Petition to The Secretary of State for Health UK re: NICE guidelines on Lyme Disease
This petition had 10,900 supporters
Update post publication of the NICE Guidelines on Lyme Disease
There’s nothing unexpected in the published guidance.
NICE are tied to the flawed process that they use which excludes non-human or older data. (See update dated 13th April 2018 for further detail).
The premise of any guideline is that it is ‘evidence based’. This document is based on “poor” evidence (NICE’s assessment) and as such, NICE have produced poor guidance, exactly as we detailed in the original petition below.
It fails to meet their own standards as it does not represent the Lyme disease patient population, as a whole, and as such it will not improve patient health or outcomes.
“The greatest danger of flawed clinical guidelines is to patients. Recommendations that do not take due account of the evidence can result in suboptimal, ineffective, or harmful practices. Guidelines that are inflexible can harm by leaving insufficient room for clinicians to tailor care to patients’ personal circumstances and medical history. What is best for patients overall, as recommended in guidelines, may be inappropriate for individuals... (BMJ 1999)”
This process needs to be challenged and changed so this petition will continue until the Secretary of State for Health intervenes, as is his duty to protect of the physical and mental health of the people.
Petition to The Secretary of State for Health
We hereby petition The Secretary of State for Health (SoSH) to intervene and to give direction to The National Institute for Health and Care Excellence (NICE) to review and modify its guideline methodologies and procedures with respect to the forthcoming guideline GID-NG10007; Lyme Disease (Lyme Guidelines), due for publication on 4 April 2018, as the current standards represent a significant failure in the performance of its functions.
Whilst we understand the need for high standards and cost efficacy and are aware that there is a degree of transparency throughout the process and that individuals working for NICE are performing to rigorous process and set protocols, the current process has created draft guidance that is dangerously flawed and must not be allowed to proceed to publication on the intended date.
We ask that in his intervention the SoSH directs NICE to actively listen to our concerns and engage with the patients and those who are both experienced and willing to treat Lyme patients, who will be prejudicially hindered by the limiting guidance if it proceeds to publication. Only by such engagement with a large patient population who have been diagnosed with Lyme disease and with those doctors who routinely treat and manage patients with persistent infection will meaningful guidelines be devised.
By petitioning the SoSH we remind him of his duty under section 1 of the National Health Service Act 2006 to secure improvement in:
(a) the physical and mental health of the people of England, and
(b) the prevention, diagnosis and treatment of illness.
The Lyme Guidelines if published, will necessarily mean that the SoSH is failing in his duties and they will:
(a) contravene NICE’s own remit with respect to reducing uncertainty in all respects of prevention, patient management and treatment. The data clearly does not represent the Lyme disease patient population, as a whole, and as such it will not improve patient health or outcomes; and
(b) due to shortcomings and an unwillingness, to date, to revise the process, it will inadvertently fail to respect, protect or fulfil patients’ human rights under the following UN treaties (as detailed in Joint Fact Sheet WHO/OHCHR/323):
International Covenant on Economic, Social and Cultural Rights (ICESCR), 1966 Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), 1979
Convention on the Rights of the Child (CRC), 1989
European Social Charter, 1961
and under the Human Rights Act 1998; and the Lyme Guidelines certainly do not “reflect the values of society” to which NICE are committed
The severity of our claims is substantiated below:
NICE have presented the Lyme Guidelines based on data from only 315 seropositive patients (detail below). This is not going to change prior to the proposed publication, unless the engagement we are asking the SoSH to direct pursuant to this petition is undertaken.
None of these patients:
(a) had a rash but did not get diagnosed for months/years
(b) had a tick bite but did not get diagnosed for months/years
(c) had either but then had a negative blood test
(d) had neither bite nor rash but had a clear clinical profile and were not treated (these patients were not included in any of the three accepted studies)
(e) were children
(f) were pregnant women
(g) were people who went undiagnosed for years as clinical symptoms were slow to develop
(h) were people with co-infections, or if they were the co-infections were not disclosed
(i) were people with immune issues possibly caused by Lyme or co-infections
(j) were born with Lyme disease
In fact, the Lyme Guidelines do not uphold the high standards of validity to which NICE must be held accountable under the The Health and Social Care Act 2012 and The National Institute for Health and Care Excellence (Constitution and Functions) and Health and Social Care Information Centre (Functions) Regulations 2013 (SI 2013/259).
It is based on a group of patients who were not clinically diagnosed and were – most likely - within a few months of contracting Lyme Disease. As such, the Lyme Guidelines, especially the treatment protocols are erroneously based on a very limited population that is unrepresentative of the variability of Lyme disease patients as a whole.
The Lyme Guidelines will not only anger and upset people (and their relatives) who are already dealing with physical pain and the trauma of other associated symptoms of Lyme disease but it violates their human rights to access to healthcare which should be both protected and fulfilled by our government.
