BALANCING COSTS, EFFICACY, AND SIDE-EFFECTS

Drug approval processes in most developed countries generally do not p rovide the comparative information necessary for clinicians, patients or policymakers to make informed choices between similar agents, balan cing efficacy and toxicity. These questions have been made exponential ly more complex with the addition of cost as a third dimension to cons ider in making therapeutic choices. Application of cost-containment pr essure in the absence of adequate data provides a poor foundation for optimal decision making. A systematic, disciplined process is needed f or the comparison of similar drugs along each of the three dimensions of efficacy, safety, and cost. Such an inquiry will require use of sev eral different methodologies, from conventional randomised controlled trials, to pharmacoepidemiological studies and cost-effectiveness anal yses. Such information need not form the basis for drug registration, but instead would be made available to practitioners, patients, and pa yers to inform their therapeutic choices. The cost of such an ambitiou s research endeavour would be more than offset by the opportunity for enormously greater efficiencies in the rational use of cost-effective drug therapy.