This Is MS Multiple Sclerosis Community: Knowledge & Support

Below is the gist of communication from BNAC-


- started testing 10 patients in June. Aim is to study for safety.
- enrolling +20 patients for phase 2. Aim is to study treatment efficacy and duration is 6 months.

The cost of this trial is expected to be around 700K and they need our help to complete this phase.

Thanks ...

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A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die and a new generation grows up that is familiar with it
- Max Planck

My business training suggests that BNAC are wasting 700K USD. With well over 2000 pwMS having already undergone balloon venoplasty, doing a safety study is a waste of money.
A test for efficacy must first define the change or changes to measure. Start by asking pwMS about changes (quite cheap with the internet). Then conduct a pilot study.

I hope BNAC do not design a placebo controlled double blind drug trial for CCSVI syndrome. CCSVI syndrome is a physical diagnosis, treated by a surgical intervention not a new drug. Time to think outside the box, I hope.

MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

http://tinyurl.com/36ucsss

There are good arguments here as to why surgical interventions to fix physical problems also need placebo controlled double blinded trials to measure efficacy.

What do you think it would hurt or are you saying CCSVI is not measurable?

In case there are other people reading this thread. I repeat:
My business training suggests that BNAC are wasting 700K USD. With well over 2000 pwMS having already undergone balloon venoplasty, doing a safety study is a waste of money. A study of 10 for safety is valid for what ?

I note that a Colin Rose website is quoted as an authority on surgical trial design !!!

A good use of 700K would be to undertake case studies to investigate short term changes in pwMS, after de-stenosis by balloon venoplasty.

MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Ok. Nevermind. I thought it was a normal question.

I've always thought that Jabba the Hut was just E.T. in a fat suit.

(I guess this joke is irrelevant post editing, but I chuckled as I typed it so I'm going to leave it, unless people want me to delete it.)

I'm curious, I talked about the cost of these clinical trials and all the sniping by neuros about this with my opthalmologist (who treats me to check on my optic nerves after all my optic neuritis). He said he thought these types of trials might be paid for by the balloon manufacturers, like how drug trials are paid for by drug manufacturers. He also said he's seen opthalmologists nearly come to fisticuffs at conferences when new ideas that break the mold are presented and upset people . Guess doctors egos are pretty fragile!

Balloon costs and manufacturers profits are tiny compared to the costs of placebo controlled double blind drugs trials.

Dr David Hubbard explains how he is organising a trial on:
http://www.komonews.com/home/video/106175483.html
Insurance companies and pwMS will pay be the procedure and will in effect pay for the trial. I suggest CCSVI syndrome supporters use this trial as soon as the centers are open.

MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Clinical trials and sham procedures are imperative. The US is leading the way in Albany, BNAC and Stanford. Dr. Zamboni is beginning his 500 patient double blinded placebo controlled treatment trial in Ferrara, Italy. The Haacke protocol measuring cerebral O2 and perfusion before and after angioplasty is also important. Anecdotal reports will not suffice. Medical tourism is not helping. Please listen to Dr. Michael Dake and Dr. Manish Mehta discuss this in the CCSVI Alliance video.

www.ccsvi.org

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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

whilst agreeing with Mark I am happy that concerned references the article he did. Colin Rose expresses his usual preferences/prejudices but does reference two pieces of research which broadly support what he says.

The problem is the age old one of placebo effects. Which can be a very slippery subject. I think this term is very misused and often ill defined. But in these two reports the effect is simply defined. it is pain perception. Because pain perception can vary greatly and is easily influenced by the attention of doctors then I find these results are quite credible. But I don't think that is what is going on in 'Liberation.'

Pain is a symptom reported in MS and CCSVI though it is not considered definitive of MS. If the test of efficacy of Liberation was based on pain perception I would tend to agree with concerned. But there are a number of other measurable factors which improve and can be objectively assessed (balance, visual accuity, fatigue, perceptiuon of temperature etc.) The one I always do when I am not feeling so good is the one-foot in front of the other walk. I can do it time after tiime now. Before my liberation I couldn't do it once.

So I think, like Mark, that by now we could have had an extensive body of case-book data for very little cost that would be far more useful than a very small scale double-blinded study.

Cheer, I agree clinical trial are important but at this stage the Hubbard designed IRB is the best way forward. Many case studies combined into a trial (not anecdotal). Also showing the CSF flow changes after de-stenosis (Mark Haacke's work) is required.

However, are sham procedures for diagnosis and treatment possible???. You need to insert a catheter into all veins with a possible stenosis to obtain a definitive diagnosis. If the patient has a septum in a vein, the catheter will pierce it during diagnosis and diagnosis is in effect de-stenosis or treatment, even if partial treatment.

Sham procedures are not possible on conscious patients because when balloons are inflated many patients report feeling a sensation. So the patient is not blind to whether they have been treated (ballooned) or not.

Also post procedure medication must be placebo for the placebo / sham arm of the trial, not a simple consideration.

If I can pick holes in trial design, vis a vis, sham procedures then be sure that MS neuros will enjoy trashing these studies.
I know Prof Zamboni, BNAC and others are trying to answer the MS neuros with these studies. Unfortunately double blinding of this surgical procedure to a conscious patient is not feasible in my experience.

I simply do not want these researchers to spend time and money on trials only for MS neuros to trash their trials.
Try not to shoot the messenger.

Kind regards,
MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Thanks for saying this. I am pretty sure most would agree with you Cheer.

Hello AMcG.
I have to agree to differ with you:
Liberation - I never will use this term referring to me. I have been de-stenosed and still have MS. The procedure did not liberate me from MS, unfortunately.

However, we agree on this:
AMcG wrote: "by now we could have had an extensive body of case-book data for very little cost that would be far more useful than a very small scale double-blinded study."

I have posted that when 5000 pwMS have undergone balloon venoplasty there will be overwhelming data. The number is not plucked at random..................

Kind regards,
MarkW

_________________
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

What I think people need to realize is that although the "data" from 5000, which is actually anecdotal information, may convince some people of the benefits of the liberation procedure, it leaves the people who need more proof scratching our heads. Contrary to popular belief most people(including people with MS, neurologists, Malden, etc.) are open minded and would be convinced that CCSVI plays a role in MS with, what we consider, good scientific proof(via double blinded trials). If you want more funding for CCSVI research I would think the trials are very important towards that goal.