The NICE (National Institute for Health and Clinical Excellence) Consultation Committee met on 13 October
in London to discuss draft guidance on Venoplasty in CCSVI.
I think a few other matters have arisen since that meeting including a UK neurologist, Gavin Giovannoni, blogging about CCSVI "It is a great pity it has taken so much energy and cost so much in research expenditure to finally diss CCSVI." (I think the total spend on CCSVI in the UK amounts to £zero by the way).
Dear Professor Campbell
NICE - IP89 Percutaneous venoplasty for chronic cerebro spinal venous insufficiency in Multiple Sclerosis
I think it is a great pity that the words ‘in Multiple Sclerosis’ are included in the above title. How will this guidance apply to people who have CCSVI but no diagnosis of MS?
An expert panel already reached conclusions regarding the diagnosis and treatment of CCSVI in 2009.
I attach a full copy of the document with this email.
http://www.ms-ccsvi-uk.org/home/files/other-papers/iup-consensus-doc-full.pdf
Diagnosis and treatment of venous malformations
Consensus Document of the International Union of Phlebology
(IUP)-2009
The document opens as follows:
“The International Union of Phlebology (IUP), the largest international organization devoted to the investigation and management of venous disorders, established an expert panel to formulate guidelines for physicians and health care professionals around the world on the evaluation and treatment of venous malformations (VMs).”
CCSVI is included in this document as a congenital venous malformation. See page 4 of the document:
“Truncular VM lesions may also occur in veins with the same embryologic origin or draining the same territory (e.g., stenosing lesions of the extracranial jugular veins, superior vena cava, and azygos vein system along the main outflow pathways of the cerebro-spinal venous system as suspected cause of multiple sclerosis).96-99”
I contributed during the Public Consultation phase of the Guidance. I was unable to attend the recent meeting on 13 October myself but I gather some sensible comments were finally made regarding the safety of the procedure. My friend who did attend the public session felt that issues may arise around ‘efficacy’ and that there may be a restriction of the procedure to clinical trials only.
This would be a travesty for many people with MS who simply do not have years to wait for the outcome of clinical trials for a simple venoplasty procedure. We have clinical symptoms of hypoxia NOW. We have symptoms consistent with venous hypertension NOW. We require treatment NOW.
The lack of oxygenisation contributes towards fatigue and cognitive issues such as word finding, concentration, etc. We have clinical symptoms of autonomic dysfunction attributable to venous hypertension - temperature regulation cold extremities, heat intolerance, constipation, urinary urgency, hesitancy, incontinence, sexual dysfunction, lack of perspiration etc.
Of the 20,000 of us who have been treated for CCSVI improvements in these areas are the most commonly reported. I was treated for CCSVI in Poland and they released some preliminary statistics regarding improvements in the patients they have treated:
http://ameds.co/ftp/CCSVI_Treatment_and_Results_at_AMEDS_Centrum.pdf
We should not even be in the position of trying to prove a link with MS to have observable venous insufficiency treated. There is an elevation of venous pressure in the veins draining our brains and spinal chords. From Tallantyre et al and other research we know (and every neurologist should know) that MS lesions follow the venous system. There is a vein at the centre of almost every MS lesion. How might that have happened?
Please see these very recent presentations by Trevor Tucker and Clive Beggs on the physics of fluid dynamics on the blood flow of people with CCSVI.
Dr Trevor Tucker
http://www.youtube.com/watch?v=WriNVSNy6Qw&feature=related
Prof Clive Beggs
http://www.youtube.com/watch?v=37hFWVFFgXs&feature=mfu_in_order&list=UL
Please see below some more research which has appeared since the NICE Consultation meeting on 13 October.
On 19 October 2011 the results of a new meta analysis concluded there is a strong and statistically significant association between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS).
http://www.medscape.com/viewarticle/751767?src=nl_topic
The following paper, dated 21 October 2011 has also just become available:
Post mortem examination of the IJV and AZY veins of MS patients and non-MS controls demonstrated a variety of structural abnormalities and anatomic variations.
http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=137778&XNSPRACHE_ID=2&XNKONGRESS_ID=150&XNMASKEN_ID=900
In the following presentation Professor Sclafani makes the point that conducting meaningful randomised clinical trials into the final efficacy of this procedure for MS may be premature. The doctors who have been treating us have not even yet reached a definitive protocol for treatment, they are still finding out the nature and extent of the vein abnormalities and refining their treatment techniques.
http://www.youtube.com/watch?v=dhmgv4sPlUc&feature=related
We have a myriad of issues within our veins blocking the flow of blood - Professor Sclafani checks for, and has observed, the following when treating people with CCSVI: absent veins, misplaced valves, hypoplasia - isolated and multiple, reflux, annular stenoses, reversed valves, stasis, incomplete valves, collaterals, duplication, fused valves, septum, web, false channels etc
Since this presentation Professor Sclafani suggests that venography may only detect half of venous problems in the azygos, he believes that intra vascular ultrasound is a better diagnostic tool. The skills required to treat us are still being developed.
