The Stamina story, the stem-cell “therapy” used by the italian researcher Davide Vannoni, “a psychologist turned medical entrepeneur”, as Nature caustically called him, has gained extensive media coverage this year in Italy and internationally. Many italians relived the nightmare of the supposedly effective treatment for cancer, the Di Bella multi-therapy: like nowadays, in 1998, following growing public demand, the Italian Parliament passed an act authorising that clinical trials be conducted and making funds available despite lack of scientific basis for the claims. A similar, but even more complex story, showing the growing power of social media, is that of a controversial new treatment for multiple sclerosis (MS), proposed by another Italian physician, Dr. Paolo Zamboni, a vascular surgeon who theorized a condition called “chronic cerebrospinal venous insufficiency” (CCSVI) as playing a role in the pathogenesis of MS and proposed a “liberation therapy” (unblocking the extracranial venous obstruction using angioplasty). The MS and CCSVI case is more complex because controlled multicentre “liberation” trials have been allowed by many (not only in Italy) local IRBs, i.e. the committees that have been formally designated to protect the rights and welfare of the research subjects. The Author analyzes her own experience as member of one of those IRBs that approved by majority such a trial, without solid scientific evidence of a causal relationship between CCSVI and MS and despite the concerns about potential risks associated with the proposed therapy (hemorrage, dislodgment of blood clots resulting in heart attack or stroke, nerve damage in the neck, among others). The remaining sense of bitter of an approval arrived at the end of an animated discussion amongst IRB members and prompted by the considerable public pressure of MS sufferers, who rushed off to get the surgery by many clinics offering liberation therapy, has raised a reflection on how to prevent similar future cases, having the common denominator of a physician/researcher putting himself out of the good clinical practice. The way forward seems to promote a culture of research integrity, in which misconduct is not tolerated.
|Titolo:||About patients, "inventors", journalists, scientists and IRBs (to say nothing of the institutions) : CCSVI and MS|
|Parole Chiave:||clinical trials; IRB; research integrity; misconduct|
|Settore Scientifico Disciplinare:||Settore MED/43 - Medicina Legale|
|Data di pubblicazione:||2014|
|Enti collegati al convegno:||Unesco Chair in Bioethics|
|Appare nelle tipologie:||01 - Articolo su periodico|