Category: Submissions

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.

Name:	Vicki Hyde, Chair
If this submission is made on behalf of an organisation, please name that organisation here:	NZ Skeptics Inc.
Please provide a brief description of the organisation if applicable:	For the past 25 years, the NZ Skeptics have monitored the claims and use of alternative health products and services to encourage critical thinking regarding such; the assessment of evidence supporting such; and to call for changes in position which reflect the provision of the positive or negative empirical evidence for such.
Address or email:	[email protected]
Interest in this topic (for example, consumer of natural health products, health professional, manufacturer of natural health products, etc):	Consumer protection issues relating to claims and evidence.

Questions on Proposals for a Natural Health Products Bill

Question 1

Do you support the proposed scope, purpose and principles for natural health product legislation?  If not, what other suggestions do you have?

NZ Skeptics Inc, in general, supports the scope, purpose and principles of the proposed legislation.

We consider it important that this industry has some regulatory oversight to support consumer protection, particularly in the area of claims and proof of efficacy, as well as safety, marketing material and labelling. The use of terms such as “natural” concerns us as it is used to imply benign, which is not a supportable claim.

In addition we are concerned that there appears to be very little in the way of supervisory oversight or quality control in this industry, particularly with regard to imported products. This is potentially of major concern as, on the rare occasion when such checks have been made, product quality has been found to be severely compromised, such as with the Pan Pharmaceuticals scandal in Australia in 2003.

http://www.nzfsa.govt.nz/consumers/food-safety-topics/recalls-and-product-advice/pan-pharmaceuticals/questions-answers.htm

Some “natural health products” have been found to have significant levels of contaminants such as heavy metals, or to contain pharmaceutical products, such as viagra and paracetamol, deliberately introduced to give the product a measurable effect not obtainable from the “natural” products.

See: http://www.medicine.ox.ac.uk/bandolier/band132/b132-6.html

We believe that informed choice for the consumer is critical in this area, as in all areas relating to health. Labelling requirements need to be clearly defined to ensure that the natural health industry does not use archaic, misleading or inappropriate terminology to boost its claims to the detriment of consumer understanding.

Question 2

Do you think the scope proposed for the definition of natural health product is appropriate?

Clearly the definition of “natural health product” will need careful deliberation. This industry has been seen in the past as quick to claim any and all modalities that suit their business. The Ministerial Advisory Committee on Complementary and Alternative Health sacrificed credibility with the definition of its interests as “all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being”. This universal claim was seen as rather self-serving, given that that five of the eight committee members were self-identified CAM practitioners, with business interests in iridology, naturopathy, natural medicines, traditional Chinese medicine, acupuncture, aromatherapy, massage therapy, counselling, sclerology, osteopathy, homeopathy, anthroposophy and culturally defined health sectors.

Such an all-encompassing definition does not help the consumer trying to decide if a recommended practice is safe and effective, and it reflects poorly on the industry as a whole. Two CAM practitioners who were members of the White House Commission on CAM Policy, were honest enough to warn that:

Generic recommendations neither serve the public interest nor protect the public health because they fail to distinguish between approaches, practices and products for which there is some scientific evidence and those that either stretch the realm of logic or are demonstrably unsafe.

“Natural health” should be regarded as a marketing term, not a scientific one. The extension of this business into “synthetic equivalents” gives this industry even more scope for misleading consumers (cf the claims of BZP as providing a “herbal” high).

The claimed health benefit/s should be specific and clearly defined, and noted on the product packaging with reference to publicly available evidential material supporting the claims. There should be consumer redress if such is not achieved.

There must also be a clear distinction made between the products which fall under this legislation and those which can be legitimately termed medicine. We note that the MOH questions and answers section regarding this legislation included “alternative, traditional or complementary medicines”. Co-opting medicine as a marketing term has led already to considerable consumer confusion regarding what products and practices are well supported with good evidence regarding safety and efficacy, and what is not.

We question the assumption that “natural health” thereby implies low-risk as a matter of course. Low-risk requires empirical evidence that such products, their derivatives and their synthetic equivalents are, in fact, low-risk. This information needs to come not only from the manufacturers and the industry but also from independent third-party sources or large meta-analyses for cross-checking outside the vested interests.

The problem of assessing this is well recognised as there exists little in the form of consumer monitoring. Alternative health practitioners have been notorious for not keeping accurate detailed customer records or undertaking follow-up. In addition, many consumers would not necessarily recognise or attribute a side-effect or interaction to a “natural” product, particularly if they are also using conventional medicine.

This has been a cause for concern where herbal supplements have interacted with prescribed medicines; such as where kidney and liver damage has resulted from the overuse of natural products. Black cohosh, for example, has been demonstrated to have, at best, inconclusive evidence for any benefit but definite risk of harm; thus while it may be termed a “natural” product, there is a strong case for it being prohibited for health applications.

The assumption that natural means low-risk has been exacerbated when consumers thereby assume that their use of such products does not need to be disclosed to medical professionals. Surveys have shown very high rates of non-disclosure, and this can be life-threatening due to the sorts of interactions, contaminations and deliberate “spiking” of products noted above.

The inclusion of ingested oral and topically applied products should be accompanied by a requirement that such are cleared as safe for use, as they are likely to pose a higher risk per se than, say, a hair rinse. If we require increased standards of care for cosmetics, then alleged health products should be held to a higher standard with greater testing, accountability and monitoring as a result.

In many instances, international experience and research would be able to provide useful information regarding product safety. For those which do not have any credible evidence, the manufacturer/seller should be required to demonstrate such, with a reasonable lead-in time before being released to the market.

Suitably qualified information resources should be identified as appropriate points from which to source information – a Cochrane collaboration (http://www.cochrane.org/) has much more weight than a “scientific tests proved…” press release from a manufacturer. There are some good quality resources available which assist the evaluation of specific products in the natural health area, such as the Natural Medicines Database (http://www.naturaldatabase.com).

The Australian National Prescribing Service has recently undertaken a review of information resources applicable to this health area, aiming to identify high quality resources for use by Australian health professionals and consumers on the basis of technical quality, content quality and clinical utility.

The NPS has strongly recommended that organisations responsible for providing information to consumers and health professionals ensure they have access to the best quality information resources so identified. While their primary focus was on complementary medicines, this review, or one based on similar grounds, should provide underpinning support for evaluation and use of information resources in the more generic “natural health” market.

http://www.nps.org.au/research_and_evaluation/current_research/complementary_medicines/review_of_info_resources

The NZ Journal of Primary Health Care has a regular column, entitled Charms and Harms, which covers the evidence for efficacy and safety of herbal remedies.

http://www.rnzcgp.org.nz/journal-of-primary-health-care/

For an example, see: http://192.168.100.45/assets/Uploads/JPHC/March2010/

Question 3

Are there products that would fall outside the definition that you think should be included?  Conversely, are there products that fall within the definition that should be excluded?

We believe that it is advisable to harmonise as much as possible with other related product approval schemes, given the global scope of the industry and the prevalence of imported products.

The “natural health” industry has a tendency to follow fads, introducing new products and therapies to gain market share and tap into consumer trends. Listing both acceptable and prohibited ingredients may restrict the amount of oversight that can be applied to new materials, unless there are clear avenues for assessment of such. There will need to be monitoring of the introduction of new products and claims so that such lists can be revised.

It will also be important to monitor the use of materials not typically associated with health outcomes, but which are nonetheless used by the industry. New Zealand authorities will need to ensure that regular monitoring is undertaken and databases updated as further research regarding risk and harm – or supportive evidence – is produced.

Colloidal silver, for example, is a metal with no known nutritional needs, well-known detrimental side effects and popular in the natural health market being marketed with therapeutic claims. In 2002, the Australian Therapeutic Goods Administration amended its Therapeutic Goods (Excluded Goods) Order to note this product use.

http://www.tga.gov.au/docs/html/csilver.htm

We are also concerned at the potential for Traditional Chinese Medicine to exploit endangered species, some of which have been introduced into their industry just within the past 50 years, rather than the centuries often attributed in the marketing associated with this approach. This involves not only conservation issues, but also well-publicised animal welfare issues, as with the case of bear bile production.

The actual and potential impact on biodiversity and attention to sustainability should be recognised, and exclusions made for products that are derived from unsustainable sources or endangered plants and animals. This may well be already covered by conservation and biosecurity legislation, but should be borne in mind with regard to the health sector too.

Question 4

Are there any other functions that you consider the advisory committee should have?

The general outline of the administration principles look acceptable.

It will be vital for the Advisory Committee to clearly avoid industry capture; MACCAH was seen to be stacked with vested interests which significantly limited its credibility and capability of making independent decisions. It will be important to have appropriate and independent experts represented on the advisory committee, and/or available to them, to ensure that advice, recommendations and regulatory decisions are solidly based on high quality evidence.

Question 5

Do you agree with the concept of a consultative body and its possible role?

We agree in principle with the concept of a consultative body so long as it is not captured by industry interests and maintains clearly independent representatives from consumer and health areas. That is a danger if it focuses solely on how to manage the implementation of the legislation and administration, rather than including a watching brief on the outcomes.

Question 6

Do you agree with the proposed self-certification scheme for product approval?  If not, what would you like to see instead?

In general we agree with the concept, as it provides advantages in streamlining the process and it recognises when other regulatory schemes have approved the relevant products. It also places the responsibility on the manufacturer for their product safety, quality and record keeping. However, prior experience with this industry, and examples of self-certification in others, indicate the importance of independent oversight with regular monitoring/auditing to ensure compliance.

We believe that supply chain issues need to be addressed as safety and efficacy depends significantly on the quality of raw source materials and how these are handled. This industry has already seen too many contamination and product quality concerns raised in its vaguely self-regulated environment. Product approval, for example, could require the manufacturer to provide information on their suppliers of raw materials; that those raw materials can be certified as being pure/fit for purpose; and what the manufacturer is intending to use in their product. Manufacturers should then be held to that, and this information should be made publicly available. Any documented lapse in product quality or manufacturing should also be publicly available, such in a section on the product approvals database.

We would like to see support for the reporting of adverse reactions extended. At present it can be very difficult to gain such information as there is no obvious body to report to. Consumer attempts to track such information tend to be sporadic and rely on media reports. See http://whatstheharm.net/ for one such initiative.

While the legislation suggests that reporting adverse reactions is the responsibility of the product approval holder, this does create concerns regarding the nature of the response, consumer redress, openness of reporting etc.

An independent reporting system would allow not only the manufacturer/product approval holder to collect and report adverse reactions, but also the consumer and/or other health providers to make reports and provide ready access to that information. This could be incorporated into a broader post-market surveillance scheme to ensure that any risk management approach is substantive. And, again, such information should be publicly accessible.

The product approval holder should be required to do more than simply assert that they hold evidence that their product claims are supported. They should be required to post that evidence so that it can be assessed independently or accessed by the public. We have consistently found over the past 20 years that many in this industry state that they have such evidence, but it is exceptionally rare for them to provide information when asked to do so.

On the rare occasions when they do provide such information, it is usually found to be of very poor quality. We have had one researcher at a Crown Research Institute note that his independent tests were ignored and then later misrepresented by the natural health manufacturer looking for evidence to support their product’s claims.

