The TGA and bioresonance: RIP
In a fun sequel to Ken Harvey’s May talk, July brought a detailed examination of the legal guidelines surrounding alternative therapies and the work in amending the restrictions to encourage more evidence-based practices from Lorretta Marron of the Friends of Science in Medicine.
Since the early 19th century, various forms of electrotherapies have claimed to be able to cure everything from tuberculosis to spinal deformities. Legal restrictions relating to these therapies have historically been relatively ineffective, such as in the case of the Vega electroacupuncture device which purported to diagnose a range of conditions, from allergies to anxiety. These devices received praise from homeopaths and complaints from medical organisations, with a 1991 MJA article stating it was an “unorthodox method…with no established scientific basis [or] trials to support its usefulness”. However, despite the dearth of evidence and a scathing review from the Australasian Society of Clinical Immunology and Allergy, the Vega remained listed with the TGA until 2010.
The concept of traditional health knowledge combined with modern technology is appealing to many, despite hundreds of complaints against their misleading claims. So, close behind the Vega came the BICOM, the ‘medicine of the future’, allegedly able to neutralize any toxins or pathogens, for the low, low price of $34,800. Understandably, many medical organisations, including the Friends of Science, submitted complaints to the TGA, who persistently refused to deregister it on a technicality. Their inefficacy was thoroughly confirmed in 2018 by a team of international experts in physics, neurophysiology, and complementary medicine, who condemned the BICOM as “not biologically plausible” and “potentially harmful”, and its claims as “preposterous”, “immoral exploitation”, and “the worst kind of psychological manipulation. Nearly a decade after its release, the TGA finally undertook a review of biofeedback devices and requested that companies provide clinical evidence to substantiate their claims and comply with regulations.
So, are these devices still allowed? Well, some aren’t – as of last year, 15 products have been removed from the national Register of Therapeutic Goods. However, over 60% of these companies still make claims on their websites. Many other devices available in Australia remain unlisted, although some are under TGA review. Given the amount of work it takes to have one product deregistered, compared to the ease with which multi-level marketing schemes continue to advertise their supposedly magical ‘therapies’, it seems like it might be a while before these fraudulent products are off the market, so support the work of FSM at www.scienceinmedicine.org.au.
Listen to Loretta's talk: here Slides:
About the speaker:
Loretta Marron OAM is a science graduate with a business background, who is a high-profile campaigner against unproven and disproven health interventions. She was named Australian Skeptic of the Year in both 2007 and 2011 and again in 2012 as part of the Friends of Science in Medicine group which she cofounded in 2011. She is the only person to have won this award more than once. Loretta was granted a 2014 Medal (OAM) in the General Division of the Order of Australia “for service to community health”. Find out more at https://en.wikipedia.org/wiki/Loretta_Marron