The U.S. Food and Drug Administration (FDA) issued a warning Thursday against a controversial multiple sclerosis (MS) treatment it says has caused injuries and deaths. The treatment, called liberation therapy, was discovered by Italian doctor Paolo Zamboni.
The treatment involves unblocking veins and blood vessels in the neck and chest by inserting balloons into the veins to treat chronic cerebrospinal venous insufficiency (CCSVI).
The condition, according to Zamboni, affects the flow of blood from the nervous system to the heart. Zamboni believes this syndrome is linked to causing MS, an incurable disease affecting the nervous system. Common symptoms are fatigue and numbness or tingling in the fingers and toes.
The FDA said in its warning that there is no scientific evidence linking CCSVI and MS.
"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly- targeted research to evaluate the relationship between CCSVI and MS," Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in the FDA's statement.
The FDA received reports of one death and one stroke as a result of the procedure, performed in a handful of American clinics. The procedure is not performed in Canada.
Mark Lane decided to get the treatment in Poland in October 2010. He said the disease takes so much away from so many people that it's easy to get paranoid over treatments like these.
"Living with MS is like living in a permanent game of Russian Roulette. Every day you wake up, it's like a guessing game."
Despite the risks, Lane said he's seen his symptoms improve. Lane lost his ability to write with his right hand as a result of MS, and said he can write again thanks to the procedure.
"Myself, I feel fantastic, and I haven't lost a whole lot (to MS). I've lost it and regained it, and lost it and regained it, Lane said. And since my surgery I haven't lost anything."
The 37-year-old from St. John's was diagnosed with MS when he was in his early 30s.
The same month Lane received his treatment, Mahir Mostic, a 35- year-old man from St. Catherine's, Ont., travelled to Costa Rica for the same treatment. Mostic died after suffering complications from the procedure.
In July 2011, Marilyn Clarke, a 56-year-old Calgary woman, died from a brain hemorrhage after travelling to California for the liberation therapy.
Jessesar MacNeil, a representative for the Multiple Sclerosis Society of Canada's Atlantic division, said the MS society shares the FDA's views that the treatment is risky.
MacNeil said the society is putting millions of dollars into research to find out if there is a link between CCSVI and MS.
"People with MS deserve clarity and the hope that CCSVI (treatment) offers. It's only through rigorous research that we're going to be able to get these answers," she said.
MacNeil said the MS society is aware of both the successes and failures of liberation therapy.
"We have lots of people saying the treatment really helped them with their MS symptoms, particularly their fatigue, and their sensations in their fingers and toes, but then we've also had people who say that there was no benefit from it," she said.
Looking for evidence
In a prepared statement via email, federal Health Minister Leona Aglukkaq said Heath Canada will rely on the best scientific evidence possible before making a decision on liberation therapy.
"Before our government will give the green light to a limited clinical trial here in Canada, the proposed trial would need to receive all necessary ethical and medical approvals," Aglukkaq said. "When it comes to clinical issues, I rely on advice from doctors and scientists who are continually monitoring the latest research, and make recommendations in the best interests of patient health and safety."
Lane said the treatment is well-worth the risks.
There's risks in getting a tooth pulled, Lane said. If something happens and my health starts to deteriorate and (doctors) scan my neck and find the veins have closed again, I'm getting on a plane and going back to Poland.