Australasian Multiple Sclerosis Network of Care Multiple Sclerosis Network of Care Australia

A Voice for People Affected by MS


 
  Medical Interventions in MS

Importance of Informed Decision Making

CCSVI Australia

TurnOnthe Tap

 
A B C D E F G H I J K L M N O P Q R S T U V W X-Y Z
 

  
Contact the Network
Donations
Advanced Research
 
About this Road Map
  About the Network
  Site Map
  Topic Index
  Case Study
 
About Multiple Sclerosis
  What is MS?
  Vascular Issues
  Living with MS
  Quality of Life
  Charter of Rights
  Issues & Needs
  Networking
  Regional Support
  Service Guidelines
  Care Standards
 
CCSVI and MS
  What is CCSVI? 
  Parliament's Role
  Petition
  Dispelling the Myths
  Talking Points
  CCSVI Face Book
  Innovation  & CCSVI
  Life Quality & CCSVI
  Adapting to Change
  A Right to be Tested
  The Early Adopters
  Patients Perspective
  Treatment & Contacts
 
Support Services
  Carers & Respite
  Exercise
  Home Care
  Income Support
  Rehabilitation
  Transport/Mobility
Networking
 
 Australia
  Demographics
  Networking 
  Network of Care 
  CCSVI Australia 
 
NSW
 Demographics
 Networking
 
ACT
 Demographics
 Networking
 
Victoria
 Demographics
 Networking
 
Queensland
  Demographics 
 Networking
 
South Australia
 Demographics
 Networking
 
West Australia 
 Demographics
 Networking
 
 Tasmania
 Demographics
 Networking
 
Early Days
  Horizon Group
  Discussion Archive
  Pathways Project 
  Video Archive

 
Medical Interventions Big Picture News Headlines What is Multiple Sclerosis? Quick Reference Guide     
       
The cause/s of MS are not known and, in consequence, no cure exists. This area of the Road Map provides a number of snapshots regarding long term research outcomes associated with immunotherapy medications and related topics, It should be read in parallel with the document ''What is Multiple Sclerosis". It should also be noted that it is being shown that the drug free treatment of certain underpinning vascular irregularities can provide significant relief from many MS symptoms.
Answering an Important Question
The majority of those newly diagnosed have the relapsing/remitting MS sub-type. For these (in conjunction with their medical advisors) it is not easy  to objectively answer the question ''will this particular medication/approach significantly (and safely) delay my long term transition from relapsing remitting MS to progressive MS?. Access to Independent research to assist in answering this very specific question is vital.
 
Based upon a belief (unproven by way of long term clinical trials) many people with the relapsing/remitting form of MS have, since 1993, been offered access to a range of immunotherapy drugs intended to reduce the frequency of exacerbations.
 
Getting the Treatment You Need
These drugs are not relevant once the disease becomes progressive - usually 10-15 years after diagnosis but fluctuating greatly. Some people, around 15% of those newly diagnosed, have progressive forms of MS from the outset. There are also significant concerns about a high incidence of (undetected) cardiovascular disorders in people diagnosed with MS. Side effects and/or potentially incomplete diagnoses not only means that patients may be getting expensive and potentially harmful treatments they don't need, but may also not be getting the appropriate treatment for conditions they may have - more on this topic
Potential Effectiveness diminishes rapidly over time
In November 2017 a meta analysis of disease modifying drugs involving over 28,000 people with MS found that the usual MS drugs were less and less effective the older the average person with MS in the clinical trials was, to the point where, at age 53, they stopped being effective at all! They also showed that the newer generation, more potent MS drugs were more effective than that standard first generation drugs like Copaxone and interferons only for people with MS who were under 40 years old.
Cautionary Guidance
The researchers said, “…in view of this meta-analysis, it should serve as a reminder that aggressive immunomodulatory DMTs may be harmful in older MS patients…”. By this they meant that not only were older people likely to experience side effects without the prospect of any benefit, but that aggressive MS drugs might also hinder the usual repair processes after nervous system damage. While the researchers were quick to point out that these conclusions apply to the “average patient”, and that some may still get some benefit after the age of 53, older people newly diagnosed with MS would be well advised to discuss the pros and cons of starting a DMD with their doctor in significant detail. Likewise, those people on a DMD who are passing this age should consider a similar conversation with their doctor. Of course, not taking a DMD does not imply no treatment.....
Beyond the auto immune paradigm
In January 2012 Neurologist David Hubbard MD, provided an insightful narrative about the nature and role of the immune system as related to MS and the loss of myelin. In doing this he demonstrated that clinical evidence failed to support the MS autoimmune hypothesis whereby immune suppressing drugs are prescribed to guard against myelin damage. He identified the fundamental causes of myelin damage as likely associated with venous drainage problems, - a must watch presentation.
 
