Why animal studies are still being used in drug development. An innovation system perspective

Abstract

In Europe alone, 3.6 million animals per year are used for drug development. Animal studies are worldwide the gold standard to evaluate the safety, efficacy and quality of drugs before these drugs are tested in humans. Nevertheless the value of animal studies to predict risks for humans has never been extensively established. Nowadays, several studies indicate that the value of animal studies is often limited. Pharmaceutical companies and regulatory authorities as well as the public and governments aspire to reduce the use of animal studies because of the limited value of animal studies and the ethical issues regarding animal studies. The development of innovative methods to replace animal studies got a boost at the end of the 1970s due to campaigns of animal welfare organizations that resulted in increased public awareness and the implementation of Directive 86/609/EEC in the European Union. This Directive requires that innovative methods are used when possible and stimulates the development of innovative methods. Ever since a diversity of innovative methods has been developed. Innovative methods nevertheless only incidentally replaced animal studies. In this dissertation we tried to elucidate why animal studies are still being used in drug development. To answer the research question “Which mechanisms explain the lock-in of animal studies in drug development?” six studies were conducted. In two studies we identified the barriers that hamper the replacement of animal studies in the current regulation. Based on these studies it can be concluded that, although regulatory authorities and pharmaceuticals companies have the ambition to reduce the use of animal studies, replacing animal studies by innovative methods is challenging. On the one hand replacing animal studies by innovative methods is challenging because innovative methods have a misfit with the institutional logic of animal testing. On the other hand there is no urgency to replace animal studies. This lack of urgency slows down the innovation process because it for example makes it more difficult to obtain resources. Because innovative methods have to be adopted in the regulation to replace animal studies the institutional logic of animal studies is the selection environment. Four studies were conducted to identify why animals are implemented in the guidelines for the development of drugs in new drug classes. Based on these studies it can be concluded that animal studies often have only limited value in the development of monoclonal antibodies. Nevertheless animal studies are implemented in the guidelines because the design of the development process of new drug classes is experience driven and not science driven.