Chapter 2Research and guidelines
2.1Following the Senate Community Affairs References Committee’s report Growing evidence of an emerging tick-borne disease that causes a Lyme-like illness for many Australian patients, released in 2016, the Australian Government announced a range of initiatives to address the report’s recommendations. This included releasing guidelines and factsheets for medical practitioners and the public, and fundingresearch.
2.2This chapter provides an overview of these initiatives, evidence received in relation to their effectiveness; and suggested areas for improvement and additionalfunding.
Debilitating Symptom Complexes Attributed to Ticks
2.3The Senate Community Affairs References Committee’s final report Growing evidence of an emerging tick-borne disease that causes a Lyme-like illness for many Australian patients recommended that the terms ‘chronic Lyme disease’, ‘Lyme-like illness’ and ‘similar Lyme phrases’ be removed from diagnosticdiscussions.
2.4The Australian Government subsequently adopted the term Debilitating Symptom Complexes Attributed to Ticks (DSCATT) to ‘describe the group of Australian patients suffering from the symptoms of a chronic debilitating illness which they have associated with a tick bite’.
2.5The Government Response to the Growing evidence of an emerging tick-borne disease that causes a Lyme-like illness for many Australian patients report released in November 2017, described DSCATT as providing ‘alternative nomenclature’ to the terms ‘Lyme Disease’, ‘Lyme disease-like illness’ and ‘Chronic Lyme Disease’ – terms which it described as ‘unhelpful and divisive’.
DSCATT Clinical Pathway
2.6The DSCATT Clinical Pathway, released in October 2020, is central to the Australian Government’s response to the previous committee’s 2016 inquiry. The Department of Health and Aged Care (the department) attributes the implementation of at least half of the 12 inquiry recommendations to the release of the DSCATT Clinical Pathway. This section provides an outline of the DSCATT Clinical Pathway.
2.7The Australian Government commissioned Allen and Clarke Policy and Regulatory Specialists Limited (Allen and Clarke) to develop an ‘evidence-based clinical pathway and multidisciplinary care model’ designed to ‘support decision-making on differential diagnosis and referral pathways.’
2.8The development of the Clinical Pathway was ‘informed by relevant literature and key documents’ in the form of a literature review, released in December2020. In addition to conducting a literature review, Allen and Clarke held a DSCATT Think Tank in May 2019 where stakeholders wereconsulted.
2.9It was described as a document developed to ‘support decision-making on differential diagnosis and referral pathways for patients presenting with either new onset or unresolved debilitating symptoms with or without a history of tick bites and that cannot be attributed to another condition(acute or chronic)’.
2.10The DSCATT Clinical Pathway contains the following key sections:
Initial assessment and support;
Differential diagnosis;
Diagnostic testing;
Diagnosis;
Initial management; and
Ongoing management.
Initial assessment and diagnosis
2.11The DSCATT Clinical Pathway recommends that the initial assessment practice shouldinclude:
in the clinical examination of an acute case, specifically check for the presence of tick bite or other rashes;
from the history and examination, exclude obvious acute illnesses or chronic diagnosable conditions;
treat obvious diagnosable conditions;
provide clinical advice to assist patient with symptom management while investigating any differential diagnoses; and
arrange referral and follow-up and/or other care as required.
2.12The Clinical Pathway emphasises the importance of a travel history as ‘despite multiple studies which have thoroughly searched for it in Australian ticks and patients, the organisms that cause Lyme disease have not, to date, been identified in Australia, but are endemic in parts of the USA, Europe and Asia’.
2.13It recommends consultation with ‘appropriate experts in vector-borne diseases including specialist microbiologists with diagnostic experience and [Infectious Disease] ID physicians for treatment of vector-borne diseases’.
2.14The Clinical Pathway states that there are ‘no peer-reviewed epidemiological or clinical studies about patients experiencing DSCATT’.
2.15The DSCATT Clinical Pathway notes that the term DSCATT was adopted by the Australian Government to:
…appropriately acknowledge this patient group and the multifaceted illness they are experiencing, and acknowledge their illness is poorly understood. The Australian Government acknowledges that many of these patients experiencing debilitating symptom complexes are living in turmoil because their illness cannot be easily diagnosed and treated. With the causes of DSCATT remaining unknown, the Australian Government urges patients and health professionals to keep an open mind about the cause of a patient’ssymptoms.
2.16The DSCATT Clinical Pathway explicitly states that ‘DSCATT is not a diagnosable disease and a patient cannot be given a diagnosis of DSCATT’(emphasis in original). Further, it states that ‘DSCATT is not clearly defined and is not formally reported. It has no diagnostic criteria, known cause or causes, no treatment and associated symptoms may be the end point for several differentdiseaseprocesses’.
2.17The Clinical Pathway notes that the symptom complexes to which DSCATT has been assigned ‘incorporates a wide range of nonspecific symptoms’. As such, ‘some people may have a diagnosis that has not yet been identified that explains these symptoms while others may have a cluster of medically unexplained symptoms that require management’.
