Complementary Medicine Reform: NTRAC, TGA, etc.€¦ · Complementary Medicine Reform: NTRAC, TGA ... Quality Use of Medicines plank of

Department of Epidemiology & Preventive Medicine, Monash University

Dr Ken Harvey 1

June 18, 2014

Complementary Medicine Reform: NTRAC, TGA, etc.

1

Dr Ken Harvey MB BS, FRCPA

http://www.medreach.com.au

School of Public Health and Preventive Medicine Seminar, June 18, 2014

Disclosureof interests

• Member:– WHO Ethical Criteria

for medicinal drug promotion.

– Therapeutic Guidelines Limited.

– PHARM Committee that devised the Quality Use of Medicines plank of Australian Medicines Policy.

• Consumer rep (Choice, CHF):– Government Working Group on Promotion

of Therapeutic Products.

– TGA Transparency Review Panel.

– TGA Working Group on Regulatory Framework for Complementary Medicines.

– Government Natural Therapy Review Advisory Committee (NTRAC).


Dr Ken Harvey 2

June 18, 2014

Talk outline

• Problems with practitioners

– Natural Therapy Review Advisory Committee (NTRAC).

– Regulation of Unregistered Health Practitioners.

• Problems with products

– TGA reform progress.

• Conclusions.

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Natural Therapy Review Advisory Committee

• The review’s purpose is to ensure that taxpayer funds that are paid through the private health insurance rebate to subsidise natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality.

• The Natural Therapy Review Advisory Committee (NTRAC) will use the NHMRC review of natural therapies and will make recommendations to as to which therapies are underpinned by a credible evidence base.

http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies4


Dr Ken Harvey 3

June 18, 2014

Private Health Insurance (PHI)

• The government (all taxpayers) currently provides a rebate to the cost of PHI to around 50% of the population who choose (or can afford) PHI.

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Private Health Insurance (PHI)

• Many private health insurance (PHI) funds provide ancillary (extras) cover for a range of natural therapies.

• The ancillary benefits provided by different funds are currently a commercial decision; they take no account of clinical effectiveness and vary widely with respect to the services covered and the maximum money refunded per service per person per year.

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Dr Ken Harvey 4

June 18, 2014

Private Health Insurance: Natural therapies covered

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Natural Therapy Review Advisory Committee

• While natural therapies only provide a relatively small proportion (6.5 per cent) of all ancillary benefits paid, they are growing at a much greater rate than other services.

• For example, between September 2000 and September 2013, the number of dental services funded doubled whereas natural therapies services increased nine fold.

http://phiac.gov.au/wp-content/uploads/2014/02/benefitsAUS.zip

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Dr Ken Harvey 5

June 18, 2014

NHMRC Natural TherapiesWorking Committee

• The NHMRC have reviewed the evidence for the effectiveness of “natural therapies” such as homeopathy, naturopathy, massage, aromatherapy,reflexology, rolfing and western herbalism for NTRAC.

• They have undertaken a systematic review of available evidence on their effectiveness in treating a variety of clinical conditions in humans and they have also assessed evidence provided by stakeholders.

http://www.nhmrc.gov.au/your-health/complementary-and-alternative-medicines

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• The NHMRC was concerned that unconventional products and procedures are often promoted to improve people’s health when there is little or no evidence of their benefit, except for the benefits people experience when they believe that a treatment is effective (the placebo effect).

• Sometimes patients may be misled into rejecting practices and treatments that are proven to be effective.

• There is disagreement about whether many natural therapies are effective.

Why?

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NHMRC Natural TherapiesWorking Committee


Dr Ken Harvey 6

June 18, 2014

Homeopathy

The New Melbourne Homeopathic Hospital 1885-1934St Kilda Road, Melbourne

(In 1934 it became Prince Henry’s allopathic hospital)

Samuel Hahnemann (1755-1843): The Father of Homeopathy

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NHMRC First Draft Report: Homeopathy

• Three main sources of information:– published systematic reviews,

– information provided by homeopathy interest groups and the public

– clinical practice guidelines and government reports on homeopathy published in other countries.

• The assessment was guided by a committee of experts appointed in 2012 (The NHMRC Homeopathy Working Committee).

12https://www.nhmrc.gov.au/your-health/complementary-medicines/membership-homeopathy-working-committee


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June 18, 2014


• For each health condition, all the available evidence was grouped together to form a body ofevidence on that condition.

• A body of evidence was considered more reliable if it included studies that were high quality, well designed and with enough participants to make its results meaningful.

• A body of evidence was considered less reliable if there were very few studies, or if the studies were poor quality, badly designed, or included too few participants.

