Bill calls for national 'liberation therapy' strategy
Published Wednesday, February 29, 2012 8:20PM EST
The Liberal MP behind a bill that calls for a national strategy on a controversial MS therapy says "we absolutely have to fight for this" if the treatment offers an improved quality of life.
Members of Parliament will vote on MP Kirsty Duncan's bill later Wednesday. It calls for phase II clinical trials into the so-called liberation therapy, as well as follow-up care for Canadian patients who have had the procedure overseas.
MPs are scheduled to vote on Bill C-280 around 5:30 p.m. ET, though the proposed legislation has little chance of being passed.
Health Minister Leona Aglukkaq has expressed her opposition to the bill, and while the Liberals and NDP support the measure, it likely won't have enough votes to pass.
Duncan has advocated on behalf of MS patients who want the controversial treatment funded here in Canada. Hundreds of Canadian patients have travelled overseas for the procedure, and there are concerns that they do not receive adequate follow-up care once they return home.
Bill C-280 also calls for follow-up care in Canada for Canadian patients who seek treatment in other countries.
Duncan said Wednesday that her bill asks the federal government to "do the science," meaning launch phase II clinical trials.
"What the international data suggests is that one-third of patients significantly improve, one-third moderately improve, and one-third show no-to-little improvement," Duncan told CTV News Channel.
"Regardless, no drug has ever done this. And I do have people who have left wheelchairs, and have left assisted living and gone back to work. I don't want to hope-monger, but if there's a glimmer of hope that this improves quality of life, we absolutely have to fight for this."
Aglukkaq announced late last year that the federal government was accepting proposals from researchers interested in studying the liberation therapy. The decision came after an expert panel, convened by the government, recommended a small-scale Phase I/II trial to determine the safety of the treatment and its efficacy in MS patients.
The treatment was developed by Italian physician Dr. Paolo Zamboni, based on his theory that narrowed veins in the neck are responsible for the debilitating symptoms MS patients experience.
Zamboni maintains that the condition, known as chronic cerebrospinal venous insufficiency (CCSVI), reduces blood flow, and theorizes that this improper flow could promote the build-up of iron in the brain.
The treatment uses balloon angioplasty to open the veins and improve blood flow in the hope of alleviating symptoms.
While some patients report dramatic improvement in their symptoms, and Zamboni reports success in his patients, there have been no controlled studies comparing the effects of the balloon angioplasty to placebo, research that is considered the gold standard for science.
Saskatchewan is paying $2 million to have some of its MS patients join a U.S. study now underway in Albany, N.Y. Doctors there are performing a randomized study, where patients are unaware if they are receiving the treatment or a placebo therapy.
The president of the Canadian Institutes of Health Research says he will announce the winning proposal of the safety study to be done in Canada in March.
"It is imperative given the uncertainties related to CCSVI and its potential relationship to MS that CIHR support ethical research based on international standards of excellence to help us better understand what impact venous angioplasty procedures have on the clinical outcomes and quality of life of MS patients," CIHR president Dr. Alain Beaudet said in a news release.
"The research evidence to-date is so mixed that the only way to get to the bottom of this is to conduct a well-designed clinical trial with appropriate stringent patient safety considerations factored in."