Pharmacoeconomics and clinical trials in multiple sclerosis: baseline data from the European Union

Abstract

One of the contemporary debates between science and economics is concerned with why, and to what extent, financial cost and economic efficiency considerations affect scientific inquiry into possible solutions to human illnesses. This study inquires into clinical drug trials for multiple sclerosis (MS) in the European Union to determine the validity of a prevailing claim, advanced in the medical community, that the clinical efficacy of these drugs is undermined by cost and efficiency considerations. The first part of the study is devoted to a review of pharmacoeconomic literature (2000–2012) on clinical drug testing for MS, particularly in the member countries of the European Union. The second part presents survey results of discontinued clinical trials that we gathered from European Union registries. The study finds that cost and efficiency considerations exist in a limited number of trials in the European Union. Specifically, about 1/5 of MS drugs do not reach the pharmaceutical markets even if there may be some supporting efficacy data, or negative safety data is absent, during testing/experimentation. Their direct and controlling impact on decisions to withdraw suspend or prematurely terminate (as well as initiate) clinical testing and efficacy data collection for MS does not appear to be consistent. However, these could extend prevailing theoretical debates about the proper scope of clinical drug efficacy in MS. The study suggests that pharmacoeconomic approaches to clinical efficacy help broaden and enhance our understanding and choices of disease management options for MS sufferers, their families and health care providers in the European Union and elsewhere. Finally, there is some empirical evidence to indicate an inverse relationship between transaction costs and drug marketability: The higher the transaction costs of clinical testing, the lower is the drug's potential for funding and eventual marketing