MS vein-opening trial announced for B.C. and Quebec

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

Re: MS vein-opening trial announced for B.C. and Quebec

Postby CureOrBust » Tue Oct 02, 2012 5:32 am

drsclafani wrote:"Fantastic"
Double fantastic! They are prepared for others to further their little baby. :-D
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby 1eye » Tue Oct 02, 2012 6:34 am

drsclafani wrote:
Cece wrote:http://www2.macleans.ca/2012/09/30/finally-ccsvi-clinical-trials-so-why-is-everyone-so-pissed-off/
But he also raises a big concern: that doctors performing CCSVI treatment in the Canadian clinical trial won’t have prior hands-on experience. Interventional radiologists say it takes upwards of 60 procedures to achieve proficiency; Salvatore Scalfani, a veteran interventional radiologist in Brooklyn NY, has reported it took him 200 procedures to feel comfortable. Traloubsee told Maclean’s the technologist and radiologist involved in the trial spent a week with Zamboni and his team in Italy. The vascular team has had “extensive conversations with many international colleagues who’ve performed the procedure,” he says, including Dr. Gary Siskin who’s running the Albany trials.

I don't consider conversations about a procedure to be a substitute for experience performing the procedure.
With the stakes as high as they are, I would want this to be research done by experienced providers.



I spent a week with Dr Zamboni too. I asked Dr Galleoti how many cases it took for him to be comfortable and he said fifty.

I then showed Galleoti and Zamboni a case study and they both got it wrong and missed the stenosis.

I can tell you that a trial done by inexperienced physicians will lead to the following results:

1.It is dangerous. many patients thrombose their jugular veins
2. many patients will have benefits that last a couple of weeks to a couple of months

A group of us offered our help and advice. No one ever contacted me.

it is a situation that makes me angry

There are two locations for this trial as announced. Dr. Sclafani cannot himself be in both at once. I expect the other doctors who had made this offer with him would be world-class as well, though he is undoubtedly the best they could ask for. If they do not contact him or the group, it is an egregious error, which shows that due diligence and reasonable prudence cannot be among their concerns. If I were a patient involved in this trial, and became aware of this fact, I would have grave concerns about the care of these researchers, and would have a hard time giving my informed consent.

That being said, if I knew they had taken advantage of this offer of help and advice from the most experienced people in the world in this procedure, I would have a much easier job giving my consent to the trial.

Let's be realistic: people have died, and quite a few Canadian and American doctors have expressed their reservations about this procedure, forcefully, and in public, with all the fanfare the media could muster. We have to hope, with the government's oversight, they are willing to take the best advice and assistance when it is offered. There can be no excuse for not doing so.

I'm sure others, even in this forum, have a good awareness of what is required for such a trial. Canadian doctors, with all their training and expertise, should know as well.

These doctors are not infallible, and these people who are willing to take such risks on behalf of all Canadians, all their fellow sufferers, and the inevitable future ones, deserve the best they can be given. Not the most convenient, the cheapest, or the least challenging, but the best.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Cece » Tue Oct 02, 2012 8:32 am

drsclafani wrote:I can tell you that a trial done by inexperienced physicians will lead to the following results:

1.It is dangerous. many patients thrombose their jugular veins
2. many patients will have benefits that last a couple of weeks to a couple of months

A group of us offered our help and advice. No one ever contacted me.

it is a situation that makes me angry

It makes me feel sad and powerless.
Six million dollars is a significant amount of funding, we don't see that everyday for CCSVI research, and the results are going to be influential.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby happydance » Tue Oct 02, 2012 9:54 am

Here's a link to more details of the trial:

http://www.vchri.ca/s/MS-CCSVI-PII.asp

http://www.vchri.ca/s/MS-CCSVI-PII-WCP.asp

This was under the Q & A section:
Q: How long will the study last?
A: Each patient will be followed for two years. However, the trial itself will last up to 4 years.

I'm wonder why they will only be following the patient's for two years, but the trial will last up to 4 years. What will they be doing the other two years?
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby erinc14 » Tue Oct 02, 2012 10:12 am

Finally, CCSVI clinical trials. So why is everyone so pissed off?

http://www2.macleans.ca/2012/09/30/fina ... issed-off/
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Cece » Tue Oct 02, 2012 11:59 am

happydance wrote:This was under the Q & A section:
Q: How long will the study last?
A: Each patient will be followed for two years. However, the trial itself will last up to 4 years.

