tsue response
- When the subject was announced, what was your initial impression? Were you for or against?
- Did this presentation have an effect on your initial impression?
- What, if any, information was left out of the presentation?
- What questions do you have after the presentation?
In your responses to peers, provide at least one reference with in-text citations to current literature and assigned readings to support your assertions. If you copy and paste references from the course into your discussion, be sure to confirm APA formatting before submitting.
PEER:
Gene therapy is an innovative medical therapy that involves modifying or manipulating genes to prevent or treat disease by correcting or treating the underlying genetic problem (U.S. National Library of Medicine, 2021). There have been many advances in gene therapy since its early experiments in the 1980s, such that both inherited genetic disorders, like hemophilia, cystic fibrosis, or sickle cell disease, and acquired diseases, like cancer or HIV, can be treated with gene therapy (Gene therapy, n.d.). While the mechanisms of gene therapy can be complex, its primary function is to utilize genetic modification tools to manipulate missing or defective genes that are responsible for the development of a disease. Gene therapy can be used to replace mutated genes with healthy ones, inactivate faulty genes that are causing disease, or introduce new genes to help the body fight or treat disease (U.S. National Library of Medicine, 2021). Genetic material or gene-editing tools are carried into the cells by a vector, usually modified viruses like retroviruses or adenoviruses. Tiny particles called nanoparticles can also be used to deliver genetic material or gene-editing components into cells, and are useful because they are less likely to cause immune reactions than viral vectors and can be specifically designed to target certain cell types.
Benefits of Gene Therapy
Gene therapy carries tremendous potential to transform medicine as we know it. While many of its earliest studies demonstrated serious health risks such as toxicity, inflammation, and cancer resulting from immune reactions to viral vectors or malfunction of the genetic material, which will be discussed shortly, extensive research and regulatory developments have accelerated the progress and expanded the potential of gene therapy. Safety regulations from the U.S. Food and Drug Administration (FDA) regulate gene therapy products and clinical trials investigating gene therapy in the United States, and the National Institute of Health (NIH) provides guidelines for investigators and institutions regarding clinical trials. Additionally, an Institutional Review Board and an Institutional Biosafety Committee must approve each clinical trial, ensuring that safety considerations are a top priority through multiple levels of evaluation and oversight.
Gene therapy presents significant benefits to its recipients. Because gene therapy has the potential to cure diseases at the source by eliminating or repairing the genetic damage or malfunction causing the disease, it provides long-term effects and relief not only from the disease itself but also from the need for long-term treatment with medications that could be costly or have negative side effects. Genetic treatments can be tailored to the genetic profile of each individual receiving treatment, leading to more effective and targeted therapies that, if successful, could improve quality of life and reduce the need for ongoing treatments. This can significantly reduce the physical, emotional, and financial burden of chronic diseases on patients, their families, and the healthcare system.
Risks of Gene Therapy
While the benefits to gene therapy are substantial, it is also important to recognize its associated challenges and risks. While there are many comprehensive federal laws, regulations, and guidelines to protect those who participate in gene therapy clinical trials and ensure the safety and efficacy of gene therapy, ongoing research is still needed to minimize risks like immune reactions and off-target effects of genetic material. The body’s immune system may recognize the viral vector used to deliver the genetic material or gene-editing components into the cell as a foreign substance and mount an immune response against it, which can lead to inflammation, fever, or more serious reactions that could negatively affect the health of the patient. There is also the risk that the integration of new genetic material into a patient’s genome can disrupt normal genes, potentially causing cancer or other genetic disorders. The introduction of a new gene or gene-editing tool may also affect parts of the genome other than its intended target, causing unintended genetic modifications that can cause new diseases or health issues.
Gene therapy treatments can also be extremely expensive, making widespread access and affordability of these treatments a challenge. Additionally, curative results of gene therapy treatment cannot be guaranteed due to the ongoing nature of gene therapy research. This means an individual could pay for the expensive treatment only for it not to work or have unintended side effects, leading to further physical, emotional, and financial stress related to the disease and its treatment. There are also ethical considerations to make when considering gene therapy as a treatment modality.
