FDA has issued an alert to healthcare professionals and those suffering from multiple sclerosis. An avante garde procedure used to treat suffers of chronic cerebrospinal venous insufficiency (CCSVI), has been deemed unsafe, causing potential injury and even death.

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 :

“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 … 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.”

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 and even death. The FDA made the announcement in part to clarify that it has never approved stents for treating CCSVI.

MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.
In addition to the announcement, the FDA is warning physicians planning on treating patients with suspected CCSVI or MS that they must adhere to FDA guidelines, especially if they wish to conduct any kind of clinical trials or use procedures such as outlined above, that may put a patient at significant risk of complications or death.

The FDA has said that it will continue to monitor any reports of adverse effects associated with liberation therapy, and also confirmed that earlier this year, warned an investigator who was conducting a clinical trial of treatments for CCSVI without the necessary approval, to close their study.

Written by Rupert Shepherd