Differential diagnosis
2.18In this section of the Clinical Pathway, it is again emphasised that ‘the Australian medical profession does not support the diagnosis of locally acquired Lyme disease in Australia’. Further, ‘while some Australians and healthcare providers believe that a form of “chronic Lyme disease” exists, globally, “chronic Lyme disease” is a disputed diagnosis which lacks sufficient supportingevidence’.
2.19As such, a diagnosis of overseas-acquired Lyme disease requires thefollowing:
a careful medical history
a history of overseas travel to areas where Lyme disease is endemic;
a patient must have been exposed to ticks however, a history of documented tick bite is not essential as many tick bites go unnoticed
objective clinical findings, and
appropriate in vitro diagnostic tests undertaken by National Association of Testing Authorities, Australia (NATA) and Royal College of Pathologists of Australasia (RCPA) accredited laboratories.
2.20The Clinical Pathway also notes that a diagnosis of other tick-borne diseases endemic to Australia including Q Fever, Queensland Tick Typhus, Australian Spotted Fever, and Flinders Island Spotted Fever, is challenging. The Clinical Pathway states, ‘early clinical features are often non-specific, making diagnosis challenging. Additionally, symptoms may overlap with other infectious diseases including those that are transmitted by non-tick vectors as well as a number of chronicdiseases’.
2.21The Clinical Pathway suggests that patients without a diagnosis, including those with symptoms associated with DSCATT ‘may have a diagnosis that has not yet been identified that explains these symptoms while others may have a cluster of medically unexplained symptoms that require management’. It goes on to explainthat:
People with medically unexplained symptoms (MUS) may obtain a diagnosis over time as symptoms develop and guide to the origin of the illness. Others may find that symptoms resolve over time, without ever identifying a cause. All people with medically unexplained symptoms, (including those experiencing the symptoms associated with DSCATT) can be assisted to have an improved quality of life with good care in a partnership between patient and the health care team.
2.22The Clinical Pathway recommends that:
The identification of MUS, including identification of the symptom complex associated with DSCATT, is one of exclusion and requires ongoing review as new symptoms arise or treatments are trialled. A full history and examination are critical.
Diagnostic testing
2.23As noted above, the Clinical Pathway states that a diagnosis of overseas-acquired Lyme Disease requires testing through a NATA/RCPA laboratory. Further, such testing ‘should only be initiated following advice from appropriate experts such as a consultant physician practising in his or her speciality of infectious diseases or a specialist microbiologist…’
2.24It states that it is ‘essential to use NATA/RCPA-accredited, internationally recognised laboratories for diagnostic testing’ because such accreditation provides a means of ‘determining, formally recognising and promoting that an organisation is competent’. It notes that NATA/RCPA accredited laboratories can detect tick-borne illnesses.
2.25In Australian diagnostic laboratories, the current standard protocol for diagnosing Lyme Disease is a two-tier serology system. The first stage involves screening with an enzyme-linked immunosorbent assay (ELISA), and if positive, then an immunoblot assay (Western blot).
2.26The Clinical Pathway notes that a review conducted by the National (Serology) Reference Laboratory (NRL) of serological assays to diagnose Lyme Disease ‘determined the tests used by accredited laboratories to diagnose Lyme disease had equivalent reliability to tests used in overseas laboratories’.This thereforemeansthat:
Australian NATA/RCPA accredited laboratories are able to confidently diagnose classical Lyme disease acquired in patients who have travelled to endemic areas and have contracted the infection more than four weeks prior to testing, noting that most patients seroconvert within four to eight weeksofinfection.
2.27The Clinical Pathway notes that ‘some people believe that they have acquired Lyme disease in Australia because the results of screening antibody tests to B. burgdorferi are positive’. It states however that ‘these positives are all likely to be false positive test results’.
2.28The Clinical Pathway recommends the avoidance of a number of alternative methods of diagnostic testing including:
capture assays for antigens in urine
culture, immunofluorescence staining, or cell sorting of cell wall-deficient or cystic forms of B. burgdorferi
lymphocyte transformation tests
quantitative CD57 lymphocyte assays
“Reverse Western blots”
in-house criteria for interpretation of immunoblots
measurements of antibodies in joint fluid (synovial fluid), and
IgM or IgG tests without previous ELISA/EIA/IFA.
Diagnosis
2.29The Clinical Pathway states that ‘a confirmed case of Lyme disease in Australia requires laboratory evidence AND clinical evidence AND epidemiological evidence’. It also recommends caution in interpreting positive or indeterminate laboratoryresults.
2.30The Clinical Pathway explains that ‘the prevalence of the disease or the pre-test probability of a disease strongly influences interpretation of any diagnostic test result’. Forexample:
In a region where Lyme disease is uncommon, patients with highly characteristic clinical presentations are rarely found to have Lyme disease and positive test results are seldom associated with clinically probable infection, although the negative predictive value of Lyme disease testing will be very high. In an area of low Lyme disease incidence in the United States, a study of Lyme disease testing showed an 80 per cent false-positive rate which puts patients at risk of incorrect Lyme disease diagnosis and adverse drug reactions from inappropriate treatment.
2.31It concludes that ‘an awareness of epidemiological context and the absence of an alternative diagnosis are necessary for a clinician to decide whether a positive test is explanatory or coincidental… [and] underpin the recommendation that medical professionals seek advice from appropriate experts in infectious diseases or pathology.
