Are patients distorting the science?~Marie Rhodes

[PCakes]

The following was written by Marie Rhodes, author of 'CCSVI as the Cause of Multiple Sclerosis: The Science Behind the Controversial Theory' ..

Are patients distorting the science?.by CCSVI in Multiple Sclerosis on Saturday, April 23, 2011 at 9:32am.This is Marie (ccsvibook.com) writing this note.

The last week has been an interesting combination of ups and downs. First the BNAC research on their first batch of patients was finally published and available for review. This was followed by a critique by Direct MS's Ashton Embry PhD regarding their negative interpretation of what was essentially positive data. See this here:

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After this comment, BNAC felt compelled to publicly answer to this concern on THEIR facebook page. See this here:

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In addition to Dr Embry's critique of the study interpretation, Dr Zamboni has also weighed in on the debate regarding how we might think about the BNAC findings:

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Taken altogether this is a fantastic comment on the current environment in medical science. Things are moving away from the traditional framework in which the attitude was "we will have our discussion and we'll let you patients know when we are done" to a new one in which patient's good opinion of the scientific process and trust is being courted in social media. This is an incredible change in business as usual for scientists.

But we patients are not the first group to distort the scientific process. Many physicians have been expressing concern about how commercial interest distorts science over the last few decades. These concerned people have noted that a study underwritten by a company on their own product is far more likely to be positive for the product than a study conducted by others.

http://www.bmj.com/content/326/7400/1167.abstract

There is also a tendency for trials or studies that have the desired outcome to be published while studies that have an undesirable outcome are quietly put aside.

see this: http://www.bmj.com/content/315/7109/640.full

Some comments by MS researchers when interviewed about CCSVI suggest that they believe MS patients are distorting the discussion regarding CCSVI toward less rigorous science. They suggest this ruins the process.

But the truth is that patients may lend an equalizing balance back to the industry that is commercial science. We are insisting that the commercial forces shall not take over the debate to quietly put CCSVI aside. We demand that this new model be evaluated fairly and with all urgency now. Every patient that learns all they can about CCSVI so they can follow the debate closely and recognize shoddy work is an asset to the whole MS community.

When we stand up as a group and say to proponents of a poor study "No, that study that showed no difference between MS and healthy controls used regular dopplers and it is not therefore comparable to Dr Zamboni's work" we give the added weight CCSVI needs to keep research moving forward. The history of MS is riddled with vascular doctors who talked about vascular signs and symptoms in MS being ignored or even black balled; case in point, Dr. FA Schelling in the 1980's.

This time we say "no."

This time we insist that this lead is followed all the way to the end, and even though we know that the end of the scientific process may be different than we imagine (is MS 20% a venous problem? 80%? 100%? we don't know at this point)

So, thanks to every one of you for taking time to be involved because it means that this time we will finally have a scientific answer to the 170 year old question "why do MS patients have these enlarged veins when other people with other neurological diseases do not?".

Marie Rhodes

[MarkW]

Marie Rhodes asks: "why do MS patients have these enlarged veins when other people with other neurological diseases do not?".

This question is a distortion of science in itself. Other neurological diseases have not been tested for enlarged veins in sufficient numbers. It is not scientific to ask a question which has no basis in fact.

The first question is 'do MS patients have enlarged veins'. The recent published paper by Prof Zamboni informs us that CCSVI syndrome has certain characteristics. It does not say CCSVI equals enlarged veins.

The only question patients need to ask is:
"Does treating CCSVI syndrome (using balloon venoplasty in patients with MS for 10 years or more) appear to help progression of MS and some symptoms of MS ??"

CCSVI advocates should assist pwMS to receive this symptomatic treatment while the causes of MS are investigated. Making statements about the causes of MS or critiquing research data does not help our cause. I strongly recommend keeping our statements to those which can be fully supported by research. This is science. Most of the CCSVI debate distorts science.

That should put the cat amongst the pigeons......

MarkW

[cheerleader]

Mark----
Marie is right. She means cerebral veins. That's the 170 years of research she refers to...MS as a venocentric disease. That's what Rindfleisch noted in 1863 via a microscope...tiny veins engorged with blood at the center of the MS lesion. MS patients are the only ones with neurological disease who have lesions along the intercranial veins...not the extracranial veins. She's not referring to CCSVI and the jugulars in that last sentence, she's referring to the veins inside your brain. That's what Dawson's Fingers are. Lesions that follow the periventricular veins. No other neurological disease has this...not Parkinson's, not Alzheimers, not ALS. We've discussed this on here many times, in relation to Dr. Schelling's work. Neurologists have never had an explanation as to why MS lesions are venocentric, why Rindfleisch saw those veins filled with blood. Dr. Zamboni's discovery gives a plausible explanation...venous reflux and congestion created by extracranial stenosis.

