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Giving the right teeth to the tiger: creating an effective TGA

Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry…

Some complementary medicines fill a medical need while others are of no value whatsoever. nicholaslaughlin

Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry must have real powers to promote useful products and inform the public of the effectiveness and safety of both types.

Discussions of regulatory requirements for complementary medicines often proceed as though they are a homogenous group. They are not. Some fill a medical need while others are of no value whatsoever.

A number of supplements – such as iodine for pregnant and breastfeeding women and, vitamin B12 for pernicious anaemia sufferers and for vegetarians – are known to be efficacious and this use is endorsed by the National Health and Medical Research Council (NHMRC).

But that’s not to say that all vitamin and mineral supplements are of medical value. For healthy normal adults with no special needs, a balanced diet is the best source of vitamins and minerals.

St Johns Wort Anne Burgess

Then, there are complementary medicines that are never likely to have a scientific basis, such as homeopathic remedies. In 2010, the UK House of Commons Science and Technology Committee concluded that the principle underlying homeopathy was weak and that it should not be funded by the National Health Service.

Some herbal medicines have been investigated by reputable clinicians, but such studies are of little value without standardisation of the products. A 2009 review of St John’s Wort, for instance, concluded that the evidence for its efficacy varied according to different research trials. It concluded that “country of origin and precision with effects size complicates the interpretation”. Other influencing factors include country of origin, harvest time, method of processing, part of the plant used, and how long the harvested plant was stored before use in manufacture.

St John’s Wort contains numerous chemical components, some of which have been identified and many of which have not. It’s not known which of these components contribute to antidepresssant activity so they haven’t been tested as a mainstream medicine would be and standardisation of products is next to impossible.

What’s more, it’s highly likely that different batches of a complementary product will contain different chemicals in different ratios and have different profiles for effectiveness, adverse reactions and interactions with other medicines. To suggest, as some do, that numerous minor ingredients have subtle effects that are beyond conventional medicine to define is to indulge in witchcraft.

If the major active ingredient(s) could be identified and formulated as a standardised medicine, and safety and efficacy demonstrated in controlled studies, then St John’s Wort could make a real contribution to human medicine. The same has been done with other substances of vegetable origin, like digoxin from foxglove, morphine from poppies and and artemisinin, the life-saving drug for malaria from Chinese Sweet Wormwood, all of which became medically reliable when standardised and appropriately developed.

But the ethically dubious promotion of some complementary medicines and their extravagant claims must be restrained. So what is it that regulatory government bodies, such as the Therapeutic Goods Administration (TGA), can do about complementary products?

Regulatory options for the TGA include:

  • Publishing its own reviews of the efficacy of complementary medicines in layman’s terms. There’s already a mechanism for doing this via Medicines Talk, a part of the National Prescribing Service. More publicity and perhaps a sexier title would enhance use of this facility.
  • Monitoring advertising more rigorously. While some companies may advertise appropriately, the notorious case of Sensaslim, described by The Age as a “shonky diet nasal spray”, illustrates the depths to which advertising can fall.
  • Banning payment for items that are represented as “news” in current affairs programs.
  • Abandoning the requirement that sponsors of complementary medicines must hold data to support their claims but need not submit it to the TGA, and instead adopting a universal standard for all medicinal products. Any product that falls short of this universal standard should not be marketed, except with written TGA approval.

This fax was sent to pharmacists.

Instituting such a standard would require compliance with a set of criteria along the lines of – unless otherwise approved by TGA in writing, no medicine may:

  • contain an active ingredient that’s scheduled as prescription-only, pharmacist-only, or pharmacy-only;
  • contain a substance that’s on a list of banned substances;
  • claim efficacy for preventing or treating a serious illness, as defined by TGA;
  • recommend administration other than via oral or topical routes;
  • be manufactured at premises that are not TGA-licensed for that type of manufacture;
  • fail to comply with an applicable official standard published by TGA;
  • claim to be sterile or free of microbes;
  • fail to comply with general limits on microbial load, and the absence of defined pathogens, such as pseudomonads (this is already the case for other oral and topical medicines);
  • fail to comply with general limits on the content of heavy metals and pesticides;
  • fail to include instructions for patients on the container label or in an enclosed consumer medicines information leaflet; and
  • possibly other requirements after consideration by TGA experts.

Chinese Sweet Wormwood Ton Rulkens

The consequences for the TGA if it adopted these criteria would be:

  • a reduced commitment of resources to the existing “pretend” regulating;
  • a focus on random and targeted sampling and testing, including review of labelling;
  • a focus on review of advertising; and
  • no imprimatur for safety and efficacy of medicines that TGA hasn’t evaluated for these things (perhaps these medicines should be labelled as such).

But strong action, including publicity for recalls in the event of non-compliance, would be required to accompany such changes. The consequences of strong TGA action (even if not well handled at the time) for Pan Pharmaceuticals, which collapsed soon after a recall of a large number of products, were dire. It wouldn’t take many such events to have a salutary effect on the whole industry.