Inquiry into allergies and anaphylaxis – Amended FSM Submission

1. In support of the ‘Education Campaign’ on Bioresonance currently being run by the TGA, FSM requests that the Parliamentary Inquiry issue a specific direction to the ATMS and the ANTA, both being organisations which profess to adhere to “the highest ideals of professionalism”. These bodies should be instructed to work with the Australasian Society of Clinical Immunology and Allergy (ASCIA)*, to determine the scope of the interventions which members of the ATMS and of the ANTA may and may not do and which they may or may not advertise for people concerned about possible allergies. 2. FSM requests that the Parliamentary Inquiry direct the Chinese Medicine Board and the Australian Health Practitioners Regulation Agency to work with ASCIA, to determine the scope of the interventions which Chinese Medicine practitioners may and may not do and may or may not advertise for people concerned about possible allergies. 3. The FSM submits that this request falls within the powers of the TGA in the following respects: a. “The TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.” b. “The TGA takes a risk-based approach to regulation.” c. The risk to the public of unreliable and unproven testing is the potential delay is seeking effective treatment. Many allergies can be fatal unless scientifically managed based on reproducible evidence. d. “TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.” Note: *ASCIA is a member society of the World Allergy Organisation (WAO) and of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI). ASCIA is also affiliated with the Royal Australasian College of Physicians (RACP) as a specialty society. Reason for amendment to FSM’s submission FSM’s original submission requested “that the Committee direct the TGA to cancel BICOM and CyberScan devices”. On 31 January 2020, FSM were notified that:  “in 2019, the TGA engaged a credible Australian scientific organisation to conduct a scientific review of the evidence provided by 8 sponsors to support the intended indications for their bioresonance devices (a total of 12 ARTG entries)” ;  their “investigation and education work is continuing” ;  the BICOM had been cancelled by the sponsor, and  “by late January 2020, 4 bioresonance ARTG entries had been cancelled by sponsors. We have proceeded to cancel a further 2 ARTG entries, which will come into effect in late February 2020 unless the sponsors seek a review of these decisions.” However, even when practitioners do remove their website claims, they are still permitted to state that they use the device and to ask patients to contact them. They thereby continue to diagnose and treat allergy patients with not just bioresonance devices, but with a wide range of unproven/disproven interventions (examples compiled by ASCIA listed in Appendix A). Courses on the use of these devices have not been ceased, with a BICOM course scheduled for 20-22nd March 2020 in Adelaide (refer Appendix B). Some registered Traditional Chinese Medicine practitioners are also stating: “Chinese medicine is effective in treating both acute and chronic allergies”. They might be using unproven interventions (eg tongue and pulse diagnostics) to diagnose allergies, treating them with unproven herbal remedies, with potentially fatal results. Allergies are not a trivial matter. Summary Many hundreds of unregistered and some registered practitioners are using unlisted devices, unproven/disproven diagnostic and ineffective, potentially dangerous, treatments for allergies and asthma. Currently, there is no effective means, including the TGA, AHPRA, ATMS and ANTA or any state-based health commission, of stopping them. Courses are still being run for unlisted devices. FSM requests that these organisations work with ASCIA to determine what may and may not be done by their practitioners.

On behalf of Friends of Science in Medicine Loretta Marron OAM CEO, Friends of Science in Medicine www.scienceinmedicine.org.au Submitted: 13 February 2020 Appendix A

ASCIA Position Statement – Unorthodox Techniques for the Diagnosis and Treatment of allergy, Asthma and Immune Disorders https://www.allergy.org.au/hp//papers/unorthodox-techniques-for-diagnosis-and-treatment November 2007

(Excerpt) While our ability to accurately diagnose and treat allergic disease has benefited from scientific understanding of what happens during an allergic reaction, a number of tests and treatments have been promoted in the absence of any scientific rationale. Some non-conventional approaches to disease also claim that various disorders unrelated to allergy have an immune basis. These tests and treatments have been shown to be unreliable when subjected to careful study. ASCIA advises against use of these tests for diagnosis or to guide medical treatment.

Table of Contents

Allergy is a science-based specialty Use of unproven “allergy tests” is common in Australia and New Zealand Unproven allergy testing and treatments are not regulated Philosophies underlying unorthodox practice Advice needs to be “evidence based”

Inappropriate testing  Cytotoxic testing (Bryans' or Alcat testing)  Oral provocation and neutralisation  Vega testing (electrodermal testing)  Kinesiology  (psionic medicine, dowsing)   Pulse testing  Hair analysis  Tests for “dysbiosis”  VioceBio Inappropriate use of conventional testing  Food specific IgG, IgG4, IgE  Lymphocyte subset analysis  Allergen specific IgE (RAST, ImmunoCap testing) Inappropriate use of conventional treatments  Allergen immunotherapy  Treatments used by conventional and unorthodox practitioners  Buteyko Breathing Technique  Elimination diets Unorthodox treatments  Homoeopathy  (zone )  Autogenous therapy  Physical : therapy, , Cranial therapy  Allergy elimination techniques (also known as “Advanced Allergy Elimination”, “Nambudripad’s Allergy Elimination”)  Vega MRT (Matrix Regeneration Therapy)  Clinical Ecology/ Environmental Illness  Chronic Candidiasis  Enzyme potentiated immunotherapy  Insulin resistance / allergy Conclusions  Adverse outcomes from unorthodox testing and treatments may arise  Unproven diagnostic techniques and treatments are not inexpensive  Evidence, claims and counterclaims

Appendix B BICOM Seminar: 20-22 March 2020 https://bicomaustralia.com.au/seminar/

Excerpt: “This Advanced Allergy course will provide an in-depth understanding to assist practitioners working with complex allergy clients. Complex cases may arise when for instance: the suspected allergy doesn’t test; the allergen refuses therapy; the allergen has been treated but symptoms and complaints persist; and/or the allergy has been treated but resurfaces.”

“ADVANCED 5 ELEMENT & COUPLING PROTOCOLS: In this session the principles of Chinese medicine and the advanced concept of Five Element within this framework are explored. This Five Element concept will enable practitioners to initially uncover and identify the broad clinical issues but then refine parameters so that ultimately the specific causes of stress for an organ or meridian are identified. This primary cause within the body may or may not be identified with symptoms. The CTT Functional Circuits (5E) kit will be introduced and explained within the context of Five Element testing and also how it can direct a practitioner’s understanding into other areas of need within the body. This subsequently can be incorporated into treatment sessions. To complement this theory, the digital version of the Functional Circuits (5E) CTT kit using BICOMmultisoft® Pilot will be demonstrated and its clinical application also discussed.”