Vector-Borne Infection Research-Analysis-Strategy
Analysis of the NICE Lyme disease draft Guideline 'Research Recommendations'
The NICE draft guideline states:
"4/ Antimicrobial management of Lyme disease
What are the most clinically and cost-effective treatment options for different clinical
presentations of Lyme disease in the UK?
Why this is important
The evidence on the effectiveness of antimicrobial treatment regimens used in different presentations of Lyme diseases is of poor quality, out-dated and often based on small studies. Most studies are not UK based. No relevant cost- effectiveness evidence was identified. A series of prospective multicentre studies is needed to compare the clinical and cost-effectiveness of different dosages and length of treatment, and the clinical and cost-effectiveness of oral compared to intravenous treatments for different presentations of Lyme disease. This is felt to be of high priority as it has enormous implications for patients and for NHS costs. There is currently insufficient quality evidence on the most effective drug and dose, and the effectiveness of extended treatment or retreatment regimens in those with continuing symptoms remains uncertain. Clarification could improve outcomes, reduce costs and may minimise unnecessary treatment."
At first glance, this research recommendation looks encouraging, but examined critically some disturbing incongruities become evident.
The draft NICE guideline provides restrictive treatment recommendations, which VIRAS believe are unfounded and unethical. NICE admit that the clinical effect of "different dosages and length of treatment" are unknown, yet at the same time they make definite and restrictive treatment recommendations which according to ther own statement - cannot be 'evidence based'. VIRAS believe this to be unfounded and unethical. The proposal for 'multicentre studies' supports our view that there is no evidence or justification for restricting treatment options for patients or doctors.
The only rationale for an expensive 'multicentre' study would be if various borrelia species produce different responses to treatment and these are expected to vary according to different regions of England and Wales. 'Multicentre' studies are not required for 'prospective' studies, they are only required for such time as a full-scale Clinical Trial is designed. This research proposition is wildly excessive and as such, it does not appear to be authentic.
As noted in the introduction, Public Heath England's Dr Matthew Dryden, claims 100% treatment success for Lyme disease. If this were true, then what possible justification could there be for spending hundreds of thousands of pounds on this research? This is bogus.
Costs and savings - which do you think come first?
Note how the explanation for this recommendation repeatedly mentions 'cost', except where it makes reference to 'those with continuing symptoms'. That is where cost actually matters most, because those are the patients that if still infected, will need the longest and most expensive treatment and management. Perhaps NICE overlooked this very obvious point, or perhaps it is their intention that these patients will be made 'cost-effective' even if it requires some dodgy research to make it happen. Then the most expensive patients could be re-diagnosed with some made-up illness that will not cost a penny in treatment to either the NHS or medical insurance companies, because it has no known aetiology, no treatment or ICD coding.
The UK, a world-leader in recommending Lyme disease research
but does not do any
If these research recommendations look vaguely hopeful, please ask this question: Where do NICE imagine that the millions of pounds needed to make their research recommendations a reality, are going to come from? NICE do not fund research, and it seems that neither does anybody else in the UK.
It is notable that in the past 16 years the Medical Research Council has not allocated funding for a single study into Lyme disease. In the past 16 years, of the 7 billion pounds allocated to around 20,000 research projects of medically related research by the Wellcome Trust, only 2 projects were vaguely relevant to Lyme disease patients and doctors. One was a study of pathogens found in ticks in Europe led by the late Professor Klaus Kurtenbach which included investigation of borrelia species in ticks in the UK. The second was a study of borrelia spirochaetes in ticks in the Baltic region of Europe, led by Dr Sarah Randolph. The Cochrane library list one systematic review of Lyme disease treatment, relating to treatment of neurological complications but not focussed on the UK. The National Institute for Health Research (NIHR) list no projects for Lyme disease. However, the University of Liverpool is getting some funding from NIHR for Health Protection Research and indicate that zoonoses including Lyme: "will explore new ways of detecting and characterising pathogens". This is a drop in the ocean and cannot be expected to translate into benefit for patients or doctors in the foreseeable future.
As with the other research recommendations, #4 does not withstand critical examination but is revealed to be a disingenuous stratagem.
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