The Frustrated Voice

The Frustrated Voice
The location of the problem

Tuesday, 20 November 2012

The Frustrated Voice

CCSVI is a condition that is often found in people who have the misfortune of having an MS diagnosis. The veins that drain the brain are subject to narrowings which can be treated by balloon angioplasty. Additionally there may also be other aspects of cerebral circulation which need investigating. The balloon angioplasty treatment for narrowed veins has proved to help a significant number of people who have seen their symptoms improve and at times even disappear. Unfortunately if you have an MS diagnosis you can only get angioplasty treatment privately, however if you do not have an MS diagnosis you can expect to be treated in an NHS hospital. What follows is an exploration of the reasons why this might be.
The history of CCSVI in the UK
Since January 2010 a small group of people (MS-CCSVI-UK) have tried to get CCSVI treatment a higher profile in the UK and one of the goals was to make information available to all people suffering from MS symptoms. In that we have singularly failed and recently we have been pondering on this. The extent of our failure came to our attention by a couple of chance events.
The first occurred when one of our members was asked to guest host a chat room for MSRC recently (summer 2012). Very few people came to the room and those who did were not there out of interest, did not understand or were particularly interested in CCSVI and its treatment. It became clear to us as the evening progressed that there was reluctance in actually engaging with the concept of CCSVI and its treatment. 
The second event was a communication from the CCSVI active people in Australia. A summary of the progress they had made in the past three years revealed that people with MS had achieved a lot more than had been achieved elsewhere in the world. It appeared that their voice had been heard, in the medical and political worlds as well as on the social networks. And even Canada which refuses to treat people with MS (pwMS) for CCSVI and will not allow private clinics to carry out these procedures have move forwards towards providing a register, aftercare, clinical trials mainly through the efforts of a couple of MPs and senators.
We have been reflecting on why we have not so far managed to get the message across. Was it the way in which we went about lobbying politicians, doctors, the medical societies? Our initial approach was tempered and reasonable:
·   we sent information on CCSVI to anyone we thought ought to know about it, MS organisations, vascular surgeons, neurologist, Interventional Radiologist, MS groups, MS nurses, the media
·  we talked to our MPs, and wrote to all MPs
·  we sent letters to the Department of Health,
·  we collected 10,000 names for a petition to the Prime    Minister’s Office asking for CCSVI treatment for people with MS.
·  we built a website and a Facebook page
·  we appeared on Radio shows
·  we had articles published in local newspapers
·  we planned a rally outside the MS headquarters
·  we asked to meet an MS Society representative to hand over a letter. They organised a meeting at which we explored the status quo and questioned the information contained in their website
·   we politely reminded them of their obligations by drawing their attention to their constitution
·   we held group planning meetings on the phone and in person
·   we located a private clinic in Scotland who was willing to explore CCSVI
·   we found a vascular surgeon interested in the concept who was willing to work with them
·   we suggested and helped organise a CCSVI conference in Glasgow
·   we sent out weekly press releases for a month before the conference
·  we invited MPs, Doctors and the press to attend, one GP attended but no MPs or press
·   we made informational videos
·   we interviewed people from around the world on Blog Talk Radio
·  we raised a petition in Scotland that was presented and discussed in Holyrood, however the people who raised the petition we not allowed to report to the meeting.
·   we were witness to discussions the National Health and Clinical Excellence (NICE) organisation held in 2011.
Yet in the short term all this effort has come to nothing. The evidence of vascular involvement in Multiple Sclerosis is convincing and verifiable so why is it that CCSVI has not been taken as seriously here as in other parts of the world? In Kuwait for example the health service was charged with treating all people with MS, in Poland the surgeon who was the first to instigate the treatment of CCSVI in Europe outside of Italy was awarded a professorship. Jordan and Serbia are making CCSVI treatment available to MS patients who want it.
Possible reasons for the cold shoulder treatment
