A Right to Experimental Drugs?

The right to try experimental drugs allows predetermined access to experimental drugs to treat life-threatening diseases. It acts as a potential boon for many young biotechnology and pharmaceutical companies. The merits and demerits of experimental drugs involving scientific, clinical, machine learning, clinical decisions, and risk mitigation are considered (Mahant, 2020).

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Ethical Theories and Moral Principles

Ethical theories and moral principles play essential roles in the healthcare system. These theories explicitly define the point of view individuals seek guidance in decision-making. Each ethical theory highlights a different point of view, decision-making styles, and several rules for making decisions by predicting the outcomes. The ethical theories in healthcare include; Utilitarian ethical theory, which is based on the notion that the choice with greater benefits to the majority of people is the correct ethical choice. The acceptance of Utilitarian ethical theory in healthcare has shifted practitioners’ views. This theory allows them to focus on and realign the principles of healthcare to benefit the healthcare community and individuals (Vearrier & Henderson, 2021).

Consequentialism in medical ethics is related to consistently positive outcomes in patients and society (Love et al., 2018). Deontologism considers practices according to basic medical ethical principles. (Wang & Gupta, 2020). However, Virtue ethical theory deals with good practice in medical healthcare by the virtuous moral character of the doctor. This theory investigates how the good moral character of the doctor promotes good for patients (Carr, 2018).

The moral principles of ethics in healthcare help in the decision-making and self-government of individuals. A person should be benevolent, autonomous, just, and non-maleficent: those are the four basic principles (Pallipedia, 2021). Therefore, promoting the act of individuals in the best possible manner, ensuring them a harmless and friendly environment, treating all the patients equally, and always acting in a manner that is best for the patients are the key points of the principles.

Theory and Principles for the Ethical Use of Experimental Drugs

The ethical theories of Utilitarianism, Deontology, and Consequentialism can be applied to the current issue of experimental drugs. Prescribing a treatment that will cause harm would be unethical from a utilitarian perspective (Tännsjö, 2019).  The exposure of patients to medications in the trial is harmful. Thus, the risks associated with the trial compromise the point of utilitarianism. Deontology refers to the morality of an action, it emphasizes that harm is unacceptable (Sibanda, 2019).  Experimental trials may cause some adverse effects on the health of patients, which is an immoral act. Therefore, the deontological teachings would be disregarded. The concept of consequentialism deals with the best possible outcomes of an action. The current issue of offering preapproved drugs may result in some side effects for patients. This theory, therefore, violates this perspective. In a nutshell, the process of the clinical trial raises some ethical questions with different perspectives based on ethical theories (Tseng & Wang, 2021). 

The moral principles of ethics can also be applied to the issue of experimental drugs. Physicians must adhere to the principles of non-maleficence that include not harming the participants and beneficence to work for the participant’s benefit. If the procedure’s risks exceed the benefits, the ethical principle of non-maleficence would be violated (Markkula Center for Applied Ethics, n.d.).

 Relevancy of Informed Consent in Experimental drug Issues

The experimental drugs approach must fulfill the theory of informed consent. According to informed consent, patients must use the information disclosed rationally and autonomously (Cleveland Clinic, n.d.). It is necessary to ensure that patients understand the complex medical terms and can consent to voluntary participation in the experiment’s explanation. Firstly, this issue can be evaluated by a detailed conversation with the patient in which all aspects of the procedure are thoroughly explained. Secondly, ensure that patients can make decisions. Participants under the age of 18 and those who lack capacity must be assisted by a surrogate decision-maker. Parents reserve this right until their children turn 18 years old. Informed consent is ultimately intended to make sure patients understand what they will gain and lose from undergoing a procedure The law and ethics of informed consent both reflect and enforce the shift from physician-centered to patient-centered decision-making (Manti & Licari, 2018).

Assumptions

In some cases, patients may be unaware of the trial process as they lack understanding and do not ask for clarifications. Informed consent is mandatory in this healthcare issue otherwise, in many cases, patients leave the trial halfway. To obtain consent in clinical trials, it is challenging to maintain the standard approach to safeguarding patients. Patients sometimes fail to understand the important aspects of the clinical trial that practitioners are preparing to investigate. This leads to further limitations of the trial.

Costs and Benefits of Offering Unapproved Experimental Drugs to Patients

Experimental drugs or investigational drugs are used to check the improvement in health. It has been proven in several scientific trials that the drug is safe and effective. The use of drugs in a particular disease, the amount of intake of drugs, and information about possible benefits and risks are still under discussion. The experimental drugs are beneficial for patients with serious illnesses who are unable to get the proper treatment.

There is a limited amount of investigated drugs for experimental trials. Some companies provide these drugs for free, but some may charge patients for the trials. Drug costs are usually not paid by insurance companies. There can be other costs too, which include; charges to the clinic for providing drugs and examining the response these sorts of expenses are not paid by the health insurance companies (Commissioner, 2019).

Conflicting Evidence

Patients who are suffering from serious illnesses and cannot meet the standard treatment options are unable to enroll in clinical trials. These patients cannot wait for the marketing authorization of the investigational drugs. Though some countries, including the USA and other European countries, have allowed expanded access to investigational drugs with compassionate use programs (Cancer, 2018)

During the past few years, several public and private organizations have claimed that compassionate use programs are underemployed. Actions have been taken to remove barriers to enhancing access to experimental drugs. There is a limited supply of drug samples available for preapproval, so drug manufacturers are reluctant to provide preapproval access, and if a patient experiences adverse effects after taking a drug, this may discourage other patients from participating in clinical trials or from purchasing the product after FDA approval (Folkers et al., 2020).

