Saturday November 18th 2017

‘Disappointing news’ for Saskatchewan patients after Albany clinic cancels MS trial

duncanThe Saskatchewan government is contemplating its next step after a clinic in the United States cancelled its trial into a controversial treatment for symptoms of multiple sclerosis.

The Saskatchewan Party government was informed recently that the Albany Medical Centre is stopping its clinical trial into the effectiveness of angioplasty in treating chronic cerebro-spinal venous insufficiency (CCSVI) and relieving the symptoms of multiple sclerosis (MS).

Dr. Gary Siskin, who had been heading up the study, told the Ministry of Health that he was unable to meet the enrolment numbers necessary for the study to produce statistically valid results. Although Saskatchewan had a planned 86 participants, the research team in Albany could not recruit enough participants to meet United States government requirements for a clinical trial.

The therapy involves opening blocked veins in the neck. It is not available in Canada and despite some MS patients receiving the therapy overseas, it remains scientifically unproven.

Saskatchewan has more people suffering from MS than any province in Canada. The Ministry of Health says it will work with its health and research partners to explore other options.

“This news is disappointing for the approximately 3,500 Saskatchewan people who want to know whether this kind of treatment can help relieve MS symptoms,” said Health Minister Dustin Duncan in news release issued Monday.

“Our government wants to do everything it can to search for answers and further the science for people with MS. That’s why Saskatchewan was supportive of this trial and will continue to be supportive of research that may provide answers for those with MS and their families.”

Dr. Siskin said his centre regrets “our inability to meet our target enrolment will make it impossible to draw statistically meaningful conclusions from this study … The Government of Saskatchewan should be admired for its forward thinking approach and genuine compassion. The multiple sclerosis community is fortunate to have such a partner in its corner.”

The Saskatchewan government had committed as much as $2.2 million to allow Saskatchewan patients to participate in the study. To date, costs reached an estimated $150,000.

Canadian researchers recently found no evidence to support the controversial CCSVI hypothesis. In what was described as one of the largest studies of its kind, researchers from McMaster University in Hamilton, Ont., who scanned veins deep in the necks and heads of 100 MS patients, as well as in 100 people with no known history of MS or any neurological condition, found no significant differences in blood flow between the two groups.

The results of the study were released last month.

The Hamilton team included two vascular ultrasound technicians and a radiologist with more than 30 years’ experience who travelled to Ferrara, Italy to be trained for one week under the supervision of Italian physician Paolo Zamboni. His theory that abnormal blood flow from the brain is a central problem in MS has led to a flood of Canadian patients travelling to the United States and other countries for surgery to open narrow or blocked veins. At least two Canadians – a Calgary woman and a Niagara Falls, Ont., man – died after undergoing so-called “liberation” therapy abroad.

Zamboni coined the term CCSVI to describe obstructions in the blood flow in the floppy, fragile veins that drain blood from the brain to the spinal cord, leading to iron deposits in the brain that could trigger an autoimmune reaction.

Zamboni believes that opening the veins using balloon angioplasty, a procedure used to clear blocked vessels, improves MS symptoms.

But, reporting in the journal PLOS ONE, the McMaster team says it found no evidence to support the hypothesis that CCSVI is involved with MS.

“We, quite frankly, were astounded at how clear-cut our evidence was, that there was no blockage,” said principal investigator Dr. Ian Rodger, a professor emeritus of medicine in the Michael G. DeGroote School of Medicine in Hamilton, Ont.

However, the Vancouver doctor heading a $6-million, national clinical trial of the CCSVI treatment says the Hamilton group relied on ultrasound imaging and magnetic resonance imaging (MRI) to look for abnormalities, and not the “gold standard” test for visualizing veins, a procedure known as catheter venography.

“It doesn’t mean that the results are wrong,” said Dr. Anthony Traboulsee, medical director of the University of British Columbia Hospital MS Clinic in Vancouver. But, “as important as the research is, it has to be taken with a grain of salt,” he said.

“Our own experience with catheter venography is that we do see abnormalities and narrowing” in patients with MS, he said. The new study “doesn’t change how we want to go forward.” About 100 patients are expected to participate in the national MS trial. Traboulsee hopes to have preliminary results by summer or winter 2015.

“I’m really proud of the study we’ve designed,” he said. “I think it’s going to clearly answer the question, ‘Does dilating the veins in people with MS improve their quality of life?’ ”

Canada has among the highest MS rates in the world. There is no known cure.

In the McMaster study, MS patients aged 18 to 65 were matched with neurologically healthy people of the same age and gender. All underwent ultrasound imaging of the veins of the neck, plus the deep cerebral veins, as well as MRIs of the neck veins and brain. Each person had both procedures on the same day. Only one

MS patient fulfilled the minimum criteria established by Zamboni for CCSVI, the researchers said.

Other studies have reported the frequency of CCSVI in MS patients ranging from 100 per cent – Zamboni’s study – to almost zero.

Part of the discrepancy might be due to ultrasound techniques and the person taking the measurements, Rodger said.

“Veins are very funny – they’re very squashy, they’re very distensible and they’re very fragile,” he said. “If you take an ultrasound probe and you push a little too hard on the neck you’ll block the vein, and so it will look as if there is no (blood) flow.

“We were very careful how we did the ultrasound.”

The team did spot some abnormalities: instead of clean, straight vessels, some people had veins that looked a little twisted or distended. “But these unusual characteristics were present equally in the MS patients as the controls,” Rodger said, meaning it could just be part of normal human physiology.

In a statement emailed to Postmedia News, the MS Society of Canada, which is providing funding for the CCSVI trial led by Traboulsee, said the latest study findings “indicate there is no connection between CCSVI and MS.

“We share in the disappointment many Canadians have about these results and are aware that people with MS want more information about CCSVI. Results from ongoing research studies can offer us more definitive answers.”

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One Comment for “‘Disappointing news’ for Saskatchewan patients after Albany clinic cancels MS trial”

  • Florence says:

    Can journalists not critically look at anything? This article just repeats what was told to them by Dr. Rodgers misinforming everyone. I wish they could realize the harm they are doing. “If you don’t read the newspaper, you’re uninformed. If you read the newspaper, you’re mis-informed.”
    ― Mark Twain


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