Response to NH&MRC Draft Report on Homeopathy

Introduction

The NH&MRC report concluded “There is no reliable evidence that homeopathy is effective for treating health conditions“. It began by making the following exclusions of evidence from its analysis:

• Evidence of “whether homeopathy is good for general health.”
• “Evidence for whether or not homeopathy is effective for preventing health conditions”.
• Any evidence examining the economic cost-benefits of homeopathy.
• Evidence supporting homeopathy that was not derived from “prospective, controlled studies”, such as “observational studies, individual experiences and testimonials, case series and reports, or research that was not done using standard methods.”

Then considering evidence from prospective, controlled studies, the NH&MRC claimed that there were “no health conditions for which there was reliable evidence that homeopathy was effective. No good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment”. They made this claim despite the fact that in the studies listed by Optum[i](the research group commissioned by the NH&MRC) there were many studies reporting “significant effects in favour of homeopathy” with Jadad scores as high as 5.

So after eliminating by definition a significant body of “real world” evidence supporting homeopathy, by defining away the positive health promotion and disease prevention consequences of homeopathy and focussing on disease treatment, by ignoring the potential economic cost-benefits of homeopathy, by accepting only limited types of evidence and within that body of evidence categorising all evidence supporting homeopathy as poor quality despite the existence of positive studies of high quality, the NH&MRC has concluded that there is no evidence supporting homeopathy! Many will take an interest when Senate Estimates eventually reveal the cost to taxpayers of reaching a conclusion which was inevitable given the question asked, the methodology used and the bias in the report.

This approach by the NH&MRC was even more surprising given that their mandate from the Department of Health called for a different approach as stated on the Department’s website “The Department has entered into a Memorandum of Understanding (MoU) with the National Health and Medical Research Council (NH&MRC), who will conduct an evidence review relating in scope to natural therapies. Based on their findings, the NH&MRC will provide advice to the Natural Therapies Review Advisory Committee (Advisory Committee) about which natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality”[ii]. The NH&MRC review has ignored the last three criteria, and has structured their examination of clinical efficacy in a way that ensures a negative finding against homeopathy, as is shown below.

The following arguments contend that the NH&MRC conclusions derived from tightly defined reviews of reviews may be theoretically defensible, but are practically unhelpful in the real world.

Four Practical Tests of the Findings

It is proposed that the NH&MRC report fails four tests:

1. The common sense test
2. The reasonable question test
3. The appropriate methodology test
4. The freedom from bias test

1. The Common Sense Test

The first NH&MRC conclusion on which the remainder rests, that “There is no reliable evidence that homeopathy is effective for treating health conditions” fails the common sense test. In 2005 the World Health Organisation (WHO) published an Atlas of Traditional, Complementary and Alternative Medicine (TCAM) which showed that homeopathic medicine was the most used form of TCAM in countries with a GDP > $15,000, and the second most used form of TCAM in the remainder[iii]. Thus it can be estimated that homeopathy is currently being used successfully by over 500 million people throughout the world, and in many countries as primary care medicine, and practised by health professionals with MB BS qualifications or equivalent as well as practitioners with University level qualifications in health sciences.

Thus the “elephant in the room” in the NH&MRC analysis is the fact that over the last 200 years homeopathy has been used successfully by billions of people, and has been administered by hundreds of thousands if not millions of practitioners with MB BS (or equivalent) qualifications as well as others with specialised health science and homeopathic training, and is part of government public health systems in countries around the world. Yet by inference all these patients, practitioners and governments are wrong, and the NH&MRC is right – an incongruity for which no explanation was offered! It simply doesn’t make common sense.

2. The Reasonable Question Test

Australia is faced with an epidemic of chronic disease (“77% of Australians had at least one long-term condition”; “almost 10% of children 0–14 years had three or more long-term conditions; this figure increased to more than 80%for those aged 65 years and over”; “in 2000–01 they (chronic diseases) accounted for nearly 70% of the total health expenditure that can be allocated to diseases”[iv]). Australia is also faced with a potentially unsustainable health budget blowout in the coming decades (the two are linked). Yet the NH&MRC chose to eliminate any consideration of health and wellbeing from their analysis, and chose not to consider any economic benefits from using homeopathy.

