New MS Treatment?

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peaceseeker
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Re: New MS Treatment?

Post by peaceseeker »

New Studies Show the MS Drugs Don't Slow Progression
Dr. Ashton Embry - July 7, 2010

Five years ago, I wrote a New Pathways column on the value of the commonly used, CRAB drugs (Copaxone, Rebif, Avonex, Betaseron) for MS. It was based on published evaluations by the Cochrane Collaboration, an organization which is free from drug company influence. Based on their objective analyses, my unavoidable conclusion was that “the available data on the effectiveness of the MS drugs indicates that there is very little evidence that the interferons do much good and that there is no evidence at all that Copaxone has any value.”

Not surprisingly, this conclusion did not sit well with many people who were taking the drugs and it was completely ignored (as were the Cochrane analyses) by the neurologists who over the past 5 years have kept prescribing the drugs as fast as they can. The annual revenues from MS drugs is approaching the 10 billion dollar mark, much to the satisfaction of both the drug companies that produce them and the neurologists and MS societies that receive substantial financial and in-kind benefits from those drug companies.

I must note that, in my 2005 article, I did add the caveat “that future proper studies and honest presentations of them may one day show these drugs have some value”. The good news is that we now have three, completely independent studies which look at the value of the CRAB drugs for slowing disability progression over the long term.

I must emphasize that the only true measure of the effectiveness of an MS drug is how well it can slow MS progression. Unfortunately, because MS develops very slowly, it takes years before the
effectiveness of a drug can be properly assessed and hence it is only now that we have some good data on whether or not the CRABs are effective or not.

The clinical trials which tested the drugs and led to their approval were only two years in duration and it was impossible to determine if the drugs had an effect on disability progression over such a short time interval. Instead, the researchers used relapse rate and MRI-detected, lesion development to evaluate drug effectiveness. It was simply assumed these two variables were valid “proxies” for disease progression although the researchers had no hard evidence to support such an assumption.

Notably, subsequent studies have shown that neither of the applied proxy measures correlate to disability progression so it appears that the drugs were approved on erroneous assumptions. Because of these false assumptions, the clinical trial data for the CRABs do not tell us if the drugs have any real effectiveness or if they are no better than proverbial snake oil.

To find out if the CRABSs are actually better than snake oil, we must look at the results of the three aforementioned studies which directly examine the question of the effectiveness of the CRABs for slowing the accumulation of disability. The Boggild et al (2009) study compared the
disability progression of over 3000 British MS patients who started receiving the CRAB drugs in 2002 versus the established natural progression of untreated patients.

This study was done to determine if the British National Health Service was getting acceptable value for the high cost of the drugs. The main finding of this study is “The outcomes so far obtained in the pre-specified primary analysis suggest a lack of delay in disease progression for all disease modifying treatments”. In fact it was found that “Disease progression was worse than that in the untreated control group” although it must be noted that there was not a statistically
significant difference between the two groups.

A recently published study done in Nova Scotia, Canada (Veugelers et al, 2009) looked at the effectiveness of the CRABs on the basis of data from 1752 patients. This was accomplished by examining the time it took to reach disability level EDSS 6 (requires a cane) for both untreated patients and those on one of the CRABs. They found it took untreated persons 14.4 years with a 95% confidence interval of 12-17.4 years whereas the treated patients were estimated to reach
EDSS 6 at 18.6 years with a 95% confidence interval of 15.9-21.9 years.

The authors trumpeted these findings as proof the CRABS actually slowed progression but unfortunately they seem to have missed the meaning of confidence intervals for statistical findings. Because the 95% confidence intervals of the two findings overlap, this means there is no real statistical difference between the two results and thus their data really demonstrate that the drugs have no statistically significant effect on progression.

The third study by Ebers et al (in press) very nicely complements the other two studies in that it compares the current clinical outcomes of the persons who got betaseron during the original betaseron trial done 16 years ago (181 subjects) with the persons who were on placebo in the same trial (79 subjects). The basic finding was “No differences in outcome between original randomization groups could be discerned using standard disability measures”.

