PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

• PHI FPX 3200 Assessment 2: A Right to Experimental Drugs?

A Historical Perspective on Experimental Drugs

Before the 1906 Pure Food and Drug Act, medications were widely marketed with promises of miraculous cures, often without scientific evidence or concern for public safety. This legislation marked a turning point, establishing the Food and Drug Administration (FDA) to protect consumers from mislabeled or unsafe drugs and food. Fast forward to 2018, the Right to Try Act was signed into law (Mahant, 2020). This legislation empowers physicians to prescribe experimental therapies not yet FDA-approved to terminally ill patients. While this offers hope to many, it raises complex ethical questions about informed consent, patient safety, and the balance of benefits and risks.

Explore PHI FPX 3200 Assessment 1 Matrix of Ethical Theories for more information.

Ethical and Moral Principles Surrounding the “Right to Try” Act

Justice and Accessibility

The principle of justice underpins compassionate use programs. These initiatives aim to provide equitable access to experimental drugs for terminally ill patients, especially those excluded from clinical trials due to factors like geography, health status, or trial capacity. PHI FPX 3200 Assessment 2 delves into the ethical considerations of ensuring access to life-saving therapies for all, not just a select few.

Balancing Risks and Benefits

Beneficence, the moral obligation to act for the benefit of others, supports compassionate use. Access to experimental drugs could save or extend lives. However, these therapies come with potential dangers—nearly 25% of drugs used under expanded access programs have yet to receive FDA approval, highlighting these treatments’ uncertain safety and efficacy (Miller et al., 2017).

Autonomy and the Right to Choose

Autonomy is pivotal in this debate. Advocates argue that patients should be free to choose experimental treatments after understanding the potential risks and benefits. However, concerns about coercion arise. Terminally ill patients may feel pressured to consent due to the lack of alternatives, while therapeutic optimism might cloud their judgment, leading them to underestimate risks or overestimate benefits.

Utilitarian Considerations

From a utilitarian perspective, resources directed toward expanded access programs could detract from formal clinical trials, potentially delaying advancements that might benefit a larger population. This ethical dilemma underscores the challenge of balancing individual needs with the greater good.

Informed Consent: The Cornerstone of Ethical Treatment

Informed consent is essential for ethical medical practice. To make sound decisions, patients must understand the purpose, methods, risks, benefits, and alternatives of experimental treatments. However, several barriers complicate this process:

1. Complex Information: Consent documents often include technical and scientific language that can be difficult for patients to understand (Nakada et al., 2019).
2. Patient Competence: Elderly or terminally ill patients may struggle with cognitive challenges that impact their ability to provide informed consent (Kadam, 2017).
3. Coercion and Optimism: The looming threat of death may push patients toward accepting treatments they might otherwise decline. Additionally, therapeutic optimism can lead patients to overlook risks in pursuit of hope (Raus, 2016).

Medical professionals must prioritize clear communication, using simple language to help patients grasp the realities of experimental therapies.

The Pros and Cons of the “Right to Try” Act

Potential Benefits

The Right to Try Act aims to streamline access to experimental therapies, empowering patients and offering hope for improved outcomes. By removing FDA oversight, the legislation expedites access for patients unable to participate in clinical trials due to various factors, such as location or physical condition (Miller et al., 2017). Additionally, patients may receive these treatments closer to home, minimizing travel-related discomfort.

Addressing Concerns

However, critics highlight several drawbacks:

• Safety Risks: Without FDA oversight, patients face heightened risks from untested therapies (Mahant, 2020).
• Financial Burden: Insurance companies often refuse to cover experimental treatments, leaving patients and families with substantial costs.
• Unrealistic Expectations: When therapies fail to meet expectations, patients may lose trust in their healthcare providers or the pharmaceutical industry.
• Lack of Reporting Systems: The absence of structured safety and efficacy reporting mechanisms raises concerns about the impact on public health.

Considering the Patient’s Perspective

Providers must be transparent about experimental treatments’ physical, financial, and emotional implications. While experimental drugs offer hope, the outcome remains uncertain, and patients should fully understand this before deciding.

Conclusion: Weighing the Ethics and Realities

The debate around compassionate use and the Right to Try Act reflects broader societal values about autonomy, equity, and the role of government in healthcare. While arguments against expanded access abound, it is hard to predict how one might feel until faced with a life-or-death situation. For many, these experimental therapies represent the final glimmer of hope—a chance, however slim, to fight for more time.

PHI FPX 3200 Assessment 2 emphasizes the importance of informed decision-making, ethical considerations, and the delicate balance between hope and risk in pursuing experimental drug access.

References

Kadam, R. (2017). Informed consent process: A step further towards making it meaningful! Perspectives in Clinical Research, 8(3), 107–112.
https://doi.org/10.4103/picr.PICR_147_16

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

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(1). https://doi.org/10.1186/s13104-017-2687-5

Nakada, H., Yoshida, S., & Muto, K. (2019). “Tell me what you suggest, and let’s do that, doctor”: Patient deliberation time during informal decision-making in clinical trials. PLOS ONE, 14(1), e0211338. https://doi.org/10.1371/journal.pone.0211338

Raus, K. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17(1). https://doi.org/10.1186/s12910-016-0145-x