WITH gene therapy researchers still reeling from the unexplained death of
18-year-old Jesse Gelsinger last September during a clinical trial, critics of
biotechnology are calling for an immediate moratorium on the use of some
techniques.
Jeremy Rifkin, an activist who sued the US National Institutes of Health in
1989 in an effort to stop the very first gene therapy trial, returned last week
to accuse its Recombinant DNA Advisory Committee (RAC) of failing to protect
patients. 鈥淵ou鈥檙e just getting around to asking questions that you should have
asked ten years ago,鈥� he said. Rifkin formally asked the committee to request
the Food and Drug Administration to halt all gene therapy trials using viruses,
except those involving patients with life-threatening diseases for which there
are no other treatments.
Stewart Newman, a biologist from New York Medical College who represents the
lobby group Council for Responsible Genetics, joined Rifkin in his call for a
partial moratorium. 鈥淪cience can go on under such circumstances. Useful data can
be gathered,鈥� Newman says. George Annas, a prominent bioethicist at Boston
University, also spoke last week of the need for a temporary moratorium to
regain the public trust.
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However, Nancy King, a member of the RAC from the University of North
Carolina, argues that although risks to patients must be minimised, 鈥渢hose risks
can be addressed on a basis that allows for more flexibility than a
尘辞谤补迟辞谤颈耻尘鈥�.
Other RAC members also see no need for a moratorium, but some institutions
are voluntarily suspending gene therapy trials. Beth Israel Deaconess Medical
Center in Boston, for example, has shut down a cancer trial and a haemophilia
trial to review the safety data. And the University of South Florida recently
shut down three gene therapy trials that used a lipid gene-carrying system after
another unexplained death during a similar trial last September at a different
university.
These voluntary efforts are being matched by a tightening of controls by the
FDA. Last week, the agency announced that researchers must now submit detailed
plans explaining how they will monitor each trial鈥檚 safety, and provide more
evidence that their viral preparations are free from contamination.