Complementary medicines

Complementary medicines make a range of claims about their effectiveness, but these claims are not always backed up with sound evidence.
 
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  • Updated:2 Dec 2008
 

01 .Introduction

Mother caring for sick child

The issue

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 campaigns@choice.com.au

Read one consumers' experience  with making a complaint.

 
 

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02.A consumer's story: testing the claims

 

The purpose of advertising is to attract consumers’ attention. Where goods are concerned, the intention is that they be purchased. Claims make the product attractive, but in some fields, for example the complementary medicine area, there can be a lack of evidence to support product claims.

A consumer’s story about testing the claims made by a sponsor of a complementary medicine

I recently noticed a product called Immune Plus, claiming to help consumers fight flus and viruses advertised in a newspaper. Curious, I looked on their website for supporting evidence and considered the claims unjustified.

Who to write to with a complaint? This is what I discovered:

  1. There is a Therapeutic Goods Advertising Code 2005 which I found (eventually) and downloaded from the website of the Department of Health and Ageing, Therapeutic Goods Administration (www.tga.gov.au). It took time to read the 18 page document and seek sections relevant to my queries. Some were unclear.
  2. I learnt that advertisements for complementary healthcare products must be submitted to the Complementary Healthcare Council (CHC) or the Australian Self-Medication Industry (ASMI). I assume for approval. It was unclear which one I should complain to at first and I chose the wrong one, it ended up having to go to the CHC. All specified media advertisements must display the current approval number allocated to that advertisement. This product had such a number.
  3. My complaint citing possible infringements of the code was passed from the Complaints Resolution Committee to the Complaints Resolution Panel (how confusing is that!).

I was very happy with the process and outcome that followed:

  • My complaint was forwarded to the marketing company by the Complaints Resolution Panel asking for a response.
  • In reply the company justified their position. One comment I had made was that the ‘claims are not verified’. The company’s response was that this complaint ‘is not based on any fact and no supporting reasons are included in the complaint’.
  • The Complaints Resolution Panel considered my complaint and the response of the marketing company. In a detailed, 4 page report they pointed out that I had misinterpreted the code in making my complaints, perhaps not surprising since I found it ambiguous at times. However, they identified matters not specified in my complaint which could contravene regulations, including the TGA Code and requested the company to respond. I considered these were related to the essence of my concerns. Perhaps had I spent more time matching code and advertisement I would have found more matters of complaint.
  • The outcome is that the company was requested to withdraw the advertisements from further publication.

So I feel I won. Even if the process took some months to investigate and resolve.

However, I have major concerns:

  • How did this product receive an approval number permitting it to be advertised?
  • What safeguards are in place to ensure complementary medicine ads meet the TGAC criteria for approval?
  • Does this process need tightening up?

We know that as many as half the adult population uses alternative therapies. Few realise they have little evidence to support claims and worse, that some may react adversely with prescribed medicines. Consumers need better protection.

This consumer has decided to remain anonymous.