2.32The Clinical Pathway also provides an overview of the diagnostic requirements for Australian endemic tick-borne diseases such as Q Fever, Queensland Tick Typhus, Australian Spotted Fever, and Flinders Island Spotted Fever.
Initial and ongoing management
2.33The Clinical Pathway provides an overview of international guidelines for the treatment of Lyme Disease including antimicrobial protocols. It does however note that ‘international treatment guidelines may not be entirely applicable in the Australian health care setting even in patients whom have a travel history overseas to an endemic area’. It recommends that:
Treatment for Lyme disease in the Australian health care context should only be initiated based on the expert advice of either a consultant physician practising in his or her speciality of infectious disease or a specialist microbiologist. This advice will be based upon results of confirmatory testing conducted in a NATA/RCPA accredited laboratory and/or other clinical findings relevant to informing a treatmentdecision.
2.34It notes that ‘there is no evidence to support the use of combination antibiotics, immunoglobulin, hyperbaric oxygen, specific nutritional supplements or prolonged courses of antibiotics for the management of Lyme disease’. It also notes ‘there is a strong body of evidence that does not support ongoing and long-term treatment of Lyme disease with antibiotics’.
2.35The Clinical Pathway also provides an overview of treatment guidelines for Australian endemic tick-borne diseases such as Q Fever, Queensland Tick Typhus, Australian Spotted Fever, and Flinders Island Spotted Fever.
Medically Unexplained Symptoms
2.36The DSCATT Clinical Pathway also provides information on ‘the management of patients with persistent symptoms and who remain undiagnosed’. These patients are deemed to be experiencing Medically Unexplained Symptoms(MUS).
2.37The Clinical Pathway explains that MUS are defined as physical symptoms persisting for more than several weeks and for which adequate medical examination has not revealed a condition that adequately explains the symptoms. As such, ‘people experiencing debilitating symptoms attributed to ticks, without any definitive diagnosis could be considered to fall within the definition ofMUS’.
2.38In the management of MUS, the Clinical Pathway recommends avoiding: repeated diagnostic testing; the use of non-accredited laboratories for diagnostic testing and the use of unconventional diagnostic techniques; unnecessary referrals and interventions, and treatments with ‘known harm and no benefit (e.g. long-term antibiotics, extreme diets, miracle mineral solution, hyperbaric oxygentreatments)’.
2.39The Clinical Pathway recommends health practitioners: encourage discussion of intended natural or alternative therapies for evaluation of harm; undertake periodic re-evaluation of symptoms to determine an identifiable cause and the efficacy of any treatments; discuss information which patients may have discovered on the internet or through friends; enlist other members of a multidisciplinary team; and consider mental health strategies.
Implementation of 2016 Senate inquiry recommendations
2.40As noted above, the Australian Government credits the DSCATT Clinical Pathway as implementing many of the recommendations of the Senate Community Affairs References Committee’s report Growing evidence of an emerging tick-borne disease that causes a Lyme-like illness for many Australian patients, released in 2016. A number of witnesses however, questioned whether the DSCATT Clinical Pathway adequately addresses all theserecommendations.
2.41Recommendation 3 of the 2016 inquiry recommended the establishment of ‘a clinical trial of treatment guidelines’ developed by the Australian Chronic and Infectious and Inflammatory Diseases Society (ACIIDS) ‘with the aim of developing a safe treatment protocol for patients with tick-borne illness’. The department submitted that this recommendation has been ‘addressed’ because the ‘DSCATT Clinical Pathway has been developed as the diagnosis and referral pathway tool forpatients’.
2.42However, Dr Richard Schloeffel OAM, a founding member of ACIIDS appearing in a private capacity, told the committee that in 2018 he presented ACIIDS’ Clinical Pathway to representatives of the department, but the Guideline ‘was not accepted and no further discussion was undertaken’. DrSchloeffelstated:
This rejection reflects a broader systemic dismissal of the issue, where I and my colleagues have been encouraged to develop clinical guidelines, collect patient data, and contribute to scientific advancements, only for these efforts to be ignored or rejected by health authorities.
2.43Recommendation 5 recommended that the Australian Government facilitate a summit to develop a ‘cooperative framework which can accommodate patient and medical needs with the objective of establishing a multidisciplinary approach to addressing tick-borne illness across all jurisdictions’. The department submitted that the department convened two forums in 2018 ‘to engage with medical professionals, state and territory health authorities and patient groups on the concept of multidisciplinary care’. The department stated that ‘an evidence-based clinical pathway’ was developed following these forums and further consultation.
2.44However, the committee heard evidence that ‘in January 2020, the DSCATT Clinical Pathway was rejected by the patient community as it represented a continuation/worsening of the Australian patient situation’. Lyme Australia Recognition and Awareness (LARA) submitted that:
On the 29th of January 2020, the DSCATT Clinical Pathway was rejected by the Patient Collaborative, comprising of 15 patient support groups…At this time the Lyme Disease Association of Australia also submitted a letter of response rejecting the pathway.