Doctors can only acquire and improve their skills by treating us. The procedure is low risk. Why not just treat us and study us?
How will clinical trials be set up across all the variations in MS (relapsing remitting, primary progressive, secondary progressive etc) and take account of the variety of diagnostic and treatment techniques available?? Will it not be like comparing apples and oranges?
Of course research needs to be done but it surely need not preclude treatment in the meantime? Particularly for people with primary progressive MS who never feature in any clinical study but who need help soonest!
Attitudes of Neurologists
There are sympathetic vascular doctors who wish to help us but such is the negative reaction from neurologists that people are finding it impossible to obtain referrals to vascular consultants to have their venous hypertension symptoms investigated and treated. Neurologists are actively blocking their patients from even having conversations about CCSVI, and the following is indicative of their attitude.
On 15 October Professor Gavin Giovannoni (Chair of Neurology at the Institute of Cell and Molecular Science, Queen Mary University London and the Department of Neurology at Barts and The London NHS Trust) wrote the following in his internet blog in reference to an outdated ECTRIMS statement. I, and several other people, have a complete copy of the blog page which was subsequently taken down by Professor Giovannoni.
Gavin Giovannoni said...
Re: "Neurologists making self-referential statements about CCSVI, as if they were vascular specialists!"
They don't need to be vascular experts only experts in assessing the evidence and applying Bradford-Hill's criteria.
In fact nobody needs to be a vascular expert to assess the CCSVI literature or make a judgement. All you need is common sense.
It is a great pity it has taken so much energy and cost so much in research expenditure to finally diss CCSVI. More importantly it has cost several MS'ers their life from having inappropriate CCSVI treatment. We should all learn from this experience.
Saturday, October 15, 2011 7:30:00 AM
"to finally diss CCSVI" ???
If ever there was an example of a neurologist's attitude and motivation towards CCSVI here we have it.
After speaking to many people I believe this wholly negative attitude is absolutely the norm for neurologists in the UK and in North America.
I understand Prof Giovannoni was the lead scientist on an MS drug called Cladribrine which Merck Serono withdrew recently because they couldn't satisfy the FDA about its safety for people with MS. I shan’t go into the number of deaths attributable to the Cladribrine trial.
Incidentally based on information made available by Biogen to the end of July this year 29 people with MS have died from PML whilst on Tysabri, another MS drug. What would Professor Giovannoni like us to learn from that experience?
People with MS are for the most part stuck with neurologists who will show absolutely no professional interest in clinical trials for CCSVI.
The majority of their research funding comes from pharmaceutical companies who have only MS drug market share to lose when we have our venous insufficiency treated.
Neurologists are obstructive when we ask for our venous system to be examined or evaluated.
But have they actually thought through the ethical implications of their continued refusal to allow their MS patients to be examined for CCSVI given the existence of the IUP document, the numbers of us who have been treated worldwide and the now well established incidence of CCSVI?
In refusing to assess venous insufficiency in their MS patients and prescribing Tysabri to patients (including children) are neurologists perhaps even being negligent? If their patients subsequently contract PML would the patients and their families not now be within their rights to ask why they were not at least examined for venous insufficiency and offered low risk angioplasty to relieve their vascular symptoms in the first place?
(I was tested - positive - for coeliac disease because my neurologist had experience of ONE patient paralysed by transverse myelitis attributable to undiagnosed coeliac disease - why will neurologists not pay attention to the 20,000 of us who have been treated for CCSVI?).
Where is the funding for any clinical trials going to come from?
Next to nothing has been spent on CCSVI research in the UK, but the likes of Professor Giovannoni would begrudge even this ‘as a great pity’…
The pharmaceutical industry is unlikely to fund CCSVI research, unless perhaps they diversify into vascular equipment or blood thinning drugs markets.
http://www.companiesandmarkets.com/Market-Report/multiple-sclerosis-therapeutics-pipeline-assessment-and-market-forecasts-to-2017-468966.asp
The MS drugs market is set to reach $20.2 billion by 2017, there is little financial incentive to fund anything which threatens those revenue streams. I don’t think Merck’s shareholders were exactly excited when the projected cash flow from Cladribrine had to be removed from their financial forecasts.
