Age/disability discrimination in "MS"/CCSVI research.

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

Age/disability discrimination in "MS"/CCSVI research.

Postby 1eye » Fri Jan 27, 2012 3:57 pm

One of the fundamental cracks in the accepted foundation of knowledge about "MS"/CCSVI has to be inherent in acceptance and continued use of the terms clinically definite, relapsing-remitting, progressive, secondary and primary, as if the use of these terms confers additional legitimacy to any statement made about the disease, or syndrome, or whatever it is being called lately. At least one of these assessments/diagnoses is made primarily based on EDSS. The EDSS, or any measure of disease severity, worsens with age.

The usage of these terms, to categorize people for purposes of either drug development, or research, is a generalization that may prevent determination of real causes of disease. These terms smack of actuarial purposes. They are often used, by gatekeepers of medical treatment to exclude those who are most expensive to spend precious shared resources on: research money, insurance settlements, etc. That may or may not be a legitimate goal.

The danger is that the use of these ad-hoc characterizations to limit the cost of research may have the effect of preventing the researcher from finding fundamental disease mechanisms. What if these may only be elucidated by looking at older, or more disabled groups, or by examining, as Dr. Zamboni did, the entire panoply of "phenotypes." He might not have made the progress he has if he had limited the scope of his studies that way.

You, the person with "CIS", or "PPMS" have something fundamental in common with every "MS" sufferer. I think only by ignoring the insurance coverage and the "course" of the disease will we ever find out anything universally valid about that fundamental something. The bell tolls for every form of 'MS'.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby Cece » Fri Jan 27, 2012 4:29 pm

There is a difference in clinical presentation between the different types of MS. It is a very different experience to have relapsing remitting MS than to have progressive primary. There is a serious lack of understanding of what underlies these differences.

I think the drug companies would love to have an expensive drug for the PP or SP cohorts. They're just not finding anything that actually works, and yeah, they might not be trying to hard, if the focus is on the RRers. Big money in RR MS.

So your nickname was Eeyore? I would've thought you were more of an Owl, smartest of the bunch.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby 1eye » Fri Jan 27, 2012 5:06 pm

Cece wrote:There is a difference in clinical presentation between the different types of MS. It is a very different experience to have relapsing remitting MS than to have progressive primary. There is a serious lack of understanding of what underlies these differences.

They all have the same problems. Everybody gets worse with age. Nobody could have stopped smallpox if they only studied 'mild' cases.

I think the only difference is in the remissions. After you have enough "progression" or "attacks" you are disabled, whether you are young, old, lame or fit. The thing I found was the closer I got to "SP" the more vague the definition of an "exacerbation" became. That's what progresses. Uncertainty goes up, and charity goes down. Present company excluded. :-)

I still say they are placing artificial limits on the research. Let's say a virus is identified as being "the" culprit in "RR". Well, I guess we needn't even try the vaccine on those other people, right? After all, they are charging $100,000 per dose, and it *is* a different disease, right?
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby Nasti » Sun Jan 29, 2012 2:29 am

When I started reading on the internet in 2006, it was like RRMS, PPMS and SPMS, today new types have emerged, like primary relapsing, etc. The line between them is so thin, it can be considered non-existing. Even when people are dx as RRMS, they still have few symptoms that linger. I had symptoms that didn't go away since I was 10. Does that mean that all of us are SRMS??
And these divisions often discourage people from taking further steps, like CCSVI. They may say "I am PPMS, it doesn't work for us".
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby KateCW » Sun Jan 29, 2012 9:09 am

I am constantly searching for studies that will accept me, and even when I find one that will take PPMS my EDSS of 8.0 almost always excludes me.

i am part of a CCSVI study here in Calgary-ultrasoud, MRI,MRV etc. They were poorly prepared for me since the MRI table did not lower, the lift team in hospital took an hour to get there, etc. I am lucky that i was able to participate and had friends to accompany me etc. I cant imagine that many people with my level of disability would be able to participate.
Kathy, 49 with PPMS,full time scooter.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby blossom » Mon Jan 30, 2012 9:22 pm

yes, 1eye, age, ms "especially ones who are older and more progressed" and sadly other diseases and even in the world in general it comes into play. of course, the younger less ill we want to save--but, we that have been through the mill, i feel are being overlooked and under estimated at what we have to offer not only in the research but in many many ways.

wasn't bad enough everything was blamed on these symptoms they named ms---now i get told---well, you know you are 65 yrs. old and --you have ms. most every study etc. is based on age --what is there a useless throw away tag growing somewhere on my body i'm not aware of?
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby eric593 » Tue Jan 31, 2012 1:56 am

