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

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Name

Capella University

PHI FPX 3200 Ethics in Health Care

Prof. Name

Date

A Right to Experimental Drugs

The discourse surrounding the right to experimental drugs is contentious, evoking impassioned arguments from both proponents and critics. Advocates assert that granting access to experimental treatments offers hope and potential recovery for patients who have exhausted conventional options. Conversely, critics express concerns regarding the safety, efficacy, and ethical implications of utilizing unproven treatments lacking full establishment (Bunnik, 2019). A thorough examination of the risks and benefits of experimental drugs is imperative in this discourse. Informed consent emerges as a pivotal consideration, necessitating that patients grasp the potential risks, benefits, and uncertainties associated with such treatments. Regulatory bodies like the Federal Drug Administration (FDA) assume a critical role in evaluating the safety and efficacy of treatments (FDA, 2019). Proponents argue that excessive caution may impede access to life-saving drugs, while critics contend that stringent regulatory processes are indispensable for ensuring patient safety. The issue of the right to experimental drugs is intricate, demanding meticulous scrutiny and discussion of the ethical dimensions involved.

Ethical Theories and Moral Principles

Ethical theories and moral principles are indispensable in guiding decision-making and addressing healthcare dilemmas. Key ethical theories, including utilitarianism, deontological ethics, and virtue ethics, alongside moral principles like autonomy, beneficence, non-maleficence, and justice, shape ethical considerations in healthcare (Mathúna et al., 2020; Vearrier & Henderson, 2021). These frameworks underpin responses to contemporary healthcare challenges, encompassing issues such as medical confidentiality, informed consent, end-of-life care, and the utilization of experimental drugs. For instance, in the context of offering experimental drugs, utilitarianism may weigh the potential benefits against harms, while deontological ethics may emphasize duties to protect patients and respect autonomy (Tseng & Wang, 2021). Virtue ethics may prioritize the cultivation of compassionate decision-making. A comprehensive ethical approach to healthcare mandates the integration of these ethical theories and moral principles in decision-making processes.

Principle of Informed Consent

Informed consent assumes paramount importance in the realm of experimental drugs, given their status of ongoing testing and lack of general approval. Informed consent entails fully apprising patients or research participants about the potential risks and benefits of medical treatments or research studies prior to their involvement (Dankar et al., 2019). In the context of experimental drugs, informed consent is particularly crucial as participants assume heightened risks compared to approved treatments. Participants in clinical trials must be adequately informed about the drug’s nature, potential benefits, risks, including side effects, and alternative treatments. Moreover, ensuring participants’ cognitive comprehension of presented information and their voluntary, uncoerced participation is imperative (Varkey, 2021). In essence, informed consent safeguards respect for patient autonomy and facilitates informed decision-making in medical research.

Assumptions

Informed consent in experimental drug trials rests upon several key assumptions, including respect for patient autonomy, comprehensive information disclosure, patient comprehension, voluntary participation, and ongoing consent. These assumptions uphold the principles of respect and dignity for patients, ensuring their ability to make informed choices regarding their health.

Costs and Benefits of Unapproved Experimental Drugs

The debate surrounding the provision of unapproved experimental drugs to patients is multifaceted, with valid arguments on both sides. Proponents assert that such provision offers potential life-saving treatment options, fosters innovation, and accelerates access to critical therapies (Feustel et al., 2019). However, the endeavor entails inherent risks. Unapproved drugs lack rigorous testing and may harbor unknown, potentially harmful side effects. Furthermore, their efficacy remains unproven, posing risks of ineffective treatment. Ethical concerns regarding risk-benefit assessment and informed consent underscore the complexity of this issue (Madeddu et al., 2021). Stakeholders must navigate these complexities judiciously, balancing potential benefits against risks to patient safety and ensuring compliance with ethical standards.

Pre-approved Drug Usage for a Wider Patient Pool

Expanding the use of pre-approved drugs to a broader patient population elicits divergent perspectives. Proponents argue that such expansion could enhance patient outcomes and widen treatment access, potentially reducing healthcare burdens (White, 2022). Conversely, opponents caution against over-medication and emphasize the necessity of tailoring treatments to individual patient needs (Heydari et al., 2020). Ethical considerations regarding patient autonomy and the obligation to prioritize patient welfare underscore the importance of a balanced approach to this practice (Borysowski & Górski, 2019).

