Any new hypothesis or treatment in medicine should have a solid, logical, and explainable biophysiological basis. Any diagnostic test in relation to a new hypothesis and/or treatment should be evaluated for flaws and bias before it is ever applied.
At issue are the following: Is a test operator dependent? Was a gold standard used? Was the cutoff for sensitivity and specificity appropriate? What are the positive and negative likelihood ratios? Is the test appropriate for a specific population? But many more criteria need to be assessed, such as selection bias and sample size . None of these was considered for the Zamboni criteria for ultrasound color Doppler imaging.
Single-center experiences can be the start of a new intervention, but independent confirmation by at least one other independent source is mandatory. Lack of randomized data years after the introduction of a new medical treatment is unacceptable. Widespread acceptance of a new technique before good scientific evidence is available is dangerous, and it also makes any randomized trial very difficult: the initiator of such trials is often accused of unethical behavior by withholding a “proven” treatment to patients who need it. Advertisement of new and unproven medical treatments through the media and the Internet can potentially result in compromised patient safety. A fast accumulation of single-center publications, which are then used as a reference source for new publications from the same groups, bears resemblance to a Ponzi scheme.
Are we going to be more alert in the future—not to be too enthusiastic about a new but still unproven treatment in interventional radiology? I hope we will. However, the need of many physicians not to withhold from their patients what seems the best treatment available is understandable. However, absence of evidence is not the same as evidence of absence.
Health care providers never considered reimbursement for the “liberation treatment”—not even in Canada, were the media pressure was high. Currently the absence of evidence is the same as the absence of reimbursement. Therefore, we should also try to introduce any new interventional radiological techniques along the lines of evidence-based medicine to guarantee proper reimbursement for our patients.
Balloon angioplasty and stenting of the jugular vein for CCSVI should have been stopped 4 years ago as a result of insufficient evidence. This would have prevented false hope from gaining ground for MS patients and their physicians.