Wednesday, 21 February 2018

BREACHES OF GUIDELINE DEVELOPMENT RULES BY NICE - LYME DISEASE


Breaches of Guideline development rules by NICE and members of the Guideline Development Committee for NG10007, Lyme disease

from  Vector-Borne Infection Research-Analysis-Strategy February 2018

NICE break their own rules On September 25th 2017, in a betrayal of public trust and in breach of their own official rules, NICE pre-emptively published comments about the draft Lyme disease guideline, which the public and medical professionals would reasonably believe to be reliable and authoritative. Whereas the draft was not ready for use, contains serious errors and omissions, was based on a minimal amount of poor quality evidence and was entirely unfit for purpose. 
The Chairman of the Guideline Development Committee (GDC) for Lyme disease, Professor Saul Faust, is quoted in numerous articles in newspapers, journals and online - including Twitter, misrepresenting the draft version, as though it is valid, authoritative and ready for use by doctors and patients. 4 Furthermore, Professor Gillian Leng, Deputy Chief Executive Officer at NICE, has participated in this breach of protocol by adding her official opinions and endorsement to these incomplete guidelines. The expected publication date for the guidelines is April 4th, 2018. The purpose of publishing the draft was supposedly to allow a 6 week period for Stakeholders to evaluate the document and provide comments and evidence to be considered by NICE before producing the final version for use


Professor Gillian Leng - Deputy Chief Executive of NICE 
A small selection of statements appearing in the media and NICE’s own website quoting Professor Leng, published on the same day that the DRAFT guideline was released for stakeholder review

We are unaware of any information that Professor Leng is an expert on Lyme disease, and question the appropriateness of her unqualified public statement that, “Lyme disease is easy to treat”. The draft guideline shows clearly that there was a minimal amount of evidence available for making treatment recommendations, none of which was UK based and all of which was of ‘low’ or ‘very low quality’. Professor Leng must therefore have access to some privileged and undisclosed source of knowledge about the treatment of Lyme disease, enabling her to supersede the actual content of the draft guideline. 

This is not “transparency”. Due to pre-emptive and exclusive media exposure, Professor Leng’s comment now constitutes an official opinion and assurance by a NICE senior officer, preempting alternative views and evidence which could be provided by Stakeholders, individual members of the NICE GDC, etc. The general public, 6 patients, medical professionals and even Stakeholder Groups could hardly be blamed for accepting and trusting information provided by the NICE Deputy Chief Executive. Yet Professor Leng’s unqualified statements could result in foreseeable and serious harm to those patients whose Lyme disease is not ‘easy to treat’.


Professor Saul Faust - Chairman of the NICE Guideline Development Committee for Lyme disease A small selection of statements in national newspapers, health related magazines and online, quoting Professor Saul Faust, published on the same day that the DRAFT guideline was published for stakeholder review

If Professor Faust wished to avoid ‘confrontational politics’ it would have made more sense for him not to make misleading remarks on a subject he clearly does not understand. Firstly, the numerous points of argument around Lyme disease, are not disagreements between ‘scientists and patients’, that is misleading and is in fact, indulging in ‘confrontational politics’. The disagreements are between on the one hand; scientists and doctors, and on the other hand; other scientists and doctors. 

Patients, some of whom have already lost everything to Lyme disease, have every right to participate in these debates that directly impact on their health and wellbeing – just as they have the right to participate in the development of the Lyme disease guideline produced by NICE. 

