Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank members for their attendance at the second part of this meeting, which follows on from a previous meeting of the joint committee on the issue of Lyme disease. I welcome to the meeting Dr. Colette Bonner, deputy chief medical officer and head of the health protection unit in the Department of Health, Dr. Darina O'Flanagan, director of the health protection surveillance centre in the Department of Health, Dr. Paul McKeown, specialist in public health medicine at the health protection surveillance centre in the Department of Health, and Dr. Bartley Cryan, consultant microbiologist at Cork University Hospital. I also welcome the Lyme disease patient advocates and supporters in the Visitors Gallery and thank them for their presence. Apologies have been received from Deputy Ó Caoláin who must attend another meeting. Deputy McLellan, who is a member of the committee in her own right, will be an able stand-in. Apologies also have been received from Seanad Members who have been obliged to go to a vote.

At the outset, I remind people to ensure their mobile telephones are switched off or are in aeroplane mode as otherwise they interfere with the broadcasting of proceedings and cause difficulties for staff. Were people to do that, I would be most appreciative. I remind people about privilege that witnesses are protected by absolute privilege in respect of the evidence they are to give to the committee. However, if a witness is directed by the committee to cease giving evidence in respect of a particular matter and the witness continues to do so, they are entitled thereafter only to a qualified privilege in respect of evidence. Witnesses are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice that where possible they should not comment on, criticise or make charges against any person or entity by name in such a way as to make him or her identifiable. Members are reminded of the long-standing parliamentary practice or ruling of the Chair to the effect that Members should not comment on, criticise or make charges against any person outside the House or an official either by name or in such a way as to make him or her identifiable.

I reiterate that our second session today pertains to the microbiology of Lyme disease and I again thank the witnesses for their attendance. I invite Dr. Bonner to make her opening remarks.

Dr. Colette Bonner:

I thank the Chairman and members of the joint committee for inviting me here today to speak on the issue of Lyme disease. My two colleagues already have been introduced, namely, Dr. Darina O’Flanagan and Dr. Paul McKeown, director of and specialist in public health medicine, respectively, at the health protection surveillance centre.
Lyme disease, also known as Lyme borelliosis, is an infection caused by a spiral-shaped bacterium called borrelia burgdorferi. It is transmitted to humans by bites from ticks infected with the bacteria. Lyme borelliosis was made statutorily notifiable in Ireland in 2011 by the Infectious Diseases (Amendment) Regulations 2011. The notifiable entity is the more severe neurological form known as Lyme neuroborreliosis. In 2012, there were nine cases of neuroborreliosis and, in 2013, there were 13 cases. Up to December of 2014, we have had 20 reported cases that have been provisionally notified in 2014. However, it is expected that this number is likely to fall following validation of the numbers. Due to the diverse and unspecific nature of the symptoms, a number of the less serious cases may not be diagnosed, leading to an under-reporting of cases. Recent estimates suggest there may be up to 50 to 100 cases in Ireland per year. The infection is generally mild, affecting only the skin, but can occasionally be more severe and highly debilitating. Many infected people have no symptoms at all. Complications following Lyme borelliosis, while uncommon, do occur, though less frequently in Europe than in North America.

They tend to occur sometimes after initial infection and are more common in people who did not realise they had been infected or who were not initially treated.

Lyme borelliosis is diagnosed by medical history and physical examination. It can be difficult if there has been no rash. The rash is known as erythema migrans. The infection is confirmed by blood tests, which look for antibodies produced by an infected person's body in response to the infection. These normally take several weeks to develop and may not be present in the early stage of disease.

Common antibiotics such as doxycycline or amoxicillin are effective at clearing the rash and helping to prevent the development of complications. They are generally given for up to three weeks. If complications develop, intravenous antibiotics may be required. In order to produce a harmonised approach to the testing and treatment of Lyme borelliosis in Ireland, a consensus statement on the clinical management of Lyme borelliosis has been issued jointly from the scientific advisory committee of the health protection surveillance centre, the Infectious Diseases Society of Ireland, the Irish Society of Clinical Microbiologists, the Irish Institute of Clinical Neuroscience and the Irish College of General Practitioners. The purpose of the consensus is to ensure that patients in Ireland are clinically managed in a harmonised fashion using guidance produced with the most up-to-date evidence.

The health protection surveillance centre is establishing a Lyme borreliosis sub-committee with the primary aim of examining best practice in prevention and surveillance of Lyme disease and developing strategies to undertake primary prevention to minimise harm caused by Lyme borreliosis in Ireland. This will involve raising awareness among clinicians and the public. I hope the sub-committee will have its inaugural meeting during 2015.

Each year, as part of its ongoing awareness raising about Lyme disease and methods of prevention or minimising potential exposure through tick bites, the health protection surveillance centre holds a Lyme disease awareness week, in which media releases are sent out with the intention that media outlets would take up the important Lyme prevention messages. This year as part of the Lyme disease awareness week information was made available to the public and attention was drawn to a tick-borne disease toolkit, developed by the European Centre for Disease Prevention and Control. This is available on the centre's website. The European Centre for Disease Prevention and Control has informed the health protection surveillance centre that Ireland is the first European Union member state to make such extensive use of this material. I will hand over to my colleagues, who may answer any queries from committee members.

Dr. Bartley Cryan:

I thank the committee for inviting me in to discuss the laboratory diagnosis of Lyme disease. I will outline a little about medical microbiologists, what we are and what we do. There are approximately 40 of us in the country fulfilling approximately 30 whole time equivalent posts. There are two or three of us in most of the major teaching hospitals scattered throughout the country.

Generally speaking, our job is to manage the laboratories in conjunction with the senior scientists, to develop the service and to engage in clinical liaison with our users. They are largely hospital physicians and surgeons as well as general practitioners. We are involved in infection control, antibiotic stewardship and teaching. Our main function is to ensure that the right tests are done and are available for our catchment population, that they are interpreted correctly and that we are available to advise the clinicians on putting the patients on the correct treatment as well as monitoring that treatment and any further investigations that are required.

I work as a consultant medical microbiologist in Cork University Hospital. I have been there since 1991. Of significance, my prior position was as a lecturer in the Charing Cross and Westminster Medical School, where I was associated with the Lyme disease reference facility. I wrote several publications there which I have referenced in my submission. The publication of most significance is Lyme disease in Ireland. Under the study we reviewed the available Irish data from 1986. It is of significance that several specialties and physicians in Ireland were actively searching for and investigating the diagnosis of Lyme borreliosis at that time. In total, 484 samples were sent to us. A total of 14% of these were positive by the initial screening assays but only 13% were formally confirmed by the western blot. These were spread throughout several specialties, largely neurology, rheumatology and dermatology. People were actively searching for diagnoses for Lyme disease at the time and continue to do so.

The Cork University Hospital medical microbiology laboratory is one of the largest in the country. We deal with almost 500,000 samples a year. Approximately 50% of our work comes from general practitioners and approximately 50% comes from the hospitals under what used to be the southern health board. We cater for a population of approximately 500,000.