The UK MS Society made its mind up on CCSVI early on when its adviser, Professor Alastair Compston, neurologist, made the following comment:
"we are all agreed that people with MS are not likely to benefit by treatments that dilate blood vessels and consider these procedures to carry risks with no evidence for benefit".
Professor Compston has only very recently commented that, in his opinion, his genetic study into MS renders venous theories of MS ‘eccentric and maverick’.
I am not aware of Professor Compston’s explanation for the fact that MS lesions follow the venous system or how he would attempt to contradict the laws of physics and fluid dynamics regarding our poor blood flow. To my knowledge his genetics study did not address these matters and he has no vascular experience so I was inclined to pay more attention to the IUP document myself. He says:
"It is not in the interest of patients to go on pursuing those ideas when we now have such a convincing narrative about the nature of the disease."
He was apparently keen to stress however that his paper doesn’t identify the ’trigger’ for MS…
?
Professor Compston’s ‘narrative’ on MS isn’t relevant to my congenital venous abnormality and I am very happy I pursued ‘those ideas’ myself and had my venous insufficiency treated. I have absolutely no respect for Professor Compston’s views on CCSVI.
I don’t think he has read the French neurologist Aboulker’s research in the 1970s which found much the same as Dr Zamboni:
http://www.ncbi.nlm.nih.gov/pubmed/207125
http://www.ncbi.nlm.nih.gov/pubmed/207126
http://www.ncbi.nlm.nih.gov/pubmed/207127
I don’t think Professor Giovannoni has read it either.
Professors Compston and Giovannoni have all the symptoms of Gatekeeper Syndrome, lack of interest in anything, no matter how important to your work that doesn’t involve you being a gatekeeper.
Neurologists seem to have developed another affliction when it comes to CCSVI - a good dose of Semmelweis Reflex (
Mob behavior which occurs when a discovery of scientific fact is punished rather than rewarded).
Needless to say MS patients in their hospitals can’t get past the gates for investigation and treatment of their venous insufficiency.
The UK MS Society doesn’t care to consult with Vascular specialists. They did nothing to support those of us who wished to contribute to the NICE consultation on IP89. They have not set up a registry for people who have been treated for CCSVI and have no interest in the discrimination we face in seeking investigation and treatment for venous insufficiency.
However you will see from the attachment they were happy to ask people with MS to complete questionnaires ‘to help influence NICE’ on the MS oral drugs Fingolimod and Cladribrine (Professor’s Giovannoni’s research project).
Professor Compston’s research projects have also received considerable funding from the MS Society. Yet when a Vascular Professor I know called them about possible funding for a Cerebral Perfusion study which might indirectly support Dr Zamboni’s theories they were not interested whatsoever. It doesn’t bode well for CCSVI funding from the MS Society any time soon.
Their adviser Professor Compston might not approve.
Discrimination
?
Venoplasty is presently carried out in people with May Thurner and Budd Chiari syndromes, it is also carried out in the Internal Jugular veins of kidney dialysis patients. Will NICE be introducing retrospective guidance on these procedures particularly for people with MS? Should we not go the whole hog and introduce new clinical trials for these procedures in case a person with MS requires treatment for them too? Are there plans to revisit all NICE guidelines on venoplasty for people with MS in particular?
In view of the IUP Consensus document and subsequent research I think by failing to investigate and treat us now doctors are in danger of breaching their duty of care towards us. It is now reasonably forseeable that the risks we face from having this Internationally recognised condition are in danger of being negligently under assessed.
Whatever shape IP89 finally takes I think Primary Care Trusts are in breach of the Equality Act 2010 if they continue to refuse investigation and treatment of our clinical symptoms of venous insufficiency. The Act provides that discrimination against disabled people is prohibited conduct. A person discriminates against another if a disabled person is treated less favourably than others.
The Equality and Human Rights Commission has advised that under the Equality Act there may be three forms of discrimination against a disabled person in a medical situation. These are less favourable treatment, reasonable adjustments and victimisation.
Less favourable treatment occurs when an individual is treated less favourably for a reason relating to their disability. This is compared to how the service provider would treat (or is prepared to treat) another individual to which those reason do not apply, ie a person without a disability.
