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Paolo Zamboni in his studio at the University Hospital of Ferrara. (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. (Alessandro Vincenzi for The Globe and Mail/Alessandro Vincenzi for The Globe and Mail)

Paolo Zamboni - a Q&A Add to ...

I don't think so. But I think it is very important to divide what is speculation for business from what is a good activity. There are centres in the United States, Italy and other countries that [are doing the intervention]without big publicity and have highly qualified people capable of managing the complications. So this is very important.

Does it upset you that people are traveling far from home and paying to have this done?

I cannot control what happens. I know there are a lot of centres in the world stating that they are in contact with me or use my methodology or are formally trained by me. But really I do not know them. So I understand there is a lot of speculation and it is very difficult to defend people. The only right defence, in my opinion, is a clear action from the government. I think it's very important that the government understands this kind of non-profit treatment research is very important and needs to be done urgently for ethical protection of the patient. That's my message.

So you think governments need to step in and say we're going to do this treatment in a controlled fashion?

Absolutely. I cannot understand why a country like Canada with a very good public-health system refuses to support a treatment study on 500 people. I think that is not a good thing. It's not the correct answer.

Do you think it would save lives if they stepped in?

I think that a study like this, using the proper, conservative, safe treatment with ethical protection and the possibility of managing the event of a complication, can be very useful for people.

You've said you never recommended the use of stents in the procedure. Why do you think people keep getting them?

I think this is not a very responsible thing in this particular moment. We need to be conservative. The risk of migration is very high, as is thrombosis. I have shown that managing CCSVI with two balloon angioplasty, you may have a perfect result. So I prefer to use two approaches rather than just one in a dangerous way.

Are lots of people with MS contacting you for advice?

Yes, we have hundreds of calls and e-mails every day. This is very difficult to manage, of course.

Do you reply to all of them?

We have a website with a FAQ, we have an answer line open three hours daily with possibility for people that call with the possibility to speak English or French or another language.

Do you feel overwhelmed by the attention?

Oh yes, absolutely. All the patients have a personal story to tell. There are thousands of procedures done all over the world. I cannot control what happens in any way. My academic activities cannot control what happens in the world.

Do you feel bad that you're name is connected to these types of deaths?

We have thousands of requests for visits, consultations. But I never reply because it's not possible. I work 12 hours a day on this kind of research. I am not a consultant and I do not perform any activity related to the business of CCSVI at all.

What are you researching now?

It's going very well. I think that in the next six months we'll publish several publics, some in cooperation with other universities around the world. In one month, I believe we'll get final approval for a big, double blinded, randomized control trial on the value of balloon angioplasty in MS treatment. This may be the only study to help us understand the role of CCSVI treatment. It will involve approximately 15 centres in Italy and double blinded and randomized in order to avoid any residual doubt on the so-called placebo effect. There will be an objective measurement, not just the subjective clinical assessment of a neurologist, but also by using the proper device for measuring motor activity, balance, and neural activity.

When will that study be completed?

Two years. The observation will be 15 months. But you have to get all the data from all the centres and the analysis will require time.

If you find that the procedure is not helpful, do you think people will stop getting the procedure done?

I don't think so. My recommendation at this particular moment, from a scientific point of view -which is the only point of view interesting for me - is that we do not have enough data to recommend surgery in MS. But individuals, both physicians and patients, are completely free to do what they want. I cannot control this. I do not want to control this. But certainly, the message is that we are not ready in this moment to recommend surgery.

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