Monday, November 22, 2010

Multiple Sclerosis patient dies after controversial new treatment

A controversial and yet unproven treatment has claimed the life of a Canadian patient suffering from MS.

There has been a lot of buzz recently over a suggested treatment for patients suffering from multiple sclerosis (MS). A recent, yet obscure, research paper published by Zamboni P. et al. (2009) has suggested that multiple sclerosis, a debilitating neurological disease that can leave one with severely impaired movement and motor function, is caused by blocked or impaired veins in the head / neck that lead to problems in blood flow. The paper thus suggests that treatment for MS would be possible by opening up these blocked veins.

The hypothesis the paper suggests is that that chronic cerebrospinal venous insufficiency (CCSVI), the improper outflow of blood in the veins leaving the head due to plaque buildup, is a major cause of clinical MS.  The suggested treatment? Opening up these veins by inflating a small balloon that pushes the plaque out of the way; an angioplasty, the same procedure used to open up clogged arteries in patients with atherosclerosis.

Now, the main issue with this entire story is that the entire treatment seems to be based off of one piece of research, and a shoddy one at that. Yet many people around the world with MS are looking to this treatment as a last resort to relieve their suffering. The problem is that they usually need to turn to other countries that perform the procedure; clinical studies, in Canada at least, are not yet being conducted on the efficacy of the procedure primarily due to its iffy scientific backing. The recent death of a 35-year-old Canadian receiving the treatment in Costa Rica has come as a shock to most, and seems to be putting another nail in the coffin for the procedure (I won't go into detail about his death, more information can be found here).

Upon reading the research paper, what struck me most was the vast differences between Dr. Zamboni's hypothesis about the pathophysiology of MS compared to the current scientific model of the disease. The current model, the one founded on numerous peer-reviewed and tested research, holds that MS is caused by hyperactivity of immune cells against myelin antigens. Myelin is present in the covering of your peripheral nerves, and this constant attack causes your nerves to function improperly. Over time they become so worn out that eventually you may not be able to move, or have severely limited motor function. 

Dr. Zamboni's study, however seems to misunderstand the principle that correlation does not equal causation. Yes, plaques and impaired cerebrospinal blood flow were found in a few patients suffering from MS but does that automatically mean it directly causes MS? I'm no statistician (in fact, I should review my statistics notes), but the study tested only 65 patients presenting with clinical MS, against 235 patients in the healthy, control group. Once again, not a statistician, but doesn't that seem off? When designing a proper study shouldn't your control group and testing group be roughly equal? If someone can answer this for me I'd appreciate it, because it seems like the study was poorly conducted to begin with. On top of the methodology, the scientific theory behind it seems so far-fetched and out of sync with the clinical realities of the disease that it's definitely worth questioning more. Kudos to the Canadian government for not allowing such a risky procedure based off of scant evidence. 

Although, I'm quite surprised that so many people would flock to an unproven and untested surgical procedure based off a (frankly, heavily disputed) research paper. It's one thing where this would be minor research that would simply be retracted but as was mentioned today, someone died from a procedure based off of this research; that is something all scientists and clinicians need to keep in mind when conducting research, no matter what they are studying. Yet many seem to be crying foul about not being allowed to undergo the procedure in their native country.

I realize that those with terminal, life-long, debilitating illnesses need all the help they can get and are desperate for cures, but procedures like this cause alarm bells to go off in my head, and instead of dinging they say "snake-oil". I've always had an intense dislike for snake-oil peddlers that prey off the sick and desperate, purely for financial gain, and this is exactly what seems to be going on here. Normally, fraud in science and treatments eventually gets exposed, although it's very unfortunate that it cost the life of a fellow human being before others starting noticing.

News soureces

This is the famed research paper. It's published under a commons license, so the entire thing is available to read.
Zamboni P, Galeotti R, Menegatti E. (2009). Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg  Psychiatry; 80: 392-399.

Other papers
Lassmann H, Bruck W, Lucchinetti CF. (2007). The immunopathology of multiple sclerosis: an overview. Brain Pathology; 17(2): 210-218.
doi: 10.1111/j.1750-3639.2007.00064.x

Ratts RB, Karandikar NJ, Hussain RZ, et al. (2006). Phenotypic characterization of autoreactive T cells in multiple sclerosis. J Neuroimmuno; 178(1): 100-110.

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