Sunday, January 17, 2010

CCSVI- Is this the calm before the storm?

“With most men, unbelief in one thing springs from blind belief in another.”
  - Georg Christoph Lichtenberg

sideview Image from CCSVI as a Cause of MS

I’ve been living with multiple sclerosis for over 8 years, but I’ve never seen anything captivate the MS community quite like Chronic Cerebrospinal Venous Insufficiency, or CCSVI.

This theory hypothesizes that the string of events in a person’s life which results in their having MS does not begin with an autoimmune response, as has been the generally accepted notion for many years.  The apparent autoimmune response is instead an overzealous immune system reaction to iron deposition in the central nervous system (CNS).   

The iron deposits come about because of low and irregular blood flow leaving the CNS through two types of veins- the internal jugular veins and the azygos vein (I’m getting close to a root cause here, so stick with me).  The poor blood flow is caused by various abnormalities, called stenosis, in these veins. Is MS really, at its core, a plumbing problem?  Wouldn’t that be something. 

For more details about CCSVI please read my previous post, watch this CTV video, or look over this Facebook page.

This concept has such upside potential that I find myself temporarily disinterested in all other MS research. For the moment, everything else is just so much background noise to me.

Dr. Paolo Zamboni of the University of Ferrara (Italy) conducted the basic research and coined the term CCSVI, and also designed an angioplasty treatment for the affected veins which he aptly named "The Liberation Treatment".  If his theory stands up to scrutiny, he’ll become our Jonas Salk. But his analysis has yet to be independently verified. In the medical research community, nothing counts as legitimate research if it is not verified by at least one other source, preferably several other sources. If we are lucky, the first independent verification is only weeks away.

The Buffalo Neuroimaging Analysis Center (BNAC), a branch of the University of Buffalo Medical School, has completed phase 1 of a study, looking at 500 patients, which attempts to correlate CCSVI with MS. Plans are to continue with phase 2 of the study, looking at an additional 1200 patients. To prove a correlation, BNAC must show that most MS patients have CCSVI, and that most healthy people do not. Their phase 1 report is expected in early February. That’s getting close.

Although this study will attempt to prove correlation between the two conditions, it will not address the issue of causation. Therefore, even if a strong correlation is indicated, the questions will remain- is it CCSVI that causes MS, is it MS that causes CCSVI, or is there another condition that causes both? Furthermore, BNAC will not address treatment options for CCSVI, although others such as Zamboni, Dake, and Simka have made progress in that area. The BNAC study’s scope is quite limited, yet its results may turn the MS world completely upside-down.

I’m not privy to any information about what the BNAC results will look like.  The data could demonstrate no correlation between CCSVI and MS. If this happens then CCSVI won’t be dead, but it will lose much of its luster (I’ll start looking at the other MS research once again, for example). The study results could be mixed- many MS patients could have CCSVI but not most. That scenario would call for more study. But the most intriguing scenario, although not necessarily the most likely, is that the BNAC study will confirm Zamboni’s work and document a strong correlation between CCSVI and MS. If that happens, the period of relative calm will be over, and the storm will commence.

If the BNAC study debunks this whole concept, I may have a future blog post entitled “CCSVI- how were we so easily fooled?”  But frankly, that outcome is just not very interesting to think about.  For now, let’s consider what the MS world would look like if Zamboni’s theory is confirmed by the BNAC study. 

Regarding CCSVI, and so many other things in life, there are two groups of people: boxers and briefs, democrats and republicans, supporters and detractors. In this case I’ll call them the Go Faster Group and the Take Our Sweet Old Time Group. Those directly affected by MS will see positive news from BNAC as justification to immediately accelerate medical activity in this area.  Those involved in MS, but perhaps in a less personal way, may prefer a more cautious and deliberate course instead.  

Who will comprise the Take Our Sweet Old Time Group?
Traditional (numbers driven) research statisticians
Traditional medical professionals
Traditional MS organizations
Insurance companies
Guardians of the status quo, such as Big Pharmaceutical (who makes millions of dollars a year on the assumption that MS is primarily an autoimmune disorder)
What will the position of the Take Our Sweet Old Time Group be?
  • Correlation does not prove causation. Before anyone gets too excited, and certainly before anyone takes drastic steps like spending money on diagnosis or treatment of CCSVI, we need further study to confirm that CCSVI actually causes MS, rather than the other way around. This could take years.
  • It is too early to start lining up patients for risky treatments. Any treatments must be part of carefully monitored clinical trials. If patients are harmed, then lawsuits could ensue.
  • We have a good stable of drugs currently approved by the FDA for use by MS patients. This is not the time to abandon those proven treatments.
  • There are only so many neurologists (traditional MS doctors) and vascular surgeons (potentially new CCSVI doctors). If we don’t move slowly these doctors will be literally overrun with requests for diagnosis and treatment. We need to prevent chaos. We must control events, by proceeding deliberately.
None of these plodding scientists and administrators will themselves be suffering from the ravages of MS. None of their central nervous systems will be melting away a little bit each day. None of them will be on the brink of crushing, permanent, and total disability. If they were experiencing these things, they would belong to the second group.