It would be valuable if the post-market monitoring included blind testing of claims and information provision to see that product approval holders meet their obligations. We would like to see such monitoring include the retail sector, as that is a large area with significant potential for consumer harm, but that may well fall outside the scope of this legislation.

Question 7

Should an exemption from product approval apply to any particular types of natural health products (for example, certain homoeopathic preparations or aromatherapy products)?  If so, please specify which types of products and indicate why you consider an exemption should apply.

We do not believe that any such exemptions should apply. We have often heard that natural health products should be granted a free run as “they do no harm”, but monitoring of this industry indicates that that is not necessarily the case.

Even in the case where products are, in fact, completely harmless – such as the non-active water or sugar solutions that form the basis of the homoeopathic industry – there remains the potential for harm as such products/therapies can be substituted for evidence-based products/therapies that can actually work. Thus this form of special pleading should not be acceptable.

Question 8

Are there other situations in which it should be permissible to supply natural health products without a product approval?

Only if the product has passed a comparable or more rigorous evidence-based system in a jurisdiction that has been recognised as such, and that the product is exactly the same as the one that has obtained approval under such conditions.

We do not think that supply of products based on long-term use or cultural relevance should be grounds for avoiding product approval, proof of safety and efficacy or other requirements associated with responsible supply of a health-related product.

Question 9

Are there specific lists of substances used in other jurisdictions that you think should become part of New Zealand’s list of permitted ingredients?  If so, please specify.

The Therapeutic Goods Administration in Australia has a list of substances that may be used in listed medicines found at http://www.tga.gov.au/cm/listsubs.pdf

Presumably the advisory body will carefully assess the requirements of other jurisdictions and the basis for their provisions in determining whether additions or deletions should be made to the list. This should also be regularly reviewed to update as further understanding and evidence is obtained.

Question 10

Do you think there should be a list of prohibited ingredients, as well as a list of permitted ingredients?

Clearly where products are known to cause harm or have severe contra-indications for use with commonly prescribed and OTC medicinal products, those should be listed as prohibited. We would also want to see strong support for the prohibition of any products which are derived from endangered or threatened species, whether native to New Zealand or elsewhere. This is a significant concern in the Traditional Chinese Medicine industry, but other areas of “natural” health have been seen to be lacking in this regard.

The question of what is defined as low risk needs to be examined very closely. Length of use or lack of reported adverse effects are not sufficient to support presumption of low risk. Reference to other jurisdictions that have assessed such substances on an evidence-based basis would provide a starting point.

Question 11

Are there specific claims used in other jurisdictions that you think should become part of New Zealand’s list of allowable claims for natural health products?  If so, please specify.

Health Canada bases their allowable claims on Codex Alimentarius and states their principles on their website.

http://www.codexalimentarius.net/download/standards/351/CXG_023e_u.pdf

http://www.inspection.gc.ca/english/fssa/labeti/guide/ch8e.shtml

The Australian Therapeutic Goods Administration (particularly ARGCM Part I & II) has guidelines about levels and kinds of evidence required to support claims.

http://www.tga.gov.au/cm/cm.htm

These could form a reasonable starting point for assessing claims and gaining some international consistency. Clear definitions of what are low-level claims and minor/serious illnesses or diseases would need to be made to ensure that consumers are aware of what is being claimed and the industry knows where the boundaries are.

The evidence to support such claims should be assessed, as should the evidence held by the entity seeking product approval – assertion or merely claiming to hold such evidence is not adequate. Any additional health claims should be carefully examined, with recourse to information provided by well-regarded independent sources, such as the Cochrane Collaboration or igh-quality information resources such as those identied by Australia’s NPS.

Question 12

Do you believe that the regulator should conduct audits to assess compliance with the requirement that sponsors hold evidence to support natural health product claims?

Yes, this is very important. Such audits should be independent and unheralded. There should also be provision for blind audits to test the responsiveness to consumer-raised concerns as well as those from the regulatory body.

In addition to the holding of evidence, such evidence should also be evaluated to see that it meets evidence-based standards in terms of evidential reliability, methodology, applicability etc.

It would be good to see such audits also required at the retail end of the market. We are aware that many products sold by health shops and other outlets have enthusiastic, and often entirely incorrect or misleading, claims made verbally by sales staff. This can be a major factor in product purchase decisions, and cuts across informed consumer consent.

Question 13

Do you agree with the proposed list of labelling requirements?  If not, are there requirements that should/should not be included?

The list of required information on the labels looks as if it would address many of the concerns we have with natural health products in terms of consumer information and protection. We presume that labelling includes product information sheets that accompany these items within the packaging.

We are particularly keen to see the requirement for the name and quantity of active ingredients, and information on the “true nature” of the product. The definition of the latter could prove interesting, but we think that any health-related product should use recognised terminology that has clear and unequivocal meaning, baked up by evidence.

We have been concerned at, for example, the practice of the homeopathic industry in deliberately using archaic terminology in its labelling which disguises the true nature of the materials they use. The industry’s products also cite special homeopathic dilution factors (used to remove all active material from their products) which are not understood by the majority of even highly motivated consumers.

For example, Nux vomica is the archaic term used for an anti-nausea preparation; the ingredient is far more commonly known as strychnine. Presumably this term is not used as consumers would be far more familiar with the highly poisonous nature of the latter and potentially far warier of the product as a result.

In terms of homoeopathic dilution factors, a term such as 10x is used, with most consumers taking this to mean “ten times” something or other (typically assuming it refers to the ingredient noted on the label). However, 10x is a special homoeopathic term referring to a dilution factor of 0.0000000001; the more common larger dilution factors used in this industry result in the products not actually having any active ingredient in it. This lack of clarity is highly misleading.

Consumer consent issues are clear, as 94% of New Zealanders using homoeopathic products are not aware that homeopathy dilutes the initial material until none of it is left. Instead they believe that they are paying for concentrated medicinal products. Labelling which clearly spells this out would help to prevent such misunderstanding.

http://www.pharmacytoday.co.nz/news-details?objId=16F087C0-1C0C-4DAC-96FE-68CD1BC93D51

Product information sheets within commonly available homeopathic products skirt carefully around the lack of active ingredients. We would want to see both labelling and information sheets amended to make it clear that there are no active ingredients in these products, as recently admitted by the NZ Council of Homeopaths.

http://maryglaisyer.com/2010/01/press-release-mass-overdose/

Other health products in different sectors have similar issues with regard to clarity of labelling and the claimed basis for the efficacy of the products. It may be possible to establish a panel of health professionals (both conventional and alternative) and consumer interests to test label and advertising material to gauge the nature of the information and to provide guidelines on how to prepare and provide suitable material.

Question 14

Do you agree that an exemption from the general labelling requirements should apply to products that are ‘tailor-made’ by a natural health practitioner for supply to an individual?  If so, what do you think the labelling requirements for such products should be?

It is disappointing to note that this question appears to be have pre-answered by fiat, as the MOH questions and answers section on this legislation states unequivocally that:

… the scheme will not apply to products “tailor made” by a practitioner to meet the needs of specific patients who have sought advice from that practitioner (whether or not the practitioner receives a fee from the patient).

We do not believe that any appeal to special practice, whether “tailor-made”, “universal energies” or “traditional cultural practice”, should be permitted in this area. This is special pleading and we see no reason why it should be permitted an exemption. A health product is a health product and should have to meet the same standards, regardless of how it is marketed.

No exemptions from labelling requirements should be made in general. All consumers accessing health services should have access to full information about what is prescribed to them; what is in the product; how much of it is in there; and what effects or side-effects may occur while using a product, whether an alleged natural health product or one produced by the large conventional pharmaceutical establishment. That forms the foundation of informed consent.

There is a reasonable argument for requiring any labelling for tailor-made products to be made more rigorous, as such practices can see significant variations in the use and amount of active ingredients, which could have serious ramifications on safety and efficacy. Given the difficulty of tracking such products and resulting product quality, such information should be even more detailed than mass-manufactured materials.

Question 15

Are there other situations where a labelling exemption should apply?

No. For consumer protection and informed consent, labelling should be clear and unequivocal regarding product contents, claims, possible contra-indications or side effects.

Question 16

Do you agree with the proposed minimum requirements for advertisements?  Is there any other information that should be included?

This section seems fairly light in terms of required information, and it would be important to see more concrete proposals.

It would be useful to define what a “balanced representation of the risks and benefits” is expected to include. In the media, we are aware that “balance” for broadcast purposes can be a 10-second soundbite in a 10-minute story touting a dodgy product/service in what is little less than an unpaid advertorial.

What redress would be made regarding concerns relating to balance? Does the term “misleading” presume intent? (See the comments re our concerns relating to the practices of the homoeopathic industry above. If 94% of industry consumers are not aware of the basic fundamental principle underlying homoeopathic beliefs, then it is clear that they are not being fully informed; one can argue that they are being actively misled by deliberately vague descriptions and omissions of fact.)

We have not seen a clear indication of where product information sheets, whether contained within the product packaging or on a display stand, sit within these proposals – labelling or advertising? Does the positioning make a difference? There is the clear intent in this particular material to imitate the legitimate product information sheets contained within medicinal products, so we would argue that they should be held to the higher standards proposed for the labelling requirements, rather than the more relaxed set proposed for advertising purposes.

In addition to cautions to “always read the label”, we would like to see an additional term encouraging people to seek medical assistance if their condition does not improve or if they think they are having side-effects. Although minimal, this could assist monitoring of adverse effects and provide a little more consumer protection in the advisory.

The Advertising Standards Authority has codes for therapeutic products; presumably natural health products making therapeutic claims should be required to follow such codes as a minimum:

http://www.asa.co.nz/code_therapeutic_products.php, weight management – http://www.asa.co.nz/code_weight.php

http://www.asa.co.nz/code_therapeutic_services.php

Any claims made should be valid and be able to be substantiated by the advertiser. They should be required to provide such information on request and in a timely fashion.

We are aware that advertising claims are easy to make but take considerable time and effort to challenge. There are a number of complaints currently lodged with the ASA by one industry analyst who has recently written 30 extensive reports based on the unsupported claims made by over 500 health-related websites. Previous efforts have been successful in both New Zealand and Australia in terms of rulings against the companies concerned, but this requires a large amount of time and money to support.

Question 17

What information should be required to be provided in radio and television advertisements?

The same minimum requirements should apply no matter where the advertising is taking place — the information should be factual and provide enough information for an informed decision by the consumer. This could be in a shortened form, to allow for time limitations.

There must be a clear separation between advertising/advertorial and genuine news material. This is particularly so in the area of celeb/personality endorsements, as we are aware that many alternative products and services are touted on air in chat shows, talkback etc with very little to no attempt at balance or informed discussion.

Question 18

Are there any other types of advertising for which different requirements should be set?

There should be no area that see a reduction in requirements and responsibilities. It would be good to see product manufacturers strongly encouraged to provide publicly accessible documentation of the evidence supporting their claims on their websites, with links to independent third-party research.

Question 19

What impact do you envisage the proposed regulatory scheme will have on the ability or willingness of businesses to export natural health products?

