Minutes: First Evidence Session Held 8th May 2018

The All Party Parliamentary Group on Lyme Disease

First Evidence Session Held 8th May 2018

Panel Guests: Prof Saul Faust (SF), Chair of the NICE Lyme Disease Guidelines Committee
Dr Norma O’Flynn (NF), Chief Operating Officer of the National Guidelines Centre

Chairs of Session: Michelle Donelan MP (MD) and Simon Hoare MP (SH)


MD opened the session thanking SF and NF for their time in attending and outlined the purpose of the meeting which was to better understand how the new NICE guidelines were reached and questions around this.

MD- Was it difficult to form the Committee for the formulation of the NICE guidelines and how was this approached?

SF- Not particularly, I have sat on a number of committees and this one was no different or more challenging than any of the others. The scope of and Committee is pre- set and NICE has guidelines to follow for appointing committee members and the specialties needed which were followed in the selection. Prior to selection of members interviews were conducted and appointees made on the back of these.

Lord King of Bridgwater (LK) – Was there anyone with microbiological expertise on the panel?

SF- Yes Prof Tim Brooks was on the panel. Originally there were 2 microbiologists but one member stood aside due to a conflict of interest.

LK- We brought together this APPG to review the diagnosis and treatment of Lyme here in the UK and there are those who feel that NICE guidelines do not go beyond what the NHS can afford.

SF- I cannot speak on financial decisions taken post the Committee dissolving. I applied to Chair the Commission as I previously chaired the Sepsis Committee and I wanted to see more pragmatic guidelines for GPs going forward.

LK- What is a NICE Committee expected to do?

SF- Public scope of the Committee already decided prior to it being formed and done through consultation. The scope in this case focused on how to best identify and treat Lyme. Economics are important but in this instance secondary to best practice and pragmatism.

NF- I would like to be clear that Guideline Committees do not do an affordability test but do consider cost effectiveness which is very different.

LK- So if something is deemed cost effective it will then be funded by the NHS?

NF- This conversation happens after the Guidelines have been produced and I believe takes place in conversations between NICE and NHS England.

SF- With reference to these guidelines specifically there were no issues with health economies or suggested thresholds as there are with some expensive cancer drugs for example- they were based on straight forward clinical decisions.

Hannah Bardell MP (HB) – I have a constituent with chronic Lyme who has suggested that the Guidelines failed to take into account international best practice on diagnosing chronic Lyme- is this the case?

SF- We stayed away from using the term ‘chronic Lyme’ as it was clear from the outset that we would never reach agreement on what constituted it or the definition of it. To continue to use the term during Committee discussions would have only created endless discussion and distraction from the other work.

SF- We chose instead to split those with Lyme into two groups, those with continuing effects and symptoms and those without.

SF- A lot of people I have encountered who have chosen to go internationally for treatment have done so because they have had no NHS service close by or do not know there are NHS facilities close to hand. A lot of people who go abroad for treatment can end up with tests which are worse than the ones which are often critisised here in the UK e.g. spot testing which can be very patchy if not followed through. International clinics are often private and so have the same financial motivations which private clinics in the UK can have.

NF- There were no limits on the countries overseas which research could come from and the majority of the research used was in fact international.

MD- Would that then highlight the lack of research here in the UK.

NF- Yes it would and there are clear suggestions for additional research which have come out of the Guidelines.

SF- Guidelines accept there is a lack of research and so are based on pragmatism so for example it would allow GPs to give antibiotics even when a patient is not proven to have Lyme

The Countess of Marr (CM) – Why in the UK is the C6 test used?

NF- This is the best test we currently have, though it is important to note that even when it comes back negative GPs are able to prescribe antibiotics under the new Guidelines.

SF- Prof Tim Brooks who I believe you will be speaking to in the future would be better placed to answer this question.

CM- Why are we not able to use tests from abroad?

NF- If tests from abroad are accredited then according to the Guidelines it is possible to accept them.

SF- Where a lab is accredited in their own country then Guidelines allow those tests to be used in the NHS. The issue is that some clinics in other countries have their own reasons for producing a certain type of result which is why we need to rely on accreditation to ensure robust tests have taken place.

SF- We need to be pragmatic here and remember even when a test comes back negative GPs are empowered under the Guidelines to prescribe up to 2 courses of antibiotics where they suspect Lyme.

Baroness Masham of Ilton (BM) – GPs surgeries in Europe seem to be more confident in diagnosing Lyme than those here in the UK- what do you think is behind this?

SF – In the UK confidence in diagnosis is very much dependent on the volume of cases. There is a lot more Lyme abroad and so in certain countries this may account for the increased confidence and familiarity. Guidelines are key to supporting those GPs who do not have a large volume of Lyme cases to diagnose and treat with confidence.

BM – What did the Committee do to help get the Lyme message out to GPs?

NF- We did not have the remit to increase awareness just to draft the Guidelines.

SF- This is for NHS England to arrange and fund if they believe it to be the right area to allocate resource.

Teresa Pearce MP (TP) – You say the more you see of Lyme the easier it is to spot, however there are many examples of cases being missed by experienced GPs. You also have the issue of people from urban areas travelling to Lyme hotspots (e.g. Glastonbury) and then going to their GPs back in their city. The real challenge of course is that we do not know how much Lyme there is in the UK.

