The association CCSVI nella Sclerosi Multipla - ONLUS, made by patients and relatives of MS patients, agrees with the need for science to continue its own course to study the CCSVI, with its time and manner, but does not accept the restrictive and concerned evaluations of U.S. F.D.A.
about:
- the existence of CCSVI
- the correlation between this venous disease and multiple sclerosis,
- the safety and effectiveness of the Percutaneous Transluminal Angioplasty (PTA) in MS patients.
In fact, it was published an important amount of international independent outstanding studies demonstrating exactly the opposite on each of these issues.
These studies since 2008 (published in large numbers especially during last year) show:
- that CCSVI exists as a separate disease. In September 2009 a panel of 50 experts of the UIP, the largest scientific organization that deals with venous disease, included it among the congenital truncular venous malformations, or between those that have a development between the 3rd and 5th month of intrauterine life. The international consensus document will endorse the therapy PTA. Since then, many other studies confirm this;
- that the correlation between CCSVI and MS is very high: the latest diagnostic studies, performed with venography - internationally considered as the most effective method NOT operator-dependent differently from Doppler ultrasound (ECD) - report conclusively about a correlation more than 90% . This is a result processed by ISNVD (International Society for Neurovascular Disease) that examines 13 studies of 8 countries and finds a correlation that ranges from 92.3 to 100%.
Inevitably, it means that any further epidemiological study about the correlation between CCSVI and MS, will necessarily be confronted itself with these international data.
Regarding the safety of Percutaneous Transluminal Angioplasty (PTA), the studies thus far published show that angioplasty (a technique used for decades even in the field of deep venous system), is safe in safe hands. Prof. Paolo Zamboni, who discovered CCSVI and indicated the methodology to dealt with it, ABSOLUTELY DOES NOT recommend the use of stents in the veins. It clearly means that all adverse events due to use of stents are NOT IMPUTABLE to his methodology.
Anyway, we wish to underline that the percentage of so-called adverse events, attributed to the use of stents is very low, like very low is the risk of this technique on the veins by scholars who have dealt with it. The PTA is rightfully part of safe techniques as defined by science.
Regarding the efficacy, preliminary published studies show PTA brings undoubted benefits to MS patients, improves the quality of life, and in many cases can block the progression of the disease.
In fact, we wish recall what recently UK NICE (National Institute for Health and Clinical Excellence www.nice.org.uk/ipg420) expressed. In essence the institute, analogous to the Italian Consiglio Superiore della Sanità:
- encourages further research in this area noting that treatments currently available are very poor of efficiency;
- taking into account the data of the literature considers the available data on the safety certainly significant to certify the legality of the PTA treatment within the research trials.
Similarly, the SIR (Scientific Society of Interventional Radiologists) though is rightly prudent on the results achieved so far (we agree on this), answers to FDA statement on CCSVI:
- "Strongly supports high-quality clinical research to determine the safety and efficacy of interventional therapies in MS and is working actively to promote and accelerate the completion of necessary studies."
- "Recognizes the challenge and the potential opportunities presented by promising early studies of an interventional approach for treatment of multiple sclerosis."
- "It’s pleased that activist groups pushed forward the medical community to respond to this challenge and is committed to take a leader role in national launch of necessary efforts."
At last, we desire to remind that in Italy and around the world clinical trials aimed to evaluate the safety and effectiveness of the angioplasty procedure in MS patients, are underway or at the starting line. They, we believe, will have the last word.
Rome / Bologna, May 12th, 2012
Association CCSVI nella Sclerosi Multipla - ONLUS
Press Office
Gisella Pandolfo + 39 347 4074986
Dora Carapellese + 39 347 4581906
Translated by
Gabriele Reccia gr.ccsvi@gmail.com
http://www.ccsvi-sm.org/?q=node%2F1555