2. The Research Report:
Towards A Safer Choice

2.1 Background

The research project conducted by University of Western Sydney Macarthur and Southern Cross University investigated and reported on seven main areas:

• the regulatory frameworks in China, other countries, and all States of Australia;
  
  
• the profile of the TCM workforce in Victoria, New South Wales and Queensland, including the organisations that represent practitioners;
  
  
• the profile of patients using TCM and patient satisfaction;
  
  
• the risks and benefits of TCM;
  
  
• the nature of the links and referral networks between practitioners of TCM and other health care practitioners;
  
  
• the nature of TCM education in Australia and China;
  
  
• the adequacy or otherwise of the current State regulatory frameworks.

The project was directed by Mr Alan Bensoussan Senior Lecturer, Faculty of Health, University of Western Sydney (Macarthur), and Dr Stephen Myers Senior Lecturer and Head of Naturopathy, Southern Cross University.

All components of the study were undertaken in Victoria, New South Wales and Queensland, with contributions from a range of institutions including University of Western Sydney (Macarthur), Southern Cross University, Newcastle University, the Health Issues Centre, the law firms Blake Dawson & Waldron and Philips Fox, and the Centre for the Study of Clinical Practice at St Vincent's Hospital, Melbourne. The report of the project, Towards a Safer Choice, provides the first comprehensive view of the practice of TCM in Australia.

2.2 Key findings

Appendix 1 contains the Executive Summary of Towards a Safer Choice. Key findings were:

• The practice of acupuncture and Chinese herbal medicine carries both inherent risks and risks associated with poor practitioner training. The project surveyed over 1,000 medically and non-medically trained TCM practitioners practising in Australia, who reported a significant number of adverse events.
  
  
• Among these reported adverse events were a number that were serious, mainly related to the practices of Chinese herbal medicine and acupuncture and including 64 pneumothoraxes and 19 deaths. Since many practitioners have had periods of training and practice overseas, it is difficult to estimate what proportion of these events occurred in Australia. However, the rate of adverse events per practitioner is the same, regardless of where the events occurred.
  
  
• Cases of injury and death associated with the practice of TCM, in Australia and overseas, have included:
  
  
• adverse reactions to toxic herbs and herbal combinations;
  
  
• contamination of herbal medicines
  with pesticides, heavy metals, etc.
  
  
• adulteration of herbal medicines with
  western pharmaceuticals.
  
  
• There is a link between length of training in TCM and self-reported adverse incident rates. Those with less than 12 months of TCM training (mostly registered medical practitioners) reported more than double the adverse incident rate in TCM of those with three to five years of TCM training.
  
  
• The majority of non-medical professional associations have agreed on the content of TCM courses, and favour a minimum of four years training as the undergraduate primary care TCM qualification. Under a self-regulatory system, however, the profession is not in a position to enforce such a standard.
  
  
• There is significant black market activity in the importation of unlisted and/or unregistered patent medicines. Deficiencies exist in the ability of the Federal Therapeutic Goods Administration to address both this problem and that of the importation of raw herbs.
  
  
• A review of education programs throughout Australia identified nine fully accredited three to five year undergraduate training programs, including three in universities. The researchers raised concerns regarding the level of training in western medical science in these courses, and that external review of TCM programs and mechanisms to ensure broad professional input are poorly developed in the majority of institutions.
  
  
• Twenty-three separate professional associations representing practitioners were identified. The researchers raised concerns about conflict of interest arising from the close affiliations between certain educational institutions and some professional associations, and suggested that, given such fragmentation and vested interests, a self-regulatory approach to standards of practice will continue to be unsuccessful.
  
  
• Statutory registration of practitioners of TCM is recommended, as well as tighter regulation of importation of raw herbs and patent medicines, in order to protect the public adequately.

2.3 Risks inherent in TCM

The report surveyed the risks associated with the practice of TCM.

The risks of acupuncture are associated with the insertion of needles into the body, which is a key aspect of the discipline. An NHMRC Working Party has detailed four possible serious complications:

1. infection
   
   
2. puncture of vital organs
   
   
3. mental trauma
   
   
4. failure to detect serious underlying disease resulting in delayed diagnosis and appropriate treatment. (13)

The report stated that:

All these risks are potentially catastrophic, and deaths have occurred in Australia associated with the use of acupuncture. The risks of serious infection also affect the broader public through the spread of contagious disease. (14)

Chinese herbal medicine involves the prescription of combinations of herbs for topical application or ingestion. Potential risks include:

• inherent toxicity of the herbal substances (either alone or in combination) dispensed by practitioners;
  
  
• prescription of herbs that are inappropriate for the condition being treated;
• contaminants such as heavy metals;
  
  
• adulteration with western pharmaceuticals such as steroids;
  
  
• substitution of herbs by the dispenser without consulting the treating TCM practitioner;
• poor or non-existent labelling of ingredients, leaving consumers particularly at risk in the event of an adverse reaction;
  
  
• drug interactions in people taking herbal preparations along with prescribed pharmaceuticals.