One of the fundamental cracks in the accepted foundation of knowledge about "MS"/CCSVI has to be inherent in acceptance and continued use of the terms clinically definite, relapsing-remitting, progressive, secondary and primary, as if the use of these terms confers additional legitimacy to any statement made about the disease, or syndrome, or whatever it is being called lately. At least one of these assessments/diagnoses is made primarily based on EDSS. The EDSS, or any measure of disease severity, worsens with age.The usage of these terms, to categorize people for purposes of either drug development, or research, is a generalization that may prevent determination of real causes of disease. These terms smack of actuarial purposes. They are often used, by gatekeepers of medical treatment to exclude those who are most expensive to spend precious shared resources on: research money, insurance settlements, etc. That may or may not be a legitimate goal.The danger is that the use of these ad-hoc characterizations to limit the cost of research may have the effect of preventing the researcher from finding fundamental disease mechanisms. What if these may only be elucidated by looking at older, or more disabled groups, or by examining, as Dr. Zamboni did, the entire panoply of "phenotypes." He might not have made the progress he has if he had limited the scope of his studies that way.You, the person with "CIS", or "PPMS" have something fundamental in common with every "MS" sufferer. I think only by ignoring the insurance coverage and the "course" of the disease will we ever find out anything universally valid about that fundamental something. The bell tolls for every form of 'MS'. One of the fundamental cracks in the accepted foundation of knowledge about "MS"/CCSVI has to be inherent in acceptance and continued use of the terms clinically definite, relapsing-remitting, progressive, secondary and primary, as if the use of these terms confers additional legitimacy to any statement made about the disease, or syndrome, or whatever it is being called lately. At least one of these assessments/diagnoses is made primarily based on EDSS. The EDSS, or any measure of disease severity, worsens with age.The usage of these terms, to categorize people for purposes of either drug development, or research, is a generalization that may prevent determination of real causes of disease. These terms smack of actuarial purposes. They are often used, by gatekeepers of medical treatment to exclude those who are most expensive to spend precious shared resources on: research money, insurance settlements, etc. That may or may not be a legitimate goal.The danger is that the use of these ad-hoc characterizations to limit the cost of research may have the effect of preventing the researcher from finding fundamental disease mechanisms. What if these may only be elucidated by looking at older, or more disabled groups, or by examining, as Dr. Zamboni did, the entire panoply of "phenotypes." He might not have made the progress he has if he had limited the scope of his studies that way.You, the person with "CIS", or "PPMS" have something fundamental in common with every "MS" sufferer. I think only by ignoring the insurance coverage and the "course" of the disease will we ever find out anything universally valid about that fundamental something. The bell tolls for every form of 'MS'.


Because MS is different for each individual with different rates of progression and relapse rate, researchers have had great difficulty in MS clinical trials controlling the variables and not having trials last for 10 years to account for people who don't have frequent or annual attacks but that would still differ pre- and post-treatment. Top researchers have held meetings for decades in an effort to tighten the trial criteria in order to produce reproducible results. There has been extensive discussion for many, many years about ways to produce accurate trial results in MS research. Aging and disability levels have their own sets of variables that they would need to factor in if they didn't set limits on age and disability as well. It's all about controlling the variables in clinical trials.

No drugs so far would ever have shown a stastically significant benefit if PPMS and SPMS people were included since we know now the meds don't work in the non-inflammatory kinds of MS. The categories have some significance and value, they aren't arbitrary labels but were intended to help with consistent trial participant selection. To overcome the dilution of the non-inflammatory group that we know the meds do NOT help, it would have required far greater numbers of trial participants to show the difference in the people it does help to offset this dilution. Of course, no one would know what type of MS the drug actually worked on if all MS types were included together, so people would be taking unnecessary risks with their health and unnecessary costs for meds that didn't even help them. I can't see how that helps anyone. Either that or the meds would never have been available to anyone because they would not have shown a stastical benefit in the trials. Many MSer's who HAVE been helped by them would have been deprived under your plan.

Isn't it better that they try the meds on SPMS and PPMS separately to determine if there's a benefit there too, and continue to try to find effective treatments for those types on their own, now that we know that distinct differences exist between those groups and RRMS??
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby eric593 » Tue Jan 31, 2012 3:00 am

This SPMS trial for Tysabri seems to have a wide age and disability range:

http://www.businesswire.com/news/home/2 ... -Treatment
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby 1eye » Tue Jan 31, 2012 9:03 am

eric593 wrote:This SPMS trial for Tysabri seems to have a wide age and disability range:

http://www.businesswire.com/news/home/2 ... -Treatment


I don't wonder that they are now expanding their grasp, since "side-effects may include death", as my neurologist told me. I applaud their level of inclusion, and say it does not go far enough, until it includes everyone still alive.