The rejection of the clinical pathway was on the basis of the stakeholder exclusion, exclusions in the literature review, non-compliance with NHMRC Guidelines for guidelines and the restrictions to patient access to diagnostic testing andtreatment.
2.45Recommendation 6 recommended that federal, state and territory health agencies develop a consistent, national approach to addressing tick-borne illness. The department submitted that the DSCATT Clinical Pathway ‘was widely supported as a consistent national approach to addressing tick-borneillness’.
2.46Recommendation 9 recommended that Australian medical authorities and practitioners addressing suspected tick-borne illness ‘consistently adopt a patient-centric approach’. The department submitted that the DSCATT Clinical Pathway is ‘evidence based and patient centric’. The committee has heard however from witnesses that since the release of the DSCATT Clinical Pathway, patients have experienced worsening care. This evidence is explored later in thisreport.
2.47Recommendation 10 recommended that to assist with the referral of patients for guided and comprehensive pathology testing, ‘medical practitioners work with pathologists, especially microbiologists, immunologists, chemical pathologists and haematologists to optimise diagnostic testing for each patient’. The department submitted that this has been addressed by the release of the DSCATT Clinical Pathway, and that the Clinical Pathway ‘supports clinicians’ decision-making on differential diagnoses and referral pathways’. As explored later in this chapter, submitters argued that in practice, the Clinical Pathway ‘lacks proper diagnostic resources’.
2.48Recommendation 12 recommended that treatment guidelines should emphasise the importance of a multidisciplinary approach involving consultation between general practitioners and specialists such as neurologists, psychiatrists, rheumatologists, immunologists, microbiologists, and infectious disease specialists. The department again submitted that this has been addressed by the release of the DSCATT Clinical Pathway.
Criticism of the DSCATT Clinical Pathway
2.49The DSCATT Clinical Pathway and the adoption of the term DSCATT by the Australian Government was widely criticised in evidence provided by patient advocacy groups, and individual submitters. These criticisms include that: it isn’t widely utilised by medical practitioners, and that it has not led to any measurable improvements for patients. For example, ACIIDS stated that ‘although created with the best of intentions, the DSCATT pathway is inadequate to improve the clinical condition of patients with tick-borne disease in Australia and should be abandoned’. It noted that anecdotal reports from its members indicate that the pathway is not ‘widely utilised’, including by infectious disease physicians. In addition, the Clinical Pathway has not ‘led to any clinically significant changes in condition for patients with tick-bornediseases’.
2.50Dr Hugh Derham, Board Member, ACIIDS, described it as a ‘plaster-over. It was just papering the cracks and making sure the status quo wasmaintained’.
2.51The Lyme Disease Association of Australia (LDAA) and Sarcoidosis Lyme Australia, in a joint submission stated:
The DSCATT CP is not a solution; it is a bureaucratic roadblock designed to stifle legitimate concerns and perpetuates a culture of medical gaslighting. DSCATT, far from aiding patients, serves as a tool for denying the reality of chronic tick-borne illness, forcing countless individuals into a cycle of suffering and despair.
Usefulness of the Clinical Pathway
2.52Submitters called the Clinical Pathway a ‘farce’ and recommended that it be removed from the department’s website. For example, Dr Richard Schloeffel, appearing in a private capacity, stated that it is ‘a useless document. It does not address the issues of the patient. There are guidelines and things we could adopt now for diagnosis and treatment’. Dr Schloeffel stated:
My attitude to this DSCATT guideline is that it should be dismantled immediately, and we need to start again. There are adequate guidelinesworldwide.
2.53Similarly, Ms Elaine Kelly, a consultant for the LDAA, told the committee:
I think the most immediate and first step should be to remove the DSCATT pathway from the Department of Health and Aged Care website. I don't know if many doctors have actually read it or if they're actually just frightened from word getting out that you can't treat Lyme disease and also frightened of being audited for antibiotics. So the first thing to do is remove thatpathway.
2.54The Karl McManus Foundation also called for the suspension of the DSCATT Clinical Pathway ‘until a committee of [Infectious Diseases Specialists] IDS redevelop the pathway after receiving training in Europe and the USA on tick-borne pathogens’. The Foundation also recommended that:
It is important that they do not focus only on Lyme disease and lose focus on Relapsing Fever and other tick-borne pathogens. The IDS could then train general practitioners (GPs) via the Royal Australian College of General Practitioners(RACGP).
2.55Ms Karen Smith, Founder and Researcher, LARA, told the committee that the Clinical Pathway lacks ‘proper diagnostic resources’ and utilises ‘confusing terminology’. Ms Smith stated that these ‘have created significant barriers for patients seeking proper diagnosis and treatment’. Ms Opeia Stefanovic, Researcher, LARA, also stated:
…the clinical pathway was very ambiguous as to its fit within the existing healthcare system and highly ambiguous in communicating enforceability and practitioner compliance requirements. This led to practitioner hesitation and even more patient service denial, which I have personally experienced.
