MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Guest post by: Loretta Marron

In March 1991, the Australian College of Allergy published an article in the Medical Journal of Australia (MJA) about a ‘bioresonance’ device for allergy testing. Titled “VEGA testing in the diagnosis of allergic conditions”, it stated that it was “an unorthodox method of diagnosing allergic and other diseases” with “no established scientific basis” and “no controlled trials to support its usefulness”.

The article raised concerns that this test “may lead to inappropriate treatment and expense to the patient and community”. VEGA is one of nearly 30 ‘energy medicine’ devices, some of which continue to cite Therapeutic Goods Administration (TGA) ‘listing numbers’.

Sometime costing more than $34,000, the sponsors tell practitioners that they can earn up to $150,000 annually with these computerised devices. Referring to ‘bioresonance’ as “the medicine of the future”, they claim that all toxins, viruses and bacteria have unique ‘frequency patterns’, which, when ‘neutralised’ by the device, restore the patient to health. They may also claim that it can cure addictions to alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, ‘legal highs’ and other medications. Some claim that it can cure cancer, hay fever, allergies, auto-immune diseases, behavioural problems, smoking addiction and that they can kill parasites – the list goes on.

The devices are ‘based’ on acupuncture, homeopathy and ‘quantum physics’. More than 60 reviews in the Cochrane Collaboration (the ‘Gold Standard’ for evidence-based Medicine), have failed to find robust evidence for clinically significant outcomes for acupuncture for any disease or disorders. The National Health & Medical Research Council concluded, “there are no health conditions for which there is reliable evidence that homeopathy is effective” and quantum physics “is not at work”. In February 2020, nearly 30 years after that MJA article, the TGA’s cancellation of two of these devices saw the last of them removed from their register, but not from permissible advertising or practice.

From 2014 to 2018, Friends of Science in Medicine (FSM) had repeatedly written letters and submissions to the TGA asking for these devices to be investigated. Meeting with the national manager in 2016, we were told that these devices could not be cancelled because they were ‘biofeedback’ devices, which had a legitimate place in health care. In 2018, FSM sourced comments from informed experts here and overseas. These disputed the ‘biofeedback’ claim. FSM sent screenshots from more than 200 websites to the TGA advertising complaints. In 2019, after issuing a warning on bioresonance, the TGA closed the complaints and commenced an ‘education campaign’. They also engaged a credible Australian scientific organisation to review the evidence provided by eight ‘sponsors’ of 12 bioresonance’ devices listed in the Australian Register of Therapeutic Goods).

All devices have now been cancelled by their sponsors or by the TGA. The ‘education campaign’ continues. Even though the devices are still widely used, and courses still being run, FSM considers this a modestly satisfactory outcome.

Informed opinions:

Biofeedback:

o Michelle G Aniftos BCN, FCCLP, QEEGD, MEd, MPsych (Clinical), GradCertClinNeurophysiology, Fellow, Biofeedback Certification International Alliance, &

o Dr Tania M. Slawecki, PhD. Energy and the Environment Laboratory (formerly Materials Research Lab), Penn State University, USA (Author of “How to Distinguish Legitimate Biofeedback/Neurofeedback Devices”;

Electronic devices:

o Dr Stephen J Roberts, BSc ARCS DIC PhD. Consultant on electronic devices;

Psychology:

o Emeritus Professor Joseph P Forgas, AM, DPhil, Dsc (Oxford), FASSA, Scientia Professor, Psychology, UNSW &

Alternative medicine:

o Emeritus Professor Edzard Ernst MD, PhD, FMed Sci, FSB, FRCP, FRCP(Edin)

Their comments include the following:

· Ms Aniftos: “Having reviewed the specifications of the BICOM device, I find that its inclusion on the ARTG as a ‘biofeedback device’ is erroneous”;

· Dr Slawecki: “the BICOM device does not fit the criteria of a legitimate biofeedback device”;

· Dr Roberts: “The claims of how the BICOM and CyberScan work are preposterous.”Quantum physics” is not at work”;

· Professor Forgas: “The BICOM is NOT a biofeedback device and should be cancelled”; “The description of this device makes it crystal clear that it cannot possibly have any effective diagnostic or therapeutic function, and certainly has nothing at all to do with biofeedback.

“The claims made for the device amount to the worst kind of psychological manipulation, and their sole purpose is to mislead and exploit vulnerable people for financial gain. As a civilised society, we should not allow this kind of immoral exploitation to continue and the device should be banned forthwith”;

· Professor Ernst: “Bioresonance is not biologically plausible, not of proven effectiveness, potentially harmful and associated with exorbitant costs. I cannot recommend it for anyone or any purpose”.

17 Responses to Australia cancels all Bioresonance devices

  • The UK situation is much worse. Most of the many `bioresonance’ devices on the market have CE marking, which means nothing other than that they have have safety certification. Manufacturers claim that this is regulatory approval, but it isn’t. No such product has any approved diagnostic or therapeutic applications. CE marking is conferred by notified bodies, which are independent organisations approved by the EU. For UK bioresonance products I am not aware of any notified body based in the UK. They are usually in eastern Europe, and don’t reply to enquiries. It is very difficult to find out the regulatory status of any medical device, as the MHRA does not keep records of any approvals by notified bodies outside the UK. Neither does the MHRA regulate marketing claims – it says that any complaints must go to the Advertising Standards Authority. Excellent as the ASA is, it applies only a voluntary code and I have yet to see any manufacturer take the slightest notice of any ASA action. So despite the MHRA being the statutory regulator of medical devices, and these products make medical claims, the MHRA does not actually regulate the products at all. Hence any adverse ruling by the MHRA would mean nothing anyway, because it never approved them in the first place.

