- The Definition of Lyme Disease
- The Cause of Lyme Disease
- Treatment for Lyme Disease
- Lyme Research
The Australian Department of Health (DoH) are currently uncomfortable with associating patients’ illness with Lyme disease. This is partly because they are concerned that international controversy about chronic Lyme disease (CLD) will negatively influence our cause.[note]Lum, Official Committee Hansard, Emerging Tick-borne disease, 20 Apr 2016, p5, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Public_Hearings [/note]
We appreciate this view, and agree that there appears to be a bias towards patients of Lyme-like illness, based on this controversy. However, we believe that CLD is perceived to be more controversial and complex than it actually is. The stigma has resulted from a lack of education and clear communication. As more information is made readily available, the stigma is lessening. We are confident that this trend will continue. Accordingly, we remain comfortable with using the term Lyme-like illness.
The aim of this page is to provide an overview of the issues surrounding CLD. We hope this assists in reducing the stigma here in Australia.
[sta_anchor id=”thedefinitionoflymedisease” unsan=”TheDefinitionofLymeDisease” /]The Definition of Lyme Disease
Currently, there is no universally recognised definition for symptoms of Lyme disease that remain after a short course of antibiotics. This makes discussions between authorities confusing; each one thinks of CLD and its cause as something slightly different. Even the terms used to describe the illness vary; from ‘CLD’ to ‘Post-Lyme Disease Treatment Syndrome’, ‘late stage Lyme’, ‘post Lyme disease syndrome’ and ‘post-infectious Lyme disease.’[note] National Institute of Allergy and Infectious Diseases, Chronic Lyme Disease, accessed Mar 2018 https://www.niaid.nih.gov/diseases-conditions/chronic-lyme-disease Centres for Disease Control and Prevention, Post-Treatment Lyme Disease Syndrome, accessed Mar 2018 https://www.cdc.gov/lyme/postlds/index.html National Health Service UK, Lyme disease, accessed Mar 2018, https://www.nhs.uk/conditions/lyme-disease/ European Centre for Disease Prevention and Control, Factsheet about Borreliosis, accessed Mar 2018, https://ecdc.europa.eu/en/borreliosis/facts/factsheet [/note]
Only the International Lyme and Associated Diseases Society (ILADS) and the Infectious Diseases Society of America (IDSA) appear to have suggested detailed definitions. Both organisations agree that the illness occurs when symptoms persist for at least six months after treatment.[note] International Lyme and Associated Diseases Society, Chronic Lyme Disease: A Working Case Definition, 2007, p1, http://www.associationlymesansfrontieres.com/wp-content/uploads/Chronic-Lyme-Working-Case-Definition.pdf Infectious Diseases Society of America, The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the IDSA, 2006,Table 5 http://cid.oxfordjournals.org/content/43/9/1089.full [/note] The ILADS’ definition also includes untreated patients who have been sick for six months or more.
In Australia, the Federal Government does not provide a CLD definition at all. The Australian Chronic Infectious and Inflammatory Diseases Society (ACIIDS) agree with the ILADS’ definition.[note]Australian Chronic Inflammatory and Infectious Diseases Society, Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 370, p 15, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions [/note]
For the purposes of this page, we need to stick with a single term. Like the ACIIDS, we agree with the ILADS definition, and so will use ‘chronic Lyme disease’.
CLD and its cause is still being debated; that’s why agreeing on a definition has been so difficult.
The ILADS believe that CLD is usually due to the Borrelia infection surviving short-term antibiotic treatment. This may occur for the following reasons:
- Borrelia exists in three forms; spirochete, L form/cell wall deficient, and Cyst. The bacteria is capable of changing form to avoid the effects of certain antibiotics. Currently, no single antibiotic kills all forms of Borrelia. Therefore, if treatment has not included a variety of antibiotics, it will not be successful.[note] Horowitz, Official Committee Hansard – Emerging tick-borne disease, 2 Nov 2016, p6 http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lymelikeillness45/Public_Hearings International Lyme and Associated Diseases Society, Chronic Lyme Disease: A Working Case Definition, 2007, p3, http://www.associationlymesansfrontieres.com/wp-content/uploads/Chronic-Lyme-Working-Case-Definition.pdf [/note]
- Borrelia may produce a sticky substance called a ‘biofilm’ to hide in. Antibiotics and/or responses from the immune system may not be able to penetrate this.[note] Sapi et al, Characterisation of Biofilm Formation by Borrelia burgdorferi In Vitro, PLOS, 2012, http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0048277 [/note]
- The immune system’s cells are not able to access every part of the body. Borrelia may hide in these inaccessible sites, which include the central nervous system, eyes, joints, connective tissues, and the genital tract.[note] International Lyme and Associated Diseases Society, Chronic Lyme Disease: A Working Case Definition, 2017, p3, http://www.associationlymesansfrontieres.com/wp-content/uploads/Chronic-Lyme-Working-Case-Definition.pdf [/note]
- Borrelia can evolve into ‘persister cells.’ These are mutant cells that have developed the ability to become dormant or ‘sleep’ during antibiotic treatment.[note] Sharma et al, Borrelia burgdorferi, the Causative Agent of Lyme Disease, Forms Drug-Tolerant Persister Cells, 2015, http://aac.asm.org/content/59/8/4616.full Feng et al, Drug Combinations against Borrelia burgdorferi Persisters In Vitro: Eradication Achieved by Using Daptomycin, Cefoparazone and Doxycycline, 2015, http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0117207 Feng et al, Identification of novel activity against Borrelia burgdorferi persisters using an FDA approved drug library, 2015, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4126181/ Horowitz et al, The Use of Dapsone as a Novel “Persister” Drug in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome, 2016 https://www.researchgate.net/publication/304000313_The_Use_of_Dapsone_as_a_Novel_Persister_Drug_in_the_Treatment_of_Chronic_Lyme_DiseasePost_Treatment_Lyme_Disease_Syndrome [/note] Because most antibiotics only kill bacteria that is growing and multiplying, they are unable to affect the persister cells.