Looking deeper into the data, we see findings such as everyone got to EDSS 6 by about the same time, 12.8 – 16.1 years. This finding is important because these values agree very closely with those of the Veugelers et al study. Also of importance is the finding that 38.6% of untreated patients (those on betaseron for less than 10% of the time) reached EDSS 6 within the past 16 years. This compares with 35.7% of treated patients (those on betaseron for over 80% of the time)
reaching EDSS 6 in the same time interval. Once again no significant statistical difference was detected so we can say with some confidence that using betaseron for 16 years will not decrease your chances of declining to EDSS 6 within that time period.

Because the results of any single study can always be questioned, given imperfections in design and data collection, it is important that we now have three independent studies which look at the effectiveness of the CRABs in slightly different ways. Notably, all three studies robustly show that the CRABs have no statistically significant effect on the long term progression of disability.

Given the same result from three different and quite rigorous studies, there now is no reasonable doubt that the CRABs don’t work. Thus we can say the CRABS are really no different than snake oil. I realize this must be somewhat discouraging for many persons with MS who were hoping the drugs would slow their decline. However, at least we now know the drugs do not slow decline and persons with MS can make a rational, science-based decision on their use.

It is also hard to ignore the fact that the neurologists who have been unreservedly prescribing drugs that clearly don’t work are the same ones who now are warning their patients not to address an established, serious pathological problem which is commonly associated with MS - impaired venous drainage from the brain. What makes this even worse is the fact the angioplasty treatment, which can safely and effectively resolve the problem and which has resulted in very obvious, beneficial effects (often spectacular) for almost every one of the 1500+ people who have had it done, is being withheld from persons with MS.

To me, something has gone terribly wrong in how persons with MS are being treated by neurologists. Ineffective drugs are being pushed and a potentially very helpful treatment is being suppressed and denigrated. I suspect when the smoke eventually clears and rationality returns, it will be found that monetary factors rather than health concerns are behind this ugly and unacceptable situation.


References

Boggild M, Palace J, Barton P, Ben-Shlomo Y, Bregenzer T, Dobson C, Gray R.,
Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with
historical comparator. BMJ. 2009, 9 pages.

Ebers, G, Traboulsee A, Li D, et al., Analysis of clinical outcomes according to
original treatment groups 16 years after the pivotal IFNB-1b trial. J Neurol
Neurosurg Psychiatry, in press, 6 pages.

Veugelers PJ, Fisk JD, Brown MG, Stadnyk K, Sketris IS, Murray TJ, Bhan V.,
Disease progression among multiple sclerosis patients before and during a
disease-modifying drug program: a longitudinal population-based evaluation. Mult
Scler. 2009 Nov;15(11):1286-94.
"I think our society is run by insane people for insane objectives...I think we're being run by maniacs for maniacal ends...but I'm liable to be put away as insane for expressing that. That's what's insane about it."
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Catz
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Re: New MS Treatment?

Post by Catz »

I was watching the news the other day and a lady with MS went to Mexico to have her jugular dilated,,,a tube was put in. Huge symptoms were gone following this procedure. She was able to walk, the numbness gone, etc. I think it was BC global.??
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peaceseeker
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Re: New MS Treatment?

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Puffy wrote:I was watching the news the other day and a lady with MS went to Mexico to have her jugular dilated,,,a tube was put in. Huge symptoms were gone following this procedure. She was able to walk, the numbness gone, etc. I think it was BC global.??


You're correct, Puffy...and many, many others also have experienced great benefit from having the procedure. I was in contact with a friend-of-a-friend whose wife went down to Mexico to have the procedure done...he (and she) told me that soon after (having the procedure) she was running on the beach - this is something that's inconceivable to most living with MS due to its various symptoms.

My sister and I are looking into going to Mexico - since it still could be years before the procedure is offered here in Canada...pwMS do not have time to waste! The procedure is not rocket-science, and contrary to the propaganda being spewed by MS societies and neuros, it is very low risk. Many vascular surgeons (here in Canada) are 'biting at the bit' to provide it to pwMS but are not allowed.

