In 2005, Jonathan Fishbein, then director of the NIH Office for Policy in Clinical Research Operations, alleged that the NIH-funded HIVNET 012 trial of nevirapine in Africa suffered from poor data collection, faulty record-keeping, and lax quality control. The drug was being evaluated as a low-cost way to prevent mother-to-child HIV transmission. Fishbein and other NIH employees said internal concerns were not disclosed to the Bush administration before a major initiative to subsidize nevirapine use in Africa, and Fishbein argued that NIH had become too invested in the trial’s favorable outcome to judge its reliability objectively.
The NIH attempted to terminate Fishbein, attributing the action to inadequate performance during a probationary period; Fishbein alleged retaliation for his complaints. That explanation was challenged by his recent recommendation for a cash performance bonus. He also raised allegations involving nevirapine testing on foster children and sexual harassment of female NIH staff. An independent Institute of Medicine review subsequently concluded that HIVNET 012’s methodology was sufficiently sound and that nevirapine was safe and effective for preventing mother-to-child HIV transmission. The episode nevertheless exposed weaknesses in clinical-trial oversight and federal whistleblower protections.
