Madison Area Lyme Support Group

The UK government will soon be finalizing their Lyme Guidelines. To date, all recommendations to the draft Lyme Guidelines made by patient stakeholders groups and those medical and scientific Lyme experts who represent patient priorities have been roundly ignored, as have the peer reviewed science of persistent infection, low reliability of the recommended two-tiered diagnostic tests and other critical areas requiring immediate attention.

In the UK, it is not only Lyme patients who are being obstructed from diagnosis and medical care for biological illness because of guidelines developed by the UK government. The UK government has become a routine violator of its own laws and regulations regarding clinical guidelines development and patient-centered policy.

This communication outlines this history of shameful practices, as well as their related human rights violations.

Please know this letter was a collaboration between myself and many UK Lyme advocates representing different patient organizations. This letter was also forwarded Alexander Burnett and Mark McDonald, Members of The Scottish Parliament, because it shares on-going concerns with the CFS/ME Guidelines.

Tell me what you think! Jenna

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March 14, 2018

To:   Sir Andrew Dillon Chief Executive, National Institute for Health and Care Excellence (NICE)

The Right Honourable David Gauke MP Lord High Chancellor Secretary of State

cc:   All Party Parliamentary Group for Lyme Disease: Chair Michelle Donelan, Co-Chair Simon Hoare, Vice Chair Teresa Pearce, Treasurer Jim Shannon, Vice Chair Alex Chalk, Vice Chair Lord Keen of Elie, Vice Chair Lord Astor of Hever, Vice Chair The Countess of Mar, Vice Chair Lord Trees

David Coombs, Associate Director – Corporate Office NICE

From:   Jenna Luché-Thayer. Founder, Global Network on Institutional Discrimination™. Founder and Director, Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes.

Subject: NICE Lyme Guidelines and the Human Rights of Lyme Borreliosis Patients

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Dear Sir Andrew Dillon and The Right Honourable David Gauke,

Sir Andrew Dillon, thank you for your March 1, 2018 response to my concerns regarding the bullying of Lyme patients by one of the lay members of the NICE Lyme Guidelines Committee.

As you correctly noted, bullying is but one of the concerns my correspondence has covered. To note, your March 1, 2018 response stated,

“The [guidelines] process is based on finding the best available evidence and using the expertise of healthcare professionals and lay members to develop recommendations based on the evidence.”

“The guideline development process is transparent with the clinical questions, the evidence found in the literature and committee discussion reported in the guideline. The draft guideline is then consulted with stakeholders, and subject to quality assurance by NICE.”

• My first observation is that we both share respect for evidence-based science, diagnostic technologies, and medical practices such as those found in clinical practice guidelines.
• My second observation is that, from a global perspective, the UK scientific and medical community has not produced a majority of internationally recognized experts in Lyme borreliosis and the NICE Lyme Guidelines Committee does not appear to be made up of, nor supported by, world renowned experts in Lyme borreliosis (LB), also referred to as Lyme disease.
• My third observation is that your patient-based (and patient-oriented) stakeholders and many renowned LB scientific and medical professionals have noted the draft NICE Lyme guidelines excludes many evidence-based publications regarding the poor reliability of the serology-based two-tiered diagnostic tests as well as evidence-based clinical practice guidelines that have met internationally accepted criteria.
• My fourth observation is that unlike the evidence-based criteria developed by institutions such as the (US) Institute of Medicine or the World Health Organization, the NICE Lyme Guidelines Committee set forth ‘unique parameters’ for defining evidence-based criteria that do not have clear scientific nor medical reasons.

For example, the Committee emphasized the importance of that which ‘focuses on the UK population.’ What is the precise scientific advantage to focusing on the UK population when the UK population is exposed to the same LB as other European countries and there is little to no difference among the diverse population groups based in the UK and those found in many countries throughout Europe?

Also, do I understand correctly that the NICE Lyme Guidelines Committee believes their evidence-based criteria for the two-tiered serology Lyme diagnostic tests are superior to any number of diagnostic tests that have met evidence-based standards in other countries, the European Union and other international standards?

For example, the Elispot method belongs to the family of Gamma Interferon Release Assays (IGRA), and has a history of use worldwide, having been approved by the FDA in May 2011 for M. tuberculosis. In Germany alone, there are around 20 different laboratories offering the Elispot, both for Borrelia burgdorferi as well as every other type of infection and virus for which the Elispot test has been developed. There are approximately 100 laboratories worldwide offering Elispot tests as well as many universities.