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Preapproved Drugs

Through Expanded Access Programs and the Right to Try Act of 2017, patients who are enrolled in experimental drug programs can request approval for their participation. Patients are provided direct contact with pharmaceutical companies. The advocates of pre-approved drug programs ensure the complete testing process. Moreover, the best possible solutions are supervised by FDA, and proper safety standards are held by the pharmaceutical companies (Commissioner, 2020)

Certain arguments exist regarding the pre-approved drugs available to a wider pool of patients and whether this practice harms the patient’s health. The exposure of patients to the harmful effects of medicine is unnecessary. Pre-approved drugs can have negative effects on some patients. A medicine that cures one kind of treatment is not effective in treating another. The widespread use of preapproved drugs decreases the quality of healthcare. The reliance on experimental drugs can have harmful consequences for the healthcare system (Mahant, 2020).

On the contrary, ill patients are terminated from the program by the practitioners. The time for the approval by FDA and research capacities are considered efficiently.

Arguments

There are certain arguments regarding the demerits of the use of investigational drugs. Even the safety information gathered for investigated drugs is not beneficial for FDA approval. The problems may occur due to inaccurate monitoring of patients in clinical trials. There is a possibility that the benefits from these medicines are not long-lasting. There can be undiscovered harmful side effects (The University of Rochester Medical Center, n.d.).

However, the recently approved investigational drugs for treating Ventilator-associated pneumonia have proved beneficial for patients with respiratory infections. Therefore, there can be different opinions regarding these drugs. In a nutshell, it can be said that patients taking experimental drugs must know the possible outcomes. Patients already suffering from various diseases and allergies should be terminated to avoid unfavorable outcomes (Bassetti et al., 2018).

Knowledge Gaps

From the key points mentioned above, I have learned that experimental drugs also cause harmful effects rather than only providing benefits. In case a patient needs these drugs, he must be aware of the possible consequences and strictly adhere to the guidelines of a health care practitioner. Otherwise, there can be a big knowledge gap in the use of experimental drugs.

Conclusion

Experimental drugs are thus not a reliable solution for improved quality of life. Not every patient’s disease or medical condition counters the effects of these drugs. The approved drugs, on the other hand, have gone through extensive clinical trials and are safe to use. In the case of the intake of experimental drugs, healthcare practitioners need to talk to patients about their possible effects.

References

Bassetti, M., Vena, A., Castaldo, N., Righi, E., & Peghin, M. (2018). New antibiotics for ventilator-associated pneumonia. Current opinion in infectious diseases, 31(2), 177–186. https://doi.org/10.1097/qco.0000000000000438 

Cancer (2018). Compassionate drug use. Cancer.org https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/compassionate-drug-use.html 

Carr, D. (2018). Cultivating moral character and virtue in professional practice. https://doi.org/10.4324/9781315182414 

Cleveland Clinic. (n.d.). Why informed consent matters. https://my.clevelandclinic.org/health/treatments/24268-informed-consent 

Commissioner, O. of the. (2019). Understanding investigational drugs. FDA. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-investigational-drugs#:~:text=An%20investigational%20drug%20can%20also 

Commissioner, O. of the. (2020). Right to try. FDA. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try#:~:text=The%20Right%20to%20Try%20Act%20permits%2Fallows%20eligible%20patients%20to 

Folkers, K. M., Bateman-House, A., & Robertson, C. (2020). Paying for unapproved medical products. Wake forest journal of law & policy, 11, 85. https://heinonline.org/HOL/LandingPage?handle=hein.journals/wfjlapo11&div=6&id=&page= 

Love, E., Salinas, T. C., & Rotman, J. D. (2018). The ethical standards of judgment questionnaire: Development and validation of independent measures of formalism and consequentialism. Journal of business ethics, 161(1), 115–132. https://doi.org/10.1007/s10551-018-3937-8 

Mahant, V. (2020). “Right-to-Try” experimental drugs: An overview. Journal of translational medicine, 18(1). https://doi.org/10.1186/s12967-020-02427-4

PHI FPX 3200 Assessment 2 A Right to Experimental Drugs?

Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2), 145–152. https://doi.org/10.1183/20734735.001918 

Pallipedia. (2021). What is ethical principles – meaning and definition – Pallipedia.    Pallipedia.org. https://pallipedia.org/ethical-principles/ 

Sibanda, O. (2019). Moral, ethical, and human rights arguments for using experimental and clinically unproven drugs to combat the ebola virus disease. Journal for juridical science, 44(1), 35–62. https://doi.org/10.18820/24150517/jjs44.i1.2 

Tännsjö, T. (2019). Setting health-care priorities: what ethical theories tell us. In google books. Oxford university press. https://books.google.com.pk/books?hl=en&lr=&id=SUyeDwAAQBAJ&oi=fnd&pg=PP1&dq=Utilitarianism+in+experimental+drugs+According+to+Utilitarianism 

Tseng, P.-E., & Wang, Y.-H. (2021). Deontological or utilitarian? An eternal ethical dilemma in outbreak. International journal of environmental research and public health, 18(16), 8565. https://doi.org/10.3390/ijerph18168565 

University of Rochester Medical Center. (n.d.). Using investigational medicines – health encyclopedia – Www.urmc.rochester.edu. https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=34&contentid=22702-1 

Varkey, B. (2021). Principles of clinical ethics and their application to practice. Medical principles and practice, 30(1), 17–28. https://doi.org/10.1159/000509119 

Vearrier, L., & Henderson, C. M. (2021). Utilitarian principlism as a framework for crisis healthcare ethics. HEC Forum, 33(1), 45–60. https://doi.org/10.1007/s10730-020-09431-7 

Wang, S., & Gupta, M. (2020, June 3). Deontological ethics by monotonicity shape constraints. Proceedings.mlr.press; PMLR. https://proceedings.mlr.press/v108/wang20e.html 

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