An appropriate question would be – can properly prescribed homeopathic medicine make a positive contribution to the total health and wellbeing of Australians and contribute to reducing the cost burden of chronic disease on the Australian health budget? Instead the authors asked the question “Is homeopathy an effective treatment for health conditions, compared with no homeopathy, or compared to other treatments?” NH&MRC did not consider evidence for whether or not homeopathy is effective for preventing health conditions (including evidence about homeopathic ‘vaccines’), or whether homeopathy is good for general health.

In other words the authors rejected an analysis of the potential health benefits of homeopathy and avoided any comparative economic cost-benefit analysis of homeopathy and pharmaceutical medicine in favour of a tightly defined focus on disease management. This approach reflectsthe essential philosophical difference between complementary and alternative medicine (CAM) and pharmaceutical medicine (holistic vs reductionist).

In the present budgetary environment it is suggested that it is not responsible to ignore the potentially significant net benefits of homeopathy in practical health care situations. Some examples of relevant cost-benefit studies are referenced [v]^{,[vi],[vii],[viii],[ix],[x],[xi],[xii],[xiii]}. These studies clearly demonstrate that homeopathic medicines are “underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality” which are the criteria which the NH&MRC are required to address for the Natural Therapies Review Advisory Committee.

3. The Appropriate Methodology Test

The researchers narrowed their definition of acceptable evidence to “only evidence from systematic reviews that included prospectively designed and controlled studies conducted in humans (including randomised controlled trials, pseudo-randomised controlled trials, non-randomised controlled trials and prospective cohort studies)”.

This recognises that randomised controlled trials (RCT’s) are at the pinnacle of the evidence hierarchy in pharmaceutical medicine. However the orthodox literature carries many contributions showing the inherent flaws in this evidence. Examples range from Ioannidis in 2005[xiv], to Kaplan in 2011[xv] and the Harvard University findings in 2013[xvi].

Walach described what he called the efficacy paradox. This demonstrates that RCT’s will endorse a treatment with a relatively strong specific effect but with a weak or negative impact on the total health and wellbeing of subjects, compared to another treatment with a relatively weaker specific effect but a significantly positive impact on the total health and wellbeing of subjects[xvii]. He and others propose using a range of statistical methods to thoroughly evaluate the holistic benefits of therapies[xviii], especially CAM therapies such as homeopathy which produce large positive non-specific effects.

The W.H.O. recently published theWHO Traditional Medicine Strategy, 2014 – 2023. They made clear the need to “Develop research methodologies consistent with T&CM theories and practice” – “A knowledge-based policy is the key to integrate T&CM into national health systems. Research should be prioritized and supported in order to generate knowledge. While there is much to be learned from controlled clinical trials, other evaluation methods are also valuable. These include outcome and effectiveness studies, as well as comparative effectiveness research, patterns of use, and other qualitative methods. There is an opportunity to take advantage of, and sponsor such “real world experiments” where different research designs and methods are important, valuable and applicable. The importance of embracing various kinds of contributory research methods and designs in the effort to build a broad evidence base to inform national policy and decision making has been underlined by the National Institute for Health and Care Excellence (NICE), as well as others[xix]”. This contemporary international view is completely different to the approach taken by the NH&MRC.

The Homeopathy Research Institute observed that “The  reason  for  this  difference  of  opinion  becomes clear when you look at the method used by the Overview  Report  team.  In their assessment of URTIs, the authors
found three relevant systematic reviews, reporting that two found homeopathy to be effective in the treatment of URTIs, whilst one didn’t. The most recent of these reviews[xx], found 25 studies of sufficient quality for inclusion  in  the  Overview Report  (prospectively  designed  and  controlled  studies),  yet  only  7  of  these  are considered  in  this  report. Furthermore, they then pick out one trial – deemed to be of the best size and quality – on which they base their final conclusions that homeopathy is not effective in the treatment of URTIs. This study involved parents being given a choice of only three homeopathic medicines with which to treat their children for URTIs[xxi]; usual treatment would be an individualized prescription from a qualified homeopath, selected from hundreds of possible medicines. It  is no surprise that this inappropriate approach proved to be no better than placebo and its results  clearly  do  not  tell  us  anything  about  the  effectiveness  of  homeopathic practice  in  the treatment  of  URTIs. This  exemplifies  a  very  serious  flaw in  the Overview Report, in that no consideration has been  given  to  the quality  of  the  homeopathic  approach  used in  the  trials  (known  as  model  validity)[xxii]^,[xxiii]

It is thus contended that the NH&MRC’s refusal to accept any evidence outside of their narrow definition above, immediately eliminated relevant evidence that measured the health effects of homeopathy, and that their selective use of evidence that was admissible further biased their findings.

