When Two Plus Two Must Not Equal Four

The document discussed the challenges faced by the pharmaceutical industry in developing combination therapies, particularly in the urological field for conditions like BPH. Despite evidence showing the efficacy of combining 5-α-reductase inhibitors with α-blockers, regulatory requirements demanded that the combination's clinical profile exceed that of each component alone, making trials costly and complex. The industry was hesitant to invest in such studies due to modest returns and the availability of generic components. The document highlighted the need for regulatory acceptance of additive clinical benefits and suggested that patient advocacy could drive change, though this was deemed unlikely. Bayer's initiative to study a combination of a PDEi and a soluble guanylate cyclase activator was noted as a rare exception in the field.