How can a study claim to be presenting true statistics, when 90% of the positive findings are thrown out? That's correct. 90% of the positive findings of CCSVI in people with MS in the Italian COSMO study were thrown out by the head of the study. Here is Dr. Zamboni on this fact:
Asked for comment on the findings, Dr. Zamboni confirmed that he was not happy with the COSMO study design.
"Our seminal paper published in 2009 in JNNP compared Doppler sonography with catheter venography, and found 90% and 75% abnormalities respectively in the jugular and in the azygous veins of MS patients," he told Medscape Medical News. "COSMO trial was initially aimed to verify my data in a wide sample and in a multicenter setting."
"Unfortunately," he said, the study compared Doppler sonography with the agreement of 3 central readers. "This design is not [as] solid of course as comparing ultrasound with venography," Dr. Zamboni added. Moreover, 90% of CCSVI cases discovered in peripheral centers were over-ruled by the central readers, and classified as false positive.
"To me, this study mainly confirms the absence of reproducibility of Doppler sonography in the absence of good CCSVI training, and further suggests to assess patients via [multimodal] diagnostic techniques."
http://www.medscape.com/viewarticle/773381
+++++++++++++++++++++++++++
Dr. Michael Dake refers to this in his presentation at ISET last weekend---
There was local blinding of the sonographic readings---but the "central investigators" got the final say. That's right, they could overturn the sonographers findings of CCSVI. And that's exactly what they did.
90% of the CCSVI cases diagnosed by local sonographers were overturned by central investigator interpretations.
page 68 from http://www.eventscribe.com/2013/ISETCIO/assets/pdf/52589.pdf
+++++++++++++++++++++++++++
The three central readers who overturned these positive CCSVI findings stated they over-ruled the findings because the local sonographers might have been biased by seeing people with MS.
Stolz attributed the lack of concordance on positive findings to the fact that "local sonographers are not on the moon." He suggested that seeing participants, and noting any physical or mental impairments, could have biased them toward diagnosing CCSVI.
The three central readers/lead investigators who made the final decisions to over rule CCSVI findings are:
Erwin Stolz, MD, of Justus-Liebig University in Giessen, Germany;
Dr. E. Stolz has received lecture fees from Boehringer Ingelheim, Bracco and Sanofi-Aventis and support from Schering. http://www.youtube.com/watch?v=kkI6G306rXc
Massimo Del Sette, MD, chairman of the Italian Society of Neurosonology and Cerebral Hemodynamics;
it has been noted that research he participated in, involving treatment of thrombolysis in stroke, was potentially affected by pharmaceutical sponsorship.
http://lib.bioinfo.pl/pmid:22224134
and Giovanni Malferrari, MD, chairman of the Italian Interdisciplinary Neurovascular Society, a specialist in neurosonology, pharmacology and toxicology
http://www.asmn.re.it/ListaMedici.jsp?cognome=Malferrari&nome=Giovanni
++++++++++++++++++++++++++++++++++++++++++
This is not science. This is manipulating medicine to maintain control of a disease aetiology. And it is wrong.
For more on the conflicts of interest in the COSMO CCSVI study:
https://www.facebook.com/notes/ccsvi-in-multiple-sclerosis/in-the-press-the-cosmo-ccsvi-study-and-attacks-on-dr-zamboni-/10150366960927211
Here is the abstract for the COSMO study, which the authors proudly claim has finally "put an end to CCSVI."
http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=158400&XNSPRACHE_ID=2&XNKONGRESS_ID=171&XNMASKEN_ID=900
Ironically, the text for authors' pharmaceutical disclosures is as long as the text for the abstract.
Dr A. Bertolotto has been on steering committees in clinical trials sponsored by Biogen Idec, Roche, and has received speaker honoraria from Biogen Idec, Merck Serono, TEVA, Bayer Schering, Sanofi-aventis, and Novartis; and has received research support from Biogen Idec, Bayer Schering, Merck Serono, Sanofi-Aventis, from the Italian Multiple Sclerosis Society, and the European Union Sixth Framework Programme.
Dr. Comi has received consulting fees for participating on advisory boards from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, and Bayer Schering; lecture fees from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, Biogen Dompè, Bayer Schering and Serono Symposia International Foundation. He is member of the Board of the Italian MS Foundation.
Dr A. Ghezzi received honoraria for speaking from Bayer-Schering, Biogen-Dompè, Merck-Serono, Novartis, Sanofi-Aventis and Allergan, for consultancy from Actelion, Merck-Serono, Teva and Novartis, received support for participation to National and International Congresses from Bayer-Schering, Biogen-Dompè, Merck- Serono, Novartis and Sanofi-Aventis.
Dr. GL Mancardi received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Schering, Biogen Idec, Sanofi-Aventis, Novartis and Merck Serono Pharmaceuticals. He is member of the Board of the Italian MS Foundation.
Dr. M Salvetti declares grant support from Bayer-Schering, Merck-Serono, Sanofi-Aventis and Biogen Idec.
Dr. MP Sormani has received consulting fee or honoraria from Biogen Idec, Merck Serono, Actelion, Synthon and TEVA.
Dr. E. Stolz has received lecture fees from Boehringer Ingelheim, Bracco and Sanofi-Aventis and support from Schering. Dr. L. Tesio is member of the Board of the Italian MS Foundation.
Please share this note, and let people know. This is not science.
Joan
