Members of the Recombinant DNA Advisory Committee (RAC), the federal group that publicly reviews gene transfer experiments, have met to discuss a death during a recent experiment, but the group provided no answers to key ethical questions raised by the tragedy.
Marcy Darnovsky, associate director of the Center for Genetics and Society, urged the RAC to promptly address the issue. The nonprofit organization urges responsible uses and oversight of human genetic and reproductive technologies.
The clinical trial, sponsored by Targeted Genetics of Seattle, was designed to test the safety of a gene transfer product for rheumatoid arthritis. A key issue raised by the death of Jolee Mohr, 36, is whether patients whose conditions are not life-threatening should be enrolled in gene transfer studies. Experts have not reached consensus on the matter.
Darnovsky called for a moratorium on enrolling some subjects in the experimental procedure.
“Until scientists have a better understanding of the deaths and the hundreds of serious adverse events that have been reported but not investigated, gene transfer studies should be limited to people with life-threatening conditions and no good alternatives,” she said.
Darnovsky is concerned about a critical aspect of the informed consent process accompanying clinical trials.
“Many patients would be astonished to learn that their own doctors are being paid to sign them up,” she said. “Some might well see this as a betrayal of trust. This sort of payment should not be allowed. Yet in this case, it was not even disclosed.”
A portion of the targeted genetics consent form suggests prospective subjects could expect medical benefits from their participation, but the goal of the stage of trials in this case was to determine safety. Mohr was apparently asked to sign the form immediately rather than taking it home for review.
Attributing Mohr’s death to the gene transfer procedure cannot be ruled out, said experts who testified at the RAC meeting earlier this week.
The RAC, which advises the National Institutes of Health, has adopted several recommendations about its role in the ongoing investigation of the direct cause of death. However, no plans for additional consideration about enrolling subjects not suffering from life-threatening conditions, or other ethical issues, were discussed.
