A Right to Experimental Drugs?

Many doctors, nurses, medical technicians, and other health care workers are involved in medical research. The field of medicine is not limited to the direct treatment of patients but also involves the continued expansion of medical research. A large part of such research is clinical research, which puts patients into the role of experimental subjects. This raises a number of challenging questions for health care ethics, many of which follow from the fact that physicians, nurses, and others involved in clinical research have a dual role. As researchers, they are committed to generating new knowledge about diseases, developing new treatments and drug therapies, and, in general, helping to improve the welfare of human beings by eliminating or controlling diseases and increasing longevity. However, researchers involved in clinical research must also be committed to the highest quality care for individual patients taking part in research studies. This assessment explores some of the ethical issues that clinical research raises and some of the safeguards in place to protect the interests of patients involved in research.   

Demonstration of Proficiency

By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment 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.

Competency 2: Apply sound ethical thinking related to a health care issue.

• 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. 

• 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. Refer to Evidence and APA for guidance.
• 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.). Wadsworth.
  Resources
  Research Ethics and Informed Consent
  As we have seen, when it comes to the ethics of medical research using human test subjects, there are a number of moral concerns raised. Researchers must be careful to not only avoid harming patients, but also ensure that study participants have given truly informed consent. Determining precisely what that involves, and whether it has been given in a specific case, can be challenging.
• Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Wadsworth. Available in the courseroom via the VitalSource Bookshelf link.
• Chapter 2, “Research Ethics and Informed Consent,” pages 59–118.

As you read the chapter, consider the following questions (especially as you consider pages 88–90):

• Should Mrs. Wilkins’s consent to participate in a Phase-1 trial be regarded as informed, in your view? Why or why not?

Is Mrs. Wilkins an appropriate candidate for participating in a Phase-1 clinical trial?

How should investigators go about getting people to consent legitimately to Phase-1 trials?

• Miller, J. E., Ross, J. S., Moch, K. I., & Caplan, A. L. (2017). Characterizing expanded access and compassionate use programs for experimental drugs. BMC Research Notes, 10.

This article presents findings related to the characteristics of expanded access and compassionate use programs and the percentage of drugs from said programs that ultimately cleared through the full FDA trials process.

• Raus, K. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17.

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