SASKATOON — The Saskatchewan government is putting its money where its mouth is by ponying up $5 million for clinical trials of a controversial multiple sclerosis treatment.
The province says the first step will be to establish an expert advisory panel on the so-called liberation therapy by early November and develop a call for proposals. It’s expected that a research team will be chosen early next year and a process leading to clinical trials will be announced by April.
Premier Brad Wall said in July that Saskatchewan would help pay for clinical trials despite a lack of scientific evidence that liberation therapy works.
Wall said that’s what the funding will help determine.
“People in Saskatchewan are spending a lot of their own money. They’re in some cases raising money through bake sales and getting support from friends and families to go to far away places to have this treatment done,” he said Tuesday in a phone interview from Saskatoon.
“What we’re saying in Saskatchewan is, those people, those patients and those families deserve some answers to find out if there is some real hope here for symptom relief and maybe something bigger.”
However, MS sufferers should not rush to line up for trials.
The province says until a research team has been announced, there is no list or requirement for patients to register their interest in participating. Neither the Ministry of Health nor the Saskatchewan Health Research Foundation will collect information about a patient’s future interest. That role lies solely with the successful research team.
The actual start of clinical trials will depend on the research team’s plan and timeline.
Provincial and territorial health ministers said at their meeting last month that liberation therapy is a top priority. Several have since set aside money for studies or future clinical trials.
Wall said Saskatchewan should be leading the way because it has the highest rate of multiple sclerosis among provinces.
“We understand there’s some controversy, but we’re prepared to take the next step with the research community helping us.”
Liberation therapy involves unblocking narrowed neck veins using a procedure called balloon angioplasty. The treatment was developed by Italian vascular specialist Dr. Paolo Zamboni. He has hypothesized that MS may be caused by a narrowing and twisting of veins that drain blood from the brain. It’s a condition he has dubbed CCSVI, or chronic cerebrospinal venous insufficiency.
Some patients have posted testimonials on websites, in chat rooms and in YouTube videos, saying the liberation procedure has reduced their symptoms.
Multiple sclerosis has long been viewed as an autoimmune disease, so Zamboni’s contention that it is caused by vascular anomalies has been hotly debated. Many medical experts are urging caution. Dr. Paul Hebert, a critical-care physician and editor-in-chief of the Canadian Medical Association Journal, has said that manipulating veins can be dangerous and there is no established link between venous blockages and MS.
The Multiple Sclerosis Society of Canada said Tuesday that it’s thrilled with the funding announcement from Saskatchewan.
“This will no doubt help the MS community come closer to the answers that everyone is yearning for on this important topic,” Yves Savoie, the society’s president and CEO, said in a phone interview from Toronto.
But Savoie also cautioned that there are no details yet about how the research team will be selected or how scientific rigour and independence will be maintained. Researchers also need a reliable imaging method to determine if a person’s neck veins are indeed blocked, he said.
“Knowing how to get a reliable image of the anatomical blockage that we are talking about ... is actually a fundamental building block to doing a trial to examine the potential efficacy of treatments to unblock the vessel,” said Savoie.
“At the end of the day, if you do a treatment trial to look at unblocking the veins, and you’re not sure of whether or not they’re blocked in the first place, you could bias your results.”