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 enacte