Dr. Hubbard's update on the FDA

[MrSuccess]

.... well it looks like everyone has professionaly done their jobs , and now the continuation of exploring CCSVI can proceed further afield. I applaud Dr.Hubbard AND the FDA.

Sometimes redtape .... can be a good thing.

So if I understand how this all works ....... Dr.Hubbard has the approval of the FDA ... for the use of medical devices [ balloons] to treat plugged blood veins. We have come to label that as having CCSVI.

The FDA has given their approval .... with strict guidelines . I have no information as to what those restrictions are. Probably stents , and stent locations ....

So now Dr.Hubbard can reach out to approximatly 10 interventional radiologist's , and give them the green light - with restrictions - to treat 662 patients . Why 662 and not 500 or 1000 ...... puzzles me . But I'll take the 662 .

Now comes the hard part .... ALL of the 662 patients are to SELF pay . And this procedure is certainly not cheap. Note : THIS IS NOT A CLINICAL TRIAL.

My hope is that the results gathered by Dr.Hubbard .... will pave the way for a large Clinical CCSVI Trial. That is MY hope and words .... not Dr.Hubbards . We can only dream.

At this point ..... I have full confidence that Dr.Hubbard will carefully select 10 of the best interventional radiologists that will in turn ,provide the Hubbard Registration with important data collected from their treated patients. Dr.Hubbard can then crunch the numbers.

I hope this will put an end to the fly-by-night and crooked hole-in-the -wall CCSVI opportunists out there ..... that have milked pwMS ....often for thousands of dollars. MrSuccess has had this concern from Day One.

Now you can ask ... Are you working under Dr.Hubbards Registry ? Trust ... but verify if they really are. If not ..... WALK AWAY.

I am thrilled with the idea that 662 pwMS [ or other Neuro problems ] .... can seek out medical help in a dignified manner ..... in a professionaly respected setting.

The devil in the details .... will be the cost . A high hurdle to overcome. For everyone.

We now need 662 people with deep pockets.


MrSuccess

[Cece]

Now you can ask ... Are you working under Dr.Hubbards Registry ? Trust ... but verify if they really are. If not ..... WALK AWAY.

I can't agree with this. (Although I agree with many of the hopes expressed.) Remember DIR from Michigan was previously allowed into the Hubbard registry despite having performed minimal numbers of procedures (less than ten) and having an IR whose primary experience had something to do with adding cement to the spine. I am sure I am not explaining that cement/spine procedure correctly.

I have believed for years that the first big decision is whether or not to have the CCSVI procedure, and the second big decision is which doctor to see. That second decision may be even more critical than the first. There are lots of factors and contribution to data-collection such as being in a registry is absolutely one of them, but experience of the IR, going local, price, use of IVUS, etc are all important.

[vesta]

I’m glad to see there will be some progress in the USA on the study of CCSVI.
I wonder how a double blind study can work. (Another "blinded" Researcher studies the outcome.)
In spite of the title to the Traboulsee article, the Canadian study seems more civilized. Participants don’t pay for their procedure, and everyone is guaranteed CCSVI treatment.
Quotes taken from the UKMS website, under CCSVI
MS-UK - http://www.ms-uk.org/

10/09 sept /2013
Clinical trial into MS “liberation treatment” cancelled due to lack of participants
“Clinical trial lead Dr. Gary Siskin told Saskatchewan’s Ministry of Health that he wasn’t able to meet the overall target enrolment needed for the study to meet U.S. government requirements for a clinical trial.

Siskin told CTV News that he’s “very disappointed” the trial had to be cancelled.

He spoke about the difficulty in getting people to enrol in the study, as participants seemed reluctant because of the 50/50 chance that they would receive a placebo treatment instead of the real thing.

Siskin, an interventional radiologist, has treated several hundred patients outside of the trial -- but he stopped in favour of doing formal research into the treatment. His was the only FDA-approved study for CCSVI therapy.

He says despite the setback, his interest in CCSVI is undeterred. "This in no way diminishes my interest in CCSVI," he said.”

Traboulsee study. 9/10 Oct /2013 “
No link between narrowed veins and MS: Canadian led study”
“For his part, Traboulsee is still working on a study on the effectiveness of the so-called “liberation therapy."

His team is providing angioplasty to MS patients with narrowed neck veins as well as sham (placebo) treatments. Each group will then "cross over" to the other treatment after a year, so that all patients will receive the angioplasty at some point. Results from that study are expected in late 2015.

Traboulsee says many MS patients want to know if the liberation procedure is beneficial.

