efficacy of new treatments.
Preparation
When a new drug is undergoing clinical trials to be approved for treatment, it must pass through a number of distinct phases of testing. These phases require rigorous study and evidence to demonstrate the safety and efficacy of new treatments. Passing through these phases and achieving approval takes many years for some trials. Before approval, patients not part of a clinical trial have limited or no access to experimental drugs, even though these drugs could be helpful and potentially save their lives. There are various groups pushing for greater patient access to drugs still in the experimental stage. In recent years, the FDA has made it somewhat easier to receive treatment with experimental drugs, but according to advocacy groups there are still too many restrictions (Munson, 2014).
This leads to a potential quandary when early stages of research on a drug sometimes suggest that the drug could be effective in treating a certain disease. On one hand, offering easier access to early stage trial drugs could help individuals suffering with a medical condition. However, on the other hand, making early access to experimental drugs easier could limit the pool of patients available to participate in clinical trials that establish whether or not the drug is truly effective and safe. This is an important consideration, as the vast majority of experimental drugs turn out to be completely ineffective or could have very dangerous side effects that will only show up over time and across a wider test population.
When completing this assessment, it is important to keep in mind the ethical arguments that are relevant to both views regarding the right to experimental drugs. It may be useful to review the suggested resources and conduct additional independent research while you are planning your assessment submission.
Instructions
Do patients with no other treatment options have a moral right to unproven drugs? Write a paper that explains and defends your view on this issue. In addition to reviewing the suggested resources, you are encouraged to locate additional resources in the Capella library, your public library, or authoritative online sites to provide additional support for your viewpoint. Be sure to weave and cite the resources throughout your work. In your paper, address the following points:
Identify relevant ethical theories and moral principles.
Explain how the principle of informed consent is relevant to the issue.
Explain the costs and benefits of making unproven, unapproved experimental drugs widely available to patients. Consider the costs and benefits not only to the individual patients who take these drugs but also potential costs and benefits to other patients.
Explain arguments using examples for and against offering pre-approved drugs to wider pools of patients.
Support your view using ethical theories or moral principles (or both) that you find most relevant to the issue.
Additional Requirements
Written communication: Written communication is free of errors that detract from the overall message.
APA formatting: Resources and citations are formatted according to current APA style and formatting guidelines.
Length: 2–3 typed, double-spaced pages.
Font and font size: Times New Roman, 12 point.
Reference
Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Boston, MA: Wadsworth.
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