This Is MS Multiple Sclerosis Community: Knowledge & Support

Lyon wrote:

You're welcome, its been quite interesting to find the Italian articles and have Google translate them into English. I feel we are losing some of the content by the limitations of computer generated translation, but enough is still there to get a clue as to what's happening.

I find these medical turf wars (at least it seems to me that's what's going on) very sad.

I can't understand why the AISM (Italian MS Society) wouldn't follow Dr. Zamboni's protocol to the letter, and let him train the sonographers. This should not interfere with the results of the trial, which would still be blinded.

Following Dr. Zamboni's protocol exactly is really the only way people with MS who are believers in CCSVI will be satisfied with a study's results (be they positive or negative).

If you want to find out if someone else's protocol works, you have to test that protocol, not some other protocol.

Mary Ann

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DX 6-09 RRMS

Concerned wrote:

Hi Concerned, I think you like to debate!

As far as I know, sonographers who detect Budd-Chiari and May-Thurner have been trained in how to detect Budd-Chiari and May-Thurner. Despite some similarities, those are different viens in different locations with different issues.

Its very hard for me to understand why others can't accept that finding a particular condition, in this case a very complex condition involving veins that change dimension depending on the patient's position, as well as have a wide variety of issues, such as malformed valves, stenoses, webs, septums, reflux, etc, would not require specialized training to detect.

I pretty much take Dr. Sclafani's at his word when he says that his sonographer who is an expert sonographer, had difficulty finding CCSVI until he went through the training, and now he finds it quite readily. This is no different than learning any other new skill. It is not a sign that the condition is imaginary. Its a sign that its a specific learned skill.

What we really need in order to be able to determine to everyone's satisfaction if CCSVI is real, is a study where the sonographers have recieved extensive training from Dr. Zamboni, and THEN have the sonographers test a number of patients in a double blind fashion, where half have MS and half do not, and see what they find.

I'm not opposed to skepticism, it can be healthy. But in order to get past the skepticism, to determine whether Dr. Zamboni's protocol is or is not effective, one must use that protocol, test that protocol. In order to test the protocol, you have to train the sonographers in the protocol.

By the way, I remember reading in Dr. Sclafani's thread that thrombosis of the IJV'is very easily found with standard ultrasound, it does not require additional or specialized training beyond what sonographers learn in sonography school. Some techniques just are simpler, others are more subtle and complex, requiring more training.

I think its a little like learning to play chopsticks versus a sonata on the piano.

Mary Ann

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DX 6-09 RRMS

Hi Mary Ann.

It's a little too late and I'm a little to discombobulated to debate right now, but when I'm in better form I'll really respond to your post. You're right, I do like to debate. I've been a purveyor of unpopular ideas all my life, and I don't take offence to people disagreeing with me, so hopefully we can have a good debate tomorrow!!!

It's only 1:06 AM and I'm seeing backwards already!

To better understand this topic one has to read all the documents provided in http://www.fondazionehilarescere.org/it ... vanti.html

A google translation of most of them will follow.

Learn with regret that without giving any reply to the President of the Foundation Hilarescere here below, AISM self-IMF decided to proceed (go to website AISM-IMF) without confronting the clear and objective reasons expressed therein, we make it transparently known reasons for our decision.
Clearly did not agree with the methods of the study funded by the IMF, the University of Ferrara and Fondazione Hilarescere participate in other studies aimed at identifying epidemiology and diagnostic modalities of CCSVI in its correlation with multiple sclerosis.

Read the documentation:
> The Rector of the University of Ferrara to the President of the Foundation Hilarescere
> Meeting Minutes AISM-IMF Training Course on CCSVI
> Communication AISM-IMF study on the prevalence of MS in CCSVI
> The President of the Foundation to the President Hilarescere AISM-IMF
> Prof. Zamboni resigns by the Steering Committee of the epidemiological study AISM-IMF

