CCSVI 2013: ‘debunking,’ spin, and legal drama

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Dr. Paolo Zamboni. (THE CANADIAN PRESS/Nathan Denette)

Ifthere were a drinking game that called for taking a shot whenever the term chronic cerebrospinal venous insufficiencyor CCSVIappeared in 2013 in a headline alongside debunked or death knell, we all would have been plastered well before New Years Eve. Studies discounting the theorythat a link exists between CCSVI and MS proposed by Italian vascular specialist Paolo Zamboni prevailed;MS vein unblocking was named by the CBC as one of the top 6 news stories of 2013. A clinical trial in Albany, NY, scheduled to include 86 Saskatchewan residents, was shut downin Septemberdue to lack of enrolment. CCSVI was declared a fiasco, even invoked as cautionary tale.

But a rear-view look at CCSVI in 2013 reveals a more complex pictureone in which positive studies were eclipsed by negative, clinical data was spun to fit prevailing wisdom, and rhetoric uttered unsupported by fact. There was glee that studies showed CCSVI is not the cause of MS, nor CCSVI treatment its cure (a claim Zamboni himself never made), and apparent disregard for the fact the treatment could offer some relief for those with extracranial venous blockages who exhibit neurodegenerative symptoms. Lost in the shuffle was emerging research on the role of blood flow, perfusion, and how luminal defects within the vein might impede flow and contribute to neurodegenerative conditions.

The first body blow to the CCSVI hypothesis appeared in March with the results fromthe first randomized CCSVI treatment trial, PREMiSe,at the University of Buffalo. Leadresearcher Robert Zivadinov was one of the first MS neurologists to team up with Zamboni; hisprevious researchrevealedassociation between CCSVI and MS, though not to the extent Zamboni found it. Results were broadcast in avideo released on the eve of the 2013 American Academy of Neurology meeting, where the findings were presented as a poster; CCSVI treatment was safe, they said, but it did not improve patient outcomesand, in some cases, made them worse. Most media coverage of the 19-person study, which has not been published, failed to note that it didnt meet its stated endpoint to improve venous flow, proving its conclusions moot. The first part of the PREMiSe trial, which did restore blood flow in subjects, was publishedbut didnt receive press coverage, perhaps because its conclusions were more difficult to parse:It found that cerebral spinal fluid was moving faster through the brain, an improvement that continued a year past treatment.

Research that did receive ink was an MS Society-funded studyin April that measured blood flow inteenagers with MS versus normal teens using ultrasound and MRI. A MS Society press release declared minimal signs of CCSVI in children with MS. Joan Beal, a high-profile CCSVI advocate since her husband, Jeff, experienced lasting improvements afterCCSVI treatment in 2009,crunched the data;she foundthat teenagers with MS had 27 per cent less blood flow out their left internal jugular veins compared to normals. Yet the finding that children with MS have significantly reduced venous blood flow wasnt noted by researchers themselves.

The years serious debunking of CCSVI began in August, when a McMaster University study that found no evidenceof CCSVIin 99 adults with MS compared with 100 healthy controls was issued with a press release declaring CCSVI had been debunked. (The same day research out of Italy investigating the safety and efficacyof angioplasty to treat CCSVI was published but received virtually no media mention: it found blockages in 98 per cent of 1,200 subjects.)

In October, researchers published an Italian study announced at a meeting of theEuropean Committee for Treatment and Research in Multiple Sclerosis(ECTRIMS) in 2012.The study found CCSVI in only about three per cent of MS patients and in only slightly fewer healthy controls or patients with other neurological conditions. On its heels came University of British Columbia researchpublished in The Lancet thatfound venous narrowingin 74 per cent of people with MS. But it also found similar narrowings in 66 per cent of unaffected siblings of people with MS and 70 per cent of healthy controls. So in other words, veins defined as narrowed are in fact the norm. The study used catheter venography, which the researchers billed as the gold standard. But as Zivadinov pointed out in a 2012 interview,theres no gold standard yet in diagnosing CCSVI: As a matter of fact, we are establishing standards, and catheter venography is [not a] gold standard for a number of reasons, he said, referring to thisstudy. As research is increasingly showing, its whats within the vein intraluminally in terms of blockage, valves and blood flow that counts.

In reporting the UBC study, news editors didnt even bother to get the Thesaurus out: Zamboni MS vein theory debunked by study, read one: Study debunks CCSVI: Narrowed neck veins found in people with and without MS read another.Many headlines proclaimed, incorrectly, that the scanning studies discredited CCSVI treatment: Controversial Treatment May Not Help MS Patients andCanadian study casts further doubt on liberation treatment for MS. TheCBC continued the thread announcing its top 6 health stories of 2013: A series of studies in 2013 debunked Italian Paolo Zambonis belief that clearing blocked or narrowed neck veins could relieve symptoms of multiple sclerosis.

But whether or not MS symptoms are relieved by CCSVI treatment has not been established beyond anecdotal reports. These reports suggest between one- and two-thirds of patients experience some benefit, which may or may not endure.Research in the U.S. (here,hereandhere)and Europe (hereandhere) conducted in 2013 concluded CCSVI treatment was safe, and resulted in physical and psychological improvements ranging from mild to significant. Zamboni has a clinical trial underway in Italy. In Canada, a four-centre treatment trial with 100 participants has commenced; results are expected in late 2015. Other research is apace.

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CCSVI 2013: ‘debunking,’ spin, and legal drama