Jodie Sinnema, Saturday, October 30, 2010

Dr. Paolo Zamboni talks at the American Academy of Neurology annual meeting, Wednesday, April 14, 2010, in Toronto. Photo Credit: Brett Gundlock/National Post, Brett Gundlock/National Post

Dr. Paolo Zamboni, who heralded the controversial liberation treatment for multiple sclerosis, has written a letter to Alberta’s health superboard, calling its position statement on the treatment “extremely confusing” and “irresponsible.”

Zamboni said he found the Alberta position statement “extremely confusing because it mixes facts, fiction and assumptions without making the appropriate differences,” reads the letter addressed to Ken Hughes, chairman of Alberta Health Services. “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 (to open the veins), given the fact that the current standard of care for MS is incapable of preventing progression to disability.”

The letter was sent Oct. 5 from 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.

There is no cure for MS and many patients, including Edmontonian Jennifer Noriega, get little relief from their symptoms with current medications.

Noriega went to Costa Rica in August to have the “liberation” treatment, which uses a procedure similar to angioplasty, to open a blockage in her right jugular vein. Doctors there discovered both jugular veins, plus the azygous vein in her chest, had narrowed to about 50 per cent of their width.

In a 2008 study, Zamboni found 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, causing vertigo, fatigue, vision problems and loss of sensation.

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. She said she can understand the position of Alberta Health Services to some degree, which warns people not to rely on anecdotal evidence but to consider the medical risks of undergoing the procedure overseas.

The statement says 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 definitively, 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.

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, noting his studies suggest 56 to 100 per cent of people with MS have blocked veins.

“I think (Alberta Health Services) should take notice of it,” Noriega said of Zamboni’s letter. “Why are they not doing experiments to figure out if this works?”

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.

“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.”