Wayne State University School of Medicine neurologists are strongly cautioning against a potentially risky surgical procedure promoted by an Italian researcher as a potential cure for or alleviation of multiple sclerosis.
In "Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis," published in the March edition of Annals of Neurology, Omar Khan, M.D., professor of Neurology and director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory for the Wayne State University School of Medicine, disputes the research that led to claims that narrowed neck veins cause iron carried by the blood to build up deposits in the brain, damaging brain cells and contributing to or causing MS.
Those claims, made by Italian vascular physician Paolo Zamboni late last year, caught worldwide attention and raised the hopes of thousands of MS sufferers. To combat the condition, called chronic cerebrospinal venous insufficiency, Zamboni suggests angioplasty and stenting of the veins, as therapeutic approaches.
Zamboni's research and testing, according to published reports, was limited to a small number of patients at a single site.
Dr. Khan, director of the MS Clinic for Harper University Hospital, criticized Zamboni for being "overzealous" and "having no real expertise in neurology or looking after MS patients." Zamboni, he noted, promoted his angioplasty findings to the media before publishing his results or presenting them at scientific meetings.
"The message is powerful, no doubt, but the real question is: Is the science powerful? Preying upon desperation always makes noise, but after a while one may question the ethics of such an approach," he said. "Monetary incentives are usually the main motive in these instances. The trial they conducted was not controlled, not blinded, and all patients were on active disease-modifying therapy. It is ill-advised to embark upon such endeavors without conclusive studies from multiple sites with no conflicts of interest."
Several studies, Dr. Khan said, are under way and a number have already been completed that refute Zamboni's findings. Those studies will soon be accepted for publication and then become public knowledge. Dr. Khan is initiating an Institutional Review Board-approved protocol at the Wayne State University MS Center to examine CCSVI in MS and other neurologic diseases. The study will start May 1.
"We first need to determine if CCSVI even exists as a phenomenon, and if it does, does it cause the disease or is it a secondary phenomenon in an injured brain," Dr. Khan said. "These questions can only be addressed in controlled studies at multiple sites with several investigators, not just one or two sites, especially if the claims are based on causing a major shift in the MS pathophysiology paradigm."
Dr. Khan and his co-authors - including Paula Dore-Duffy, Ph.D., professor, and Robert Lisak, M.D., professor and Chair of the WSU Department of Neurology, and Imad Zak, M.D., associate professor of the School of Medicine's Department of Radiology -- conclude that it is critical not to compromise patient safety during the conduct of further research. They note that anecdotal reports indicate endovascular procedures, including placement of stents, have been carried out in patients as a clinical treatment procedure for MS. In some cases, that has led to serious injury. Potentially fatal outcomes, including migration of the venous stent into the heart and perforation of the ascending aorta, while not common, are known complications of venous stent insertions.
"Any invasive endovascular procedures, including angioplasty and venous stent placement should be discouraged until there is conclusive evidence to justify their indication in MS," they wrote.
Of the more than 100 patients that Dr. Khan has discussed the issue with since Zamboni's announcement last November, not one has insisted on undergoing the stenting procedure. "We discuss candidly and explain to patients all the science that negates CCSVI and the safety of stenting veins," he said. "Patients listen when it's explained with patience and respect for their desire to find a cure quickly."
Other co-authors of the paper include physicians and researchers from the Research Unit of the Scientific Institute and University Hospital San Raffaele, Milan, Italy; the Multiple Sclerosis Research Unit, Ottawa Hospital General Campus, University of Ottawa, Ottawa, Ontario, Canada; the Department of Radiology and Amsterdam MS Center, VU University Medical Center, Amsterdam, the Netherlands; the Center for Brain Research, Medical University of Vienna, Vienna, Austria; the Department of Neurosciences, Lerner Research Institute, Cleveland Clinic; the Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada; and the Mallinckrodt Institute of Radiology, Washington University School of Medicine.