Initially, in this country at least, we feel there was an element of arrogance and xenophobia in the reaction to the announcement of Paulo Zamboni’s hypothesis. To a certain extent this is still evident in the blogs authored by Gavin Giovanonni and the Mouse Doctor, whose writing is littered with pictures of a machine used to smooth ice rinks which happens to be called a Zamboni ( & This level of ridicule is unforgiveable. Colin Rose (a cardiologist and assistant professor in the United States) is another person culpable of gross arrogance and disrespect to a scientist who had the audacity to propose an idea that went against the favoured but unproven auto-immune theory. Arrogance is a trait of this man (as witnessed by some of his patients: ) so we cannot attach too much importance to his words, however they do influence people who have little knowledge of CCSVI. These research scientist and teachers have good reason of course to disregard the vascular idea, there is not the same level of revenue from surgery as there is from drugs, and pharmaceutical companies have the income which allows them to fund research into the aetiology of MS and find more disease events which might be managed using drugs. Of course this is not the first time this kind of ridicule and studied avoidance of new ideas has happened. The number of innovative scientists who have been ignored for decade, even centuries is very long: John Snow (cholera), James Lind (rickets), Gregor Mendal (genetics), Franz Schelling (vascular MS), Barry Marshall (heliobacter pylori), to name but a few.
The MS Society’s own adviser, Alastair Compston, himself doing research into drugs and stem cell therapy, famously pronounced in December 2009:
"The treatment for CCSVI is not available for patients with multiple sclerosis in the United Kingdom because there is no convincing evidence to suggest that it is safe or beneficial to people with MS.
People with MS are unlikely to benefit from treatments that dilate blood vessels."
When we received the disappointing response to our petition from the Prime Minister’s Office we realized from the wording of that reply that the Government was actually taking its lead from the MS Society. So now we were faced not only with a society which asserted that it was speaking for all people with MS symptoms but which also influenced the statements issued by the Government’s Health Department.
In a nutshell we were faced with a confrontational situation from the beginning. Rightly or wrongly I felt and still feel that confrontation is not going to get us anywhere. We need to negotiate, inform and convince, but for that to happen we need the voice of reason to be heard. Not being heard is the continuing theme of our cause. We were not heard at the MS Society meeting in May 2010, the Department of Health, or the meetings arranged by NICE in 2011; we were present and could have enlightened so called experts who quite clearly were not au fait with the basics of CCSVI and its treatment. At the NICE meeting in August, we were witness to a discussion about the safety of the procedure which ended in the conclusion that angioplasty/venoplasty could not be less safe for people with MS than for others. Yet this conclusion was omitted from the Guidance document which NICE eventually published in March 2012; instead much was made of the need for well-constructed double blind clinical trials to ascertain safety and efficacy.
Double standards and vested interests
Another event which took place at the NICE meeting which highlights the double standard which seems to dominate the CCSVI cause was the discussion on another surgical procedure which was reviewed at the same meeting. TAVI is a procedure that uses a catheter to insert a valve in the aorta: NICE (March 2012) “TAVI can be offered routinely as a treatment option to patients with aortic stenosis who cannot have open heart surgery because of poor health or technical difficulties”. This is a highly risky procedure available to a small number of people, yet no double blind clinical trials were held to ascertain its safety or efficacy.
Additionally the one person who could have testified to the effectiveness of the CCSVI procedure, the surgeon who carried out over 100 procedures in Scotland, was prevented from attending the meeting by the Vascular Society, although his reports were made available to the committee.
The Vascular Society had originally been quite open-minded about the theory of CCSVI and the venoplasty treatment, however, sometime between May 2010 and August 2011 their attitude became one of scepticism and doubt. We speculate that some kind of debate might have taken place which prompted the cautious response evidenced in their comments to the NICE consultative process.