We get many types of samples. One point of significance to the committee is that we deal with approximately 180,000 serology or virology samples per year. We run at approximately 1,000 Lyme disease serologies per year. Our testing tends to be seasonal, as is the nature of the illness. We tend to get most of these in the autumn. Of the 1,000 serologies that we examined in 2013 some 30 were confirmed positive cases. We send all our positive enzyme immunoassay tests, which we carry out in-house, to the rare and imported pathogens laboratory, which is the United Kingdom reference laboratory for Lyme disease. That laboratory carries out an enzyme-linked immunosorbent assay test. Then it does the western blots and report back to us.

As previously mentioned by Dr. Bonner, Lyme disease results from the transmission of Borrelia burgdorferi by hard bodies, Ixodes ticks. The ticks need to be attached to the patient for over 24 hours for transmission to occur. The disease was first identified by Steere et al in 1975 and the organism was identified by Willi Burgdorfer, who died recently, in 1981.

In the United States, where the disease is more numerous and of more significance, between 10% and 20% of untreated patients will go on to develop nervous system symptoms. Arthritis will develop in approximately half of those cases. Arthritis is far more common in the United States than in Europe and this is related to the different species. The common species in Ireland is Borrelia garinii, which tends to give rise to skin and neurological signs but rarely arthritis. Generally speaking, the Borrelia burgdorferi sensu stricto, the specific strain which occurs in the United States, is more pathogenic.

Traditionally, infections and all illnesses are diagnosed by eliciting the appropriate clinical signs and characteristic symptoms. Then, the diagnosis is confirmed by detecting or growing the implicated organism in the infected tissue. When we can do that, we can make a firm diagnosis of an illness. Unfortunately, organisms like Borrelia burgdorferi and spirochetes in general are difficult to grow. Therefore, we cannot apply the normal standards that we would apply in diagnosing infections. Instead, we must resort to looking for antibodies or activated cells to counteract these infections. This means we are looking for evidence of previous contact with the organism rather than actual disease. One of the other problems associated with serology is that it takes time for people to develop antibodies. In the case of Lyme disease it may take up to 30 days before antibodies are detectable in blood. Moreover, there may be cross-reactions, which is a common problem in spirochetal illnesses. There may be false positive results as well as results that may be true positive but which are not related to the actual symptoms that the patients are suffering from. Another problem with antibody-associated diagnoses is that the antibodies tend to remain positive for life. Generally speaking, we cannot use them as an indicator for adequate treatment and it is difficult to determine relapse or reinfection because the antibody levels will still be present.

The earliest clinical manifestation of Lyme is the pathognomonic erythema migrans. This is a circular red rash which spreads out from the area of the tick bite. Generally, it occurs within seven or eight days of the bite, but it can take up to 30 days to occur and it lasts for approximately a month.

It is seen in most infections, but if it is not in an obvious body site, the patient might not be aware of it. Approximately 30% of people who display chronic signs of Lyme infection have no evidence of having had erythema migrans. We see quite a lot of these cases in west Cork and County Kerry. General practitioners regularly send us serology which turns out to be negative. If we are told when we telephone them that the characteristic rash is present, a repeat serology is carried out approximately one month later. If the serology is positive at this point, a diagnosis can be made. Approximately 30% of patients with the rash will have a negative serology. Those who are well aware of this problem get over it by repeating the serology. People can have flu-like symptoms at the same time.

The guidelines we follow when diagnosing Lyme disease were proposed by the US Center for Disease Control and Prevention, the Infectious Diseases Society of America, the UK Health Protection Agency and the European Centre for Disease Prevention and Control. They are probably the most widely applied guidelines, certainly in the United States, the United Kingdom and elsewhere in Europe. In the two-pronged approach taken we initially do an enzyme-linked immunosorbent assay, ELISA, test which, if positive, we follow with an immunoblot test. I ask members of the committee to bear in mind the caveat that in early infections people may have a negative serology. If the clinical syndrome is suggestive, we always go back and recommend that a repeat serology be done.

When we get a positive result in the initial ELISA test, we telephone the doctor involved to discuss the case and make him or her aware that it will take approximately three weeks for the western blot results to come back from the reference laboratory in the United Kingdom. If the clinical syndrome at that stage is very suggestive of Lyme disease, a decision will frequently be made to treat the patient to eradicate the organism as quickly as possible and avoid long-term complications. When the western blot results are available, we contact the clinician again to discuss the case with him or her. As I mentioned, we might suggest a further serology at that stage. I reiterate that just 30 of the 1,000 samples we examined in 2013 were actually confirmed. We tend to see a peak of samples late in the summer.

Anecdotally, having spoken to clinicians, it seems that most Lyme infections tend to occur in Ireland. However, we also see many cases that originated in central Europe, Scandinavia and the west coast of the United States. We have an active neurological centre within the hospital. The neurologists regularly test patients for Lyme disease. If there is any suggestion of a positive Lyme disease serology in a neurological patient, we will always also examine his or her cerebral spinal fluid to confirm the diagnosis. Where Lyme arthritis is an issue, joint fluid may also be taken to confirm the diagnosis.

I will stop there. I will be happy to answer questions members might have.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank both delegates who have made presentations.

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I apologise for being late. I had something else on.

I welcome the delegates. The joint committee has discussed Lyme disease on a number of occasions and varying and contradictory views have been expressed by medical professionals and advocacy groups. We are trying to get to the bottom of the issue. We have met people who have Lyme disease and they often claim that traditional medical science seems to be resistant to believing there is something wrong with them in the first place. They have suggested medical professionals can be slow and reluctant to test for Lyme disease. Very often there are contradictory views-----

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Can I stop the Deputy for one second?

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Of course.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I apologise, but there is a vote in the Dáil. Perhaps we might suspend the sitting after the Deputy has finished his opening remarks.

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The implication seems to be that my opening remarks must be short.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

In fairness, that is in the Deputy's nature.

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Okay. I will ask a few questions.

Why are there such disparities between the varying views held? I refer, for example, to the view within traditional medical science on testing for Lyme disease. Why is there not a more uniform opinion on the efficiency of the serologies of the western blot and ELISA test methods? Is there still a doubt within traditional medicine about people contracting Lyme disease? We often hear claims about chronic Lyme disease, for example. We understand the initial testing will identify the pathogens. Many people have longer term concerns about the chronic Lyme disease element.

According to people who have contracted Lyme disease, there is a lack of understanding of their plight within traditional medicine. Why is that the case? In the light of all the advances in microbiology and testing, why have we not reached a point at which we can definitively identify whether there is such a thing as chronic Lyme disease? I have met many patients, some of whom have appeared before the committee, who say they have met a huge well of resistance. They often have to travel to Germany for tests. Why is that the case? Do the delegates have any view on this?

