PHIFPX 3200 Assignment: Running Head A Right to Experimental Drugs
PHIFPX 3200 Assignment: Running Head A Right to Experimental Drugs
A Right to Experimental Drugs?
Healthcare professionals, including nurses, physicians, medical technicians, and specialists, conduct clinical trials once a new drug is introduced. These trials are conducted to evaluate a particular drug’s effectiveness, tolerability, and safety before using it for treating the targeted patient population. The FDA does not approve a new prescription if adverse drug events and severe side events are reported during its clinical trial. In such cases, the drug is considered unsafe and intolerable. Additionally, the FDA does not approve a drug, which results in adverse events during the clinical trial. Different groups of participants are involved in various testing phases during the clinical trial. People involved in the clinical trials benefit from the new drug once it is approved for treating a particular disease. This paper explains if patients with no alternative treatment intervention have a moral right to unproven drugs, including ethical theories and moral principles, application of the principle of informed consent to this matter, costs and benefits of availing unapproved medicines to patients, and argument for offering pre-approved drugs to patients.
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Do Patients with no Alternative Treatment Intervention have a Moral Right to Unproven Drugs?
Patients are entitled to various moral rights, including promoting and protecting their health. Thus, healthcare providers are morally responsible for protecting patients from potential harm during healthcare delivery. Treating patients with no alternative treatment intervention using unproven drugs exposes them to potential harm due to possible drug reactions and severe side effects, including death. According to Van Norman and Drugs (2018), administering drugs that have not obtained the FDA approval to patients might harm them. Thus, patients with no alternative treatment intervention do not have a moral right to unproven drugs due to potential safety issues.
Relevant Ethical theories and Moral Principles
Ethical theories and moral principles guide healthcare providers during healthcare delivery. The ethical principles of nonmaleficence apply to the provided issue. This ethical guideline holds that healthcare providers should not harm their patients while providing healthcare services (Varkey, 2021). Therefore, healthcare professionals should not administer unproven drugs to patients with no alternative treatment to prevent potential harm such as side effects and adverse drug events. Additionally, the presented issue is influenced by the moral principle of beneficence. This ethical guideline states that healthcare providers should focus on doing good for their patients (Varkey, 2021). Hence, medical professionals should administer unproven drugs to patients without alternative treatment. Administering these drugs will not go to the patients since their effectiveness in treating patient disorders has not been approved.
Application of Principle of Informed Consent to this Issue
The ethical principle of informed consent applies to this issue. This ethical consideration holds that a clinician should provide a patient with adequate information regarding a certain treatment procedure to enable individuals to make an informed decision regarding their medical care (Varkey, 2021). In this issue, the healthcare professional should provide adequate information regarding the unproven drug to the patients. Particularly, the healthcare provider should state the benefits and potential risks of being treated with an unproven medication. This information will enable the patients to make informed decisions regarding their treatment.
Costs and Benefits of Availing Unapproved Experimental Drugs to Patients
Unapproved experimental drugs are proposed as a treatment for a particular disease. Hence, making these drugs accessible to the patients might provide treatment for the targeted illness, resulting in positive health and improved quality of life. Additionally, these drugs might benefit other patients. Improvement in reported clinical manifestation indicates effectiveness and tolerability of administered treatment. A prescription with a successful history can be taken by individuals diagnosed with the same illness. However, the efficacy and safety of these drugs have not been proved; hence might result in adverse drug events, including disability and death. Such incidents would impose psychological torture and distress on individuals who have been diagnosed with the disorder.
Should Pre-Approved Drugs be offered to wider Pools of Patients?
The efficacy and tolerability of these drugs have not been proved. For this reason, the medications might not effectively improve reported clinical manifestations or illnesses in the targeted population. Additionally, these drugs might result in adverse drug events, including disability or death. According to Davari et al. (2018), efficacy and safety are significant factors that medical professionals should consider while prescribing medications to enhance patients’ compliance. Therefore, patients should not be availed of pre-approved drugs to prevent potential drug-related side effects and adverse events.
