Essay Example on Jesse Gelsinger: Battling OTCD and Pursuing His Dreams

Jesse Gelsinger was a sharp and very ambitious kid who loved professional wrestling and motorcycles. He has a metabolic disorder called ornithine transcarbamylase deficiency syndrome that is simply referred to as OTCD. It is a condition where ammonia builds up to some lethal levels in the blood. Children born with the condition either die after birth or get brain damage (Turrens & Springer, 2019). The mild version of Jesse was identified at his two years ago. The condition was only managed by taking pills, about fifty per day, but he declined the use at his 17 years of age. One day he was found by the father to be vomiting severely, and that led to him being inducted into a comma.

Is your time best spent reading someone else’s essay? Get a 100% original essay FROM A CERTIFIED WRITER!

Save 25%

Jesse was approached by Dr. Randy, who was his pediatric geneticist for a gene therapy trial on the corrective OTC genes that were encased in attenuated cold flu, which is a combination of the adenoviral vector. The clinical trial determined the creativeness of OTC and could, therefore, help the new bourns that suffered the fatal disease, therefore not benefiting Jesse (Ballyram, 2017). However, he was willing to participate for the sake of the young ones that were being born.

Clinical trials follow different phases and steps that are planned differently depending on the stage. The first phase of the clinical trial is to test the new treatment that is being studied for the first time. In that phase, there is a small number of people who receive the experimental treatment with the main aim of finding out if the treatment is safe and also gaining information on the testing dose recommended. Jesse was infused with corrective OTC on September 13th, 1999, in his hepatic artery.

Jesse experienced a very severe immune reaction to the infused vector and died after four days. After post mortem, it was identified as the exact cause of death to be adult respiratory disease syndrome. The lungs had shut down, but before that, she had a failure of multiple organs that led to the blood clotting, kidney failure, and brain death.

The IRB is responsible for verifying the research protocols that comport with the federal criteria that ensure human subject protection. IRB serves the hospital or a research institute with the membership being voluntary (Ballyram, 2017). The members of IRB assume great legal and ethical obligations that ensure the subject's health and have a safe and health considerations in the human-based research. The IRB assessed whether the protocol was aimed at minimization of the risks to the study participants as well as the provision of the equitable selection of subjects. They also ensured the safety of the data and confidentiality as well as privacy observation. There was a signing of the informed consent documents as well as procedures.

Dr. James was the co-founder of the investigation and the main sponsor of the clinical trial. He was one of the leading gene therapy researchers in the world. Therefore he had some financial interests in the research trial. He had different patents of vectors that were used in gene transfer. He had the aim of increasing the stock for his company Genova Inc. and hoped to earn much. The financial interest was clearly stated in the consent form, making Jesse aware of his intentions.

The financial interest of Dr. James was not a problem in the research trial. The FDA had already investigated the disclosure statement and the effects of the financial interest study. It was monitored to ensure there was no bias in the clinical trial. The conflict of interest was evaluated, ensuring that there was no bias in the research trial (Turrens & Springer, 2019). There was a concern for Dr. James not to make unethical decisions with resources allocated in the implementation of ethical and academic researches.

There was no proper documentation of the death procedure for investigation of the study's financial intentions. The information on the consent form stated that the trial was designed towards the improvement of the patient experience and improvement of their wellbeing. However, the Canadian ethical guidelines state that the research should not be aimed at financial benefits or benefits from any kind of sponsor.

Jesse died from the body, eliminating the enzymes responsible for degrading the newborn (Resnik, 2018). This leads to the accumulation of ammonia in the bloodstream, causing severe damage to the brain. He has a metabolic disorder called ornithine transcarbamylase deficiency syndrome that is simply referred to as OTCD. It is a condition where ammonia builds up to some lethal levels in the blood. Those children born with the condition either die after birth or get brain damage. The mild version of Jesse was identified at his two years ago.

There were many shortcomings from the trial, from the way the professionals performed the trial as well as their true intentions. From the infusion, there was a serious change in the liver functions as well as the blood count; they experienced minor strokes and nausea. The investigators never informed the participants of the severe side effects of participating in the trial. The participants could be provided with every information and given a chance to quit the process in case they were not comfortable.

They investigated the cause of death of Jesse and the other participants and determined the conflict of interest from Dr. James in the trial. They identified that the researchers had not informed Jesse of any prior tests and the performance of the infusion (Resnik, 2018). However, Wilson denied the financial considerations affected the study and that it was not possible to predict the suffering for Jesse from the bad reactions. The family of Gelsinger was, however, sued, and Penn's settled the undisclosed sum taking responsibility for Jesse's death.

Conclusion

The death of Jesse could be prevented by the use of clear ethical guidelines in carrying out the trial. It is clear from the trial that the aspect of protocols was not provided in the clarity on the key issues such as the issue of eligibility.

To market the discoveries, there is a need to have financial attachments. Dr. Wilson and the family had a 30% equity stake while the UPenn had a 3.2% equity stake.

There is no problem in attaching financial interests in the trial (Turrens & Springer, 2019). However, the financial interests must be clearly stated and disclosed in the statement. The effects of the financial interests must be clearly stated, ensuring there is no bias. In the case of Dr. Wilson, there was no statement of the effects.

References

Ballyram, R. (2017). Research integrity and ethical biomedical research on humans (Doctoral dissertation, University of Pretoria).

Resnik, D. B. (2018). Research Integrity. The ethics of research with human subjects (pp. 235-256). Springer, Cham.

Turrens, J. F., & Springer, M. S. (2019). How to Train Undergraduates in Research Integrity and the Responsible Conduct of Research (Vol. 7). Council on Undergraduate Research.