This page provides an overview of the politics associated with Lyme disease in Australia and overseas. Should any clarification regarding content be required, please contact the LDAA.
- Within Australia
- International Lyme Controversies
- What are the Recent Developments in Australian Lyme Politics?
- What are the impacts of denying Lyme disease in Australia?
- What do Lyme patients want?
Why is Lyme disease controversial?
There is considerable controversy within the medical profession, both nationally and internationally, in nearly all aspects of Lyme disease.
"There is no evidence of Lyme disease in Australia"
Despite rapidly growing numbers of Australians being diagnosed with Lyme, the prevailing viewpoint within the Australian medical community is that "there is no evidence of Lyme disease in Australia."
- There are no official statistics on the number of Lyme cases in Australia because Lyme disease is not a notifiable disease.
- The denial of Lyme disease arises from a government funded research project that failed to detect Borrelia burgdoferi (the common North American strain) in Australian ticks (Russell and Doggett, 1994).
- The LDAA continues to contest the official position, arguing that a single 20-year-old research study with failed to find Borrelia in indigenous ticks should not be used as the basis for ruling out the possibility of Lyme disease or Lyme-like illness in Australia and to deny providing treatment to patients with Lyme disease.
- The LDAA challenges this position on the following basis:
- Other researches have found evidence that Australian ticks do carry the Borrelia bacteria.
- There are numerous strains of Borrelia known to infect humans, other than the common American strain (Borrelia burgdorferi) sought in the Russell and Doggett study.
- The Russell and Doggett study identified spirochete-like objects, but these were discounted as bacterial 'artifacts' [sic] and were not further investigated.
- Given Australia's history of European and Asian migration and travel, any credible research should include study of Borrelia strains originating from these regions.
- Testing processes used in the Russell and Doggett study may have been flawed or inadequate and relied on now-outdated processes.
- This study did not consider vectors other than ticks (such as flies, mites, fleas and mosquitoes).
- It is possible a unique Australian strain of Borrelia (or similar pathogen) capable of causing Lyme-like illness exists in Australia (as has recently been discovered in Brazil).
- The LDAA also maintains that the medical community's reliance on the Russell and Doggett study to justify its position on Lyme disease overlooks the evidence of rapidly growing numbers of patients diagnosed with Lyme disease (confirmed with overseas testing) and fails to take into account:
- The extent of human migration from and travel to areas where Lyme disease is known to exist. Patients have been denied treatment for Lyme disease even when reporting a history of tick bite in a Lyme-endemic country.
- The potential for Lyme disease to be transmitted by other means, such as:
- Human to to human transmission - via sexual interaction, transplacental transfer during pregnancy, breastfeeding and transfusions from infected blood supplies, and;
- Exposure to infected bodily secretions from animals, such as livestock and rodents.
- In the 20 years since the highly controversial Russell and Doggett (1994) study, six more pathogenic Borrelia genospecies have been discovered. Despite increasing anecdotal evidence of Lyme-like illness, Australia has not responded with appropriate diagnostic capability or investigation of the new strains.
- Further research into alternate modes of transmission has been deemed unnecessary, again based on the position that "there is no evidence of Lyme disease in Australia.".
"Only Australian pathology tests are valid and overseas testing is unreliable"
- The medical community's position on Lyme disease is supported by Australian pathology laboratories, with inadequate testing processes, where interpretations are biased toward producing negative results.
- The LDAA has raised a number of concerns regarding Australian testing processes including:
- The initial screening tests (ELISA) are not standardised and are carried out by local pathology labs. In many cases the tests only detect the North American strain of Borrelia burgdorferi.
- Manufacturers of commonly used test kits note that negative results (either first or second-tier) should not be used to exclude Lyme disease.
- Despite this, only patients receiving a positive result on the ELSIA (first tier) test will have their blood tested using more Borrelia-specific immunoassay test (Western Blot) by one of two Australian laboratories: Westmead or PaLMS.
