The doctor whose name has become synonymous with a controversial treatment for multiple sclerosis is speaking out, saying it's time for the Canadian government to step in and offer a solution.
In a rare interview on Tuesday from the University of Ferrara in Italy, Paolo Zamboni said he has been inundated with urgent pleas for help from MS sufferers around the world and seen his name attached to dangerous practices that have led to accidental deaths and dashed hopes. His theory - which suggests that MS might be caused by blocked veins and could be cured with a simple procedure known as an angioplasty - has spawned an industry beyond his control, he said, and led him to conclude that governments must take responsibility to prevent unsafe treatments abroad by offering MS patients a safe procedure at home.
"The only right defence, in my opinion, is a clear action from the government," Dr. Zamboni said.
It has been just one year since the Italian medical professor turned the MS community on its head by suggesting that MS - long regarded as an autoimmune disease - might be caused by chronic cerebro-spinal venous insufficiency. Since then, hundreds of Canadians have sought out the unproven "liberation" treatment overseas, including an Ontario man named Mahir Mostic, who died last month after undergoing an angioplasty in a Costa Rican clinic.
So far, the Canadian government has followed the recommendations of an expert panel convened earlier this year to examine Dr. Zamboni's theory. The panel has advised against clinical trials of the procedure, opting instead to fund research exploring the connection between blocked veins and MS. If evidence emerges that supports the introduction of surgical trials, said Tim Vail, a spokesperson for the Ministry of Health, the ministry would "fully support and fund" them.
"I cannot understand why a country like Canada with a very good public-health system refuses to support a treatment study on 500 people," Dr. Zamboni said. "I think that is not a good thing. It's not the correct answer."
Mr. Vail said the government will not be pressured into okaying a potentially dangerous procedure. "Just because people are going to get it anyway, that doesn't make it safe," he said. In response to Dr. Zamboni's statements, he said "we make our own decisions based on the expert advice of Canadian doctors and Canadian researchers."
MS is a debilitating disease that can affect vision, memory, hearing, balance and mobility, and Dr. Zamboni said Canada's step-by-step approach to investigating his theory is taking too long, wasting time that MS patients simply do not have.
His office receives hundreds of calls and e-mails every day from MS patients around the world, many of whom beg for private consultations. The University of Ferrara, where he works, has set up a dedicated website to answer some of their questions, as well as a phone line that is open for three hours each day to provide information in a variety of languages.
The doctor himself works 12-hour days, attempting to balance his own research with the weight of his new-found following.
"All the patients have a personal story to tell. To manage this requires a considerable amount of time each day," he said. "And this is not a good thing for progressing the research."
It bothers him that his name is referenced in connection to Mr. Mostic's death, and procedures carried out in clinics around the world that do not adhere to his theory or his advice.
A stent was used in Mr. Mostic's angioplasty, a technique Dr. Zamboni has spoken out against because the device used to hold veins open can migrate and cause blood clots like the one that killed the Canadian patient.
And he agrees that there is not enough evidence to suggest that angioplasty offers any actual benefit when it comes to MS. But he also knows that people will not stop seeking out the treatment, even if he tells them to.
"Individuals, both physicians and patients, are completely free to do what they want. I cannot control this," he said. "I do not want to control this."
The only answers he can provide will come from research, he said.
Next month, he will begin a state-approved double-blinded trial which will follow a large group of MS patients after they receive balloon angioplasties. The study will involve approximately 15 centres in Italy, and Dr. Zamboni hopes it will clear up any "residual doubt on the so-called placebo effect."
The patients will be observed for 15 months following the procedure, their motor activity, balance and neural responses measured to see if there has been any objective improvement in their condition. Dr. Zamboni expects to have concrete findings in two years' time.
In Canada, a similar clinical trial of the angioplasty procedure is being planned in Saskatchewan, where provincial officials say they are undeterred by Mr. Mostic's death.
"The case you mention does not change our position," said Kathy Young, communications director for Premier Brad Wall. The Premier and Health Minister Don McMorris "have said from the beginning that patient safety comes first and that we will be led by experts, and that's what we're doing," she said. The provincial government has earmarked $5-million for clinical trials, which could begin as early as next spring, she said.
Dr. Zamboni hopes surgical trials like this one will be allowed to go forward even in the absence of evidence that they will work.
"All these studies can be carried out contemporaneously and give us a lot of information in a reduced time," he said. "Because time is very important for people."
With a report from Caroline Alphonso