St. Anna Hospital of Ferrara, Emilian town of about 135 thousand inhabitants and UNESCO, is located in the historic center, within walking distance of the city walls. Inside the building, founded in 1445, are the new clinic. Through a long corridor that starts from the main hospital in the course Giovecca, we arrive at the studio of Paolo Zamboni, the one whose name, for almost a year, stands in the pages of Italian newspapers, scientific journals and international press.
A desk, a computer, a diary, framed collage of photos on the walls and a toy car license plate of the Zamboni Maple Leaf on the wall. A gift from Canada will explain later. A few square meters that are now in a short time the center of the universe, the epicenter of an earthquake whose seismic wave came up in Canada.
The debate on his discovery continues unabated. Both in Italy where the doctor resigned recently by the Scientific Committee for the epidemiological study of the Italian Multiple Sclerosis Foundation, is in Canada where the re-opening of the autumn session of the Bundestag, the patients were gathered in sit-in protest at the ' Government inaction on skeptical therapy. In an all-out Zamboni takes stock of the situation, insisting, as he had announced in a recent interview with the Canadian Courier, his total willingness to open the gates, with work experience and training, experts and centers in Canada.
How should move the team of Canadian experts in Saskatchewan
The province of Saskatchewan was the first to announce funding for testing cerebrospinal chronic venous inadequacy (CCSVI), a genetic malformation of some in his veins discovered by Zamboni sclerosis. The narrowing of these veins cause, according to the doctor, abnormal accumulations of iron that are closely related to disease. The origin of the MS would then be sought in this malformation.
Premier Brad Wall had expressed his determination to go all the way, despite the negative opinion of Ottawa. The MS Society of Canada, immediately after the announcement of the Zamboni at the end of 2009, announces the intention to participate in the research and makes available in June, with the National MS Society of the United States, $ 2.4 million for seven research projects the link between CCSVI and sclerosis. One study, however, that has already been conducted for years by Zamboni and which therefore has already found some confirmations, those published by the doctor last November.
One of these diagnostic studies in Canada is led by Katherine Knox, director of the MS Clinic of Saskatchewan, according to Zamboni, "not the slightest idea of CCSVI."
"If the province wants to do a study on the treatment - he explains - the principal investigator must be an endovascular interventional radiologist or a surgeon. What is needed, Dr. Knox or his team? In measuring changes in patients. These neurologists do not need to know if the patient is subjected to treatment or not. Then analyze the data before surgery and the patient held in check by a neurological point of view to an end, for example, quarterly. They do not need to increase their background. They just do their job. In this way the process should be extremely quick. The radiologist and the interventional radiologist have, however, a background that allows diagnostic and interventionist with little to enable them to "run". Dr. Knox must not change anything nor "struggling" ... but simply to analyze the results in an objective and calm. Only then the trials in Saskatchewan could be done quickly."
Zamboni is in constant contact with the Reformed MS Society, whose founder, Steven Simonyi-Gindele, had recently attacked the Federal Health Minister Leona Aglukkaq. The doctor reiterated his call for a collaboration with experts from Canada to save time and money. "Dr. Knox and radiologists can come here in Italy - he says - we have a master who could capture a major title at the international level and could be part of the budget of the province, for example. And yet, we have made available material, movies to download in e-learning, which is then added a fortnight's work experience. Or join us potrebberp multicenter study. It took us nine months to complete the project, so they save time and we would be able to standardize the methods of data collection in order to do a meta-analytic study. With a uniformity of methodologies can greatly increase the high number of cases."
With a significant advantage for patients. "We would get a response, positive or negative, but as soon as possible - he continues - Instead of having so many fires blocks that need to be confirmed, this data can be merged together and become funds to be allocated to arrive at answers that people expect . If it is a matter of background that I am willing to exchange and to speed up the process in order to make studies available quickly is total."
The seven studies in Canada? - "Doomed to failure"
Zamboni also focuses on the debate starring patients and multiple sclerosis society, driven by a single goal in their opinion. Economically. "Unfortunately, the scientific strength not motivated by a desire for knowledge but burdened by a conflict of interest in trying to design studies that have methodological flaws that only one person can see the field," explained the doctor, referring to German and Swedish studies have recently dismantled his theory and would not follow his protocol. "By measuring the height with a tape measure with an inch or not you will never get the same results. I and others have written to the publisher. They would have to wait for our remarks before publication, at least in the name of the completeness of the information."
The doctor points out that the studies funded in Canada do not refer to the methodology that he experienced in 4-5 years. "They are doomed to failure. Two million 400 thousand U.S. dollars thrown out the window and that could be used more appropriately. Seek only to make me go to a visionary. I do not think, however, that through this funding will come fully to destroy me like they want to do instead. We, in Italy, with rates ten times lower than defend ourselves."
The doctor points out that "behind these experts are often shady types. As Freedman."
"A neurologist in Ottawa - he explained - after the funding said it was a shame to see all this wasted money to do research on a deception. Years ago, Freedman said that the sclerosis had a ten per cent mortality. In an interview with CTV said that people should be ready to fight to the death for this disease. Three years later he told reporters in Ottawa that I am a fool who exposes people's lives in danger by doing this angioplasty. I should point out that none of my patients has ever had complications."
