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27 May, 2020

Rewind – the start of NHMRC’s focus on natural therapies, 2010-11. Part 1


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This article chronicles the untold story of the start of the National Health & Medical Research Council (NHMRC) focus on natural therapies from 2010. It provides a fascinating insight into what happens when science, bureaucracy and ideology converge.

The events that began in 2010 led to fourteen natural therapies (including massage, yoga, pilates, naturopathy and herbal medicine) being removed from Private Health Insurance rebate eligibility in April 2019, on the basis of reviews conducted by the NHMRC between 2012 and 2015. Released in 2015, these reviews concluded there was ‘no conclusive evidence’ that any of the natural therapies examined worked. In the case of homeopathy, this was framed as ‘no reliable evidence’.

Given the extensive amount of positive research conducted into these therapies and their long and widespread history of use around the world across all cultures, how did the NHMRC reach this conclusion? Were the reviews conducted ethically and impartially, using accepted scientific procedures and methods, as claimed?

Rewind, 2010:

Here we chronicle the timeline of events from 2010 – when the NHMRC first turned its attention to natural therapies – to mid-2011 when, controversy over bias forced the NHMRC to abandon its plans in favour of a more orthodox approach. What happened from mid-2011 on will be followed up in subsequent parts. 

The NHMRC’s conduct has resulted in a Commonwealth Ombudsman investigation into alleged procedural and scientific misconduct, which is expected to conclude soon.

Did the NHMRC approach the task ‘impartially’, ‘collaboratively’, ‘respectfully’, ‘transparently’ and ‘ethically’ – principles enshrined in the Australian Public Service (APS) Values and Code of Conduct that defines the integrity framework that all APS agencies are legally required to uphold?

Read the following story and judge for yourself.

NHMRC Strategic plan 2010-2012:

In 2010 the NHMRC announced it would undertake a program to “examine the evidence for natural therapies most highly used” under the auspices of its Strategic Plan 2010-2012 [1].

First cab off the rank was homeopathy, a topic the NHMRC had no experience or expertise in and had never funded any research into. It was also one of the least (not ‘most’) highly used natural therapies in Australia. 

October 2010 – CEO directs NHMRC Council to develop a Position Statement:

In October 2010, the then NHMRC Chief Executive Officer (CEO), Professor Warwick Anderson, directed NHMRC Council (the agency’s principal committee) at its 183rd Session to develop a Position Statement on homeopathy for uploading to the NHMRC website [2].

A review of published research evidence was not commissioned and no research experts in the field were consulted to assist in the development of an evidence-based position.

Professional stakeholders in the homeopathy sector were also not notified or consulted.

This was an unprecedented departure from NHMRC’s established administrative/ scientific ‘quality assurance’ protocol.

Meanwhile, the NHMRC Service Charter stipulated that the NHMRC is bound by the APS Values and Code of Conduct, which includes principles of ‘respectful’, ‘collaborative’ and ‘impartial’ conduct towards stakeholders. The Charter also outlined how NHMRC applies the Australian Government’s Charter of Public Service in a Culturally Diverse Society – noting that homeopathy is widely used amongst culturally diverse communities within Australia (including people with European, South American and Indian subcontinent origins).

Trigger – political, not scientific report rejected by the UK Parliament:

The CEO brought the matter to Council on the sole basis of a 2010 UK House of Commons Science and Technology Committee (STC) Report [3].

The UK STC Report was a political, not scientific process overseen by 14 Members of Parliament, not scientists, during two hearings on 25 November 2009. Eleven out of the fourteen members of the STC abstained from voting in protest over bias inherent in the process. Of the three members who voted in favour of the report, two were not present during the brief (3-hour) hearings.

Being a parliamentary committee process, no systematic scientific method was applied and it was not carried out by expert academics in the field. Hence the report was not part of the scientific literature. The report itself was associated with extensive data exclusion and was based exclusively on a single, out of date study that had been critiqued in the scientific literature for questionable methodology (forensic analysis revealing that the data had been manipulated in a way that altered the findings from positive to negative, without being reported in the study) [4, 5].