Professor Faust’s statement implies that some patients are in conflict with scientists per se. This indicates bias against the credibility of patients and patient campaign groups, whose views he evidently considers to be inferior with the implication that they must be irrational. He also considers patients to be too stupid to be able to discriminate between ‘unscrupulous private providers’ and legitimate practitioners. Exactly how Professor Faust formed this derogatory view of patients and patient campaigners is unknown to us, as he does not appear to have any dealings with Lyme disease patients. Therefore it appears that the Chairman of the GDC has been influenced by some ‘unscrupulous private provider’ of misleading information about patients, and is now prejudiced against a very large number of the very patients who are supposed to be helped by the NICE guideline. This back-door psychologisation of patients and campaigners may have originated from Public Health England (PHE). In a document prepared by PHE of which Dr Tim Brooks was a co-author and who is currently a NICE GDC member, and submitted to the Health and Safety Executive (HSE), are these remarks: (http://www.hse.gov.uk/aboutus/meetings/committees/acdp/161012/acdp_99_p62.pdf 


The draft only specifies the use of insensitive tests while misrepresenting their reliability – for newly presenting patients. Patients over the past 30+ years who were not investigated and denied a diagnosis and treatment because they never had a blood test, or had a negative blood-test, are not even considered, even though some of those chronically infected patients will have suffered decades of ill health. These patients must have been diagnosed with something. But NICE have evaded this entire issue. 

Even for new patients, the insensitive tests will predictably lead to a substantial proportion of infected patients getting a delayed diagnosis and others not getting diagnosed at all. NICE claim to produce ‘evidence-based’ guidelines. 

In the case of Lyme disease they have proffered a draft guideline based on smoke and mirrors and produced by a committee whose Chair evidently has a negative view of patients, and ‘experts’ who apparently believe that a laboratory test Sensitivity of 41% can be represented as “high sensitivity” with no qualifications. 

There is no excuse for deceiving doctors, patients, the public and the government about the unreliability of serological tests for Lyme disease. Objective facts do not require propaganda. Sensitivity figures are stated as a percentage and do not require interpretation or exaggeration. 

A credible Stakeholder Consultation should not be pre-empted by publication of official endorsements for a draft that is entirely unfit for purpose. 

A Guideline Development Committee should be unbiased and objective. 

The Guideline Committee and draft NICE guideline for Lyme disease fails in regard to all these requirements and more. 

We request that the publication of the Guidance is cancelled and the GDC discharged.

Please go to this link for full details
 http://counsellingme.com/VIRAS/VIRAScomplaintNICE.pdf  

INTERVENTION NECESSARY ON NICE LYME DISEASE GUIDELINE



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.
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
Click on the link below to read the detail in this petition that explains why lives will be put at risk. Please sign this important petition

Friday, 29 December 2017

DRUG DISCOVERY METHODS FOR CHRONIC LYME DISEASE

“Our goal is to find alternatives to antibiotics to treat Lyme disease, which is caused by the Borrelia burgdorferi bacterium, and illnesses that arise from the Bartonella pathogen,” said Neil Spector, M.D., the Sandra Coates Associate Professor Breast Cancer Research at Duke Cancer Institute and the study’s co-principal investigator.
“We’re hoping to move from isolating targets to identifying potential drugs to testing in animal models within three years – so a very aggressive timeline,” said Spector, who was a Lyme patient himself and nearly died from complications of disease. “Our goal is to identify drugs that will target the Achilles’ heel of these pathogens while sparing the normal gut microbiome.”

Lyme Study Uses Drug Discovery Methods That Have Fueled Cancer Breakthroughs

Labs at Duke and other academic centers collaborate to identify alternatives to antibiotics



CHRONIC PERSISTENT LYME DISEASE IN NON HUMAN PRIMATES

Two important new studies :-

Variable manifestations, diverse seroreactivity and post-treatment persistence in non-human primates exposed to Borrelia burgdorferi by tick feeding