On the broader issue, we have heard that of the 1,000 samples taken, approximately 30 were confirmed. Why is the test carried out in the microbiology unit not as accurate as it should be? What are the real reasons for this? Reference was made to the use of lumbar puncture to take samples. What is the most common method of taking samples to be assessed and analysed for Lyme disease?

I will leave it at that because other members will have questions, too.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I apologise to the delegates and those in the Visitors Gallery for having to suspend the sitting. We have to do our duty in being part of the system of parliamentary democracy.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

We are resumed in public session and apologies to our guests for the delay. As Deputy Kelleher has concluded, I call Deputy McLellan.

Sandra McLellan (Cork East, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I welcome our guests and thank them for their presentations. I pass on apologies on behalf of Deputy Ó Caoláin who could not be here as he had to attend another meeting.

Dr. Bonner referred to a consensus statement and that its purpose is to ensure that patients are clinically managed in a harmonised fashion using guidance produced with the most up to date evidence. We have had some conflicting discussion on this disease. Do the guests believe that the condition of Lyme disease exists because there is evidence that people contradicts that it does exist?

A vaccine for Lyme disease was introduced in 1998 but it has since been withdrawn by the manufacturer due to controversies over alleged side effects. How are patients treated? I ask each of our guests to outline the number of patients with Lyme disease they have personally dealt with and the way they treated them.

Do general practitioners readily recognise the symptoms of Lyme disease? Are patients sent for correct screening and testing or does the disease go undetected for a long period with sufferers not being treated? Are patients living with chronic Lyme disease who do not even know they have it because they are being treated for something else?

Dr. Bonner in her presentation mentioned the Lyme Disease Awareness Week and the Tickborne Disease Toolkit. Can she elaborate on what the Tickborne Disease Toolkit is?

Séamus Healy (Tipperary South, Workers and Unemployed Action Group)
Link to this: Individually | In context | Oireachtas source

I welcome the guests and thank them for their presentations. I also welcome the advocates and some patients who are in the public gallery. It appears Lyme disease affects a small number of people, although the numbers have been growing during the past number of years. For the people affected, it is a very significant illness and it can be very severe and chronic. I know from contact I have had with sufferers in the south Tipperary area that there is confusion and difficulty in diagnosing the disease and patients suffering from the disease are often not diagnosed with it or only diagnosed with it after a prolonged period. It appears there is a question over the accuracy of the various testing that takes place to identify the disease. Some people have said that the tests are 70% inaccurate and only 30% accurate. Is that correct? Are different tests that are more specific and accurate done in other European countries, for instance, in the UK or Germany? That has been suggested.

The disease can be very debilitating, severe and chronic for people who are affected by it. There is a general unease that there are probably no specialists in this area in the country. A number of general practitioners have a specific interest in this disease. Can I establish if there are any specialists in this field in the country and, if not, are there any proposals to appoint a specialist here, or to have a specialist from another European country come here as an interim measure?

Is there any indication that specific age groups or categories in the population are affected by this disease? It has been suggested the disease can be linked to redwater in animals or ticks in sheep. I seek more information on the disease from our guests and I hope it can be dealt with. Even though it affects only a small group of people, it is very debilitating and severe.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I call Senator Crown.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

I welcome the our guests. I apologise for not being here for their presentations as I was a little over-booked for parts of the morning.

Lyme disease is a very real and potentially very serious condition. I am not an expert in this area but having lived for many years in New York I was well aware of the people who had it. I had the tragic experience of seeing my closest professional colleague and mentor from the Memorial Sloan Kettering Cancer Center when we were both speaking at a meeting develop heart block and become extremely unwell. I do not want to bore everyone here who is not used to looking at cardiac tracing, but I saw longer and longer gaps emerging between his cardiac complexes and he had reached the stage technically of cardiac arrest and had to have a pacemaker put in. The diagnosis of Lyme disease was only made thereafter but that is what it was. I am under no illusions about what a terrible illness this can be.

I would like to amplify what my colleague, Deputy Healy, said by throwing in more question, which I have already put to other groups this morning and which I will put to our guests here. We are in general extraordinarily understaffed in every medical specialty in Ireland by international standards. I understand we have people here who do this analysis through a microbiology background and through an infectious disease background and I ask them what is the number of consultants per head of population here in this respect compared to those in the UK, to continental Europe and to North America?

A specific issue in regard to Lyme disease arose with respect to our previous hearings. Evidence was presented by another doctor who came here that there was an entity of chronic Lyme inflection which could occur wholly in the absence of any blood test evidence of Lyme infection. In other words, everything could be negative but the diagnosis could still be Lyme disease. As a result a certain number of substantive suggestions were made as to how patients who presented with this clinical syndrome should be dealt with and a clear suggestion was made that they were not being dealt with appropriately in Ireland because of our failure to recognise this entity. I thought for the sake of balance it was important that it we would have people in before the committee who could tell us exactly where the evidence stacks up on that. If there is no doubt there is Lyme disease, I am sure there is chronic Lyme disease, but is there a chronic Lyme disease which occurs wholly in absence of any blood test evidence of Lyme infection?

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I call Deputy Doherty who indicated earlier that she wished to speak. Following her contribution, I will go back to the panel and then I will go back to the members.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I ask the witnesses to intervene if my questions have been asked by previous speakers. I was struck by the differences between the figures provided by Dr. Bonner and Dr. Cryan on the number of patients who were diagnosed with Lyme disease last year. Will the witnesses explain the difference between their figures? Both Dr. Bonner and Dr. Cryan suggested that Lyme disease is underdiagnosed. Why is that the case? Is it related to the use in Ireland of a test that may be less specific that the tests used elsewhere? Does the test used here correspond with international best practice? Why do we not use the test that is used in the United States, Canada and Germany given that it yields different results? While my observations may be anecdotal, they are based on the information we have received.

Dr. Cryan suggested that in some undiagnosed or misdiagnosed cases, the outcome can be more severe than in cases where the disease is detected and treated in a timely manner. Will he describe the outcomes for such patients and what is the effect on their lives? Dr. Cryan referred to nine cases in 2012, 13 cases in 2013 and 30 cases this year. In how many of these cases have the patients shown symptoms other than the general symptoms that occur when the disease is detected on time?

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Who wishes to reply first?

Dr. Colette Bonner:

It would be appropriate for Dr. Cryan to start as we are discussing laboratory testing and symptoms.

Dr. Bartley Cryan:

I will deal with the easiest question first. Redwater disease in cattle is caused by an organism called babesia, which is common in this country and is spread by the same tick that causes Lyme disease. A different version of the disease found in New England is much more serious. Humans can contract babesiosis and the literature records in the order of five or six cases in the past 20 years or thereabouts. People whose spleen is absent or malfunctioning can get babesiosis. In the past ten years, there have been three cases in Galway and one case in Cork. The infection is relatively common in New England.

I recently discussed Lyme disease serology with a general practitioner. The GP's patient, who is a lady from County Kerry, got the infection in Nantucket and was admitted to hospital with babesiosis, which to all intents and purposes is similar to malaria. She was also treated for Lyme disease.