- The likely presence of other tick-borne infections, commonly referred to as ‘co-infections’, may make Borrelia “more difficult to eradicate” and “prolong the duration of infection.”[note] International Lyme and Associated Diseases Society, Chronic Lyme Disease: A Working Case Definition, 2017, p4-5, http://www.associationlymesansfrontieres.com/wp-content/uploads/Chronic-Lyme-Working-Case-Definition.pdf [/note]
ILADS also acknowledge that not all patients with symptoms remaining after treatment have ongoing infections. Other causes may be a dysfunctional immune system, damage to tissues and/or secondary conditions caused by the Borrelia.[note]International Lyme and Associated Diseases Society, Chronic Lyme Disease: A Working Case Definition, 2017, p5, http://www.associationlymesansfrontieres.com/wp-content/uploads/Chronic-Lyme-Working-Case-Definition.pdf International Lyme and Associated Diseases Society, Advanced Topics in Lyme disease – diagnostic hints and treatment guidelines for Lyme and other tick-borne illnesses, 2008, p3, http://www.ilads.org/lyme/B_guidelines_12_17_08.pdf [/note]
For many years the IDSA have strongly opposed the concept of an ongoing infection. They have not updated this stance in light of the recent research that has helped shape ILADS’ beliefs. Instead, they suggest that symptoms after short-term antibiotic treatment may be “related to the emotional state of the patient” or “aches and pains of daily living.”[note] Infectious Diseases Society of America, The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the IDSA, 2006, http://cid.oxfordjournals.org/content/43/9/1089.full [/note]
The American Government provides no clear guidance, and often contradicts itself:
- The National Institute of Allergy and Infectious Diseases (NIAID) state that long-term treatment doesn’t work. However, the studies they refer to as evidence of this actually indicate it does work (see Lyme Research below); Their opposition of long-term treatment implies their disbelief in ongoing infection. However, they admit that ongoing infection is a possibility based on recent studies;[note] National Institute of Allergy and Infectious Diseases, Chronic Lyme Disease, accessed Mar 2018, https://www.niaid.nih.gov/diseases-conditions/chronic-lyme-disease [/note]
- Centres for Disease Control and Prevention (CDC) oppose long-term antibiotic treatment, stating that the cause is “not known;”[note] Centres for Disease Control and Prevention, Post-Treatment Lyme Disease Syndrome, accessed Mar 2018, https://www.cdc.gov/lyme/postlds/index.html [/note]
- The Agency for Healthcare Research and Quality (AHRQ) promotes the ILADS treatment guidelines, which recognise ongoing infection by recommending long term antibiotic treatment where appropriate.[note] International Lyme and Associated Diseases Society, Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease (summarized version), Recommendation 3c, 2014, https://www.guideline.gov/summaries/summary/49320/evidence-assessments-and-guideline-recommendations-in-lyme-disease-the-clinical-management-of-known-tick-bites-erythema-migrans-rashes-and-persistent-disease [/note]
The European Centre for Disease Prevention and Control suggests that symptoms are due to tissue damage caused prior to treatment.[note] European Centre for Disease Prevention and Control, Factsheet about Borreliosis, accessed Mar 2018, https://ecdc.europa.eu/en/borreliosis/facts/factsheet [/note]
Authorities in the UK simply say the reason is unknown.[note] Public Health England, Lyme disease: signs and symptoms, accessed Mar 2018, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/463701/LymeDisease_SignsAndSymptoms.pdf [/note] Public Health England is open to the possibility of ongoing infection.[note] Public Health England, Lyme disease: diagnosis and treatment, accessed Mar 2018, https://www.gov.uk/government/publications/lyme-disease-diagnosis-and-treatment/lyme-disease-diagnosis-and-treatment [/note]
Australia’s NSW Health Department does not provide an explanation for CLD and raises concerns that some patients don’t even have laboratory evidence of Lyme disease.[note] NSW Health, Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 457, p 2, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions [/note] This point seems irrelevant given NSW Health also states that “Laboratory tests are rarely definitive.”[note]NSW Health, Lyme disease fact sheet, accessed Mar 2018, http://www.health.nsw.gov.au/Infectious/factsheets/Pages/Lyme_disease.aspx [/note] In fact, the manufacturer of tests used by a laboratory specifically endorsed by NSW Health,[note] The ICPMR lab is specifically endorsed by NSW Health on this site – NSW Health, Lyme disease testing advice for clinicians, accessed Mar 2018, http://www.health.nsw.gov.au/Infectious/factsheets/Pages/lyme-disease-testing-advice.aspx According to the following document, the ICPMR use the NovaTec NovaLisa ELISA test – National Serology Reference Laboratory, Final Report: Investigation of the Performance of Assays for Lyme Disease in Australia, 2017, p12 http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-lyme-disease.htm/$File/NRL-2017.pdf [/note] state that definitive “diagnosis of Lyme disease is difficult. Only early detection permits efficient control by antibiotics, since in the chronic phase borreliae are nearly inaccessible.” [note] NovaTec, NovaLisa Borrelia burgdorferi IgG – ELISA (recombinant), p2. This document is no longer available online, but the LDAA can provide a copy on request. [/note]
Given the debate regarding the cause of CLD, it is unsurprising that treatment recommendations are also a controversial topic.
