Potential Conflict of Interest

During the RAC meeting, one of the committee’s greatest concerns was a potential conflict of interest. Among other financial involvements,

  • Immunologist Carl June at the University of Pennsylvania, who is a science adviser on the project, says that it could begin by the end of the year. June has ties to the pharmaceutical company Novartis, holds patents on T-cell technologies, and could stand to benefit from the success of this trial. June declined to give details on the exact nature of his conflicts of interest, but says that his university is taking steps to manage it, such as preventing him from being involved in selecting patients. Several RAC reviewers suggested that the University of Pennsylvania not be allowed to recruit patients at all and to leave it to other institutions: this language did not make it into their final approval.
  • However, the RAC members say they are being extra careful with this study. “Penn has a very extensive conflict and has a history,” says Laurie Zoloth, a bioethicist at Northwestern University in Evanston, Illinois. Looming over the discussion is the name Jesse Gelsinger, who died at age 18 while participating in an early gene-therapy trial conducted by researchers at the University of Pennsylvania in 1999.
  • A subsequent investigation found numerous problems with the study, including unreported animal data on the therapy’s ill effects and the fact that the investigators had a financial stake in the study’s outcome. The incident is generally considered to have set gene therapy back by decades. “Any first use in humans we have to be extraordinarily careful,” Zoloth says. So a lot is riding on this trial.
  • Mildred Cho, a bioethicist at Stanford University in California and an RAC member, says that safety work in animals for a new therapy will take researchers only so far. “Often we have to take the leap of faith.”