Pharmaffiliation: A Model of Intra-Elite Communication in Pharmaceutical Regulation

Abstract

In 2005, the House of Commons (HoC) Health Committee produced a report on The Influence of the Pharmaceutical Industry – the first of its kind since 1914. The inquiry concluded that there were ‘over-riding concerns about the volume, extent and intensity of the industry’s influence, not only on clinical medicine and research but also on patients, regulators, the media, civil servants and politicians’, and stressed the need ‘to examine critically the industry’s impact on health to guard against excessive and damaging dependencies’ (HoC 2005, p. 97).

It also noted that it is important to comprehensively analyse pharmaceutical regulation in order to ascertain whether there are systemic problems:

In some circumstances, one particular item of influence may be of relatively little importance. Only when it is viewed as part of a larger package of influences is the true effect of the company’s activity recognised and the potential for distortion seen. The possibility that certain components of any such campaign are covert and their source undeclared is particularly worrying. (HoC 2005, p. 97)

This study addresses this recommendation and was primarily conducted to examine whether recognised concerns are merely ad hoc or as a result of systemic flaws in the current system of pharmaceutical regulation. The work addresses a gap in the academic literature by drawing on the fragmented criticisms of the pharmaceutical industry in order to produce a model to illustrate how various stakeholders collaborate with drug companies to promote licensed products, and to explore the nature of the relationships between these elite stakeholders.

The thesis begins with a literature review which determines who is involved in pharmaceutical regulation; how the regulatory system works; and explores the key role of communication in this process (Chapters 1 to 3). The recurrent theme is the neglect or exclusion of the patient/consumer, which leads to the development a model of intra-elite communication in drug regulation called Pharmaffiliation (Chapter 3).

The thesis then looks for evidence to support or refute this model, using multiple methods (Chapter 4). Four case studies (with specific selection criteria) are chosen to test the model’s constructs and indicators (Chapters 5 to 8).

The research uncovers systemic problems in the current system of pharmaceutical regulation which can ultimately harm the patient/consumer, and the implications of these findings are discussed (Chapter 9). Solutions on a micro-level include consumer involvement in decision making processes, which can be enhanced through public education and awareness campaigns and the instigation of public inquiries whenever drugs are withdrawn from the market (HoC 2005, p. 105). On a macro-level, however, this will involve critically exploring neoliberal capitalism and the empowerment of the citizenry (Street 2001).