Ethical Dilemmas In A Clinical Study

The purpose of this paper is to examine the ethical questions related to the rights of terminally ill patients to receive experimental medications by participating in clinical trials which they were not pre-selected for entrance into the study. I will attempt to evaluate the implications from a rights and utilitarian perspective, whilst examining these issues from a multitude of different stakeholders’ perspectives. The ethical questions posed by this case were ultimately brought in front of United States courts, in which adjudications were made on the pertinent facts that will therefore impact future decisions made with similar cases in regards to individual rights, regulatory agencies and the data integrity of clinical trials. Abigail Burroughs was a young woman who was diagnosed with head and neck cancer and became terminally ill. She was nearing the end of available treatments, when her family found out about several investigational medications that were in the midst of clinical trials, specifically, Erbitux. This novel medication, at the time, was available only to pre-selected candidates actively participating in carefully designed clinical trials for colon cancer. The family petitioned for Abigail to be granted access to this medication under the FDA’s “compassionate use exception doctrine,” which can permit access to unapproved medications when; there is no comparable treatment alternative; clinical trials are underway, and formal FDA approval is being sought. The FDA, however, does have the power to deny such a claim if they conclude that there is no scientific basis that …show more content…
As we learned in class, utilitarianism can be defined as the aggregate happiness, which does not concern itself so much with what happens to a given individual except as that might affect the bottom line common