Further background to the UK STC Report can be read here.

The UK Parliament rejected the report’s recommendations in July 2010, in favour of supporting homeopathy on the National Health Scheme as well as supporting further research. [6] The UK Department of Health had also dismissed the report.

Adoption of UK report:

Regardless, NHMRC Council approved the use of the UK STC Report on face value, without critically appraising its flaws and limitations, including its political (not scientific) basis. No independent evidence review was instigated and no expert stakeholders or researchers in the field were engaged or consulted [2].

Yet according to the NHMRC, when developing health advice for the Australian public on matters related to health it [7]:

“implements a number of processes to ensure that the evidence underpinning its advice has been comprehensively reviewed and that its translation into an evidence-based summary has been done in an accurate and robust manner”.

Not in this instance.

Conflicts of interest?

The same month (October 2010), Professor Anderson submitted an article to the Medical Journal of Australia openly expressing his personal antipathy towards complementary medicine, framing modalities such as homeopathy in particular as “alleged therapies” and a “retreat from reason” [8]:

“Many people seem to regard their own views and beliefs as being of equal value to any other, whether or not they are founded on any factual, scientific or logical base. There are many examples, such as the widespread use of such alleged therapies as homoeopathy, or the belief that crystals have magic healing powers.”

The CEO iterated increasingly adversarial rhetoric towards natural therapies on a number of occasions during his tenure as agency Head.

For example, in 2015 during his National Press Club speech [9] he pejoratively referred to natural therapists as “unscrupulous people” who “exploit the sick for their own personal gain selling products that have no hope at all of helping the patient”. He framed natural therapists as:

“practitioners who we must assume either believe in magic or perhaps are just dishonest. Ill health has attracted charlatans since time immemorial. Snake oil merchants wanting to take your money by promising false hope. … So it’s fairly astounding to me that 19th century quackery lingers into the 21st century.” 

Section 42A(2) of the NHMRC Act 1992 requires:

“If the CEO has, or acquires, an interest that could conflict with the proper performance of the CEO’s functions, the CEO must, as soon as possible after the relevant facts have come to his or her knowledge, disclose the nature of the interest to the Minister.”

No such disclosure was made.

The Public Service Act 1999 defines principles of good public administration that all APS employees must uphold, embodied in the APS Values and Code of Conduct. According to the Australian Public Service Commission (APSC), these legislated principles “lie at the heart of the democratic process and the confidence the public has in the way public servants exercise authority when meeting government objectives”.

The APSC stipulates that these principles apply to an even greater degree to senior staff within APS agencies. CEOs and department heads, in particular, are required to “promote [the principles] by personal example and other appropriate means”. This is because they hold positions of public prominence and influence the cultures within their agencies, setting the scene for ‘how things are done around here’.

December 2010 – NHMRC Council approves Draft Position Statement:

At its 184th Session in December 2010, NHMRC Council members were provided with a draft Position Statement on homeopathy for consideration, based on the UK STC Report [10].

Prof Anderson’s MJA article, which openly revealed his personal opposition to the topic, was published the same month. 

NHMRC Council approved the content of the Statement and advised the CEO to upload it to the NHMRC website, subject only to consultation with “relevant stakeholders” and developing a “plain English summary” – and not a check of the Statement’s content and/or scientific accuracy [10].

The list of “relevant stakeholders” did not include professional (or any other) stakeholders in the natural medicines/ homeopathy sector, who were not notified or consulted, despite being the main professional stakeholder groups impacted.

By excluding professional stakeholders from the consultation loop, this prevented any avenue for subject/ research specialists to provide expert feedback or commentary on the scientific accuracy of the draft Statement.

