A Right to Experimental Drugs - Special Academic Support

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The field of medicine is not restricted to patients direct treatment and involves the constant expansion of medical research. Compassionate use programs provide critically ill patients with no other treatment options with an access to experimental new drugs (Munson, 2014). The issue of whether they have a right to use it has been at the center of active debate over the rights of terminally ill patients, however, they have a legitimate moral claim to it.

The question of whether patients should have access to experimental drugs for treatment is based on the ethical standards governing the protection of humans in this area of clinical research. The three basic principles required for this include beneficence, justice, and respect for the individual (Raus, 2016). The principle of beneficence is a duty to promote well-being and minimize harm. It requires that the potential advantages reasonably contain any risk associated with participating in research. The norm of justice dictates the fair distribution of burdens and benefits. Its primary application to the conduction of clinical research is in the judicious selection of subjects, so that potential harms and services are allocated fairly (Raus, 2016). The justice principle mandates the exclusion, where possible, of subjects who already are at heightened vulnerability, such as the disabled, institutionalized, or incarcerated.

The principle of respect for a person includes two ethical standards. First, people who are capable of self-determination must be treated in such a way as to recognize them and respect their choices (Raus, 2016). Second, people with limited self-determination capacity should be provided with superior protection (Raus, 2016). Thus, respect for a person refers to the requirement to obtain informed consent either from the research participant or, in the case of limited legal capacity, from a third party acting on his or her behalf. Given the status of a compound or device research, the provision of experimental drugs must entail a rigorous informed consent process that clarifies their development stage and therapeutic purpose.

By providing experimental drugs to a larger subset of patients than usually presented in clinical trials, more realistic and generalizable information about drugs effects can be obtained. Therefore, expanded access is beneficial not only for people involved but also for future patients and society as a whole. The cost is that using experimental compounds in people too ill for clinical trials will lead to biased data on drug side effects.

The argument in favor of liberal access policies consists in the concept that it is the persons right to choose using investigational compounds and that restricting access infringes on the autonomy and civil liberties. The patients are their own best judges of what constitutes an acceptable risk threshold and should not be prohibited from assuming such risks, especially to promote their survival. Even if a person with an end-stage disease derives no medical benefit from trying experimental drugs, there are significant psychological gains. Individuals who are disempowered by terminal prognoses will feel strengthened by having the continued choice at the end of life.

Those opposing expanded access point to the potential worrisome implications for society at large. They argue that it will intensify the hype surrounding drugs, generating false hope, and exacerbating impatience with the legitimately slow pace of developing new drugs (Ebunoluwa & Kareem, 2016). A focus on expanded access diverts attention from other efforts that would bring more substantial improvements to the care of patients with serious illnesses. However, these arguments have been under-explored to date and merit closer consideration.

To summarize, patients with no other treatment options have a moral right to unproven drugs because it is in line with ethical principles, while the arguments against it are insufficiently studied. Despite the explicit treatment goal for accessibility programs, it is both acceptable and preferable for such programs to be a hybrid of research and therapy. In turn, physicians can work with the media to interpret the real meaning of new medical technologies and reduce the misconceptions, which often distort reports of new healings.

References

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), 2240. Web.

Munson, R. (2014). Intervention and reflection: Basic issues in bioethics. Wadsworth.

Raus, K. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17(1), 60. Web.

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