PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

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Capella University

PHI FPX 3200 Ethics in Health Care

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A Right to Experimental Drugs

Advancements in medical technology continue to save lives, allowing patients to live longer due to research and discoveries that were once unimaginable. New technologies provide patients with options that were not available in the past; however, a recurring question arises: do patients have the right to access experimental drugs before they receive official approval when no other alternatives exist? Are these drugs safe, and what are the potential side effects? Do the benefits outweigh the risks? Are patients adequately informed and providing consent for treatment while fully understanding the associated risks? In today’s world, patients often seek miracles when confronted with terminal conditions, and experimental drugs can sometimes represent that miracle.

Ethical Theories and Moral Principles

Various ethical theories apply to different situations, and in the context of experimental drugs, the relevant ethical frameworks include Ross Ethics, Natural Law Ethics, and Utilitarianism. Ross Ethics posits that there are prima facie obligations or guidelines that should be considered when deciding on the use of experimental drugs for patients with no other options. The decision-making process should be deliberate, with a foundation centered on fidelity, which involves avoiding deception, preventing harm, promoting beneficence by doing good, encouraging self-improvement, ensuring justice, and respecting patients by not imposing treatments upon them. Recognizing the significance of these actions will help ensure that ethical decisions are made regarding experimental drugs. Fidelity in ethics means ensuring that actions do not involve deception or misleading patients to encourage their participation in using the drugs.

Non-injury and harm prevention are the responsibilities of the drug companies to avoid causing unjust or intentional harm to patients. Self-improvement is the goal of experimental drugs, aiming to provide options that enhance the quality of life or prolong the lives of patients who are struggling with their current health conditions. Justice is crucial as it involves presenting options along with the benefits and burdens of the experimental drugs, ensuring that patients receive all relevant information—both positive and negative—so they can make informed decisions about their treatment. Lastly, respect for autonomy emphasizes the importance of avoiding coercion, deception, or manipulation to promote or discourage the use of experimental drugs (Garret, 2004).

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Natural Law suggests that every individual has the right to live their life, and that law and morality are interconnected. Each patient has the right to make decisions about their life, guided by what is considered human nature, which ultimately shapes what is deemed lawful (Deinhammer, 2016). Utilitarianism focuses on actions that promote happiness for the majority, with decisions made for the collective rather than individuals. This approach implies that all individuals will be treated equally, and decisions regarding drugs will apply uniformly to everyone (Duignan, 2017).

The Belmont Report Principles and Guidelines were established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify the fundamental ethical principles that should be adhered to prior to any biomedical and behavioral research. The three core principles are respect, beneficence, and justice. The principle of respect ensures that each patient receives comprehensive information about the research, including its intent, protocol, and a clear informed consent that outlines the associated risks and benefits. The principle of beneficence emphasizes the importance of doing no harm to the patient. The principle of justice ensures that the risks are balanced against the potential benefits (HHS, 2016).

Principles of Informed Consent

The principles of informed consent are ethical obligations that require providers to ensure that each patient is thoroughly educated about the experimental drugs and the associated risks. As patients consider the use of experimental drugs, it is the responsibility of the research committee to provide clear and truthful information that will assist in guiding their decision-making process. A consent form will be presented and signed by the patient, clearly defining all necessary information. The principle of full disclosure mandates that patients are fully informed about their illness and the proposed treatment, including risks, alternative treatments, and potential benefits. Providers must ensure that no pertinent information is omitted and that patients are fully aware of all relevant details regarding the treatment and other available options.

Principles of respect for autonomy involve ensuring that providers recognize each patient’s right to make their own decisions after receiving full disclosure and a clear understanding of their options. Providers must respect the patient’s choice to either proceed with treatment or decline it. This principle also encompasses respecting the decisions of patients, including those who may have a diminished capacity to make choices. The principle of subsidiarity asserts that each patient has the right to be involved in all decisions that affect their care. The principle of integrity of totality requires providers to consider the overall well-being of the patient, taking into account their conscience, will, and intellect (Careertrend, 2019).

Utilizing informed consent for patients offered experimental drugs ensures they have a clear understanding of the available treatments, other options, associated risks, benefits, and a comprehensive understanding of their medical diagnosis. It respects the patient’s self-determination and acknowledges their right to make the best decision for themselves while ensuring that providers fully understand the patient’s needs. Informed consent is essential for helping patients make the most informed choices available to them.

