3. Unusual delay in a Randomized Control Trial (RTC) testing perispinal etanercept Unfortunately, a clinical trial of these promising observational studies continued to be delayed for over a decade. In the course of much favorable off-label treatment of post-stroke patients, many independent observers, from 2011 to the present, including non-neurological medical practitioners, nurses, speech pathologists, and neuroscientists, have witnessed this negligibly invasive treatment technique and its outcome in post-stroke patients. When faced with a striking mix of rapid onset, effectiveness, and persistence of outcome in an important circumstance where the usefulness of present treatments is very low, a common conclusion by these observers has been that this novel approach warrants an independent Randomized Control Trial (RCT). Nevertheless, the American Academy of Neurology (AAN), despite no member of its governing board having witnessed the treatment, or having addressed the science behind it, continues to display an on-line Clinical Advisory that explicitly discourages its members, and indeed any neurologist who reads it, from any association with this approach. In effect, the AAN fell in line behind the Big Pharma patent owners. Their position continues unchanged, despite the validity of the AAN’s actions being questioned in an editorial some years ago in Expert Review of Neurotherapeutics [Citation18] and the publication of additional supportive evidence [Citation19,Citation20]. Thus almost all neurologists, following the AAN’s advice, have ignored invitations to observe or engage in this work, thereby establishing, for years, a quite unjustified barrier to clinical translation of the perispinal method, with its potential for wide application in disease and research.
Overcoming Barriers Chapter 7 pdf