Cure For Multiple Sclerosis? Treatment Wildly Popular Despite Scant Evidence It Works

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There are 2.1 million people worldwide suffering from multiple sclerosis. It is thought to be an autoimmune disorder in which the immune system attacks the body’s own nervous system. To date there is no known cure. At best, some therapies can slow the progression of the disease. The array of symptoms, such as loss of muscle control, some vision and widespread pain plague patients. Desperate, some of these patients are turning to a treatment that is widely condemned by experts in the MS field. The treatment, pioneered by an Italian surgeon, also has powerful support from a small handful of practitioners and patients continually in search of options.

The layer of cells surrounding neurons, myelin, have been shown to be damaged in the brains and spinal cords of MS patients. Myelin serves as an insulator for neurons and is vital to the ability of neurons to pass electrical signals to one another. When they’re damaged, as in MS, signaling between neurons is impaired, resulting in lack of bodily control, pain, and other symptoms.

Most researchers and clinicians attribute the myelin damage to autoimmunity, the cause of which still remains uncertain. But Paolo Zamboni, a vascular surgeon at the University of Ferrara in Italy, disagrees. He doesn’t think MS is primarily an autoimmune disorder. Instead, he hypothesizes that the disease is caused by chronic cerebrospinal venous insufficiency, or CCSVI, a vascular disorder that results in the insufficient drainage of blood from the brain and spinal cord. Zamboni thinks that the accumulation of blood in the brain causes a buildup of iron and that the iron damages the layer of tissue surrounding neurons, myelin.

Zamboni published a study in 2009 in which he found CCSVI to be present in 100 percent of M.S. patients at a particular stage in the disease. Following the finding he tested a treatment for M.S. that included inflating a balloon to open the veins that carry blood away from the brain and thus restoring normal blood flow.

But there were problems with the study. First, with only 65 subjects, it wasn’t large enough to reach a robust conclusion about whether or not the treatment was effective. And even though the study compared the treatment between people with MS and healthy controls, Zamboni wasn’t blinded to the groups – he knew which participants had MS and which did not, making bias a serious concern.

But for many patients these concerns paled in comparison to the possibility, no matter how remote, of being cured. In the face of this new demand the procedure spread quickly. The first neck angioplasty for MS in the US was thought to have been performed in 2009. The unproven procedure was restricted in many countries, but patients could still travel to the US, Costa Rica, Poland, Bulgaria and Egypt to have it performed.

Paolo Zamboni's procedure to treat MS has generated great enthusiasm among patients. Not so much among fellow researchers and clinicians.

Patients also generated pressure to investigate the link between CCSVI and MS, eventually prompting the US National Multiple Sclerosis Society to announce in 2010 that $2.4 million, or about 7 percent of its research funding, would support research on CCSVI.

Robert Fox, medical director at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, was not impressed. As he told the New York Times, “People without a scientific background often view all scientific papers with equal weight. Well, scientists don’t. I don’t know of a more prominent example where there’s been such profound pressure, driven by a nonmedical and nonscientific – though rightfully very self-motivated – constituency on what specific treatments should be explored with weak scientific basis.”

Zamboni isn’t the only one to look into CCSVI. The largest study to date was performed by Robert Zivandinov at State University at Buffalo. He did find an association between CCSVI and MS but at just 56 percent association compared to 23 percent in healthy controls, it falls well short of Zamboni’s all-or-nothing finding. Furthermore, the increased CCSVI wasn’t seen only in MS patients but in patients with other neurological disorders, suggesting that it may not have a specific link to MS.

Florian Doepp, a researcher at the Department of Neurology at Charité Hospital in Berlin, published a study in 2010 looking at blood flow in 56 MS patients. Except for a single patient, blood flow for the group was perfectly normal. As Doepp decisively told the New York Times, “I conclude there is no evidence for CCSVI in multiple sclerosis and no evidence to support” the surgical procedure to treat it.

The notion that MS is caused by faulty blood flow and too much iron – and not primarily an immune disorder – is not only weak on evidence, it’s also weakened by evidence. Previous research has pointed to over 50 genes associated with M.S., and all of them are involved in the immune system. Also, Parkinson’s disease patients have abnormally high levels of iron in their brains, yet do not consequently develop MS.

