Response (Nov 2011) by the Neuroinflammation & Multiple Sclerosis Subcommittee of the Association of British Neurologists to NICE Interventional Procedures Programmes (IPG) 420, and reply by NICE (Mar 2012).
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ABN on NICE IPG venoplasty
1. Professor
Director, Centre for Health Technology Evaluation
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London
WC1V 6NA
25 November 2011
Dear Professor
Re: IP891 Percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis (MS)
We are writing to you as clinical neurologists practising in the UK and as members of the Multiple Sclerosis
subcommittee of the Association of British Neurologists (ABN).
We are aware the above NICE guidance is in its final phase prior to publication. Given its potential impact for people
with MS (pwMS) in the UK and elsewhere, we feel compelled to add our concerns to the comments by the
representative of the ABN, Alasdair Coles, during the consultation process, and we would like to urge NICE to reconsider
its draft guidance in the light of the following evidence (much of which has emerged very recently indeed and so will not
have been available to you in previous submissions) : -
The draft guidance considers ‘CCSVI’ to be a well described entity that can be diagnosed
“using venography, ultrasound or magnetic resonance imaging” (paragraph 2.2.2). This assumption however, does not
take into account that studies by Zamboni and co-workers1
, and other groups2
suggesting ‘CCSVI’ as a cause of (or
significant causative factor in the pathogenesis of) MS have been comprehensively challenged, if not refuted3-8
(to some
extent even by Professor Zamboni himself9
). Moreover, were changes in the venous outflow detected, their significance
for any neurological disease would need to be demonstrated as such changes are frequently seen in healthy
volunteers10-12
. NICE may be aware that even early adopters of the ‘CCSVI’ theory have recently taken a significant step
backwards by now claiming the existence of ‘CCSVI’ to be almost as common in other neurological disorders as in
pwMS12
.
Against this backdrop we are mystified the draft guidance (including post consultation literature review) only refers to
poorly designed, uncontrolled and biased reports of ‘CCSVI’ treatments, whilst robust studies questioning the existence
of this proposed syndrome are entirely neglected. Although we have not been invited by NICE for further comment we
feel the above challenges their draft guidance on the grounds that ‘it contains factual errors that will have a significant
impact on the guidance issued by the Institute’ (resolution ground 2).
The draft guidance succinctly refers to the doubts surrounding the existence of ‘CCSVI’ by stating that “research to
resolve these uncertainties would be useful” (Paragraph 2.5.2). However, explicitly recommending studies into the
2. treatment of ‘CCSVI‘, whilst describing studies into the existence of this condition simply as being ‘useful’ contravenes
any logical scientific approach and is, in our opinion, fundamentally flawed.
We are concerned publication of this guidance may have two further effects we urge NICE to consider: Firstly, under the
current climate of financial austerity, funding for clinical research has come under significant pressure. Diverting more
funds into an area that (i) is already being addressed with important – albeit largely negative – results and (ii) has
received substantial funding elsewhere, would be detrimental to the development in the UK of new therapies that are
underpinned by proper scientific evidence.
Secondly, and more importantly, even more pwMS will unnecessarily take the risk of undergoing venoplasty for a
condition that has – according to the best available evidence – no bearing on their MS. Centres in the UK and around
the globe are offering ‘CCSVI’ treatment. Various profit-making enterprises in the UK, working outside the NHS, are
selling ‘CCSVI therapy', at no small cost, directly to vulnerable patients. Such units are likely to interpret the current
proposed guidance as 'NICE’s stamp of approval' should this be published in its current form.
With kind regards.
Yours Sincerely
Chair MS Section, Association of British Neurologists
Honorary Secretary, Association of British Neurologists
President, Association of British Neurologists
3. References
1. Zamboni P, et al. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol
Neurosurg Psychiatry 2009;80:392-9.
2. Lee AB, et al. Embryological background of truncular venous malformation in the extracranial venous pathways
as the cause of chronic cerebro spinal venous insufficiency. Int Angiol 2010;29:95-108.
3. Doepp F, et al. No cerebrocervical venous congestion in patients with multiple sclerosis. Ann Neurol.
2010;68:173-83.
4. Mayer CA, et al. The perfect crime? CCSVI not leaving a trace in MS. J Neurol Neurosurg Psychiatry 2011;82:436-
40.
5. Meyer-Schwickerath R, et al. Intracranial venous pressure is normal in patients with multiple sclerosis. Mult Scler
2011;17:637-8.
6. Baracchini C , et al. No evidence of chronic cerebrospinal venous insufficiency at multiple sclerosis onset. Ann
Neurol 2011;69:90-9.
7. Baracchini C, et al. Progressive multiple sclerosis is not associated with chronic cerebrospinal venous
insufficiency. Neurology 2011;77:844-50.
8. Centonze D, et al. Proposed chronic cerebrospinal venous insufficiency criteria do not predict multiple sclerosis
risk or severity. Ann Neurol 2011;70:51-8.
9. Zamboni P & Galeotti R. The chronic cerebrospinal venous insufficiency syndrome. Phlebology 2010;25:269-79.
10. Niggemann P, et al. Positional Venous MR Angiography: An Operator-Independent Tool to Evaluate Cerebral
Venous Outflow Hemodynamics. AJNR Am J Neuroradiol. 2011 Nov 3. [Epub ahead of print].
11. Doepp F. et al. Venous drainage in multiple sclerosis: A combined MRI and ultrasound study. Neurology.
2011;77:1745-51.
12. Zivadinov R, et al. Prevalence, sensitivity, and specificity of chronic cerebrospinal venous insufficiency in MS.
Neurology. 2011;77:138-44.