In March 2019 the Medical Board of Australia issued a public consultation around new guidelines for ‘complementary and unconventional medicine and emerging treatments’. These guidelines will impose a separate set of guidelines on doctors who practice Integrative Medicine. As part of the public consultation the MBA asked 11 questions. All 11 questions are answered below. These answers are provided as a resource and to provoke thought and discussion around the proposed guidelines.
We encourage all people who are concerned to make a submission to the MBA. Submission are due by 30 June 2019. For information on how to submit a response visit the MBA site here.
If you are a doctor/practitioner and your patients are asking about this public consultation you can refer them here for guidance on how they can make a submission.
Answering the Questions.
Q.1 Do you agree with the proposed term ‘complementary and unconventional medicine and emerging treatments’? If not, what term should be used and how should it be defined?
No. We do not agree with the term ‘complementary and unconventional medicine and emerging treatments’.
Each of these three separate terms, ‘complementary’, ‘unconventional’ and ’emerging’, describes a different concept scientific approach/set of conditions and while there may be some overlap, combining them as a single term is highly problematic for regulatory purposes, let alone being highly flawed as a scientific definition.
In the context of medicine, ‘complementary’, ‘unconventional’ and ’emerging’ are not fixed, definite terms but can be considered, qualitative and subjective terms whose individual definitions can be debated ad infinitum. It is not possible to merge the three terms into a single entity. To further clarify, the three terms may be debated along these lines:
- Complementary – eg Traditional Chinese Medicine, western herbal medicine, mindfulness, probiotics, vitamins, osteopathy, massage, yoga
- Unconventional – this terms connotes a cultural approach to acceptable practice rather than an evidence-based scientific approach. Who decides what is conventional? This term should not be used to describe a practice of medicine. Its use could be seen as cultural discrimination or bigotry.
- Emerging – Medicine is a rapidly changing field, new concepts arise all the time, giving rise to new discoveries and advances which may or may not stand the test of time. Eg Marshall & Warren, The Cause of Gastric Ulcers, H. pylori and the Nobel Prize.
The term which should be used is medical practice which is ‘outside the Code of Good Medical Practice‘. It should be defined by the lack of adherence to the Code of Good Medical Practice not by the vague, polarising, and ineffectual term, “conventional”.
Q2. Do you agree with the proposed definition of complementary and unconventional medicine and emerging treatments – that is not usually considered to be part of conventional medicine, whether used in addition to, or instead of, conventional medicine. This includes unconventional use of approved medical devices and therapies.’ If not, how should it be defined?
No, we do not agree with the proposed definition.
It is impossible to answer to answer this question without first attempting to define the term “Conventional Medicine”.
It would appear that the MBA is confusing Good Medical Practice with Conventional Medicine as if they are one and the same. Good Medical Practice includes, but is not limited to, Conventional Medicine.
Good Medical Practice in Australia is currently determined through the professional, ethical and legal framework set out in the AMA’s Code of Good Medical Practice.
Conventional Medicine, on the other hand, is more narrowly defined approach to medicine referring generally to the use of drugs, radiation or surgery. Clearly, there is much that falls outside of this definition which still falls well within Good Medical Practice.
The issue remains that the definition of ‘conventional medicine’ has not itself been scientifically determined and that all medical practice in Australia is already subject to the Code of Good Medical Conduct.
The proposed definition appears to assume that patients always fall into clear cut, singular diagnoses that should be treated using a linear pathway (which is ‘conventional’). In contrast, most medical practice occurs in the grey zones of differential diagnoses, multifactorial aetiologies and psychosocial contexts with very real financial and ethical constraints.
Q3. Do you agree with the nature and extent of the issues identified in relation to medical practitioners who provide ‘complementary and unconventional medicine and emerging treatments’?
Your discussion paper provides examples of the nature of the issues identified by as yet unidentified stakeholders but there is no quantitative publication of the extent of the issues identified.
The nature of the issues identified in the discussion paper is applicable across the whole of medicine. In no way could this be seen as limited to those doctors who might find themselves included in ‘complementary and unconventional medicine and emerging’ medicine.
The nature of the issues provided is absolutely relevant to how medicine is practiced across all realms, hence the Code of Good Medical Practice.
A single case of an iatrogenic death from an emerging treatment is reported; a case of liposuction where a consent process, pre-operative preparation and post-operative management were all inadequate. Liposuction has been in common use since at least the 1980s. There is an existing regulatory framework to deal with such situations and it hardly applies to what most people would consider ‘integrative’, ‘nutritional’, ‘complementary’ or ‘alternative’ medicine. Compared to the staggering rates of iatrogenic complications within mainstream medicine, a single case (apart from not being relevant to the issues in question) actually speaks positively about the relative safety of the sorts of approaches under consideration.
The discussion paper also lists a number of tribunal decisions in situations which have been dealt with under existing regulations. Five of the seven cases cited were for the inappropriate use of hormone prescriptions. Hormones are commonly prescribed now; the issue in these cases was simply whether the medical justification was appropriate in these individual cases, not whether anything complementary, unconventional or emerging was being offered. There is an existing regulatory framework to deal with this.
