POLITICS, SCIENCE, ANDEVIDENCE:THE ROLE OF SOCIAL MEDIAIN SHAPINGSCIENCE POLICY IN THE CCSVI/LIBERATIONTHERAPY DEBATEDaryl Pullman, PhDProfessor of Medical Ethics
Guiding question:• Is the Canadian experience with CCSVI exceptional (inthe sense that something similar is unlikely to occur againin the near future), or is it a harbinger of things to comewith regard to how citizen‘s (and by extension, politicians)engage directly in setting the science and health policyagenda?CADTH May 2013 2
Multiple Sclerosis• MS is a neurodegenerative disease involvinginflammation and degeneration of myelin, the protectivecovering around nerve cells in the brain and spinal cord• Common symptoms:• Visual disturbance, speech problems, numbness, pain, loss ofbalance, loss of coordination, bladder and bowel problems,stiffness, weakness, paralysis, fatigue• No consensus about the cause :• Often characterized as an autoimmune disorder• Other potential causes include: toxins, environmental triggers,vitamin D deficiency, infectious agents, genetics, vascularabnormalities (CCSVI)CADTH May 2013 3
CADTH May 2013 6Nov 21, 2009CanadianMediaResponse―It was not your typical90 second TV newsstory, but a 30-minutedocumentary, monthsin the making. Thestory focused onZamboni‘s work andthe timing of thedocumentary waspegged to thepublication of hisresearch in a peerreviewed journal . . .‖.A. Picard
CADTH May 2013 9At what point is science more important thantreatment? W5 investigates, interviewing doctors whourge patients to slow down; patients who are movingahead and seeking treatment, and presents theshocking revelation that the CCSVI treatment for MSwas proposed by an Austrian doctor more than twentyyears ago – but his research proposals were rejectedout of hand by MS experts who summarily declaredthere was no link between the disease and blocked ornarrowed veins . . .April 6, 2010
The scientific/political ―measured‖ response . . .• In the absence of clear and convincing evidence for CCSVI, theperformance of an interventional venous angioplasty trial with itsattendant risk to MS patients is not appropriate at this time.CADTH May 2013 10Recommendations1. Effective immediately, establish a scientific expert workinggroup made up of the principal investigators of the seven MSSociety-sponsored studies (four from Canada and three from theUS), scientific leadership from CIHR and the MS Societies, and arepresentative from the provinces and territories, to monitor andanalyze preliminary and final results from these studies, as wellas from related studies from around the world related to venousanatomy and MS.Chair: Alain Beaudet—President CIHR
CIHR/MS Society Expert Panel• Membership included PIs of seven studies carefullydesigned to examine various aspects of the CCSVIhypothesis (4 Canadian; 3 U.S.)• Several sent sonographers for training in the Zamboni technique• Panel functioned mainly as an oversight committee for the7 studies in order to assess the emerging evidence withregard to the CCSVI hypothesis• Solicited additional information from outside sourcesCADTH May 2013 11
Various provincial responses . . .CADTH May 2013 12$700,000 (3 yrs)tracking registry$1 million (3 yrs)observational study$400,000observational study• $5 million for clinical trials (Oct 2010);$5 million match from Manitoba &$250,000 from Yukon• SHRF decides not to fund any projectsJan. 2012--Premier Wallannounces $2.2 million soSask residents can participatein clinical trail in Albany, NY
Expert Panel Meeting—June 28, 2011• Updates on 7 on-going studies• Most had not yet completed enrollment• Brief report on a small study of autopsies conducted on 7MS patients that indicated possible venous abnormalitiesin some• Systematic review of 8 previous studiesCADTH May 2013 13
CADTH May 2013 14• Analysed 8 studies• The combined results indicated anassociation between CCSVI & MS• However, significant heterogeneityamong the studies (e.g. prevalence ofCCSVI in MS patients varied from 0%to 100%) suggests the performance ofultrasonography to detect CCSVIvaried greatly between the studiesFox, CMAJCommentary
CADTH May 2013 15June 29, 2011At yesterdays meeting, experts discussed the sevenongoing studies looking at CCSVI and linkages toMS, and reviewed scientific reports that are presentlyavailable. Based on this information, Dr. Beaudet hasadvised me that there is unanimous agreement thata clinical trial should proceed at the Phase I/II level.
CADTH May 2013 18Feb 29, 2012―CIHR put a political process inplace instead of a scientificprocess. Evidence was beingwillfully ignored from theliterature, from scientificconferences, and from returningCanadians treated forCCSVI.‖—Kirsty Duncan, MPA politician accusesscientists of playingpolitics . . .
CADTH May 2013 28― . . . the process by which ‗evidence‘ ismanufactured may be changingirrevocably.As the Canadian experiencewith CCSVI illustrates . . . the advent ofthe internet and social media mean theivory tower of academia might bestormed at any moment by aninterested, enthusiastic, and motivatedpublic. Researchers and clinicians mustlearn how to utilize these resources toensure that the message that emergesis both balanced and informed.‖