There is no doubt there has been intense world-wide focus on Dr. Paolo Zamboni’s hypothesis since his study in 2009 suggested “clinical improvement” in MS patients with narrowing of the cervical veins, otherwise known as CCSVI. The hope of the neck vein-widening “liberation therapy” was that full drainage of the central nervous system would be a single strategy to cure MS, or at least halt progression of the disease. With drug interventions available that merely mediate symptoms, and with so much to lose over time, thousands of MS sufferers have travelled far and wide to have this procedure as a potential therapeutic approach for MS management. Even though there was early symptomatic relief in most cases, many of these patients have not experienced long-term benefits after surgery. Almost inevitably, restenosis of the neck veins occurs at some point after the venoplasty, and patients may (justifiably) worry that evidence-based trials aren’t going to support their early intuition that expanding narrowed jugular veins is effective. MS sufferers and patient promoters who were hopeful of a new-found control over their disease, now lose hope with each new patient report of therapeutic failure over time.
It’s certainly too early to say whether this therapy has been helpful at all, but the results don’t look encouraging. Based on current trial interpretations and many anecdotal testimonies from patients, it is clear that whether or not CCSVI exists as a pathologic entity, efficacy of treatment cannot be substantiated even if there is an association between CCSVI and MS. That has not stopped patients from seeking this therapy. Each MS patient who has had CCSVI liberation therapy has spent a lot of personal money outside of insurance plan coverage, sometimes having the procedure done more than once. About 60-70,000 patients have paid hundreds of millions of dollars to get this done—not counting the costs of airfare and accommodations, as the therapy has only been available in far-flung locations. Many patients and a few persistent practitioners have a lot invested in the theory being correct and, in such circumstances, views become biased and objectives obscured.
What has happened over the past four years, and is still happening, is that some patients and patient-advocates who are active on social media sites are distorting the picture of the efficacy of the liberation therapy as a single MS management strategy. In continuing to promote the therapy, backers are simply picking out the few examples that have demonstrated success as so-called ‘evidence’. But, in science, the entire body of evidence must be represented and respected. Supporters of CCSVI liberation therapy have a theory that MS can be cured by simple neck vein expansion. But the theory weakens, with failure after failure that has shattered early optimism. So at some point, it’s important to look at all of the evidence and re-think the strategy because the theory has been challenged, and you can’t just discard some of the evidence and explain it away. Medical science is a process of continuous testing, and the outcome is not always going to be positive, especially when there’s already so much at stake. The promoters of the hypothesis as it is currently understood—as well as the practitioners—must soon admit that their interpretations and methods are flawed.
To those who maintain fixed beliefs and who continue to promote CCSVI liberation therapy as a single intervention strategy, we must ask this: Are you open to examining all of the evidence, or will you continue to focus only on patients and information that supports your own point of view?
Some of us are saying, “Let’s look again at this treatment in context and see how we can avoid making the mistakes we made in rushing to get this done.” There are lessons to be learned from what has happened, and the new debate should be about what really makes this therapy more effective and long lasting, because we can clearly see that there is a connection between the vascular pathology and the disease. Many symptoms of MS do go away as long as the veins remain fully open.
With something as new as CCSVI liberation therapy, I think it’s wise to re-examine the hypothesis and ask ourselves if we’ve understood it properly: have we got it right? Through clinical trials and other types of medical research, we will always be getting new information, shifting perspectives, and discovering new data that helps us put other pieces of the puzzle together. This is true of all medical science. What happened in the past helps us understand the way forward in the future. The more we think we know, the more helpful it is to realize what we don’t know. While we believe we are on the right track with free flowing drainage of the central nervous system, perhaps the solution to a permanent cure for MS is more complex than popping a balloon in a weakened vein and hoping for the best.