Consumer Survey on Complementary Medicines (Supplement) Regulation

I’m the Choice representative on the Therapeutic Goods Advertising Consultative Committee (TGACC). I need your help.

I invite you to participate in an anonymous online survey about your understanding of the regulation of the complementary medicines (supplements) by the Therapeutics Goods Administration (TGA).

The survey is being conducted by one of my Monash University research students, Shuyi Wu. It has been approved by the Monash University Human Research Ethics Committee (ID: 26044). It will take 10-15 minutes to complete.

Your response will assist us in understanding what consumers know about the regulation of complementary medicines and how this might be improved. The results will be published on this forum.

The survey is available online now and will be up for the next 3 weeks. Please give it a go.

Shuyi and I are available on this forum to answer any questions you might have.

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Happy to participate and hopefully drives a better outcome to complementary medicine labelling and advertising. Just completed it and relatively easy to follow and understand. The only one which could have been expressed better is the last one on TCM.

Just also wonder if complementary medicine should be called something else as the term medicine may confuse it with pharmaceutical medicines (and infer benefits)…when in fact complementary medicines, unless scientifically proven efficacy, isn’t really a medicine. It could be an complementary elixir, biologic, tonic or such like.

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It would be helpful if you could let Shuyi know offline how you think the last question on TCM could be better expressed: email: Shuyi Wu swuu0009@student.monash.edu

We also appreciated your last comment; Shuyi will record these as part of her research.

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I’m with @phb in questioning the definitions.

Is ignorance bliss? A challenging survey if you only follow the professional advice of a GP and occasionally a pharmacist for standard treatments. Done.

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I have done the survey and emailed Shuyi some suggestions.

I think the survey needs to clarify that you are only looking at one aspect of TCM, the medicines, and not the whole gamut.

The question about one’s knowledge of TCM was tricky to answer because I know a bit about acupuncture, cupping, meridians, massage, etc, but next to nothing about the medicines.

Now I will go away and chew on some sylvia to improve my focus. :sweat_smile: Sorry focus is already gone, that was meant to be salvia.

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Done, I understood the TCM health claims about removing heat/fire from my blood to be wishful thinking and nonsense!

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Done.

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In my ISO-madness condition here in Melbourne, willing to help out and do the survey. Mind you I am biased. “Complementary medicine” = “Snake Oil” in my view and that is what any regulation should reflect.

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Thank you so much to everyone who has taken the time to participate in the survey and for all the feedback! Your responses will help us to understand your understanding of the regulation of complementary medicines and how it could be improved.

If you haven’t completed the survey, there is still time yet! It can be accessed here.

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There are some complementary ‘medicines’ which do work, but they are very far and few in-between. Some are downright dangerous to take and may harm the health of an individual rather than have any proven benefit. The challenge for the average consumer is differentiating between the limited number that do have some scientifically proven benefits and the mass of products which don’t.

Choice has also covered complementary ‘medicines’ in the past as well…

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phb’s response to Gregr’s comment, “Complementary medicine” = “Snake Oil” hits the nail on the head.

Does the current TGA regulatory system help consumers choose CMs wisely? And, if not, could the system be improved?

In 2018, as part of CMs regulatory reforms, the TGA introduced a new AUST L(A) category of listing in which industry could submit evidence for the claims made and, if the TGA assessment agreed, add a logo to their label to help consumers decide. However, two years on, NO Aust L(A) products have been listed. I wonder why?

tga-assessed

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“Complementary medicines” that are demonstrated to work under proper trials for efficacy, suitability and possible side effects and contraindications are called “medicines” and are able to obtain registration as such.

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The TGA’s scope is safety, not efficacy, for non prescription medicines and everything ‘L’ registered. If it does no harm (beyond the wallet) it seems to be accepted.

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Scientists discovered that an extract from the berries of a tree that only grows in a few pockets in FNQ rainforests can successfully treat tumours and melanomas.

I recall reading one article which had a very strong warning to the public not to go foraging for the berries for self-treatment as they are toxic.

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Australian doctors are also prescribing “traditional Australian medicines” without adequate scientific evidence.

I must have been told to use a urinary alkaliniser (like Ural, or Citravescent sold by chemists) by at least 10 different doctors over many years including recently for urinary tract infections (UTI). In fact they have always told me to do this when I attended for this problem. When I told a Danish doctor friend about this, I was surprised it was not recommended treatment in Denmark. Doctors here were so unwaveringly firm in this advice I had never thought to question it. So I looked it up to see if Cochrane had done a review. They had and wrote:
“Urinary alkalisers are widely used in some countries for the symptomatic treatment of uncomplicated UTI, and they are recommended in some national formularies. However, there is a lack of empirical evidence to support their use for UTI and some healthcare guidelines advise against their use.”
They concluded:
“Until relevant evidence is generated from randomised trials, the safety and efficacy of urinary alkalisers for the symptomatic treatment of uncomplicated UTI remains unknown”
(https://www.cochrane.org/CD010745/RENAL_urinary-alkalisation-uncomplicated-urinary-tract-infections).

My pack of Citravescent has AUST R 27908 on the pack, and when I looked this up on the TGA website the public summary notes:
“Systemic and urinary alakalinisation where indicated in the relief of symptoms associated with urinary tract infections such as cystitis, pyelonephritis, urethritis; … Citravescent may increase the effectiveness of sulphonamide antibiotics in the treatment of urinary tract infection.” https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=6A4192732C66FDAFCA2577DD0003633A&agid=(PrintDetailsPublic)&actionid=1

How is the public to make sense of all this? Most have no idea Cochrane exists and “Cochrane summarizes the findings so people making important decisions – you, your doctor, the people who write medical guidelines – can use unbiased information to make difficult choices without having to first read every study out there…” (Sifting the evidence, The Guardian, 14 September 2016).

I had assumed the consistently firm advice of Australian doctors had a clear evidence base. The advice is traditional and may be good, but there is no adequate scientific evidence for it. And there is a significant cost at the chemist.

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Unfortunately, that is not correct. The TGA has a list of what they say are evaluated ‘registered’ complementary medicines (labelled (AUST R). While most products on this list are unremarkable vitamins and minerals, it also contains ‘ARTHRO-AID Glucosamine hydrochloride 750mg’ added in 08/04/1999 on the basis of initial evidence of efficacy.

Subsequently, discrepancies in efficacy reported in studies that were industry sponsored as opposed to publicly funded raised serious concerns about publication bias. The data that were deemed to have the lowest risk of bias failed to show any important benefits over placebo. Current expert medical opinion states, ‘Glucosamine is strongly recommended against in patients with knee, hip, and/or hand osteoarthritis’.

Regrettably the TGA have failed to re-evaluate this AUST R glucosamine product. Nor, despite complaints, have they provided any updated information about the 400+ AUST L glucosamine products which continue to make unsupported claims of efficacy for osteoarthritis.

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Yet the Therapeutic Goods Act 1989, which the TGA administers, says, ‘4 (1) The objects of this Act are to do the following, so far as the Constitution permits: (a) provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods…’

In addition, apart from listed products causing direct harm or injury, there is also indirect harm. The latter occurs when consumers believe misleading and deceptive claims and, as a result, forgo more evidence-based products, fail to consult a medical professional when they should or waste their scarce financial resources on ineffective products. Should these concern the TGA as well?

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Always good to look at the ARTG start date, in this case 21/10/1991. The Cochrane review was dated 19 April 2016. Another example (see glucosamine above) where the sponsor (and TGA) conveniently ignore recent clinical trials and fail to update ‘approved’ product information.

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Always happy to be corrected by those who know far more about complex issues than I do. That’s the way forward.

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