Trials in Italy: ten centers for 500 patients, the study year-long
The protocol for the trial, already postponed for months, should be approved soon by the Emilia-Romagna and the scientific committee. The first center could start as early in November. The other Italian cities, around a dozen, should join in a few months. More than 500 patients will be seen in Italian cities. The study, explained the doctor, will last one year and the first result will be probably a year and a half from now.
In Italy the debate goes on without much fanfare, as confirmed by the doctor, "even if this does not mean that the fight is not hard as in Canada. With us is channeled in a way that patients are not forced, perhaps because I do I load the battle more directly, to get a tummy ache due to political and so on. There are eight or nine months that has left the work on treatment, not years. If we have one year after starting with the randomized trial is a big step forward. " Waiting lists are now closed for months. 24 thousand requests that are received by the Zamboni sclerosis patients in Italy and abroad. Then, he admits, has stopped counting. For those who wish to have information has been provided a point of listening (0532 236524) available three to four hours every day, which meets a college student of languages.
The stent controversy
The processing of the release of Zamboni, which is the placement of a balloon to reopen the blocked veins, "lasts an average of an hour depending on the complexity and operator experience." Zamboni not recommend the use of the stent, a metal mesh that is introduced into the vein is expanded to the level of obstruction, for two reasons: "At this moment we must show that the treatment is useful for neurological disease and to do this we should not have any type of complication. The use of stents involves more procedures that can be successful so it is also an increased risk of complications. Normally, the jugular vein is very large and small when we sleep when we are awake. This means that different volumes. If you put a piece of iron fixed in the neck this regulatory game is lost. The second reason is that I do not have a material dedicated to the problem of CCSVI so I have to use the materials rather questionable. Once it has proved its usefulness, you can create technology tools devoted to this problem, much more comfortable and flexible."
Zamboni wants to clarify once and for all the case with the American surgeon Michael Dake and the tragic death of a young woman after this type of intervention: "It was a ride report from neurologists who have then spread to the media. After the insertion of the stent should take an oral anticoagulant. On the flight to Phoenix, the patient had a cerebral hemorrhage due to an aneurysm, could happen to the 6 years as at 96. Happened to her after the operation. An adverse event and then chronologically concomitant intervention but not caused by the doctor."
Dake had been discussing for another episode, this time with a happy ending, but not without having presented complications for the patient had undergone open-heart surgery. "This was the only real serious complication of Dake - he explains - During the operation, the stent has migrated to the heart. Luckily I managed to save the patient, a researcher at Berkeley which I had written long before there was a notion so popular CCSVI. I had to wait but he had seen suggested that the risk was low enough and wanted to do it now. Now you regret not having done only the dilation of the veins. If you use these systems is obviously more drastic possibility of complications. I'm more on the way slower. If I come twice a patient and do not risk anything is a disgrace. I have people that after four years do not even know anymore what multiple sclerosis (Zamboni as the wife of the doctor himself has taken care of and now it no longer has any symptoms of the disease, ed) and have two of these interventions.
One thing though, he says, has not been understood. "I never proposed angioplasty as a treatment of disability. I do not expect angioplasty to clear the neurological damage in a patient stabilized after many years. It is a therapy that should prevent further disability."
What is certain is that Zamboni has been able to rekindle hope in people with MS. A real hope. Even for those who are devastated by years of illness. "The symptoms tend to fade and fade. The hope comes from the fact that I offer something concrete, measurable and visible that I do not know whether it is part of the thirty or one hundred percent of the disease but it is certainly one of the causative. Probably competes with other issues and perhaps to varying degrees in people. Also because I think there is only one multiple sclerosis. But CCSVI occurs in most patients and at least now you have something you can control and treat. " "You no longer have an unknown monster that lies with you to bed every night, but a monster that you can keep quiet for the time being - continues the doctor - is very different psychologically. Facing the unknown, dark, black, what your mind can not understand or doctor can not explain is much heavier."
The internal struggle between radiologists and neurologists
Being a complex and multifactorial disease, amyotrophic is of interdisciplinary interest, and the interventional radiologist should offer a service to the neurologist who does not want to either work or figure out if this service could be useful, it would pass just in the wrong. And this is very wrong.
The answer to Florio
In what was a real scientific and political earthquake, which has drawn critical acclaim and with it, Zamboni calls for dialogue and constructive response to Francesco Florio, chairman of the Radiology Section of Vascular and Interventional Radiology Society, which by pages of the Corriere had harshly criticized his treatment. "Dr. Florio has no evidence to speak - he says - His attitude is a bit 'stupid because it goes against a position internationally. He never studied the veins do not know the CCSVI.
The moment of discovery
Zamboni was fond of all patients who have to care. "How not to be?" He asks. And remember the time of its discovery. "All persons to whom I explained the treatment they are subjected to my delight with the project. In the first three years I had told them not to tell anyone, not even his girlfriend, otherwise the project would be skipped. They had to suppress their joy. But at least I managed to get to the publication of the study safely ...», jokes.
Translated from:
http://www.corriere.com/viewstory.php?storyid=102668
Alternate Link:
http://www.ccsvi-sm.org/?q=node%2F425