KOLEJ TEKNOLOGI YPC-iTWEB
Merck, the FDA, and the Vioxx Recall
Business and Society
Miss Rozlina binti Mat Shadid
Ahmad Wahab bin Muklis
LJMU ID: 639986
Table of Contents
Merck, one of the world’s leading pharmaceutical markets, had enjoyed a long reputation as one of drug companies that prioritize ‘ethical and socially responsible’ as their company’s main core values. They once had been recognized as “most admired company” for unbelievably seven successive years by Fortune magazine and also persistently listed as one of best companies to work for. With their flawless and honorable reputation, no wonder Merck ranked fourth in sales, fifth in assets and market values, and first in profits; where they earned $7.33 billion in 2005 (Lawrence, 2006). However, no one would have thought that someday, this company’s stability will be in questioned. That’s what happened in 2004. The company’s best-selling prescription painkiller, Vioxx turned out from a “blockbuster drug” to “blockbuster disaster” when it is believed that it increased the risk of heart attacks and strokes. Consequently, Merck had to deal with many challenges; the plunge in the stock’s price, lawsuits, investigations and others. Until, in September 2004, Merck had to pull Vioxx off the market to focus on taking responsibilities for every trouble they have caused. This report will discuss in summary about what had happened; the behavior of Merck towards risk associated with Vioxx, safety measures that should have been taken, the recall of Vioxx and some recommendations; which all will be explained further later on.
2.0 Socially Responsible and Ethical Manner
This section will focus on the action of Merck; whether they have acted ethical and socially responsible with regard to Vioxx, and these actions will be addressed in terms of drug development and testing, marketing and advertising, relationships with government regulators and policy makers, and the handling of the recall. Also, this section will provide a few suggestions; what could or should Merck have done differently, if anything. George W. Merck, the company’s long-time CEO once said that, “We try never to forget that medicine is for the people, not for the profits. As long as we remembered that, the profits will follow; they never fail to appear”. This statement then decided to be set as their priority and guidance for every of their actions. However, did they really have acted ethical and socially responsible towards this value? No, they’re not. Why? 2.1 Drug Development and Testing
Let’s take a look at the situation first. Back in the old days; before the drug was approved, there are some doubt on the safety of prescribing Vioxx. Although it is still in the early stage, research made by Merck scientist suggests that there are high cardiovascular risks associated with the prescription of Vioxx. This was confirmed as stated in an e-mail by Dr. Alise Reicin (one of the Merck scientists), according to The Wall Street Journal. In the e-mail, she expressed her concerns in the possibility of cardiovascular events prior to prescribing Vioxx. She also had planned to communicate those results to her senior management; however, nothing’s happened. In 2000 (when Vioxx already in market), a research financed by Merck was conducted. This study; code-named VIGOR was designed to study gastrointestinal side effects by comparing it with the effects of taking naproxen (Aleve). The results of VIGOR later suggest that although Vioxx are easier on the stomach compared to naproxen, it also contribute to risks of suffering heart-attacks fives time higher. However, they denied the risks inherent in Vioxx by simply stating that the findings were in favor of the heart-protective effect in naproxen. In 9 March 2000, Dr. Edward Scolnick; the company’s research director finally admitted the presence...
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