ANPA submission – NHMRC Homeopathy Review

Introduction

The Australian Naturopathic Practitioners Association (ANPA) is the peak body representing naturopaths in Australia. Many ANPA members are also homoeopaths. Homoeopathy has been and in many curricula still is a core modality of naturopathy education. Providing homoeopathy care is within the scope of practice as a naturopath.

The NHMRC’s call for public comment has been constricted and controlled to three questions. These three questions fail to include clear options for critical appraisal of the review process employed by the NHMRC. This goes against ethics espoused by the NHMRC in providing the highest level of conduct for public health and clinical practice guidelines. Australian public deserve autonomy and choice in their health care. This choice is based on clear and unambiguous information. The Homoeopathy review has not been conducted in a fair and equitable manner. Homoeopathy has been available to Australians for many years and this should continue.

The Australian government should follow the response of the British Government where the decision about Homoeopathy was put back into the domain of the practitioner with  health care deemed most appropriate for the patient decided by the practitioner. The ANPA supports the UK government decision as a fair, equitable and respectful conclusion for a profession and the rights of practitioners and the public.

The primary flaw in this NHMRC Review is to evaluate homoeopathic remedies without homoeopaths’ consultations and active involvement. Surely the NHMRC is not so foolish to evaluate medically prescribed pharmaceuticals without GP consultations and active involvement. Homeopathic remedies as tools of trade were excluded erroneously in this review.

Q1. Is the draft Information Paper presented and written in a manner that is easy to understand?

The NHMRC Draft Information Paper  (DIP) may be presented and written in a manner that is easy to understand; however, it is even easier to misunderstand the context and application of the review for real patients with limited understanding of the complexities of ‘evidence’ in the midst of trying to make fully informed health choices.

The DIP delegitimizes a longstanding tradition going back to a set of health practices offering efficacy for many health conditions in the context of real world clinical practice.

The three questions posed by the NHMRC are an insult to CAM health practitioners and the public seeking reliable information about homoeopathy. These questions offer no scope for exploration or defence of a profession in a fair, reasonable, and equitable manner.

If the NHMRC process was underpinned by rigorous scientific integrity, all responses, comments and critical appraisal would have been encouraged, included, and welcomed. 

The NHMRC Review is a flawed process for the following reasons:

1. The public consultation offers no opportunity for comment or challenge of the terms of reference, criteria, or decision-making tree for this review.
2. Fundamental questions respectful of a profession were ignored and not included. These questions include:
   1. From a research model perspective, how best is the practice of homoeopathy understood and evaluated?
   2. What are the possible limitations of the NHMRC model of research being used to try and explain the health outcomes for Homoeopathy?
3. A fair and equitable review process would demonstrate respect for a profession that is based on very different CAM approaches from that of mainstream medicine.
4. No Homoeopathy expert was invited onto the Homoeopathy Working Committee. This is a gross miscarriage of process. If the rationale was to avoid bias, it was and is seriously misguided. This decision goes against any reasonable and acceptable approaches used in the medical scientific community internationally to evaluate via a peer review process. Any reputable medical journal would consider it unthinkable removing experts in the specified field from the peer review process. The NHMRC has sanctioned an academically flawed Homoeopathy Review. This abuse of the peer review process smacks of a gross waste of tax-payer funds as well as a blatant abuse of science.
5. The external research contractors for the NHMRC have no expertise in homoeopathy. A further miscarriage of an equitable and fair process when evaluating the evidence for Homoeopathy.

Q2. Does the draft Information Paper clearly outline how the evidence was reviewed and interpreted by the Homeopathy Working Committee?

The HWC was made up of experts in evidence-based medicine, clinical trials and complementary medicine. (pg 22 NHMRC DIP)

1. No expert with homoeopathy clinical practice was included on the Homoeopathy Working Committee. Any conclusions made for the public from this deficient HWC are therefore unreliable. This is a clear negation of the ‘peer review process.’
2. Until Homoeopaths with clinical expertise from peak bodies representing Homoeopathy in Australia are invited to participate on the HWC, the public and the CAM profession cannot trust nor should they accept the NHMRC HWC conclusions or information as reliable, rigorous or credible.
3. The history of a leaked draft in 2011 linking the NHMRC agenda to the aims of the Friends of Science in Medicine highlights a prejudiced course for this review from its inception.
4. Primary evidence was not reviewed. A review of reviews is two steps removed from the original evidence. There is potential for misinterpretation of the research evidence.
5. The timeline for evidence inclusions may not go back far enough, and some evidence may have been missed.
6. The NHMRC standardised ‘levels of evidence’ models are inappropriate in reliably measuring the effectiveness of homoeopathy.
7. The HWC did not include evidence on the prevention of health conditions, nor did they include research on the homoeopathic remedies – tools of trade for the profession.
8. There was no explanation for the public of p-values.
   