2.56The committee heard that the DSCATT Clinical Pathway is ‘based on an assumption that the medical system has competence to diagnose complex and chronic diseases in general; it does not’. Ms Kelly, LDAA,explained:
A recent Australian study found that the average timeframe to diagnose sarcoidosis was four to five years, although that range varied from six months to 15 years. From a patient's perspective, five to 15 years is a large chunk of life in which you're sitting unwell and unlabelled and in the same MUS category as DSCATT patients are.
2.57Similarly, the Karl McManus Foundation submitted that the DSCATT Clinical Pathway is ‘underwhelming as it does not provide any specific help, only offering very broad advice to consult an infectious diseases specialist (IDS)’. The Foundationcontinued:
The pathway assumes that all IDS are well-informed on tick-borne diseases and competent in providing advice on tick-borne diseases to other healthcare practitioners. Most IDS in Australia treat patients with pathogens that are not tick-borne. Tick-borne pathogens require a unique approach…
2.58Further, the Clinical Pathway does not adequately facilitate patients transitioning from being categorised as having MUS to receiving a diagnosis. Ms Kellystated:
That was meant to be the entire purpose of the pathway, but it just did not happen. A tick-borne disease patient only ends up labelled MUS if the doctor has missed the signs and symptoms or if an infectious diseases specialist has denied that the symptoms are tick-borne. In that case, ongoing management and review of symptoms is to be led by a GP, who usually has little or no experience with any tick- or vector-bornediseases.
2.59Ms Kelly was critical of the lack of detail contained in the Clinical Pathway, particularly in relation to the management of MUS. MsKellystated:
…[what] constitutes 'adequate medical examination'? Who's defined that? The question has no specific answer; the answer likely depends on the doctor's experience, knowledge and beliefs. How many GP visits or specialist visits or tests constitute 'adequate medical examination'? How is adequate medical examination confident that it's instigated the right specialists and the right tests? When a patient in the MUS or the DSCATT category presents new symptoms or variations of old symptoms, what then becomes adequate medical examination? Do Medicare and MBS restrictions impact on adequate medical examination? The CP doesn't adequately address any of those things, and that was its main purpose. The CP summary diagram directs that diagnostic testing is to determine differential diagnosis according to normal clinical practice, but normal clinical practice has already failed anyone under the MUSbanner.
2.60Ms Kelly told the committee that ‘MUS is a sophisticated way to evade responsibility for further investigation’, and was critical of the Clinical Pathway for recommending that additional testing be avoided. Ms Kelly suggested:
Sometimes the right doctor and the right test are required. Nothing changes about the patient's symptoms and signs. The only thing that changes is the doctor's thought processes. So a patient being in a MUS category is frequently less about the patient's illness and more about the doctor's lackofknowledge.
DSCATT terminology
2.61The committee heard that the adoption of the term DSCATT is problematic. For example, the LDAA and Sarcoidosis Lyme Australia in a joint submission described DSCATT as being ‘an ostensibly benign acronym’ that has now ‘become a tool of coercion in the medical profession’. Ms Sharon Whiteman, President LDAA, told the committeethat:
'DSCATT’ itself is a gaslighting term: 'These people think they're sick after a tick'—the very name of it is gaslighting. And it further separates doctors, patients and communities. It needs to be removed.
2.62Ms Smith, LARA, similarly stated that the ‘term DSCATT is confusing and implies that patients are only attributing their condition to ticks’. Ms Smith also told the committee that DSCATT ‘was only ever proposed as a temporary term’ and that an alternative, objective term would be preferred. Ms Smithstated:
In 2018, after patient dissatisfaction with the name, the department of health and the Chief Medical Officer both noted they were open to changing it, provided an agreed consensus was reached. There was no attempt to coordinate a consensus. I think everyone can agree that an objective name that is in line with the rest of the world and directs practitioners to a body of existing evidence, such as that on vector- or tick-borne disease, would be so much more appropriate than the subjective and undiagnosable'DSCATT'.
2.63One submitter described the DSCATT Clinical Pathway as ‘confusing and misleading’. They stated, ‘there is a DSCATT clinical pathway to be used in diagnosis, however the pathway itself says DSCATT is not a diagnosis’.
2.64While acknowledging that DSCATT itself is not a diagnosis, Professor Gary Lum, Principal Medical Adviser, Interim Australian Centre for Disease Control,clarified:
While it's true that DSCATT is not a diagnosable condition, and the clinical pathway is to assist with decision support, one of the final decisions that can be made is that there could be a final diagnosis. It could be a diagnosis of spotted fever. It could be a diagnosis of Q fever, because Q fever can also have chronic fatigue and symptoms associated with chronic Q fever disease. So the outcomes of the DSCATT clinical pathway are not always going to be, 'We don't have an answer,' because it's not easily explained or not diagnosable; there will be patients for whom there is a diagnosableresult.
2.65A number of submitters called for the term DSCATT to no longer be used and instead adopting the term tick-borneillness.
Worsening level of care
2.66A number of submitters told the committee that since the release of the DSCATT Clinical Pathway, they have experienced and observed a worsening level of care and awareness of tick-borne illnesses from medical practitioners. For example, one submitterstated:
I was sick before and after the DSCATT pathway was published. Access to medical care and awareness by practitioners has worsened beyond measure. I have witnessed significantly increased dismissal and lack of care to those suffering and in need. I have witnessed people dying from complications without appropriate treatment for this underlying cause.
