Introduction
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 (http://multiple-sclerosis-research.blogspot.co.uk/2012/03/research-ccsvi-monthly-march.html
& http://multiple-sclerosis-research.blogspot.co.uk/2011/12/ccsvi-equivacal-results.html).
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: http://www.ratemds.com/doctor-ratings/1491982/Dr-Colin-Rose-Montreal-QC.html
) 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.
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 (http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
) 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: http://www.abpi.org.uk/industry-info/knowledge-hub/uk-economy/Pages/voi.aspx
· 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. ( http://bit.ly/RRwj0T )
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.