The Ethics of Gene Therapy: Balancing the Risks Introduction [Cover: discussion about how risks are balanced during risk assessment, why this is a difficult task -> proposing a set of principles and practical measures that might assist both researchers and patients, to enable more informed decisions about risk] Ethics and gene therapy Since its inception, gene therapy has captured the attention of the public and ethics disciplines as a therapeutic application of human genetic engineering. The latter, in particular, has lead to concerns about germline modification and questions about the distinction between therapy and enhancement. The development of the gene therapy field and its progress to the clinic has not been without controversy. Although initially considered as a promising approach for treating the genetic of disease, the field has attracted disappointment for failing to fulfil its potential. With the resolution of many of the barriers that restricted the progress of gene therapy and increasing reports of clinical success, it is now generally recognised that earlier expectations may have been premature. High profile adverse events resulting in disproportionate media attention have prevented a greater difficulty for the field, with the death of Jesse Gelsinger in a trial of gene therapy for ornithine transcarbamylase deficiency undermining public trust of clinical research in the US. There is a danger that the gene therapy field may have become too risk-averse in response to these adverse events, and that this could manifest as fewer trials that take longer to commence. In the context of a research environment that is increasingly turning to the developing world for the expedient conduct of clinical trials, it is imper... ... middle of paper ... ...matopoietic compartment using integrating vectors particularly need to understand genotoxicity risks in relation to the risks of conventional bone marrow transplantation. A QPL could direct them to ask questions about risk, benefits and survival rates following transplantation at local centres; the prognosis of patients in the different haematopoietic gene therapy trials; the number and status of patients that developed leukaemia in the SCID-X1 gene therapy trials; and whether there are any differences between the proposed vector and the vector used in the SCID-X1 trial and any possible safety developments. This kind of guidance may help patients understand both what is known and unknown about specific applications of gene therapy. Conclusion [Could invite the GT societies to develop their own standards/guidelines and post on websites for use of their members?]
A person's individuality begins at conception and develops throughout life. These natural developments can now be changed through genetically engineering a human embryo. Through this process, gender, eye and hair color, height, medical disorders, and many more qualities can be changed. I believe genetically engineering a human embryo is corrupt because it is morally unacceptable, violates the child's rights, and creates an even more divided society.
Over 20 years after the proclamation of these specific ethical guidelines, we are introduced to the University of Pennsylvania’s Institute for Human Gene Therapy’s study on a delivery mechanism for gene therapy that resulted in the death of an 18 year old research subject Jesse Gelsinger. Gelsinger suffered from partial OTC (ornithine transcarbamylase) deficiency caused by a defective single gene (Obasogie, 2009).
...the tools meet both CPA and Health of the Nation outcome scales requirement (DOH 2007). The Risk is assessed using the Face Risk Profile. This tool is really easy to use as it has Five sets of Risks indicators, these are then coded as present or absent and a risk status (0-4) is judged (DOH 2007). The problem with this assessment is that the patient would sometimes need to be involved and at present because of Julie’s presenting problems this would not be able to happen but parts of the Risk Profile can be filled in by the Nurse who is in charge of Julie care and wellbeing. The problem with the actuarial approach is that sometimes these tools may not give a conclusive answer to the problem. However many researchers would suggest that the use of both actuarial and clinical risk assessment would be better for a nurse to use to come up with an accurate risk assessment.
... fight the disease. It is crucial that regulation be a necessary component of gene therapy research and applications. In hopes that the government can regulate and can receive this treatment, not restricting it to people that has serious genetic diseases. Gene therapy will change the field of medicine from what it is today. As scientist discovers more genes and their functions, the potential of this treatment is limitless. Though gene therapy is an auspicious treatment choice for numerous diseases (including inherited disorders, some types of cancer, and certain viral infections), the procedure remains precarious and is still under study to make sure that it will be safe and effective. Thus government regulators and scientist must take a lead role in adopting a practical approach to address these issues and determining the correct procedures for dealing with them.
Human gene therapy is a method used in the medical field that treats diseases at a molecular level, by solving the source of the problem; our genes. Today, diseases and disorders are commonly treated by solving the symptoms, the surface of the problem. Many disorders and diseases are caused by defective proteins and within those defective proteins are damaged and defective genes. These defective genes can be treated through gene therapy. Gene therapy is not new and has been developed and improved by researchers for the past couple years. Being an experimental technique, gene therapy also has its pros and cons, but so far is showing positive and rising success rates.
