BECG – Assignment 1

MERCK & THE MARKETING OF VIOXX

Section B: Group 10
Sanket Sourav Bal- 19BM63012
Sagar Patel-19BM63032
Kanika Yadav-19BM63048
Dhawal Thacker-19BM63050
Aparna JR-19BM63084
 1. Identify ethical issues created by diverse business situations and relationships and the
level of decision making required to address them

The decisions that Merck made regarding to Vioxx were not ethical because the company knew
beforehand that the drug was not safe before it got approved by the FDA in 1999. Through rigorous
drug testing before approval by the FDA, Merck had already discovered that Vioxx increased the risk
of a heart attack or stroke in 1998. Merck was very well aware of the possible cardiovascular effects
such as congestive heart failure that patients would experience if the drug was released in the market.
Merck’s decisions were not ethical because they did not display utilitarianism ethics.
Utilitarianism is virtue based on utility and that conduct should be directed to the benefit of the
greatest number of people. Merck acted immoral in considering how releasing this drug would
affect the stakeholders which would include Merck, shareholders, users of the product, the public,
and families. Merck acted more on the basis of pure self- interest for the company in gaining profit
than understanding the ethics of consequentialism. The consequentialist approach requires for Merck
to understand the harms and benefits to multiple stakeholders and to come to a decision that is
greater good for the greatest number of people. Merck had several problems since the very beginning
with Vioxx including the trials in arthritis being extremely challenging and having difficulty in requiring
3-year placebo controlled safety studies prior to the drug’s approval.
Merck did not initially act in accordance with virtue ethics either, as virtue ethics requires the
character of integrity of the moral actor and looks to moral communities to help identify ethical issues
and guide ethical action. Towards the end of the drug in September 27, 2004, Merck requested a
meeting to discuss with the FDA to halt the long-term study of Vioxx in patients at increased risk of
colon polyps. Merck informed the FDA it would remove the drug from the market voluntarily. The data
that they presented showed that there was an increased risk in cardiovascular problems and strokes
starting at the eighteen-month time point compared to placebo. This was another indication of a
difference in comparison to the placebo group and it supported the previous signs observed in the
VIGOR trial.
Merck decided that this drug was too much of a risk to patients who use it but the major issue
at hand is that they already knew about all of the problems from the very beginning. The company
understood well the differences that would occur between the actual drug and the placebo during
vigorous testing but they allowed the drug to be placed on the market.

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2. Recognize the role of ethics in the conduct of business, with respect to economic principles
and the law

Like Every other company operating in the capitalist market to maximize the output and hence the
profits, Merck was also on the same path. Despite the side effects that came to limelight in studies
(like instances of cardiovascular problems), the company didn’t halt the production, but instead it
went a step ahead in maximizing the sales and thus spending $500 million on marketing. The only
corrective measure they took was the relabelling of Vioxx citing the side effects. We can here
analyze the economic and lawful considerations for such decisions

From an Economics perspective: This was justified for a firm that operates in a perfectly competitive
market. Some of Merck's patents were due for renewal, the arrival of generic drugs in the market,
aggressive expansion by competitors and mergers going on in the industry are some of the factors
that could cause a dent to the top-line and bottom-line of the company. So from the point of
sustaining the short term profits they continued the sales of Vioxx.
 From a Legal perspective: Nothing is above Law, especially when a company like Merck, which is
operating in a highly regulated industry like pharmaceuticals. The guidelines and the required
compliances of FDA should have been followed by the company. Though this might mean calling off
Vioxx from the market and taking a hit on profits for some time, but anyways the company was in a
position to afford it as it spent vigorously on promotions of the drug. Infact, when the anomalies in
compliances were confirmed and the company was charged with allegations, Merck anyways had to
pay hefty fines with the added intangible loss of reputation

Hence, the conclusion that we can draw is: though profit maximization is one of the prime purpose
of business, it should not come at the cost of unlawful or unethical acts, as it might hamper the
goodwill and reputation in the minds of customer for long which may or may not me mended in
future.
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3. Distinguish between ethical management and the management of ethics, and each of the
three main roles of a manager

A) Ethical management vs management of ethics

Ethical management:

 Ethical management refers to the fundamental principles that should be followed by

corporations.
 People in business face ethical dilemmas in the ordinary course of their work. These
dilemmas sometimes result from misconduct by others, as when a subordinate is ordered to
commit an unethical or illegal act, but they are also inherent in typical business situations.
 It should be complied within the corporation’s relationships with customers, employers,
suppliers and shareholders.
 Ethics are the principles or moral codes that are followed by an individual or by a group of
people.
 It defines the right and wrong conduct. It includes professional ethics, social ethics, personal
ethics, and normative ethics.

