Institutional corruption & off-label drug use
Rodwin, Marc A.
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Although sometimes reasonable, off-label drug use typically is unsupported by substantial evidence of effectiveness and safety. At the root of inappropriate off-label drug use lies institutional corruption of pharmaceutical practice. Institutional corruption involves perverse incentives for pharmaceutical firms, the lack of evaluation of off-label prescribing and conflicts of interest in the design, oversight, and reporting of clinical trials. Typical reform proposals such as increased sanctions for manufacturers, education for physicians, registration of clinical trials, and disclosure of conflicts of interest do not remove the source of the problem. The speaker explores alternative reform options. These include: 1) tracking off-label prescriptions to monitor the risks and benefits of off-label uses and the manufacturers' conduct; 2) changing pharmaceutical firm reimbursement to remove incentives to encourage off-label prescribing; and 3) independent clinical trials to evaluate drugs.