Overall, clinical trials are conducted to evaluate the efficacy and safety of a particular drug before using it in treating certain illnesses. Patients with no alternative treatment intervention do not have a moral right to unproven medications due to potential safety issues and potential harm, including drug-related side effects. The ethical principles of nonmaleficence, beneficence and informed consent apply to the provided issue. Lastly, pre-approved drugs should not be availed to a wider pool of patients to prevent them from potential drug-related side effects and adverse events.
References
Davari, M., Khorasani, E., & Tigabu, B. M. (2018). Factors influencing prescribing decisions of physicians: a review. Ethiopian Journal of health sciences, 28(6). doi: 10.4314/ejhs.v28i6.15
Van Norman, G. A., & Drugs, D. (2018). The FDA: Part 2: An overview of approval processes: FDA approval of medical devices, JACC: Bas. Transl. Sci; 1: 277–287.
Varkey, B. (2021). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30(1), 17-28. https://doi.org/10.1159/000509119
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Introduction
Many doctors, nurses, medical technicians, and other health care workers are involved in medical research. The field of medicine is not limited to the direct treatment of patients but also involves the continued expansion of medical research. A large part of such research is clinical research, which puts patients into the role of experimental subjects. This raises a number of challenging questions for health care ethics, many of which follow from the fact that physicians, nurses, and others involved in clinical research have a dual role. As researchers, they are committed to generating new knowledge about diseases, developing new treatments and drug therapies, and, in general, helping to improve the welfare of human beings by eliminating or controlling diseases and increasing longevity. However, researchers involved in clinical research must also be committed to the highest quality care for individual patients taking part in research studies. This assessment explores some of the ethical issues that clinical research raises and some of the safeguards in place to protect the interests of patients involved in research.
Demonstration of Proficiency
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:
• Competency 1: Articulate ethical issues in health care.
o Explain how the principle of informed consent is relevant to these issues.
o Explain the costs and benefits of offering unapproved experimental drugs to patients.
• Competency 2: Apply sound ethical thinking related to a health care issue.
o Identify relevant ethical theories and moral principles.
o Articulate arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Competency 5: Communicate in a manner that is scholarly, professional, and respectful of the diversity, dignity, and integrity of others and is consistent with health care professionals.
o Exhibit proficiency in clear and effective academic writing skills.
Preparation
When a new drug is undergoing clinical trials to be approved for treatment, it must pass through a number of distinct phases of testing. These phases require rigorous study and evidence to demonstrate the safety and efficacy of new treatments. Passing through these phases and achieving approval takes many years for some trials. Before approval, patients not part of a clinical trial have limited or no access to experimental drugs, even though these drugs could be helpful and potentially save their lives. There are various groups pushing for greater patient access to drugs still in the experimental stage. In recent years, the FDA has made it somewhat easier to receive treatment with experimental drugs, but according to advocacy groups there are still too many restrictions (Munson, 2014).
This leads to a potential quandary when early stages of research on a drug sometimes suggest that the drug could be effective in treating a certain disease. On one hand, offering easier access to early stage trial drugs could help individuals suffering with a medical condition. However, on the other hand, making early access to experimental drugs easier could limit the pool of patients available to participate in clinical trials that establish whether or not the drug is truly effective and safe. This is an important consideration, as the vast majority of experimental drugs turn out to be completely ineffective or could have very dangerous side effects that will only show up over time and across a wider test population.
When completing this assessment, it is important to keep in mind the ethical arguments that are relevant to both views regarding the right to experimental drugs. It may be useful to review the suggested resources and conduct additional independent research while you are planning your assessment submission.
Instructions
Do patients with no other treatment options have a moral right to unproven drugs? Write a paper that explains and defends your view on this issue. In addition to reviewing the suggested resources, you are encouraged to locate additional resources in the Capella library, your public library, or authoritative online sites to provide additional support for your viewpoint. Be sure to weave and cite the resources throughout your work. In your paper, address the following points:
• Identify relevant ethical theories and moral principles.
• Explain how the principle of informed consent is relevant to the issue.
• Explain the costs and benefits of making unproven, unapproved experimental drugs widely available to patients. Consider the costs and benefits not only to the individual patients who take these drugs but also potential costs and benefits to other patients.