Q4. Are there other concerns with the practice of ‘complementary and unconventional medicine and emerging treatments’ by medical practitioners that the Board has not identified?
Yes there are other concerns.
The concerns raised by the MBA are not actually issues relevant to ‘complementary and unconventional medicine and emerging treatments’ but rather are related to Good Medical Practice.
Our concern in fact is that not enough doctors consider the possibility of evidence-based “complementary” or “unconventional” or “emerging” approaches, which indeed many patients are actively seeking, especially when their needs are not being met through a conventional medical approach. We wonder to what extent many doctors who practice “conventionally” access and implement up-to-date, evidence-based medicine in their practices.
There is “unease with the medical model may be contributing to doctors’ low morale and to problems with the recruitment and retention of the medical workforce. But the unease is also being expressed in how doctors are thinking about and practising medicine. Some doctors are expressing concern about overdiagnosis and overtreatment and the attendant potential for harm and waste, particularly among people with multiple conditions and those who are frail or at the end of their lives. Others are concerned about the limited effectiveness of what they have to offer in the face of the wider social determinants of health.”
The Board could do more to address the unnecessary and unhelpful polarising reactions to different ways of thinking that serve to accentuate controversy rather than find common ground between all stakeholders, for the good of the patient, the profession and the community as a whole.
We would encourage the broader consideration of evidence for holistic or non-pharmaceutical approaches, especially in chronic conditions. The quick and easy method of prescribing medication is no longer a tenable default management option. Given there actually is evidence of safety and efficacy for at least some of what appears to be considered by the MBA a single non-evidenced-based entity outside of conventional medicine, our concern is that the MBA and its advisors are prejudiced, consciously or otherwise, for and against certain practices and would encourage a wider consultation process in future.
Drawing directly from The HEALTH PRACTITIONER REGULATION NATIONAL LAW (NSW), as at 25 February 2019, Act 86a of 2009, known to the MBA as The National Law, Part 1, Section 3 includes the following:
“Objectives and guiding principles
(e) to facilitate access to services provided by health practitioners in accordance with the public interest; and
(f) to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners.
(3) The guiding principles of the national registration and accreditation scheme are as follows-
(a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way;”
Given the lack of relevant stakeholder engagement in the process of developing and delivering this discussion paper, draft guidelines and call for public submissions and the nebulous definitions therein, questions arise as to the actual intended targets of these proposed guidelines and to the interpretation by the MBA of the terms “Public Interest”, “Innovation”, “ transparent, accountable, efficient, effective and fair”.
Q5. Are safeguards needed for patients who seek ‘complementary and unconventional medicine and emerging treatments’?
Yes, as they are for ALL of medicine.
No evidence has been provided for an assertion that additional safeguards are needed.
In fact, safeguards for patients may best be provided, or at least advised upon, by an integrative GP who is well-trained in individualised risk/benefit analysis and shared decision-making with individual patients and their treating team.
Further, a specialty-specific Code of Good Medical Conduct is not required beyond the code of conduct.
The current code of conduct appears to cover these areas fully.
Q6. Is there other evidence and data available that could help inform the Board’s proposals?
There may be, however this has not been provided by the Board. Concerns from stakeholders is all we have been offered.
In the context of accusations of lack of evidence, we would ask what is Evidence Based Medicine ( EBM)?
EBM is the triad of best available evidence, clinician acumen and patient preference. ‘The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. Evidence-based medicine does not mean “cook-book” medicine, or the unthinking use of guidelines. It does imply that evidence should be reasonably readily available in an easily understood and useable form.’*
Is all evidence reliable? Of course not. It is obvious that many investigations and treatments are not able to be tested in an RCT for a wide range of reasons. The emerging, unconventional use of Real World Evidence and other sources of data and analysis, to complement conventional randomised controlled trials needs to be considered especially in the light of Marcia Angell’s 2009 article “Drug Companies & Doctors: A Story of Corruption”, published in The New York Review of Books magazine, in which she wrote, ‘…similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.’
Other concerns with EBM include:
- Selective publication
- Rigged outcomes
- Reprint revenues
- Bribery of journal editors
- Publication bias
- Financial conflicts of interests
There is NO need for a different standard or guidelines for integrative medicine. The same burden of evidence needs to be applied by the board to all forms of medical practice. There is no shortage of evidence of the risks and costs across to the community from conventional medicine. For example:
- Missing or ineffectual discharge summaries from hospitals to GPs
- Iatrogenic mortality due to “conventional” medical practices
- Unnecessary procedures
- Hidden or exorbitant costs
The Code of Good Medical Practice can be considered “the constitution of medicine in Australia” and needs to be adequate to protect the community. If it is deemed adequate to protect those who use “conventional” medical practice then it should be adequate to protect the community who see IM doctors. IM doctors need to continue to work under the Code of Good Medical Practice, to work according to EBM (best available evidence, clinical experience, patient preference).
Q 7. Is the current regulation (i.e. the Board’s Good medical practice) of medical practitioners who provide complementary and unconventional medicine and emerging treatments (option one) adequate to address the issues identified and protect patients?
