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 treatment trial was a failure?
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• 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:
http://www.hubbardfoundation.org/CCSVI_key_scientific_papers.html
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I have added the picture of the chart that showed the failure of treatment to correct venous insufficiency below. Scroll down to view.
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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?
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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 acheived 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 acheive greater than 75% restoration of venous outflow in phase 2.
Phase 2 was a failure. And this fact negates your data.
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.
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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?
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Here is the chart which shows the failure of the treatment. Notice that the phase 1 patients (the ones with the sold line that drops down) had a LARGE reduction in their VHISS number---this shows that their venous insufficiency was treated correctly by venoplasty. They went from a 6 in VHISS severity to a 3 within a month. This shows a reduction of CCSVI. These patients did quite well...with reductions in symptoms and EDSS. But BNAC did not mention phase 1 in their PR.
Then, in phase 2, the PLACEBO GROUP had a better outcome in their VHISS 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
