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December 2009 > CCSVI Treatments at Stanford Shut Down

Those of you who attended the advisory meeting this weekend in Boston know how much discussion there was on the subject of CCSVI. The origins of this paradigm stem from radiologic findings of MS as peri-venulitis, and an Italian center’s published observations that the extracranial venous vasculature in MS patients is abnormal disproportionately to normal controls (this latter finding is under independent review). Most of you also are aware that a vascular surgeon on the campus here at Stanford University has been performing intravascular stenting on self-referred MS patients in what some have termed “The Liberation Procedure.” We are certain you are fielding questions regularly about this—and wondering what in the world is going on at Stanford.

Please know that no patient seen or cared for at the Stanford MS Center has ever been referred for this procedure. We have without exception advised those who have made inquiry to NOT have this procedure performed. There are no metrics any of us would considerable reliable that suggest therapeutic benefit; and there have been at least two serious adverse events as a consequence of CCSVI stenting.

Effective immediately, this procedure has been SUSPENDED by the highest levels of medical leadership here on campus. A grant has been submitted to investigate any potential merit in a pre-clinical milieu only. We are in active communication with many interested organizations to let patients be aware that, contrary to the favorable reports they have been hearing, this is a procedure that cannot be defended, supported or recommended on risk-benefit considerations at this time. We hope it will help you, in your own counsel to patients, to know this procedure has been discontinued at Stanford for these reasons.

Please let us know how we might be able to help you in this matter as we go forward.

Very best wishes, and hope you all enjoyed safe travel home;

Jeffrey Dunn, MD

Associate Professor

Associate Director, Stanford Multiple Sclerosis Center

Department of Neurology and Neurological Sciences

November 2013 > Disease-modifying therapies for nonrelapsing multiple sclerosis

Absence of evidence does not constitute evidence of absence

The lack of clinical trial data demonstrating efficacy of disease-modifying treatments (DMTs) for nonrelapsing forms of multiple sclerosis (MS) does not prove that DMTs are ineffective for nonrelapsing MS.

It has been argued that DMTs have met primary endpoints inrelapsing MS, but not in nonrelapsing forms of the disease. This does not prove that such treatments are ineffective for nonrelapsing phenotypes.

It could mean that clinical trial endpoints are ineffective in identifying true differences between treatment and placebo arms, or do not properly account for individual variation within clinical trial cohorts.

Jeffrey Dunn, MD