Her plan is to study forensic psychology or, alternatively, to oversee recreational therapy in a nursing home, she said.
But the committee, set up by the National Institutes of Health to help oversee gene therapy clinical trials, raised questions about the process used to enroll the woman in the study.
Roughly half of all 300 gene therapy experiments that have been conducted in the United States have used retroviruses, said Dr. Philip Noguchi, the F.D.A. official who oversees gene therapy.
The company sought guidance last month from a National Institutes of Health panel, the Recombinant DNA Advisory Committee, which oversees gene therapy issues.
But both have drawn the attention of members of the Recombinant DNA Advisory Committee, the National Institutes of Health panel that oversees gene therapy research.
Dr. Philip Noguchi, the agency official who oversees gene therapy trials, described the rationale for the agency's decision.
At the same time, the health institutes office that oversees gene therapy has asked all scientists using adenovirus vectors to submit data relating to patient safety.
The Recombinant DNA Advisory Committee, a federal body that oversees gene therapy, called a meeting this June to debate how scientists planned to avoid these and other side effects.
The dispute over Gelsinger's treatment, aired in dueling news conferences, lent a bizarre, circuslike air to the first day of a three-day session of the Recombinant DNA Advisory Committee, the National Institutes of Health panel that oversees gene therapy research.
At the National Institutes of Health, officials are re-examining the role of the Recombinant DNA Advisory Committee, which oversees gene therapy research but lost much of its authority in a reorganization four years ago.
Gelsinger's acceptance into the study is one of "a number of different areas that we have concerns about," said Kathryn Zoon, director of the FDA's Center for Biologics Evaluation and Research, which oversees gene therapy.
