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In a surprise move, the Canadian federal government has reversed its previous decision, and decided to fund CCSVI treatment trials on MS patients (click here). Just last year, government officials decided against funding such trials, citing a lack of evidence that a clear link existed between CCSVI and MS. Now, a working group of scientific advisors, after reviewing already published research in addition to the preliminary data from the seven ongoing studies funded by the MS societies of Canada and the USA, has concluded that there is enough evidence of a relationship between the vascular abnormalities collectively known as CCSVI and Multiple Sclerosis to warrant federally funded treatment trials (click here).
This is extremely welcome news to MS patients worldwide. Although treatment trials won't answer many of the scientific and medical questions surrounding the CCSVI hypothesis, such trials will determine whether catheter venoplasty, when used to open blocked veins and improve impeded bloodflow through the central nervous system of MS patients, results in an improvement of symptoms and/or a slowed progression of the disease. While academic questions such as cause and effect ultimately must and will be answered, the most pressing issue for MS patients themselves is whether or not getting treatment for CCSVI will improve their symptoms and lessen the long-term impact their potentially crippling disease.
What's of primary importance now that a mandate has been given to commence treatment trials is the design of those trials and exactly which treatment protocols will be used on the patients enrolled in them. Over the last 18 months we've learned that treating CCSVI is far less simple than was originally thought, and the physicians most experienced in the treatment of CCSVI are in unanimous agreement that the learning curve involved with perfecting the technique is steep, and the methodologies used are still a work in progress. The fact is that many of the treating physicians use quite disparate treatment protocols, and there is no clear consensus on best practices and a standardization of treatment methodology.
As CCSVI treatment has thus far been unavailable in Canada, there is an absence of Canadian physicians experienced in the treatment procedure. I trust that the scientists involved in the Canadian trials are fully aware of such issues, and that the physicians who will be performing the treatment procedures will undergo training at the hands of the experienced physicians outside of Canada who have been blazing the trail in performing what is still an experimental procedure. It's vital that these trial procedures be done using the latest and most effective techniques, as sub-optimal procedures will lead to sub-optimal results, which would be disastrous for the advancement of the science, and could easily lead to false conclusions about the effectiveness of treatment.
I would expect that the Canadian trials will not only demonstrate whether CCSVI treatment is effective, but, if it is, which symptoms are most impacted by improving venous blood flow, and which patient populations stand to most benefit from CCSVI treatment. MS is an extremely heterogeneous disease, with no two patients experiencing the malady quite the same way. A recent study (click here) by a CCSVI treatment practice in Poland found that patients most likely to benefit from CCSVI treatment are younger females (under the age of 30) with Relapsing Remitting Multiple Sclerosis, who have had the disease for relatively short amount of time and have not yet experienced severe mobility issues. Keeping in mind that the study was based on a relatively small sample size (47 patients), and the long-term effects of successful CCSVI treatment are still unknown, such data does make some sense in the context of what is known about MS pathophysiology, especially once the disease moves from its relapsing remitting form into its progressive stages.
Recent evidence has provided tantalizing clues that suggest that the progressive stages of the disease may be driven by an abnormal immune response contained entirely within the central nervous system, in a sense approximating a rogue immune system that operates separate and apart from the systemic immune system at work in the rest of the body (I'll blog about this in the near future). The implications of these findings, if correct, are profound, and would suggest that once the disease enters its progressive stages, treatments that are effective in RRMS, even CCSVI, may be rendered useless, as they do nothing to address an aberrant immune response that is contained entirely behind the blood brain barrier, operating independently and completely unto itself.
Be that as it may, the MS community on the whole should loudly applaud the Canadian government for taking the bold if belated step of federally funding vitally important CCSVI treatment trials. At the very least, such trials will pry scientific attention away from its current togmatic insistence that MS is strictly an autoimmune disease confined only to the central nervous system, and see it as a systemic problem with physical implications reaching beyond the brain and spinal cord. For far too long the autoimmune model of the disease has ruled the day, generating billions of dollars of profit as it turned the treatment of Multiple Sclerosis a hugely lucrative business, while at the same time generating tangible but limited benefits to patients suffering from the disease. Let these Canadian trials be a huge step towards a new understanding of the MS, one that will lead to its final eradication and an end to the suffering of millions of patients worldwide.