Indeed, it's very unfortunate we are being forced to leave our own country in order to have such a simple procedure...I believe Dr. Embry's article (posted above) says it all.
"I think our society is run by insane people for insane objectives...I think we're being run by maniacs for maniacal ends...but I'm liable to be put away as insane for expressing that. That's what's insane about it."
~ John Lennon
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Queen K
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Re: New MS Treatment?

Post by Queen K »

Unfortunate? More like, "criminal" to be forced to leave Canada to seek help. Someone sitting on a money tree doesn't want that tree to be chopped down.
Spend some time and money on establishing an Estate plan, a Legal Will, your wishes and who is the Executor. Watch Grant of Probate videos. Understand the process to help yourself and loved ones.
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peaceseeker
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Re: New MS Treatment?

Post by peaceseeker »

Queen K wrote:Unfortunate? More like, "criminal" to be forced to leave Canada to seek help. Someone sitting on a money tree doesn't want that tree to be chopped down.


Agreed @ 'Unfortunate?' - I think I bit through my tongue when I wrote that...I was trying to be kind...bad choice. You're absolutely correct, 'criminal' is more like it.
"I think our society is run by insane people for insane objectives...I think we're being run by maniacs for maniacal ends...but I'm liable to be put away as insane for expressing that. That's what's insane about it."
~ John Lennon
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Re: New MS Treatment?

Post by Phoenix Within »

Puffy wrote:I was watching the news the other day and a lady with MS went to Mexico to have her jugular dilated,,,a tube was put in. Huge symptoms were gone following this procedure. She was able to walk, the numbness gone, etc. I think it was BC global.??

It was CHBC, but since they changed their goddamned background to look like Global, I can't tell one from the other anymore.
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Re: New MS Treatment?

Post by Catz »

Phoenix Within wrote:
Puffy wrote:I was watching the news the other day and a lady with MS went to Mexico to have her jugular dilated,,,a tube was put in. Huge symptoms were gone following this procedure. She was able to walk, the numbness gone, etc. I think it was BC global.??

It was CHBC, but since they changed their goddamned background to look like Global, I can't tell one from the other anymore.

Maybe...LOL...I just found it amazing to watch and see the difference with this lady.
Having been in a wheel chair with an incomplete spinal cord injury, and a lot of similar symptoms, I feel for her and what she goes through on a daily basis.
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Re: New MS Treatment?

Post by Catz »

Interesting article in the Edmonton Journal today about this.
I don't know how to paste the sight, but go look.
Hmmmm.....
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Bsuds
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Re: New MS Treatment?

Post by Bsuds »

Wisdom has been chasing you but you have always been faster!
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Re: New MS Treatment?

Post by Catz »

thank you, Sudsy! :sunshine:
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Re: New MS Treatment?

Post by flamingfingers »

Excellent article that everyone should appreciate: Good science over bad.

The placebo effect is well known over thousands of years and still flourishes - the effect is often called a 'miracle'. And while I grant that on occasion what cannot be rationally explained could fall into the realm of a 'miracle' it often is, later on, explained and often dis-proven by scientific progress. (eg. ulcers caused by H pylori).
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Re: New MS Treatment?

Post by Tootsie »

I just had a conversation today with a lady who went to Mexico (Cabo San Lucas) & had the procedure done. She says there is no wait list there - she flew down there on a Saturday , two days later had the procedure done & was home the following weekend. She feels fabulous. I didn't ask her what the cost was but she feels it was very well worth it.
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Re: New MS Treatment?

Post by Queen K »

Tootsie wrote:I just had a conversation today with a lady who went to Mexico (Cabo San Lucas) & had the procedure done. She says there is no wait list there - she flew down there on a Saturday , two days later had the procedure done & was home the following weekend. She feels fabulous. I didn't ask her what the cost was but she feels it was very well worth it.


I do believe that if someone told her she was experiencing a "placebo effect" she would have to ask, "Do you have a point?"

She has documented conditions before and after the procedure right? I believe she knows what her body did and didn't do better than anyone and most definitely better than the MS Society.
Spend some time and money on establishing an Estate plan, a Legal Will, your wishes and who is the Executor. Watch Grant of Probate videos. Understand the process to help yourself and loved ones.
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Re: New MS Treatment?

