The federal panel that rejected the idea of an immediate clinical trial into an experimental vein procedure for Canadians with multiple sclerosis had several deficiencies that should be remedied in future panels, researchers say.
In September, the Canadian Institutes of Health Research (CIHR) and the Multiple Sclerosis Society of Canada released a review of evidence on unblocking veins to battle MS. The panel concluded it would be inappropriate to perform a clinical trial, a recommendation that Health Minister Leona Aglukkaq accepted.
Dr. Andreas Laupacis and Dr. Arthur Slutsky of Toronto's St. Michael's Hospital and the University of Toronto fault the panel's approach to the problem and its membership in an article in Wednesday's issue of the journal Open Medicine.
The panel did not include any advocates of the procedure, Laupacis and Slutsky said.
Their commentary calls on the CIHR to involve members of the public in "scientifically based but patient-relevant and emotionally charged issues" where science, advocacy and policy-making intersect.
Laupacis and Slutsky said the panel's approach to its membership was too narrow to fulfil its mandate of answering three questions:
- Do MS patients have a higher frequency of chronic cerebrospinal venous insufficiency, or CCSVI, the theory put forward by Italian doctor Paolo Zamboni that blocked veins in the neck or spine are partly to blame for MS?
- Does current evidence show that the benefits of vein treatment in patients with MS outweigh the risks?
- Should a publicly funded randomized trial of the treatment for MS be started now?
The risks of using stents to open veins in MS patients can be fatal, although rare.
Last month, CBC News reported on the death of Mahir Mostic, 35, of St. Catharines, Ont. Mostic initially improved after the treatment, then died in October in Costa Rica after a blood-clot complication, his vascular surgeon said.
Treatment trial option
"Would these patients [who travel to other countries] be better off, and policy-makers and the public better informed, if a randomized trial were conducted now?" the commentators wrote.
"If patients are fully informed about current doubts regarding the association of CCSVI and MS, as well as the limitations of Zamboni's non-randomized trial of endovascular treatment, and the potential side-effects of endovascular treatment, should they be given the opportunity of participating in a trial now?"
If there had been more public members on the panel, they likely would have raised these questions, the paper said. Also, the legitimacy of the report in the eyes of some people would likely have increased, the paper concluded.