> Meeting Minutes AISM-IMF Training Course on CCSVI
Meeting Minutes Training Course on IMF CCSVI (Ferrara 8 to 9 July 2010)
Present: Zamboni, Finocchi, Menegatti, Coppo, Mancini, Zedda, Marinoni, Saia, Gaeta, Viaro, Sette, Ciuffoli, Sanguigni, Milite, Nuzzaco, Zuddas
On 09.07.2010, at the end of the course, IMF researchers have gathered for some final comments, which are summarized below and include the following:
Need to make any future exercises and a recall protocol completed and distributed to all centers in order to work on their learning curve on parameters set by the Protocol.
It is expressed by most neurosonology present course the need to draft a simpler protocol, can be performed strictly by all study participants, which allows the detection of hemodynamic parameters and ultrasound diagnostic CCSVI.
Some centers of excellence will reserve the right to supplement the protocol with a larger number of data, however, be used for the study.
The comparison between the classroom of Dr. Sette and Prof. Zamboni to the factors likely to influence venous hemodynamics, it is suggested to add the protocol that the examinations are performed at a constant temperature, which can be the most comparable between centers.
We discuss some aspects of ultrasound for the various pathological characteristics of intraluminal echoes observed between J1 and J2 in B-mode ultrasound in the cases examined, we shall refine these findings by creating a synopsis that will be prepared by Dr. Zedda and made accessible to all centers.
After discussion it is concluded that the participatory budget of a probe microconvex centers conducting the study could help to facilitate the detection of pathological intraluminal echoes in J1, which are sometimes due to the anatomical location, poorly visualized with the only linear probe.
Finally recognized the necessity to use the same equipment in all centers involved in the study.
The discussion showed that the colleges threshing machine that offers the best performance on the extracranial is Esaote Mylab Vinco, and for its technical features is found to be particularly powerful for this type of study. In particular, investigators have noted that the subtle malformations intraluminal are soundproofed and made visible in the best way is with small linear probes that microconvex with that in this model has. For the intracranial district, from being held in Reggio Emilia last June 17 to 19 showed that when using the time window, the device is the most powerful Esaote Mylab 30 Gold, already supplied to the laboratory of Dr. Malferrari (RE). The bulls argue that experience, although an 'older generation equipment has been implemented with the hardware changes thanks to the information and experience of the group of Dr Malferrari same. This implementation is able to detect more effectively with the forms and color Doppler signal of the intracranial veins.
It is established to require the manufacturer to make similar changes to the model Vinco My Lab to improve its performance for the intracranial portion, currently poorly performing.
The need to equip all the centers of the unit itself is all bull experience a prerequisite for implementing the survey in order to reduce bias as much as possible.

