SUNDAY – FEBRUARY 19, 2012 11:45am-12:00pm
Bringing neurologists into the CCSVI arena (Jack Burks, USA)
Why are many neurologists so resistant to CCSVI? They believe the theoretical basis of CCSVI is flawed. The
diagnostic test results are not consistent. One study says CCSVI is correlated 100% to MS while another study
says no correlation to MS. “Should we fund studies to get rid of flying saucers?” The clinical trials are not
scientifically meaningful and do not have acceptable “follow-up” which leads to patients’ false hopes, financial
hardship and serious adverse events, including death. Interventionalists are “getting rich” from desperately ill,
financially strapped patients who may become disenfranchised from their neurologists for not supporting
CCSVI. Many neurologists believe CCSVI is touted to MS patients as providing “liberation” from MS. While that
is unrealistic, angioplasty may be helpful to some patients. If CCSVI exists, treating the vascular factor may
improve MS symptoms and Quality of Life. In early RRMS, it may help more. On the other hand, the positive
reports may represent a placebo response. Scientific data through collaboratively planned and implemented
research will provide many answers and put CCSVI into better perspective. Working in isolation will prolong
the “battle”. If collaborative research projects are positive, the procedure will gain wide acceptance and
insurance funding. If negative, we have saved patients from the medical disappointments and financial drain.
Specific ideas will be presented Wednesday.
Not all of this is objectionable. But in the interest of lowering animosity, Dr. Burks and the other neurologists might consider toning down the colorful language. I hear it on the interventionalists side as well, although not as heated. "Now you sound like a neuro" is not flattering to the neurologists, but not in the same way as "studying CCSVI is like studying flying saucers" is to the interventionalists, or accusations that the interventionalists are in it for the money. We've heard it here too among supporters and nonsupporters in the forum. It is the absence of facts that makes the language and metaphors and opinions run so wild.
I am in favor of collaborative research between any interventionalists who are willing and any neurologists who are willing to step up instead of waiting for CCSVI to go away.
And this is to come, on Wednesday:
CCSVI Clinical Trial Design from a Neurologist’s Perspective (Jack Burks, USA)
In Sunday’s talk I discussed the opportunity for a collaborative approach to designing and implementing
scientifically rigorous research to put CCSVI into perspective. For most neurologists, they do not know what to
think of CCSVI except over 100 other “breakthrough treatments” for MS have reached this stage of patient
interest – and none have been successful over time. Therefore, to get involved, most neurologists are insisting
on scientifically sound data as well as a halt to the commercialization (charging patients for angioplasty) on
desperately ill MS patients. Legitimate clinical trials should precede “fee for service”. Further, much CCSVI data
at neurology meetings are negative, i.e. CCSVI does not exist. “Why should we fund studies to get rid of flying
saucers?” Most believe CCSVI will naturally go the way of snake venom and bee stings. However, collaborative
efforts are gaining attention from some neurologists. The next step is developing a trusting collaboration
between Neurologists, CCSVI Diagnosticians and Endovascular Interventionalists. This also might include
patient groups, immunologists, iron metabolism experts, other health care professionals, MS advocacy groups,
and other interested parties. A format: A multidisciplinary steering committee convenes a conference entitles
“What do we really know about CCSVI and MS - and how can we put CCSVI into a scientific and clinical
perspective through more scientific research?” Six questions will begin the collaborative process. 1) What data
do we agree are known facts about CCSVI and MS, based on solid scientific data? 2) What postulates do we
think might be true, but lack solid scientific data? 3) What postulates do we agree are not known? 4) What
research is needed to fill the knowledge gaps? Prioritize these issues. 5) What are the roles of each
collaborative group in implementing the research designs and clinical trials? 6) How can the research be
funded? With this approach, scientific data will drive the CCSVI success – or not.
Financial Disclosure: Acorda, Allergan, Avanir, Bayer, Novartis, Serono, Sanofi-Aventis
If it is correct that what's slowing CCSVI research more than anything is the lack of neurologist collaboration (as Ms. Kingston reported Dr. Sclafani saying and Dr. Zivadinov agreeing), then we need to understand the neurologist perspective. Objectionable though it may be. To get involved, neurologists are insisting on a halt to the commercialization? I think that one is out of the barn and not coming back. Commercialization of CCSVI took off in the summer of 2010. If a multidisiplinary steering committee were to come into being, would the neurologists participate in forward movement, or would it be a way to block research into CCSVI, if neurologists are indeed just waiting for this all to blow over? And, indeed, how can the research be funded? Acorda, Allergan, Avanir, Bayer, Novartis, Serono, or Sanofi-Aventis would not have any interest. What if the only trials that are financially feasible are smaller trials? Would there be neurologist cooperation? The next step is developing a trusting collaboration! How can he even say that after slinging words like flying saucers around, and talking about IRs getting rich off of the desperately ill? Those are divisive words, not coming-together words.
more thoughts from neurologists on what their problem is:
Audience member: Gap needs to bridged between abnormalities and plaques in the brain to convince neurologists
Neurologist in audience: hard to engage neurologists when definitions not agreed upon
Neuro Jack Burks: "I am so embarrassed that we (neuros) have not been more open to this (CCSVI)."