Below, we outline the guidelines of the IDSA, who do not believe in persistent Borrelia infections, and the ILADS, who do.
In the past, many governments exclusively recommended the 2000 IDSA guidelines for treating Lyme disease. The guidelines recommended two to four weeks of antibiotic treatment for most cases of Lyme disease, and a maximum of eight weeks treatment.[note] Infectious Diseases Society of America, The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the IDSA, 2006, http://cid.oxfordjournals.org/content/43/9/1089.full [/note] Doctors who had successfully treated patients with long-term antibiotic regimes were alarmed by this. The ILADS stated “The duration of therapy should be guided by clinical response, rather than an arbitrary (ie 30 day) treatment course.” They protested that the guidelines “… fall short of meeting the needs…of individuals with chronic Lyme disease” and “fail to take into account the compelling, peer-reviewed, published evidence confirming persistent, recurrent and refractory Lyme disease and, in fact, deny its existence.”[note]International Lyme and Associated Diseases Society, Evidence-based guidelines for the management of Lyme disease, 2014 https://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900 [/note]
Although the IDSA guidelines are voluntary, some authorities incorrectly assumed they were mandatory. As a result, some American states have introduced laws to ensure health insurance agencies covered long-term treatment, and to protect prescribing doctors.
The IDSA reviewed their guidelines in 2006, but unfortunately did not make any significant changes. Corruption within the IDSA was suspected, and an anti-trust investigation was launched by the Connecticut Attorney General (CAG).[note] Until recently, the CAG’s Press Release regarding this was published on the site of Connecticut’s Office of the Attorney-General. It has since been removed, but a copy is included as Attachment 2 of Senate Submission 122, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions [/note] The CAG and the IDSA agreed to the creation of a new panel to review the guidelines. This new panel however excluded doctors who treated CLD, as “…a financial or other beneficial interest… might bias his or her judgement.” [note]Infectious Diseases Society of America, Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America, 2010, p1, http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/IDSALymeDiseaseFinalReport.pdf [/note] Most of the Panel members eventually selected were IDSA members – in fact, the Panel’s Chairperson was previously employed as the IDSA’s President!
Lorraine Johnson, CEO of America’s largest patient advocacy group, lymedisease.org, and co-author of the ILADS guidelines is an attorney advocate on issues related to the medico-legal and ethical aspects of Lyme disease. She commented that the selection process “…was anything but ‘independent’. Imagine a jury trial where the defendant selects a jury of friends.” [note] Lymedisease.org, Publication Alert: IDSA Review Hearing Report – Lipstick on a Pig, accessed Mar 2018, https://www.lymedisease.org/600/ [/note] The Panel decided that no changes to the guidelines were necessary. Ultimately, the Panel dismissed successful case studies with the unconvincing explanation that “Some patients were abnormal hosts and not representative of the general population.” [note] Infectious Diseases Society of America, Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America, 2010, p20, http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/IDSALymeDiseaseFinalReport.pdf [/note] This outcome was even worse than expected. Lorraine wrote “…we had our reservations about the ability of a panel stacked with IDSA members to impartially review the guidelines, but there were 1,600 pages of peer reviewed evidence that had been presented to the panel and independent scientists had attested to the persistence of the Lyme bacteria and the low quality of the tests. How could they ignore the weight of such evidence?” [note] Lymedisease.org, Publication Alert: IDSA Review Hearing Report – Lipstick on a Pig, accessed Mar 2018, https://www.lymedisease.org/600/ [/note]
Congressmen and Senators unsuccessfully wrote to the AHRQ to request the removal of the IDSA guidelines from their treatment guidelines database.[note] Lymedisease.org, Congressmen Call For Removal of Outdated IDSA Guidelines from National Guideline Clearinghouse, accessed Mar 2018, https://www.lymedisease.org/898/ Lymedisease.org, Senators Request Removal of IDSA Lyme Guidelines from National Guidelines Clearinghouse, accessed Mar 2018, https://www.lymedisease.org/lymepolicywonk-senators-request-removal-of-idsa-lyme-guidelines-from-national-guidelines-clearinghouse/ [/note]
In an unrelated activity, Congress asked the Institute of Medicine (IOM) to review treatment guidelines in general and advise how they might be improved.The IOM’s resulting 2011 report, ‘Clinical Guidelines We Can Trust’, highlighted the IDSA guidelines as an example of bad practice.[note] Institute of Medicine, Clinical Practice Guidelines We Can Trust – Trustworthy Clinical Practice Guidelines: Challenges and Potential, 2011, https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0079461/[/note]
