Pharmaceutical Physicians and Crisis Management
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CURRENT OPINION
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Pharmaceutical Physicians and Crisis Management Wayne L. Pines Healthcare, APCO Worldwide, Washington, DC, USA
Abstract
Product crises are inevitable for companies that make medical products. Crises can stem from many sources, including new clinical data or reports about a product, tampering or counterfeiting, or quality issues. The processes for managing such crises have been well defined, stemming originally from the principles derived from how the Tylenol tampering was managed by Johnson & Johnson in 1982. Pharmaceutical physicians have a central role to play in helping to manage pharmaceutical crises. For example, they serve as the central coordinator of the medical aspects of a crisis; they play a role in communicating with the media and with medical and other audiences; and they bring an essential medical perspective to the management team. Pharmaceutical physicians can also play an active role in helping their companies take steps to avoid a crisis from occurring.
In their excellent article on pharmaceutical medicine, Stonier et al.[1] set forth the numerous functions of a pharmaceutical physician. They mentioned the need for such physicians to ‘‘have a wide range of experience, including training and expertise in basic research, drug development and evaluation, clinical trials and registration as well as a thorough understanding of pharmacoeconomics, medical aspects of the marketing of medicines, business administration and the social impact of healthcare on patients and public health.’’ What might also have been included on this list is the important role that pharmaceutical physicians play in managing and preventing product crises, albeit that successful crisis management will draw from all these sub-disciplines from time to time. Hardly a day passes when a pharmaceutical or medical device company is not involved in some crisis or other. This is inevitable. The discovery, development and marketing of healthcare products involve inherent risks, unpredictable variables and frank unknowns. It is axiomatic that there is no effective medical product that, regardless of the amount or nature of testing, or care of use, can be perfectly safe. Furthermore, the scientific impossibility of proving a negative (i.e. lack of harm) poses unique challenges in managing crises involving pharmaceutical products. While a crisis for every product may not be inevitable, the chances are high that at some point, a product crisis will occur. Recent examples of crises underscore the point. Merck withdrew rofecoxib (Vioxx) when new evidence linked it to heart attacks and stroke in chronic users. GlaxoSmithKline needed to deal with conflicting interpretations of data involving its
diabetes mellitus drug rosiglitazone (Avandia). Baxter withdrew heparin products in 2008 as a result of reports of death, later discovering that someone had found a way to substitute a counterfeit ingredient. Each of these incidents had worldwide implications. These three exampl
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