Products which are well supported with good documentable evidence of their safety and efficacy relating to health and therapeutic claims should have their export potential boosted by this environment. What is recognised as acceptable for the New Zealand consumer should be acceptable to all, if based on such grounds.

Requirements for and costs of export certification and/or meeting the standards of the country to which products are exported should certainly fall upon the exporter, as with other exporters.

Question 20

How would having to obtain product approvals for different markets affect your willingness or ability to export?

This question clearly relates most to those with a vested interest in ensuring that product approvals are not rigorous.

We are well aware that any attempts to provide any form of regulation, oversight or consumer protection in this industry have been met in the past with very loud dissent, primarily focusing on the principles of consumer rights and freedom of choice. The industry is a large one, with highly vocal supporters, who attempt to position themselves as the underdog fighting against the large conventional pharmaceutical establishment. The common claim is that they will lose their livelihood if asked to be more responsible for their products and their sector.

We expect that these proposals will be greeted with similar complaints, and have already received emails indicating the development of an orchestrated campaign against any attempt at regulation.

Would we expect a small producer of children’s nightwear to say they can’t afford to test flammability of their products? We should not accept equally specious – and potentially dangerous – special pleading from this sector.

Question 21

Do you agree that a code of practice for the manufacture of natural health products should be developed?  If not, what standards do you think should apply?

A code of practice is a good idea, but it will require independent oversight and organised monitoring to ensure that more than just lip service is paid to it. We support the idea of annual audits and spot checks to ensure compliance.

Given the highly variable nature of products sourced from overseas, supplier certification should be supported, so long as this is backed up by the certifying body providing suitable audit trails and/or checks of the supplier on a regular basis. Ideally there should be spot checks of product quality, particularly given the concerns raised regarding contaminants and additional active materials, which may not necessarily be picked up by a local user/retailer.

We would like to see manufacturers required to undergo reapplication on a regular basis, rather than simply having a license revoked in the case of non-compliance. In this case, reapplication could take into account the results of audits and be required on a longer time-frame such as every five years following the initial approval.

Question 22

What key risk management principles do you think should be included in a code of practice for the manufacture of natural health products?

Staff should be qualified for the work done at the plant.

There should be adequate storage of raw materials for production.

The manufacturing plant should be designed to be clean and protect from cross-contamination from other product lines through to packaging/labelling.

Equipment should be appropriate for the task of preparing the final product (mixing/tableting etc) and a quality control system should be in place to ensure consistency in the end product.

Products need to be stored under appropriate conditions so they don’t deteriorate on storage.

Written records need to be kept and should be retained past the expiry of batches; this should include quality testing records to ensure consistency in batches.

There should also be records kept of any adverse events or quality issues and any subsequent recalls.

Question 23

Would you prefer the costs of post-market activities to be recovered through an annual product approval maintenance charge or an annual levy based on company or product turnover?  Please give reasons for your preference.

This is aimed at the industry, so not relevant to our concerns. We would expect that a set levy would allow manufacturers to factor that into costs, particularly for the smaller companies involved in the industry.

Question 24

Should there be an exemption from, or reduction in, the annual charge or levy for small businesses or those supplying low-turnover products?  If so, who should qualify and how should ‘low turnover’ be defined?

In principle such charges should be a part of their business planning. This is not membership of a club, where such reductions may be appropriate, but an important part of the industry in which they operate. That said, the industry will try to position itself as the underdog being penalised by big fees, so, if operationally prudent, a scale of fees may be appropriate to answer this likely complaint.

Question 25

What would be the impact on your business if there were to be an annual product approval maintenance charge of $500 or $1,000 or $2,000?  What do you consider would be a reasonable charge?

Not relevant to us. A reasonable charge should go some way to funding necessary oversight operations.

Question 26

Do you agree that the costs of completing new ingredient safety assessments should be largely recovered through levies paid by all product approval holders?  If not, what cost-recovery mechanism would you prefer?

Not relevant to us.

Question 27

Should there be a cap on the number of new ingredient assessments undertaken each year?

Yes. These should be managed to allow the regulator to do the assessments in a thorough and systematic manner. This would also make costs of administration more quantifiable.

Question 28

Do you agree with the range of tools suggested for inclusion in the compliance and sanctions tool box?

They seem reasonable and would allow the regulator to respond appropriately depending on the triggering incident. This will, of course, be predicated on an adequate level of monitoring and auditing to ensure that the industry is compliant.

We would also like to see provision for public notification of non-complaint companies and products, and additional information relating to product safety and efficacy. This could most readily be addressed by notification of such actions on the advisory body website, in much the same manner as the BSA provides access to its complaints process and decisions.

Given the health focus of this area, timely responses and decisions would be very important.

Question 29

Do you think the legislation should include other types of offences?  Please specify.

At this stage, the legislation looks reasonable.

Question 30

Do you have any specific suggestions about how to manage appeals and dispute resolution?

It will be important that any review committee is seen to be balanced and reasonably independent. While industry representatives have a role to play, it is also important that independent, suitably qualified assessors are also involved.

We have been concerned in the past when, for example, we were told that the Health and Disability Commissioner will ask alternative health practitioners if a complaint made about their modality is in line with their own beliefs or not, rather than providing any independent assessment of whether the modality itself meets recognised standards for health treatment. This approach has been a surprise to many, including those making complaints who feel that this does not provide adequate redress or consumer protection.

If the legislation provides clear guidelines as to acceptable practices and requirements, then this problem may not arise, but the industry and the advisory body needs to accept independent oversight to maintain credibility.

Question 31

Do you think the proposed transition periods for product approvals and manufacturing standards would be adequate to give suppliers and manufacturers time to achieve compliance with the legislation?

Provided enough time is taken to get the regulatory agency set up and compliance requirements clear prior to the transition period commencing.

Question 32

Are there any other aspects of the proposed regulatory scheme for which transitional measures would be needed?  Please specify.

Not at this point.

Current Policies and Policy Issues in New Zealand and Selected Countries

This submission was completed by:

Vicki Hyde
Chair
New Zealand Committee for Scientific Investigation of Claims of the Paranormal Inc.

NZCSICOP Inc is a New Zealand-based non-profit organisation operating as an incorporated society since 1986. It includes a large number of health professionals and others who have a strong interest in seeing the presentation of reliable, accurate information across a number of areas, including biomedical and complementary and alternative medicine.

The society supports careful, fair investigation of paranormal claims, open-minded inquiry and examination of evidence. It seeks to understand phenomena and to critically examine these, particularly where there is potential for harm (whether physical, mental, emotional or economic).

Postal: Box 19-760, Christchurch
Email: [email protected]

Informal Summary

The list below covers the general recommendations made in this submission; each point is covered in detail in the remainder of the document.

Problems of Basic Focus

• The basic question is whether CAM can help, not how
• MACCAH definition of CAM is too broad
• Better definitional analysis of CAM is required
• Categorisation and prioritisation necessary for evaluation, research and application
• Broader representation on MACCAH needs to be addressed for credibility of policy recommendations

Regulation

• Need to recognise public demand for regulation
• Does training imply competency? Disclosure and liability responsibilities must be enforced
• Regulations required against disproven and unsafe practices and products
• Need to ensure that apparent safeguards arising from regulation are not misleading to consumers
• Costs should be borne predominantly by CAM industry with independent monitoring
• Regulations need to recognise range of risks
• Lower standards for CAM harm its own credibility and should not be accepted
• Self-regulation is inadequate and inappropriate
• Issues of public accountability and enforcement have to be addressed
• Failure to regulate products leads to public harm
• Clear, consistent product regulation is vital and achievable
• Recommended response to ensure safety and efficacy

Consumer Information Needs

• Informed choice should be a primary requirement and must include totality of available evidence
• MOH database needs to be balanced, neutral to achieve credibility
• Vested sources can be inaccurate, misleading and potentially dangerous
• Publication bias has to be recognised and assessment provided

Research, Evidence and Efficacy

• Identify practices, products outside the scope of research
• CAM is big business and should contribute to research
• Credible research programmes can provide useful information
• Public research programmes need to prioritise promising approaches over questionable ones
• Public funding should be based on results and capped at appropriate levels
• All research programmes need to be robust and defensible
• Binding negotiated research protocols required
• Negative results need to be acknowledged, accepted and publicised
• Anecdotal evidence should be treated as an indicator for research, not a research result

Integration

• First, do no harm; second, do some good
• Education and training required; acknowledged where limited or conflicting
• Evidence of safety and efficacy vital prior to integration
• Integration efforts require monitoring and evaluation as current examples are inadequate
• Ethical standards necessary regarding declaration of commercial interests
• Cost-benefit analysis required prior to integration

References

 

Problems of Basic Focus

The Basic Question is Whether CAM can Help, not How

The following statement is found in MACCAH’s terms of reference:

to provide advice on how complementary and alternative health care can improve outcomes in the priority areas signalled in the NZ Health Strategy

A less biased wording, which does not break the basic rule of presupposing one’s results, would have been:

to provide advice on whether complementary and alternative health care can in fact improve outcomes in the priority areas signalled in the NZ Health Strategy

The basic questions which need to be asked, given the costs of investigation, regulation and training, are as follows:

• whether such health care can contribute to better health outcomes?
• whether those health outcomes are likely to be significant?
• whether that health care is concentrated in areas which are not addressed adequately by present means?

The Discussion Document does not permit these questions to be adequately addressed as it fails to distinguish between those CAM modalities which may, in fact, usefully contribute to better health outcomes for New Zealanders and those which, for a variety of reasons, should be rejected as not offering anything of credible value.

MACCAH Definition of CAM is Too Broad

Combining a huge range of modalities together does not serve to provide a useful base on which to structure any kind of public policy.

MACCAH’s definition of CAM included the following:

CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being.

It needs to be noted that this “definition” is so sweeping that it would allow almost anything to come under the CAM mantle, including orthodox, allopathic, conventional biomedicine. Psychotherapy and hypnotherapy are two areas listed in the CAM modalities (MACCAH Appendix 3), which could legitimately claim to be a part of current professional practice in biomedicine. Under this definition one could claim to be a CAM cardiologist.

Such a broad grouping across a range of modalities makes any generalised recommendations sought as part of the submissions process extremely difficult to make in any sensible fashion.

It can be argued that attempts to compartmentalise health practices into artificially opposing views are, by their very nature, inappropriate. At the most basic level, anyone purporting to provide health advice or treatment, must bear in mind two basic determinants:

• is what is being advised safe?
• will it help?

Bearing those questions in mind, there are grounds to argue that there is no such thing as CAM or biomedicine, as Marcia Angell, editor of the New England Journal of Medicine, put it:

There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence.

There is a clear marketing imperative for the CAM industry in maintaining an artificial divide and, until sufficient adequate research is undertaken to answer the safety and efficacy questions, there is clear ethical imperative in the biomedical arena in continuing to distinguish between proven and unproven modalities.

The problem with lumping everyone’s CAM modalities together in one box for the purposes of policy discussion, is that it does not allow anyone – supporter, critic or consumer – to distinguish between accepted, promising, as-yet-unproven or to-be-rejected approaches.