Post by Tootsie »

QueenK - not sure if you got my PM back - I was having trouble replying. Anyway - no it wasn't the lady you mentioned. A different happy camper !
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peaceseeker
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Re: New MS Treatment?

Post by peaceseeker »

Surprise, surprise...

Federal agency won't yet fund studies into MS theory
http://www.ctv.ca/CTVNews/Health/201008 ... dies-cihr/


...I believe Dr. Embry gives a well-founded explanation as to why...

Why National MS Societies Are Not Acting in the Best Interests of Persons with MS
https://docs.google.com/viewer?a=v&pid= ... HiAw&pli=1
Ashton Embry

Introduction
With the advent of CCSVI as a major factor in multiple sclerosis, it has become painfully apparent that national MS societies do not have the best interests of persons with MS as their highest priority. This has taken many people by surprise because most people are under the assumption that the main concern of national MS societies is the well being of persons with MS. This assumption is not, and has never been, true. Perhaps one more benefit of the discovery of CCSVI as an important causal factor of MS, has been to expose the myth the national MS societies have people with MS as their #1 priority.

The Groups of the MS Societies
To understand the priorities of national MS societies, it is essential to understand the various groups which compose their structure. These groups are the scientific advisors, the staff members, the board members, and the members of the society who are mainly persons affected by MS. Each of these groups plays a very specific role in how a given national MS society functions.

The most important and influential group is the scientific advisors who determine the type of information the society provides to the members and to the public at large. They also determine what research will be done and what overall policies will be followed when it comes to lobbying efforts to influence government decisions. The scientific advisors are clinical neurologists who specialize in multiple sclerosis. Many of them also carry out research activities in addition to their clinical work.

The next important group is the paid staff of the society and, in the case of a large society, they can number in the hundreds. Their salary and benefit packages are on par with workers in similar jobs in both the private and public sectors. Importantly, the staff, for the most part, puts into action the policies and plans of the scientific advisors, that is, the neurologists. There is a very strict adherence to this and no deviation or independent thinking is tolerated. The staff members are like soldiers who do what they are told and are not expected to contribute to the scientific or public policies of the society. They are simply the “go-betweens”, the neurologists and the all those seeking information from the society. Notably, most staff members are not affected by MS.

By far the greatest responsibility of the staff is to raise money by running various fund raising projects. Most of staff time in spent on this critical activity which is understandable given the majority of the money raised goes to pay staff salaries and benefits. Staff members also arrange some programs for people with MS in terms of education but this activity is rather minor in terms of actual time and effort expended. The staff also fields questions from persons with MS and, as noted previously, the provided information is only that sanctioned by the scientific advisors (neurologists).

The board of directors of a given national society is most often composed of people who usually have good connections for fund raising from corporations or who have strong political connections. Usually a few persons with MS are included on a board but, in most cases, the majority of board members are not affected by MS. One or more staff members also usually are part of the board.
Most board members have at best a rudimentary understanding of science in general and the science of MS in specific. They have very little influence on any major policies of the society and, in most cases, simply rubber stamp the scientific and political policies determined by the neurologists and implemented by the staff. Their main responsibility seems to be ensuring that the society is on a firm financial footing and discussing the merits of proposed fund raising campaigns.

The final group in a national MS society consists of the members themselves and they, for the most part, are persons affected by MS. They are the consumers of the products of the society which consist mainly of information dictated by the neurologists and packaged by the staff. Such information is both hard copy and web-based. Some members act as volunteers and volunteer activities are related to both money raising activities and to helping other people with MS. The members essentially have no say in terms of the main policies of the society although on a local level they can help to get new member services initiated.

In summary, a national MS society spends most of its time raising money which is used to pay fund-raising costs, the salaries and benefits of the staff members, and substantial administrative expenses. Such expenses require about 80-85% of all money collected. The amount left over is mainly used to fund research projects approved by the scientific advisors (neurologists) and, not surprisingly, projects of former and current advisors usually are well funded. Proposals from “outsiders” don’t fare so well.

