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Jesse Gelsinger: a Case of Failed Clinical Gene Therapy

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Jesse Gelsinger: a Case of Failed Clinical Gene TherapyThe death of Jesse Gelsinger in September 1999 following a clinical gene therapy trial came as a shock, which rocked the medical field of research and prompted investigations of the actual cause of his death. His death became a warning to clinical trial participants and carried a strong message for the need of protecting clinical trial specimen. Jesse Gelsinger was diagnosed with uncommon metabolic disorder medically referred to as orinthine trascarbamlase deficiency (OTCD) (Obasogie, 2009; Stolberg, 1999). OTCD is a disorder characterized by inability of the body to break down ammonia and other toxic substances (Kelly, 2007). Gelsinger case was identified as a mild version of OTCD.

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Jesse got himself in clinical trial following the fact that his case was a special one which was identified to be a single-gene defect of the OTCD. Therefore, Gelsinger was the prime specimen for clinical gene therapy. Jesse’s enrolment into OTCD clinical trial was an altruistic act, because he knew the trial would be of no benefit to him (Obasogie, 2009).

Immediately after the Penn researchers injected Jesse with a replacement gene, his level of ammonia rose drastically. Shortly afterwards it was reported that Jesse was suffering from organ failure and brain damage, which made him comatose (Stolberg, 1999).  

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The concept of gene therapy is dated back to 1990s. Gene therapy is an embryonic system cell experiment, which alters the generic materials of the patient in order to prevent or fight genetic defects from further generational transmission. Although this is a very promising treatment and prevention option (especially for gene disorders), the technique is very risky (Kelly, 2007).

The growing minority of researchers is of great concern in the field of clinical gene experimentations. As evidenced with the death of Jesse, researchers often fail to adhere to clinical and medical ethics and standards stated in clinical manuals. For instance, the common clinical misconduct is information asymmetry, where researchers fail to disclose critical information to their clients (Garrett, 2000). Thus, clients often make uninformed decisions, which increase the risks of death. 

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