Growing safer medicine and better health in New Zealand

Herb Federation of New Zealand Conference – Wellington 2007

By Chris Tuffnell.
Dip Clin Herb Med (with Distinction), NZRGON, BA, Dip Quality Assurance (with Distinction), Dip Health Admin (Massey).MNZAMH,MNHAA.

This paper to the 11th Biennial Conference of the Herb Federation of New Zealand considers progress made in the quality, safety, and access to herbal medicine. It also explores issues of efficacy of herbal medicine and approaches to integrative care for better health.

Chris is a Medical Herbalist in private clinical practice in Richmond, Nelson, New Zealand. She is also a New Zealand Registered Nurse with a background in medical nursing.

Chris was awarded the Altrusa International Inc.Career Exchange in 2006 to study herbal medicine in the Eastern U.S.A., Canada, and Bermuda. She is a professional member of the New Zealand Association of Medical Herbalists and a past National President of the Association.

Chris has wide experience in the health sector – in clinical, teaching, management, auditing, research and governance roles. She has had two Ministerial appointments in health governance and has twice served as an elected representative on the health board in the Nelson/Marlborough region.

Chris is a past National President of the New Zealand Organisation for Quality . She won the Carter Holt Harvey Quality Award in 1989 and 1991 and the Beca Quality Prize in 1995 and 1998.

She is passionate about ordinary people having access to and preparing their own herbal remedies. She is currently writing a series of books called the Herbs4USeries.

2006/07 was a vintage year for Western Herbal Medicine in New Zealand.

• The Ministry of Health agreed that Western Medical Herbalists become registered under the Health Practitioners Competency Assurance Act 2003.
• Herbal medicine consumers flexed their muscle and influenced their political representatives not to pass the enabling legislation for the proposed Australia New Zealand product regulatory authority (ANZTPA).
• The Medicines Classification Committee of the Ministry of Health’s regulatory body Medsafe did not act on a proposal (in line with some international opinion) to withdraw the herb Kava (Piper methysticum) from use.

Detracting from the sweet bouquet of success however was the Ministry of Health’s “Towards a New Zealand Medicines Strategy” – released for consultation on December 2006.

The Medicines Strategy is remarkable in that it takes no account of the contribution that herbal medicine may be able to make to achieving the New Zealand Health Strategy (2000).

Registration of Western Medical Herbalists

The advice to the Minister of Health from the Ministerial Advisory Committee on Complementary and Alternative Health (MACCAH) ( June 2004) was that regulation of practitioners is a major way of managing risks to consumer safety, namely:

• unprofessional or unethical behaviour
• lack of monitoring of practice
• unsafe or unsanitary environment
• financial loss
• lack of redress if something goes wrong
• lack of training or competency
• lack of professional development
• lack of first aid knowledge
• misleading claims leading to financial and other losses
• lack of appropriate referral

The New Zealand Association of Medical Herbalists (NZAMH), with the support of a submission from the Herb Federation of New Zealand, was successful in gaining approval of the Health Minister for Western Herbal Medicine to become a regulated profession.

Angela Haldane, Chair of NZAMH’s Political Sub-committee sums up as follows:

What is in it for medical herbalists?

1. It gives greater access to and control over medicinal herbs that might be prohibited for general public use.
2. It increases greatly the chances of integrating Western herbal medicine into our predominantly conventional medical healthcare system.

What is in it for the public?

1. It protects the health and safety of the general public by ensuring that when they go to see a Western Medical Herbalist, they are in the hands of a fully qualified healthcare professional.
2. It offers the consumer greater value and choice in obtaining their healthcare, by being able to visit a practitioner who is able to combine the qualities of traditional medicines with modern science and knowledge of our conventional medical system.
3. We hope that government funding of herbal medicine may be available in the near future. [Avena: Journal of the New Zealand Association of Medical Herbalists. Spring, 2007.pp3.]

The process of becoming regulated is likely to take several years. One of the most important decisions along the way will be which registration authority regulates Western Herbal Medicine. It is vital that medical and pharmaceutical dominance is avoided and that the philosophy and core values on which herbal medicine is based are preserved. Attention will be paid to education standards, identifying and making explicit clinical, phytopharmaceutical, good manufacturing ,and research competencies. Audit capability will be required to monitor competency.

Therapeutic products and medicines regulation

Annette King, the Minister who first set sail for a combined Australia New Zealand regulatory body to include complementary and alternative medicines by co-signing a Treaty with her Australian counterpart lacked the numbers this year for the legislative enablement of the ANZTPA. However millions of dollars have been spent developing the bi-nation system as set out in the Therapeutic Products and Medicines Bill, 2006.

On 16/7/2007 in a press release the then Health Minister Pete Hodgson stated that the status quo of an unregulated market for complementary medicines cannot remain and Annette King (now Minister of State Services) advised that the Bill had been postponed, but will remain on the Parliamentary Order Paper to be revisited when sufficient Parliamentary support is available.

With Natural Products NZ, (claiming to represent a significant proportion of New Zealand natural health product manufacturers and marketers) supporting the Bill and keen to distribute “the truth” (Natural Products NZ Media Release 27 April 2007) how did the Bill come to wane when it came to Parliamentary vote?

