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ABOUT THE NETWORK
 
Our Vision
Becoming Involved
Donations
A to Z Master Index
Advanced Research 
About HorizonsSCAN
 
POPULAR BOOKMARKS
 
About MS
About CCSVI
Advocacy
 
Benchmarking 
Blood Brain Barrier
Blood Flow Issues
Bookmarks - all
Brain Plasticity
Brain's Vasculature
 
Carers
Cardiovascular Issues
Change Management
Chronic Infections
Clinical Trials
Cognitive Issues
 
Demographics
Diet
 
Endothelial Issues
Evaluation 
Exercise   
 
Fatigue
Financial Planning 
Future Directions
 
Genetic Factors
 
Healthy Eating 
Homecare
Hope
 
Inflammation
Innovation   
 
Leadership 
Lifestyle Issues
Lympathetic System
 
Medications
Misdiagnosis
Misinformation
 
NDIS 
Nutrition  
Needs and Issues
Neuronal Death
Neurovascular Issues
News Headlines
 
Pain Management
Parliament's Role
Patient-Centred Care
 
Quality  of Life
 
Rehabilitation
Respite
Road Map
 
Satisfaction Levels
Shortfalls in Support
Sleep Importance
Social Media Impact
Stem Cells
Support Networks
 
Temperature Intolerance
Testimonials
Transport
Trials - clinical
 
Vascular Issues
Vitamin D
 
 
 
 
       
What is Multiple Sclerosis? Parliamentary Open Letter News Headlines Quick  Reference  Guide
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Important Turning Points

 

In March 2016 two of Australia's nationally focused MS consumer organisations (Multiple Sclerosis Network of Care Australia and CCSVI Australia) jointly commenced a National awareness Program aimed at creating greater political awareness of warnings by many leading medical researchers that cardiovascular dysfunction in MS is incompletely understood and likely under recognized. Find out more about subsequent developments.

 

Early Days
Parliament In July 2015 the Reference Group, jointly established in 2010 by the Multiple Sclerosis Network of Care Australia (the Network) and CCSVI Australia, provided a report  titled 'Treatment Delayed is Treatment Lost''.  The Executive Summary says ‘’It seems extraordinary that, after five years, less than 3% of the Australian MS population has been able to gain access to (CCSVI related) treatment - something is seriously wrong. Apart from potentially providing significant relief to seriously ill people, substantial economic benefits are being forgone''  
 
On 24 July 2015 a joint submission on this topic was lodged with the Inquiry by the Australian Parliament into Chronic Disease Prevention and Management in Primary Health. This patient-centered submission (submission 15) was subsequently published by the Inquiry under parliamentary privilege.
 
   Following are details of the background issues that gave rise to these developments.
  1. In the Beginning - Hansard Report 6.  Australian Clinical Trial - International Recognition
  2. Parliamentary Discussion Paper - Broader Awareness 7.  Avalanche of Neurovascular Research and Economic Impact
  3. What was learnt - The 34 Discussion Points 8.  Understanding Divergent Research Outcomes
4.  Working Together - A United Bipartisan Approach  9.  Protecting the Vulnerable
  5.  Leadership by Example - CCSVI Australia Steps forward 10. Submission to Parliamentary Enquiry
Hansard Report
During 2011 and in conjunction with World MS Day Janelle Saffin, the Federal Member for Page addressed the Australian Parliament on CCSVI and its association with Multiple Sclerosis. Shortly stated, Janelle advocated  (read Janelle's Hansard address) on behalf of the MS Network of Care on the following issues:
  *   The formal recognition of CCSVI conditions as vascular disorders in their own right
  *   Collaborating with the medical profession in fostering CCSVI awareness.
  *   Funding programs to monitor the long term effectiveness of treatment procedures, including but not restricted to, clinical trials recommended by vascular specialists.
  *   Funding and promoting a national CCSVI screening program.
  *   Clarifying the availability of Medicare rebates.
  *   Assisting those without private insurance to gain access to appropriate treatment and care

An Emerging Parliamentary IssueCCSVI in Australia—a strategic overview—f the perspective of those with MS

When referencing the role of Multiple Sclerosis Australia (MSA) Janelle said ''I note that the MS Australia website has a page on CCSVI headed 'Your questions answered' and that there are differences between what MS Australia says and what the MS Network of Care says but this is certainly an emerging issue that we will have to turn our minds to" - on 16 August 2012 MS Australia and CCSVI Australia provided a United Statement to the Parliament.

