Hi Choochy. Sorry this isn’t going to be helpful about Campath either! It’s just a heads up that, if past experience is anything to go by, David603’s comments might spark off a verbal battle which might get a bit heated - please don’t take it remotely personally - just ignore it! Kx
Sooooooo, I cannot let David603’s comment go without responding. The suggestion that you should consider LDN instead of Campath is utterly irresponsible, but I am not going to get into that again(!). However, as far as CCSVI goes, I guess David603 didn’t see this (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm):
FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
Date Issued: May 10, 2012
Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs).
Medical Specialty: Neurology, Interventional Radiology, Vascular Surgery.
Purpose: The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.
This communication is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.
Summary of Problem and Scope: MS is a progressive, immune-mediated disorder of the brain and spinal cord. In this disorder, 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. Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord. This narrowing of neck and chest veins has been called CCSVI.
Studies exploring a link between MS and CCSVI are inconclusive. Some studies have suggested a link exists, while others have found no such connection. At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS. In addition, the criteria used to diagnose CCSVI have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.
Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins. This procedure is sometimes called “liberation therapy” or the “liberation procedure”.
The FDA believes that using these medical devices in CCSVI treatment procedures poses a risk to patients because:
- There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.
- Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.
- The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.
- There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.
- It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.
The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.
Adverse Events: CCSVI procedures have been associated with serious, even fatal, complications. The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment. Other serious complications of the CCSVI procedure reported primarily as individual incidents or case series in medical journals include: at least one death, stents migrating from their original location to another part of the body (including the heart), venous injury, blood clots forming in the jugular vein or in stents, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding. The frequency of these serious complications is not known.