2.67Another submitter stated ‘GPs are less helpful and understanding than ever. Not one has adopted the new clinical pathway with me. Specialists are even more dismissive than GPs are’. This submitter went on to state:
The clinical pathway isn’t easy to access. Many doctors don’t know it exists and refuse to look it up. Re-educating all doctors would help immensely.
2.68Ms Tanya Dupagne OAM, told the committee that ‘the DSCATT clinical pathway has not made things better for patients, in fact it has made things worse’. Ms Dupagne explained that she received a tick bite in a Lyme-endemic area of the United States of America and had symptoms consistent with Lyme disease including a bullseye rash. However, because she sought diagnosis years after the bite, she was unable to meet the requirements to receive a diagnosis under the DSCATT Clinical Pathway. Ms Dupagne explained:
Your clinical pathway states that in order to get a diagnosis, a patient must have laboratory evidence AND clinical evidence AND epidemiological evidence. How is this possible when there is no laboratory test that is 100% accurate and EM rashes only occur in up to 70% ofpatients?
In the initial assessment and support section of the DSCATT pathway (yellow section) it states that the clinical examination should check for the presence of a tick bite and rash. This doesn’t allow for those like me who were bitten years ago and don’t still have obvious signs of the tick bite.
In the differential diagnosis table of the DSCATT pathway (green section), it states that if a likely erythema migrans (EM) rash is present, antibiotic treatment should be started. This doesn’t allow for patients like me who were bitten years ago and are no longer presenting with therash.
2.69Other submitters went further in their criticism of the utility of the Clinical Pathway. For example, Tezted, a company engaged in research and development of diagnostic tests for complex diseases, submitted that ‘DSCATT offers perilously misguided counsel to Australian physicians that could lead to patient harm or fatality’. Tezted, submitted that:
The Pathway neglects co-infections, utilizes antiquated medical theories, and enforces rigid treatment protocols, intensifying patient distress.
2.70Tezted concluded that:
It is imperative to revise the deficient DSCATT Clinical Pathway using evidence-based, internationally standardized criteria alongside physician education and augmented research funding to investigate new infections andtherapies.
2.71Other submitters told the committee that the release of the DSCATT Pathway has led to practitioners feeling intimidated, and less likely to provide treatments such as antibiotics to patients. For example, one submitter stated:
In fact, awareness has DECREASED, because GPs are now intimidated…The DSCATT ‘pathway’ informed healthcare professionals about tick-borne diseases but BANNED from treating them with simple antibiotic therapy (e.g. doxycycline), and certainly not with advanced therapies that have since emerged in the USA…In summary, the publication of the DSCATT clinical pathway has ensured that GPs and specialists have become LESS helpful and engaged in treating patients, because they risk prosecution byAHPRA.
Research funding
2.72In April 2017, the then Minister for Health and Aged Care, the Hon Greg Hunt MP, asked the National Health and Medical Research Council (NHMRC) to fast track a Targeted Call for Research (TCR) into Lyme-like illnesses in Australia, with funding of up to $3 million. A TCR is a one-time solicitation for grant applications to address a specific health issue.
2.73An NHMRC Advisory Committee for Research into DSCATT was established to define the context, objectives and desired research outcomes of a TCR on DSCATT to ensure best use of available research funds. The resultant TCR into DSCATT aimed to support research that helps to:
better understand the nature, prevalence and causes of DSCATT and the way they impact on the physical, social and psychological health of patients;and
obtain evidence to guide the development of effective tools and procedures for diagnosis, treatment and symptom management.
2.74NHMRC opened a TCR into DSCATT on 30 May 2018. Given the public interest in the call following the Senate Inquiry and the government’s response to fund further research on this issue, the NHMRC decided to re-open the call to accept additional applications to ensure that a breadth of the highest quality research was funded. The extended call for applications closed on 29 August 2018.
2.75Applications received during the call were peer reviewed by an expert panel of researchers. Following peer review, two applications were funded by NHMRC:
Professor Richard Kanaan at the University of Melbourne was awarded $1,055,766 for an application titled ‘Developing Treatment for Debilitating Symptom Complexes attributed to Ticks’;and
Professor Peter Irwin from Murdoch University was awarded $1,934,748 for an application titled ‘Troublesome Ticks: Determining the aetiology of DSCATT in Australia’.
2.76In 2017, the NHMRC also provided a third grant of $657,496 through an ‘open investigator-scheme’ to Professor Edward Holme from the University of Sydney. Professor Holme undertook a study using ‘metagenomics to determine the causative agents of tick-borne disease in Australia’.
2.77The department noted that in addition to the $3 million provided by the Australian Government to the NHMRC, the department was also provided $4.5million in funding for research into tick-borne pathogens.
2.78In 2019 the department engaged the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to undertake two projects:
A tick survey to determine which bacteria, viruses and pathogens are carried by ticks in Australia, and their impact on human health; and
A study to analyse samples taken from ‘DSCATT and tick-bitten patients’ to identify any possible biomarkers.
2.79In 2021, the department also engaged CSIRO to undertake additional research into novel Borrelia species, and to examine the significance of the findings of the biomarkerproject.
