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.

I will put this in simple, plain English, in the hopes this question might be asked and answered.  Please share this, everyone.

BNAC, you admit that you did not correct patients' CCSVI.

Therefore, using your own end point standards, your trial was a failure.  

How can you use the data from Phase 2 to prove anything about venoplasty for CCSVI?

The PLACEBO GROUP had a better outcome in their venous insufficiency severity reduction after one month.  The treated group went from a 6 to a 5.5 in venous insufficiency severity.  This shows that they were not treated correctly.  Venoplasty should LOWER the VHISS number a few points, as it did in phase 1.

But phase 2 was a failure.  The patients in phase 2 did not have their CCSVI corrected.

Why didn't BNAC simply say, treatment didn't improve venous hemodynamics?  It didn't change CCSVI.  In phase 2, our venoplasty treatment protocol didn't work.

I know I'm not alone in hoping for an answer,

Joan