Better Definitional Analysis of CAM is Required

The House of Lords report on Complementary and Alternative Medicine noted that many of the submissions it had received were concerned that the list of therapies cited “var[ied] hugely in the amount and type of supportive evidence that is available”. As a consequence, it divided its listing into three groups:

Group 1 included “the most organised professions”, which were claimed by some to be well-established (such as acupuncture and chiropractic)

Group 2 contained those therapies which the committee decided “most clearly complement[ed] conventional medicine” (such as aromatherapy, counselling and hypnotherapy)

Group 3 contained therapies for which the committee said there was no evidence of therapeutic effect superior to that of the placebo effect (such as anthroposophy, crystal therapy and iridology)

The report concluded, with regard to Group 3 that, in the absence of any credible evidence, these modalities could not be supported “unless and until convincing research evidence of efficacy, based upon the results of well designed trials, can be produced”.

MACCAH’s terminology paper says that “the purpose of [the House of Lords] model was not stated”, but it is clearly identified as a response to criticisms in submissions from a broad range of groups both within and without the CAM industry regarding inappropriate generalisation and the problems this causes for dealing with policy issues.

Categorisation and Prioritisation Necessary for Evaluation, Research and Application

The grouping also provides a clear indication with regard to the prioritisation of research support and, as MACCAH itself acknowledges, a potential means of assessing the appropriate focus for the different modalities so identified.

This definitional problem, and the need for prioritisation of modalities for policy discussion and decision-making, was also clearly identified by two CAM practitioners who were members of the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). As a consequence, they repudiated the final WHCCAMP report, warning that:

The Report’s inclusion of all ‘CAM’ practices, without appropriate nuance, fails to adequately appreciate the heterogeneity of these practices. This omission undermines those areas within CAM that have already demonstrated safety and efficacy and may be ready for integration into the healthcare system.

Generic recommendations neither serve the public interest nor protect the public health because they fail to distinguish between approaches, practices and products for which there is some scientific evidence and those that either stretch the realm of logic or are demonstrably unsafe. The Report’s inability to discriminate amongst ‘CAM’ practices, products and practitioners leaves its recommendations open to interpretation. This limits their applicability as public policy.

The Report’s lack of definitional clarity undermines the legitimacy of safe and effective non-conventional approaches by failing to distinguish them from treatments that are improbable or fraudulent.

Note that these criticisms came from within the CAM industry and within the Commission itself: Commissioner Tieraona Low Dog, M.D. is medical director of the Tree House Center of Integrative Medicine, chair of the United States Pharmacopoeia Dietary Supplements and Botanicals Expert Panel, and former President of the American Herbalist Guild; Joseph J. Fins, M.D., F.A.C.P, is director of medical ethics at New York Weill Cornell Medical Center of New York., and holds a number of other positions within the Weill conglomerate.

The NCCAM model which MACCAH adopted in its Terminology Document has its uses for classifying CAM modalities into “families”. However, it has very little value with regard to determining appropriate regulatory environments, identifying research priorities, or assessing evidence and efficacy claims, and so does not serve a useful purpose with regard to the determination of policy issues identified in the MACCAH Discussion Document.

It is unfortunate that neither the UK nor US experiences, both cited by MACCAH, have informed the current MACCAH Discussion Document. This of particular concern when considering the stated term of reference with regard to reviewing overseas evidence-based research and identifying priorities for evidence-based research, most particularly with regard to safety and efficacy.

Broader Representation on MACCAH Needs to be Addressed for Credibility of Policy Recommendations

If MACCAH is to act in the role of providing credible advice to the Minister on public health issues which could have significant effects on our health system, both with regard to patient outcomes and economic ones, then it has to be seen as a credible body which incorporates a representative sample of the CAM and biomedical community.

At the moment it looks to have been captured by vested interests in the CAM industry. While describing its membership as “broad-based and inclusive”, it has to be noted that the eight committee members include five self-identified CAM practitioners, and specifically represent between them professional/business interests in the areas of:

• iridology
• naturopathy
• natural medicines
• traditional Chinese medicine
• acupuncture
• aromatherapy
• massage therapy
• counselling
• sclerology
• osteopathy
• homeopathy
• anthroposophy
• culturally defined health sectors

It would understandably difficult for such a group to remain neutral on this topic in which they are personally, professionally and commercially involved. A thorough reading of MACCAH’s Discussion Document indicates that, probably as a consequence of this heavily biased make-up, there has been relatively little examination of the basic assumptions that underpin many of the questions involved, and little critical analysis in a number of important areas.

Capture of such an important public policy area by any vested interest is unacceptable. It is unfortunate that there has been no move to make for a more balanced approach by the inclusion of biomedical representatives or medical researchers beyond those representing Maori and Pacific health issues.

This is not a problem in New Zealand alone, as a number of government-appointed boards and commissions overseas have lost credibility, and with it the chance for action, through lack of balance or accuracy. It does a disservice to the CAM industry for such initiatives to be seen as so partisan.

Whether a therapeutic practice is ‘Eastern’ or ‘Western,’ is unconventional or mainstream, or involves mind-body techniques or molecular genetics is largely irrelevant except for historical purposes and cultural interest. . . . As believers in science and evidence, we must focus on fundamental issues – namely, the patient, the target disease or condition, the proposed or practiced treatment, and the need for convincing data on safety and therapeutic efficacy.

Regulation

 

Need to Recognise Public Demand for Regulation

It is often reported that there is a prevalent use of CAM, although the statistical analysis of this uptake varies hugely (from 1-80%) depending on the nature of the survey questions, the sample group etc.

What has often gone unremarked is equally strong public and professional desires to see that the practices and products involved are safe and effective, and support for the notion that, in order to for safety and efficacy aspects to be addressed, some form of regulatory system is required.

According to research reported in the New Zealand Family Physician journal, 71% of New Zealand patients surveyed wanted regulation of complementary medicine to be on a par with orthodox medicine. Almost all the GPs in the survey had concerns about the safety of complementary therapies, and 84% wanted them subjected to better controls.

In discussing the new regulations in Canada, one health commentator had this to say:

After a 6-year process of review, fact-finding and consultation with all interested parties, they obtained a consensus that the old laissez faire approach put consumers at risk, and they formulated new regulations to protect them. The action of the Canadian government, which is not part of an ideological battle over CAM, should carry considerable weight with your government.

I think that you can make a strong case for increased regulation in view of the recent disclosures in Australia about PAN products, the ephedra problems and adulteration of herbal medicines. The industry needs regulation and consumers need more information in order to make informed decisions.

This is not just a phenomenon in New Zealand caused by recent publicity over the Pan Pharmaceuticals recall, but has also been noted in the US by CAM practitioners and WHCCAMP Commissioners Low Dog and Fins:

In fact, if we consider the regulation of dietary supplements as a well-studied case in point, the literature indicates that the use of dietary supplements has decreased and that the majority of Americans support increased regulation of supplements, including requiring the Food and Drug Administration to review the safety of new dietary supplements prior to their sale. This support for increased regulation and safer products is likely a consequence of publicity surrounding St. John’s Wort and drug-interactions, the potential liver toxicity of Kava, the presence of the anti-coagulant warfarin in PC-SPES, an herbal product used for prostate cancer and the presence of heavy metals in a number of Asian herbal preparations.

The Australian Medical Association, in its position paper on Complementary and Alternative Medicine, has also noted increasing calls for regulation of practice and product.

It may well be that such concerns will continue to increase as the CAM industry grows and, with it, greater reporting of mis-manufacture, mis-labelling and mis-use of associated therapies and products in the absence of adequate regulations regarding safety, efficacy and production standards.

If the ingredients in a natural product are potent enough to affect one’s physiology in an advantageous way, they are certainly powerful enough to cause side effects as well. To say otherwise is to admit that one is administering an inert substance. In fact, some popular herbal concoctions are far from benign — a growing number of reports show allergic, toxic, even lethal, reactions among users of certain herbal remedies.

Numerous examples of mislabelling and serious contamination of popular herbal products have also been reported. As usage rates rise, interactions with prescribed medications are also becoming more prevalent, since patients rarely know what is in the concoctions they are self-prescribing or receiving from herbalists. This danger is compounded by the fact that users are often reluctant to admit such indulgences to their physicians. Public awareness of the possible adverse effects of herbal concoctions has tended to be sparse because, unlike prescription drugs, there is no requirement that ill effects of supplements and herbal medications be reported to central registries.

Does Training Imply Competency? Disclosure and Liability Responsibilities Must be Enforced

Should it be considered acceptable for people to be able to provide health advice without having to prove any form of competence to do so?

Consumer-oriented media coverage of CAM practitioners has often stressed the need to use “trained, registered practitioners”, implying that the main caution required relates to those who may have earned their certification through mail-order or books. The MACCAH Discussion Document echoes this with its reference to “inadequately trained practitioners”.

The Australian Medical Association has called it “essential” for CAM practitioners to be regulated appropriately, stating that “such regulation should ensure that non-medical complementary therapists cannot claim expertise in medical diagnosis and treatment”.

CAM practitioners should be required to assume full liability if they make a diagnosis or treat an individual without providing full disclosure of the nature and extent of their training.

In examining the NZQA standards covering the CAM modalities currently supported by NZQA-approved course, it is clear that scientific merit is not among the criteria. Nor, given NZQA’s brief, would it be expected to be so. That said, as the MACCAH report implies and as is generally perceived, an NZQA imprimatur is seen as some recognition of quality of training and level of competency, not necessarily deserved.

This still does not bring into focus the underlying concern: if the actual modality has no validity, then it doesn’t matter how many NZQA credits or Polytech Diplomas or emailed certificates or one-day workshops or continuing professional development courses one has or undergoes, the modality still doesn’t work, there are no health outcomes, and charging for goods or services on this basis is tantamount to fraud.

Regulations Required Against Disproven and Unsafe Practices and Products

One vital element in CAM regulation which appears to have been totally ignored in the Discussion Document is any consideration of how to go about establishing and policing regulations against those modalities or products which are found not to be safe nor effective.

It is suggestive to note that amongst the CAM industry responses to the recent Pan Pharmaceuticals recall was the strong emphasis that even if the products did not contain the material as stated on the labels (such as where beef cartilage had been substituted for shark), the products were nonetheless “safe” and therefore should not have been subject to recall. There was little, if any, acknowledgement of:

• whether this meant that it didn’t matter what was in the material as all were equally ineffective
• the implications of fraudulent claims being acceptable

Health Canada has recognised in its recent framework for claim assessment (3.2.1):

All claims for natural health products must be substantiated and must not be misleading.

As a society, we have legislation in place to protect the consumer against shonky claims and the capability of recalling products and fining or jailing industry players where such claims cause public danger or are not true. If we can do this for pushchair manufacturers, it is even more important that we do this for people putting public health at risk or defrauding the public.

We need regulatory muscle and enforcement which enables the public to be made aware of those practices which are not safe (such as regulations regarding the manufacture of pharmacologically active products) and those which are ineffective because of the nature of the modality (such as iridology).

Need to Ensure that Apparent Safeguards Arising from Regulation are Not Misleading to Consumers

The House of Lords report emphasised that:

in recommending the regulation of training in CAM we specifically exclude training in the asserted modes of action of many CAM therapies. We do so because regulation could lead to a misleading public perception of improved status; such regulation is in fact an attempt to safeguard the public.