Abstract

The efficacy and accepted regimen of antibiotic treatment for Lyme disease has been a point of significant contention among physicians and patients. While experimental studies in animals have offered evidence of post-treatment persistence of Borrelia burgdorferi, variations in methodology, detection methods and limitations of the models have led to some uncertainty with respect to translation of these results to human infection. With all stages of clinical Lyme disease having previously been described in nonhuman primates, this animal model was selected in order to most closely mimic human infection and response to treatment. Rhesus macaques were inoculated with Bburgdorferi by tick bite and a portion were treated with recommended doses of doxycycline for 28 days at four months post-inoculation. Signs of infection, clinical pathology, and antibody responses to a set of five antigens were monitored throughout the ~1.2 year study. Persistence of Bburgdorferi was evaluated using xenodiagnosis, bioassays in mice, multiple methods of molecular detection, immunostaining with polyclonal and monoclonal antibodies and an in vivo culture system. Our results demonstrate host-dependent signs of infection and variation in antibody responses. In addition, we observed evidence of persistent, intact, metabolically-active Bburgdorferi after antibiotic treatment of disseminated infection and showed that persistence may not be reflected by maintenance of specific antibody production by the host.


Late Disseminated Lyme Disease: Associated Pathology and Spirochete Persistence Post-Treatment in Rhesus Macaques


Abstract

Non-human primates currently serve as the best experimental model for Lyme disease due to their close genetic homology with humans and demonstration of all three phases of disease following infection with Borreliella (Borrelia) burgdorferi (Bb). We investigated the pathology associated with late disseminated Lyme disease (12 to 13 months following tick inoculation) in doxycycline-treated (28 days; 5mg/kg, oral, 2x/day) and untreated rhesus macaques (Rm). Minimal to moderate lymphoplasmacytic inflammation, with a predilection for perivascular spaces and collagenous tissues, was observed in multiple tissues including the cerebral leptomeninges, brainstem, peripheral nerves from both fore and hind limbs, stifle synovium and perisynovial adipose tissue, urinary bladder, skeletal muscle, myocardium, and visceral pericardium. Indirect immunofluorescence assays (IFA) combining monoclonal (outer surface protein A) and polyclonal antibodies were performed on all tissue sections containing inflammation. Rare morphologically intact spirochetes were observed in the brains of two treated Rm, the heart of one treated Rm, and adjacent to a peripheral nerve of an untreated animal. Borreliaantigen staining of probable spirochete cross-sections was also observed in heart, skeletal muscle, and near peripheral nerves of both treated and untreated animals. These findings support the notion that chronic Lyme disease symptoms can be attributable to residual inflammation in and around tissues that harbor a low burden of persistent host-adapted spirochetes and/or residual antigen. 

Various reports of this study give details - 
Tulane University announcement -

Study finds Lyme bacteria can survive antibiotic treatment months after infection

Outbreak news Today -

Lyme disease: Borrelia burgdorferi survive 28-day course of antibiotics months after infection, according to study


Lyme Disease.org 

 New study finds Lyme bacteria survive a 28-day course of antibiotics



An excellent in depth look can also be found here- http://counsellingme.com/VIRAS/Embers.html








LAWSUIT FOR LYME DISEASE

'A lawsuit asserts that the design and implementation of Lyme disease care–as outlined in the treatment guidelines of the Infectious Diseases Society of America—is rooted in corruption.' 

Mary Beth Pfeiffer is an investigative journalist and writes for the Huffington Post her recent article - 10 points about suing the architects of Lyme policy - as a task force meets to review it.


To read the full article go to this link -
 https://www.huffingtonpost.com/entry/10-points-about-suing-the-architects-of-lyme-policy_us_5a2764bbe4b0650db4d40bb5

Friday, 17 November 2017

ADDRESSING GLOBAL OBSTACLES TO CARE OF BORRELIOSIS PATIENTS (LYME AND RELAPSING FEVER)