Janelle commended a paper "CCSVI in Australia - A Strategic Overview from the Perspective of those with MS'. The paper (Attachment B) provides an overview of MS issues from the perspective of Australian's living with MS and illustrates why emerging knowledge about the impact of vascular irregularities on MS progression is attracting so much attention. Janelle also referenced the work of the Australian CCSVI Reference Group in the development of a discussion draft for a national Action Strategy whereby the Australian families living with MS can benefit from the knowledge that vascular irregularities have significant associations with many of the most common issues associated with MS.

PARLIAMENTARY DISCUSSION PAPER - BROADER AWARENESS
To assist  with this process, and commencing from 22 September 2011, a Parliamentary Briefing Note (PBN) was provided to all of Australia's Federal Parliamentary representatives requesting that "the Australian Parliament to put in place policies, programs and practices that support the advancement of CCSVI medical knowledge while, at the same time, addressing the ongoing CCSVI needs of Australians living with MS". Since that time there has been a considerable escalation in knowledge that strengthen the need for the Australian Parliament to also turn its mind to CCSVI issues.
 
PRIME MINISTER SEEKS GUIDANCE ABOUT MULTIPLE SCLEROSIS AND CCSVI
In consequence of these (and associated) representations, the Prime Minister sought the advice of Australia's National Health and Medical Research Council (NHMRC). Some of the issues were also discussed by Australia's peak Health Policy Advisory Committee on Technology (HealthPACT).  In doing this HealthPACT also highlighted a number of the Reference Group's recommendations - see later. By December 2011 a wide range of responses were forthcoming.
GREATER INSIGHT IS NEEDED BY THE AUSTRALIAN PARLIAMENT
Feedback While the 'first round' of responses by the Australian Government were supportive and informative they did not address the key issue that  "the Australian Parliament to put in place policies, programs and practices to support the advancement of CCSVI medical knowledge while, at the same time, addressing the ongoing CCSVI needs of Australians living with MS".
 
 In a number of respects emphasis was placed on 'what is not known' at the expense of focussing on the real world environment of 'what is known' as illustrated by the following examples
 
 
* Responses frequently highlighted the Government's long standing funding commitment to support programs and research for Multiple Sclerosis and/or neurological based disorders as evidence of it's ongoing commitment to CCSVI issues - whereas the clinical indicators and treatment modalities for CCSVI related neurovascular disorders and MS are largely unrelated.
* For example, a response by the Health Minister (via Senator Wong) provided a detailed breakdown of the Governments support for neurological based research over the past decade.  A response by NHMRC to requests from the Prime Minister and also the Minister for Mental Health and Ageing similarly highlighted the government's financial support for multiple sclerosis research in this fashion. Many other responses followed a similar pattern. In doing this, the substance of the key issue was often not addressed
* The inescapable truth is that CCSVI is not Multiple Sclerosis nor does it have an identified neurological origin.. The clinical indicators for CCSVI are unrelated to those for MS with different treatment and research frameworks
* The response by NHMRC did however include the comment "although CCSVI treatment may show promise for the relief of MS symptoms, the success or otherwise of this treatment is still unknown" and that "properly designed clinical trials will help answer this question" - about subsequent research outcomes. For details of a subsequent Australian clinical trial click here.
* The 'real world' situation is tens of thousands of pwMS across the globe (several hundred in Australia) have been/are being treated for CCSVI conditions on an ongoing basis - the outcomes of many of which are progressively becoming more generally known. One issue that warrants highlighting is that (in Australia) many of these outcomes are not being systematically aggregated and monitored on a national basis. It is disappointing that this key issue was not highlighted by NHMRC to enable the Parliament to better consider its role in fostering  a national monitoring system, to capture information to help identify disease patterns and track CCSVI treatments - see later where HealthPACT references the potential role of such a program.
* It became clear that the Australian Government had no policies, programs or funding in place that specifically address CCSVI issues per se. Agencies (with the very notable exception of  HealthPACT) often identified polices relating to MS or other neurological disorders as evidence of their commitment to CCSVI issues - whereas the clinical indicators and treatment modalities for CCSVI and MS are unrelated -- for subsequent developments click here
 
ON A POSITIVE NOTE

By contrast, HealthPACT specifically focused on establishing whether Venoplasty was a safe and effective procedure for addressing vascular related multiple sclerosis symptoms. This is precisely the focus that is needed. In doing this it referenced research that described benefits as including  significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up, in MS patients diagnosed with CCSVI. It emphasised that at this stage  (November 2011) this research is limited to low level case series studies and that outcomes over longer term studies are not yet available - about subsequent research outcomes.

 
Encouragingly, HealthPACT also highlighted some of the key issues identified by the Reference Group relating to the diffusion of CCSVI research outcomes. Included were  recommendations relating to the development of a national monitoring system, to capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS and the tying of immunotherapy subsidies to CCSVI screening. In doing this HealthPACT identified the Network of Care as an important a source of information for individuals living with MS and their families - more about HealthPACT's comments.    
 

 
WHAT WAS LEARNT - THE 34 DISCUSSION POINTS
Strategy The PBN evoked a range of responses that enabled the identification of 34 position points - a valuable planning resource in its own right. In summary, the responses highlighted  a need to better emphasise three key points
 
Strategy First, CCSVI is a multi faceted vascular faceted condition impacting across a range of disciplines and chronic conditions, including MS.

Second, is the need to highlight that CCSVI is not MSť.

Third is the need to delineate between “What has been Learnt and What there is yet to Learn''
Doing this clears the way for established knowledge to be translated into “here and now policies, programs and practices to improve the well being of people with CCSVI conditions while at the same time developing frameworks for ongoing learning - appropriately designed clinical trials to be part of this process. Without building upon these three key points “misinformation resulting in confusion, inaction and communication breakdown is/and will continue to be common. The resultant feedback enabled the identification of six Key Result Areas to guide future direction along with a Quick Reference Guide relating to the top twenty most frequently asked Questions and Answers.

WORKING TOGETHER - A UNITED BIPARTISAN APPROACH
Subsequently, under the auspices of Senators Kate Lundy and Gary Humphries (and organised by MS Australia in collaboration with CCSVI Australia) a briefing was conducted at Parliament House, Canberra on Monday 25 June 2012 with the aim of building common ground at a political level. MS Australia was represented by their President, Rob Hubbard and Robert Pask. CCSVI Australia was represented by Kerri Cassidy and Helena Webb. An excellent clinical overview of CCSVI and MS was provided by Doctor Paul Thibault.
 
In consequence, and of significance, it was agreed to progress CCSVI issues in Australia on a bipartisan basis. Laura Smyth MP committed to meet with Janelle Saffin MP on what to present to the Parliament's Health Committee with the aim of obtaining agreement from the Health Minister and NHRMC to fast track appropriate action. MSA and CCSVI Australia agreed to produce a 'united statement' for them to use in their work. A very important step forward.
THE UNITED STATEMENT
United
Statement
On 16 August 2012 MS Australia and CCSVI Australia jointly signed off on a United Statement to the Parliament that said, inter alia, "as covered at the Parliamentary briefing, while the diagnosis of CCSVI by Doppler ultrasound can be accessed under the Medicare Benefits Scheme, the most common form of treatment – balloon angioplasty – cannot.
 
Angioplasty is available under the scheme for various conditions involving venous abnormalities, but it is not available for treatment of venous abnormalities if patients have multiple sclerosis"
MS Australia  The statement went on to say "we will be working with representatives of the phlebological community to progress a campaign to rectify this issue, and would warmly welcome any advice or support from our Parliamentary friends. In addition to these two pressing matters, we will endeavor to raise awareness of this important issue and will shortly be seeking briefing meetings with the Department of Health and Ageing to appraise them of our activities and the latest research"
The United Statement addressed the (then) recently commenced clinical trial at the Alfred Hospital as follows "MS Australia will actively work with  the Alfred Hospital to engage funds to complete this vital research. In addition we ask for your (Australian Parliament) support in advocating for funding support of the trial to the National Health and Medical Research Council and the Minister for Health to ensure the future of this vital research" - read the full statement. At that time this was seen to be an important step forward. Unfortunately, the calling of a Federal Election shortly thereafter made it impracticable for Laura Smyth MP and Janelle Saffin MP to progress their presentation to the Parliament's Health Committee. This became important unfinished business

