BioCentury
ARTICLE | Politics, Policy & Law

Adverse publicity rattles gene therapy

November 8, 1999 8:00 AM UTC

WASHINGTON - Newspaper disclosures that the deaths of at least six gene therapy patients were not reported to the NIH has roiled the gene therapy community, casting researchers unhappily into the midst of a long-simmering dispute over the role and authority of NIH in the oversight of gene therapy research.

The publicity over the failure of investigators and sponsors to report deaths to NIH's Office of Recombinant DNA Activities (ORDA) and the Recombinant DNA Advisory Committee (RAC), as well as one instance in which an investigator asked NIH officials and RAC members to treat a reported death as confidential information, has provoked FDA to quickly revise its policies on sharing information with NIH. ...