The list is not exhaustive, but there were concerns about:

1. Definitions of therapeutic products, herbal medicine, and Complementary and Alternative Medicine (CAM)
2. the possible driver of the changes being new markets – mainly to the benefit of Australia
3. Capture of politicians by pharmaceutical multinationals and the dominant medical model
4. Loss of control and influence over New Zealand’s regulating system
5. Lack of clear information about process and outcomes – but a lot of detail about ANZTPA structure
6. How to create and communicate a ‘white list’ of permitted ingredients due to lack of clinical trials in herbal and CAM.
7. That the nature of clinical herbal medicine in New Zealand had not been duly taken into account.
8. Access to a comprehensive range of herbal medicines for New Zealanders was threatened
9. Lack of differentiation between Over–the–Counter (OTC) and Practitioner–Only herbal medicines.
10. Continuing increase in the cost of herbal medicine to consumers for a medicine that does not enjoy the same generous Government subsidy as pharmaceuticals

It is interesting to note that with regard to market opportunities, both the Australian Self–Medication Industry (Annual Report 2005–2006) and Natural Products New Zealand (Phytobrief, 2007) saw the single market concept in a positive light and a stepping stone to becoming a more integral part of the global market.

Fact and fiction were difficult to separate. In the end this lack of clarity led to community uproar and nervous politicians paying attention to their constituencies.

But the need for regulation has not gone away.

While one can point the finger and demand that the safety of pharmaceuticals is a much, much bigger problem than the safety of herbal and CAM medicines, safety issues can be identified. It is important that a risk appropriate regulation system is developed for all therapeutic products and medicines.

Over the past few years Medsafe has been putting most of its energy into running on the ANZTPA treadmill. Much of the work done is good work. Progressing further depends on gaining the confidence of New Zealander’s. An acceptable strategic plan for making the changes needed to bring New Zealand’s therapeutic products regulation up to world class standards needs to be developed in consultation with stakeholders. Scientific alliances will be necessary to enable cost effective assessment of new products, effective market surveillance, and establishment of efficacy.

Towards a New Zealand Medicines Strategy

It seems strange that a medicines strategy for New Zealand was not proposed before changes to regulation of medicines and therapeutic products. This would have at least given some context to the proposed changes.

As previously stated the proposed strategy confines itself to pharmaceuticals apart from a side swipe at St John’s Wort (Hypericum perforatum) on page 63.

Background to the proposed strategy however does give some telling information:

• There are 40 million dispensings of subsidised pharmaceuticals per year.
• Each year District Health Boards spend about $1 billion on pharmaceuticals and pharmaceutical services.
• Community pharmacies receive approximately $225 million per year in dispensing fees
• 50% of New Zealanders do not take their pharmaceutical medicines or do not take them as prescribed.
• 50% of people receiving pharmaceutical medicines do not receive regular review of these medicines by their doctor.
• 9% of New Zealanders are given the wrong medicine or the wrong dose.
• There is little or no monitoring/reporting on medicines related to incidents in the primary care sector.

Towards a New Zealand Medicines Strategy. Ministry of Health. December 2006 Document available on line www.moh.govt.nz

So why do we waste so much money on pharmaceuticals?

And are pharmaceuticals effective?

Dr Allen Roses, the world vice-president of genetics at GlaxoSmithKline has said that the vast majority of drugs – more than 90% – only work in 30% – 50% of people they are prescribed for. This, despite the ‘proof’ of clinical trials of drugs to establish efficacy prior to market release.

The Guardian Newspaper,London, Tuesday 9 December 2003:The great drugs lottery.

Safety

It’s a dangerous world.

As Simon Mills in Mills and Bone (2005) pp3–4 points out, it is difficult to be entirely safe these days. For some people some foods are unsafe eg. A1 milk,(Woodford,2007) gluten containing foods, green potatoes and their teratogenic alkaloids, cyanide containing stone fruits, not to mention the dangers of food additives and preservatives.

Some dangers are local. In Nelson methyl bromide sprayed in the holds of ships and containers exporting cargo may be linked to causing motor neurone disease. (Shaw, 2007)

Near New Plymouth dioxin contamination and associated community ill health is a major concern. (TV3 Documentary: Let us Spray, October 2006; Minister of Health Pete Hodgson, 24/1/2007 Reviews endorse serum dioxin studies –www.behive.govt.nz)

Internationally foot and mouth disease, mad cow disease, and avian influenza and now horse flu are poised, waiting their chance to cause havoc.

Xenoestrogens in our environment are increasing eg. in food and its preparation, in skin care and cosmetics. New Zealand’s primary industries have high use of pesticide and herbicide sprays and forests and horticultural areas now often border domestic subdivisions. Even some water supplies are of less quality than that required for safety.

On 25 September 2007 TV One News it was reported that four companies manufacturing sun screen products were being investigated because of false label efficacy claims. An expert advised that many sunscreens on the market lose their efficacy over time, commencing even 30 minutes after manufacture.

Around the same time a new childcare care centre was not permitted to open because the children would be at risk from heavy metal contamination from nearby main road traffic.

Inherent herb safety

Medical herbalists who are members of the New Zealand Association of Medical Herbalists have been trained to know herbs that are poisonous, potentially toxic, may possibly trigger allergy, and those which have the potential to interact with certain pharmaceuticals.

The New Zealand Medicines Act already lists herbs that are Pharmacy Only Medicine, which effectively puts them out of circulation.

There is potential for a number of herbs to be hepatotoxic, neurotoxic, cardiotoxic, renotoxic, phototoxic, aborfacient, or teratogenic.

For example the well known herb Arnica Montana –due to its sesquiterpene lactone, helenalin, can be cardiotoxic, aborfacient, and teratogenic if taken internally in usual tincture dose range. It is used homeopathically and topically (on unbroken skin) with apparent safety. Even common herbs such as Rheum palmatum (Chinese rhubarb) and Rumex crispus (Yellow Dock) can be renotoxic due to their oxalate content, while culinary herbs such as celery and parsley have the potential to cause phototoxicity.

