RTT Right To Try, FDA Food and Drug Administration, EAP Expanded Access Program, experimental drugs, public health, ethics, safety, american society
In his article, Right-to-Try' experimental drugs: an overview, Vijay Mahant delves into the right to try (RTT) law on experimental drugs. Mahant, the founder of MediLite Diagnostika Inc., located in San Diego, has offered great insight regarding RTT, including its advocacy and criticism. The article highlights some of the pros and cons of the RTT law passed in May 2018 by the former president of the US, Donald Trump. Mahant (2020) explores the origin of RTT following the death of Abigail, a patient whose doctor had recommended the use of the investigational drug for her colorectal cancer. However, due to the limitations of the FDA, she was unable to get this drug, prompting her death and the start of the advocacy of experimental drugs without FDA involvement.
[...] For example, when this policy was enacted into law, it enabled individuals with life-threatening conditions to seek alternative treatment and drug trials as a way of giving them a second chance at survival and hope to live healthy lives when all the other treatment options have failed. With the patient's consent, RTT enables physicians and other healthcare providers to help patients recover from their illnesses and even prolong their lives, which may have been cut short if the normal treatment models are applied (Brown et al., 2018). [...]
[...] H., & Zettler, P. J. (2020). Right to try requests and oncologists' gatekeeping obligations. Journal of Clinical Oncology38 (2), 111. Mahant, V. (2020). "Right-to-Try" experimental drugs: an overview. Journal of Translational Medicine, 18(1), 253. [...]
[...] Additionally, due to the medical terminologies used, the patient usually has limited understanding of the investigational drugs, thus hampering their informed consent regarding the administration of trial drugs, which may cause more severe health issues and even death (Mahant, 2020). Lastly, RTT is often associated with creating high optimism and high patient expectations, which may be misleading and give false hope to the patient and their families. V. The Public's Perception of RTT There is a contentious debate on the right to try law used in public health. [...]
[...] Implementing this law in the community would give hope of survival and living healthy lives to many individuals who have run out of options and lost hope of survival. The provision of these drugs would enable patients to take control of their lives by building optimism and accessibility to several therapeutic interventions that may positively contribute to improved quality of life and, thus, prolonged lives, especially among these patients for whom the investigational drugs yield positive results. III. The Role of Public Health Officials and the Ethical Protocol They Ought to Follow When Dealing with RTT in Relation to Public Health Program Delivery, Quality, and Effectiveness Public health officials play a critical role in ensuring the community's public safety. [...]
[...] Thus, this aspect depicts the vital role that oncology health workers play in ensuring effective RTT applications by adhering to specific protocols. Lynch et al. (2020) argue that these healthcare providers are responsible for helping patients pursue research and clinical options with experimental drugs to reduce the harms of these trial drugs. Besides, the physicians have an obligation to discard experimental drugs even when the patient meets the eligibility criteria as a way of observing the principle of beneficence and ensuring the overall good of the patient and safety from any form of harm that may be linked to the drug (Lynch et al., 2020). [...]
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