Interventional Radiologists, who because of their practice should be best placed to diagnose and treat stenoses were also arrogant and dismissive about CCSVI and its treatment. One practitioner told me in an email communication that he felt quite capable, with his extensive experience of Doppler Ultrasound, of diagnosing reflux in a patient’s Internal Jugular Vein, in his opinion this reflux was non-existent in the pwMS he had examined. Unfortunately it was not until he had persevered for several months that he was eventually able to find this reflux in one of his patient. It is to his credit that he retained an open enough mind throughout this trial and error process, but it highlights the surmise some specialist have that they know everything there is to know about venous flow but may also demonstrates the difficulties attached to this diagnosis.
In fear of hope?
And what of people suffering from MS symptoms? One might think that they would be curious about the theory and the treatment process but it seems that the subject has succumbed to a recognised pattern of uptake of new ideas, ‘the technology adoption sequence’, ‘new’ ideas are assimilated in a predictable sequence which goes like this: 
1. Innovators: the people who think of the idea, about 2.5% of the population
2. Early adopters: 13.5% of the population, maybe a way to describe people active in the CCSVI cause.
3. Early majority: 34%, we are still waiting for this group to manifest. These are the people who are interested but waiting for approval from health services     and government. These could be doctors as well as patients
4. Late majority: 34% won’t come on board until a good few people have been treated and the treatment proves effective for a significant number
5. Laggards: 16% who may never adopt the idea.
It is a bit of mystery to us why not more people are interested in CCSVI. Is it because of the mistaken advice of neurologists, is it because it is not available on the NHS, is it because there have been so many ‘miracle cures’ that have failed people in the past? Admittedly the cost of this procedure takes it outside many people’s reach, but that should not preclude people’s interest and curiosity about the subject.
Neurologists of course hold a central place in the care of people with MS and it is not surprising that patients cling to their every word. It is therefore important that these doctors are educated in the theory and practice of CCSVI. They, however, have been very resistant to the idea of Venodynamic MS. Their career and research depend on the auto-immune theory. There is no doubt that the immune system is involved in the pathogenesis of MS but the cause that triggers it has not yet been pinpointed. In spite of the evidence of the post mortem and MRI studies which show veins at the centre of plaques, there is still a lot of research to be done on the circulation in the brain.
Evidently there are risks attached to surgery, even minimally invasive surgery, however there are real and damaging risks attached to drugs, especially those that aim to modulate the immune system. Is it because of the hype, history and hyperboles that drugs are acceptable to patients? The risks are born by the patient not the doctor who prescribes these medications (POISONS), very few doctors are prosecuted for prescribing a drug recognised as treatment for a particular condition. However much is made in the press and on social media sites of surgeons who have harmed a patient, maybe this is what is instilling fear into pwMS. Proportionally more people have died as a result of taking Tysabri (0.06%) than have died as a result of CCSVI surgery (0.01%).
There is also a self-defeating process at work with some pwMS and that is the fear of more psychological pain. A majority of people with MS live with constant loss, with every relapse or every progression, with every loss of function they have to go through the grieving process, mourning the death of their previous physical status. Many are unwilling to put themselves through the possibility of dashed hope, to such an extent that they would rather deal with the familiar progression than ‘jump’ through the hoops of the unknown. And who could blame them, there have been so many ‘theories’ and ‘cures’ and ‘drugs’ in the past few years that have born little fruit and disappointed many; the many we only ever hear about as figures or percentages, which does little to reveal the pain and anguish people go through.
Social Media
The social media has been a great asset for people seeking information on the treatment of CCSVI. It has also enabled many people to do the research to satisfy their enquiring minds or answer their questions. And for those unable to do their own research either through physical or mental disability, the internet forums have helped them make contact with people who could explain things to them.
However there are downsides to social media: it is easy enough to misunderstand comments when you are not face to face with people you are conversing with, it is a prime milieu for bullying and it is much more likely that people will verbally abuse others when there is little chance that they will ever meet face to face. One of our members was likened to the devil on one Facebook MS site, and people regularly fall out on CCSVI sites mainly through misunderstandings and personal prejudice.
