GENE THERAPY: Children Potentially Exposed to HIV, HCV
Researchers at Memphis, Tenn.-based St. Jude Children's Research Hospital discovered in December that they may have accidentally exposed children to two potentially lethal viruses, but waited until last week to inform federal regulators, the Washington Post reports. More than two dozen patients suffering from the brain cancer neuroblastoma, the second most common childhood malignancy, underwent a corrective gene therapy that may have been contaminated with AIDS virus HIV-1 and HCV, the virus that causes hepatitis C (Weiss/Nelson, 2/11). For almost three years, researchers at St. Jude and Baylor College of Medicine in Houston, Texas, have worked to develop a gene-altered therapy, encased in a weakened cold virus, adenovirus -- the same type of virus used in the therapy that killed UPenn volunteer Jesse Gelsinger (Stolberg, New York Times, 2/11). Last fall, Laura Bowman, the study's lead investigator at St. Jude, discovered that two recent volunteers had "received genetically engineered viruses that had not been processed correctly" (Washington Post, 2/11). Further examination showed that the company that had supplied the weakened viruses did not test properly for contamination risks. But Bowman said, "The chances they (the patients) got exposed to a virus with any chance of getting infected is infinitesimally small." The FDA is conducting additional testing, the results of which could be available late next week (Powers, Memphis Commercial Appeal, 2/11). Baylor spokesperson Claire Bassett said no contamination has been found in the six children treated at its facility. She said, "Everything that took place that the FDA has a concern about did take place at Memphis" (Associated Press, 2/11).
Failure to Report
Although the possible contamination was discovered in December, St. Jude did not report the incident to the FDA or to the patients or their parents. Bowman contacted the FDA only after testing had twice "indicated the presence of DNA from HIV and HCV." Bowman and Malcolm Brenner, who initiated the study at St. Jude and has continued to work at Baylor, decided to contact patient families after they found out that the Washington Post had learned of the problem. Brenner theorizes that if the samples are contaminated, it may be because they were "accidentally splashed" with HIV-infected blood or mixed with contaminated viruses. But officials say the "scare might prove to be a false alarm," as the tests "are extremely sensitive and prone to give 'false positive' results." Pending resolution of the problem, the study has been terminated. The event at St. Jude adds to the already questionable reporting practices of researchers conducting gene therapy experiments. Last month, the FDA closed facilities at the University of Pennsylvania and the NIH has uncovered "hundreds of deaths and other 'adverse events'" associated with gene therapy trials (Washington Post, 2/11).