"high fatalities"

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

"high fatalities"

Postby erinc14 » Tue Feb 12, 2013 8:38 am

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Re: "high fatalities"

Postby Cece » Tue Feb 12, 2013 9:49 am

According to Dr. Lance Kim, a neurologist at the Florida Neurological Center in Ocala, “LDN has some promising results. It was originally used to treat narcotic addicts, but in low doses has a positive effect for MS patients. The CCSVI surgery tries to improve the drainage of the venous blood from the brain to the heart. It’s not approved by the FDA. It’s a high-risk procedure with high fatalities.”

There are safety studies showing jugular venoplasty to be a low risk procedure. The issue is that although the risk appears to be very low, there is not yet enough evidence in the medical literature to show that the benefit outweighs the risk.

I take as much issue with the statement that it is not FDA approved as I do with the high-risk statement. Here's the FDA statement in their May 2012 communication:
You should be aware the FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and use of such devices in treating CCSVI are considered off-label at this time. While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject.

Saying something is not FDA approved when it does not need to be FDA approved is misleading.

Thanks, erinc14, for posting. I saw this on Facebook just now too.
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Re: "high fatalities"

Postby Anonymoose » Tue Feb 12, 2013 11:13 am

Sounds like someone needs to write a letter to the editor...oops, just saw the comments...someone(s) already did. :D I wonder if the woman in the article is upset about the misrepresentation.
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