Past Situation
In the past, everything went along rather smoothly with the society advertising the need to raise money to cure MS, with such a cure being attainable through the research activities funded by the society. Given the severe disabilities sometimes associated with MS, the need for finding a cure for MS is not a hard sell, and the large MS societies raise tens of millions of dollars every year. In the 60 years this routine has been going on, the research funded by the societies has not brought us anywhere even remotely near the prospect of developing an effective treatment for MS. This impressive failure has only led to louder calls for more money for more research.

The scientific and medical information provided by a national MS society is entirely centred on drug therapies that have been approved for use. The staff members strongly advocate the use of such drug therapies and almost all other proposed therapies are ignored, discouraged and/or denigrated. The main government lobby efforts of the societies usually are to fight for the approved use of the drugs.

It is imperative to appreciate that most (often all) of the scientific advisors of the societies and the societies themselves have strong financial ties to the pharmaceutical companies which manufacture and market the approved drug therapies for MS. The most blatant of such ties is that of the NMSS of the United States. It partners with drug companies and gives substantial grants to them.

The existence of such financial ties readily accounts for the policy that only drug therapies are advocated and that the value of such therapies is never, ever remotely questioned. These financial ties also create a serious conflict of interest for the neurologists and MS societies when it comes to any proposed, non-drug therapy and that is one, big reason why non-drug therapies are ignored or downplayed by the societies.

There can be no doubt that the national MS societies are there mainly for the benefit of the neurologists (scientific advisors) in that they provides them much needed research funding. The societies also provide an excellent vehicle for promoting drug therapies which are financially very important for the neurologists. Of course the societies are also there for the benefit of the staff members who make a good living from keeping everything running smoothly and ensuring the information from the neurologists reaches the desired destinations.

Before the advent of CCSVI, the drug therapies were the only conventional medical therapies available. By advocating such therapies, the societies could easily claim to be acting in the best interests of persons with MS even though such advocacy was driven mainly by the best interests of the neurologists and the societies themselves. Whether or not the use of the current drugs is really in the best interests of persons with MS is a completely separate issue and will be explored in a separate document.

CCSVI Rocks the Boat
The sudden emergence of CCSVI as an important factor in MS, and the great promise of CCSVI treatment for slowing and perhaps even halting MS disease progression for many, have caused a great problem for MS societies around the world. Given all that we now know about CCSVI and its treatment, the national MS societies would best serve the interests of persons with MS by immediately funding a major, comprehensive research program which definitively tests the effectiveness of CCSVI relief in the next few years. Furthermore, it would also be in the best interests of persons with MS if the MS societies lobbied to have CCSVI treatment available as soon as possible given the health problems associated with having impaired venous drainage from the brain and the many hundreds of credible, experiential accounts of very significant positive changes following CCSVI treatment.

The MS societies have studiously avoided funding any clinical trial studies for CCSVI treatment as was clearly demonstrated by the rejection of proposals from top CCSVI researchers by North American national MS societies. (e.g. University of Buffalo, Stanford University, McMaster University). Notably, those who got their proposals accepted seem to have either very strong ties to the pharmaceutical industry (e.g. Wolinsky at U of Texas) or do not know what they are doing. A fine example of this latter category is Dr Kathleen Knox at the University of Saskatchewan who recently was quoted as saying “The biggest difficulty her team faces, is that they don’t know how to test patients to see if they have the blocked veins”. This is a stunning admission of incompetence and shows the type of researchers favoured by the national MS societies when it comes to CCSVI “research.

Some national MS societies are actively lobbying their respective government NOT to allow CCSVI treatment. A fine example of this is a recent letter the director of the Ontario division of the MS Society of Canada wrote to the Ontario Health Minister emphasizing that the province should not fund any CCSVI testing or treatment. The notice on the website of the Multiple Sclerosis Society of Canada says it all - “the MS Society does not recommend that people with MS be examined or treated for CCSVI outside of an established research protocol”. All in all, any thought that MS societies are acting in the best interests of persons of MS must be abandoned. So who’s best interests are they serving with their actions?

