BNAC commn.

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

Postby AMcG » Sat Dec 18, 2010 11:54 am

‘Clinical trials and sham procedures are imperative... Anecdotal reports will not suffice. Medical tourism is not helping.’

This is undoubtedly true now. And I am happy that we may soon have suitable data to enable treatment to proceed ‘normally’ in the US/Canada. But I am not happy that a large amount of data collected in a scientific and controlled fashion in other countries than USA/Canada is dismissed as ‘anecdotal’ and that their pioneering efforts are denigrated as ‘Medical Tourism.’ What is wrong with research supervised by the Medical University of Silesia ? Is this simply Xenophobia? I also think this is playing the game of those people who oppose CCSVI treatment.

I share the view that this agenda is being driven by the actions of a politically motivated group of neurologists and I don’t think it is the only or the best way to proceed. I agree with Doctor S – we need more exploratory work before trying to define best practice or set standards of care. That hopefully will still be done but it may well take longer because of the rush to do double-blinded trials. The greater issue to me is the totally unjustified ban on treatment on compassionate grounds. Urgent cases should be treated now. If they were and people could also see the real likelihood of treatment being available in their own country through the normal channels there would be a lot less people going abroad. My own decision to go to Poland was strongly influenced by the fact that I could not see the treatment ever being available thru the NHS in my own country (I still can’t)

I also worry about the precedence this sets. Not all science proceeds on a double-blinded basis and nor does it need to. Also I am not alone in thinking that double-blinded research is in fact often a sham and substantial amounts of un-blinding are common. The only thing certain about double-blinding and strict controls is that they cost a lot of money. Unfortunately that can have the effect of limiting the studies which are carried out to those which ‘big money’ are willing to finance. And big money always has it’s own agenda.

Having said all that we are where we are. I hope Joan does not think I am in any way attacking what she said. What she said was spot-on as usual and I know we have little choice now but to follow this path. Looking back on where we were 12 months ago this is in fact a great position to be in.

MarkW – I have no objection to you calling the treatment whatever you want. I hope we are more in accord now.

Best wishes to all.
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Postby David1949 » Sat Dec 18, 2010 11:56 am

On a different subject why is a sham procedure required? The idea is to test for the placebo effect. Why couldn't the placebo group be given a pill with the words "MS cure" stamped on it? For that matter couldn't the placebo group results from previous drug tests be used?
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Postby Cece » Sat Dec 18, 2010 1:12 pm

AMcG wrote:The only thing certain about double-blinding and strict controls is that they cost a lot of money. Unfortunately that can have the effect of limiting the studies which are carried out to those which ‘big money’ are willing to finance. And big money always has it’s own agenda.

From the video on ccsvi.org, Dr. Dake was talking about this initial study being funded but that then with results he'd be able to get funding for the bigger study to come. When we're talking big money, maybe we are talking stent manufacturers funding that study? If so, in order for that to be a valid comparison, the angio only arm needs to be done with the best methods of angio only, as compared to stenting. Those best methods are still being determined.
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Postby concerned » Sat Dec 18, 2010 1:25 pm

David1949 wrote:On a different subject why is a sham procedure required? The idea is to test for the placebo effect. Why couldn't the placebo group be given a pill with the words "MS cure" stamped on it? For that matter couldn't the placebo group results from previous drug tests be used?


There is a myriad of reasons.

http://en.wikipedia.org/wiki/Sham_surgery

ALSO- The idea is to weed out the placebo portion of the procedure, and surgical interventions may even have a higher placebo response. Comparing it to the placebo group results from previous drug tests would be worthless.

Why are some people so opposed to utilizing the gold standard of medical research?



