Research Ethics Blog

Canadian Working Group Recommends Against Funding for Controversial MS Trial

By Nancy Walton

On August 2nd, we blogged about the controversial treatment for MS, called the “liberation procedure”, created by Italian neurosurgeon Paolo Zamboni, who has theorized that MS is caused by a narrowing of the veins that drain blood from the brain, a condition known as chronic cerebrospinal venous insufficiency (CCSVI). His procedure, which is basically a venous angioplasty, opens up the veins allowing for better drainage and, according to his studies, helping to cure MS. The link that he has claimed exists between CCSVI and MS is highly controversial.

Across Canada, provincial governments are trying to decide if they will help fund clinical trials to further test the procedure for patients with MS. Saskatchewan (the province with the highest prevalence of MS) has confirmed that they will support fund clinical trials of the procedure but so far, there are no commitments from other provinces one way or the other.

But now, a working group from the Canadian Institutes of Health Research and The MS Society of Canada have unanimously recommended against supporting clinical trials of Zamboni’s procedure in Canada, according to a CBC news story this morning. They have recommended that a Canadian/US working group be formed to analyse outcomes from CCSVI studies elsewhere in the world and over time, make further recommendations about pursuing research on the link between CCSVI and MS before forming conclusions about the validity of the treatment.

Here’s a link to the story: Experts urge rejection of MS therapy trial

In a Globe and Mail report on this story, the president of CIHR is quoted as saying,“There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed ‘liberation procedure’. There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is a link between blocked veins and MS.”

There have been no independent replications of Zamboni’s work (which has been criticized from a methodological standpoint). Claims about the success of the procedure are anecdotal and these claims, as the CBC story notes, are motivating patients to spend thousands of dollars seeking the procedure elsewhere. What is unknown is whether the procedure is being offered elsewhere as part of a trial or as a therapeutic/curative intervention for those who might be willing to pay for it and travel to get it.

This will be an interesting story to follow. Tomorrow the Health Minister Leona Aglukka will hold a press conference to comment on the recommendations of the working group.