As Gelsinger case ends, gene therapy suffers another blow

J Couzin, J Kaiser - 2005 - science.org
J Couzin, J Kaiser
2005science.org
Five years after 18-year-old Jesse Gelsinger died in a gene therapy experiment, the US
Department of Justice has reached a settlement with the researchers and with their
institutions. The department announced last week that the University of Pennsylvania (U.
Penn) will pay fines of $517,496, and Children's National Medical Center in Washington,
DC, will pay $514,622. The settlement also restricts the clinical research of the three
investigators.The Department of Justice alleged that toxic reactions in humans should have …
Five years after 18-year-old Jesse Gelsinger died in a gene therapy experiment, the US Department of Justice has reached a settlement with the researchers and with their institutions. The department announced last week that the University of Pennsylvania (U. Penn) will pay fines of $517,496, and Children's National Medical Center in Washington, DC, will pay $514,622. The settlement also restricts the clinical research of the three investigators.
The Department of Justice alleged that toxic reactions in humans should have halted the trial earlier and that the lead investigators misrepresented clinical findings to the study's overseers, such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). James Wilson of U. Penn, who had a financial interest in a company that stood to profit if the trial was successful, has agreed not to lead any FDA-regulated clinical trials for 5 years and be monitored for 3 years. Steven Raper of U. Penn and Mark Batshaw of Children's face less severe restrictions. Under the agreement, the scientists do not admit responsibility for Gelsinger's death.“Outrageous,” responds Gelsinger family attorney Alan Milstein, who said the family had hoped for a formal apology and the release of the clinical trial documents.
AAAS