GENE THERAPY: Exposure to AIDS, Hepatitis C Is Unlikely
"Faced with questions about whether more than two dozen childhood brain cancer patients may have been exposed to the viruses that cause AIDS and hepatitis C during a gene therapy experiment," scientists involved in the study said Saturday that the odds were "infinitesimally small" (Stolberg, New York Times, 2/12) Newspaper reports revealed that the FDA is investigating whether or not children dying from cancer were accidentally exposed to HIV during a gene-therapy experiment. But the FDA called the "initial contamination testing ... so tenuous that it would not have alarmed the children's families by telling them until confirmatory tests now under way settle the issue." Both St. Jude Children's Research Hospital in Memphis and Baylor College of Medicine in Houston, the two centers administering the experiment, notified the children's families (Neergard, AP/Philadelphia Inquirer, 2/12). The New York Times reports that Dr. Laura Bowman, a pediatric oncologist at St. Jude, said that if the therapy the patients received was contaminated, "it was probably contaminated by genetic snippets of virus, not whole virus particles that could cause an infection." Bowman added, "We doubt very much that it was really a virus. But obviously we are pursuing it."
Gene therapy research has been under intense scrutiny since the death of Jesse Gelsinger last September at the University of Pennsylvania. An internal investigation into the brain cancer matter revealed that St. Jude had not screened the master batch for the viruses that cause AIDS and hepatitis C, a requirement of the FDA. Bowman, however, noted that samples from the experiment tested "weakly positive," and experts cautioned that such tests are sensitive and "often give 'false positive'" results. Dr. Savio Woo, president of the American Society for Gene Therapy, a group that represents researchers, said, "I don't think this is real. But of course, we are going to have to wait for the tests" (Stolberg, 2/12).