The AHRQ eventually removed the guidelines from their database, called the National Guidelines Clearinghouse (NGC), in early 2016, as they had not been “developed, reviewed or revised within the last five years.”[note] Lyme Disease Association Inc, Official Word on IDSA Guidelines’ Removal from NGC, accessed Mar 2018, https://www.lymediseaseassociation.org/index.php/lda-news-a-updates/1456-official-word-on-idsa-guidelines-removal-from-ngc [/note]
The IDSA are currently rewriting their guidelines; a lengthy process considering the IOM’s stringent recommendations. They estimate this will take two to five years.[note] Lymedisease.org, IDSA say revision of Lyme disease guidelines expected to take 2-5 Years, accessed Mar 2018, https://www.lymedisease.org/lymepolicywonk-idsa-says-revision-of-lyme-disease-guidelines-expected-to-take-2-5-years/[/note]
Since the IDSA’s guidelines were first introduced, at least ten American states have taken legal action to formally recognise long-term antibiotic treatment as a legitimate approach. Actions include:
- Protection to ensure doctors cannot be disciplined for using long-term antibiotic treatment;[note]State of New York, Assembly Resolution 2155, 2002, http://www.lymeinfo.net/nyresolution.html
- Office of Professional Medical Conduct, Investigation of Practitioners Utilising Treatment Modalities that Are Not Universally Accepted by the Medical Profession, Jun 2005, http://legislature.vermont.gov/assets/Documents/2014/WorkGroups/House%20Health%20Care/Bills/H.123/Drafts,%20Amendments%20and%20Summaries/H.123~Katie%20McLinn~New%20York%20State%20Memorandum%20of%20Understanding~2-25-2014.pdf
- State of Rhode Island General Assembly, Lyme Disease Diagnosis and Treatment Act, 2002, http://webserver.rilin.state.ri.us/Statutes/TITLE5/5-37.5/INDEX.HTM
- Legislative Council of the State of California, Assembly Bill No. 592, Chapter 304, 2005,
- State of Connecticut General Assembly, An Act concerning the use of long-term antibiotics for the treatment of Lyme disease, 2009, https://www.cga.ct.gov/2009/ACT/PA/2009PA-00128-R00HB-06200-PA.htm
- The State of New Hampshire, An Act relative to the use of long-term antibiotics for the treatment of Lyme disease, 2011, https://legiscan.com/NH/text/HB295/2011
- Vermont General Assembly, An Act relating to Lyme disease and other tick-borne illnesses, 2014, http://legislature.vermont.gov/bill/status/2014/H.123
- Maine State Legislature, An Act To Improve Access to Treatments for Lyme Disease, 2015, http://www.mainelegislature.org/legis/bills/bills_127th/billtexts/HP028901.asp
- The General Court of Massachusetts, Section 12DD Administration of long-term antibiotic therapy upon diagnosis of Lyme disease, 2010, https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112/Section12DD
- The General Assembly of the State of Iowa, Medical treatment of Lyme or other tick-borne disease, 2017, [/note]
- Requirements for health insurers to cover long-term antibiotic treatment;[note] State of Rhode Island General Assembly, Lyme disease diagnosis and treatment Act – amendment, 2003, http://webserver.rilin.state.ri.us/PublicLaws/law03/law03113.htm
- State of Rhode Island General Assembly News, House passes Lyme disease bill, 2004, http://www.rilin.state.ri.us/pressrelease/Lists/PressReleaseData/DispForm.aspx?ID=969
- The General Court of Massachusetts, An Act relative to long-term antibiotic therapy for the treatment of Lyme disease, 2016. https://malegislature.gov/Bills/189/House/H4491
- Massachusetts Lyme Disease Legislative Task Force, For Immediate Release, 2 August 2016, https://www.lymediseaseassociation.org/images/NewDirectory/Government/State/Massachusetts/Lymelegislationpressreleasessaug22016.pdf
- West Virginia Legislature, An Act requiring health insurance providers provide coverage for certain Lyme disease treatment, 2018, http://www.wvlegislature.gov/Bill_Status/Bills_history.cfm?input=242&year=2018&sessiontype=RS&btype=bill[/note]
- Education of healthcare professionals, governmental agencies, insurers and patients on different treatment options;[note] The General Assembly of Pennsylvania, Act 83 – Lyme and related tick-borne disease surveillance, education, prevention and treatment Act, 2014, http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2014&sessInd=0&act=83 [/note]
- Requirements for government sites to provide links to the ILADS guidelines, as well as those of the IDSA.[note] The State of New Hampshire, An Act relative to Lyme disease awareness, 2015, https://legiscan.com/NH/text/HB363/2015
- The subsequent update can be found here: https://www.dhhs.nh.gov/dphs/cdcs/lyme/ [/note]
ILADS’ most recent guidelines met the IOM and NGC’s stringent inclusion criteria and were published in the database in 2015. They are currently the only Lyme disease guidelines in the NGC. They do not provide rigid protocols like the IDSA, but rather, give options for healthcare practitioners and patients to consider. There are numerous references to minimising the risk of CLD, as caused by an ongoing Borrelia infection. The ILADS panel explain the significance of CLD as follows:
“…the panel placed a high value on reducing patient risks for developing the chronic form of the disease… Thus, the panel’s values align with the Institute of Medicine goal of reducing the impact of chronic illness at the individual and national levels by, among other things, treating the treatable.”
“The panel placed a high value on reducing the morbidity associated with chronic Lyme disease and improving the patient’s QoL [Quality of Life] as well as on the need for individualised risk/benefit assessment and informed shared decision-making.”
“Shared decision-making takes into account the best scientific evidence available, clinical expertise and the role of patient’s values and preferences in deciding among available treatment options. Despite the terminology, decision-making is not truly shared between clinician and patient; the responsibility for choosing between options remains with the clinician. To effectively engage in shared decision-making, patients need to understand the implications of their choices. Physicians should not assume that patients share their values in making risk/benefit determinations…. Patients may also tolerate more risk when they have severe presentations of disease or when there are no other treatment options available.”[note] International Lyme and Associated Diseases Society, Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease (full text), p3 2014, http://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900 [/note]
The ILADS recommend considering long-term antibiotic treatment when short term regimes have proved insufficient. The panel said “…we moved away from designating a fixed duration for antibiotic therapy and instead encourage clinicians to tailor therapy based on the patient’s response… We not only recommend that clinicians perform a deliberate and individualised assessment of the potential risks and benefits of various treatment options before making their initial selection, we also recommend careful follow-up because this allows them to adjust therapy as circumstances evolve. This patient-centred approach should reduce the risk of chronic illness due to inadequate antibiotic therapy.”[note] International Lyme and Associated Diseases Society, ILADS treatment guidelines are now summarised on the National Guideline Clearinghouse website, accessed Mar 2018, http://www.ilads.org/ilads_news/2015/ilads-treatment-guidelines-are-now-summarized-on-the-national-guideline-clearinghouse-website/ [/note] Their guidelines state “For patients who improve yet continue to have persistent manifestations…following 4–6 weeks of antibiotic retreatment, decisions regarding the continuation, modification or discontinuation of treatment should be based on several factors… length of time between the initial and subsequent retreatment, the strength of the patient’s response to retreatment, the severity of the patient’s current impairments, whether diagnostic tests, symptoms or treatment response suggest ongoing infection and whether the patient relapses when treatment is withdrawn.” [note] International Lyme and Associated Diseases Society, Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease (summarized version), Recommendation 3c, 2014, https://www.guideline.gov/summaries/summary/49320/evidence-assessments-and-guideline-recommendations-in-lyme-disease-the-clinical-management-of-known-tick-bites-erythema-migrans-rashes-and-persistent-disease [/note]
The 2008 ILADS guidelines, replaced by the version on the NGC database, also include some recommendations that are still valid today. In our experience, the following advice is invaluable:
“Many collateral conditions result in those who have been chronically ill so it is not surprising that damage to virtually all bodily systems can result. Therefore, to fully recover not only do all of the active infections have to be treated, but all of these other issues must be addressed in a thorough and systematic manner. No single treatment or medication will result in full recovery of the more ill patient. Only by addressing all of these issues and engineering treatments and solutions for all of them will we be able to restore full health to our patients.”[note] International Lyme and Associated Diseases Society,, Advanced Topics in Lyme disease – diagnostic hints and treatment guidelines for Lyme and other tick-borne illnesses, 2008, p4, http://www.ilads.org/lyme/B_guidelines_12_17_08.pdf [/note]
“If treatment can be continued long-term, then a remarkable degree of recovery is possible. However, attention must be paid to all treatment modalities for such a recovery – not only antibiotics, but rehab and exercise programs, nutritional supplements, enforced rest, low carbohydrate, high fibre diets, attention to food sensitivities, avoidance of stress, abstinence from caffeine and alcohol, and absolutely no immunosuppressants, even local doses of steroids.” [note] International Lyme and Associated Diseases Society, Advanced Topics in Lyme disease – diagnostic hints and treatment guidelines for Lyme and other tick-borne illnesses, 2008, p20, http://www.ilads.org/lyme/B_guidelines_12_17_08.pdf [/note]
In 2008, the UK Parliament acknowledged that Lyme is a “potentially chronic disease” with “a growing body of evidence that suggests patients are frequently subject to…under-treatment.” [note] UK House of Commons, Early Day Motion 958 – Lyme disease, 19 Feb 2008, http://www.parliament.uk/edm/2007-08/958 [/note] However, the lack of funding for related investigation has recently led English researchers to report that there is insufficient evidence available to produce “a useful or meaningful” analysis of effective treatment.[note] Sutcliffe et al, Patient, clinician and researcher experiences of the treatment and management of Lyme disease: a systematic review, 2017,http://eppi.ioe.ac.uk/cms/Portals/0/PDF%20reviews%20and%20summaries/Lyme%20disease%20treatment%202017%20Sutcliffe.pdf?ver=2017-12-21-121024-253 [/note]
