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Vioxx Case Study
The ethical case study that I will analyze is Vioxx. In May 1999, Vioxx was
approved by Food and Drugs Administration (FDA) for the treatment of inflammation
and pain. Vioxx is one of the agents commonly referred to as COX-2 inhibitors that
usually impede the production of enzyme cyclooxygenase-2. The major role of Vioxx is
to relieve pain and inflammation, without hampering (inhibiting) COX-1). Its key function
is to protect the lining of the stomach.
The approval of Mercks Vioxx resulted in a fierce competition in the market. This
was because it was going against already established drugs like Celebrex, and other
NSAIDs like Tylenol and Advil that are also pain relievers (DesJardins & McCall 25). In
2000, Merck used $160.8 million dollars in marketing DTC and simultaneously
completed the VIGOR study. A major reason for carrying out this study was to show the
positive side effect of the drug. It indeed had GI effects of Naproxen. The study also
indicated that Myocardial infarction (MI) was five times higher in Vioxx group as
compared with the Naproxen group.
Scientists argued that the increased rates in MI would be explained using
Naproxens cardioprotective effects. Merck carried out as a second study, where Vioxx
was tested against placebo for a treatment. The study showed that there was no
incidence of MI. Nevertheless, there was a recognized relationship between

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Rheumatoid Arthritis and cardiac problems. It was ethically wrong for FDA to let Merck
carry out a second study because it would put the participants at a greater risk
(DesJardins & McCall 27). On April 25th 2000, Merck held a board meeting to talk about
the situation of Vioxx and how to deal with the marketing attempts to move forward. The
outcome of the discussion was that Merck was in agreement with their hypothesis that it
did not lead to an increase in MI, but it is the cardioprotective effects of Naproxen that
resulted in MI events. Furthermore, FDA wrote a letter to Merck in September 2000 with
respect about this hypothesis on MI events indicating that because of lack of evidence,
there was likelihood that Vioxx would have resulted in an increase in MI.
The ethical system that will guide me through this study is the utilitarianism
perspective. Utilitarianism simply refers to providing maximum happiness to the affected
population. With respect to Vioxx case study, the argument of maintaining vioxx in the
market was not only essential, but also imperative (DesJardins & McCall 28).. Patients
with RA undergo pain daily and vioxx offers a superior efficacy profile to assist in
alleviating pain. Additionally, the patients usually have GI side effects that are as severe
as those of ulcers and they need surgical expense procedures. Financially, these
expenses accumulate over time and can lead to increased insurance expenses to the
entire public. For Merck to carry out his studies and in due course remove the product
from the market would not be of great advantage to the public, instead it would result in
a detriment.
Maintaining Vioxx in the market would assist majority of the individuals with RA
because they would get a proper treatment and Merck would continue to get more
sales. If the drug was to be removed from the international market immediately, Merck

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projected to take 2.5 billion dollars to revenue annually. Therefore, to continue to market
Vioxx, Mercks company would grow. Furthermore, HCPs would keep on giving a
greater medication of RA with limited GI events, while increasing their income. This
solution would still create demand and result in a rise in income. It would also increase
the required supply enabling the pharmaceutical industries continue to develop.
Alternative ways would be to give a press release that Merck should accept that
this drug is associated with some risk and they are working with stakeholders to issue a
Vioxx therapy to reduce the risk. Additionally, they would have included information in
their package that indicates that Vioxx is contraindicated in patients with high MI risk
(DesJardins & McCall 32). This would mean extra work and education for salespersons
to pass information with regard to patient profiles with HCPs and would reduce the
probable income since some patients would not continue using Vioxx. However, it would
be of great benefit to the affected patients in this scenario.
From a utilitarian perspective, Merck is supposed to carry on with marketing
Vioxx because this drug benefits individuals who can take it and be relieved of their pain
from this drug with less GI events. This would also make Merck Vioxx team remain
employed, and would continue to generate revenue that would be of great benefit to the
pharmaceutical industry, company, and stakeholders. Although there would be some
damage to individual with high risks of MI, but in terms of happiness by those affected
by this scenario, this would accomplish a utilitarian solution. On the other hand,
although MI was only caused in a small number of patients, who were previously at a
high risk, the outcome can be serious death. Studies indicate that the benefit to most of
those affected is possibly more than those who would be at risk for MI. The expenses

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that would have been incurred if Merck carried out an incremental study to pay attention
to the safety of Vioxx would be very costly and it would make Merck remove the drug
from the market. This would result in a huge hit to their net income, and it would put at
risk jobs of those individuals who worked on the drug. It is also costly to treat an MI
patient as compared with the costs incurred to switch therapy or test for the Mi risk.
Basing on the utilitarianism perspective, Merck and his company made the right
decision to continue marketing Vioxx as a pain reliever. This is because there are many
individuals suffering from pain and inflammation and they require this drug in order to
live happily. Additionally, the production of the drug is supposed to continue because if
Mercks company is closed, most individuals will lose their jobs and this would make
them happy.
Ethically, every person has rights and they should be treated with respect and
dignity. There are various types of rights for instance derivative and basic rights. I think
the Vioxx study did not make the right decision because it violated the basic right to life
of an individual. This is because for individuals who were at higher risks of cardiac
events, Vioxx increased their likelihood of presenting with death or MI. Even though it
was just a small number of patients, it would still have a negative effect on individuals
and their families. Merck did not adhere to the warning letter that he received from FDA
and his failure to abide by this letter led to death of several patients. From an individual
perspective, Merck would have removed the drug in the market to eliminate the risk to
any patients who would possibly be affected by the drug. This would treat every patient
with dignity and respect, showing the value of their life and health. This would however
lead to significant results to Mercks and his team. The workers who were employed on

