Puneet Cheema 12/5/2014
PHIL 355 Professor Stacey Elizabeth Ake
Extra Credit Opportunity #1: What is the story of Jessie Gelsinger? What was its impact on the development of gene therapy? In September 1999, Jesse Gelsinger passed away. It is often remembered by many medical researchers despite not really being a household name. It happened through the gene therapy clinical trial that altered the field, similarly to the Tuskegee experiments. The research practices were very questionable and eventually led to the death of Jesse Gelsinger (Obasogie). Gelsinger was an interesting medical participant because he suffered from ornithine trascarbamlase deficiency (OTCD) which was considered a rare metabolic disorder that blocks the body from being able to …show more content…
A big question was the information gap between the researchers and the clinical trial patients that can turn a volunteer quickly into a victim. Questions such as: “What constitutes informed consent? And what’s relevant a patient’s decision to participate in a clinical trial?” It was clearly seen that the University of Pennsylvania’s clinical trial lacked aspects of these three important questions. First off, Gelsinger and his family were often under the idea that the pre-clinical animal studies would make sure of the safety of the trial despite the fact that two monkeys actually passed away. This was seen by the National Institutes of Health review board but not the consent form that was signed by Jesse Gelsinger. The Penn researchers are not disclosing to either Gelsingers or federal investigators that other human volunteers suffered similar reactions. Only fewer than 6% were found to have adverse events associated with the given gene therapy at the time, this was collected slightly after Gelsinger’s passing. The lead researcher, James Wilson, did not disclose the fact that this clinical trial was part
PHIL 355 Professor Stacey Elizabeth Ake
Extra Credit Opportunity #1: What is the story of Jessie Gelsinger? What was its impact on the development of gene therapy? In September 1999, Jesse Gelsinger passed away. It is often remembered by many medical researchers despite not really being a household name. It happened through the gene therapy clinical trial that altered the field, similarly to the Tuskegee experiments. The research practices were very questionable and eventually led to the death of Jesse Gelsinger (Obasogie). Gelsinger was an interesting medical participant because he suffered from ornithine trascarbamlase deficiency (OTCD) which was considered a rare metabolic disorder that blocks the body from being able to …show more content…
A big question was the information gap between the researchers and the clinical trial patients that can turn a volunteer quickly into a victim. Questions such as: “What constitutes informed consent? And what’s relevant a patient’s decision to participate in a clinical trial?” It was clearly seen that the University of Pennsylvania’s clinical trial lacked aspects of these three important questions. First off, Gelsinger and his family were often under the idea that the pre-clinical animal studies would make sure of the safety of the trial despite the fact that two monkeys actually passed away. This was seen by the National Institutes of Health review board but not the consent form that was signed by Jesse Gelsinger. The Penn researchers are not disclosing to either Gelsingers or federal investigators that other human volunteers suffered similar reactions. Only fewer than 6% were found to have adverse events associated with the given gene therapy at the time, this was collected slightly after Gelsinger’s passing. The lead researcher, James Wilson, did not disclose the fact that this clinical trial was part