New Australian drug regulator proposals should... - CLL Support

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New Australian drug regulator proposals should give Aussies a better idea whether complementary medicines do what they say on the packet


One change proposed by the Therapeutic Goods Administration (TGA) is a “stamp of approval” on the packaging and promotional material of some vitamins, minerals, herbs and other supplements to tell you there is enough evidence to back health claims.


But the proposed changes do not yet address the need for greater transparency in the regulatory process. For instance, it is not clear whether the TGA’s assessment of evidence to back higher-level health claims for complementary medicines will be publicly available, as they are for prescription medicines.


If the TGA implements this package of recommendations, Australia will be a world leader in how complementary medicines are regulated. Despite the substantial and increasing use of supplements, no other country has developed a system that helps consumers and health professionals separate the evidence-based wheat from the chaff, improves confidence in the industry, stimulates more evidence-based products and has the potential to boost exports. (My emphasis)

Which supplements work? New labels may help separate the wheat from the chaff, by Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash University:

The above article references the excellent Four Corners program of 13th Feb 2017 on Complementary Medicine in Australia titled 'Swallowing it'. These are my notes from watching the program:

TGA only requires that a company proposing to see a complementary medicine fill out an Online form, saying the product complies with its rules.

Dr John Skerritt, National Manager, TGA

Products (approved for use in complementary medicines sold in Australia - Neil) have been from facilities that have been inspected and approved by the TGA.

They can only contain ingredients that are permitted, so the safety and the quality is there. They can only make certain claims about indications, so they can't cure cancer, they can't fix arthritis, they can't fix asthma. They can only make general claims about wellbeing.. and so we also monitor claims they make on products and their advertising. But that's done in a post market sense after they are on the market.

Reporter and Associate professor Ken Harvey, Department of Epidemiology and Preventive Medicine,Monash University

Of the less than 500 complementary medicines checked last year of the 11,000 on sale, 80% failed, (mainly because no evidence and false advertising claims, efficacy data is missing and is required but some of them had problems with the product and ingredients as well. 13 products were high risk) but the public are never told which ones, because compliance problems are treated as commercial in confidence.

98% of complaints lodged with the independent therapeutic goods advertising complaints resolution panel were upheld.


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A similar proposition in the UK caused concern. Manufacturing purity - great. How well they work was more of a problem because many traditional and widely used materials have never gone through the double-blind testing that the 'scientists' and big pharma claim as the only route to safety checking have never been carried out. So, whether the item has been used for decades or hundreds of years it doesn't meet this particular 'test'.

There was an attempt to get these products and supplements banned - which is clearly a problem for those who wish to take a more natural and often less harsh route. This led to many protests and eventually there was something of a climb-down. Such products are now labelled as eg. traditional herbal medicinal product used for . . . and 'based on traditional use only'. Widely seen by consumers as a victory for common sense and choice.


More on the situation in Australia regarding 'Complementary medicine (which) has received a lot of attention in the past couple of weeks. First, a study focused on potential safety concerns about taking herbal products. Second, ABC’s Four Corners looked at the need for better regulation of product claims, and questioned the credibility of the pharmacy industry for endorsing and selling these products.

Both of these are particularly relevant, considering complementary and alternative medicines are widely used by different populations and by more than half of all people. People like complementary medicines often because they find such natural alternatives to be more in line with their values and beliefs, and desire to lead a more “natural” life.

However, in many instances complementary medicines have no added benefit when compared to placebo, or weak evidence. These include dietary supplements such as vitamin C and echinacea for the common cold, and weight-loss supplements.

On the other hand, there is evidence for complementary medicines in preventing or managing a range of conditions.


In contrast to pharmaceuticals (otherwise known as conventional “Western” medicines), government typically does not subsidise complementary medicines. Therefore, the cost burden is shifted to consumers. While this is good news for government budgets, consumers need to have confidence the products they’re spending their money on are safe and effective.

All herbal medicines (these are products derived from plant sources and fall under the complementary medicines umbrella) must be listed on the Australian Registry of Therapeutic Goods before they are made available for sale. This gives them an AUST-L number. However, this still relies on the manufacturer’s honesty with respect to its effectiveness.

This stands in stark contrast to pharmaceuticals. These have high up-front development costs, go through rigorous registration processes and have no guarantee of approval. Once pharmaceuticals are approved they are given an AUST-R number, which is different to the AUST-L number.

Nicholas Fuller, Research Fellow, Clinical Trials Development & Analysis, University of Sydney explains how complementary meds end up on our shelves in his article Do you know what’s in the herbal medicine you’re taking? :

Sue Ieraci's comment on the confusion of what is meant by the terms ‘natural’ and ‘herbal’ is pertinent:

Many modern pharmaceuticals were originally derived from plants. Herbs were the pharmaceuticals of the pre-technological era - when there were no methods for analysing or purifying the constituent chemicals, and there was only human observation, via trial and error, with no methods for distinguishing true therapeutic effects from placebo or independent events.

The problem with plants as medicines is that they vary widely in their chemistry, from plant to plant, genetically, as well as regionally and seasonally. They also contain complex mixtures of chemicals - some toxic - in a fibrous matrix. While some herbalists try to argue that this complexity of structure is part of the therapeutic effect, this defies logic.

So, the way pharmacology developed out of herbal medicine was when technology allowed us to isolate the various chemicals, purify and test them, and standardise the dose.

Capsules of ‘herbal medicine’ in bottles, then, are not ‘herbal’. But then there is no advantage to the whole herbs. The fact that they are less pure and less standardised does not confer any magic - they’re just less reliable.

Note the referenced article on green tea extracts causing liver damage: If you are taking green tea capsules/EGCG to slow down your CLL progression, make certain that you are checking your liver function tests regularly, namely your ALT and AST results.

The referenced article also states 'Clinical pharmacokinetic and animal toxicological information indicated that consumption of green tea concentrated extracts on an empty stomach is more likely to lead to adverse effects than consumption in the fed state.', but taking green tea with food binds with the iron in our food, reducing the uptake of this essential element needed to make haemoglobin for our red blood cells. I haven't noticed a difference in my liver function tests or my haemoglobin with changes in when I take green tea capsules, but I do sometimes experience stomach discomfort if I take them an hour or more before a meal.


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