The Right to Experimental Drugs: Ethical Considerations

The debate over whether patients with no other treatment options should have access to unproven, experimental drugs is both complex and ethically charged. While new drugs undergo rigorous clinical trials before approval, these trials can take years, leaving terminally ill patients with limited options. This paper argues that patients who have no other treatment avenues have a moral right to access unproven drugs, provided that informed consent is maintained and the potential benefits justify the risks.

Ethical Theories and Moral Principles

Two ethical theories—utilitarianism and deontology—are central to this debate. Utilitarianism believes that actions are judged in regard to their consequences, ensuring the best for the most number. With this in mind, giving terminally ill patients experimental drugs would have good consequences since the medication sometimes proves good and prolongs life to alleviate suffering. Even if only a small portion benefits from it, the overall utility would support this action (Tseng & Wang, 2021).

Contrary to this, deontology maintains the obligation of health caregivers to conduct their practice professionally, particularly in non-maleficence, that is, not causing harm. Deontologists would argue that administering drugs that have not been proven would amount to a violation of such obligations because such treatments may result in unforeseen evil. However, if there are no alternatives and the patient is fully informed, respect for persons cannot be overridden. The autonomy principle declares a person’s right to choose for themselves in regard to their care, particularly where suffering is extreme. Health professionals respect the dignity of the patient in the cognizance of the decisions made by the latter with independence and accurate information. This is essential in attempting to weigh the ethical dilemma between keeping harm minimal and showing respect for the patient’s autonomy.

Informed Consent

Informed consent plays an important role when there is the involvement of experimental drugs. Informed consent would imply that patients understand the risks, benefits, and uncertainties involved with experimental treatments before consenting to the treatment. The process safeguards patients from making uninformed decisions and being coerced into taking up experimental treatment.

In a scenario where the only hope is an experimental drug, informed consent takes on an even greater level of importance. Patients need to recognize that such treatments can be difficult: side and other effects might be unknown, or the treatment might not work. On the other hand, informed consent might also be a source of power for patients in their decisions about treatment possibilities, even under conditions of uncertainty (Pietrzykowski & Smilowska, 2021). When patients are well-informed, they can balance the potential benefits of treatment against the risks and make decisions consonant with their values.

Costs and Benefits of Offering Unproven Drugs

Offering unproven experimental drugs presents both costs and benefits, not only to the individual patients but also to the broader medical community. For individual patients, the potential benefits are significant, including access to a treatment that could extend life or alleviate suffering when no other options remain. In cases of terminal illness, the chance for even a modest improvement can offer hope. Additionally, for the medical community, early use of experimental drugs can provide valuable data, potentially accelerating the development of new treatments.

However, the costs are also considerable. The main concern for patients is the possible lack of efficacy or adverse effects of the drugs. Unproven treatments can have unintended side effects or possibly worsen the patient’s condition (Borysowski & Górski, 2020). Further, the availability of experimental drugs may make fewer patients come forward to be part of controlled clinical trials, slowing down the overall approval process. This may delay the discovery of drugs that can benefit more people or, worse, lead to the discovery of drugs that benefit no one at all.

Arguments for and Against Offering Pre-Approved Drugs

There are strong arguments for making experimental drugs available to patients with no other options. The Right to Try Act adopted in the United States provides approval for the theory that patients should be able to choose to try out an experimental drug. This act is grounded on the principle of benignity, which states that patients should be given any opportunity that might be devoid of a clinical trial (Manley et al., 2022).

However, there are also arguments against such access. Critics point to the principle of non-maleficence and state that using unproven treatments may be less effective but certainly cannot be helpful. In addition, providing these drugs is potentially dangerous to recreation. Their usage may decrease the number of patients willing to participate in clinical trials, which may slow down the development of treatment for patients in the future.

Conclusion

In conclusion, patients with no other treatment options should have a moral right to receive unproven drugs if they understand the risks involved and the benefits to be accrued outweigh the consequences. Applying all four principles of ethical decision-making, especially the principles of autonomy, the principles of utilitarianism, and the principle of non-maleficence, brings the best of both worlds in trying to offer hope to a patient who has virtually no hope of survival.

References

Borysowski, J., & Górski, A. (2020). Ethics framework for treatment use of investigational drugs. BMC Medical Ethics, 21(1). https://doi.org/10.1186/s12910-020-00560-9

Manley, H., Sisk, B. A., Master, Z., & Scott, C. T. (2022). Prescribing unproven cancer drugs: Physician perspectives on expanded access and right to try. Journal of Law and the Biosciences, 9(2). https://doi.org/10.1093/jlb/lsac031

Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension—systematic review. Trials, 22(1). https://link.springer.com/article/10.1186/s13063-020-04969-w

Tseng, P.-E., & Wang, Y.-H. (2021). Deontological or utilitarian? An eternal ethical dilemma in outbreak. International Journal of Environmental Research and Public Health, 18(16), 1–13. https://doi.org/10.3390/ijerph18168565

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Assessment 2 Instructions: The Right to experimental drugs

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.

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.

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.

The Right to Experimental Drugs: Ethical Considerations

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.