In a number of situations, sham-controlled interventions have identified interventions that are useless but had been believed by the medical community to be helpful based on studies without the use of sham surgery. Thus in 1939 Fieschi introduced internal mammary ligation as a procedure to improve blood flow to the heart. Not until a sham-controlled study was done two decades later could it be demonstrated that the procedure was ineffective.[2][4] In neurosurgery, cell-transplant surgical interventions were offered in many centers in the world for patients with Parkinson disease until sham-controlled experiments involving the drilling of burr holes into the skull demonstrated such interventions ineffective and possibly harmful.[5] Subsequently over 90% of surveyed investigators believed that future neurosurgical interventions (ie. gene transfer therapies) should be evaluated by sham-controlled studies as these are superior to open-control designs, and half found it unethical to conduct an open-control study because the design is not strong enough to protect against the placebo effect and bias.[5] Kim et al. point out that sham procedures can differ significantly in invasiveness, for instance in neurosurgical experiments the investigator may drill a burr hole to the dura mater only or enter the brain.[5]
In a classic experiment in orthropedic surgery Moseley and coworkers studied the effect of arthroscopic surgery for osteoarthritis of the knee establishing two treatment groups and a sham-operated control group.[6] They found that patients in the treatment arms did no better than those in the control group. The fact that all three groups improved equally points to the placebo effect in surgical interventions.
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Postby Cece » Sat Dec 18, 2010 1:35 pm

concerned wrote:Why are some people so opposed to utilizing the gold standard of medical research?

For me it's because treating congenital abnormalities that result in outflow obstructions from the CNS is a no-brainer. I do not like that people will be denied this treatment and put through a sham when it is a treatment already known and recognised as urgent and necessary for people with dialysis-related jugular outflow obstructions, superior vena cava syndrome, etc.
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Postby concerned » Sat Dec 18, 2010 1:59 pm

I don't see how CCSVI in MS can be compared to end-stage renal failure or superior vena cava syndrome, which are both immediately life threatening (except in benign SVCS, which has no effect on life expectancy and doesn't result in MS, and similarly, CCSVI doesn't result in most of the symptoms of SVCS, such as facial and arm swelling, etc.) and have clearly defined and accepted reasons for performing the procedures.


EDIT: I guess I should have just said that SVCS isn't life-threatening, rather, the underlying diseases that cause it are life threatening, hence the radiation therapy, etc.
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Postby Cece » Sat Dec 18, 2010 2:10 pm

They are comparable because they are outflow obstructions, whether acute or chronic.
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Clinical Evidence is Not Anecdotal Data

Postby MarkW » Sat Dec 18, 2010 2:58 pm

If those posters who demand placebo controlled double blind clinical trials could explain the design of such a trial, including the design of a sham arm. Then I will accept you are challenging from a position of logic. Otherwise like many surgical procedures I asert that a drug style clinical trial is impossible (not a gold standard).

CCSVI syndrome has a symptom of restricted veins. Long standing medical practise has been to treat the symptoms of a syndrome. What is the logic of demands to test CCSVI and MS before treating a symptom ???

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Last edited by MarkW on Sat Dec 18, 2010 3:18 pm, edited 2 times in total.
Mark Walker - Oxfordshire, England. Retired Pharmacist. 16 years of study about MS.
CCSVI Comments:
http://www.telegraph.co.uk/news/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Re: Clinical Evidence is Not Anecdotal Data

Postby concerned » Sat Dec 18, 2010 3:33 pm

MarkW wrote:If those posters who demand placebo controlled double blind clinical trials could explain the design of such a trial, including the design of a sham arm. Then I will accept you are challenging from a position of logic. Otherwise like many surgical procedures I asert that a drug style clinical trial is impossible (not a gold standard).

MarkW


One word: anesthesia.

Like other surgical procedures, a placebo controlled double-blind clinical trial is very possible, and furthermore, desirable.
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Postby jimmylegs » Sat Dec 18, 2010 4:38 pm

"ThisIsMS is a MS discussion forum with a worldwide audience. The purpose of ThisIsMS is to facilitate communication between MS patients, their caregivers and other individuals, such as doctors and researchers, with an interest in MS. The goal of ThisIsMS is to provide helpful information to those who need it so that by working together we can solve our common problems. ThisIsMS does not exist to be any particular individual's soapbox from which to conduct a battle. It is not a sporting arena. Flame wars and other antagonistic behavior will not be tolerated. There are other newsgroups and forums where such activity is acceptable. However, it will not be tolerated at ThisIsMS. Where appropriate, as deemed by the forum administrator and the forum moderators, a single warning will be issued and accounts will be closed without prior notice upon continuation of such activity."
take control of your own health
pursue optimal self care at least as actively as a diagnosis
ask for referrals to preventive health care specialists eg dietitians
don't let suboptimal self care muddy any underlying diagnostic picture!
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Postby MrSuccess » Sat Dec 18, 2010 5:05 pm

wow ... talk about overreacting ....


