The benefits and costs of biologic registers

Abstract

The era of biological therapy has arrived, and we would do well to learn the lessons of the ‘steroid era’, in which too many years passed before the side effects of these new ‘wonder drugs’ were fully appreciated. Will biological agents be as good as we hope, will they have complications we have not anticipated, and will they be affordable? Pharmacovigilance is the name of the game. Furthermore, it is clear from the Vioxx ® (Merck & Co., Inc., New Jersey, NY) experience that the normal 6–12 months of pharmacovigilance carried out by pharmaceutical companies could be too short a time to make any balanced judgements. In order to circumvent these problems, several countries—Sweden, Germany and the United Kingdom, for example—have established biological registers to determine the long-term outcome of treating patients with tumor-necrosis-factor (TNF) blockers, principally in patients with rheumatoid arthritis. The largest register established to date is the British Society for Rheumatology (BSR)’s Biologics