In particular. if the Secretary of State for Health fails to intervene then he can be held accountable for a failure in his duties under section 1 of the National Health Service Act 2006.
In terms of determining the incidence of Lyme disease across the UK, NICE found 8 acceptable studies. All these studies, bar 1 (where it is not clarified), used blood serology to classify actual Lyme cases. Not one accepted study utilised clinical diagnosis and some even excluded patients with EM rash.
This unfortunately means that the estimations of a widespread 0.06-6.8 persons infected per 100,000 is most likely grossly inaccurate. Additional to this, the data concerning patient cases across differing areas of the UK is worthless as people cross county lines and occasionally travel abroad. To suggest that a person is more likely to contract Lyme in one area of the UK cannot be substantiated. This data is unreliable, incomplete and may lead to under-diagnosis in apparently “low incidence areas”.
Other tick born disease
The incidence of additional tick born disease including Bartonella and Babesia “are thought to be rare in the UK” according to NICE but they acquiesce that they have no data to confirm or refute this.
Despite failing to analyse any data on this issue, co-infections were excluded from this guideline process. The suggestion that “better evidence may improve diagnostic and treatment decisions” is based on guesswork (no doubt in part due to the fact that tests for these pathogens are extremely insensitive and only available for a small number of species).
Failure to address co-infections as part of this procedure will undoubtedly negatively affect patient treatment and care.
The clear majority (if not all) patients with a diagnosis of Lyme disease will have multiple-pathologies and at least one other co-infection and will require very different treatment.
Mycoplasma and other opportunistic and/or viral infections are relatively common. Further to this, many sufferers have compromised immune systems, and little is understood about the link with Lyme.
Randomised Controlled Trials
With respect to Randomised Controlled Trials (RCT) involving Lyme patients, including those found acceptable by NICE, there are major variables that would most certainly skew the data. It would be almost impossible to level the starting field for any treatment protocol, making no treatment “one size fits all” standardised and especially not if the data pool is as small as that accepted by NICE.
A data pool of 315 patients that didn’t have additional tick born disease or co-infections seems unlikely (or perhaps fortunate) and we have no way to determine whether this data is skewed in any way.
Having only deemed 3 clinical studies acceptable for review of management and treatment of patients with persistent symptoms and found NONE acceptable for review of “non-specific” symptoms of Lyme they have based all management and treatment guidance on data from only 315 Lyme positive patients (see overview above) . Additional to this, they have stated that this data, on which they base their guidance, is of low to moderate quality.
We can only assume that this means that their guidance is also of low to moderate quality. This cannot possibly be the standard to which we expect our physicians to guide patient care.
Also with respect to any/all RCT, we need to point out that with current available testing inadequacies for Lyme it is on a practical level impossible to accurately determine a control group. A percentage of people may present with negative serology and be currently symptom free. The Kalish study 2001, rejected one such control subject due to a positive serology. This makes it probable that all controlled RCT will provide inaccurate or uncertain data.
Review documents “E” and “L” state that the question that dictates which data was reviewed is: What is the most clinically and cost- effective treatment for seropositive people, who have non- specific symptoms that may be related to Lyme disease? If NICE have complied with this instruction, then they would have failed to review any documentation where the patients had been diagnosed clinically (which does appear to be the case).
Of the 315 Lyme positive patients whose data have been extrapolated to form this guideline all were seropositive or had the EM, Erythema migrans rash and Lyme proven by biopsy or alternative. This represents only a small subset of the Lyme patient population.
Having reviewed the documentation it is, however, unlikely that research based on purely clinically diagnosed patients will exist. After all, how many peer-reviewed journals will accept a publication based on the clinical diagnosis of a physician alone – despite assurances that acknowledge current blood testing inadequacies, clinical diagnosis in the absence of positive serology is rare? The guidelines will stipulate that clinical diagnosis alongside review of blood serology is important however, the research on which they have based ALL guidance has not done so.
If a patient does not have a positive blood test or an EM rash, how exactly are they being treated, if at all? Should their treatment differ in some way from an individual presenting with a rash/positive test? This is potentially a group of very large subsets as a relatively small proportion of patients present with the rash and those who don’t are rarely even tested for Lyme.
We have no way to currently determine how many people to whom this applies or ways in which these subgroups vary with respect to treatment response. It is not reasonable to extrapolate data for example a) from a group with a recent infection that responds well to antibiotic therapy to a person who has been misdiagnosed for 5, 10 or 15 years as is regularly the case or b) to a child born with Lyme who may not make antibodies to the disease (so will be seronegative and also probably undiagnosed).
This important issue has not been addressed and therefore NICE guidance cannot be close to accurate and will fail to protect patient health outcomes.
