The liberation therapy for MS targets chronic cerebrospinal venous insufficiency. (File photo) Food and Drug Administration (FDA) authorities have warned that an experimental treatment for multiple sclerosis (MS) called "liberation therapy" has no proven benefit and may even cause death. The FDA has issued a warning saying that using the unproven treatment for MS patients has caused death, strokes, nerve damage and abdominal bleeding. The unproven treatment targets chronic cerebrospinal venous insufficiency (CCSVI) or narrowing of the veins in the head and neck that is often linked to MS. The procedure includes widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents. Both of the techniques are commonly used to treat the blocked or narrowed coronary arteries of the heart. "Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS, the federal agency recommended in a statement. Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes," the statement added. … Continue reading →

Editor's Choice Main Category: Multiple Sclerosis Article Date: 11 May 2012 - 13:00 PDT Current Article Ratings: 2.75 (4 votes) The procedure, known as liberation therapy or liberation procedure, uses stents, also known as angioplasty, to widen veins in the chest and neck. Stents are small spring loaded devices placed into arteries or veins to hold them open. They have been used successfully in heart patients, although even that has its controversies. Theory has it that CCSVI is caused by poor drainage from the brain and upper spinal cord, so the procedure makes sense to some. However, the theory is just that and research into the causes of the disease, especially in terms of finding a link between MS and CCSVI, have been inconclusive. Even the criteria used to diagnose CCSVI has not been properly established. William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, confirm's the FDA's stance on the treatment : Widening the veins in the neck and chest has been associated with a variety of issues including: stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding … Continue reading →

CAROLINE ALPHONSO TORONTO From Friday's Globe and Mail Published Thursday, May. 10, 2012 9:32PM EDT Last updated Friday, May. 11, 2012 8:31AM EDT In stark contrast to Canadas go-slow approach, U.S. drug regulators have issued their strongest warning yet to multiple sclerosis patients about the dangers of a controversial new treatment. The Food and Drug Administration issued its alert on Thursday after it received adverse reports connected with two patients who had the experimental therapy in the United States: One died from bleeding in the brain and another was paralyzed from a stroke. The agency said it also has heard reports of stents (sometimes used in the procedure) migrating to the heart, cranial nerve damage, blood clots and abdominal bleeding related to the procedure. The frequency of these complications is unknown. Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between [the therapy] and MS, said William Maisel, chief scientist and deputy director for science in the FDAs Center for Devices and Radiological Health. Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist … Continue reading →