Month: June 2003

Current Policies and Policy Issues in New Zealand and Selected Countries

This submission was completed by:

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

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

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

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

Informal Summary

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

Problems of Basic Focus

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

Regulation

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

Consumer Information Needs

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

Research, Evidence and Efficacy

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

Integration

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

References

 

Problems of Basic Focus

The Basic Question is Whether CAM can Help, not How

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

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

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

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

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

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

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

MACCAH Definition of CAM is Too Broad

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

MACCAH’s definition of CAM included the following:

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

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

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

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

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

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

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

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

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

Better Definitional Analysis of CAM is Required

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

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

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

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

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

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

Categorisation and Prioritisation Necessary for Evaluation, Research and Application

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulation

 

Need to Recognise Public Demand for Regulation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulations Required Against Disproven and Unsafe Practices and Products

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

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

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

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

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

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

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

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

The House of Lords report emphasised that:

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

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

Costs Should be Borne Predominantly by CAM Industry with Independent Monitoring

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

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

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

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

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

Regulations Need to Recognise Range of Risks

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

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

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

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

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

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

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

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

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

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

Self-regulation is Inadequate and Inappropriate

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

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

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

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

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

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

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

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

Issues of Public Accountability and Enforcement Have to be Addressed

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

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

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

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

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

Failure to Regulate Products Leads to Public Harm

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

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

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

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

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

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

Clear, Consistent Product Regulation is Vital and Achievable

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

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

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

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

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

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

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

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

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

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

Recommended Response to Ensure Safety and Efficacy

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

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

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

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

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

Consumer Information Needs

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

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

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

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

the health consumer must be able to make an informed choice

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

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

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

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

MOH Database Needs to be Balanced, Neutral to Achieve Credibility

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

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

The House of Lords report noted the following:

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

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

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

Vested Sources can be Inaccurate, Misleading and Potentially Dangerous

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

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

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

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

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

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

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

Publication Bias Has to be Recognised and Assessment Provided

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

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

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

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

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

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

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

Research, Evidence and Efficacy

 

Identify Practices, Products Outside the Scope of Research

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

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

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

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

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

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

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

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

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

CAM is Big Business and Should Contribute to Research

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

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

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

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

Credible Research Programmes can Provide Useful Information

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

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

Public Research Programmes need to Prioritise Promising Approaches over Questionable Ones

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

All Research Programmes Need to be Robust and Defensible

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

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

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

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

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

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

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

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

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

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

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

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

Binding Negotiated Research Protocols Required

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

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

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

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

Negative Results Need to be Acknowledged, Accepted and Publicised

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

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

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

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

MACCAH notes that there is:

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

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

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

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

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

Integration

 

First, do No Harm; Second, do Some Good

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

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

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

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

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

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

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

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

Education and Training Required; Acknowledged where Limited or Conflicting

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

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

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

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

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

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

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

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

Evidence of Safety and Efficacy Vital Prior to Integration

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

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

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

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

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

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

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

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

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

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

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

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

Integration Efforts Require Monitoring and Evaluation as Current Examples are Inadequate

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

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

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

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

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

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

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

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

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

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

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

Ethical Standards Necessary Regarding Declaration of Commercial Interests

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

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

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

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

As the Australian Medical Association Code of Ethics state:

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

Cost-benefit Analysis Required Prior to Integration

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

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

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

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

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

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