A number of members asked about testing. The ELISA test that we do is exactly the same as the test performed by the UK reference laboratory. The two-tier, two-pronged method of doing an ELISA and a western blot test is the most validated and studied approach to Lyme disease and the one recommended in the United Kingdom by the authoritative bodies, as well as in the United States and elsewhere in Europe.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I apologise for interrupting but why are there so many misdiagnoses?

Dr. Bartley Cryan:

Other tests are available. An activated lymphocyte test is available and is performed by some laboratories, particularly in Germany. One of the previous speakers set great store by this test but much of the medical literature does not concur with his conclusions. In some of the literature it is found to be much less sensitive and specific when compared to ELISA testing. In any case, the activated lymphocyte test looks at different versions of the same thing. One is not directly looking for the organism, which is what one would like to do, but at the body's response. The activated lymphocyte test looks at a cellular response, whereas the ELISA test looks at an antibody response. The latter approach is a very common way of dealing with infections, usually viral infections because they are hard to grow.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Why is there so much misdiagnosis?

Dr. Bartley Cryan:

I will finish if I the Deputy does not mind. In Cork University Hospital, we use the most internationally validated test available. Our laboratory was accredited by a UK body, Clinical Pathology Accreditation or CPA, until recently when we changed over to Irish National Accreditation Board, INAB, accreditation. The laboratory was visited recently by INAB. All the medical microbiology laboratories in the country had INAB visitations last year or will have them this year and all are being accredited. As part of this accreditation, they must all have in place a quality system that includes the use of a CE marked assay system and must be validated internationally and locally to ensure international standards apply. We are also part of a quality control system under which we receive anonymised specimens from a central laboratory in the United Kingdom. These are tested and the results compared. This is done on an ongoing basis in all areas.

All the medical staff in the department undergo full continuing medical education and so forth. Teaching and knowledge of Lyme disease are widespread in medicine. As I stated, I work in an area where there are four highly active neurologists for adults and one for children. In many cases, they want to find a diagnosis of Lyme disease because it is a treatable condition, whereas many neurological conditions are difficult to treat or can be treated inadequately. As many of them are relapsing-remitting and autoimmune, they are hard to treat. Lyme disease is a diagnosis that is sought because it can be treated.

The condition is generally treated with antibiotics, either tetracycline in the early stages or intravenous antibiotics in the later stages. Three weeks of treatment is generally adequate. There are no studies showing benefit beyond that period. For instance, if people are treated for six months on intravenous antibiotics, it is necessary to have intravenous access for the entire period, which brings its own pathologies. There have been cases of people acquiring candida bloodstream infections from which some have died. Long-term use of cephalosporins can result in C. diff infections, which are serious and increasing in number. People can also experience gallbladder problems from the build-up of biliary sludge as a complication of using these antibiotics. For this reason, the use of antibiotics is not a trivial matter.

The reason we use validated tests is obvious. Our main goal is obtain the correct diagnosis. The same circumstance used to arise in respect of brucella which, thankfully, is no longer a problem. In north County Cork, half the farmers and all of the veterinarians had antibodies to brucellosis 20 years ago. If a farmer or vet experienced depression or backache, his or her condition was not necessarily caused by the brucella, however. They had antibodies to brucella in their blood all the time. One must take this into consideration when diagnosing any infection.

In New England, where there is a high incidence of Lyme disease, one would have to say that a background population - it is probably between 9% to 10% in this country, depending on the area - will have antibodies to borrelia that are probably not causing any problems and may not be the cause of any current symptoms. For instance, if we obtain positive serology in a patient who has a neurological condition, we will do a lumbar puncture to look for the presence of antibodies in the cerebral spinal fluid which would go with neurological Lyme disease. We will then do some further testing on it to make sure it is being produced in the cerebral spinal fluid. We also do this in other scenarios.

Generally speaking, one has a list of differentials with different priorities. If one has a list of illnesses causing a neurological condition, including Lyme disease, and nothing is becoming obvious, the patient will be retested several times and may even be treated to ensure Lyme disease is ruled out of the diagnosis. There is, therefore, a bias towards having treatable conditions ruled out.

We were asked whether chronic Lyme disease exists. It is definitely the case that people who are not treated for Lyme disease can develop chronic complications. People who have been treated for Lyme disease can get what is called a post-Lyme syndrome. Post-infective syndromes are relatively common. For example, Epstein-Barr virus is tremendously common among teenagers at the moment and many of them will experience a protracted period of fatigue post having the infection. This is well described after a number of viral and bacterial infections.

There is a syndrome, so-called chronic Lyme disease, which is described in the literature I have been reading as causing excessive fatigue, neurocognitive issues, aches, pains, joint pains and muscle weaknesses. It is a relatively weak syndrome in terms of clinical syndromes. Senator Crown asked whether it could be associated with Lyme disease and the absence of antibodies. I do not believe there is evidence in the literature to support such a position.

What would be the etymology of the condition if Lyme disease were associated with it? Is it persistent infection? If a person had persistent infection, antibodies would be produced.

The problems with the antibodies and false negatives are early in the infection, within the first two months where somebody has the rash. When they are tested, 30% are found to be negative. The rash is so characteristic that there is very little else it can be. In New England such people get tetracycline and the person may repeat the serology in a month to confirm that it has become positive.

As I said, there is a drive towards getting treatable diagnoses on an ongoing basis with the clinician we are dealing with, and Lyme disease is one of those. On education, all the GPs in our area are very well aware of Lyme disease, as are all the neurologists in our area. Most have trained in the United States. Generally speaking, most of the physicians in the country will have trained in the United States. They will be very cognisant of Lyme disease.

We do not have specific Lyme disease specialists in the country. We have infectious disease consultants, although not very many, and neurologists who will deal with the vast majority of Lyme disease cases. Rheumatologists are involved to a lesser extent, but that would usually be an American associated Lyme disease.

Dr. Colette Bonner:

In regard to the difference in numbers, I will let Dr. Darina O'Flanagan deal with that. The difference to the diagnosis Dr. Cryan referred to relates to the total number of cases of Lyme disease, whereas I am discussing notifications which relate to neuroborreliosis, a very specific neurological complication of it. Dr. O'Flanagen will talk to that. Dr. McKeown will explain the toolkit and other educational material that has been available from HPSC for a long time for clinicians and the public.

Dr. Paul McKeown:

I thank the Chairman for the opportunity to respond. I will discuss the toolkit first. It was an initiative developed between the European Centre for Disease Control, ECDC, which is the equivalent of the CDC in the United States of America. It is an overarching infectious control forum for the member states in managing infectious diseases. Across Europe there are a range of vector borne diseases, that is, diseases carried largely by insects or insect-like creatures. Lyme disease is carried by ticks, which are not insects. They are like beetles. Tick borne diseases are very common across Europe. Lyme disease is the most common, but there are other diseases such as tick borne encephalitis which is extremely common in eastern Europe but not in central Europe. We do not see any cases unless they are imported.