Marie's essay is brilliant. It's thanks to her dedication and research we have a book on CCSVI available for sale now. And as an advocate, I believe this discussion is very important. I don't understand your blasting other people's hard work. If it weren't for Marie and I...well, I don't know....
Please read it again.

Here's Marie's book, for those who'd like to learn more-
http://www.ccsvibook.com/

cheer

[1eye]

I strongly recommend we lighten up a bit. It all seems to me like a wind we will grow to increasingly love the smell of in the future. I would love to be around to see the day. While I read about the pigeons, I saw no cat.

"There's a seabird above you, gliding in one place,
Like Jesus in the sky." - Jackson Browne

[PCakes]

Marie's essay is brilliant. cheer

Cheer, I was energised reading Marie's piece and wanted to share it over here on TiMS. I hoped as I pasted that the response would be respectful. I am sorry.

If it weren't for Marie and I...

I will never forget.

Happy Easter

[gauchito]

I would like to jump in for this is very interesting. Science should not be an object belongig to a given institution or profession, neither scientific should be an adjective that one can appropriate by simple membership to a given group or class. It all refers to a defined mental procedue to approach the reality. Anyone can do science without labeling so, and also not all stuff called sicence actually is.
For instance: you postulate that MS is a multifactoral disease. When someone brings in a potential new factor (vascular) thus creating a potential new avenue for research, you get nervous rather than happy and enthusiastic. Is that science?
Science is not a label and therefore noone owns it but everyone can own it.
Just imagine life 150 years ago. How many things changed thanks to science. OUR ISSUE, however, went back thus trimming life and dreams of millions
In MS perhaps, it is time to resume science !

[eric593]

Anyone who has reviewed the wealth of MS research over the past 20+ years, that continues to increase each day (I receive pubmed hits for at least 10-15 new MS medical journal publications EACH DAY) is very well aware that MS has many unique anomalies not shared with other neurological diseases, venocentric lesions being only one.

Why anyone thinks that venocentric lesions should have stood out and been explored further over the countless other unique characteristics that have also been found in MS and not pursued, is beyond me.

That's often the problem with tunnel vision - you can't see the forest for the trees. And sometimes egocentricity can also result in people believing their own role in a possible discovery makes that discovery somehow more meaningful than others' discoveries. And any further information gets unfortunately viewed and fit into this existing construct regardless of how well or how poorly it may fit, all other information is made to fit within this new paradigm that people now have a vested interest in and that they want to now be the answer to every lingering question about MS.

If it weren't for Marie and I...well I don't know

Wow. Perhaps one can have too close a personal and vested interest in a potential discovery that they lose their objectivity and ability to critically review information, and instead just try to shove it all within the existing theory whether it fits or not, and ignore the information that clearly cannot be explained by the favoured theory. That becomes dangerous. Defensiveness doesn't lead to answers and is inconducive to scientific inquiry. Not keeping an open mind and enthusiastically embracing debates raises red flags. Criticizing research that doesn't support your theory doesn't help. Criticizing the authors helps even less. Understanding the weaknesses in a theory that come to light and accepting them helps to seek out truth and resolve conflicts or explain discrepancies, search for answers to why some things don't seem to fit. Sometimes the theory itself needs to be tweaked.

At this early stage, people should be willing to acknowledge the questions that haven't been answered, and seek answers and be open to explore the weaknesses, not turn a cold, critical view towards them or their authors. Criticizing those who reach different conclusions seems petty and immature. It doesn't advance science. Criticizing skeptics makes some look too protective of their theory as opposed to being open to critically examining it and wanting to look carefully at the challenges posed.

Yes, CCSVI theory has a lot of murky areas, and more independent research is raising more questions than answers. Yes, MS has a lot of other unique characteristics beyond venocentric lesions, and countless other aspects of MS have also not been pursued or followed up. Many aspects can't yet be explained by CCSVI as a primary pathology. Perhaps time and more research will strengthen or weaken this position. The agenda should be to search out the answers, not search out only the answers that fit nicely to support the theory.

I should hope we all continue to have open minds to ALL new research in this area that will lead us further to knowing CCSVI's role, if any, in MS. I agree with Mark, it doesn't help to personally attack every piece of what is perceived as negative CCSVI research that comes out. Let's take a step back, encourage many different avenues of research, discuss it, and hopefully a clearer picture will begin to emerge as time passes and further research continues.

