Gene Therapy HIV Scare a False Alarm, FDA Testing Concludes

The Food and Drug Administration said Thursday that in-depth testing concluded that gene therapy given to a group of dying cancer patients was not contaminated with HIV or with the hepatitis C virus.

Newspapers last week reported that highly preliminary laboratory testing suggested an experiment at St. Jude Children’s Research Hospital in Memphis, Tenn., and Baylor College of Medicine in Houston might have exposed children to the viruses.

That lab test is prone to errors, the FDA said.

Most of the children, who had advanced cases of the nervous system cancer neuroblastoma, have died of their disease since the experiment. After the media reports, the hospitals tracked down survivors’ families to warn them.

The agency said it is still looking into the circumstances that led to the contamination scare, including apparent lapses in safety testing and record keeping at St. Jude and questions about whether federal officials were notified “promptly” of the potential problem as required by regulations.

Laura Bowman, leader of the gene therapy study, said last week that she first became aware of the possibility of contamination last fall. FDA officials said they weren’t informed of the possible problem until this month.

Separately, the University of Pennsylvania announced Thursday that the dean of its School of Medicine and founder of the school’s troubled Institute for Human Gene Therapy is leaving.

William N. Kelley built the gene therapy program from scratch into one of the largest and most prestigious in the country. The FDA shut the program in January after an investigation of a teenage patient’s death there revealed widespread violations of patient protection and record keeping rules.

University officials emphasized that Kelley’s departure as dean is unrelated to the gene therapy institute’s woes but was motivated by a need for a new financial leader.