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Updates on Stanford trial?

Posted: Thu Mar 04, 2010 11:15 am
by healthymama
Has anyone heard of any updates on Dr. Dake's clinical trial? I understood something would be approved by mid-February but that it wouldn't be completely set up until late summer. It hasn't been denied has it? Anyone have any sources?

Posted: Thu Mar 04, 2010 1:16 pm
by Ruthless67
It's my understanding from an erlier post that Dr. Dake is still currently working on the formalities but has hired the extra employees. Trials will probably start in late summer.

Lora

Posted: Thu Mar 04, 2010 4:54 pm
by Rosegirl
Stanford University halts CCSVI treatments after two serious incidents
01 Mar 2010

Researchers at Stanford University have halted treatments for chronic cerebrospinal venous insufficiency (CCSVI) according February's edition of the journal Annals of Neurology.


The decision came after two people experienced serious side effects following stenting of the jugular veins, a procedure thought to correct CCSVI. One patient died from a brain haemorrhage following the procedure in August and another required emergency open heart surgery in November after a jugular vein stent dislodged into the right ventricle of the heart.

Dr Jeffrey Dunn, associate director of Stanford’s MS centre, called on other neurologists to speak out about the potential "dangers" of the unproven procedure: "If I can do anything to protect MS patients from the potentially devastating effects of false hopes or the risks of invasive and unproven treatment, I am happy to do so".

The theory that CCSVI may play a role in causing MS was developed by Italian Cardiovascular Surgeon Dr Paolo Zamboni and has resulted in much debate and controversy. It has also sparked interest in many of the 2.5 million people with MS world-wide as a potential cause of MS.

Dr John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society in the USA said, "When dealing with a disease like MS, where we don’t know the cause or have many therapeutic options, it’s important to think outside the box. Dr Zamboni is doing this, but his techniques need to be confirmed.

He went on to add, "All of the evidence today is preliminary. There is not even enough evidence to say that obstruction of veins might be a factor in MS, or to determine when this obstruction may occur in the course of disease."

MS Societies around the world have emphasised that new research studies will be pivotal in determining the link between CCSVI and MS before surgical procedures should be made available to treat CCSVI.

Researchers in Buffalo NY are investigating the prevalence of CCSVI in people with MS. Dr Robert Zivadinov, Director of the Buffalo Neuroimmaging Analysis Centre and principle investigator of the Buffalo says: "If we can prove our hypothesis, that cerebrospinal venous insufficiency is the underlying cause of MS, it's going to change the face of how we understand MS", but he added that media coverage of CCSVI so far has been premature and "unrealistic".

Source: Annals of Neurology February 2010

Rosegirl

Posted: Thu Mar 04, 2010 7:09 pm
by onesickrace
i spoke with alex, dr dakes assistant two days ago and she assured me that they were still working out the protocol. she said its been slow going but they are working it out. she still had no inclusionary or exclusionary details nor did she have any time frame. she, as always, was more than friendly and as informative as i think she allowed to be.

Posted: Thu Mar 04, 2010 8:52 pm
by larmo
Those problems happened 4 and 6 months ago and they didn't happen in North America.
That reporter has quite a bit of catching up to do :) Question: If it took you 4 or 6 months to do your job, how long would it be before you were deservedly fired ? To think, the guy/gal got paid to do it and he/she still has a job !!!!

Posted: Fri Mar 05, 2010 4:06 am
by Motiak
larmo wrote:Those problems happened 4 and 6 months ago and they didn't happen in North America.
That reporter has quite a bit of catching up to do :) Question: If it took you 4 or 6 months to do your job, how long would it be before you were deservedly fired ? To think, the guy/gal got paid to do it and he/she still has a job !!!!
Those problems happened at Stanford but it has nothing to do with the upcoming trial.

Posted: Fri Mar 05, 2010 4:32 am
by Rosegirl
This article in the Annals of Neurology was in the February issue. Apparently, our friendly neighborhood neurologists still aren't waving the CCSVI flag.

For those of us who are not able to get into a CCSVI study, perhaps the best course of action is to get scanned by a properly trained radiologist and then look for a vascular surgeon to correct any blockages found? The link to MS doesn't even have to be mentioned because a severe blockage will be fixed and insurance will pay for it.

How's that for a plot twist?