I refer to these diseases because whenever we examine them we try to take a holistic approach because what will prevent one disease may reduce the incidence of a number of diseases. The ECDC has always had an interest in this, as has HPSC, and in 2012 a notifiable entity of neuroborreliosis was introduced. In doing so we followed ECDC advice that it was best to count those forms of diseases of which one is very sure. We know from evidence that about 10% of cases of Lyme disease end up as neuroborreliosis. We have been seeing about ten cases, on average, a year since we started collecting the figures in a systematic way. That would suggest we have ten or 15 times that number of erythema migrans Lyme disease, which is the milder form. I will return to the toolkit.

Chronic Lyme disease exists. As a locum GP 25 years ago I worked in Bristol which is, I understand, quite near the New Forest. Deputy McLellan referred to it. I saw it very regularly. Lyme disease is extremely interesting. Dr. Cyran referred to serology. We know from studies undertaken in different countries and Ireland that blood tests will show up Lyme disease. One will be left with a ghost of Lyme disease in one's blood if one was infected in the past. Studies would suggest that urban areas have relatively low levels of people with these antibodies, whereas rural areas have quite high levels. One study in Ireland showed that about 1% of a sample of the Dublin population had antibodies to Lyme disease, whereas parts of the west had 15%.

That indicates that many people are bitten by ticks and exposed to the Lyme bug which is carried in the saliva of these ticks. Whenever they feed they have a blood feast. Only a small proportion go on to develop erythema migrans, and an even smaller percentage go on to develop the more serious forms. The more serious forms are very debilitating and difficult to live with.

We consider it extremely important to raise awareness of this issue. We were very happy to become deeply involved with the ECDC initiative, namely, the development of its toolkit which has material that was pre-prepared. We made it relevant for GPs, other clinicians and the general public in Ireland. In previous years we produced material for national parks and linked with support groups that contacted us. We identified which organisations could provide literature, material and advice on what to do. HPSC has a lot of information on its website. We are in the process of bringing together a group of the scientific advisory committee which will extend and carry on this work.

The toolkit was designed to raise awareness, and the awareness raising for Lyme disease has to take place across a spectrum. It is something of which we can all be aware. There is quite a high degree of awareness of Lyme disease among our GPs and clinicians, but that can be continued.

I was also asked about specific age groups. We know from our cases and serological studies that individuals who are most likely to be bitten by a tick and have a positive Lyme disease test or go on to develop Lyme disease are those who come in close contact with ticks in their habitat. Ticks live outside in woodland and heathland and people who are in those areas, because of their job or leisure interests, are those most likely to come into contact with them.

We see about ten cases of neuroborreliosis a year. We have a pretty good idea of the number of cases. Our departments of public health are keenly aware of the condition, link closely with GPs and report back data from their areas to GPs. One step I was very pleased to see and which I am grateful to the department for was that Lyme disease as neuroborreliosis became notifiable. The act of making something notifiable brings it to people's attention.

We were asked whether the general public was aware of Lyme disease. I do not think we can ever be totally happy with our awareness of many diseases. The awareness raising we have undertaken in HPSC will continue because it is important for people to have the information at the back of their heads, in particular since it is seasonal. Lyme disease can be contracted throughout the year, but whenever people are out more and in contact with nature more they need to take more precautions. On our website we have a lot of information about how people can minimise the chances of being bitten by a tick and developing Lyme disease.

Dr. Darina O'Flanagan:

It is important, when speaking about chronic Lyme disease, that we differentiate between people who have been treated for it and those who have not because, obviously, those who have not been treated for it can go on to develop the chronic complications referred to, be it neuroborreliosis or arthritic manifestations. There is a danger in labelling people who do not have laboratory diagnostic evidence of positive serology indicating chronic Lyme disease because, as stated by Dr. Cryan, prolonged antimicrobial treatment can lead to side-effects such as central vascular catheter infections, fungal infections and so on. There is also a concern about people who have other conditions such as multiple sclerosis, motor neuron disease and so on. There are many documented cases of people who turned out to have diagnoses that had not been adequately investigated at a proper stage because of a false diagnosis of chronic Lyme disease. We must be very careful in this regard. It is important that diagnoses be made by accredited laboratories in Ireland. I would be reluctant to depend on the diagnoses of some laboratories, for example, in Germany which are not accredited and do not operate to the same high standards applied in Ireland.

Colm Burke (Fine Gael)
Link to this: Individually | In context | Oireachtas source

My apologies for not being present for the presentations, but I had to attend in the Seanad for votes. However, the delegates have given good responses to the questions put to them thus far.

I would like to follow on from an issue highlighted by Deputy Billy Kelleher. There appears to be a huge difference of opinion on the diagnoses people are receiving from laboratories in Germany and Belgium and those being offered here. Has this issue been discussed at international conferences and, if so, in terms of the line being taken on this issue in Germany and Belgium and what the delegates have told us today, what has been the general outcome? It has been stated there is no laboratory support for diagnoses. I presume this matter has been discussed at international conferences. I would welcome some feedback in that regard.

Mary Mitchell O'Connor (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Delegates from Chronic Pain Ireland appeared before the committee a couple of months ago. Approximately two years prior to that meeting I attended a conference on the issue. The view of people who spoke at that conference was that the problem of chronic pain was not recognised in Ireland. The conference was attended by experts from Australia who were also of the view that the problem was not recognised here. The group was then invited to appear before the committee at which time it put its case to the then Minister, Deputy James Reilly, who had the matter investigated. The problem of chronic pain is now recognised in Ireland. Are doctors in Ireland inclined to dismiss the issue? I refer to the story about Mark as outlined in the three-page letter sent to us by his mother. I am sure he is experiencing exactly what is set out therein. Are doctors in Ireland quick to dismiss the idea that someone is suffering from chronic pain?

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank the delegates for attending. I have received a letter from a constituent on the Dingle Peninsula in County Kerry who believes she contracted Lyme disease when hiking in Killarney National Park. Kerry is one of the counties identified as high risk in that regard. The experience of the person in question has been absolutely appalling. Despite undergoing numerous tests in Ireland, she was misdiagnosed as having many conditions. When she travelled to Germany for further tests her condition was finally correctly diagnosed. Because the correct diagnosis was so late in coming she is not in as good a condition as she could have been. Her family have had to sell the family home to meet the cost of tests and treatment. Their lives have been ruined and she can no longer work because of her medical condition. She is at her wit's end at this stage and hugely concerned about the failure to acknowledge huge flaws in our testing system and the negative attitude to diagnoses of Lyme disease. She has asked me to put a number of questions to the delegates.

