The Actual Data from PREMiSe Do Not Support the Highly Publicized, Anti-CCSVI Claims and Warnings of the University of Buffalo Researchers, by Ashton Embry, DIRECT-MS, April, 2013

Quick Summary

The actual data from the PREMiSe Trial do not support the highly publicized claim that CCSVI correction by angioplasty is not of value for MS and may worsen disease activity. In sharp contrast, the data suggest that CCSVI correction may well be of substantial value for MS. The misleading claims made by University of Buffalo researchers are based on irrelevant data from the failed Phase 2 portion of the trial in which no one had their CCSVI corrected. The anti-CCSVI bias and baseless claims may be explained by the conflicts of interest.

Executive Summary

University of Buffalo (UB) MS researchers put out a press release and Youtube video with claims that the Phase 2 portion (controlled, randomized and double blind) of their PREMiSe clinical trial demonstrated that CCSVI correction (restoration of >75% venous blood flow from the brain) by means of venous angioplasty, was not of value for MS and was possibly harmful. An inspection of the PREMiSe data on the poster presented by UB researchers at the recent AAN convention in San Diego reveals the following

1) All the subjects in the open label, Phase 1 portion of the PREMiSe trial had their CCSVI was corrected (>75% blood flow restored by venous angioplasty). They had very good clinical results over the 6 months with no relapses and only 2 new lesions among the ten subjects.

2) The controlled and blinded Phase 2 portion of the PREMiSe trial was a failure because those receiving angioplasty did not have their CCSVI corrected (i.e. they did not have their blood flow restored to >75%).

3) Among the nineteen, Phase 2 subjects, all of whom did not have their CCSVI corrected, there were a total of 4 relapses and 20 new lesions.

4) The reason for the failure ofthe angioplasty procedure to
correct CCSVI in any of the Phase 2 subjects is unknown and is of concern because there was 100% success in Phase 1.

5) The failure of angioplasty tocorrect CCSVI in the Phase 2
patients means any comparison between the clinical outcomes of the angioplasty patients and sham ones has no scientific significance. Any detected differences between the clinical outcomes of the two groups are purely random and a consequence of the very small trial size and the acceptance of only persons with active MS into the trial.

6) The excellent clinical results of Phase 1 subjects, all of whom experienced CCSVI correction, compared to the adverse clinical results of Phase 2 subjects, none of whom experienced CCSVI correction, suggest CCSVI treatment may be of substantial value for MS.

An added complicating factor is that some of the researchers involved with PREMiSe are in a major conflict of interest in that they receive large sums of money from MSdrug companies. Because CCSVI treatment has the potential to replace drugtherapy in some cases, the compromised researchers and their drug company benefactors would potentially financially gain from a bogus claim that CCSVI treatment was of no value and might even be harmful.

The PREMiSe researchers launched a major media campaign
a) to claim their data showed that CCSVI treatment was of no value and may be of harm, b) to dissuade persons with MS from getting CCSVI treatment outside of trials, and c) to dissuade practitioners from doing CCSVI treatment. These claims and warnings are entirely baseless because of the lack of significance of the results from Phase 2 in which no one had their CCSVI corrected. They may have been motivated by the major conflicts of interest referred to above.

The University of Buffalo should retract the currently available press release and Youtube video and replace them with ones that contain the real story told by the data of the PREMiSe trial.

Read more/source: Source: http://www.direct-ms.org/sites/default/files/Embry%20Premise%20Evaluation%20April%202013.pdf