[cheerleader]

All Marie is saying is that patients and advocates are providing a balance to commercial science....and I agree. So does Dr. Schelling, Dr. Zamboni, Dr. Embry, Dr. Dake and many others.

That balance will apply to all different types of research in multiple sclerosis, whether it be vitamin D studies (as funded by Direct-MS) or hormone studies, or dietary studies, or anything outside the pharma box/EAE model. Many people are able to read pubmed now. And that is a good thing.

And if you don't think venocentric lesions are important, that's fine, eric. You are allowed to follow whatever path you please...that's the beauty of the wealth of MS research. I was merely responding to Mark's misinterpretation of Marie's post...carry on...
cheer

[cheerleader]

Marie's essay is brilliant. cheer

Cheer, I was energised reading Marie's piece and wanted to share it over here on TiMS. I hoped as I pasted that the response would be respectful. I am sorry.

If it weren't for Marie and I...

I will never forget.

Happy Easter

no worries-PCakes. I agree, it was good to share it.
Happy Easter to you, too.
He is risen, indeed.
cheer

[griff]

We are insisting that the commercial forces shall not take over the debate to quietly put CCSVI aside. We demand that this new model be evaluated fairly and with all urgency now.

Well said.

[MarkW]

Marie and Joan,

I realise that you will feel that I am against you. Instead I am trying to convince you to stick within science in the strict sense.
I used Marie's exact words in my post. These words must not require Joan's explanation 'Mark----Marie is right. She means cerebral veins.'

Marie's book is titled:
'CCSVI as the Cause of Multiple Sclerosis: The Science Behind the Controversial Theory.
The cause of MS is not known, this means Marie's title has not been fully demonstated by research, making it unscientific. Joan says: 'That's the 170 years of research she refers to...MS as a venocentric disease'. True, MS lesions are venocentric, but this does not mean the cause of MS are venous problems.

Research indicates that MS lesions are not the first stage of MS (reseach - vitamin D, MS genes, astrocyte death to understand this). This calls into question the whole 'auto-immunity' theory. However just because the auto-immunity is not 'the cause of MS' does not mean that auto-immunity is not part of the etiology of MS.

Prof Zamboni's says "CCSVI has every right to be included in the idea of multifactor accepted by all scientists," I agree with Prof Z that the causes of MS are multifactorial. This is accepted by most MS scientists, probably not all.

Marie wrote:
We are insisting that the commercial forces shall not take over the debate to quietly put CCSVI aside.
I agree that commerical forces should not prevent the safe treatment of CCSVI syndrome using balloon venoplasty (PTA). This my goal, and not arguing about what causes MS.

Marie added:
We demand that this new model be evaluated fairly and with all urgency now.
There is no 'new model' for the cause of MS from Prof Zamboni. Please read his exact words (recent abstract below). The 'new model' for the cause of MS appears to be an invention of some pwMS and their carers. Prof Zamboni exact words simply are:
"Chronic cerebrospinal venous insufficiency (CCSVI) is a syndrome characterized by stenosies of the internal jugular and/or azygous veins (IJVs-AZ) with opening of collaterals and insufficient drainage"

I urge you, Marie and Joan, along with all caregivers and CCSVI advocates to keep within the science as published by Prof Zamboni. Extending his thoughts may make CCSVI more interesting but it really does make Prof Zamboni's position more difficult to demonstrate scientifically.

I repeat that the only question patients need to ask to those opposing us, is:
"Does treating CCSVI syndrome (using balloon venoplasty in patients with MS for 10 years or more) appear to help progression of MS and some symptoms of MS ??"

MarkW

Recent abstact/press release:

