Case Study on Drug Testing in Nigeria

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Drug Testing in Nigeria

Table of Contents
Ethical Dilemma4-5
Situational Analysis5-6
Stakeholder Analysis6-7
Analysis Based on Ethical Theories7-8
Conclusion and Recommendations8-9

Drug Testing in Nigeria
‘What if a drug company experimenting on critically ill children does not get the proper Parental consent, 11 of those children die and a whistleblower is fired?’ (Perlroth. 2008) This paper will discuss the issues caused by the actions taken by Pfizer Pharmaceutical Company. First, we will discuss the ethical dilemmas caused by the testing and identify the factors related to individuals involved; companies and managerial practices and policies, as well as factors that helped create the ethical dilemma. Then we will identify the stakeholders and discuss how the factors that cause the dilemma affect them. Third, we will analyze the ethical dilemma based on ethical theories. Finally, the paper will conclude with analyzing whether Pfizer took the right action and if not what action should have been taken. Background

A group of Nigerian families has taken legal action against the pharmaceutical company, Pfizer. The lawsuit, which was filed in a US court, claims that the families' children were entered into a trial of Pfizer's Trovan (trovafioxacin) for bacterial meningitis in 1996 without informed consent. The families accuse the US-based drug company of violating "international law, federal regulations, and medical ethics, in its zeal to carry out its test" (Ahmad, 2001). According to the Trovan Fact Sheet 1996 marked the beginning of the most serious meningitis epidemic ever recorded in Nigeria. The epidemic took almost 12,000 lives over a six-month period, affected close to 110,000 people, and constituted a severe public health crisis for the government of Nigeria. Amongst all recorded cases, the fatality rate was as high as 20% in the first weeks, and eventually decreased to 10.7%. There were hundreds of children brought to hospitals in the city of Kano on a daily basis. The Leading physician of Pfizer thought this epidemic presented a unique opportunity to test Trovan pills on children. Most of the patience in Nigeria was very sick, had no other medication and Trovan had a good chance of saving their lives (Spar and Day, 2006, p. 2) The Nuremberg Code of 1946 was the first international document to give guidance on the ethics of medical experimentation on human subjects. One of its core principles was that “medical research involving human subjects is only justified if there is a reasonable likelihood that the population in which the research is carried out stand to benefit from the results of the research” (HHS, 2001). According to the Trovan Fact Sheet Pfizer obtained all required approval from federal and state government in Nigeria prior to conducting the Trovan study in Kano. Pfizer has at least 12 letters with dialogue between the company and Nigeria’s Ministry of Health and Ministry of Finance as well as the U.S. Food and Drug Administration, discussing and approving the study. Ethical Dilemma

Pfizer faced the ethical dilemma of whether to stay out of Kano or to run the clinical trials, because of the chaos of the meningitis outbreak the integrity of the clinical trial could not be guaranteed (Spar and Day, 2006, p. 11). Several things caused Pfizer this dilemma. On one hand, they had to decide whether the trial was worth the risks involved. Risks such as conducting a clinical trial in the conditions of Kano as the condition of the facilities could undermine any valid medical research and the effort required to start a trial could take away resources from the sick. Then they had to decide whether they wanted to personally-conduct the trials or outsource it. They also had to obtain permission from a hospital ethics committee and complete the trial at a cost less than what they invested. There was also the risk of...
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