SASKATOON – A Saskatoon man is going to the U.S. to see if he can take part in a clinical trial of the so-called liberation treatment for multiple sclerosis.
Andrew Dahlen is the first Saskatchewan resident to go to Albany, N.Y., for the final eligibility screening in a two-year, double-blind clinical trial.
“I think the possible benefit will outweigh the real risks of it. I’m certainly terrified for going but I’m more excited, so I’m not really too concerned about the risks,” Dahlen said Thursday.
The province is putting up $2.2 million to have 86 Saskatchewan patients take part in the trial.
All prospective participants are first screened by a neurologist to ensure they meet eligibility requirements. A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment.
Candidates then spend several days at Albany Medical Centre, where a final assessment determines whether they will be accepted into the trial.
The nature of the double-blind study means half of those participating will receive liberation therapy and half will get a placebo procedure.
Dahlen, 28, is optimistic.
“In any scientific test there has to be a control group, so I’m thinking even if I do just get the placebo effect it will still have some good research,” he said.
With a population slightly more than one million, Saskatchewan has some of the highest rates of MS in the country. An estimated 3,500 Saskatchewan residents have the illness. Canada’s rate of MS is among the highest in the world at 240 per 100,000 people. On the Prairies, the rate is 340 per 100,000 people.
The treatment is based on a hypothesis by Italian vascular surgeon Dr. Paolo Zamboni that a condition he dubbed chronic cerebrospinal venous insufficiency, or CCSVI, may be linked to multiple sclerosis. The theory suggests that narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation. Liberation therapy involves opening up blocked neck veins.
The procedure is not offered in Canada and some patients have travelled around the world to seek it out.
Saskatchewan patients in the Albany trial will get followup care back home – something that hasn’t been available to people who paid for liberation therapy in other places. That has frustrated MS patients. One Regina man has gone so far as to say that his wife died in July because she couldn’t get followup care in the province.
However, Saskatchewan Health Minister Dustin Duncan said that will change.
The College of Physicians and Surgeons of Saskatchewan has approved an application to allow physicians at Radiology Associates of Regina to provide Doppler ultrasound to patients who have received CCSVI treatment outside of the country.
It’s not an insured service, so patients will have to pay for the diagnostic procedure out of pocket.
Duncan said the change is not a direct reaction to the death of the Regina woman.
“We wanted to make sure that those patients that have chosen or … that aren’t chosen as a part of this trial, but want to pursue therapy outside of Saskatchewan and outside of Canada, that when they come back … they have the ability to have followup care in Saskatchewan,” he said.
“There was a physician that wanted to provide that care and it took some time to work through the approval process through the College of Physicians and Surgeons, but that has now finally been approved.”
Dahlen, who was diagnosed with MS six years ago, said he has spent the last two years trying to raise money to have liberation therapy in California.
He’s hoping to stop the progression of the disease.
“I started my life being left-handed and now I’m right-handed, so that was a big step. And I used to play a lot of music. Now I can’t play guitar any more because the MS is affecting my left side.”
The idea that CCSVI might be linked to the progressive neurological disease has divided the medical community.
Some patients have reported substantial improvements in their symptoms after liberation treatment. Other studies have raised doubts about its effectiveness and questioned the benefits when weighed against the risk of complications.
The U.S. Food and Drug Administration issued a warning in May about liberation therapy. It warned health-care professionals and patients that injuries and deaths have been associated with the experimental procedure.
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