When the Hype Outpaces the Medical Evidence

What’s a responsible healthcare provider to do when the hype for an unproven medical procedure far exceeds the evidence?  


Patients with multiple sclerosis (MS) were elated after a 2009 study published in the Journal of Vascular Surgery suggested that the blockage of major venous outflow from the brain and spinal cord might be associated with the development or progression of MS. The authors of the study called this blockage “chronic cerebrospinal venous insufficiency” (CCSVI) and proposed in their study that, in many cases, balloon angioplasty or a stent placed in the central thoracic veins, reduced or eliminated the signs of the disease. Although the procedure was reported to be both painless and safe, the data were based on a very small number of patients and used a study methodology that was flawed.


The authors of the paper were interviewed extensively on television and in print; the story quickly went “viral” via social media outlets and YouTube, which posted testimonials from patients who had undergone the procedure. As might be expected, the outcry from the community of people with MS wanting to access the procedure has been overwhelming. While the procedure is not available here in the United States, some people are traveling to Canada or Europe to undergo the procedure at a cost of at least $10,000, exclusive of travel costs.


In addition to a paucity of evidence showing that revascularization improves clinical outcomes in patients with MS, subsequent studies have been unable to establish whether CCSVI causes or even contributes to MS disease activity. Recently published results from one of the trials—the largest to date—suggest that CCSVI may actually be the result of MS rather than the cause. And there are other issues, as well—including the fact that there are currently no clinical guidelines for following patients who have the procedure done abroad or for the management of MS complications that might occur in the meantime.


Clearly, more objective data is needed before routine interventions for CCSVI can be recommended, and, hopefully, ongoing registries and trials will provide that data. In fact, the Society for Interventional Radiology has published a statement citing that until real scientific data are available for CCSVI and balloon dilatation, this treatment should not be offered to MS patients outside of a well-designed clinical trial.


Highly publicized reports of medical research present a growing challenge for patients, healthcare providers, and administrators. How can we temper enthusiasm for experimental therapies, now widely and effectively marketed through social media and personal testimonials, until evidence shows that the treatments are likely to do more good than harm?

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