In yesterday’s blog titled FDA Warns MS Patients About Experimental Treatment After Reports of Paralysis, Fatalities we introduced the U.S. Food and Drug Administration’s (FDA) recent concern regarding experimental and unconfirmed treatments for chronic cerebrospinal venous insufficiency (CCSVI). Additional information has been released by the FDA in connection with this advisory.
In way of background, CCSVI disorder refers to the narrowing, or stenosis, of veins in the neck and chest. MS, on the other hand, is a progressive, immune-mediated disorder of the brain and spinal cord characterized by disabling neurological symptoms resulting from damaged nerve fibers and lining. Some practitioners and researchers believe that CCSVI-type symptoms may contribute to the development of MS, as those symptoms would naturally result in an impaired blood supply to the brain and spinal cord—a hallmark cause of nerve fiber death and injury. Accordingly, some physicians have begun to treat MS patients with a CCSVI procedure known as “liberation therapy”; this experimental treatment uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck to increase blood flow to target areas.
However, to date studies exploring a potential link between MS and CCSVI are inconclusive, and CCSVI diagnosing criteria has not been adequately vetted. The tenuous link—if any—between MS and CCSVI calls into question the use of liberation therapy for MS treatment. As the chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health explained: “Because there is no reliable evidence from controlled clinical trials that [liberation therapy] is effective in treating MS, FDA encourages rigorously -conducted, properly-targeted research to evaluate the relationship between CCSVI and MS.” Of more concern, and as highlighted in yesterday’s blog, the FDA has received reports of death, stroke, vein damage, blood clots and abdominal bleeding attributed to liberation therapy. In fact, the balloon angioplasty devices and stents used to treat CCSVI—and now MS—are not FDA-approved.
Pursuant to a May 10, 2012 FDA News Release, “[p]atients are encouraged to discuss the potential risks and benefits of [liberation therapy] with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”