Research by popular demand
This is a story quite specific to Canada, but it certainly has global implications. Recently, one provincial government made public the fact that they are approving clinical trials on the new, experimental “liberation procedure” for patients with multiple sclerosis (MS). The procedure itself isn’t innovative – it’s simply a venous angioplasty (or opening of the veins in the neck and spinal cord to, as claimed, improve blood flow by allowing greater venous blood drainage away from the brain) but as a “cure” for MS, it’s very new and the evidence is, well, simply anecdotal. Dr. Zamboni is an Italian neurosurgeon who has, through this procedure, claimed to cure MS through neurosurgical means even though a surgical solution has never been even vaguely hinted at in the past. He suggests that patients with MS have an underlying condition called “chronic cerebrospinal venous insufficiency” (CCSVI) and that this procedure can provide a cure. Some patients have had the procedure and claim an almost miraculous recovery and palliation of symptoms and the neurological community is modestly intrigued.
As of now, the province of Saskatchewan will fund trials on the procedure while Ontario’s premier, Dalton McGuinty has stated that he would rather see something more than “anecdotal evidence” for the claims of the procedure before allocating funding towards further formal testing of it on patients with MS.
Here is the story from the Globe and Mail: Wall sticks by MS plan, but other premiers skeptical
I don’t often agree with Margaret Wente of the Globe and Mail, but I do agree with her views in her article on the politics of MS. In this, she is critical of decision-making regarding funding for research based on political waverings, anecdotes or popular demand. Here’s her article: The explosive politics of MS
A few quick points:
I also don’t tend to agree much with Dalton McGuinty, however his point about wanting “more than anecdotal evidence” before making decisions about funding clinical trials is one that should be seriously considered. While there have been “stories” about the success of the procedure, in two independent replications of Zamboni’s procedure, the results were completely negative. Here is a posting from the Neurologica Blog about these two studies and the importance of replication: CCSVI – The Importance of Replication. Of course, some might argue that the only way to accrue evidence is, in fact, through conducting trials. That’s true, of course. But in this case — one which involves a catastrophic and debilitating disease with no apparent cure — it seems obvious that we should take particular care and demand strong reputable evidence while actively rejecting anecdotal evidence, i.e. evidence in its weakest form. Zamboni, as the writers of Neurologia state, may not have necessarily found the cure for MS, but he may well have found a piece of the puzzle. And in this posting I’m not, in any way, taking sides here with claims that his procedure either works or doesn’t: I’m simply saying that until we know more, we should demand more rigorous evidence from a variety of independent sources before we make these kinds of big decisions.
Second, I’m quite interested in the fact that the provincial premiers are the ones speaking out here. Research and funding for research is and always has been influenced by politics and by governmental decisions on allocation of resources and money. However, I find it interesting that the highest provincial politicians are speaking out on this issue at this time. They’re not talking about other kinds of decisions related to clinical trials. Why not? Because this one, as Margaret Wente notes, has “gone viral”.
Certainly there is, and should be, a place for the voice of the public in contributing to these sorts of decisions, but these voices must be well informed and clearly must state their stake in the matter up front. We shouldn’t make decisions about how to fund large clinical trials based on what’s “gone viral” or because something has gained in popularity through “word of mouth”. Sure, we can make decisions about what cute kitten video to watch on YouTube based on what’s gone viral, but clinical research decisions? Let’s keep popular demand and politics out of it.
Research Ethics Blog 
The role of venous drainage issues in neurodegenerative diseases such as MS is not new. I have been writing about it for well over twenty years now. What’s more, MS is just the tip of the iceberg and baby boomers and neurodegenerative diseases such as Alzheimer’s and Parkinson’s are the iceberg. I do have some points of contention with Zamboni’s theory of stenosis of internal jugular vein routes as the source of the CCSVI. His theory also fails to explain the peculiar demographics associated with MS. It also fails to explain the pathology of MS. I am currenty discussing these issues on my blog. Please take a look at my posts and let me know your thoughts and comments.