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Experimental Intervention for Multiple Sclerosis Cannot Be Considered as Standard of Patient Care Until Further Evidence is Available

by Kathy Jones on Dec 15 2011 5:44 PM

 Experimental Intervention for Multiple Sclerosis Cannot Be Considered as Standard of Patient Care Until Further Evidence is Available
Before being considered as a standard of care, a new and increasingly popular invasive treatment for patients with multiple sclerosis (MS) must have proven results.
This is the opinion of LifeBridge Health neurologist Michael A. Williams, M.D., the medical director of The Sandra and Malcolm Berman Brain & Spine Institute, and lead author of an editorial in the December edition of the Archives of Neurology. In the editorial, which he co-wrote with Arun Venkatesan, M.D., Ph.D., assistant professor at the Johns Hopkins University School of Medicine, Williams also stated that it is the ethical responsibility of the medical community to inform patients about the experimental nature of this procedure.

This interventional treatment uses a catheter to either dilate or insert a stent into the jugular veins coming from the brain for a condition known as chronic cerebrospinal venous insufficiency (CCSVI). This endovascular intervention was developed by Italian surgeon Paolo Zamboni, M.D., who reported that CCSVI could contribute to the development of MS.

However, despite initial reports of success by Zamboni, researchers from around the world have been unable to verify the results of either his initial report of CCSVI or the success of dilating the jugular veins. Despite the lack of research support, this treatment method has begun to be used worldwide to treat MS patients.

"Research is needed to demonstrate whether dilating the jugular veins is effective for MS before it can be offered as a standard of care. This procedure should be held to the same research standard as all other forms of treatment for MS," said Williams. "It is the ethical responsibility of the medical community to ensure that patients understand that this form of treatment is still an experimental procedure, and it should not be offered as if it were ‘proven.'' It is not. We owe it to our patients to ensure their safety."

Williams, who is the former co-chair of the American Academy of Neurology''s Ethics, Law and Humanities Committee, explained that more research should be done as quickly as possible to determine whether this treatment is effective. Until that occurs, patients should not have the procedure unless they are enrolled in clinical trials.

LifeBridge Health is one of the largest, most comprehensive providers of health services in northwest Baltimore, MD. LifeBridge Health includes Sinai Hospital, Northwest Hospital, Levindale Hebrew Geriatric Center and Hospital, Courtland Gardens Nursing & Rehabilitation Center, and related subsidiaries and affiliates. For more information, visit www.lifebridgehealth.org.

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