Management of ethics:

 Management of ethics states the ethical treatment of the company towards the employees
and stakeholders.
 It includes creating a trustworthy environment, code of conduct and open communication.
 Management ethics protects an individual from the negative consequences of managerial
acts.
 Ethics in management helps to ensure ethical, legal, environmental responsibilities of the
corporations.
 The management of ethics is acting effectively in situations that have an ethical aspect.
These situations occur in both the internal and external environments of a business firm.
Internally, organizations bind members together through myriad rules, procedures, policies,
and values that must be carefully managed. Some of these, such as a policy on conflict of
interest or the values expressed by a company’s mission statement, explicitly involve ethics.
 Effective organizational functioning also depends on gaining the acceptance of the rules,
policies, and other guides, and this acceptance requires a perception of fairness and
commitment.
 In many cases, the underlying principle of a proposed global ethic has been the so-called Golden
Rule, typically articulated in the form, ‘‘Do unto others as you would have others do unto you.’’

In order to practice the management of ethics and ethical management, it is necessary for
managers to possess some specialized knowledge. To make sound ethical decisions and to
implement them in a corporate environment are skills that come with experience and training. Some
managers make mistakes because they fail to see the ethical dimensions of a situation. Other
managers are unable to give proper weight to competing ethical factors or to see other people’s
perspectives. Thus, a manager may settle a controversial question to his or her satisfaction, only to
discover that others still disagree. Moral imagination is often needed to arrive at creative solutions
to problems.

The resolution of a problem usually involves persuading others of the rightness of a position, and so
the ability to explain one’s reasoning is a valuable skill.

 In case of Vioxx, although Merck had a strong core value system centred around courage,
achievement, responsibility, respect, integrity and transparency and the upper management
enunciated on balancing success and responsibility. Yet, despite a strong code of conduct,
the stress given by the former CEO on aggressive marketing and the external pressures from
the expiry of several product patents and the competitive, fast-evolving landscape of the
pharma industry forced the company to underplay the negative effects of the drug on their
labels in order to convince physicians of the effectiveness and safety of the drug. In fact, at
many levels of management, there was a confusion with regards to conclusive evidence of
Vioxx’s side-effects. Although the study, called VIGOR (for Vioxx Gastrointestinal Outcomes
Research), showed that Vioxx users had heart attacks at a rate four to five times that of the
naproxen group, researchers were uncertain whether the difference was due to an adverse
effect of Vioxx in causing heart attacks or a beneficial effect of naproxen in preventing them.

The case here thus depicts the actions of an organisation conflicting with its ethical management,
due to lack of specialized knowledge by several managers and the pressure to launch a successful
drug.

B) Ethics & the 3 roles of a Manager

Managers serve at all levels of an organization—top, middle, and lower—and fulfill a variety of roles.
Usually, these are defined by a job description, such as the role of a purchasing agent or a personnel
director. Uncertainty arises mainly when we ask about the role of top managers, that is, high-level
corporate executives who make key decisions about policy and strategy. The higher one goes in a
business organization, the more roles one occupies. Many of the ethical dilemmas for top managers
are due to conflicts between three main roles.

Many of the ethical dilemmas facing managers involve not merely a conflict between one’s personal
morality and the morality of a role but also a conflict between the moral demands of different roles.
For example, a manager may have to balance fairness to employees or a benefit to the community
against an obligation to act in the best interest of the company. Or a CEO may find that he or she
cannot easily serve both as a company leader and as a community leader when a decision must be
made about a merger that would close a local plant. Some of the hardest dilemmas in business
ethics result from such role conflicts.
 Managers as Economic Factors Managers as Company Managers as Community
Leaders Leaders