A final methodological point is that NH&MRC started from the null hypothesis that “homeopathy has no effect as a treatment…” (Appendix C p.298). However because a null hypothesis is not rejected, it does not prove it is true, something which the experienced NH&MRC panel surely understand.

4. The Freedom From Bias Test

A number of factors raise a concern about the potential for bias in the NH&MRC report.

(i)      The report claimed that “The Homeopathy Working Committee was made up of experts in evidence-based medicine, clinical trials, and complementary medicines research”. However there were no experts in homeopathy on the panel, and the only person on the panel not directly involved in pharmaceutical medicine was not trained or experienced in homeopathy.

(ii)    The 4^th NH&MRC conclusion directs that “People who are considering whether to use homeopathy should first get advice from a health professional (e.g. GP, specialist, nurse practitioner or pharmacist)”. This shows that the NH&MRC does not regard fully qualified Australian homeopaths as health professionals despite University level accredited training which is among the best in the world, including rigorous studies in the orthodox health sciences as well as an extensive homeopathic curriculum. It also ignores the fact that in Australia there are homeopaths with MB BS qualifications and that internationally this is very common – are these people not regarded as health professionals because they use homeopathy? Further, it is recommending that the public seek advice on a subject from the people they list who know nothing about the subject, i.e. homeopathy.

(iii)The NH&MRC considered two Government related investigations:   “A report by the UK House of Commons Science and Technology Committee stated that ‘the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos’. This report concluded that any health benefits that people experience when they use homeopathy is solely due to the placebo effect. In contrast, a Swiss Health Technology Assessment report on Homeopathy commissioned by the Swiss government concluded that homeopathy is a ‘valuable addition to the conventional medical landscape’[xxiv]. The difference between the findings of the UK and Swiss reports was mainly due to their different methods for assessing research evidence”. “Both the UK and Swiss reports have been criticised by those who disagree with their methods and findings”.

The UK report relied very heavily on the research published by Shang et al. The Commons Committee wrote- “(paragraph) 69. The review which we consider the most comprehensive to date is that by Shang et al. The review compared 110 placebo-controlled trials of homeopathy matched according to disorder and type of outcome to trials of conventional medicine. The study only included trials that were controlled, included randomised assignment to treatment or placebo groups and were accompanied by sufficient data for odds ratio calculations…. 89. The authors concluded that “when analyses were restricted to large trials of higher quality there was no convincing evidence that homeopathy was superior to placebo”[xxv].

However, even though Shang first claimed that their conclusions were based on 110 homeopathy trials compared to 110 trials of conventional medicine, it was subsequently shown that they had based their conclusions on just eight homeopathy trials compared with six conventional trials only. When re-analysing the data of this study, researchers found that homeopathy had a significant effect beyond placebo, and the conclusions drawn by the original authors were highly (and intentionally) influenced by one single trial [xxvi]^{,[xxvii],[xxviii]}. Moreover, Shang acknowledged that the overall quality of homeopathy trials was significantly higher than in the conventional trials.

“The Swiss report was criticised by a review that argued it was ‘scientifically, logically and ethically flawed’, ‘misinterprets studies previously exposed as weak’ and ‘attempts to discredit randomised controlled trials as the gold standard of evidence’”. These comments were made by a professed opponent of homeopathy[xxix], and fail to meet the criteria for an objective scientific rebuttal. On the other hand, the recent WHO Traditional Medicine Strategy included the Swiss report.

“In assessing the evidence, NH&MRC considered these reports and their methodologies”. The fact that they chose to reject a broadly based method of analysis drawing on practical results, in favour of a tightly defined and inherently flawed approach is suggestive of bias.

(iv)The NH&MRC report claims that there are no high quality trials of homeopathy. Yet the report by Shang on which the UK House of Commons Report (quoted by the NH&MRC as support for their position) was largely based, found 21 higher quality homeopathic trials[xxx]. The Shang report also referred to “a study of 23 trials of homoeopathy that were considered to be of high methodological quality”. In the report by Optum commissioned by the NH&MRC there were many studies reporting “significant effects in favour of homeopathy” with Jadad scores as high as 5. The fact that the NH&MRC report claimed (incorrectly) that there were no high quality trials supporting homeopathy is suggestive of bias.

