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Testing
Describe one ethical issue surrounding the Uniform Care Requirement, which requires that all participants of clinical research across the world should receive the same treatment that they would in a Developed country. Disease transcends culture. Health care workers have an obligation to promote health, and to refrain from interventions that are unethical. Any impediment to people receiving HIV / AIDS medications can be deemed unethical, but using human beings as guinea pigs is surely unethical. When good clinical practices (GCPs), including adequate human subject protection (HSP), are used, clinical trials are efficacious (FDA, 2014). This means that even in third world countries, clinical trials are necessary to all but those who believe that residents of developing nations are not fully human and do not therefore deserve the same ethical considerations as wealthy people.
The Uniform Care Requirement has been proposed as a "minimum ethical standard" but profit-driven researchers claim it may conflict with other ethical standards in making HIV / AIDS medications available to more people in the developing world (Killen, Grady, Folkers & Fauci, 2002, p. 201). According to the Uniform Care Requirement, all participants should receive equal treatment regardless of their geographic location. Opposing the Uniform Care Requirement seems appalingly unethical. For one, there is no ethical reason why studies conducted in the developing world should not conform to the same ethical standards they must follow in the United States. Killen, Grady, Folkers & Fauci (2002) claim that the Uniform Care Requirement decreases the likelihood that all studies conducted will be relevant to the target population due to constraints in methodologies. Yet that is simply not true. Creating relevant studies for a target population does not mean sacrificing ethics in research methodology.
2. Is this Clinical Trial necessary to furthering the treatment of disease in third world countries?
3. Search the FDA's website for a recent drug that was approved after clinical trial. Give name, how long it took for the drug to be approved, the manufacturer. Also summarize the results of trial and target population?
The FDA recently approved Akynzeo (netupitant and palonosetron) to treat symptoms of nausea and vomiting in patients undergoing chemotherapy (FDA, 2014). Japanese firm Eisai manufacturers the drug. One of the components of Akynzeo had already been approved in 2008. The new drug, Netupitant, plus…
References
Dreaper, J. (2012). Concern at outsourced clinical trials in developing world. BBC News. Retrieved online: http://www.bbc.com/news/health-20468396
FDA (2014). Retrieved online: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/
Killen, J., Grady, C., Folkers, G.K. & Fauci, A.S. (2002). Ethics of clinical research in the developing world. Nature Reviews 2.
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