Vector-Borne Infection Research-Analysis-Strategy
November 2017

Analysis of the NICE Lyme disease draft Guideline 'Research Recommendations'

Recommendation #5

The NICE draft guideline states:

"5 What are the best laboratory tests to diagnose initial and ongoing infection and determine re-infection in the different presentations of Lyme disease in the UK.
What is the most clinically and cost effective serological antibody-based test, biomarker (such as CXCL13), lymphocyte transformation and ELISPOT for diagnosing Lyme disease in the UK at all stages, including reinfection?

"Why this is important
Determining the most clinically and cost effective diagnostic tests for Lyme disease will improve patient care and is of high priority. The clinical presentation of Lyme disease is very variable, with diagnosis of all presentations except erythema migrans relying in part on laboratory testing. Current literature suggests that a combined IgG/IgM ELISA based on the C6 peptide and immunoblot are useful but published evidence is of either low or very low quality and is not UK based. There is evidence of variation in the C6 peptide between the principal Borrelia genospecies in UK ticks and a combination of ELISAs may improve sensitivity.

"A 'test of cure' for Lyme disease does not exist, and, consistent with most other infectious diseases, positive serology is likely to remain positive following successful treatment of acute infection in the majority of patients. However, we know little about the evolution of antibody titres over time in those who have been treated successfully and in those who have persisting symptoms. It is frequently stated that early antibiotic treatment of Lyme disease abrogates the immune response, so that serology remains or becomes negative. The evidence base for this is minimal, and this is not a common occurrence in other infections. Understanding the natural course of Lyme disease serology and non-serological tests over time may assist in the interpretation of test results in patients who remain symptomatic and in those who are high risk for re-infection, such as those with occupational exposure.

"In particular, further research into the value of CXCL13 and other biomarkers including, ELISPOT testing and lymphocyte transformation tests may be helpful to support the current low quality evidence."

VIRAS appreciate the acknowledgement that NHS testing is inadequate and that improving it is 'high priority', but this statement reveals some disturbing assumptions and prejudices.

Direct detection tests are not mentioned: culture, immuno-flourescent antibody staining, including molecular beacons (the latter being 100% specific) and PCR, all of which can detect the presence of the actual infective organism - not only an immune response which NICE have already indicated can last for 3 years after treatment, making NHS tests irrelevant to a substantial number of patients at risk and useless for determining treatment failure or prevalence.

NICE state: "However, we know little about the evolution of antibody titres over time in those who have been treated successfully and in those who have persisting symptoms."

This loaded statement implies that there are only two possible outcomes to treatment: 1/ the patient is cured, or 2/ "persisting symptoms", and as already noted, NICE explain the latter as NOT treatment failure (p12 lines 1 - 10). Even though "treatment failure" is mentioned in the draft, it is not addressed. There are no good medical or scientific justifications for this omission. The draft guideline evasion of treatment failure is unjustifiable.

'Reinfection' is mentioned but failed-treatment or delayed-relapse due to failed-treatment are not. Perhaps NICE do not want these patients to have a valid test, which could be interpreted as a strategy to discriminate against and marginalise those patients, deny them treatment and permit their ongoing infection to progress. This stratagem would permit PHE to claim that all cases of proven 'post-treatment' Lyme must represent 'reinfection'. That would give PHE a useful get-out for their years of individual and collaborative failures. They can evade blame for harms resulting from inadequate treatment because the patient must have got 'reinfected'. Therefore this serves the interests of PHE whilst discriminating against patients and their medical needs.

The claim that "diagnosis of all presentations except erythema migrans relying in part on laboratory testing", is badly misleading and reconfirms our objections that this draft guideline assumes that NHS testing for Lyme can reliably diagnose the disease and must therefore also be able to rule it out. No diagnosis of Lyme disease can 'rely' in part or whole on NHS laboratory tests. These tests can only provide support for a positive clinical diagnosis in-line with the test kit manufacturer's instructions.

How will 'cost effectiveness' be calculated? What price will NICE put on a formerly healthy person spending years or decades confined to their home due to undiagnosed, untreated or under-treated Lyme disease?

The gold-standard test for any infection is direct detection of the infective organism, which for some reason best known to themselves, NICE have omitted. The draft guideline specifies a "serological antibody-based test". This bias would allow PHE/RIPL tests to be judged only against tests with related methodologies, rather than against the best that can be achieved. This would predictably help to preserve the PHE/RIPL monopoly on UK testing. This anti-trust strategy must be eliminated. The 'customer' for NHS Lyme tests is not PHE or RIPL or doctors, it is the patients that get tested and whose health may depend on their accuracy. It is the interests of patients and what they want and need that must come first. Patients may understandably place a high value on their health. They may appreciate being able to go to work, have holidays and play an active role in their social circles. They may enjoy being able to walk, talk, read and watch TV. Those that understand that severe Lyme disease could deprive them of all of those things, might well consider that a £200 test with 60% sensitivity would be a better purchase than a £50 test with 50% sensitivity. Society at large might also agree if it understands that inaccurate testing could deprive it of thousands of formerly productive citizens, who have become disabled because of a false-saving on testing.

Conclusion to the NICE Research Recommendations
Only a fool would believe for one second that the research recommended by NICE will ever be carried out in the UK. The cost would be colossal and it would take many years. Thirty years of inaction by the public health authorities should be sufficient to convince anyone that these recommendations are pure hot-air which cost nothing to NICE or Public Health England.

The bias and assumptions which SHOULD be eliminated by bona-fide research are glaringly obvious by what is included and what is omitted from the recommendations. This cannot be put down to ignorance. These recommendations were contrived by people that knew exactly what they were doing, what they want, and what they absolutely cannot allow the public to know about Lyme disease.

If all of these projects were actually completed, the public would still not know that chronic Lyme disease is a terrible reality for tens of thousands of patients. Doctors would not know that laboratory testing can only help in diagnosing around 50% of patients, and that is for patients that get tested within months of getting infected. Those infected for a year or longer will probably have a much smaller chance of testing positive with the tests used by the NHS, even though the infection could still be progressing and causing injury. Many patients will still not get adequate treatment and along with undiagnosed patients, thousands will still be misdiagnosed with M.E., CFS, MS, Fibromyalgia, etc., and left to rot and die in a medical limbo created by PHE and NICE.

It is clear that these issues are not about differences of opinion - because authentic scientific research aims to establish facts and should never be designed to prove one side of genuine disagreement. It can therefore be concluded that the NICE research recommendations are evidence of a biased Guideline Development Committee exploiting its power to control what they want doctors, patients and the public to believe about Lyme disease. As the product is so blatantly discriminatory, patients might at least hope that their own doctors will act based on their sensible judgement and a sincere wish to help their patients. Neither of which feature in the NICE draft guideline or its research recommendations.

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