Analyzing Research: Rofecoxib, FDA, and Public Health Crisis

This case study critically examines a research article concerning the marketing of Rofecoxib (Vioxx) and its approval by the Food and Drug Administration (FDA). The analysis highlights shortcomings in the research, particularly the delayed publication of cardiovascular risk data and the need for more rigorous clinical trials. It discusses strategies for improving system thinking within the FDA and pharmaceutical companies, including mandatory clinical trials, enhanced medication education, and stricter advertising regulations. The study concludes that a thorough critique of the research article reveals the adverse effects of Rofecoxib and emphasizes the importance of adhering to safety protocols to protect public health. Desklib provides access to similar case studies and solved assignments for students.

Running head: CRITIQUING RESEARCH ARTICLE
CRITIQUING RESEARCH ARTICLE
Name of the Student:
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1CRITIQUING RESEARCH ARTICLE
Introduction
The study will focus on the concept of critiquing a research article that will allow the
researcher to understand the possible shortcoming of the significant traits and skills of the
research article (Dale, Hallas & Spratling, 2019). Complete critiquing of the research article
will also assist the researcher and the readers to understand and identify effective strategies
that will help the researcher to improve and utilize their system thinking. The study will focus
on the research article that revolve around the marketing of Rofecoxib and permitted by the
Food and Drug Administration (FDA) (Topol, 2004).
Possible shortcomings of the traits and skills in the research article
The research article had focused on approval of Merck by the Food and Drug
Administration (FDA) to endorse Rofecoxib (Vioxx). The Company had withdrawn the
marketing of the medicine due to high risk of myocardial infraction as large number of
patients were consuming this medicines. This withdrawal was considered as the biggest
prescription-drug removal in history (Dimmer et al., 2019). A pivotal trial was conducted that
involved 8076 patient suffering from rheumatoid arthritis and exhibited that coxib comprise
of reduced gastrointestinal toxicity as compared to naproxen. In 1999, the approval of drug
was submitted to the Food and Drug Administration (FDA) but the record of the drug
approval was not submitted in any peer-reviewed article until November 2000 and later it was
submitted to the research article after one and half year of commercial approval. The risk of
cardiovascular data was not submitted completely in the research article and the concern was
raised that focused on highlighting the risk of cardiovascular condition associated with
rofecoxib (Topol, 2004). The research article highlighted the risk of myocardial infraction
that was associated with the drug rofecoxib. The necessity of conducting a trail was also
stated in this research article that would allow the researcher to understand and identify the

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risk of coronary heart disease. The patient who are consuming rofecoxib were under high risk
of developing coronary heart disease associate with arthritis. On the basis of the trail that was
conducted it was exhibited that arterial inflammation was the primary reason of stroke and
myocardial infraction and consumption of coxibs would help the patient to decrease the
production or invention of inflammation biomarkers like C-reactive protein and thereby
develop the endothelial function that would be beneficial for the patient to reduce the risk of
myocardial infraction associated with stroke (Blankstein, Libby & Bhatt, 2019). Therefore,
an extensive trail was suggested that would determine the prevalence of cardiovascular
activity associated with the treatment of coxib as no such trail was conducted that would
elaborate the prevalence or incidence of cardiovascular activity associate with stoke for the
patient who are consuming medication like coxib and hence this strategy was majorly
suggested by the researcher in the research article (Topol, 2004).
Approaches for system development utilizing system thinking in the research article
The primary strategy to improve the system thinking was suggested to conduct a
mandatory clinical trial that would be permitted by the Food and Drug Administration (FDA)
to confirm the safety of consuming Vioxx medicine by Merck that would be supported by
diverse peer-reviewed research article (Topol, 2004). The idea of enhancing medication
education would allow the people to understand the severe cardiovascular effect and also
comprehend that rofecoxib has no adverse cardiovascular toxicity as an alternative naproxen
was beneficial and cardio protective in nature. In huge population, consumption of
nonsteroidal anti-inflammatory medicines like coxibs would assist the researcher to gain
information regarding high risk or adverse effect activity on the patient. Merck was
marketing the product with high level of advertisement and effective trail was conducted that
would provide scientific data regarding the benefit or risk of consuming medicine. Strict
action was taken by the Food and Drug Administration (FDA) to prohibit Merck from

3CRITIQUING RESEARCH ARTICLE
advertising the medicine as the medicine did carry adverse risk of cardiovascular condition
and hence, agency educated Merck regarding including the precaution or prevention strategy
that will reduce the risk of cardiovascular activity (Topol, 2004). Large number of population
were suffering from severe public health condition that was due to consumption of the
medicine and hence serious action should be considered that will reduce the risk of public
health issue.
Conclusion
It can be concluded that complete critiquing of the research article had allowed the
researcher and the reader to understand the adverse effect of consuming medicine, rofecoxib
that would result in severe cardiovascular problem associated with stroke. The research
article had explained the strategies that should be followed by the agency and permitted by
the Food and drug Administration (FDA) in order to confirm if the medicine is beneficial for
the patient to consume.

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References
Blankstein, R., Libby, P., & Bhatt, D. L. (2019). Arterial Inflammation. Journal of the
American College of Cardiology, 73(12).
Dale, J. C., Hallas, D., & Spratling, R. (2019). Critiquing Research Evidence for Use in
Practice: Revisited. Journal of Pediatric Health Care.
Dimmer, S. C., Mayse, M. L., Deem, M. E., & Gifford III, H. S. (2019). WITHDRAWN
PATENT AS PER THE LATEST USPTO WITHDRAWN LIST.
Topol, E. J. (2004). Failing the public health—rofecoxib, Merck, and the FDA. New England
Journal of Medicine, 351(17), 1707-1709.