Vioxx Recall

KOLEJ TEKNOLOGI YPC-iTWEB

Merck, the FDA, and the Vioxx Recall
Coursework 1

Business and Society
YPCBM4005B
Miss Rozlina binti Mat Shadid

Student ID
Name
B124001
Ahmad Wahab bin Muklis

LJMU ID: 639986
Table of Contents

1.0 Introduction
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 of cardiovascular risks inherent in Vioxx. Then, they considering to reformulate Vioxx by adding an agent to prevent blood clots (in the meantime, might reduce cardiovascular risk), but somehow, they dropped the project.
Analyzing from the situation above, clearly that Merck have not acted ethical and socially responsible in the Vioxx’s development and testing. Why? Here are the reasons. At first, if Merck already knew about Vioxx’s dangers and defects, especially in the development phase, they should never ever try to even put the drug in the market for prescription. Instead, they should finance and urge their research or scientist team to try reformulating the drug so that the harmful side effects can be removed, or at the very least, minimized. As for the results of VIGOR; where Vioxx was already there in the market, they should not denied whatever test or research that have been made and was proven to be true. Alternatively, Merck should have taken the drug off the market right then and explored other options to improve the drug.
2.2 Marketing and advertising
As a fact, the advertising technique used by Merck and other drug companies at that time was Direct-to-Consumer (DTC). Granted by the FDA in 1997, this technique allows companies to directly advertise their prescriptions to respective target customers. To seize the opportunities, Merck then employed tens of thousands of sales representatives; mostly attractive young men and women. These people will then go to promote the drugs; often around the doctors’ offices where they will talk about the drugs and give out free sample.
Aside of that, Merck also snatch the occasion by placing numerous ads on television, magazines and newspapers. One example of famous ad for Vioxx will be the ad featuring Olympic figure skating champion, Dorothy Hamill. In the ad, she slither elegantly across an outdoor ice rink, and later telling the commercial viewers that she would not let arthritis stop her.
By all means, Merck did not act in an ethical manner in this term too. Why? Firstly, it does not communicate the full aspects of the products well enough; no message regarding the safety precaution. This is illustrated in the Dorothy’s commercial, where the ad did not convey their message strong enough about it safety. It is afraid might exposed patients to prescribe without having knowledge about the medicines, whether it is safe or not. Thus, what Merck could do differently is that, they should disseminate the full features about the drug, especially if the drug does inherent some risk in prescribing it. In addition; they can also convey the message simply by labeling or tag the bottle of the drug with some safety and precaution measures.
In terms of DTC advertising, they should not put pressures on the doctors, because this might forced these doctors to recommend drugs that might not suitable for the patients. One way to deal with this approach is to forbid companies from giving gift or other forms of briberies in attempt to persuade doctors to bring their drugs to the attention of patients; since this is what Merck do behind the door.
2.3 Relationships with government regulators and policymakers
Back in the United States, the main body that regulate and conduct clinical trials to measure the safety and effectiveness’s of a drug before it can be sold to the public was the Food and Drug Administration (FDA). To relate with this context, one of the reason why Merck became the leader in pharmaceutical industries is because it’s strong influence “at the top”. By lobbying, Merck and other drug companies consistently donate large sums of money to political parties, and this benefits them in terms of influence they had over some superiors, even at the FDA.
The unethical actions of Merck were demonstrated during the “one-by-one” discovery of Vioxx’s bad side effects; where Merck keeps ignore the findings over and over again with various excuses. It is undisputable that such actions might be simply because those influences they thought they had over the regulators. If analyzed carefully, their actions in handling the controversy might be influenced by the notion of “bribe” they have done over the past years; where they donate money to political parties. Thus, the act of so-called “donation” should be prohibited (fortunately, it was banned in 2003).
2.4 Handling of the recall
Though Merck consistently irresponsible socially and ethically in the way they dealt with the Vioxx situation, the handling of Vioxx recall from the pharmaceutical market seems to be managed appropriately and in a professional manner by Merck. On September 30, 2004, Vioxx was officially withdrawn from market associated with Merck press conference. In addition, Merck also revealed that the Vioxx issue was being investigated by the US Justice Department, the Securities Exchange Commission and the US Congress.
In this context, the only thing that Merck should have done differently is that whenever they found out any risk associated with their drugs, they shouldn’t wait any longer, even for one week, to withdraw their drugs out of the market.

