Ethical Issue

Topics: Ethics, Clinical trial, Pharmaceutical industry Pages: 5 (1621 words) Published: May 18, 2013
Ethical Issue in Business – Pfizer, Examined
Staci Holt
Cassandra Giles
Sunday, August 1, 2010

Ethical Issue in Business - Pfizer, Examined
Pfizer, Inc (Pfizer hereafter) is an international pharmaceutical firm with $45.2 billion in profits in previous years and has an estimated allotment for research and development around $7.9 billion (Pagnattaro, 2005). Currently involved in a legal battle originating from allegations that the company unethically pursued clinical trials in an impoverished nation, which resulted in the death of 11 Nigerian children as well as causing deafness, blindness, and paralysis in many other children puts Pfizer under a microscope of ethical scrutiny. The purpose of this paper is to examine the issues behind the ethics of the clinical trial in Nigeria including what caused the deficiencies in ethical standards, what were the ethical decision-making systems in place at the time of the issue and what roles did management and executives have in the situation. A proposal of a plan on how to avoid the same ethical dilemma from happening again, incorporating both a perspective and psychological approach, becomes the final focus of this paper. The Ethical Issue Defined

Obtaining Food and Drug Administration (FDA) approval for clinical trials in the United States has many stages and costs pharmaceutical companies millions. Reproducing a drug is a relatively low-cost undertaking after establishment in the mainstream market, but to develop a new drug can cost as much as $500 million (Pagnattaro, 2005). “Pfizer’s testing took place in 1996, when an epidemic of bacterial meningitis, measles, and cholera occurred in Kano, an impoverished Nigerian city,” (Pagnattaro, 2005, p. 171). The issue has many ethical sub-issues in the situation in which Pfizer conducted a clinical trial in Nigeria that would never meet approval in America, some of which include the following: * The control group received an established drug but at a lower-dosage level than was the standard prescription. * Pfizer sought consent from parents of the children participants even though the parents did not read English, understand the potential risks involve, or that they could even deny participation, and the non-test subjects received a different drug altogether from Doctors Without Borders as approved by the World Health Organization (Pagnattaro, 2005). * No dissemination of information about a previous animal trial of Trovan™ suggesting high-risk side effects if given to children occurred. * Practitioners and trial administrators for Pfizer failed to use standard protocols of following up with test subjects to ensure they were not acquiring side effects to the trial drugs. * Pfizer allegedly forged documents giving them approval by the Nigerian government and the Nigerian medical ethics committees after the children died, nearly a year after the trial administration. At the time, the trial was taking place the Nigerian medical ethics committee did not yet exist. Examination of Pfizer Organizational Role

Pfizer’s two primary ethical systems used to justify the Nigerian drug trial were consequentialism (goal-based) and entitlement-based approaches. They viewed the choice to justify using an experimental drug in an under-developed country because it would help them save lives in the long as well as speeding up the process of gaining market approval and mass access to the drug, which is goal-based theorem. The entitlement-based system result in their belief that they did not have to follow proper protocols and international guidelines because they were a powerful pharmaceutical company and this was a rural foreign area with high death rates from the diseases they were testing against, regardless to Pfizer’s involvement. Therefore, the organization believed they right was to go forward on a risky trial despite other repercussions. Unfortunately, for the organization, it seems most of the...

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Pagnattaro, M. (2005). International Legal and Ethical Considerations at Pfizer, Inc. Journal of Legal Studies Education, 22(2), 169-197. doi:10.1111/j.1744-1722.2005.00017.x
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