 LEADERSHIP BY EXAMPLE - CCSVI AUSTRALIA STEPS FOWARD
In the ''communication void'' that transpired MSA noticeably stepped back from the substance of these commitments and in its broader participation in CCSVI understandings, The involvement of MS Australia was revisited in May 2016. By contrast CCSVI Australia (a registered charity in its own right) became nationally recognised for its leadership in ensuring that the interests of people with CCSVI have continued representation and that the understanding and treatment of CCSVI continues to advance.  CCSVI Australia's research capability is significantly enhanced through the purpose developed HORIZONSscan database - arguably one of the most comprehensive CCSVI and multiple sclerosis research databases across the globe
TREATMENT DELAYED IS TREATMENT LOST
In July 2015 the Reference Group provided an Executive Summary titled 'Treatment Delayed is Treatment Lost''' - the purpose of which is to add weight to the Health Committee referral, Comments include ‘’It seems extraordinary that, after five years, less than 3% of the Australian MS population has been able gain access to treatment - something is seriously wrong. Apart from potentially providing significant relief to seriously ill people, substantial economic benefits are also being forgone’.
 
Feedback from this wide ranging report prompted a joint submission (24 July 2015) by the Multiple Sclerosis Network of Care and CCSVI Australia to an already existing  Inquiry by the Australian Parliament into Chronic Disease Prevention and Management in Primary Health. This submission specifically focuses on key issues and associated short and long term outcomes from a Parliamentary perspective - more about this important submission.

AUSTRALIAN CLINICAL TRIALS
In collaboration with the MS community, the Alfred Hospital, Service Organisations and Charitable Bodies, CCSVI Australia is the focal point for fund raising to support the internationally acclaimed Alfred Hospital CCSVI clinical trial. The identification of this trial by the International Society of Neurovascular Disease (ISNVD) as one of  the worlds most ''sophisticated research projects into palliating, treating and curing neurovascular diseases, such as MS - aiming towards meaningful diagnostic and treatment strategies''. is testament to the importance of this trial on the world scene.
INTERNATIONAL RECOGNITION AND SUPPORT
In March 2015 the ISNVD, in partnership with the Annette Funicello Research Fund for Neurological Disease (AFRFND), selected the Alfred trial as one of four recipients of its 2015 research grants.  In announcing these grants Society President, Professor Ziv J Haskal M.D. said "With these grants, the AFRFND takes a substantial step forward in directly supporting sophisticated research into palliating, treating and curing neurovascular diseases, such as MS.  Our grant winners represent a remarkably broad range of study, from controlled trials to basic receptor science. I expect great things,"  Contrary to earlier expectations the Australian Parliament is yet to become a partner in this process.
UNFINISHED BUSINESS
It is disappointing that the incoming Liberal/National coalition government has (so far) failed to follow through on the spirit of earlier parliamentary commitments to those with serious CCSVI related vascular regularities - especially those commitments relating to advocating for funding support of the Alfred Hospital trial to the National Health and Medical Research Council and the Minister for Health to ensure the future of this vital research. Equally disappointing is a lack of response to requests to put in place a national process to monitor those being treated outside of clinical trials to capture relevant information.

AN AVALANCH OF NEUROVASCULAR RESEARCH
Midway through 2014 and of  'game changing'' significance, is the avalanche of new knowledge relating the outcomes of ongoing research independent of, but complementary to, the real world knowledge being gained by vascular specialists when treating people with MS for neurovascular disorders.. This new research prompts serious questions about the relevance of many long standing beliefs and practices in exclusively treating multiple sclerosis as an immune focussed neurological disorder.
 
By addressing the issue of vascular associations with multiple multiple from entirely new and rapidly evolving clinical perspectives this new research appears to go a significant way in validating the first hand experiences of the tens of thousands treated for CCSVI conditions across the globe, as well as providing an enhanced clinical foundation to build upon.
 
