Balancing Burdens and Benefits: Ethical Issues of Off-Label Prescription Pharmaceutical Use

I remember when Botox (Allergen, Irvine, CA) was becoming all the rage in rehabilitation in the mid 1990s. As I recall, the only U.S. Food and Drug Administration (FDA) approved uses at the time were for spasmodic torticollis and blepharospasm. In a short period of time, however, Botox was the new treatment du jour for adults and children alike with spasticity from CP, traumatic brain injury (TBI), and stroke. I also remember feeling a bit queasy about it. Perhaps having recently completed a fellowship in clinical medical ethics colored my view. Images of thousands of people with limb deficiencies, the tragic consequence of the widespread and unregulated use of thalidomide, were fresh in my mind. Bioethicists and professional organizations were beginning to voice concerns about the perceived erosion of patient protections and professional norms between industry and medical practice. Some examples of these concerns included fast-tracking of new drug approvals with the FDA, the hefty finders fees for enrolling patients in pharmaceutical research studies, the elaborate gift giving by pharmaceutical companies to buy the loyalty of future prescribers; the marketing ploys of pharmaceutical-sponsored speakers bureaus, the ghost writing of pharmaceutical-sponsored research articles, and the surreptitious promotion of off-label uses .
Source: PM and R - Category: Rehabilitation Authors: Tags: Ethical Legal Source Type: research