The University of Saskatchewan has been in the Canadian spotlight recently for research into a potential multiple sclerosis treatment.
CCSVI, chronic cerebrospinal venous insufficiency, hypothesizes that MS is caused by blockages in veins in the neck. The treatment proposed by the Italian doctor Paolo Zamboni involves using angioplasty to unblock those veins.
Since Zamboni’s treatment was created in late 2009, some people with MS have spent thousands of dollars to travel to other countries to have the procedure.
Darrell Derkson, president and owner of J&A Heating, travelled to Sofia, Bulgaria, in July to have the treatment.
“It was at a point in my life where I had to make a decision,” said Derkson. “What was being offered in pharmaceutical drugs wasn’t making my MS stop.”
He reports feeling less fatigued, gaining an improved tolerance to heat and feeling less tension on his neck.
“Just by eliminating some of those symptoms I was able to function better,” he said.
Unfortunately, the treatment has also been surrounded by controversy.
On Sept. 1, the Canadian Institutes of Health Research and the federal government announced that they would not fund research into the liberation treatment, citing that any research would be unethical. The announcement was a disappointment to the thousands of Canadians suffering from MS who believe there is a link between CCSVI and their disease.
So if patients report positive results, why don’t the CIHR, the federal government and the MS Society of Canada support further research?
“To be frank, when a patient says that they feel better, to some extent, that’s a subjective evaluation,” said Dr. Allen Blackman, director of programs at the U of S School of Public Health. “If we put them through some kind of objective testing procedure we might not find [an improvement].”
Blackman says there simply isn’t enough evidence to support a link between CCSVI and MS, and to make matters more complicated, there’s a significant risk to the patient because Zamboni’s treatment is a surgery.
“If the researcher doesn’t actually believe that there is a good chance that an intervention would result in a benefit to the patient, it’s unethical to do the research,” he explained. “There is no expectation that this might actually work and therefore you can’t do the studies.”
But for someone like Derkson, who has been suffering from MS for 20 years and experienced relief from the treatment, this view is hard to swallow.
“They’re basically accusing me of faking my good fortune which is irritating,” he said.
While clinical studies of Zamboni’s treatment may not be on the horizon for some time, research happening right now at the U of S and the University of British Columbia will eventually provide some answers.
Both universities are currently studying whether there is a link between CCSVI and MS.
Funded by the Saskatoon City Hospital Foundation and the MS Society of Canada, the study will enrol 100 people in Saskatoon and 100 people in B.C. both with MS and control subjects.
A second study which is only happening in Saskatoon will enrol people 30 subjects, some with possible MS, some who definitely have MS and some healthy controls.
Sometimes science can be a slow process: the current studies may take up to two years to complete. In the meantime, any proposals to test Zamboni’s treatment must be reviewed by the CIHR and without further evidence, it’s unlikely CIHR will reverse it’s stand that any proposed research is unethical.
Both Saskatchewan and Newfoundland and Labrador have announced they will help fund any research into the procedure, but the promise of funding will do little good until researchers make a proposal.
“The more research that’s done that doesn’t involve taking a knife to human patients, the more research that’s done that suggests a link, the more likely a researcher has an expectation that this intervention might have a benefit,” said Blackman.
So despite a community of MS patients and their friends and family members desperate for a cure, and mounting anecdotal evidence that the treatment provides some relief, the scientific community in Canada will not move forward to test the treatment until more basic evidence has been confirmed.
Without the backing of the scientific community, the federal government will not fund the treatment.
Still, the current lack of evidence doesn’t mean MS patients should lose all hope. There is research on the go and Blackman says that in science there is never a definitive answer.
“There have been serendipitous discoveries in medicine,” he said. “It is possible that this treatment is in fact effective in spite of no evidence for it and in spite of no theoretical foundation for why it should work.”