ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS

Running head: ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?
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ASSESSMENT 2 - A RIGHT TO EXPERIMENTAL DRUGS?1
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