“I can move my hand, I can see, I can move my head,” says Sims, “and I can move my feet and toes, it’s a remarkable the things I can do its so much better now.”

Sims encourages any MS patients to get the vein widening surgery.  The treatment has proven to decrease MS symptoms and is currently going through clinical tests in Canada.

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Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute in Miami, advocates a controlled clinical trial to obtain credible evidence that the experimental procedure to treat chronic cerebrospinal venous insufficiency (CCSVI) is beneficial for MS. The FDA reported injuries and death related to the therapy.

“Any new treatment like this gives hope to people with multiple sclerosis. Because it is a high-risk procedure, we need new clinical trials to obtain evidence that confirms it is truly effective in treating multiple sclerosis,” said Dr. Katzen, who has performed the procedure in other instances.

Some researchers believe that CCSVI, distinguished by a narrowing of veins in the neck and chest, either may cause or contribute to MS by blocking blood flow from the brain and upper spinal cord.

The FDA warned researchers who use balloon angioplasty devices and stents for widening the veins they must comply with FDA regulations for investigative trials. Clinical studies considered to be high risk require the necessary FDA approval, called an investigational device exemption.

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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.

‘Guessing game’

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.

Recognizes risk

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.

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The therapy was devised by Italian physician Paolo Zamboni, who says MS is caused by vein blockages in the neck and upper chest that prevent blood from being drained from the brain.

He says opening these veins with balloon angioplasty reverses symptoms of MS; Zamboni calls the vein blockages chronic cerebrospinal venous insufficiency or CCSVI.

The FDA says studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

Scores of Canadians have travelled overseas to get the treatment; at least two Canadians are known to have died after undergoing the therapy.

Dr. William Maisel, the chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, says patients considering the treatment should discuss the pros and cons with a neurologist or other doctor familiar with MS and CCSVI.

In a release, the FDA says it has learned of adverse events experienced by people who have undergone the treatment, including death, stroke, detachment and migration of stents that are sometimes used to open the veins, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the procedure.

The agency says it is informing doctors and researchers that if they want to do clinical trials on CCSVI, they must comply with FDA regulations. Earlier this year the FDA sent a warning letter to a researcher and his or her sponsor after learning they were conducting a trial without FDA approval. The trial has since been stopped.

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Being able to go back to work was something Mr. Perry thought he would never be able to do again after being diagnosed with MS.

Since his Liberation treatment ten months ago, he feels well enough to give it a try.

Dale suffered from severe fatigue, stress, depression, headaches, memory and vision loss, and vertigo. His monthly medical costs were approximately $1,600.00 and he was unable to work to support his family. Last year this time, Dale was unable to walk for any amount of time or even stand. The light from the sun would hurt his eyes and everyday was a struggle for him.

The Liberation Treatment was his only hope of gaining back some quality of life and the cost for this procedure was really expensive. After friends and family raised $27,000, Dale and his friend Chris Fudge who also has MS were able to travel to Poland to receive this procedure in June 2011.

“The liberation treatment is a whole new approach to MS. It is a treatment to open block veins by using balloons or stents so blood could travel out of the brain and not reverse back up-ward. This disorder is known as the CCSVI or Chronic Cerebrospinal Venous Insufficiency,” said Perry.

When Dale traveled to Poland to receive this treatment, he was very uncertain about his future. Once he arrive there, the test began from having neurological consultations, MRI and colour Doppler ultrasounds performed to check for blockages. Angioplasty was preformed on both jugular veins and no stent was needed.

“The neurologist in Poland didn’t recommend that I stop taking my regular medications even after my surgery. He said that we do know about the out flow of blood but they didn’t know about the inflow of blood in the brain. So for now I keep taking my injection of copaxone (20mg) every day. It has been almost a year now since having this treatment and with the headaches alone being gone it was well worth it. I don’t get as fatigued anymore and I definitely have a lot more energy. The numbness and tingling in my feet and hands have disappeared and I find that my balance is way better. The inflammation of the nerves in my eyes is almost better to and hopefully there will be no permanent damage to my nerves. I don’t get depressed any more and I feel so much better about myself. My family and I were so happy to get this procedure done. We were always positive that it would work, and we really appreciated all donations that allowed me to have this procedure preformed.”

“For someone with my kind of MS it has definitely improved my life for the better. I have been given back my life.”