• Explain arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Support your view using ethical theories or moral principles (or both) that you find most relevant to the issue.
Additional Requirements
• Written communication: Written communication is free of errors that detract from the overall message.
• APA formatting: Resources and citations are formatted according to current APA style and formatting guidelines.
• Length: 2–3 typed, double-spaced pages.
• Font and font size: Times New Roman, 12 point.
Reference
Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Boston, MA: Wadsworth.
Introduction
Many doctors, nurses, medical technicians, and other health care workers are involved in medical research. The field of medicine is not limited to the direct treatment of patients but also involves the continued expansion of medical research. A large part of such research is clinical research, which puts patients into the role of experimental subjects. This raises a number of challenging questions for health care ethics, many of which follow from the fact that physicians, nurses, and others involved in clinical research have a dual role. As researchers, they are committed to generating new knowledge about diseases, developing new treatments and drug therapies, and, in general, helping to improve the welfare of human beings by eliminating or controlling diseases and increasing longevity. However, researchers involved in clinical research must also be committed to the highest quality care for individual patients taking part in research studies. This assessment explores some of the ethical issues that clinical research raises and some of the safeguards in place to protect the interests of patients involved in research.
Demonstration of Proficiency
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:
• Competency 1: Articulate ethical issues in health care.
o Explain how the principle of informed consent is relevant to these issues.
o Explain the costs and benefits of offering unapproved experimental drugs to patients.
• Competency 2: Apply sound ethical thinking related to a health care issue.
o Identify relevant ethical theories and moral principles.
o Articulate arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Competency 5: Communicate in a manner that is scholarly, professional, and respectful of the diversity, dignity, and integrity of others and is consistent with health care professionals.
o Exhibit proficiency in clear and effective academic writing skills.
Preparation
When a new drug is undergoing clinical trials to be approved for treatment, it must pass through a number of distinct phases of testing. These phases require rigorous study and evidence to demonstrate the safety and efficacy of new treatments. Passing through these phases and achieving approval takes many years for some trials. Before approval, patients not part of a clinical trial have limited or no access to experimental drugs, even though these drugs could be helpful and potentially save their lives. There are various groups pushing for greater patient access to drugs still in the experimental stage. In recent years, the FDA has made it somewhat easier to receive treatment with experimental drugs, but according to advocacy groups there are still too many restrictions (Munson, 2014).
This leads to a potential quandary when early stages of research on a drug sometimes suggest that the drug could be effective in treating a certain disease. On one hand, offering easier access to early stage trial drugs could help individuals suffering with a medical condition. However, on the other hand, making early access to experimental drugs easier could limit the pool of patients available to participate in clinical trials that establish whether or not the drug is truly effective and safe. This is an important consideration, as the vast majority of experimental drugs turn out to be completely ineffective or could have very dangerous side effects that will only show up over time and across a wider test population.
When completing this assessment, it is important to keep in mind the ethical arguments that are relevant to both views regarding the right to experimental drugs. It may be useful to review the suggested resources and conduct additional independent research while you are planning your assessment submission.
Instructions
Do patients with no other treatment options have a moral right to unproven drugs? Write a paper that explains and defends your view on this issue. In addition to reviewing the suggested resources, you are encouraged to locate additional resources in the Capella library, your public library, or authoritative online sites to provide additional support for your viewpoint. Be sure to weave and cite the resources throughout your work. In your paper, address the following points:
• Identify relevant ethical theories and moral principles.
• Explain how the principle of informed consent is relevant to the issue.
• Explain the costs and benefits of making unproven, unapproved experimental drugs widely available to patients. Consider the costs and benefits not only to the individual patients who take these drugs but also potential costs and benefits to other patients.
• Explain arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Support your view using ethical theories or moral principles (or both) that you find most relevant to the issue.
Additional Requirements
• Written communication: Written communication is free of errors that detract from the overall message.
• APA formatting: Resources and citations are formatted according to current APA style and formatting guidelines.
• Length: 2–3 typed, double-spaced pages.
• Font and font size: Times New Roman, 12 point.
Reference
Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Boston, MA: Wadsworth.