The socio-political roots of pharmaceutical uncertainty in the evaluation of ‘innovative’ diabetes drugs in the European Union and the US

The prevalence of diabetes is growing in many countries. Prescription oral medications have been developed to treat the disease since the 1950s. More recently, a group of diabetes drugs, known as the glitazones, have been developed and introduced on to North American and European markets since the late 1990s. When first introduced, the glitazones were widely regarded as ‘innovative’ pharmaceuticals and have remained on the American and EU markets, among others, throughout the 2000s. Yet, enormous uncertainties about their therapeutic value have remained since they came on the market a decade ago. This paper investigates how socio-political systems of drug development and regulation generate such pharmaceutical uncertainty consequent upon the limited informational value that diabetes drug trials provide about the health risks and benefits of such medications when used in clinical practice. Drawing on documentary research and fieldwork interviews, the first in-depth analysis of regulation of ‘innovative’ pharmaceuticals in both the US and supranational EU is presented. It is argued that these pharmaceutical uncertainties can be explained by reference to four key factors: regulatory paradigms using surrogate markers for drug efficacy; drug approval standards in policy and legislation; ideological expectations of innovation within regulatory agencies; and pharmaceutical industry shaping of drug evaluation.

► Clinical studies of new drugs for type II diabetes may provide information that is of limited relevance to clinical practice.
► This case-study of the ‘glitazones’ locates the socio-political roots of this problem in current systems of drug development and regulation in the EU and US.
► These systems produce scientific uncertainty about new drugs that may persist for years.
► Pharmaceutical uncertainties are explained by four key factors: regulatory paradigms using surrogate markers for drug efficacy; drug approval standards in policy and legislation; ideological expectations of innovation within regulatory agencies; and pharmaceutical industry shaping of drug evaluation.