Jenna Luché-Thayer: Addressing Systemic Obstacles in the Borreliosis Pandemic 


Jenna Luché-Thayer gave this presentation at the International Lyme and Associated Diseases Society (ILADS) Annual Scientific Conference in Boston, November 10, 2017. Jenna is the founder of the Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes. In this presentation, Jenna explains how the Ad Committee is trying to address global obstacles to care experienced by Lyme and relapsing fever borreliosis patients and describes how you can use this information to address these human rights abuses. The Ad Hoc Committee was formed in 2016 to:  update the World Health Organization’s (WHO) International Classification of Disease (ICD) codes for Lyme borreliosis (LB)  demonstrate how the outdated codes are contributing to human rights violations The Ad Hoc Committee members:  represent Asia Pacific region, Africa, North and South America and Eastern, Western and Northern Europe  represent scientific, medical and human rights experts, clinicians and professors across well respected academic and research centers and as advisors to governments and WHO  have worked on borreliosis for two and three decades  have many hundreds of peer-reviewed publications and studies The Ad Hoc Committee’s report, Updating ICD11 Borreliosis Diagnostic Codes was accepted by WHO prior to the March 30, 2017 deadline for code revisions. Also, as per WHO’s required rules and process for ICD revisions, each recommendation with supporting references was entered onto the WHO ICD Beta Platform. The Updating ICD11 Borreliosis Diagnostic Codes report was also submitted to Dr. Dainius Pūras, the United Nations Human Rights Council’s Special Rapporteur for the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The Ad Hoc Committee was then invited to meet with Dr. Pūras in his official capacity on June 7, 2017 —an event that does not take place unless there exists a legitimate cause for concern about violations of the right to health and other health-related human rights. Dr. Pūras accepted all the Committee’s documentation including reports, books and videos, PowerPoint and verbal testimony, his Senior Human Rights Officer and Team Leader put them into record. Dr. Pūras also told the Ad Hoc Committee how he could support this effort within the framework of his mandate. The report is now a published document with an assigned ISBN number. Therefore, it may be cited and quoted as a reference for many purposes including medical, scientific, legal, human rights, public health and economic analysis. For more details - see https://www.linkedin.com/pulse/addressing-systemic-obstacles-borreliosis-pandemic-jenna-luche-thayer/ 
 (posting below for those who don't use linkedin.)

Addressing Systemic Obstacles in the Borreliosis Pandemic

November 15, 2017 —contact jennaluche@gmail.com


On November 10, 2017 global human rights expert Jenna Luché-Thayer gave a comprehensive presentation to over 700 medical and scientific professionals attending the International Lyme and Associated Diseases Society (ILADS) 18th Annual Scientific Conference in Boston [1].

Luché-Thayer is the founder of the Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes. In this videoed presentation, Jenna explains how the Ad Hoc Committee is trying to address human rights abuses such as the obstruction to healthcare experienced by Lyme and relapsing fever borreliosis patients across the globe.

Luché-Thayer provides compelling evidence as to how this disease has been politicized by the World Health Organization (WHO) and other key institutions responsible for public health and medical care. The entire presentation —Addressing Systemic Obstacles in the Borreliosis Pandemic— is for available for free viewing on YouTube.

The presentation also explains how the Ad Hoc Committee’s report, Updating ICD11 Borreliosis Diagnostic Codes: Edition One [2], may be used by those concerned with the injustices associated with this pandemic.

The report was accepted by WHO prior to the March 30, 2017 revisions deadline for international classification of diseases (ICD) codes. Also, as per WHO’s required rules and process for ICD revisions, each recommendation with supporting references was entered onto the WHO ICD Beta Platform. 

The Updating ICD11 Borreliosis Diagnostic Codes report was also submitted to Dr. Dainius Pūras, the United Nations Human Rights Council’s Special Rapporteur for the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Ad Hoc Committee was then invited to meet with Dr. Pūras in his official capacity on June 7, 2017 —an event that does not take place unless there exists a legitimate cause for concern about violations of the right to health and other health-related human rights. Dr. Pūras accepted all the Committee’s documentation including reports, books and videos, PowerPoint and verbal testimony, his Senior Human Rights Officer and Team Leader put them into record. Dr. Pūras also told the Ad Hoc Committee how he could support this effort within the framework of his mandate.

