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:	chair@skeptics.org.nz
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: skeptics@spis.co.nz

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.

References

Alternative Medicine Review
http://www.thorne.com/alternative/alter_main.html

Angell M, Kassirer JP, “Alternative medicine–the risks of untested and unregulated remedies.”
New England Journal of Medicine 1998;339:839.

Australian Medical Association Position Statement: Complementary Medicine
http://www.ama.com.au/web.nsf/doc/SHED-5FK4YN/$file/healths_gd_ps_compl%20medicine.pdf

Baratz, Robert S. MD, PhD, DDS, and Barrett, Stephen M.D.
NCAHF Position Statement on White House Commission on Complementary and Alternative Medicine
http://www.ncahf.org/pp/whcpp.html
Baratz is President of the National Council Against Health Fraud
Barrett is chair of Quackwatch, vice-president of the National Council Against Health Fraud, a scientific advisor to the American Council on Science and Health; 2001 Distinguished Service to Health Education Award from the American Association for Health Education.

Betz, Willem, Recogntion of Unproven Therapies in Europe; The Skeptical Intelligencer Vol 4 2000

Beyerstein, Barry M.D.; Social and Judgemental Biases That Make Inert Treatments Seem to Work,
The Scientific Review of Alternative Medicine
http://www.hcrc.org/contrib/beyerst/inert.html

Calder, J. et al. “Health information provided by retail health food outlets,” Canadian Journal of Gastroenterology, Vol. 14 No. 9, 2000.
http://www.canadian-health-network.ca/html/newnotable/jan1a_2002e.html

Canadian Natural Health Products Directorate.
http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html

Ernst, E Professor; Herbal medicines: where is the evidence? BMJ 2000;321:395-396
Ernst is professor of the Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter

Frenkel Moshe A and Borkana Jeffrey M; An approach for integrating complementary– alternative medicine into primary care; Family Practice Vol. 20, No. 3, 324-332, OUP 2003
Frenkel is in the Sackler Faculty of Medicine, Tel Aviv University and Department of Family Medicine, Brown Medical School, and has worked as director for an integrated CAM clinic.
Borkana is with the Complementary and Traditional Medicine Unit, Department of Family Practice, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology.

Fontanarosa P.B., and Lundberg G.D. “Alternative medicine meets science” JAMA. 1998; 280: 1618-1619.

Gorski Timothy MD, Current Issues in Protecting the Public from Health Fraud: “Dietary Supplements” as a Public Health Problem, Testimony to the United States Senate Special Committee on Aging, September 10 2001
Gorksi is Assistant Clinical Professor, University of North Texas Health Science Center

House of Lords Select Committee on Science and Technology – Sixth Report, Complementary and Alternative Medicine 21 November 2000
http://www.parliament.the-stationery-office.co.uk/pa/ld199900/ldselect/ldsctech/123/12301.htm

Jungi WF, Schweiz Rundsch Med Prax. 1997 Oct 8;86(41):1593-7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9417579&dopt=Abstract

Low Dog Tieraona, and Fins Joseph J. Fins; Open letter to The Honorable Tommy G. Thompson, US Secretary, Health and Human Services
http://www.quackwatch.org/07PoliticalActivities/WHC/minority.html

Marcus, Donald MD et al. Integrative Medicine Is a Trojan Horse , Arch Intern Med.2002; 162: 2381-2383.
How Should Alternative Medicine Be Taught to Medical Students and Physicians? Academic Medicine (2001) 76: 224-229.
Botanical Medicines, the Need for New Regulations, New England Journal of Medicine, Vol 347, No 25, 2073-2076
Marcus is professor of medicine and immunology, Departments of Medicine and Immunology, Baylor College of Medicine, Houston, Texas

National Council Against Health Fraud Position Statement on White House Commission on Complementary and Alternative Medicine
NCAHF http://www.quackwatch.org/07PoliticalActivities/WHC/00.html

Sampson, Wallace MD ‘The Need for Educational Reform in Teaching about Alternative Therapies; Academic Medicine (2001) 76: 248-250.
Sampson is emeritus clinical professor of medicine at the Stanford University School of Medicine, and former acting chief of medical oncology at the Santa Clara Valley Medical Center.

Special Commision on CAM Practitioners, Jan 2002
http://www.state.ma.us/reg/current/2002medp/rminor.pdf

Taylor, Marion, Dr; New Zealand Family Physician, May 2003