RESEARCHERS running gene therapy and xenotransplantation trials in the US
will have to make the details of their work public, according to rules proposed
by the Food and Drug Administration.
Critics have been calling for tighter regulations, especially after
18-year-old Jesse Gelsinger died during a gene therapy trial in 1999. But some
companies say the rules will hamper research.
Researchers will have to reveal the genes and methods they are using, for
example, and the results of preclinical studies. They will also have to report
all deaths and adverse reactions, even if the treatment was not to blame. The
FDA…