As has been found with Kava (Piper Methysticum), often it is the preparation process that can affect safety.

Contact dermatitis is not uncommon in certain herb groups eg. those containing sesquiterpene lactones or those of the daisy family such as Arnica, Chamomile, Feverfew, and Echinacea. Even linseed and psyllium have been known to cause anaphylactic allergic reaction.

Dose, as Paraceslus said, is everything!

The importance of careful dosage is illustrated in the line between therapeutic and toxic dose in herbs such as Pokeroot (Phytolacca Americana).

The CYP 450 epidemic

Herbs have come into the spotlight over recent years as science has been able to understand more about the complex enzyme system used by body organs, and particularly the liver, to detoxify the potentially dangerous substances and chemical combinations that the human body is subjected to daily.

Increasing information has come to light about how the many components of the pharmaceutical arsenal prescribed by orthodox medicine practitioners are detoxified by the body. Along with this information has come knowledge of what substances speed up or slow down this breakdown of pharmaceuticals for excretion by the body. For example grapefruit slows down metabolism of anti–allergy drugs and Warfarin whereas broccoli speeds up the metabolism of some drugs.

This is where St John’s Wort gained its unwarranted reputation as a villain! Because it is an effective liver herb it speeds up the metabolism of many drugs eg. digoxin, oral contraceptives, theophylline, phenytoin, cyclosporin, and some drugs for treating HIV–Aids. In addition it enhances the effect of some drugs used to treat mental illness eg. serotonin reuptake inhibitors, tricyclic antidepressants and benzodiazepines.

And so, the practice of herbal medicine, requires the Medical Herbalist, to keep up to date with the effect of herbs they prescribe on the CYP450 enzyme system. The Medical Herbalists also needs an understanding of pharmaceutical drugs and their groupings, functions, and side affect.

David and Goliath – herbs and pharmaceuticals

Most members of the public in New Zealand are on one or more medication. Hall and Martin (2003) found that 69% of people 20–44 years of age were on one or more medication. Most frequently prescribed were antidepressants, respiratory inhalers, oral contraceptive pill, and drugs for gastric reflux. NZ Family Practitioner, Volume 30, No 6. December 2003.

In my own herbal medicine practice around 70% of my clients are taking pharmaceutical medicines. It is vital to public safety that Medical Herbalists are competent to practice herbal medicine in the milieu of a dominant medical paradigm that leans heavily on prescription of pharmaceuticals.

Herbs do interact with pharmaceutical drugs. As more is known about the pharmacology and pharmacokinetics of herbs and pharmaceuticals the list of possible herb/drug interactions grows. Concurrent use of pharmaceuticals and herbal medicine is increasingly common. There is much literature available on herb/drug interactions, for example: Brinker (2001); Whitteker, M.(2001); Rotblatt and Ziment (2002); Braun (2002.); Rasmussen (2005); Mills and Bone(2005); Braun and Cohen(2005).

The most common interactions are pharmacokinetic in nature – involving the extent of and way in which absorption, distribution, metabolism, and excretion of a specific drug is affected by a specific herb. This includes the many herbs having an influence on the drug transporter protein P–glycoprotein (P–gp). It also includes herbs that affect metabolism via the Cytochrome P450 system. Pharmacodynamic interactions can also occur simply because herbs work! Herbs can potentiate the efficacy of some pharmaceutical drugs, for example Gymnema sylvestre in treatment of Type 2 Diabetes, Ginkgo biloba in treatment of schizophrenia, and herbs which stimulate the immune system such as Echinacea species.

Some chemical groupings of herbs are more likely to precipitate pharmacokinetic affects eg. tannin containing herbs (which can reduce absorption).

Concern of herb–drug interaction is highest when pharmaceuticals with a narrow therapeutic index are used eg. Digoxin, Warfarin.

Herb–Drug interactions are not prevented through regulating the products themselves, but through adequate training of practitioners and integrative patient management between orthodox and herbal medicine practitioners.

Competence to prescribe herbal medicine is essential

It is important that health professionals work within their scope of practice. In 2001 in the United Kingdom one study found that one in ten specialist physicians are actively involved in CAM treatments, although only 13% of these specialist physicians had received any CAM training. (Lewith et al, 2001).

Orthodox medical practitioners and pharmacists are not automatically competent to prescribe herbal medicine. In New Zealand statutory regulation of Western Medical Herbalists will require that orthodox medical practitioners and pharmacists prescribing herbal medicine are trained and competent to do so. Mendel (2007) provides insight into ethical and professional issues in the practice of complementary medicine in retail pharmacies. Mendel acknowledges that the biomedical model is firmly entrenched in the culture of pharmacy.

There is a difference between being knowledgeable in and being qualified to advise and prescribe herbal medicine.

The Medicines Act 1981 and Regulations 1984 will require updating to enable Western Medical Herbalists, as a regulated profession, to become “designated prescribers” i.e. authorised under the Medicines Act to prescribe a subset of medicines (i.e. Herbal Medicines.) This will also require update of Medicine (as opposed to Pharmaceutical) Schedules to the Act.

Reporting side affects/interactions

The most pressing need for both pharmaceutical and herbal medicine is for an effective adverse effects reporting system.

Internationally, the World Health Organisation (WHO) database has exceeded 3.6 million reports. Of these 41,439 had listed a herb as suspected, interacting, or concomitant. In 17,112 of these reports the herb was listed as a suspected or interacting drug. Note that these are still only 1.15% and 0.47% respectively of the total reports.