MACCAH even recognised this potential to mislead (DD pg 27), yet went on to state that “enhanced professional status” was an advantage to CAM practitioners following regulation. This indicates the need to have a broader base in the committee to include people without a vested interest in the status of the CAM industry.

Costs Should be Borne Predominantly by CAM Industry with Independent Monitoring

It is astonishing to note that the main disadvantage the Committee came up with regard to regulation was that of cost. This suggests that there were few qualms regarding the capability of CAM practitioners of meeting competency levels, which has a further implication that self-regulation will see requirements for practice eligibility set sufficiently low that applicants will need to be concerned predominantly with costs.

From a public policy and protection viewpoint, such costs should be well compensated for through improved consumer protection and health outcomes.

Public funding of CAM modalities and products should be held to the same criteria as that of current biomedical practices, and should not be extended to any area which does not operate in a robust regulatory environment. The House of Lords report recommended that:

only those CAM therapies which are statutorily regulated or have robust mechanisms of voluntary self-regulation should be available through public funding

As with any other flourishing industry, CAM should be responsible for providing funding for regulation, research and other operational aspects. Given increasing concerns regarding public safety and unacceptable business, manufacturing and marketing practices, it will be necessary for an independent third-party to take responsibility for monitoring and evaluating any practices or activities in this industry.

Regulations Need to Recognise Range of Risks

The MACCAH Discussion Document refers to high risk and low risk modalities (pg 3), noting that the proposed HPCA Bill covers statutory regulation for practices which pose “a risk of harm to the public”. Acupuncture is identified as one, being an invasive treatment (and unnecessarily so if acupressure is able to achieve the same results without use of potentially contaminated needles, lung punctures and the like).

Health Canada has recognised the range of risk, with its Standing Committee on Health accepting a hierarchy of evidential support based on different types of claims and treatments, with regard to natural health products. Thus products used to treat minor, self-limiting conditions do not require full clinical trials, but are expected to have reasonable degrees of support.

The level of supporting evidence required will increase as the risk associated with the product increases. The risk varies depending on several considerations; for example: whether the ingredient is intended to be the sole therapy or an adjunct therapy; whether the ingredient is intended to help with symptom management or to cure/treat the condition; and the seriousness of the condition to be treated.

However, there are other risks of harm, beyond the simple, direct harm from adverse effects of inappropriate treatment, as identified by Dr Timothy Gorski:

• indirect harm from the omission or delay of appropriate medical evaluation and treatment
• economic harm when people spend their money on worthless products
• psychological harm when people realize that they have been harmed directly, directly, or merely duped into wasting their money
• social harm when [public] understanding of the facts and principles of health and disease are undermined and corrupted, impairing their ability to make wise choices for themselves, their loved ones, and for their country when important health-related issues of public policy are at stake

Thus is it necessary to ensure that any CAM modality or product is addressing real needs in areas which are not already being adequately addressed by practices and products which do meet adequate standards.

Lower Standards for CAM Harm its own Credibility and Should Not be Accepted

Those proponents of CAM practices and products which can address basic needs safely and effectively will be done a disservice by being lumped in with those which don’t, as it is clearly the later which stand to benefit from a laissez faire environment.

Widespread public discussion of regulation recommendations will no doubt focus on which of the modalities and products is willing to provide evidence of safety and effectiveness and which are not.

The establishment of a double standard for the approval or rejection of a treatment technique, based on ignoring or actively rejecting reasonable evidence-based recommendations, would be harmful to the public’s health and to the CAM industry as a whole. As noted by a number of commentators, it has flow-on loss of credibility for the types of treatment approved with the lower standard, and even to the credibility of the institutions that recommend its use.

Self-regulation is Inadequate and Inappropriate

Voluntary or self-regulation is not adequate. The House of Lords report may have suggested that such bodies could enforce ethical and conduct codes as well as disciplinary and complaints procedure, but it is clear from other areas of human endeavour that self-regulation is rarely satisfactory nor particularly helpful in ensuring public good.

In particular, there have been considerable concerns raised regarding self-regulation leading to a lack of transparency with regard to critical areas of adverse reaction monitoring and the adequate treatment of patient complaints.

In 2001, the US FDA received around 500 reports of adverse events relating to dietary supplements. That year, US poison control centres received almost 20,000 report (up dramatically from 7,000 in 1998). The Office of the Inspector General estimates that less than 1% of adverse events are reported and, of these, very few are investigated because of a lack of information regarding the consumer or the manufacturer or the material involved.

In one recent case, the manufacturer of a dietary supplement product was found to have had 13,000 customer complaints, including reports of several hundred hospitalisations and 80 incidents of serious injury or death. Under current US regulations there was no penalty available with regard to failing to pass these reports on, and the FDA could do nothing. In an ironic follow-up, the Justice Department is instigating criminal proceedings because the manufacturer’s marketing claims stated that the product has no side effects – commerce legislation proved more relevant than health regulations!

As Professor Willem Betz, Head of Family Medicine at the University of Brussels, put it when discussing the effect of EU directives over the past decade:

Any attempt to obtain monopolies on recognition and inside regulation are very dangerous for public health because they allow the organization to escape effective control.

These concerns have been raised within the CAM industry itself, with some practitioners concerned at the possibility for control to be handed to a small group of competing businesses, making it vulnerable to abuse. Betz notes a number of EU countries have fiercely competing organisations within their borders “each striving for a monopoly and viciously attacking its competitors”.

A number of states in the US have held Commissions into regulation of CAM practices. In looking at naturopathy, one report noted that “self-regulation statute cannot result in meaningful regulation and public protection in a field that is inherently irrational and unethical”, concluding that “an endorsement of naturopaths through licensure would pose a clear threat to public health and safety”.

Issues of Public Accountability and Enforcement Have to be Addressed

New Zealand has already seen cases where products that have significant potential for harm can be sold with impunity or any apparent action taken on the part of our regulatory bodies. Homeopathic products labelled “meningococcal vaccine” and “hepatitis B vaccine” are being sold by pharmacies here and bought in good faith by the public under the impression that they are purchasing a real vaccine against these diseases. (It should be noted that many in the professional homeopathic community argue against this practice.)

As well as major safety concerns for those individuals who purchase these believing they are then immunized against the diseases noted, this also has major implications for public health projects such as the planned meningococcal vaccination programme.

Such products can be readily tested as to the validity of the claim being made – vaccines confer immunity through the production of antibodies which can be readily detected. However, the Health Ministry’s compliance team has ruled that such preparations are permissible so long as they were “sufficiently diluted”. A previous incident saw the Commerce Commission refuse to act on a complaint, passing the buck to the Ministry of Health as a health-related issue; the latter ruled that it had no need to act, saying that “water is not a medicine”.

It is clear that our regulatory agencies need to revise their attitudes and be prepared to examine what little current protection the consumer has under health or fair trading laws.

A major problem in defining any kind of self-regulatory environment is in policing it adequately, particularly where practitioners use a broad range of modalities in their businesses. At what point does someone using chiropractic techniques become a chiropractor and thus require registration? Given the casual nature of this industry, it is likely that there is widespread abuse of what little regulatory requirements exist at present.

Failure to Regulate Products Leads to Public Harm

There are clear and increasing problems with regard to inadequate regulations governing CAM products. The major ones identified by Marcus and others include lack of standardisation, contamination of or adulteration of botanical preparations, lack of reporting of adverse effects.

Consistency in composition and biological activity are essential for the safe and effective use of therapeutic agents. There are many variables in the preparation of natural health products, and these need to be eliminated for reasons of safety and efficacy as well as to avoid misleading product labelling.

Increasing scrutiny of natural health products is brining up increasing incidences of products which contain undisclosed drugs or pharmacologically active substances, as well as contaminants such as heavy metals. In 1998, 32% of Asian patent medicines sold in California were found to containing drugs such as ephedrine or heavy metals such as lead and arsenic (Marcus, NEJM). As a result some were removed from the market.

In 2002, Japan’s Ministry of Health, Labor and Welfare began requiring manufacturers to undertake chemical analyses on all imported dietary supplements after at least three deaths and around 150 hospitalisations were caused by a Chinese dietary supplement which caused hepatic failure and hyperthyroidism (Marcus, NEJM).

Even though herbal remedies may be effective, do their benefits outweigh the risks? Most herbal remedies in the United Kingdom and United States are sold as food supplements. Thus they evade regulation of their quality and safety. The UK’s minister for public health recently pointed out that “the regime for unlicensed medicines does not give systematic protection to the public against low quality and unsafe unlicensed herbal remedies.” Two recent British cases of severe nephropathy caused by Chinese herbal tea administered to treat eczema illustrate this. Huge variations exist in the quality of herbal medicinal preparations. When, for example, German commercial products of devil’s claw were tested, an unacceptable variability of quality was noted. Yet Germany is often praised for the exemplary standard of quality control of herbal medicines.

There are many more such cases, and indications that fewer than 1% of adverse reactions to use of natural health products are reported should be a concern for any health system which looks to safeguard public health.

Clear, Consistent Product Regulation is Vital and Achievable

The Australian Medical Association has welcomed the country’s new TGA regulatory reforms concerning the safety and quality of complementary medicines. It stated that:

Complementary medicines should meet the same standards of safety and quality as orthodox medicines. Labelling and advertising of complementary medicines must be based on the appropriate level of evidence of efficacy.

It also called for greater regulatory enforcement over the importation and use of raw herbs (3.2).

As the MACCAH Discussion Document notes, product categorisation depends on the wishes of the manufacturer. Given the stringent demands on medicines and products claiming therapeutic benefits, it is hardly surprising that the bulk of CAM products are marketed as unregulated supplements.

Even CAM professionals are calling for greater regulation to address growing concerns regarding safety and quality standards:

As far as herbal medicines used as drugs are concerned, it’s time for physicians and regulatory bodies to consider herbal preparations not as alternative medicine based on experience and tradition, but as phytotherapy, a part of medical treatment. If so, herbal medicines (or, with a better definition, herbal medicinal products) have to comply with drug regulations to get a marketing authorisation. This will end the current regime of therapeutic agents sold as foods or nutrients without the needed quality and safety standards.

Canada has recently set in place a comprehensive set of standards of evidence for evaluating the safety and claims made for natural health products, after considerable public consultation across all areas of the Canadian health system. The products that fall within the new regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids (such as Omega-3).

All natural health products in Canada will now require a product licence before being marketed. Obtaining a license will require detailed information on the product submitted to Health Canada, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use. The product licence number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety and efficacy.

Labels will be required to specify directions for use, the recommended use or purpose (health claim), medicinal and non-medicinal ingredients, and any cautions, contra-indications or known adverse reactions associated with the product

Health Canada is also requiring that if the wording of a claim or product name conveys an implied claim as well as an expressed claim, the evidence provided must substantiate both claims. Implied claims on labels should be avoided because of the potential to mislead consumers.