• The quality of evidence found was generally low.

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• The NHMRC concluded that there were no health conditions for which there was reliable evidence that homeopathy was effective.

• This conclusion is similar to that of a 2010 UK House of Commons Science and Technology Select Committee, which also looked at the scientific evidence and stated:

– “In our view, the systematic reviews and meta‐analyses conclusively demonstrate that homeopathic products perform no better than placebos”.http://consultations.nhmrc.gov.au/public

_consultations/homeopathy_health 14


Dr Ken Harvey 8

June 18, 2014


https://www.mja.com.au/journal/2010/192/8/homeopathy-what-does-best-evidence-tell-us15

Industry response (I)

• Australian professional homoeopathic organisations expressed concern at the limitations of the NHMRC evaluation which considered only systematic reviews of homeopathy rather than searching for all individual published studies of homeopathy.

• They also believed that the NHMRC failed to directly examine submitted evidence and instead relied on what others had found from systematic reviews.

• In particular, they stated that the NHMRC “named the discredited UK House of Commons Science and Technology Committee report as the basis of the NHMRC inquiry” and that it appeared to repeat both the language and opinion of this source.

16http://www.asbrm.com.au/images/ASBRM_News_LetterV5_June2014.pdf


Dr Ken Harvey 9

June 18, 2014

Industry response (II)

• Homoeopathic bodies submitted for consideration 192 randomised controlled trials of which 96 were positive, 88 were inconclusive and 8 were negative.

• They expressed concern that the evaluation failed toreport on these 96 positive trials, noting that although this evidence may in some instances be of a lower quality, it does not support a conclusion that homoeopathic treatment equates to placebo treatment.

• The homeopathic bodies felt that the NHMRC evaluation ignored such positive findings, effectively distorting the conclusions of many systematic reviews, and excluded observational and outcomes studies that examined effectiveness of treatments in real‐world conditions.

17http://www.asbrm.com.au/images/AROH-NHMRC-final-response.pdf

What’s evidence?

• Colleagues, friends, social media (and testimonials) might say, “It worked for me”.

• But the plural of anecdote is not evidence.

• There are a number of reasons why practitioners (and consumers) convince themselves that a treatment is effective when it is not including:– Placebo effect (patient’s perceived response to an intervention),

– The natural history of disease (symptoms may be short‐lived or wax and wane) ,

– Confirmation bias (seeing what you expect to see),

– Cognitive dissonance (ignoring results not in accord with expectations),

– Extensive promotion, including endorsement by “celebrities” who receive multi‐million payments (be especially suspicious).

• In short, personal evaluation is quick, convincing and often wrong, while blinded, controlled clinical trials are slow, complex, and costly.

• However, the latter are important as they often show that initially promising results are not replicated by larger and better conducted studies. 18


Dr Ken Harvey 10

June 18, 2014

Possible Implications: Practitioners

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Possible implications: Products & the TGA

HCG Diet Products Are Illegal• The Food and Drug Administration (FDA) is

advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight‐loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores.

• FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight‐loss drugs that have not been approved by FDA, and that make unsupported claims 20

http://www.biomedicals.com.auThe acronym hCG is for human Chorionic Gonadotrophin.

Homeopathic Drops for Weight lossLoose Weight Fast & Easily


Dr Ken Harvey 11

June 18, 2014

Possible implications: Products & the TGA

Ingredients: Arnica Montana (Leopard’s Bane) - 30C: Bellis Perennis(Daisy) - 30C: Chamomilla (Wild Cham o mile) - 30C: Ipecacuanha

(Ipecac) - 30C: Lycopodium (Clubmoss) - 30C21

Possible Implications: Pharmacy

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Pharmacy Board of Australia Code of Conduct (March 2014)• S.2.2 Good Care

n) practising in accordance with the current and accepted evidence base of the health profession, including clinical outcomesp) facilitating the quality use of therapeutic products based on the best available evidence and the patient or client’s needs.


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June 18, 2014

Possible Implications: Educational institutions

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HLT60612 - Advanced Diploma of Homoeopathy (Release 1)

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Possible Implications: Educational institutions

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June 18, 2014

Possible Implications: Public education

http://www.youtube.com/watch?v=p2FT8kNCYMs25

And there are many more reviews to come!

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Dr Ken Harvey 14

June 18, 2014

AHPRA registered practitioners not affected

• Services subsidised under Medicare by health professionals regulated by AHPRA under the National Registration and Accreditation Scheme (NRAC) will not be affected by the review.

• These include Chinese Traditional Medicine, Chiropractic and Osteopathy.

http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies

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Should AHPRA registered practitioners be exempt?