Who will comprise the Go Faster Group?
MS patients, their close family and friends
Sympathetic or forward thinking medical professionals
Sympathetic or forward thinking MS organizations
Sympathetic or forward thinking researchers
What will the position of the Go Faster Group be?
  • If time were not an issue, we would agree that more data is needed. But we don’t enjoy the luxury of time. Every minute spent on further proving the theory before acting on it means more irreversible, permanent damage to our central nervous systems. For some patients, time wasted means the difference between walking and not walking, seeing or not seeing, even living or not living.
  • There are well thought out models of how CCSVI might cause MS. Nobody has presented a theory of how MS might cause CCSVI. If it quacks like a duck, it almost certainly is a duck.
  • The standard models used for approving new treatments are inadequate here.  This is a special case- a revolutionary idea. We need to break the mold so that we get treatment to as many people as possible, as quickly as possible, while still managing the risks to patients.
  • The status quo is not acceptable. Today we have a bevy of treatment options, all of which involve sticking a needle into our bodies and injecting designer pharmaceuticals. These treatments have had marginal success in slowing down the disease, have caused any number of horrible side effects up to and including death, have cost us outrageous amounts of money, and have garnered huge profits for the pharmaceutical companies. Furthermore, these treatments don’t work at all for large subsets of the MS population (my subset, for example).
    Hence, the gathering storm, which I reference in the title of this post. The Take Our Sweet Old Time Group will have their foot on the brake pedal, coasting warily toward the eventual solution.  The Go Faster Group will have their foot firmly planted on the gas pedal, racing toward a destination nobody even knew existed, trying to get there before it is too late.  When met with resistance, the Go Faster’s will become loud, obnoxious, belligerent, and indignant.  At least I hope they will. 

    But it doesn’t have to be this way. If we partner with visionary leaders from governments, the MS patient community, and the medical community, we can create a system that balances the needs of all parties, and still gets help to chronically ill people as quickly as possible.  For example, there are at least two diagnosis and treatment studies waiting in the wings- one at Stanford University and the other at the University of British Columbia.  But clinical trials like these will only address hundreds of patients at a time.  We’ll need to treat thousands of patients at a time.   

    I don’t know what the BNAC data will show when released in early February. I won’t even hazard a guess.  But if CCSVI is proven, and I am diagnosed with this condition and treated for it, how will I feel? I'll feel like I just woke up from a horrible nightmare.


    1. Interesting prognostications!

      An update from NMSS on 1/7/10 - - indicates that they will begin funding new research July of this year after reviewing proposals.

    2. I so appreciate your thoughtful, deliberate approach to explaining this. I especially appreciate the emotions expressed in your closing sentences.

    3. Hoi Mitch,
      Great post, well written and well explained.
      The best and clearest explanation I have read.
      Like Judy I too appreciated your emotions in the last sentence.
      Hope we get to wake up from 'this nightmare'.
      Keep warm and dry.
      Hope you have a good Monday.

    4. Darren,

      Thanks for posting that link. I know that the Canadian MS Society is also funding CCSVI research.

      Judy and Herrad,

      I'm glad you find my explanation helpful. I was worried that I was blabbing on too long. There is so much that I didn't mention though, like the 200 or so patients around the globe who have had procedures done to correct CCSVI, and other researchers like Dr. Mark Haacke in Detroit who are doing such great work.

    5. Glad you left a comment on my ms blog so I could find your blog. An interesting read from a perspective I understand!

    6. Lee,

      I'm glad you could stop by. Things may get very interesting in the coming weeks.

    7. Mitch--Great post! I have been out of the blogging loop for a while because of frustrating personal setbacks--no excuse offered here--but I have to admit I came very close to giving up. Yikes what a bad idea! I am back paying attention again--whew--dodged that bullet. Can't wait to see how this turns out. Cheers.