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Stakeholdparties the development of guidance for clinicians on dealing with the disaffected group
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| parties the development of guidance for clinicians on dealing with the disaffected group
with un-provable Lyme disease. This will cover the therapeutic approach, investigation of
cases and disengagement strategies when further investigation is counter-productive.”
In view of their plans for ‘development of guidance for clinicians’, one may speculate that
PHE will attempt to steer the NICE GDG process to meet their predetermined agenda.
That agenda appears to include a 6 month period after which they deem it acceptable for
doctors to ‘disengage’ from patients if the patient cannot ‘prove’ that they Lyme borreliosis.
This agenda could deprive patients of medical care and deny them treatment and could be
attractive to some who are more concerned about financial costs than patient welfare.
The strategy might also be favourable to medical re-insurance companies who have saved
a lot of money thanks to a few psychiatrists who compounded the neurological disease,
Myalgic Encephalomyelitis with ‘CFS’ and then classified CFS as a Functional Somatic
Disorder. This has meant that policy claims can be limited to 2 years for a notoriously
chronic and severely debilitating neurological disease. Are people with chronic Lyme
borreliosis destined for the same?
'Professor Sir Simon Wessely's group' are psychiatrists, and it seems that PHE would like
them to take control of the fate of patients who do not recover in an allotted time. They
have some history with NICE, as observed by Professor Malcolm Hooper (2007) in his
written evidence to the Parliamentary Select Committee on Health regarding the NICE
GDG for ‘CFS/ME’:
“14. The advisors upon whom NICE relies have been shown to have undeclared vested
interests: These psychiatrists and their adherents are heavily involved with the medical
insurance industry, including UNUM Provident, Swiss Life, Canada Life, Norwich Union,
Allied Dunbar, Sun Alliance, Skandia, Zurich Life and Permanent Insurance, as well as the
re-insurers Swiss Re...”
Dr Darrel Ho-Yen (1990), who became the head of the Lyme Reference Laboratory at
Inverness, commented on the Wessely group’s ideas in the Journal of the Royal College of
General Practitioners: “…it has been suggested that a new approach to the treatment of
patients with postviral fatigue syndrome would be the adoption of a cognitive behavioural
model (Wessely S, David A, Butler S, Chalder T: Management of chronic (postviral) fatigue
syndrome. JRCGP 1989:39:26-29). Those who are chronically ill have recognised the folly
of the approach and, far from being maladaptive, their behaviour shows that they have
insight into their illness”.
VIRAS rejects the concept of a 6 month period for the transformation of a patient’s LB
infection from one stage to another as inaccurate, negligent and unethical. We are curious
to know where this idea originated and what scientific justification was provided for this
notion of an infectious disease progressing according to a calendar.
References
CDC/Fukuda. 1994. Guidelines for the Evaluation and Study of CFS. Centres for
Disease Control and Prevention. http://www.cdc.gov/cfs/case-definition/1994.html
Health and Safety Executive (2012). Lyme disease and services in the HPA. Advisory
Committee on Dangerous Pathogens (ACDP) - ACDP/99/P62.
http://www.hse.gov.uk/aboutus/meetings/committees/acdp/161012/acdp_99_p62.pdf
Hjetland R1, Nilsen RM, Grude N, Ulvestad E. 2014. Seroprevalence of antibodies to
Borrelia burgdorferi sensu lato in healthy adults from western Norway: risk factors and
methodological aspects. APMIS. 2014 Nov;122(11):1114-24. doi: 10.1111/apm.12267.
http://www.ncbi.nlm.nih.gov/pubmed/24730472
Hooper, Malcolm. 2007. Evidence submitted by Professor Malcolm Hooper (NICE 07).
Select Committee on Health.
http://www.publications.parliament.uk/pa/cm200607/cmselect/cmhealth/503/503we79.htm
ILADS (International Lyme and Associated Diseases Society). 2012. Peer Reviewed
Evidence of Persistence of Lyme Disease Spirochete Borrelia burgdorferi and Tick-Borne
Diseases. http://www.ilads.org/ilads_news/wp-
content/uploads/2015/09/EvidenceofPersistence-V2.pdf
Miklossy J. 2012. Chronic or late lyme neuroborreliosis: analysis of evidence compared to
chronic or late neurosyphilis. The Open Neurology Journal. 2012;6:146–157. doi:
10.2174/1874205X01206010146. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551238/
Mygland A, Skarpaas T, Ljøstad U. (2006). Chronic polyneuropathy and Lyme disease.
