TORONTO- It has been a medical story like no other. On the first anniversary of the W5 documentary report that brought a new theory about Multiple Sclerosis to patients around the world, we review the developments.
August 2009 was when we first heard about a radical new theory about the origin and treatment of MS -- a debilitating neurological illness. It suggested that MS was not merely an autoimmune disease but a vascular problem that could be fixed surgically.
The discovery drew intense scrutiny and skepticism from the mainstream medical community and galvanized MS patients who staged protests in front of Parliament to demand immediate testing and treatment. Ultimately, it pitted many MS patients against their neurologists and also prompted thousands of people to travel to foreign clinics to get the new therapy which produced significant improvements in some -- but also resulted in tragedy.
At its heart, it was research sparked by a quest by a husband desperate to help his MS-afflicted wife. Dr. Paolo Zamboni, a vascular surgeon and professor at the University of Ferrara, was watching his wife Elena, endure terrifying attacks of MS.
After intense research, Dr. Zamboni uncovered an intriguing clue. Other scientists had discovered iron in the brains of MS patients during autopsies. The question -- how did it get there? Using Doppler ultrasound, Dr. Zamboni found that over 90 per cent of MS patients he examined had some blockages in the veins that drained blood from the brain. He surmised that these blockages were causing blood to reflux back into the brain and deposit toxic loads of iron -- triggering MS symptoms like fatigue, brain fog and paralysis.
He dubbed the newly discovered condition -- CCSVI or cerebrospinal venous insufficiency.
The hypothesis was medical heresy. It went against conventional wisdom that MS was strictly an autoimmune disorder in which the body turns on itself causing symptoms such as paralysis, brain fog and debilitating fatigue.
Dr. Zamboni decided to go one step further. His team began treating MS patients with balloon angioplasty -- opening up blocked veins. His wife Elena was among the first patients.
His patients lined up to share their stories -- they said their symptoms improved, their fatigue disappeared, their brain fog lifted and some were able to move arms and legs after years of disability. One wept, stating through his tears that Dr. Zamboni had given him back his life.
One of the doctors on his team dubbed the treatment "The Liberation Procedure" -- an Italian turn of phrase to indicate the resumed blood flow through the jugular and azygos veins.
Meanwhile, in Buffalo, New York, a team headed by neurologist Dr. Robert Zivadinov- encouraged by early data and in collaboration with Dr. Zamboini -- launched a larger study of 1,600 adults patients to determine the association between vein blockages and MS.
The response among patients living with MS was immediate and unprecedented.
Shortly after the W5 story aired, patients visited the University of Buffalo website for more information and crashed the site within hours.
This story exploded, as Internet chat sites and social media groups began to learn about the new treatment. MS patients are a highly articulate, media savvy group.
The sentiment expressed over and over again was that Zamboni's therapy offered hope where none had existed before. Soon the same patients armed with studies and data found on the Internet stormed their neurologists' offices asking and in some cases, demanding to get tested for vein blockages and treatment with angioplasty.
The MS Societies of Canada and the U.S. expressed their skepticism -- stating in press releases: "Based on results published about these findings to date, there is not enough evidence to say that obstruction of veins causes MS... It is still not clear whether relieving venous obstructions would be beneficial."
But on November 23rd, 2009 -- two days after the W5 story aired report, the Multiple Sclerosis Society of Canada made an announcement. It amended its position on CCSVI and issued an open call to researchers to submit proposals for funding.
Early December – The Journal of Vascular Surgery, published the preliminary findings showing that patients who underwent treatment had a decline in the number of new MS attacks and the number of brain lesions associated with MS. In fact, the only time symptoms returned for the patients was when the jugular veins re-narrowed -- which occurred 47 per cent of the time.
New websites devoted to the treatment sprung up almost weekly. A year ago there were only two sites discussing to CCSVI information but today there are hundreds.
Those who sought treatment and found improvements, further fuelled the fire, by posting before and after videos, showing new found balance and strength.
But the response from the mainstream medical community was one of deep concern.
Many neurologists pointed out that Dr. Zamboni's study was small, not a blinded, controlled study -- the gold standard of scientific research. The results showing close to 100% of MS patients had some form of CCSI seemed to be statistically suspect. The results raised eyebrows and drew scorn from specialists who had devoted their careers to understanding MS. One neurologist called it a "hoax" in a national Canadian newspaper.
Subsequent studies published in the Annals of Neurology were unable to replicate the Italian team's findings and could not find the same strong correlation between blocked veins and MS.
Some doctors concluded the therapy offered no proven benefit and they pointed to the risks -- one U.S. patient died following treatment that used a metal stent, and blood thinners. Another had to undergo emergency surgery when a stent used to prop open his blocked vessel migrated to his heart.