 As economic actors, managers  As leaders of business  Top managers of companies

are expected to consider organizations, managers are exert enormous power both
primarily economic factors in entrusted with enormous inside and outside their
making decisions, and the assets and given a charge to organizations.
main measure of success is manage these assets  Although they are not
profitability. prudently. elected in a democratic
 This is the goal of managers  Employees, suppliers, process, they nevertheless
who serve as economic actors customers, investors, and have many attributes of
even if they operate a sole other so-called stakeholders government officials, such
proprietorship, a partnership, have a stake in the success as the power to make
or any other kind of business of a firm, and managers are decisions that profoundly
enterprise. expected to meet all of their impact society.
 However, ethical issues are legitimate expectations and  The CEO of a large
intertwined with business to balance any conflicting corporation also serves as
considerations in decision- interests. an ambassador,
making, and the soundness of  They also must build and representing the company
business decisions often maintain a company’s in its relations with its
depends on the recognition of culture, develop a shared myriad constituencies.
these ethical issues and their purpose and strategic  In any political system, such
appropriate resolution. vision, and meet challenges great power must be
 This requires the ability to to create a strong, enduring legitimized by showing how
solve ethical problems that organization it serves some generally
arise in the course of everyday accepted societal goals
business.  Ex: In case of Merck,  So, top managers are
managers, especially the expected to demonstrate
 Ex: In case of Merck, managers former CEO, gave more corporate leadership that
were driven towards impetus to marketing and serves the interests of
profitability and quick success quick profitability of society as a whole.
of Vioxx and were ready to products, during the course
overlook certain aspects of of which the impetus given  Ex: the top-level managers
ethics o achieve these to ethics became dimmed showed a lapse in their
objectives, partly because they and vague responsibility as community
weren’t convinced of the side- leaders, by underestimating
effects and their severity the importance given to
health and safety of even a
small percent of society

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 4. Analyze how ethical business conduct is challenged by decision making on individual and
organizational levels.

Business ethics act as a guiding principle and help employees to make better decisions.
Trust, Respect, responsibility, care and fairness constitute significant components of ethical
decision making. This increases employee productivity and overall employee morale.

But various factors at individual and organizational level in decision making act as challenges
to ethical business conduct. These are:
• Improper framing
• Cognitive biases
• Psychological tendencies
• Moral rationalizations
• Self-interest

Improper framing takes place when we ignore the ethical implications of the situation, and
instead only recognize the economic and/or legal implications of the situation
Throughout the entire ethical decision‐making process, self‐interest, which is often ignored
in ethical decision‐making research despite its acknowledged importance in influencing
behaviour, should be considered to play an important role as an impediment to ethical
behaviour.
The other individual causes are: Conflict of interests among team members, different
opinions they bring into decision making to interpret situations differently.
The other factors at organizational level are: Lack of knowledge about ethical standards,
awareness of SOPs, fear of criticism and financial incentives

Decision making in organizations is marked by four features that contribute to mistakes, big and
small.

 First, major decisions are not made all at once with all their consequences and ramifications
understood; rather, they are made over time in a series of small steps, no one of which
may raise any particular concerns.
 Second, as they are made over time, these multiple decisions develop a commitment to a
course of action that is usually difficult to stop. Once a project is underway, there may be
considerable sunk costs that cannot be recovered, and anyone who proposes a halt to a
project bears a burden of proof to justify it, whereas little justification is needed to proceed
with a project underway. Stopping a project also means that mistakes were made, which it
may be difficult for managers to admit since someone must bear the blame. With
commitment to a course of action also comes a psychological tendency to interpret evidence
in ways that support one’s beliefs and interests.

 This factor probably goes far toward explaining why, in the development of Vioxx, Merck
executives misinterpreted the results of the VIGOR study and concluded that they were due
to the heart-protection benefit of naproxen and not to any harmful effect from Vioxx.

The third and fourth factors are the most important namely:

 the diffusion of information and

 the fragmentation of responsibility that occurs in organizational decision making
The information that would show that a product has a defect, for example, may exist within an
organization in an unassembled form in which different facts are known to different individuals.
However, unless this information is assembled and made known to at least one person, there
may be no reason for anyone in the organization to conclude that a product is defective.
Furthermore, when information is distributed in organizations on a need-to-know basis, each
decision maker may have sufficient information for the decisions that that person makes but
lack the necessary information for recognizing a defect.

Ex: In case of Merck, when a drug is recalled, it may be that no one is responsible since no one
has failed in discharging his or her responsibility. It is often said that “the buck stops at the top,”
that the CEO or some other senior executive has a responsibility to ensure, in this example, that
a drug is safe, but that person is hostage to a host of decisions made by others that he or she
cannot fully assess. In such cases, only the organization as a whole can be blamed or held
responsible, and the only remedy to prevent a recurrence is to improve the decision-making
process within the organization.