “Acupuncture a critical analysis” stating that:

Acupuncture has occasionally been associated with several serious adverse effects, in particular, trauma to internal organs (e.g. pneumothorax or cardiac tamponade) and infections, such as hepatitis C or HIV. Several large prospective studies have shown that such adverse events are extreme rarities, provided acupuncture is carried out by well trained practitioners. These studies also show that mild, transient adverse effects, e.g. needling pain or bleeding at the site of needling, occur in about 7-11% of all cases. The largest study included 190 924 chronic pain patients. The data revealed 2.4 serious adverse events per 10 000 patients. However, the authors suspect this figure to be distorted through under-reporting. In their series, only 5% of the average death rate in the German population was reported. Assuming therefore that under-reporting of acupuncture-unrelated death (and by implication serious acupuncture-related adverse events) was 95%, the true incidence of serious adverse events after acupuncture could be as high as 48 per 10 000 patients. A recent UK survey suggested that, in 3% of all cases, non- medically qualified acupuncturists interfere with the prescribed medications of their patients, which could therefore constitute an indirect risk of acupuncture. The totality of this evidence nevertheless suggests that acupuncture, as used by well-trained professionals is probably a reasonably safe therapy. Serious adverse effects may be a consequence of poor training and the large number of paramedics exercising the technique.

We are concerned that any move to legitimate TCM as an accepted health practice alongside evidence-based medicine will see a rise in negative patient outcome through encouraging public uptake of inappropriate practices and the use of unmonitored substances.

5. Other than on the basis of risk of harm, is it in the public interest that the profession of TCM be regulated?

The only public interest that it would appear to serve is that of the industry itself. We already have a number of medically dubious practices covered by our regulations, and this legitimisation has been used as a marketing tool by them to justify public funding, expand their clientele base and gain credibility without requiring to provide evidence as to the safety and efficacy of their practices. The public of New Zealand will not be better served by adding to this.

Currently there are a few organisations offering voluntary membership for members of this industry, including the New Zealand Register of Acupuncture Incorporated and the New Zealand Acupuncture Standards Authority Incorporated. Membership in either organisation allows its members to become ACC acupuncture providers. Currently neither has the authority to register an acupuncture practitioner as a health care provider under the HPCA Act.

Regulation also occurs through the practice of TCM being subject to the Code of Health and Disability Services Consumers’ Rights. The Code has ten rights covering being treated with respect and dignity; being given information in a way that is clear; being given quality care and having the right to make a complaint if there is the belief that these rights have been breached in any way. Members of the public have rights to ask any health practitioner what qualifications they have. Members of the public also have the right to contact professional associations to ask what is required of their members, in terms of qualifications, professional development and code of practice. Members of the public can also contact a professional association to ask if a particular practitioner is a member of that association.

The Ministry of Health provides Guidelines for Skin Piercing and local Councils have regulations and licensing processes covering areas such as skin piercing and tattooing which includes acupuncture practice. Local authorities are required to appoint Environmental Health Officers under Section 28 of the Health Act 1956 and under Section 128 have rights of inspection and to execute works under the Act in order to promote and protect the health of the public by ensuring minimum standards of hygiene and health are practised. TCM may also be impacted by provisions in the

Medicines Act and MedSafe guidelines as well as general consumer legislation such as the Fair Trading Act and Consumer Guarantees Act and bodies such as the Advertising Standards Authority.

This current self-regulation regime with external regulations broadly applicable to practicing TCM appear to cover most health and safety issues, but should be strengthened. It would be preferable to see more TCM practitioners comply with general requirements as regards advertising and claims whilst in the process of applying for recognition under the HPCAA.

As stated earlier, there are concerns about granting official legitimacy ahead of there being adequate evidence for TCM. If such is granted, scopes of practice would need to be strictly limited to areas where sufficient evidence is supportive of the treatment being effective and for risks to be managed. Otherwise, regulation may fail in its aims by creating the situation where it is difficult for a health care consumer to determine the best provider and, additionally, the situation where care can be inappropriate or even harmful for the condition, but the provider cannot be deemed to be acting outside the regulations that cover their practice.

Given this, it would be preferable to improve the current self-regulatory regime or look at other means such as accreditation to strengthen the current regulatory environment and ensure compliance with safety guidelines and evidence based practice. Currently, there is encouragement for practitioners of TCM to gain membership with the NZASA or the New Zealand Register of Acupuncture Incorporated to become ACC Acupuncture providers, the majority of treatment provided by TCM practitioners. If the organisations were required to develop and maintain rigorous and open standards of practice under third-party independent scrutiny, this could have the desired effect in maintaining standards within the practice of TCM and protecting the public from harm.

6. Are practising TCM practitioners generally agreed on the standards that

TCM practitioners are expected to meet?

With a disparate workforce consisting of some who are voluntary members of an organisation and others who work independently, it is difficult to ascertain whether there is any agreement between practitioners outside of the general standards set by the current self and external regulatory environment.

It appears that, in some cases, the codes and standards as set out by various bodies may not be fully complied with in such areas as claims in advertising of their services. This suggests that TCM practitioners themselves may hold differing views of these codes and standards of practice or not feel that they are fully applicable to their practice as it is currently. The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA and that this will happen may be an issue for some practitioners that may face a number of changes to how they currently practice.

7. Are practising TCM practitioners generally agreed on the competencies for scopes of practice for TCM?

It is difficult to ascertain whether there is any agreement between practitioners outside of the exceptions of general standards set by any organisation they are members of and the external regulatory environment. The situation appears too fluid to suggest there is general agreement on such. The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA. In the event of regulation some practitioners may not agree with what the competencies should be or any restrictions or limits that may be set on competencies and/or scopes of practice and this may make it difficult to determine appropriate competencies that apply to TCM practitioners.

8. What qualifications are generally held by members of the profession, and what is the degree of uniformity in qualifications across members?

The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA.

With a disparate workforce consisting of some that have previously trained in New Zealand qualifying with a Diploma, others that have studied to Degree level, some who have overseas qualifications that may differ in content to New Zealand qualifications as well as others that have done short courses and who may or may not have other health-related qualifications, it is difficult to ascertain what, if any, qualifications may be held by any one TCM practitioner or whether this is uniform over all practitioners. Given that there is this inconsistency it appears that there is a distinct lack of uniformity in what qualifications are generally held by members of the profession.

With regard to all three questions above, one of the defining features of an alternative health practice is the tendency to have very fluid definitions relating to their scope practice, knowledge base, product offerings, application of service etc. It is clear from examining marketing material and listening to those involved in the industry, that apart from the use of TCM as a marketing term, there can be a highly variable provision of services and product. It is clear from examining the various offerings of TCM educational services, that equal variability exists in the training aspects of this industry.

9. Does your organisation accord any standing or status to the profession of TCM, or to those who practise as TCM practitioners?

No, not outside its social context as a cultural and political response to well-being.

For consumer protection, in terms of safety and efficacy as well as informed consent, it is imperative that we assess the benefits and risks of any particular health care practice by:

• Investigating whether the treatment(s) provided offer therapeutic benefits greater than placebo
• Determining the safety of the treatments
• Establishing how it compares in outcomes and cost effectiveness with comparable treatments

It would be generally accepted that we should be cautious about health claims made by one individual practitioner, particularly working in an area which provides little in the way of independent verification of such claims. We should be equally cautious regarding claims of status based on the vested interests of those involved in the industry.

Most other regulated health professions provide comparable levels of evidence- based services and products. The public generally understands the educational level and standards which are required in order to participate as a practitioner. To afford similar mana on TCM practitioners would be misleading and to the detriment of general health outcomes.