2.80CSIRO also expanded its survey of Borrelia in Australian ticks and undertook work to characterise Australian Borrelia species. The department noted that the findings of this study indicate that Australian Borrelia species are largely restricted to specific wildlife hosts, and are not carried by common human-biting tick species. The department also explained that CSIRO successfully isolated an Australian Borrelia species (B. tarchyglossi) for the first time, and were able to experimentally demonstrate that this bacterium is not infective tohumans.
Developing Treatment for Debilitating Symptom Complexes attributed to Ticks
2.81Professor Kanaan’s project, Developing Treatment for Debilitating Symptom Complexes attributed to Ticks, plans to:
(a)review referred cases to determine a case definition and a set of diagnosticrequirements;
(b)adapt the therapeutic treatment approach for unexplained syndromes to the specifics of DSCATT;and
(c)conduct a feasibility randomised controlled trial to confirm the suitability of the therapeutic method to the population as well as assess the feasibility of a future trial using a priori parameters.
2.82Professor Kanaan, Professor of Psychiatry, University of Melbourne, gave evidence that the ‘intervention we proposed to develop, was, broadly speaking, a psychotherapy’. Professor Kanaan acknowledged that ‘people feel that psychotherapy can’t possibly help someone with what might seem to be a physical disease’, however, he explained that psychotherapy has been shown to work in relation to other conditions such as long COVID and chronic fatigue syndrome. Professor Kanaanexplained:
It's been shown to be effective in other diseases where there is unclear aetiology, where it's not clear what the cause is, where people have a range of physical ailments with no clear cause. Lots of those arise following infections, and treatment in this way iseffective.
2.83Professor Kanaan told the committee that the treatment provided as part of this studyis:
…acceptance and commitment therapy. That is encouraging and helping people to live with their symptoms. You might think of that as helping them to live with the problems they have. That being said, what we often find is that it also helps with the symptoms themselves, and really that's what we are hoping that it will do.
2.84Professor Kanaan acknowledged the perception that this trial is seen to be attributing the cause of patients’ ill-health to psychological factors rather than physical ones. However, Professor Kanaan clarified:
…all of our patients have had clear biological components to their illness, and I would never assume that anything is purely psychological. I think it's a completely false dichotomy that unfortunately is very widespread and is the root of the problem that we have with our study in terms of its perception.
2.85Many submitters were critical of the Australian Government providing funding to Professor Kanaan’s study, rather than providing funding to alternative research with a focus on the biological causes of patients’ ill-health. The Tick-borne Illness Community Network Australia (TICNA) submitted:
One million dollars was provided to research if psychological interventions, such as CBT at the time, now changed to ACT therapy, can treat patients affected (and infected) by tick bites. This cuts straight to the heart that it is often considered that tick-infected patients are making up their symptoms, and it is psychological. I know this treatment is now outlined as an adjunct therapy, but the community felt there were far more pressing needs to invest that money.
2.86Some submitters expressed concern this study may ‘create the public impression that the physical symptoms of patients with a "Lyme-like" illness are not "real" but rather psychological’. Another submitter stated, ‘we are sick of being labelled as psychiatric patients. We have a real physical illness, not a mental healthissue’.
2.87Dr Nicholas Johnson, Executive Director, Research Partnerships Branch, NHMRC, in explaining why Professor Kanaan’s project was selected to be funded noted that the grant guidelines had two aims:
The first aim was to better understand the nature, prevalence and causes of DSCATT and the way they impact on the physical, social and psychological health of patients. The second aim was to obtain evidence to guide the development of effective tools and procedures for diagnosis, treatment and symptom management. Where that advice came from was to try and better understand the aetiology of the disease but also to ensure the aim included treatment to helppeople.
2.88Dr Johnson explained that only four applications were received under the TCR, and ‘the two highest-scoring applications were funded’. Dr Johnson explained that it is a ‘highly competitive program’ and that applicants have to ‘bring their best proposal – one that they think they can demonstrate is feasible and achieve outcomes’. Dr Johnson stated:
If they fail in demonstrating that, they will be poorly scored by the peer reviewers and will not get funded without such competitive rates. The applications need to be world-class and quality science, and we have dedicated assessment criteria that evaluates those different things. It has to be of excellent quality, it has to be feasible and we have to be able to see the benefit, largely—and this is the team that can achieve that. They need to do those things separately, and ultimately it's the competitive nature of the system that will determine that.
2.89Dr Johnson concluded:
We entirely rely on the expertise of the medical and research community to give their opinions about the merits of the research, and the highest scoring are those that are passed through to the minister. That might see certain areas of disease being more represented than others from time to time. We don't intervene in that process, so we will fund research that is determined to be of excellent quality and competitive by peers on any areas of tick-borne disease, whether it be in psychosocial or in other biologicalfunctions.
2.90Dr Johnson also told the committee that there is an opportunity for the community to highlight the need for research into a particular topic. Dr Johnsonexplained:
We also have a community portal where interested groups and patient groups can come to us and say: 'This is an area of unmet need. We think NHMRC should run a TCR.' We will collect those periodically through the year. And we have an independent committee that will review those against a rubric to determine which ones are most meritorious based on which is most likely to give benefit, which one is most likely to be feasible and whether the outcomes can be implemented. That is evaluated and scored, and then the highest ranking will come forward to be proposed as aTCR.
