The Alberta government is hoping a new study announced Wednesday will help them get a better idea on whether or not a controversial multiple sclerosis (MS) treatment should be offered in the province.
Health Minister Gene Zwozdesky announced from Calgary the province will fund a $1-million Internet-based observational study on MS to determine if it should move ahead with clinical trials for liberation therapy.
Zwozdesky said the participation of MS sufferers will be key to making sure the study — known as The Alberta Multiple Sclerosis Initiative (TAMSI) — gets off the ground.
“We’re encouraging Albertans with MS to please, please sign in and help us find the information needed to help us move to the next steps. This is so critical.” Zwozdesky added he was spurred into action on MS and liberation therapy after a meeting of provincial health ministers in Newfoundland last year.
The study will last three years, although researchers will be reporting to the government quarterly and preliminary results could be made available in a little over a year.
At six-month intervals, respondents will be asked to report indicators such as their level of fatigue or their quality of life on a sliding scale.
“It is a lot more than a questionnaire, but the questionnaire is the beginning,” said Dr. Luanne Metz, Calgary MS clinical director and TAMSI lead researcher.
Metz added there are fail-safes built into the survey to ensure the data collected is complete and accurate.
“They must provide us with an Alberta Health Care number so we will be confirming that participants are actual real people, that they actually have multiple sclerosis,” she said, noting researchers will also be checked against Alberta Health Services administrative databases, which would indicate whether or not they have been diagnosed with MS.
Approximately 11,000 to 12,000 Albertans suffer from MS with 700 new cases diagnosed in the province each year.
Liberation therapy was only developed in recent years by Dr. Paolo Zamboni, a professor at the University of Ferrara in northern Italy. In some cases, tiny balloons are inflated inside the veins in the chest and neck leading away from patients’ brains, while other practitioners use stents designed to hold the veins open. The intent is to clear blockages and twists in veins believed to be related to MS, known as chronic cerebrospinal venous insufficiency (CCSVI).
While liberation therapy has not yet been approved in Canada, many MS sufferers have been fighting for it and some have even travelled to the United States or overseas for treatment.
“The people who have undergone the Zamboni treatment and called me, called some of our other doctors, have come forward with overwhelming accounts of improvement to their mobility and general quality of life,” Zwozdesky said. “While these testimonials are a joy to hear, we also hear the other side, people who have suffered and had adverse effects.”
Two Canadians have died after undergoing liberation therapy. Maralyn Clarke, 56, of Calgary had the treatment in April at a private clinic in California and, after complaining of a major headache, went to sleep and couldn’t be woken. She was later admitted to an intensive care unit with bleeding in her brain and spent several days on life support before dying.
In the fall of 2010, 35-year-old Mahir Mostic of Niagara Falls, Ont., died after undergoing a procedure in San Jose, Costa Rica, where doctors inserted a stent into one of his veins.
Metz said Alberta’s study isn’t out to prove or disprove anything about liberation therapy.
“This survey is … to give a description of what is happening,” she said. “I think it’s really important that people who are hesitant recognize they’re safe in this. Their information will be private and we really want to delve down and look at the differences between the treatments.”
The federal government announced in late June it would fund clinical trials. The province has already earmarked $6 million to $7 million for its own clinical trials.
Neil Pierce, president of the MS Society of Canada, Alberta and Northwest Territories Division, said he was excited to see what new light the study would shed on MS treatment.
“This is the only way we’re going to be able to advance our knowledge, [by] using the experience of those people who have had the treatment and also those who haven’t had the treatment, so they can make informed choices,” he said.
Potential respondents can sign up for the survey at www.tamsi.ca.
