MS treatment revolutionised

MS treatment revolutionised by scientific method

Have years of animal research been denying patients this simple procedure?

Multiple Sclerosis (MS) is a painful, debilitating and progressive disease that holds so many people’s lives in a constant grip.  Progress in treating the condition has been minimal despite large investment.

However, recent findings have revealed startling new facets of the condition which promise nothing short of a revolution in treatments for sufferers.  Early small-scale trials and a much larger recent programme are supportive of the theory, which is so far reaching as to offer screening and pre-emptive treatment to those considered at risk, with no symptoms.

The study builds on findings that MS patients frequently have a blocked vein leading from the brain.  The azygous and jugular veins allow blood to flow away from the brain; in MS patients, a blockage causes a build up in the brain, which is also linked to deposits of iron at toxic levels.

The theory is known as chronic cerebrospinal venous insufficiency (CCSVI), and the experimental treatment is a simple procedure performed on a conscious patient. Entry to veins enables access to the veins at the neck allowing doctors to blow up a balloon, forcing the vein to widen and unblock.  A scan can identify whether a blockage is present and the procedure is advisable.   In 2009 the discoverer Dr Paulo Zamboni’s published two landmark papers. The first describes the condition and the second shows the effects of the “liberation” treatment on 65 patients. Read more here.

Results have been striking, with patients reporting a rapid improvement in conditions.  As consultant cardiac surgeon Dr Campalani, an MS patient explains:
"I am 64 and I was diagnosed with MS in 1986. I have being working full-time as a consultant cardiac surgeon in Belfast for the last 17 years. I met Dr Zamboni in my home town of Ferrara over three years ago and, following a Doppler study, I underwent angioplasty of both jugular veins by his team with significant improvement of my condition. Last Summer I noticed a slight deterioration and a Doppler study in Ferrara revealed re-occurrence of the narrowing of the jugular veins. I underwent a second liberation procedure in Belfast last October, with consequent improvement.”  (source here)

As trials progress, researchers have high hopes that this will also have implications for conditions of the spinal cord.

Wasted years and animal models

Progress before this breakthrough has been painfully slow, although not due to a lack of effort.  Unfortunately the main thrust of research has been directed towards a theory that was accepted for years, and is now increasingly felt to be entirely misleading.

The animal model Experimental Allergic Encephalitis (EAE) had been accepted as a parallel of the human condition for many years, which led to the assumption that MS was caused by the patient’s own immune system attacking the myelin sheath in the brain.  As the myelin sheath insulates the nerves of the brain, this attack was believed to be damaging, and meant MS was referred to as an autoimmune disease.  This was despite notable differences between EAE and MS.  EAE either kills or permanently disables animals, whereas MS attacks generally subside and reoccur.    Animals with EAE also suffer severe nerve inflammation, but in MS inflammation is usually mild or non existent.  EAE doesn’t have the same clinical symptoms as MS. (I New Scientist 28/02/04, 2436:17; iiJ R Coll Physicians Edinb 2002, 32: 244-65)

The new research indicates that the EAE model has not only failed to provide information needed to treat MS, but that it has served to divert the time of researchers and the limited resources of research budgets away from the priceless discoveries of Dr Zamboni and his CCSVI-based team.

New obstacles

The tremendous hope this now offers to MS patients is not without further obstacles.  The cost of the scan which may identify blocked veins and related doctor’s consultation is placed at an affordable £450, and the procedure is relatively simple.  MS patient Dr Campalani continues:

“For the last three years I have been campaigning in favour of the theory of CCSVI amongst colleagues in my hospital with no avail. I believe that the medical establishment has to wait for further evidence to be produced before accepting this new and revolutionary approach to the understanding and the treatment of MS."

However, new evidence, regardless of its medical rigidity, may not be welcomed.  As a doctor writing on the matter has noted, MS patients learning of the technique have not been able to access a clinic prepared to perform a scan.  He also expects other people to react badly to the developments.

“When it comes to fear and loathing, I expect these feelings are being harboured by other constituencies of the MS community, namely the MS clinicians, researchers, drug companies and charities. Why would such pillars of medicine fear and hate CCSVI? Regarding the clinicians, I have no doubt that they quickly realized that, if relief of CCSVI is an effective treatment, especially for the newly diagnosed, then they would essentially be cut out of the action when it comes to treating MS patients. Once a person was diagnosed with MS they would be immediately be referred to a vascular specialist who would then oversee the person’s treatments. It would be “diagnose and adios” for the neurologists, a somewhat ironic development given that is how the neurologists used to treat MS patients before the advent of MS drugs in the mid-90s.

As far as the MS researchers go, I can definitely empathize with them. I have been involved in research for over 40 years and I know, if someone suddenly demonstrated that I had spent the last 40 years barking up the wrong tree, I would have a variety of intense, negative feelings. One thing that has never been mentioned is how the Zamboni results demonstrate that the EAE animal model, which is widely used in MS research and upon which 10s of millions of dollars are spent every year, is clearly not suitable and is almost worthless. The mice do not develop CCSVI and thus the EAE model is no better than an animal model in which the mice developed CCSVI but no CNS lesions. A viable animal model for MS needs to exhibit both phenomena – end of story. Such a realization will cause great gnashing of teeth in the wide world of MS research.”

It is also not a stretch to predict that fear and loathing in the MS research community will turn to anger and I hope Dr Zamboni is prepared for some blistering attacks on both his work and his character. Hell hath no fury like a researcher proven wrong or disenfranchised. Finally, I won’t belabour the fears and anger of both the clinicians and the researchers regarding the potential loss of all that drug company largesse and research money which has been a bonanza over the past 15 years.

That brings us to the drug companies that supply the drugs that currently are used to treat MS or are in development...The bottom line is that there are tens and possibly hundreds of billions of dollars at stake in the foreseeable future and the drug companies are not going to let that kind of serious cash simply disappear without a fight. It is impossible to predict how the companies will deal with this real threat to their bottom lines and stock prices but you know it is not going to be pretty.”

So are we to conclude that the terrible waste of the time of our greatest medical minds, of research millions in numerous currencies, of opportunities and of the lives of MS patients was attributable to the EAE model, yet was seen as entirely acceptable for commercial reasons by many involved?  It would seem that this terrible truth is the reality.