Ethics of Vioxx Withdrawal From the Market

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Introduction

Merck launched Vioxx in 1999 as a substitute for non-steroidal anti-inflammatory medications to manage osteoarthritis pain. After research found an elevated risk of major cardiovascular events, including stroke and heart attack, five years later, Merck withdrew Vioxx, one of the best-selling painkillers internationally, from the market. Nevertheless, there had already been billions of dollars in sales of the medicine for Merck around the world (Prakash & Valentine, 2007). Scientists at Merck distorted clinical trial findings for the osteoarthritis medicine Vioxx to conceal evidence that the treatment increased patients risk of developing heart disease.

What Merck Might Have Done

Patients on Vioxx showed more warning symptoms of cardiovascular risk than those taking naproxen. According to preliminary results from the Vigor trials published in March 2000, Mercks researchers designed a deception that the naproxens cardioprotective effects were to blame for the apparent increase in cardiac issues (Cote, 2021). Merck may have decided to use defective methodology slanted toward preset outcomes to inflate the drugs beneficial effects to contribute to its eventual approval by the FDA for use as an anti-inflammatory and arthritis treatment. Merck may also have bribed researchers to conceal evidence indicating Vioxx increased patients risk of cardiovascular diseases and bias the researchs conclusions in favor of the drug.

Sponsorship Withdrawal

Mercks decision to stop sponsoring the dissenting researchers was unethical behavior. There was controversy about the medicine for years before Merck finally removed it from shelves due to concerns about cardiovascular risks (Prakash & Valentine, 2007).

Greater openness and regulation are needed in the parameters of the interaction between universities and pharmaceutical firms to foster research and protect the publics health. However, Merck crossed a line by using the universities research money for commercial purposes, leading to debate about the limits of academic integrity and the restrictions placed on what can be published by scientists. Spending lavishly on cultivating experts who would stimulate sales was a terrible strategy, costing Merck dearly (Cote, 2021). Merck offered speaking engagements and financial support for studies to entice the researchers. Instead of pulling funding and threatening educational institutions, the company should have addressed the problems the researchers and academics raised.

Strategies of Merck and Tobacco Companies

What Merck did to influence the Vioxx findings is very similar to what tobacco corporations did in the 1950s to discredit studies that linked smoking and cancer. The tobacco industrys initial tactic was to back and finance studies that would yield positive outcomes. In a similar approach, when researchers and academic institutions expressed any criticism of Vioxx, Merck threatened to cut off funding (Cote, 2021).

The tobacco companies financed the scientific publishing of studies favorable to its interests, including books, scholarly articles, reports, symposium materials, and correspondence to the editors of peer-reviewed journals. When it came to marketing, Merck followed suit, using the same method that mostly used ghostwriting scientific studies. A Merck worker was recognized as the articles primary author in sixteen of the twenty publications written about clinical studies. However, an unaffiliated scholar is deceptively credited as the papers primary author in the published edition.

Conclusion

Vioxx was one of the best-selling painkillers in the world, but Merck pulled it from shelves after studies found it doubled the risk of serious cardiovascular events like stroke and heart attack. Researchers at Merck skewed clinical trial results for the osteoarthritis drug to cover up evidence that it raised patients risk of developing cardiovascular disease. It is not hard to draw parallels between what Merck did to influence the Vioxx findings and what tobacco companies did in the 1950s to discredit research that associated smoking with cancer. Universities and pharmaceutical companies need more transparency and regulation in their interactions so that research can flourish while the publics health is safeguarded.

References

Cote, R. (2021). Ethical perspective: Ethics in the pharmaceutical industry: Vioxx recall. Journal of Leadership, Accountability and Ethics, 18(1), 11-22. Web.

Prakash, S., & Valentine, V. (2007). Timeline: The rise and fall of Vioxx. NPR. Web.

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