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
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