NURS-FPX4900 A Right to Experimental Drugs Essay

Write a 2-3 page paper that explains and defends your view on the issue of whether or not patients with no other treatment options have a moral right to unproven drugs. NURS-FPX4900 A Right to Experimental Drugs Essay

Introduction

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.

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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.
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.

Sample Approach – A Right to Experimental Drugs? (NURS-FPX4900 A Right to Experimental Drugs Essay)

Capella University

Introduction

The issue of unrestricted access to unproven, unapproved treatment and drug therapies raises a myriad of legal and ethical dilemmas for medical researchers and health professionals who might decide to make these modalities available to people outside the experimental group. On the one hand, people involved in clinical research have a moral responsibility of improving human health by controlling or eradicating disease. On the other hand, physicians have a legal and ethical duty of ensuring the safety and quality of treatment modalities they provide their patients. this essay examines the ethical dilemma of whether it is right/ethical to offer patients experimental treatment therapies whose safety and efficacy is yet to be established.

Relevant Ethical Theories and Moral Principles Concerning Access to Experimental Drugs

It can be argued that patients with stubborn health conditions that are not responding to approved therapies and drugs have a right to be offered experimental treatment therapies and drugs that may improve their condition. Experimental therapies sometimes show efficacy in managing bothersome symptoms such as pain reduction, albeit on a smaller sample of the population. Autonomy is an ethical principle in health care that allows patients the right to choose their treatment option as long they understand the consequences (Butts, & Rich, 2020). For the medical professional, the moral concept of beneficence requires them to act in ways that are beneficial to the patient. In addition, the principle of justice makes it unfair to deny patients potential interventions that may improve their outcomes. It is commonly argued that denying patients access to experimental treatments is designed to protect them from potential adverse effects. However, every patient has a right to equal access to medical care, and with informed consent, every patient has the power to choose what interventions they are willing to try, even when such interventions are in their clinical trial stages.

The Principle of Informed Consent

Informed consent in healthcare context refers to the principle of seeking permission from clients before introducing a treatment method or before sharing sensitive patient data (Katz, Webb, & Committee on Bioethics, 2016). Within the context of access to experimental drugs, the principle of informed consent requires medical professionals to disclose to the patient that the medical intervention(s) they are recommending is in its trial stages. This principle also applies when medical researchers are recruiting subjects to try novel treatment methods. For informed consent, patients need to be provided with all the facts, implications, and expected outcomes of the clinical trial.

The principle of informed consent stems from patient autonomy in selecting their preferred treatments option. Only patients with a sound mind can be expected to give informed consent, which excludes minors, comatose patients, and people suffering from mental disorders. However, it has been argued that patients whose health has not improved from conventional treatment techniques might give their consent to be put on experimental therapies out of desperation. In such a case, it is recommended that a competent member of their family may give permission to try new therapies on their behalf.

Costs and Benefits of making Unproven Drugs Widely Available

The benefits of allowing all patients access to experimental treatment modalities include the opportunity to bring about equal access to health care since not everyone can be included in clinical trials, neither is it feasible. There is also the chance to improve the health and welling of many people through widespread availability of alternative medical interventions. There is also the possibility of saving people’s lives since there would be no need to wait for a long time.

Early access to experimental drugs can reduce health car costs because drugs will be produced in large-scale even during their clinical trial stage, making then cheaper (Rawlins, 2004). The costs of denying patients access to experimental drugs are increased healthcare costs since most medical insurance plans do not cover experimental therapies, which may further worsen medical conditions and may lead to preventable deaths. NURS-FPX4900 A Right to Experimental Drugs Essay

Arguments for And Against Offering Pre-Approved Drugs to Wider Pools of Patients

Support for adhering to approved drugs comes from the believe that untested drugs could have severe negative effects. Allowing people easy access to experimental medical interventions may potentially expose a large section of the population to a dangerous drug or therapy, with devastating consequences. In addition, it is easier for the FDA to oversea research into new treatment methods if experimental medical procedures must be approved before they are rolled out (Jarow, et al., 2017). Advocates for the relaxation of regulation of experimental drugs content that such new interventions could save many lives. Terminally ill patients do not have the time needed for a new drug to be approved, and relaxing the rules could allow them access to live- saving medical interventions (Klopfenstein, et al., 2015). This view holds that the testing, roll out, and approving of new drugs could be done concurrently.

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Conclusion

Debate still rages regarding the morality and necessity of allowing all patients access to experimental treatment methods, despite the adoption of Expanded Access program of 1987 and the Right to Try Act in 2017, policies which allow patients to seek special permission to take part in drug trials. The ethical principles of autonomy and justice imply that patients should be allowed to make decisions about their treatment, including taking part in experimental therapies. On the opposite side is the issue of patient safety and quality of care, which means that the medical interventions provided must be shown to work and to be safe. However, when we analyze the issue from the perspective of terminally-ill patients, it makes sense, both morally and medically.

References

Butts, J. B., & Rich, K. L. (2020). Nursing ethics: across the curriculum and into practice (5th ed.). Jones & Bartlett Learning.

Jarow, J. P., Lurie, P., Ikenberry, S. C., & Lemery, S. (2017). Overview of FDA’s Expanded Access Program for Investigational Drugs. Therapeutic innovation & regulatory science, 51(2), 177–179. https://doi:10.1177/2168479017694850

Katz, A. L., & Webb, S. A. (2016). Informed Consent in Decision-Making in Pediatric Practice. Pediatrics, 138(2), e20161485. https://doi.org/10.1542/peds.2016-1485

Klopfenstein, M., Van Campen, L. E., & Garnett, T. (2015). Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors. Therapeutic innovation & regulatory science, 49(3), 352–358. https://doi:10.1177/2168479015578154

Rawlins, M. D. (2004). Cutting the cost of drug development? Nature Reviews Drug Discovery, 3(4), 360–364. https://doi.org/10.1038/nrd1347 NURS-FPX4900 A Right to Experimental Drugs Essay