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