The most frequently reported herbs were Nicotiana tabacum (1,426), Ginkgo biloba (595) and Hypericum perforatum (493). The most frequent adverse reactions were pruritis, urticaria, and skin rash. Kayne, S.(2006)

In New Zealand Medsafe, the New Zealand Medicines and Medical Devices Safety Authority (a business unit of the Ministry of Health) is responsible for overseeing pharmacovigilance activities. The University of Otago is contracted by Medsafe to provide medicines monitoring services. As part of this service the Centre for Adverse Reactions Monitoring (CARM) collects and evaluates spontaneous reports of adverse reactions in relation to pharmaceuticals, vaccines, herbal products and dietary supplements made to it voluntarily by health professionals in New Zealand. Despite CARM receiving over 3000 reports of adverse reactions per annum, it is commonly believed that this amounts to less than 5 percent of all adverse reactions that occur. (Towards a New Zealand Medicines Strategy, 2006, pp30/31.)

When adverse reactions are reported appropriate review of the alleged reaction is essential. It is crucial to ongoing practitioner cooperation with reporting that reports of review are credible. For example in the Medicines Adverse Reactions Committee ( MARC) Minutes of 14 June 2007 under item 4.1.4 Complementary and Alternative Medicine – an adverse reaction was reported as follows:-

Red Rice Yeast Extract, Saw Palmetto, CoQ10, Multivitamins, and myalgia, CK elevated, LFT’s abnormal, chest pain (74641)

Discussion

NZphvC (New Zealand Pharmacovigilance Centre) noted that Red Rice Yeast Extract contains compounds which are very similar to statins, particularly lovastatin, and the product literature suggests that statin–like reactions have been observed. This may be a potential reason for the myalgia, CK elevation, and abnormal LFTs. There have also been reports of hepatitis attributed to Saw Palmetto. This case report illustrates the pharmacologically active nature of some complementary medicines.

The causal association with Red Rice Yeast Extract, Saw Palmetto, CoQ10, Multivitamins was considered to be ‘possible’ for myalgia, CK elevated, LFTs abnormal, chest pain.

Recommendation

The Committee recommended that a paragraph be published in Prescriber Update to illustrate the pharmacologically active nature of some complementary medicines.

www.medsafe.govt.nz/profs/adverse/Minutes130.htm

There was no medical herbalist on the MARC committee to provide expertise in herbal medicine.

The analysis refers to Red Yeast Rice and Saw Palmetto, yet in discussion of causal association CoQ10 and Multivitamins are included.

No mention is made of the patient’s medical history or pharmaceuticals the patient may have been taking concurrently or in the six months prior to the incident.

What was the history of the symptoms, particularly the chest pain?

Where are the evidence–based references for the conclusions reached by the committee?

There has been little effort made to engage medical herbalists in this reporting process or in prescriber update notices. In fact, there is little or no monitoring and reporting on pharmaceutical medicines–related incidents in the primary care sector apart from the national adverse events system, which tends to record only the most significant adverse events. (Towards a New Zealand Medicines Strategy, 2006,pp 71.)

Clearly Medsafe needs to be meeting its responsibilities in regard to pharmacovigilance by ensuring robust reporting processes and event evaluation processes and engage all health professionals to participate. Providing regular feedback to them on the findings would be a considerable incentive to improve prescribing and monitoring in clinical practice.

Increased use of herbal products

The popularity of herbal products, particularly over–the–counter and internet herbal products, has increased over the past decade. There are multiple explanations for this increase in use including high adverse effects of pharmaceuticals, more public awareness of non pharmaceutical approaches to keeping well, and herbs to date being defined as lsquo;dietary supplementsrsquo; and therefore easier to bring to the marketplace than pharmaceuticals under the classification of lsquo;medicines&rsquo.

It has been estimated that over 50% of the Australian population use some form of complementary medicine with almost 25% of Australians visiting CAM practitioners. (O’Brien, 2004). A comprehensive survey of herbal medicine and naturopathy practices in Australia showed there were approximately 1.9 million consultations annually and an estimated turnover of $AUD 85 million in consultations (excluding the cost of medicines).

Data suggests that practitioners experience 2.3 adverse events per 1000 consultations . (Bensoussan et al, 2004).

It is likely that this incidence of adverse reactions i.e. 0.23%, is much lower than that of adverse events for orthodox practitioner consultations.

At the same time in New Zealand it was established that 23.4% of New Zealanders had seen a CAM practitioner in the past year. The main reason for attending was that the practitioner could help with conditions that other health care providers were unable to deal with. 32% of those attending a CAM practitioner had a chronic condition while 28.3% had a short term illness or temporary condition. (MACCAH report, June 2004).

