Tougher Regulation of Complementary Medicines Needed

Dr Ken Harvey, Adjunct Senior Research Fellow of the School of Public Health at La Trobe University in Melbourne, and his co-authors say the current controls on the supply and promotion of complementary medicines in Australia are weak.

Complementary and alternative medicines (CAM) are classified by the Therapeutics Goods Administration (TGA) as 'listed goods' and are not evaluated for efficacy. In contrast, 'registered medicines' are individually evaluated by the TGA for quality, safety and efficacy before market entry.

"Despite the widespread and increasing use of CAM, many consumers are unaware that listed medicines do not undergo the same stringent evaluation process as registered medicines," Dr Harvey says.

The authors found that, from 1996 to 2006, over 1000 CAM 'weight loss' products were listed by the TGA; most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy.

Promotional claims made about these products were often not in accord with the scientific evidence available. Over the same period, only nine conventional 'weight loss' medicines were registered; each contained one evaluated ingredient of proven efficacy.

"Our investigation shows that failure to evaluate listed products for efficacy has created a commercial opportunity for the sponsors of CAM products at the expense of informed consumer choice and protection," Dr Harvey says.

"Complaint procedures (now overloaded) are no substitute for adequate regulation at the time of market entry."

The authors list a number of recommendations to improve the regulation of CAM, including:

• public education campaigns to inform consumers of the current regulatory processes,
• more stringent sanctions for companies that repeatedly breach marketing codes, and
• assessment of the efficacy of CAM by the TGA..

The Medical Journal of Australia is a publication of the Australian Medical Association.