> Communication AISM-IMF study on the prevalence of MS in CCSVI
Italian Multiple Sclerosis Foundation
a world free from 3M
Prot N. 199/10/F14
Genoa, August 3, 2010
To
Steering Committee
CCSVI prevalence study of multiple sclerosis and other neurodegenerative diseases
Dear all,
after the meeting of the "Steering Committee" held in Milan on July 26, the subsequent mail circulated between us and the ensuing discussion, we must come to some final decisions in relation to the programming of the University of CCSVI prevalence of MS than in normal controls and other neurological diseases. The fixed points on which we all agree that arise from a number of collegiate meetings, and that must necessarily be shared by all those participating in the study are as follows:
1 The study must be organized and carried out relatively quickly, otherwise it could lose all of its interest and its importance, since in many other cities in the world certainly Similar research is under way. This means that we must combine education, training and quality of players with the number of patients will be evaluated and the schedule of reading examinations.
2 Therefore, the study must necessarily begin with an initial group of centers, where they operate neurosonology certificates at the beginning of November 2010, followed by a second group of centers that will neurosonology certificates in December and will then begin enrolling patients in January 2011.
This third program of two groups, with the first recall of the training and certification in September and October and the second recall in November and December certification had already been decided in Milan on July 26 and it 'should respect those deadlines.
4 Despite all the reservations, we should remember that, with respect to neurosonology participants, this is the almost absolute majority of specialists with broad and extensive experience in eco arterial Doppler, and particularly interested in participating in the study on eco venous Doppler. We agree on the necessity and importance of training, but the venous abnormalities identified by Prof. Zamboni in recent years, on the other hand must necessarily be detectable by other specialists in the field of quality and therefore should be generalizable, if they want to have real relevance clinical and epidemiological. For this dedication AISM neurosonology of training funds that will participate in the study and potentially use this diagnostic approach in the future throughout the country.
5 The number of centers and 'about 20, as shown in the table you have all received. Following the suggestions of many non-MS will be reduced to 20 normal controls, 10 other neurological degenerative neurological diseases and 10 other "inflammatory. The number of people with MS will be maintained at 60 (30 RR, 15 SP, 10 CIS, 5 PP).
6 The total number of cases carried out in Italy (20 centers) will be 1200 MS (600 RR, 300 SP, 200 CIS, 100 PP) and 800 controls (400 normal, 200 and 200 other degenerative inflammatory diseases), however, a number that retains all its size and statistical power.
7 The data of concordance and discordance of the various participants in the study, very important, will be studied later, after the evaluation and provide general information certainly very interesting.
8 The firm must be quick and easy to have a primary endpoint, ie the prevalence of CCSVI according to criteria developed by Prof. Zamboni the various types of patients.
9 Since we still want to collect even the most interesting scientific information possible, and do not mark only the sample size, it is essential to also carry out an ancillary study large enough to be able to get additional information on venous flow in MS. This ancillary study will be to free participation of the centers involved, but patients must have a size of not less than 400 to 500 cases. 4-5 centers already expressed interest to participate, using the protocol developed by colleagues Sette, Malferrari, and Zamboni, and then certainly we will reach a very large number of cases performed, giving further quality research supported by the IMF.
10 The time will therefore be:
Check out the study:
Time of inclusion of patients:
Deadline reading data. Data processing and final report:
beginning of the end of June 2011 November 2010
end September 2011
end of 2011
We hope that you all agree with these points, however, had already been decided partly in Milan and then everyone's efforts we can now devote to the preparation and conduct of the study.
Sincerely
Giancarlo Com i Gianluigi Mancardi Maria Pia Sormani Paola Zaratin Mario A. Battaglia

> The President of the Foundation to the President Hilarescere AISM-IMF
Dear Prof.
IMF President Mario Alberto Battaglia
Via Workers 40
16149 Genova
Bologna, September 8, 2010
Dear Prof. Battaglia,
Our letter of 12 July showed structural problems in coordination with the IMF-AISM imagined and the Center for Vascular Diseases, University of Ferrara Hilarescere sponsored by the Foundation. How do you see the letter that the allegations, the same was born in a little over two months of intense collaboration between the University of Ferrara and our Foundation. It 'a new reality, the relevance of the problems generated, highlight it again and again unnecessarily by prof. Zamboni (who she calls with incorrect shared instrumentality as such way), would have required an urgent response to effectively resolve them without further difficulties.
She has found sensible reply, however, with a number of undeniable, self-evident as, statements of principle when he entered as a pearl, a statement (the comparison with people with multiple sclerosis after the intervention had a beneficial or anyone, or are worse) completely anecdotal, have to ask, then, the president of a research foundation, what is the scientific rationale for this, totally unfounded in our experience, published statement. As is often pointed out, are slow, incomprehensibly Byzantine procedures to understand and recognize the effects of our research. And this attitude only confirms once more. On the road of science does not proceed with clarity and linearity along, however, wanted to appear only in the public auto-justification.
In the meantime, you have self-referentially proceeded to go forward in establishing a working hypothesis for the validation or less than suggested by our research on the prevalence of MS in CCSVI than the normal population; IMF wrote the letter dated 3 August, enclosed, and sent the Protocol to the CRO to make it enforceable without changing any of the aspects that the Prof. Zamboni for months has sought to have the same solid scientific credibility. No response from you, Professor Battaglia, in all scientific questions posed about the feasibility study to ensure its accuracy epidemiological. Yet she herself, by an epidemiologist, of course is aware that if the collection of data was lacking, the whole epidemiological survey would be emptied of its scientific value.
Not even considered response to the hypothesis of significant issues raised by Prof. Zamboni, even when suggested by others, members of the steering committee, which Prof. Tesio, also investigators, chosen by you, signed a document (attached) which required clarification and methodological techniques designed for the efficient execution of the study. They too have been completely disregarded. This is unacceptable. What do you think? Hastily proceed in what is visible without worrying about building the foundations of a solid system and the result is bound to collapse noisily. And the repeated references to the logical root operator has opposed a plastic silence imagining that the mere presence at meetings of Prof. Zamboni or amendments to the result. Well, the thought of the professor about it is attached.
Curious anzichenò; already collaborate in similar studies in various parts of the world, even by state institutions, and scientific criteria adopted do not intend to totally ignore, even without discussion, as well as the demands of those who will practically realize, the way of 'exploration and testing suggested the experience of the discoverer of what we want to investigate. Given that this was blatantly not sure why you wanted by Professor Zamboni tame the investigative capacity, but maintained and protected, with this to please inform us that 'the Prof. Paolo Zamboni, I 'Foundation Hilarescere are available, in these conditions for this activity. Do not we end up seriously because it did not publicly endorse the necessary methodological premises.
We are aware of the problem that our decision creates in those who used the stage to raise funds this relationship as the foundation, but are not trivial differences of opinion to move to that, but the non-acceptance of a methodology that allows the efficient feasibility study and the veracity of the resulting epidemiological survey.
Sincerely.
Fabio Roversi-Monaco