Quality production and products

Product quality of dietary supplements, including herbal products, can be highly variable. While there are high performing manufacturers in the market there are also manufacturers with systems lacking quality assurance. Without comprehensive quality manufacturing systems some of the quality problems which can arise are:–

• inadequate identification of raw herbs used for manufacturing
• inadequate screening of raw herbs for contamination Eg by heavy metals, microbes, aflatoxins, pesticides, radiation.
• undeclared substitution of raw herbs
• adulteration of raw herbs (particularly in Chinese herbal medicines)
• efficacy of raw materials not adequately established i.e active constituents and phytochemical profile
• inadequate materials control
• Lack of use of relevant measurement Reference Standards eg. Pharmacopoeia, National Formulary
• Lack of standard operating procedures (SOP)
• Good Manufacturing Practices (GMP) not known or not adhered to
• poor product specification and design control
• lack of standardisation between batches
• inadequate traceability throughout manufacturing processes
• reliance on final product testing rather than process and final product tests
• lack of verification of active constituents of final product
• lack of stability testing of final product
• lack of systems for dealing with non-conforming products
• poor product traceability systems for enabling product complaint review and product recall
• lack of retention samples
• inadequate labelling
• lack of product information accompanying product
• inaccurate claims made about product – on label or in advertising
• lack of information /research about specific formulation efficacy

Mitchell(2007) puts forward the case for herbal product regulation highlighting the wide disparity between different raw herb suppliers, adulteration of herbal extracts (using the example of Bilberry), the need for careful testing of raw herbs using core quality control technology such as chromatography, the measurement and definition of marker phytochemicals which can be used as indicators of herb quality, the need for comparison of samples to authoritative phytochemical measurement standards, and for finished product to be true to label claims.

It is clear that all manufacturers of herbal products destined for the New Zealand market should demonstrate good manufacturing and laboratory practices. The World Health Organisation has Manufacturing Practice Guidelines for Herbal Medicine (revised July 2005). This would seem to be a good place for herbal product manufacturers to start.

Quality of herbs and ultimately quality of herbal products however has a wider scope than the manufacturing process. To keep compliance costs and screening and testing costs down quality of raw herb materials must be assured. Quality Management systems such as the International Standards Organisation (ISO) 9000 series emphasise the need for quality supplier systems. These standards are widely used internationally in manufacturing and service industries and would provide a suitable context for all aspects of herb quality. ISO also has standards for testing laboratory quality management systems (ISO 17025).

Incidence of unsafe herbal products

It is surprising that very few warnings have had to be issued by the Ministry of Health about herbal product safety. As at 26/9/2007 the list was:

• April 2007 – Chinese herbal products containing undeclared sildenafil and sibutramine.
• July 2006 – Chinese herbal products containing undeclared sildenafil and sibutramine.
• May 2006 – Herbal products containing undeclared prescription medicines.
• March 2006 – LiDa capsules and Nasutra capsules
• June 2005 – Super fat burning weight loss product warning
• March 2005 – Herbs Health brand of herbal products warning
• Oct 2005 – Chinese herbal remedies containing sildenafil and tadalafil.
• May 2003 – Health Canada warning about Chinese herbal product containing tadalafil – Hua Fo ‘Vigor–Max’ tablets
• May 2003 – Pan Pharmaceuticals recall, Australia
• Jan 2003 – Traditional Chinese medicines containing aristolochia, sildenafil, arsenic, diclofenac, chlorpheniramine, paracetamol.
• June 2002 – Health Canada warning not to use seven herbal supplements – Arthrin, Osporo, Poena, Neutralis, Oa Plus, Ra Spes and Hepastat.
• April 2000 – St John’s Wort and Prescribed medicines

www.medsafe.govt.nz/hot/herbalcontents.asp

It is also apparent that there must be independent monitoring of product quality and safety.

From the above Ministry list of concerns it is obvious that Chinese herbal medicine products need to be more closely monitored than other herbal products. It would appear that safety of new products coming into the New Zealand market has been allowed to fall between the responsibility gap of the Ministry of Health’s Medsafe and the New Zealand Food Safety Authority (NZFSA).

As NZFSA states: Over the past 21 years the types of products being sold under the Regulations has extended well beyond the intended coverage&hellep;and therapeutic – type dietary supplements are no longer appropriately regulated as food under the Food Act. NZFSA Discussion paper 02/07. Proposed Changes to the Regulation of Dietary Supplements. February 2007.

Both Medsafe and NZFSA have been assuming that the ANZTPA combined agency would proceed. The fact is that one or the other of these Government agencies needs to take responsibility for past, present, and future safety and quality of herbal products reaching the New Zealand market.

The opportunity for herb/pharmaceutical reaction remains high while patients do not inform their orthodox medicine practitioner of their use of herbal medicine. It is estimated that around 50% of people concurrently using pharmaceutical and herbal medicine do not tell their doctor. (MacLennan and Taylor, 2002). The question which needs to be answered is why do patients not tell their doctor they are using herbal medicine. They certainly tell medical herbalists what pharmaceuticals they have been or are taking.

Access

Self care/home remedies

Home remedies are an important part of primary health care. Self care and ‘cover care’ for others is the first point of entry when a person needs assistance with maintaining health and wellbeing.

The traditional use of herbs by tangata whenua and the range of herbs used traditionally by European and more recently Pacific Island and Asian peoples and people of other cultures should be recognised and valued by health authorities. As the Herb Federation of New Zealand stated in its NZAMH Submission on the Therapeutic Products and Medicines Bill.

“Herbs are a valid means for maintaining health and many men and women use herbal remedies to treat minor ailments (colds, low grade fevers, skin complaints),as the first line of defence. Such herbs allow individuals to:

• take active responsibility for their own health, and thereby take pressure off the over–stretched health system
• avoid the ever increasing costs of orthodox (pharmaceutical–based) medicine
• avoid the side effects of the strong medicines and limit their intake of antibiotics, which many agree are over prescribed
• take a holistic approach to their health, a strategy largely absent in modern professional medicine

Most people take a responsible approach to maintaining their health self-medication using herbs. Some grow their own herbs and consult widely as to how to use these effectively and safely; the Herb Federation assists in providing access to published knowledge. Herbs and information are freely exchanged and this will always continue. But the majority of people who use herbal remedies rely on herbal products that are widely sold in health stores. These products are produced within the country by local businesses, or by reputable companies in other countries and imported into New Zealand.” Herb Federation of N.Z. Inc. Submission on the Therapeutic Products and Medicines Bill to the Government Administration Select Committee. February 3, 2007.

