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A Right to Experimental Drugs: An Ethical Perspective

A Right to Experimental Drugs: An Ethical Perspective

The debate in healthcare ethics about patient access to pre-approved drugs has grown increasingly complex. While the FDA has developed strict clinical trial processes for ensuring the safety and efficacy of drugs, there is considerable debate about the need to expand access to treatments that show promise but have not yet received full approval (Munson, 2014). This paper addresses the use of preapproved drugs for more patient populations, focusing on areas such as the protection of human subjects through informed consent, implications of costs, and issues relating to individual freedoms and public interest: A Right to Experimental Drugs: An Ethical Perspective.

Relevant Ethical Theories and Moral Principles

The ethical issue of access to pre-approved drugs requires several foundational ethical theories and moral principles. Autonomy thus grants the patient permission to make decisions regarding treatment; however, beneficence and non-maleficence maximize benefit while limiting harm from the perspective of healthcare providers (Varkey, 2021). Justice demands the fair distribution of healthcare resources, a consideration particularly relevant when considering expanded access programs. These are principles that need balancing carefully in consideration for wider access to pre-approved drugs, which have shown safety and efficacy in clinical trials but for which final approval has not yet been granted.

The Principle of Informed Consent

A special case for informed consent pertains to access to pre-approved drugs. In addition to the elements of consent, there are several important matters that a patient needs to understand: First, an explanation of the difference between standard approved treatments and pre-approved drugs, which, though showing promise through clinical trials, have yet to receive final approval. Second, the specific evidence regarding safety and efficacy from the existing trial data.

Thirdly, there are possible risks of getting treated outside the controlled clinical trial environment. The financial aspect involves possible out-of-pocket costs because usually insurance doesn’t cover pre-approved treatments (Pietrzykowski & Smilowska, 2021).

The informed consent process must also cover the psychological underpinnings associated with the management of hope and expectation. Healthcare providers must clearly communicate that while the preapproved drugs demonstrated promise in trials, individual responses may vary. This expanded understanding of informed consent helps protect both patient autonomy and welfare while maintaining integrity in the drug approval process.

Costs and Benefits Analysis

Supplying patients with unapproved experimental drugs is a sensitive balance of potential benefits and costs. The primary benefit is providing terminally ill patients with access to potentially life-saving treatment when all licensed options have been exhausted. Access is a manifestation of patient autonomy and a source of hope when conventional medicine cannot help. A small number of patients can be provided with therapeutic benefits that would otherwise be denied to them.

However, there are large costs to consider. First, the safety profile of unapproved experimental drugs is not well understood, risking the exposure of vulnerable patients to serious side effects or accelerated deterioration. Second, treatments are often out-of-pocket since insurance infrequently covers experimental treatments, introducing financial hardship and access disparities. Third, widespread compassionate use can discourage clinical trial participation, ultimately slowing down drug approval for everyone.

Scientifically, uncontrolled use generates anecdotal and unreliable data, which can mislead the medical community about efficacy. It becomes increasingly expensive for drug firms to maintain parallel access programs in addition to full-scale trials. There is also the emotional cost of heightened and potentially unsubstantiated hope that must be balanced because the vast majority of experimental drugs ultimately fail to demonstrate themselves effective in completed trials (Mahant, 2020).

This creates an ethical dilemma between the individual patient needs and the collective public health interest in maintaining strict drug approval protocols. Ultimately, finding a middle ground that respects patient rights while maintaining rigorous drug approval processes is essential for the advancement of medical science and patient care.

Arguments for and Against Wider Access

The arguments for wider access, regarding pre-approved drugs specifically, as distinct from experimental drugs, are centered on the fact that such treatments have already made demonstrations of safety and efficacy in clinical trials, though they await final approval. Advocates note that it is ethically unjustifiable to withhold promising treatments that have passed initial safety trials from seriously ill patients (Mahant, 2020). Cancer patients can, for example, hope for pre-approved immunotherapies that were tested with positive results in Phase III trials when other standard treatments have been exhausted.

However, counter-arguments are against the disruptions this might create for clinical trials and developing two-tier medicine that allows the rich to be first in line while the rest wait for full approval. Concerns are also raised regarding how such a model would impact the drug approval process integrity, which is based on controlled clinical trials necessary for reliable data about safety and efficacy.

Conclusion

While the moral call to action in patients’ needs cannot be more imperative, access to pre-approved drugs has to be tempered by solid safeguards and transparent guidelines. This solution probably involves forming structured expanded access programs that would protect the integrity of clinical trials while affording opportunities for judiciously selected patients to try promising treatments. These would include full informed consent processes, transparent financial disclosure, and provisions that guarantee equal access regardless of social status. Individual patient needs must be weighed against the greater public health interest in the maintenance of rigorous drug approval processes.

References

Mahant, V. (2020). “Right-to-Try” experimental drugs: an overview. Journal of Translational Medicine, 18(1). https://doi.org/10.1186/s12967-020-02427-4

Munson, R. (2014). Intervention and Reflection: Basic Issues in Bioethics, (concise ed.). Wadsworth Publishing Co Inc.

Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials, 22(1), 1–8. https://doi.org/10.1186/s13063-020-04969-w

Varkey, B. (2021). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30(1), 17–28. https://doi.org/10.1159/000509119

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Question

Assessment 2: A 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.

      A Right to Experimental Drugs: An Ethical Perspective

      A Right to Experimental Drugs: An Ethical Perspective

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