If age and disability are excluded, what I am saying is that that in itself is a systemic and arbitrary bias that does invalidate some results, because the relative health of one sick person over another may have something, nothing, or everything to do with the medicine's effectiveness. That is especially so for age, when the bias may have been a more important factor than the medication.

If those people are included in a trial, why doesn't your argument work to exclude younger or less disabled or more "remitting" people?

I think for some people it's "RR" and "the harder cases", which is everybody else.

I am 58, EDSS 65, called "SPMS", yet I still have inflammation as much as I ever did. Anti-inflammatory drugs are a staple for me. Someone being pedantic might say the benefit I had (much of it gone now) was just a remission. But if they did, they would have to admit I am "RR", whereas from 2004 to 2010 I was "SP". You can't have it both ways.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby Cece » Tue Jan 31, 2012 9:49 am

Here MS is defined as an autoimmune inflammatory disease: www.ncbi.nlm.nih.gov/pubmed/11804546. But eric refers to SPMS and PPMS as noninflammatory types of MS. The existence of noninflammatory MS calls into question the definition of MS as an autoimmune inflammatory disease and necessitates research into explanations, such as CCSVI, where inflammation is a part of the process but not the root of the process.

If RR is the group most likely to show effects of a treatment in blinded trials, then I would tend to think that we want CCSVI tested in RR MS first. Sorry 1eye. I agree with your way of thinking but it seems most important to validate CCSVI, and if that's best done on RRMS, then full speed ahead.

I have been thinking about SPMS for a week or two now ever since I came across some MR images of disappearing veins in the brains of pwSPMS. Why would veins disappear like that. Is that what causes the shift between RR and SP. Can it be reversed. Can it be prevented. Is it present (or rather, absent) in all pwSPMS.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby eric593 » Tue Jan 31, 2012 10:03 am

Maybe there is something more consistent about the MS course in the younger cohort.

They DO try to exclude those with a more remitting pattern, you typically have to have a certain level of disease activity in the couple year's before trial entry to qualify. Of course the counter argument is that RRMS relapses and then remits, so the lessening of disease activity during a trial is only the natural subsiding of the relapsing phase of the couple years before trial before the disease then enters a natural remission at trial time, nothing to do with the drug. This is why researchers have struggled with this issue for decades, lots of variables with the disease itself.

Tysabri now has a test that can determine if you are at higher or lower risk of developing PML. The drug apparently works very well for a lot of people, even improving disability levels in addition to impacting progression. Tens of thousands of people who are on it apparently believe it is worth the risks, and the new test lowers them even more than the monitoring system in place.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby 1eye » Tue Jan 31, 2012 10:37 am

I haven't heard of veins disappearing, just capillaries, but I guess eventually they would. I think the order has to be capillaries, venules, veins, because of the load sharing, which would bring with it a sharing of the effects of congestion. If there is BBB damage, wouldn't you expect it to show up first in the capillary beds, where the molecules actually pass through? Or another possibility, the capillaries are the first to go because they have they greatest role in dwindling oxygen and glucose supply. Or they are more fragile and easiest to replace with angiogenesis. Certainly there are more of them, and redundancy may have something to do with it.

I any case, I would guess veins, venules, and capillaries get resorbed when they are no longer in use, or have died of food or oxygen starvation. Maybe less with veins, because restenosis can happen and they got re-used.. Anyway it's a good avenue of inquiry, I think.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby 1eye » Tue Jan 31, 2012 11:04 am

Cece wrote:...
If RR is the group most likely to show effects of a treatment in blinded trials, then I would tend to think that we want CCSVI tested in RR MS first. Sorry 1eye. I agree with your way of thinking but it seems most important to validate CCSVI, and if that's best done on RRMS, then full speed ahead.
....


So we'll cheat a little, because the end justifies the means? That is what happens when you accept the argument that they are different diseases. (I think there is an appreciable likelihood of SP"MS" or PP"MS", or "none of the above" or all three "phenotypes", being the groups most likely to show effects of a treatment in blinded trials.) I guess if it is more politic to do that, I'll go along with it, but under protest.

I met one lady who wouldn't take Tysabri again, with good reason. I think the first time you lose some ability after being told of low risks, is often the last time you will believe something is worth the risk. If it's breathing ability, that will definitely be the last time.
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Re: Age/disability discrimination in "MS"/CCSVI research.

Postby Cece » Tue Jan 31, 2012 11:05 am

I can't find the one I was talking about. I'll look again another time. This is along the same lines, showing decreased vasculature in CCSVI patients, but they weren't looking at SP vs RR like the other research was.
http://www.biomedcentral.com/content/pd ... 11-128.pdf

Agreed that no-longer-functional blood vessels getting resorbed is a likely, but disturbing, explanation.
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