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Paolo Zamboni in his studio at the University Hospital of Ferrara, Italy on Nov. 19, 2009. (Alessandro Vincenzi for The Globe and Mail/Alessandro Vincenzi for The Globe and Mail)
Paolo Zamboni in his studio at the University Hospital of Ferrara, Italy on Nov. 19, 2009. (Alessandro Vincenzi for The Globe and Mail/Alessandro Vincenzi for The Globe and Mail)

Suspicions of bias on both sides of the MS divide Add to ...

Champions of a controversial new treatment for multiple sclerosis contend that conflict of interest is keeping it from being accepted in Canada.

They say the medical establishment is beholden to drug companies determined to protect $300-million in annual sales of MS medication, whereas Paolo Zamboni, the Italian surgeon who came up with the new approach, is motivated simply by patients' well-being.

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When Dr. Zamboni published his remarkable assertion that, instead of being an incurable autoimmune disease, MS can be alleviated by freeing up blocked veins in the neck, he was asked to make public any ties that might influence his research. His answer: "None."

But he failed to disclose that he has worked closely for years with a leading Italian manufacturer of imaging devices used to detect the condition he calls chronic cerebrospinal venous insufficiency. Genoa-based Esaote advertises an ultrasound machine specially for the task said to be worth $75,000.

In a telephone interview from the University of Ferrara, Dr. Zamboni confirmed that his lab has received between $200,000 and $250,000 in equipment and technical assistance from Esaote.

His relationship with the company began in 1996, and is a "historical co-operation" that has "led to more than 60 [academic]publications," according Fondazione Hilarescere, a funding agency in nearby Bologna that supports medical research "with special reference" to that of Dr. Zamboni.

Esaote also is a major booster of CCSVI-related events, underwriting Dr. Zamboni's trip last month to a conference in Australia, and contributing in March to the first gathering, in Bologna, of the International Society for Neurovascular Disease, a body founded and until recently led by Dr. Zamboni.

Having a researcher work so closely with a company can raise eyebrows.

"If you are financially interested in seeing a given product make it to commercialization, you may be less inclined to collect and report information that's adverse," said Jonathan Kimmelman, an expert in biomedical ethics at McGill University.

Dr. Zamboni argues that his ties to Esaote do not constitute a conflict because he has not profited personally: "They gave us just equipment and technical assistance, nothing more. I am really completely independent from Esaote." The company has declined repeated requests to comment on the situation.

Dr. Zamboni confirmed that he holds intellectual-property patents for his system of diagnosis, which he insists is the only way to identify CCSVI properly, and for a special catheter designed to open blocked veins.

However, he added, there is no market for products related to CCSVI because the science is still emerging, so his patents do not constitute a conflict - at least for the moment.

Money, however, is not the only source of conflict, according to Prof. Kimmelman. Personal attachment also can skew a researcher's judgment.

Dr. Zamboni countered that his "scientific passion" is a positive force, and drives his work. But others suggest it tempts him to play down criticism of that work.

He has accused researchers who couldn't replicate his results of using flawed methods - or of failing to follow his diagnosis "protocol," which is an especially weak complaint, according to Anthony Traboulsee, director of the University of British Columbia Hospital MS Clinic.

"If something is real, you should be able to find it using different techniques," said Dr. Traboulsee, currently conducting research on the Zamboni hypothesis. "It shouldn't be completely technique-dependent."

Dr. Zamboni also has resigned from a major study led by the Italian MS society, citing reasons that society chair Mario Battaglia says "are not justified." And he has attempted to reinterpret findings that appear to undermine his own.

Last month, one of his closest allies, Buffalo-based neurologist Robert Zivadinov, reported blocked veins in barely half of the latest MS patients he has studied, as well as almost one-quarter of his healthy test subjects.

Therefore, he concluded, CCSVI does not cause MS. But Dr. Zamboni objected, arguing that, even though so few patients had blocked veins, the study actually reinforced his theory.

"He's shifting his criteria around - first, it was 100 per cent; now he's taking anything to be conciliatory," said Steven Novella, assistant professor of neurology at Yale University.

"He obviously is hugely invested in this conclusion."

Next: What lies ahead for the Zamboni treatment.

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