Hi Cureious--
not sure it can be called a "raid"...since they didn't take anything or shut them down. But it sure was a surprise!
from Arlene Hubbard-
Quote:
Yesterday, the FDA made a surprise visit to one of our sites. They asked to see all of our documentation and will be returning again today. They provided no information on the reason for the visit or why that site was chosen first but did say that they would be doing inspections “all over the country”. The FDA did not shut down the site and as we have posted before we have already applied to the FDA for an exemption. Although the FDA’s primary intent is to prevent “advertising non approved uses for stents and balloons” it is unclear, so far, whether they also will stop research on CCSVI.
The Hubbard Foundation intends to continue to collect data on adverse events and changes in symptoms related to venoplasty (and ,hopefully, soon in relation to dietary and supplement interventions). An analysis of our first 259 patients has been accepted for publication and our multicenter Registry has collected data on over 400 people so far. We can’t see why the FDA would not want this data to be collected but we’ll keep you posted.
Venoplasty is performed every day in a variety of situations around the globe, and all of these procedures use balloons, catheters and stents in an "off label" manner. (The label refers to the FDA approved usages of a device or drug.) This is because angioplasty was designed for arteries, not veins. Any of these procedures in veins is considered an off label use of devices created for arteries. An this is within the FDA's realm. The reason why the FDA does not get involved in other venous procedures is anyone's guess. But the fact is, they do not. Renal veins are stented for Nutcracker syndrome, and iliac veins are stented for venous insufficiency, and the FDA doesn't say a word.
I think it is naive not to consider the 15 billion a year market in MS drugs. Not that there is a grand conspiracy, but perhaps we need to consider that there is an established business model interested in keeping MS treatments within the immune system paradigm. And power structures will get involved when corporate interests are challenged.
cheer
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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS