More Accountability Needed in Gene Therapy Deaths

public interest group has recently called for a moratorium on enrolling some patients in gene therapy studies.

The Recombinant DNA Advisory Committee (RAC), the U.S. body dedicated to publicly reviewing gene transfer experiments, met in September 2007 to discuss a recent death in an experiment, but offered no answers to important ethical questions raised by the tragedy.

Associate director of the Center for Genetics and Society (CGS; Oakland, CA, USA), Marcy Darnovsky, Ph.D., called on the RAC to take quick action to address these issues. "This is the only government body whose deliberations on gene transfer are in any way open to the public,” she pointed out. "If the RAC doesn't take action, these problems will disappear from the public's radar and the biotech companies' agendas.”

Sponsored by Targeted Genetics (Seattle, WA, USA), the clinical trial in question was designed to test the safety of a gene transfer product for rheumatoid arthritis. One major issue raised by the death of 36-year-old Jolee Mohr is whether patients whose conditions are not life threatening should be enrolled in gene transfer studies. Experts at the meeting disagreed on this point.

CGS's Dr. Darnovsky called for a moratorium on enrolling such subjects. "Gene transfer is an experimental procedure with significant risks,” she said. "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.”

Dr. Darnovsky also commented on one longstanding problem of the informed consent process that accompanies 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.”

Other departures from accepted "best practices” were raised at the meeting but not fully addressed. Some language in the Targeted Genetics consent form suggested that prospective subjects could expect medical benefits from their participation, although the goal of this stage of trials was to simply determine safety. Additionally, Ms. Mohr was asked to sign the consent form immediately rather than taking it home for further consideration.

According to experts who testified at the meeting, attribution of Ms. Mohr's death to the gene transfer procedure cannot be ruled out based on current information. The RAC, which advises the U.S. National Institutes of Health, 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.

The Center for Genetics and Society is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies.


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