The report is now a published document with an assigned ISBN number. It may be cited and quoted as a reference for many purposes including medical, scientific, legal, human rights, public health and economic [3]. The following key information can be cited from the report:

The record now shows 100s of peer-reviewed studies —written by nationally and internationally recognized scientists and medical researchers from across the globe— describing:

Congenital Lyme disease, persistent infection, Borrelial lymphocytoma, Granuloma annulare, morphea, localized scleroderma, lichen sclerosis and atrophicus, Lyme meningitis, Lyme nephritis, Lyme hepatitis, Lyme myositis, Lyme aortic aneurysm, coronary artery aneurysm, late Lyme endocarditis, Lyme carditis, Late Lyme neuritis or neuropathy, Meningovascular and Neuroborreliosis – with cerebral infarcts, Intracranial aneurysm, Lyme Parkinsonism, Late Lyme meningoencephalitis or meningomyelo-encephalitis, Atrophic form of Lyme meningoencephalitis with dementia and subacute presenile dementia, Neuropsychiatric manifestations, late Lyme disease of liver and other viscera, late Lyme disease of kidney and ureter, late Lyme disease of Bronchus and lung and seronegative and Latent Lyme disease, unspecified.

Furthermore, no medical condition was entered into record if it had less than three supporting peer-reviewed publications. The Committee members then gave verbal and additional written testimony as to how medical practitioners on the Committee had collectively and effectively treated tens of thousands of patients with persistent and complicated LB with clinical practice guidelines that have meet internationally accepted standards

These materials firmly establish the significant possibility that patients with persistent Lyme require biological medical care —not as a matter of opinion, but as a matter of scientific fact. Furthermore, treatment options for persistent Lyme —including extended and combination antimicrobial therapies— that have met internationally recognized standards for clinical guidelines are available, as are accredited educational programs on how to implement such therapies.

The record also shows many different types of health human rights violations. These include how obstruction of access to treatment options from clinical practice guidelines that meet internationally accepted standards for guidelines violates the Availability, Accessibility, Acceptability, Quality (AAAQ) of Health Human Rights imperatives for "non-discriminatory" practices and medical ethics. The record also shows how LB patients who have received clinical diagnosis are routinely denied care should laboratory tests fail to confirm their clinical diagnosis.  

Many practices resulting from these codes are recognized as human rights violations. Furthermore, the codes are linked to policies recommending practices that:

—for many patients, prevent proper diagnosis and obstruct access to treatment options that meet internationally accepted standards

—promotes discrimination based on illness manifestations 

—misapplies somatic diagnosis [4] to deny medical care 

—obstructs treatments based on illness manifestations  

—promotes discrimination based on financial status 

—supports attacks on human rights defenders —including medical practitioners, scientists and researchers who act on behalf of this vulnerable patient group

—restricts information regarding treatment options that meet internationally accepted standards

—routinely excludes key stakeholders —such as medical practitioners, researchers, patients and caretakers who are concerned with persistent and complicated cases of LB —from decision-making venues … making these stakeholders invisible to policy makers, economists and other practitioners and researchers

—permit sick children under treatments that meet internationally accepted standards be forcibly removed from their parents —and there are many cases where such parents are falsely accused of poisoning their children or Munchausen by Proxy  

—support alarming cases where euthanasia is encouraged over treatments that meet internationally accepted standards

To summarize, the science and medical knowledge regarding persistent and complicated LB —from hundreds of peer reviewed publications written by nationally and internationally recognized experts— has been routinely ignored or suppressed. Furthermore, the human rights defenders of this patient group are routinely threatened and punished for fulfilling their Hippocratic oath to this marginalized patient community. Despite this institutionalized obstruction to care, tens of thousands of patients with persistent and complicated Lyme and relapsing fever borreliosis have regained quality of life, manage their illness and have become productive and contributing members of society by overcoming these obstructions and gaining access to extended treatments that meet internationally accepted standards for clinical guidelines.

The widespread discrimination experienced by Lyme and relapsing fever patients has been systemic and institutionalized across ICD codes, national health policies and medical and insurance systems. Altogether, these factors have led to gross human rights violations that are on record with the United Nations Human Rights Council’s Special Rapporteur for the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.