Why are patients who test positive for Lyme disease in other EU countries not given access to treatment in Ireland? While I acknowledge that that question was answered earlier, I would welcome elaboration on the response, including the reason in 60% of cases the disease is not detected and why, following testing, many patients are diagnosed with other conditions. Is it the case that people are being tested numerous times until there is a negative result, despite the initial result being positive? Has any progress been made since this matter was last discussed here in the setting up of the proposed sub-committee and inclusion of sufferers of Lyme disease in it? As I said, according to my constituent, the culture here appears to be not to try to accommodate people.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I have two further questions arising from the delegates' responses to my earlier questions. Lest Dr. Cryan thought I was insinuating anything about the calibre of any person, I was not. I apologise if that impression was given; I was only trying to tease something out.

Dr. Cryan has stated that in the case of 30% of the tests carried out the results are negative. Is there a common reason for this? I may have misunderstood an earlier response, but, as I understand it, according to Dr. McKeown, there is what is called chronic Lyme disease. However, according to Dr. Cryan, there can be no such disease if there are no antibodies. If antibodies are detected, there is such a thing as chronic Lyme disease. If antibodies are not detected but people are experiencing the symptoms on the list, what is Dr. Cryan's explanation for what the people concerned are going through, or is that too broad a question to ask?

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Reference was made to Germany, which is not a basket case but rather a First World country. Why is there such a discrepancy between the accreditation systems in Germany and Ireland? Is the laboratory in Germany acting independently? Many people have told us that they were diagnosed in Germany as having chronic Lyme disease. Is it the view of the delegates that the accreditation system in Germany is not up to scratch or that some laboratories there are acting outside internationally accepted accreditation systems? I would welcome clarity on that issue.

As asked by Deputy Regina Doherty, what is the explanation in the case of a person who has all the symptoms associated with Lyme disease but in whom no antibodies are detected? Dr. Cryan has stated people would almost welcome a diagnosis of Lyme disease because it is treatable.

Is there almost a yearning that a person needs to find out what is wrong and that one hopes it is this? Is that what Dr. Cryan was inferring?

Dr. Bartley Cryan:

I mentioned that there is an active neurological service in Cork University Hospital. A number of people there have progressive neurological conditions and there will be quite long differentials for the potential causes of those conditions. If a treatable cause can be found, the onus will be on the neurologist and the investigating doctors to exclude as vigorously as possible all treatable causes. Lyme disease, being one of the treatable causes, would be vigorously pursued by the neurologist and the investigating doctors. It is not that the patient wishes he or she has Lyme disease; it is that the treating physician will vigorously check for any treatable condition in somebody who might otherwise have an untreatable relapsing condition.
Deputy Doherty mentioned that a person may have the symptom complex but not the antibodies. It is very difficult to explain scientifically, and it is difficult to prove it if one reviews the literature, how in the absence of the organism and an immune response to the organism somebody can get the symptoms that are part of that chronic Lyme syndrome caused by the organism. One has either an infection or an immune reaction to the infection. In either case one should be able to detect one or other of those. If there is no evidence of it detectable and the person has symptoms - the symptom complex is very broad and the list of things that can cause that is extremely long - one can rule out Lyme disease by the absence of the bacterium or by the absence of the body's response to it. Obviously, people who have been infected and are not treated can get chronic Lyme disease. On the issue of the use of the term chronic Lyme disease in the absence of antibodies or evidence of infection, there is no literature proving that it actually exists.
One wonders why some people, such as Deputy Brendan Griffin's constituent, is not responding to treatment, and perhaps she is not being treated for the right thing. He mentioned that 30% of the tests were false negatives. The vast majority of the false negatives occur early in the infection where the erythema migrans has come because one gets the erythema migrans in the first 30 days, usually in the second week. The antibodies only start to become positive around then. One may find that the antibodies are positive in week four and the rash is present in week two. It is a very characteristic rash. Any GP who sees this and recognises it will repeat the test about six weeks later and it will confirm it. When one takes that out of the count, the testing is quite accurate.
On the German laboratories, there are a number of laboratories. If one searches the Internet, one will find people in the US saying they will PCR and will detect Lyme disease in a whole series of body fluids. A professor in our department has been trying to do that with Lyme disease for the past two years without any success. The people I referred to will do that test at great cost to the individual. Many people are offering very questionable tests to people at great expense. The test used by the laboratory in Germany is a lymphocyte stimulation assay. The speaker at the committee's previous meeting, who seems to have enormous experience in Lyme disease, surprisingly has not written very much in the literature. I actually looked it up to find some of the bases for his suppositions. He has written only one letter but no scientific publications, which is extraordinary given his interest in the syndrome.
However, on the tests that he recommends and about which he is quite positive, the literature is very mixed on that particular test. It is a cellular version of what we do with antibodies so one is looking at versions of the same thing, but in other hands the sensitivity and specificity would suggest that it is not as good as the test we do. Germany seems to have a particular interest in all of this but where is the most Lyme disease in the world? New England. Where are the people who have the longest experience of dealing with lyme disease? The US. Where is the most serious Lyme disease, the specific borrelia burgdorferi? We have a variety of other species that are less pathogenic. The US. Whose advice would one be best advised to follow? The people who deal with it most often, the most serious forms of it and have the most problems with it and who actually diagnosed it, in the first place. We follow the IDSA guidelines, the CDC guidelines, the UK guidelines and the ECDC guidelines, all of which are singing from the same hymn sheet. In fact, it could be the same document.

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

It could be groupthink.

Dr. Bartley Cryan:

There is actual evidence to back up all of this.

Billy Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I was being devil's advocate.

Dr. Bartley Cryan:

Yes, it could be a groupthink. I would suggest the reverse. I would suggest the other side is groupthink. The Deputy mentioned international conferences. There has been quite an amount of debate, both verbally at conferences and in the literature, about this whole subject. Following a diagnosis of chronic Lyme disease, the scientific basis for protracted antibiotic therapy for this poorly defined condition is non-existent. When it becomes existent. the treatment, modification and management of it will change. At the moment there is not a sufficient weight of scientific evidence to suggest that seronegative patients who have this symptom complex with the huge potential list of differentials have actual occult Lyme disease. While variety of suggestions have been put forward, if one goes through them one after another, it is very difficult to prove a negative. We got blood in from a person who wanted to find the undetectable viruses. I rang back asking which undetectable ones she specifically wanted us to look for. She said that if we could not find them, they must have an undetectable virus. The absence of something does not mean it is present. There is no scientific proof to suggest that this occult Lyme disease syndrome actually exists. People are doing a lot of research. The Lyme disease diagnosis is not an exact science at the moment. It should, hopefully, be improved. People have been looking for this particular cause.

I was present at a conference 25 years ago where chronic fatigue syndrome and Lyme disease were being discussed and they were trying to find linkages between the two. This line of investigation has been going on for quite some time and there still is not tangible scientific evidence. The crucial thing is that people do not get misdiagnosed. If one is diagnosed with the syndrome and one does not respond to the treatment, the chances are that one has got something else, but time has moved on. We do not repeat testing until it goes negative. The only reason we might repeat a test is to confirm there was not a mix-up with patient labelling or something like that. In fact, every significant test we get, we will always get a second sample from the patient to confirm that it is positive, and occasionally one will do them to monitor therapy. Once one is positive, one will be positive for life and those antibodies will be present. It is the same with all the viruses and various other infective agents that we have come in contact with.