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June 18, 2014


http://www.universalhealth.com.au/services/pdf/chiropractic_paediatric.pdf

http://www.malchiro.com.au/testimonials.html

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Dr Ken Harvey 16

June 18, 2014

The National Law (s.133) prohibits advertising that:

• Is false, misleading or deceptive or is likely to be so,

• Offers a gift, discount or other inducement to attract a user of the health service without stating the terms and conditions of the offer,

• Uses testimonials or purported testimonials,

• Creates an unreasonable expectation of beneficial treatment, and/or

• Encourages the indiscriminate or unnecessary use of health services.

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Regulation of CM practitioners

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Dr Ken Harvey 17

June 18, 2014

Regulation of practitioners

• National registration of some health professions(AHPRA) aims to ensure a minimal level of education and training, appropriate standards of professional behaviour and effective and efficient complaint mechanisms.

• Naturopaths and many other complementary medicine (CM)practitioners have not achieved national registration, in part because of division in their ranks, but also because of their varied training.

• CM practitioners may be members of professional associations but this does not necessarily ensure evidence‐based practice, continuing professional education or good complaint handling processes.

• State based health complaints entities and/or the ACCC are available for complaints about unregistered practitioners but have problems.

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Options for unregistered practitioners

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Dr Ken Harvey 18

June 18, 2014

Code of conduct for unregistered practitioners

3. Health practitioners to provide services in safe and ethical manner

(a) A health practitioner must maintain the necessary competence in his or her field of practice,

(d) A health practitioner must recognise the limitations of the treatment he or she can provide and refer clients to other competent health practitioners in appropriate circumstances.

11. Health practitioners required to have clinical basis for treatments

A health practitioner must not diagnose or treat an illness or condition without an adequate clinical basis.

12. Health practitioners not to misinform their clients

(3) A health practitioner must not make claims, either directly or in advertising or promotional material, about the efficacy of treatment or services provided if those claims cannot be substantiated.

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AHMAC Standing Council on Health, 1 August 2013

• Ministers agreed in principle to strengthen state and territory health complaints mechanisms via:– a single national Code of Conduct for unregistered health practitioners to be

made by regulation in each state and territory, and statutory powers to enforce the Code by investigating breaches and issuing prohibition orders;

– a nationally accessible web based register of prohibition orders; and

– mutual recognition of state and territory issued prohibition orders.

• Each State and Territory will be responsible for:– enacting new (or amending existing) legislation and regulations to give effect to the national Code

of Conduct, the national register of prohibition orders, and mutual recognition of prohibition orders across state boundaries;

– determining a suitable local body to receive and investigate breaches of the Code of Conduct and issue prohibition orders, noting that existing Health Complaints Entities (HCEs) already have statutory roles to investigate complaints about unregistered health practitioners but only NSW and South Australia have a code of conduct and prohibition order powers.

• AHMAC will undertake a public consultation on the terms of the first national Code of Conduct and proposed policy parameters to underpin nationally consistent implementation of the Code, for consideration by Ministers. 36


Dr Ken Harvey 19

June 18, 2014

Problems with products

April 30, 2013

Adverts pulled from TV after public backlash

Supplement regulation by TGA is completely cactus… 12 April 2013, 10.59am EST

Academic quits over Swisse deal with uniFebruary 5, 2014

Rules under review?

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Date Initiative

2002 Report of a Review of Advertising Therapeutic Products in Australia and New Zealand

2003 Report of Expert Committee on Complementary Medicines in the Health System

2005 Description of the joint (Trans‐Tasman) regulatory scheme for the advertising of therapeutic products

2006Consultation (Draft) Regulation Impact Statement on the proposed amendments to the current regulatory system for herbal and homoeopathic medicines in Australia

2007 Consultation ‐ draft (Trans‐Tasman) advertising rule

2008 Regulation of homoeopathic and anthroposophic medicines in Australia

2009Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss

2010 TGA Consultation: Improving advertising arrangements for therapeutic goods

2011

Consultation and Report of the Working Group on Promotion of Therapeutic Products

Report of the Review to improve the transparency of the Therapeutic Goods Administration

ANAO Report. Therapeutic Goods Regulation: Complementary Medicines

TGA reforms: A blueprint for TGA's future

2012Delivering reforms ‐ Implementation plan for TGA Reforms

TGA Advertising regulatory framework: Options for reform

2013TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public

A decade of procrastination

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Dr Ken Harvey 20

June 18, 2014

What do consumer groups want?

• A regulatory system with teeth!

• Mandatory labelling, “This product has NOT been evaluated by Australian Health Authorities to see if it works”.