3.0 Rate of stakeholders
In this section, the focus will be converged on the best ways to protect consumers of prescription medicines. This section also will outline what are the specific roles of stakeholders available in assuring the safety and effectiveness of prescription medicines. And by the term ‘stakeholders available’, explanation of the roles will be viewed from four perspectives of pharmaceutical companies, government regulators and policymakers, patients and their physicians and the court system.
3.1 Pharmaceutical companies
Not just Merck, other pharmaceutical companies also should realize that they have a huge responsibility to ensure the safety of their respective customers, so that it can benefits themselves in return. As for Merck, who having “try to never to forget that medicine is for the people, not for the profits” as their touchstone of core values, they should have been a better pharmaceutical companies in protecting their consumers. How?
There are various ways to do so. First and foremost, and the most basic one is to remember the idea that medicines is for people, not for the profit. As long as they put people first, it is possible that customers will keep their loyalty with the company. Aside of that, companies also should realize that they are accountable to conduct more research and testing on their drugs before it can be placed in a market; so that nothing bad happened to their customers in the future. In addition, if their drugs do possess some risks in consuming it, at least put some warning or safety labels so that patients aware of that risk before prescribing it.
3.2 Government regulators and policymakers
This might be harsh, but the fact that all the problems occurred in the case of Merck and Vioxx are not just because of them alone, but the FDA too. If FDA pays more attention, awareness and inspect on the safety of Vioxx more rigorously, Vioxx may not be in the market at all, and thus might save people’s life.
As a lesson, the following recommendations might help government to not let the same thing happened. First, drug-area regulators should ensure all new drugs that are going to be released to the public have been tested long enough and proven to be safe. In addition, all government regulators and policymakers in the field of pharmaceutical industries also should bear in mind that they have a huge responsibility in protecting the public against any harmful and risky drugs, so that they will not go easy on the companies that do not abide the law.
3.3 Patients and their physicians
Aside of government and pharmaceutical companies, consumers also should know their responsibility in protecting themselves against various harmful and risks associated with prescription medicines.
One way to ensure the effectiveness and safety of a drug before prescribes it, is by looking for extra information about the prescription medicines. Consumers can do that by asking for opinion from their physicians and other experts, or even by accessing Internet. This way, patients will have the knowledge whether the drugs is harmful or not.
On the other hand, physicians should be more aware against any types of bribes and kept in mind to avoid it no matter what, and be more honest to their patients to guide them about the safety of prescription medicines.
3.4 The court system
To protect consumers of prescription medicines, what the court system can do is to be more strict in the jurisdiction against any company that do not abide the law in assuring the safety of drugs, and zero tolerance with those who attempt to involve in briberies.

