Ethical Guidelines in Corporate Practice: A Pfizer Case Study

This report examines the ethical dimensions of corporate practice, focusing on a case study of Pfizer's 1996 drug trials in Kano, Nigeria. The report begins by defining Corporate Social Responsibility (CSR) and its ethical components, particularly in the context of pharmaceutical companies and clinical trials. It poses the research question of whether pharmaceutical companies strictly adhere to ethical guidelines during drug testing and presents the hypothesis that they do not. A literature review explores the context of clinical trials in developing nations, highlighting the potential for exploitation and the influence of marketing ethics theories. The case study details the Pfizer trial, where Trovan was tested on children during a bacterial meningitis epidemic, leading to fatalities and legal challenges. The report reflects on the ethical implications, emphasizing the vulnerability of participants in developing countries and the challenges of accessing advanced drugs. The conclusion supports the hypothesis, asserting that large pharmaceutical companies may not strictly follow ethical guidelines during drug testing. References are provided to support the analysis.

Running head: ETHICAL CORPORATE PRACTICE
ETHICAL CORPORATE PRACTICE
Name of the Student
Name of the University
Author’s Note:

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Introduction:
CSR or Corporate Social Responsibility can be defined as the continuous commitment
shown by the business corporation to the society so that the corporation have an overall
positive impact on the society (Servaes & Tamayo, 2013). In 2010, ISO or International
Organization for Standardization issued a series of voluntary norms to support businesses in
carrying out their corporate social responsibility. ISO 26000 provides guidance instead of
requirements unlike the other ISO standards because CSR is of a qualitative rather than
quantitative nature and its standards cannot be certified (Hahn, 2013). ISO 26000 instead
clarifies the role of social responsibility and enables organisations to translate CSR values
into efficient measures. One of the major parts of the CSR is its ethical aspect. This is
particularly true is case of pharmaceutical company where human clinical trial regarding drug
testing is involved. A very significant element of health care lies in the behaviour of clinical
trials for medicine development and licensing (Hahn, 2013). There can be no overemphasis
on the need for better and safer medicines for tackling current illnesses and tackling fresh and
emerging illnesses. Drug study, growth, and advocacy have become a worldwide company
for millions of dollars. It is anticipated that the worldwide pharmaceutical industry will reach
USD 1 trillion by 2014 and USD 1.3 billion by 2020 (Okonta, 2014). By far, most of these
revenues come from drug companies based in Europe and North America. This income is
governed by a large number (Okonta, 2014). Recently, however, South American and Asian
businesses have gradually increased numbers in pharmaceutical business. This article
examines the ethical questions engaged in clinical studies in specific in the case of Pfizer
(1996) in the Nigerian context.
Research Question:
The research question for this article is:

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“Whether big pharmaceutical company strictly follows ethical guideline during clinical trials
of drug testing?”
Research hypothesis:
The research hypothesis for this article is mentioned below:
H1 = Big pharmaceutical company do not strictly follows ethical guideline during clinical
trials of drug testing.
Literature review:
In the Nigerian context, pharmaceutical and international non-governmental
organizations are generally sponsored by clinical trials (Ewuoso, 2016). Pharmaceutical
companies are corporations and, like all corporations, they are mainly aimed at maximizing
profits and lowering manufacturing costs. Clinical trials are attractive to pharmaceutical
companies based in developed countries in developing nations (Okonta, 2014). There is a big
body of disease in developing nations, and within a brief period of time the necessary amount
of physicians can be hired. The compensation paid to respondents in studies in developing
nations for lost time and salaries is also low compared to the amount payable to respondents
in studies in developed countries, respectively. In developing nations, demands for the
permission of such research are generally much lower than in developed countries (Okonta,
2014).
Marketing ethics theories indicate that people tend to apply guidelines based on
distinct morals if confronted with morally questionable circumstances. Studies show, for
instance, that moral philosophies offer norms for assessing the act, motives of the actor, and
the implications of the act (Al-Khatib et al., 2005). Similarly, their model has always been
based on general marketing theory and on normative moral philosophy. These moral
philosophies may be inherently teleological or deontological. Researchers investigating

