The Need to Standardize Ethics
Pfizer Permanente, in the late 1990s tested a medication for meningitis in Africa. Subsequently, court cases were filed by the Nigerian government against Pfizer Permanente. Pfizer was accused of testing a new medication called Trovan, during a 1996 meningitis epidemic. It is believed that the use of this drug caused death and deformities due to side effects. Pfizer denied that it did any wrong and claims it tested the drug in Nigeria as part of a humanitarian effort to assist in the outbreak. This case represents a major problem in which pharmaceutical companies often take advantage of the diverse laws and ethics of different nations to further research while overlooking ethical standards.
Approximately 200 children took part in trials for the new anti-meningitis drug in 1996. Officials in Kano say more than 50 children died in the experiment, while many others developed mental and physical deformities. Plaintiffs claim that Pfizer failed to explain to the children’s parents that the proposed treatment was experimental. They could refuse it, or that other organizations offered more conventional treatments at the same site free of charge. In addition, Plaintiffs assert that half of the children who participated in Pfizer’s treatment program were deliberately given inadequate doses of cetriaxone, a FDA approved drug shown to be effective in treating meningitis, so that Trovan would look more effective by comparison. Pfizer says only 11 of the 200 children in the drug trial died. Pfizer also claims that they explained the study to the families using practices in line with U.S. and international guidelines, even employing Nigerian nurses and doctors who spoke Hausa, a main Nigerian language (BBC, 2007).
This situation led to serious outcomes as many African nations now boycott the testing of drugs in their countries. Unfortunately, not only did people die and become disabled from the Trovan testing, but this case was cited as the reason a polio vaccine was boycotted by residents of Kano in 2003. As a result, polio became a serious outbreak issue in Nigeria and eventually spread to 25 previously polio-free countries.
The serious nature of the Trovan incident reflects the diverse nature of laws and ethics and the need for them to be standardized. Without some form of standardization, the ethics of clinical trials is unknown and this can lead to incidents such as with Trovan where both parties continue to blame one another. On a global scale, this impacts all people because research is halted and new research cannot proceed in a timely fashion. For these reasons, a variety of stakeholders have taken interest into standardizing global clinical trial ethics. These stakeholder include: governments, the Bill and Melinda Gates Foundation, National Institutes of Health, Welcome Trust, and multi-national pharmaceutical companies (Li, Barnes, Aldinger, & Bierer, 2015). While standardization is slow the process has yielded the beginning of standardizing ethics with sets of precepts that can be agreed upon:
(1) scientific or social value;
(2) scientific validity;
(3) fair subject selection;
(4) favorable risk-benefit ratio;
(5) independent review;
(6) informed consent; and
(7) respect for potential and enrolled subjects of multi-regional clinical trials (Li, Barnes, Aldinger, & Bierer, 2015).
Standardizing ethical guidelines creates a blueprint for how clinical trials should be handled. While Pfizer may well have believed that it was acting ethically, there is no way to judge the circumstance due to a lack of standard ethical procedures. As a result of this situation, the case between Nigeria and Pfizer continues to be fought in courts.
Standardizing ethical guidelines creates a blueprint for how clinical trials should be handled. While Pfizer may well have believed that it was acting ethically, there is no way to judge the circumstance due to a lack of standard ethical procedures. As a result of this situation, the case between Nigeria and Pfizer continues to be fought in courts. This litigation has been fought for close to a decade already. Besides eliminating costly litigation, standardization of ethics in clinical trials would also save pharmaceutical companies billions of dollars in cost by increasing the efficiency of the clinical trial process (Conroy, McIntyre, Choonara, & Stephenson, 2000). Continued efforts to standardize clinical trial practices and ethics is necessary.
BBC. (2007, June 26). Pfizer wins early Nigeria battle.
Conroy, S., McIntyre, J., Choonara, I., & Stephenson, T. (2000). Drug trials in children: problems and the way forward. British Journal of Clinical Pharmocology, 49 (2), 93=97.
Li, R., Barnes, M., Aldinger, C. E., & Bierer, B. E. (2015). Global Clinical Trials: Ethics, Harmonization and Commitments to Transparency. Retrieved from Harvard Public Health Review
Vitiello, B., & Jensen, P. (1997). Medication development and testing in children and adolescents. Current problems, future directions. General Psychiatry , 54 (9), 871–876.
Triola Vincent. Thu, Mar 18, 2021. Pfizer & the Testing of Trovan in Nigeria Retrieved from https://vincenttriola.com/blogs/ten-years-of-academic-writing/pfizer-the-testing-of-trovan-in-nigeria