Welcome! This blog contains research & information on lifestyle, nutrition and health for those with MS, as well as continuing information on the understanding of CCSVI and cerebral hypoperfusion. This blog is informative only--all medical decisions should be discussed with your own physicians.

The posts are searchable---simply type in your topic of interest in the search box at the top left.

Almost all of MS research is initiated and funded by pharmaceutical companies. This maintains the EAE mouse model and the immune paradigm of MS, and continues the 20 billion dollar a year MS treatment industry. But as we learn more about slowed blood flow, gray matter atrophy, and environmental links to MS progression and disability--all things the current drugs do not address--we're discovering more about how to help those with MS.

To learn how this journey began, read my first post from August, 2009. Be well! Joan

Wednesday, April 17, 2013

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.

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



No comments:

Post a Comment