This Is MS Multiple Sclerosis Community: Knowledge & Support

from the Hubbard Foundation newsletter

Asked to discontinue enrolling subjects. New guidelines by September. I don't think this affects patients who are currently a part of the registry? I hope that the FDA will be reasonable and allow this research to continue.

Maybe they think if they just close enough businesses the whole problem will quickly go away? Or if they can just get through to Labour day (or failing that, to election day) without anyone actually finding out anything, then it will be someone else's problem? Do they just want to outlaw some medical practices, or just any that are involved with CCSVI? And, we must ask again, if they're really trying to protect American citizens, why are they allowed to travel outside the US? Just confine them completely, to a jail cell, if necessary. In fact, why not have everyone with MS locked up? Sterilized also, so they can''t make any more bureaucrats any problems? Maybe Dole could sell us some pesticides?

Here in Canada, it's different. Similar, just a tad less American.

_________________
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

I had thought that Dr. Hubbard's registry might be left alone because it is a registry. The FDA covers prospective research, not retrospective research.

I think that the key word in the above quote is "enroll" which seems to state that they wish to prevent any new patients from joining the registry not eliminate the follow-up of prior patients already in the registry. It appears that they are methodically going out of their way to stop CCSVI treatment. However, more people have likely been harmed from drugs such as Tysabri and Novantrone yet that argument seems to fall on deaf ears plugged with pharmacash.

The Hubbard newsletter mentions that they should receive a response from the FDA by April 8th.

If procedures are still proceeding with or without the FDA approval on the registry, then the only thing a 'no' response accomplishes is the loss of the data.

Hi Cece,

Iirc, the loss of patient data means the data cannot be used in a published study, but can you please clarify the first part of your sentence? Does this mean that Dr. Hubbard will continue to perform CCSVI procedures even if the FDA does not give its approval? Thx.

I thought Dr. Hubbard's patients were treated by Dr. Ponec and that Dr. Ponec would choose on his own whether or not to continue treating either way? Is he currently treating, quietly? The approval (or lack of approval) coming on the 8th is just for the registry.

Ok I reread my sentence and it was confusing. I meant that procedures are still proceeding by many different IRs, not just Dr. Ponec through the Hubbard Foundation but Dr. Arata, Dr. Sclafani, etc. If the FDA does not approve registry studies, then there are still procedures being performed (30,000 estimated thus far) with the data being lost.

Thanks, Cece! Such a shame that so much data is lost.