In 2018, the UK’s National Institute for Health and Care Excellence stated that “Further antibiotic treatment (beyond 21-28 days) is now recommended as an option if persisting infection is a possibility.”[note]National Institute for Health and Care Excellence, Lyme disease, 2018, p36,https://www.nice.org.uk/guidance/NG95[/note]
The French Government has been investigating a new national treatment protocol, due to be published by mid 2018. Infectious Diseases Specialist Dr Christian Perronne, who was involved in the investigation, has said “…there will be no maximum for the duration of an antibiotic treatment. It will be left to the discretion of the doctor.[note] La Montagne, Plan Lyme: Christian Perronne announces “a big step forward” for the sick, 12 Mar 2018 https://www.lamontagne.fr/clermont-ferrand/sante/2018/03/11/plan-lyme-christian-perronne-annonce-une-grande-avancee-pour-les-malades_12768540.html Note: This page will initially appear in French, but your internet browser should give the option to translate it into English [/note]
The German Borreliosis Society are a group of doctors and scientists who aim to “develop and promote the scientific and practical knowledge of the complex and diverse disease of Lyme disease, especially in the advanced stage.”[note]The German Borreliosis Society, The German Borreliosis Society, accessed Mar 2018, http://www.borreliose-gesellschaft.de/de/DieDBG Note: This page will initially appear in German, but your internet browser should give the option to translate it into English [/note] They promote the ILADS guidelines, and have also written their own guidelines, which support long term use of antibiotics in chronic cases. These guidelines state that “The duration of treatment is of decisive importance for the success of antibiotic treatment. There are now a few studies available which provide evidence of the positive effect and the safety of long-term antibiotic therapy.” [note] The German Borreliosis Society, Diagnosis and treatment of Lyme borreliosis, 2010, p12, http://www.borreliose-gesellschaft.de/Texte/guidelines.pdf [/note]
The Australian DoH specifically and repeatedly directs readers to the IDSA website for treatment advice, rather than the NGC.[note] Australian Department of Health, An Australian guideline on the diagnosis of overseas acquired Lyme Disease/Borreliosis, accessed Mar 2018, p1 and 9, http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-lyme-disease.htm/$File/Aust-guideline-diagnosis-overseas-acquired-Lyme-disease.pdf [/note]
NSW Health also refers to the IDSA recommendation of “a few weeks of antibiotics.”[note]NSW Health,Lyme disease fact sheet,accessed Mar 2018http://www.health.nsw.gov.au/Infectious/factsheets/Pages/Lymedisease.aspx[/note] They refer only indirectly to the ILADS guidelines, which they vaguely attempt to discredit, by saying “The chronic Lyme disease term is used by a small number of doctors…to describe patients whom they believe have a persistent B. burgdorferi infection, a condition they suggest requires long-term antibiotic treatment and/or a range of other treatments with little evidence of clinical benefit but with a significant risk of harm.”[note]NSW Health,Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many AustralianPatients, Senate Submission 457,p2,http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions[/note]
NSW Health seems unaware that the term CLD has been used by Australian scientists since the 1980s.[note]NSW Health,Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 457,p2,http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions[/note]
A 1994 paper that states “Treatment of chronic cases of LB [Lyme Borreliosis] is problematic as persistent symptoms and relapses are seen often in the Northern Hemisphere. Similar problems have been observed in Australian cases…where repeat courses of oral and intravenous antibiotics have been given… physician-observed reoccurrences…are best explained by failure of antibiotic therapy.”[note] Hudson et al, Does Lyme Borreliosis Exist in Australia?, 1994, http://www.lymedisease.org.au/wp-content/uploads/2016/11/Does-Lyme-Exist-in-Australia-by-B-Hudson.pdf [/note]
The ACIIDS have documented their own “consensus-based treatment guidelines for the treatment of borreliosis and related co-infections,” which they say “are closely aligned with those of ILADS.” They state “ACIIDS doctors are aware of the possible dangers of long-term antibiotic treatment…Our patients are closely monitored…ACIIDS considers that the risk of not treating this illness is greater than the risk of potential adverse reactions to treatment.”[note] Australian Chronic Inflammatory and Infectious Diseases Society, Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 370, p 14, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions [/note]
This approach is consistent with one written by the Tick-borne Diseases Research Unit of Sydney’s Royal North Shore Public Hospital.[note] Tick-borne Diseases Research Unit, Royal North Shore Hospital, Diagnosis and Treatment of Lyme borreliosis, accessed Mar 2018, http://www.tickalert.org.au/doctors.htm#AustralianLyme [/note] Dated 2001, it warns that “Prompt treatment of early suspected Lyme-like disease may prevent chronic debilitating infection.” It suggests that if symptoms are not resolved via an initial antibiotic regime, and no alternative diagnosis is suspected, antibiotics are repeated. Unfortunately, that advice is not currently being followed by the mainstream medical profession.