    • CE marking is conferred by notified bodies

      Not even that. A CE marking is nothing but a statement from the manufacturer that basically says “This product complies with EU safety and EMC directives”.
      The vast majority of products is CE self-certified, which means that the manufacturer or seller simply slapped on the CE sticker, without any involvement of a notified body or other certification agency. One can only hope that the manufacturer is speaking the truth – which often is not the case, especially with cheap products originating from China and other countries in the Far East. For instance, I’ve seen CE-marked USB charging circuits that were directly connected to mains voltage levels, with potentially lethal consequences

      Even for medical devices (BTW, I’m a biomedical electronics engineer), self-certification used to be allowed for Class 1 medical devices, which means that these devices were not life-critical and could not present hazardous voltages or currents to the patient. Higher class devices, however, did require certification by a notified body.
      As of 2017, higher standards applied as per the Medical Device Regulation (MDR), and these are actually mandatory for all existing and newly designed devices as of tomorrow (May 26th).
      Unfortunately, not only is there a huge waiting list with the notified bodies for devices to get registered and approved, with at least a 6-month backlog, but quite a few guidelines and regulations are so poorly defined that they are practically unworkable, and cause far more uncertainty than they solve.

      Things are becoming even more complicated now, because the MHRA no longer resorts under EU regulations, and any clarity with regard to actual regulations is hard to get. As an example, I was asked in March if I could design a cheap and easy-to-build patient ventilator controller, but still in accordance with a list of MHRA guidelines. Because of the coronavirus crisis, normal certification procedures could be suspended, and a fast-track approval for emergency use was promised.
      But alas, even though the designs were ready within a week and complied with the guidelines, approval never materialized due to of ‘internal incompatibilities within regulatory bodies’. So my contractor decided to pull the plug on the project, and that was a wise albeit rather frustrating decision.

      As for all those quack devices: I’m afraid that most of these will simply be offered without any explicit medical or health claims whatsoever, thus avoiding expensive certification by notified bodies. On the other hand, I wouldn’t be surprised if the more lucrative of these are offered for certification by a notified body, because certification is only based on safety and EMC regulations, not on actual functionality.

  • Congratulations Doctor. A small but very significant victory and one that can be cited around the world.

  • Well done. Thank you.

  • I’m under the impression that the folks ‘down under’ are rather more rational than elsewhere in the world. This isn’t the first time that Australian organizations clamp down on fraudulent quackery and related fear mongering; I recall a regulatory authority imposing a huge fine on homeopath Frances Sheffield for false antivaccine propaganda. And I believe there was another similar case even more recently (although I’m not completely sure).

    Anyway, well done! Let’s hope that more countries will take a closer look at all the ongoing SCAMs endangering people’s health, or at least their wealth. Because even if most SCAMs have relatively little consequence from a medical point of view, they still cost the patient money.

  • The recent case Richard Rasker refers to above is that of unqualified crank and TV cook Pete Evans, who was selling a “subtle energy platform” product online called the ‘BioCharger NG’ for AUD$15,000, which he claimed had a “recipe… there for Wuhan coronavirus”. After investigation, the TGA issued two infringement notices to Peter Evans Chef Pty Ltd totalling AUD$25,200.

    See https://en.wikipedia.org/wiki/Pete_Evans

    Many Australian chiropractors still sell quack therapies, including ‘bioresonance’ snake oil. FSM and the Australian Skeptics continue to lobby the regulators to do more to protect the public. This chiroquack is still advertising it at https://www.onewaychiropractic.com.au/bioresonance-therapy/

    • Ken McLeod. Perhaps you could do a review of this medical practitioner. First, his list of qualifications, are they legitimate and also his “claims to fame”.

      It might be more interesting for you to do, than focus on “non-risk therapeutics”.

      https://www.linkedin.com/in/geoff-edelsten-551944151/?originalSubdomain=au

      • @GibletGiblet (Kiwi chiro crank),
        “non-risk” therapies, like chiro, which does nothing but kills through ruptured cervical arteries?

        Is there any hope you might make sense at any point, rather than continuing to advocate for the same discredited chiro nonsense?

        BTW, using Tu Quoque only shines more light on your ignorance and lack of understanding of reason and logic. It is tiresome to read the same tripe, with ho effort to educate yourself about basic schoolyard stuff.

  • Clarification: A ‘cancelled’ device is one that is no longer included on the ARTG (Australian Register of Therapeutic Goods). This is a list/database, maintained by Australia’s Therapeutic Goods Administration (TGA). All bioresonance devices have now been ‘cancelled’ in Australia, therefore sponsors must cease advertising them. Strong penalties apply for sponsors that advertise a cancelled device. https://www.tga.gov.au/advertising-advertising-code-and-guidance

  • Congratulations to Loretta Marron and everyone involved. Even if these devices are still out there, at least they no longer have the regulatory legitimization that the TGA’s Register had conferred. That in itself is a great step.

  • I have simply heaps of good quality anecdotal evidence that these machines are at least three times more effective than acupuncture and twice as effective in comparison to homeopathy. How can you argue with that eh?

    Oh, nearly forgot – what about the 1918 flu epidemic eh? And also, real medicine sometimes makes people a bit poorly so VEGA testing must work, it’s a well known fact!

    Seriously, this is excellent news – can we have a link to the original paper please?

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

If you want to be able to edit your comment for five minutes after you first submit it, you will need to tick the box: “Save my name, email, and website in this browser for the next time I comment.”
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories