A Right to Experimental Drugs
Identify relevant ethical theories and moral principles.
Autonomy is the ethical principle that patients should be allowed to make decisions regarding the care they want without coercion. The patient must have all the relevant information to make an informed decision. Beneficence means that medical care is provided to do good. Non-maleficence requires that any procedure that the patient is involved in does not bring harm to the patient (Fink, 2019). Hire our assignment writing services in case your assignment is devastating you.
In treating patients with treatment options that are yet to be tested, these three ethical principles come into play. The patient should be given accurate information, including that the treatment option is yet to be approved for larger populations. The information should, among other things, include the benefits and disadvantages of opting for the treatment. The patient should not be forced into getting the treatment, especially for purposes of research where the treatment developers seek human subjects. The medicine should also not cause harm to the patient (but in this case, because it is still on trial, the treatment benefits should outweigh the damage).
Deontology is the moral principle that asserts that the actions taken by a person are deemed to be right or wrong based on the consequences of the said actions (Mandal et al., 2016). When medication is administered to patients without proven efficacy, the results will determine whether such an action is good or bad. The move is considered good when the drug improves the patient’s health, while the reverse is true.
Explain how the principle of informed consent is relevant to the issue.
Informed consent is very critical in this case. Because the treatment and medication are yet to be approved, the patient will need to have all the information available on the outcomes of the medication treatment. The patient should know the statistics on mortality following the use of the new medication (Grady, 2015). A team of healthcare professionals needs to be involved, including a psychologist, who will each inform the patient of the expected effects of the medication’s success or failure. Based on the unbiased information, the patient will decide and sign a consent form. This consent form will act as evidence and deter liability cases against the medical team.
Explain the costs and benefits of making unproven, unapproved experimental drugs widely available to patients.
Unproven drugs in the market pose a significant risk to the general public. The uncertainty of the future impact of the drug, for example, mutation of offspring or development of cancers or tumors and early mortality. These would result in higher costs for the healthcare system. On the other hand, if the drug works successfully, it can save millions of lives and improve the health of previously untreatable diseases. However, a warning should be placed as part of the medication labeling, warning patients that the drug is yet to be approved for general public use.
Consider the costs and benefits to the patients who take these drugs and the potential costs and benefits to other patients.
In this case, the patients are more like the test subjects, and the medication’s success in treating the illness forms the basis for the manufacturers to seek the medication’s approval at the FDA. However, patients are also at risk of worsening their health condition or even mortality. On the other hand, the success of the medication will more than likely be beneficial to other patients and propel the approval of the medicines for wider population use.
Explain arguments using examples for and against offering pre-approved drugs to more expansive pools of patients.
As mentioned earlier, when unapproved drugs are distributed en-mass and proven beneficial, the positive result can translate into saving lives and a healthier population. However, pharmaceutical companies argue that they focus on completing trials, getting their drugs to the market as fast as possible, and not having to get derailed via manufacturing unapproved drugs to meet the demand of critically ill patients. When resources are diverted from completing the research phases, then the release of the drug could be slowed down. Also, using the medicine outside of studies can deter a patient from enrollment and risk getting a placebo (Patil, 2016).
Support your view using ethical theories or moral principles (or both) that you find most relevant to the issue.
Moral laws call for researchers to complete their studies and avail the drug when it is deemed safe and effective for use by patients. Non-maleficence can only be achieved when a drug’s safety is proven through research that it causes no harm to the patient. However, patients’ right to autonomy dictates that with accurate information, a patient can make informed consent and request to use an unapproved drug.
References
Fink-Samnick, E. (2019). The essential guide to interprofessional ethics in healthcare case management. HCPro.
Grady, C. (2015). Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), 855-862.
Mandal, J., Ponnambath, D. K., & Parija, S. C. (2016). Utilitarian and deontological ethics in medicine. Tropical parasitology, 6(1), 5.
Patil, S. (2016). Early access programs: benefits, challenges, and critical considerations for successful implementation—perspectives in clinical research, 7(1), 4.
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Question
Write a 2-page paper that explains and defends your view on whether patients with no other treatment options have a moral right to unproven drugs.