Human death caused by genetic research. Social Sciences Essay

HUMAN DEATH CAUSED BY GENETIC RESEARCH
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Case overview and key facts
Jesse Gelsinger was involved in a genetic research clinical trial that led to his death. From the details of the case, it seems that Jesse and his father Paul Gelsinger were not sufficiently informed on the probable side effects of the procedure that Jesse went through. At the time of his death, Jesse was already eighteen and he participated in the research voluntarily hoping that it could lead to breakthroughs in treating OTC in children and probably himself. The doctors had informed him about possible side effects such as flu-like symptoms, little chance of hepatitis and very slight chance of death. The doctors who briefed Jesse failed to informed of earlier complications to other human subjects who had undergone the procedure earlier had suffered grade 3 or higher toxicities. Grade 3 or higher toxicities should have halted the clinical trials before Jesse was subjected to them. additionally, two monkeys which had been used as clinical trial subjects had also died. Additionally, at the time of Jesse’s commencement into the clinical trial, his blood ammonia was 114 which was higher than the eligible level of 70. It is also important to note that Jesse was healthy by the time he undertook the procedure and he had been managing his condition well such that he was relatively enjoying his life. thus, he did not have any life-threatening condition that would make him desperate to try the new ‘therapy treatment.’ Additionally, the researchers withheld a lot of important information from Jesse and his family about the outcome of previous cases on animal and other human subjects and that they also had a financial interest in the research should it be successful.
The ethical issues and problems raised by the case
The researchers had a financial interest in the conducting the clinical trials. Dr. Wilson who was the head of IHGT (the Institute for Human Gene Therapy) and the sponsor and chief investigator of the OTC deficiency study had a 30% stake in a Genovo. IHGT was accepting $4 million a year for five years from Genovo for genetic research, and in return it allowed Genovo to seek licenses and patents and to earn profit on future developments by the IHGT or its researchers. Dr. Wilson having a stake in Genovo, a company that stood to benefit from the research is itself a conflict of interest given that he was the chief investigator of the clinical study.
The researchers failed to follow FDA approved guidelines to conduct clinical trials. First, they gave Jesse a FDA non approved form to sign. Secondly, they did not report the earlier cases of monkeys that died during earlier trial of the same procedure. Fourthly, they violated the guidelines that stipulated that the trials should have stopped when earlier subjects developed grade 3 or higher toxicities from earlier subjects. They also proceeded to carry out the exercise on Jesse who had blood ammonia levels at 114 higher than the approved levels. Additionally, the researchers failed to sufficiently inform Jesse and his family on the potential side effects of the treatment including details of how earlier subjects had suffered grade 3 toxicities...