Patient Empowerment: Consequences for Pharmaceutical Marketing and for the Patient–Physician Relationship - Innovation and Marketing in the Pharmaceutical Industry - page 419

14.1 Introduction

On December 17, 1996, the Food and Drug Administration (FDA) sent a letter to
Byron Scott, the then Director of Worldwide Regulatory affairs at Parke-Davis, a
division of Warner-Lambert, communicating their approval of an application he had
submitted 6 months earlier. The new drug application sought market approval for a
lipid-lowering drug to be prescribed to patients with primary hypercholesterolemia,
mixed dyslipidemia, or homozygous familial hypercholesterolemia. 1 By 2007, the
new drug, Lipitor, had become a dream brand. With almost $13 billion in global
revenues, Lipitor became the symbol of Big Pharma's successful blockbuster model:
develop a new drug for a disease affecting a very large number of patients, promote
it to physicians as the best-in-class treatment, and profit from the ensuing massive
volume of sales and a reasonably good margin.
Today, the pharmaceutical industry's blockbuster model, which guaranteed high
profitability for many years, is under threat. Between 2000 and 2008, the top 15
firms in the industry have lost $850 billion in shareholder value, a problem typically
attributed to complex challenges for pharmaceutical firms' traditional R&D and
marketing models (Garnier 2008 ). In 2007, amid these developments, a coalition of
institutional investors with more than $1.1 trillion in assets invested in the pharma-
ceutical industry expressed serious concern over the sustainability of the block-
buster model and asked pharmaceutical firms to consider new ways to market their
therapies (The Economist 2007 ). This coalition is not alone in its plea for a new
business model. Bain & Co.'s senior consultants (Gilbert et al. 2003 ) also declared
that the blockbuster business model is “irreparably broken” (p. 1). They suggest that
fixing Big Pharma's business model will require changes across the whole cycle of
therapy development (i.e., R&D), launch, and promotion. In this chapter, I propose
that pharmaceutical firms should adapt their marketing model by putting the patient
at the center of their strategies for therapy launch and therapy promotion.
I review evidence that suggests we are witnessing a fundamental change in the
medical decision-making paradigm. The traditional model for medical decision-
making, a “white-coat” approach whereby physicians apply their biomedical knowl-
edge to choose a therapy on behalf of their patients, is being replaced by a model in
which patients are encouraged and required to play a more participatory role in
therapy choice (Camacho et al. 2010 ). The emergence of patient empowerment as a
new paradigm in medical decision-making implies that patients will play an increas-
ingly important role in therapy choice, and consequently in the patient-physician
relationship and pharmaceutical marketing.
Figure 14.1 illustrates a conceptual overview of this chapter. I first review the
main trends that precede patient empowerment. Next, I build upon the discussion

1 See Food and Drug Administration's NDA 20-702, December 17, 1996, available at: http://www.
accessdata.fda.gov/drugsatfda_docs/nda/pre96/020702_s000.pdf (last accessed September 19,
2011).