Why Were NIH Adverse Event Reporting Guidelines Misunderstood?
The death of a patient in a gene therapy trial last October (see News, Jan. 19, p. 98) highlighted widespread confusion among investigators regarding adverse event reporting. In spite of the National Institutes of Health guidelines, many serious adverse events (SAEs) encountered over the last 7 years apparently were not reported to the Recombinant DNA Advisory Committee (RAC) when they occurred. In the months since the death threw a spotlight on clinical trials of gene therapy, the RAC has received a veritable blizzard of reports on SAEs, many of them years old. In February, Rep. Henry A. Waxman (D-Calif.) claimed that 94% of 691 gene therapy SAEs had not been reported to the RAC in a timely fashion. Retrospective reports are continuing to mount. From January through mid-April 2000, the committee received 780 gene therapy SAE reports, said Amy P. Patterson, M.D., director of NIH s Office of Biotechnology Activities, . . .