                                                  ###

[1] The full presentation is available for viewing on youtube: https://www.youtube.com/watch?v=LLIO0r1mCcE (titled: Jenna Luché-Thayer: Addressing Systemic Obstacles in the Borreliosis Pandemic)

[2] Updating ICD11 Borreliosis Diagnostic Codes Authors: Jenna Luche-Thayer,‎ Holly Ahern,‎ Dominick DellaSala, Sherrill Franklin,‎ Leona Gilbert,‎ Richard Horowitz,‎ Kenneth Liegner, Clement Meseko, Mualla McManus, Judith Miklossy,‎ Natasha Rudenko,‎ Astrid Stuckelberger‎. Contributing researchers: Joseph Beaton,‎ John Blakely,‎ Phyllis Freeman,‎ Kunal Garg,‎ Huib Kraaijeveld,‎ Vett Lloyd,‎ Leena Merilainen. Cees Hamelink - Senior Advisor, Jeff Levy - editorial support, Angelica Johannson - organizational support. Publisher: CreateSpace Independent Publishing Platform (October 7, 2017). ISBN-10: 1978091796 and ISBN-13: 978-1978091795

[3] The report is now available on Amazon and all proceeds support the voluntary work by the Committee.

[4]Medically Unexplained Symptoms or MUS has been repudiated by the American Psychiatric Association (APA) and removed from the Diagnostic and Statistical Manual of Mental Disorders (DSM). 




Sunday, 5 November 2017

NICE DRAFT LYME DISEASE GUIDELINES SHAME UK MEDICINE

CONCLUSION TO THE VIRAS STAKEHOLDER COMMENTS 

In view of the extraordinary number of opportunities that these NICE (National Institute for Health and Care Exellence) guidelines provide for putting doctors and patients at serious risk, it is essential for all interested parties to be aware that NICE take no responsibility for any misleading information or dangerous advice included in their guidelines. Here is a typical NICE Guidance disclaimer:



 “Health care providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidances. The recommendations cited here are a guide and may not be appropriate for use in all situations. The decision to adopt any of the recommendations cited here must be made by the practitioners in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources. The National Clinical Guideline Centre disclaims any responsibility for damages arising out of the use or non-use of this guidance and the literature used in support of this guidance.” (https://www.nice.org.uk/guidance/cg138/evidence/full-guideline-pdf-185142637) 


Whilst NICE have discarded a wealth of research and evidence as unsuitable in preparing their guidance, that same evidence may nevertheless stand-up in court.

Examples of foreseeable harms to patients are: if and when the restrictive treatment recommendations fail to eradicate a Lyme infection and a patient suffers injury as a result, or, if and when laboratory testing deprives a patient of a necessary diagnosis and treatment, and they suffer injury as a result. 

Then the evidence that has been ignored may receive a fair hearing in legal proceedings, especially as much of this information comes from very experienced scientists and physicians. Harms to patients and complaints against doctors are not just predictable, they are inevitable if doctors with Lyme disease patients follow the advice as presented in the draft form. However, none of this is any consolation to doctors who do not want to spend their time dealing with GMC complaints and law suits, but who simply want to help their patients based on a balanced presentation of the available pool of knowledge.


VIRAS and others have provided ample evidence of foreseeable harms resulting from misleading advice about Lyme disease. NICE may wash their hands of any responsibility by claiming that individual doctors are responsible for their clinical decisions, but they can and will be held to account for negligently misleading the public and government agencies, discriminating against sick and disabled patients, and permitting their procedures to be exploited by groups and individuals with competing interests. 