2.91Dr Johnson noted that the NHMRC has not received a community proposal for research into tick-borne illnesses.
Need for additional research
2.92The committee heard that there is a need for additional research to be conducted in a range of areas. For example, the Black Dot Project called for an expansion on ‘funding for human biological sample research and epidemiological studies’. Itsubmitted:
This should also include a broader cross-section of research on developing more accurate diagnosis protocols, investing in the construction of trial integrative medicine treatment centres, and addressing the physical, mental, social, and financial impacts of living with a debilitating and often undiagnosed illness that may be attributable to causes such as ticks andvector-bites.
2.93Another submitter called for more engagement with general practitioners who have been treating patients with symptoms of tick-borne illnesses to learn more about the treatment protocols they are utilising to treat their patients.
2.94Dr Stephen Graves highlighted that at present it is currently unclear if the symptom complexes attributed to ticks are ‘due to infection by a new/unknown tick-transmitted microbe, an abnormal inflammatory response to a tick bite, an abnormal psychological response to a tick bite, or some other cause’. Dr Graves concluded, ‘once data and conclusions become available from current studies, the nature of DSCATT (and hence its treatment) may become clearer’.
2.95The Karl McManus Foundation recommended enhanced research funding into pathogen identification, immune dysregulation, and treatment protocol validation. It submitted:
More investment in studies to identify and characterise Australian tick borne pathogens and their pathogenicity in humans is needed. Novel Australian species of tick- borne pathogens have been found but there is no evidence that any research has been done to show if they are pathogenic inpeople…
Research into the immune dysregulation caused by tick-borne pathogens is essential to improve diagnostics and treatment protocols…
Support is needed for clinical trials to establish effective treatment regimens tailored to Australian patients.
2.96The Karl McManus Foundation also noted that there is a lack of required data collection in Australia. It explained, ‘Australia lacks a tick-bite registry or systematic collection of data on tick-borne diseases, making it difficult to track disease prevalence and outcomes’. The Foundation suggested that:
A registry could provide valuable insights into geographical hotspots, pathogen types and patient outcomes, aiding in both research and public healthefforts.
2.97Dr Richard Schloeffel recommended that ‘ongoing patient-focused, scientific research and biomarker development must be prioritised’ in research funding. Dr Schloeffelstated:
Creating a vital biobank that includes disease biomarkers and Government funding and collaboration in this effort would significantly enhance our ability to understand and manage tick-borne diseases in Australia.
Public awareness and education materials
2.98In addition to the DSCATT Clinical Pathway, the department released a number of fact sheets for the general public, and guidance notes for clinicians in relation to tick bites and tick-borne illnesses. These are available on the department’s website.
2.99It was however argued that there should be a more focused effort on community education and awareness campaigns designed to prevent tick-bites. This would have a two-fold benefit – reducing the incidence of tick-borne illnesses and reducing the need for ‘complex and costly treatment pathways’.The LDAA submitted:
…the primary focus should be on empowering individuals with the knowledge and tools to prevent tick bites in the first place. This necessitates a shift towards community-led initiatives, leveraging local knowledge and expertise to develop and implement targeted prevention campaigns in high-riskareas.
2.100The LDAA stated that it has ‘long advocated for a multi-pronged strategy’ thatincludes:
Public awareness campaigns: These campaigns would educate the public about tick bite prevention, early symptom recognition and proper tick removal techniques.
GP education: Improved education for general practitioners is crucial for accurate diagnosis and timely treatment of tick-borne diseases.
School education programs: Integrating tick bite awareness and prevention into school curriculums can empower future generations to protect themselves.
Workplace safety protocols: For individuals working in high-risk areas, implementing tick bite prevention strategies in the workplace isessential.
2.101Tick-induced Allergies Research and Awareness (TiARA) noted the Australian paralysis tick (Ixodes holocyclus) is the species most likely to bite humans in eastern Australia. This tick significantly impacts human health causing conditions such as paralysis, allergic reactions (including Mammalian Meat Allergy), and the transmission of Queensland Tick Typhus. TiARA submitted that ‘preventing tick bites is crucial to reducing the risk of these conditions’. It notedthat:
…it is surprising—and concerning—that despite the growing attention ticks have received in recent years, research into tick-bite prevention has long been neglected and underfunded.
2.102Other submitters such as Mr Dan Rosser also called for ‘public awareness campaigns to educate Australians on tick prevention and early diagnosis’. Another submitterstated:
It also imperative that public awareness of the possible side effects of being bitten by a tick needs to be addressed. This way, if people are well informed, early treatment can be obtained if required and also better protection from ticks in the first instance to avoid this issue altogether can occur.
2.103TICNA suggested that both federal and state and territory governments should implement ‘extensive social media campaigns’ to educate the public – similar to those implemented for mosquito bite prevention. TICNA also suggested that endemic tick-affected areas should have in situ warning such as signs, and localeducationcampaigns.