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Ethics and budgets demand that rigorous research precede clinical trials of Dr. Zamboni’s liberation treatmen
From Wednesday's Globe and Mail
As many as 75,000 Canadians have multiple sclerosis. It is a heartbreaking affliction that can slowly rob individuals of the ability to do the most basic of physical acts.
It is no surprise, then, that the possibility of a new treatment has generated international attention. Paolo Zamboni’s 2009 announcement of a surgical procedure, known as the liberation treatment, produced both hope-heightening headlines (MS Sufferers Buoyed By New Evidence Of Surgical Cure, reads one example) and a market for the “cure,” populated by desperate patients.
True medical breakthroughs with immediate clinical relevance do occur, but just a bit more frequently than the passage of Halley’s comet. The discovery of insulin and penicillin, the development and distribution of various vaccines, and the perfection of anesthetic and safe surgical techniques are all good examples. Could the liberation technique be placed in this same category?
On Aug. 31, a joint report issued by the Canadian Institutes of Health Research and the MS Society of Canada made the breakthrough scenario seem less likely. The report, which stands as a wonderful example of the mobilization and utilization of independent scientific expertise, examined both the biological theory, a phenomenon that Dr. Zamboni has called Chronic Cerebrospinal Venous Insufficiency (CCSVI), and the clinical procedure used in the liberation treatment.
What did the report conclude?
That Dr. Zamboni’s research has numerous methodological flaws and should be viewed as a pilot study at best. That the liberation treatment involves an intervention, venous angioplasty, that is potentially dangerous and could lead to stroke and heart complications. And, perhaps most importantly, that “there is little support for the notion that ‘venous insufficiency’ for the brain or spinal cord contributes to the development of MS.”
This report, which accords with the emerging conclusions of other professional and scientific organizations from around the world, has a clear message: There is no good evidence that the liberation treatment works, or even that it could work. More research on the possible mechanics of the theory behind the treatment – that is, on the phenomenon of CCSVI – is required.
The day after the report was issued, federal Health Minister Leona Aglukkaq said she intends to follow the recommendations of the report and not devote federal money to clinical trials at this time. However, several provinces, specifically Saskatchewan and Newfoundland and Labrador, have reaffirmed a commitment to fund the clinical work.
In addition to the scientific reasons outlined in the CIHR-MS report, any decision to fund must tackle several other questions.
First, given the scant evidence to support the start of a clinical trial, is it appropriate to use scarce public research money in this manner? So much health research is required and lacking financial support – shouldn’t this kind of decision be driven by the science? If not, what kind of precedent does this establish for future funding decisions?
Second, is it ethical to conduct this research on MS patients? Research ethics demands that there be a degree of basic scientific evidence, such as studies on the possible biological link between CCSVI and MS, to support the move to research involving humans – this is particularly so when the intervention is invasive and has known risks. Moving to clinical trials before there is supporting data can result in missteps that hobble progress. This happened with gene therapy in the late 1990s, when patient Jesse Gelsinger died in a clinical trial that many believe was premature. The area of gene therapy is still recovering from that controversy.
Third, might support from provincial governments legitimize this currently questionable technique in the eyes of desperate patients, thus helping to buttress a market for the less reputable clinics throughout the world that are offering the treatment, often at a hefty price? There are reports of numerous, perhaps thousands, of Canadians travelling to receive the liberation “cure.” Given what the existing evidence tells us about efficacy, this trend seems both risky and, perhaps, an exploitation of vulnerable individuals.
The first reaction to any claim of a major medical breakthrough, especially for a complex disease like MS, should be healthy skepticism, flavoured with a dose of hope. I realize that this might sound crushingly cynical. It’s not. Healthy skepticism is at the heart of good science. And good science is an essential element of good health-care decisions. The surest way to determine whether clinical benefit can be derived from this new approach to MS is to study it in a rigorous and systematic manner, starting with basic research and then moving, if and when the data are sufficient, to clinical trials.
Timothy Caulfield is Canada Research Chair in Health Law and Policy at the University of Alberta."