Merck Vioxx recall is an adverse event highlighted in the “What Can Go Wrong, Will Go Wrong: Quality Case Studies” article. Pharmaceutical giant Merck introduced an anti-inflammatory drug, Vioxx, in 1999 (Freeman, 2018). According to the accepted standards, the company sponsored studies to investigate the negative impacts of the medication. In 1998, the organization excluded data about adverse effects on the cardiovascular system, which led to the drug application by the US Federal Drug and Food Administration (FDA) in 1999. That year, the company conducted another study, Vioxx Gastrointestinal Outcomes Research (VIGOR), to show how the drug reduced gastrointestinal side effects. However, the article neither commented on increased cardiovascular risk nor presented any adverse impacts at all to ensure that the results would be published in the New England Journal of Medicine. It later became evident that the VIGOR study had been fabricated for marketing purposes, and 2004 witnessed a clinical trial revealing an increased risk of a heart attack after consuming Vioxx. The drug was withdrawn from the market in 2004, and Merck agreed to spend a large sum of money to cover numerous lawsuits and legal costs.
Even though the adverse event resulted in health issues for multiple people, it led to many positive effects for the healthcare industry. On the one hand, the problem bared the existing inefficiencies regarding how medical journals, government agencies, and manufacturers approached quality standards. Medical industry stakeholders understood that they should have implemented rigorous tests to investigate the quality of drugs and announce all the results, including negative side effects. In other words, the scandal was positive for the field because it indicated that an organization would bear personal liability for presenting invalid test results. On the other hand, the adverse event revealed that the healthcare industry lacked cooperation and a system of control. In particular, the FDA and the medical journal did not have any procedures to check whether Merck presented credible and reliable data about its drug testing. Now, these organizations are expected to avoid such harmful mistakes. One can mention that the Merck Vioxx recall brought a few positive changes to the medical industry. This statement allows for supposing that the existing procedural rules and requirements will not let a dangerous drug enter the market.
It is challenging to find a single cause leading to a problem, and the adverse event under analysis is not an exception. That is why I believe that some steps were missed in the process, which resulted in the Merck Vioxx recall. Firstly, the problem emerged because of the absence of precise regulations on how clinical trials should have been conducted and what data should have been included. That issue provided Merck with an opportunity to fabricate study findings to get approval from the FDA. Secondly, the adverse event happened because the medical sphere did not have any established recommendations stipulating how the regulatory bodies should have checked the presented studies. It seems that the absence of these rules resulted in the fact that the FDA and the medical journals accepted Merck’s words for granted. That inefficiency resulted in the fact that patients took millions of Vioxx doses until its harmful effects became clear and the drug was withdrawn. Thus, I suppose that if these two processes had been in use, the selected drug would not have entered the market and caused harmful impacts.
It has already been mentioned that the error led to versatile outcomes, and it is now reasonable to focus on adverse results. Patients experienced the most harmful outcomes because many individuals suffered from an increased cardiovascular risk. Their health conditions worsened, and people were forced to suffer from physical and mental problems. Adverse consequences also affected Merck, which was fair because it initiated the scandal. According to Freeman (2018), “Merck agreed to pay $4.85 billion to settle more than 27,000 lawsuits related to Vioxx, in addition to its legal costs of $1.2 billion” (p. 5). Even though the information above has commented on how the problem positively affected healthcare, the industry still witnessed essential drawbacks. Firstly, Merck damaged the reputation of the FDA and the New England Journal of Medicine. The problem demonstrated that these professional organizations did not draw sufficient attention to their responsibilities, and ordinary citizens did not like it. Secondly, the entire medical industry was then forced to deal with an unexpectedly high number of patients with cardiovascular issues. Consequently, it is challenging to underestimate the negative impacts of the Merck Vioxx recall on healthcare.
It seems that specific efforts could have been used to prevent the error. In the beginning, it was necessary to develop professional and detailed rules on how to conduct clinical trials and how these research projects should be presented. This step was necessary to prevent Merck from fabricating study findings. The second useful intervention could have been to make the FDA and all scholarly journals establish clear and rigorous recommendations on how they should have checked clinical trials. These organizations could also have employed independent experts who should have been responsible for monitoring some of the clinical trials. Another effective solution could have been to impose high fines for presenting invalid data in studies. Merck spent much money to cover the consequences that it brought, but those payments were settled after the problem had occurred. However, one can suppose that the organization would not have engaged in the unlawful behavior if there had existed clear and massive fines for deceiving the FDA and medical journals. These three actions represent a comprehensive approach that is needed to prevent the problem and similar ones in the future.
Since I am employed within the healthcare industry, the case under analysis provided me with a few helpful tips that can improve my professional practice. Firstly, the problem teaches me that it is not appropriate to take everything for granted. Even when data comes from seemingly reputable sources, it is reasonable to rely on critical thinking to check whether the findings are reliable and credible. Secondly, the case demonstrates that it is rational to consider new drugs with caution. I will not advocate for using newly developed medications until I become aware of evidence supporting their safety for people’s health. For that purpose, I will rely on multiple sources to collect and analyze data. Finally, I believe that I will combine my employment and research practice because this mixture contributes to the versatile development of professional and personal skills. After reading the adverse event, I will draw sufficient attention to ensure that every study, in which I participate, presents valid and complete results. This step is necessary to ensure that the scientific field generates valuable and safe data.
Reference
Freeman, G. (2018). What can go wrong, will go wrong: Quality case studies[PDF document].