Kirsty Duncan PhD MP CCSVI IN CANADA: A CALL FOR SCIENCE AND CONSENSUS

‘THE CONTROVERSIAL MS TREATMENT’ Controversial MS treatment (15 M) Liberation treatment (20 M) CCSVI treatment (301 k) Treatment for CCSVI (296 k)

ADDRESSING THE BRANDING OF CCSVI TREATMENT Growing body of science regarding abnormal venous anatomy and MS patients, improvements in the quality of life of MS patients following the procedure, as well as the safety of the procedure Public polarization regarding whether or not CCSVI causes MS, and whether or not liberation is a cure for MS--rather than answering the fundamental question, regarding whether or not MS patients improve following the procedure? Public polarization serves no one; what is needed in Canada is science (i.e. clinical trials and a registry), and not mere opinion

CCSVI MUST BE SUBJECT TO THE SCIENTIFIC METHOD Opinion over evidence -’I think there are millions of dollars spent now to follow a hoax…If I thought for one instant there was substance to this, I’d be all over it (Freedman)’ Single studies that ‘disprove’ theory -’One can say that this provides absolutely no support whatsoever for that idea’, and casts aside ‘eccentric and maverick ideas’ Failure to collect relevant data -MS patients were left with no follow-up, and important data was lost post- procedure at one, three, six, twelve, and twenty-four months Willful ignorance of any qualitative and quantitative data -evidence from academic conferences was not sufficiently scrutinized, and qualitative data is now summarily dismissed as ‘anecdotal evidence’

CLINICAL TRIALS Provide funding for an ‘Adaptive Phase II/III trial’(i.e. clinical trials for the CCSVI procedure in multiple centres across Canada) -CIHR is currently recommending Phase 1/11 trial -Phase 1 is usually undertaken to assess safety; angioplasty is an accepted standard of care in Canada

100 RESEARCH QUESTIONS Venous system Venous system and MS CCSVI and MS CCSVI diagnosis CCSVI treatment Determining the best CCSVI treatment Possible impacts of CCSVI treatment on MS Patients CCSVI re-stenosis and diagnosis Secondary procedures for CCSV Prevention of CCSVI in the next generation

CCSVI DIAGNOSIS How do the results of MR compare with those of ultrasound for diagnosis of CCSVI? What is the best way to image the venous system, and venous pathology? What are the limitations of current diagnostic tools to image the venous system? Should intravascular ultrasound be used, and what are the benefits and the risks? What is the learning curve for the various diagnostic procedures, and what should practitioners undertake to become sufficiently accomplished? Can a standardized protocol be established for diagnosing CCSVI in MS patients, and when should MS patients be tested for CCSVI? Can a standardized system for describing lesions (e.g. type, location) be established? What should be the decision-making process regarding whether to treat or not to treat (e.g. anatomy, flow, etc)? Should arterial, venous and CSF flow be monitored, how often, and for what purpose?

CALL FOR CONSENSUS Need consensus among CCSVI groups Need consensus among CCSVI practitioners and researchers regarding working towards best practices in CCSVI diagnosis, treatment, follow-up care, and re- treatment based on evidence to date

THANK YOU Thank you to the doctors for their science, their compassion, and their courage to be pioneers Thank you for standing strong in the face of adversity— for doing science, and hoping that eventually evidence over egos, politics, and the various Government lobbies will prevail Thank you to those living with MS for your courage, your tireless efforts to help bring clinical trials to Canada... you inspire me every day