2.4 Analysis of risk

Towards a Safer Choice argues that growth in the popularity of TCM and the changing profile, both in terms of training and experience, of those offering TCM modalities is changing the significance of the associated risks, and it points to this changing significance as the basis for its recommendations on the need for occupational registration. The report makes the following points:

• The survey of the TCM workforce carried out as part of the research project made it clear that the risks inherent in the practice of TCM are being realised in practice, and confirmed that the risks of acupuncture are different to those of Chinese herbal medicine, although the adverse effects of each include both the predictable and the unpredictable, and can be serious or sometimes fatal.
  
  
• To date, nevertheless, the risk inherent in TCM has been relatively well contained in Australia. The relative risk of adverse events from TCM is less than that from western medicine, although greater than for some other forms of accepted health care practice in the community.
  
  
• Adverse events associated with TCM are usually associated with poor training and/or unethical conduct. Potential harm is likely to be minimised if the patient's response to treatment is adequately monitored by an appropriately trained practitioner, who will make appropriate referrals when necessary. Practitioners should have sufficient knowledge of western medicine to know when to refer a patient to a medical practitioner.
  
  
• While data before the report suggested a low rate of litigation and complaints to
  bodies such as the Health Services Commissioner, this may be partly explained by:
  
  
• the small numbers of primary TCM practitioners in Australia (approximately 2000 compared to over 10,000 medical practitioners) who may be relatively cautious in their practice;
  
  
• a lack of public awareness that the statutory complaints units accept complaints regarding complementary therapies and therapists;
  
  
• under-reporting of adverse incidents by TCM practitioners and their patients.
  
  
• Incidents referred to in the report include:
  
  
• a Coroner's call for accreditation of acupuncturists (1988);
  
  
• a series of serious incidents pre-1982, including acupuncture rendered to persons suffering hepatitis, and broken needles travelling, for example, from the back into the peritoneal cavity;
  
  
• a case in 1986 of an acupuncture needle deliberately broken by a registered medical practitioner which travelled from its point of insertion in a woman's shoulder across her chest;
  
  
• moxibustion injuries suffered in 1990 at the hands of a practitioner who had previously failed the examinations required for membership of an Australian TCM professional association;
  
  
• inappropriate response in 1990 by an acupuncturist whose patient became ill whilst undergoing treatment, requiring subsequent hospital attention. (15)
  
  
• Whilst some associations may be effective in controlling their members, they have no capacity to control those who are not members and particularly those whose training and qualifications do not qualify them for membership in the first place.
  
  
• The risks are likely to be increased by the changing demographics of the profession; deregulation of the education sector; and progressive weakening of the existing self-regulatory mechanisms, particularly through the effects of National Competition Policy on health fund provider recognition procedures.
  
  
• While there has been a significant increase in overseas-trained practitioners in Australia, particularly since the Tiananmen Square incident in Beijing in 1989 (16), there is no uniform, systematic evaluation of the adequacy of overseas courses or the validity of claimed qualifications. Particular concerns relate to whether overseas-trained practitioners have adequate training in western medicine.
  
  
• Medical and other practitioners seeking to make referrals that accommodate consumer preference for a wider range of health care options are unable easily to identify appropriately trained practitioners, given the plethora of TCM professional associations. Similar problems are faced by health insurance funds.

2.5 The need for regulation: assessment against the AHMAC criteria

Towards a Safer Choice assessed the need for occupational regulation of TCM against the AHMAC criteria. This assessment is reproduced in Appendix 4 of this report.

In answer to Criterion 6, "Do the benefits to the public clearly outweigh the potential negative impact?", Towards a Safer Choice sets out the arguments for and against occupational regulation of TCM as follows.

In brief, some of the concerns are that occupational regulation:

• restricts entry to a profession
  
  
• increases the costs of entry, in that minimum standards of training and education are set for professional practice and therefore may also narrow the range of persons eligible to practise
  
  
• may stifle innovation and interaction between different groups of health practitioners and/or encourage undesirable 'medicalisation' in order to justify TCM practice in western scientific terms
  
  
• may increase the cost of TCM services to individuals and the community, through passing on of the increased costs associated with educational requirements, indemnity insurance, and the regulatory mechanism. (17)

Major benefits of registration are that it can:

• help protect the public by promoting the standards established through various national bodies for professionally trained, competent and safe practitioners
• promote the public's right of access to the health care of their choice, by providing a mechanism for identifying practitioners who should be safe and competent
• facilitate cross-referral amongst different types of health practitioners and promote the integration of patient care
• provide enforceable sanctions against practitioners whose practice is incompetent or unethical
• provide a mechanism for identifying those practitioners who can be safely exempted from the relevant provisions of the Therapeutic Goods Administration. (18)

The report concludes that on balance, the benefits of promoting public safety clearly outweigh the potential negative impacts of occupational regulation, and recommends that State governments proceed to implement occupational regulation of TCM as a matter of urgency.