ABC RN Roundtable: New regulatory framework for complementary medicines called into question

 

Presented by Hugh Riminton
Producer Skye Docherty

 

Broadcast Sunday 18 February, 2018. Listen or download here.

Hugh interviewed:

  • Adjunct Professor John Skerritt, Deputy Secretary for the Federal Department of Health in charge of medicines’ regulation
  • Dr Cameron Loy is the Chair of the Royal Australian College of General Practitioners in Victoria.
  • Dr Vicki Kotsirilos AM is a general practitioner who uses therapies such as acupuncture, nutritional and herbal medicine; also associate professor at Western Sydney University

Professor John Skerritt’s statements and my comment follow:

  1. ‘So, if you list a medicine in Australia you actually have to have evidence that the product works. And what we do is call in the evidence, so, let’s say there is a group of products making claims about weight loss, we call in that group, we assess the evidence, and if the evidence isn’t held, the product gets cancelled’.

This conveniently ignores the fact that TGA post-marketing surveillance, over many years, shows that non-compliance of Listed products with regulatory requirements runs consistently around 80% of products sampled; lack of evidence is the most frequent violation. The Complaint Resolution Panel reports similar findings for upheld complaints.

In addition, despite long-standing concerns about claims for weight loss products that lack evidence[1] the TGA has never called in the evidence for that group of products and on the rare occasion they have cancelled a weight loss product it has immediately been re-listed with a ‘traditional’ indication.[2]

  1. ‘There’s a small group, and we think in the marketplace it might be 5%, of medicines, that are allowed to be on the register but with a statement on the label, and a statement in the register, that they are based on traditional use’.

This ignores the fact that of 1019 final permitted indications (submitted by industry and endorsed by the TGA) only 14% the require the manufacturer to have scientific evidence to back them up. For the rest, evidence of “traditional” use can suffice; that is, use for more than 75 years in an alternative medical tradition, such as traditional Chinese medicine, Ayurveda, Unani, Western herbalism or Homoeopathy.

We anticipate this decision will result in a flood of ‘traditional’ products that will confuse, mislead and waste consumers money. Meanwhile, too many consumers are forgoing evidenced-based prescription medicines because they cannot afford increasing PBS co-payments.[3]

  1. ‘Most of those [traditional] products are actually provided through a relevant traditional medicine practitioner’ … ‘and generally, the traditional Chinese medicines are not advertised to the wider products [public?] so it will be the science-based claims that are on that list’.

I’m unaware of what data Professor Skerritt bases this statement on. Traditional medicines are increasingly being promoted to Australian consumers and their advertisements are being complained about (see examples). As noted above, the TGA decision to allow 86% of 1019 permitted indications to be based on traditional claims will accelerate this trend. Why else would industry have provided such a large list of traditional indications?

  1. ‘AHPRA regulate[s] Traditional Chinese Medicine practitioners’.

TCM practitioners were registered because of safety concerns, not because there was evidence their treatment modalities such as Chinese herbal medicine and acupuncture was clinically effective.[4]  In addition, there are increasing complaints about the advertising of these practitioners.[5]

More importantly, other traditional practitioners such as Ayurveda, Western herbalists, Homeopaths are not registered by AHPRA, yet the TGA has listed products citing these traditions that are increasingly being promoted to the public.

Australia is a multicultural and pluralistic society and it’s appropriate that we respect, understand and allow access to traditional, alternative and complementary medical traditions and products.However, it’s also important that we restrain purveyors of these medicines from taking advantage of consumer ignorance and that we protect consumers from misleading and deceptive claims about the products provided.

At a time when Australia’s health budget is severely stressed and Australians struggle to afford medical benefit cover and, quite often, proper medical treatment, it seems  highly questionable for a government to be knowingly supporting alternative health treatments that consistently fail to show any evidence of effectiveness and many of which the government’s own NHMRC has condemned in those terms.

The WHO Traditional Medicine Strategy 2014-2023 identified the following challenges for Member States: Development and enforcement of policy and regulations, Ability to control and regulate advertising and claims, and Ensure consumers can make informed choices.

This is why many civil society groups have demanded that these medicines be accompanied by an appropriate advisory statement to enable consumers not familiar with the ‘tradition’ to understand the often creative promotional claims involved.

  1. ‘All complementary medicines, including those based on traditional indications… have ingredients where there is evidence of safety, positive evidence of safety…. what we can do as a regulator is make sure that the products are safe’.

The Therapeutic Goods Advertising Code 2015, s4(2)(i) states that advertisements must not claim that goods are completely safe, harmless, or free of side-effects. Yet Professor Skerritt states the TGA makes sure these products are safe.The reality is that the TGA’s ‘Catalogue of permitted ingredients for use in listed medicines’ includes substances that are regarded as ‘relatively safe’.[6] For example, Black cohosh (Cimicifuga racemosa) has sometimes been associated with liver failure[7] while allergic reactions to Echinacea have included anaphylaxis (the most severe type of allergic reaction), acute asthma attacks, severe urticaria (hives) and swelling.[8]

  1. ‘People are taking these things [vitamins and minerals] to supplement dietary deficiencies’.

Professor Skerritt should have pointed out that vitamin and mineral supplementation is not a substitute for a healthy diet. Indeed, some trials suggest that micronutrient supplementation in amounts that exceed the recommended dietary allowance (RDA) e.g. high doses of beta carotene, folic acid, vitamin E, or selenium—may have harmful effects, including increased mortality, cancer, and haemorrhagic stroke.’[9]

  1. ‘Within defined periods, and for the most serious ones a matter of days, where advertisements will be able to be pulled; there will be penalty notices, a bit like a speeding fine, but with a higher cost to the advertiser, or the ability to seek a court injunction’.

These timelines appear improbable.[10] Even if a penalty notice is issued quickly, the recipient has the right to dispute the notice in Court. If fast-track legal proceedings are contemplated, the TGA must, as a matter of the government’s own Model Litigant Policy, provide adequate opportunities for sponsors to consider claims against them and respond. Average case completion times for the ACCC are closer to a year than a few weeks. The Administrative Appeals Tribunal and the Australian court system will not tolerate lack of due process.

[1] https://www.mja.com.au/journal/2008/188/1/commercialism-choice-and-consumer-protection-regulation-complementary-medicines

[2] https://www.youtube.com/watch?v=12ww26sQF7E

[3] https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-13-484

[4] http://ncp.ncc.gov.au/docs/VIC%20traditional%20chinese%20medicine.pdf

[5] http://www.ahpra.gov.au/annualreport/2017/downloads.html

[6] https://www.tga.gov.au/catalogue-permitted-ingredients-use-listed-medicines

[7] https://www.tga.gov.au/alert/black-cohosh-cimicifuga-racemosa

[8] https://www.allergy.org.au/patients/medication-allergy/adverse-reactions-to-alternative-medicines

[9] https://jamanetwork.com/journals/jama/fullarticle/2672264

[10] https://www.doctorportal.com.au/mjainsight/2018/6/tangled-web-around-the-tga-2017-measures-no-1-bill-2017/

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Medicine policy, Natural Therapies, Senate and tagged , , , , . Bookmark the permalink.

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