Wait a second!
More handpicked essays just for you.
More handpicked essays just for you.
Essays on gene therapy
Issues surrounding gene therapy
Gene therapy disagreement essay
Don’t take our word for it - see why 10 million students trust us with their essay needs.
Recommended: Essays on gene therapy
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004) 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 …show more content…
The Gelsinger family was unaware of the resultant death of two test rhesus monkeys receiving the same treatment that Jesse would undergo, and both the family and the governmental agencies were not given notice to the adverse events that had occurred in previous research subjects in the same study. Moreover, investigation into the study has declared that Jesse Gelsinger was ineligible to be a participant, as his liver (into which the gene therapy adenovirus was injected) was not functioning well enough to participate in the first place. The last aspect that was undisclosed was the fact that the individual overseeing the study had a monetary interest in achieving a successful result. Dr. John Wilson, owned a considerable stake in the private corporation that was providing funding. (Stolberg) The lack of the comprehensive disclosure required in obtaining an informed consent had been argued and found to be insufficient, with restrictions placed on Dr. Wilson’s operation and ability to conduct future clinical trials. (Stolberg). We are unable to know if the Gelsinger family would have changed their minds had they been given such information, completely and correctly, but we do know that Jesse Gelsinger was failed by the study investigators in the ability to give the informed consent as outlined by the Respect for Persons …show more content…
(n.d.). The New York Times - Breaking News, World News & Multimedia. Retrieved September 24, 2011, from http://www.nytimes.com/2000/11/04/us/penn-settles-suit-on-genetic-test.html?ref=jessegelsinger STOLBERG, S. G. (n.d.). Institute Restricted After Gene Therapy Death. The New York Times - Breaking News, World News & Multimedia. Retrieved September 22, 2011, from http://partners.nytimes.com/library/national/science/health/052500hth-gene-therapy.html?scp=9&sq=FDA%20jesse%20gelsinger&st=cse STOLBERG, S. G. (n.d.). F.D.A. Officials Fault Penn Team in Gene Therapy Death - New York Times. The New York Times - Breaking News, World News & Multimedia. Retrieved September 21, 2011, from http://www.nytimes.com/1999/12/09/us/fda-officials-fault-penn-team-in-gene-therapy-death.html?ref=jessegelsinger STOLBERG, S. G. (n.d.). U.S. Panel Moves to Force Disclosure in Gene Testing - New York Times. The New York Times - Breaking News, World News & Multimedia. Retrieved September 22, 2011, from
During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure assures that all human rights are safeguarded during the entire research process.
The beginning of Gene Therapy began in the late 1980’s, which was completely unsuccessful. In the fall of 1999 the death of University of Pennsylvania trial participant, Jesse Gelsinger was followed by much public outcry and legal problems that put an immediate halt on all gene therapy research. The reason Jesse was being treated with Gene therapy was to attempt to cure the teenager’s rare liver disease.
... 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.
Teutch, S., & Tuckson, R. Department of Health & Human Services, (2008). U.S. system of oversight of genetic testing: A response to the charge of the secretary of health and human services. Retrieved from website: http://osp.od.nih.gov/sites/default/files/SACGHS_oversight_report.pdf
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.
Lee, Thomas F. “Gene Therapy is Beneficial.” Genetic Engineering: Opposing Viewpoints. Ed. Carol Wekesser. San Diego: Greenhaven Press, Inc., 1996. 166-173.
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
"What's the worst that can happen to me? I die, and it's for the babies," said Jessie Gelsinger as he left for the hospital to receive gene therapy treatment. (Stolberg) People risk their lives everyday in the name of science. One such science that people have recently been drawn to is gene therapy. Although, gene therapy may be new and exciting and it may be helping to find cures to diseases we only dreamed of curing, we have to remember it is dangerous. It needs to be done with much supervision. Every new step we take in the advancement of gene therapy should be thought over because the consequences could reach farther then we ever believed they could. There are so many dangers of the techniques used that can lead to consequences as serious as death. The government imposes many guidelines, and it needs to stay that way. The biggest dangers, however, may be in what is to come.
Herscher, Elaine. "Fighting Diseases with Genetic Therapy." Los Angeles Times. Los Angeles Times, 13 Sept. 2012. Web. 19 May 2014.
Advancements in medical technology can be associated in great part to human experimentation. It is widely known that medicine created for humans, in order to be proven effective, must undergo human clinical trials. When this form of experimentation is voluntary it benefits all of humanity. It just so happens that unfortunately, sometimes volunteers are misinformed of the dangers of the trial or are tested without their knowledge. This world wide issue has been attempted to be remedied through laws and regulations, but loopholes can still be found within them. Time has proved to the world that these laws are simply not enough. Stricter laws should be enacted to prevent the world's history of unethical human experimentation from repeating itself.
Walters, LeRoy, and Julie Gage Palmer. Ethics of Human Gene Therapy. Oxford University Press, New York. 1997.
...obert J.. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg, 1986. Print.
The controversy arises from both the techniques and aims of gene therapy. Gene therapy attempts to correct the "deleterious effect(s) of a genetic disorder"(Wheale & McNally, 212) through the replacement or repair of defective genes in human cells. The basic technique of such therapy involves either replacing the activity of a defective gene with a previously dormant gene or inserting genetic material into defective cells(212). The danger of such therapy is due to risks inherent in the techniques. Scientists, for example, may not fully and accurately...
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.
Jan.-Feb. 1998: 39-43. Gregory, Tanya and Nelson A. Wivel. "Clinical Applications of Molecular Medicine" Patient Care 15 Nov. 1998: 86-102. " Human Gene Therapy" National Reference Center for Bioethics Literature 1999 Internet.