PHI FPX 3200 Assessment 2 A Right To Experimental Drugs

Capella University

PHI-FPX 3200

Prof Name

November 2024

A Right to Experimental Drugs

The right to experimental drugs raises the debate on the welfare side: compassion for fatally ill patients versus stringent rules against drug approval (Palazzani & Daverio, 2021). Advocates argue that access to unapproved drugs ensures patient autonomy and offers some hope when conventional treatments fail, where questions of moral obligation have arisen to overcome suffering. Opponents have raised concerns that unproven therapies may pose unknown risks, including unforeseen side effects and a weakening of the clinical trials that serve as crucial determinants of long-term safety and efficacy. Properly balancing these interests will depend on careful attention to important ethical considerations-in this case, beneficence, non-maleficence, and justice.

Ethical Theories and Moral Principles

Philosophical theories and moral principles in healthcare present basic frameworks for looking into current issues  (Voisard & Ivo Wallimann-Helmer, 2023). Among the most relevant ethical theories is utilitarianism, the theory that aims to maximize overall happiness or to minimize harm. In healthcare, the related application of this theory would be seen in decisions based on resource allocation or experimental drug access. For example, providing experimental drugs to terminally ill patients without other hope of relief might be performed utilitarily if it will alleviate suffering or extend life, despite the risks. But utilitarianism also demands attention to effects beyond consequences: in this case, how access might interfere with clinical trials or steal resources from better treatments.

The final important ethical perspective is one of deontology, which focuses on duties or rules rather than results  (Soto-Pérez et al., 2021). This considers patient rights and self-determination to be supreme, where people have the moral right to decide on their care with full knowledge. For instance, deontologically, one may not be allowed to deny a terminally ill patient drugs used in experiments, despite their dubious performance for use on him/her. The issue of justice also arises, in which fairness and equity are emphasized. This principle ensures that experimental drug policies are ethically and qualitatively applied discrimination based on class or geography to prevent their inequitable administration.

With these theories merged into the principles of, most importantly, beneficence, which is promoting well-being, and non-maleficence, avoiding harm, healthcare providers can navigate the fairly complex moral landscape of today’s issues. The frameworks merge individual patient needs with some societal goals, bringing ethical decisions into a comprehensive and equitable outcome.

Principle of Informed Consent

The principle of informed consent is crucial in ethical decision-making in healthcare, especially concerning drugs that are considered experiments and clinical trials  (Pietrzykowski & Smilowska, 2021). Informed consent ensures patients understand the risks, the benefits, and the alternatives relative to treatment or procedure. It keeps autonomy alive by allowing individuals to have a say over their care without coercion or misinformation. For instance, in the case of access to unapproved drugs, patients should be informed that such treatments may not have evidence regarding their safety or efficacy and hence could pose extensive risks. The process of obtaining informed consent must be coupled with clear communication and consideration of the patient’s capacity to understand complex medical information.

This principle assumes that patients are rational agents who can weigh out risks and benefits in making decisions in their best interest (Birchley, 2021). However, the situation becomes complicated when desperate circumstances such as those created by terminal illnesses direct decision-making. That is when decisions may not necessarily be well-informed and voluntary because of what a person undergoes mentally. Not all patients also have equal opportunities and connections to comprehensive medical information and support systems. Language and health literacy or system inequities can undermine the process of informed consent. Healthcare providers have to make extra efforts in these areas.

Assumptilability of unapproved experimental drugs has costs and benefits that need to be weighed (Dahlén et al., 2022). First, access to these drugs may offer hope and possibly lifesaving therapy to those patients who have run out of standard treatments. This aspect is more aligned with the principle of beneficence because it aims to relieve the person of pain and potentially improve their quality of life. Moreover, providing access to experimental drugs can create useful real-life information that may enrich the existing clinical studies. Furthermore, it is in accord with the idea of autonomy, enabling patients to make an informed decision regarding their treatment at a time when nothing else is available for them to try.

Still, there are considerable risks associated with drugs that have not been approved, namely unknown side effects, inefficacy, or even the possibility of aggravating the patient’s condition (Mogale et al., 2024). Widespread access could also compromise the integrity of clinical trials by lowering the number of participants critical research findings will be delayed. Equity is another issue, as access would markedly benefit those with greater wallets or health access further exacerbating disparities. Balancing these considerations requires a fair and all-inclusive analysis to safeguard public health, respect patient rights, and advance medical research.

Pre-approved Drug Usage for a Wider Patient Pool

Proponents of pre-approved drugs for larger patient groups argue that they may offer life-saving opportunities in the absence of any other alternatives. Programs through expanded access can give patients who are terminally ill a chance to take part in experiments that might prolong their lifespan or alleviate symptoms (Rizk et al., 2021). This approach also follows ethical considerations such as beneficence, because it will enhance the well-being of the patients; meanwhile, with autonomy, it allows individuals to make informed decisions regarding their care. Meanwhile, these programs also provide real-world safety and efficacy data that are valuable additions to the results of controlled clinical trials. Advocates frequently cite striking instances in which access to these treatments has dramatically improved health outcomes.

On the other hand, critics caution that making experimental drugs widely available may undermine clinical trials. Bypassing clinical trials to access experimental drugs means that fewer patients may participate in the study, weakening the reliability of the outcomes and the lengthening time it takes for the drugs to be approved for general use. There are also still important unknowns, such as potential toxic effects or long-term risks of these drugs. Questions about equitable access and how to manage these risks remain unanswered. These must be addressed through more research and thoughtful policies to protect both public health and the integrity of clinical trials.

Knowledge Gaps and Missing Information

Indeed, there are knowledge gaps and missing information here when it comes to administering pre-approved drugs to a greater population. For example, the long-term safety and efficacy of these experimental treatments are not established as yet because most clinical trials have not been completed (Haeussler & Assmus, 2021). Moreover, issues on equitable access to these medications also remain, and vulnerable populations would even be doubly burdened when given these medications, worsening health disparities even further. The other very crucial concern revolves around the threatening potential of undermining clinical trial integrity since a smaller pool of participants is likely to drop out of trials to receive early access to these drugs. Addressing these gaps, through targeted research and careful policy-making, may help create a more balanced framework for expanded access programs.

PHI FPX 3200 Assessment 2 Conclusion

The provision of unapproved experimental drugs is, thus, an ethical dilemma that requires much consideration. On one hand, these drugs offer hope to patients who have no other alternatives, hence saving a patient who otherwise stands at a higher risk of their condition or life worsening (Cox, 2023). However, these benefits come with significant risks; on the negative end, the unknown side effects and the aspect of diminishing participant populations in clinical trials. It is a delicate balance between respecting autonomy and safeguarding research integrity. This requires well-structured policies, transparent informed consent processes, and ongoing efforts to fill knowledge gaps. Ultimately, innovation in medicine must proceed without compromising patient safety or the collective welfare of society.

PHI FPX 3200 Assessment 2 References

Birchley, G. (2021). The theorization of “best interests” in bioethical accounts of decision-making. BMC Medical Ethics, 22(1). https://doi.org/10.1186/s12910-021-00636-0