In 2015, Australia’s Chief Medical Officer claimed that no one was preventing doctors from treating CLD.[note] Department of Health, Supplementary Budget Estimates 2015-2016, Senate Hansard, 21 Oct 2015, p22, http://www.aph.gov.au/Parliamentary_Business/Senate_Estimates/clacctte/estimates/sup1516/index [/note] We dispute this. We believe, as do professional medical organisations, that the Australian Health Practitioner Regulation Agency (AHPRA) are specifically targeting these doctors for disciplinary action.[note] Lyme Disease Association of Australia, Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 528, p25-29, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions Australian Chronic Inflammatory and Infectious Diseases Society, Growing Evidence of an Emerging Tick-borne Disease that causes a Lyme-Like Illness for many Australian Patients, Senate Submission 370, p 16, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Submissions Australian Doctors Fund, Medical Complaints Process in Australia, Senate Submission 7, p 3, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MedicalComplaints45/Submissions [/note]
We also believe that the DoH’s repeated focus on controversy is an attempt to delay action. This opinion was shared by Senator Bilyk, who said to the DoH’s Dr Gary Lum “You have used that term a few times…Why is it so controversial if people have symptoms and illnesses? I do not think we are denying that there is actually some disease…Why can’t whoever is causing the controversy just sort it so that people’s lives are not so disrupted and ruined?”[note] Community Affairs Reference Committee, Official Committee Hansard, Emerging Tick-borne disease, 20 Apr 2016, p9, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Public_Hearings [/note]
Senator Bilyk’s frustration is understandable; there is action our Government could have taken on this issue, but has not. The National Health and Medical Research Council (NHMRC) state “NHMRC has a very particular role with [treatment] guidelines—that is, where we have been specifically asked to develop guidelines, we will pull together an expert committee to do that, to review the full body of evidence that would provide guidelines for best clinical practice. We are also sometimes asked to endorse guidelines. We review what needs to be re-evaluated every five years and decide whether to undertake another exercise of examining whether there is new evidence that would alter the guidelines.”[note] Community Affairs Reference Committee, Official Committee Hansard, Emerging Tick-borne disease, 20 Apr 2016, p10, http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Lyme-like_Illness/Public_Hearings [/note] This service has not been utilised, and the Government’s resulting ignorance is obvious.
While we do agree that CLD is controversial, we believe the issues can be broken down very simply:
- The IDSA guidelines have been considered highly controversial for almost 20 years. They were the subject of an anti-trust investigation, and American laws were created to ensure long-term treatment outside the guidelines could still be provided. These guidelines, now over a decade old, are no longer endorsed by America’s leading authority on evidence-based treatment guidelines, the NGC. They were also criticised by the IOM;
- ILADS guidelines, whilst also controversial, are the only Lyme disease guidelines endorsed by the NGC. They meet the IOM’s standards for trustworthy clinical guidelines, and actively promote the IOM’s commitment to patient-centred care. They also reflect the findings of current research. Therefore, they are indisputably best practice.The DoH’s claim that “…the concept of chronic Lyme disease is disputed and not accepted by most conventional medical practitioners, not only in Australia but around the world” [note] Australian Department of Health, Lyme disease, accessed Mar 2018, http://www.health.gov.au/lyme-disease [/note] is incorrect. The NGC, by its very nature, is “conventional” and serves a conventional audience.
Research related to CLD falls into two key areas, both of which are covered below. For the purpose of this page, we’ll focus only the studies specifically mentioned by the NIAID, as these are often used in the CLD debate.
Although the NIAID do not recommend long-term antibiotic treatment, they admit that “Several recent studies suggest that B. burgdorferi may persist in animals after antibiotic therapy… Additional research is needed and continues to be supported by NIAID to learn more about persistent infection in animal models and its potential implication for human disease.”[note]National Institute of Allergy and Infectious Diseases, Chronic Lyme Disease, accessed Mar 2018, https://www.niaid.nih.gov/diseases-conditions/chronic-lyme-disease [/note] Three studies found Borrelia DNA in the tissues of infected monkeys and mice after 28-90 days antibiotic treatment.[note] Embers et al, Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection, 2012, http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0029914 Bockenstedt et al, Spirochete antigens persist near cartilage after murine Lyme borreliosis therapy, 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3386809/Hodzic et al, Resurgence of Persisting Non-Cultivable Borrelia burgdorferi following Antibiotic Treatment in Mice, 2014, http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086907 [/note] On the basis of this, the NIAID investigated whether Borrelia DNA could be found in treated humans. To do so, they raised ticks in a laboratory to ensure they were disease-free. They then allowed the ticks to feed on volunteers, including patients who had already received antibiotic treatment. The ticks were then tested to see for Borrelia DNA. This was found in ticks that fed on a patient who had already been diagnosed with ‘Post-treatment Lyme Disease Syndrome.’[note] Marques at al, Xenodiagnosis to Detect Borrelia burgdorferi Infection: A First-in-Human Study, 2014, http://cid.oxfordjournals.org/content/58/7/937.long [/note]
It is no wonder that the NIAID is maintaining an open mind on the idea of ongoing infection.
