“Did we miss anything?” Yes, yes you have.
In November 2016, Multiple Sclerosis Research Australia (MSRA) produced an Executive Summary of a recent survey seeking community views. It was a quantitative survey; respondents were asked structured questions and then given closed options to select. At the end of the survey was one qualitative question, “Did we miss anything?” where some participants raised questions regarding Chronic Cerebrospinal Venous Insufficiency (CCSVI).
MSRA’s response to the MS community was this:
Chronic Cerebrospinal Venous Insufficiency (CCSVI) has also received funding from MS Research Australia in the past. However, following a considerable level of international attention in this area, there is now a global consensus that abnormalities in venous drainage of the spinal cord and brain are unlikely to contribute to the development of MS and further investment into this area is not currently warranted (MSRA 2016)
We have these concerns:
MSRA did indeed contribute $35,000 to investigate CCSVI at the Austin Hospital. They used Doppler Ultrasound to test 70 people with MS and 70 matched controls. They did not find a significant difference between the two groups when applying the Zamboni criteria for CCSVI diagnosis. They did find however, “abnormal internal jugular vein valves in 7 people with MS and one control” which, they say, “warrants further investigation” (MSRA 2012). What we now know is that Doppler Ultrasound is not an externally validated method for diagnosing the condition. A consensus document prepared by both Neurologists and Vascular specialists was published in the Journal of Vascular and Interventional Radiology. They stated:
Because the reproducibility of the categoric CCSVI color Doppler US-based diagnosis depends on the training level and skills of the operator and blinding and reading criteria, the usefulness and applicability of the CCSVI color Doppler US-based diagnosis in clinical research and practice is limited (Zivadinov et al. 2014)
There have been countless studies comparing ultrasound results with high variability and the only conclusion that can be drawn from the Austin study and other negative Doppler Ultrasound studies is that they had insufficient evidence to suggest an association between CCSVI and MS. MSRA have not provided any evidence to suggest that venous drainage is unlikely to contribute to MS.
In research there can be confusion between causation and association. Never before in any Multiple Sclerosis research has there been proof of the cause of MS – only associations. We do not know the cause. Therefore to put a dampener on research because it is ‘unlikely to contribute to the development of MS’ could be applied to many areas of MS research investment. What we are seeing is an association between MS and venous drainage abnormalities across many research centres around the globe. The Alfred study identified CCSVI in 80% of participants using venogram (an invasive technology where a catheter wire is inserted into the vein) who then received angioplasty treatment for these abnormalities. The question is – what impact do venous abnormalities have for people with MS and is there a treatment that can improve symptoms and quality of life? The answer for this is irrespective of whether CCSVI causes MS. Understanding the vascular connection in MS may provide further answers that lead to discovering causation – it is irresponsible to say that further investment is not warranted. After all, veins are found at the focal point of MS lesions (Sati et al 2016) – an inconvenient truth?
And what of this ‘global consensus’ (MSRA 2016)? Who has provided this advice? Which experts have collaborated on this position? Have they considered all available research and conducted a meta analysis? Have they, with openness, considered the ongoing work of the International Society of Neurovascular Disease who are finding not only CCSVI in MS, but significantly higher levels of cardiovascular disease, cerebral microbleeds and slowed blood and cerebral spinal fluid flow in people with MS? What about the discovery of lymphatic vessels in the brain and their drainage to the venous system? There continues to be ongoing findings relating Multiple Sclerosis to various cardiovascular abnormalities and the CCSVI Alliance has an exhaustive list of hundreds of papers relating to these http://ccsvi.org/index.php/component/search/index.php?option=com_search&task=search
We find it curious that MS Research Australia made this brief statement without an author, without providing evidence and without consultation with all stakeholders as to what areas of MS research are ‘currently warranted.’ As Peter Sullivan from the MS Network of Care has identified in an open letter this week to Robyn Hunter, CEO of Multiple Sclerosis Limited, we have:
concerns about the possible consequences of highly vulnerable people relying on significantly understated and at times outdated information. It should go without saying that organisations presenting a public face under the MSA banner are operating from a position of trust – as such they have very significant obligations in terms of Duty of Care. In the case of CCSVI, human rights issues are also now squarely on the table see http://www.msnetwork.org/basics/UN-conventions.htm (MS Network of Care 2016)
We cannot agree more strongly with Mr Sullivan, there are people with MS who may benefit from treatment for venous abnormalities in terms of symptoms and quality of life. To deny individuals the facts to investigate this option is a travesty, to publicly state a ‘global consensus’ of faceless ‘experts’ without evidence or consultation with major stakeholders is potentially negligent. Dear MSRA, you have indeed missed something – there is a vascular connection in Multiple Sclerosis and we’re always happy to talk.
The CCSVI Australia Team.
MS Network of Care (2016), CCSVI journey in Australia – Protecting the vulnerable, Open letter to Robyn Hunter – CEO, MSL, 13 December 2016, http://www.msnetwork.org/advocacy/MS%20Ltd-questions.pdf
MS Research Australia (2012), Australian results published on prevalence of CCSVI in early MS, 17th September 2012, http://www.msra.org.au/australian-results-published-prevalence-ccsvi-early-ms
Sati P. et al. (2016), The central vein sign and its clinical evaluation for the diagnosis of multiple sclerosis: a consensus statement from the North American Imaging in Multiple Sclerosis Cooperative, Nature Reviews Neurology, 12, pp. 714-722, http://www.nature.com/nrneurol/journal/v12/n12/full/nrneurol.2016.166.html
Zivadinov R. et al. (2014), Recommendations for Multimodal Noninvasive and Invasive screening for detection of extracranial venous abnormalities indicative of Chronic Cerebrospinal Venous Insufficiency: A position statement of the International Society of Neurovascular Disease, Journal of Vascular and Interventional Radiology, vol 25 (11), pp. 1785-1794. http://www.jvir.org/article/S1051-0443(14)00746-5/pdf