Clinical trials for drug approval involve several distinct testing phases requiring rigorous study and evidence to demonstrate the safety and efficacy of new treatments. Approval takes many years for some trials. Before approval, patients outside the clinical trial have limited or no access to experimental drugs, even though these drugs could be lifesaving. There are various groups pushing for greater patient access to experimental drugs. In recent years, the FDA has made it somewhat easier to prescribe experimental drugs, but advocacy groups say there are still too many restrictions (Munson, 2014).
This may lead to a quandary when early stages of research suggest that a drug could be effective in treating a certain disease. On one hand, offering easier access to early-stage trial drugs could help patients suffering with a medical condition. But easing access to experimental drugs could decrease available participants for clinical trials that establish whether 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 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 planning your assessment submission.
Do patients without 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 websites 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 to the patients who take these drugs as well as other patients.
Explain arguments using examples in favor of and opposing prescription of trial drugs to wider pools of patients.
Support your view using ethical theories and/or moral principles that you find most relevant to the issue.
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.
Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (Concise ed.). Boston, MA: Wadsworth.
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