• Legislation for timely and meaningful sanctions for advertising violations (civil penalties, enforceable undertakings).

• Increased and better targeted post‐marketing surveillance and transparent reporting of problems and cancellations.

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What did we get?

http://www.tga.gov.au/about/tga-reforms-blueprint.htmhttp://www.tga.gov.au/pdf/tga-reforms-blueprint-implementation.pdf 40


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June 18, 2014

What did we get?

Transparency Review - Rec 7

• The TGA implement mechanisms to educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.

• Clear mandatory labelling: This product has NOT been evaluated by Australian Health Authorities to see if it works.

July 2012 to June 2013

• The TGA will work in partnership with other information providers to develop ways to achieve wider public understanding that listed medicines are not evaluated for effectiveness by the TGA prior to market.

2014: Still no clear mandatory labelling

What did we get?

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Advertising Consultation -Rec 2c.• Develop a more effective

approach to sanctions and penalties (including use of the infringement notice provisions).


• The TGA will consult further with stakeholders.

http://www.tga.gov.au/pdf/consult/consult-advertising-ris-130531.pdf

2014: still no timely or effective sanctions for advertising violations


Dr Ken Harvey 22

June 18, 2014

What did we get?

• Complaint to CRP 2011-10-027• CRP determination 2012-03• CRP to TGA re non-compliance 2012-08• Regulation 9 order 2013-06• Regulation 48 review 2013-09• Order upheld and final compliance 2013-12

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Long delays in handling complaints• Complaint to CRP 2011-10-027• CRP determination 2012-03• CRP to TGA re non-compliance 2012-08• Regulation 9 order 2013-06• Regulation 48 review 2013-09• Order upheld and final compliance 2013-12

What did we get?

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ANAO Report - Rec 3

• Make information available in a timely manner to the Australian public, for each listed complementary medicine, stating whether it has been subject to post‐market review by the TGA, when it was reviewed, and the outcome of that review.


• The TGA will provide the public with information on the complementary medicines that have been subject to post-market reviews and the outcomes of reviews.

2014: Implemented


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June 18, 2014

What did we get?

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• From Sept 2012 to Dec 2013), 249 post‐marketing reviews of listed complementary medicines were undertaken by the TGA; 69% had regulatory violations.

• Of 121 regulatory violations analysed in 2013, 76% related to labelling and advertising violations, including inadequate evidence to substantiate the claims made.

What did we get?

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ANAO Report - Rec 1

• To achieve timely completion of key guidance material for complementary medicines, provide target dates and regular progress reports.


2014: ARGCM updated


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June 18, 2014

Complementary Medicines Working Group - Rec 3• Update ‘Guidelines for

levels and kinds of evidence’ and include ‘Guidelines for levels and kinds of evidence’ in regulations.

What did we get?


• The Evidence document was released in July 2012 and refined via feedback received through public consultation.

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2014: The TGA decided not to include compliance with this document in the regulations.

The new guidelines are generally excellent but there are flaws.

Non-compliance continues.

What did we get?

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Flaws: e.g. homoeoprophylaxis


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June 18, 2014

The battle continues:

• We await with interest the government’s response to the TGA’s advice concerning advertising RIS options and other legislative changes.

• Meanwhile, complaints, assessment of regulatory performance and use of the media are being ramped up in 2014.

Friends of Science in Medicine

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Swisse Chlorophyll

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Dr Ken Harvey 26

June 18, 2014

In conclusion:

• The Natural Therapy Review has highlighted the fact that many natural therapies subsidised by the PHI rebate lack an evidence base.

• This has implications for professional bodies, educational institutions that conduct advanced diploma and degree courses, their accrediting bodies (which appear to rely solely on industry for advice) and government Fee‐help assistance for their students.

• The slow progress towards a single national Code of Conduct for unregistered health practitioners also highlights the failure of AHPRA Boards to act on obvious breaches of the National Law and Codes of Conduct and the need for all practitioners to be ethically responsible.


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In conclusion:

• While the TGA is slowly adopting greater regulatory rigor towards complementary medicines, industry has been slow to adopt TGA evidence guidelines and we still lack timely and effective sanctions for regulatory breaches.

• Legislative additions are required yet the government wants to deregulate and cut “red tape”.

• There is an ongoing need for civil society organisations (including universities) to keep the pressure up on both government and the TGA by engaging students and the media in these issues, submitting complaints and monitoring the outcome.


Documents

Complementary Medicine Reform: NTRAC, TGA, etc.€¦ · Complementary Medicine Reform: NTRAC, TGA ... Quality Use of Medicines plank of