Jesse Gelsinger

Jesse Gelsinger

Jesse Gelsinger (June 18, 1981 - September 17, 1999) was the first person publicly identified as having died in a clinical trial for gene therapy. 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 the result of a genetic mutation and as such was not as severe - some of his cells were normal which enabled 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 (FDA) investigation concluded that the scientists involved in the trial, including the lead researcher Dr. James M. Wilson (U Penn), broke several rules of conduct:

  • Inclusion of Gelsinger as a substitute for another volunteer who dropped out, despite 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[1] but paid the parents an undisclosed amount in settlement. Both Wilson and the University are reported to have had financial stakes in the research.[2][3] The Gelsinger case was a severe setback for scientists working in the field.[citation needed]

Notes

  1. ^ "Institute for Human Gene Therapy Responds to FDA - Almanac Between Issues". Upenn.edu. 2/14/2000. http://www.upenn.edu/almanac/between/FDAresponse.html. Retrieved 2010-11-16. 
  2. ^ Greenberg, Daniel S. "Science for Sale. The Perils, Rewards, and Delusions of Campus Capitalism". Chicago: U. Chicago Press, 2007, 324pp., pages 104-106.
  3. ^ "Don't Compromise Ethics in Human Experiments, Bioethics Expert Says". Law.virginia.edu. 2008-04-18. http://www.law.virginia.edu/html/news/2008_spr/milstein.htm. Retrieved 2010-11-16. 

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