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Increased research in medicine has led to the development of numerous medicines that must be taken through the testing phase by the responsible body before being approved for commercial and medical purposes. The increased interest in medical research and the need to access a variety of medications in cases where all medical options have been exploited has prompted the development of situations like early access to investigative drugs. Availability of information on the internet has also influenced people with different terminal ailments to volunteer for tests of unproven drugs to get medication for their conditions. Participation in such experiments has raised varied opinions on the requirements for patients to be part of the project, the ethical considerations involved, and the costs and benefits of untested drugs.
The Right-To-Try laws give terminally ill patients the right to access treatment or medication even in its trial phase. A terminally ill patient has exhausted all the available treatment option and are ineligible to participate in clinical trials (Borysowski & Górski, 2020). In most cases, patients seek the approval from their physician and the pharmaceutical manufacturer to participate in clinical trials (Brown et al., 2018). Written informed consent is required before the patient is considered for the trial experimentation. For example, a patient needs to be informed about the drug tested, the risks involved, and the perceived outcome of the experiment for decision purposes. Opponents of the right to try unproven drugs argue that patients have limited understanding due to the technical terms used, the confusing rate of success, and potential misconceptions (Munson & Lague, 2016). Such a process must ensure that all the parties agree before the patient is subjected to the medication.
Numerous ethical considerations must be met for patients to be considered for experimenting with unproven drugs. For example, the drugs should be specifically made for terminally ill patients. It is unethical to subject individuals with mild conditions to life-threatening medications or unproven drugs (Borysowski & Górski, 2020). In addition, investigative drugs are used when no other medical option for a disorder is available. Advocates of the Right-To-Try argue that unproven drugs used for experimentation are past Phase 1 of the drug development and obtained positive results for the specific condition (Brown et al., 2018). Benefits of such experiments include the likelihood of an extension of patient lives, enhanced drug safety due to adequate scientific knowledge on the drug, fair access to medication, and increased treatment options (Munson, 2014). With informed consent, such benefits make it ethical to grant terminal illness patients their right to try investigative drugs.
Although ethical principles like beneficence, justice, and respect for persons are highly encouraged in the experimentation of unproven drugs, the process is linked to numerous costs to the patients and stakeholders involved. The lack of hospice coverage for experimental treatment costs increases the financial burden on the patient’s families (Brown et al., 2018). The states that have passed the Right-To-Try legislation do not provide insurance incentives to cover the treatment costs. In addition, safety consequences are also involved in the experiments causing side effects to the patients worsening their conditions (Munson & Lague, 2016). Investigative drugs are also associated with reduced liabilities of pharmaceutical companies and physicians since they lack FDA oversight (Brown et al., 2018). The lack of reporting of the results leads to a lack of information to the public, who may hold the financiers of the experiments liable for the impacts on the patients.
In conclusion, patients with no treatment option have a moral right to unproven drugs. Patients with terminal illnesses usually exhaust available treatment options. Such experiments maintain ethical principles like beneficence, justice, and respect for persons, and therefore, it would be unethical to deny them the right to try any medication if with informed consent. Investigative drugs are safe and past the first trial; therefore, the pharmacist has the information about their medical significance. Such medications provide more medical options to patients who have explored all available medical options.
References
Borysowski, J., & Górski, A. (2020). Ethics framework for treatment use of investigational drugs.BMC Medical Ethics, 21(1).
Brown, B., Ortiz, C., & Dubé, K. (2018). Assessment of the right-to-try law: The pros and the cons. Journal of Nuclear Medicine, 59(10), 1492-1493.
Munson, R., & Lague, I. (2016). Intervention and Reflection: Basic Issues in Bioethics (10th ed.). Cengage Learning.
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