PHI-FP3200 Assessment 2: Right to Experimental Drugs?

This paper addresses the ethical issue of whether patients lacking other treatment options possess a moral right to utilize unproven drugs. It begins by acknowledging the expanding medical field and the role of clinical research, highlighting the ethical complexities of using human subjects. The ...Read More

Running head: ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
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1ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
The ethical issue of using experimental drugs on patients with no other
treatment options
The medical field is vast and expanding with time, which is not limited to direct
treatment but involves continuous researches in the healthcare sector. In the clinical practice,
the use of human subject is stated to be an ethical dilemma as it may cause harm to them.
According to Foroughi-Heravani et al. (2020), Good Clinical Practice (GCP) is international
guidelines that guarantee that clinical research to be conducted in a scientific and ethical
manner. The paper aims to discuss the opposing viewpoint related to the ethical perspective
of the issue of whether patients with no other treatment options have the moral right to use
unproven drugs.
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH)-GCP guidelines state that clinical trials need to be
conducted in compliance with ethical standards, scientific protocol and evidence. There are
various researches conducted on a global basis opines that on a historical basis early access to
experimental drugs was reserved for patients that are enrolled on clinical trials. In 2009, the
Food and Drug Administration (FDA) had modified its access program allowing terminally
ill patients for clinical trials who do not have alternative therapies. It was found that
approximately 1500 patients had received treatment or use of experimental drugs under 2014
FDA’s program (Borysowski, Ehni & Górski, 2017). In the present context of the legislation,
adoption of a step known as ‘Right to Try’ is envisioned to be offered access to critically ill
patients to investigational drugs, however, limiting the involvement of FDA. This was
introduced in thirteen states and it became legislation in additional more 20 states in 2014
even though it is an ethical issue. According to Spencer (2018), for conducting a clinical trial
on a human subject, it is essential to abide by the principle of informed consent. It is based on
the legal and moral boundary of the patient autonomy, and thus, the patient has the right to

2ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
make the decision-related to health and medical condition. It is often found that this become
critical in conducting medical research. Van Norman (2018) opined that the cost of offering
unapproved drugs to patients is stated skyrocketing as it involves several variables as human
involvement require maintenance of various legal and ethical aspects. However, it has several
benefits in the application of unapproved drugs on terminally ill patients who do not have any
other options is it give hope to the patient, maybe economically acceptable in nature and can
be of greater good if the results were promising.
The ethical or moral aspects related to the use of compassionate drugs of critically ill
patients can be discussed Utilitarianism that is based on the ability to predict the outcome of a
particular action. The use of the experimental drug can have a positive consequence on the
patient in clinical trial or knowledge can be attained that is of prime importance in healthcare.
The argument in favour of the use of liberal experimental drugs offers the right to the patient
for choosing fate and accessing treatment. The right involves the promotion of survival to a
certain degree and thus, abides by the principle of justice (Raus, 2016). It offers practical and
generalised information related to the effect of drugs that not only satisfy the need of
participating patient but also helpful for future patients and the community. For example, a
patient with a newly found disease can be used as a subject for understanding the impact of
an innovative drug.
On the contrary to this, the drugs are minimally tested or not approved thus can be
misleading or harmful to all the concerned parties. Ebunoluwa and Kareem (2016) opined
that these drugs might confer considerable risks that may pose physical harm to the patient.
For example, when AIDS was detected, there was no cure; however, it was ethical wrong to
testify the drug as it may harm them and may kill them. The phase I trial offer limited
knowledge and the issue of toxicity is high. Therefore, it is stated that terminal illness need
not be considered as a situation of anything to lose and thus, deterioration in the quality of

3ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
life can be quickly done. Some evidence indicates that the use of experimental drugs and the
liberalising access of policies is responsibly endangering the welfare of the future patients
who are dependent on the outcome of the clinical trial to understanding the level of safety and
efficacy of the potential new drug (Mackey & Schoenfeld, 2016).
From the paper, it can be concluded that there are positive and negative consequences
related to the use of experimental drugs on patients that do not have any other treatment
options. Even though it offers the moral right of using unproven drugs on such patients;
however, on weighing the value of both the aspects, it was found that adverse outcomes are
more prevalent than the positive ones. Moreover, it can be seen that people that require the
therapies mostly are not always taken into account because of inclusion criteria; thus, it is not
as useful for them as it should have been.

4ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
References
Borysowski, J., Ehni, H. J., & Górski, A. (2017). Ethics review in compassionate use. BMC
medicine, 15(1), 136.
Ebunoluwa, O. O., & Kareem, F. A. (2016). Ethics of trial drug use: to give or not to
give?. BEOnline : journal of the West African bioethics training program, 3(2), 22–
40.
Foroughi-Heravani, N., Hadavandkhani, M., Arjmand, B., Payab, M., Rahim, F., Larijani, B.,
& Goodarzi, P. (2020). Good Clinical Practice: Guidelines and Requirements.
In Biomedical Product Development: Bench to Bedside (pp. 117-129). Springer,
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Raus, K. (2016). An analysis of common ethical justifications for compassionate use
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Spencer, M. (2018). Prescribing a Cure for Right-to-Try Legislation. Geo. Wash. L. Rev.
Arguendo, 86, 30.
Van Norman, G. A. (2018). Expanding Patient Access to Investigational Drugs: Single
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