Impact on professional & public stakeholders not considered:

The potential impact on practitioners, industry, the education and small business sectors, and the estimated million Australian consumers that use homeopathy products and services (including those from cultures where homeopathy is a commonly used traditional therapy) was not considered or assessed. Government portfolios responsible for professional, industry, and consumer stakeholders were not consulted.

Consumers Health Forum hired to conduct ‘literacy’ (not content) check:

Before uploading the Statement to the NHMRC website, the NHMRC contracted the Consumers Heath Forum (CHF) to conduct a ‘literacy check’, for the purpose of ensuring that the Statement was “understood” by the Australian public.

On 5 April 2011 the NHMRC wrote to the CHF, stating (emphasis added) [11]:

“NHMRC has developed a public advisory statement on homeopathy. The intended audience of this statement is Australian consumers. NHMRC would like to have the draft statement reviewed by consumers to ensure the writing style is able to be read and understood by a lay audience. The nature of the advice has required us to use some specific scientific terms. Where possible, we have explained the meaning of these terms, but seek feedback on whether this has been done effectivelyIs this something the Consumers Health Forum would be able to assist with?”

This confirmed that the NHMRC was not seeking feedback on the content or scientific accuracy of the draft Statement (which in any case was outside the CHF’s scope), but on making sure it was in a readable format for the public. This was reiterated and confirmed in subsequent correspondence between the NHMRC and CHF, as well as in CHF correspondence to its members (see below).

The proposed contract price for the CHF to do this work was $4,400 [11].

Peak stakeholder group accidentally learns of draft Statement’s existence:

At 11:16 am on 19 April 2011, the CHF emailed the draft Statement to selected members for comment, “to ensure that it is well written and that terminology is explained in a consumer-friendly and accessible way”. Responses were requested by 2 May 2011 [12].

The following morning, on 20 April 2011, the Australian Homoeopathic Association (AHA) accidentally learned of the existence of the process via a CHF member who was concerned about bias inherent in the process, including the exclusion of key professional stakeholder groups [13].

At 11:42 am, the AHA emailed the CHF requesting to see a copy of the NHMRC draft Statement and requested to make a formal submission, as the peak professional body representing homeopathy in Australia [14].

At 2:32 pm, the CHF responded [15]:

“Thanks for your interest in this – we are really trying to seek a consumer view on the readability of the statement, not the content, so you may not wish to comment.” 

Draft Statement leaked to the media:

Later that day (20 April), the NHMRC draft Position Statement on homeopathy was published in the Australian Doctor [16], leaked to the media via the CHF network.

The timing of the leak was striking in the context of the day’s events.

The 2011 NHMRC draft Statement on homeopathy:

The leaked draft Statement provocatively proclaimed [17]:

“NHMRC’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.”

It revealed an openly adversarial stance that was not based on independent or impartial review of published research evidence or consultation with subject/ research experts or stakeholders (i.e. it was not ‘evidence-based’).

It also proclaimed, “There is sufficient scientific evidence to conclude that homeopathy is no more efficacious than placebo” – without having looked at any basic/ fundamental scientific evidence directly testing this claim (i.e. non-human/ laboratory research models where the placebo effect is annulled). Yet by 2010, close to 75% of laboratory and in vitro experiments on ultra-high dilute homeopathic preparations showed the substance having a biological effect over placebo, with nearly 75% of replications being positive [18]. The reproducibility of these results had also been increasing as scientists were improving their understanding of factors influencing the results [19].

The draft Statement further alleged that those who prescribed homeopathic medicines were engaging in “deceptive” conduct: emotive language denigrating professional practitioners and researchers in the field.

NHMRC, CHF & the Skeptics movement – all in house:

When in December 2010 NHMRC Council approved the content of the draft Position Statement, it asked the Office of NHMRC to liaise with Ms Cahill Lambert “in relation to the development of a plain English summary” [10].

At the time, Ms Cahill Lambert was both a member of the CHF and NHMRC Council as a ‘consumer representative’.

