IDEAL for CCSVI Research

I read with great interest the editorial titled “No Endovascular Innovation Without Evaluation in Chronic Cerebrospinal Venous Insufficiency: A Call for the IDEAL Model” by Williams and Venkatesan.¹ Although I very much support the IDEAL model to prevent uncontrolled dissemination of unproven or even harmful procedures, this does not mean that any sort of research can be done. The authors stated that the demand by patients with multiple sclerosis for research on endovascular interventions in chronic cerebrospinal venous insufficiency (CCSVI) is so great that any call to halt it would serve only to propel the unregulated and unmonitored off-label practice, which is likely to cause more harm than would carefully monitored clinical trials. What this actually means is that you have to tell your patient during informed consent, when you perform research for CCSVI, that you do this to prevent further unregulated off-label use, which is likely to cause harm. In article 9 of the Declaration of Helsinki, it is stated: “Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights.” Asking patients to participate in a trial just to prevent unregulated and unmonitored off-label practice means that the researcher does not believe the CCSVI hypothesis is true. The overwhelming accumulation of high-quality papers all speaking against CCSVI in the last 2 years, some published in this journal, actually make it impossible to believe that the CCSVI hypothesis is or can be true. Medical research should only be conducted to find an answer to a research question, not to satisfy the popular voice. The original IDEAL paper also stated: “Trials are unnecessary when an advance is clear and substantial.”² I would argue that the opposite is also true: Trials are also unnecessary when the advance is clearly unproven. Research should be conducted to challenge scientific doubt and when there is no scientific doubt, either positive or negative, any trial is unethical and should not be performed.