NIH Proposal Would Require More Disclosure of Trials
A National Institutes of Health committee yesterday proposed a plan that would "bee[f] up" the amount of information gene therapy researchers would have to submit to the NIH, the Wall Street Journal reports. The NIH's Recombinant DNA Advisory Committee voted 11-0 yesterday for a proposal that would require the "vast majority" of gene therapy researchers to report to the agency any "serious" and unexpected adverse events that occur during gene therapy research. Researchers also would have to submit annual reports on experiments, including such information as the doses being used, the number of patients enrolled and the experiment's status. The proposal also would create the NIH Gene Transfer Safety Assessment Board, a safety-monitoring panel that would review the information submitted by researchers and make it publicly available in all but "exceptional circumstances."
The idea for the proposal stems from concerns surrounding the 1999 death of Jesse Gelsinger, during a gene therapy experiment, as well as "subsequent revelations that researchers weren't properly reporting safety information to the NIH," the Wall Street Journal reports. According to Jon Gordon, advisory committee member and a professor at that Mount Sinai School of Medicine, publicizing information on gene therapy trials would allow for "the identification of risky trends" and would provide "a greater sense of comfort on the part of the public that nothing is being held back." The proposal will now go to NIH Acting Director Ruth Kirschstein for approval.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.