An adventure down a rabbit hole
Written by Kerri Cassidy
A response to article “Goodbye to all that: A short history of CCSVI” published in Multiple Sclerosis Journal, October 2013.
This article left me wondering just who is Alice and who is the Queen of Hearts?
Alice laughed: “There’s no use trying,” she said; “one can’t believe impossible things.” “I daresay you haven’t had much practice,” said the Queen. “When I was younger, I always did it for half an hour a day. Why, sometimes I’ve believed as many as six impossible things before breakfast.” “Lewis Carroll. Alice in Wonderland ”
It looks like Michael Rasminsky (former member of Canada’s MS Medical Advisory Committee) is missing some pertinent points about the current debate on CCSVI.
Quoting negative ultrasound studies in an effort to ‘shut down treatment trials’ is irresponsible. Four years on we know that Doppler ultrasound cannot be validated and used as the sole research tool to test CCSVI. Ultrasound has failed to be reliably replicated with extreme differences in study results from numerous research centres. Whilst this article quotes a variety of negative studies there are also many positive studies that have been ignored here. Why?
The studies quoted by Rasminsky could be seen as a ‘Straw Man‘: “A straw man approach involves deliberately attacking an opposing argument in order to strengthen their own argument. Authors create a decoy — the straw man — that will be deliberately destroyed. This straw man argument is weak and easily refuted, so it can be comprehensively discredited (L. Burton, 2012). There is no reference in this article to the limitations for the method used in these studies nor recommendation for future research to counter these limitations, for example, to study venous abnormalities by venogram or internal ultrasound. There is also no mention that the Austin study found that 10% of participants with MS had jugular valve abnormalities that warranted further investigation.
In 2010-2011 CCSVI Australia wrote to MS Research Australia a number of times about concerns around the trial design of the Austin Ultrasound study. The same concerns are held for the COSMO and other studies using ultrasound as the method of diagnosis. Time and time again vascular experts and people who have experienced testing and treatment for CCSVI have said that ultrasound is not adequate for drawing meaningful conclusions – yet Neurologists and MS Specialists continue to quote these studies to back up their position, or worse, to call for a halt to further research into understanding venous abnormalities in people with MS.
Treatment trials should be encouraged so that it can be shown one way or the other. If there are no venous abnormalities present in a trial participant there will be nothing to treat, in effect a treatment trial could not be done. It should become clear very quickly if CCSVI does not exist and is in fact destined to ‘sink without a trace’ as a treatment trial would not be possible – this is an inconvenient truth to Rasminsky and friends.
I do not know of any other research in the history of Multiple Sclerosis that has been required to show causality to justify further research. Does low Vitamin D cause MS? There is no evidence to suggest this. A large portion of the population have low vitamin D levels and do not have MS – yet over $2.4 million is being contributed to this research here in Australia. That does not mean the research is bad – it is just not likely to find a definitive cause of MS even if results show that Vitamin D treatment is beneficial. It seems that the potential improved quality of life outcomes is worth the investment in Vitamin D research. The real question we need answered is, do people with MS have venous abnormalities (using the most accurate testing methods) and does correcting these abnormalities result in improvements in quality of life? That has not yet been answered and frankly we deserve to know. Is it possible that CCSVI is a condition in its own right and does not play a causal role in MS? Is it possible that having poor venous drainage causes a range of symptoms such as fatigue and brain fog (neither of which can be adequately explained by MS lesions) and can be relieved by treatment? Most people with MS are happy to have improvements in these areas even if treatment won’t cure their MS.
I find it ironic that Rasminsky states that this debate “has resulted in the unnecessary expenditure of significant resources, has tragically aroused false hopes in many, and has resulted in serious side-effects in some and death for others.” Hundreds if not thousands have lost their lives or suffered severe side effects from research and use of MS drugs. Tysabri alone has resulted in 401 cases of PML world wide (as at 3 Sept 2013) and over a fifth of these people with MS have died. The expenditure on these drugs makes the cost of CCSVI research appear like a drop in the ocean. The Alfred trial of balloon angioplasty to treat CCSVI will cost $450,000 and is the equivalent of less than 12 yearly prescriptions of Tysabri. The small number of deaths involving CCSVI treatment (three cases which were related to the use of stents) are more a reflection of the dangers of medical tourism than of treating people in sound research conditions. Treatment trials would further serve to protect people with MS from travelling to Mexico or India which we have seen in recent years. No Australian has died from Angioplasty treatment in over 700 angioplasty procedures since January 2010.