With regards to the reliability of the two-tiered serology tests recommended in the draft Lyme guidelines, the UK’s recent history is quite questionable. As you may recall, the Lyme Disease Reference Laboratory at Southampton was closed in 2012 following an audit of the quality management systems that was triggered by patients tested at the laboratory. In parallel, a second patient-led investigation identified many violations of test method procedures and these were confirmed during the UK Parliamentary and Health Services Ombudsman complaint process. The audit and investigations led to the discovery of multiple issues and the laboratory was closed. Manager Susan O’Connell’s laboratory was found to have falsely claimed an International Organization for Standardization (ISO) accreditation. An investigation by the UK Parliamentary and Health Services Ombudsman found many violations including:

▪      use of a test certified only for use with blood serum for testing cerebrospinal fluid (CSF)

▪      modification of the incubation time of the LB Western Blot test kit without validating for sensitivity and gave incorrect interpretation of Western Blot test results

▪      use of a test kit specific for Borrelia burgdorferi B31 strain in Europe where other species are far more prevalent without validating the performance sensitivity

▪      failure to notify clinicians that the test was used off-label

▪      failure to follow the test kit manufacturer’s instructions, e.g. calibration sheets were destroyed, and visual judgement used

▪      the laboratory recording system was so poor it resulted in misinterpretation by Public Health England (PHE) and erroneous results submitted to patients during the complaint process

With regards to clinical practice guidelines, do I understand correctly that the NICE Lyme Guidelines’ Committee believes their evidence-based criteria for guidelines is of such superior quality that they are willing to:

▪      Deny the testimonials supplied by your UK citizens showing that many of those suffering from LB and co-infections require extended treatments beyond those offered by the draft NICE Lyme Guidelines?

▪      Obstruct access to clinical practice guidelines that meet the internationally accepted evidence-based criteria of the US Institute of Medicine (IOM or US National Academies of Sciences, Engineering and Medicine)?

▪      Defy the Helsinki declaration? “Unproven Interventions in Clinical Practice: In the treatment of an individual patient, where proven interventions do not exist, or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.”

In contrast to NICE, the government of France has committed to promoting a flexible Lyme framework[1] that recognizes ‘the state of evidence’ with regards to LB. According to a recent interview with world renown LB expert Christian Perronne,[2] [3]

“Will the [French] protocol define the ideal treatment? No, because today we are unable to say: “The best treatment is this one”. For example, there will be no maximum for the duration of an antibiotic treatment. It will be  left to the discretion of the doctor. You cannot set a maximum for the simple reason that … We have no data, all the studies that have been done have been limited to three months. Now, we will be able to monitor patients, record practices, see what works best … It was the goal of the working group to formulate what is being done now and to evolve from that. Our approach is pragmatic, it leaves the door open … And it suits me well.

Of course, it will be expensive at first. But afterwards, the state will save money, because these patients will be better managed.

It is expensive, a patient wandering through the medical system for fifteen or twenty years. There are work stoppages, repeated hospitalizations, hundreds of scans, MRIs, biological tests, tons of antidepressants, physiotherapists … All those things are expensive, the accumulated cost is astronomical. With recognition of the disease, health economics researchers will be able to make assessments.”

As stated, the current draft NICE Lyme Guidelines have ignored the patient-led (patient-oriented) stakeholders and obstruct access to diagnosis and treatment options that meet internationally accepted evidence-based criteria.

As a result, these draft Lyme Guidelines ignore the UK government’s obligations to human rights. The right to health, like all human rights, imposes on the State Party three types of obligations:

Respect: This means simply not to interfere with the enjoyment of the right to health.

Protect: This means ensuring that third parties (non-State Actors) do not infringe upon the enjoyment of the right to health.

Fulfill:    his means taking positive steps to realize the right to health.”

“…In this context, it is important to distinguish the inability from the unwillingness of a State Party to comply with its right to health obligations.”

On October 24, 2017, The United Nations (UN) Special Rapporteur (SR) on the right to health, Dainius Pūras presented his report on corruption to the UN General Assembly. The SR noted that health is among the most corrupt sectors in many countries and this corruption is driven by global causes as well as the weakening of institutional accountability and transparency. He described the insidious nature of this corruption and how it undermines previously fair practices of medical ethics and social justice; even illegal acts become normalized.

