Capella University
PHI-FPX3200: Ethics in Health Care
Dr. Kim Carter-Cram
August 14, 2023
A Right to Experimental Drugs?
The development of new drugs is necessary to enable people cope with complex conditions. The various phases of testing characterized by rigorous study and evidence demonstrate researchers and manufacturers commitment to launching efficient and effective drugs. The FDA’s move to make experimental drugs accessible to patients is among the issues surrounding the need to help patients suffering with a medical condition to recover faster. However, questions over the efficacy and safety of such drugs undermines approval of the medications for use under special circumstances.
Ethical Theories and Moral Principles
Using experimental drugs raises questions about their safety and efficacy. Considering the arguments against and narrative supporting the move helps make informed conclusions on viability and sustainability of the interventions. Notably, healthcare professionals have a duty to protect life and alleviate suffering. The responsibility requires healthcare providers to consider using experimental drugs to maintain patient-centered care (Edlin, 2018). The moral principles of beneficence, autonomy, and justice explain the need for access to experimental drugs. Justice enables healthcare providers to provide fair and transparent services.
The fact that terminally ill patients may not participate in clinical trials for experimental drugs undermines the principle of justice. The beneficence aspect requires healthcare providers to ensure that interventions produce benefits and save the lives of vulnerable patients (Edlin, 2018). However, the fact that most experimental drugs turn out to be ineffective with harmful side effects discourages the use of such interventions. Further, administration of the drugs requires patients’ informed consent. Compassion health care practice makes it necessary for providers to explain the relevance of experimental drugs to enable individuals to make objective decisions to use the medications to improve their health.
The Principle of Informed Consent
Informed consent includes comparing experimental drugs with current standard treatment and their implications on patients’ health and well-being. The concept entails providing patients with accurate and complete information to allow for objective decisions about participation in treatment. Informed consent entails describing a proposed intervention, acknowledging patients’ roles in decision-making, and describing alternative solutions (Millum & Bromwich, 2020). The concept also requires healthcare professionals to discuss risks to ensure that the patient makes the right decision. Concerns over adverse outcomes and overestimation of the benefits of experimental drugs call for healthcare professionals to provide accurate and adequate descriptions of the intervention (Millum & Bromwich, 2020). Ideally, patients should understand the nature of drugs, their purpose, and alternative options available to increase confidence in using experimental drugs. The shared-decision making process portrays efforts to provide services that match patients’ values and preferences.
Costs and Benefits of Unapproved Experimental Drugs
Vulnerable patients with multiple complications could utilize experimental drugs to improve quality of life. A benefit of the process is that it allows patients to avoid the time-consuming FDA approval process. The trials and testing processes reveal the thoroughness of the development framework and emphasis on patients’ safety (Mahant, 2020). Further, the voluntary aspect also allows patients to make independent decisions on using experimental drugs. However, it is necessary to complete the trial process to ascertain the advantages and disadvantages of experimental drugs. The goal is to eliminate concerns about the efficacy and safety of the drugs by assuring patients about the conclusive nature of the experimental process (Mahant, 2020). Further, the risk of driving patients away from clinical trials undermine the relevance of experimental drugs in responding to the needs and expectations of terminally ill patients. The emphasis on trial population jeopardizes the need to ensure that more people benefit from the intervention.
Conclusion
Generating new knowledge about diseases and developing new drugs and treatments create opportunities for terminally ill patients to reduce morbidity and mortality risks. The rigorous study and evidence to ascertain the safety and efficacy of new drugs provide insights into the safety of experimental interventions. However, healthcare providers should consider the principles of beneficence, autonomy, justice, and informed consent to ascertain the safety and effectiveness of experimental drugs and treatments in reducing morbidity and mortality risks.
References
Edlin, M. (2018). Right to try pros and cons. Medical Economics, 28(6), 1-68. https://www.managedhealthcareexecutive.com/view/aduhelm-great-expectations-fizzle
Mahant, V. (2020). “Right-to-Try” experimental drugs: an overview. Journal of Translational Medicine, 18(253), 1-5. https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-020-02427-4.pdf
Millum, J., & Bromwich, D. (2020). Informed consent: What must be disclosed and what must be understood? The American Journal of Bioethics 21(973), 1-19. https://www.tandfonline.com/doi/abs/10.1080/15265161.2020.1863511