Doctors do not have to follow NICE guidelines but they must be able to justify their clinical decisions. The USA Centers for Disease Control and Prevention (CDC) now estimate that they have over 300,000 cases of Lyme disease per year. Some of the most experienced and knowledgeable Lyme disease doctors and scientists in the USA have produced reliable and trustworthy advice on the management of diverse aspects of Lyme disease. For doctors who want a thorough understanding of Lyme disease medicine, including the limitations of current 18 knowledge, VIRAS recommends the authoritative resources listed here: 
http://www.ilads.org/Lyme/treatment-guideline.php


VIRAS reject the NICE draft guideline as unfit for purpose. It contains some downright dangerous advice and too many contradictions to even form the basis of a semi-reasonable guideline. It is biased, discriminatory and appears to be designed to serve undeclared agendas. It implies certainty where there is none. Where it admits uncertainty it omits to provide balanced views to allow doctor’s and patients to make informed choices and give informed consent as is required in the practice of medicine in the UK. This makes the draft unethical. It evades awkward and potentially embarrassing issues such as the inaccuracy of testing provided by the NHS, which it misrepresents with false assurances. It evades the serious medical issues of chronic Lyme disease, coinfections, misdiagnosis of Lyme as some other condition, and inadequate treatment. The guideline is not quantitative or qualitative or a rational amalgam of both. It is bereft of scientific discipline or basic humanistic and medical values.


NICE should have halted the process and rejected the task of producing a guideline when it became apparent that the vast majority of research did not meet the threshold for inclusion. Instead, it has produced a draft based on just a tiny and biased proportion of decades of research. The draft guideline is irrelevant to 99% of UK Lyme patients who would be harmed by its publication. The number and nature of the Research Recommendations clearly shows that not enough is known to produce a guideline that could remotely approach the required standards for NICE Guidance. These Research Recommendations relate to absolutely basic medical science concerned with the diagnosis, treatment and management of Lyme disease. Without good data to work with, or a balanced presentation of all the evidence available, the end product could only ever be a self-contradictory and impractical mess. 


Thousands of UK Lyme disease patients have been obliged to take matters into their own hands due to the ignorance and incompetence of Public Health England. PHE (incorporating the HPA) have actively obstructed the diagnosis and treatment of Lyme disease patients for decades. The victims of this discrimination have been forced to either accept terrible illness which for many, represents a life-sentence of loss and suffering, or to seek medical help elsewhere. Patients spend their often meagre income and all their savings to get accurate tests and treatment that have been denied to them by the NHS. 


The outcome of the treatment that they are forced to pay for, may not always be the cure that they sought. This is partly due to the incompetence that has delayed their diagnosis and treatment for months, years or even decades. Yet for many, their treatment brings great relief. Some of the appalling chronic symptoms improve or resolve completely. Physical and mental functioning which could have been reduced to just a tiny percentage of their pre-Lyme infection levels, are substantially improved and can be maintained with treatment. These patients KNOW what PHE policies have done to them and are doing to others. They will recognise the PHE official position on Lyme disease permeating the NICE draft guideline. They are not paranoid or conspiracy-theorists, they know from their own lived experience that Lyme disease is a national health threat that is being controlled by vested interests that disregard their Human Rights and the fundamental tenets for the practice of medicine. It is in spite of PHE that many of these patients have improved health, and such is the suffering that many have endured, they do not want others to have a similar experience. With the finest motives that grace humanity, even though their health and fitness may still be just a sad remnant of the energy they once enjoyed, they give of that time and energy to help others who will otherwise be doomed by PHE to the living hell of chronic Lyme disease. 


The draft guideline shames UK medicine and will bring the good names of the NHS and NICE into disrepute. The danger to patients is obvious. This confused and confusing guide will predictably harm patients and threaten the reputation and values of doctors who place their trust in it


The above is the Conclusion, the Summary can be read in full from the VIRAS ( Vector-borne Infection - Research, Analysis, Strategy)  website.
  

Summary of VIRAS response to NICE Draft Guideline for Lyme Borreliosis available
 http://counsellingme.com/VIRAS/VIRAS.html 


the Draft Nice Guidelines for Lyme Disease.
https://www.nice.org.uk/guidance/indevelopment/gid-ng10007/consultation/html-content-2