eth2

A Right to Experimental Drugs

Darion Alexander

PHI-FPX3200

Capella University

Professor Kim Carter-Cram

July 23, 2022

A Right to Experimental Drugs

Drugs are an essential part of the health sector because they have to treat various diseases

or disorders, and nothing can be cured without them. The drug and the relevant research are not

limited to clinical practice or the discovery of fewer drugs. The researchers keep researching the

new drugs, but ethical concerns arise when the drugs are unproven yet given limited patient access.

The topic is debatable, and the following paper will discuss it in detail.

Ethical Theories and Moral Principles

The ethical theories regarding unproven drugs or the research of drugs are numerous. The

people need to create awareness about the approval of drugs and the relevant ethical concerns. The

ethical considerations usually used in healthcare are benevolence, social justice, non-maleficence,

and autonomy. When it comes to unproven drugs, the patients have two ethical concerns. The right

to use and the right to refuse are the two theories and moral principles that can be used. The right to

refuse means that the patients should be legally informed about the FDA trials and the unproved

status of drugs. The right to use is implemented similarly because if a critically ill needs to use the

drug, the patient will use it on his own. The moral principles are involved that the drug might not

be useful for them, but the willingness of the patient and urge to use the drug can be considered in

this regard.

Principle of informed consent

The topic is already said to be problematic because if FDA has not approved the

effectiveness of drugs, they must not be used. On the other hand, many drugs are not yet proven

but are used by the patients and are available in markets. The use of informed consent as the moral

principle to use the unproven drug is important because the patients cannot be given any medically

ineffective drug. The international ethical codes are designed for the patients and physicians to

decide. Still, it is a physician's right to guide the patients about the status of a drug. Informed

consent is necessary when the physician thinks the drug could be effective. If the physician has the

decision that the drug cannot give any benefit, the moral principles associated with informed

consent becomes weak (Loree, 2018).

Costs and benefits of making unproven, unapproved experimental drugs widely available to

patients

The costs of unproven experimental drugs widely available to patients are high. The drugs

that FDA does not approve are usually restricted in the markets. The costs can be certain side

effects to the patients using such drugs. The costs of such drugs are generally higher because the

manufacturer demands the direct shipping and distribution costs to the customers. Moreover, the

costs of such medicines are also higher because Medicare and Medicaid do not cover the costs of

such medications (Fountzilas, 2018).

The benefits of such unproven medicines that were experimented with for specific reasons

but are used for other reasons are numerous. The benefit that is significant and leads the patient to

use the right of informed consent and right to use is the treatment of critical diseases. The patients

are usually available with certain drugs that act as the alternate line of medicines. These are of high

importance for those patients who do not have other options to get recovered. The costs of

investigational drugs will be considered regarding whether the physician will be responsible for the

fatal circumstances or whether the informed consent of patients will be enough (Munson, 2014).

Arguments using examples for and against offering pre-approved drugs to wider pools of

patients.

The arguments in favor of offering pre-approved drugs to wider pools of patients can be

explained through autonomy and informed consent. The patients have the right to make decisions

for them, and if they think the unproven drugs can better treat them, they can be given. On the

other hand, it is observed that the patients cannot decide everything good for them. Physicians have

to think of good actions and social justice for patients, so they need to show the fact that the

medication might not be suitable for them (Darrow, 2020).

Conclusion

It is concluded that unproven medicines can be fatal for health, but there are various ethical

and legal concerns regarding them. The patients have the right to make the decisions, but the

physicians should guide them regarding the rules and regulations of the FDA to make better

decisions.

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2020). FDA approval and regulation of

pharmaceuticals, 1983-2018. Jama, 323(2), 164-176.

Fountzilas, E., Said, R., & Tsimberidou, A. M. (2018). Expanded access to investigational drugs:

balancing patient safety with potential therapeutic benefits. Expert opinion on

investigational drugs, 27(2), 155-162.

Loree, J. M., Anand, S., Dasari, A., Unger, J. M., Gothwal, A., Ellis, L. M., ... & Raghav, K.

(2019). Disparity of race reporting and representation in clinical trials leading to cancer

drug approvals from 2008 to 2018. JAMA oncology, 5(10), e191870-e191870.

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

ed.). Wadsworth.