Experimental Drugs
NURS FPX 3200 Assessment 2 Attempt 1 A Right to Experimental Drugs?
Experimental drugs are medical products that have not yet received any kind of approval from the regulatory body for routine use in human or veterinary medicine. These drugs may be used for one disease or any condition but still, they are called experimental drugs for other diseases. In some cases, experimental use of the unapproved drug is used on patients in a serious life-threatening situation or during the unavailability of any authorized drug (Medhi et al., 2020). Experimental use of the drug is often seen as a therapeutic process, it may not be planned appropriately and administered to the patients without adequate consent and such experiment also do not have any monitoring plans for the adverse effects and outcomes. However, there is an ongoing debate among health care practitioners and social scientists whether such practices follow normative ethical values of medicine or create ethical issues.
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Ethical Theories and Moral Principles
There are various ethical theories and moral principles that affirm and, in the meantime, deny the use of experimental drugs. Non-maleficence and autonomy are important for ethics including beneficence and justice for the application of experimental drugs.
Principle of Autonomy
For example, principles like autonomy or respect for persons require medical practitioners to adequately inform the patient regarding the benefits and the possibility of harm in the process of experimental trials.
Principle of Justice
The principle of justice makes sure that health practitioners ensure fairness in the selection of the patient for medical trials. It also checks transparency in procedures and ensures access to products during experimental trials (Medhi et al., 2020).
Principle of Non-maleficence
Meantime, the principle of non-maleficence prioritizes the best procedures for safety, monitoring, and protection from harm. However, the health care practitioners must alleviate the suffering of the patient and increase the chances of well-being but due to safety compulsions and inadequate data arises situations where experimental drugs may not be justified (Borysowski & Górski, 2019). Moreover, patients are prone to significant abuse in the context of experimental use in some instances as there can be a conflict of interest of health care practitioners to prioritize research of experimental drug use over clinical care. There may also be the possibility of commercial interests of drug manufacturers to promote their experimental drug for approvals which influences decisions in patient selection (Medhi et al., 2020).
NURS FPX 3200 Assessment 2 Attempt 1 A Right to Experimental Drugs?
Principle of Informed Consent Related to Issues
It is important to protect patients’ autonomy and provide safeguards against any potential abuse of rights. Informed consent is a process that ensures patients’ or person’s right to information, discussions, and informed decision-making that results in the patient’s authorization or agreement to undergo a specific medical intervention (Gossman et al., 2021). Informed consent is important because there may be the possibility of potential harm due to the implementation of unapproved trials on experimental grounds. It is important to carry out the process of obtaining informed consent in a manner that is culturally relevant and minimum influence must be imparted on patients during decision-making. Sometimes it becomes impossible for the practitioner to take consent from the patients due to their morbid conditions. In such cases, consent must be taken from appropriate legally acceptable representatives. It is important to consider patient wishes to minimize the undue abuse of un-informed consent (Arunachalam et al., 2021).
Costs and Benefits of Unapproved Experimental Drugs
The most important benefit of experimental trials for patients is to get a chance to receive useful experimental drugs in an emergency. Expanding access to experimental products provides an alternative to unmet needs. Experimental drugs may also minimize the gap between the developmental and approval phase, and this may lead to expanded use of the drug (Fountzilas et al., 2018). Data can be collected from the trials of treated patients which may further aid the manufacturer and researchers alike. In the United States, most clinical trials get sponsors from pharmaceutical or biotechnological companies. The sponsor covers the costs of the experimental drugs and makes them available to research subjects/patients without any cost. The trial budget includes provider fees, facility fees, and visits or tests along with incentive payments to trial participants (Folkers et al., 2020). It is noted that the therapeutic advantage of experimental trials is less than 10 percent and informational dissymmetry can make patients prone to threats (Fountzilas et al., 2018). In addition to this, ethical challenges like financial limitations, unknown safety profiles, and providing drugs pre-commercially are common to experimental drugs.
