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Dr. Paolo Zamboni.

Nathan Denette/The Canadian Press/Nathan Denette/The Canadian Press

When international specialists in disorders of the nervous system gathered in Toronto last year for their discipline's largest annual conference, they were confronted one afternoon by two men determined to change the world of neurology with a radical new theory about one of the great mysteries of modern medicine: multiple sclerosis.

Paolo Zamboni, the Italian surgeon who had developed the theory, and his disciple and ally, Buffalo-based neurologist Robert Zivadinov, faced intense questions from the many skeptics in the crowd. But they held their own, steadfastly declaring that further research would determine whether what they were saying was true.

Last month, the neurologists gathered again, this time in Honolulu, but Dr. Zivadinov was no longer at Dr. Zamboni's side. A major journal had just published his contribution to the "further research," and now he was distancing himself from the assertion that MS is not, as science has long thought, an incurable autoimmune affliction, but a simple vascular disease caused by blocked veins in the neck.

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This diagnosis, and the notion that minor surgery can ease their suffering, has sparked overwhelming hope among patients and a million-dollar industry, as well as accusations of conflicts of interest and a scientific turf war to such a degree that even its biggest champion cautions against fully embracing his theory before it has been proved beyond a doubt.

"We need to collect more data," Dr. Zamboni said in a telephone interview from his office at the University of Ferrara.

The debate is especially intense in Canada, which has one of the world`s highest rates of MS - 240 cases for every 100,000 citizens, more than double that of Britain.

Last Thursday, demonstration marches were held across the country to press politicians to give the Zamboni procedure the green light. Ottawa and the provinces have thus far refused public access due to a lack of evidence. As a result, desperate patients have travelled vast distances and spent thousands of dollars to obtain the treatment for a disease that is chronic, debilitating and can lower life expectancy by years.

However, Dr. Zivadinov's findings are part of a growing body of evidence that suggests that they are wasting their time and their money - and perhaps putting their lives in danger.


Trained as a vascular surgeon, the 54-year-old Dr. Zamboni began working toward his unorthodox approach in the mid-1990s when his wife, Elena Ravalli, was diagnosed with MS. He pored over medical literature in search of answers and came upon repeated references linking the disease with of build-up of iron in the brain.

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Examining MS patients, he found virtually all of them, including his wife, had malformed or blocked veins in the neck that he suspected might be responsible for the iron accumulation, since the veins in all the healthy people he studied were normal. To see if he could restore normal blood flow, he performed a "liberation procedure," or as balloon venoplasty (similar to angioplasty in the heart), to widen the veins.

He published his findings in December, 2009, and they reverberated around the world. Not only was the procedure safe, but most of the patients said their MS symptoms, ranging from numbness to speech problems to loss of balance, had disappeared.

Media reports of his astonishing feat soon had Canadian patients clamouring for the surgery. When that wish was denied, hundreds flocked to clinics that had begun to offer it as far away as Poland, India and Costa Rica, spending up to $20,000. The tide continued even after 35-year-old Mohir Mostic of St. Catharines, Ont., became one of two people known to have died after having the procedure, and others began to experience serious side-effects.

But researchers trying to duplicate Dr. Zamboni's findings could not do so, and began to poke holes in them. At least six studies published in the past year have raised serious questions.

Last August, two reports in the same issue of the Annals of Neurology found scant evidence of the condition Dr. Zamboni had dubbed chronic cerebrospinal venous insufficiency (CCSVI). In fact, none of the MS patients studied met more than one of the five criteria Dr. Zamboni said are needed to diagnose CCSVI.

A paper in February's issue of the Journal of Neurology, Neurosurgery and Psychiatry again found no vein problems, prompting its authors to "cast serious doubt" on the concept.

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Finally, Dr. Zivadinov, a specialist in MS who teaches neurology at the University of Buffalo, fanned the flames even further.