SF- I agree and one of the recommendations for research which the Committee made was into the scale of the problem and geographical distribution.

MD – Guidelines allow GPs to refer to a specialist if you do not recover with 2 courses of antibiotics. The issue is there are no Lyme specialists here is in the UK.

SF – This may be controversial but I do not agree with Lyme specialists. The main reason is that there will be a lot of people with Lyme symptoms but who do not know they have Lyme or they may have other conditions which are misdiagnosed as Lyme and so would delay them getting the right treatment.

NF – There is a risk that GPs could start putting everything down to Lyme, especially as the symptoms are not dissimilar from those of other diseases and this would delay people getting an appointment with the right specialist.

MD – There is a real risk though that you could be sent from specialist to specialist when you have Lyme and take a long time to get the right diagnosis. This costs the NHS appointments and money but delays you getting the right course of treatment.

SF – I appreciate that there is a real concern in this and that is why the Guidelines are there to help support GPs in diagnosis and in making sure people get signposted to the right treatment. The initial feedback from GPs has been very positive and we need to build confidence in diagnosis here in the UK.

SH – It is the lack of confidence which you allude to that is driving people to go overseas for treatment and answers, which as you pointed out is not always properly regulated or of a high standard.

SF – I agree with you but I do not think a Lyme specialist would solve this as it would be a magnet for all sorts of people with vague symptoms and who may not be getting the right course of treatment for their condition. Guidelines are the start of building that confidence but NHS England need to work out how to increase from there on.

SH – Given the lack of confidence in the NHS which many Lyme sufferers have experienced would it not be good to have a specialist/ expert to drive the knowledge agenda and could lead on driving up this confidence?

SF – I agree with what you are saying in terms of outcome but think the journey in getting there should be different. I feel it would be better to identify research needed and then to employ people to conduct it which would then become the de- facto experts and drive up the knowledge and future research. There is a thirst for knowledge in the area and we should be harnessing and feeding that. I would not like a Tsar or Expert or whatever you would like to call them to detract from centers of excellence which could really drive the knowledge agenda.

MD – I do not think having a specialist or a leader in the field and a center of excellence are mutually exclusive.

CM – Prof Tim Brooks sent around a flyer 3 years ago to increase awareness which people said was very good and we can raise it with him when we speak to him in the following sessions.

SH – Medical students in Germany are taught about Lyme from the outset of their training, this does not seem to be the case here in the UK.

SF – I cannot speak of the quality of medical training as this is not my specialty but I assume that this is a reflection of the level of Lyme in Germany. Here in the UK where medicine is taught in areas of high Lyme concentration I assume that it would get more focus than in some inner city urban areas. This is not specific to Lyme but the nature of medical training generally.

TP – Based on what you have said before about the lack of robust research and evidence would it not be good to have a Lyme Tsar to correct this?

SF – This is not the way that research works here in the UK. NICE recommend and commission research and then people are able to bid and apply to conduct it.

TP – There are some alarming gaps in knowledge e.g. do we really know whether Lyme can be passed from mother to child during pregnancy?

SF – That is a very difficult question to answer as there are so few cases to make a meaningful conclusion. The Lyme Guidelines do however cover Lyme during pregnancy and suggest that it should be treated with pregnancy safe antibiotics and then should the baby be born with symptoms these should be referred immediately to a pediatric specialist.

MD – When we have so little evidence as you have said how can we be sure that 2 courses of antibiotics is the right course of action?

SF – There is some evidence such as that in the New England Journal which has been robustly researched and points to a longer course having no significant impact. The challenge with antibiotics is that the Guidelines have to be specific otherwise GPs would be conservative and under prescribe. We have gone to the max amount which the current drugs licenses would allow and it is the discretion of the GP to go below that amount on a case by case basis.

SF – For rarer forms of Lyme you need global research as it is too costly for too few cases to do UK alone and so should be coming together with the international community to commissions.

MD – Is there not a risk that people are being exploited by the private clinics who charge and often provide care which could be provided on the NHS?

SF – Yes this is a real concern as I have spoken to people who have spent thousands of pounds on treatment which they could have gone down the road and received on the NHS. Again this is an issue of confidence and that people should have the confidence to go to their GP and not feel the need to spend their own money on tests which are often no more reliable or in some cases less reliable than the NHS approved ones.

SH – Would it not be a good idea to have the international community peer review what NICE are saying and the level of care here in the UK?

SF – I think that risks over exaggerating the issue as many people get Lyme but do not know they even have and recover, many get Lyme and treatment and make a full recovery and there are those of course who do have long term side effects though this is a very low percentage overall. I would like more research commissioned into the true scale of the issue and other such areas before we start talking about peer review. The international community should work together on research though and sharing best practice where appropriate to do so.

Adam Wintour (AW) – Testing is not effective which you said was the challenge, when this is the case it is impossible to know how many have Lyme.

SF – This is indeed the case though there is no infectious diseases test which is 100% accurate.

NF – We need to keep reiterating that even when someone is presented with a negative test the Guidelines still allow for the issuing of antibiotics where the GP sees a need. Testing will not be a barrier to treatment because of the Guidelines.

SF – Testing for Lyme will evolve like it does for all diseases and we will be focusing less on blood and spot tests and more on gene testing which will be much more accurate though this is all in the future and we need to work with the testing we have now.

MD closed the meeting and thanked again SF and NF for their time and answers to the questions.