Dr. Darina O'Flanagan:

I will pick up on the issue of following the science. I wish to comment on two trials that have followed up patients who have been treated for Lyme disease and that have compared them with healthy controls. One of the studies, a Slovenian study, shows that the symptoms after treatment at six and 12 months were the same in the treated group as the control population. Another similar study was done in a Swedish group. Again there was no difference in the outcomes following treatment. The issue is that both studies highlighted the background prevalence of non-specific symptoms in the general population such as arthralgia, aches and pains, myalgia fatigue and other subjective symptoms. Unless one compares it with a control population the evidence does not exist that there is a difference once people have been adequately treated. There is no scientific evidence to support the need for long-term chronic use of antibiotics.

There was another question from Deputy Brendan Griffin in regard to the sub-committee of the scientific advisory committee. This year we have deferred a number of our committees because of the issue of Ebola virus disease and we have had to pull a number of our people in the HPSC to work on Ebola.

We will pick up those committees next year, hopefully, prioritise them and resume the work that had begun on them. If we have an emerging viral threat, we must prioritise what we focus on. That is the nature of the business we are in. Hopefully, if there are no other competing priorities like the Ebola virus disease, we will be able to pick that up.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Is the centre open to representations from sufferers?

Dr. Darina Flanagan:

We open our documentation for a consultation process. Whenever we produce a document, we send it out widely for consultation and sufferers will have the opportunity to provide their comments for consideration by the committee at that stage.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Is there scope on the committee itself for someone who represents sufferers?

Dr. Darina Flanagan:

The way we do it is to receive and consider all comments when we put it out for consultation.

Dr. Paul McKeown:

I should clarify for Deputy Doherty that when I spoke about chronic Lyme disease I meant that there are chronic conditions. In terms of chronic seronegative Lyme disease, the human body is designed to fight off alien substances, including infections. One of the ways it does this is through antibodies. My feeling is that if somebody has an infection, they must mount an antibody response. If the antibodies are not there, it means the person has a desperately damaged immune system and is open to all sorts of infections or that the diagnosis would be something else.

In terms of guidance, it is extremely important that we produced our consensus statement and highlighted a number of guidance documents. Whenever we develop guidance, we look for confluence and a majority of evidence pointing in one direction. To do that, we have access to a vast amount of evidence through various repositories of information that are made freely available to us. It is a wonderful resource. We look for confluence of evidence which does not mean that we discard other evidence. All the evidence in terms of diagnostics and treatment very much point in a particular direction, and that is the basis upon which we have developed guidance.

I note to Deputy Griffin that it is shocking to hear of someone who is placed in that awful position. I would be very concerned that if that person got a diagnosis outside the country, he or she was given the wrong diagnosis. Quality assurance in our labs is very high and extremely important because our medics - my microbiological colleagues - are here to protect people. That is why across all developed countries the laboratories operate to a very high quality assurance standard. That is necessary to ensure that people get the correct diagnosis in order that they do not go down a road of being given inappropriate antibiotics that could damage them or having an inappropriate lumbar puncture, which very occasionally has complications.

Dr. Darina Flanagan:

We are very fortunate in Ireland in the quality of the laboratory services we have.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

In accepting that, I note that in a presentation last year, one of the people before us made a very strong statement that, unfortunately, lab testing for disease in Ireland is currently limited.

Dr. Darina Flanagan:

I do not support that.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

That was just presented to us last year.

Dr. Darina Flanagan:

My concern would be that in some countries there is a preponderance of private labs and they do not have the same standards we do in the laboratories here.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Can I go back to my constituent and tell her there is no way that if she is positive for Lyme disease, the labs in Ireland would have missed it on foot of the tests that were carried out? Could I confidently say that is what the witnesses are saying to her here today?

Catherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

My question is really the same. I accept that where someone is diagnosed out of the country, there may be labs that are not up to standard. We had a group in an hour ago who said the same thing about labs and people doing medical work who are not fully qualified. If somebody is diagnosed outside the country, whether through a national lab or a dodgy lab - I do not want to say that but it is the only way I can describe it - and comes back here, what help can they be given to assure them that what they have is not what they have been told? If I went away and had a test done and came back to the country and the medical experts here did not agree with the test, would I be retested here?

Dr. Darina Flanagan:

Yes.

Catherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

If someone goes away and is told he or she has Lyme disease, he or she can have the diagnosis corrected here. Is that correct?

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

We all bring a variety of different life skills to the committee, but I am worried that some of the scientifically inexperienced members may have an understanding that somehow there is a consensus in Germany that is different from a consensus in Ireland. I can tell someone with a high degree of confidence what treatment one of my patients will get where, as happens, he or she goes for an international second opinion. I have a pretty good idea what he or she will hear if he or she goes to see the head of breast oncology at Harvard, Yale, UCLA, Stanford, or the Royal Marsden. I know what is being published and have a couple of hundred papers myself. Many of these people are amply published. Dr. Cryan has given the most masterful and professional testimony I have ever heard anyone give to the committee. It has been forensic, accurate, dispassionate and informed and I commend him on it. There are mainstream infectious disease professors in Berlin, Düsseldorf, Hanover and Munich. Is any of them espousing the notion or technique of, to say his name as he was here, Dr. Schwarzbach? If Deputy Griffin thinks the question is inappropriate, I ask him to refuse to answer it.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

He is not here to defend himself now.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

Was the person who made the diagnosis in the case of Deputy Griffin's constituent the same person who benefited from the proceeds of the sale of the house?

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

That is not appropriate.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I ask for that to be withdrawn. There is a likelihood that this lady is watching these proceedings.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Deputy Griffin, I am chairing the committee.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Can Senator Crown imagine how that person must feel to hear his remarks right now when looking in on these proceedings? I ask the Senator to have a think about that now and about a lady in serious ill health back in Kerry hearing his remarks. I ask for the remark to be withdrawn.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I ask the members to respect the Chair. I will intervene.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

I am not going to withdraw the question.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I am not going to have this type of behaviour in the committee. The Senator made a remark that was not relevant to the discussion and which is inappropriate in terms of the discussion we are having.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

It is highly relevant as the suggestion was made that we should devote health service resources.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

It is not relevant, it is arrogant.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

In fairness now, I will hand back to Dr. Cryan. I echo the point that Senator Crown made that Dr. Cryan has given powerful testimony and I commend him on that.

Dr. Bartley Cryan:

The two Deputies asked what the reaction will be where someone gets a diagnosis abroad and returns to the country. Generally speaking, where someone has a diagnosis of an infectious disease from abroad, the treating physician and-or GP will redo the tests, serologies, etc. here. The person will be treated exactly the same as anyone else. In the UK roughly 15% of Lyme disease is acquired and diagnosed abroad. We would have many people who come back from central Europe who have Lyme disease and had a diagnosis abroad. We will confirm that ourselves and, whether they have had the lymphocyte stimulation assay done or not, we will do our ELISA test on it. If we get discrepant results, we will look into it further.