The proper study would be to perform the angioplasty on some MS patients and a sham operation on others – in a double-blind study where neither the patients nor the researchers know who received the procedure and who received the sham. But these studies are hard to perform because they’re costly and unattractive for a condition like MS which is incurable, and for which present medications can significantly prolong life. However, two such studies are now being conducted, largely due to patient demands.

There is no cure for MS. Drugs like betaseron used regularly to treat the disease can only slow its progression.

This past May the FDA issued a warning about CCSVI, saying “there is no reliable evidence from controlled clinical trials that this procedure is effective,” adding that “the criteria used to diagnose CCSVI has not been adequately established.” One person has died following the procedure, and the FDA has learned of “stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure.”

What the science lacks in hard data, patients are making up for in an abundance of testimonials. The CCSVI procedure overwhelmingly makes them feel better, sleep better, move around better with more energy. Many patients even come back for repeat procedures when the effects of a previous one had seemed to wear off.

Is there something to Zamboni’s procedure or is this some kind of mass placebo effect? Michael Arata, a vascular surgeon who has performed the procedure on about 1,200 patients, thinks it works, but for CCSVI patients. Not those with MS. He acknowledges that changing a person’s blood flow will make them feel different regardless of whether or not it’s beneficial. As he told the New York Times, “If I would operate on people’s veins, I’m quite sure I’d have effects. Yet I know those effects will disappear and will not be really clear.”

Sounds like placebo to me, and probably also to attendees at a recent conference of European MS researchers and clinicians. Data from a study was presented at the conference that included 462 patients. The study showed that, while the CCSVI surgery lacked any benefits revealed by “objective measurements,” about half of the patients reported feeling better. One professional group at the meeting attributed the effects to “high expectations.”

More studies, like the ones being performed by the Multiple Sclerosis Society, are still needed to definitively assess any link between CCSVI and MS. Hopefully, at the end of it all, the patients will be proven right, that the surgery does work. It would be a shame to reach the alternate conclusion with so much time, work, and funding wasted on a procedure with lots of devotion but not much data.

Peter Murray

Peter Murray was born in Boston in 1973. He earned a PhD in neuroscience at the University of Maryland, Baltimore studying gene expression in the neocortex. Following his dissertation work he spent three years as a post-doctoral fellow at the same university studying brain mechanisms of pain and motor control. He completed a collection of short stories in 2010 and has been writing for Singularity Hub since March 2011.

Discussion — 11 Responses

  • Beth November 3, 2012 on 4:49 pm

    There is no doubt CCSVI has helped many people with MS type symptoms. The numbers treated are between 20,000 to 50,000, with 3 deaths, not due to the procedure. Actually, venoplasty has helped Alzheimers, ALS, Lupus, Parkinsons, Autism, and possibly many more neuro type health issues. Anybody with inappropriate blood flow deserves to be treated. I have felt the benefits of venoplasty! My vision was sharper, my voice became more like my old self, my gait improved, my fatigue was gone and I felt more alive. Unfortunately something caused my veins to narrow again. Something is wrong with my blood or my veins. THAT is what needs to be researched! And the researchers need to follow the exact testing protocol to replicate Dr. Zamboni’s findings. There are some who want to discredit CCSVI, instead of understanding the theory and really looking for answers. Angioplasty has been used for many years with a 1% chance of a possible problem, usually it’s the drugs involved. History of poor blood flow in MS patients dates back to the 1800’s. This theory has been touched upon many times since then, but continued to get buried. The drugs for MS are harmful, expensive and useless, yet drug companies and neuros continue to push them on fearful people. Currently, 57 people on Tysabri MS drug have died! Over 200 have the JVC virus connected to PML. And that’s just one MS drug. It’s time to find the cause and stop pushing useless medication that doesn’t work and is harmful. It’s time all involved open their minds to a new, old way of thinking. I think Lyme disease plays a part in why the veins narrow again. It could be the bio-film or cysts that narrows the veins OR the bacteria from Lyme in the blood. Remember how ridiculed the doc was who said ulcers are from a bacteria? Same deal here! CCSVI needs more research as to why it helps some and not others, not whether it works. IT DOES WORK!