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ethical questions in the field of marketing and management have discovered that ethical
judgments between businessmen and people are mediated by their ethical ideology
(Palihawadana, Oghazi & Liu, 2016). Academics have discovered, more idealist and less
relativist, that their less idealistic and relativistic counterparts have demonstrated greater
honesty and integrity. In relation, the high standards of idealism and low dogmatism were
perceived as more significant than their less ideological and more relativistic brethren
by social and ethical responsibility (Al-Khatib et al., 2005).
The overall trend of globalization has been accompanied by clinical research by
scholarly organizations and pharmaceutical companies which has inexorably shifted into low-
and middle-income nations (LMICs). This tendency has posed several issues about the
importance of studies in these nations to public health or whether socially disadvantaged
individuals are being abused for the profit of wealthy patients (Weigmann, 2015). However,
clinical trials and accompanying trials and healthcare can profit patients immediately,
especially those with little or no access to healthcare facilities. For those who conduct the
tests, LMIC has a significant advantage in that patients who are prepared to engage are easily
enrolled, especially if they are poor. Clinical trials are the only way to access medical
attention for many of these patients (Nelson et al., 2015). However, the risk for exploitation is
exactly this unsatisfactory medical requirement. The origin and future globalization of
clinical trials can be attributed to the thalidomide scandal in early 1960s in Germany. It was
then evident that thalidomide, a sedative created by Grünenthal in Germany, caused birth
defects in infants whose mothers used the drug during pregnancy (Weigmann, 2015). Many
kids were born with serious deformations of their extremities.
An important issue is the ethical treatment of respondents in human trials, especially
those in nations where protection is insufficient. Pfizer once set up a health camp in
Kano, Nigeria to provide therapy in its fresh antibiotic Trovan for children affected by a

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bacterial meningitis epidemic. Many patients have been registered uninformed. Patients and
relatives did not know about the proven use of antibiotics by Doctors Without Borders in the
neighbouring medical facility (Yang, Chen & Bennett, 2018). Trovan was subsequently
found to be very likely to cause instant liver failure. The research of 33 fresh goods screened
and approved for use by the FDA in 2011 and 2012 showed that 21 (80 per cent) out of the 26
drugs offer no therapeutic benefit over current medicines and have significant negative
impacts (Yang, Chen & Bennett, 2018). Furthermore, many of these medicines have never
been sold in the host country or marketed at prices that residents cannot afford. In conclusion,
many challenged the validity of overseas testing information. Most overseas surveys are often
unaware of by the FDA and incomplete location and registration data is obtained. Data
received are often submitted in incompatible formats without standard use (Yang, Chen &
Bennett, 2018).
Case Study – Pfizer case, Kano, Nigeria (1996):
In 1996, during an epidemic of bacterial meningitis, Pfizer performed a drug test in
Kano, Nigeria. The business tested Trovan on about 200 kids in that moment. An
experimental antibiotic drug was used. Pfizer was sued at the Federal High Court in Kano in
2001 by the group of Nigerians (Business-humanrights.org, 2019). The plaintiffs claimed
that Pfizer's drug tests were illegal in this situation, Zango. But the complainants chose to
cancel this case after serious delays. The Adamu action in the US included some of the
Zango plaintiffs. The claimants also argue that the drug trial resulted in 11 kids being killed
and many others being seriously injured (Loue, 2013). In November 2002, Pfizer was
brought under a second US lawsuit, Adamu v. Pfizer. These complainants were also
wounded in the Trovan drug trial by a group of Nigerians. Infringements of ATCA and
Connecticut legislation were reported by the Adamu plaintiffs (Business-humanrights.org,
2019). The US Appeals Court overturned in January 2009 the rejection of the case by the

