The death of Jesse Gelsinger made the Gene Therapy Experiment appear as a disaster in the world the clinical research. Jesse Gelsinger died in 1999 during a clinical trial that attempted to treat genetic diseases making him the first in human history to lose his life and the public being made aware. The main reason why the family of Gelsinger opted for the trial was that he has suffered from ornithine transcarbamylase deficiency. According to Greenberg (2007), the disease was an X-linked genetic disease of the liver, exhibit symptoms some of which are the inability to metabolize ammonia a byproduct of protein breakdown. The trail that Jesse got involved with on 13 September 1999 was a project operating under the watch of the University of Pennsylvania that had the main objective of formulating a medical solution to an infant born with the severe illness. The injection process that Jesse underwent of introducing a corrected gene in his system using adenoviral took place of the same date, 13 September 1999. After four days of the whole process, Jesse Gelsinger died on the 17th of September 1999 at 2:30 pm at the age of 18, thus making the whole process a disaster. The primary cause of his death was attributed to a failure of a number of his organ and the death of his brain as a result of massive immune response.
The death of Jesse contributed to various consequences that both the operators of the project and the Gelsinger family had to undergo. For example, on January 21, all gene therapy trials were shut down by the FDA after a serious study of the whole process that took a period of three months. Some people were affected since Pennsylvania Institute, the largest in the generic therapy project, with an annual budget of $25 million, a staff of 180, and a relation with various companies (Tom, 2000). The staff members of the institution lost their jobs because the FDA had found several law offenses that violated the human right that underpinned the institution. For example, the offenses included the admission of 18 patients for the study without following the proper channels as stipulated in the federal rules and regulation. About eight institutions that got engaged with gene therapy were closed down. In addition, the family of Jesse had to go through certain consequences too, such as facing the law to find justice for their child and preventing others from falling victim of the same fate. Therefore, this called for some legal issues that both the institution and the family had to go through, especially the FDA rules and regulations in OTC trials (Tom, 2000).
Some ethical/legal issues that came up during the law trial on the issue of Jesse's death and they include. It is a correct of every individual to determine his/her willingness to participate in any given medical experiment. The belief that a given individual should be fully aware of the medical experiment is minute in as far as using the human subject for an experiment is a concern. Conflict of interest is another ethical issue that cropped up since it may have influenced the decisions of the scientists carrying out the project. For example, the motive of some doctor involved in the experiment saw it as money making opportunity for them, in the sense that, in case the trial on Jesse worked, they would sell it to other researchers in exchange for money
The situation of Jesse Gelsinger has contributed greatly to the growth and development of research work that involves troubled humans in the modern world. It is reported that, in the recent times, the 20 largest American drug companies mostly use the outside world to carry out clinical trials, and half of where the trials are carried out are in a foreign land (NEJM, 2009). As a result, this has created an economic boom to the US, increased the curiosity of poor states in the medical field and provided the license for research to be carried out.
Greenberg, Daniel S. "Science for Sale. The Perils, Rewards, and Delusions of Campus Capitalism". Chicago: U. Chicago Press, 2007, 324pp., pages 104106.
New England Journal of Medicine report: Health Care 2009: The role of medical liability reform in Federal Health Care Reform: July 2nd, 2009.
Tom Bishop (2000). Gene therapy trials shut down at the University of Pennsylvania following patient death. http://www.wsws.org/sections/category/news/health.shtml.
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