The NIAID refers to the three studies when discrediting long-term antibiotic treatment.[note]National Institute of Allergy and Infectious Diseases, Chronic Lyme Disease, accessed Mar 2018, https://www.niaid.nih.gov/diseases-conditions/chronic-lyme-disease [/note] In each, patients who experienced chronic symptoms despite earlier treatment were given either further treatment, or a placebo for 28-90 days.
Atlhough the NIAID use the studies as evidence long-term treatment doesn’t work, every study actually reports improvement in the treated patients.[note] Klempner et al, Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease, 2001, http://www.nejm.org/doi/full/10.1056/NEJM200107123450202#t=article Krupp, Study and treatment of post Lyme disease (STOP-LD): a randomised double masked clinical trial, 2003, https://www.ncbi.nlm.nih.gov/pubmed/12821734 Note: Unfortunately this study cannot be viewed in its entirety for free. We paid for our copy, but are unable to distribute it due to the T&CS of our purchase. Fallon et al, A random, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy, 2007, http://www.neurology.org/content/70/13/992 Note: Unfortunately this study cannot be viewed in its entirety for free. We paid for our copy, but are unable to distribute it due to the T&CS of our purchase. [/note] This is a remarkable result, particularly considering the studies were criticised for flaws that skewed the results towards the opposite conclusion.[note] International Lyme and Associated Diseases Society, Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease (full text), 2014, http://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900 DeLong et al, Antibiotic retreatment of Lyme disease in patients with persistent symptoms: A biostatistical review of randomized, placebo-controlled, clinical trials, 2012, https://www.ncbi.nlm.nih.gov/pubmed/22922244 [/note]
Some of the co-authors of one of the studies later reviewed all three studies, and stated “The conclusions of this analysis of the chronic Lyme trials emphasise the benefits of repeated antibiotic therapy for patients with specific chronic symptoms…the majority of published guidelines… overlook and/or dismiss the evidence that demonstrates that additional antibiotic therapy can lead to sustained benefit. We hope that our review will lead to more carefully detailed and balanced summaries in future guidelines.”
“Treatment guidelines that dismiss the research findings …do an injustice to the evidence and are not helpful to clinicians and patients.”[note] Fallon et al, A repraisal of the US clinical trials of post-treatment Lyme disease syndrome, 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474942/ [/note]
We believe the fact that the NIAID continue to promote the outdated IDSA guidelines, using these studies as justification, shows that their position is a weak one. Not only are they unable to reference any studies with no improvements, but they ignore the findings of the above analysis.
Lorraine Johnson of lymedisease.org wrote of the studies “Even though there are over 100 000 cases of chronic Lyme each year…only three government treatment trials have ever been conducted. And those three trials didn’t look at treatments actually used by physicians treating chronic Lyme disease, but were instead limited to 90 days of a single form of antibiotics. And they didn’t study ordinary patients. One screened over 32 000 patients to finally enrol just 23, who met the researchers’ highly specific criteria. Patients in these treatment trials are by definition not typical.” [note] Johnson, My speech at MedX on Lyme disease and patient-centred big data research, accessed Mar 2018, http://www.lymedisease.org/lymepolicywonk-my-speech-at-medx-on-lyme-disease/ [/note]
As a result, lymedisease.org launched its own research initiative, called MyLymeData. They describe this as “a new survey tool that tracks patient progress over time. It allows patients to use today’s computer technology to quickly and privately pool diagnosis and treatment experiences. When large amounts of data are combined, we can see patterns that help us determine which treatments work best.
“Patients with Lyme disease tell us about their experience, symptoms, treatments, and results. Periodically, they update their information to let us know what has changed. This allows us to better understand the progression of the disease and what works—and doesn’t work—to help people get better. It lets patients learn from each other and provides data that can drive research to improve patients’ lives.
“MyLymeData expects to gather more data about Lyme disease than any research study has done before. Consider this: The largest Lyme disease trial funded by the National Institute of Health enrolled only 64 patients in the treatment group. Our patient surveys draw over 9,000 responses! We’ll use the information provided by patients to help figure out how to prevent and treat all stages of Lyme disease. It’s that simple.”[note] Lymedisease.org, What is MyLymeData and why is it important?, accessed Mar 2018, https://www.lymedisease.org/mylymedata/ [/note]
The international patient community, together with the Lyme Disease Association of Australia, are looking forward to MyLymeData’s findings.