It is surprising that MS specialists such as Rasminsky do not see any worth in understanding the vasculature of people living with MS and that Vascular experts are being vehemently discouraged from looking at MS from a different perspective. Surely novel research should be encouraged for a condition for which there is no known cause or cure? If Rasminsky was going to do a rounded article he would have discussed the history of vascular research in MS from researchers such as Charcot and Dawson who very clearly showed a relationship between veins and MS lesions. Now we have the technology to develop their ideas further it should be done. Even the welcome to this week’s ECTRIMS conference referred to pioneer Professor Torben Fog who “meticulously studied thin sections of MS plaques. Following their shape and course with direct drawings of each section he described that plaques consistently followed the course of the venous system.” http://www.ectrims-congress.eu/2013/welcome/welcome-to-copenhagen.html There is a flippant disregard of the possible relationship to CCSVI which reflects the general lack of curiosity as to the relationship between plaques and veins by MS researchers.
People with MS are being treated as if their voice is of no importance and does not deserve to be heard. There are many people who have been tested for CCSVI and subsequently treated with improvements in symptoms. People like myself, who were treated over three years ago are still here calling for understanding. Why would we not want to share our experience with other people with MS? Why would we not want this better understood in the hope that it may help some people? Why should we not have a say in where research is headed? Why should people with MS not put pressure on ‘granting agencies’ and governments? Why is it assumed that people living with this condition do not have some very important and insightful contributions to make?
Rasminsky states, ‘The scientific process, in the face of enormous pressures, seems to have done its work.’ What a ridiculous assertion. The science is nowhere near finished. Scientists should never close the book on anything, not until every possibility is exhausted and even then should be open to new information. Scientists have never proven the autoimmune theory of MS yet billions continue to be poured out in research based on this premise.
At this point I would like to make a comment about conflicts of interest. In any industry there are safeguards against conflicts in order to protect the interests of companies and consumers. For example, in stockbroking, there are strict insider trading laws. Most corporates have guidelines about receiving gifts from suppliers to ensure financial decisions are not based on personal gain and politicians have to declare every interest lest it affect the choices they make on behalf of their constituents. Yet we have a very worrying situation when it comes to Medicine and the MS industry in particular.
I have concerns that there are few protections for the interests of people living with MS. Some may be tempted to call this a conspiracy theory, I simply consider it a lack of governance. I will give one example: the Head of the MS Research Australia (MSRA) Research Council, Professor William Carroll (the committee who review proposals for MS research investment and advises the MS Research Australia Board on the best opportunities to pursue), is also a board member of MS Research Australia and of MS Australia (the body who represent people with Multiple Sclerosis in Australia). Professor Carroll is the co-editor of the Multiple Sclerosis Journal who published Raminsky’s article. Professor Carroll is the lead in the $2.4 million Vitamin D study funded by MSRA – the organisation for which he chairs the committee who decide what research is funded. It would seem, to me, that there is potential for serious conflicts of interest in the case of Professor Carroll should he, for example, see CCSVI research as a direct threat on his own research interests. The Austin and Gardiner Hospital CCSVI studies were both employing the use of ultrasound, drew negative conclusions about CCSVI and were published in the Multiple Sclerosis Journal under his co-editorship. The Austin study was funded by MSRA and not incidentally Prof Carroll practices at the Gardiner Hospital. Now it is completely possible that Professor Carroll is an honest and upstanding individual, however, is it ethical for one person to hold such influence?
Whilst the vast majority of Multiple Sclerosis research funding is channeled through the hands of Professor Carroll and MSRA, there should be a more ‘arms length’ approach to decisions of funding allocations.
I cannot see a greater reason for having independent research into CCSVI such as is underway at the Alfred Hospital.
A little bit more on the Queen of Hearts:
“She is a foul-tempered monarch that Lewis Carroll himself pictured as “a blind fury”, and who is quick to decree death sentences at the slightest offense. Her most famous line, one which she repeats often, is “Off with their heads!” The Queen is referred to as a card from a pack of playing cards by Alice, yet somehow she is able to talk and is the ruler of the lands in the story, alongside the King of Hearts.”
The Queen of Hearts does not sound like an analogy of a patient group who want answers for something that many have found significant. Many have had lasting benefits for years now. This doesn’t sound like people who have generously shared their stories, and are openly seeking answers with good and thorough research. We want thorough and fair research done and we’re not afraid of the answers it may bring. Research that does not prove causality is not wasted. We have seen billions spent world wide on MS and I am yet to meet someone who has been cured by any of it. Take one moment to think, just who is the ruler of the MS land? I think you will find it is not the patient group. This is a fabulous analogy and I thank Michael Rasminsky for using it.
To people living day to day with MS and your supporters, we really need to stand up and be heard and not shrink back. I cannot recommend highly enough that you become voting members of your state’s MS Societies. Be critical thinkers, you don’t have to think CCSVI is something worth investigating to support the right of people with MS to approach government, ‘funding agencies’ and the wider community with issues that matter to them without the likes of Rasminsky and Carroll seeking to “prevent such fiascos from occurring in the future.”
The internet has given us something that we have never had before and that is a voice that is not scripted or censored.
This story is far from over and it will be interesting to see how history remembers it.
If you’d like to learn more about the centuries of research that has indicated that vascular abnormalities are indeed associated with MS, the CCSVI Alliance has collated an excellent summary.