Practitioner–Only medicines

In its submission on the Therapeutic Products and Medicines Bill the New Zealand Association of Medical Herbalists stressed the need for recognition of Practitioner–Only products. The availability of a Practitioner-Only market to herbal medicine practitioners is essential. Practitioner–Only products enable optimum safety for the public wanting to gain benefit from herbal medicines. Along with these products comes significant manufacturer research supporting their product and its indications, and some excellent ongoing education opportunities for clinical practitioners. (NZAMH submission on Therapeutic Products and Medicines Bill(2006) February 7 2007).

The market for Practitioner–Only products is much less than the retail market and therefore high compliance costs could lessen the range of products available through the present manufacturer initiated Practitioner–Only system.

Access gatekeeping

For pharmaceutical medicines the access gatekeepers are orthodox medicine practitioners – medical specialists and general practitioners, and in the case of Pharmacy–Only medicines, hospital and community pharmacists. Heavy Government subsidy of both pharmaceutical products and prescriber and dispensing services means relatively affordable consumer co–payments.

The access gate–keeper for herbal medicine access is price. There is no Government subsidy of herbal medicine. It is easy to see why the proposed ANZTPA approach to regulation was seen as a threat by New Zealand consumers – paying more from their own pockets made these medicines unaffordable. Government should subsidise herbal medicine and give consumers real choice.

Registration of Western Medical Herbalists under the HPCA Act 2003 provides potential for some herbal medicines to be accessible only through a registered medical herbalist eg. herbs with low therapeutic index such as Pokeroot (Phytolacca Americana).

EFFICACY – What proof is needed?

Medical herbalists can provide endless anecdotal case studies to demonstrate that herbal medicine does work. From practice analysis I know that in my practice only around 5% of clients do not get some improvement from herbal medicine. The message coming clearly from the World Health Organisation, Governments, health policy makers and the dominant medical paradigm is that anecdotal case studies are not proof enough. (Haynes, 1999) advises CAM practitioners to “get empirical or else!” (World Health Organisation Traditional Medicine Strategy 2002-2005) is clear in its requirement for evidence based medicine.

WHO advise that clinical research aimed at evaluating traditional medicine should incorporate the conventional concepts of research design, such as randomised controlled trials or other types of clinical studies, such as observational studies (i.e. collecting findings on a therapeutic treatment under routine conditions, with or without a control group). World Health Organisation: Guidelines for Methodologies on Research and Evaluation of Traditional Medicine.(2000).pp 12–13.

As Ernst (2003) notes, in commenting on the research base of herbal medicine. “the relative paucity of rigorous clinical trials is mostly due to the fact that, compared with the pharmaceutical sector, the herbal industry is small and can rarely afford the considerable expense of a clinical trial.”

He concludes that “the evidence on herbal medicines is incomplete, complex, and confusing. As more and more people try herbal medicines, the pressure increases on healthcare professionals to be well informed about the subject, and on researchers to fill the many and somewhat embarrassing gaps in our current knowledge. Failing to do (and fund) this work would, in my view, constitute the true risk associated with herbal medicines.” (pp 881/882).

The World Health Organisation (WHO) (2002) advises that objectives specific to the assessment of traditional medicine through clinical research are to:

• evaluate traditional medicine in its own theoretical framework;
• evaluate traditional medicine in the theoretical framework of conventional medicine;
• compare the efficacy of different systems of traditional medicine and/or conventional medicine; and
• compare the efficacy of different traditional practices within a system of traditional medicine.

EBM – levels of evidence

The New Zealand MACCAH Report (2004) pp 29–31 discusses types of research ‘appropriate’ for the CAM sector and the levels of evidence specified for orthodox medicine. The following table, showing the different levels of evidence is included in the MACCAH report.

Table 4.1: Ways of gaining evidence in research –: ‘levels of evidence’
Source: Clinical Evidence Online 2002

LEVELS OF EVIDENCEEVIDENCE IS OBTAINED THROUGH:ISystematic reviews and meta–analysisIIRandomissed controlled trials with definitive resultsIIIRandomised controlled trials with non–definitive resultsIVCohort studiesVCase–control studiesVICross–sectional surveysVIICase reports

Quoting the UK Department of Health 2001 Select Committee on Science and Technology’s Report on Complementary and Alternative Medicine to the House of Lords the MACCAH report outlines evidence needed to prove efficacy of CAM therapies i.e. that the patient outcomes are due to the therapy and the applicability of outcomes to other populations. The report asks whether demands for a high level of evidence of efficacy for CAM is reasonable given that the evidence base for other forms of health care is weak in some areas.

In 2004 The New Zealand National Health Committee hosted a symposium exploring how mainstream and CAM sectors could work more closely together in treatment of chronic conditions. A keynote speaker for the day, Professor Ian Coulter of the University of California proposed that presently only 20% of mainstream medicine is evidence based. There is disagreement among clinicians and academics as to just how much of orthodox medicine is evidence based and how much is not. Some place it as high as 60% evidence–based.