The stakeholder reviews of the draft NICE Lyme Guidelines were shared among patient-oriented groups and the NICE Lyme Guidelines Committee. The stakeholder reviews noted the demonstrated bias in the Guidelines and that well documented scientific evidence —including mother to fetus transmission, poor test sensitivity and reliability, evidence of persistence of disease, the failure of restricted treatment as promoted by the Infectious Diseases Society of America (IDSA)— were ignored by the Committee. As of March 12, 2018, the Committee has ignored the inputs from all such reviews.

UK Lyme advocates question whether there was any genuine stakeholder process. This is, in part, due to one lay member of the NICE Lyme Guidelines Committee, representing a UK Lyme charity, who advertised many aspects of the draft Guidelines via social media almost 11 months prior to their public release.

This NICE Lyme Committee member claims to represent the LB patients’ priorities but was promoting disability payments for LB patients instead of medical care and treatment options that have met internationally accepted standards. This Committee member is also on record stating that the UK’s National Health Service (NHS) cannot afford these treatment options and cannot afford or manage to interpret more reliable diagnostic tests than those currently promoted.

Should those disabled by LB go on disability instead of receiving medical care, their disability support would be covered by the Department of Work and Pension (DWP) instead of the NHS. Adoption of this recommendation by NICE would result in a cost savings for the NHS and an increase of costs for the DWP.

While this Committee member was promoting disability support rather than medical care, many thousands of UK citizens who were previously classified as disabled are being thrown off disability support. An August 2017 report by the UN Committee on the Rights of Persons with Disabilities concluded that the UK has failed to ensure the UN Convention on Disabled Peoples’ Rights, to which it has been a signatory since 2007 and this discrimination is reflected in current UK policies and laws. Furthermore, the UK government decided to ‘incentivize’ disabled people by trying to cut their desperately needed benefits.

The promotion by this NICE Lyme Committee member for disability support instead of medical care for LB patients is particularly disturbing given the UK context regarding disability.

The preview of the NICE Lyme Guideline recommendations provided by this NICE Committee member indicated that the new Guidelines would follow the 2006 IDSA Lyme Guidelines; she also encouraged patient groups to accept the status quo … meaning treatment options that meet internationally accepted standards would not be recognized or honored and, in many cases, positive test results from unreliable serology tests would confirm the need for treatment.

As noted in my previous correspondence, many of the views of this Committee member were reflected in the NICE Lyme Guidelines draft that was publicly shared nearly 11 months later. Also noted, in violation of UK government regulations, the NICE Lyme Guidelines Committee has been actively promoting for use the draft version of the new Lyme Guidelines to hospitals and other medical establishments.

In order to best understand the irregularities surrounding the development of the NICE Lyme Guidelines, it is important to note there are other UK patient groups experiencing similar marginalization, stigmatization, denial of medical care and treatment options and human rights abuses.

For example, ME and LB are ‘emerging illnesses’ that have been emerging for four decades. It is estimated that there are between 15 and 30 million persons worldwide suffering from Myalgic Encephalopathy (ME), also known as Chronic Fatigue Syndrome (CFS). The few doctors willing to openly treat ME patients are also routinely harassed, discredited and threatened in the same manner as are LB doctors and scientists.

The worldwide guidelines on ME are based on findings from the 2011 Lancet publication of the Pacing, graded Activity, and Cognitive behavior therapy, a randomized Evaluation or PACE trial. These ME guidelines have come under increasing international scientific and medical scrutiny.

As you know, the PACE study was funded by the UK government’s Department of Work and Pension; the same agency responsible for supporting disabled LB patients. The study compared ‘standardized specialist medical care’ (SMC) alone to SMC plus Adaptive Pacing Therapy, Cognitive Behavioral Therapy (CBT), or Graded Exercise Therapy (GET). The experimenters determined that the patients who received CBT and GET did better than other groups of ME.

These findings have been very influential; they were used to formulate NICE’s ME Guidelines for clinical practice and have been adopted by most nations including the USA, the Netherlands, Canada and Scandinavian countries. Policies based on PACE are used to determine coverage by both government funded healthcare and private medical insurers.

