Developing new drugs is a complex and lengthy process that requires much resources and effort. At the same time, their development and sale are accompanied by significant risks for both consumers and the manufacturer. New medications can have unpredictable side effects harming many people.
Companies, in turn, can suffer substantial losses if development does not meet expectations. Moreover, enterprises are responsible to both consumers and their employees. All new drugs, therefore, require careful review through research and follow-up monitoring. The history of painkiller Vioxx created by Merck Pharmaceutical Company illustrates the importance of drug validation, the complexity of their release, and the ethical dilemmas that accompany the process. Despite significant concerns about the dangers of Vioxx, Merck continued to sell and advertise heavily.
Like all drugs, Vioxx underwent trials and was authorized by the Food and Drug Administration (FDA) before being introduced to the market. However, after the start of sales, another Vioxx Gastrointestinal Outcomes Research (VIGOR) was initiated, where researchers compared the drug with another painkiller, naproxen (Presley, 2009). The study found an increased risk of cardiovascular (CV) disease in groups taking Vioxx. Merck continued selling and did not pay due attention to the danger. Instead, the company should have immediately developed a data analysis plan to examine CV incidents. Moreover, they should have informed the public and doctors of the danger and suspended aggressive marketing. According to the US FDA (2018), all claims and advertisement information about a product cannot mislead consumers and must be truthful. Therefore, Merck should have changed its marketing approach, which claimed the drug’s safety for the heart.
Merck also turned to strategies for manipulating researchers to justify its medicine and distract attention from danger. For example, the company wanted to convince the public that CV incidents are more common in the Vioxx group because naproxen helps strengthen the heart. Researchers refuted this assumption, but the company’s marketing continued to struggle for sales (Presley, 2009). Merck acted unethically by withdrawing sponsorship of researchers who criticized the drug. This strategy is not good because it is manipulative and harms the company’s image while maintaining adverse effects from the medication. The company had to extract the drug from the market several years after the start of sales when it could not deny the harm. However, many patients were affected, as the sales scale was significant.
The hurdles that Merck provided to research to protect its product are not the only incidents in history. Many companies strive to profit and can use unethical methods to achieve this goal. For example, in the middle of the 20th century, researchers revealed a link between smoking and cancer development, which was highly unprofitable for tobacco companies. As a result, companies began to impede such studies and finance researchers, which supported their business interests (Union for International Cancer Control, 2021). Such manipulations mislead consumers and cause risks to their health.
Thus, the case of Merck’s Vioxx painkiller demonstrates unethical behavior that some companies are willing to take for profit. Studies that examined Vioxx after its release on the market found increased risks for CV incidents. However, the company did not develop the necessary analysis plans and did not suspend aggressive marketing as it should have. Moreover, Merck used deception and manipulation to continue marketing activities to keep sales high. The company’s actions were unethical, but similar precedents have happened before, for example, with tobacco companies.
References
Presley, H. (2009). Vioxx and the Merck team effort. Kenan Center for Ethics at Duke University.
Union for International Cancer Control. (2021). The smokescreen of the tobacco industry’s use of science. Web.
US Food and Drug Administration. (2018). Step 5: FDA post-market drug safety monitoring. Web.