(v)    The Homeopathy Research Institute observed that “the  fact  that  the  NH&MRC authors found a lack of definitive positive evidence of the effectiveness of homeopathy in specific conditions is not surprising, as this is a common result with systematic reviews:  for  example, 49% of systematic reviews on conventional medicine reach similar ‘inconclusive’ conclusions  and  96%  recommend  further  research[xxxi]. Furthermore, of 2500 treatments with good evidence used within the NHS, only 15% have been shown to be clearly ‘beneficial’, showing that the evidence base for most treatments needs further development [xxxii]^,[xxxiii]. Further,The Editors at British Medical Journal Clinical Evidence selected around 3000 orthodox treatments that had been evaluated in research for analysis and divided their effectiveness for specific indications into categories, showing that only 11% were beneficial, 24% were likely to be beneficial, 50% had unknown effectiveness and the rest were either unlikely to be beneficial or possibly harmful [xxxiv]. The fact that the NH&MRC has set a bar for homoeopathy that current pharmaceutical medicine cannot pass is another indication of bias in their analysis.

(vi)The most thorough study yet of the impact of institutional corruption on orthodox medicine clearly shows the bias present in orthodox medical training, bias in the so called high quality RCT trials of pharmaceutical products which the NH&MRC claims are superior to homeopathy, and bias in the way in which health officials and politicians are given medical information. These factors all have the potential to bias the very data used by the NH&MRC report against homeopathy. For example, Lab Fellows from the Edmond J. Safra Center for Ethics at Harvard University undertook exhaustive research over five years, the findings of which were presented in a series of sixteen articles in the Journal of Law, Medicine and Ethics, Vol. 41, No. 3 (2013). They reported that (i) “widespread practices in the medical and pharmaceutical industries can lead to doctors who are psychologically, financially, or intellectually dependent on drug companies, a phenomenon which has resulted in insufficiently tested drugs, many of which cause harmful side effects”, (ii) “top medical researchers can be financially tied to drug firms”, (iii) “pharmaceutical marketing … distorts medical practice”, (iv) “drug firms are … funding social network websites for doctors in order to quietly track their opinions on issues that affect their bottom lines”, and (v) “lawmakers and patient advocacy organizations can be dependent on money from drug companies, resulting in representation that serves the interests of Big Pharma rather than the public” [xxxv]. Professor John Ioannidis and colleagues also demonstrated that the pharmaceutical “industry has created means to intervene in all steps of the processes that influence healthcare research, strategy, expenditure and practice. These include: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of harms issues, (iv) cost-effectiveness evaluation, (v) clinical guidelines formation, (vi) healthcare professional education and (vii) direct influences on healthcare professional decisions”[xxxvi]. These findings suggest that the motivation, methodology and data used in the NH&MRC report are inherently biased towards pharmaceutical medicine and against CAM in general and homeopathy in particular.

(vii)  The fact that the NH&MRC report failed the common sense test, the reasonable question test, and the appropriate methodology test posed above suggests the presence of bias. This suggestion is reinforced by the fact that the NH&MRC had already reached an anti-homeopathy stance in 2012 by stating “NH&MRC‟s position is that it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy (as a medicine or procedure) has been shown not to be efficacious” based largely on the UK parliamentary findings which were in turn based around the discredited Shang analysis[xxxvii]. The current analysis would seem to be merely an attempt to validate this earlier conclusion.

(viii)  It is not suggested here that the bias in the NH&MRC report was in any way a malicious attempt by the panel to corrupt the findings – but that evidence above shows that the existing data-base of pharmaceutical medicine is already corrupted, as is the training and information sources of many people working in pharmaceutical medicine (including presumably panel members), and that the question asked and the data and issues ignored by the panel is reflective of this inherent bias in the pharmaceutical medicine evidence evaluation system. To see the consequences of Big Pharma influence is simple – in countries where the pharmaceutical industry has less control, then CAM (including homeopathy) is successfully used in the mainstream health system, and in countries such as America and Australia the opposite occurs.

Some thoughts on the Implications of the NH&MRC Report

It is worth considering the effect of the report in the community if the findings of the final report do not differ greatly from those of the draft now being considered.