Also at the time, Dr Ken Harvey – Australia’s foremost anti-complementary medicine activist and current President of the anti-complementary medicine lobby group ‘Friends of Science in Medicine’ (FSM) – was the CHFs official ‘complementary medicine spokesperson’.

The CHF has close, long-standing ties with Dr Harvey, FSM and other groups pursuing an anti-CM agenda spanning many years. In early 2018, the CHF threw its support behind a Harvey/FSM-led push to try and overturn a therapeutic goods Amendment Bill which was aimed at improving Australians’ access to complementary medicines. This was rejected by the Senate, who labeled the move as “offensive” and “disrespectful”.

In 2010/11, NHMRC Council included members who became FSM Supporters when the group formed in late 2011, without their conflicts being declared, at any stage. FSM’s overt and aggressive anti-complementary medicine agenda was broadcast throughout the media, leaving little doubt about what the group stood for and its agenda. The NHMRC Health Care Committee (HCC) that presided over the 2015 homeopathy review also included FSM Supporters.

Section 42A of the NHMRC Act 1992 (‘Disclosures of interests’) requires:

that members of NHMRC Council and committees “must”, at or before meetings, declare any conflicts in a matter being considered.

At no stage did members of NHMRC Council or the HCC declare their FSM affiliations in relation to the 2012-15 review of homeopathy.

May 2011 – controversy erupts:

The NHMRC claims that it only became aware that the draft Statement had been leaked in May 2011 [7], even though it was in the public domain from 20 April 2011 and a number of formal complaints had already been lodged with the agency by the end of April.

Stakeholder groups were angered by the lack of consultation and overt disrespect shown to a healthcare sector comprising thousands of health professionals trained to government-endorsed standards.

In subsequent correspondence with stakeholders, NHMRC attempted to distance itself from the draft Statement process by stating that it was ‘only a draft’ and that ‘it had not been approved by Council’.

However, this directly contradicted published NHMRC Council proceedings [10] and other correspondence [11, 12, 13] evidencing that the content of the draft Position Statement had in fact been approved by NHMRC Council, subject only to administrative (not content) checks. Although the draft Statement had not yet been formally signed off, Council had already approved its conclusion subject only to ensuring that a lay audience could comprehend it.

Fresh start – Reference Group established to oversee a formal evidence review:

In May 2011, NHMRC abandoned its draft Position Statement due to widespread controversy over bias and lack of procedural or scientific rigour in its development.

The NHMRC then set up a Reference Group to oversee a formal evidence review under the auspices of its 2010-2012 Strategic Plan. The Reference Group formed the nucleus of the Homeopathy Working Committee (HWC), which formally came into being on 4 April 2012 to oversee a (first) evidence review [20] that NHMRC did not report existed. 

‘Distinct and separate process’?

To distance itself from the controversy surrounding the abandoned draft Position Statement, the NHMRC stated that this was now a fresh start and ‘distinct and separate’ to the previous process.

The agency was under scrutiny to demonstrate that the key elements of controversy that underpinned the 2011 draft Position Statement did not characterise the new process initiated from mid-2011.

Was this the case?

Continuing lack of involvement of homeopathy subject and/or research experts:

The NHMRC CEO continued to actively refuse to appoint any suitably qualified experts in homeopathy or homeopathy research to the expert Reference Group, even though this was a key criticism of the abandoned 2011 draft Position Statement process, also despite continuing protest from professional stakeholder groups.

This appeared in open breach of what NHMRC describes as its ‘quality assurance processes’ [7], which are informed by policies and guidelines that require the establishment of an expert committee that includes, “members with a high level of expertise relevant to the matter under investigation” [21]. NHMRC guideline/ review processes must, in the topic under review, include as a mandatory requirement a committee comprised of [22]:

“a multidisciplinary group that includes end-users, relevant disciplines and clinical experts”.

