“Their on-the-ground solution to the Nevirapine toxicity problem in Africa was to simply not monitor for safety,” says Farber. Dr. Smith realized the monumental implications of her findings, which jeopardized the mission-critical project to license Nevirapine to prevent maternal to child transmission of HIV. Dr. Smith therefore trod delicately. She concluded her report by stating “safety reporting did not follow DAIDS reporting requirements during the conduct of HIVNET 012. Safety conclusions from this trial should be very conservative.”