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Unfortunately for Judy Butcher, the “liberation” treatment pioneered by researcher Dr. Paolo Zamboni, is unavailable in Canada. She travelled to Egypt in March 2011 to be treated at a clinic in Alexandria – a treatment she says has made such a difference in her condition that “I’m back dancing again.” Butcher’s appeal of a decision by OHIP not to reimburse her for the $7,000 treatment was denied on April 25.

However, good news may be on the horizon for Canadians living with MS. The federal minister of health, Leona Aglukkaq, announced in mid-April that a team of Canadian researchers has been selected to undertake clinic trials of the Zamboni procedure, which uses angioplasty to open up the jugular veins in a patient’s neck. The clinical trials are to be co-funded by the MS Society of Canada.

Butcher said the procedure is already approved for use in 60 other countries. There is so much evidence of the effectiveness of the treatment, she added, that “It’s like seeing the murderer with the smoking gun and three eye witnesses.”

According to information from the MS Society’s Leeds and Grenville Chapter, which plans to hold its annual fundraising Carnation Campaign May 10, 11 and 12, multiple sclerosis is an unpredictable, often disabling disease that attacks myelin, a protective coating on nerves. This disease of the central nervous system can cause loss of balance, impaired speech, extreme fatigue, loss of vision, and paralysis. MS is the most common neurological disease in Canada. While most patients are young adults aged 15 to 40, MS can also affect children as young as two.

Butcher first became aware something was wrong with her health during a trip with a friend to the Picton Sandbanks in 1995. She noticed tingling sensations in her arms which continued on the trip home, and at first assumed it was a reaction to the long ride. Her next symptom was numbness in her hand, which prompted a visit to a chiropractor, but no diagnosis of what was really going on.

Later, Butcher’s family doctor told her “You might have MS,” and sent her to a neurologist. It took another year to reach a final diagnosis.

At the time Butcher, like most people, was aware that MS could affect a person’s ability to walk, but didn’t know the full extent of how serious the disease can be. “I wasn’t seeing the image in my head that someone might be blind,” she recalled. “I didn’t know people died from it.”

In fact, an average of 400 Canadians die from MS each year. This number, said Butcher, doesn’t include people who are driven to suicide by their condition. Butcher said one of her own neighbours, who had watched several relatives cope with MS, took his own life after being diagnosed with the same disease.

Before undergoing the experimental angioplasty treatment which she says “has been a lifeline for a lot of people,” Butcher tried many other treatments, from both conventional and alternative medicine, in an effort to manage her symptoms, with varying degrees of success.

Medication is very expensive, said Butcher, and at the same time is only effective in 30 per cent of cases. Having learned that bee stings could have an anti-inflammatory effect, she installed a bee hive on her property and submitted herself to up to 18 bee stings a day, while taking vitamin C. The bee stings worked better than conventional medication, she said, but the bees died in the 1998 ice storm, and she never replaced them.

As time progressed, Butcher’s ability to walk was affected. Her doctor pointed out that her left leg was dragging as she walked – something she had been unaware of until it was pointed out. In 2007 she had surgery to implant a pump in her abdomen designed to administer a constant level of medication, but had the pump removed three years later when the medication proved ineffective. The drugs, she said, are all toxic, and come with a range of negative side effects from heart palpitations to mental confusion.

Butcher said MS patients have long been impatient at the lack of progress in having Zamboni’s angioplasty treatment for MS approved for use in Canada. Some, she said, are upset at the head office of the MS Society for not doing more to move the approval process forward.

Butcher first learned about the procedure from the television program W5 in 2009. Since undergoing the treatment herself on March 5 2011, she said, “It’s made the world of difference in me, as my family can testify.” She had lost her driver’s licence due to the mental confusion caused by medication, but now has her licence back. Once an avid ballroom dancer, she has been able to go back to her favourite hobby, if only in a limited way. And, she added, “I do all my own shopping now!”

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Surrounded by supporters wearing matching t-shirts, the 22-year-old Orillia woman ¬– once housebound due to multiple sclerosis – was walking at a comfortable clip.

For that, Murray says she can thank a controversial medical procedure, performed at a clinic in Albany, New York in late January.

“I have more energy, I’m not as tired,” said Murray, who took part in the annual MS Walk last weekend. “(In the past) I would have found a way to participate, but I wouldn’t have been able to do the walk.”

