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.

BNAC research : A Tale of Two Studies

March 27, 2013 at 2:43pm

There have been two venoplasty studies undertaken by the University of Buffalo and recently released/publicized.  I thought it might be good to compare them, side by side.  Because the conclusions and results are worlds apart, and there needs to be an explanation.

Dr. Robert Zivadinov is the lead investigator in both studies.

PREMiSe Study Phase #1  Cine/CSF Study  

Published in the Journal of Vascular Radiology March 2013

No publicity  

Discussed at International Society for Neurovascular Disease Conference

http://www.ncbi.nlm.nih.gov/pubmed/23523158

PREMiSe Study Phase #2

Poster/Publicity at American Academy of Neurology  March 2013

Press conferences, videos, lots of news coverage all over the world.

http://www.buffalo.edu/news/releases/2013/03/021.html

Both are Venoplasty studies in mainly RRMS patients.  

PREMiSe study phase 1--Dr. Robert Galleotti, treating IR 

has worked with Dr. Zamboni for many years, has treated hundreds of CCSVI patients

an expert in venoplasty for CCSVI.  Venous drainage is improved >75%

"Improved venous parenchyma drainage"  Lower number of lesions on MRI for treated patients, less relapses.  

More studies are warranted!  PTA is good for the brain.

PREMiSe study phase 2-- Dr. Adnan Siddiqui, treating IR, relatively new to CCSVI venoplasty
Venous drainage is NOT improved to marker of >75%.  In fact, it is only improved to 50%!  (meaning treatment was a failure!!!)

 Headlines read, Liberation Therapy may make MS worse!

Nine patients treated, showed 19 new lesions on MRI.  PTA is bad.

 "more sizable changes in venous outflow [were] associated with increased disease activity primarily noted on MRI,"  Dr. Zivadinov and his colleagues concluded.

How are we to know what to believe? 

Is venoplasty helpful or harmful?  Is this about experience in the treating IR?  

Is this about how research is framed for the different audiences of vascular vs. neurological conferences?  

If phase 2 of PREMiSe did not reach a restoration of <75% venous flow, as it was supposed to....is this trial a failure?  

Because one study shows the venoplasty for CCSVI reduces lesions, relapses and improves CSF and venous drainage when flow is restored to <75%.

while the other study shows the exact opposite.

Which is the truth?

Does anyone want to answer this?

Joan

Cerebrospinal Fluid (CSF) and CCSVI

   March 14, 2013

Researchers at BNAC discover that venoplasty increases the rate of flow of CSF in the brains of those treated with for CCSVI.  CSF flow continues to improve a year after treatment.  

http://www.ncbi.nlm.nih.gov/pubmed/23523158

CSF and CCSVI will be the focus of an upcoming roundtable discussion, hosted by CCSVI Alliance in New Orleans this coming April.

http://events.r20.constantcontact.com/register/event?oeidk=a07e760jpn3867c9dc5&llr=pflw7ieab

Most of us are familiar with cerebrospinal fluid as it is used in the diagnosis of MS.  A lumbar puncture (or spinal tap) removes some of this liquid from the spine.  If there are specific markers in the fluid, called oligoclonal banding, it is a sign that myelin is degrading in the central nervous system, and indicative of MS.

CSF is vitally important to brain health. We've know that CSF is part of the equation in blood flow in CCSVI.  In fact, Dr. Zamboni noted that the severity of CCSVI was related to altered CSF flow in this study: 

http://www.ncbi.nlm.nih.gov/pubmed/20018140

Most of the published CCSVI research is focused on measuring blood flow.  But the brain and spine are unique in the body, in that CSF factors into blood volume in the central nervous system.

I first wrote about CSF on the forum This is MS in 2009--because I'd returned from Bologna and heard a neurologist discuss how he found parallels in CCSVI venoplasty and shunting for normal pressure hydrocephalus (NPH). 

 http://ccsviinms.blogspot.com/2012/11/normal-pressure-hydrocephalus-once.html#more

I wanted to explore this topic, because we are going to hear more about the importance of CSF flow in the coming months.  There are some very exciting developments happening right now in CCSVI research, and they involve CSF flow. 

Cerebrospinal Fluid has four very important functions for the brain.

1. Supports the brain.  The weight of the brain is suspended in cerebral spinal fluid.

2. Protects the brain.  By providing a cushioning space around tissue

3. Cleanses the brain.  Rinses metabolic waste through the blood brain barrier and out through venous bloodflow.

4. Maintains perfusion level of the brain. CSF is self-regulating, and lessens volume when there is a problem with perfusion.   When CSF levels increase, perfusion (cerebral blood flow) of the brain decreases.