In Australia, the NH&MRC report has already been greeted enthusiastically by anti-CAM groups such as sceptics and The Friends of Science; it will be welcomed in the boardrooms of Big Pharma; it will no doubt be used to influence politicians into pressuring health funds to further withdraw support from homeopathy; but it will been seen by those hundreds of thousands of satisfied users of homeopathy as yet another example of the influence of Big Pharma on official medicine in this country, and will further reduce the trust that such people have in their country’s peak medical body. It may also threaten the rights of at least some of the 60% of Australians who currently support and use CAM in general (and homeopathy in particular) to maintain access to their preferred method of health care (and incidentally a method which reduces the cost burden on the public health system through effective health promotion and prevention of disease).

Internationally the report will receive support from equivalent groups as above; it will be similarly dismissed by informed users of CAM. I cannot suggest how it will perceived by health officials in countries that have successfully incorporated homeopathy into their mainstream health systems, given that the NH&MRC are in effect suggesting that they are gullible fools.

Overall, the report will be divisive. It will convince the already convinced, and further alienate the already partially alienated – because it does not begin with the needed question, it does not use appropriate methodology, it is subject to bias, and it fails the common sense test, and thus ignores the practical needs of Australian health consumers and governments. It certainly fails to address the criteria established under the MOU with the Department of Health referred to in the Introduction.

Conclusions

Australia has a disease management system which is advanced in many ways, especially in emergency medicine and surgery, but has not been able to control chronic disease levels. It is following the American path of becoming unaffordable. Australia needs a new medical paradigm focusing on health and wellbeing, involving the integration of proven CAM modalities into the current system for the immediate benefit of patients and an immediate reduction in costs in the short-term, and in chronic disease rates (and hence costs) in the long-term. The NH&MRC should lead the new paradigm and not relentlessly protect the old one, which will be the main outcome of this report unless the panel redefines the question being asked and takes a holistic view of evidence and includes all relevant material relating to effectiveness, safety, quality and cost-effectiveness in an appropriately restructured analysis.

If the NH&MRC draft report aims to be a political document, intended to entrench a medical paradigm which delivers first class health care to wealthy Australians, reasonable care to others and is unavailable to a minority, all the time accepting steadily growing chronic disease levels in Australia at increasingly unsustainable costs, then it is a successful document. If the NH&MRC draft report aims to be an objective, scientific document then it fails on many levels as shown above. If the NH&MRC draft report aims to provide the people of Australia and their elected officials with objective, relevant, and useable information about how to make our medical system focus on health and wellbeing, and achieve excellence in truly preventative medicine, then it fails.

If the NH&MRC draft report aims to satisfy the terms of the MOU with the Department of Health to “provide advice to the Natural Therapies Review Advisory Committee (Advisory Committee) about which natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality” then it once again fails.

Australians need the best of all the medical modalities working co-operatively together – with the interests of patients first and foremost, and of our national economy a close second, to create a health system that is the envy of the world. This should also be the NH&MRC’s only objective, and it is the sincere hope of this author that one day this will occur, and every Australian will be able to rely without hesitation on the NH&MRC for objective guidance. This draft report sadly makes it clear that we are not there yet.

The final word can rest with the WHO concerning traditional and complementary medicine (T&CM): “T&CM is an important and often underestimated part of health care. T&CM is found in almost every country in the world and the demand for its services is increasing. TM, of proven quality, safety and efficacy, contributes to the goal of ensuring that all people have access to care. Many countries now recognize the need to develop a cohesive and integrative approach to health care that allows governments, health care practitioners and, most importantly, those who use health care services, to access T&CM in a safe, respectful, cost-efficient and effective manner”. The NH&MRC approach stands in sharp contrast to this modern, unbiased, needs-based, empirical view of the future of health care which includes the use of homeopathic medicine.

Declaration of Interests: Isaac Golden PhD has been a homeopathic practitioner since 1984. He has been actively involved in homeopathic research for most of that time, and has worked with the Finlay Institute in Cuba, collecting and publishing data on their national homeopathic immunisation programs involving millions of people. He has booked a 4^th visit to Finlay Institute in August this year to examine data on their current Dengue Fever immunisation program, as well as other immunisation and health promotion programs.

Contact: P.O. Box 695, Gisborne, 3437. Em

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