Settlement reached in gene therapy death

	Tweet

The US scientist who ran a gene therapy study that ended with the death of an 18-year-old is barred from leading human research trials for five years under a settlement with the government, the Justice Department said on Wednesday.

Dr. James Wilson of the University of Pennsylvania also agreed to lecture and write about what he learned from the study, which was testing whether injections of an altered virus carrying healthy genes could cure a potentially fatal liver condition. Jesse Gelsinger died during the study, shortly after getting an injection.

His 1999 death, the only known fatality from gene therapy, shook the emerging research field. Some gene therapy trials were halted for months, and regulators promised closer monitoring to protect patients.

Government investigators said Wilson’s study should have been stopped earlier because of side effects.

The Justice Department charged Wilson and two other researchers with submitting false statements about the study to regulators, and with failing to obtain proper consent from people who volunteered to take part. The consent form did not disclose all possible side effects, the government said.

Wilson and the two other scientists, who agreed to lesser research restrictions to settle the government’s charges, admitted no wrongdoing and contend their conduct was legal and appropriate, the Justice Department statement said.

Wilson has not been involved in human research since January 2000. In a statement, he said he had focused in the last few years on designing ways to deliver gene therapy and genetic vaccines.

Reaching the settlement “means that I may continue to devote myself fully and without restriction to my laboratory research, and that I may conduct clinical research when it would be appropriate for scientific advancement,” Wilson said.

The University of Pennsylvania and the Children’s National Medical Center, also involved in the gene therapy experiment, agreed to pay more than $500,000 each to settle the government’s charges. Neither institution admitted wrongdoing, the Justice Department said.

“Over the last five years Penn has established what is now a national model for the conduct of research, including mandatory training of investigators and staff coupled with a comprehensive internal monitoring program for research volunteers,” the university said in a statement. 

RELATED STORIES:
First gene therapy human trial in the United States for a form of muscular dystrophy under way   Cheaper, more effective treatment of type 1 Gaucher disease possible   Genes, low iron tied to restless legs in kids   Genetic factors influence female infidelity   Scientists and physicians use genetic sequencing to identify and treat unknown disease   Developing Gene Therapy to Fight Blindness   Europe’s most common genetic disease is a liver disorder   Discovery of a new gene that stimulates the growth of natural bypasses   Disease genes that followed the Silk Road identified   Low-LDL gene quite common in African Americans   Asthma Not Determined by Genetics Alone   Treatment of Down Syndrome in Mice Restores Nerve Growth in Cerebellum

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]