The Therapeutic Goods Administration (TGA) has published a draft list of “permitted indications” for listed complementary medicines that includes many terms and concepts that are straight out of the pseudoscience catalogue.
“Permitted indications” are statements that will describe the therapeutic uses for listed medicines. When the permitted indications reform is implemented, sponsors will be required to use them to enter their product indications in the Australian Register of Therapeutic Goods. Permitted indications will be assessed against a set of eligibility criteria to ensure that they are appropriate for low risk listed medicines that are not assessed pre-market.
The Commonwealth Government announced in September last year that the TGA would introduce such a list, with the purpose of:
• ensuring that listed medicines can only make low level indications that are suitable for medicines that do not undergo pre-market assessment;
• providing transparency for sponsors on what indications are suitable for listed medicines to help prevent inadvertent non-compliance; and
• avoiding consumers being misled by inappropriate indications on listed medicine labels.
Dr Ken Harvey, a regular campaigner against pseudoscientific claims in the alt med industry, says that among the 1345 permitted indications in the draft list are many which lack evidence, and for which complaints have previously been upheld by the TGA Complaints Resolution Panel, such as #740-747 Muscle cramp (typically claims made for magnesium).
“In addition, the list contains numerous nonsensical TCM ‘traditional indications’ without any disclaimer, such as #1 ‘Harmonise middle burner (Spleen and Stomach)’; #6 ‘Unblock/open/relax meridians’; #115 ‘Balance Yin and Yang’.”
Other ‘traditional indications’ are “Emmenagogue”, “Lactifuge”, “Sialagogue”, “Vermifuge” and “Vulnerary”.
Harvey and others had argued that the proposed list should be short and only contain modest claims such as, “May assist”, “May help”, etc.
“In addition, we argued that, for consumers to make an informed purchase, claims based on ‘traditional use’ should always have a disclaimer along the lines of what the US FTC proposed for homeopathic products: ‘Warning: 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.’”
However, industry representatives argued that they needed a long list of permitted indications to obtain market differentiation of their numerous products and that disclaimers were unnecessary, or would be misunderstood, or would have no impact on consumers.
The list is due to come into effect at the start of next year, with the draft lists available on the TGA website until October 31, 2017. During this period, interested parties, including suppliers, can review and provide comments on the list and propose additional indications or evidence qualifiers prior to the lists being finalised.