They are treated exactly as if they picked up Lyme disease in Killarney.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

I asked a question which has not been answered.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Any outstanding questions will be taken at the end. Questions have been asked of other witnesses. This is not about argy-bargy but obtaining information so we can arrive at a decision.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

On a point of information, I asked-----

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The Senator will receive the information at the end of the discussion.

John Crown (Independent)
Link to this: Individually | In context | Oireachtas source

I want to ask Dr. Cryan whether any other mainstream professors would espouse the same methods suggested by the previous anonymous-----

Dr. Bartley Cryan:

The proof of this particular pie is in the eating. The European Centre for Disease Prevention and Control, ECDC, the Infectious Diseases Society of America, IDSA, the Centers for Disease Control and Prevention, CDC, in the US and the equivalent bodies in the UK, which are all highly reputable, agree on the two-tier approach to diagnosis and the treatment regimens. It was mentioned the testing was limited in this country

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

That was a just remark made at the previous committee meeting.

Dr. Bartley Cryan:

To an extent it is true, but it is limited to the recommended two-tier approach. The second part of the two-tier approach for almost all laboratories in this country is the UK reference laboratory. The first part we use, which many others do also, is the same test used in the UK's national reference laboratory.

Dr. Colette Bonner:

We have demonstrated that we are looking at a condition which has chronic symptoms which can be related to many pathologies. We have learned today that it is very important for people to get an accurate diagnosis and not end up with a diagnosis which misses something very important whereby they do not get adequate treatment for that condition when they should.

Dr. Darina O'Flanagan:

I agree and I support what Dr. Bonner stated. It is essential that people obtain an accurate diagnosis. If there is no supportive evidence, other conditions must be considered.

Dr. Paul McKeown:

I echo this exactly. In medicine one starts by trying to identify the cause of the condition and one needs to start with the correct diagnosis. It is like divergent roads. If one goes too far down a road one can end up causing a patient harm, so getting the diagnosis right at the beginning is crucial. This is why we rely on good clinical acumen, which we have in abundance in this country, and the appropriate tests, as Dr. Cryan stated.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Notwithstanding the arrows being thrown around with regard to particular institutions, how would one conduct a test for Lyme disease if there were no antibodies? The witnesses have spent the past number of hours explaining that one will get a diagnosis if one is testing for the disease itself or the body's reaction to antibodies. How can somebody go to Timbuktu and get tested and receive a positive diagnosis without one of these two things?

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Have there been cases where people have tested negative here, gone abroad to a reputable or non-reputable clinic and obtained a positive diagnosis, returned here, been retested and found positive? In cases where people have obtained positive results abroad, what happens when they return? What happens if someone goes to mainland Europe after receiving a negative diagnosis here, gets a positive diagnosis there, returns and further tests show something else?

Séamus Healy (Tipperary South, Workers and Unemployed Action Group)
Link to this: Individually | In context | Oireachtas source

Is someone who tests negative here retested after two, three or four weeks? Is there a case to be made for preventative antibiotics prior to a positive test result which may occur a fortnight or a month later?

Dr. Bartley Cryan:

I will attempt to answer Deputy Doherty's question first. It depends on what one is seeking. If a particular test seeks antibodies and another test examines stimulated cells, the two tests seek different things which may have come from the same source. There will always be some tests which are slightly divergent. Another spirochetal disease is very similar to Lyme disease and has three phases. We screen for this and do two other tests afterwards. Quite frequently we have divergent results because each test examines different things.
Some of the earlier Lyme disease enzyme-linked immunosorbant assays, ELISAs, were non-specific because in the earlier tests the ELISA sought antibodies to the entire bacterium. They have been defined and refined. We have many spirochetes, which borreliais, in our mouth. They are common organisms and there are many common bits to them for which people can develop antibodies. We need to use an assay which takes out these common bits and focuses on the specific borreliabit. There can also be differences because there are different species in Europe and the United States. This has all been gone into in considerable detail, so the available assays, including the one we use, is up there with the best internationally and the most accepted.

Regina Doherty (Meath East, Fine Gael)
Link to this: Individually | In context | Oireachtas source

If somebody travels and tests positive, then something has been found, albeit something in the person's mouth-----

Dr. Bartley Cryan:

A positive result has been obtained but the relevance of the positive result is the issue. There are false positives and false negatives and the activated lymphocyte assay is not internationally standardised and is not recommended by the IDSA or the CDC in the United States. For these reasons we do not use it, because it is not an internationally approved assay.

To answer the question on antibiotics, if I phone a general practitioner with a strong positive result for somebody with a facial nerve palsy, which is one of the neurological manifestations which comes on reasonably early in Lyme disease, it will be sent to the reference laboratory. I know it will take three weeks to come back so I will suggest the patient is treated so the Lyme disease will be treated as early as possible. The result from the reference laboratory is likely to be positive and the person will have completed treatment by the time the result comes back. If the result is not confirmed then the facial palsy has another cause, although we would repeat the serology six weeks later to be sure. If it is Lyme disease, it will have been treated as early as possible, which reduces the long-term complications.

There is a suggestion that if someone with an infective illness is treated early, the antibody response can be blunted so the person does not develop as many antibodies as would be the case if he or she got the full disease. This is in theory, but in practice it does not really happen. Many people are well treated for infections but they still have many antibodies.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I wish to press my questions on people who tested negative here.

Dr. Bartley Cryan:

I do not know. I am not that intimately involved with people who tested negative here and tested positive abroad. I do not know whether they had subsequent positive tests here. I am not aware of any case anecdotally. I am aware of some people who have tested negative here and went abroad to be tested, but I do not know where they went or what tests they had.

Brendan Griffin (Kerry South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Were other conditions diagnosed later, even after a positive test abroad?

Dr. Bartley Cryan:

One can get positive Lyme disease serology with rheumatoid arthritis or autoimmune conditions. Many conditions make it very difficult for one to diagnose anything serologically. In the reference laboratory in which I worked, if we had a positive test for Lyme disease, we tested for three or four other illnesses to exclude them because one can have cross-reacting antibodies. We ensured the antibodies were due to the borreliaand not due to another spirochete, rheumatoid arthritis or a connective tissue infection.

Jerry Buttimer (Cork South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Dr. Bryan, Dr. Bonner, Dr. O'Flanagan and Dr. McKeown for attending. I also thank them for their excellent presentations and testimony. We appreciate their taking the time to come before us. I also wish to thank members for their participation and to acknowledge those in the Gallery who have been present for the entirety of proceedings.

I take this opportunity, on behalf of members, to thank the staff of the committee and the reporting and technical staff for all their work and co-operation during the year. I wish those present and their families a very happy Christmas and a prosperous new year. I urge members and staff to enjoy the break and to return refreshed in the new year.