The extraordinary standoff between the Therapeutic Goods Administration (TGA) and the website Homeopathy Plus! has escalated. Well, a bit.
As a bit of background you should know that to be sold in Australia, all health products must be on the Australian Register of Theraputic Goods. For a product to make treatment claims other than an anodyne “may assist with …”, the TGA must see evidence that those claims are supported. Typically this involves boxes and boxes of the original data from animal experiments and clinical trials, which are pored over by independent experts to evaluate the claims. Seriously, the boxes of data from the preclinical work alone can fill an entire wall to chest height.
Making treatment claims without evidence is considered rather naughty, after all the consequences of a product making a claim that it will reduce blood sugar levels in diabetics, when it doesn’t are somewhat more serious that a product claiming to leave dishes sparking clean when it doesn’t.
Back in 2009 a complaint was made to the TGA about advertisements for, amongst other things, “homoeopathic vaccines”, including “vaccines” for meningococcal disease. The meningococcal vaccine was a 10-60 dilution, and therefor has a negligible probability of having any molecule of the starting material in it.
Given that the homoeopaths freely admit this lack of material, and claim that an undefined “energy” is somehow producing this effect, and the seriousness of meningococcal infection, you would expect the TGA would require a bucket load of evidence, along the lines of the masses required for conventional medicines, to allow these vaccines to be licensed to be advertised and sold. A couple of papers in homoeopathic publications so obscure I can’t even find their abstracts will not cut it.
Unsurprisingly, if somewhat slowly, the TGA had determined in August 2011 that Homeopathy Plus! was making claims for homeopathic, homeoprophylaxis and homeoprophylactic products that were misleading and unsupported by evidence (see here for some examples), and told them to alter their advertising and website.
Homeopathy Plus! promptly ignored them.
The next step could have been legal action to force Homeopathy Plus! to make the changes or fine them. Instead the TGA have done the equivalent of looking stern and wagging their finger harder and issued another order for them to alter the advertising and web site and issue a retraction (see the full text in legalese here).
As of this evening (March 29) Homeopathy Plus! has not altered its website. Anyone willing to take a bet on the chances of Homeopathy Plus! complying this time?