Simon Mills (in Lewith et al (2002)) expands application of levels of evidence to herbal medicine. He suggests that:

• it is impossible to rule out the possibility that non-specific effects, including placebo, account for popular claims about herbal evidence.
• tests on plant constituents in isolation eg. in vitro (test tube laboratory research) and in vivo (animal studies) have almost no bearing in the clinical context. Herbs are often administered by injection to the animals and are given in dose rates much higher than therapeutic uses in humans
• open clinical trials with human subjects are easily confounded by strong non-specific variables
• the value of controlled clinical trials depends on methodological vigour used

Mills (in Lewith et al (2002)) also notes that research into herbal medicine should:

• have regard to the holistic nature of the treatment system rather than particular variables in isolation
• aim to measure quantifiable components of health, rather than of morbidity, mortality or other indicators of disease
• involve minimal intervention eg. observational/field studies rather than random controlled trials

The New Zealand Devil in the Milk saga (Woodford, 2007) presents evidence regarding the link between a milk protein in A1 milk and Type 1 Diabetes, heart disease, and autism. The author highlights the long time span needed for the scientific establishment to accept proof. He also illustrates the professional rivalry and corporate profit motives which thwart the search for clarity and truth. There appears to be loss of opportunity for reducing harm or accruing benefits of better health in the meantime.

The studies quoted demonstrate how clinical trials cannot control all variables. Clinical trials fail to recognise the unique nature of each individual – their genetics, metabolism, differing enzymatic cascades, cell/mitochondrial health, and the individual pharmacokinetic response to specific pharmaceuticals and herbs. It is a sobering reminder that clinical trials are man made.

Devil in the Milk brings into the public glare the need for full disclosure and opening information sharing with the public by health authorities about risks to their health – even when risks cannot be shown to be absolute. People have a basic human right to make choices about their health.

Can herbal medicine defy the straight jacket of reductionist research?

There is recognition of the limitations of scientific method and those who produce and interpret results. The World Health Organisation has given guidance on clinical research in herbal medicine. This should be considered and wide, inclusive debate follow on acceptable research designs for establishing efficacy levels acceptable to the public, health professionals, and health system decision makers.

WHO also recognises that there are many products and substances that have not been subject to quantifiable scientific research to establish their mode of action and effect. WHO accepts evidence of traditional use to support claims for therapeutic goods. Traditional use is defined as “documentary evidence that a substance has been used over three or more generations of recorded use for a specific health related or medicinal purpose.” World Health Organisation: Guidelines for Methodologies on Research and Evaluation of Traditional Medicine.(2000).pp 41.

It is interesting that some believe that there are double standards that exist in judging orthodox and alternative medicine, and that these need to be challenged, and reliable tools found that can validate both approaches.

At a 1998 Conference in London on Integrated Medicine organised by the Prince of Wales the Health Secretary, Frank Dobson, summed up the feeling: “I believe that what works is what counts and what counts is what works.” (Bower, 1998).

In New Zealand medical research programmes should give priority to cost effective high impact low risk research. This would include more research into herbal medicine.

A paradigm shift – are we ready for it?

It is frightening how primary medical care via general practitioner services has been reduced on average to a 10 minute slot where only symptoms rather than self can be dealt with.

Testimony to this was the Timaru GP who had put up a notice asking her patients not to bring any more than two issues per visit. (New Zealand Doctor, 10 October 2007. pp2). This is clearly a reductionist view of health. People are holistic beings. It is impossible for them to comparmentalise themselves into ‘issues’. In this same article Dr Johnathan Fox, President of the Royal New Zealand College of General Practitioners, stated that he is aware of at least one low cost primary healthcare organisation (PHO) that asks its GP’s to deal with only one or two issues in a consultation.

More recent evidence for this reductionist approach to health is the sudden death of my husband last month. In trying to understand this tragedy I went to his GP and asked to see his clinical notes. What I found was profoundly disappointing. He had been a victim of the short consult, symptom only approach. Key risk factors had not been patterned together, and when they were identified, planned monitoring action had failed to be implemented.

A pivotal diagnostic test result was not in his notes and obviously his GP had never reviewed this result.

I asked why the risk profile apparent in his case notes had not been picked up on case review and was told that the practice does not do case review. They rely on a patient contacting them with symptoms, rather than identifying signs and other health/illness patterns.

I was assured new computer systems may provide some opportunity for targeting specific people likely to be at risk. Given that the history sheet and problem list in the file I reviewed were virtually blank I can only be left wondering how this important information could have found its way into the computerised system.

So yes, we are ready for a paradigm shift in primary medical care – where the patient an integrated unique human being and their holistic health are the focus.

We need to lobby politicians, health authorities, and health professional groups for change to this unsafe system of primary medical care where the Hippocratic Oath has become a farce. Safe practice is reflective practice. Primary medical care must be proactive not reactive. The current system must change.

The New Zealand Government has initiated some steps towards ‘integrated medicine’, however, we must ensure that the model of integration they propose advances health.

Leckridge (2004) discusses possible models of integration. The Market Model is a consumer/supplier model with an absence of regulation; the Regulated Model is similar to the market model with a number of public protections in place; the Assimilated Model is identical to the regulated model but strengthens orthodox medicine by redefining CAM and using the dominance of the orthodox system to keep unassimilated therapies marginalized; the Patient-Centred Model shifts power from professionals to patients. There is regulation in the patients’ interests and an emphasis on teamwork and integrative care pathways.

Leckridge concludes that current CAM versus orthodox debate is profession and manufacturer centred. This is not in the best interest of patients. He suggests a shift to a truly patient–centred debate would focus our thinking on the broader issues of health, illness and disease rather than on the two worlds problem of CAM and orthodox medicine and the difficulties involved in trying to regulate dozens of therapies.

So how can a Patient-Centred Model of care work in our New Zealand environment?