You may recall that forty-two scientists and clinicians wrote an open letter to the Lancet criticizing the PACE study’s authors violation of the Declaration of Helsinki, which mandates that prospective participants be ‘adequately informed’ about researchers’ “possible conflicts of interest.”[4] More analysis by independent research groups indicate the PACE findings to be unduly biased and/or fraudulent.

The reanalysis of the raw data calls into question the research integrity of the PACE trials. This reanalysis also puts NICE into the spotlight, as NICE recently attempted to again ‘formulate ME guidelines’ based on PACE findings. This has led to hearings and debates in the Scottish Parliament and have contributed to ME advocates successful disruption of NICE’s attempts to again base their ME Guidelines on the PACE trial.

ME patients, like Lyme and relapsing fever borreliosis patients, have witnessed a cohort of actors representing the State and private interests deliberately suppress the scientific and medical evidence showing these complex systemic illnesses are biological in nature and promote the fraud that these patients are basically ill-adjusted hypochondriacs undeserving of medical care. Like Lyme and relapsing fever borreliosis patients, ME patients and their families bear the personal brunt of the medical costs and the humiliation and degradation of inhumane treatment by the health care system.

ME patients, mostly children patients, have been forcibly removed from their homes, forcibly required to implement the PACE protocols and died as result. The UK movie, Voices from the Shadows, details such cases.

In addition to the ME and Lyme and relapsing fever borreliosis patient groups, there are other patient groups with complex illnesses who are being systematically humiliated, degraded, stigmatized and denied adequate medical care. In many cases, this pattern of abuse is accompanied by fabricated psychosomatic labels such as ‘medically unexplained symptoms’, ‘bodily distress disorder’ and ‘bodily distress syndrome’. These deceptive terms are now also being applied to an increasing number of patient groups that were previously recognized as having medical conditions and are currently being deliberately ‘somaticized’ away from medical care. These patient groups include persons with traumatic brain injury and females with extensive noncancerous growths and adhesions surrounding their reproductive organs who have ‘symptoms lasting more than six months’.

As noted, NICE, the same entity responsible for promoting PACE as a basis for ME treatment, is currently reformulating its Lyme Guidelines. NICE’s Lyme Guideline development appears to have many of the same issues as those uncovered in the NICE ME Guidelines development.

Many UK Lyme advocates characterize the process as disingenuous, disrespectful, suppressing important scientific and medical knowledge, and politically and financially motivated by powers that have little interest in the health and welfare of LB patients and future LB patients.

Furthermore, the human rights of these patients and their human rights defenders are under attack —human rights defenders include those practitioners treating those persistent and complicated cases of Lyme borreliosis as well as parents who are protecting their children’s access to treatment options that meet internationally accepted standards.

The issues noted have many legal and ethical implications in the context of the UK healthcare system. For example, some of the issues raised do not conform to the UK government’s commitments made in The Human Rights Act 1998, which came into law in 2000. As you know, this Act incorporates the human rights set out in the European Convention on the Protection of Human Rights and Fundamental Freedoms (ECHR) into domestic British law.

Additionally, there are concerns regarding the Public Health England and NHS agreements for ‘Involving people in their own care’. For example, UK Lyme advocates note that because the draft Lyme Guidelines obstruct patients’ access to treatment options that meet internationally accepted standards for evidence based medicine, NICE does not support and honor NHS’ “commitment to become much better at involving patients (and their carers) by (1) giving them the power to manage their own health and make informed decisions about their care and treatment; and (2) supporting them to improve their health and give them the best opportunity to lead the life that they want.”

Furthermore, in the context of the UK healthcare system, the human rights, including health human rights, of Lyme patients and their human rights defenders include:

▪     Right to liberty and security of person

▪      Right to privacy and confidentiality

▪      Right to information

▪      Right to bodily integrity

▪      Right to life

▪      Right to highest attainable standard of health

▪      Right to freedom from torture and cruel, inhuman and degrading treatment

▪      Right to participation in public policy

▪      Right to nondiscrimination and equality

▪      Right to a remedy

These rights are detailed in the following ten international and regional treatises:

▪      Convention Against Torture (CAT)

▪      European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (ETS No.126)

▪      Convention on the Elimination of All Forms of Discrimination against Women (CEDAW)

▪      Convention on the Rights of the Child (CRC)

▪      Convention on the Rights of Persons with Disabilities (CRPD)

▪      European Convention on the Protection of Human Rights and Fundamental Freedoms (ECHR) as noted

▪      European Social Charter (ESC)

▪      International Covenant on Civil and Political Rights (ICCPR)

▪      International Covenant on Economic, Social, and Cultural Rights (ICESCR)

ICESCR’s Article 12 states that steps for the realization of the right to health include those that:

✓  reduce infant mortality and ensure the healthy development of the child;

✓  improve environmental and industrial hygiene;

✓  prevent, treat and control epidemic, endemic, occupational and other diseases;

✓  create conditions to ensure access to health care for all.

