Australasian Science: Australia's authority on science since 1938

TGA Endorses Pseudoscience for Complementary Meds

By Ken Harvey

We are about to be exposed to hundreds of approved “remedies” that are ineffective at best and potentially dangerous.

Higher-risk medicines (all prescription medicines) are regulated by the Therapeutic Goods Administration (TGA) as registered medicines (labelled AUST R). They are thoroughly evaluated for quality, safety and efficacy prior to market release (except for some “grandfathered” products), and receive stringent post-marketing surveillance.

By contrast, most complementary medicines are regulated by the TGA as lower-risk listed products (labelled AUST L). These have no pre-market evaluation, limited post-marketing surveillance and no effective penalties for companies that breach the rules.

This “light touch” regulation trusts companies to meet TGA quality and safety standards and hold evidence supporting the indications and claims made. Regrettably, the trust placed in the complementary medicines industry is misplaced. The TGA’s limited post-marketing surveillance has consistently shown high levels (around 80%) of regulatory non-compliance. Many proposals to improve this situation are currently under consideration, the most recent being a TGA draft list of “permitted indications” for listed complementary medicines.

The aim was to eliminate the industry’s use of creative, voluminous free-text “indications” for their products, entered online (without TGA oversight) as part of their listing application and used in unjustified advertising claims.

Instead, industry was to be restricted to a limited list of “low-level” permitted indications for listed products, such as “may relieve the pain of mild osteoarthritis”. If a company wanted to use an “intermediate-level” indication or claim such as “our formulation of cranberry powder reduces the frequency of recurrent urinary infections in women” then a new assessment pathway was proposed that involved the company submitting clinical trial data for assessment by the TGA.

The rarely used registration pathway would still be available for complementary medicines with clinical trial evidence to support “higher-level” claims. More effective sanctions and penalties for companies breaching regulatory requirements were also part of the reform package.

At the TGA stakeholder meeting on these reforms, consumer representatives (including myself) argued that the proposed list should be short and contain only modest claims such as “may assist” and “may help”. In addition we argued that, for consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer similar to that used in the USA for homeopathic products. For example:

Traditional use does not imply efficacy or guarantee safety. This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no scientific evidence that this product works.

Industry representatives argued that they needed a long list of “permitted indications” to obtain market differentiation of their numerous products, and disclaimers were unnecessary.

The draft list now released by the TGA is based entirely on industry submissions and ignores consumer concerns. It contains 1345 “permitted indications”, many of which appear to lack scientific evidence, such as “supports transport of oxygen in the body”, “regulates healthy male testosterone levels” and “relieves muscle cramps (and restless legs)”.

The list also contains around 140 Traditional Chinese Medicine (TCM) indications such as “harmonise middle burner (spleen and stomach)”, “unblock/open/relax meridians” and “balance yin and yang”. Finally, there are around 900 additional “traditional indications” including “renal tonic”, helps healthy liver regeneration”, “vermifuge” and “vulnerary”! What will consumers make of these indications, especially without the disclaimer suggested above?

While industry is no doubt delighted by the TGA’s capitulation to their submissions, my own view is that the TGA’s acceptance (and endorsement) of this draft list represents official government acceptance of pseudoscience. Worse, it will encourage consumers to purchase often ineffective and potentially dangerous products to the potential detriment of their health.

The increasing promotion and popularity of traditional medicines are associated with perceptions that they are safe, but this belief is belied by the emerging body of data highlighting the true prevalence of adverse reactions and drug interactions. In China, of the 1.33 million adverse drug event reports received by the National ADR Monitoring Center in 2014, TCM drugs represented around 17.3% (about 230,000 cases).

Indications based on scientific evidence must be capable of substantiation. Indications based on “traditional use” must have a disclaimer on the label and all promotional material pointing out that “traditional use does not imply efficacy or guarantee safety”.

Dr Ken Harvey is Associate Professor in Monash University’s School of Public Health and Preventative Medicines, and the Choice consumer representative on TGA meetings about complementary medicine reform.