David Hubbard's commentary is reinforced by subsequent findings whereby the blood clotting protein fibrinogen is identified as triggering attacks on the brain including initiating myelin loss and inhibiting remyelination. Fibrinogen is also extensively deposited in the motor cortex  accompanied by significantly reduced neuronal density.  The role of the primary motor cortex is to generate neural impulses that control the execution of movement.
 
Subsequently and in the light of a range of long term studies (see later) on 6 April 2016 the National MS Society (USA) issued a press release that said ''There are FDA-approved therapies that can impact the underlying disease course in people with the more common forms of MS.  However, none of these can stop progression or reverse the damage to restore function".
Quick Reference Guide to these Therapies

Review a specific Medication Find out More  Display Abstracts for all Medications 

 
The following  historical snapshots reference some of the research outcomes that support the statement by the National MS Society Click Here
 
Some Down to Earth Guidance
Australian Professor Jelinek provides down to earth guidance regarding these drugs and associated lifestyle options. He observes ''many authorities argue that once the industry sponsored trials of the drugs that enable them to be brought to market are completed, it is important to undertake independent observational research examining how the drugs perform in the real world setting of ordinary people with MS, who potentially have other medical conditions and take other medications''. More broadly questions are asked about the need for impartial research regarding the belief that autoimmune factors do, in fact, underpin MS progression. Watch a short video clip regarding the importance of informed choices.
Pregnancy, Hormones, Bloodflow, Reduced MS Relapses - Much More Yet to Learn

While MS medications are not recommended for women who are pregnant or planning pregnancy there is also significant evidence that pregnancy is associated with a reduced relapse rate, particularly during the last trimester. The Pregnancy and Multiple Sclerosis (PRIMS) trial, which looked at 269 pregnancies, found that pregnancy resulted in a 70% reduction in relapse rate in the third trimester with a corresponding increase in the relapse rate in the three months after childbirth. Despite the increase in the period after childbirth, 72% of women experienced no relapses during this period.

Research (over 7 years and published December 2015) relating to these reduced relapse rates indicated the involvement of the Estriol hormone. However this was subsequently described as an "overly optimistic" informative failure. While the reasons for these "pregnancy related" fluctuations are yet to be properly understood there are striking similarities between what is being learnt regarding the ovarian peptide hormone Relaxin (especially as it relates to the function of nitric oxide) in regulating blood flow dynamics during pregnancy and the irregular bloodflows experienced by the majority of those with MS. More about pregnancy and MS.

 More about  Immunotherapies  - Some earlier Developments
On 17 July 2012 the Canadian press reported on a study involving 2,656 patients with MS (published in the Journal of the American Medical Association) that found that exposure to a group of drugs known as the beta interferons was not strongly associated with a reduction in progression of long-term disability in people with multiple sclerosis
 
Researchers said "Our main finding suggests the drugs aren't preventing the progression of disability" .Dr. Helen Tremlett, one of the study's authors, says the finding is just coming to light because in the past, not enough time had elapsed from when the drugs were approved to treat the disease.
 However, the researchers warn that the study's results weren't meant to suggest that MS patients stop taking the drugs as the medications are still effective at reducing relapse rates - more about MS medications
 
Subsequently, on 6 April 2015 researchers from the Division of Neurology and Brain Research Centre, University of British Columbia, Canada reported that amongst patients with relapsing remitting MS the use of beta interferon (IFNβ), the most widely prescribed drugs for patients with multiple sclerosis, was not associated with a delayed onset of secondary progressive MS. The study encompassed more than 2500 people with MS with a time span to the point of onset of secondary progressive MS
 
Holism Study - DMD's do not delay Disability Progression
On 24 April 2015 the international journal Neurological Research reported on a study (by the HOLISM research group) of 2276 PwMS from 56 different countries around the world. The study looks at MS relapse rate, disability and quality of life in a real world setting. Around half were taking a disease-modifying drug (DMD), mostly Copaxone or one of the interferons. Those taking a DMD did not demonstrate a lower relapse rate than those not taking a DMD, although for those who had taken a DMD for longer than 12 months, there was a 24% reduction in relapse rate, similar to the sort of level of relapse rate reduction seen in clinical trials, BUT with no difference in disability compared to those not taking a DMD.
 
