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: *
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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 hildren 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 wrongdoings and bad judgments came from executives in the research and development department, and there is some evidence of knowledge at the middle management level in clinical trial units. The executives and middle managers made decisions to administer Trovan™ in Nigeria, to falsify documents and not to follow global standards for clinical drug trials.
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The role of these upper-level employees caused the entire organization to receive a bad reputation as well as a formal government review of their ethical standards in all business operations (Wise, 2001).
Plan for Ethical Issue Resolution Society has a global need and an ethical obligation to protect all persons entering clinical trials regardless of where those trials take place. Perhaps the best way to achieve this would come from reforming the way large transnational businesses conduct themselves in foreign relations.
The creation of an international business community, one in which standardized practices and ethics seek development and companies doing business throughout the world reach accountability for their practices, would make it easier for global companies to uphold the ethical practices. Therefore, firms achieve accountability for their actions as well as making it easier to control the business practices of their worldwide branches (Logsdone & Wood, 2005).
The first step in this process; develop a code of conduct that translates from smaller, local branches to large international branches of an organization with clarity of the character and integrity of the core values expressed by the company (Logsdon & Wood, 2005).
After the development of this code, dissemination of these values and principles must effectively communicate and efficiently demonstrate to all levels of employees what to do when making ethical decisions.
Completing this communication in such a manner that employees are precisely aware of the guidelines within the conduct standards, which these values and principles apply to; and with what expectations for conformance and compliance the corporation deems pertinent (Logsdon & Wood, 2005).
In addition, the company needs to build in to its core values the idea that diversity between cultures showing they value and respect these differences, which taken into account regularly in the business practices of the company will aid in ethical decision-making processes (Logsdon & Wood, 2005).
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Even when the prevalent regulations are permissive or absent, the code must clearly reflect to stakeholders, executives, and employees at all levels that the highest integrity employed must happen in all their business dealings. This is particularly true if these values and principles become the standard for company practices, which will achieve a high transparency with consumers, resulting with an increase in the level of accountability for the company.
The best prescriptive approach to implement the changes in resolving this ethical issue for Pfizer is a deontological approach, which would focus on honesty and fairness of the situation from a virtuous perspective. Whereas, the duty of the clinical researchers derives its merits on the Hippocratic Oath to fully inform the participants (or parents of minors) about the possible side effects of any trial drug clearly to the fullest understanding of the patient. What kind of world would it be if researchers were routinely dishonest? It would be one where we simply could not rely on the integrity of scientific research,” (Trevino & Nelson, 2007, p. 100).
Using duty-based deontology or the Golden Rule, clinical researchers would not want trials conducted on their own children without full disclosure of possible side effects; therefore, they should not conduct experiments without giving full disclosure to patients.
The best psychological approach for this situation comes from the post-conventional level of cognitive moral development. In instituting, a Global Business Community (GBC) stage five of Kohlberg’s moral stages enhances any prescriptive approach by upholding the deontology as a higher order than any social laws (Trevino & Nelson, 2007).
The focus on justice and what is right for all transnational pharmaceutical organizations would apply to the standards, rules, ethics, and values upheld regardless of where the clinical trials take place.
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If a particular location has no regulations on conducting clinical trials, no Internal Review Boards, or oversights on medical research Pfizer would hold them accountable to the standard set forth by the GBC, which would achieve guidelines no less a stringent as they are in the United States trials. Conclusion Many world organizations that have set standards for international clinical trials of new market entry drugs to help ensure all participants, regardless of where they live, receive ethical treatment; but each country has to choose to embrace and enforce these guidelines to obtain maximum protection.
With both a prescriptive and psychological approaches, Pfizer can avoid making the same unethical decisions as they did with this particular situation. This paper thoroughly defined and examined Pfizer ethical dilemma in testing Trovan™ in a foreign country as well as laying out a plan to help avoid committing the same ethical violations in the future. Ultimately, this paper shows that serious ethical breaches occurred during the Nigerian trial of Pfizer’s drug Trovan™ with a better awareness of internal organizational ethical systems, and with a plan for conducting global drug trial this unfortunate situation will never happen again.