Eur J Neurol. 2006 Nov;13(11):1213-5. http://www.ncbi.nlm.nih.gov/pubmed/17038034
NHS Choices. 2014. Syphilis.
http://www.nhs.uk/Conditions/Syphilis/Pages/Symptomspg.aspx
Public Health England. 2015. Lyme disease: diagnosis and treatment.
https://www.gov.uk/government/publications/lyme-disease-diagnosis-and-treatment/lyme-
disease-diagnosis-and-treatment
Under Our Skin. 2007. LYME DISCOVERER WILLY BURGDORFER BREAKS SILENCE
ON HEATED CONTROVERSY 2007. Online: http://underourskin.com/news/lyme-
discoverer-willy-burgdorfer-breaks-silence-heated-controversy
U.S. Library of Medicine, MedlinePlus. 2015. Lyme Disease.
https://www.nlm.nih.gov/medlineplus/ency/article/001319.htm
West, Stirling. 2014. Rheumatology Secrets. Elsevier Health Sciences. Mosbey. 3rd
edition. ISBN-13: 978-0323037006.
Thank you for your comment on the
issue of the classification of early and
late Lyme disease as described in the
consultation version of the scope. We
have invited stakeholders to provide
comment on this in a specific question
at consultation to ensure that we
collected the widest views on this
issue. We now propose to present the
guideline committee with the
stakeholder feedback on this issue to
allow them to determine the best
approach for the guideline to take. As
such, we have removed the detail
linked to the definitions of early and
late Lyme disease from the final
scope. .
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VIRAS Vector- borne Infection, Research – Analysis - Strategy
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DQ5
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Diagnostic Testing for Lyme Disease
Diagnosis of Lyme borreliosis infections by indirect methods, i.e. looking for certain
antibodies in patients’ blood, has been proved to be unreliable by many studies published
over the past 3 decades. The criteria necessary for providing accurate clinical decision-
making and for the safe stewardship of maintaining Public Health have not been met.
A recently published meta-analysis by Leeflang et al., (1), reviews all testing methods to
date and shows that this problem is evident:
"We found no evidence that ELISAs have a higher or lower accuracy than immunoblots;
neither did we find evidence that two-tiered approaches have a better performance than
single tests.
“However, the data in this review do not provide sufficient evidence to make inferences
about the value of the tests for clinical practice. Valid estimates of sensitivity and specificity
for the tests as used in practice require well-designed cross-sectional studies, done in the
relevant clinical patient populations.
“Furthermore, information is needed about the prevalence of Lyme borreliosis among
those tested for it and the clinical consequences of a negative or positive test result. The
latter depend on the place of the test in the clinical pathway and the clinical decisions that
are driven by the test results or not. Future research should primarily focus on more
targeted clinical validations of these tests and research into appropriate use of these
tests."
It should be realised that all of the validity data sets for test kits, as published by their
manufacturers, have been determined in patients with known or highly probable borreliosis
infection, as seen from their symptoms, such as EM rash, or frank symptoms such as facial
palsy or Bannwarth’s syndrome. Rarely have any antibody tests been matched against
true microbiological evidence, which would have had to have been done by checking each
patient with a culture test.
The test kits have not been validated in patients who have less obvious presentations of
Lyme borreliosis. The only true validation would be to test each patient with manufacturer’s
kits and then to assess each patient by means of culture and/or DNA detection of the
bacteria.
It is of the utmost clinical importance that the true state of the infection in each patient
should be accurately assessed, This should be done in microbiological terms by looking for
evidence of the bacteria themselves, instead of looking for the immune response. There
are many reasons why the immune response is variable and often suppressed in patients
with Lyme borreliosis. (2)
Microscopic visualization of live Borrelia spirochetes offers the strongest of all proofs that
an infection is present. Borrelia burgdorferi can be visualized directly in infected vectors,
reservoir hosts, laboratory animals and clinical specimens from patients with Lyme
borreliosis using dark-field or phase-contrast microscopy. The spirochetes may also be
microscopically visualized after Giemsa, Gram, immunological or silver staining of
specimens
The BIA have dismissed microscopy and culture investigations of patients. They cite the
long time period necessary for the borrelia spirochetes to grow, and the cost of technical
manpower. However, if we are on the brink of a public health hazard, liable to affect future
generations - because of the high probability of congenital transfer of the infection, and
possible contamination of the nation’s blood supply - then the cost has to be met. In fact,
costs will not be as high as expected, since advanced culture methods have recently been
patented which enable identification of borrelia species in patient sera within 1 week, in
many cases:
This advanced culture method has been in operation as a successful commercial
enterprise in Pennsylvania, at Advanced Laboratory Services, for the last 3 years, and has
been published in the peer-reviewed literature (3, 4) and patented (5).