    • Denise Baillie Beth November 3, 2012 on 5:28 pm

      As of August 1, 2012 the numbers for Tysabri were: 271 cases of PML (progressive multifocal leukoencephalopathy) and 59 of those have died. These deadly brain infections and deaths are a direct result of the drug Tysabri. The 3 or 4 deaths were not a direct result of the angioplasty procedure. At least one of them was a Canadian who was refused follow up care in his own country, so he felt forced to fly back to the clinic where he had been treated even though he had a clotting issue (any doctor will tell you that is very strongly contraindicated) and the bloodthinning drugs he was given caused his death. One was due to an aneurysm which may not have been related to the procedure (family history). One other was due to a bad reaction to the bloodthinning drugs. In all of the deaths associated with this procedure, the patients had stents put in; and you will note that at least two of the deaths were a result of the drugs they were given to prevent clots from forming in those stents. Of around 30.000 procedures done worldwide, I only know of one adverse event that required any medical measures that did not involve a stent, and that one issue was successful remedied. I haven’t been treated yet because I didn’t think the government would be so idiotic about it….expecting intelligence from government, what was I thinking!?

  • Denise Baillie November 3, 2012 on 4:53 pm

    First of all, the only people all along who have been claiming CCSVI treatment is a cure for MS are those who are trying to discredit CCSVI, and you are apparently a member of that group. The vascular theory of MS predates the autoimmune theory but it was virtually abandoned when they found MS-like lesions in mice with an autoimmune disease. The mice that created this complete shift of focus did not have MS, and even though there are more than 100 different conditions that may be misdiagnosed as MS they continue to bark up the wrong tree (autoimmune). Since all of the Immune-system inspired disease-modifying drugs only have around a 30% chance of MAYBE slowing the progression of MS, doesn’t it stand to reason that only 30% of cases of MS have any autoimmune component? It is also interesting to note that during the 1930’s a cheap and easy way for medical science to ‘induce’ MS-like illness in the mice they were studying was to tie off their jugular veins! The simple fact is that CCSVI treatment is safer than liposuction or breast augmentation surgery, and it has far more potential medical benefit. There are no fewer than four peer-reviewed articles that have been published in medical journals that have all found the procedure to be safe. It helps around one-third who are treated by a significant amount (being able to discard a wheelchair at best, or being able to return to work); it helps around one third to some degree (even if it is just reduction in fatigue levels or improved heat tolerance it is a significant help to many with MS); and around one third experience little or no improvement. That means that CCSVI treatment can improve the quality of life of 60% or more people with MS! Why? The only thing that makes sense to me, is that it is non-pharmaceutical and so doesn’t have a very good profit margin for any large medical (pharmaceutical) companies. I’m not a conspiracy theorist, so I would love to hear a different possibility that has some logic behind it. Bottom line is…it is a safe, inexpensive procedure that has the potential to significantly improve the quality of life of people with MS and may allow them to become productive people again (i.e. allow them to return to work); but for some unfathomable reason, it is being blocked and ridiculed by those who stand to lose a great deal if it is allowed!

  • johnathanstein November 4, 2012 on 1:40 am

    You left out a few “minor” points, like:

    1. Dr. Zamboni’s first patient was his WIFE!
    2. Three-quarters of his 60+ patients has no symptoms after two years.
    3. The extreme negative side-effects of long-term treatment using for-profit drugs.

    The business side of human nature being what it is, there is QUITE likely to be a concerted to protect the market for drug-biased treatment.

  • Christopher Alkenbrack November 21, 2012 on 6:59 am

    Contrary to popular belief, and contrary to what most neurologists will tell you, the use of INTERFERON medications for MS does NOT slow progression. This abstract, published in the Journal of the American Medical Association states clearly in the conclusion: “Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.”

    Please see the original abstract at the following link.

    • johnathanstein Christopher Alkenbrack November 21, 2012 on 8:36 am
      • Christopher Alkenbrack johnathanstein November 21, 2012 on 10:06 am

        Yes, I love the writings of Dr. Wahls. My wife and I (I am the one with MS), have been following the principles of her “life-style” changes for several months now. Before I became familiar with her writings, I went gluten free and dairy free.

        I have Secondary Progressive MS, and was treated successfully for CCSVI in May of 2010. Many of my autonomic symptoms declined drastically. Now with proper blood flow, and significantly improved diet, I hope to keep “healthy” for as long as possible. I cannot believe that the National MS Society in the U.S. outright refused to fund Dr. Wahls’ research stating something like “she doesn’t understand the aetiology of Multiple Sclerosis” (my paraphrase of their comment to Dr. Wahls). In my humble opinion, proper nutrition plays a significant role in the management of Multiple Sclerosis, far more than taking dangerous immune-modifying drugs.