Zamboni P, and Galeotti R: The chronic cerebrospinal venous insufficiency syndrome. Phlebology. 2010 Dec;25(6):269-79. PMID 21106999, doi:10.1258/phleb.2010.009083.
Vascular Disease Centre, Interventional Radiology Unit, University of Ferrara, 44100 Ferrara
Abstract
Chronic cerebrospinal venous insufficiency (CCSVI) is a syndrome characterized by stenosies of the internal jugular and/or azygous veins (IJVs-AZ) with opening of collaterals and insufficient drainage proved by reduced cerebral blood flow and increased mean transit time in cerebral MRI perfusional study. The present review is aimed to give a comprehensive overview of the actual status of the art of the diagnosis and treatment of this condition. As far as the origin of venous narrowing is concerned, phlebographic studies of the IJVs and AZ systems demonstrated that venous stenoses were likely to be truncular venous malformations; mostly, they are intraluminal defects such as malformed valve, septa webs. CCSVI condition has been found to be strongly associated with multiple sclerosis (MS), a disabling neurodegenerative and demyelinating disease considered autoimmune in nature. In several epidemiological observations performed at different latitudes on patients with different genetic backgrounds, the prevalence of CCSVI in MS ranges from 56% to 100%. To the contrary, by using venous MR and/or different Doppler protocols, CCSVI was not detected with the same prevalence. Two pilot studies demonstrated the safety and feasibility in Day Surgery of the endovascular treatment of CCSVI by means of balloon angioplasty (PTA). It determines a significant reduction of postoperative venous pressure. Restenosis rate was found out elevated in the IJVs, but negligible in the AZ. However, PTA seems to positively influence clinical and QoL parameters of the associated MS and warrants further randomized control trials.
*****

Zamboni's Press Release (their translation):

Some clarification of inaccurate information disseminated in the media, in particular the April references to the study of Dr. Zivadinov published in Neurology.

CCSVI has every right to be considered among the causative factors of MS, having been seen in 60% of pediatric forms of MS

The published data had already been released in 2010 and then considered unsupported data.

The study conducted by researchers at the University of Buffalo and published in Neurology, the journal of the American Academy of Neurology April 13, 2011. ( www.neurology.org ), the relationship between CCSVI and MS, is attracting a lot of noise, but the news needs to be clarified.

And that is that the study disproves the theory of the relationship between MS and CCSVI, emphasizing the fact that MS is not a cause but a consequence of MS.

The study published in Neurology, confirms the results of last spring, in fact the study and the data contained in it are the same as advertised by a press release in spring 2010 and defined data unsupported.

The data coincide with those presented April 14 at the 2010 Live Web Forum in Toronto, organized by a National MS Society and attended by Prof Paolo Zamboni, director of the Vascular Disease Center, University of Ferrara and discoverer of CSSVI, Dr .Zivadinov Robert University of Buffalo, Dr. Andrew Common, radiologist at St. Michael's Hospital University of Toronto, and Dr.Aaron Miller, professor of Neurology and Director of the MS Center at Mount Sinai in New York. During the live web forum, broadcast live on 5 continents by doctors and patients, and these four experts in the room that scientists had considered the study of Buffalo as a confirmatory study, data analysis and indeed led to state CCSVI that was also a negative prognostic factor in the course of MS.

The data emerging from the study by Professor Zivadinov, does not detract from the work of Professor Zamboni, but contrary to what is erroneously reported by other media sources. The data instead strongly supports that CCSVI has every right to be included in the idea of multifactor accepted by all scientists, including the causative factor of MS having found in nearly 60% of pediatric forms of MS and in almost 40% of people with clinically isolated syndrome (CIS). Obviously it is difficult to consider the CCSVI a consequence of MS even when it is presents in pediatric MS.
*****

[Lyon]

..

[1eye]

Between reading this, seeing Dr. Zamboni doing Dopplers, the anecdotes we've all seen, Dr. Sclafani's IVUS work, the descriptions of old Dawson lesions on autopsy, the Haacke/Hubbard graphs, can anyone doubt what is going on here? It would be nice if someone could come up with a system as nicely balanced and delicate as the one most people have, that was produced by billions of years of evolution. I would trade the flaky one I've got now, in for a new one, even if it would only last the age of the average North American car, because the one I've got is not likely to get that far. Besides, they've been using the same cars in Cuba for 60 years!

[MarkW]

Please be aware that I do not agree with Lyon's position on CCSVI.

My view is that there is ample evidence that:
- CCSVI syndrome correlates with MS.
- CCSVI syndrome may be safely treated using balloon venoplasty.
- the majority of pwMS benefit from this treatment.

Treating symptoms before understanding the causes of a syndrome or a disease is a well established medical practice and must be adopted for people with the life long and progressive disease, MS.

1eye wrote:
Between reading this, seeing Dr. Zamboni doing Dopplers, the anecdotes we've all seen, Dr. Sclafani's IVUS work, the descriptions of old Dawson lesions on autopsy, the Haacke/Hubbard graphs, can anyone doubt what is going on here?

I do not doubt that treatable symptoms have been indentified. As a rational scientist I doubt that CCSVI is the sole cause of MS. CCSVI may well be a causative factor of MS but this is still being researched.

MarkW

[Lyon]

..