Monday, March 13, 2000
WASHINGTON - The hurricane that has engulfed gene therapy research
for the last five months isn't over yet, but signs have emerged from the Recombinant
DNA Advisory Committee (RAC), FDA, and Congress that the storm will not consume
the field. Regulators, researchers and politicians are pulling back from extreme
measures that were proposed in the immediate aftermath of Jessie Gelsinger's
death and revelations of widespread disregard for NIH reporting guidelines.
During their three-day meeting last week, members of the RAC
reiterated their hopes that gene therapy can make important contributions to
medicine and that reasonable measures can be taken to minimize risks to patients.
They also said that FDA should take the lead in regulating gene therapy.