Dáil Éireann Debate, Tuesday - 4 December 2018
431. Deputy Maureen O'Sullivan asked the Minister for Health his plans to address the concerns raised by persons with Lyme disease in terms of diagnosis, patient services and general care; and if he will make a statement on the matter. [50857/18]
View answerLyme disease (also known as Lyme borreliosis) is an infection caused by a spiral-shaped bacterium called Borrelia burgdorferi. The infection is generally mild affecting only the skin but can occasionally be more severe and highly debilitating. Lyme Disease is the commonest cause of tick-borne infection in Europe. Lyme disease was made statutorily notifiable in Ireland by the Infectious Diseases (Amendment) Regulations 2011 (S.I. no 452 of 2011). The notifiable entity is the more severe neurological form of Lyme disease: Lyme neuroborreliosis. The best protection against Lyme disease is to prevent tick bites when walking in grassy, bushy or woodland areas, particularly between May and October.
Lyme disease is diagnosed by medical history and physical examination. The infection is confirmed by a standard two-staged set of blood tests. A 2016 survey reported that all laboratories offering this testing in Ireland are appropriately accredited and are testing in accordance with best international practice. Testing and treatment for Lyme borreliosis is widely available in Ireland in all major hospitals. Lyme borreliosis is diagnosed by medical history and a physical examination which may be carried out by a General Practitioner.
Lyme disease may be treated by infectious disease specialists or by general internal medicine available in all acute hospitals. Medical training programmes at undergraduate or postgraduate level in Ireland provides specialist training in infectious diseases, including Lyme disease. Lyme disease can be very successfully treated using common antibiotics by General Practitioners. These antibiotics are effective at clearing the rash and helping to prevent the development of complications. Antibiotics are generally given for up to three weeks. If complications develop, intravenous antibiotics may be considered.
The Infectious Diseases Society of Ireland (IDSI) has recently expressed concern that the use of tests that are not validated as clinical diagnostic tests to diagnose Lyme infection can result in the over-diagnosis of Lyme disease and often of other infections. IDSI is particularly concerned that vulnerable individuals with non-specific, chronic symptoms are being encouraged to access non-accredited diagnostics related to tick-borne infections offered by commercial laboratories overseas, often at considerable personal expense. Use of such unvalidated, exploratory diagnostics can result in public misinformation, undue anxiety to individuals and their families, and unnecessary personal financial burden. Additionally, in the worst cases, there is the potential for misdirected referral, inappropriate treatment and missed opportunities for formal medical assessment to out-rule significant alternative pathology as explanation for the chronic symptoms. These are concerns that I, as Minister, share.
The U.S. Centers for Disease Control and Prevention have cautioned physicians of the serious risks associated with inappropriate prolonged intravenous antibiotics for what is described as ‘chronic Lyme disease’, stating:
“Patients given a diagnosis of chronic Lyme disease have been prescribed various treatments for which there is often no evidence of effectiveness, including extended courses of antibiotics (lasting months to years)........ At least five randomized, placebo-controlled studies have shown that prolonged courses of IV antibiotics in particular do not substantially improve long-term outcome for patients with a diagnosis of chronic Lyme disease and can result in serious harm, including death”.
The IDSI endorses the Infectious Diseases Society of America Treatment Guidelines. It has been argued by various parties that there are two sets of US guidelines for the treatment of Lyme and that it is reasonable for a physician to choose either: those of the IDSA or those of ILADS (International Lyme and Associated Diseases Society). However, an independent review of the ILADS guidelines, instigated by the Chief Executive of the Health Protection Agency, UK and chaired by Professor Brian Duerden CBE, Inspector of Microbiology and Infection Control, Department of Health, England found that they are poorly constructed and do not provide a scientifically sound evidence-based approach to the diagnosis and care of patients with Lyme Borreliosis. This independent review also concluded that:
“There is potential for harm from use of ILADS guidelines.
. Patients with other serious conditions who receive a misdiagnosis of Lyme through ILADS guideline risk losing opportunities for diagnosis and treatment of their illness.
. Patients receiving prolonged antibiotic treatment are at risk of organ damage from adverse effects of the drugs as well as risk of secondary infections such as Clostridium difficile enterocolitis, multi-resistant Gram–positive or Gram-negative bacterial infections and fungal infections. Patients receiving prolonged treatment with parenteral antibiotics have additional infection-related and other risks associated with long-term intravascular access devices.
. Other potential harms to patients associated with misdiagnosis include psychological damage through fixation on an unsubstantiated diagnosis of Lyme disease and financial hardship from recommendations and provision of repeated and prolonged courses of oral or parenteral antibiotics”.
Given the risks entailed by the models of diagnosis and treatment outlined, and in the absence of robust scientific testing and evidence to demonstrate their efficacy, it would be inappropriate for either the Government or myself as Minister to endorse such methods. Given that appropriate treatment is available in Ireland, it is unnecessary (and, potentially, unsafe) to seek treatment for Lyme disease abroad.
A Lyme Disease Sub-Committee was established by the Health Protection Surveillance Centre (HPSC). This aims to examine best practice in prevention and surveillance of Lyme Disease and to produce a report which identifies the best strategies for the prevention of this disease in Ireland. The HPSC delayed the publication of its Report in order to incorporate the findings of an extensive systematic review of the evidence on Lyme Disease by the National Institute for Health and Care Excellence (NICE) in the UK. This was published earlier this year and the HPSC’s own report is now due to be published early in the New Year. In considering the NICE report, the Subcommittee focused solely on the evidence and recommendations contained in the report that related to its remit (specifically in relation to awareness-raising - diagnostics and clinical management aspects fell outside the remit of the Subcommittee). I have been advised that the report of the subcommittee will be recommending the formation of a group of clinicians to review evidence regarding the diagnostics and clinical management of Lyme disease in Ireland as part of its report.
