U.S. issues chilling warning on MS therapy

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This article was published 11/05/2012 (5158 days ago), so information in it may no longer be current.

TORONTO — The U.S. Food and Drug Administration issued a warning Thursday about the so-called “liberation therapy,” a controversial procedure that proponents claim helps alleviate the symptoms of multiple sclerosis.

The FDA is warning health-care professionals and patients that injuries and deaths have been associated with the use of the experimental procedure, which involves widening veins in the neck and upper chest.

The therapy was devised by Italian doctor Paolo Zamboni, who has suggested MS may be caused by narrowed veins that prevent blood from properly draining from the brain, resulting in iron deposits that damage neurons. He calls the condition chronic cerebrospinal venous insufficiency, or CCSVI.

His treatment uses balloon angioplasty to open up the veins, in the same way coronary arteries narrowed by plaque are unblocked. But unlike Zamboni, some doctors doing the procedure also use tube-like devices called stents to prop open the blood vessels.

In its warning, the FDA said it received reports of one patient who died from bleeding in the brain and another who suffered permanent paralysis from a stroke after the treatment.

Other serious complications reported include: at least one death; stents migrating from a vein to another part of the body, including the heart; injuries to veins; blood clots in the jugular vein or in the brain; cranial nerve damage and abdominal bleeding. The frequency of such complications is unknown, the FDA said.

At least two Canadians have died from complications after undergoing the therapy. While exact numbers aren’t known, a few thousand Canadians are reputed to have paid out-of-pocket for the treatment in clinics outside Canada, with varying results.

Multiple sclerosis is a progressive disorder that causes injury to neurons in the brain and other cells of the central nervous system, resulting in what can be significant and disabling neurological symptoms. The underlying cause of MS has not been determined, but the disease is known to have a strong immunological component.

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

“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,” said Dr. William Maisel, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.

“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,” Maisel said in a release.

While the Multiple Sclerosis Society of Canada said it supports the FDA recommendation that further research is needed to understand the link between CCSVI and MS, “we respect and honour the right of people living with MS to make their own treatment decisions,” the organization added in a statement.

— The Canadian Press