Intended for healthcare professionals


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

BMJ 2012; 344 doi: (Published 12 June 2012) Cite this as: BMJ 2012;344:e3974
  1. Edwin A M Gale, emeritus professor of diabetic medicine, University of Bristol
  1. 1Diabetes and Metabolism, Learning and Research, Southmead Hospital, Bristol BS10 5NB, UK
  1. Edwin.Gale{at}
  • Accepted 6 June 2012

Edwin Gale’s analysis of registered post-marketing studies of new treatments for diabetes showed that studies of insulin analogues have involved some 400 000 participants worldwide. One company recruited nearly 360 000 individuals. Most studies were performed in middle or low income countries, had limited scientific value, and promoted wider use of more expensive insulins

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

Post-marketing studies

Post-marketing research has received little scientific scrutiny. Current procedures to license a drug represent a compromise between the need to make potentially valuable new drugs available without undue delay and the need …

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