Recommended Response to Ensure Safety and Efficacy

It would be reasonable to expect a competent government body to be given the responsibility for:

• reviewing the safety of new products
• regulating advertising and other claims relating to efficacy
• recommending the removal of unsafe or ineffective products from the market

Marcus and Grollman (NEJM) recommended six legislative proposals which could support these aims without denying consumers access to what they described as “a popular class of products”. These proposals, with the inclusion of material from the new Canadian regulations would provide an appropriate model for New Zealand to consider:

• the registration of clear identification and contact information throughout the product chain, including manufacturers, distributors and outlets
• the mandatory provision of evidence of good manufacturing practices and the ability to inspect records
• clear and unequivocal demonstration prior to product release that any such products present no substantial or unreasonable risk of harm under conditions of recommended use as noted on the label; manufacturers should assume and bear full responsibility for ensuring the safety of their products
• prompt notification of any and all adverse effects to a suitable government body for monitoring and follow-up
• clear labelling containing at a minimum a list of constituents (both botanical and common names); information about possible adverse effects, contraindications and herb-drug interaction; identification and contact information to facilitate the reporting of adverse reactions; purpose of use information which is appropriate and truthful; conditions of use information for safe and appropriate use
• the establishment of broad-based expert panels to review safety and efficacy

Canada’s National Academy of Science Drug Efficacy Study was able to evaluate the safety and efficacy of 4,000 drugs on the Canadian market in three years, so while such reviews may seem daunting, they are possible.

Consumer Information Needs

The MACCAH Discussion Document is absolutely right where it says that consumers need easily accessible, reliable, objective information about CAM that is, where possible, based on sound evidence (pg 13).

Few would disagree with this. The problem is in ensuring that those standards are met.

Informed Choice Should be a Primary Requirement and Must Include Totality of Available Evidence

We agree with the House of Lords report and the position papers of many organisations throughout the world, as well as our own health system:

the health consumer must be able to make an informed choice

This cuts both ways. As a society, we demand informed choice from biomedical practitioners. We must also be able to require it from CAM practitioners. This informed choice should include, but not be limited to:

• information regarding the competency and training of the practitioner
• the nature of the modality and an indication of its place within the biomedical/CAM categorisation
• discussion of adverse reactions or major critiques of the modality or product

The new Health Canada regulations relating to natural health products (2.4.1) stress the importance of providing the “totality of available evidence pertinent to the claim”. This is because they recognise that there is a tendency for the presentation of just evidence which supports a claim. It goes on to say that:

The claim should be based on a systematic review of all the available evidence-based references relating to the validity of the health claim. These references should be published in respected and objective medical/scientific/health care journals as well as expert group reports containing clinical data, acceptable surrogate markers, and acceptable preclinical data to support the product rationale, if any. Proprietary data may also be submitted to support the claim. “Evidence-based references” means peer-reviewed, reputable references which cite primary sources (i.e., scientific research articles) and whose authors have academic credentials within the subject-matter of the reference.

MOH Database Needs to be Balanced, Neutral to Achieve Credibility

According to its first Annual Report, MACCAH is involved in the development of a new database to inform consumers about the safety and efficacy of such treatments. MACCAH, with its current membership, is not a neutral body and, as the House of Lords reports notes above, is not likely to be in a position to provide balanced views. MACCAH’s Discussion Document says that the Ministry of Health is establishing the database. Lines of responsibility and communication need to be clarified, and the protocols for information provision need to be open and transparent if this initiative is to have any credibility.

MACCAH should not be involved significantly in developing a public information source unless there is clear representation from biomedical (alternative!) critical viewpoints, as well as ultimate responsibility vested in a suitably neutral body. The latter could well be an advisory committee which is truly broad-based and representative, and which needs to be open to public scrutiny.

The House of Lords report noted the following:

There is a clear need for more effective guidance for the public as to what does or does not work and what is or is not safe in CAM. There is no central information provision for patients and healthcare practitioners; thus the media and other unregulated sources have an undue influence on opinion in the field. We are not convinced that many CAM professions themselves are yet in the position to provide balanced and consensual views on these issues of public interest.

It recommended the provision of government or neutral party resources for the support of an information source that could “ensure that the public has access to balanced and fair advice on CAM”. This does present difficulties, as has been noted elsewhere:

The public needs information on what not to use, based on the plausibility or implausibility of the practice. Whether government agencies can supply such information is unclear. Worldwide, few government agencies have provided information on what doesn’t work. Many agencies and organizations state that various methods are unsubstantiated, but few recommend abandoning methods that are unsubstantiated and lack a plausible rationale.

Vested Sources can be Inaccurate, Misleading and Potentially Dangerous

In an areas as important as public health, it is not adequate for our public health system to devolve the responsibility of providing information to the public solely to the industry. Support for public provision of information that is balanced, accurate and up to date is required, and this should be accompanied by a public education strategy that encourages people to investigate a number of sources when making health decisions.

There have been a number of consumer research projects undertaken within New Zealand and overseas which have indicated that people seek health information from their pharmacy and, increasingly, from health food shops. Such studies have also indicated that the health information provided can be very poor, in some cases downright dangerous.

In one Canadian study (Calder) cited by the Tzu Chi Institute for Complementary and Alternative Medicine, researchers posed as the parent of a 6-year-old child with an inflammatory bowel condition (Crohn’s disease). When health food store employees were asked if they could make any suggestions:

• 24% suggested seeing a doctor
• 93% offered specific advice
• 72% asked for more specific information

Many consulted a consumer-oriented natural health and nutrition book prior to recommending a broad variety of natural health products, primarily supplements stocked by the stores:

[Natural health product] experts like to describe web-based information on supplements in terms of a jungle. Little of the vast amount of information available can be considered reliable or unbiased. Overwhelmingly, Natural Health Product information on the Net favours the use of Natural Health Products.

It is clear from examining many of the sources of information cited in the MACCAH report that involvement of vested interests plays a huge role in the presentation of information. It should be noted that the majority of Websites cited, for example, are heavily pro-CAM involving CAM businesses and organisations, with limited analysis or information; very few, if any, were critical.

Publication Bias Has to be Recognised and Assessment Provided

Increasing public access to information over the past ten years with the development of the Internet has led to significant problems in assessing the veracity and competency of available information and sources. In an area as contentious as that of CAM, this is a major concern, particularly given that general searching on this topic is far more likely to present the consumer with CAM marketing material than any balanced assessment of the various modalities.

The nature and quality of the Websites and publications cited by MACCAH reflects this concern. Many of the organisations involved have a vested interest in CAM therapies and products, and relatively few cover research or information which is critical of CAM. Recent systematic reviews of publications that are cited to support the efficacy of CAM have concluded that the quality of most of these papers is so poor that no conclusions can be drawn.

The information sources which are the most credible and robust, providing a broad range of research results which meet reasonable levels of rigour, are also the ones which have the most references to research regarding claims which are unsubstantiated or, at the very least, where “further research is required”. Examples include the Department of Complementary Medicine at the University of Exeter and the Cochrane reports.

It would be extremely difficult for a member of the public to determine without major time and effort, which publications are in fact suitably balanced and, ideally peer-reviewed. Even the use of the latter term is open to question – the Alternative Medicine Review, which the now-defunct Tzu Chi Institute of Complementary and Alternative Medicine cites as peer reviewed, is published by a supplement company and supports their product advertising which has to call into question its independence.

It is interesting to note that there are no references to the Scientific Review of Alternative Medicine in the MACCAH document. The review is sponsored by the Council for Scientific Medicine and includes five Nobel Laureates on its Board; its aim is to provide science-based peer review material devoted to evaluations of CAM.

Clearly there are problems in trying to present a balanced viewpoint in this area, which makes it all the more important that there is support for a neutral party to be involved in information provision with a truly representative mandate and the ability to present and evaluate competing claims.

It is essential that consumers have improved access to well researched information about Complementary Medicine so that they are empowered to question and to raise relevant issues with any complementary therapist they consult and to make well informed choices. The AMA considers it important that education campaigns are provided to assist the public to take an informed role in relation to Complementary Medicine and to be aware of the importance of continuing to consult medical practitioners in relation to medical conditions and health concerns. It is important that patients inform their medical practitioner of complementary medicines and/or therapies they are using.

Research, Evidence and Efficacy

 

Identify Practices, Products Outside the Scope of Research

Given public interest in CAM and its extensive market growth, it would be appropriate that

CAM should, and in many cases can, be studied. The MACCAH Discussion Document notes that the evidence base for CAM is generally perceived to be poor (pg 16) – that is because, for the most part, it is poor. MACCAH suggests two reasons for this:

1. the difficulties of applying standard medical research methods to some forms of CAM
2. the lack of funding available for CAM research

Unfortunately the Discussion Document does not provide any further explanation of (1). Presumably this is because there are numerous instances in the modalities it lists which depend on metaphysical, psychic or other forces/beliefs which cannot be observed, tested or otherwise treated in an objective fashion by someone who does not share the world view of those involved. The “etheralised Cosmic-Astral influences” of anthroposophy is one such example.

If time, effort and money is to be spent on researching CAM, the modalities involved will have to be sufficiently describable to allow acceptable research guidelines and parameters to be drawn. If, as is argued in many cases, objective proof is not possible because the modality requires evidence that is by its nature unmeasureable and untestable, then one is no longer dealing in medicine (of any kind) but more in philosophy, metaphysics and religion.

In such cases, there should be no public involvement or support for research or product development, and the public health system should clearly differentiate these practices from those which are amenable to research. The practitioners and products sales literature should be required to make it clear to consumers that they are purchasing on the basis of belief systems, not evidential proof.

An argument against testing CAM is often raised on the grounds that the modalities are culturally based or gender-based and, hence, should not be put to the test of “Western” science. As Dr Barry Beyerstein, of Simon Fraser University, puts it:

The truly racist and sexist attitude would be to hold empirically testable claims from other cultures or female proponents to a lower standard of proof than any others — this would amount to an assertion that their defenders are intellectually inferior.

Even if such patronising discrimination is demanded by the CAM industry, more interest in the CAM area is leading to what the Australian Medical Association referred to as “creative research designs which allow evaluative studies to be carried out which have valid controls and that are sensitive to the nature and, in some cases, the context of the treatments being tested”. The AMA and many other organisations, both CAM and biomedicine based, believe that research on safety, quality and efficacy can be undertaken on CAM practices and products.

CAM is Big Business and Should Contribute to Research

As regards lack of funding, CAM has become big business around the world, with billions of dollars in products and services. The US market for dietary supplements alone reached $US17.1 billion in 2001 (Marcus) (cf the worldwide spend on vaccines of $5.4 billion). In Australian in 2000, the CAM market was worth $A2.3 billion, almost as much made by the country’s wine exports.

Positive and, in most cases, unsubstantiated endorsements of herbal products can lead to huge jumps in sales volume – St Johns Wort, for example saw sales increases of 2,800% in a single year following high-profile marketing campaigns, according to Professor E Ernst, of Exeter University’s Department of Complementary Medicine.

If we can ask a small clothing manufacturer to undertake research and provide acceptable results on their products’ flammability so as to meet certain safety standards, then it should be possible for CAM practitioners and product manufacturers to meet similar requirements.

That said, the CAM industry must be required to meet adequate standards when undertaking research, and should make a significant contribution to cross-disciplinary, independent monitoring and verification of research results.

