FDA Issues Warning About Experimental Therapy

iStockphoto/Thinkstock(WASHINGTON) — The U.S. Food and Drug Administration has issued a warning about the potential risks of an experimental therapy used to treat a condition — chronic cerebrospinal venous insufficiency, or CCSVI — often linked to multiple sclerosis.

CCSVI is characterized by a narrowing of veins in the neck and chest, and some researchers believe that the narrowing can lead to some of the central nervous system inflammation that is a hallmark of multiple sclerosis.

“However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established,” the FDA said in a news release.

CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as “liberation therapy,” or a “liberation procedure,” the agency said.

But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.

CCSVI was first identified in 2009 by Dr. Paolo Zamboni, an Italian vascular surgeon. He later tried inflating the veins using the balloon procedure in 65 patients and, despite the fact that the study was unblinded and had no placebo group, Zamboni found some improvement in MS symptoms among most of them.

Despite Zamboni’s reported success, MS researchers in the U.S. said it’s too soon to know for certain how — and if — CCSVI and MS are related. There have been many patients in the U.S. and Europe who have had CCSVI therapy, though not as part of any clinical trial. Feedback about the therapy, experts said, has been mixed.

“Some patients will say they’ve had improvement, and others will say there’s been no symptom improvement,” said Timothy Coetzee, chief research officer at the National Multiple Sclerosis Society. “We need to assess whether or not opening up veins has any beneficial effect in changing the course of the disease.”

The CCSVI Alliance, a group dedicated to promoting education and research on CCSVI, says on its website that while it does not promote or deter against having CCSVI therapy, patients should make risk assessments based on their individual situation and by careful discussion with their doctor.

A clinical trial to assess the safety and efficacy of the treatment is about to get underway in Canada, and as research continues, so will the debate over CCSVI.

Copyright 2012 ABC News Radio

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