Challenges in Benefit/Risk Appraisal

Abstract

The essential issue for any drug is: How much side-effect risk should be judged acceptable, for how much therapeutic benefit? Manufacturers must take benefit/risk considerations into account as they develop drugs and bring them into market, and iteratively, then, as they refine and shepherd the drugs through their commercial lifespans. Regulators must do the same as they control the admission of drugs into the market and guide refinements (such as reformulation, setting of indications and restrictions, provision of information to users, and so on). Obviously, physicians and other health-care providers and payers must also do so. All of these authorities must consider technical, personal, and social factors, and should think and act throughout in the interest of the ultimate public consumers of the drugs. Because I believe that continuity should be fostered among RAD-AR efforts, and because what I presented at the 1988 Wolfsberg conference [1] is still valid, I will briefly state my core concerns as I have articulated them before.