Ethical Considerations
Gene therapy raises several significant ethical considerations. Given its safety concerns, such as immune reactions or off-target effects, the ethical principle of nonmaleficence must be considered as the potential benefits of gene therapy are balanced against the potential for harmful side effects (Morrison & Furlong, 2019). The ethical principle of justice must be considered in the discussion of gene therapy, as gene therapy treatments are often very expensive and may be self-limiting in terms of equitable access to these treatments. This raises the ethical dilemma of potentially creating disparities in access to these treatments, where patients from different socioeconomic statuses may not have fair access or the opportunity to benefit from gene therapy.
Privacy may be a concern with gene therapy as well, as it involves collecting and manipulating patients’ genetic information. If this genetic data is not securely protected, it may be misused or accessed without authorization, negating a patient’s autonomy and right to privacy. A breach in the privacy of one’s genetic information could lead to discrimination by employers, insurance, or healthcare providers, causing physical and emotional damage to the patient. Patients must also be given the opportunity to provide informed consent before submitting to gene therapy treatments, with thorough education regarding the potential risks, benefits, and uncertainties associated with gene therapy.
There is a type of gene therapy called germline editing which raises significant ethical concerns within the healthcare community, where genes in eggs, sperm, or embryos are modified to create changes that can be inherited, rather than treatment that only affects the treated individual. Many people have moral and religious objections to this type of gene therapy, and the NIH does not fund any research using germline editing (What are the ethical concerns of genome editing, n.d.). While evidence-based practice is the cornerstone of healthcare, spirituality plays a large role in healthcare delivery, and ignoring the moral and spiritual aspects of healthcare, especially regarding such a controversial topic, could itself be unethical (Freeman & Morrison, 2019). Ethical concerns exist regarding the use of gene therapy for the purpose of genetic enhancement of basic human traits like height, intelligence, or athletic ability, as this raises issues of justice, consent, and societal impact of the ethical implications of therapeutic genetic modifications.
Personal Beliefs
Gene therapy is a complex issue that reflects the impressive advancements in science and healthcare and also represents the controversial power that the human race could have over their very genetic makeup. I believe that there is unique potential within the realm of gene therapy that can significantly benefit individuals with rare or severe genetic disorders. Given the potential risks of gene therapy, I think that as with any medical treatment, patients should be thoroughly educated on the risks, benefits, and potential complications of gene therapy and given the opportunity to provide informed consent to available and approved gene therapy treatments, and that special care is taken to ensure that consent is truly informed, especially when dealing with vulnerable populations like children. As with anything, I think that too much power can be a dangerous thing, and I think the limitations on germline therapy and therapeutic genetic enhancement are justified. I am interested to see the way gene therapy changes as more research is done in the future.
Conclusion
Gene therapy is a complex modality that offers many significant potential benefits and presents complex ethical challenges. Addressing these challenges requires a multifaceted approach involving informed consent, just and equitable access, rigorous regulatory oversight, and ongoing research and development. Gene therapy holds great potential to revolutionize medicine, and despite its challenges, the promise of gene therapy and its potential for personalized medical treatments continue to drive significant growth and progress in the medical world.
References
Freeman, D.R. & Morrison, E.E. (2019). Spirituality and healthcare organizations. In Morrison, E.
E., & Furlong, E. (Eds.), Health care ethics: Critical issues for the 21st century (pp. 161-182). Jones & Bartlett Learning.
Gene therapy. (n.d.). National Human Genome Research Institute. Retrieved July 22, 2024 from
Morrison, E. E., & Furlong, E. (Eds.). (2019).Health care ethics: Critical issues for the 21st
century(4th ed.). Jones & Bartlett Learning.
U.S. National Library of Medicine. (2021). Help me understand genetics: Gene therapy and other
medical advances. https://medlineplus.gov/download/genetics/understanding/therapy.pdf
What are the ethical concerns of genome editing? (n.d.) National Human Genome Research
Institute. Retrieved July 24, 2024 from https://www.genome.gov/about-genomics/policy-issues/Genome-Editing/ethical-concerns.
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