A Right to Experimental Drugs?
The Right to Access Experimental Treatments by Terminally Ill Patients
Over the last few months, various states including Michigan, Colorado, and Missouri passed the right to try legislation or laws that allow terminally sick people to have an access to medication that have passed clinical trials and the FDA phase. All the patients require a permit from drug companies and a doctor’s prescription. The legislation is designed to ensure that there is true volunteerism to patients taking part in clinical trials. In recent times, the laws have been dubbed as misguided and a lot of debate has been put forward on the ethics that allow the sick to use trial drugs. The laws do not provide a guarantee on accessing experimental medications and patients have no choice but to pay for them. Critiques of the laws have worries that there might be alternative trial models that may significantly delay the development of better and effective clinical therapies (Raghavan, 2018). The right to try laws is ethically defensible due to the fact that they render a choice to desperate terminally ill patients. The access to experimental ought to be availed to all terminally and patients who are about to die. This is in the case that a doctor believes that the medication can help improve the overall health of the dying patient and hence saving their lives. Patients should have the autonomy to assuming the overall risks involved in the process of experimental medication. In most cases, patients may trust the experimental drugs but rarely have the time to wait for these drugs to be passed through the various regulations of FDA until they are available for use. The patients can mostly participate in the controlled drug trials where they are placebo utilized. From the Helsinki states declaration, a patient should be guaranteed for the best therapeutic and diagnostic methods in all medical studies. The associated risks of the medication are entirely negligible when compared to the inevitability of the progression of a certain disease. The experimental therapies ought to be made by doctors and patients without the interference of any government. While these trials are done, there are various implications that may arise and hence the need to adhere to the nursing principles of informed consent and beneficence to essentially benefit the patients. Moral procedures have to be executed for the betterment of the health of the involved patients.
Ethical Theories and Moral Principles
The principle of beneficence can be considered at low risk and declared to assist terminally ill patients as death is imminent on the concerns of using experimental medications in healthcare settings. On the other hand, autonomy can be argued to aid in accessing free medication in the case that the risks are known (Kasper, 2016). Additionally, the natural law theory shows relevance in this case through its commands on the right to freedom and life of both mind and body. The rights ought not to be breached and are to be adhered to for the great good towards the accomplishment of a universal rule. Furthermore, the utilitarianism theory may be used in the case of utilizing drugs for experiments. It can also be argued that using medications for certain experiments may benefit all people in the case that the overall process leads to a positive outcome.
Informed Consent
Two crucial elements exist in informed consent. They include free consent and understanding. Informed consent is mainly composed of taking hold of the actions and life of a person. The elements presume the ability of a patient to consent and understand every aspect. Overall, consent implies that patients have been provided with enough information on their prognosis, diagnosis, and alternative models of treatment. Furthermore, free consent is mostly a willing and deliberate choice that prompts a person to act freely in an intervention that concerns medication in the form of experimental medication, treatment or participation. It involves one’s abilities to choose among various options regardless of the recommended ones. A major ethical requirement of informed consent is the overall benefits that patients attain after participating ion their own choices on matters of medical care. The choices of these patients are crucial as they contribute to their positive wellbeing. An informed consent view defines the discussions that occur between healthcare providers and patients as they aim to support and respect the principle of autonomy for every patient. It requires minimal practitioners to agree to the requests of patients for treatment models that are unproven and harmful.
Explain the costs and benefits of making unproven, unapproved experimental drugs available to patients not participating in clinical drug trials.
A major benefit to patients may be that they might receive an investigational treatment model that is life-saving or altering. In most cases, Medicare and Medicaid failed to cover the costs the associated medications and no obligations of the manufacturer on giving free drugs and hence patients pay for them. Furthermore, a legal issue arises in the case that healthcare professionals are responsible for the fatal or adverse of when informed consent is adequate. The overall costs of drugs may increase as manufacturers may apply shipping, manufacturing, reporting, and monitoring costs (Fountzilas et al., 2018). Patients who request access to medication under development are usually in the late stage of a disease or extremely sick. A higher risk may hence be experienced ill effects. When such occasions take place and are reported to the FDA, the overall approval process is affected leading to decreased profits in the manufacturers’ side.
Opposing and In Favor of prescribing trial drugs
Favouring experimental drugs, it can be argued that they offer access to medication to desperate patients who might be in need of them. Furthermore, the drugs give them autonomy to participate in the overall treatment process. Having control of one’s disease is a crucial aspect in this case. however, many concerns arise on the safety associated with using trial drugs in the treatment of diseases in terminally ill patients. In support of the prescription of trial drugs, it can be noted that autonomy and beneficence are important principles in the overall process of medicating using trial drugs. The principle of beneficence and the right to patients to have control over their disease and treatment process plays an important role in the medical process. In my opinion, natural law has relevance in the use of trial drugs for treating patients who are terminally ill. Natural law puts dignity and human life at the forefront and allows people to work out the important rights entitled to them.
References
Fountzilas, E., Said, R., & Tsimberidou, A. M. (2018, February). Expanded access
to investigational drugs: Balancing patient safety with potential therapeutic benefits. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291242/
Kasper Raus. (2016, October 18). An analysis of common ethical justifications
for compassionate use programs for experimental drugs. Retrieved from https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-016-0145-x
Raghavan, D. (2018). right-to-try legislation: Primum non-nocere just went out the window. Retrieved 2018, from https://www.healio.com/news/hematology-oncology/20180619/righttotry-legislation-primum-non-nocere-just-went-out-the-window