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reduced judges. A split tribunal held that the suspension of non-consensual human medical
experiments is obligatory under international humanitarian law. (The two cases were
merged). The sides announced on 23 February 2011 that a settlement had been achieved in
the proceedings. The settlement conditions are confidential (Business-humanrights.org,
2019).
Reflection on Case study:
Ethical treatment of respondents in human studies is of considerable interest,
especially in nations where protection is insufficient. LMIC patients who have little or no
access to either novel drugs or conventional pharmaceuticals in the United States that are
locally expensive are given the chance of Clinical Tests.8 Higher incidence of certain
illnesses and absence of exposure to prescription drugs make LMIC people ideal, albeit
vulnerable, participants in studies (Weigmann, 2015). This facilitates recruitment, reduces
time, and reduced expenses for the big pool of prospective volunteers, along with reduced
study expenses. Another significant problem continues the availability of the advanced drugs.
Drugs are often far too expensive for LMIC individuals to afford, but that can alter with time.
Everybody was concerned because the drugs were too costly that the HIV studied in LMIC
would not respond to local health requirements (Patel, 2013). The amount for transport
reimbursement and loss of salaries has been a cause of heated discussion in the clinical
studies in developing nations. On one hand, the call for a standardized sum for research
participants engaged in multi- centre global studies in developing and developed nations has
been made.
Conclusion:
Clinical trial conduct is the cornerstone for the growth of fresh disease therapies. It
also plays a key role as a multi-billion dollar company with significant stakeholders include

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pharmaceutical companies, international NGOs, clinical scientists, and human studies. It is
essential to make all actors conscious of the ethical difficulties in clinical trials and of the
ethical benchmarks for the behaviour in Nigeria, particularly in developing nations together
with the ever-growing globalization of studies. However, from the discussion above, the
hypothesis that is presented here can be accepted and it can be said that the ‘Big
pharmaceutical company do not strictly follows ethical guideline during clinical trials of drug
testing’.

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References:
Al-Khatib, J., Rawwas, M. Y., Swaidan, Z., & Rexeisen, R. J. (2005). The ethical challenges
of global business-to-business negotiations: An empirical investigation of developing
countries’ marketing managers. Journal of Marketing Theory and practice, 13(4), 46-
60.
Business-humanrights.org. (2019). Pfizer lawsuit (re Nigeria) | Business & Human Rights
Resource Centre. Retrieved from https://www.business-humanrights.org/en/pfizer-
lawsuit-re-nigeria?page=1
Ewuoso, O. C. (2016). Bioethics education in Nigeria and West Africa: historical beginnings
and impacts. Global Bioethics, 27(2-4), 50-60.
Hahn, R. (2013). ISO 26000 and the standardization of strategic management processes for
sustainability and corporate social responsibility. Business Strategy and the
Environment, 22(7), 442-455.
Loue, S. (2013). Forensic epidemiology in the global context: a case study of Pfizer and the
trovafloxacin trial. In Forensic Epidemiology in the Global Context (pp. 1-18).
Springer, New York, NY.
Nelson, E. C., Eftimovska, E., Lind, C., Hager, A., Wasson, J. H., & Lindblad, S. (2015).
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Palihawadana, D., Oghazi, P., & Liu, Y. (2016). Effects of ethical ideologies and perceptions
of CSR on consumer behavior. Journal of Business Research, 69(11), 4964-4969.

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Patel, V., Belkin, G. S., Chockalingam, A., Cooper, J., Saxena, S., & Unützer, J. (2013).
Grand challenges: integrating mental health services into priority health care
platforms. PloS medicine, 10(5), e1001448.
Servaes, H., & Tamayo, A. (2013). The impact of corporate social responsibility on firm
value: The role of customer awareness. Management science, 59(5), 1045-1061.
Weigmann, K. (2015). The ethics of global clinical trials: In developing countries,
participation in clinical trials is sometimes the only way to access medical treatment.
What should be done to avoid exploitation of disadvantaged populations?. EMBO
reports, 16(5), 566-570.
Yang, Y. T., Chen, B., & Bennett, C. L. (2018). Offshore Pharmaceutical Trials: Evidence,
Economics, and Ethics. Mayo Clinic proceedings. Innovations, quality &
outcomes, 2(3), 226.