Abusive Prescribing of Controlled Substances

Abstract

Reith et al. (Sept. 12 issue)1 suggest that clinical trials comparing widely accepted therapies should not be held to the “excessively detailed informed consent” standards of trials involving new therapies. Their justification appears to be as follows: for treatment purposes, patients already accept the risks of well-understood therapies for which evaluative data are sparse, so why should clinicians and researchers need to adhere to more stringent consent standards when providing those same therapies in a research context? Clinical research is designed to narrow the scope of clinical uncertainty by identifying unknown risks and benefits and determining which therapy is most effective. Inviting patients (who are already in a vulnerable state) into this realm of uncertainty — no matter how small — without fully acknowledging the implications of their participation is to treat them as passive instruments of medical expertise rather than as people who deserve to exercise control over their lives. That such invitations may take place in the clinical setting without this acknowledgment is not an argument for easing research consent requirements — it is an argument in favor of strengthening clinical consent standards.