Thus, a review of oncology would involve oncologists and research experts in the field to enable a meaningful assessment to take place – as would reasonably be expected and occurs in practice. This is a basic principle routinely applied to any scientific review process, enshrined in NHMRC’s own guidelines [21]:

“[NHMRC] Guideline development, the provision of advice and peer review all require persons with expertise relevant to the topic under review. … Guidelines, advice and peer review would be of lesser quality without relevant experts”.

Not in this instance.

Ongoing use of derogatory language on NHMRC website & CEO public orations:

Between 2012 and 2015, the NHMRC Complementary Medicines website and NHMRC documentation pertaining to the review continued to iterate the same preemptive themes and language espoused in the draft Position Statement, including before the formal evidence review commenced.

This included the reiteration of language used in the draft Position Statement that homeopathy was ‘implausible’, ‘not evidence-based’, ‘unsafe’, ‘unethical’, ‘placebo’, ‘ineffective’ and also that people were being ‘misled’ (cf. ‘deceptive’).

The NHMRC webpage was not updated to remove such partial messaging until 5 March 2015, the week before the final Information Paper and Statement on homeopathy was released on 11 March, which formalised the conclusion of the 2011 draft Position Statement.

These themes were also iterated by the CEO in his public orations between 2012 and 2015, employing even stronger language such as: ‘snake oil merchants’, ‘waste of money’, ‘useless’, ‘charlatans’, ‘pushed by practitioners who believe in magic’ and who are ‘dishonest’.

July 2011 – NHMRC Chairman divulges ongoing culture of bias:

After ditching the draft Position Statement and claiming that the elements of bias that had underpinned it were now a ‘thing of the past’, on 22 July 2011 the NHMRC Chairman (Dr Michael Good) confirmed an ongoing culture of bias towards the subject in an interview with the Australian Skeptics [23]:

“Let me assure you I am no supporter of homeopathy. As Chairman of NHMRC I can also assure you that NHMRC does not support homeopathy.”

This indicated that whatever outward steps the NHMRC had taken to portray it was now ‘doing things properly’, internally things had not moved on. Dr Good was Chair of NHMRC Council during 2010 when Council approved the development and content of the draft Position Statement [2, 10].

The Chairman’s comments were consistent with elements of bias that persisted on the NHMRC website framing the evidence review from 2012-15, the ongoing exclusion of topic/ research experts, in public documentation pertaining to the topic, the CEO’s public orations, and the dismissive nature of communications with expert stakeholders. In fact, from October 2011 the NHMRC did not respond to any correspondence from expert stakeholders until after the review was released in 2015.

Could a fair and impartial evidence review occur within this cultural milieu?

Complaint & Commonwealth Ombudsman investigation:

Abuse of power by public institutions and governments and their attempts to protect their establishments and hierarchies over addressing harm done to constituents is a prominent issue of public interest.

A Complaint detailing allegations of procedural and scientific misconduct was tendered to the Commonwealth Ombudsman in 2016/17 and met the Ombudsman’s threshold for opening an investigation of the NHMRC’s conduct of the 2012-2015 homeopathy review. This is also pertinent to reviews of 14 other natural therapies conducted by the NHMRC in 2014/15, which were based on the approach taken in the homeopathy review.

According to the Ombudsman (‘What we do’):

“The Office of the Commonwealth Ombudsman safeguards the community in its dealings with the Australian Government. … If an Australian Government agency has treated you unfairly or unreasonably, we can help you find a solution. Our service is free and we are independent.”

The Australian public awaits with interest how the Ombudsman will view and interpret the conduct described above, as it applies its ‘reasonable person’ test to the Complaint. How would the ‘average person’ regard such conduct by a taxpayer-funded institution? The Ombudsman’s final determination is expected soon.

The Commonwealth Government is currently undertaking new $2 million ‘review updates’ of 16 natural therapies, announced on 7 April 2019 in response to sustained public protest over the removal of these natural therapies from PHI rebate eligibility.

While the events chronicled in this article may raise questions regarding ethical conduct, they are eclipsed by the events that unfolded from April 2012 on when the formal evidence review commenced. This will be covered in subsequent Parts in this series.

