Professor Karina Butler:

I am a consultant paediatrician and infectious disease specialist and have been diagnosing and treating patients with infectious diseases for more than 30 years. I speak on behalf of the Infectious Diseases Society of Ireland, IDSI, and am joined on the panel by Dr. Gerard Sheehan. In the Public Gallery are Dr. Catherine Fleming from Galway and Professor Colm Bergin, Professor Patrick Mallon and Dr. Ceppi Merry from Dublin. The IDSI submission has been co-authored and approved by 22 infectious disease specialists representing each of the Dublin and regional centres, affiliated universities and the RCSI. An overwhelming consensus of expert opinion supports the written submission. As doctors, we care for patients of all ages who have or are suspected to have an infectious disease. We seek to ensure that all patients under our care, including those who have or believe they may have Lyme disease, receive the highest quality of evidence-based medical care. We have no other agenda.

Lyme disease is a significant infection which, if untreated, may progress to cause serious illness. However, early Lyme disease is a clinical diagnosis which does not require laboratory testing and can be cured by a relatively short course of antibiotics. Early Lyme infection does not always return a positive result in laboratory testing. However, the reliability of testing increases over time such that one would expect those who have had symptoms for months or years due to Lyme disease to test positive. In Ireland, samples are tested according to best international standards and the absence of a positive test is not a barrier to treatment. If clinical suspicion is high, physicians can and do prescribe an appropriate three or four-week duration antibiotic treatment either orally or intravenously depending on the clinical symptoms. Treatment in Ireland is based on international evidence-based guidelines drawn from several sources, including European guidelines and those of the IDSI. None of those guidelines recommend prolonged courses of antibiotics to treat Lyme disease.

A small minority of patients experience persistent symptoms following appropriate and adequate treatment for Lyme infection. However, prolonged courses of antibiotics have not been shown to benefit these patients. There is no evidence of benefit, but there is evidence of potential harm. Some patients have chronic disabling symptoms that are not readily explained medically although the symptoms are undeniable and can have a profound effect on quality of life. Chronic Lyme infection may be proposed as the cause of such symptoms in spite of negative Lyme antibody tests and the patient having been afforded appropriate treatment. However, there is no evidence to support the concept of chronic or persisting Lyme infection that is resistant to standard courses of antibiotic therapy. Such diagnoses are frequently based on tests that are not accredited for clinical diagnosis and are carried out in overseas laboratories. One of the major problems with such testing is that in an effort to achieve better sensitivity, that is, that a test will detect all possible cases, there is a profound loss of specificity. That means that the tests may produce false positives indicating that persons without Lyme disease have been infected with the disease.

We sympathise with patients and families who are affected by chronic symptoms that significantly impact on their quality of life. Our sincere goal is that all patients can have the best possible treatment outcome. Prolonged antibiotic therapy does not benefit these patients. Conversely, as I stated, it is associated with increased risk of serious unintentional harm. We take very seriously the tenet of our profession: primum non nocere; first, do no harm. It is a potent reminder that every medical and pharmacological decision carries the potential for harm. Decisions regarding patient care should be based on validated scientific evidence. Modern medicine is an evidence-based science and best outcomes are achieved when that underpins medical practice.

The IDSI is concerned that the use of tests not accredited as clinical diagnostic tests for Lyme disease may result in overdiagnosis of the disease and, often, other infections. Additionally, in the worst cases the misleading results are associated with the potential for misdirected referral and inappropriate treatment. Opportunities may be missed for thorough medical assessment to detect or exclude significant alternative pathology as the cause of the symptoms. We recognise that there are research gaps in terms of the epidemiology, diagnostics and treatment of vector-borne diseases.

We appreciate that all present today and those involved in this issue undoubtedly seek the best outcomes for those affected. However, we must acknowledge the real problem of the overdiagnosis of Lyme disease based on unaccredited tests carried out overseas. Diagnosis and treatment of Lyme disease must be evidence-based. Deployment of limited resources towards unvalidated treatments will necessarily deprive or curtail resources spent in other areas. As doctors, my specialist colleagues and I are concerned to learn of patients travelling overseas for prolonged courses of intravenous antibiotics, often coupled with an array of nutritional supplements and treatments at significant cost and personal hazard but with no proven benefit. There is no evidence of benefit to such treatments but there is potential for harm. In our submission, we have sought to present accurately the current situation with regard to Lyme disease, its diagnosis and treatment. We have no agenda other than to provide evidence-based, high-quality care for our patients.