   The NHMRC concludes that the assessment of evidence from research in humans does not show that homoeopathy is effective for treating a range of health conditions considered. 
9. German, French, Spanish and other languages besides English were excluded from the review. This is an omission of possible evidence that calls into question the decision making of the NHMRC HWC and any conclusions without these inclusions deemed unreliable.
10. This conclusion is a clear overstatement framed in the most negative language. It in fact distorts for the public the full spectrum of findings and fails to state anywhere that insufficient evidence does equate to no efficacy!
11. The Australian Register of Homoeopathy (AROH)’s submission of evidence has identified 12 health conditions where there is positive evidence. (Table 1, page 21 of their submission to the NHMRC.) The findings of the NHMRC HWC do not reflect these findings.
12. The British Homoeopathic Association (BHA) www.britishhomoeopathic.org highlights clearly postive evidence for homoeopathy in RCT’s for Fibromyalgia, Influenza, Insomnia and Seasonal Allergic Rhinitis. These findings from an expert group in homeopathy flies in the face of the findings by the NHMRC HWC.
13. The NHMRC HWC is seen to be ‘going through the motions’ with a public consultation, but the NHMRC HWC have made offensive predetermined conclusions about a profession with no fair opportunity for discussion and engagement with the profession in question.
14. It is clear from a professional and the public’s perspective that this negative conclusion is the only conclusion the HWC are seeking.
15. The NHMRC DIP outlined the process and methodologies used, but that did not mean the process was appropriate or fair to the subject matter in its clinical context.
16. It is clear the ‘scientific’ analysis by the NHMRC HWC has been carefully positioned and manipulated. The evidence or absence of acceptable evidence is being used to unfairly denigrate, deligitimise and marginalise a profession.
    A more appropriate NHMRC HWC conclusion for a non-scientifically literate public would be:The NHMRC’s overview was based on finding systematic reviews of Homoeopathy rather than searching for all individual published studies of homoeopathy. Some studies and evidence may have been excluded, including recent studies as a result of this process decision. It was not possible to separate the evidence for clinical homoeopathy and individualised homoeopathy. Systematic reviews did not analyse these two aspects separately. It was not possible to make conclusions about the effects of homoeopathy on each of the specific health outcomes because of the large number of outcomes and the different reporting of outcomes between different systematic reviews. The NHMRC deems the findings of this review inconclusive. The NHMRC supports more research funding for Homoeopathy.
17. The blinded RCT model is relevant and appropriate for single drug testing with pre-determined drug dosages.
18. Homoeopathy practice requires that prescribed remedies may change as the treatment progresses.
19. As the symptom picture changes the type of remedy, potency or dosing frequency may change.
20. Acceptable and reliable research conclusions about Homoeopathy must include and respect these important differences and study design must integrate methodology that captures these approaches.
21. Only English language evidence was included. The effectiveness of Homoeopathy cannot be made when relevant evidence may have been missed.   Homoeopathy originated in Germany with a significant research base in that language as well as in French, Italian, Portuguese and Spanish.Excluding these studies adds to the unreliability of any NHMRC HWC conclusions.
22. Homoeopathy does not treat a labelled ‘health condition’ but rather a symptom picture that leads to the remedy or remedies prescribed. This is a significant difference from mainstream medicine. Two patients with the same medical diagnosis of Type 2 Diabetes may be treated entirely differently homoeopathically. This is the fundamental basis from which any interpretation of Homeopathy should commence. The NHMRC has failed to acknowledge and recognise this fundamental difference. Unless this difference is taken into account, any reliable conclusions about Homoeopathy cannot be made.
23. The NHMRC HWC went to the public media before the review was completed and denigrated the profession of Homoeopathy to the public and other health professionals. This unacceptable and unprofessional behaviour clearly demonstrated biases against Homoeopathy.
24. The NHMRC’s approaches are discriminatory against an entire profession.
25. The NHMRC HWC expectations and review criteria and scope has been created with unrealistic and unachievable research evidence targets.

People considering whether to use Homoeopathy should first get advice from a health professional (eg. GP, specialist, nurse practitioner or pharmacist) NHMRC DIP pg 19.

This statement is misleading and ignores, insults, denigrates and disrespects the entire profession of Homoeopathy. Furthermore, the public could be harmed when referred for advice to health practitioners untrained in Homoeopathy. These untrained health practitioners in Homoeopathy would be the least qualified to guide the public seeking advice about using Homoeopathy.

The public should only be referred to practitioners who have been educated and sanctioned to practice Homoeopathy by the Australian Government.  

Q3. Is there additional evidence on the effectiveness of homeopathy for the treatment of clinical conditions in humans that needs to be considered?

There is additional evidence for inclusion that fits all of the NHMRC criteria.

– Psorinum Therapy in treatment of stomach, gall bladder, pancreas and liver cancer. 2011. Aradeep Chattergee, Jaydip Biswas, Ashim Chaitergee, Sudin Bhattacharya, Bishnu Mukhapadnya.

-176 primary studies were included in the NHMRC review. However, nine more studies were submitted by the public. At the time of the release of the DIP 59 more studies appear to satisfy the inclusion criteria. Ten of these studies were published in 2013-14.

-The Institute of Classical Homoeopathy – Montreal. (www.michmontreal.com)

“The Evidence for Homoeopathy” all are controlled clinical trials. Not all of these studies have been included the review.

-The Society of Homoeopaths reports ‘By the end of 2010 156 RCT’s of homoeopathy had been published in good quality journals. 75 medical conditions reported on all had good to very good outcomes with homoeopathic treatment.

-Heel (Germany) reports at www.heel.com controlled trials for their complexes. Many trials for both oral and injectable Lymphomyosot and Traumeel; as well as specific and specialized multiagent medication treatment for Alzheimer’s disease. All trials show positive outcomes and have been presented in various symposiums internationally.

-The NHMRC HWC has chosen to ignore veterinary and laboratory evidence of the efficacy of homoeopathy. Homoeopathy is well accepted as a modality for animals. To leave this body of knowledge out of the review is misguided.