 

Sources:

[2] 2010.10.10. NHMRC Council 183rd Session Report. Item 3 ‘CEOs report’, p.4. https://webarchive.nla.gov.au/awa/20110601231107/http://www.nhmrc.gov.au/_files_nhmrc/file/publications/reports/183_council_session_report.pdf

[3] 2010.02.22. UK House of Commons – Science and Technology Committee (2010) Evidence Check 2: Homeopathy. http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4502.htm

[4] Lüdtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol. 2008 Dec; 61(12):1197-1204. doi: 10.1016/j.jclinepi.2008.06.015. Epub 2008 Oct 1

[5] Rutten AL, Stolper CF. The 2005 meta-analysis of homeopathy: the importance of post-publication data. Homeopathy, 2008 Oct; 97(4): 169-77 | PubMed

[6] 22.07.2010. UK Parliament response to UK House of Commons Science & Technology Committee report into homeopathy – Evidence Check 2 Homeopathy

[7] 2015.12.22. Letter from NHMRC to peak stakeholder groups

[8] Anderson, WP (2010). A balloon, the beach, biology and blood pressure. MJA. Volume 193 Number 11/12 • 6/20 December 2010

[9] 2015.04.15. Anderson, WP. National Press Club speech, p.15

[10] 2010.12.16. NHMRC Council 184th Session report. Item 6 Homeopathy, p.8. https://webarchive.nla.gov.au/awa/20110602184956/https://www.nhmrc.gov.au/_files_nhmrc/file/publications/reports/184_council_session_report.pdf

[11] 2011.04.05. Email from NHMRC to Consumers Health Forum (CHF) re. quotation for assessment of draft NHMRC advisory Statement on homeopathy. NHMRC Freedom of Information (FOI) doc 2015/16 002-15

[12] 2011-04-18. Email correspondence between NHMRC and Consumers Health Forum (CHF) re. NHMRC draft Statement on homeopathy. NHMRC Freedom of Information doc (FOI) 2015-16 002-16

[13] 2011.04.19. Email from Consumers Health Forum (CHF) to CHF members re. Statement on homeopathy

[14] Personal communication, Australian Homoeopathic Association (AHA)

[15] 2011.04.20. Emails between Australian Homoeopathic Association (AHA) & Consumers Health Forum (CHF) re. Statement on homeopathy

[16] 2011.04.20. Smith, P. NHMRC declares homeopathy ‘not efficacious’. Australian Doctor

[17] 2011.04.20. NHMRC draft position Statement on homeopathy

[18] Witt CM, Bluth M, Albrecht H, Weisshuhn TE, Baumgartner S, Willich SN. The in vitro evidence for an effect of high homeopathic potencies–a systematic review of the literature. Complement Ther Med., 2007;15(2):128-38 |PubMed

[19] Endler P, Thieves K, Reich C, Matthiessen P, Bonamin L, Scherr C, Baumgartner S. Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10(-23): a bibliometric study. Homeopathy, 2010; 99(1):25-36

[20] 2012.04.04. NHMRC Official Order (UniSA contract & Statement of Requirement. NHMRC Freedom of Information (FOI) doc 2014/15 021-04

[21] NHMRC Conflicts of interest policy (referenced by NHMRC as part of its ‘Quality Assurance’ policy in elation to the inclusion of topic/ research experts on NHMRC expert committees)

[22] NHMRC Procedures and requirements for meeting the 2011 standard for clinical practice guidelines, Standard A.3, p.16 (referenced by NHMRC as part of its ‘Quality Assurance’ policy in elation to the inclusion of topic/ research experts on NHMRC expert committees)

[23] 2011.07.22. Griffith Uni Rejects Homeopathy Link, Australian Skeptics Inc. https://www.skeptics.com.au/2011/07/22/griffith-uni-rejects-homeopathy-link/

 

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