Australasian Science: Australia's authority on science since 1938

When ARTG and CAM Spell SFA

By Rachael Dunlop

Recent moves to improve the regulation of alternative medicines looked promising until the Therapeutic Goods Administration caved under pressure from the industry.

Readers might recall recent moves by the Australian government to remove $30 million in private health insurance subsidies for complementary and alternative medicine (CAMs). On the chopping block were homeopathy, aromatherapy, ear candling, crystal therapy, flower essences, iridology, kinesiology and naturopathy.

The basis for the cuts is that there is scant evidence these remedies are effective beyond placebo, and some are just pure pseudoscience. Indeed Prof Ken Harvey, an outspoken advocate for evidence-base medicine, welcomed the move, saying: “If there is no good evidence that they are better than a placebo, then they should not be funded by the taxpayer”. And I agree.

It’s a breath of fresh air to see the government take affirmative action on subsidising pseudoscience. They have taken their lead (at least in part) from the UK. In 2010, following a thorough assessment of the evidence (or lack thereof) for homeo­pathy, the UK government declared that homeopathy is no more effective than a placebo.

Just over 2 years later, a draft statement from the Australian government stating it was “unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy… has been shown not to be efficacious” was leaked. This statement remains in draft form, but it’s a step in the right direction for evidence-based medicine.

More encouraging signs came with a proposal to tighten up the “evidence” required to get CAMs listed on the Australian Register of Therapeutic Goods (ARTG). Under the current system, all that is needed to get CAMs such as supplements stamped with an official-looking government number called an Aust-L is to make an online application, select from a list of pre-approved ingredients, indicate that there is evidence that the product is useful, and sit back and wait.

But the proposed changes to the ARTG had the CAM industry crying that the end was nigh. The proposal required the CAM industry to document evidence of efficacy for products in the form of an expert report consisting of a comprehensive analysis of all the scientific evidence going back at least 10 years and sourced from at least two scientific databases. The government also indicated that not just any old studies would do, citing meta-analyses (analyses of analyses) as the gold standard for evidence.

The proposal went even further, stating that these studies must specifically support the claims of the product. Thus, for a product claiming to be effective at weight loss, studies that describe body reshaping or improved muscle mass were not acceptable.

As you can imagine, this would be a gargantuan and time-consuming task. As testament to this, the government recommended that applicants seek the assistance of a librarian to collate the expert report.

The recommendations even defined what exactly constituted an “expert” – someone who had either a specialist medical qualification or a tertiary degree of at least 3 years duration in a health profession. The expert must also have completed either a course in critical appraisal or biostatistics from a tertiary institution, or hold a PhD in a scientific or health-related discipline.

That’s a lot of qualifications. And people with that many letters after their names don’t generally give their time for nothing. At least, not as much time as such a detailed report will require. So this was going to hit the CAM industry hard – in the hip pocket.

I was impressed with this draft legislation, except for one critical aspect. The expert report would not be required to be submitted with the application for listing a product. Applicants had to state they had it, but they only needed to produce it if they were audited – and the chances of that were about as likely as finding a molecule of the original compound in a 12C dilution of homeopathy.

I submitted feedback on this aspect of the legislation when the Therapeutic Goods Administration was asking for public comment. I praised the TGA for this move towards evidence-based medicine, and suggested that asking for the report to be submitted with an application would go even further to strengthening consumer protection.

It appears I needn’t have wasted my breath, or rather my interwebs as the government has caved in to pressure from Big CAM and cancelled the draft legislation altogether. Thus they will continue to lend legitimacy to products for which there has likely been no evidence presented nor any tests for efficacy performed.

It remains up to the consumer to differentiate between which products stamped with an official-looking government number either work, are placebos or, even worse, can be harmful.

It’s no wonder the TGA are known to their critics as a paper tiger. All bark and no bite.

Rachael Dunlop is a medical researcher focusing on the causes of motor neurone disease. She is a Vice President of Australian Skeptics Inc, blogs at The Skeptics Book of Pooh Pooh, and tweets @DrRachie.