One month after receiving the “liberation therapy” he had hoped would loosen the debilitating grip of multiple sclerosis on his life, Jamie McGowan was still racked with pain and felt like a ticking time bomb.

He feared one of four stents inserted into veins in his neck at a hospital in India could come loose and launch into his heart, or that an accidental blow might drive one of them into his brain.

“If anyone ever said ‘we'll need to do this again' . . . I would never do it, never,” says McGowan, who as a fan of body piercing could not be counted among the squeamish. “I would never go through that pain again.”

The 26-year-old Albertan is one of apparently few patients who have suffered complications after undergoing the new MS treatment pioneered by Italian doctor Paolo Zamboni, which involves using balloon angioplasty to open veins in the neck and sometimes inserting tiny cylinders called stents to keep them open. Canadians must travel to foreign hospitals for the procedure because it's not available here.

However, the recent death of an Ontario man who had the treatment and reports of complications suffered by another half dozen Canadian patients have raised fresh concerns about the risks involved.

Mahir Mostic of Niagara Falls died in October after having liberation therapy in Costa Rica in June.

Mostic died of bleeding apparently linked to medication used to treat a blood clot he developed after the surgery. His is the second such bleeding death reported. The other Canadian patients suffered clots that can result in dangerous complications if they travel to other parts of the body such as the lungs.

The recent cases have also prompted calls for medical follow-up and care of Canadians who have travelled overseas for the Zamboni treatment, which they have been doing in considerable numbers since it was unveiled a year ago.

In research released in November 2009, Zamboni linked MS to a condition he called chronic cerebrospinal venous insufficiency (CCSVI), a blockage in the veins draining blood from the brain. Zamboni theorized CCSVI could increase iron deposits in the brain, triggering the autoimmune response that occurs in MS. In a pilot study, “liberation” of blood flow in blocked veins reportedly reduced MS symptoms in patients.

Zamboni's research ignited a firestorm of controversy in Canada's MS community, with patients clamouring for access to liberation therapy and doctors warning it is unproven and unsafe. Canada has one of the highest MS rates in the world, with an estimated 75,000 citizens living with the disease.

Drawn by hope offered in the face of MS's grim progression toward disability and encouraged by patient reports in online blogs and chat rooms of dramatic decreases in symptoms following the treatment, McGowan decided to join the steady stream of Canadians travelling to foreign hospitals for liberation procedures.

Unable to work since his diagnosis in 2008, McGowan has suffered attacks of MS causing memory loss, numbness in his legs, difficulty walking, severe headaches, extreme fatigue and difficulty swallowing as well as bowel and bladder problems.

His $30,000, 10-day medical journey to India was financed by a generous aunt and uncle. On Sept. 25, McGowan found himself lying in an operating room at a Bangalore hospital with a tube in his groin and an angioplasty balloon being threaded through his blood vessels to be inflated in his neck.

“I must have been ballooned 50 or 60 times,” he recalls, “and every time I'm being ballooned, something else is snapping in my neck and there was this horrible cracking.” The noise was “like somebody taking a dying tree branch, a really thick one, and just snapping it. . . . It was a horrible sensation. And it was painful.”

The reason he was being ballooned so often, McGowan explains, was because his veins kept collapsing. The doctor finally suggested stents be put in, an option McGowan had decided against while researching liberation due to the extra risk involved. One of the reasons the Zamboni therapy is controversial is because angioplasty carries a risk of blood clots, which can lead to heart attack or other dangerous complications, and placing stents requires the use of blood thinners that can lead to bleeding, with possible consequences including stroke and death.

As well, stents are usually placed in arteries and rarely in veins, and doctors have warned little is known about what can happen when they are used to hold veins open, though there is much debate on this issue. It has been suggested they could come loose and be carried to other locations in the body. There is one documented case of a stent dislodging and travelling to the heart of a patient who had undergone liberation therapy, requiring surgery to remove it.

In the middle of his liberation procedure, McGowan had to weigh these risks.

He chose the stents, and after the same problem was encountered on the other side of his neck, he ended up with four — two on each side.

According to McGowan, the doctor then told him he had “the longest stents that anyone in India has ever had” and that his team had never done this before. “So now I'm a little freaked out. What do you mean they've never done this? Holy God, what have I got myself into?”

McGowan did start to feel a bit better about things when he was wheeled out of the operating room and noticed the lights didn't look as “smoky and hazy” as when he went in. “That gave me a lot of hope . . . what I just went through, maybe it was worth it.”

But hope was soon overwhelmed by more pain. “Those first two days after the procedure I felt like I was dying, really, and I'm not trying to be dramatic when I say that. . . . The pain was unbelievable . . . and it was pain throughout my body. My head hurt more than anything, my head and my neck.”

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On the third day, for reasons that remain unclear, McGowan's tongue swelled to “six to seven times the size that it should be,” and his throat distended as well. He has been told by doctors back in Canada that it could have been a reaction to blood thinners he was given to prevent clots. He has also been told his symptoms might have been the result of a minor stroke, an MS attack, or something else unknown.

After six days in hospital, McGowan came home to Lethbridge. Just over a month later, the right side of his face remained “excruciatingly painful.” The left side hurt, too.

Improvement in his vision has remained, though he thinks it's not quite as clear. He can feel parts of his right leg he hasn't felt in a year and his usually cold feet seem a little warmer. “It's more improvement than I've seen in 21/2 years.”

McGowan is optimistic the pain will diminish, but remains anxious about the stents. Doctors here have told him they don't know what the long-term ramifications can be and aren't sure how they could help him if something went wrong.

McGowan admits he used to be critical of doctors and government for not acting more quickly on launching trials or making the Zamboni treatment available to Canadians, but says he now agrees with their cautious approach. “They are protecting us from the unknown which could leave us with devastating results.”

Rob Hamilton, 52, of Georgetown, doesn't agree. He also travelled to India for liberation therapy and had three stents put in his neck. He has the same form of relapsing-remitting MS McGowan has, but suffered no apparent ill effects from the procedure and says he now feels more clear-headed and less fatigued.

Hamilton says he's only felt a bit of soreness from the small stents in his neck and is not particularly concerned about them. Still, he thinks doctors here should be willing to follow up with patients who took the risk of getting treated overseas and have, in effect, made themselves willing guinea pigs.

“That's what the trouble is. There's not a lot of feedback after you get back. There's no re-checking.” He would like to see his and others' experiences with liberation therapy tracked in a database that patients and researchers could use to help judge its efficacy and safety.

Andrew Katz, an Ottawa-area financial adviser and MS patient who helps run a website promoting liberation therapy, says reports of complications by MS patients who have gone overseas for treatment only strengthen the case for providing it here. He had it himself with no ill effects, but no progress yet.

“Why hasn't the government jumped in and said, ‘enough already, let's take control here,' ” Katz asks. “Let's do things in Canada where we know what we're doing, instead of having our Canadian citizens go abroad, have experimental treatment and take risks.”

Failing that, Canadian patients should at least be offered monitoring and proper care when they return, Katz says.

Dr. Paul O'Connor is among those MS specialists who tell patients planning to go for the treatment to come and see him afterwards.

“I don't advise them to get the procedure by any means, but I also respect their autonomy, their freedom to make their own decision,” says the neurologist, who is director of the MS clinic and MS research at St. Michael's Hospital in Toronto. So far, he has seen more than 20 patients who have had it. Some patients report no benefit at all, O'Connor says, but many report improvement, particularly less fatigue.

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