U.S. FDA warns of injuries, deaths linked to 'liberation therapy' for multiple sclerosis

The FDA is warning health-care professionals and patients that injuries and death have been associated with the use of the experimental procedure.

The therapy was devised by Italian physician Paolo Zamboni, who says MS is caused by vein blockages in the neck and upper chest that prevent blood from being drained from the brain.

He says opening these veins with balloon angioplasty reverses symptoms of MS; Zamboni calls the vein blockages chronic cerebrospinal venous insufficiency or CCSVI.

The FDA says studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

Scores of Canadians have travelled overseas to get the treatment; at least two Canadians are known to have died after undergoing the therapy.

Dr. William Maisel, the chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, says patients considering the treatment should discuss the pros and cons with a neurologist or other doctor familiar with MS and CCSVI.

In a release, the FDA says it has learned of adverse events experienced by people who have undergone the treatment, including death, stroke, detachment and migration of stents that are sometimes used to open the veins, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the procedure.

The agency says it is informing doctors and researchers that if they want to do clinical trials on CCSVI, they must comply with FDA regulations. Earlier this year the FDA sent a warning letter to a researcher and his or her sponsor after learning they were conducting a trial without FDA approval. The trial has since been stopped.

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U.S. FDA warns of injuries, deaths linked to 'liberation therapy' for multiple sclerosis