- There is no external Quality Assurance Process (QAP) for these labs (Royal College of Pathologists, Position Statement on Lyme disease, p. 5).
- There is a lack of standardisation in the Borrelia strains tested in the reference labs and in the interpretation of test results.
- Westmead laboratory tests for the North American strain plus one European strain of Borrelia, using a non-standard 'in house' immunoblot test method. In interpreting test results, a test is positive if it shows at least five out of ten positive 'bands' (based on criteria set by the US Centre for Disease Control (CDC).
- The PaLMS laboratory tests for the North American strain plus two European strains of Borrelia, using a commercial test kit. In interpreting test results, PaLMS uses the standard European criteria, which requires three 'bands' for a positive Borrelia diagnosis.
- Read further detailed discussion of testing concerns.
- Westmead laboratory concedes that approximately 900 Australian patients would have received a positive test result for Lyme disease had the laboratory used the same testing methods and assessment criteria as PaLMS and other overseas labs.
- While acknowledging that Australia has a 'small pond' of experts in the area of bacterial research, the LDAA has echoed patients' expressed concerns regarding the potential for conflicts of interest when senior members of the Westmead staff are cited as co-authors of the 1994 Russell and Doggett tick study.
- Numerous patients report receiving negative results from Australian blood tets while their results from overseas labs have been positive. Other patients report being told their Australian lab results must be 'false positives' because Australia has no endemic Lyme disease.
- The Australian medical community has frequently been critical of specialist overseas laboratories testing for Lyme disease, suggesting that their positive results are 'false positives'.
- An example of the unsubstantiated criticism of overseas laboratories is evident in the Royal College of Pathologists of Australasia's (RCPA) 'Position Statement' Diagnostic Laboratory testing for Borreliosis ('Lyme Disease' or similar syndromes) in Australia and New Zealand.
- The LDAA contends that, to the contrary, it is Australian testing methods that require review. The Westmead laboratory has indicated it intends to update its testing procedures, but this has not occurred to date and many Australian patients relying on Australian tests may be misdiagnosed as a consequence.
- The LDAA has published detailed arguments supporting these concerns in its formal responses to both the Department of Health's Scoping Study and the RCPA's Position Statement. See Recent Developments in Australian Lyme Politics section. See recent developments in Australian Lyme Politics section.
International Lyme Controversies
Although Lyme disease is acknowledged as endemic in other countries, controversy still surrounds the condition, particularly in the United States of America, with regard to its clinical presentation, definitions, diagnosis and treatment. The Australian Lyme situation is strongly influenced by American medical politics and policy guidelines.
The two main factions in the United States of America Lyme debate are: the Infectious Disease Society of America (ISDA), which is involved in setting official guidelines; and the International Lyme and Associated Disease Society (ILADS), an association of medical practitioners who specialise in treating Lyme disease.
"There's no Chronic Lyme disease and extended treatment with antibiotics is not justified"
- The two main issues under debate between the factions involve: the existence of a condition known as Chronic or Late-stage Lyme disease and, following on from this; the efficacy of treatments involving long-term use of antibiotic medications.
- The IDSA generally does not recognise Lyme disease as a chronic illness, although the CDC does use the term 'Post Treatment Lyme Disease Syndrome (PTLDS)' to describe a condition that occurs after a patient has received an initial short course of antibiotic treatment, usually ascribing this condition to an immune disorder.
- Experts in the IDSA faction contend that Lyme disease can be easily and effectively eradicated with several weeks of antibiotic treatment and their treatment guidelines reflect this view.
- These guidelines are supported by the medical insurance companies that refuse to fund treatment extending beyond the recommended treatment period, even when symptoms persist; a situation of major concern to American Lyme patients.
- In 2006, the Attorney General of Connecticut launched a formal investigation into exclusionary practices and commercial conflicts of interest of the IDSA panel members who formulated the guidelines, finding that the IDSA had failed to screen for conflicts of interest and had shown bias in selection of panel members.
