The fortunes of two controversial gene therapy researchers shifted in late January—one for the worse and one for the better. James Wilson was further sidelined in his role of director of the Institute for Gene Therapy at the University of Pennsylvania, while Tufts University researcher Jeffrey Isner seemed set to get by with a little help from his friends in re-starting at least one gene therapy trial.
The University of Pennsylvania has announced that, as part of its application to the FDA to restart experiments, it has revamped two gene therapy clinical trials and removed them from the purview of James Wilson and his troubled Institute.
Wilson was in charge of the fateful gene therapy trial that resulted in the 1999 death of Jesse Gelsinger (Nature Med.6, 6, 2000). The teenager died after being injected with genetically altered virus. That case led to the FDA to halt all trials at the Institute and triggered a major debate among researchers and regulators about gene therapy, financial conflicts of interest and patient protections. Wilson is currently facing FDA action that may lead to his being banned for life from clinical experimentation (Nature Med.7, 6, 2001).
The two trials about to restart—which involve treatments for lung cancer and mesothelioma—were among eight studies that the FDA shut down last year. Wilson will remain Institute director, but his program will instead concentrate on basic research, says University Provost Robert Barchi, adding "... that will be the case for the foreseeable future." Wilson remains a tenured professor.
Further north, a Boston area couple who are friends of Isner have donated $1 million to St. Elizabeth's Hospital specifically to support his work there. Isner has been allowed to resume one of three gene-therapy trials shut down by the FDA in February 1999. Like Wilson, Isner was charged last winter with failing to protect study participants. For example, the FDA said that he allowed a man with strong evidence of lung cancer into a study that excluded cancer patients. In November, the FDA granted Isner permission to resume one trial, and he says that he also expects to get the green light on the other two studies.
Isner says that he has received a letter from the FDA exonerating him of all charges, but he declined to release the letter at the advice of lawyer. An FDA spokeswoman told Nature Medicine that regulations preclude the agency from commenting on the case.
A proposed FDA rule would broaden public access to agency documents regarding the regulation of gene therapy and xenotransplantation studies.
