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”.
23 Responses to Australia cancels all Bioresonance devices
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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.
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.
@ Richard Rasker
I’ve been asked to write about this for a charity newsletter. may I use your comments, suitably attributed?
Congratulations Doctor. A small but very significant victory and one that can be cited around the world.
congrats to Loretta Marron!
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.
Australian consumer organisations have been pushing the Australian Therapeutic Goods Administration (TGA) to get more teeth for some time. Purveyors of so-called ‘low-risk’ therapeutic goods have been allowed to flood the Australian market with shonky but profitable products for years; a consequence of a ‘trust-based’ regulatory system with no pre-market evaluation and failure to apply effective sanctions to companies who repeatedly break the law.
More recently,the TGA has been given the new investigative compliance powers which they are slowly starting to use, see:
https://www.tga.gov.au/infringement-notices
https://www.tga.gov.au/media-release/federal-court-australia-grants-interim-injunction-prevent-advertising-evolution-supplements-australia
https://www.tga.gov.au/media-release/civil-penalties-ordered-against-peptide-clinics-pty-ltd-advertising-breaches
There is also an independent inquiry into the new TGA advertising framework, see:
https://www.medreach.com.au/independent-review-therapeutic-goods-advertising/
https://www.medreach.com.au/independent-review-consumer-consultation/
With respect to bioresonance machines, I have suggested that the TGA applies s.19D of the Therapeutic Goods Act, ‘civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods (including supply of product not on ARTRG) to https://bicomaustralia.com.au/; Maximum civil penalty: for an individual—5,000 penalty units (currently A$210); and for a body corporate—50,000 penalty unit.
I’ve also suggested multiple infringement notices should be applied to alternative health practitioners who use these machines and advertise numerous claims that lack scientific evidence (including prohibited and restricted representations); the penalties for an individual—12 penalty units; and for a body corporate—60 penalty units.
Consumers will only be protected from shonky therapeutic goods when the penalties applied by the regulator outweigh the profit that currently comes from breaking the rules.
Dr Ken Harvey, MB BS, FRCPA, AM
President, Friends of Science in Medicine
https://www.scienceinmedicine.org.au/
Meanwhile, whilst Ken Harvey and his ilk wax lyrically over the dangers of some low risk therapeutic goods, Paracetamol is prescribed in abundance as the “go to drug”, for low back pain and most other pain of neuro-musculo-skeletal origin even though it is no better than a placebo. It can do significant damage to the liver. Then there is the over prescription of opioids in the U.S. that has killed hundreds of thousands of people. Corrupt science working here Ken, yet your group is surprisingly quiet about these issues.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30489-6/fulltext
Then there are some serious issues with orthopedic surgery for knees that is ineffective.
Just remember Ken, for every finger you point to someone else, you are pointing three back at yourself.
please take a little time and learn about logical fallacies.
you might produce less nonsense when you comment next time.
thank you.
This may be a good opportunity to point out this tidbit of linguistic curiosity:
https://www.urbandictionary.com/define.php?term=Gibley
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?
I have had positive personal benefits for myself and family members. After lengthy treatments with steroid wet wraps and light therapy we turned to Bio Resonance as an alternative to Methotrexate for my 10 year old. After years of horrific rashes and itching his skin issues resolved in 6 one hour treatments over 3 months. I personally know people with chronic auto immune problems who have found benefit and relief of symptoms from Bio Resonance. While we have many more measurable sometimes miraculous treatments today, usually pharmaceutical drugs, this form of therapy should not be dismissed. My body my choice.
Loren
The plural of anecdote is not evidence. Yes you do have choice, but it should be informed choice. What happens if you make the wrong decision, and need real medicine to get you out of trouble? You are free of course to refuse that and die.
Loren,
I am not very clear from your post whether the rashes and itching were caused by the methotrexate or a feature of the (presumably autoimmune) condition that it was prescribed in order to treat. Nor am I clear whether the light therapy you refer to is a conventional treatment such as PUVA (the use of psoralen drugs activated in the skin by exposure to ultraviolet light) or something else entirely.
It would be helpful if you could provide a bit more detail to help us understand what points you are making.
Your child clearly has a very serious medical problem if he or she has been prescribed lengthy courses of steroids, which have serious adverse effects on growth and development, let alone a strong immunosuppressive drug such as methotrexate, which is also a cytotoxic. No paediatrician would prescribe these drugs lightly, nor risk stopping them suddenly without good reason.
I am pleased to hear that their condition is improving, though this is more likely due to their immune system changing as they get older than as a result of bioresonance.
Iatrogenic harm looks to be creeping up to a leading cause of death in the world. This from WHO:
Administrative errors account for up to half of all medical errors in primary care
Recent literature reviews have revealed that medical errors in primary care occur between 5 and 80 times per 100 000 consultations. Administrative errors – those associated with the systems and processes of delivering care – are the most frequently reported type of errors in primary care. It is estimated that from 5 to 50% of all medical errors in primary care are administrative errors.
Patient harm is the 14th leading cause of the global disease burden, comparable to diseases such as tuberculosis and malaria
It is estimated that there are 421 million hospitalizations in the world annually, and approximately 42.7 million adverse events occur in patients during these hospitalizations. Using conservative estimates, the latest data shows that patient harm is the 14th leading cause of morbidity and mortality across the world.
https://www.who.int/news-room/facts-in-pictures/detail/patient-safety
In this article, it is called ‘unacceptable’ – yet it seems so accepted, soon to take the No 1 spot thanks to the big push for mRNA vaccines (not a vaccine). – soon to be halted I hope.
https://www.who.int/news/item/13-09-2019-who-calls-for-urgent-action-to-reduce-patient-harm-in-healthcare
The level of myocarditis detected in my clients is horrific since this roll out.
Come meet me.
Bioresonance has killed no-one and never will. I use it and have directly benefitted. You cannot argue with that.
I do not hold out much hope for allopathy in the future.
@Joanne Papenfus
“Iatrogenic harm looks to be creeping up to a leading cause of death in the world.” Tu quoque fallacy.
“…the big push for mRNA vaccines (not a vaccine)”. Please explain how a vaccine is not a vaccine. Or provide your credentials in immunology.
“The level of myocarditis detected in my clients is horrific since this roll out.” You appear to practise in the UK. There is an established adverse event reporting system operated by the MHRA. Have you reported these events?
“Bioresonance has killed no-one and never will”. Is there an established adverse event reporting system for bioresonance machines? If not, how do you know what their safety record is?
“I use it and have directly benefitted. You cannot argue with that”. Do you know what science is? Clue – it is not anecdotes.
Bioresonance machines are unlicensed medical devices.
Let’s just say that this Mrs Papenfus is not exactly a fan of science-based medicine, and member of an organisation that promotes every known form of non-science-based medicine under the sun.
And please note how carefully I avoided words such as “medically incompetent” and “quackery”.