Post-marketing studies of new insulins: sales or science?

In 1994 David Kessler and colleagues from the Food and Drug Administration described ways in which pharmaceutical companies could promote their products in a crowded marketplace. These included the “switch campaign” and studies designed to market a drug as well as study its behaviour.1 The switch campaign is designed to persuade prescribers to substitute a new drug for an established but less expensive treatment. The marketing study is a clinical investigation whose predominant objective is to change the prescribing habits of the participating physicians.

The literature on marketing studies is sparse. One example was the ADVANTAGE study (such studies are characterised by their upbeat acronyms) which involved 5557 participants treated with rofecoxib. Access to confidential company documents confirmed that the study was designed as a marketing tool.2 The accompanying editorial pointed out the dubious legality of such studies under US law, and cited guidance issued by the Office of the Inspector General to the effect that “post-marketing research activities should be especially scrutinised to ensure that they are legitimate and not simply a pretext to generate prescriptions of a drug.”3 Recent guidelines from the European Medicines Agency also stress that “such studies should not be performed where the act of conducting the study promotes the use of a medicinal product.”4