There will be 100 patients in the trial so it would take some time to schedule and treat all patients initially. Could that take six months to a year? After the last patient to be treated gets their final two year assessment, it could be another 6 months to a year to process the data and prepare for publication. We should get some preliminary results before that point.

Or wait! They are doing a sham group. They do the real patients first and the sham patients get the sham, and then after a year, the sham patients get let in on the joke, and the sham patients get the real procedure, so for that group it's a year of sham plus two years of follow-ups.
The research team will enroll 100 subjects. Patients will be randomized to receive venoplasty (interventional radiology treatment using a balloon, not stent) treatment or a sham treatment and cross over to the other treatment at year one, so all patients will receive the venoplasty at some point.
http://www.vchri.ca/s/MS-CCSVI-PII.asp
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Cece » Tue Oct 02, 2012 1:48 pm

"It's going to be a randomized-control study where patients who have the presence of CCSVI will be randomly selected to either have the venoplasty, which is dilation of the vein, or a sham treatment, which is not an actual dilation, just a pretend dilation," Traboulsee said from Vancouver.

"And after a year, the groups will switch so that everybody eventually gets the dilation of the vein."

A venoplasty to widen veins is the same technique as an angioplasty used to expand coronary arteries; a tiny balloon is fed into the blood vessel, then expanded.

None of the participants will know which treatment they received or during which half of the study, Traboulsee said.

"The patients won't know when they're getting the dilation, the first time or the second time, so it doesn't bias their interpretation of benefit," he said. http://www.ottawacitizen.com/health/Pat ... z28B0VIJhf

The researchers will know if restenosis (or underdilatation or thrombosis) occurs in the initially treated group. The IR will be doing a sham venography a year after the first one. I would hope that, when doing the data analysis, they'd separate out the restenosed patients from those in whom the veins were successfully opened. I would also hope that restenosis would be treated when found, but I don't know if that's the case.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby drsclafani » Tue Oct 02, 2012 6:21 pm

Cece wrote:
"It's going to be a randomized-control study where patients who have the presence of CCSVI will be randomly selected to either have the venoplasty, which is dilation of the vein, or a sham treatment, which is not an actual dilation, just a pretend dilation," Traboulsee said from Vancouver.

"And after a year, the groups will switch so that everybody eventually gets the dilation of the vein."

A venoplasty to widen veins is the same technique as an angioplasty used to expand coronary arteries; a tiny balloon is fed into the blood vessel, then expanded.

None of the participants will know which treatment they received or during which half of the study, Traboulsee said.

"The patients won't know when they're getting the dilation, the first time or the second time, so it doesn't bias their interpretation of benefit," he said. http://www.ottawacitizen.com/health/Pat ... z28B0VIJhf

The researchers will know if restenosis (or underdilatation or thrombosis) occurs in the initially treated group. The IR will be doing a sham venography a year after the first one. I would hope that, when doing the data analysis, they'd separate out the restenosed patients from those in whom the veins were successfully opened. I would also hope that restenosis would be treated when found, but I don't know if that's the case.


Will they treat numerous restenoses that are likely to occur before one year?
Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Cece » Tue Oct 02, 2012 10:30 pm

I have to assume that they're not going to treat restenosis at all.
How would you maintain blindedness if the procedure gets repeated? You can't schedule random repeat sham procedures for the sham group. The trial design assumes the IR will get the procedure right on the first try. They must be gifted IRs. :(
"We've been surveying patients who have gone out of the country for the treatment and we found a complication rate of 11 to 12 per cent. That's what patients are reporting," he said.

"My impression is it's mostly related to stents, and we're not going to be using stents in our study. We don't think the stents are the best idea at this point."