"We are committed to evaluating this treatment with robust methods and utilizing patient-focused outcomes," he says.”

Patient focused outcome. Sounds good to me if they mean it.

[AMcG]

Traboulsee set out to find no difference between stenoses in normals and stenoses in pwMS and then developed a methodology to show exactly that. He will do the same with the treatment study. This study is meant to be the last. The study which finally puts the lid on CCSVI. Don't expect anything else.

[vesta]

The Italian MS Society set out to put the lid on CCSVI as well. see here "Italian MS Society seeks to discredit CCSVI theory"

"RnRrider of the French ForSeps.org wrote a summary of the Italian MS Society's (AISM) 2 year "controlled" study of CCSVI which was recently presented at the Lyon ECTRIMS conference. Directed by the Neurologist Dr. Giancarlo Comi of the University of Milan and his colleagues, given the name CoSMo, 35 clinics in Italy participated while 107 clinics were excluded. Early on Dr Zamboni participated in the study but then pulled out, denouncing the protocols which he felt would lead to inaccurate, biased results. Apparently the only diagnostic tool was a Doppler Sonogram undertaken on 1,874 participants, 1,165 with MS, 376 controls and 226 other neurological diseases. Only 3 % of MS were "positive", slightly less for the controls. Conclusion, the CCSVI MS theory was pronounced dead and finished, this was their final word. (Interestingly, 89% of the positive results found at local clinics were declared invalid by the central examiners.) The Italian MS Society spent 2 million euros on the study. This is the first time that a national MS Society has definitively declared the CCSVI link to MS theory of no further value. (All but one of the principal researchers have links to major drug companies List to follow.)

It looks like the Semmelweis reflex is alive and well in Italy.

Comi declared having received consultation fees for participating in consulatitive comittees for Novartis, Teva, sanofi-aventis, Merck Serono, et Bayer Schering. Des honoraires de conférencier de Novartis, Teva, sanofi-aventis, Merck Serono, Biogen Dompé, Bayer Schering, et Serono Symposia International Foundation . Mancardi declared having received honoraries for conferences and fees for attending meetings as well as financial support for research with Bayer Schering, Biogen Idec, sanofi-aventis, Novartis et Merck Serono.
Stolz declared having no concerned financial interest."

From Phlebologist;
The study got "standing ovation" in Lyon.
It is very interesting - however - what went wrong with this study. One thing is the censure of "positive" results, but it is only part of the story. Of note, in very "negative" reports by Centonze and Baracchini 30-40% prevalence of CCSVI has been found (in the patients and controls alike), thus ~10 times more than in this very strange study. Probably, Comi and coll. were looking for refluxes during Valsalva, or other patterns not related to CCSVI.
Nonetheless, this study is a perfect example how different results can be got using not standardized diagnostic tool, especially if a parameter is interpreted by layperson. It is also, unfortunately, far away from science and very alike to what we see everyday in the politics.

[MrSuccess]

...it looks like my post on Dr.Hubbards FDA approval .... was misunderstood. Let me expand on my post. Firstly ,there are many health professionals involved with CCSVI , that I hold in the highest esteem. If they wander over here to TIMS , and read ALL of my posts , they will be in agreement and delighted with my comments about them.

No need to name names. They know who they are.

Cece , you make a valid point as usual. But let me point something out. As we are all painfully aware .... there has been significant resistance to advancing the science of CCSVI. It's been tough sledding in getting support [ publically ,at least] from medical professionals . Dr.Hubbard was in no position to pick and choose.

This should all change now. Having FDA approval [ even limited and with strings attached ] should result in an increase of interventional radiologists now interested in CCSVI treatment. This approval more or less .... covers their ass'. That's important.

To the betterment for everyone , this FDA approval will allow Dr.Hubbard more leeway to select those he wants to participate . Money to be made will no doubt be a motivating factor for the IR's. I have no problem with that. Health Insurance or selfpay , makes no difference . They get paid for services provided , either way. Again , I support that.

IR's.... ARE NOT ... the badguy's. Quite the opposite .... they are the people that make it all happen. As we know , thanks to Dr. Scalfani[sp] .... there is a learning curve ....

After posting yesterday .... it dawned on me .... that I forgot to ask ....

Quanto costa .... ?


MrSuccess

[Cece]

Having FDA approval [ even limited and with strings attached ] should result in an increase of interventional radiologists now interested in CCSVI treatment.