Knowledge Gaps and Missing Information

Addressing knowledge gaps and missing information is essential for advancing understanding and decision-making regarding the use of unapproved drugs. Research is needed to elucidate the safety, efficacy, and ethical implications of extending pre-approved drugs’ usage. Moreover, comprehensive exploration of long-term effects, ethical considerations, and patient populations at heightened risk is imperative (Cohen et al., 2020). Gathering robust data and conducting further research are indispensable for informed decision-making in this domain.

Conclusion

In conclusion, the issue of the right to experimental drugs necessitates nuanced examination of ethical considerations and moral principles. While experimental drugs may offer potential benefits, their utilization entails significant risks and ethical dilemmas. Striking a balance between potential benefits and patient safety is imperative, with regulatory oversight playing a pivotal role in ensuring adherence to ethical standards. Ultimately, decisions regarding experimental drugs should prioritize patient welfare, guided by comprehensive risk-benefit assessments and ethical frameworks.

References

Amrutkar, S. S., Patil, S. B., & Mundada, A. S. (2022). Abbreviated new drug submission approval process: An overview. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 174113432211460. https://doi.org/10.1177/17411343221146094

Bendicksen, L., Kesselheim, A. S., & Rome, B. N. (2022). The vexing voyage of vasopressin. Chest, 162(2), 433–435. https://doi.org/10.1016/j.chest.2022.02.048

Borysowski, J., & Górski, A. (2019). Compassionate use of unauthorized drugs: Legal regulations and ethical challenges. European Journal of Internal Medicine, 65, 12–16. https://doi.org/10.1016/j.ejim.2019.04.008

Bunnik, E. M., & Aarts, N. (2019). What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands. BMC Medical Ethics, 20(1). https://doi.org/10.1186/s12910-019-0420-8

Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2020). Five unapproved drugs found in cognitive enhancement supplements. Neurology: Clinical Practice. https://doi.org/10.1212/CPJ.0000000000000960

Dankar, F. K., Gergely, M., & Dankar, S. K. (2019). Informed consent in biomedical research. Computational and Structural Biotechnology Journal, 17, 463–474. https://doi.org/10.1016/j.csbj.2019.03.010

FDA. (2019). Drugs. Fda.gov. https://www.fda.gov/drugs

Feustel, A. C., MacPherson, A., Fergusson, D. A., Kieburtz, K., & Kimmelman, J. (2019). Risks and benefits of unapproved disease-modifying treatments for neurodegenerative disease. Neurology, 94(1), e1–e14. https://doi.org/10.1212/wnl.0000000000008699

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Heydari, M., Mehraeen, M., & Joulaei, H. (2020). Overmedication and waste of resources in physicians’ prescriptions: A cross-sectional study in southwestern Iran. Shiraz E-Medical Journal, 21(9). https://doi.org/10.5812/semj.97662

Madeddu, C., Neri, M., Sanna, E., Oppi, S., & Macciò, A. (2021). Experimental drugs for chemotherapy- and cancer-related anemia. Journal of Experimental Pharmacology, Volume 13, 593–611. https://doi.org/10.2147/jep.s262349

Nandifa, V. N. P., Jena, Y., & Joewana, S. (2020). Beneficence is the highest moral imperative of a doctor dealing with the poor quality of patient autonomy. Jurnal Pendidikan Kedokteran Indonesia: The Indonesian Journal of Medical Education, 9(1), 44. https://doi.org/10.22146/jpki.44511

O’Mathúna, D. P., Escartín, C. P., Roche, P., & Marlowe, J. (2020). Engaging citizen translators in disasters. Translation and Interpreting Studies. https://doi.org/10.1075/tis.20003.oma

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PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

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), 8565. https://doi.org/10.3390/ijerph18168565

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

Vearrier, L., & Henderson, C. M. (2021). Utilitarian principlism as a framework for crisis healthcare ethics. HEC Forum, 33(1), 45–60. https://doi.org/10.1007/s10730-020-09431-7

White, C. M. (2022). Continued risk of dietary supplements adulterated with approved and unapproved drugs: Assessment of the US food and drug administration’s tainted supplements database 2007 through 2021. The Journal of Clinical Pharmacology, 62(8), 928–934. https://doi.org/10.1002/jcph.2046

 

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