4.0 Suggestion for Improvements
Prior to this case study, it can be said that the main reasons why there are so many risky and harmful drugs in market are because the pressures put on the FDA to approve new drugs faster by consumers and drug companies alike. This led the FDA to sometimes overlook the risk and safety of certain drugs because of the pressure to meet the demands for these medicines.
In this context, one of the changes that can be made is the FDA should extend the time of approval of new drugs so that any necessary research can be made. This thus led to a better knowledge about the safety of the drugs before it can be sold into a market. Aside of that, DTC advertising system also need to be monitored continuously so that any acts of bribe such as gift, donation, etc. can be avoided. Lastly, it is suggested that all present system that regulates the law and policy of pharmaceutical industries to put some restrictions and even punishment for those companies that simply do not comply with the standards set.
5.0 Conclusion
Through the case study, it can be said that Merck was indeed a successful company in their time. Although their low-point period was kept “in the eye of the storm” more than whatever success, honors, and recognition they did achieved before, Merck should be more appreciated for whatever great things that they have done in the past years. If only Merck do patience a little bit and not to rush with the introduction of Vioxx; instead they spent a longer time in minimizing the risks inherent in Vioxx to a much more safer, it is possible that Merck might continue to be one of the most successful company in today’s world.
Unfortunately, the past cannot be changed. What was left for Merck now is to build back their image, but it’s all depends on the company itself. Should or shouldn’t they? Of course they should. Everybody deserved a second chance. Yes, Merck did not act socially and in ethical manner before, but if they do get back to do what they were used to do; of course, without all those illegal and immoral behavior, comeback sure to follow.

6.0 References
i. Ali, K.K. et al. (2008) Business Management: A Malaysian Perspective. Selangor: Oxford Fajar ii. Couturier, M. (2008) A Case Study of Vioxx using STAMP. [Online] Available from: http://dspace.mit.edu/bitstream/handle/1721.1/59557/668214373.pdf?sequence=1 (Accessed on 05 Feb 2013) iii. Edward, B. et al. (2010) Blockbuster Disaster. [Online] Available from: https://mytmc.thomasmore.edu (Accessed on 5 February 2013) iv. Ferrel, L. et al. (2011) Business Ethics & Policy: Ethical Decision Making & Cases. Asia ed. Singapore: Cengage Learning.
v. Lawrence, A. T. & Weber, J. (2011) Business & Society: Stakeholders, Ethics, Public Policy.13th edition. New York: McGraw-Hill. vi. Martinez, B. (2004), "Vioxx lawsuits may focus on FDA warning in 2001" The Wall Street Journal, Issues (October), p. B1. vii. Simmons, J. and Stipp, D. (2004), "Will Merck survive Vioxx?” Fortune Magazine, Issues (Nov), pp. 90-104. viii. Steiner, J. F. & Steiner, G. A. (2012) Business, Government, and Society: A Managerial Perspective, Text & Cases. 13th ed. New York: McGraw-Hill. ix. Shaw, W. H. & Barry, V. (2010) Moral Issues in Business. 11th ed. United States: Wadsworth Cengage Learning.
x. Hawthorne, F. () The Merck Druggernaut: The Inside Story of Pharmaceutical Giant. Available from: http://www.amazon.com/Merck-Druggernaut-Inside-Story-Pharmaceutical/dp/0471679062 (Accessed on 5 February 2013).
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References: i. Ali, K.K. et al. (2008) Business Management: A Malaysian Perspective. Selangor: Oxford Fajar ii iii. Edward, B. et al. (2010) Blockbuster Disaster. [Online] Available from: https://mytmc.thomasmore.edu (Accessed on 5 February 2013) iv v. Lawrence, A. T. & Weber, J. (2011) Business & Society: Stakeholders, Ethics, Public Policy.13th edition. New York: McGraw-Hill. vi. Martinez, B. (2004), "Vioxx lawsuits may focus on FDA warning in 2001" The Wall Street Journal, Issues (October), p. B1. vii. Simmons, J. and Stipp, D. (2004), "Will Merck survive Vioxx?” Fortune Magazine, Issues (Nov), pp. 90-104. viii. Steiner, J. F. & Steiner, G. A. (2012) Business, Government, and Society: A Managerial Perspective, Text & Cases. 13th ed. New York: McGraw-Hill. ix. Shaw, W. H. & Barry, V. (2010) Moral Issues in Business. 11th ed. United States: Wadsworth Cengage Learning. x. Hawthorne, F. () The Merck Druggernaut: The Inside Story of Pharmaceutical Giant. Available from: http://www.amazon.com/Merck-Druggernaut-Inside-Story-Pharmaceutical/dp/0471679062 (Accessed on 5 February 2013).