- In 2008, an American documentary on Lyme disease, Under our Skin, exposed the effects of the American deregulation of health care and demonstrated conflicts of interest, including financial relationships with Lyme vaccine manufactures and patents on Borrelia strains used by testing laboratories.
- ILADS argues that, in patients where the infection has not been detected early or for those who received sub-optimal treatments, Lyme disease can develop as a chronic condition affecting multiple infection sites within the body and requiring long-term antibiotic treatment to alleviate symptoms.
- The LDAA contends that the majority of cases in Australia fir the category of 'Chronic' or 'Late-stage' Lyme disease as the medical community's denial of the disease means there is no early intervention treatment and, by the time they are successfully diagnosed, most patients are experiencing severe symptoms as a result of the bacteria being disseminated to multiple sites within the body and brain.
- The LDAA's 2012 Patient Experience Survey indicated that the most patients had seen an average of five doctors and spent six and a half years before receiving a Lyme diagnosis, with the majority of patients reporting that they showed no improvement in symptoms following a 30 day course of antibiotics.
- References and further reading regarding Lyme controversies.
What are the Recent Developments in Australian Lyme Politics?
- In 2012, the LDAA welcomed the announcement that the Chief Medical Officer (CMO), Professor Chris Baggoley, would establish the Clinical Advisory Committee on Lyme Disease (CALCD). The LDAA was successful in lobbying to have a patient representative appointed to the committee and has been active in supplying input to the review process.
- The CMO published a formal Advice to Clinicians notifying them of the formation of the CACLD and stating: "While the investigation into an indigenous causative organism for Lyme disease continues, there is a need to raise awareness of Lyme disease as a possible diagnosis in returned travellers who may have acquired the infection whilst visiting overseas endemic areas."
- The CMO established a Diagnostic Working Group to draft updated guidelines for the diagnosis of Lyme-disease in Australia. The guidelines are not yet available.
- In 2013, the Department of Health (DoH) commissioned an Australian microbiologist to produce a Scoping Study to develop a research project(s) to investigate the presence or absence of Lyme disease in Australia.
- The LDAA submitted an extensive and detailed 63-page formal response to the Scoping Study report, challenging many of the findings and research sources cited by the author. LDAA (2014) Lyme Disease in Australia: Patient submission to the Australian Government Department of Health's "Scoping Study to develop a research project(s) to investigate the presence or absence of Lyme disease in Australia."
- Several other lyme patient advocacy groups also made formal submissions.
- One of the main recommendations of the LDAA's response was that epidemiological research should be conducted to study the unique patterns of Lyme disease or Lyme-like illness in Australia, rather than simply following North American research and policy.
- Accompanying the formal response to the Scoping Study report, the LDAA supplied the government with a detailed Patient-focused Action Plan, which outlines a blueprint for the actions required to address issues facing existing Lyme patients and to protect the general public through awareness and preventative strategies.
- In March 2014, the Royal College of Pathologists (RCPA) published a Position Statement, Diagnostic Laboratory testing for Borreliosis ('Lyme Disease' or similar syndrome) in Australia and New Zealand, which was subsequently the subject of several articles in popular medical journals in Australia and New Zealand. The LDAA produced an extensive and detailed response: Lyme disease pathology: Counter argument to the Royal College of Pathologists Australasia Position Statement on Diagnostic Laboratory Testing for Borreliosis ('Lyme disease' or similar syndromes) in Australia and New Zealand, LDAA April 2014.
- The LDAA's Counter Argument highlights that the RCPA's Position Statement continues to propagate misinformation through the articulation of many inaccuracies which are not supported with references, or even on topics that fall within the remit of the RCPA.
- The RCPA's Position Statement again relied on the indigenous tick research mentioned above to continue promulgating to pathologists and other medical practitioners the widely held but contentious view that Lyme disease does not exist in Australia.