The local woman was diagnosed with relapsing remitting MS in June of June 2010 after experiencing a flood of symptoms, including seizures, loss of balance and paralysis on her right side.

A Barrie-based specialist confirmed she had the blocked neck veins that some believe are linked to MS – a claim now being studied by the federal government.
The so-called ‘liberation’ procedure – in which narrowed veins are opened through angioplasty – remains unavailable in Canada.

As a result, Murray and others have paid thousands for the surgery out-of-pocket at clinics in the U.S. and elsewhere.

A pair of community-driven charity events “raised enough for the procedure,” Murray said of the roughly $7,000 cost.

Her family bore other expenses related to travel and accommodations, she added.

“I really appreciate that everybody helped me,” she said.

Federal Health Minister Leona Aglukkaq this month announced a team of researchers was selected to undertake a clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in individuals with MS.

The announcement follows a call for research applications by the Canadian Institutes of Health Research in November.

“Our government is committed to advancing research in MS with the goal of improving the health of those who live with this condition,” Aglukkaq said. “This clinical trial should provide more insight into the safety and effectiveness of the procedure proposed by (Italian physician) Dr. (Paolo) Zamboni.”

Co-funded by the MS Society of Canada, the clinical trial seeks to determine the safety of venous angioplasty and its impact on patients.
However, the government said the researchers must receive ethics approval from “relevant institutional research ethics board(s) before conducting the trial.

“The funds will be released and the study will begin if and when ethics approval is granted,” stated a government press release.

Murray hopes to see the procedure allowed in Canada.

Prior to the operation, “my fatigue was huge, my back pain was huge,” she said. “I couldn’t really walk because when I got tired my leg dragged.”

Her energy levels have improved, though the back pain that had initially subsided has returned.

“Some days the pain is not as intense as it was but it is still there,” she added. “My neck used to be really sore but it’s not sore now.”

A scientific expert working group of the Canadian Institutes of Health Research continues to review any new research evidence on CCSVI, said president Dr. Alain Beaudet.

Murray says a Barrie-based specialist will follow-up on her progress in May.

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Judy Butcher, a 48-year-old resident of Jasper, Ont., near Merrickville, paid $7,000 for balloon angioplasty to open blocked neck veins at a clinic in Egypt on March 5, 2011.

Butcher was diagnosed with MS in 1996. It had progressed to the point that she was confined to a wheelchair and frequently in excruciating pain.

But after undergoing so-called “liberation treatment” — pioneered by Italian vascular surgeon Paolo Zamboni — Butcher’s pain subsided and circulation improved. She now walks with a cane and has been able to regain her driver’s licence.

Despite that, when she applied for reimbursement, her claim was rejected by the Ontario Health Insurance Plan (OHIP) because the treatment is considered experimental and unproven in Canada.

Butcher appealed OHIP’s decision to the Health Services Appeal and Review Board, which heard the case in February. She received the board’s 18-page decision Monday.

In rejecting her appeal, the board found that the evidence “strongly suggests that the treatment is generally accepted in Ontario as experimental. Ontario experts in general are of the view that, based on the research, the treatment is not yet proven and requires more investigation.”

Based on that, the board concluded that the angioplasty treatment performed on Butcher in Egypt “is not prescribed as an insured service of OHIP.” The board had previously rejected two other appeals from MS patients who underwent the Zamboni procedure.

In an interview, Butcher said she was disappointed by the decision, but not surprised.

“I was kind of expecting it. They’re bound and determined to not recognize this procedure,” she said. “Obviously they knew that if this case was decided in my favour, it would set a precedent.”

Since Zamboni published his study in 2009 suggesting a link between MS and blocked veins in the neck — a condition known as chronic cerebrospinal venous insufficiency (CCSVI) — more than 12,000 patients worldwide have undergone the treatment worldwide, including hundreds of Canadians.

In this country, though, Zamboni’s treatment has encountered stiff opposition from a medical establishment unconvinced of its benefits.

Last year, the federal government agreed to fund clinical trials after a panel of experts agreed there was sufficient evidence to warrant them.

And earlier this year, the government of Saskatchewan began funding 88 patients from the province to participate in clinical trials now underway in Albany, New York. No results have yet been reported.