Credible Research Programmes can Provide Useful Information

If credible research programmes are undertaken on CAM (or indeed on any medical practice or product), it has the following advantages:

• practices, whether alternative or established, that depend mostly on anecdotal and empirical evidence, will be given a fair chance to be heard in the forum of rigorous scientific research
• practices which are unproven because of old, inadequate or shoddy research will be able to be evaluated to see whether further research is justifiable or whether they deserve to be formally counted as of no further interest

Public Research Programmes need to Prioritise Promising Approaches over Questionable Ones

With regard to undertaking research, it is vital to first identify which are the most promising areas on which to concentrate limited public research resources or to establish public-private research programmes.

This has to be undertaken in a broad-based fashion and should not be left up to a small committee composed of CAM industry representatives. In preliminary work on its health products legislation, Health Canada, in co-operation with Dalhousie University, held a Natural Health Products Research Priority-Setting Conference which had over 60 representatives from the scientific, governmental, academic, industry and community sectors. The New Zealand health system and the New Zealand public deserve no less. We already undertake such assessment in allocating science and industry research funding, and CAM should be treated no differently.

Assuming requirements of safety and efficacy as well as a limited resource base, it would be appropriate to prioritise the focus into those areas of CAM which look the most promising. This has been called for by CAM proponents themselves, such as WHCCAMP Commissions Low Dog and Fins:

A lack of a prioritization strategy for research initiatives, given the many areas that “CAM” encompasses, makes a general endorsement of research of limited value. Promising areas of research should be investigated because they potentially have something to offer to the health of the American people or because they advance our scientific understanding of illness and healing. Asking for more research money to investigate an approach, practice or product simply because it is “CAM” is an ideological, not evidence-based approach to science.

Recommendations for research on “frontier areas of science” without a strategy for building this research on scientific foundations may result in spending precious health care research dollars on areas that are unlikely to yield any beneficial data such as “iridology”, “psychic healing” et. al. While dogmatic disbelief of everything that is not currently explainable is foolish, and indeed unscientific, it seems equally foolish to ask the taxpayer to bear the enormous expense of sorting out those areas that are plausible from those that are improbable.

Thus we could look to build a research strategy that focuses on those areas most likely to have the greatest benefit for the health consumer, particularly in areas where there are gaps in current treatment regimes. It is reasonable for taxpayers to expect that their financial support will be used to study promising rather than implausible methods.

The House of Lords report looked to prioritise its research resources on the basis of the groupings it had made, and noted that:

Other therapies will need to build up their respective evidence bases with small preliminary studies before large scale studies are justifiable

Such therapies would have to be assessed with regard to a number of factors including apparent degree of success, patient safety and protection, protection of the public from misinformation, cost-benefit ratio and so forth.

Promising methods are likely to have had some research that indicates possible usefulness and effectiveness. Questionable methods are those that are unproven and which lack a scientifically plausible rationale. Some of these are still promoted even after repeated failures in scientific testing. Such methods aren’t just unproven; they are — for practical purposes – disproved, and it would be inappropriate for public funding to go into further research or application of these methods.

Public Funding Should be Based on Results and Capped at Appropriate Levels

Scrutiny must be on-going, as new developments may provide evidence for accepting or rejecting modalities. There does need to be sensible economic rationale for pursuing lines of research based on assessment of the cost-benefit ratio involved. Public funds need to be closely controlled to prevent limited funds being spent on questionable areas and to prevent inappropriate increases in funding.

A salutary example is provided by US experience in this area. In 11 years of existence, the Office of Alternative Medicine, now known as the National Center for Complementary and Alternative Medicine, has seen its budget rise from $US2 million per year to over $US100 million per year (significantly higher than the $68 million noted in the MACCAH DD).

Over that period, despite the significant research and funding support, it has yet to produce any acceptable research results that the broad range of alternative modalities it supports actually work. this is in spite of the fact of including the more scientifically promising ones, such as acupuncture, alongside much more questionable ones, such as Rudolph Steiner’s anthroposophy.

It appears, as one commentator has put it, that “as the quality of studies improve, the less support they provide for the claim” (Barrett, pers comm). Acupuncture, for example, was listed by the World Health Organisation in 1981 as being appropriate for 40 different conditions; as a result of support from this and other reputable organisations, acupuncture has becoming increasingly adopted in mainstream biomedicine. A study by the British Medical Association in 2000 (cited in BMJ 2000;321:11) saw the number of conditions against which acupuncture showed some evidence of effectiveness drop to just three main areas (back and dental pain, nausea and vomiting, and migraine), and there is even continuing debate about these.

All Research Programmes Need to be Robust and Defensible

Any research programme, whether public or industry-based, should have sufficient operational rigour to withstand informed criticism if it is to be used to support claims.

The Australian Medical Association has come out strongly in support of scientific research into CAM to enable them to be assessed on an evidence basis. It has called for federal funding for the design and implementation of appropriate evaluative research.

This key principle of evidence based assessment should be the basis of evaluating complementary medicines and therapies and their use by the medical profession. It should also be the basis of any collaborative relationships between medical practitioners and complementary therapists.

There is on-going debate regarding the nature of CAM and calls to treat the 100+ modalities as a special case with regard to standards of evidence required in biomedicine. This debate needs to be undertaken in New Zealand with broad-based involvement across the medical spectrum so that a suitable set of research protocols can be established that will address the needs for assurance of safety and efficacy, as well as permit assessment of evidence that may not meet the full standards of, for example, randomly controlled trials.

It should be noted that the new director of the US National Center for Complementary and Alternative Medicine, Dr Stephen Straus, has given strong support for analysis of CAM by means of random controlled trials.

Medical ethics dictate that before any medical practices are adopted or spread, they should be validated by appropriate scientific studies. Doing less would endanger the public and remove safeguards that have evolved over centuries in the practice of rational and caring medicine.

Health Canada has examined this as part of the development of its new regulations, and this may well provide a useful basis on which to build a suitable New Zealand model. Like most health systems worldwide (see the House of Lords report 7.10-7.30), it pays greatest heed to those areas which can provide scientifically acceptable and scrutinised evidence-based research results. It goes on to say:

If a meta-analysis or systematic review of the RCT is not available, it says, evidence from at least one large, well-designed, multi-centre RCT may be considered sufficient. The trial must have well-defined objectives, an appropriate selection of the patient population, appropriate and objective clinical assessments, adequate sample size (i.e., statistical power) to detect the desired treatment effect, and an appropriate statistical analysis.

There are several types of evidence that it is desirable to obtain before a therapy is advocated:

• that the therapy is efficacious above and beyond the placebo effect
• that the therapy is safe
• that the therapy is cost-effective
• evidence concerning the mechanism of action of the therapy

The first two are the most important and require the highest level of objective, scientific scrutiny. Whether a therapy is cost-effective is more political in nature, as it relates to the current methods of treatment, comparisons of the costs involved and suchlike. It would be unacceptable for it to be the major determinant.

As regards the mechanism of action, that is not absolutely necessary to be clarified before it can be advocated. It is sometimes cited by CAM supporters as a major barrier to their acceptance by biomedicine, but there are numerous cases where practices and products have been accepted without a complete understanding of the mechanism involved (aspirin and penicillin are commonly cited examples of this). What has always been important in those cases has been the level of evidence for effectiveness and safety.

Binding Negotiated Research Protocols Required

Before research can begin, certain mutually agreed upon objective standards should be established such as:

• end states (desired effects)
• stopping rules
• confidence limits
• blinding
• randomization
• falsifiability

If publicly funded, there should be written protocols covering the nature of the research, the standards required and other aspects common to good research programmes. Because of the problematic nature of CAM research, such a protocol should also include the agreement of all parties that the results of the research will be accepted as binding.

There are many incidences where proponents of alternate world views have put them up for scrutiny using carefully negotiated agreed-upon protocols, only to reject the results once they are found to be negative or unsupportive of their world view. This sort of lack of responsibility and accountability cannot be considered acceptable in a publicly funded research programme.

Negative Results Need to be Acknowledged, Accepted and Publicised

It is vital that negative results are given appropriate coverage to avoid the selection bias that has dogged attempts to undertake useful research into CAM. And, when such results are found to be repeated consistently at an acceptable level, the only ethically acceptable response is to publicly discard the modality. Anyone continuing to use such methods should then be open to public challenge on consumer protection grounds relating to fair trading.

Negative results have to be recorded and available publicly. Any attempt to develop a credible public database of information will have to include critical research as well as supportive, and also would need to include ratings regarding the nature of the research, methodology etc.

The very existence of government-funded research of CAM modalities is used by their proponents to legitimise their methods. This makes it all the more important that adverse reactions and negative results are accurately reported.

Anecdotal Evidence Should be Treated as an Indicator for Research, Not a Research Result

MACCAH notes that there is:

a great deal of anecdotal evidence regarding the safety and efficacy of some complementary and alternative therapies. There are also many unpublished case studies collected by complementary and alternative practitioners supporting the efficacy of various therapies.

One could just as easily say that there is a great deal of anecdotal evidence regarding the lack of safety and efficacy of some complementary and alternative therapies and there are many case studies which do not support the efficacy of various therapies.

Public safety and health outcomes should not be based on anecdotes and unpublished reports. Anecdotes may be used as the starting point for identifying potentially promising lines of research and gathering of evidence, they should not be the stopping point.

Those who sell therapies of any kind have an obligation to prove, first, that their products are safe and, second, that they are effective. The latter is often the more difficult task because there are many subtle ways that honest and intelligent people (both patients and therapists) can be led to think that a treatment has cured someone when it has not. This is true whether we are assessing new treatments in scientific medicine, old nostrums in folk medicine, fringe practices in CAM, or the frankly magical panaceas of faith healers.

Unless a ritual, technique, drug, or surgical procedure can be shown to have met these logical and evidential requirements, it is ethically questionable to offer it to the public, except on an admittedly experimental basis — especially if money is to change hands.

Integration

 

First, do No Harm; Second, do Some Good

Without credible evidence that a method is safe, effective, and cost-effective, no method deserves to be “integrated” into clinical practice.

Safety and efficacy have to be the bottom line when it comes to deciding what is used in our public health system. These are both issues which can be evaluated objectively.

Decisions of cost-effectiveness are more political in scope relating to what the government is willing to pay, and whether there is political value in it. It would be unacceptable, however, for public funds to pay for a thoroughly discredited modality, such as therapeutic touch, when there are other approaches more likely to provide beneficial outcomes for the patient.

The MACCAH Discussion Document says that integration is “low cost”, without providing any supporting evidence for this. It is difficult to evaluate just what the costs are, but there is plenty of anecdotal evidence to suggest that they can be high, such as when families are charged $48,000 per month for alternative cancer treatments which fail to live up to their claims – very high costs economically, emotionally and personally for those involved.

The Discussion Document also cites “high degree of consumer satisfaction”, again without any data to support this; such data that is on record appears to be equivocal. In any case, popularity contests do not make a suitable basis for any major revision of the public health system.

So far as public popularity is concerned, clinical studies suggest that patients value medical attentions in complex ways, and effectiveness is not necessarily one of them. For example in studies of various treatments for back pain, hands-on kinds of treatment such as manipulation or massage were associated with higher patient satisfaction than more detached kinds of medical management, even though patients do not necessarily get out of bed or back to work quicker. It is not that consumer preferences and the satisfaction of other human needs is necessarily an unworthy aspect of medical care, but it is desirable to understand what exactly is going on, and especially whether the benefits are worth the cost.

