28 Dec 2022

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Experimental Drugs - Clinical Trials & New Treatments

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When a new treatment is discovered, diverse steps of clinical trials must be taken before its approval. This may take a long time and therefore brings up a matter for treatment that could advantage terminally sick patients. Many critically sick patients around the world eagerly wait to hear if they'll have an opportunity to try some of the world's most cutting-edge experimental medicines. They hope that these unproven drugs might have different outcomes on their terminal illnesses, acute infectious diseases, or odd genetic states (Scott, 2017). They are also aware that the treatments might fail to work, but these patients are ready to take the chance. Some institutions and healthcare groups are inclined to offer them these last-resort options because other treatments have not been of help to them and some have stopped functioning. 

Relevant Ethical Theories and Moral Principles 

High ethical standards are important for patients' healthcare. These standards fall under medical ethics, concerned with virtual decision making relevant to medical operations ( Scott, 2017) . Some of the ethical standards include autonomy which states that every patient has a right to control their bodies. This means that a healthcare professional can only advise but not persuade a patient to make certain decisions. The beneficence principle states that healthcare personnel must do everything in their power to help and do well to the patients. The principle Non-Maleficence principle dictates that medical practitioners must ensure no harm to the society or people even if the decision is of benefit to an individual patient. The principle of justice ensures justice and fairness in all healthcare decisions made. 

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Relevance of the Principle of Informed Consent to This Issue 

The principle of informed consent requires the patient to be informed of all benefits, risks and procedures involved in the kind of treatment they are going to receive. In this case, the physicians will need to make sure the patient understands that the drugs are not proven and what that means. The patient needs to be helped understand the possible risks and benefits of taking the unproven drugs. Now, with the understanding of all that, if the patient chooses to go ahead and receive the treatment, it will be alright otherwise administration of the drugs without their consent is illegal and unethical. 

The Costs and Benefits of Offering Unapproved Experimental Drugs to Patients 

Each country should have a healthy system that is responsible for taking care of its people. The major cost-benefit of this is for the pharmaceutical companies who need to spend very less amount on their research projects ( Folland, Goodman, & Stano, 2016). Pharmaceutical industries usually spend much on patenting the drugs. Unproven, unapproved drugs save many investments from these companies. Such drugs can be a financial burden to the patient. These drugs are frequently in scarcity with finite manufacture runs, causing them to be quite costly. There are also expenses for physicians and healthcare teams in administering the drug. The fact that the drugs are experimental, throws off most insurance plans, and hence only a few can cover the costs. 

The benefits apply to d ying patients who have depleted standard treatment. They should be allowed to seek treatment with experimental drugs since the danger linked with such drugs is insignificant compared to the certainty of disease progression (Kearns, & Bateman-House, 2017). Hence the argument in favor should be that the individuals can decide for themselves if they can or not use investigational drugs and should not be hindered from assuming such risks, especially if it is for the benefit of promoting their own survival. 

Administering unproven drugs however may be risky and harmful to patients. In the case of the unique vulnerability of a terminally ill patient, experimental drugs may or may not help. They may be potentially dangerous to all those involved, including current patients, future cases, and society as a whole. The desperation that may arise due to this terminal illness may serve as its own compulsion to try anything to get well. Unapproved drugs may have unknown side effects, which may lead to the patients becoming sicker. Not to mention, the patient may simply be too far along in the disease process to benefit from the drug. 

Conclusion 

According to the principle of autonomy however, the sick should be allowed to employ their autonomy and be able to make their own choice whether or not to use experimental drugs, and they should be fully aware of the risks and consequences of their decision. In line with the principle of beneficence, it can also be argued out that terminally ill patients stand to get much aid at less risk since they are in fatal conditions already. On the other hand, justifications can be made in accordance with the justice principle, whereby compassionate use programs should be viewed as a just as a method used to supply experimental new drugs to patients who have been denied access to RCT’s by no liability of their own (Borysowski, Ehni, & Górski, 2017).

References 

Borysowski, J., Ehni, H. J., & Górski, A. (2017). Ethics review in compassionate use. BMC medicine , 15 (1), 136. 

Folland, S., Goodman, A. C., & Stano, M. (2016). The Economics of Health and Health Care: Pearson New International Edition . Routledge. 

Katz, A. L., Webb, S. A., & Committee on Bioethics. (2016). Informed consent in decision-making in pediatric practice. Pediatrics , 138 (2), e20161485. 

Kearns, L., & Bateman-House, A. (2017). Who stands to benefit? Right to try law provisions and implications. Therapeutic innovation & regulatory science , 51 (2), 170-176. 

Miller, J. E., Ross, J. S., Moch, K. I., & Caplan, A. L. (2017 ).  Characterizing expanded access and compassionate use programs for experimental drugs 

Scott, P. A. (2017). Ethical Principles in Healthcare Research. In Key Concepts and Issues in nursing Ethics (pp. 191-205). Springer, Cham. 

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StudyBounty. (2023, September 15). Experimental Drugs - Clinical Trials & New Treatments.
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