Overall, people taking one of the DMDs did not have a better quality of life than those not taking a medication; in fact, in several domains, their quality of life was worse. When comparing the four most commonly used DMDs, only Copaxone users had a better quality of life than people not taking a DMD. In relation to low dose naltrexone (LDN} the data showed a similar pattern to the DMDs -  that is a worse quality of life for those taking LDN than for those not taking a medication. The authors point out ''as the HOLISM data only shows a snapshot in time, we cannot infer causality''.
Management of Adverse Effects
In August 2015 the Medical Journal of Australia published a paper titled ''A new era in the treatment of multiple sclerosis'' authored by a number of Australian and New Zealand medical professionals whose interests include the use of pharmaceuticals to modulate the impact and progression of MS..
Risks When introducing this paper they said ''most of the newer, more effective therapies are associated with risks and practical problems that necessitate an active management strategy and continuous vigilance''. They went on to say ''while the initiation of these therapies is likely to remain the responsibility of neurologists, other specialist physicians and general practitioners will be involved in the identification and management of adverse effects'' - more about these adverse effects.
Independent Peers Advise against Prescribing New Generation of MS Drugs
Established in the early 1980's Prescrire is a fully accredited not for profit European based continuing education organisation that offers practice improvement programmes specifically adapted to the needs of healthcare professionals. It also provides entirely independent medical guidance that aims to provide subscribers with the guarantee of the most reliable information possible. It is written by health care professionals for health care professionals, Most of it's editorial staff are in active practice.
It uses evidence based science to make recommendations on drugs to help healthcare professionals to prescribe for their patients in an informed and fully independent manner. Each article is reviewed by 20-40 other peer-reviewers.
 

 In March 2015 it provided what is described by some as startling evidence on the new generation of multiple sclerosis drugs. Specifically referenced were Tysabri (full text courtesy of Prescrire) and Pubmed abstracts relating to Lemtrada, Aubagio and Tecfidera (due April 2015).

 

In summary what they say is that when looking at all of the data we now have, these new drugs are too dangerous, with too many side effects and known and unknown risks. In the case of Aubagio they say ''It is better to choose interferon beta, despite its limitations'' - because these new, more powerful drugs have had biased trials and/or have not proven any long term benefit. Joan Beal, internationally recognised advocate for those with MS, provides a more expansive overview of these developments.

Soaring Costs of MS Therapies
Also on 24 April 2015 the journal Neurology shed light on the soaring costs of disease-modifying medications and therapies for multiple sclerosis in the USA. A study showed that the cost of MS therapies have increased 5 to 7 times more than prescription drugs. New MS therapies are entering the market 25-60% more expensive than current drugs, MS therapies are 2-3 times more expensive in the US compared to other similar countries and the increase in cost of MS therapies was not observed for other similar drugs. They conclude that there is an urgent need for all associated to confront the spiraling costs of therapies in multiple sclerosis. - find out more. The situation in Australia is not known.
Neuroprotection - New Directions in MS Medications
Neuroprotection .When Dr. Zamboni discovered the link to slowed venous return, hypoperfusion and MS, he opened up a new way of looking at the MS disease process, On Thursday, May 14, 2015 Joan Beal identified the new buzzword in MS drug development as neuroprotection - which simply means protecting neurons by re-establishing blood flow and perfusion after a loss of oxygen to the brain
 
Neuroprotective agents are used in an attempt to save ischemic neurons in the brain from irreversible injury - representing a subtle shift from drugs which modulate the immune system to drugs which address blood flow irregularities. Some of these medications are frequently prescribed for use by those who suffer from stroke. Specifically highlighted in recent times as having potential MS protective benefits are Ibudilast, Guanabenz and Biotin and also Lisinopril and Statins - there is a growing list.
What it is all about - Endothelium Dysfunction

Significant interest is being expressed in the role of Endothelium Dysfunction in MS progression. For example an activated endothelium could secrete proinflammatory cytokines, including GM-CSF.and TGF-beta. A study published on April 27th 2015, in the Journal of Immunology, confirms that the cytokine GM-CSF (Granulocyte macrophage colony-stimulating factor) likely plays an important role in human disease and offers a new explanation for why the MS treatment interferon-Beta (INF-β) is often effective at reducing MS attacks.

 

Similarly reported is that blocking the molecule MACAM could delay the onset of multiple sclerosis and significantly slow its progression. A potentially disease-modifying antibody, called PRX003, is designed to inhibit MCAM function and thus prevent migration of destructive lymphocytes across the blood brain barrier. Lots more about endothelial dysfunction.

Guidance by Vascular Specialists is the the Starting Point

 

The Neuroprotective approach aims to negate the destructive ability of agents that cross the blood barrier because of endothelial damage. The chronic cerebro spinal venous insufficiency (CCSVI)  approach aims to address the cause of this damage - for many the restoration of normal blood flow is the start of this process. The different approaches may transpire to be complementary in some circumstances. Identifying and addressing the underlying reasons for disturbed blood flow is a matter for vascular specialists, with expertise is in this rapidly emerging area of medicine. They will assess individual veins and underlying issues in order to determine the appropriate course (if any), including medications. For example, some vascular specialists may identify vascular by-passes as a possible option.

.

Making  Good Sense
 
Key Messages A key message is that the range of MS related chronic disabilities associated with vascular irregularities continues to grow. Options for treating such underlying vascular disorders (collectively referred to as CCSVI) may vary from one individual to the next - more about this key message.
It also makes good sense to adopt lifestyle choices that enhance vascular health - rather than place additional pressure on what, for many, may already be a compromised vascular system. Proper nutrition, appropriate exercise and effective sleep readily spring to mind.
  Facts Sheet RM1874MS

Road Map Reference

 | Disclaimer