What I found thought-provoking is that off-label promotion (of pharmaceutical companies) can be prosecuted as a criminal offense. That is, the attempt to influence physicians’ prescribing behavior using good or bad, but not “officially” approved information is a criminal act. [Remember, when the pharma promotes their drugs, off or on label, their intent is to influence doctors, who ultimately prescribe these drugs. That is, in the final analysis, if the patient is harmed/helped by (in)appropriate administration of treatments, it is because of the act of physicians].
I was a bit surprised that a few people commented on this (perhaps, due to pre-holiday fervor?) The reason that I find this so interesting is that it has tremendous implications for the way we practice medicine (and EBM). Physicians are free to prescribe whatever treatments they want as long as they believe that it will do more good than harm to their patient(s), regardless, if the administration of the drug is “off label” or “on label”. In fact, in my own field (hem-onc) it is estimated that up to 70% of treatment prescription is “off label”. So, what does it mean when individual physicians prescribe treatment, which is “off label”? Should we be criminally prosecuted? Which brings me to the question for this group: should we only accept the use of “on-label” indications as evidentiary standards for the practice medicine?
Ben