When it comes to CCSVI, the interests of the neurologists and the societies are best served by having CCSVI marginalized, by not funding any CCSVI treatment research, and by lobbying the government to not allow any treatment of impaired venous drainage in persons with MS despite the obvious health hazard such a condition represents. The reasons for such actions are straightforward.

If CCSVI treatment by venous angioplasty turns out to be far more effective than the current drug treatments, and there is every reason to expect it will be, then MS drug revenues will plummet precipitously. Such a huge loss of revenue will have a devastating effect on the financial well being of MS neurologists and the national MS societies themselves. Furthermore, persons with MS will be treated primarily by interventional radiologists, thus adding to the financial losses of the neurologists. There is no question that any activity which helps to bring the implementation of CCSVI treatment forward is not in the best interests of the neurologists and the national MS societies that they control and everyone is well aware of this indisputable but somewhat awkward fact.

Because of the advent of CCSVI, we now have an unprecedented situation of conflicting interests. What is in the best interests of persons with MS is clearly not in the best interests of both the neurologists who provide the scientific guidance for the MS societies and the staff of the societies who put into effect the policies of the neurologists.

The Current Reality
Not surprisingly, the best interests of the neurologists and the society staff members will always trump the best interests of the persons with MS. Thus the policies and actions of the national MS societies have been to avoid any funding of proposed CCSVI treatment studies and to lobby government bodies not to provide any CCSVI treatment. They also advise persons with MS not be tested or treated for CCSVI despite the obvious medical need for such treatment (blocked veins are hazardous to one’s health).

The neurologists and the MS societies also have instituted a policy of casting doubt on the validity of the CCSVI concept and on the safety of CCSVI treatment. This has even gone as far as blatant fear-mongering when it comes to having venous angioplasty to relieve CCSVI. One good example of this recently appeared in a governmental health report written by MS neurologists. The writers claimed that the only venous blockages that exist in persons with MS are clots caused by angioplasty and the only results of venous angioplasty are injuries to the vein. This is of course sheer nonsense but, as they say, truth is the first casualty in any war.

The current actions of the national MS societies regarding CCSVI are entirely rational once the structure of the societies is understood. The societies are acting in the best interests of the neurologists and staff members as they always have and always will. Unfortunately, when it comes to CCSVI, such actions are not in the best interests of persons with MS. However, it is the false perception that the national MS societies are there primarily to serve the best interests of persons with MS that has created the shock and disappointment with the current actions of the societies in regards to CCSVI. When it comes to the policies and actions of the national MS societies, persons with MS must fully realize that they are lower in priority than the neurologists and staff members. The CCSVI issue has clearly demonstrated this beyond any reasonable doubt.

Consequences of the Actions of the National MS societies
We now have sufficient data to say that, each day a person with MS suffers the consequences of impaired venous drainage, they are doing harm to themselves and such a reality has to be clearly understood. It has been said, “MS Never Sleeps” and one of the main reasons for this is that impaired venous drainage never sleeps and this serious pathology is causing problems every day for persons with MS. Thus it logically follows that every dollar the national MS societies raise is potentially doing harm to persons with MS because that dollar is potentially contributing to actions that are designed to delay the availability of CCSVI treatment for all persons with MS.

Given the above, it is clear that the interests of persons with MS would be best served by halting any support of national MS societies and by supporting groups which are actively promoting the need for CCSVI treatment research and government support for the availability of CCSVI treatment as soon as possible.

Summary
The advent of CCSVI has revealed the highest priorities of the national MS societies. These are actions and policies that are in the best interests of neurologists and society staff members. The interests of persons with MS are a distant third in this contest of competing interests. Continued support for national MS societies is potentially harmful for persons with MS because of the societies’ deliberate lack of appropriate and much needed actions regarding CCSVI. All persons affected by MS should be supporting organizations which are funding clinical trials to test the effectiveness of CCSVI treatment and which are lobbying governments to make CCSVI treatment widely available in the near future.
"I think our society is run by insane people for insane objectives...I think we're being run by maniacs for maniacal ends...but I'm liable to be put away as insane for expressing that. That's what's insane about it."
~ John Lennon

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