Death knells and coffins...

Death knell for CCSVI!---Another nail in the coffin---
Goodbye to all that; a short history of CCSVI---
CCSVI debunked!---The end for CCSVI

If all you read were the headlines, you might think that CCSVI was nothing more than a scourge, a fantasy, a vampiric spector that science has, thankfully, stabbed through the heart and removed forever.
It's over. Move along, people.  Nothing to see here.

But there is much more going on.

This week, a paper published in a neurological journal showed
"severe extracranial venous anomalies that signficantly impaired normal outflow from the brain" occur in some people with MS.
The full paper, in a provisional pdf, can be viewed here for free:
http://www.biomedcentral.com/content/pdf/1471-2377-13-151.pdf

These scientists do not think CCSVI is over.  They're still finding it.

Jeff and I know all about these extracranial venous anomalies that significantly impair the flow of blood from the brain to the heart.

Four and a half years ago, Jeff and I saw that very same problem happening in his body.  We were astounded at the MRV images on the computer screen in his doctor's office, which showed slowed collateral circulation and two malformed, stenotic jugular veins.

I put up an image from his magnetic resonance venography on an MS Forum.

And in doing so, poked a hornet's nest.

You can see in this MRV picture on the left from Stanford, Jeff had no jugular flow on the left side (right on pic), and reduced flow on the right.  This is evidenced by the collateral veins that are lit up like Satan's curly fries.  This is not normal.
What you should see are straight and open jugular veins, that look like drinking straws.  Like the picture on the right.  Can you see the difference???  Well, our doctor saw the difference, and we decided to treat Jeff's venous malformation.



In fact, both of the images were taken at Stanford University, by one of the premiere vascular specialists in the world.  He and his radiology team would later publish a paper on what healthy normal venous MRV looked like, compared to people with MS.  He believes that the kind of collateral circulation and pulsatility found in pwMS could well be damaging to the brain.  Here is one of his papers on this.
http://www.ajnr.org/content/33/8/1615.abstract


When Jeff's jugular veins were opened up, the collaterals went away, his cerebral blood flowed through his jugular veins in a timely manner, no more pulsatility.  And Jeff's brain has healed.  No MS progression.  His gray matter looks normal on MRI.

It's hard not to wonder what would have happened if I had simply taken the research to Stanford, where Jeff was treated, and then gone home to live out our days.  But I was part of an online MS forum, and we'd been sharing information between pwMS and caregivers.  In fact, that was how I first read Dr. Zamboni's published papers.

Maybe the research would have progressed more readily without patient involvement.  Maybe the scientific community would have been more accepting of Dr. Zamboni's research, without the media and patient spotlight.

But I doubt it.
And anyway, there's no going back.
I'm sorry for the way neurologists have used patient advocacy to prevail against the science.... but I'm also not sorry.  Because I got my energetic, brilliant husband back.  And he no longer has heat intolerence, sleep apnea, or crippling fatigue.  No MS progression.  He's still working more than full days, jogging, biking and living.

CCSVI exists.  It impairs blood flow from the brain.  It may not affect everyone with MS, and it may be present in normal people.  It's showing up in other neurological diseases.  There is great debate as to how it should be treated.  Jeff's doctor used stents, others have replaced veins, ballooned, used cutting balloons--others believe lifestyle and exercise may be enough, or antibiotics might help.  There is no agreement on the best course of treatment, and that has created confusion and controversy.

It's also clouded the fact that there are newly discovered and very obvious venous problems related to neurological disease.  

CCSVI exists.
How it is best treated will be debated, but this exploration is not even close to being over.
Joan

A simple question for BNAC

April 17, 2013 at 12:22pm

I have a very simple question for BNAC-- and the researchers, patient advocates, participants and supporters of the PREMiSe trial.

Why did you report on patient results of Phase 2 when, by your own admission, you didn't improve CCSVI, your endpoint was not met, and the venoplasty treatment was a failure? 

• In phase 2, improvement was observed also in treatment (p=0.02) and sham (p=0.04) arms at month 1 but did not reach >75% restoration of the venous outflow compared to baseline. No differences in VHISS improvement (Venous Hemodynamic insuffiency Severity Score) were detected between phase 2 treated and sham groups (p=0.894).

Here is the full poster, which shows that Phase 2 did NOT reach the end point of venous restoration.  Note, there has never been a published paper in a journal, just this poster.

http://www.hubbardfoundation.org/CCSVI_key_scientific_papers.html

If you did not correct CCSVI, and the venous insufficiency score of the treated patients was the same as those who were not treated, how can you use any of the phase 2 data?  

Doesn't that mean your venoplasty treatment was a failure?  

++++++++++++++++++++++++++++++++++

How can you report on any of the EDSS data, relapse data, or new lesions data if the treatment did not correct CCSVI?

According to your study outline, the end point for venoplasty "success" was  >75% restoration of the venous outflow compared to baseline. 

And you achieved this in the unblinded phase 1 part of the study!  

So we know it's possible.
Here is the PREMiSe trial booklet for participating patients, where you list the endpoints.
http://www.bnac.net/wp-content/uploads/2011/05/patient-forum-5-7-2011.pdf

However, you did not achieve greater than 75% restoration of venous outflow in phase 2.  

Phase 2 was a failure.  And this fact should negate your results.  

Yet you reported on the failed treatment outcome of these patients to the world media.  You made videos, press releases and public statements based on a failed study and a poster.  

You NEVER once said the treatment didn't address their CCSVI.  You made it seem like the venoplasty was to blame for worsening MS, higher EDSS and lesions.  

But that's not true, because your ineffective venoplasty treatment left these poor people with the exact same venous insufficiency.  

You did nothing to relieve their CCSVI.