Hi Sotiris,

Thank you for posting these translations!

I so wish we had a native Italian speaker to shed more light on some of the subtleties of these articles.

I can readily pick up on the tone of frustration and discord in the letter and meeting minutes, but I am unsure who is saying what to whom. It is clear that there was a falling out between Dr. Zamboni and the Italian study sponsors, and that Dr. Zamboni felt that the study sponsors were not including him in its decision making process or responding to his concerns about the viability of the study's design and implementation.

This quote from the translated letter, which I think must be from Dr. Zampboni's Italian CCSVI foundation to the study sponsors, kind of sums it up:


Yikes! What can be done? I again wonder if a letter writing campaign, or going to the press might be helpful...

_________________
DX 6-09 RRMS

Concerned wrote:

Me too, as long as it is a cordial and respectful exchange of ideas.

I stayed up WAY too late last night reading through ThisIsMS. I probably should focus on real world tasks today like laundry and cooking, but thanks for the interesting exchange, and I'll check back later!

Mary Ann

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DX 6-09 RRMS

HILARESCERE PRESS STATEMENT of November 20, 2010

Who is responsible for the current problems?

If as seems to be the case, paying or waiting on Dr. Zamboni to do training is anathema to anyone, I am sure by now there are many technicians and doctors who can do this. They have probably even kept notes! Arguing ad hominem is completely unnecessary. I think he is often the object of misplaced and ridiculous debate because he takes it all so seriously, for which we can be grateful.

He has certainly had enough problems with people who had no training and went on to publish their wrong-headed findings in well-established journals. Maybe that is one reason he is slow to give his approval to a study which promises to do more damage to reputations, and excuse more foot-dragging, though negative findings can always be easily dismissed. It is just not a way one would want to spend one's life, forever analyzing broken studies.

Appropriately trained personnel should be more available by now, even though they seem to become extremely busy upon finishing their courses. Perhaps one of the objects of these trials is to evaluate the quality of training. I would have thought that would be a separate issue. I think it safe to say we are not studying our own ability to provide cheap technicians quickly.

It may be difficult to do, but perhaps it is time Dr. Zamboni kicked some of his trainees out of the nest. Also time for opponents of the science of CCSVI to stop depending so much on their assessments of the man, and more on rational argument.

I have seen very little here, for instance, that leads me to think any of these electronic scientists have read word one of his or his colleagues' writing, maybe believing it undignified to do so. There have been precious few direct quotations of these papers. Why? They are translated well. It's not lack of brains, even in this backwater we call Canada, so what is it?

Dr. Zamboni is not the only person who can do this training. It is precise, but not nuclear physics. Let's let that issue rest and start discussing reality, instead of the legends which seem to exist in the minds of Dr. Rose and those of his stripe. Driving out demons may be good fun, but it does nothing to further human knowledge.

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

I speak fluent Italian. There are some subtle differences from the translated text, but not enough to substantially alter the context from what has been presented herein.

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Three veins angioplastied.  One renewed life.