This is very, very good in the long run, especially considering some of those IRs will be academic IRs which will lead to more research, and some will be clinical IRs which will lead to greater local availability. It's really nice to be able to get a CCSVI follow-up done without getting on a plane.

In the short run, though, an increase of IRs means that we will have more beginner CCSVI IRs, who will make beginner mistakes. I had too many friends and acquaintances here back in 2010 who posted or pm'd about clotted or scarred jugular veins, and those veins were lost, and sometimes it was both jugular veins lost. It's devastating for that to happen to even one of us. So taking a step back emotionally, what would be needed would be for Dr. Hubbard to make sure that any IRs who come onboard the registry are also brought into the community of CCSVI IRs and that sharing and learning takes place and hopefully those beginner mistakes, which really are inevitable because of the learning curve, will be fewer than they would be if a new CCSVI IR is simply going it alone.

None of this should detract from the congratulations that Dr. Hubbard is due for the very real and significant accomplishment of getting that FDA approval, finally!

[MrSuccess]

All valid points and concerns. I agree. So let's hope Dr.Hubbard sets the bar high for those involved. I doubt very much that there will be a lack of interest expressed by the IR's , as this is very much .....good income for them. And better them ,than Big Pharma....

And as I've said before ...... either way ..... Health Insurance or Self Pay .... these skilled medical professionals are full value for their skills.

As is GENERALLY bandied about here at TIMS ..... the success ratio for CCSVI is often described as " THIRDS". One third .... continue to decline. One third ...no improvements BUT do not get worse. And One third ... report very good outcomes.

So about a successful ratio of about 66%. A hellovalot better than CRAB drugs.

I'd sure like to see the group that continued to decline ..... have insurance cover their CCSVI costs.

Overall .... this is a very positive step forward , for CCSVI research.


MrSuccess

[Robnl]

FDA Registry Status
We have now received our final, unconditional approval from the FDA. Drs Sperling (New York City), Sclafani (Brooklyn), McGuckin (Philadelphia), Syed (Dayton, Ohio), Ferral (Chicago) have begun the process of obtaining IRB credentialing, and Drs Ponec (San Diego), and Cumming (Minneapolis) are also planning to enroll. The FDA is allowing us only 10 sites, so there are still 3 sites available. We are updating the Hubbard Foundation web site google map as progress is made.

This is the way it should be with a ccsvi trial! Dont you think??

[Cece]

Sperling, Sclafani, McGuckin, Syed, Ferral, Ponec, Cumming
3 out of 7 use IVUS
Dr. Syed was the one I had concerns about. I hate to have singled him out though.
It's a registry not a trial but it's still excellent, Robnl!

[Robnl]

Cece,

The registry documents treated ccsvi patients, right?
So, when it looks positive, next step could be a trial?

[Cece]

Cece,

The registry documents treated ccsvi patients, right?
So, when it looks positive, next step could be a trial?

Next step would probably be a trial if the results are positive and if there is funding. The FDA was so involved with delaying this registry and requiring certain things that it worries me. Are they measuring MS outcomes or CCSVI outcomes? Can you even measure some of the improvements? Among my most profound improvements are cognitive clearing, fatigue improvement, a change in how I perceive color and taste and sound...those don't get measured easily. At this point I need assurance that research will be done well, and by well I mean exceptionally well, because we've seen it done poorly.

Also, the number of people getting the procedure is dropping off. How long will it take for the registry to start getting numbers? A lot of people seeking out the procedure had already undergone the procedure previously. What will the data show on people who are repeats, not first-timers?

I am pro-registry, especially with the caliber of IRs involved with this and their cumulative experience and wisdom. I am also weary, and a registry is not first-line evidence. What's the word for that? Level 1 evidence. A registry is a step on the way to getting to level 1 evidence. This many years into the journey and we're still on the first step. Ok, I'm excited that we're still on the path, and I think it's the right path.

[MaggieMae]

"Also, the number of people getting the procedure is dropping off."

When I read this sentence I had to make this comment. I know many people who would like to have the procedure, but cannot because they can't afford it. Insurance covered it for my husband three years ago, but as you know it is no longer covered. So they wait and decline.

[Rogan]

Too bad insurance carriers don't cover this.

I guess the actuarial experience with spending 183k a year is cheaper than a 10k procedure with unknown follow up costs?

Time for new insurance companies I guess?

Question for FDA

For an agency formed in early 1900's

How do regulators handle the need for personalized medicine?
MRI's, modern medicine, continue to show how MS folks and everyone is so anatomically unique.

[tzootsi]

Haven't heard anything from Dr Hubbard in a while.