▪      International Convention on the Elimination of All Forms of Racial Discrimination (ICERD)

▪      In addition, international standards now stipulate:

✓  the right to liberty and security of the person has been held to prohibit unauthorized disclosure of personal health data

✓  the rights to bodily integrity and security of the person have been held to prohibit the administration of medicine to a child against parents’ wishes

During the course of our correspondence, I have detailed patterns of institutional behavior on the part of NICE that indicate deliberate disregard for the health and welfare of patients suffering from complicated and persistent cases of LB.

These are grave observations and the documentation I have shared with you is but a small portion of what I have collected from and shared with the UK Lyme advocates. Please note this communication as well as my previous communications were vetted by many UK Lyme advocates representing different entities.

I will close by requesting that the NICE Lyme Guidelines Committee do not obstruct access to LB diagnosis technologies and treatment options that meet internationally accepted standards for evidence-based medicine.

The deliberate exclusion of such options would create violations across all the human rights, conventions and treaties listed in this correspondence. I state this as these violations have already been documented in circumstances where such obstruction to diagnosis and treatment options occur.

Please confirm you have received my correspondence.

Thank you for your time and consideration.

Faithfully,

Jenna Luché-Thayer

32 years working globally on the rights of the marginalized — Former Senior Adviser to the United Nations and US Government. Founder, Global Network on Institutional Discrimination™ — Holding institutions accountable for political and scientific solutions. Director, Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes.

Email — jennaluche@gmail.com

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[1] The term ‘framework’ has the same general meaning as ‘guidelines’

[2] Christian Perronne, MD, PhD, Internal medicine, is highly qualified and a recognized expert in medicine and infectious diseases; he has been taking care of chronic Lyme patients since 1994 and has followed thousands of them. His extensive list of credentials includes: Professor of Infectious and Tropical Diseases at the Faculty of Medicine Paris-Ile de France-Ouest, University of Versailles-St Quentin en Yvelines (UVSQ), Paris-Saclay, France; Chief of the Department of Medicine at the Raymond Poincaré University Hospital in Garches and a member of the research unit for biostatistics biomathematics pharmacoepidemiology and infectious diseases; Vice-President of the Fédération française contre les maladies vectorielles à tiques (FFMVT, French federation against tick-borne diseases), and President of the scientific committee of the FFMVT; He was vice-chairman of the National Reference Centre on Tuberculosis and Mycobacteria at the Pasteur Institute in Paris until 1998; Past-President of the French College of Professors of Infectious and Tropical Diseases (CMIT); Co-founder and past-President of the French Federation of Infectiology (FFI); President of the French National Technical Advisory Group of Experts on Immunisation (CTV); Chairman at the French Drug Agency (ANSM, ex-Afssaps), of the working group making national evidence-based guidelines for the antibiotic treatment of respiratory tract infections; Principal investigator of several major clinical trials on HIV, mycobacteria and viral hepatitis, for the Agence Nationale de Recherches sur le SIDA (ANRS, French agency for research on HIV and viral hepatitis); President of the Communicable diseases section at the Conseil Supérieur d’Hygiène Publique de France and then of the Communicable diseases commission at the High Council for Public Health (HCSP), making recommendations for the public health and vaccination policies until March 2016; Member of the scientific committee of the French Institute of Research in Microbiology and Infectious Diseases (IMMI, Inserm) until January 2013; President of the National Council of Universities (CNU), subsection Infectious and Tropical Diseases; Member and co-chair of the European Advisory Group of Experts on Immunization (ETAGE) at WHO; and Author or co-author of more than 300 scientific publications.

[3] https://www.lamontagne.fr/clermont-ferrand/sante/2018/03/11/plan-lyme-christian-perronne-annonce-une- grande-avancee-pour-les-malades_12768540.html

[4] http://www.virology.ws/2016/02/10/open-letter-lancet-again/

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