PHI-FPX3200_ThompsonNia_Assessment2-1
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A Right to Experimental Drugs?
Nia B. Thompson
PHI-FPX3200
Ginger Raya
May 04, 2023
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A Right to Experimental Drugs?
Chronic illnesses have risen over the years and because of that increase, there’s been an increase in medical research. Medical experts have increased these efforts in the hopes to discover cures for these illnesses as quickly as possible. “The prevalence and cost of chronic disease in the United States is growing and will continue to grow, not just as a result of the Baby Boomer generation aging but also due to increased disease prevalence among children and younger adults” (Hayes & Gillian, 2020). In May of 2018, then President Donald Trump sign the “Right-to-Try” Act. This act allows for physicians to prescribe experimental therapies that are unapproved by the Food and Drug Administration (FDA). The FDA was enacted to protect the public by assuring the safety, efficacy, and security of drugs, medical devices and our nation’s food supply. Ethical Theories and Moral Principles
When it comes to the various forms of researching human drug trials, it is often very controversial and sometimes difficult to conduct. There are often times that questions arise regarding the ethical and moral significance of performing these studies (Rakowski, 2010). “One ethical concern is that most people overestimate the odds researchers will determine an experimental drug is safe and effective” (Evolving Ethics). There are four basic ethical principles that apply to forensic activities. They are the “respect for autonomy, beneficence, nonmaleficence, and justice” (Jahn, 2011). In my opinion, the ethical principle that specifically applies to right to try is nonmaleficence. “The principle of nonmaleficence holds that there is an obligation not to inflict harm on others” (Jahn, 2011). Many of these experimental drugs and treatments can cause some level of harm. This concept suggest that the level of harm not be in excess.
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Informed Consent
In order for patients to consent to experimental drugs and/or treatment they must be informed of the risk, purpose, benefits, methods, and any alternatives that may be available for treatment. “Informed consent is one of the most important aspects of research ethics” (Gupta, 2013). The Food and Drug Administration (FDA) put in place criteria that informed consent was essential to
protecting any patient who agreed to participate in experimental treatment or drug research. Obtaining informed consent conveys to the physicians that the patient made an educated and informed decision on their treatment options. Unapproved Experimental Drugs
There are patients who may not have many options when it comes to receiving treatment or medication for their illness. This could be due to not having the financial means to cover treatment or their insurance policy isn’t going to cover it. As a result of these challenges, they may seek out unapproved experimental treatment or drug research. Although federal law requires most insurance plans cover patient care expenses that may be associated with clinical trials, there are often loopholes in the plan, so sometimes the care isn’t covered. The costs of these treatments will then fall on the patient. If a pharmaceutical company engages in an unapproved drug research, there’s little to no regulation in place by the FDA. This could lead to the product being defective which could impact the patients’ health. The use of unapproved experimental treatment and drug research is often utilized by those with debilitating diseases and life-threatening illnesses. Because of the potential for a defect in these unapproved drug treatments, the FDA amended the regulations over the years to offer guidelines on how unapproved experimental research should be conducted, and any incorporating standards (Rakowski, 2010).
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Pre-Approved Drugs
The implementation of the Right to Try Act and the Expanded Access Program allowed for patients to request permission to enter into pre-approved experimental drug programs or treatments with or without the approval of the FDA (Raus, 2016). The Right to Try Act allows patients to contact the pharmaceutical company directly thus allowing them to skip the waiting time put in place by the FDA. This doesn’t mean that the company has to accept the patient into their program, they can still be denied access to the drug or treatment. Those who oppose pre-
approved medicine believe that careful and more thorough testing should be done before expanding to a broader group of patients. “The majority of alternative medicine users appear to be doing so not so much as a result of being dissatisfied with conventional medicine but largely because they find these health care alternatives to be more congruent with their own values, beliefs, and philosophical orientations toward health and life” (Astin, 1998). There are patients who are terminally ill, along with their doctors and supporters that feel very differently about the expansion of pre-approved experimental treatments. Patients who are terminally ill have a limited time left and are more inclined to seek alternative drug treatment. Cancer patients who are terminally ill are a prime example of those who seek alternative drug treatment plans. Conclusion
In conclusion, patients are often faced with many obstacles when it comes to treating illnesses
or diseases, especially when they are life-threatening. The option to seek an alternative approach
such as experimental drug studies may be the only option they have. The implementation of the Right to Try Act, the expanded access program, as well as the informed consent of the patient
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gives them hope for extending their life or having a normal one. In my opinion, these factors lead me to feel that the patient has the right to seek access to experimental drugs or treatment.
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References
Mahant, V. (June 23, 2020). “Right-to-Try” experimental drugs: An Overview
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02427-4
Food and Drug Administration
https://www.usa.gov/agencies/food-and-drug-administration#:~:text=The%20Food
%20and%20Drug%20Administration,and%20products%20that%20emit%20radiation
.
Rakowski, S. (September 28, 2010). Ethical Considerations in Access to Experimental Drugs for Treatment Use.
https://elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1153&context=ymtdl
Jahn, W. (September 2011). The 4 basic ethical principles that apply to forensic activities are respect for autonomy, beneficence, nonmaleficence, and justice. Journal of Chiropractic Medicine
https://www.sciencedirect.com/science/article/abs/pii/S1556370711001052
Evolving Ethics of ‘Right to Try’ Unproven Drugs (February 01, 2021). https://www.reliasmedia.com/articles/147475-evolving-ethics-of-right-to-try-unproven-
drugs
Gupta, U.C. (Jan-March 2013). Informed consent in clinical research: Revisiting few concepts and areas. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601699/
Astin, J. (May 20, 1998). Why Patients use Alternative Medicine
https://jamanetwork.com/journals/jama/fullarticle/187543
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