The method is endorsed by Philip M. Tierno, Jr., PhD Frm Director of Clinical Microbiology
and Immunology, New York University School of Medicine
Dr Tierno refutes accusations by some CDC scientists that there might have been
contamination during the method. (6).
Criticism of the method by UK scientists has been quashed with research by Dr Sheila
Woods and her team at Advanced labs. PHE have claimed that the spirochaetes seen in
the microscope were artefacts, or pieces of collagen or fibrin. Sheila Wood used a special
Rhodium-based stain which has the property of only attaching to collagen and fibrin, and it
was conclusively shown that, in the very small percentage of cases where the obvious
shape of Borrelia spirochaetes was not so distinct (about 2% of samples), the Rhodium
stain did not attach to what were suspected to be Borrelia spirochaetes. The Rhodium
stain did attach to bits of the background extra-cellular matrix, as it is designed to do, but
absolutely did not stain the Borrelia. (7).
The Abstract states : "In order to distinctly differentiate the organisms from the collagen of
this matrix that could be observed as background in the staining process, we developed an
immunostaining procedure using polyclonal and monoclonal antibodies in combination with
rhodamine fibronectin. The culture samples from both control organisms and patient
samples were tested using the new immunostaining protocol. Results showed clear
delineation of organisms compared to the collagen pieces gathered in the harvesting
process. This new immunostaining process, used with in vitro cultivation, provides for
precise identification of cultured organisms."
Given that the true prevalence of borreliosis in the UK has not been fully monitored, and
that it will be bound to increase in the British Isles, as it has been seen to do so across the
Northern hemisphere , we can expect tens of thousands of cases each year (8,9).
The Health and Safety of the UK over the next 10 to 15 years will depend on how the NICE
committee decides to tackle the problem of not just Lyme disease, but also other
arthropod-borne infections. It is imperative that our health service chooses the best
diagnostic techniques .
References
1)The diagnostic accuracy of serological tests for Lyme borreliosis in Europe: a systematic
review and meta-analysis Leeflang et al. BMC Infectious Diseases (2016) 16:140. DOI
10.1186/s12879-016-1468-4
2) http://www.ilads.org/ly…/primary-care-physician-brochure.pdf
3) Improved Culture Conditions for the Growth and Detection of Borrelia from Human
Serum. Sapi E, Pabbati N, Datar A, Davies EM, Rattelle A, Kuo BA.
Int J M.5698. ed Sci 2013; 10(4):362-376. doi:10.7150/ijms
4)Assessment of New Culture Method to Detect Borrelia species in Serum of Lyme
Disease Patients”. B. Johnson, Mark A. Pilgard, and Theresa M. Russell
J. Clin. Microbiol. doi:10.1128/JCM.01674-13
5) http://advanced-lab.com/news/borrelia_culture_patent.pdf
6). http://www.advanced-lab.com/news/comment-lyme-tierno.pdf
7) Differentiation of Borrelia Microbes from Collagen Debris and Collagen Fibrils in Blood
Cultures. J. Microbiology & Experimentation Volume 2 Issue 1. January 02, 2015 Sheila
Wood, Akshita Datar, Namrata Pabbat, Divya Burugu and Amy Rattelle J. Microbiology &
Experimentation Volume 2 Issue 1. January 02, 2015
S http://medcraveonline.com/JMEN/JMEN-02-00033.pdf
8) http://www.nhs.uk/…/Concern-about-rise-in-UK-Lyme-disease-c… and
http://www.bristol.ac.uk/n…/2015/april/big-tick-project.html
9) An estimate of Lyme borreliosis incidence in Western Europe Robert A. Sykes, Phoebe
Makiello Journal of Public Health | pp. 1 –8 | doi:10.1093/pubmed/fdw017
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Thank you for your response and
detailed comments on our questions.
We will bring the detail of your
response to the Guideline
Committee's attention. The
information will be used to inform the
Committee's decision making as they
develop the review protocols that
guide the searches for and review of
the evidence for the questions
outlined in the guideline scope.