Another problem about social media, is that to reach an audience you have to describe your aims, either through a domain name or through tags so that search engines can find the site. That often polarises the membership group and the ability of open and friendly dialogue is quickly lost. Early on in the CCSVI story the pro sites were often visited by a particularly vociferous doctor who would vehemently contradict pwMS. It was very tempting to ban him from posting on the sites, however doing so would have limited the frankness of any discussion. If we are to reach a wider audience we must remain open to criticism and the possibility of strong disagreement. We must be able to plead our case with calm deliberation even when faced with strong and unreasonable disagreement.
It is easy to incite anger and frustration in the social media arena, for the same reason as it is easy to insult someone. Frustration is contagious and this can lead to unreasonable and counterproductive attitudes which make it more difficult for the cause to be taken seriously by Government, doctors and the wider MS community.
The result of this negative aspect to discussion on the internet is that people who want to talk seriously or sensitively about a subject do so in closed groups, and that of course precludes anyone who does not know about CCSVI from learning about it. There are many pwMS in our country who do not know about or are frightened of getting treatment for this condition. It is difficult to think of a way round this problem: how can we create a significant open forum if people are too frightened to expose themselves to criticisms.
On power and money
Briefly the bodies who hold the power in our area of concern are principally the Government, the pharmaceutical industry, the media, NICE and the NHS and unbelievably the Federal Drug Agency (FDA) of the USA.
One person with MS told me that “good economics equals bad medicine” and a truer word could not be said. In 2004-05 a parliamentary white paper ( ) was issued regarding the Influence of the Pharmaceutical Industry. The report concluded (p 99) that:
The commercial success of the industry is not in doubt, nor is its ability to produce excellent science and important drugs; however, its ability to put the health of the nation consistently before the needs and expectations of its shareholders may be questioned. The evidence to this inquiry indicated that, in recent years, large pharmaceutical companies have become ever more focused on a marketing-based approach. In our view, this is the source of many of the problems we have identified…
… Our over-riding concerns are about the volume, extent and intensity of the industry’s influence, not only on clinical medicine and research but also on patients, regulators, the media, civil servants and politicians.
We could quote more of the document, it is well worth a read but the above gives a summary of the committee’s findings which is also reflected in the work of Marc-Andre Gagnon who in 2011 said this at a forum at York University in Toronto, Canada on “Capital as Power”:
Since the mid-1980s, a curious paradox is found in the pharmaceutical sector: while the therapeutic innovation is constantly decreasing, the rate of profit for dominant pharmaceutical firms is constantly growing… …A more detailed analysis of Big Pharma’s earning-capacity shows that profits are not related to the production of innovative product, but to the growing corporate control over medical research and medical practice. Producing the right medical discourse through massive promotional campaigns has become central in developing “blockbuster drugs”, even when these drugs are in fact less efficacious than previous ones.
The influence of the pharmaceutical industry is in large part thanks to its financial contribution to the UK exchequer. It appears that they are now the number one contributor to the national purse. No wonder the government might be anxious to keep the boat on an even keel and preserve the market of some very expensive and mostly ineffective drugs used to treat MS patients.
In this extract from the ABPI website, the extent of the industry’s financial contribution is listed:
·   In 2008, the pharmaceutical sector’s contribution to the balance of trade was the greatest of 9 major industrial sectors, up from 5th in 1975 and 3rd in 1990.
·  The pharmaceutical sector has, over the past decade, generated an ever-widening trade surplus (i.e. more exports and therefore money into the country than imports which means money out of the country), reaching almost £7 billion in 2009.
Which strapped for cash government is going to ask awkward question of their best income provider?