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Postby HappyPoet » Sat Dec 18, 2010 5:11 pm

jimmylegs wrote:"ThisIsMS is a MS discussion forum with a worldwide audience. The purpose of ThisIsMS is to facilitate communication between MS patients, their caregivers and other individuals, such as doctors and researchers, with an interest in MS. The goal of ThisIsMS is to provide helpful information to those who need it so that by working together we can solve our common problems. ThisIsMS does not exist to be any particular individual's soapbox from which to conduct a battle. It is not a sporting arena. Flame wars and other antagonistic behavior will not be tolerated. There are other newsgroups and forums where such activity is acceptable. However, it will not be tolerated at ThisIsMS. Where appropriate, as deemed by the forum administrator and the forum moderators, a single warning will be issued and accounts will be closed without prior notice upon continuation of such activity."

Excellent policy.
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Postby CureIous » Sat Dec 18, 2010 6:04 pm

Dumping on sham procedures and the ethics involved was all the rage here not six months ago, now all the sudden it's SOP with nary a whimper? My how quickly times change. Glad to see everyone on the same page for the most part. Shams can be done, must be done, and will be done, they don't need to be done on everyone or in all modalities, just in limited fashion. Balloons can be partially inflated with all their concomitant sensations, no need to put the patient fully under, Dr. Dake didn't seem to have a problem with it when I asked him about it, if he's good to go with it, I say bring on the balloons because it will be difficult to scientifically pick that apart, not impossible, just difficult.
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Postby Lyon » Sat Dec 18, 2010 6:11 pm

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Postby CureIous » Sat Dec 18, 2010 8:00 pm

Lyon wrote:
CureIous wrote:I say bring on the balloons because it will be difficult to scientifically pick that apart, not impossible, just difficult.
Image I agree. It'll be hard and imperfect but otherwise the theory of CCSVI is just going to simmer on a back burner indefinitely and I don't think any of us on the bottom tier want that.



Yes, and we are fortunate enough to have visionaries like Dr. Dake that put their careers where their mouth's are to state it a bit crudely.

There's a difference between making an argument to the population at large, and making it to strict scientific protocol adherents. While being fully aware that there are other means for creating controls via treatment studies, and by that method both treating and using relapsers/restenosers (a very convincing argument I might add) as the controls among other methods, it will just invite the scientific community to blow more holes in the theory, Mack truck sized ones. Look at how much mileage the dinky little studies done by neuros have traveled, let em have their placebo controlled cake and eat it too..

I see this as a means to an end, not a real pretty, or even palatable means, but a means nonetheless. There's doesn't appear to be any study we can design that will be unassailable, thats a gimme, but this small sacrifice patients are willing to make, and granted, for a limited time, talking in months not years, will leapfrog this entire paradigm farther and faster than all the imaging studies put together, not that those are bad, but this is about treatment working or not, that's a long long way from where we were last year at this time, then maybe the news networks will start reporting more nobly and responsibly in the US than they have.

That of course is best case scenario, could go precisely the other direction too. Imagine if 100% of the control sham patients report improvements for instance vs. 50-80% of the real deal patients...

Of course my money is on the first horse right out the gate...

I think sometimes this gets mistakingly cross referenced with treatments for individuals, as if saying, "nobody should be treated until a double blind placebo controlled trial is done", or insinuating that that is what is being said here. Well, some may be saying that, but the fact is, treatment IS available to EVERYONE right now, only limited by one's individual resources, traveling limitations, money etc.

These folks in Dr. Dake's study should be commended very highly, I have no doubt they are fully aware of all this entails.

Big picture, very big picture.
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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