On May 21, 1999, the Food and Drug Administration (FDA) approved the sale of a drug called rofecoxib to treat rheumatoid arthritis (Topol, 2004). However, after the sale of the drug to more than 80 million patients, authorities realized that it had a high risk of myocardial infarctions and strokes (Topol, 2004). Consequently, they withdrew it from the market. The FDA and the senior executives of Merck (the producer of the drug) were the primary leaders in the case study. Both parties had the duty of protecting and informing the public about the cardiovascular toxicity of the drug, but did nothing in this regard. This paper depicts this case study as a classic example of poor leadership in the public health sector.
Skills and Traits of the Primary Leaders
The paragraph above has already shown that the primary leaders in our case study were the executives of Merck and the FDA. Both parties had the skills and competencies to understand the health risks associated with the use of rofecoxib because they could carry out reliable tests to understand the drug’s health risks. The FDA had a particularly greater responsibility in this regard because it could regulate the production, sale, and distribution of this drug. Furthermore, it had the power to force the executives of Merck to stop the production of the drug, but failed to do so (Genat & Robinson, 2010). Indeed, as Topol (2004) observes, although different independent health agencies could conduct tests and experiments to test the toxicity of rofecoxib, only the FDA had the authority to act on such findings.
The agency’s biggest undoing was its reluctance to act on emerging data that demonstrated the toxicity of the drug. Instead, it passively waited for data to accrue before it could take action. Many lives were lost because of this inaction. One trait of the executives of Merck that came out of the case study was greed. This trait emerged from the company’s quest to pursue profits at the expense of public health safety. In other words, the company was more concerned about how to increase the sales of rofecoxib, thereby disregarding the cardiovascular toxicity of the drug, or its effects on public health. Lastly, the major trait that characterized the actions (or inaction) of the FDA in managing the health crisis was negligence. As mentioned above, the agency had immense powers to not only control the production of the drug, but also control its sales and advertising processes. However, the agency abdicated its duties in this regard and compromised the public health safety of the people it should have protected in the first place.
The case study cited in this paper highlights the importance of upholding high safety and health standards in the manufacture and sale of drugs. The most important take away of this analysis is the need to put public health safety concerns before financial or monetary concerns. Indeed, there is no need for a company to claim to improve people’s health problems, if it would only make them worse (Nahavandi, 2014). This is a morally and ethically wrong principle that emerged in the production and sale of rofecoxib because the drug was supposed to treat the symptoms of a relatively common health problem – arthritis, but, instead, added an even “deadlier” health complication of cardiovascular problems and stroke. Authorities and the public should evaluate public health leaders with higher levels of accountability because they have a duty to safeguard people’s health (Murray, 2011). Therefore, commercial interests should not trample public health and safety concerns.
Shortcomings of the Skills and Traits of the Primary Leaders
Public health issues usually pose special ethical, moral, and legal challenges because they are complex and multifaceted. If we analyze the case study sampled in this paper, we find that regulatory and financial issues emerged as the most important problems characterizing the public health incident (Topol, 2004). Relative to this fact, the main issue that emerged in this analysis is the ethical principle of “do no harm,” which the primary leaders ignored. This ethical principle highlights a disconnect between law enforcement and public health systems, which abstractly highlights the shortcomings of the FDA in managing the side effects of rofecoxib use (Koh & Jacobson, 2009). If we analyze the shortcomings of the FDA and Merck, independently, we find that both parties have significant shortcomings that led to the public health crisis in the first place.
The major shortcoming of the FDA was its failure to undertake its primary responsibility of undertaking clinical trials to determine the incidence of cardiovascular events associated with rofecoxib use. Merck was also culpable in the saga because it either knowingly, or unknowingly, underplayed the cardiovascular concerns associated with the use of rofecoxib (Topol, 2004). Instead, it chose to spend millions of dollars in advertising to underplay the public’s concerns about the effects of the drug. It also sponsored countless medical symposiums to debunk concerns about the emerging health concerns associated with the use of rofecoxib (Topol, 2004). In this regard, one significant flaw of Merck was its constant dismissal of independent trials that affirmed the health concerns of the drug use. Constantly, the company claimed that such trials were flawed (Topol, 2004). However, they never took the initiative of conducting independent trials themselves. The FDA also never requested or demanded them to do so. This action, or inaction, from both primary leaders was in breach of public trust (Mumford, Zaccaro, Harding, Jacobs, & Fleishman, 2000).
Description of Systemic Issues and Strategies
Systemic thinking requires that all people follow an orderly decision-making process (Peters, 2014). Its application in public health is important because systemic thinking helps to overcome some of the common public health implementation challenges that often undermine the work of public health professionals. In the context of our case study, systemic thinking helps us to understand the linkages and interactions that define the entire public health system. Concisely, this decision-making tool helps to manage some of the complexities that often characterize public health work. Indeed, as Peters (2014) observes, different types of inquiry, both qualitative and quantitative, could benefit from systemic thinking. If we use this analogy to explain the public health concerns in our case study, we find that systemic thinking could have helped to manage the problem at different levels. For example, it could have helped the FDA and Merck to understand and continuously test the efficacy and health concerns of rofecoxib use. This way, it would be easy for them to revise their understanding of the cardiovascular issues associated with the drug use before marketing it as a safe alternative for treating arthritis. In the same breadth of analysis, they would be in a better position to understand how to intervene in the public health matter after ascertaining the cardiovascular concerns of the drug use.
Koh, H., & Jacobson, M. (2009). Fostering public health leadership. J Public Health, 31(2), 199-201.
Mumford, M. D., Zaccaro, S. J., Harding, F. D., Jacobs, T. O., & Fleishman, E. A. (2000). Leadership skills for a changing world: Solving complex social problems. The Leadership Quarterly, 11(1), 11–35.
Peters, D. (2014). The application of systems thinking in health: why use systems thinking? Health Research Policy and Systems, 3(9), 12-51. Web.
Topol, E.J. (2004). Failing the public health—Rofecoxib, Merck, and the FDA. The New England Journal of Medicine, 351(17), 1707–1709.