SKELETONS are still tumbling from the cupboard in the US as investigations
into gene therapy continue to find serious shortcomings.
The investigations began last autumn after teenager Jesse Gelsinger became
the first person to die from gene therapy, given to him at the University of
Pennsylvania in Philadelphia. It emerged in December that researchers had bent
the trial鈥檚 rules to get him accepted.
As officials from the US National Institutes of Health (NIH) cast their net
wider, they found other abuses. Researchers are supposed to report serious side
effects of gene therapy to the NIH鈥檚 Recombinant DNA Advisory Committee (RAC).
But last week, the officials announced that only 5 per cent of side effects
recorded across the country had reached the RAC
(see p 12). Worse, Jesse鈥檚
father, Paul, revealed that researchers downplayed the risks of gene therapy
when his son enrolled on the trial.
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In Britain, tougher safeguards have been designed to prevent these kinds of
events. The government鈥檚 Gene Therapy Advisory Group has absolute power. It
approves all trial protocols and consent forms and must be told of any side
effects.
This system is not infallible, but it removes some of the potential for
abuse. Ironically, the RAC used to have similar powers, but in 1997 it was
demoted to a mere advisory role because of the supposed administrative burden it
placed on researchers.
The NIH and FDA need to act now to restore confidence in gene therapy. One
simple way to do that would be to reinstate the old system. Power to the RAC, we
say.