Jesse Gelsinger

Jesse Gelsinger (18 June 1981 – 17 September 1999) was the first person publicly identified as having died in a clinical trial for gene therapy. 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 13 September 1999, Gelsinger was injected with an adenoviral vector carrying a corrected gene to test the safety of the procedure. He died four days later at the age of 18, on 17 September 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 co-investigator Dr. 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,^[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.^[4]

Notes

↑ "Institute for Human Gene Therapy Responds to FDA – Almanac Between Issues". Upenn.edu. 2000-02-14. Retrieved 2010-11-16.
↑ Greenberg, Daniel S. "Science for Sale. The Perils, Rewards, and Delusions of Campus Capitalism". Chicago: U. Chicago Press, 2007, 324pp., pages 104–106.
↑ "Don't Compromise Ethics in Human Experiments, Bioethics Expert Says". Law.virginia.edu. 2008-04-18. Retrieved 2010-11-16.
↑ "A History Lesson for Stem Cells". Sciencemag.org. 2009-05-08. Retrieved 2012-02-29.

External links

Another Chance For Gene Therapy?: http://www.wired.com/1999/10/another-chance-for-gene-therapy/
Paul Gelsinger, Jesse's father, tells of Jesse's death: http://www.guineapigzero.com/jesses-intent.html
On gene therapy and informed consent (2008 debate): http://blog.bioethics.net/2008/01/on-gene-therapy-and-informed-consent/#comments
BBC Horizon Trial and error – the rise and fall of genome therapy: http://www.bbc.co.uk/science/horizon/2003/trialerror.shtml
The Biotech Death of Jesse Gelsinger: http://www.nytimes.com/1999/11/28/magazine/the-biotech-death-of-jesse-gelsinger.html

Medical ethics cases

Assisted suicide	Betty and George Coumbias Dax Cowart Giovanni Nuvoli Sue Rodriguez Ramón Sampedro Piergiorgio Welby Jack Kevorkian

Euthanasia	Andrew Bedner Tony Bland Carol Carr Nancy Cruzan case Baby Doe Law Eluana Englaro June Hartley Robert Latimer Karen Ann Quinlan case Terri Schiavo case Gloria Taylor

Physician's opinion against patient wishes	Betancourt v. Trinitas Mordechai Dov Brody Lantz v. Coleman Tirhas Habtegiris Rom Houben Sun Hudson case Baby K Jesse Koochin Joseph Maraachli case Jahi McMath case Spiro Nikolouzos case Aruna Shanbaug case David Vetter

Informed consent to treatment	Ashley Treatment Gillick competence Marion's Case Schloendorff v. Society of New York Hospital Christiane Völling

Research	Albert Stevens Albert Kligman's dermatology experiments Deep sleep therapy Doctors' trial Guatemala syphilis experiment Henrietta Lacks Human radiation experiments J. Marion Sims Jesse Gelsinger Joseph Gilbert Hamilton Moore v. Regents of the University of California Surgery to try to improve mental health Medical Experimentation on Black Americans Milgram experiment Radioactive iodine experiments Skid Row Cancer Study Stanford prison experiment Plutonium injections Tuskegee syphilis experiment Willowbrook State School Greenberg v. Miami Children's Hospital Research Institute

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