I don't think stents are used in 11 to 12% of patients these days. More like 2%. So how could all those complications be related to stents?
Back in 2010, we as patients thought most complications were related to stents. But I remember keeping a list as more and more complications were reported.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Cece » Tue Oct 02, 2012 10:42 pm

drsclafani wrote:I can tell you that a trial done by inexperienced physicians will lead to the following results:

1.It is dangerous. many patients thrombose their jugular veins
2. many patients will have benefits that last a couple of weeks to a couple of months
Aglukkaq, in Halifax for a meeting with provincial and territorial health ministers, said about 100 MS patients will be enrolled in the Phase I and II trial to assess the safety of the procedure to unblock narrowed neck veins and its efficacy in improving MS symptoms.
http://www.huffingtonpost.ca/2012/09/28 ... 22718.html

So the trial is to assess safety and efficacy, and the prediction for safety is #1 and the prediction for efficacy is #2.
As an optimist, it is possible that the IRs will be fortunate and do better than this prediction. I don't think relying on luck, however, is a good strategy.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby CureIous » Wed Oct 03, 2012 10:23 pm

This is the neuros way of owning ccsvi as their own and cutting IR's out of the loop. Since neuros will be doing the evaluating as to efficacy, they will have the final say so. This has been their goal from the get go and was patently obvious more than two years ago.

1. Obfuscate and delay, use media or whatever means necessary to buy time to formulate gameplan for dealing with this audacious frontal assault on their territory.
2. Once sufficient time has elapsed they now have the ideal way of putting this to bed once and for all, a study which THEY run, THEY evaluate as to efficacy, and THEY do the writeups on.

Not too sophisticated, fairly transparent, but highly effective. Thereafter no one can complain "no studies were done". We've already seen what happens just with simple imaging studies they run, wholeheartedly negative, why expect much else from this "collaborative effort"?

I have little confidence in government run studies with neuros at the helm coming back anything but negative. Dr. S has already laid out the scenarios we can expect to see by cutting the most experienced physicians out of the loop.

Once Canada has laid the track, the US pharma/neuro express will just chug right down the road....

Which is why I insist we are truly as patients all alone in this save for a few courageous souls willing to work outside the halls of academia proper....

(and as it has been said, "it's not a conspiracy THEORY if they really are out to get you lol).
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby erinc14 » Thu Oct 04, 2012 7:26 am

Yes, you can be paranoid and be right .
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby 1eye » Thu Oct 04, 2012 7:57 am

Anyone can see that blinding is not enough. If the researcher has a personal bias against the treatment, for whatever reason, it may be impossible to avoid deliberate sabotage by omission or commission. The omission of a response to Dr. Sclafani's offer of assistance is one example. As far as commission goes, I'm sure it makes less than zero difference that there will be vascular specialists involved. There will be some found to suit. There are plenty around.

The Canadian taxpayer is being royally ripped off, probably so that the drug companies will be able to continue their outrageous greedy fraudulent theft. The only appropriate response by a self-respecting "MS" patient is to refuse to pay, refuse to buy these phony and dangerous drugs.
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Re: MS vein-opening trial announced for B.C. and Quebec

Postby Azaeleaprawn » Wed Oct 10, 2012 12:30 am

CureIous wrote:This is the neuros way of owning ccsvi as their own and cutting IR's out of the loop. Since neuros will be doing the evaluating as to efficacy, they will have the final say so. This has been their goal from the get go and was patently obvious more than two years ago.

1. Obfuscate and delay, use media or whatever means necessary to buy time to formulate gameplan for dealing with this audacious frontal assault on their territory.
2. Once sufficient time has elapsed they now have the ideal way of putting this to bed once and for all, a study which THEY run, THEY evaluate as to efficacy, and THEY do the writeups on.

Not too sophisticated, fairly transparent, but highly effective. Thereafter no one can complain "no studies were done". We've already seen what happens just with simple imaging studies they run, wholeheartedly negative, why expect much else from this "collaborative effort"?

I have little confidence in government run studies with neuros at the helm coming back anything but negative. Dr. S has already laid out the scenarios we can expect to see by cutting the most experienced physicians out of the loop.

Once Canada has laid the track, the US pharma/neuro express will just chug right down the road....

Which is why I insist we are truly as patients all alone in this save for a few courageous souls willing to work outside the halls of academia proper....

(and as it has been said, "it's not a conspiracy THEORY if they really are out to get you lol).


My own negative opinion of neuros being the ones running this study was created by a UBC neuro at our local MS Clinic, who told me during my Dx when I asked about treatment for CCSVI that venous angioplasty was nothing more than a "cash grab" and that I shouldn't waste anymore time thinking about it. Now I'm supposed to think the neuros have the best interests of this study in mind after that statement?
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