The Italian researcher behind the controversial ‘liberation’ treatment for multiple sclerosis patients has written a letter to Alberta’s provincial health board, calling its position statement on the treatment “extremely confusing” and “irresponsible.”
In an Oct. 5 letter addressed to Ken Hughes, chairman of Alberta Health Services, Dr. Paolo Zamboni said he found the Alberta position statement “extremely confusing because it mixes facts, fiction and assumptions . . .
“It is simply naive not to think that CCSVI (the narrowing of veins) significantly affects MS and (to) discourage research in the field. Moreover, it is irresponsible to criticize the pilot study on the value of angioplasty, given the fact that the current standard of care for MS is incapable of preventing progression to disability.”
In August, Alberta Health issued a strongly-worded position paper urging MS sufferers against seeking out the treatment because it is unproven and could have serious health side-effects.
“People with MS should be wary about getting information solely from media stories and reports or from patients’ blogs,” the paper said. “Be careful about where you get information and where you go for treatment.”
The Oct. 5 letter was drafted by Zamboni and Fabio Roversi-Monaco, who set up the Fondazione Hilarescere Foundation in Bologna, Spain, to support medical research into diseases that don’t have clear causes or treatments with satisfactory results.
In a 2008 study, Zamboni reported 90 per cent of MS patients had malformed or blocked veins in the neck that couldn’t adequately drain blood from the brain. Zamboni believes a buildup of iron in the brain ensues from this blockage, causing vertigo, fatigue, vision problems and loss of sensation.
There is no cure for MS. The liberation procedure involves using a form of angioplasty — injecting and inflating balloon catheters into dilated veins to increase blood flow.
Many MS patients, including Edmontonian Jennifer Noriega, get little relief from their symptoms with current medications.
Noriega went to Costa Rica in August to undergo the liberation treatment. Doctors there discovered both jugular veins, plus the azygous vein in her chest, had narrowed to about 50 per cent of their width.
Noriega said after her veins were unblocked during the trip, which cost $20,000, she thought everyone around her was yelling, then realized the hearing in her right ear had come back. Although she still has balance problems, she can now walk on her own rather than hold onto her boyfriend. The bath chair she used to sit in to shower has been moved to the garage. And she no longer needs five- to six-hour naps every day.
“It’s been 11 years of losing (balance, sensation, hearing and sight), so it’s not all going to come back in one day,” said the 39-year-old, who is on permanent disability from her job as a Kindergarten teacher.
The Alberta position paper said there is no proof using balloons in veins is safe, since veins have thinner, more vulnerable walls than arteries. It argues studies show Zamboni’s technique has a high failure rate, with 47 per cent of jugular veins closing again 18 months after being opened with a balloon.
“I think they are trying to scare people,” Noriega said. But while she acknowledged getting Zamboni’s new treatment is a leap of faith, since more studies need to be done to prove it works, Noriega said she risks her life every time she takes traditional MS medication. She was on chemo for one year, which kept a flare-up at bay for nine months.
She took a medication that increases her risk of developing leukemia. She has had allergic reactions to medications and developed an antibody to another. She is currently losing her hair and has developed marble-size tumours under the skin on her legs.
“I’m really disappointed in Canada,” she said, adding she’s pleased Zamboni read and took notice of Alberta’s response. “I thought that was quite cool, I guess, because in Alberta and all of Canada, there is a big MS community.”
She agrees with Zamboni that the position by Alberta Health Services is confusing.
In his letter, Zamboni said more scientific research needs to be done to verify his results and suggests some studies, used to disprove his results, were similarly small and didn’t use the same kind of diagnostic tests to determine blockages in the neck veins.
“The CCSVI condition (or chronic cerebrospinal venous insufficiency where the veins are blocked) has been found to be strongly associated with multiple sclerosis,” the letter reads.
The Government of Saskatchewan has invested $5 million to fund clinical trials for the procedure. Newfoundland and Labrador has launched an observational study to track the progress of patients who go overseas for the treatment.
No one from Alberta Health Services, from doctors to administrators, has spoken publicly about the liberation treatment. The health authority issued another written, unsigned statement Friday.
“Alberta Health Services staff and physicians are committed to the ongoing review of clinical learnings and developments in medical research and practice,” it reads.
“Our analysis reflects all of the current available information and that we will review the clinical trials underway when they conclude and any new information as it becomes available.”