In 2005, Jonathan Fishbein, then director of the NIH Office for Policy in Clinical Research Operations, alleged that HIVNET 012—a NIH-funded African clinical trial of nevirapine to prevent mother-to-child HIV transmission—was compromised by poor data collection, faulty record-keeping, and inadequate quality control. Fishbein and other NIH employees argued that the agency had become too invested in the trial’s favorable result. Internal NIH documents reportedly showed that concerns existed before the Bush administration launched a major program to subsidize nevirapine in Africa, yet the administration was not notified of them.
The NIH subsequently sought to dismiss Fishbein, who claimed the action was retaliation for his complaints; the agency attributed it to poor performance during a probationary period. That explanation was challenged by his recent recommendation for a cash performance bonus. Fishbein also raised separate allegations involving testing on foster children and sexual harassment of female NIH staff, but the supplied record does not establish those claims. The Institute of Medicine later conducted an independent review and concluded that HIVNET 012’s methodology was sufficiently sound and that nevirapine was safe and effective for the stated use, leaving the episode as a dispute over research oversight, disclosure, and whistleblower protection rather than a proven invalid trial.