The media also have a lot to answer for in the way in which CCSVI has been handled in the UK. Many newspaper articles have sensational and overstated headlines. One TV programme, BBC South West Inside Out (reporter Sam Smith) set out with the explicit intention of putting a stop the CCSVI treatment which one private practice was carrying out. And in the end it succeeded in doing just, as the clinic’s insurers hiked their charges to a non-sustainable level.

People take notice of the information they get from the media, even though it might be incorrect or incomplete and sensationalising CCSVI treatment as a “Miracle Cure” or “Dangerous” sets up expectations and fears in the person in the street, something which is very difficult to undo. We were told at one time by a noted reporter in a well-respected Canadian magazine, that big business had control of newspaper groups and that it was in their interest to sensationalise items such as CCSVI in an effort to sell more newspapers and to maintain their grip on health related business.

Before the inception of NICE a doctor in the UK had the freedom to inform him or herself on innovative treatments or scientific discoveries and apply these to their patients if they thought it might be helpful. This is what happened in the case of the original venoplasty procedures. Now NICE issue guidance which doctors feel obliged to adhere to, even in Scotland where NICE has no jurisdiction, this fact alone has contributed to the hesitancy which has characterised the way in which CCSVI treatment has been dealt with.

It was even more surprising to us that the FDA’s influence reached across the water to the extent that it frightened a senior TV doctor in dropping a campaign aimed at informing the general public about CCSVI, not recommending it or putting pressure on the NHS to deliver a safe and well tried procedure to pwMS, but questioning the reasons why it was not being considered.

And what is the risk that the FDA was warning about? Angioplasty is after all a procedure which takes place in all our hospitals daily. The acceptable risk of death attached to this procedure when carried out on people without an MS diagnosis is 1% which is far higher than the 0.06% of people who have died as a result of lack of aftercare post angioplasty in MS diagnosed patients. It has crossed our minds that this was a ring fencing exercise on behalf of neurologists and upon digging a little deeper we did indeed find that the people who alerted the FDA about angioplasty in MS patients was a group of neuroscientists. ( )

Conclusion: conflicts of interest
It is our opinion that conflicts of interest are the reasons why CCSVI and its treatment have not be examined seriously in the UK, they are the reason why we do not have a voice here. The Pharmaceutical Industry, Neurologists, MS organisations, government, some politicians, scientists and researchers all have something to lose from a surgical treatment for what we call MS symptoms. Most of them would lose out financially, and a few might lose status and power. It seems as if revenue comes before the welfare of patients who live with this devastating condition. There is ample evidence now that angioplasty for CCSVI works for a significant number of people, there is also evidence to demonstrate that the benefits far outweigh the risks.
We have not been able to sit round a table and talk to people who might be in a position to influence researchers and policy makers in our area of interest. There are opportunities to get involved in local health delivery forums but they are not the place to discuss progressive ideas about the treatment of a neurological condition. What we need is some influential person to become interested in CCSVI and its treatment, someone whose voice is respected and believed. So far we have not found that person but we will carry on looking. Our one glimmer of hope at the moment rests with Private Eye who hopefully will prod a few politicians into action with their forthcoming article. It is time that the voice of people with MS, who want to receive treatment for a condition readily treated in others who do not have the dreaded diagnosis, to be heard.


the unaccustomed exerciser said...

nice work Michele, lots of gathering together of strands of info. this is a useful resource :) but could it be split up into 2,3 or 4 entries? I started skimming toward the end... and I'm an invested/interested party!

Christopher ALKENBRACK said...

Excellent work. C. Alkenbrack, Canada

Lori Batchelor said...

Keep fighting--the truth will have to win...sometime...

Canada is with you!

Michele said...

I agree with you and I intend to split it up into chapters for future use on our website, but thought it would be a good idea to post the whole lot in one place to start with.

Christopher and Lori, thanks for your support

John said...

Thank you Michele.
Well typed, collated , remembered and you mostly, did. Good show.

Franz Schelling said...

Clear insight into the relationship between CCSVI findings and MS lesions is mandatory ... and we can only explain and properly treat what we have fully understood.

AEA said...

I think it is probably more simple than all of that. People with MS cost the health system more money than people without. If you prolong the life of an MS patient, you prolong the cost. Socialized medicine is brutal. The alternative is equally brutal, just on a socioeconomic rather than disease specific basis (in other words, in a 'free market' denial of care is based on income bracket rather than illness). I think the best way to go about it is take the decision out of the medical communities hands. You have to find a 'test case' where a person with MS has close to the same stats as a person without who received the therapy, then take that to the courts as a case for discrimination.