Vascular results thrown out by COSMO: researchers publish their own

February 16, 2013 at 10:49am

A team of vascular researchers from Naples was part of the multi-center COSMO CCSVI study in Italy, but the three main auditors decided to throw out their results, since they felt their finding of CCSVI was too high to be valid.

The data from this group has just been published in the BMC Neurology Journal.  This trained vascular team found CCSVI in 76% of pwMS and 16% of controls.  They find longer circulation time in those with progressive MS, "suggesting a role of hypoperfusion in neurodegeneration." Here is the study.

http://www.biomedcentral.com/1471-2377/13/20/abstract

How can the COSMO study claim to be independent when 90% of the positive findings of CCSVI were thrown out by three men who were not even in the room when the doppler tests were done? In what way is this science?  

Here is more on this ongoing story:

Vascular specialists in the Lombardi region are angered that positive results are discarded by COSMO study. They offer a blinded doppler "redo" for people who participated.

http://it.paperblog.com/sclerosi-multipla-facciamo-luce-sullo-studio-cosmo-aiutaci-anche-tu-1596046/

The COSMO study results were adjusted by three central readers, who threw out 90% of the positive CCSVI results in pwMS, because they felt the number of positive findings was too high.

http://www.medscape.com/viewarticle/773381

The study coordinator, Giancarlo Comi, blatantly violated a feature of clinical trials, in that he came out announcing negative results at ECTRIMS 2011, when more than 75% of the patients had yet to be tested.

the outrage continues,

Joan

New, Independent research from Serbia

September 12, 2011 at 9:10am

A new paper was recently published in Phlebology, Sept. 2011 issue.

Morphological and haemodynamic abnormalities in the jugular veins of patients with multiple sclerosis

D Radak, J Kolar, S Tanaskovic, D Sagic, Z Antonic, A Mitrasinovic, S Babic, D Nenezic and N Ilijevski Vascular Surgery Clinic, Dedinje Cardiovascular Institute, School of Medicine, Belgrade University, Heroja Milana Tepic ́a 1 Street, Belgrade, Serbia

(This study was not conducted by neurologists, nor was it funded with pharmaceutical monies.  These are vascular doctors --This study was partly funded by the Serbian Ministry of Science and Techonological Development – Project No. 41002.)

I have the full paper, and will break down what the researchers discovered.  

First, it is important to note that they only looked at the jugular veins with doppler.  No transcranial doppler, per the Zamboni criteria, and no venography or azygous.  These researchers wanted to see if they could find "morphological and haemodynamic abnormalities" in the jugular veins.  This means they were looking for physical irregularities and flow distubances in pwMS.  Not completely CCSVI, per Dr. Zamboni's definition.

The limitation of our study is that we did not examine the CCSVI prevalence in patients with MS because we did not investigate the intracranial and vertebral veins. The aim of our study was to evaluate morphological and haemodynamic IJV abnormalities in patients with MS and compare it with healthy controls. For morphological and haemodynamic abnormalities assessment of the IJVs, we used some of Zamboni’s criteria and two other parameters (parameters 1 and 2), which in our practice proved to be a good indicator of IJV flow disorder.

--What they were surprised to discover was that the IJV flow was very different in pwMS, and that they could pick this up with doppler ultrasound.

All these might result in IJV haemodynamics changes that could be assessed by non-invasive and cost-effective colour duplex sonography.6 The main finding of this study was to demonstrate a significantly higher prevalence of morphological and Doppler haemodynamics abnormalities in patients with MS in relation to healthy subjects.

Our study showed that 42% of the patients with MS had Doppler haemodynamic evidence of venous flow abnormalities as compared with 8.1% of the healthy controls. These data not only indicate that venous flow abnormalities were significantly associated with the presence of MS but also indicate that it can be seen in the population not suffering from MS, yet the difference remains statistically significant (P , 0.001).

--Also interesting was that they found faulty valves and stenosing lesions in some of the normal controls, but these irregularities didn't affect the blood flow as much as they did in pwMS.

Press Release from Fondazione Hilarescere

December 1, 2010 at 1:40pm

Dr. Zamboni has stepped down as lead investigator from the Italian MS Society's (AISM) proposed epidemiological study of CCSVI.  He has stated many times that this group is not following his methodology of testing.

Here is a new press release on this topic---

Who is Responsible for the current problems?

November 20, 2010

The Hilarescere Foundation and its scientific committee chaired by Prof. Paolo Zamboni have always clearly warned that the diagnosis and therapy of CCSVI cannot be improvised. The papers published have underscored the extreme importance of the learning curve required to manage both aspects in an ethically sound manner. 

This very seriousness that must be guaranteed to patients both scientifically and in terms of the methodology adopted has led Prof. Zamboni and Dr. Salvi to make painful choices, among which the decision to resign from the FISM/AISM study after having devoted time to it and made a series of proposals that have gone unheeded because said study has proven to be inadequate to achieve the set goal. It is a study that is all but a comparison with the "Zamboni method", since its basic principles have been neglected. All too often and misleadingly the FISM/AISM epidemiological study is referred to as a study promoted by Prof. Zamboni. However, for the aforementioned reasons he has clearly and consistently kept a due distance from it. 

Great concern has been clearly expressed in the Foundation's website and it has been stressed in every interview that CCSVI interventions are spreading and that these do not follow approved protocols that ethically ensure patient safety. The Foundation rejects clinical activities that prey on the desperation of patients to generate forms of medical tourism that offer absolutely no guarantee of quality to patients. Unfortunately, it is obvious that all this leads to extremely painful situations. We cannot offend people's suffering by exploiting it. It is absolutely shameful. This is still the time of studies and research; diagnosis and treatment must be managed within this framework with all the necessary guarantees. When carried out correctly, the treatment is mini-invasive and has an excellent level of safety as proven by many international experiences and articles.

Anything outside of this framework is wrong. But it must also serve as a stern warning for all those who do not heed the legitimate expectations of patients frustrating them with slow, all too slow studies that are blatantly inadequate. 

 Press Office: 

Francesca Rossini - Laboratorio delle Parole

Tel. 051-273861 – mobile 331-6752354 and 335-5411331  notizie@laboratoriodelleparole.it