Reuter's article
Posted: Sat Oct 06, 2012 7:18 am
Dr Arata is a name I'm familiar with as someone in the forefront who has performed the operation for CCSVI. His recent statement in an article makes me wonder who, if anyone in the US, DOES have jurisdiction over the procedures being done in the US
If not the FDA I would like to think that someone is overseeing and documenting procedure and safety concerns. Does the American Medical Association oversee it?"We are not seeking approval of a new use. This has nothing to do with the FDA," said Arata, who practices at Synergy Health Concepts in Newport Beach. "They have absolutely no jurisdiction."
DEGREE OF RISK
One of Arata's MS patients died after suffering bleeding in the brain several days after a CCSVI treatment last year. Arata attributed her death to the blood thinners used to prevent clots after CCSVI procedures, which he said have life-threatening effects in three or four out of 1,000 cases, compared with his experience of a single patient out of 1,200.