Economic
Impact
In 2010 the Menzies Research Institute referenced a 2005 study by Access Economics whereby the economic cost of MS in Australia was identified as $2 billion per annum based on a then MS population of 16,000. Given the current MS population is around 24.000, allied with cost increases over nearly 10 years. this figure would now probably be in excess $4 billion per annum
 
Conservatively, at least 25% of the Australian MS population, following proper treatment for CCSVI conditions, will reduce their impact on this cost by around  $1 billion per annum. Given that more than 5 years have passed since Australians first began receiving treatments for CCSVI conditions it seems extraordinary that it is largely being left to the MS community itself to raise the funds for vital Australian neurovascular research
 
Equally, it seems reasonable to ask why the Australian Government, with its concerns about escalating budget deficits, does not take time out to again meet face to face with those who 5 years ago were severely disabled and reliant on extremely expensive government subsidised and often inappropriate drugs who are now in excellent health as productive members of the Australian community, CCSVI Australia is the starting point.

UNDERSTANDING DIVEREGENT RESEARCH OUTCOMES
Concerns about divergent research outcomes were addressed by Dr Simka (in a meta-analysis published on 3 March 2014) when he said, in relation to CCSVI prevalence studies, ''not only were investigators using different diagnostic modalities and distinct protocols, but they were not looking for the same pathology. Since these abnormalities were indeed differently prevalent in patients and healthy controls, the results inevitably became conflicting. This review suggests how future research, preferably using a multimodal approach, should be directed.''  In contrast Dr Simka observed  ''catheter venography studies gave a regular picture, with the majority of patients with multiple sclerosis presenting with demonstrable outflow abnormalities in the veins draining the central nervous system. The prevalence of these lesions was over 50%, and even higher (about 90%) when more liberal definition of an abnormality or intravascular sonography was used.''
 
Notwithstanding the comprehensive nature of Dr Simka's findings there continue to be instances whereby ''divergent outcomes'' are cited as conclusive evidence to support differing agendas - thereby creating ongoing uncertainty in the minds of some. Fortunately in Australia we have a range of independent resources to call upon including the Alfred trial which is currently reporting an 80% CCSVI prevalence rate for people with MS.'
ACKNOWLEDGING CONFLICTING VIEWS
While there is no disagreement that properly designed clinical trials are important there still remains a need to contend with these fluctuating/conflicting levels of information/misinformation  - including from sources with less than transparent linkages to the pharmaceutical industry. It is important to acknowledge that, in the minds of some, rapidly emerging vascular understandings may have a commercial impact on the extent to which people diagnosed with MS will continue to rely on the range of medications falling under the broad umbrella of immunotherapy drugs - an industry globally valued annually at around $20 billion. In a purely business sense many will argue that a 'selective information bias' is no more than accepted commercial practice aimed at maintaining and expanding (for as long as possible) an established marketing edge.


Related References    
     
Misinformation Misdiagnosis Debunking/Misinformation





 
PROTECTING THE VULNERABLE
Beyond the business model there is the issue of how best to protect vulnerable often seriously ill people with MS, from potentially over zealous commercial marketing practices. The Network's CCSVI Reference Group anticipated this eventuality in 2011 when it recommended that 'screening for possible vascular irregularities be undertaken during the diagnostic stages of MS as a prerequisite to qualifying for immunotherapy subsidies'.. HealthPACT referenced this recommendation when commenting on the diffusion of Percutaneous Venoplasty for pwMS. While this is clearly an important role for government regulatory bodies nothing has yet transpired.    
 
The real world situation is that around 1,000 Australians each year are newly diagnosed with multiple sclerosis and that around 80% of these, to varying degrees, will have venous abnormalities that may contribute to many of the most common systems of MS. Under the guidance of vascular specialists many of these abnormalities may be manageable and/or treatable. The issue is that there is no nationally recognised process in place to ensure awareness, at an individual level, of the potential significance of these underlying vascular disorders. Instead most are fast tracked onto a range of largely ''vascular inappropriate'' immunotherapy drugs now being shown to have no impact on MS progression - not good enough.
 
Advocacy Brief RM1429MS
Road Map Reference

 

 

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