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the Vioxx account would become unemployed. The bottom line of Merck would highly
suffer because it would lead to a decline in the value of the company for stakeholders.
Alternatively, Mercks team would have invested its time and money in educating
the sales persons to cooperate with HCPs to screen for MI risk before proving a
prescription for Vioxx. This would have shown some level of dignity and respect for
individuals who use this drug as well as HCPS who prescribe it.
One of the main characters in this case study is Merck. The ethical system that
guided him was utilitarianism. Mercks objective was to make his patients happy by
giving them a drug that would assist in relieving pain. He was not bothered about the
side effects this drug had on patients after carrying out several studies. Additionally, he
wanted to make himself happy and this would be through making sales that would
enable him generate revenue. Another character is FDA. Ethically, it was concerned
with the safety of patients and this was because it did not want their personal rights to
be violated. Having understood that Vioxx was not safe for human consumption, it
decided to write a warning letter to Mercks and his company with regard to marketing
the drug. This was because it needed to maintain the reputation of the pharmaceutical
industry.
I think FDA made the right decision to write a warning letter to Merck about the
production of the drug. It was ethically wrong for him to continue marketing a drug that
had devastating effects on the life and health of the patients. With respect to the
utilitarianism perspective, it was wrong for FDA to argue that Mercks would stop
producing the drug. Utilitarian is focused on making individuals attain maximum
happiness (Federal Food, Drug, and Cosmetic Act 1). Lack of the drug would make

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patients suffering from inflammation and pain unhappy because they would not be in a
position to relieve their pain. On the other hand, I think FDA did not take the right steps
to back up the warning letter. This is because it is charged with the responsibility of
protecting public health by making sure that drugs, food, biologics, and medical services
are safe. Although it wrote a warning letter to Merck, it did not take any action to ensure
that the drug is pulled out of the market because it was not safe for human
consumption. In order to ensure safety of drugs in the public, it would have made sure
that Vioxx no longer exists in the market.
As a professional ethicist, I would recommend Merck to carry on with the
marketing of the drug, but on condition that he revises the package insert for individuals
to understand the high risk as a contraindication. Additionally, I would issue a press
release to inform the whole public of the situation and advise them that Merck and his
company are dedicated to ensuring the safety of all individuals. This would not only give
good reputation to Mercks company, but it would also build trust with the stakeholders,
patients, and HCPs. Although this would result in a decrease in revenue for a short
period, both the public and the company would benefit in the end.
In terms of the Vioxx therapy, I would recommend that suitable patients would be
in a position to continue the Vioxx therapy, getting a better relief for their RA that has
little to no GI effects. This would not have violated the rights of patients at high risk
because they would not be appropriate for Vioxx therapy. The Merck Vioxx staff would
continue to have job opportunities through marketing the drug, and Vioxx Company
would continue to generate income. The reputation of Mercks company would be
valued and its staff would remain happy. This would be of great benefit to all major

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stakeholders and most significantly, and it would be a morally and ethically acceptable
response to a warning letter that Merck received from FDA (Federal Food, Drug, and
Cosmetic Act 1).
There are various lessons that I have learned from this study. Firstly, systematic
bias can make it difficult to understand the response to ethical dilemmas and make a
project take a wrong direction. In this case study the sunk cost bias made Mercks
company to take a wrong path.
Another lesson can be related to what psychologist refers to as conservatism bias. This
is a scenario where individuals assume new information (Karha and Eric 1). They are
not willing to revise their previous beliefs based on new information that they receive
and more so if the information would significantly change their opinions. In this case
study, patients were informed about the side effects of Vioxx, but they were not willing to
change their views because initially they were of the opinion that it was a strong pain
reliever (Karha and Eric 1)
I have also learned that patients should consider using gastroprotective
medications like proton pump inhibitors, simply because they do not hamper with
NSAID actions. If there is proof of potential harm, t should be dealt with aggressively. If
not already carried out, extra clinical trials should be done with immediate effect. In this
case Vioxx was found out to be harmful for human consumption and it is now out of the
market.
It is significant to learn about the risks that are associated with a particular drug
before approval. In Vioxx case study, if the risks of vioxx would have been identifies

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earlier then it would not have been approved. FDA should carry out a thorough
investigation on a drug before it is allowed in the market (Karha and Eric 1)
There is need for government agencies, academic medicine, and medical journal
s to come together and outline a set of principles through which patients can have trust
in new treatments that can have a positive impacts on patient care.
There is need for FDA and drug companies to have a higher burden of proof in
the near future as they assess the cardiovascular safety of medications that have an
impact on platelet physiology.

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Works Cited
DesJardins, Joseph & McCall, John. Contemporary Issues in Business Ethics , 2005 (5 th
ed.). Belmont, CA: Wadsworth, Cengage Learning.
Federal Food, Drug, and Cosmetic Act (FD&C Act) (2010). Retrieved from:
http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmetic
actfdca ct/default.htm.
Karha, Juhana, and Eric J Topol. 'The Sad Story Of Vioxx, And What We Should Learn
From It'. Cleveland Clinic Journal of Medicine 71.12 (2004): 933--939. Print.
Steinzor, Rena, and Margaret Clune. The Hidden Lesson of the Vioxx Fiasco: Reviving
A Hollow FDA. 1st ed. 2005. Web. 27 Apr. 2014.