Death of Jesse Gelsinger (1999) Conflicts of Interest Example
The first subject in a gene transfer clinical trial to die from a reaction to a recombinant viral vector. Jesse suffered from a deficiency of ornithine-transcarbamylase (OTC), a necessary enzyme, and enrolled in a Phase I dose-escalation trial at the University of Pennsylvania. The clinical trial involved the injection of an adenoviral vector containing the gene. Jesse died after receiving the injection.
Subsequent investigations found that the Principal Investigator was an inventor for the technology used in the trial and held equity in the start-up company to which the technology was licensed. This case brought significant attention to the issue of financial conflicts of interest in research. Additional information about financial conflict of interest can be found on the NIH Conflict of Interest (COI) Page (http://grants.nih.gov/grants/policy/coi/index.htm)