...2011). Risk assessment has evolved and research has shown that Structured Professional Judgement emerges as the most promising way forward in risk assessment, as it includes both static and dynamic risk factors, and combines statistical accuracy with clinical experience.
Over 40 years ago, two men by the names of James Watson and Francis Crick discovered deoxyribonucleic acid, or DNA. DNA is hereditary material in humans and almost all other organisms (What is DNA?). From this finding, gene therapy evolved. Today, researchers are able to isolate certain specific genes, repair them, and use them to help cure diseases such as cystic fibrosis and hemophilia. However, as great as this sounds, there are numerous ethical and scientific issues that will arise because of religion and safety.
Gene therapy is a technique which has developed in the wake of recombinant DNA (rDNA) technology. It is a process which results in the correction of a genetic disorder by the addition of a piece or fragment of DNA into the genetic material of a living, functioning cell. A mere thirty years ago this concept belonged to the realm of the human imagination made manifest in the works of science fiction. Today it belongs to the realm of the human imagination made manifest in the works of science, period. It is mind boggling to try to comprehend the far reaching effects of gene therapy. How is it affecting society? Who will benefit from its use? Should it be used at all? Should research continue? How do we answer all of these questions? The answers are not readily available, nor are they black and white, but an attempt at finding some solutions must be made. Before exploring this line of thought further, a basic understanding of the technical aspects of gene therapy is essential.
Despite being magical of gene therapy, it is high-risk. Few people got benefits from it, and it has a low rate of success. Prior to the human trial, Batshaw and Wilson had done experiment on animals to ensure the safety. Over 20 experiments have been done on mice but only 12 of them survived at last (Sophia, M. and Kolehmainen, J.D., 2000). More seriously, complicating diseases, which can be more dangerous than genetic diseases, might set in during the treatment period. In December 200...
It was a treatment for a four-year-old girl named Ashanthi DeSilva, who were born with an adenosine deaminase (ADA) deficiency, an autosomal recessive disorder that affect the immune system. Her doctors genetically modified her defective immune cells to function as normal ones. Then, they used a virus that also had been genetically modified to remove its harmful genes to deliver the corrected immune cells back to her body. This early success led to many other gene therapy trials in the 1990s for different kinds of genetic diseases, until a tragic setback happened. In September 1999, Jesse Gelsinger became the first person who died after undergone a gene therapy for ornithine transcarbamylase (OTC) deficiency, a rare metabolic disorder. He died from massive organ failure caused by a bad reaction of his immune system to the virus used in the therapy (Thompson
In this paper, I will argue that genetic therapies should be allowed for diseases and disabilities that cause individuals pain, shorter life spans, and noticeable disadvantages in life. I believe this because everyone deserves to have the most even starting place in life as possible. That is no being should be limited in their life due to diseases and disabilities that can be cured with genetic therapies. I will be basing my argument off the article by “Gene Therapies and the Pursuit of a Better Human” by Sara Goering. One objection to genetic therapies is that removing disabilities and diseases might cause humans to lose sympathy towards others and their fragility (332). However, I do not believe this because there are many other events and conditions in society that spark human compassion and sympathy towards others.
The Human Genome Project is the largest scientific endeavor undertaken since the Manhattan Project, and, as with the Manhattan Project, the completion of the Human Genome Project has brought to surface many moral and ethical issues concerning the use of the knowledge gained from the project. Although genetic tests for certain diseases have been available for 15 years (Ridley, 1999), the completion of the Human Genome Project will certainly lead to an exponential increase in the number of genetic tests available. Therefore, before genetic testing becomes a routine part of a visit to a doctor's office, the two main questions at the heart of the controversy surrounding genetic testing must be addressed: When should genetic testing be used? And who should have access to the results of genetic tests? As I intend to show, genetic tests should only be used for treatable diseases, and individuals should have the freedom to decide who has access to their test results.
Bergeson, E. (1997) The Ethics of Gene Therapy [Online] Available at: http://www.ndsu.edu/pubweb/~mcclean/plsc431/students/bergeson.htm [Accessed 14 July 2011]
Due to the fact that the field of biotechnology is very serious and potentially dangerous, rules must be set down in order to keep the research in check. The high risk research of genetic therapy needs guidelines that have to be followed in order to keep the study just. The articles that are discussed in this essay focus on ethical issues and ideas that should be followed in the field in order to keep research safe and valid.
Among these technical holdups, research in biotechnology has run into serious problems. In his article titled “Human Gene Therapy: Harsh Lessons, High Hopes”, Larry Thompson, tells of more setbacks the industry has come upon.