Career
He was 18 years old. Gelsinger suffered from ornithine transcarbamylase deficiency, an X-linked genetic disease of the liver, the symptoms of which include an inability to metabolize ammonia – a byproduct of protein breakdown. The disease is usually fatal at birth, but Gelsinger had not inherited the disease. In his case it was apparently the result of a spontaneous genetic mutation after conception and as such was not as severe – some of his cells were normal, enabling him to survive on a restricted diet and special medications.
Gelsinger joined a clinical trial run by the University of Pennsylvania that aimed at developing a treatment for infants born with severe disease.
On September 13, 1999, Gelsinger was injected with an adenoviral vector carrying a corrected gene to test the safety of the procedure. He died four days later, September 17, at 2:30 pm, apparently having suffered a massive immune response triggered by the use of the viral vector used to transport the gene into his cells, leading to multiple organ failure and brain death.
A Food and Drug Administration (Food and Drug Administration) investigation concluded that the scientists involved in the trial, including the co-investigator Doctor James M. Wilson (Director of the Institute for Human Gene Therapy), broke several rules of conduct:
Inclusion of Gelsinger as a substitute for another volunteer who dropped out, despite Gelsinger"s having high ammonia levels that should have led to his exclusion from the trial;
Failure by the university to report that two patients had experienced serious side effects from the gene therapy;
Failure to disclose, in the informed-consent documentation, the deaths of monkeys given a similar treatment. The University of Pennsylvania later issued a rebuttal, but paid the parents an undisclosed amount in settlement.
Both Wilson and the University are reported to have had financial stakes in the research.
The Gelsinger case was a severe setback for scientists working in the field
