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Thursday, August 15, 2013 12:57 AM | CCSVI in Multiple Sclerosis Volg link

In the continuing saga of poorly conducted CCSVI doppler studies, we have the recently unveiled McMaster University CCSVI study, initiated in 2010--which claims to "debunk" CCSVI.   We need to look more closely at this study, behind the headlines.  

The McMaster team claims they trained with Dr. Zamboni, and utilized his doppler protocol.  But reading the full paper, we learn that they removed several important points of his protocol, and replaced them with the techniques of neurologists Dr. Florian Doepp and Dr. C.A. Mayer--authors of two negative CCSVI studies.

1. They threw out the transverse plane technique, claiming it was "ambiguous" --but this is where most of the intraluminal venous malformations can be seen.

To be consistent with Zamboni’s ultrasound technique, color flow analysis of the IJVs was also performed in the transverse plane. This technique produced inaccurate and ambiguous results. By changing the angle of insonation to the vessel or changing the pulse repetition frequency (PRF) we were able to demonstrate that flow direction, blockage and reflux could not be assessed in the transverse orientation. 

This is the exact same thing the Doepp study did, and I wrote about it in 2010. They assessed jugular vein narrowing in the “sagittal” plane only (the ultrasound probe is placed parallel to the length of the vessel.) The Zamboni technique uses the transverse plane as well ( the probe is placed at a 90 degree angle to the length of the vessel) to look for narrowing, webs, or abnormal valves that Dr. Zamboni believes are often missed in the sagittal plane examination. 

If the wand is used in the sagittal manner only--it picks up collateral flow and sees it as "normal"...that's how the doppler technician at Stanford gave Jeff a "normal" result, but his MRV showed it was a tortuous collateral, not his jugular vein (which was 95% occluded) taking the blood back.  The transverse plane test would have shown this.

2. They did not use the full Esaote transcranial doppler technique, choosing instead to use a "2.5 MHz sector probe (PST 25BT)."  The tool they used was popular in the 1990s--it is 20 years old.  And they didn't see any deep cerebral vein reflux, no surprise.  Quality doppler processing (QDP) is the technique utilized by Zamboni.  When the Cleveland Clinic used QDP technology, they found reflux in the deep cerebral veins that regular TCD didn't show.

Fox et al compared traditional transcranial Doppler (TCD) ultrasound with QDP in 20 MS subjects undergoing CCSVI testing.[17] Seven of the 20 were found to have intracranial reflux on QDP, but none demonstrated reflux using traditional TCD duplex imaging.


3. They changed Zamboni's cross sectional area calculation changes from erect to supine postures, to the proposal of Frankfurt neurologist, CA Mayer.

The change in CSA (cross sectional area) between supine and erect position was evaluated. The original analysis of this criterion by Zamboni [7] has been challenged as incorrect by Mayer et al [17] who  proposed that the calculation should be ?CSA supine - upright and not the other way around, an analysis with which we agree.  Thus, we have adopted the Mayer et al proposal to analyse the data for this criterion. 
(the Mayer protocol they use is detailed in the paper, "The Perfect Crime?  CCSVI Not leaving a trace in MS")

4.  They did not use any M-mode analysis to detect criteria #3.  Doppler ultrasound M-mode (motion mode), part of the protocol, is how Zamboni sees intraluminal malformations and fixed valves and leaflets moving or immobile.

As they show us in the full paper--they really didn't use Dr. Zamboni's full doppler protocol, and their claim they did so is simply not true.  What a waste of time and money.  I feel badly for all of the honest, hard-working Canadians who gave of their time and money to this "study."

Their research also goes against findings of CCSVI at UBC, Rush University, Stanford University, the University of Buffalo, Georgetown University and other worldwide universities.  Are they claiming all of these other positive doppler studies are manufactured?


For some more background, I read up on lead investigator, Dr. Ian W. Rodger-- 

Here is his bio:

Ian Rodger is Professor Emeritus, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.  Previously he was Vice President, Research and Academic, Director of the Father Sean O’Sullivan Research Centre at St Joseph’s Hospital and Professor, Department of Medicine, McMaster University. 

Prior to this Dr Rodger was Executive Medical Director at Merck & Co Inc, USA and before that Senior Director and Head of the Department of Pharmacology at the Merck Frosst Centre for Therapeutic Research in Montreal, Canada. During this period he was responsible for leading the pharmacological effort that led to the discovery of the anti-asthmatic drug, montelukast (Singulair®), and the non-steroidal Cox-2-selective anti-inflammatory drugs, etoricoxib (Arcoxia®) and rofecoxib (Vioxx®).'

Dr. Rodger was Executive Medical Director at Merck from 1998-2006- during the years when Vioxx was developed, sold, found to be responsible for tens of thousands of strokes and heart attacks, and eventually recalled.  

  more on Vioxx fiasco

Vioxx is considered to be the largest drug recall in history, and one which elicited one of the greatest public outcries. Vioxx, prescribed to more than 20 million people as a pain reliever for arthritis, was found to be responsible for increased risk of heart attack and stroke. Both Merck and the FDA were roundly criticized for ignoring evidence of the dangers of Vioxx before its eventual recall. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking the drug in the US alone. Merck settled Vioxx litigation in the US for $4.8 billion, with close to $1 billion in legal expenses. 


The whole time that Merck was promoting Vioxx as a superior alternative for those with gastrointestinal problems, the company was also brushing aside the drug’s cardiovascular risks. It wasn’t until April 2002, years after the VIGOR trial results showed the risks, that the FDA and Merck decided to include the heart and stroke information on the drug label. Critics would later point to this as evidence of the cozy relationship between Merck and the FDA and the company’s blasé attitude toward the risks.


I've been told that Dr. Rodger is a lovely man, that this was an independent CCSVI study, funded by people with MS-- why would he not be telling the truth?  Here he is speaking in 2010 about the McMaster CCSVI study.  He seems quite enthused and honestly open-minded.  But to hear him speak about the importance of clinical trials is slightly disconcerting--considering what Merck did to the studies that showed cardiovascular risk with Vioxx while he was Executive Medical Director at the company.

The facts remain.  


Dr. Ian Rodger's specialty is not vascular studies, but pharmacology. 

Yet he was chosen as lead investigator of this CCSVI trial--a vascular trial--which did not utilize the Zamboni CCSVI diagnostic protocol and claims CCSVI does not exist.

And in case memory doesn't serve--here's the case against Merck Serono by the US government from 2011, which fined the company for paying doctors to prescribe Rebif to MS patients.  Merck paid $44 million dollars to settle the suit.  

To say that Merck doesn't have a vested interest in maintaining the MS autoimmune paradigm might be understating the situation.  


I do not like to "get all ad hominum" on Dr. Rodgers, as my son says....but someone has got to say something about this situation.

Doug Walton, Canadian academic and author, has argued that ad hominem reasoning is not always fallacious, and that in some instances, questions of personal conduct, character, motives, etc., are legitimate and relevant to the issue, as when it directly involves hypocrisy, or actions contradicting the subject's words.