As we have stated earlier, the definition, “complementary and unconventional medicine and emerging treatments” is not a workable one but YES the Board’s Good medical practice addresses all the issues raised.
There appears to be no justification provided in the MBA’s discussion paper or guidelines, for the use of an ill-defined notion of “usual practice” as the gold standard, against which all other interventions should be measured.
Q8. Would guidelines for medical practitioners, issued by the Medical Board (option two) address the issues identified in this area of medicine?
No. However, appropriate early stakeholder participation in discussions around issues of concern would contribute to a more constructive and consensus-building process. This may lead to enhancement of the current “conventional” model by different ways of practicing medicine, with the distinct possibility of better outcomes for all. We would welcome such engagement at this and time in the future.
Q9. The Board seeks feedback on the draft guidelines (option two) – are there elements of the draft guidelines that should be amended? Is there additional guidance that should be included?
Again, we fundamentally disagree with the need for a separate set of guidelines. We believe that this has the potential to create an official ( let alone an unofficial, as is already the case) two-tiered system in which one group of doctors practices ONLY very conservative, defensive, medicine, ensuring that their practice falls squarely within that practiced by their peers and condoned by their governing organisations, while any doctors who dare to practice in a way which may not be seen to conform to such convention keeps risks losing their livelihood.
We will not be offering guidance or specific comments on amending the proposed guidelines. We will however, offer some guidance on how this process can and should be better managed and we are, as previously stated, open to appropriate engagement at this and any future time.
As a major stakeholder with an obvious place in the history of integrative medicine in Australia we, AIMA, were surprised that the MBA did not consult with us before drafting these guidelines. We call on the MBA to abide by the COAG principles ( especially 7: Consulting effectively with affected key stakeholders at all stages of the regulatory cycle; ) which demand that appropriate expert, stakeholder and community consultation take place BEFORE new guidelines are developed. We call on you, the MBA, to withdraw the proposed guidelines and start this process properly from the beginning. This means that the MBA seek guidance on the development of guidelines for use within a specific area of medicine from clinicians and experts in our field.
In order to progress, the Medical Board needs to:
- Present evidence that separate guidelines are necessary
- Define what they mean by ‘conventional practice’ and be explicit about who determines what constitutes ‘conventional’.
- Clearly articulate and describe ALL terms and definitions that they use. It is not acceptable to define something by its opposite. Precision is needed to define what is meant by ‘conventional practice’, ‘complementary medicine’, ’emerging practises’ and ‘unconventional medicine’. The terms and definitions used need to be clarified in a satisfactory manner: that is: entirely rewritten.
- Input and guidance from relevant stakeholders including, but not limited to, AIMA, should be sought as a matter of course in any issue relating to what might be thought of as “complementary and unconventional and emerging medicine”, just as any specialty college or expert group would be asked for advice in the case of alleged malpractice or suspicious activity within its realm.
- The MBA has a role to protect the public but not to assert or control the style of medical practice to which the public turns.
Q10. Are there other options for addressing the concerns that the Board has not identified?
Yes. The Board could put a lot more energy into finding out why consumers elect to use approaches to their health that are outside of the conventional mainstream, before assuming that their decisions to do so are based on the fact that they must be gullible and easily led. (Most studies actually seem to indicate the opposite[i].)
The discussion documents point to the extent to which consumers are voting with their feet and their wallets, in terms of unconventional approaches. Very few patients would completely abandon conventional medicine in favour of alternatives; but a large proportion elect to gain the benefits of both, as shown by the positive correlation between the use of conventional care and complementary and alternative medicine use[ii].
[i] Note, though, that these studies may tend to conflate health literacy with multi-morbidities and higher education with socio-economic confounders. Sharp D, Lorenc A, Morris R, et al. Complementary medicine use, views, and experiences: a national survey in England. BJGP Open. 2018;2(4):bjgpopen18X101614. Published 2018 Nov 14. doi:10.3399/bjgpopen18X101614
[ii] Canizares M, Hogg-Johnson S, Gignac MAM, Glazier RH, Badley EM. Changes in the use of practitioner-based complementary and alternative medicine over time in Canada: Cohort and period effects. PLoS One. 2017;12(5):e0177307. Published 2017 May 11. doi:10.1371/journal.pone.0177307
Q11. Which option do you think best addresses the issues identified in relation to medical practitioners who provide complementary and unconventional medicine and emerging treatments?
- OPTION ONE.
- Option one – Retain the status quo of providing general guidance about the Board’s expectations of medical practitioners who provide complementary and unconventional medicine and emerging treatments via the Board’s approved code of conduct.
Dr Christabelle Yeoh and Dr Gull Herzberg for the AIMA steering group.
The MBA public consultation closes on 30 June 2019 – it is imperative that all members of the integrative medicine community let the MBA know that integrative medicine is safe and that the current Code of Good Medical Conduct adequately covers our practise. To find out how to submit a response visit the MBA site here.
If your patients are asking about this consultation you can refer them here.