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VIRAS Vector- borne Infection, Research – Analysis - Strategy
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Gener
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Gen
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VIRAS response to NICE request for comments on:
“4) The inclusion of the following strains of Lyme Borreliosis for consideration as part of our
review of the evidence:
B. burgdorferi (and the subtype B. burgdorferi sensu stricto), B. garinii, B. afzelii”
Borrelia Species causing Lyme borreliosis and Travel Risks
Key Points
Since the discovery of borrelia burgdorferi in 1982, more species and strains have been
discovered and implicated in Lyme borreliosis (LB)
As recently as 2016, the CDC and Mayo Clinic have announced a new LB species
As recently as 2016 Rudenko et al (14) provide evidence of the involvement of B.
bissettii in human Lyme borreliosis
Regions endemic for LB species have expanded and are expected to continue to do so
A high number of UK residents travel abroad with increased risk of exposure to a
greater range of LB species and strains
The species of borrelia specific for ‘Lyme Disease’ were b. burgdorferi s.s., b. garinii and b.
afzelii. This artificial restriction has long been discarded by scientists and physicians to
recognise additional borrelia species responsible for ‘Lyme Borreliosis’ (LB).
All authorities recognise LB as a growing threat. The World Health Organization Europe
report on Lyme Borreliosis and Global Warming states (1): “Since the 1980s, tick vectors
have increased in density and spread into higher latitudes and altitudes in Europe. It can
be concluded that future climate change in Europe will facilitate a spread of LB into higher
latitudes and altitudes, and contribute to increased disease occurrence in endemic areas.”
To meet this challenge, the Guidelines must recognise that non-endemic species could
spread to the UK and accept the possibility of further unknown species and strains yet to
be discovered.
In Scientific American’s guest blog, Lyme Time Is upon Us Again. Pfiefer (2016)(2)
remarks on Ixodes ricinus, (castor bean tick) which transmits LB in Europe: “In Europe,
disease-ridden castor bean ticks, a relative of those in the U.S., are on the move too,
spreading 300 miles north in Sweden and Norway to latitudes that were considered too
cold only a generation ago. Prolific and resilient, they are even scaling mountains, climbing
1,300 feet up the Dinaric Alps of Bosnia and Herzegovina and moving to new heights in
the Czech Republic and Scotland.”
LB species causing disease in Europe include: burgdorferi, afzelii, garinii, spielmanii,
lusitaniae, valaisiana, bisettii (Heyman et al. 2010)(3). Rizzoli et al state in
Eurosurviellance (4): “LB is likely to become an increasingly relevant health risk in the near
future due to complex interactions between diverse environmental and socio-economic
factors, which will affect various aspects of disease ecology and epidemiology”.
Risk to UK Residents Travelling Abroad
Worldwide species of Lyme borreliosis spirochaetes pose a threat to UK residents travelling abroad. The CDC (2015)(5) state that LB in Europe is: “endemic from southern Scandinavia into the northern Mediterranean countries of Italy, Spain, and Greece andeastward from the British Isles into central Russia.”
According to the UK Government, British nationals make millions of visits abroad each year. This increases the risk of exposure to Lyme borreliosis and a greater diversity of LB species and strains.
Destination / Number of visits / (LB incidence per 100k pop)
France 17 million 44
Germany 2 million 261
Netherlands 1.8 million 149
Austria 774,000 300
Switzerland 710,000 30
Sweden (Southern) 664,000 464
Czech Republic 300,000 38
Slovenia 100,000 155
UK reported incidence of LB per 100k pop:
Scotland 5.9
England and Wales 1.73
(Source for travel abroad: https://www.gov.uk/foreign-travel-advice/france [change country name for other destinations in lowercase]) (Sources for incidence figures: see below)
According to the Office for National Statistics (6) 62% of travel abroad by UK residents is for a holiday and 11% for visits to friends and relatives and might therefore be expected to be of at least several days. Therefore each year there are millions of visits by British nationals to other European countries where LB incidence ranges from 17 to 268 times the ‘official’ rate in England and Wales. Notwithstanding UK incidence figures which appear to be absurdly low, the high numbers travelling abroad are subject to a significant risk of exposure to diverse species and strains of borrelia.
Pfiefer (2016)(7) observes: “In the Netherlands, rates of people diagnosed with the telltale Lyme rash ranged up to 514 per 100,000 in 2014. In areas of Germany and Sweden, studies of patient records found Lyme rates of 261 to 464 per 100,000. In Europe, the highest national rate—315 per 100,000 in 2009 – has been reported in Slovenia, one of few countries to aggressively track cases.”
Travel to the USA
UK residents make over 3 million visits to the USA each year (6). The CDC (2013)(8)
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