Blood testing/delayed diagnosis
With respect to blood testing, again the research is defined by NICE as of “very low quality”. “There is a strong potential for the results to be an overestimate of the true sensitivity and specificity values due to the way case-control studies are conducted.” We can therefore surmise that the guidance in this respect is also of low quality and that “there is a strong potential” that many cases will be missed.
As such, they also state “it may be appropriate to give a ‘possible’ or ‘probable’ diagnosis of Lyme disease and treat accordingly …before test results become available”. So, whilst they acknowledge that the sensitivity and specificity of blood tests is most likely inaccurate, and they say that treatment should be started, the interpretation is that treatment will/should stop once blood results are received, if negative of course, despite the inadequacies in specificity.
This contradiction, does not create certainty in this area and will ultimately result in treatment withdrawal for a number of Lyme positive patients.
A number of Lyme sufferers have gone undiagnosed for many years despite presenting with an EM rash or remembering a bite many years prior to illness. There has been no research to date to explain why some people can carry Lyme apparently symptom free for so long and/or whether treatment for these patients should be different from “standard”. We don’t even know why in some cases they have negative blood results despite repeated testing and continuing severe symptoms. NICE has completely failed to address this population’s needs or concerns, and the potential variability with respect to this group makes setting a specific guideline for the population as a whole very presumptuous and will also lead to lowering of patient healthcare outcomes.
The Lyme Guidelines state that “if a person has persisting symptoms following 2 courses of antibiotics” they will be referred to a specialist. At no point does the guidance mention potential for continuing infection despite compelling research in this area; currently stating solely that other specialists might include rheumatologists.
Most alarmingly, however, the experience repeatedly borne out by a large patient group of Lyme disease suffers attests to the fact that there are, in fact, no specialists in the UK at the current time (infectious disease, neurology, rheumatology, gastroenterology or otherwise), accessible via the NHS who are sufficiently knowledgeable about Lyme disease such that any meaningful help can be offered to these patients.
The Lyme Guidelines will therefore simply perpetuate this hopeless situation if they proceed to publication. The patients will be referred to so called “specialists” who know little if anything about Lyme disease and when their symptoms are dismissed because the specialist does not have the requisite knowledge or guidelines to treat, their GP will most likely employ 'disengagement strategies' to remove the patient from their care leaving them with no one to treat the potential infectious underlying cause of these symptoms. This will in no way improve patient outcomes and may in fact be extremely detrimental to mental as well as physical health.
Related to this and of concern is the statement that “most people recover completely” (under the heading “information for people with Lyme disease” at paragraph 1.4 of the Lyme Guidelines). Unfortunately, where diagnosis is delayed, persistent and relapsing Lyme disease is a reality suffered by a large patient population. Indeed, the reason why this statement is so alarming is because the antibiotic treatment set out in the Lyme Guidelines at tables 1 and 2, will only ensure that most people do not recover completely as there is significant research to show that longer courses and repeated courses of antibiotics are necessary for longstanding and complex cases.
Yet, NICE state that they did not review any clinical literature with respect to assessment and management of persistent symptoms related to Lyme disease and rather insinuate that these people cannot possible still have the infection unless they have been re-infected.
The recommendations include psychiatric help and “symptom” relief, the example given being "heart block" which is seemingly based, not on any quality of data but apparently, on personal opinions from the committee. As such we find these recommendations unsubstantiated, lacking in clinical judgement and sympathy and open to facilitate abuse of the patient.
The number and nature of the Research Recommendations from basic diagnosis and treatment to management clearly indicates that NICE does not have enough data to produce a guideline that could remotely approach the required standards for NICE Guidance.
Use of other accepted guidelines
Where there is little/poor evidence from scientific studies usually NICE is expected look to other sources to see if it concurs or differs ('triangulation'). So, on the basis that there is already a group of experts in this field with experience working with thousands of patients across all subsets of Lyme disease treatment and management worldwide, why hasn’t NICE worked with The International Lyme and Associated Diseases Society (ILADS)?
A good starting point would have been to review ILADS’ US Federally approved guidelines (which have been written against the backdrop of over seven hundred peer reviewed, published scientific articles) and we urge the SoSH to intervene and direct that these guidelines be considered in detail prior to any publication of NICE guidelines.
For all of the above reasons we respectfully urge the SoSH to remove the current Lyme Guidelines from the NICE website and to direct NICE to engage with the UK’s Lyme patient population (as represented by the numerous patient groups) and with ILADS in order that a set of guidelines can be produced that will meaningfully secure improvement in the physical and mental health of the people of England, and in the prevention, diagnosis and treatment of illness caused by Lyme disease.
Indeed, only by doing so will a set of guidelines be produced that is fit for purpose and that can discharge the duties of the SoSH under section 1 of the National Health Service Act 2006.
This petition is produced and published by the Lyme Protest 2018 Working group, a team established from multiple web based groups concerned with the health and well being of individuals with Lyme disease and associated co-infections.
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