A right to Experimental Drugs?

By successfully completing this assignment, you will demonstrate your proficiency in the following course competencies and assignment criteria:

Competency 1: Articulate ethical issues in health care.

Explain how the principle of informed consent is relevant to these issues. Explain the costs and benefits of offering unapproved experimental drugs to patients.

Identify relevant ethical theories and moral principles.

Articulate arguments using examples for and against offering pre-approved drugs to wider pools of patients.

Competency 5: Communicate in a manner that is scholarly, professional, and respectful of the diversity, dignity, and integrity of others and is consistent with health care professionals.

Exhibit proficiency in clear and effective academic writing skills.

In Chapter 2 of your course text, you learned about the rigorous process of clinical trials that tests new drugs before being approved for treatment. The process, which involves three distinct phases of testing, takes a great deal of time, with some trials lasting many years. 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. The “Case Presentation” on pages 67–68 discusses the Abigail Alliance, one of the 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 such as the Abigail Alliance, there are still too many restrictions. As the text explains, defenders of the FDA policy point out that making unproven, experimental drugs widely available to patients has a consequence—a pool of fewer patients available to participate in clinical trials that establish whether or not the drug is truly effective and safe.

Early stages of research on a drug sometimes suggest that the drug could be effective in treating a certain disease. But without going through the full clinical trial process, doctors do not know if the drug is effective at all. The vast majority of experimental drugs turn out to be completely ineffective, and the drug might have very dangerous side effects.

Assignment Description

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 your textbook, 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.

Submission Requirements

Your paper should meet the following 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.

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