Articulate Arguments Using Examples to Wider Pools of Patients
Since experimental drugs are usually permitted to patients with advanced disease, it becomes doubtful to evaluate the efficacy and safety of the drug. It is also argued that experimental drugs may pose ethical challenges if not given to the patient who is in dire need and can deprive a chance to save a life. Experimental use can also lead to difficulty in conducting clinical trials in the future for expanded use of the drugs to many patients, it may also deplete the supply of the drugs for clinical research. Patients as well as health care practitioners discourage to participate in clinical trials thereby showing the trial process. Few patients want to opt for the placebo group in a randomized controlled trial which makes it more difficult to study the efficacy and safety of the clinical trial. For example, experimental use with peramivir in N1H1 patients but clinical trials showed clinical benefits with experimental drugs are negligible (Rome & Avorn, 2020).
NURS FPX 3200 Assessment 2 Attempt 1 A Right to Experimental Drugs?
It has been witnessed in some cases that experimental drugs can potentially extend life. During the Ebola outbreak in 2013-16 vaccines were compassionately given to subjects in hope of improving life and the results were quite plausible to gain trust in experimental drugs (Brown et al., 2018). What makes pre-approved drugs beneficial is that desperate patients with no other option can ask companies to try investigational products outside a clinical trial setting. However, pharmaceutical companies can now withhold the distribution of drugs to patients not active in clinical trials. For the sick and terminally ill patients, it seems unfair to refuse access because they do not have other treatment options left. There are several reasons why someone might decide against pre-approved drug access. It is hard for companies to provide experimental drugs to a large pool of patients due to a lack of resources. This means there are not enough experimental drugs to meet the demand outside clinical trials. Also, there are not enough resources to manage, regulate, and control experimental drug access. Some companies do not issue potential experimental drugs outside clinical trials because they consider experimental drugs a high risk. They think there is a chance of misuse in everyday life settings.
Conclusion
Experimental drug use requires policies and legislation for unapproved intervention for needy patients in an emergency and is a welcome step proposed by health care practitioners and drug regulators. There is a prospective pathway for patients having life-threatening diseases to receive interventions who are waiting for health benefits. Even though the risk-benefit ratio is unknown given limited safety and efficacy data. Experimental drugs should be carefully prepared and never be considered as a substitute for the clinical trial. However, there are ethical challenges in implementing experimental drugs due to limited scientific evidence and challenges related to autonomy, fairness, and the possibility of misuse for commercial gains.
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References
Arunachalam, M. A., Halwai, A., & Arunachalam, C. (2021, February 16). National guidelines for ethics committees reviewing biomedical & health research during COVID-19 pandemic: An analysis. Indian Journal of Medical Ethics, 06(01), 68–73. https://doi.org/10.20529/ijme.2020.120
Borysowski, J., & Górski, A. (2019, July). Compassionate use of unauthorized drugs: Legal regulations and ethical challenges. European Journal of Internal Medicine, 65, 12–16. https://doi.org/10.1016/j.ejim.2019.04.008
Brown, B., Ortiz, C., & Dubé, K. (2018). Assessment of the right-to-try law: The pros and the cons. Journal of Nuclear Medicine, 59(10), 1492–1493. https://doi.org/10.2967/jnumed.118.216945
NURS FPX 3200 Assessment 2 Attempt 1 A Right to Experimental Drugs?
Fountzilas, E., Said, R., & Tsimberidou, A. M. (2018, January 22). Expanded access to investigational drugs: Balancing patient safety with potential therapeutic benefits. Expert Opinion on Investigational Drugs, 27(2), 155–162. https://doi.org/10.1080/13543784.2018.1430137
Folkers, K., Bateman-House, A., & Robertson, C. (2020). Paying for Unapproved Medical Products Paying for Unapproved Medical Products Recommended Citation. https://scholarship.law.bu.edu/cgi/viewcontent.cgi?article=1999&context=faculty_scholarship
Gossman, W., Thornton, I., & Hipskind, J. E. (2021). Informed Consent. Nih.gov; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK430827/
Medhi, B., Goyal, P., & Mathur, R. (2020). Understanding the challenges and ethical aspects of compassionate use of drugs in emergencies. Indian Journal of Pharmacology, 52(3), 163. https://doi.org/10.4103/ijp.ijp_665_20 Rome, B. N., & Avorn, J. (2020, June 11). Drug evaluation during the Covid-19 pandemic. New England Journal of Medicine, 382(24), 2282–2284. https://doi.org/10.1056/nejmp2009457
