FDA Warns against MS Liberation therapy

The U.S. Food and Drug Administration has issued a warning about the so-called 'liberation therapy,' a controversial procedure that proponents claim helps with the symptoms of 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.

In response to the latest interest in CCSVI.

This is a similar problem that is experienced with drugs that have been licensed for use and adverse side effects that do not appear until a later date.

We only hear about the "positive" stories but because there is no follow up or register kept by the private clinics who undertake the “Liberation” procedure it is increasing difficult to know the success and failure rate. 

It is the same old story, everybody is dragging their feet. There has been ample opportunity to study and undertake clinical trials to establish the necessary guidance and protocols that would have enabled the “Liberation” procedure to be made available to all, in a safe and proper manner. Why not? The rationale behind CCSVI is not new and given the amount of money the international MS charities have between them and given the level of interest within the MS community the opportunity to undertake acceptable trials could have been funded as far back as 2008-2009.

Yet again we see those who can afford it, and indeed those who cannot being driven by “hope” undertaking long journeys without the knowledge of whether the “Liberation” procedure will help them or not.

There are success stories and failure stories but no real statistics. What we do know is that it is an expensive procedure and is out of reach of the majority of people who have MS.