New Zealand’s Primary Healthcare Strategy was launched in 2001 with the main vehicle for delivery being Primary Health Organisations (PHO). PHO’s are not–for–profit groups of providers whose main concerns are the primary healthcare needs of people enrolled with them.

The Governance Guide for Primary Health Organisations (July 2007) makes the assumption that : “The majority of first–level services will generally be provided by GPs and practice nurses,” and indeed composition of PHO Boards and strategic plans have been largely dominated by the dominant medical model.

The Public Health Advisory Committee, reporting to the Minister of Health (June 2006), uses pandemic planning as an exemplar for an intersectoral model. Despite requests to be involved in this planning, given that herbal medicine can have an important role to play, NZAMH, despite requesting involvement at ministerial and local district health board level, was not involved in these plans.

This is an example of the need for health authorities to move to a more inclusive model of health service provision.

A Patient-Centred Model of care can work if PHO’s look to what kinds of services their population want to use to meet their health needs, including herbal medicine and CAM services, and then contracting with relevant providers to meet these needs. There is a major role for herbal medicine in wellness promotion and continuous and coordinated care – two of the key platforms of the Primary Health Care Strategy.(2001).

Medical herbalists have a significant contribution to make to meeting the health objectives of the NZ Health Strategy (Dec 2000). eg. the population health objectives of:-

• Reducing smoking
• Improving nutrition
• Reducing obesity
• Increasing physical activity
• Reducing suicide rate and attempts
• Minimising harm from alcohol and illicit drugs
• Reducing the incidence and impact of cancer, cardiovascular disease, and diabetes
• Improving oral health
• Reducing violence in relationships
• Improving health status of people with mental illness
• Ensuring access to well child and family healthcare

Herbal medicine can also contribute to management of chronic conditions such as degenerative joint disease, heart failure, chronic lung disease, circulatory disorders, gastro–intestinal disorders, diabetes, and chronic stress, anxiety and depression. The Government in recent years has provided extra funding for management of chronic health conditions through the Care Plus system. Medical herbalists should have access to this funding and be encouraged to participate in providing care to their clients through this programme.

The Guide for Establishing Primary Health Organisations (2002) states “ Primary Health Organisations must demonstrate that all providers and practitioners can influence the organisations’ decision making, rather than one group being dominant.” Pp 25. However, PHO communities are enrolled through specific general practitioner practices.

This reinforces the medical model of health and makes movement to a patient-centred model difficult, given that general practices are private for-profit businesses. Referral out to herbal medicine practitioners could mean transfer of a portion of the Government funds allocated to care of that individual as a member of a specific population. PHO processes will need to be changed in order to pursue a Patient-Centred Model of health.

In conclusion then

• • Statutory registration of Western Medical Herbalists under the HPCA Act 2003 ensures competency of practitioners thus protecting public safety and increasing consumer choice.
  • Regulation of all therapeutic medicines is essential for public safety. An appropriate risk based system is needed which has public confidence. Cost of compliance (and particularly flow-on charges to the consumer) must be kept to a minimum to preserve access.
  • Independent review of the safety of pharmaceutical medicines ( as the major component of a New Zealand Medicines Strategy) is required given current noncompliance and waste levels.
  • Government Advisory and decision making bodies whose agendas consider herbal medicine should include members with qualifications and experience in clinical herbal medicine.
  • Priority should be given to developing an inclusive adverse effects reporting and monitoring system. Clear, public processes for incident assessment and reporting findings need to be developed and readily available for study and appeal.
  • All manufacturers of herbal products who provide products for market should comply with WHO Good Manufacturing Practice Guidelines for herbal product manufacture.
  • Medsafe’s quality monitoring programme should include focus audits of high risk manufacturers. For example current trends show the need for focus audits on specific brands of Chinese herbal products.
  • The Medicines Act 1981 and Regulations 1984 will require updating to enable Western Medical Herbalists to become “designated prescribers” i.e. authorised under the Medicines Act to prescribe a subset of medicines (i.e. Herbal Medicines.) This will also require update of Medicine (as opposed to Pharmaceutical) Schedules to the Act.
  • Research is needed as to why patients do not tell their doctor that they are taking CAM and barriers to open information sharing removed.
  • With the patient’s consent, Medical Herbalists should have access to copies of laboratory and other diagnostic tests undertaken ordered for their patients by orthodox medical practitioners.
  • That Government subsidise medical herbalist consultations and costs of herbal medicines prescribed by registered Western Medical Herbalists.
  • That the WHO definition of traditional evidence be accepted for all herbal medicine where this can be demonstrated, and that herbs requiring higher levels of evidence be identified.
  • That research is funded to provide higher levels of evidence for identified herbs. This will require an international research network to enable this to happen cost effectively.
  • That a Patient-Centred model of care be pursued in consultation with health consumers and all health practitioners contributing to patient care.
  • That the Care Plus scheme for patients with chronic health conditions be extended to include the contribution medical herbalists can make to patient care and health
  • That health authorities recognise the role medical herbalists can play in meeting the NZ Health Strategy objectives.
  • That all health professionals undertake regular case review to identify and treat patients at risk.

The end or the beginning, its up to US.

If you have actual examples of how patients have been put at risk by reductionist primary medical care eg. not given adequate consultation time, reduced in number of issues they can raise in a consultation, examples where key signs, symptoms or risk patterns have been missed or not addressed appropriately, or where outcomes of treatment should have been better I would appreciate you contacting me at:

Your information may help in lobbying to change the present system of primary medical care.

© Chris Tuffnell 2007

“Reproduced with permission”

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© Chris Tuffnell 2007

“Reproduced with permission”