Multiple Sclerosis Treatment Warning Issued By FDA
A risky, experimental multiple sclerosis treatment has been warned against by the Food and Drug Administration (FDA) after incidents including serious side effects and death have been reported.
The multiple sclerosis treatment implicated by the severe warning is called liberation therapy, and focuses on chronic cerebrospinal venous insufficiency (CCSVI), which is a narrowing of venous structures in the neck and head. However, the treatment that uses stents or balloon angioplasties to open up veins between the head and heart has been linked to two deaths, as well as paralysis, strokes and nerve damage in some patients.
Worse yet, the risky multiple sclerosis treatment demonstrates no evidence of conferring any benefit to MS patients. So far, no devices have been approved by the FDA for this sort of treatment, and Reuters obtained a quote from the agency regarding their position on the risky treatment and its potential outcome for multiple sclerosis sufferers:
“Our position is that the evidence is simply insufficient to determine whether there’s a link,” said Dr. William Maisel, deputy director and chief scientist of the FDA’s devices division. “We want patients to be aware this treatment (with stents or balloon angioplasty) is unproven, that there are significant risks associated with the treatment, (and) the benefits are uncertain.”
However, some multiple sclerosis patients who have experienced the treatment report some improvement that they believe is linked to CCSVI. Sharon Richardson is an MS sufferer and head of the CCSVI Alliance, and she explains:
“I had my original procedure in June of 2009. I had a back pain for approximately eight years, and that pain was gone the day after I had the procedure and it has not come back since.”
Richardson acknowledges some eventual backsliding with multiple sclerosis symptoms, symptoms she reports disappeared after undergoing CCSVI a second time.