Less favourable treatment occurs when a service provider offers a lower standard of service, worse terms of service or refuses a service to a disabled individual.
Also I note the following from Dept of Health publication "Human Rights in Healthcare"
?
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_088971.pdf
Discrimination takes place when someone is treated in a different way compared with someone else in a similar situation.
I have been refused investigation and treatment for stenoses in my internal jugular veins, despite providing written and venography evidence of my stenosed veins. This refusal was made because I have a diagnosis of Multiple Sclerosis.
Efficacy
The vast majority of the 20,000 of us worldwide who have been treated for CCSVI have had to travel abroad and have been unable to access proper follow up care at home. We can only imagine how much better we might do with support, follow up scans and repeat treatment if required - like patients who have coronary angioplasty for example.
I note the guidance in IP75
IP75 Balloon Angioplasty of Pulmonary Vein Stenosis in infants
http://guidance.nice.org.uk/nicemedia/live/11137/31238/31238.pdf
“The available evidence suggests that the procedure is not efficacious.”
“Current evidence on the safety and efficacy …..does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research”
Section 2.3 Efficacy
2.3.1 The evidence was limited to four very small, poor-quality case series, the largest including only five patients. The two largest studies found no benefit from the procedure in any patients. Another study of of three patients found an immediate reduction in pulmonary vein pressure in all patients, as well as angiographic evidence of relief of stenosis in one patient. However this patient died of infection within 36 hours of surgery.
2.3.2 The Specialist Advisors considered that this procedure may have only short-term efficacy (if any at all).
The Guidance suggests that clinicians who wish to undertake the procedure (ie treat their patients!) should, inter alia, ensure that the parents of patients understand that the limited available evidence indicates a lack of efficacy (in giving their consent to the procedure).
The guidance says the procedure should only be offered to infants with a poor prognosis and there is currently no reliable alternative treatment. The babies almost all die but under the terms of the Guidance doctors may try to treat them.
Putting aside for a moment that 20,000 of us have already been treated worldwide for CCSVI and all treatment centres report improvements in a significant number of their patients, IP75 may offer some useful precedent over efficacy.
People with MS do not have a good prognosis. None of the available MS drugs alter the ultimate disability outcomes in the patient population.
http://www.independent.co.uk/life-style/health-and-families/health-news/ms-drug-trial-a-fiasco-ndash-and-nhs-paid-for-it-1991104.html
In any case as only about 12,000 out of an estimated 100,000 patients in the UK have access to any MS drug I think it is fair to say that we have no reliable alternative treatment.
I notice IP75 refers to audit and review of clinical outcomes of all patients having balloon angioplasty for pulmonary vein stenosis. Clinicians are encouraged to enter all patients onto the UK Central Cardiac Audit Database. Publication of safety and efficacy outcomes is sought (from the treatment of patients). Why could doctors not do something similar whilst treating our CCSVI?
Part of an emerging protocol for treating CCSVI includes assessment of the inferior and superior vena cava. The Oxford Radcliffe hospitals issue a leaflet for patients currently having venoplasty/stent placement in the superior or inferior vena cava. The leaflet sets out the treatment and risks exactly in keeping with my experience of CCSVI treatment. There is absolutely nothing in the small print of this leaflet which says people with MS cannot be treated.
Will doctors now have to refuse treatment if they find out that a patient has MS? How will IP89 affect this?
http://www.oxfordradcliffe.nhs.uk/forpatients/090427patientinfoleaflets/100422venoplasty.pdf
People with MS are offered next to nothing in the way of medical care in the UK. There is no structured pattern of support or treatment after diagnosis. Physiotherapy services are derisory. Follow up appointments with neurologists might be offered on an annual basis but they may discharge you when you don’t qualify for any MS drug or they deem you unsuitable fodder for one of their pet MS drugs trials. Even the MS Society wishes to close respite care homes for the most severely disabled for more suitable ‘holiday options’.
Neurologists are derailing their MS patients’ access to investigation and treatment of a venous condition because their professional noses are out of joint. Under the IUP Consensus Document CCSVI is classified as a distinct venous malformation not unlike May Thurner and Budd Chiari. Just because we happen to be talking about the veins that drain the brain does not mean that we ‘belong‘ to neurologists.
The NICE Guidance for IP89 needs to come up with sufficient teeth to allow vascular doctors/radiologists to treat the clinical symptoms of our venous insufficiency now.
With kind regards
Yours sincerely
Alison Fisher
28 October 2011