- The LDAA asserts that, in publishing its Position Statement, the RCPA has also been inappropriate by pre-empting the official role of the Clinical Advisory Committee on Lyme Disease (CACLD) before the committee has concluded its public consultation or published its formal findings, definitions and diagnostic guidelines.
- DoH held a Lyme disease Roundtable on 27 May 2014 with representatives from medical colleges, the Clinical Advisory Committee on Lyme Disease and General Practitioners. You can review a list of outcomes from the meeting here.
- The Clinical Advisory Committee on Lyme Disease met in Canberra on 15 July 2014 for the last time.
- On 18th August 2014, the DoH updated it's Lyme Disease page - indicating that while the CACLD has ceased, the Department will maintain an interest in an Australian Lyme disease-like syndrome. There are multiple publications which can be found here: Department of Health Progress Reports
- Significant progress towards Lyme awareness in Australia is summarised in the Chief Medical Offers Progress Report. In brief and of particular and immediate significance for patients is Prof Baggoley's words on:
- Clinical presentation is frequently the base for diagnosis but no case definition could be agreed upon;
- The doubts around the sensitivity and the specificity of diagnostic tests available in Australia hinder the exploration of Borrelia infection in Australian patients with no travel history;
- Opened the discussion of vectors other than ticks;
- Advice for patients who have relapsed or are non-responsive to treatment to consult with a medical practitioner who has experience in treating Lyme disease;
- Acknowledgement of the complexity of co-infecitons;
- An outline of communication lines for future communications inclusive of Lyme patient groups;
- A commitment to work with state and territory health authorities about public health messages associate with tick bites including prevention and treatment; and
- Way forward - The department's interest in an Australian Lyme disease-like syndrome will be maintained.
What are the impacts of denying Lyme disease in Australia?
- Australian patients experience difficulties obtaining a reliable diagnosis for Lyme-like illness within Australia and in accessing appropriate and affordable medical treatment for their condition(s). As a consequence, their medical conditions often progress to an advance stage where they can become seriously (and unnecessarily) impaired.
- Patients with Lyme-like illness frequently experience discrimination on many fronts and are burdened with unnecessary testing and treatment costs because their medical condition is not formally recognised.
- The Australian public has not been made aware of the potential risks of exposure to Lyme-like illness from ticks and other possible vectors and modes of transmission, nor has a national health policy been developed to address treatment issues.
- Lyme disease costs the Australian economy tens of millions of dollars, through misdiagnosis and inappropriate treatment regimens, as well as through loss of income. (The 2012 LDAA Patient Experience Survey page 8) reported that almost 50% of Australian Lyme patients had to quit their jobs, with 25% of these patients now receiving sickness or disability benefits.
What do Lyme patients want?
In early 2014, the LDAA facilitated a consultation process with over 200 Lyme patients to ascertain their responses to the Department of Health Scoping Study on Lyme disease. The following points were raised in terms of the changes Lyme patients wish to see adopted by the Australian government in relation to their disease:
- The Chief Medical Officer to issue a public statement acknowledging the existence of Lyme-like illness in Australia and ensure widespread dissemination throughout medical and public agencies, as well as through mass media.
- Implement a broad scale Public Education Program, targeting the medical community and sectors of the public identified as 'at risk'.
- Implement an Interim Treatment Strategy for existing patients while further research into causative factors is conducted.
- Review Australian laboratory testing processes to ensure reliability of testing.
- Conduct a study of the unique patterns (epidemiology) of Lyme-like illness in Australia before making assumptions about its causes.
- Pursue research into 'causative factors' ensuring an open focus to consider all potential sources of transmission.
For further information about the LDAA's recommended strategies for addressing the Lyme disease problem, please refer to the Patient-focused Strategic Plan which was submitted to the Chief Medical Officer as part of the LDAA's formal response to the Scoping Study on Lyme disease.