Costs and Benefits of Offering Unapproved Experimental Drugs

The costs and benefits associated with offering unapproved experimental drugs remain a contentious issue. Patients face financial burdens and potential impacts on their quality of life, while drug companies incur costs related to the production of these drugs. When patients have no alternatives other than experimental drugs, these options often come with high financial costs. Even with insurance approval, out-of-pocket expenses can be significant and sometimes unaffordable. Medicare and Medicaid typically do not cover experimental drugs, and manufacturers are not obligated to provide them at no cost due to the high costs of production and research. Generally, it takes 10 to 12 years for a drug to receive approval from the Food and Drug Administration (FDA) before it becomes available on the market, with research and approval costs averaging around $2.87 billion. Consequently, the financial burden on patients can be extremely high (Matthews, 2015).

Only 25 to 30 percent of drugs that enter the experimental phase ultimately reach the market. The drug approval process consists of three phases: Phase One involves human testing to assess safety, dosages, and effectiveness; Phases Two and Three focus on evaluating toxic side effects and overall effectiveness. Currently, 33 U.S. states have enacted laws allowing terminally ill patients to access experimental drugs in early testing stages, as these patients are often willing to try anything to prolong their lives. Patients advocate for their right to be informed and to access experimental drugs, believing they should have the option to try these treatments given their dire circumstances. However, researchers at New York University have found no documented cases of patients successfully using these laws to obtain drugs. Ultimately, the decision to offer the drug lies with the manufacturer, while insurance companies determine whether to cover the costs.

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

The FDA serves as a safeguard for patients, protecting them from physicians and drug companies that might exploit their vulnerabilities, desperation, and fear of dying. Therefore, drugs must undergo a rigorous 10-12 year approval process, which means many patients may not survive long enough to benefit from these treatments. The FDA also ensures that products are produced safely without cutting corners. Additionally, physicians who prescribe these drugs may find themselves in legal predicaments, as they are responsible for patient outcomes, leading to hesitance in offering experimental treatments. If insurance companies deny coverage for these drugs, the financial burden falls on the patient and their families, potentially causing stress and worry, especially if the desired outcomes are not achieved (NPR, 2017).

The ethical question remains: is it beneficial for patients to balance the risks associated with experimental drugs? Considering the financial costs, the potential impact on human life, and the risk of patients being exploited, individuals must weigh whether the potential benefits justify the costs. Delaying treatment could result in loss of life, while proceeding with treatment may also lead to adverse outcomes, including side effects and reduced life expectancy, which could diminish the potential benefits. Quality of life may be compromised in either scenario. However, there is also the possibility that the experimental drug could provide significant benefits. Patients must clearly understand all options through the lens of autonomy, ensuring that they are aware of the potential benefits and risks before making a decision, allowing for clear and rational decision-making.

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

The potential consequences for patients can be severe, impacting their quality of life or even resulting in death. Only 25-30 percent of drugs that undergo clinical trials successfully reach the market, as they often fail to demonstrate benefits that outweigh the associated risks. Some of these risks include serious side effects, which can be permanent or, with some luck, may subside after the trial. These side effects can manifest during the trial or emerge much later. The inherent risks and unknowns necessitate that patients are thoroughly informed about all relevant information before participating in a trial. Knowledge gaps, uncertainties, and missing information can arise when there is insufficient diversity among the volunteers selected for the trial. Even with comprehensive information, there remains the pressure of uncertainty regarding side effects, challenges, and the varying effects of drugs on different individuals. Inadequate information or lack of detail in the trial can lead to misinformation, posing risks to future patients. The support of the FDA is crucial, as it provides guidance and structure for the studies. The FDA oversees clinical trials, ensuring that the process is monitored and supported. Protecting the rights, welfare, and information of patients is essential for maintaining the quality and integrity of the data under review (FDA, 2014).

Conclusion

Ultimately, there are no guarantees regarding treatment outcomes; however, these trials offer hope to patients when other options may be exhausted. The decision rests with the patient, and understanding the reasons for participating in the study adds value to the research. Providing informed consent and allowing patients to make their own decisions enhances the value of both the experimental study and the patient experience.

References

Deinhammer, R. (2016). Can natural law ethics be tenable today? Towards a critical natural law theory. Heythrop Journal, 0018-1196.

Duignan, B., & West, H. R. (2017). Utilitarianism. In Encyclopedia Britannica. Retrieved from https://www.britannica.com/topic/utilitarianism-philosophy

Garret, J. (2004). A simple and usable (although incomplete) ethical theory based on the ethics of W. D. Ross. Retrieved from http://people.wku.edu/jan.garrett/ethics/rossethc.htm

Inside Clinical Trials: Testing Medical Products in People. (2014, November 6). Retrieved from https://www.fda.gov/drugs/drug-information-consumers/inside-clinical-trials-testing-medical-products-people

Matthews, M. (2015, April 13). The high cost of inventing new drugs — and of not inventing them. Retrieved from https://www.forbes.com/sites/merrillmatthews/2015/04/11/the-high-cost-of-inventing-new-drugs-and-of-not-inventing-them/#53987ed1c490