6/16/10

Zamboni Says Vein Procedure Should be Offered in Clinical Trial

(Posted By: Josi Creek)

People with multiple sclerosis should be able to have surgery on blocked neck veins as part of a clinical trial, says the Italian doctor who pioneered what has become known as the liberation therapy.

Dr. Paolo Zamboni talked to MPs on the House of Commons health committee on Tuesday. He maintains the procedure has resulted in better cognitive and motor function — and fewer symptoms of chronic fatigue — among people with MS who were treated with balloons to open up blocked neck veins.
Zamboni calls the condition "chronic cerebrospinal venous insufficiency," or CCSVI.
His research suggests that narrowed or blocked veins cause blood to move backward, or reflux, back into the brain and spine, causing damage that results in the symptoms shown by some MS patients.
"It is not responsible not to proceed with [the] treatment," Zamboni said by videoconference.
Zamboni said the vein procedure should be offered in a randomized clinical trial under the supervision of an ethical committee.
The MS Society of Canada announced last week that it is spending $700,000 on four studies to determine if there is a link between blocked veins and MS, before it will support surgical treatment. The society says researchers elsewhere in the world haven't been able to reproduce Zamboni's findings.

Evaluation needed

The society wants more people assessed for blockages that are objectively evaluated by doctors, said spokeswoman Karen Lee.
Research needs to include people who receive vein treatment to see whether they improve, just as a drug therapy would be compared with a placebo, said Dr. Robert Maggisano, a vascular surgeon at Sunnybrook Health Sciences Centre in Toronto.
"We're wasting time and money, and certainly not helping our people, who are going overseas to get treatment, when we should be able to do the studies in a blinded fashion within Canada," Maggisano said.
Alain Beaudet, president of the Canadian Institutes of Health Research, said the institute is seeking proposals for a blinded, randomized control trial that includes the procedure. The deadline for proposals is mid-August.
The government committee also heard from Dr. Marian Simka, of Euromedic in Krakow, who is part of a team that charges $10,000 for a scanning and surgery package. After doing about 400 vascular surgeries since last fall, Simka said 80 to 90 per cent of MS patients have experienced improvement.

Labels: CCSVI, Clinical Trials