It is a concern that the MACCAH Discussion Document refers to support for CAM practices which have the “potential to relieve symptoms and improve health”. “Potential” should not be sufficient reason to offer a treatment in a publicly funded facility. The minimum that one should accept is the oft-quoted “proven safe and effective for its intended purpose”.

Adding worthless methods to effective ones raised cost but not effectiveness. For this reason, third-party payers are increasingly demanding proof of effectiveness.

Education and Training Required; Acknowledged where Limited or Conflicting

Research overseas indicates that medical schools and training establishments for other health care professionals such as nurses and midwives, do not present CAM material in a form that encourages critiques and analyses of the claims made for the practices and products.

A survey of CAM curricula in U.S. medical schools in 1995-1997 showed that of 56 course offerings related to CAM, only four were oriented to criticism. All medical schools should include in their curricula methods to analyze and assess critically the content validity of CAM claims.

If the health care providers at whatever level they are serving, are not privy to any critiques of such practices, and are subject to only strong, positive marketing of CAM practices and products, then their advice will be inappropriate and potentially dangerous. As Frenkel and Borkana indicate, clear open lines of communication are necessary if effective evaluation is to be undertaken and appropriate integrative steps undertaken.

Education about CAM needs to be incorporated into medical education and postgraduate training. Physicians need to become familiar with the conceptual basis of CAM therapies, and with current data on their efficacy and safety. They need to incorporate questions about CAM use into their histories, to provide advice to patients who seek guidance, and to be sensitive to the needs of patients with chronic, incurable diseases. However, there should be only one standard of evidence for medical care, and CAM therapies should meet that standard.

Physicians need additional education in order to provide guidance to patients, but teaching about alternative medicine should be evidence-based, not merely the transmission of unproven practices.

There are distinct problems with regard to suggestions of providing biomedical training to CAM practitioners.

As the House of Lords report note, clear distinctions need to be made with regard to the different CAM modalities when integrating it into training and publicly funded health initiatives in order to avoid misleading the public regarding the status of the more questionable approaches. The six stages taken from the report (MACCAH DD pg 21) fail to include the vital step of discarding those CAM services which fail to pass the evaluation outcome and making this known not only to the medical community but also to the public.

In addition, there are numerous CAM modalities which clash with basic knowledge and understanding of anatomy, physiology, physics et al. Those practising in these areas should be required to disclose to their customers that this is the case as part of an informed consent process.

Evidence of Safety and Efficacy Vital Prior to Integration

If practitioners are to assist patients with advice or referrals to appropriate CAM modalities, and if practitioners in high priority CAM areas are to gain recognition of their area, there must be a means for provision of evidence regarding the efficacy and safety aspects of the specific treatments and guidelines to assist with any suitable integration of conventional and CAM therapies.

Frenkel and Borkana have suggested a comprehensive and rational, best-evidence strategy for integrating CAM by primary care practitioners into primary care. An initial evaluation needs to involve a family physician to provide an accurate diagnosis and evaluation of the best course for treatment, which may or may not include CAM. Such evaluation, according to Frankel and Borkana, has to be based on evidence from the medical literature, applying the same principles of evaluation of any therapy that one may want to incorporate into practice. This includes the need to ensure safety, efficacy, knowledge of potential interactions or adverse reactions.

Patients requesting advice on the use and integration of CAM modalities as part of their health care should be evaluated initially by their primary care physician. The physician’s responsibilities are to evaluate the appropriateness of that use, and to maintain contact, monitoring outcomes. Advice on referrals should be based on the safety of the method in question, current knowledge on indications and contraindications of that modality, and familiarity and an open dialogue with the specific therapist.

While it is focused on a practice, rather than on the totality of the health system, Frenkel’s detailed iterative model has some important aspects missing from the House of Lords one presented by MACCAH (pg 21). These include:

• the importance of expanding practitioner knowledge and consulting broadly regarding the evidence for the modality under question
• a recognition of the importance of safety aspects (not specially referred to in the House of Lords model!)
• specific mention of evaluating whether conventional therapy can offer a better, effective and safe therapy
• the involvement of the patient and CAM practitioner in the decision as part of encouraging dialogue, informed consent and better monitoring

Significantly, these family physicians (who have considerable experience in CAM and integrated environment) also state:

if the modality has been clearly shown to be ineffective, the physicians may be compelled to caution the patient

They also note an onus on CAM providers to be able to identify conditions that would not respond to their treatment modality and discuss limitations with their patients, and the importance of involving the patient in the discussion and decision-making process.

Not surprisingly, Frenkel and Borkana stress the need for open communication and co-operation between the three possible parties (the physician, the CAM provider and the patient), with the development of clear lines of responsibility.

The Australian Medical Association has called for government and professional bodies to develop information sources for CAM comparable to the ones which exist for biomedicine, as a means of ensuring medical practitioners are informed about the potential benefits and any potentially adverse effects of complementary medicines and therapies. This should include provision for systematically recording information regarding adverse events and alerts.

The NZ Medical Council guidelines need to bear in mind the importance of informing patients regarding adverse effects and also advising them on what is not effective.

Many medical associations have a Code of Ethics which requires their members to maintain accurate contemporaneous clinical records, and CAM practitioners should be held to account with regard to keeping adequate patient records and providing timely, detailed information regarding adverse events.

Integration Efforts Require Monitoring and Evaluation as Current Examples are Inadequate

The examples provided in the MACCAH Discussion Document (pg 22) are not good ones regarding integration at any level. They indicate major concerns with regard to the need for careful monitoring and evaluation of both information and implementation.

Wellington Hospital’s oncology ward has been using “healing touch” (aka therapeutic touch or TT) for five years. In a news report which covered this, the departmental doctor Dr John Carter stated that there was no evidence to prove that such practices cause healing. However, the hospital’s nursing staff consistently referred to healing powers in media publicity, in patient discussions and on signs. This raises major concerns regarding informed consent, diversion of resources to inappropriate areas and fraudulent claims.

There have been no demonstrable, consistent efficacious results regarding healing touch, and further, this form of faith healing is based on belief in an undemonstrable human energy system which has failed to be exhibited in any evidential tests. This achieved a great deal of attention in 1998 when it was critically evaluated by a 10-year-old girl who even co-authored a paper on the subject which was published in the Journal of the American Medical Association. This is a prime example of one of the modalities which does not deserve further investigation, and which should not be used in our public health system as unethical diversion of resources from other areas of proven medical care.

In awarding Wellington Hospital the Bent Spoon for 1999, the NZ Skeptics noted that:

We understand that the use of TT can be attractive in that it does not require any expensive equipment or extensive training — something that would no doubt appeal to any cash-strapped hospital. Like any form of extra caring or positive interaction — from a basic smile to a relaxing massage — TT may well make patients feel better. But it is not ethical to take advantage of a common psychological reaction and dress it up as some form of special treatment when it is not. Delusion or deception is not an acceptable basis for something claiming medical support and public funds.

Anecdotal stories and formal reports all identify a profound, disturbing lack of basic patient management and care at many of our larger hospitals, so it is particularly sad to see valuable nursing time taken up with this sort of deception, however well-meaning.

In other areas quoted by MACCAH as indicating integrated successes, it should be noted that:

The Australasian Integrative Medicine Association appears to be doing little more than acting as a marketing tool for referrals to CAM practitioners.

The Sloan-Kettering Cancer Center is cited as an example of complementary integrative medicine. According to the Council for Scientific Medicine, Sloan-Kettering has found very limited use of CAM practices and products. Of their 300-item database regarding herbal and dietary supplements, the majority of research results reported indicate that the CAM claims for their use are unsubstantiated (Barrett, pers comm).

The White House Commission on Complementary and Alternative Medicine has been strongly criticised across a broad range of grounds, including by its own Commissioners. To date, the Department of Health and Human Services has not adopted any of its recommendations or even made moves to promulgate its final report (Barrett, pers comm).

The Tzu Chi Institute, said to be offering integrated care, has now closed. Half its operational funding was paid for by the government and, when this was reduced, the programme were found not to be sufficiently cost-effective to permit its operations to continue.

Ethical Standards Necessary Regarding Declaration of Commercial Interests

Another area of concern is that of vested interest. It appears to be relatively common practice for CAM practitioners to prescribe CAM products in which they have a direct financial/commercial interest, or similarly related services. This sort of relationship should be disclosed.

A brief search of the Internet for treatment in Crohn’s disease reveals over 40 herbal medicines, many with testimonials to their ability to cure patients in whom conventional medical has been unsuccessful. AMP Molo-Cure Platinum (concentrated aloe vera) is one such herbal preparation and costs over £100 for a one month supply. We must resist attempts to promote any medicine – herbal or otherwise without adequate controlled trials; or those who are profiting from the vulnerability of patients with chronic disease may be strengthened by our double standards.

Those medically qualified who also practice CAM modalities must be required to make a clear disclosure to their patients when they are suggesting the latter, including a full informed consent process which covers the nature of the proposed treatment, including efficacy and safety information.

There have been a number of highly publicised cases in New Zealand where patients have undertaken such treatment programmes unaware that they were engaging in unproven or disproven modalities, assuming that they were protected by the usual standards of medical care. In most cases this has only come to light where a complaint has been laid with the Medical Council, and the only redress that the patients or their families have had is via disciplinary proceedings which have removed the doctor from biomedical practice but which had no effect on their CAM business.

As the Australian Medical Association Code of Ethics state:

Protect the right of doctors to prescribe, and any patient to receive, any new treatment, the demonstrated safety and efficacy of which offer hope of saving life, re-establishing health or alleviating suffering. In all such cases, fully inform the patient about the treatment, including the new or unorthodox nature of the treatment, where applicable.

Cost-benefit Analysis Required Prior to Integration

Prior to any integration at a national level, there will need to be a clear case made that the adoption of CAM practices are cost-effective and provide benefits that are not otherwise obtainable with current methods.

When looking at the goals of the New Zealand Health Strategy, it is clear that there numerous ways of achieving those objectives. It would make far greater sense, both in economic and public health terms to concentrate the greatest resources on those modalities we know which work and which can be readily adopted by the public. Encouraging greater uptake of exercise and sport, for example, has demonstrable benefits across a number of those objectives.

Therefore, in order to control the steadily increasing wild growth of complementary medical offerings, several states have introduced examinations for the registration of such paramedical practitioners. Whether complementary (paramedical) medicine will really reduce costs of health care remains unproven so far. According to several surveys most alternative methods are used in addition to “school medicine” (academic medicine). Health insurance companies should subject reimbursement of costs to the fulfillment of standards regarding efficacy, appropriateness and economy equal to all other medications and therapies

There has been relatively little independent research undertaking comparing the results of CAM and biomedical outcomes with regard to costs. Blanket assurances that CAM offers cheaper alternatives are not well supported, as there are clear examples where this has not been the case.

With rationing looming in virtually all healthcare systems, the question whether herbal medicines can save money is important. Not all plant based medicines are cheap. A standard daily dose of St John’s wort, for instance, will cost more than that of a tricyclic antidepressant.

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