After defending the procedure to his colleagues at the Toronto conference, he went home, looked at it more closely and found blocked veins, but in just 56 per cent of patients with MS. What's more, the veins of 23 per cent of the people he examined without the disease also had blockages.

Concluding that CCSVI does not cause MS, he largely distanced himself from the theory he'd once endorsed - and "created a lot of controversy," he admitted in an interview. "We have been really bombarded by questions."

Zamboni defends work

Despite all the skepticism, Dr. Zamboni has strengthened his resolve, leading observers such as Steven Novella, assistant neurology professor at Yale University and executive editor of Science-Based Medicine, to suggest that he is too invested in his idea.

"There's a fine line between a crank and a genius," Dr. Novella said. "I think that Zamboni is skewing toward the crank side now."

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Claudio Baracchini, a neurologist at the University of Padua, not far from Dr. Zamboni's base in Ferrara, led one of the studies of CCSVI, and said in an interview that he suspects the fault lies with inferior technology and flawed research methods.

Ultrasound machines, which Dr. Zamboni uses to look at neck veins, are unreliable and can be wildly inaccurate, if the people operating them aren't well trained, he explained.

Dr. Baracchini also said that he has met Dr. Zamboni and dismisses the ultrasound device he employs as a "garbage machine."

A panel of experts convened last summer by the Canadian Institutes of Health Research also has sounded the alarm, reporting that veins are notoriously difficult to examine with ultrasound technology, which can easily compress them to seem constricted.

The panel also noted that Dr. Zamboni's research wasn't "blind" - researchers knew which test patients had MS, and the patients knew they were receiving treatment that might help. In such circumstances, the report noted, there is a "natural human tendency to find what one is looking for."

In the beginning, Dr. Zamboni agreed with this criticism, admitting in his 2009 paper that not making the blind was a "major shortcoming" and "there is a great possibility that bias could be playing an important role."

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Now, however, he staunchly defends his work, saying it has become the target of medical infighting. "It seems that researchers coming from neurological background [are]trying to interpret … findings in a negative way," the vascular specialist said in an interview.

He also claimed that Dr. Zivadinov's findings, even though the abnormal veins were in barely half of the MS patients, confirms his theory rather than disproves it. But there is one discrepancy he cannot explain: If CCSVI causes MS, or is even caused by it, why are researchers finding abnormal veins in people who don't have the disease?

His supporters seem unfazed by this. Often patients who are highly mobilized on social networking websites, they dismiss any contradictory findings, citing a Polish researcher's claim last month that 90 per cent of his MS test subjects had abnormal veins, as well as the fact that an international organization dedicated to venous diseases has recognized CCSVI.

The problem is that Dr. Zamboni was a member of the panel that recommended endorsing his theory, and Marian Simka, the Polish researcher, happens to perform the "liberation procedure" himself.

"We've been here before," said Yale's Dr. Novella. "Most of the time, when enthusiasm races ahead of evidence, it's to the detriment of everyone involved, especially patients."

Which is a concern Dr. Zamboni appears to share. Although confident about his discovery, he worries about one of its major byproducts: the growing number of clinics that have not waited for the final word on his procedure before putting it into practice.

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What they do, he says, is "unethical."

NEXT: The trouble with unregulated clinics.


55,000-75,000 - The estimated number of Canadians that have multiple sclerosis.

100 - Per cent of MS patients Paolo Zamboni said had malformed or blocked veins, which he says may cause the disease.

56 - Per cent of MS patients Robert Zivadinov, a Buffalo neurologist, said had blocked veins.

22,000 - Number of MS patients who applied for 100 spots on a Canadian clinical trial of Dr. Zamboni's theory.

At least 2 - Number of patients, including one Canadian, that died after receiving the "liberation procedure."

$5-million - Amounts both the Saskatchewan and Manitoba governments have pledged to study Dr. Zamboni's theory and procedure. The provinces have some of the country's highest rates of MS.

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