Complementary medicines make a range of claims about their effectiveness, but these claims are not always backed up with sound evidence.
Worse, in some cases, complementary medicines can harm consumers’ health. Current regulatory action does not do enough to protect consumers.
The Therapeutic Goods Administration (TGA) classifies medicines into two main categories, 'Listed' and 'Registered', but most consumers don't know the difference.
Listed (AUST L) medicines:
- are considered to be 'low risk' by the TGA
- companies are required to hold evidence to prove they work but are often not asked to produce it
- complementary medicines generally fall into this category, for example, herbal medicines, vitamins and mineral supplements.
Registered (AUST R) medicines:
- are considered to be 'high risk' by the TGA
- are subject to stringent testing for safety, quality and efficacy
- prescription drugs usually fall into this category, for example, antibiotics
The TGA claim that approximately 25% of new listing applications are assessd each year for compliance with requirements, including that sponsors must hold evidence to support promotional claims made. However, we understand that the TGA does not assess this evidence for quality, nor are literature searches performed to see if more recent clinical trial evidence contradicts that submitted by the sponsor. Our Choice investigation into weight loss products found that the evidence companies hold is often insufficient to substantiate the claims made.
There are over 16,000 complementary medicines listed with the TGA. The industry enjoys an annual retail turnover of more than $800 million. This is not surprising as more than half of Australia’s population has used at least one complementary medicine.
Just because you don’t need a prescription, doesn’t mean it’s completely safe. Although complementary medicines are considered ‘low risk’ by the TGA, they can still harm consumers by producing side-effects and interacting with other drugs. Three percent of reports to the Adverse Drug Reactions Unit (ADRU) of the TGA are for complementary medicines and another 3% for over the counter products. It depends on how your body reacts to different drugs and what other medication you are taking.
Apart from health consequences, financial costs are also a concern. It is natural to make an assumption that because a product is on the market, that it's effective and has been tested. Consumers may be wasting money on products which simply do not work.
We support consumers having the right to choose from a variety of treatments offered in teh market place. However, good decision-making requires evidence-based information about risks and benefits, regardless of whether the medicine is prescription or complementary.
What we want
- Complementary medicines should be evaluated in the same way as other pharmaceutical products. As an interim measure we support an opt-in system where a manufacturer could choose to pay an additional fee to have the effectiveness of their complementary medicine independently evaluated. A product with reasonable evidence of effectiveness would be awarded a 'Green Tick' similar to the National Heart Foundation 'Red Tick'.
- A disclaimer for the label and advertising material of products whose sponsors choose not to pursue the opt-in system above as such as, 'This medicine has not been evaluated by Australian health authorities for efficacy'.
- The provision of up-to-date, independent, evidence-based information about the benefits and risks of complementary medicines (the National Prescribing Service would be an appropriate organisation).
- A more effective responsive advertising complaints system which will deter breaches of the rules. This should include fines to deter repeat offenders and help fund a more responsive system.
What we’re doing
CHOICE is lobbying the Senator Jan McLucas, Parliamentary Secretary to the Minister for Health and Ageing, and the TGA on these and other issues. We participate as a member of the Complementary Medicines Implementation Group (CMIRG) to ensure effective implementation of the recommendations made by an expert committee about changes to the complementary medicines industry.
In a letter published in The Age, CHOICE argued that the effectiveness of all products sold as 'medicines' in Australia should be regulated.
See also the article by Ken Harvey, Viola Korczak (former CHOICE health policy officer) and others in the Medical Journal of Australia.
What you can do
To check ingredients of complementary medicines for evidence of effectiveness go to the U.S. National Centre for Complementary and Alternative Medicine (NCCAM) website.
Find out more or make a complaint about the Therapeutic Goods Advertising Code and remember to send a copy of your complaint to CHOICE at firstname.lastname@example.org
Read one consumers' experience with making a complaint.