FDA warning about surgery for CCSVI

[Guest guest]

I found the article. It appears that the FDA is targeting the clinical

studies. I'm curious to learn more about the two Canadians who supposedly

died after the surgery. I had the procedure last August, and I didn't have

any of the adverse events listed in the article. Since the procedure is

basically angioplasty, I don't think it's possible for the FDA to ban it

(without banning ALL angioplasty procedures).

Thanks,

Larry

http://news.yahoo.com/u-fda-warns-injuries-deaths-linked-liberation-therapy-1443\

14523.html

By The Canadian Press | Associated Press

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. 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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