But in June the Canadian and US MS societies announced $2.4 million in research grants to fund studies on the association between MS and blocked veins. (MS Society of Canada committed $700,000 to study the theory while the National MS Society said it will spend $1.7 million)
Patients frustrated with the slow pace of scientific research continued to demand treatment studies that offered the treatment itself -- not just efforts to quantify the link between venous malformations and MS. The battle between patients and their specialists and even the government was heating up.
In August, after reviewing the data and consulting with neurologists, radiologists and other specialists, Canadian Institute of Health Research president Dr. Alain Beaudet stated: "It is premature to support pan-Canadian clinical trials on the proposed 'liberation procedure.'"
Responding to reporters, he added the procedure also carried risks.
"Balloon angioplasty is relatively safe -- and I think we have to insist on relatively," he said. "Any procedure where you inject a catheter in a vein, where you compress the vein, where you risk damage to the internal sheath of the vein is not without risk."
Recently, Health Minister Leona Aglukkaq said that the federal government will make a decision whether to fund clinical trials when research from MS studies are complete.
The decision enraged patients who posted online that the committee was influenced by neurologists who are biased against the CCSVI treatment.
Saskatchewan -- with the highest rate of MS in the country -- broke rank and became the first province to announce funding for a treatment study.
"We don't need federal government approval here," Saskatchewan Premier Brad Wall told CTV News Channel. "We believe we can move ahead with it."
Explaining his decision he stated: "People in Saskatchewan are spending a lot of their own money. They're in some cases raising money through bake sales and getting support from friends and families to go to far away places to have this treatment done.
"What we're saying in Saskatchewan is, those people, those patients and those families deserve some answers to find out if there is some real hope here for symptom relief and maybe something bigger."
Officials are currently reviewing proposals with an eye to selecting project winners early in 2011.
But many patients are not waiting --- hundreds, perhaps even thousands, have flocked to foreign clinics. A burgeoning medical tourism industry has emerged. Clinics are offering the "liberation procedure" in Poland, Costa Rica, India and Mexico. The price tag varies from $10,000 to 20,000 dollars. Many promote the use of metal stents- used to prop open the veins, which are prone to re-narrowing.
Board members of the local MS chapters began leaving the society as they made their own plans to get treatment.
While many people continued to report significant improvement -- some patients remained unchanged. And a small but growing number of patients were returning from foreign clinics with complications like blood clots around their metal stents. What's more many said they were denied treatment in Canada when they returned with health problems.
The situation prompted a November press conference from the Quebec College of Physicians to warn patients about medical complications but also offer a reassurance that patients who run into trouble would receive care. Alberta's Health Minister Gene Zwozdesky made a similar announcement but the situation in the rest of Canada remains unclear.
Last week, CTV reported that a 35-year-old Niagara Falls, Ont. man died after travelling to the Clinica Biblica hospital in San Jose, Costa Rica in June.
Mahir Mostic developed a blood clot around a stent that was inserted to open his blocked veins. His symptoms worsened he returned to Costa Rica in October. He died October 19th.
At a meeting in New York, vascular surgeons Dr. Paolo Zamboni express sadness that Mahir never received proper care and deep concern over the proliferation of foreign doctors that promote the use of metal stents.
"In our scientific paper -- (we) always recommended not to use stents in the jugular vein. What was performed is not the methodology that we proposed"
And for some doctors the growing complications being reported underscores the need for fast scientific study
"The problem with all of that is there has not been a good randomized controlled double-blinded study that says it's either effective or ineffective. Nor has there been a trial done that actually assesses what the risks are or aren't. So we don't have a lot of data to go on which is unfortunate," Dr. Sandy McDonald said. He has been testing patients using Dr. Zamboni's ultrasound protocol. He also helped to treat six patients in Barrie Ontario – piquing his interest in the theory and treatment, and prompting him to propose clinical research studies being discussed.
Data from several studies is expected early next year.
Researchers in Buffalo have started a randomized double-blinded study to test the "safety and efficacy" of angioplasty treatment in North America's first clinical trial to test the "liberation treatment."
Studies are underway at St. Joseph's in Hamilton, Ontario and at the University of British Columbia. Saskatchewan plans to begin its treatment studies trying to answer the questions at the heart of this very emotional story.
It is a story that very much continues to unfold. CCSVI may be more complicated than originally thought -- with more blood vessels and verterbral veins involved.
The story of CCSVI is one of scientific innovation -- and provocative questions. But among patients, it's the story of a long simmering discontent with the existing understanding and treatment of MS.
