The pharmaceutical industry is undergoing a profound change, largely imposed by external forces. The shift will acutely affect
the information stakeholders want, and the way in which they want it communicated to them. This piece focuses on four major
transitions that are occurring simultaneously and offers advice to marketers on how to keep pace with their audience's changing
Wayne L. Pines
The focus shifts from drug efficacy to drug safety and quality.
Two seminal events of 2004 were Merck's withdrawal of Vioxx (rofecoxib) and the controversy over antidepressants. Both were
front-page stories that drew Congressional interest. The testimony by an FDA statistician challenging how the agency evaluates
drug safety raised underlying questions about whether FDA itself and the industry that it regulates could be trusted to disclose
risks. On a larger scale, FDA's initiative to require risk management programs for certain products heralded a new emphasis
on drug safety.
Did You Know?
The industry had always relied on the positive "medical miracle" or "we save lives" message, while on the defensive side addressing
high pricing. The new industry messages must also address the harm that medicines can cause, as well as the integrity of the
industry that develops and markets the products.
A different aspect of drug safety was raised in the context of the importation issue. In an effort to save money, states enacted
legislation that permitted drugs to be imported from Canada and other countries. The counter-argument is that such imports
will cause the US drug supply to be suspect from a quality and safety standpoint.
Thus, the industry now finds itself in a position where it must continue to tout the value of its products and defend its
pricing, but also the safety and quality of its products. Further, it must prove that it can be trusted to present a balanced
picture of a drug's true benefits and risks. These are new messages for a new era.
Full disclosure is a must in the new environment, a change from keeping underlying data supporting pharmaceutical safety and
Until recently, companies could selectively disclose data. Human nature and business instincts prevailed—positive data were
published, negative data were not.
The new paradigm, stimulated by litigation instigated by the New York Attorney General Elliott Spitzer against GlaxoSmithKline,
demands full disclosure of all studies. Companies now have websites that promise to post both positive and negative studies,
as well as ongoing research. The FDA-approved labeling no longer is the best and only resource for information about the nuances
of a product's safety and effectiveness profile. Each physician and ultimately each patient now has access to the same data
that FDA reviews in writing the labeling.