Written answers
Wednesday, 16 January 2013
Department of Health
Disease Classification
Derek Nolan (Galway West, Labour)
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To ask the Minister for Health further to Parliamentary Question No. 648, if he will consider reviewing the guidelines from the International Lyme and Associated Diseases Society, rather than the guidelines of the IDSA, which Ireland currently follows in view of the fact that the two sets of guidelines make for different reading in dealing with lyme disease; and if he will make a statement on the matter. [58149/12]
Derek Nolan (Galway West, Labour)
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To ask the Minister for Health if, following information received from Tick Talk Ireland in March, a response will be issued to them about the problems they identified in testing for and diagnosing Lyme disease; and if he will make a statement on the matter. [58154/12]
John McGuinness (Carlow-Kilkenny, Fianna Fail)
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To ask the Minister for Health the steps he or the Health Service Executive have taken relative to the care of the needs of those with Lyme Disease; his response to those involved in a campaign to have the disease properly recognised; and if he will make a statement on the matter. [1115/13]
James Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 993, 996 and 1018 together.
Since September 2011, Lyme Disease has been statutorily notifiable under the Infectious Diseases Regulations. The standard approach to the treatment of Lyme Disease is to follow the guidance laid out in the Infectious Diseases Society of America (IDSA) guidelines on the clinical assessment, treatment and prevention of Lyme Disease. This is accepted as being the most up to date synthesis of best available evidence on the clinical management of Lyme Disease and treatment of Lyme Disease in Ireland is based upon this guidance. A consensus statement on the clinical management of Lyme Disease 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, all of whom support the use of this guidance.
The diagnosis of a case of Lyme Disease can be difficult. The standard approach to Lyme diagnostics is a two-stage approach and involves using a sensitive enzyme immunoassay (EIA) as an initial screening step. However, screening EIA's can be insufficiently specific and can give other false-positive reactions in the presence of various other infections from syphilis to glandular fever. In addition, sera from patients with autoimmune disorders and other inflammatory conditions can also lead to false-positive results. Samples giving reactive or equivocal results in screening tests are further investigated in a second stage immunoblot test. The use of immunoblot testing greatly increases specificity. Using this two stage approach gives a greater degree of certainty around the diagnosis of Lyme Disease.
A response to Tick Talk Ireland will issue shortly.
Comments
Jennifer O'Dea
Posted on 23 Apr 2013 12:28 pm (This comment has been reported to moderators)
In September 2012 Tick Talk Ireland submitted pages & pages of studies relating to the problems with current day testing (Elisa & Western Blot). Shortly after this a consensus statement was issued by the IDSI, HPSC & others (as mentioned in James Reilly's reply above). Tick Talk Ireland then issued a further statement asking for the following amendments to be made - we have not had a single reply from any of the entities despite sending a follow up reminder earlier this year. We would therefore like to publicly declare our concerns:
To: Dr Paul McKeown, Health Protection & Surveillance Centre, Royal College of Physicians Ireland, Royal College of Surgeons Ireland, Infectious Disease Society of Ireland & Irish Society of Clinical Microbiology
Dear sirs, on the 18th September 2012 a full & lengthy report was submitted to the entities above with regards to the many problems associated with Lyme Disease testing. This was accompanied with numerous studies supporting the points put forward. It has been noted however that a consenus statement has since been drawn up & published online by the following entities:
Scientific Advisory Committee of the Health Protection Surveillance Centre,
Infectious Diseases Society of Ireland, the Irish Society of Clinical Microbiologists,
Irish Institute of Clinical Neuroscience and the Irish College of General Practitioners
As a concern for patients we believe the following affidavits should be included:
1. Guidelines are designed for voluntary use only & should not be used to replace the knowledge of the treating physician:
Per IDSA: http://www.idsociety.org/Guidelines_Patient_Care/
Quote: "It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgement with respect to particular patients or special clinical situation. IDSA considers adherence to the guidelines listed below to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances."
Per European CDC: http://ecdc.europa.eu/en/healthtopics/tick_borne_diseases/ly...
Quote: "The information contained in this factsheet is intended for the purpose of general information and should not be used as a substitute for the individual expertise and judgement of healthcare professionals."
2. Testing can be problematic causing false positives & false negatives for several reasons:
Per Trinity Biotech: http://www.trinitybiotech.com/Product%20Documents/2346580-29...
The test kit states “The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. *Negative results (either first- or second step) should not be used to exclude Lyme disease.*"
Some reasons for the possible pitfalls with Elisa testing per the kit manufacturer’s notes include the following…
*B. burgdorferi is antigenically complex with strains that vary considerably.
*Early antibody responses often are to flagellin, which has cross-reactive components.
*Patients in early stages of infection may not produce detectable levels of antibody.
*Early antibiotic therapy after EM may diminish or abrogate good antibody response.
Thus in their own words “Serological tests for antibodies to B. burgdorferi are known to have low sensitivity and specificity, and because of such inaccuracy, these test cannot be relied upon for establishing a diagnosis of Lyme disease”.
More information on the downfall of testing is available in the attached reports..
3. Lyme testing criteria set by the CDC is for 'surveillance' criteria & should not be used to exclude diagnosis
Per CDC: http://wwwn.cdc.gov/NNDSS/beta/bcasedef.aspx?CondYrID=752&am...
Quote: "This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis."
Per European CDC: http://ecdc.europa.eu/en/healthtopics/tick_borne_diseases/ly...
Quote: "Further improvements in diagnostic tests are also required."
As a team we have access to many scientific papers as well as lab test kit information from various manufacturers & feel very concerned that information with regards to the problems with testing is not being relayed sufficiently to doctors. We are aware that consultants are still telling patients that Lyme doesn't exist here in Ireland therefore rashes are being missed or blamed on a spider bite. Too much reliance is also placed on testing (a negative leads to patients being refused treatment). We know that early diagnosis is key to successful treatment; those treated later their prognosis for a full recovery is not so good.
Per Trinity Biotech: Late, delayed, or inadequate treatment can lead to the more serious symptoms, which can be disabling and difficult to treat.
Until testing can significantly be improved we feel that more must be done to ensure swift & effective clinical diagnosis. We also feel adherence to restrictive guidelines & testing does little to help patients, & welcome the day when improvements can be made. In the interim if our concerns can be met regarding the points mentioned above we would be grateful.
With sincerest wishes,
Tick Talk Ireland
Jennifer O'Dea
Posted on 23 Apr 2013 12:43 pm (Report this comment)
The CDC link above is broken - this one may be better!
http://wwwn.cdc.gov/NNDSS/script/casedef.aspx?CondYrID=752&a...
Ann Maher
Posted on 22 Apr 2013 7:04 pm (Report this comment)
How disappointing to read all this again.After nearly 18 years of Chronic Lyme Disease,I will not give up that our Minister for Health might look at the Broader problem with diagnosing and treating of Lyme Disease in Ireland.Please DO NOT keep following the IDSA guidelines, check out I.L.A.D.S. for more info
Put 10/11th May in your diary, there is a WorldWide Lyme Disease Protest taking place.To date 30 countries are taking part....Protesting, Raising Awareness or whatever sick People can do on the day.
http://www.google.ie/url?sa=t&rct=j&q=worldwide%20ly...