Jesse Gelsinger

Ethical Shortcomings in the Jesse Gelsinger Case

Jesse Gelsinger was an 18-year-old male suffering from ornithine transcarbamoylase (OTC) deficiency. On Sept. 13, 1999, he participated in a gene therapy procedure during a clinical trial at the University of Pennsylvania (hereby University) seeking to correct the disorder in infants suffering from the disease who die in infancy. It was an altruistic gesture, as Jessie himself had his disease under control by limiting his diet to low protein foods and taking medicines, but he unselfishly wished to help infants inflicted with the disease. By September 17th, 1999 he died, succumbing to multiple organ failures due to a complication with the viral vector injected into his bloodstream to deliver

These ethical debates were numerous, but the most central to this case argue that firstly, there was a financial conflict of interest between the head researcher James Wilson and Genovo, the biotech company who stood to profit if the experiments worked. Furthermore, that researchers failed to obtain Jesse’s informed consent. Lastly, that the trial was not safe because of its lack of transparency with regulatory organizations, its selection of participants, and its inclusion of Jesse in the study itself due to his current health state. In this paper, I will discuss these three ethical considerations by providing background, arguments, and analysis from both the victim’s side and the researchers on each ethical question. I will then conclude with my thoughts on how this tragedy has actually provided some good, as it forced a hard look at gene therapy research and at the safety of the overall scientific protocol for trials, that it prompted a reexamination of the informed consent procedure, and led to

The Washington Post reported that after fact-checking interviews with Wilson and others involved, they found Genovo had contributed more than $4 million dollars per year to the University’s Institute for Human Gene Therapy; Wilson and his family owned 30% of the equity stake; the University had a 3.2% equity stake; and that many past and present employees of both the Institute and the University were shareholders as well (Steinbrook, 2008). Jesse’s parents argued that Wilson and the University’s role as potential financial benefactors potentially interfered with their judgment in conducting the trial (R. Wilson, 2010). In addition, it might have enticed the involved parties to conceal adverse events to shield themselves and protect the company and their financial interests (R. Wilson, 2010). The University and its researchers felt that they had already done their due diligence on this issue. In 1994, the University’s Conflict of Interest Standing Committee reviewed the case to help manage these potential conflicts (Steinbrook, 2008). Members met again on February 6th, 1995 to discuss their concerns that Wilson’s roles as both shareholder for Genovo and as researcher for the University would conflict and furthermore create problems with managing resources or administering ethical and academic policy (Steinbrook, 2008). In the minutes, two