At the February hearing, Butcher argued there is already enough evidence that the treatment relieves symptoms for many MS patients. Hundreds will die unnecessarily if treatment is denied until clinical trials are completed several years from now, she said.

“I don’t know why on earth they’re not listening to Dr. Zamboni,” Butcher said Monday. “He’s a 30-year vascular surgeon. They don’t seem to get it that 13 (MS patients) are passing every month in Canada.”

Butcher said she is considering an appeal of the board’s decision to Ontario’s Divisional Court. She has already filed a human rights complaint about OHIP’s refusal to pay for the treatment and plans to file a complaint with Ontario Ombudsman André Marin as well.

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Now, the federal government has made another step towards their own trial here at home. A research team has been chosen and is now awaiting approval by an ethics committee.

“Once the approval has been given, which we don’t expect will take too long, the funding can be released and the researchers can begin their work which we expect to begin in the fall of this year,” explained Tom Lukiwski, Member of Parliament for Regina Lumsden-Lake Centre.

The national study is co-sponsored by the MS Society of Canada who have donated half a million dollars to phase one and two of the trial.

“Phase one trials are really to determine safety,” said Janet Nicolson with the Saskatchewan branch of the MS Society of Canada. “We have seen cases across the world where people who’ve gone for CCSVI, Liberation Therapy, have seen complications with that and we really want to minimize that risk if this procedure is approved in Canada.”

Saskatchewan will likely participate. Last year the Wall Government announced $5 million to fund MS trials. Almost half will be spent sending patients to Albany, New York, the other potentially to the federal study.

“I’m interested, in terms of finally coming to the conclusion that angioplasty is a safe procedure and that’s on the key research questions that the feds are looking at,” said Mark Docherty. The Regina Coronation Park MLA also suffers from MS and travelled abroad to have the liberation therapy.

The number of patients, procedure, location, criteria and cost for the federal study will be mostly in the hands of the research team once they pass their ethics review.

Hundreds of Saskatchewan patients applied for the trial in New York. Roughly 90 are being randomly selected for eligibility screening that is expected to be finished at the end of the month.

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The MS Society of Canada, a co-funding partner of the project, said it’s “thrilled” by the announcement that may bring “definitive answers” about the controversial treatment developed by Dr. Paolo Zamboni.

The clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Canadians with multiple sclerosis seeks to determine the safety of venous angioplasty, also known as “liberation treatment” which requires the opening of blocked veins, the Canadian Institutes for Health Research said in a release about the announcement.

Liberation treatment rejects long-held medical opinion that MS is an autoimmune disease. At least two Canadians have reportedly died overseas from complications of the procedure, which is currently unavailable in Canada.

Asked about the controversy surrounding the procedure, MS Society of Canada CEO Yves Savoie said he supports the call of those concerned about the treatment for more rigorous research.

“We’re thrilled at this very important step and because of this question of the risk, that’s why there are appropriate safeguards for participants going to be involved in that, including an ethics approval,” he said.

The trial is subject to an ethics approval in Canada in “a way that balances our hunger for innovation and research with respect for dignity of human life,” Savoie said.

The government is withholding the names of the researchers and institutions involved in the project “to protect the independence” of the ethics review, according to CIHR which launched a call for research applications to select the team of researchers.

Savoie said withholding the names is standard CIHR practice and will ensure that the ethics approval process “can happen without intense public pressure.”

The trial will only begin after ethics approval is granted, he added.

Meanwhile, a 2011 study by a team of University of Calgary doctors found complications for five MS patients after undertaking liberation treatment abroad.

“As the debate about CCSVI and its relationship to MS continues, the complications and risks associated with venous stenting and angioplasty in jugular and azygous veins are becoming clearer. As increasing numbers of MS patients are seeking such procedures, these five cases represent the beginning of a wave of complications for which standardized care guidelines do not exist,” the Calgary neurologists wrote in The Canadian Journal of Neurological Science.

CIHR said it will continue to review and analyze any new research evidence on CCSVI.

“CIHR and the MS Society will continue to collaborate with provincial and territorial partners to ensure implementation of the clinical trial if the team of researchers meets the research ethics boards criteria,” said CIHR president, Dr. Alain Beaudet in a statement.

Canada has among the highest MS rates in the world. There is no known cure, but symptoms may be managed.

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